Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Feb. 28, 2017 | Jun. 30, 2016 | |
Document And Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2016 | ||
Document Fiscal Year Focus | 2,016 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | CORT | ||
Entity Registrant Name | CORCEPT THERAPEUTICS INC | ||
Entity Central Index Key | 1,088,856 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well Known Seasoned Issuer | No | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Accelerated Filer | ||
Entity Public Float | $ 427,665,971 | ||
Entity Common Stock, Shares Outstanding | 112,942,391 |
BALANCE SHEETS
BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Current assets: | ||
Cash and cash equivalents | $ 51,536 | $ 40,435 |
Trade receivables, net of allowances | 9,860 | 6,221 |
Inventory | 2,329 | 1,682 |
Prepaid expenses and other current assets | 1,964 | 642 |
Total current assets | 65,689 | 48,980 |
Strategic inventory | 2,835 | 2,800 |
Property and equipment, net of accumulated depreciation | 205 | 98 |
Other assets | 24 | 24 |
Total assets | 68,753 | 51,902 |
Current liabilities: | ||
Accounts payable | 2,290 | 1,325 |
Accrued clinical expenses | 1,467 | 1,171 |
Other accrued liabilities | 8,953 | 3,257 |
Long-term obligation - current portion | 14,664 | 14,965 |
Deferred revenue | 0 | 158 |
Total current liabilities | 27,374 | 20,876 |
Long-term obligation, net of current portion | 0 | 12,528 |
Commitments (Note 11) | 0 | 0 |
Stockholders’ equity: | ||
Preferred stock, par value $0.001 per share, 10,000 shares authorized and no shares outstanding at December 31, 2016 and December 31, 2015 | ||
Common stock, par value $0.001 per share, 280,000 shares authorized and 112,710 and 109,642 shares issued and outstanding at December 31, 2016 and December 31, 2015, respectively | 113 | 110 |
Additional paid-in capital | 363,534 | 348,796 |
Accumulated deficit | (322,268) | (330,408) |
Total stockholders’ equity | 41,379 | 18,498 |
Total liabilities and stockholders’ equity | $ 68,753 | $ 51,902 |
BALANCE SHEETS (Parenthetical)
BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2016 | Dec. 31, 2015 |
Statement Of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 280,000,000 | 280,000,000 |
Common stock, shares issued | 112,710,000 | 109,642,000 |
Common stock, shares outstanding | 112,710,000 | 109,642,000 |
STATEMENTS OF COMPREHENSIVE INC
STATEMENTS OF COMPREHENSIVE INCOME (LOSS) - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Statement Of Income And Comprehensive Income [Abstract] | |||
Product revenue, net | $ 81,321 | $ 50,286 | $ 26,551 |
Operating expenses: | |||
Cost of sales | 2,058 | 1,361 | 882 |
Research and development | 23,844 | 15,419 | 18,372 |
Selling, general and administrative | 45,240 | 36,949 | 34,916 |
Total operating expenses | 71,142 | 53,729 | 54,170 |
Income (Loss) from operations | 10,179 | (3,443) | (27,619) |
Interest and other expense | (2,039) | (2,965) | (3,764) |
Net income (loss) and comprehensive income (loss) | $ 8,140 | $ (6,408) | $ (31,383) |
Basic and diluted net income (loss) per common share | $ 0.07 | $ (0.06) | $ (0.31) |
Weighted average shares outstanding used in computing net income (loss) per share | |||
Basic | 110,566 | 106,883 | 100,978 |
Diluted | 116,139 | 106,883 | 100,978 |
STATEMENTS OF STOCKHOLDERS EQUI
STATEMENTS OF STOCKHOLDERS EQUITY (DEFICIT) - USD ($) shares in Thousands, $ in Thousands | Total | Employees and Directors [Member] | Non-employee [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Additional Paid-in Capital [Member]Employees and Directors [Member] | Additional Paid-in Capital [Member]Non-employee [Member] | Accumulated Deficit [Member] |
Beginning Balance (in shares) at Dec. 31, 2013 | 99,849 | |||||||
Beginning Balance at Dec. 31, 2013 | $ 21,017 | $ 100 | $ 313,534 | $ (292,617) | ||||
Issuance of common stock upon exercise of options (in shares) | 1,381 | 1,381 | ||||||
Issuance of common stock upon exercise of options | $ 1,777 | $ 1 | 1,776 | |||||
Issuance of common stock upon exercise of warrants, net (in shares) | 165 | |||||||
Stock-based compensation | $ 4,731 | $ 470 | $ 4,731 | $ 470 | ||||
Net income (loss) and comprehensive income (loss) | (31,383) | (31,383) | ||||||
Ending Balance (in shares) at Dec. 31, 2014 | 101,395 | |||||||
Ending Balance at Dec. 31, 2014 | $ (3,388) | $ 101 | 320,511 | (324,000) | ||||
Issuance of common stock upon exercise of options (in shares) | 2,041 | 2,041 | ||||||
Issuance of common stock upon exercise of options | $ 5,193 | $ 3 | 5,190 | |||||
Issuance of common stock upon exercise of warrants, net (in shares) | 6,206 | |||||||
Issuance of common stock upon exercise of warrants, net | 17,088 | $ 6 | 17,082 | |||||
Stock-based compensation | 5,926 | 87 | 5,926 | 87 | ||||
Net income (loss) and comprehensive income (loss) | (6,408) | (6,408) | ||||||
Ending Balance (in shares) at Dec. 31, 2015 | 109,642 | |||||||
Ending Balance at Dec. 31, 2015 | $ 18,498 | $ 110 | 348,796 | (330,408) | ||||
Issuance of common stock upon exercise of options (in shares) | 3,068 | 3,068 | ||||||
Issuance of common stock upon exercise of options | $ 7,683 | $ 3 | 7,680 | |||||
Stock-based compensation | $ 7,002 | $ 56 | $ 7,002 | $ 56 | ||||
Net income (loss) and comprehensive income (loss) | 8,140 | 8,140 | ||||||
Ending Balance (in shares) at Dec. 31, 2016 | 112,710 | |||||||
Ending Balance at Dec. 31, 2016 | $ 41,379 | $ 113 | $ 363,534 | $ (322,268) |
STATEMENTS OF CASH FLOWS
STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Cash flows from operating activities: | |||
Net income (loss) | $ 8,140 | $ (6,408) | $ (31,383) |
Adjustments to reconcile net income (loss) to net cash generated from (used in) operations: | |||
Stock-based compensation | 7,058 | 6,013 | 5,201 |
Accretion of interest expense | 1,929 | 2,848 | 3,678 |
Amortization of debt financing costs | 21 | 22 | 29 |
Depreciation and amortization of property and equipment | 87 | 155 | 141 |
Changes in operating assets and liabilities: | |||
Trade receivables | (3,639) | (2,887) | (1,906) |
Inventory | (682) | 815 | 249 |
Prepaid expenses and other current assets | (1,322) | 799 | (531) |
Other assets | 0 | (7) | 10 |
Accounts payable | 965 | (561) | (495) |
Accrued clinical expenses | 296 | 835 | (2,952) |
Other accrued liabilities | 5,696 | 1,381 | 575 |
Deferred revenue | (158) | 125 | 8 |
Net cash provided by (used in) operating activities | 18,391 | 3,130 | (27,376) |
Cash flows from investing activities: | |||
Purchases of property and equipment | (194) | (17) | (174) |
Cash used in investing activities | (194) | (17) | (174) |
Cash flows from financing activities: | |||
Proceeds from exercise of warrants, net of issuance costs | 0 | 17,088 | 0 |
Proceeds from exercise of stock options, net of issuance costs | 7,683 | 5,193 | 1,777 |
Payments related to long-term obligation | (14,779) | (9,207) | (4,856) |
Net cash provided by (used in) financing activities | (7,096) | 13,074 | (3,079) |
Net increase (decrease) in cash and cash equivalents | 11,101 | 16,187 | (30,629) |
Cash and cash equivalents, at beginning of period | 40,435 | 24,248 | 54,877 |
Cash and cash equivalents, at end of period | $ 51,536 | $ 40,435 | $ 24,248 |
Basis of Presentation and Summa
Basis of Presentation and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2016 | |
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 Korlym ® . Basis of Presentation The financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). Use of Estimates The preparation of financial statements in conformity with U.S. 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 evaluate our estimates and assumptions on an ongoing basis, including those related to revenue recognition, sales returns, inventory, allowances for doubtful accounts, accrued liabilities including our bonus accrual, clinical trial accruals, stock-based compensation and the timing of payments with respect to our long-term capped royalty obligation, which determines our interest expense. We base our estimates on relevant experience and on other specific assumptions that we believe are reasonable. Fair Value Measurements We categorize financial instruments in a fair value hierarchy that prioritizes the information used to develop assumptions for measuring fair value. The fair value hierarchy gives the highest priority to quoted prices in active markets for identical assets or liabilities (Level 1 input), then to quoted prices in non-active markets or in active markets for similar assets or liabilities, inputs other than quoted prices that are observable for the asset or liability, and inputs that are not directly observable, but that are corroborated by observable market data for the asset or liability (Level 2 input), then the lowest priority to unobservable inputs, such as our own data about the assumptions that market participants would use in pricing an asset or liability (Level 3 input). Fair value is a market-based measurement and should therefore be based on the assumptions that third-party market participants would use in pricing the asset or liability. Cash and Cash Equivalents We consider all highly liquid investments purchased with maturities of three months or less from the date of purchase to be cash equivalents. Cash equivalents are carried at fair value as measured using Level 1 inputs, which approximates cost. As of December 31, 2016 and December 31, 2015, all of our funds were held in checking and money market fund accounts maintained at major U.S. financial institutions. Credit and Concentration Risks Our cash and cash equivalents are held in one financial institution. We are exposed to credit and concentration risks in the event of default by the financial institution holding our funds and investments or by the entity or entities that issued the securities held by the funds to the extent of the amount recorded on our balance sheet. We mitigate these risks by investing in money market funds that invest primarily in short-term U.S. Treasury notes and bills. We have never experienced a loss or lack of access to our operating or investment accounts. Among other services, Dohmen Life Science Services (“Dohmen”), a specialty pharmacy, dispenses Korlym to patients for us, with title to the medicine passing from us to the patient upon the patient’s receipt of the drug. Accordingly, our receivables risk is spread among various third-party payors – pharmacy benefit managers, insurance companies, private charities, government programs – and individual patients. We extend credit to third-party payors 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. We have a concentration of risk in regard to the manufacture and distribution of our product. As of December 31, 2016, we had one tablet manufacturer for Korlym – Alcami Corporation (formerly known as AAI Pharma Services Corp.). In addition, we have a single-source manufacturer of mifepristone, the active pharmaceutical ingredient (API), in Korlym – Produits Chimiques Auxiliaires et de Synthèse SA (PCAS). If either of these companies is unable to manufacture API or Korlym tablets in the quantities and time frame required, we may not be able to manufacture our product in a timely manner. In order to mitigate these risks related to the manufacture of our product, we purchased and hold in inventory additional quantities of mifepristone API and Korlym tablets. Dohmen is our sole specialty pharmacy. Its unwillingness or inability to dispense Korlym to patients in a timely manner would harm our business. Inventory We value our inventories at the lower of cost or net realizable value. We determine the cost of inventory 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 disposed of and the related costs are recognized as cost of sales in the statement of comprehensive income (loss) in that period. Inventory amounts that are not expected to be consumed within 12 months following the balance sheet date are classified as strategic inventory, a noncurrent asset. We expense the manufacturing costs for product candidates incurred prior to regulatory approval as research and development expense as we incur them. We begin capitalizing costs related to the manufacture of a product candidate when we obtain regulatory approval to begin marketing that product. Long-term Obligation In August 2012, we entered into a Purchase and Sale Agreement (Financing Agreement) with Biopharma Secured Debt Fund II Sub, S.à r.l (Biopharma), a private limited liability company organized under the laws of Luxembourg. Under the terms of the Financing Agreement, we received $30.0 million from Biopharma, which upon receipt we recorded as a long-term obligation. In return, we are obligated to make payments to Biopharma totaling $45.0 million. These payments equal a percentage of (i) our net product sales, which include sales from any product containing mifepristone or any of our proprietary selective cortisol modulators (Covered Products), and (ii) cash or cash equivalents received from any licensing transaction or co-promotion arrangement involving Covered Products, including any upfront or milestone payments, if any (together, Korlym Receipts). Once we have paid Biopharma a total of $45.0 million, no more payments will be due and the obligation will be extinguished. We recognize a portion of each quarterly payment under the Financing Agreement as interest expense, which we determine by calculating the interest rate to Biopharma implied by the stream of quarterly payments we expect to make. The amount shown on our balance sheet as the current portion is an estimate of the amount we expect to repay Biopharma within the 12 months following December 31, 2016. We record the balance of the outstanding portion of the obligation, if any, as a long-term liability. Our estimate of the amount and timing of our quarterly payments to Biopharma is subject to uncertainty and may change. Any changes in our assumed payment stream will change the accretion of interest expense and our split between the current and long-term portions of the obligation, although the total we will pay Biopharma is fixed at $45.0 million. See Note 5, Long-Term Obligation Net Product Sales We primarily sell Korlym directly to patients through Dohmen, a specialty pharmacy. Prior authorization and confirmation of coverage by the patients’ private or government insurance plan or by a third-party charity is a prerequisite for Dohmen to ship Korlym to a patient. We recognize revenue upon the delivery of Korlym to these patients. We recognize revenue from sales of Korlym upon delivery to patients as long as (i) there is persuasive evidence that an arrangement exists between ourselves and the customer, (ii) collectability is reasonably assured and (iii) the price is fixed or determinable. Prior authorization or confirmation of coverage level by the patient’s private insurance plan or government payor is a prerequisite to the shipment of Korlym to a patient. In order to conclude that the price is fixed or determinable, we must be able to (i) calculate gross product revenues from the sales to our customers and (ii) reasonably estimate net product revenues. Effective January 1, 2016, we recognize sales to our specialty distributor (SD) at the time of sale to the SD. Before that date, we did not recognize these sales until the SD had in turn sold to its customers. Sales to the SD were less than two percent of our revenue in the year ended December 31, 2016. We donate cash to the National Organization for Rare Disorders (“NORD”), an independent non-profit organization that helps patients with financial need pay for the treatment of Cushing syndrome. We do not include in revenue payments we receive from NORD. We calculate gross product revenues based on the price we charge our customers. We estimate our net product revenues by deducting from our gross product revenues (a) estimated government rebates and chargebacks, (b) estimated costs of our patient co-pay assistance program, (c) trade allowances, such as discounts for prompt payment and (d) reserves for expected product returns. We initially record estimates for these deductions at the time we recognize the gross revenue. We update our estimates as new information becomes available. Rebates and Chargebacks: We contract with Medicaid and other government agencies so that Korlym will be eligible for purchase by, or qualify for partial or full reimbursement from, Medicaid and other government programs. We estimate our rebate and chargeback amounts by applying the discount rates applicable to each government-funded program against our sales to patients covered by such programs. Our reserve activity for doubtful accounts, prompt pay cash discounts and chargebacks is summarized as follows: Balance at Beginning of Period Charges Deductions Balance at End of Period (in thousands) Year ended December 31, 2015: Accounts receivable allowances $ 12,543 $ 45,401 $ (39,609 ) $ 18,335 Year ended December 31, 2016: Accounts receivable allowances $ 18,335 $ 2,081,419 $ (1,749,074 ) $ 350,680 There were no material changes in reserve estimates relating to prior periods. Allowances for Patient Assistance Program: We provide financial assistance to eligible patients whose insurance policies require them to pay high deductibles and co-payments. We calculate the cost of assistance by applying our program guidelines to the eligible sales in the period. Sales Returns : We estimate the amount of Korlym that we believe will be returned and deduct that estimated amount from gross revenue at the time we recognize such revenue. When estimating future returns, we analyze quantitative and qualitative information including, but not limited to, actual return rates, the amount of product in the distribution channel, the expected shelf life of such product, current and projected product demand, the introduction of competing products that may erode demand, and broad economic and industry-wide indicators. If we cannot reasonably estimate product returns with respect to a particular sale, we defer recognition of revenue from that sale until we can make a reasonable estimate. Research and Development Research and development expenses consist of direct expenses, such as the cost of discovery research, pre-clinical studies, and clinical trials relating to our portfolio of proprietary, selective cortisol modulators, manufacturing development, preparations for submissions to the FDA or other regulatory agencies and related overhead expenses. We expense nonrefundable payments to third-parties as well as the cost of technologies and materials used in research and development as they are incurred. We base our cost accruals for research, preclinical activities, and clinical trials on estimates of work completed under service agreements, milestones achieved, patient enrollment and past experience with similar contracts. Our estimates of work completed and associated cost accruals include our assessments of information from third-party contract research organizations and the overall status of clinical trial and other development and administrative activities. Segment Reporting We determine our operating segments based on the way we organize our business to make operating 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 related to option grants under the fair value method, based on the value of the award at the grant date using the Black-Scholes option valuation model and we recognize expense over the requisite service period, net of estimated forfeitures. Employee stock-based compensation expense is calculated based on awards ultimately expected to vest and is reduced for estimated forfeitures. Forfeitures are revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates and an adjustment to stock-based compensation expense will be recognized at that time. We recognize the expense of options granted to non-employees based on the fair-value based measurement of the option grants at the time of vesting. Recently Issued Accounting Pronouncement In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-09, “Revenue from Contracts with Customers.” The standard states that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. In August 2015, the FASB issued ASU No. 2015-14, “Revenue from Contracts with Customers: Deferral of the Effective Date,” which deferred the effective date of ASU No. 2014-09. ASU No. 2014-09 will now be effective for us beginning January 1, 2018 and can be adopted on a full retrospective basis or on a modified retrospective basis. Early application is permitted in 2017. In March 2016, the FASB issued ASU No. 2016-08, “Revenue from Contracts with Customers (Topic 606): Principal versus Agent Considerations,” which clarifies the implementation guidance on principal versus agent considerations. In April 2016, the FASB issued ASU No. 2016-10, “Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing,” which clarifies certain aspects of identifying performance obligations and licensing implementation guidance. In May 2016, the FASB issued ASU No. 2016-12, “Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients,” related to disclosures of remaining performance obligations, as well as other amendments to guidance on collectability, non-cash consideration and the presentation of sales and other similar taxes collected from customers. We plan to adopt the accounting standard update using the modified retrospective approach, with the cumulative effect of adopting the update being recorded to our retained earnings on January 1, 2018. At present, we have only one source of revenue: the sale of Korlym to our customers. Our evaluation of the customer contracts governing these sales is still underway. Because each of our arrangements contain variable consideration, we have focused our analysis on how the update will affect our estimate of the transaction price. We are also reviewing our financial policies, procedures and controls and at the time we adopt the update will make appropriate changes to them. We have not completed our assessment of the adoption on our financial statements. In August 2014, the FASB issued ASU No. 2014-15 (Subtopic 205-40), “Presentation of Financial Statements—Going Concern: Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern” (“ASU 2014-15”), which provides guidance about management's responsibility to evaluate whether or not there is substantial doubt about the Company's ability to continue as a going concern and to provide related footnote disclosure. ASU 2014-15 is effective for fiscal years, and interim periods within those fiscal years, ending after December 15, 2016. The adoption of this standard had no impact on our Financial Statements as we have generated positive cash flow in the years ended December 31, 2015 and 2016 and expect to generate positive cash flow in the year ended December 31, 2017. In April 2015, the FASB issued ASU No. 2015-03, Simplifying the Presentation of Debt Issuance Costs (ASU 2015-03), which requires an entity to present such costs in the balance sheet as a direct deduction from the related debt liability rather than as an asset. Amortization of the costs will continue to be reported as interest expense. ASU 2015-03 is effective for fiscal years beginning after December 15, 2015 and interim periods within those fiscal years, with early adoption permitted. The new guidance will be applied retrospectively to each prior period presented. We retrospectively adopted ASU 2015-03 as of January 1, 2016, resulting in a $35,000 decrease to long-term assets and long-term debt as of December 31, 2015 on its balance sheets. The adoption of this standard had no impact on our Statement of Comprehensive Income (Loss). In July 2015, the FASB issued ASU No. 2015-11, Simplifying the Measurement of Inventory (ASU 2015-11), which simplifies the measurement of inventory by requiring certain inventory to be measured at the lower of cost or net realizable value. The amendments in this ASU are effective for fiscal years beginning after December 15, 2016 and for interim periods therein, with early adoption permitted. We plan to adopt this new standard on January 1, 2017, and do not expect this to have a material impact on our Financial Statements. In November 2015, the FASB issued ASU No. 2015-17 (ASU 2015-17) "Balance Sheet Classification of Deferred Taxes." ASU 2015-17 requires that deferred tax liabilities and assets be classified as noncurrent on the balance sheet. Previous guidance required deferred tax liabilities and assets to be separated into current and noncurrent amounts on the balance sheet. The guidance will become effective for us beginning in the first quarter of 2017 and may be applied either prospectively or retrospectively. We plan to adopt this new standard on January 1, 2017. At the time of adoption, we will reclassify current deferred tax amounts on our Balance Sheets as noncurrent. As we have a full valuation allowance against its deferred tax assets for all periods presented, the adoption is not expected to have a material impact on our Financial Statements. In February 2016, the FASB issued ASU No. 2016-02, “Leases” (ASU 2016-02), which increases transparency and comparability among organizations by recognizing all lease transactions (with terms in excess of 12 months) on the balance sheet as a lease liability and a right-of-use asset (as defined). ASU 2016-02 is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years, with earlier application permitted. Upon adoption, the lessee will apply the new standard retrospectively to all periods presented or retrospectively using a cumulative effect adjustment in the year of adoption. We plan to adopt this new standard prospectively on January 1, 2019. We are evaluating the impact of the adoption of this standard on our Financial Statements. We expect that it will increase our lease assets and correspondingly increase our lease liabilities. In March 2016, the FASB issued ASU No. 2016-09, Compensation - Stock Compensation (Topic 718) “Improvements to Employee Share-Based Payment Accounting” (ASU 2016-09), which is intended to simplify several aspects of the accounting for share-based payment award transactions, including the income tax consequences , an option to recognize gross stock compensation expense with actual forfeitures recognized as they occur, as well as certain classifications on the statement of cash flows 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 addresses eight specific cash flow issues with the objective of reducing the existing diversity in practice. The guidance will be effective for the fiscal year beginning after December 15, 2017, including interim periods within that year. We plan to adopt this new standard on January 1, 2018, and do not expect it to have a material impact on our Financial Statements. |
Significant Agreements
Significant Agreements | 12 Months Ended |
Dec. 31, 2016 | |
Significant Agreements Disclosure [Abstract] | |
Significant Agreements | 2. Significant Agreements Commercial Agreements In May 2013, we entered into a services agreement with Dohmen to provide exclusive specialty pharmacy and patient services programs for Korlym beginning July 1, 2013. Under the terms of this agreement, Dohmen acts as the exclusive specialty pharmacy distributor of Korlym in the United States, subject to certain exceptions. Among other services, Dohmen 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 Dohmen, which it dispenses to patients. Dohmen does not take title to the product, which passes directly from us to the patient at the time the patient receives the medicine. The initial term of the agreement is a period of three years, with successive automatic renewal terms of three years unless either party gives at least 180 days’ prior notice of non-renewal. The agreement contains customary termination provisions, representations, warranties and covenants. Subject to certain limitations, we have agreed to indemnify Dohmen 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 Active Pharmaceutical Ingredient In March 2014, we entered into a new long-term manufacturing and supply agreement with PCAS for the manufacture of mifepristone, the active pharmaceutical ingredient (API) in Korlym. We have agreed to purchase a minimum percentage of our mifepristone requirements from PCAS; the amount of the commitment will depend on our future needs. The initial term of the agreement is five years, with an automatic extension of one year unless either party gives 12 months’ prior written notice that it does not want an extension. We have the right to terminate the agreement if PCAS is unable to manufacture the product for a consecutive nine-month period. Tablet Manufacture In April 2014, we entered into a new manufacturing agreement with Alcami Corporation for the manufacture and package of Korlym tablets. The initial term of this agreement is a period of three years, with consecutive automatic extensions of two years unless either party gives written notice – in the case of Alcami Corporation, 18 months prior to the end of the applicable term, and in our case 12 months prior to the end of the applicable term – that it does not want such an extension. We have the right to terminate the agreement if Alcami Corporation is unable to manufacture the product for a consecutive four-month period or if the product is withdrawn from the market. There are no minimum purchase obligations under this agreement. Research and Development Agreements In 1999, we entered into an agreement with The Board of Trustees of Leland Stanford Junior University (Stanford) in which Stanford granted us an exclusive license to patents covering the use of glucocorticoid receptor antagonists for the treatment of psychotic depression, early dementia, and cocaine-induced psychosis, as specified in the license agreement. This license agreement expires upon the expiration of the related patents or upon notification by us to Stanford. In exchange for the license, we paid Stanford an initial non-refundable fee, immediately issued 30,000 shares of our common stock to Stanford and are obligated to pay Stanford $50,000 per year as a nonrefundable royalty payment. In addition, we are obligated to pay additional milestone payments in the future, which are not material and a portion of which are creditable against future royalties and will pay a royalty based on net revenue generated by any product arising from the patent until its expiration. We have also exclusively licensed from the University of Chicago two issued U.S. patents for the use of cortisol modulators in the treatment of triple-negative breast cancer and a second patent family with applications in the United States and Europe having claims directed to the use of cortisol modulators to treat castration-resistant prostate cancer. In exchange for these licenses, we paid initial non-refundable fees to the University of Chicago and are committed to additional annual and milestone payments in the future, which are not material and which are creditable against future royalties. We will also pay royalties based on net revenue generated by any product arising from these patents until their expiration. In January 2016, we entered into an agreement with Chiltern to assist in the management of a clinical trial evaluating CORT125134 for treatment of Cushing syndrome. The total commitment under this agreement is $2.1 million, but the actual amount to be paid is dependent on actual services provided under this agreement. Approximately $741,000 of the costs under this agreement were incurred through December 31, 2016, with the remainder to be incurred over the course of the trial. In March 2014, we entered into an agreement with Quotient Clinical Limited (“Quotient”), a clinical research organization, to assist in the management and conduct of our Phase 1 study of CORT125134, our lead selective cortisol modulator. The total commitment under the agreement was approximately $3.0 million. All of the costs under this agreement were incurred through December 31, 2016. In September 2016, we entered into an agreement with Quotient to assist in the management and conduct of our Phase 1 study of CORT122928, a selective cortisol modulator. The total commitment under the agreement was approximately $2.2 million, which is expected to be expended over an approximately two-year period. Approximately $0.1 million of the costs under this agreement were incurred through December 31, 2016. In December 2016, we entered into an agreement with Quotient to assist in the management and conduct of our Phase 1 study of CORT118335, a selective cortisol modulator. The total commitment under the agreement was approximately $2.2 million, which is expected to be expended over an approximately one-year period. No costs under this agreement were incurred through December 31, 2016. |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 12 Months Ended |
Dec. 31, 2016 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Instruments | 3. Fair Value of Financial Instruments As of December 31, 2016 and 2015, we had invested our financial assets in a money market fund that can be converted to cash at par on demand. We measured these funds, which totaled $31.6 million as of both December 31, 2016 and 2015, at fair value, which approximates cost, as of the respective dates and classified them as Level 1 assets in the fair value hierarchy for financial assets. All cash equivalents and short-term investments held as of December 31, 2016 and 2015 were in active markets and valued based upon their quoted prices. We did not recognize any realized gains or losses on sales of investments for any period presented. |
Composition of Certain Balance
Composition of Certain Balance Sheet Items | 12 Months Ended |
Dec. 31, 2016 | |
Balance Sheet Related Disclosures [Abstract] | |
Composition of Certain Balance Sheet Items | 4. Composition of Certain Balance Sheet Items Inventory The composition of inventory was as follows: December 31, 2016 2015 (in thousands) Raw materials $ 1,848 $ 2,141 Work in progress 1,414 3 Finished goods 1,902 2,338 Total inventory 5,164 4,482 Less strategic inventory classified as non-current (2,835 ) (2,800 ) Total inventory classified as current $ 2,329 $ 1,682 In order to be prepared for potential demand for Korlym and because we have single-source manufacturers of both the API for Korlym and Korlym tablets, we have invested in inventory of both of these materials. Inventory amounts that are not expected to be consumed within 12 months following the balance sheet date are referred to as “Strategic Inventory” and classified as a noncurrent asset. Property and Equipment Property and equipment consisted of the following: December 31, 2016 2015 (in thousands) Furniture and equipment $ 300 $ 270 Software 351 193 Leasehold improvements 6 — 657 463 Less: accumulated depreciation (452 ) (365 ) $ 205 $ 98 Other Accrued Liabilities Other accrued liabilities consisted of the following: December 31, 2016 2015 (in thousands) Government rebates $ 3,426 $ 1,663 Accrued compensation 4,702 1,103 Commercialization costs 308 111 Legal fees 164 69 Professional fees 34 220 Other 319 91 Total other accrued liabilities $ 8,953 $ 3,257 |
Long-Term Obligation
Long-Term Obligation | 12 Months Ended |
Dec. 31, 2016 | |
Debt Disclosure [Abstract] | |
Long-Term Obligation | 5. Long-Term Obligation As discussed in Note 1, Basis of Presentation and Summary of Significant Accounting Policies – Long-term Obligation Under the terms of the Financing Agreement, our payments are variable, with no fixed minimums. If there are no net sales, upfront, milestone or other contingent payments in a period with respect to Covered Products, then no payment will be due for that period. We are obligated to make future payments as follows: • 20 percent of our net product sales of Covered Products. • 20 percent of payments received for upfront, milestone or other contingent fees under co-promotion and out-license agreements for Covered Products. • The percentage used to calculate our payments to Biopharma would increase to 50 percent and any applicable payment caps would lapse if we (i) fail to provide Biopharma with certain information regarding our promotion and sales of Covered Products, (ii) do not devote a commercially reasonable amount of resources to the promotion and marketing of the Covered Products or (iii) violate the indebtedness covenant by incurring indebtedness greater than the sum of earnings before interest, taxes, depreciation and amortization, including such items as non-cash stock-based compensation, for the four calendar quarters preceding such incurrence and, in each case, fail to cure within the applicable cure period. • Upon the occurrence of a Corcept change of control transaction or the licensing of Korlym to a third-party for promotion and sale in the United States, the entire $45.0 million, less any amounts already paid by us, would become due. To secure our obligations in connection with the Financing Agreement, we granted Biopharma a security interest in our rights in patents, trademarks, trade names, domain names, copyrights, know-how and regulatory approvals related to the Covered Products, all books and records relating to the foregoing and all proceeds of the foregoing (together, the Collateral). If we (i) fail to deliver a royalty payment when due and do not remedy that failure within 30 days, (ii) fail to maintain a first-priority perfected security interest in the Collateral in the United States and do not remedy that failure within five business days of receiving notice of such failure or (iii) become subject to an event of bankruptcy, then Biopharma may attempt to recover up to $45.0 million (after deducting any payments we have already made). In addition, pursuant to this agreement, we are not allowed to pay a dividend or other cash distribution, unless we will have cash and cash equivalents in excess of $50.0 million after such payment. As discussed in Note 1, Basis of Presentation and Summary of Significant Accounting Policies, Long-term Obligation . We recorded interest expense of $1.9 million and $2.8 million for the years ended December 31, 2016 and 2015, respectively, and total interest of $14.5 million for the period from August 2012 through December 31, 2016 . The following table provides a summary of the payment obligations under the Financing Agreement as of December 31, 2016 and 2015, utilizing the payment assumptions discussed above. December 31, 2016 2015 (in thousands) Total repayment obligation $ 45,000 $ 45,000 Less interest in future periods (456 ) (2,385 ) Less unamortized financing costs (14 ) (35 ) Less payments made (29,866 ) (15,087 ) Less current portion (14,664 ) (14,965 ) Long-term obligation, net of current portion $ — $ 12,528 The estimated fair value of the long-term obligation, as measured using Level 3 inputs, approximates the carrying amounts as presented on the balance sheet as of December 31, 2016 and 2015. The estimated fair value was calculated using the income method of valuation. The key assumptions required for the calculation were an estimate of the amount and timing of future product sales and an estimated cost of capital. We capitalized $140,000 of issuance costs related to the Financing Agreement, which are being amortized over the estimated term of the obligation, based on the assumptions discussed above. At December 31, 2016 and 2015, the unamortized issuance costs were $14,000, and $35,000, and are included in long-term obligation, netted against debt on our balance sheets, pursuant to ASU 2015-03 |
Lease Obligation
Lease Obligation | 12 Months Ended |
Dec. 31, 2016 | |
Leases [Abstract] | |
Lease Obligations | 6. Lease Obligations In July 2015, we exercised our option to extend the lease for our office space through December 2016. We subsequently amended the lease agreement in February 2016 to extend the lease through 2019 and to add additional space. In March 2016, we early terminated the lease and replaced it with a new lease effective May 1, 2016 through March 31, 2019. Rent expense for the years ended December 31, 2016, 2015 and 2014 was $885,000, $678,000, and $609,000, respectively. As of December 31, 2016, future minimum lease payments under non-cancelable operating leases were as follows: Lease Payments 2017 937 2018 1,115 2019 279 Thereafter — Total $ 2,331 |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2016 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 7. Related Party Transactions See discussion below in Note 8, Preferred Stock and Stockholders’ Equity Common Stock |
Preferred Stock and Stockholder
Preferred Stock and Stockholders' Equity | 12 Months Ended |
Dec. 31, 2016 | |
Equity [Abstract] | |
Preferred Stock and Stockholders' Equity | 8. 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, 2016 and 2015, we had no outstanding shares of preferred stock. Common Stock Significant stock transactions We issued approximately 6.2 million shares of our common stock in March 2015, upon the exercise of warrants that had been issued in two private placement transactions, one in 2008 and the other in 2012, to qualified investors, including members of our board of directors and their affiliates. The transactions generated aggregate net proceeds of approximately $17.1 million, after the deduction of issuance costs. Approximately 3.1 million shares of the securities, which generated aggregate gross proceeds of $5.9 million, were issued in these transactions to venture capital funds, trusts and other entities affiliated with members of our Board of Directors. We also issued 164,666 shares of common stock related to the exercise of a warrant in May 2014 that had been issued in the 2008 private placement. This warrant was exercised on a cashless net-exercise basis, wherein an unaffiliated investor surrendered a warrant for 529,567 shares in exchange for the issuance of 164,666 shares of common stock. We have never declared or paid any dividends. Shares of common stock reserved for future issuance as of December 31, 2016 are as follows: Common stock: (in thousands) Exercise of outstanding options 17,663 Shares available for grant under stock option plans 7,920 25,583 On February 10, 2017, our Board of Directors authorized an additional increase of 4.5 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, 2016. Stock Option Plans We have two active stock option plans at December 31, 2016 – 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 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 expect the vesting period of the options that we grant under the 2012 Plan to be generally equivalent to the requisite service period. Upon exercise of options, new shares are issued. On February 26, 2016, our Board of Directors authorized an increase of 4.4 million shares in the number of shares available under the 2012 Plan, which was equivalent to 4% of the shares of our common stock outstanding as of December 31, 2015, pursuant to the terms of the 2012 Plan. Option activity during 2014, 2015 and 2016 The following table summarizes all stock plan activity: 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 (in (in years) (in Balance at December 31, 2013 4,926 14,712 $ 2.63 Increase in shares authorized for grant 3,993 — — Shares granted (2,140 ) 2,140 $ 2.62 Shares exercised — (1,381 ) $ 1.34 Shares cancelled and forfeited 767 (767 ) $ 5.03 Balance at December 31, 2014 7,546 14,704 $ 2.62 Increase in shares authorized for grant 4,056 — Shares granted (4,902 ) 4,902 $ 3.88 Shares exercised — (2,041 ) $ 2.55 Shares cancelled and forfeited 1,370 (1,370 ) $ 3.07 Balance at December 31, 2015 8,070 16,195 $ 2.98 Increase in shares authorized for grant 4,386 — Shares granted (5,906 ) 5,906 $ 4.92 Shares exercised — (3,068 ) $ 2.50 Shares cancelled and forfeited 1,370 (1,370 ) $ 3.98 Balance at December 31, 2016 7,920 17,663 $ 3.63 6.83 $ 64,122 Options exercisable at December 31, 2016 10,471 $ 3.00 5.37 $ 44,598 Options fully vested and expected to vest at December 31, 2016 16,720 $ 3.56 6.70 $ 61,909 The total intrinsic value of options exercised during the years ended December 31, 2016, 2015 and 2014 was $14.8 million, $5.5 million and $3.0 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, 2016, 2015 and 2014 was $7.0 million, $5.4 million and $4.6 million, respectively. The following is a summary of options outstanding and options exercisable at December 31, 2016. 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) $ 0.96 - $ 2.00 2,174 3.7 $ 1.40 $ 12,751 2,058 $ 1.37 $ 12,116 $ 2.01 - $ 3.00 3,486 5.4 $ 2.33 17,184 3,261 $ 2.31 16,141 $ 3.01 - $ 4.00 6,201 8.1 $ 3.55 22,991 2,575 $ 3.48 9,745 $ 4.01 - $ 6.92 5,802 7.5 $ 5.33 11,196 2,577 $ 4.70 6,596 17,663 6.8 $ 3.63 $ 64,122 10,471 $ 3.00 $ 44,598 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, 2016. The aggregate intrinsic value is the difference between our closing stock price on December 31, 2016 and the exercise price, multiplied by the number of in-the-money options. 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, 2016 2015 2014 Weighted-average assumptions for stock options granted: Risk-free interest rate 1.31% 1.77% 1.80% Expected term 5.8 years 7.2 years 6.0 years Expected volatility of stock price 69.0% 77.0% 79.0% Dividend rate 0% 0% 0% Weighted-average grant date fair value-based measurement $2.98 $2.72 $1.77 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 differentiated by whether the grantee is an employee, an officer or a 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 a weighted-average combination of the volatility of our own stock price and that of a group of peer companies for those grants with expected terms longer than the period of time that we have been a public company. For stock options granted to employees with expected terms of less than the period of time that we have been a public company, the volatility is based on historical data of the price for our common stock for periods of time equivalent to the expected term of these grants. We calculated employee stock-based compensation expense based on awards ultimately expected to vest and reduced it for estimated forfeitures. ASC 718 requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates Summary of compensation expense related to options to employees and directors We recognized compensation expense of $7.1 million, $6.0 million and $4.7 million related to options to employees and directors during the years ended December 31, 2016, 2015 and 2014, respectively. As of December 31, 2016, we had $17.0 million of unrecognized compensation expense for employee and director options outstanding as of that date, which had a remaining weighted-average vesting period of 2.97 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 fair value-based measurement of the options using the Black-Scholes option pricing model. The assumptions used in these calculations are similar to those used for the determination of fair value-based measurement for options granted to employees and directors, with the exception that, for non-employee options, the remaining contractual term is utilized as the expected term of the option and the fair value-based measurement related to unvested non-employee options is re-measured quarterly, based on the then current stock price as reflected on the NASDAQ Capital Market. We recorded charges to expense for non-employee stock options of $57,000, $87,000 and $470,000 for the years ended December 31, 2016, 2015 and 2014, respectively. As of December 31, 2016, there is one award outstanding to a non-employee with an aggregate total of 4,000 shares unvested as of that date. 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, 2016 2015 2014 (in thousands) Research and development $ 1,312 $ 839 $ 723 Selling, general and administrative 5,746 5,174 4,478 Total stock-based compensation $ 7,058 $ 6,013 $ 5,201 |
Net Income (Loss) Per Share
Net Income (Loss) Per Share | 12 Months Ended |
Dec. 31, 2016 | |
Earnings Per Share [Abstract] | |
Net Income (Loss) Per Share | 9. Net Income (Loss) Per Share Basic and diluted net income (loss) per share is computed by dividing the net income (loss) by the weighted-average number of common shares outstanding during the period. The potential dilutive shares of our common stock resulting from the assumed exercise of outstanding stock options were determined under the treasury stock method. The following table shows the computation of net income (loss) per share for each period, including the number of weighted-average shares outstanding. Year ended December 31, 2016 2015 2014 (in thousands) Numerator: Net income (loss) $ 8,140 $ (6,408 ) $ (31,383 ) Denominator: Weighted-average shares used to compute basic net income (loss) per share 110,566 106,883 100,978 Dilutive effect of employee stock options 5,573 — — Weighted-average shares used to compute diluted net income (loss) per share 116,139 106,883 100,978 Net income (loss) per share attributable to common stockholders Basic and diluted $ 0.07 $ (0.06 ) $ (0.31 ) We have excluded approximately 4,400 weighted average stock options to purchase common stock that were outstanding during the year ended December 31, 2016 from the computation of diluted net income per share because including them would have had an anti-dilutive effect. We have excluded the impact of all common stock equivalents relating to shares underlying outstanding options and warrants from the calculation of diluted net loss per common share for the years ended December 31, 2015 and 2014 because all such securities are antidilutive . The following table presents information on securities outstanding as of the end of each period that could potentially dilute the per share data in the future. December 31, 2016 2015 2014 (in thousands) Stock options outstanding 17,663 16,195 14,704 Warrants outstanding — — 8,044 Total 17,663 16,195 22,748 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 10. Income Taxes 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: December 31, 2016 2015 Deferred tax assets: (in thousands) Federal and state net operating losses $ 68,605 $ 68,552 Capitalized research and patent costs 23,575 24,876 Research credits 19,058 19,208 Biopharma Financing Agreement 5,556 10,423 Stock-based compensation costs 6,508 6,246 Other 6,067 4,345 Total deferred tax assets 129,369 133,650 Valuation allowance (129,369 ) (133,650 ) Net deferred tax assets $ — $ — Realization of deferred tax assets is dependent upon future earnings, if any, the timing and amount of which are uncertain. Accordingly, the net deferred tax assets have been fully offset by a valuation allowance. The valuation allowance increased by $15.9 million and decreased by $2.4 million and $4.3 million for the years ended December 31, 2014, 2015 and 2016, respectively. At December 31, 2016, we had net operating loss carryforwards available to offset any future taxable income that we may generate for federal income tax purposes of $179.3 million, which expire in the years 2019 through 2036, California net operating loss carryforwards of $106.4 million, which expire in the years 2017 through 2036, and net operating loss carryforwards from other states of $32.5 million, which expire in the years 2026 through 2036. Our federal and state net operating loss carryforwards as of December 31, 2016 include amounts resulting from exercises and sales of stock option awards to employees and non-employees. When we realize the tax benefit associated with these stock option exercises as a reduction to taxable income in our returns, we will account for the tax benefit as a credit to stockholders’ equity rather than as a reduction of our income tax provision in our financial statements. Based upon our stock option exercise history, we believe such amounts are not a material component of our total net operating loss carryforwards as of December 31, 2016. At December 31, 2016, we also had federal and California research and development tax credits of $17.2 million and $2.8 million, respectively. The federal research credits will expire in the years 2023 through 2036 and the California research credits have no expiration date. Our deferred tax assets have been offset by a full valuation allowance as the realization of such assets is uncertain. 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, 2016 2015 2014 (in thousands) U.S. federal taxes (benefit) at statutory rate $ 2,840 $ (2,178 ) $ (10,670 ) Changes in valuation allowance (3,679 ) 2,495 11,002 Unutilized research credits (69 ) (445 ) (1,308 ) Non-deductible offset of Orphan Drug Credit — — 249 Non-deductible Compensation 2,435 — — Stock-based compensation (1,660 ) 6 673 Other 133 122 54 Total $ — $ — $ — The Company maintains liabilities for uncertain tax positions. These liabilities involve 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. No amounts have been recognized as interest or penalties on income tax related matters. The aggregate annual changes in the balance of gross unrecognized tax benefits are as follows (in thousands): Year ended December 31, 2016 2015 Beginning Balance $ 4,342 $ — Increase in tax positions for prior years 222 4,173 Decreases in tax positions for prior years (1,189 ) — Increase in tax positions for current year 152 169 Ending Balance $ 3,527 $ 4,342 As of December 31, 2016 and 2015, the Company's total amount of unrecognized tax benefit was approximately $3.5 million and $4.3 million, respectively. There would be no impact to the effective tax rate if these tax benefits were recognized while the Company maintains a full valuation allowance. The Company does not expect its unrecognized tax benefits to change materially over the next 12 months. While management believes that the Company has adequately provided for all tax positions, amounts asserted by tax authorities could be greater or less than the recorded position. Accordingly, the Company’s 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. All tax years from inception remain open to examination by the Internal Revenue Service, the California Franchise Tax Board and other state taxing authorities until such time as the net operating losses and research credits are either fully utilized or expire. |
Commitments
Commitments | 12 Months Ended |
Dec. 31, 2016 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments | 11. Commitments We have entered into a number of agreements to conduct clinical trials and pre-clinical studies for further development of Korlym and our proprietary selective cortisol modulators. See the discussion in Note 2, Significant Agreements In the ordinary course of our business, we make certain indemnities, commitments and guarantees under which we may be required to make payments in relation to certain transactions. These include indemnities of clinical investigators and contract research organizations involved in the development of our clinical stage product candidates, indemnities of contract manufacturers and indemnities to our directors and officers to the maximum extent permitted under the laws of the State of Delaware. The duration of these indemnities, commitments and guarantees varies, and in certain cases, is indefinite. The majority of these indemnities, commitments and guarantees do not provide for any limitation of the maximum potential future payments that we could be obligated to make. We have not recorded any liability for these indemnities, commitments and guarantees in the accompanying balance sheets. However, we would accrue for losses for any known contingent liability, including those that may arise from indemnification provisions, when future payment is probable. No such losses have been recorded to date. |
Quarterly Financial Data (Unaud
Quarterly Financial Data (Unaudited) | 12 Months Ended |
Dec. 31, 2016 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Financial Data (Unaudited) | 12. Quarterly Financial Data (Unaudited) The following table is in thousands, except per share amounts: Quarter Ended March 31 June 30 September 30 December 31 2016 Product sales, net $ 16,061 $ 19,724 $ 21,725 $ 23,811 Gross profit on product sales 15,658 19,298 21,057 23,250 Net income (loss) (19 ) 977 2,585 4,597 Basic and diluted net income (loss) per share (0.00 ) 0.01 0.02 0.04 2015 Product sales, net $ 10,102 $ 11,956 $ 13,261 $ 14,967 Gross profit on product sales 9,800 11,517 13,005 14,603 Net income (loss) (4,830 ) (1,936 ) (601 ) 959 Basic and diluted net income (loss) per share (0.05 ) (0.02 ) (0.01 ) 0.01 |
Basis of Presentation and Sum19
Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2016 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. 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 evaluate our estimates and assumptions on an ongoing basis, including those related to revenue recognition, sales returns, inventory, allowances for doubtful accounts, accrued liabilities including our bonus accrual, clinical trial accruals, stock-based compensation and the timing of payments with respect to our long-term capped royalty obligation, which determines our interest expense. We base our estimates on relevant experience and on other specific assumptions that we believe are reasonable. |
Fair Value Measurements | Fair Value Measurements We categorize financial instruments in a fair value hierarchy that prioritizes the information used to develop assumptions for measuring fair value. The fair value hierarchy gives the highest priority to quoted prices in active markets for identical assets or liabilities (Level 1 input), then to quoted prices in non-active markets or in active markets for similar assets or liabilities, inputs other than quoted prices that are observable for the asset or liability, and inputs that are not directly observable, but that are corroborated by observable market data for the asset or liability (Level 2 input), then the lowest priority to unobservable inputs, such as our own data about the assumptions that market participants would use in pricing an asset or liability (Level 3 input). Fair value is a market-based measurement and should therefore be based on the assumptions that third-party market participants would use in pricing the asset or liability. |
Cash and Cash Equivalents | Cash and Cash Equivalents We consider all highly liquid investments purchased with maturities of three months or less from the date of purchase to be cash equivalents. Cash equivalents are carried at fair value as measured using Level 1 inputs, which approximates cost. As of December 31, 2016 and December 31, 2015, all of our funds were held in checking and money market fund accounts maintained at major U.S. financial institutions. |
Credit and Concentration Risks | Credit and Concentration Risks Our cash and cash equivalents are held in one financial institution. We are exposed to credit and concentration risks in the event of default by the financial institution holding our funds and investments or by the entity or entities that issued the securities held by the funds to the extent of the amount recorded on our balance sheet. We mitigate these risks by investing in money market funds that invest primarily in short-term U.S. Treasury notes and bills. We have never experienced a loss or lack of access to our operating or investment accounts. Among other services, Dohmen Life Science Services (“Dohmen”), a specialty pharmacy, dispenses Korlym to patients for us, with title to the medicine passing from us to the patient upon the patient’s receipt of the drug. Accordingly, our receivables risk is spread among various third-party payors – pharmacy benefit managers, insurance companies, private charities, government programs – and individual patients. We extend credit to third-party payors 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. We have a concentration of risk in regard to the manufacture and distribution of our product. As of December 31, 2016, we had one tablet manufacturer for Korlym – Alcami Corporation (formerly known as AAI Pharma Services Corp.). In addition, we have a single-source manufacturer of mifepristone, the active pharmaceutical ingredient (API), in Korlym – Produits Chimiques Auxiliaires et de Synthèse SA (PCAS). If either of these companies is unable to manufacture API or Korlym tablets in the quantities and time frame required, we may not be able to manufacture our product in a timely manner. In order to mitigate these risks related to the manufacture of our product, we purchased and hold in inventory additional quantities of mifepristone API and Korlym tablets. Dohmen is our sole specialty pharmacy. Its unwillingness or inability to dispense Korlym to patients in a timely manner would harm our business. |
Inventory | Inventory We value our inventories at the lower of cost or net realizable value. We determine the cost of inventory 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 disposed of and the related costs are recognized as cost of sales in the statement of comprehensive income (loss) in that period. Inventory amounts that are not expected to be consumed within 12 months following the balance sheet date are classified as strategic inventory, a noncurrent asset. We expense the manufacturing costs for product candidates incurred prior to regulatory approval as research and development expense as we incur them. We begin capitalizing costs related to the manufacture of a product candidate when we obtain regulatory approval to begin marketing that product. |
Long-term Obligation | Long-term Obligation In August 2012, we entered into a Purchase and Sale Agreement (Financing Agreement) with Biopharma Secured Debt Fund II Sub, S.à r.l (Biopharma), a private limited liability company organized under the laws of Luxembourg. Under the terms of the Financing Agreement, we received $30.0 million from Biopharma, which upon receipt we recorded as a long-term obligation. In return, we are obligated to make payments to Biopharma totaling $45.0 million. These payments equal a percentage of (i) our net product sales, which include sales from any product containing mifepristone or any of our proprietary selective cortisol modulators (Covered Products), and (ii) cash or cash equivalents received from any licensing transaction or co-promotion arrangement involving Covered Products, including any upfront or milestone payments, if any (together, Korlym Receipts). Once we have paid Biopharma a total of $45.0 million, no more payments will be due and the obligation will be extinguished. We recognize a portion of each quarterly payment under the Financing Agreement as interest expense, which we determine by calculating the interest rate to Biopharma implied by the stream of quarterly payments we expect to make. The amount shown on our balance sheet as the current portion is an estimate of the amount we expect to repay Biopharma within the 12 months following December 31, 2016. We record the balance of the outstanding portion of the obligation, if any, as a long-term liability. Our estimate of the amount and timing of our quarterly payments to Biopharma is subject to uncertainty and may change. Any changes in our assumed payment stream will change the accretion of interest expense and our split between the current and long-term portions of the obligation, although the total we will pay Biopharma is fixed at $45.0 million. See Note 5, Long-Term Obligation |
Net Product Sales | Net Product Sales We primarily sell Korlym directly to patients through Dohmen, a specialty pharmacy. Prior authorization and confirmation of coverage by the patients’ private or government insurance plan or by a third-party charity is a prerequisite for Dohmen to ship Korlym to a patient. We recognize revenue upon the delivery of Korlym to these patients. We recognize revenue from sales of Korlym upon delivery to patients as long as (i) there is persuasive evidence that an arrangement exists between ourselves and the customer, (ii) collectability is reasonably assured and (iii) the price is fixed or determinable. Prior authorization or confirmation of coverage level by the patient’s private insurance plan or government payor is a prerequisite to the shipment of Korlym to a patient. In order to conclude that the price is fixed or determinable, we must be able to (i) calculate gross product revenues from the sales to our customers and (ii) reasonably estimate net product revenues. Effective January 1, 2016, we recognize sales to our specialty distributor (SD) at the time of sale to the SD. Before that date, we did not recognize these sales until the SD had in turn sold to its customers. Sales to the SD were less than two percent of our revenue in the year ended December 31, 2016. We donate cash to the National Organization for Rare Disorders (“NORD”), an independent non-profit organization that helps patients with financial need pay for the treatment of Cushing syndrome. We do not include in revenue payments we receive from NORD. We calculate gross product revenues based on the price we charge our customers. We estimate our net product revenues by deducting from our gross product revenues (a) estimated government rebates and chargebacks, (b) estimated costs of our patient co-pay assistance program, (c) trade allowances, such as discounts for prompt payment and (d) reserves for expected product returns. We initially record estimates for these deductions at the time we recognize the gross revenue. We update our estimates as new information becomes available. Rebates and Chargebacks: We contract with Medicaid and other government agencies so that Korlym will be eligible for purchase by, or qualify for partial or full reimbursement from, Medicaid and other government programs. We estimate our rebate and chargeback amounts by applying the discount rates applicable to each government-funded program against our sales to patients covered by such programs. Our reserve activity for doubtful accounts, prompt pay cash discounts and chargebacks is summarized as follows: Balance at Beginning of Period Charges Deductions Balance at End of Period (in thousands) Year ended December 31, 2015: Accounts receivable allowances $ 12,543 $ 45,401 $ (39,609 ) $ 18,335 Year ended December 31, 2016: Accounts receivable allowances $ 18,335 $ 2,081,419 $ (1,749,074 ) $ 350,680 There were no material changes in reserve estimates relating to prior periods. Allowances for Patient Assistance Program: We provide financial assistance to eligible patients whose insurance policies require them to pay high deductibles and co-payments. We calculate the cost of assistance by applying our program guidelines to the eligible sales in the period. Sales Returns : We estimate the amount of Korlym that we believe will be returned and deduct that estimated amount from gross revenue at the time we recognize such revenue. When estimating future returns, we analyze quantitative and qualitative information including, but not limited to, actual return rates, the amount of product in the distribution channel, the expected shelf life of such product, current and projected product demand, the introduction of competing products that may erode demand, and broad economic and industry-wide indicators. If we cannot reasonably estimate product returns with respect to a particular sale, we defer recognition of revenue from that sale until we can make a reasonable estimate. |
Research and Development | Research and Development Research and development expenses consist of direct expenses, such as the cost of discovery research, pre-clinical studies, and clinical trials relating to our portfolio of proprietary, selective cortisol modulators, manufacturing development, preparations for submissions to the FDA or other regulatory agencies and related overhead expenses. We expense nonrefundable payments to third-parties as well as the cost of technologies and materials used in research and development as they are incurred. We base our cost accruals for research, preclinical activities, and clinical trials on estimates of work completed under service agreements, milestones achieved, patient enrollment and past experience with similar contracts. Our estimates of work completed and associated cost accruals include our assessments of information from third-party contract research organizations and the overall status of clinical trial and other development and administrative activities. |
Segment Reporting | Segment Reporting We determine our operating segments based on the way we organize our business to make operating 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 related to option grants under the fair value method, based on the value of the award at the grant date using the Black-Scholes option valuation model and we recognize expense over the requisite service period, net of estimated forfeitures. Employee stock-based compensation expense is calculated based on awards ultimately expected to vest and is reduced for estimated forfeitures. Forfeitures are revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates and an adjustment to stock-based compensation expense will be recognized at that time. We recognize the expense of options granted to non-employees based on the fair-value based measurement of the option grants at the time of vesting. |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncement In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-09, “Revenue from Contracts with Customers.” The standard states that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. In August 2015, the FASB issued ASU No. 2015-14, “Revenue from Contracts with Customers: Deferral of the Effective Date,” which deferred the effective date of ASU No. 2014-09. ASU No. 2014-09 will now be effective for us beginning January 1, 2018 and can be adopted on a full retrospective basis or on a modified retrospective basis. Early application is permitted in 2017. In March 2016, the FASB issued ASU No. 2016-08, “Revenue from Contracts with Customers (Topic 606): Principal versus Agent Considerations,” which clarifies the implementation guidance on principal versus agent considerations. In April 2016, the FASB issued ASU No. 2016-10, “Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing,” which clarifies certain aspects of identifying performance obligations and licensing implementation guidance. In May 2016, the FASB issued ASU No. 2016-12, “Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients,” related to disclosures of remaining performance obligations, as well as other amendments to guidance on collectability, non-cash consideration and the presentation of sales and other similar taxes collected from customers. We plan to adopt the accounting standard update using the modified retrospective approach, with the cumulative effect of adopting the update being recorded to our retained earnings on January 1, 2018. At present, we have only one source of revenue: the sale of Korlym to our customers. Our evaluation of the customer contracts governing these sales is still underway. Because each of our arrangements contain variable consideration, we have focused our analysis on how the update will affect our estimate of the transaction price. We are also reviewing our financial policies, procedures and controls and at the time we adopt the update will make appropriate changes to them. We have not completed our assessment of the adoption on our financial statements. In August 2014, the FASB issued ASU No. 2014-15 (Subtopic 205-40), “Presentation of Financial Statements—Going Concern: Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern” (“ASU 2014-15”), which provides guidance about management's responsibility to evaluate whether or not there is substantial doubt about the Company's ability to continue as a going concern and to provide related footnote disclosure. ASU 2014-15 is effective for fiscal years, and interim periods within those fiscal years, ending after December 15, 2016. The adoption of this standard had no impact on our Financial Statements as we have generated positive cash flow in the years ended December 31, 2015 and 2016 and expect to generate positive cash flow in the year ended December 31, 2017. In April 2015, the FASB issued ASU No. 2015-03, Simplifying the Presentation of Debt Issuance Costs (ASU 2015-03), which requires an entity to present such costs in the balance sheet as a direct deduction from the related debt liability rather than as an asset. Amortization of the costs will continue to be reported as interest expense. ASU 2015-03 is effective for fiscal years beginning after December 15, 2015 and interim periods within those fiscal years, with early adoption permitted. The new guidance will be applied retrospectively to each prior period presented. We retrospectively adopted ASU 2015-03 as of January 1, 2016, resulting in a $35,000 decrease to long-term assets and long-term debt as of December 31, 2015 on its balance sheets. The adoption of this standard had no impact on our Statement of Comprehensive Income (Loss). In July 2015, the FASB issued ASU No. 2015-11, Simplifying the Measurement of Inventory (ASU 2015-11), which simplifies the measurement of inventory by requiring certain inventory to be measured at the lower of cost or net realizable value. The amendments in this ASU are effective for fiscal years beginning after December 15, 2016 and for interim periods therein, with early adoption permitted. We plan to adopt this new standard on January 1, 2017, and do not expect this to have a material impact on our Financial Statements. In November 2015, the FASB issued ASU No. 2015-17 (ASU 2015-17) "Balance Sheet Classification of Deferred Taxes." ASU 2015-17 requires that deferred tax liabilities and assets be classified as noncurrent on the balance sheet. Previous guidance required deferred tax liabilities and assets to be separated into current and noncurrent amounts on the balance sheet. The guidance will become effective for us beginning in the first quarter of 2017 and may be applied either prospectively or retrospectively. We plan to adopt this new standard on January 1, 2017. At the time of adoption, we will reclassify current deferred tax amounts on our Balance Sheets as noncurrent. As we have a full valuation allowance against its deferred tax assets for all periods presented, the adoption is not expected to have a material impact on our Financial Statements. In February 2016, the FASB issued ASU No. 2016-02, “Leases” (ASU 2016-02), which increases transparency and comparability among organizations by recognizing all lease transactions (with terms in excess of 12 months) on the balance sheet as a lease liability and a right-of-use asset (as defined). ASU 2016-02 is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years, with earlier application permitted. Upon adoption, the lessee will apply the new standard retrospectively to all periods presented or retrospectively using a cumulative effect adjustment in the year of adoption. We plan to adopt this new standard prospectively on January 1, 2019. We are evaluating the impact of the adoption of this standard on our Financial Statements. We expect that it will increase our lease assets and correspondingly increase our lease liabilities. In March 2016, the FASB issued ASU No. 2016-09, Compensation - Stock Compensation (Topic 718) “Improvements to Employee Share-Based Payment Accounting” (ASU 2016-09), which is intended to simplify several aspects of the accounting for share-based payment award transactions, including the income tax consequences , an option to recognize gross stock compensation expense with actual forfeitures recognized as they occur, as well as certain classifications on the statement of cash flows 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 addresses eight specific cash flow issues with the objective of reducing the existing diversity in practice. The guidance will be effective for the fiscal year beginning after December 15, 2017, including interim periods within that year. We plan to adopt this new standard on January 1, 2018, and do not expect it to have a material impact on our Financial Statements. |
Basis of Presentation and Sum20
Basis of Presentation and Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Accounting Policies [Abstract] | |
Summary of Reserve Activity for Doubtful Accounts, Prompt Pay Cash Discounts and Chargebacks | Our reserve activity for doubtful accounts, prompt pay cash discounts and chargebacks is summarized as follows: Balance at Beginning of Period Charges Deductions Balance at End of Period (in thousands) Year ended December 31, 2015: Accounts receivable allowances $ 12,543 $ 45,401 $ (39,609 ) $ 18,335 Year ended December 31, 2016: Accounts receivable allowances $ 18,335 $ 2,081,419 $ (1,749,074 ) $ 350,680 |
Composition of Certain Balanc21
Composition of Certain Balance Sheet Items (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Balance Sheet Related Disclosures [Abstract] | |
Composition of Inventory | December 31, 2016 2015 (in thousands) Raw materials $ 1,848 $ 2,141 Work in progress 1,414 3 Finished goods 1,902 2,338 Total inventory 5,164 4,482 Less strategic inventory classified as non-current (2,835 ) (2,800 ) Total inventory classified as current $ 2,329 $ 1,682 |
Property and Equipment | December 31, 2016 2015 (in thousands) Furniture and equipment $ 300 $ 270 Software 351 193 Leasehold improvements 6 — 657 463 Less: accumulated depreciation (452 ) (365 ) $ 205 $ 98 |
Other Accrued Liabilities | December 31, 2016 2015 (in thousands) Government rebates $ 3,426 $ 1,663 Accrued compensation 4,702 1,103 Commercialization costs 308 111 Legal fees 164 69 Professional fees 34 220 Other 319 91 Total other accrued liabilities $ 8,953 $ 3,257 |
Long-Term Obligation (Tables)
Long-Term Obligation (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Debt Disclosure [Abstract] | |
Summary of Payment Obligations under Financing Agreement | The following table provides a summary of the payment obligations under the Financing Agreement as of December 31, 2016 and 2015, utilizing the payment assumptions discussed above. December 31, 2016 2015 (in thousands) Total repayment obligation $ 45,000 $ 45,000 Less interest in future periods (456 ) (2,385 ) Less unamortized financing costs (14 ) (35 ) Less payments made (29,866 ) (15,087 ) Less current portion (14,664 ) (14,965 ) Long-term obligation, net of current portion $ — $ 12,528 |
Lease Obligations (Tables)
Lease Obligations (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Leases [Abstract] | |
Schedule of Future Minimum Lease Payments under Non-Cancelable Operating Leases | As of December 31, 2016, future minimum lease payments under non-cancelable operating leases were as follows: Lease Payments 2017 937 2018 1,115 2019 279 Thereafter — Total $ 2,331 |
Preferred Stock and Stockhold24
Preferred Stock and Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Equity [Abstract] | |
Shares of Common Stock Reserved for Future Issuance | Shares of common stock reserved for future issuance as of December 31, 2016 are as follows: Common stock: (in thousands) Exercise of outstanding options 17,663 Shares available for grant under stock option plans 7,920 25,583 |
Summary of Stock Plan Activity | The following table summarizes all stock plan activity: 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 (in (in years) (in Balance at December 31, 2013 4,926 14,712 $ 2.63 Increase in shares authorized for grant 3,993 — — Shares granted (2,140 ) 2,140 $ 2.62 Shares exercised — (1,381 ) $ 1.34 Shares cancelled and forfeited 767 (767 ) $ 5.03 Balance at December 31, 2014 7,546 14,704 $ 2.62 Increase in shares authorized for grant 4,056 — Shares granted (4,902 ) 4,902 $ 3.88 Shares exercised — (2,041 ) $ 2.55 Shares cancelled and forfeited 1,370 (1,370 ) $ 3.07 Balance at December 31, 2015 8,070 16,195 $ 2.98 Increase in shares authorized for grant 4,386 — Shares granted (5,906 ) 5,906 $ 4.92 Shares exercised — (3,068 ) $ 2.50 Shares cancelled and forfeited 1,370 (1,370 ) $ 3.98 Balance at December 31, 2016 7,920 17,663 $ 3.63 6.83 $ 64,122 Options exercisable at December 31, 2016 10,471 $ 3.00 5.37 $ 44,598 Options fully vested and expected to vest at December 31, 2016 16,720 $ 3.56 6.70 $ 61,909 |
Summary of Options Outstanding and Exercisable | The following is a summary of options outstanding and options exercisable at December 31, 2016. 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) $ 0.96 - $ 2.00 2,174 3.7 $ 1.40 $ 12,751 2,058 $ 1.37 $ 12,116 $ 2.01 - $ 3.00 3,486 5.4 $ 2.33 17,184 3,261 $ 2.31 16,141 $ 3.01 - $ 4.00 6,201 8.1 $ 3.55 22,991 2,575 $ 3.48 9,745 $ 4.01 - $ 6.92 5,802 7.5 $ 5.33 11,196 2,577 $ 4.70 6,596 17,663 6.8 $ 3.63 $ 64,122 10,471 $ 3.00 $ 44,598 |
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, 2016 2015 2014 Weighted-average assumptions for stock options granted: Risk-free interest rate 1.31% 1.77% 1.80% Expected term 5.8 years 7.2 years 6.0 years Expected volatility of stock price 69.0% 77.0% 79.0% Dividend rate 0% 0% 0% Weighted-average grant date fair value-based measurement $2.98 $2.72 $1.77 |
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, 2016 2015 2014 (in thousands) Research and development $ 1,312 $ 839 $ 723 Selling, general and administrative 5,746 5,174 4,478 Total stock-based compensation $ 7,058 $ 6,013 $ 5,201 |
Net Income (Loss) Per Share (Ta
Net Income (Loss) Per Share (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Earnings Per Share [Abstract] | |
Schedule of Computation of Net Income (Loss) Per Share | The following table shows the computation of net income (loss) per share for each period, including the number of weighted-average shares outstanding. Year ended December 31, 2016 2015 2014 (in thousands) Numerator: Net income (loss) $ 8,140 $ (6,408 ) $ (31,383 ) Denominator: Weighted-average shares used to compute basic net income (loss) per share 110,566 106,883 100,978 Dilutive effect of employee stock options 5,573 — — Weighted-average shares used to compute diluted net income (loss) per share 116,139 106,883 100,978 Net income (loss) per share attributable to common stockholders Basic and diluted $ 0.07 $ (0.06 ) $ (0.31 ) |
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 in the future. December 31, 2016 2015 2014 (in thousands) Stock options outstanding 17,663 16,195 14,704 Warrants outstanding — — 8,044 Total 17,663 16,195 22,748 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |
Significant Components of Deferred Tax Assets | Significant components of our deferred tax assets are as follows: December 31, 2016 2015 Deferred tax assets: (in thousands) Federal and state net operating losses $ 68,605 $ 68,552 Capitalized research and patent costs 23,575 24,876 Research credits 19,058 19,208 Biopharma Financing Agreement 5,556 10,423 Stock-based compensation costs 6,508 6,246 Other 6,067 4,345 Total deferred tax assets 129,369 133,650 Valuation allowance (129,369 ) (133,650 ) Net deferred tax assets $ — $ — |
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, 2016 2015 2014 (in thousands) U.S. federal taxes (benefit) at statutory rate $ 2,840 $ (2,178 ) $ (10,670 ) Changes in valuation allowance (3,679 ) 2,495 11,002 Unutilized research credits (69 ) (445 ) (1,308 ) Non-deductible offset of Orphan Drug Credit — — 249 Non-deductible Compensation 2,435 — — Stock-based compensation (1,660 ) 6 673 Other 133 122 54 Total $ — $ — $ — |
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, 2016 2015 Beginning Balance $ 4,342 $ — Increase in tax positions for prior years 222 4,173 Decreases in tax positions for prior years (1,189 ) — Increase in tax positions for current year 152 169 Ending Balance $ 3,527 $ 4,342 |
Quarterly Financial Data (Una27
Quarterly Financial Data (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Financial Data | The following table is in thousands, except per share amounts: Quarter Ended March 31 June 30 September 30 December 31 2016 Product sales, net $ 16,061 $ 19,724 $ 21,725 $ 23,811 Gross profit on product sales 15,658 19,298 21,057 23,250 Net income (loss) (19 ) 977 2,585 4,597 Basic and diluted net income (loss) per share (0.00 ) 0.01 0.02 0.04 2015 Product sales, net $ 10,102 $ 11,956 $ 13,261 $ 14,967 Gross profit on product sales 9,800 11,517 13,005 14,603 Net income (loss) (4,830 ) (1,936 ) (601 ) 959 Basic and diluted net income (loss) per share (0.05 ) (0.02 ) (0.01 ) 0.01 |
Basis of Presentation and Sum28
Basis of Presentation and Summary of Significant Accounting Policies (Narrative) (Details) | 1 Months Ended | 12 Months Ended | |
Aug. 31, 2012USD ($) | Dec. 31, 2016USD ($)Segmentitem | Dec. 31, 2015USD ($) | |
Accounting Policies [Line Items] | |||
Date of incorporation | May 1, 1998 | ||
Entity incorporated, State | Delaware | ||
Number of manufacturers | item | 1 | ||
Cumulative payments to be made under financing agreement | $ 45,000,000 | $ 45,000,000 | |
Number of operating segments | Segment | 1 | ||
Accounting Standards Update 2015-03 | |||
Accounting Policies [Line Items] | |||
Decrease in long term assets and long term debts | $ 35,000 | ||
Maximum | Sales Revenue, Net [Member] | Customer Concentration Risk | |||
Accounting Policies [Line Items] | |||
Percentage of sales to one specialty distributor | 2.00% | ||
Financing Agreement with Biopharma | |||
Accounting Policies [Line Items] | |||
Proceeds from issuance of long-term obligation | $ 30,000,000 | ||
Cumulative payments to be made under financing agreement | $ 45,000,000 | $ 45,000,000 | |
Financing Agreement with Biopharma | Maximum | |||
Accounting Policies [Line Items] | |||
Cumulative payments to be made under financing agreement | $ 45,000,000 |
Basis of Presentation and Sum29
Basis of Presentation and Summary of Significant Accounting Policies (Summary of Reserve Activity for Doubtful Accounts, Prompt Pay Cash Discounts and Chargebacks) (Details) - Sales Allowances, Discounts and Chargebacks [Member] - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Accounts Notes And Loans Receivable [Line Items] | ||
Balance at Beginning of Period | $ 18,335 | $ 12,543 |
Charges | 2,081,419 | 45,401 |
Deductions | (1,749,074) | (39,609) |
Balance at End of Period | $ 350,680 | $ 18,335 |
Significant Agreements (Narrati
Significant Agreements (Narrative) (Details) | 1 Months Ended | 4 Months Ended | 12 Months Ended | ||||||
Dec. 31, 2016USD ($) | Sep. 30, 2016USD ($) | Jan. 31, 2016USD ($) | Mar. 31, 2014USD ($) | Dec. 31, 2016USD ($) | Dec. 31, 2016USD ($)item | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | Dec. 31, 1999USD ($)shares | |
Debt And Credit Agreements [Line Items] | |||||||||
Number of Patents | item | 2 | ||||||||
Cost incurred under the agreement | $ 23,844,000 | $ 15,419,000 | $ 18,372,000 | ||||||
Stanford license agreement | |||||||||
Debt And Credit Agreements [Line Items] | |||||||||
Issuance of common stock in conjunction with a license agreement | shares | 30,000 | ||||||||
Stanford license agreement | Annual Payment | |||||||||
Debt And Credit Agreements [Line Items] | |||||||||
Royalty payments to be made | $ 50,000 | ||||||||
Centric Health Resources, Inc. | |||||||||
Debt And Credit Agreements [Line Items] | |||||||||
Initial agreement period | 3 years | ||||||||
Agreement termination, written notice period | 180 days | ||||||||
Agreement with PCAS | |||||||||
Debt And Credit Agreements [Line Items] | |||||||||
Initial agreement period | 5 years | ||||||||
Agreement termination, written notice period | 12 months | ||||||||
Automatic extension period | 1 year | ||||||||
Right to terminate agreement if unable to manufacture product, period | 9 months | ||||||||
Agreement with Alcami Corporation | |||||||||
Debt And Credit Agreements [Line Items] | |||||||||
Initial agreement period | 3 years | ||||||||
Agreement termination, written notice period | 12 months | ||||||||
Automatic extension period | 2 years | ||||||||
Right to terminate agreement if unable to manufacture product, period | 4 months | ||||||||
Termination notice period for manufacturer | 18 months | ||||||||
Purchase obligations | $ 0 | $ 0 | $ 0 | ||||||
Chiltern [Member] | |||||||||
Debt And Credit Agreements [Line Items] | |||||||||
Commitment amount related to service agreement | $ 2,100,000 | ||||||||
Cost incurred under the agreement | $ 741,000 | ||||||||
Quotient Clinical Limited [Member] | |||||||||
Debt And Credit Agreements [Line Items] | |||||||||
Initial agreement period | 1 year | 2 years | |||||||
Commitment amount related to service agreement | $ 2,200,000 | $ 2,200,000 | $ 3,000,000 | ||||||
Cost incurred under the agreement | $ 0 | $ 100,000 |
Fair Value of Financial Instr31
Fair Value of Financial Instruments (Narrative) (Details) - USD ($) $ in Millions | Dec. 31, 2016 | Dec. 31, 2015 |
Level 1 | Money market funds | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Money market fund, fair value | $ 31.6 | $ 31.6 |
Composition of Certain Balanc32
Composition of Certain Balance Sheet Items (Composition of Inventory) (Details) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Balance Sheet Related Disclosures [Abstract] | ||
Raw materials | $ 1,848 | $ 2,141 |
Work in progress | 1,414 | 3 |
Finished goods | 1,902 | 2,338 |
Total inventory | 5,164 | 4,482 |
Less strategic inventory classified as non-current | (2,835) | (2,800) |
Total inventory classified as current | $ 2,329 | $ 1,682 |
Composition of Certain Balanc33
Composition of Certain Balance Sheet Items (Property and Equipment) (Details) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Other Liabilities [Line Items] | ||
Property and equipment | $ 657 | $ 463 |
Less: accumulated depreciation | (452) | (365) |
Property and equipment net | 205 | 98 |
Furniture and Equipment [Member] | ||
Other Liabilities [Line Items] | ||
Property and equipment | 300 | 270 |
Software [Member] | ||
Other Liabilities [Line Items] | ||
Property and equipment | 351 | $ 193 |
Leasehold Improvements [Member] | ||
Other Liabilities [Line Items] | ||
Property and equipment | $ 6 |
Composition of Certain Balanc34
Composition of Certain Balance Sheet Items (Other Accrued Liabilities) (Details) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Balance Sheet Related Disclosures [Abstract] | ||
Government rebates | $ 3,426 | $ 1,663 |
Accrued compensation | 4,702 | 1,103 |
Commercialization costs | 308 | 111 |
Legal fees | 164 | 69 |
Professional fees | 34 | 220 |
Other | 319 | 91 |
Total other accrued liabilities | $ 8,953 | $ 3,257 |
Long-Term Obligation (Narrative
Long-Term Obligation (Narrative) (Details) - USD ($) | 1 Months Ended | 12 Months Ended | 53 Months Ended | ||||
Feb. 28, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2016 | Dec. 31, 2013 | Aug. 31, 2012 | |
Contractual Obligation [Line Items] | |||||||
Cumulative payments to be made under financing agreement | $ 45,000,000 | $ 45,000,000 | $ 45,000,000 | ||||
Aggregate payments to long-term obligations | $ 14,779,000 | 9,207,000 | $ 4,856,000 | ||||
Amount of days to remedy the fail to deliver a royalty payment | 30 days | ||||||
Cash and cash equivalents | $ 51,536,000 | 40,435,000 | 24,248,000 | 51,536,000 | $ 54,877,000 | ||
Accretion of interest expense | 1,929,000 | 2,848,000 | $ 3,678,000 | 14,500,000 | |||
Issuance costs capitalized | 140,000 | 140,000 | |||||
Unamortized issuance cost | 14,000 | $ 35,000 | 14,000 | ||||
Financing Agreement with Biopharma | |||||||
Contractual Obligation [Line Items] | |||||||
Cumulative payments to be made under financing agreement | $ 45,000,000 | 45,000,000 | $ 45,000,000 | ||||
Aggregate payments to long-term obligations | $ 29,900,000 | ||||||
Payment obligation based on a percentage of net product sales | 20.00% | ||||||
Percentage of payments received for upfront, milestone or other contingent fees | 20.00% | 20.00% | |||||
Financing Agreement with Biopharma | Maximum | |||||||
Contractual Obligation [Line Items] | |||||||
Cumulative payments to be made under financing agreement | $ 45,000,000 | $ 45,000,000 | |||||
Payment obligation based on a percentage of net product sales | 50.00% | ||||||
Financing Agreement with Biopharma | Minimum | Cash Required Under Debt Covenants | |||||||
Contractual Obligation [Line Items] | |||||||
Cash and cash equivalents | $ 50,000,000 | $ 50,000,000 | |||||
Financing Agreement with Biopharma | Subsequent Events | |||||||
Contractual Obligation [Line Items] | |||||||
Aggregate payments to long-term obligations | $ 4,800,000 |
Long-Term Obligation (Summary o
Long-Term Obligation (Summary of Payment Obligations under Financing Agreement) (Details) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Debt Disclosure [Abstract] | ||
Total repayment obligation | $ 45,000 | $ 45,000 |
Less interest in future periods | (456) | (2,385) |
Less unamortized financing costs | (14) | (35) |
Less payments made | (29,866) | (15,087) |
Less current portion | (14,664) | (14,965) |
Long-term obligation, net of current portion | $ 0 | $ 12,528 |
Lease Obligations (Narratives)
Lease Obligations (Narratives) (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Leases [Abstract] | |||
Lease expiration date | Mar. 31, 2019 | ||
Rent expenses | $ 885,000 | $ 678,000 | $ 609,000 |
Lease Obligations (Schedule of
Lease Obligations (Schedule of Future Minimum Lease Payments under Non-Cancelable Operating Leases) (Details) $ in Thousands | Dec. 31, 2016USD ($) |
Operating Leases Future Minimum Payments Due [Abstract] | |
2,017 | $ 937 |
2,018 | 1,115 |
2,019 | 279 |
Thereafter | 0 |
Total | $ 2,331 |
Preferred Stock and Stockhold39
Preferred Stock and Stockholders' Equity (Narrative) (Details) | Feb. 10, 2017shares | Feb. 26, 2016shares | Mar. 31, 2015USD ($)shares | May 31, 2014shares | Dec. 31, 2016USD ($)item$ / sharesshares | Dec. 31, 2015USD ($)$ / sharesshares | Dec. 31, 2014USD ($)shares | Dec. 31, 2013shares | Dec. 31, 2012shares |
Shareholders Equity [Line Items] | |||||||||
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | |||||||
Preferred stock, par value | $ / shares | $ 0.001 | $ 0.001 | |||||||
Preferred stock, shares outstanding | 0 | 0 | |||||||
Proceeds from exercise of warrants, net of issuance costs | $ | $ 0 | $ 17,088,000 | $ 0 | ||||||
Increase in shares authorized for grant | 4,386,000 | 4,056,000 | 3,993,000 | ||||||
Number of stock option plans | item | 2 | ||||||||
Shares available for future grants | 7,920,000 | 8,070,000 | 7,546,000 | 4,926,000 | |||||
Total intrinsic value of options exercised | $ | $ 14,800,000 | $ 5,500,000 | $ 3,000,000 | ||||||
Fair value of options vested | $ | 7,000,000 | 5,400,000 | 4,600,000 | ||||||
Non-cash stock-based compensation expense | $ | 7,058,000 | 6,013,000 | 5,201,000 | ||||||
Non-employee [Member] | |||||||||
Shareholders Equity [Line Items] | |||||||||
Non-cash stock-based compensation expense | $ | $ 57,000 | 87,000 | 470,000 | ||||||
Number of awards outstanding | item | 1 | ||||||||
Unvested shares | 4,000 | ||||||||
Employee and Director Stock Option [Member] | |||||||||
Shareholders Equity [Line Items] | |||||||||
Non-cash stock-based compensation expense | $ | $ 7,100,000 | $ 6,000,000 | $ 4,700,000 | ||||||
Unrecognized compensation expense | $ | $ 17,000,000 | ||||||||
Unrecognized compensation expense, weighted-average vesting period | 2 years 11 months 19 days | ||||||||
2012 Equity Incentive Award Plan [Member] | |||||||||
Shareholders Equity [Line Items] | |||||||||
Increase in shares authorized for grant | 4,400,000 | ||||||||
Increase in shares available for issuance based on percentage of common stock outstanding | 4.00% | 4.00% | |||||||
Shares available for future grants | 5,300,000 | ||||||||
2012 Equity Incentive Award Plan [Member] | Minimum [Member] | |||||||||
Shareholders Equity [Line Items] | |||||||||
Exercise price as percentage of fair value of common stock | 100.00% | ||||||||
Stock options, vesting period | 1 year | ||||||||
2012 Equity Incentive Award Plan [Member] | Maximum [Member] | |||||||||
Shareholders Equity [Line Items] | |||||||||
Stock options, vesting period | 4 years | ||||||||
2012 Equity Incentive Award Plan [Member] | Subsequent Event [Member] | |||||||||
Shareholders Equity [Line Items] | |||||||||
Increase in shares authorized for grant | 4,500,000 | ||||||||
2004 Equity Incentive Plan [Member] | |||||||||
Shareholders Equity [Line Items] | |||||||||
Shares available for future grants | 0 | ||||||||
2004 Equity Incentive Plan [Member] | Minimum [Member] | |||||||||
Shareholders Equity [Line Items] | |||||||||
Exercise price as percentage of fair value of common stock | 100.00% | ||||||||
Stock options, vesting period | 1 year | ||||||||
2004 Equity Incentive Plan [Member] | Maximum [Member] | |||||||||
Shareholders Equity [Line Items] | |||||||||
Stock options, vesting period | 5 years | ||||||||
Private Placement Member [Member] | |||||||||
Shareholders Equity [Line Items] | |||||||||
Shares issued upon exercise of warrants | 6,200,000 | 164,666 | |||||||
Number of private placement transactions | item | 2 | ||||||||
Proceeds from exercise of warrants, net of issuance costs | $ | $ 17,100,000 | ||||||||
Warrant exercised on a cashless net-exercise basis | 529,567 | ||||||||
Venture Capital Funds, Trusts and Other Entities [Member] | Private Placement Member [Member] | |||||||||
Shareholders Equity [Line Items] | |||||||||
Shares issued upon exercise of warrants | 3,100,000 | ||||||||
Proceeds from exercise of warrants, net of issuance costs | $ | $ 5,900,000 |
Preferred Stock and Stockhold40
Preferred Stock and Stockholders' Equity (Shares of Common Stock Reserved for Future Issuance) (Details) shares in Thousands | Dec. 31, 2016shares |
Shareholders Equity [Line Items] | |
Shares of common stock reserved for future issuance | 25,583 |
Stock Options Outstanding [Member] | |
Shareholders Equity [Line Items] | |
Shares of common stock reserved for future issuance | 17,663 |
Shares Available For Grant Under Stock Option Plans [Member] | |
Shareholders Equity [Line Items] | |
Shares of common stock reserved for future issuance | 7,920 |
Preferred Stock and Stockhold41
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, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Shares Available For Future Grant | |||
Beginning balance | 8,070 | 7,546 | 4,926 |
Increase in shares authorized for grant | 4,386 | 4,056 | 3,993 |
Shares granted | (5,906) | (4,902) | (2,140) |
Shares cancelled and forfeited | 1,370 | 1,370 | 767 |
Ending balance | 7,920 | 8,070 | 7,546 |
Shares Subject to Options Outstanding | |||
Beginning balance | 16,195 | 14,704 | 14,712 |
Shares granted | 5,906 | 4,902 | 2,140 |
Shares exercised | (3,068) | (2,041) | (1,381) |
Shares cancelled and forfeited | (1,370) | (1,370) | (767) |
Ending balance | 17,663 | 16,195 | 14,704 |
Options exercisable | 10,471 | ||
Options fully vested and expected to vest | 16,720 | ||
Outstanding Options, Weighted- Average Exercise Price | |||
Beginning balance | $ 2.98 | $ 2.62 | $ 2.63 |
Shares granted | 4.92 | 3.88 | 2.62 |
Shares exercised | 2.50 | 2.55 | 1.34 |
Shares cancelled and forfeited | 3.98 | 3.07 | 5.03 |
Ending balance | 3.63 | $ 2.98 | $ 2.62 |
Options exercisable | 3 | ||
Options fully vested and expected to vest | $ 3.56 | ||
Outstanding Options, Weighted Average Remaining Contractual Life | |||
Weighted average remaining contractual life | 6 years 9 months 29 days | ||
Weighted average remaining contractual life, Options exercisable | 5 years 4 months 13 days | ||
Weighted average remaining contractual life, Options fully vested and expected to vest | 6 years 8 months 12 days | ||
Outstanding Options, Aggregate Intrinsic Value | |||
Aggregate Intrinsic Value | $ 64,122 | ||
Options exercisable | 44,598 | ||
Options fully vested and expected to vest | $ 61,909 |
Preferred Stock and Stockhold42
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, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||||
Options Outstanding, Number of Shares | 17,663 | 16,195 | 14,704 | 14,712 |
Options Outstanding, Weighted Average Remaining Contractual Life (in years) | 6 years 9 months 29 days | |||
Options Outstanding, Weighted Average Exercise Price | $ 3.63 | $ 2.98 | $ 2.62 | $ 2.63 |
Options Outstanding, Aggregate Intrinsic Value | $ 64,122 | |||
Options Exercisable, Number of Shares | 10,471 | |||
Options Exercisable, Weighted Average Exercise Price | $ 3 | |||
Options Exercisable, Aggregate Intrinsic Value | $ 44,598 | |||
$0.96 - $ 2.00 | ||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||||
Exercise Price Of Options, minimum | $ 0.96 | |||
Exercise Price Of Options, Maximum | $ 2 | |||
Options Outstanding, Number of Shares | 2,174 | |||
Options Outstanding, Weighted Average Remaining Contractual Life (in years) | 3 years 8 months 12 days | |||
Options Outstanding, Weighted Average Exercise Price | $ 1.40 | |||
Options Outstanding, Aggregate Intrinsic Value | $ 12,751 | |||
Options Exercisable, Number of Shares | 2,058 | |||
Options Exercisable, Weighted Average Exercise Price | $ 1.37 | |||
Options Exercisable, Aggregate Intrinsic Value | $ 12,116 | |||
$2.01 - $ 3.00 | ||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||||
Exercise Price Of Options, minimum | $ 2.01 | |||
Exercise Price Of Options, Maximum | $ 3 | |||
Options Outstanding, Number of Shares | 3,486 | |||
Options Outstanding, Weighted Average Remaining Contractual Life (in years) | 5 years 4 months 24 days | |||
Options Outstanding, Weighted Average Exercise Price | $ 2.33 | |||
Options Outstanding, Aggregate Intrinsic Value | $ 17,184 | |||
Options Exercisable, Number of Shares | 3,261 | |||
Options Exercisable, Weighted Average Exercise Price | $ 2.31 | |||
Options Exercisable, Aggregate Intrinsic Value | $ 16,141 | |||
$3.01 - $ 4.00 | ||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||||
Exercise Price Of Options, minimum | $ 3.01 | |||
Exercise Price Of Options, Maximum | $ 4 | |||
Options Outstanding, Number of Shares | 6,201 | |||
Options Outstanding, Weighted Average Remaining Contractual Life (in years) | 8 years 1 month 6 days | |||
Options Outstanding, Weighted Average Exercise Price | $ 3.55 | |||
Options Outstanding, Aggregate Intrinsic Value | $ 22,991 | |||
Options Exercisable, Number of Shares | 2,575 | |||
Options Exercisable, Weighted Average Exercise Price | $ 3.48 | |||
Options Exercisable, Aggregate Intrinsic Value | $ 9,745 | |||
$4.01 - $ 6.92 | ||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||||
Exercise Price Of Options, minimum | $ 4.01 | |||
Exercise Price Of Options, Maximum | $ 6.92 | |||
Options Outstanding, Number of Shares | 5,802 | |||
Options Outstanding, Weighted Average Remaining Contractual Life (in years) | 7 years 6 months | |||
Options Outstanding, Weighted Average Exercise Price | $ 5.33 | |||
Options Outstanding, Aggregate Intrinsic Value | $ 11,196 | |||
Options Exercisable, Number of Shares | 2,577 | |||
Options Exercisable, Weighted Average Exercise Price | $ 4.70 | |||
Options Exercisable, Aggregate Intrinsic Value | $ 6,596 |
Preferred Stock and Stockhold43
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, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Weighted-average assumptions for stock options granted: | |||
Risk-free interest rate | 1.31% | 1.77% | 1.80% |
Expected term | 5 years 9 months 18 days | 7 years 2 months 12 days | 6 years |
Expected volatility of stock price | 69.00% | 77.00% | 79.00% |
Dividend rate | 0.00% | 0.00% | 0.00% |
Weighted-average grant date fair value-based measurement | $ 2.98 | $ 2.72 | $ 1.77 |
Preferred Stock and Stockhold44
Preferred Stock and Stockholders' Equity (Summary of Stock-Based Compensation) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Non-cash stock-based compensation expense | $ 7,058 | $ 6,013 | $ 5,201 |
Research And Development Expense [Member] | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Non-cash stock-based compensation expense | 1,312 | 839 | 723 |
Selling, General And Administrative Expense [Member] | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Non-cash stock-based compensation expense | $ 5,746 | $ 5,174 | $ 4,478 |
Schedule of Computation of Net
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, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Numerator: | |||||||||||
Net income (loss) | $ 4,597 | $ 2,585 | $ 977 | $ (19) | $ 959 | $ (601) | $ (1,936) | $ (4,830) | $ 8,140 | $ (6,408) | $ (31,383) |
Denominator: | |||||||||||
Weighted-average shares used to compute basic net income (loss) per share | 110,566 | 106,883 | 100,978 | ||||||||
Dilutive effect of employee stock options | 5,573 | ||||||||||
Weighted-average shares used to compute diluted net income (loss) per share | 116,139 | 106,883 | 100,978 | ||||||||
Net income (loss) per share attributable to common stockholders | |||||||||||
Basic and diluted | $ 0.04 | $ 0.02 | $ 0.01 | $ 0 | $ 0.01 | $ (0.01) | $ (0.02) | $ (0.05) | $ 0.07 | $ (0.06) | $ (0.31) |
Net Income (Loss) Per Share (De
Net Income (Loss) Per Share (Details) | 12 Months Ended |
Dec. 31, 2016shares | |
Earnings Per Share [Abstract] | |
Weighted average stock options excluded from the computation of diluted net income per share | 4,400 |
Net Income (Loss) Per Share (Se
Net Income (Loss) Per Share (Securities Outstanding that could Potentially Dilute Per Share Data) (Details) - shares shares in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Securities outstanding that could potentially dilute per share data | 17,663 | 16,195 | 22,748 |
Stock Options Outstanding [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Securities outstanding that could potentially dilute per share data | 17,663 | 16,195 | 14,704 |
Warrants Outstanding [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Securities outstanding that could potentially dilute per share data | 8,044 |
Income Taxes (Significant Compo
Income Taxes (Significant Components of Deferred Tax Assets) (Details) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Deferred tax assets: | ||
Federal and state net operating losses | $ 68,605 | $ 68,552 |
Capitalized research and patent costs | 23,575 | 24,876 |
Research credits | 19,058 | 19,208 |
Biopharma Financing Agreement | 5,556 | 10,423 |
Stock-based compensation costs | 6,508 | 6,246 |
Other | 6,067 | 4,345 |
Total deferred tax assets | 129,369 | 133,650 |
Valuation allowance | $ (129,369) | $ (133,650) |
Income Taxes - (Narrative) (Det
Income Taxes - (Narrative) (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Income Taxes [Line Items] | |||
Increase (decrease) in valuation allowance | $ 4,300,000 | $ (2,400,000) | $ 15,900,000 |
Recognized interest or penalties | 0 | ||
Unrecognized Tax Benefits | 3,527,000 | $ 4,342,000 | $ 0 |
Federal | |||
Income Taxes [Line Items] | |||
Net operating loss carryforwards | 179,300,000 | ||
Research and development tax credits | $ 17,200,000 | ||
Minimum [Member] | Federal | |||
Income Taxes [Line Items] | |||
Net operating loss carryforwards, expiration year | 2,019 | ||
Research and development tax credit, expiration year | 2,023 | ||
Maximum | Federal | |||
Income Taxes [Line Items] | |||
Net operating loss carryforwards, expiration year | 2,036 | ||
Research and development tax credit, expiration year | 2,036 | ||
California State | |||
Income Taxes [Line Items] | |||
Net operating loss carryforwards | $ 106,400,000 | ||
Research and development tax credits | $ 2,800,000 | ||
California State | Minimum [Member] | |||
Income Taxes [Line Items] | |||
Net operating loss carryforwards, expiration year | 2,017 | ||
California State | Maximum | |||
Income Taxes [Line Items] | |||
Net operating loss carryforwards, expiration year | 2,036 | ||
Other States [Member] | |||
Income Taxes [Line Items] | |||
Net operating loss carryforwards | $ 32,500,000 | ||
Other States [Member] | Minimum [Member] | |||
Income Taxes [Line Items] | |||
Net operating loss carryforwards, expiration year | 2,026 | ||
Other States [Member] | Maximum | |||
Income Taxes [Line Items] | |||
Net operating loss carryforwards, expiration year | 2,036 |
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, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Income Tax Disclosure [Abstract] | |||
U.S. federal taxes (benefit) at statutory rate | $ 2,840 | $ (2,178) | $ (10,670) |
Changes in valuation allowance | (3,679) | 2,495 | 11,002 |
Unutilized research credits | (69) | (445) | (1,308) |
Non-deductible offset of Orphan Drug Credit | 0 | 0 | 249 |
Non-deductible Compensation | 2,435 | 0 | 0 |
Stock-based compensation | (1,660) | 6 | 673 |
Other | 133 | 122 | 54 |
Total | $ 0 | $ 0 | $ 0 |
Income Taxes (Changes in Balanc
Income Taxes (Changes in Balance of Gross Unrecognized Tax Benefits) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | ||
Beginning Balance | $ 4,342 | $ 0 |
Increase in tax positions for prior years | 222 | 4,173 |
Decreases in tax positions for prior years | (1,189) | 0 |
Increase in tax positions for current year | 152 | 169 |
Ending Balance | $ 3,527 | $ 4,342 |
Commitments (Narrative) (Detail
Commitments (Narrative) (Details) | Dec. 31, 2016USD ($) |
Commitments And Contingencies Disclosure [Abstract] | |
Losses for contingent liability | $ 0 |
Quarterly Financial Data (Una53
Quarterly Financial Data (Unaudited) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Quarterly Financial Information Disclosure [Abstract] | |||||||||||
Product sales, net | $ 23,811 | $ 21,725 | $ 19,724 | $ 16,061 | $ 14,967 | $ 13,261 | $ 11,956 | $ 10,102 | $ 81,321 | $ 50,286 | $ 26,551 |
Gross profit on product sales | 23,250 | 21,057 | 19,298 | 15,658 | 14,603 | 13,005 | 11,517 | 9,800 | |||
Net income (loss) | $ 4,597 | $ 2,585 | $ 977 | $ (19) | $ 959 | $ (601) | $ (1,936) | $ (4,830) | $ 8,140 | $ (6,408) | $ (31,383) |
Basic and diluted | $ 0.04 | $ 0.02 | $ 0.01 | $ 0 | $ 0.01 | $ (0.01) | $ (0.02) | $ (0.05) | $ 0.07 | $ (0.06) | $ (0.31) |