Document_and_Entity_Informatio
Document and Entity Information (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Mar. 02, 2015 | Jun. 30, 2014 | |
Document And Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | FALSE | ||
Document Period End Date | 31-Dec-14 | ||
Document Fiscal Year Focus | 2014 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | CORT | ||
Entity Registrant Name | CORCEPT THERAPEUTICS INC | ||
Entity Central Index Key | 1088856 | ||
Current Fiscal Year End Date | -19 | ||
Entity Well Known Seasoned Issuer | No | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Accelerated Filer | ||
Entity Public Float | $184,675,000 | ||
Entity Common Stock, Shares Outstanding | 101,405,250 |
BALANCE_SHEETS
BALANCE SHEETS (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Current assets: | ||
Cash and cash equivalents | $24,248 | $54,877 |
Trade receivables | 3,334 | 1,428 |
Inventory | 1,207 | 1,096 |
Prepaid expenses and other current assets | 1,441 | 910 |
Total current assets | 30,230 | 58,311 |
Strategic inventory | 4,090 | 4,450 |
Property and equipment, net of accumulated depreciation | 236 | 203 |
Other assets | 74 | 113 |
Total assets | 34,630 | 63,077 |
Current liabilities: | ||
Accounts payable | 1,886 | 2,381 |
Accrued clinical expenses | 336 | 3,288 |
Other accrued liabilities | 1,876 | 1,301 |
Long-term obligation-current portion | 9,424 | 5,743 |
Deferred revenue | 33 | 25 |
Total current liabilities | 13,555 | 12,738 |
Long-term obligation, net of current portion | 24,463 | 29,322 |
Commitments | ||
Stockholders' equity: | ||
Preferred stock, $0.001 par value, 10,000 shares authorized and no shares outstanding at December 31, 2014 or 2013 | ||
Common stock, $0.001 par value, 280,000 shares authorized and 101,395 and 99,849 shares issued and outstanding at December 31, 2014 and 2013, respectively | 101 | 100 |
Additional paid-in capital | 320,511 | 313,534 |
Accumulated deficit | -324,000 | -292,617 |
Total stockholders' equity | -3,388 | 21,017 |
Total liabilities and stockholders' equity | $34,630 | $63,077 |
BALANCE_SHEETS_Parenthetical
BALANCE SHEETS (Parenthetical) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
CONSOLIDATED BALANCE SHEETS [Abstract] | ||
Preferred stock, par value | $0.00 | $0.00 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $0.00 | $0.00 |
Common stock, shares authorized | 280,000,000 | 280,000,000 |
Common stock, shares issued | 101,395,000 | 99,849,000 |
Common stock, shares outstanding | 101,395,000 | 99,849,000 |
STATEMENTS_OF_COMPREHENSIVE_LO
STATEMENTS OF COMPREHENSIVE LOSS (USD $) | 12 Months Ended | ||
In Thousands, except Per Share data, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS [Abstract] | |||
Product sales, net | $26,551 | $10,357 | $3,307 |
Operating expenses: | |||
Cost of sales | 882 | 143 | 91 |
Cost incurred under the agreement | 18,372 | 20,470 | 14,074 |
Selling, general and administrative | 34,916 | 31,240 | 25,414 |
Total operating expenses | 54,170 | 51,853 | 39,579 |
Loss from operations | -27,619 | -41,496 | -36,272 |
Interest and other expense | -3,764 | -4,515 | -1,776 |
Net loss and comprehensive loss | ($31,383) | ($46,011) | ($38,048) |
Basic and diluted net loss per share | ($0.31) | ($0.46) | ($0.41) |
Shares used in computing basic and diluted net loss per share | 100,978 | 99,819 | 93,015 |
STATEMENT_OF_STOCKHOLDERS_EQUI
STATEMENT OF STOCKHOLDERS' EQUITY (DEFICIT) (USD $) | Common Stock [Member] | Common Stock [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Additional Paid-in Capital [Member] | Additional Paid-in Capital [Member] | Additional Paid-in Capital [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] | Employees and Directors [Member] | Non-employee [Member] | Public Financing Transaction [Member] | Private Equity Transaction [Member] | Total |
In Thousands, except Share data | Public Financing Transaction [Member] | Private Equity Transaction [Member] | Employees and Directors [Member] | Non-employee [Member] | Public Financing Transaction [Member] | Private Equity Transaction [Member] | ||||||||
Beginning Balance at Dec. 31, 2011 | $84 | $243,281 | ($208,558) | $34,807 | ||||||||||
Beginning Balance (in shares) at Dec. 31, 2011 | 84,231,000 | |||||||||||||
Issuance of stock (in shares) | 11,000,000 | 4,202,000 | ||||||||||||
Issuance of stock | 11 | 4 | 46,119 | 12,815 | 46,130 | 12,819 | ||||||||
Issuance of common stock upon exercise of warrants (in shares) | 216,000 | |||||||||||||
Issuance of common stock upon exercise of warrants | 470 | 470 | ||||||||||||
Issuance of common stock upon exercise of options (in shares) | 165,000 | 165,000 | ||||||||||||
Issuance of common stock upon exercise of options | 1 | 288 | 289 | |||||||||||
Stock-based compensation | 5,102 | 208 | 5,102 | 208 | ||||||||||
Net loss and comprehensive loss | -38,048 | -38,048 | ||||||||||||
Ending Balance at Dec. 31, 2012 | 100 | 308,283 | -246,606 | 61,777 | ||||||||||
Ending Balance (in shares) at Dec. 31, 2012 | 99,814,000 | |||||||||||||
Issuance of common stock upon exercise of options (in shares) | 35,000 | 35,000 | ||||||||||||
Issuance of common stock upon exercise of options | 55 | 55 | ||||||||||||
Stock-based compensation | 5,069 | 127 | 5,069 | 127 | ||||||||||
Net loss and comprehensive loss | -46,011 | -46,011 | ||||||||||||
Ending Balance at Dec. 31, 2013 | 100 | 313,534 | -292,617 | 21,017 | ||||||||||
Ending Balance (in shares) at Dec. 31, 2013 | 99,849,000 | |||||||||||||
Issuance of common stock upon exercise of warrants (in shares) | 165,000 | |||||||||||||
Issuance of common stock upon exercise of options (in shares) | 1,381,000 | 1,381,000 | ||||||||||||
Issuance of common stock upon exercise of options | 1 | 1,776 | 1,777 | |||||||||||
Stock-based compensation | 4,731 | 470 | 4,731 | 470 | ||||||||||
Net loss and comprehensive loss | -31,383 | -31,383 | ||||||||||||
Ending Balance at Dec. 31, 2014 | $101 | $320,511 | ($324,000) | ($3,388) | ||||||||||
Ending Balance (in shares) at Dec. 31, 2014 | 101,395,000 |
STATEMENTS_OF_CASH_FLOWS
STATEMENTS OF CASH FLOWS (USD $) | 12 Months Ended | ||
In Thousands, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Operating activities | |||
Net loss | ($31,383) | ($46,011) | ($38,048) |
Adjustments to reconcile net loss to net cash used in operations: | |||
Stock-based compensation | 5,201 | 5,196 | 5,310 |
Accretion of interest expense | 3,678 | 4,410 | 1,680 |
Amortization of debt financing costs | 29 | 35 | 17 |
Depreciation and amortization of property and equipment | 141 | 74 | 27 |
Changes in operating assets and liabilities: | |||
Trade receivables | -1,906 | -871 | -557 |
Inventory | 249 | -883 | -4,663 |
Prepaid expenses and other current assets | -531 | -290 | -480 |
Other assets | 10 | -4 | 11 |
Accounts payable | -495 | -1,423 | 193 |
Accrued clinical expenses | -2,952 | 2,445 | 199 |
Other accrued liabilities | 575 | 255 | 275 |
Deferred revenue | 8 | 9 | 16 |
Net cash used in operating activities | -27,376 | -37,058 | -36,020 |
Investing activities | |||
Purchases of property and equipment | -174 | -127 | -151 |
Cash used in investing activities | -174 | -127 | -151 |
Financing activities | |||
Proceeds from issuance of common stock and warrants, net of issuance costs | 59,419 | ||
Proceeds from exercise of stock options, net of issuance costs | 1,777 | 55 | 289 |
Proceeds from issuance of long-term obligation, net of cash paid for issuance costs | 29,860 | ||
Payments related to long-term obligation | -4,856 | -1,025 | |
Net cash (used in) provided by financing activities | -3,079 | -970 | 89,568 |
Net (decrease) increase in cash and cash equivalents | -30,629 | -38,155 | 53,397 |
Cash and cash equivalents at beginning of period | 54,877 | 93,032 | 39,635 |
Cash and cash equivalents at end of period | $24,248 | $54,877 | $93,032 |
Basis_of_Presentation_and_Summ
Basis of Presentation and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2014 | |
Basis of Presentation and Summary of Significant 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 | |
Corcept Therapeutics Incorporated was incorporated in the state of Delaware in May 1998, and our facilities are located in Menlo Park, California. Corcept is a pharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of severe metabolic, oncologic and psychiatric disorders. Since our inception, we have been developing our lead product, Korlym®. Mifepristone, the active ingredient in Korlym, is a potent competitive antagonist of the glucocorticoid receptor (GR), which means that it competitively blocks the effects of cortisol throughout the body at one of its two receptors. In February 2012, the United States Food and Drug Administration (FDA) approved Korlym (mifepristone) 300 mg Tablets as a once-daily oral medication for treatment of hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing’s syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery. We released Korlym for sale in the United States in April 2012. In December 2013, we initiated a study of mifepristone for the treatment of triple-negative breast cancer. In addition, we have discovered and patented three series of novel selective GR antagonists. Unless otherwise stated, all references in these financial statements to “we,” “us,” “our,” “Corcept,” the “Company,” “our company” and similar designations refer to Corcept Therapeutics Incorporated. | |
Use of Estimates | |
The preparation of financial statements in conformity with U.S. generally accepted accounting principles requires management to use assumptions and make estimates to form judgments 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 our reserves for chargebacks and rebates, patient assistance, potential product returns, excess/obsolete inventories, allowances for doubtful accounts, accruals of clinical and preclinical expenses, contingent liabilities, and the timing of payments with respect to our long-term financing agreement, which determine its effective interest rate. We base our estimates on relevant experience and on other specific assumptions that we believe are reasonable. | |
We update our assumptions and estimates on a recurring basis as new information becomes available. Any changes in estimates are recorded in the period of the change. | |
Cash and Cash Equivalents | |
We invest our cash in bank deposits, money market accounts, corporate debt securities and obligations of the U.S. government and U.S. government sponsored entities. 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, which approximates cost and, as of December 31, 2014 and 2013, all of our funds were invested in cash and cash equivalents that consist of a money market fund maintained at a major U.S. financial institution. | |
Credit Risks and Concentrations | |
We have a concentration of credit risk related to our cash and cash equivalents. We are exposed to credit risk in the event of default by the financial institution holding these funds or by the entity or entities that issued the securities held by the fund to the extent of the amount recorded on our balance sheet. We mitigate this risk by investing in a money market fund that invests primarily in short-term U.S. Treasury notes and bills. We have never experienced a loss or lack of access to cash and cash equivalents in our operating or investment accounts. | |
Since the commercialization of Korlym in April 2012, we have been exposed to credit risk in regard to our trade receivables. From the launch of Korlym through June 30, 2013, 97% of our sales were to one specialty pharmacy customer, from whom we have fully collected all receivables. As discussed in Note 2, Significant Agreements – Commercial Agreements, in mid-2013 we transitioned all of our specialty pharmacy business to a new provider, Dohmen Life Science Services (Dohmen), formerly known as Centric Health Resources, Inc.. Among other services, Dohmen 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 of our product. As of December 31, 2014, we had one tablet manufacturer for Korlym– AAI Pharma Services Corp. (AAI). 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. | |
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, for example, 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, not an entity-specific measurement, and a fair value measurement should therefore be based on the assumptions that market participants would use in pricing the asset or liability. | |
No assets or liabilities in our financial statements are required to be reported at fair value other than our cash equivalents. | |
Trade Receivables | |
Trade receivables are recorded net of customer allowances for co-pay assistance, doubtful accounts and sales returns. See the discussion below under “Net Product Sales” regarding the methods for estimation of these allowances and sales returns. We determine our allowance for doubtful accounts based on existing contractual payment terms, actual payment patterns of our customers and individual customer circumstances. To date, we have determined that an allowance for uncollectible trade receivables is not required. | |
Inventory | |
We consider regulatory approval of product candidates to be uncertain, and product manufactured prior to regulatory approval may not be sold unless regulatory approval is obtained. We expense the manufacturing costs for product candidates incurred prior to regulatory approval as research and development expense as we incur them. When regulatory approval of a product is obtained, we begin capitalizing manufacturing costs related to the approved product into inventory, provided such product is produced by a facility the FDA has approved to manufacture the commercial product. | |
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 analyze our inventory levels quarterly and write down inventory that has become obsolete or has a cost basis in excess of its expected net realizable value, as well as any inventory quantities in excess of expected requirements. Any expired inventory is disposed of and the related costs are recognized as cost of sales in the statement of comprehensive loss. | |
Inventory amounts that are not expected to be consumed within twelve months following the balance sheet date are classified as strategic inventory, a noncurrent asset. | |
Property and Equipment | |
We state property and equipment at cost less accumulated depreciation. Property and equipment are depreciated using the straight-line method over the estimated useful lives of the assets, ranging from three to five years. | |
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 was recorded as a long-term obligation at issuance. We are obligated to make payments calculated as a percentage of (i) any licensing or other contingent payments arising from Korlym and any other products containing mifepristone or any of our proprietary selective GR antagonists (Covered Products) and (ii) net Covered Product revenues earned in the calendar quarter ended June 30, 2013 and thereafter (together, Korlym Receipts), until such time as we have paid Biopharma a total of $45.0 million. | |
Interest expense related to the Financing Agreement is calculated based on the internal interest rate to Biopharma that would result from these assumed payment streams. | |
The accounting for the Financing Agreement requires us to make certain estimates and assumptions, including the timing of royalty payments due to Biopharma, the expected rate of return to Biopharma, the split between current and long-term portions of the obligation and the accretion of related interest expense. Korlym has only been marketed since April 2012 and the magnitude and timing of Korlym revenue is difficult to predict. Therefore, these estimates and assumptions are subject to significant variability and are likely to change as we gain experience marketing Korlym, which will result in changes in our classification of the current and long-term portions of the amounts payable pursuant to the Financing Agreement, as well as the internal rate of return paid to Biopharma and the accretion of interest expense related to this obligation. The amount of our payment with respect to each quarter will be based on Korlym Receipts recorded in that quarter and may differ from our estimates. While changes in timing of Korlym revenue may affect the timing of recognition of interest expense and the split between the current and long-term portions of the obligation at any balance sheet date, the aggregate amount to be repaid to Biopharma is fixed at $45.0 million. | |
The amount shown as the current portion of the obligation is an estimate of the total amount under the Financing Agreement that would be paid to Biopharma within 12 months following December 31, 2014. | |
See Note 6, Long-Term Obligation, for additional information regarding this agreement. | |
Net Product Sales | |
Korlym is not available in retail pharmacies. From our initial launch in April 2012 through June 30, 2013, we sold Korlym primarily to a specialty pharmacy and a specialty distributor, which subsequently resold Korlym to patients and healthcare providers. As of July 1, 2013, we began using Dohmen as our specialty pharmacy. Dohmen operates on a consignment basis, without carrying any Korlym inventory. Accordingly, all of our sales through Dohmen are made directly to patients. | |
We recognize product revenues 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 product 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. | |
We make cash donations to a non-profit third party organization that provides patients who meet certain eligibility requirements with financial assistance for the treatment of Cushing's syndrome, which treatment may include Korlym. We do not include in net product revenues sales of Korlym tablets to uninsured patients funded through this source. | |
We calculate gross product revenues based on the price that we charge our customers. We estimate our net product revenues by deducting from our gross product revenues (a) trade allowances, such as discounts for prompt payment, (b) estimated government rebates and chargebacks, (c) reserves for expected product returns and (d) estimated costs of our patient co-pay assistance program. We initially record estimates for these deductions at the time we recognize the gross revenue. We update our estimates on a recurring basis as new information becomes available. | |
Trade Allowances: Through June 30, 2013, we offered our specialty pharmacy and specialty distributor customers a discount on Korlym sales for payment within 30 days and a small discount for providing data services. We expected these customers to earn these discounts and, accordingly, deducted them in full from gross product revenues and trade receivables at the time we recognized such revenues. Beginning in the third quarter of 2013, with the change in our sales model discussed above, we ceased incurring a prompt-payment discount on product sold through our specialty pharmacy and the cost of data services is now recorded as operating expense. | |
Rebates and Chargebacks: We contract with Medicaid and other government programs so that Korlym will be eligible for purchase by, or qualify for partial or full reimbursement from, such government programs. We estimate the rebates and chargebacks that we are obligated to provide to government programs and deduct these estimated amounts from our gross product sales at the time the revenues are recognized. We base our estimates of these rebates and chargebacks upon (i) the discount amounts applicable to government-funded programs and (ii) the percentage of sales by our customers to patients who are covered by entities or programs that are eligible for such rebates and chargebacks. | |
Allowances for Patient Co-pay Assistance Program: We provide financial assistance to eligible patients whose insurance policies require them to pay high deductibles and co-pays. We estimate the cost of assistance to be provided under this program by applying our actual experience regarding such assistance to our estimate of the percentage of our sales in the period that will be provided to patients covered by the program. | |
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. | |
Because our sales through Dohmen, our specialty pharmacy, which represents the majority of our sales from July 1, 2015 forward, are made to individual patients who do not have the right to return the product, our exposure to product returns is limited to the specialty distributor channel and is not expected to be material. | |
Cost of Sales | |
Cost of sales includes the cost of product (the cost to manufacture Korlym, which includes material, third-party manufacturing costs and indirect personnel and other overhead costs) based on units for which revenue is recognized in the current period, as well as costs of stability testing, logistics and distribution of the product. We began capitalizing Korlym production costs and the cost to acquire mifepristone, the active ingredient (API) in Korlym, as inventory following approval by the FDA in February 2012. Prior to receiving FDA approval for Korlym, we expensed all such costs when incurred as research and development expense. A portion of the product manufactured and the API acquired prior to FDA approval was available for commercial use. As of December 31, 2014, the majority of this pre-approval material has been consumed and the cost of sales for 2015 and future years will include the full cost of the product. | |
Research and Development | |
Research and development expenses consist of costs incurred for research and development activities that we sponsor. These costs include direct expenses, such as the cost of clinical trials, pre-clinical studies, manufacturing development, preparations for submissions to the FDA and other regulatory bodies and efforts to prosecute and defend those submissions and the development of second-generation compounds, as well as research and development-related overhead expenses. We expense as incurred nonrefundable payments to third parties and our cost of acquiring technologies and materials used in research and development that have no alternative future use. | |
We base our cost accruals for clinical trials, research and preclinical activities 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 concerns the discovery, development and commercialization of pharmaceutical products. | |
Stock-Based Compensation | |
Stock-based compensation for employee and director options | |
We account for stock-based compensation related to option grants to employees and directors under the fair value method, based on the value of the award at the grant date as determined using the Black-Scholes option valuation model. For service-based awards, we recognize expense over the requisite service period. For options with performance-based vesting criteria, we begin to recognize expense when we believe there is a high degree of probability (i.e., greater than 70%) of achieving the vesting criteria. | |
Stock-based compensation expense related to non-employees | |
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. For service-based awards, we recognize expense over the requisite service period. For options with performance-based vesting criteria, we recognize expense based on the minimum number of shares that will vest over time as the criteria are met based on the Black-Scholes valuation of the vested shares. | |
See Note 8 for a detailed discussion of stock-based compensation expense. | |
Income Taxes | |
We determine deferred tax assets and liabilities based on the differences between the financial reporting and tax bases of assets and liabilities, measured using the enacted tax rates that will be in effect when the differences are expected to reverse. A valuation allowance is recorded when it is more likely than not that the deferred tax asset will not be realized. | |
No amounts have been recognized as interest or penalties on income tax related matters. The determination of an accounting policy as to the classification of such costs has been deferred until such time as any such costs are incurred. | |
Recently Issued Accounting Pronouncements | |
In May 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2014-09, Revenue from Contracts with Customers. ASU 2014-09 supersedes the revenue recognition requirements in Revenue Recognition (Topic 605), and requires entities to recognize revenue in a way that depicts 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 applying this new guidance to contracts within its scope, an entity will: (1) identify the contract(s) with a customer, (2) identify the performance obligation in the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations in the contract, and (5) recognize revenue when (or as) the entity satisfies a performance obligation. Additionally, this new guidance will require significantly expanded revenue recognition disclosures. This guidance, which will become effective for us as of January 1, 2017, is to be applied retrospectively. Early application is not permitted. We are currently evaluating the new standard, but do not anticipate a material impact to our financial statements once implemented. | |
In August 2014, the FASB issued ASU No. 2014-15, Disclosure of Uncertainties about an Entity's Ability to Continue as a Going Concern, which requires an entity to evaluate whether conditions or events, in the aggregate, raise substantial doubt about the entity's ability to continue as a going concern for one year from the date the financial statements are issued or are available to be issued. The guidance will become effective January 1, 2017. The adoption of ASU 2014-15 is not expected to have an impact on our financial statements. | |
Significant_Agreements
Significant Agreements | 12 Months Ended |
Dec. 31, 2014 | |
Significant Agreements [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. | |
In May 2013, we gave notice to CuraScript, our previous specialty pharmacy provider, of our intent to terminate our agreement with them effective July 20, 2013. In June 2013, we recorded a return reserve estimate of $300,000 for inventory that CuraScript had purchased from us but had the right to return as a result of this termination. This amount, which was reflected as an adjustment to net revenue in our Statement of Comprehensive Loss for the year ended December 31, 2013, was settled and paid to CuraScript during 2014. Our exposure to product returns is now limited to the specialty distributor channel and is not expected to be material. | |
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 agreement 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 AAI Pharma for the manufacture and package 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 AAI Pharma, 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 AAI Pharma 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. | |
See the discussion above in Note 1, Basis of Presentation and Summary of Significant Accounting Policies - Credit Risks and Concentrations, for a further discussion of the business risks and mitigation measures taken in regard to tablet manufacture. | |
Research and Development Agreements | |
In 1998, we entered into an agreement with The Board of Trustees of Leland Stanford Junior University (Stanford) in which Stanford granted us an exclusive option to acquire an exclusive license for inventions and patents related to “Mifepristone for Psychotic Major Depression” and “Mifepristone and Alzheimer’s Disease” owned by Stanford. (“Psychotic major depression” is referred to in this document as “psychotic depression.”) In 1999, we exercised our option to acquire 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 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. | |
In 2003, we entered into a contract research agreement with Argenta Discovery Limited (Argenta) in which Argenta agreed to conduct research toward identifying a novel small molecule glucocorticoid receptor antagonist for the treatment of psychotic depression, Alzheimer’s disease, and other metabolic and psychiatric disorders. We continued our relationship with Argenta through the end of 2011, requesting them to conduct research projects on a regular basis. Under the agreements with Argenta, we may be obligated to make milestone payments upon the occurrence of certain events, the amounts of which are not material. These obligations remain in force after the conclusion of work under the agreement. In January 2012, we entered into a Master Services Agreement with Sygnature Discovery Limited, a contract research company located in the United Kingdom, which does not obligate us to any milestone payments. | |
Through 2014, we entered into agreements for services in connection with our ongoing Phase 3 trial of psychotic depression with ICON Clinical Research, L.P. (ICON) and MedAvante, Inc. (MedAvante) to manage the trial and conduct patient screening and evaluation services, which have been amended from time to time. This clinical trial was terminated during 2014 and all amounts due under this agreement have been paid or accrued as of December 31, 2014. | |
In November 2013, we licensed from the University of Chicago exclusive rights to the University’s U.S. Patent No. 8,710,035 “Methods and Compositions Related to Glucocorticoid Receptor Antagonists and Breast Cancer”. In exchange for the license, we paid an initial non-refundable fee 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 and will pay a royalty based on net revenue generated by any product arising from the patent until its expiration. | |
In December 2013, we entered into an agreement with Chiltern to assist in the management and conduct of a clinical trial evaluating mifepristone for treatment of triple-negative breast cancer. The total commitment under this agreement is $2.9 million, but the actual amount to be paid is dependent on actual services provided under this agreement. Approximately $1.0 million of the costs under this agreement were incurred through December 31, 2014, with the remainder to be incurred over the course of the trial. | |
In March 2014, we entered into an agreement with Quotient Clinical Limited, a clinical research organization, to assist in the management and conduct of our Phase 1 study of CORT125134, one of our new compounds. The total commitment under the agreement is approximately $2.6 million, which is expected to be expended over approximately a 1-year period. Approximately $1.5 million of the costs under this agreement were incurred through December 31, 2014, with the remainder to be incurred over the course of the trial. | |
Fair_Value_of_Financial_Instru
Fair Value of Financial Instruments | 12 Months Ended |
Dec. 31, 2014 | |
Fair Value of Financial Instruments [Abstract] | |
Fair Value of Financial Instruments | 3. Fair Value of Financial Instruments |
As of December 31, 2014 and 2013, 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 $21.9 million and $52.9 million as of December 31, 2014 and 2013, respectively, 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, 2014 and 2013 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, 2014 | ||||||
Composition of Certain Balance Sheet Items [Abstract] | ||||||
Composition of Certain Balance Sheet Items | 4. Composition of Certain Balance Sheet Items | |||||
Inventory | ||||||
The composition of inventory was as follows: | ||||||
December 31, | December 31, | |||||
2014 | 2013 | |||||
(in thousands) | ||||||
Raw materials | $ | 3,595 | $ | 4,318 | ||
Work in progress | 15 | 2 | ||||
Finished goods | 1,687 | 1,226 | ||||
Total inventory | 5,297 | 5,546 | ||||
Less strategic inventory classified as non-current | -4,090 | -4,450 | ||||
Total inventory classified as current | $ | 1,207 | $ | 1,096 | ||
The majority of the finished goods inventory as of December 31, 2014 and 2013 includes all costs of manufacture and packaging with the exception of the cost of raw materials that were expensed prior to FDA approval. | ||||||
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 twelve 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, | ||||||
2014 | 2013 | |||||
(in thousands) | ||||||
Furniture and equipment | $ | 253 | $ | 183 | ||
Vehicles | 65 | 38 | ||||
Software | 193 | 116 | ||||
Leasehold improvements | 14 | 14 | ||||
525 | 351 | |||||
Less: accumulated depreciation | -289 | -148 | ||||
$ | 236 | $ | 203 | |||
Other Accrued Liabilities | ||||||
Other accrued liabilities consisted of the following: | ||||||
December 31, | ||||||
2014 | 2013 | |||||
(in thousands) | ||||||
Accrued compensation | $ | 564 | $ | 466 | ||
Professional fees | 330 | 369 | ||||
Commercialization costs | 556 | 288 | ||||
Government rebates | 275 | 40 | ||||
Legal fees | 120 | 110 | ||||
Other | 31 | 28 | ||||
$ | 1,876 | $ | 1,301 | |||
LongTerm_Obligation
Long-Term Obligation | 12 Months Ended | |||||
Dec. 31, 2014 | ||||||
Long-Term Obligation [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 Financing Agreement with Biopharma, we are obligated to make payments, calculated as a percentage of our net sales of Korlym, any future mifepristone-based products, our selective GR antagonists (together referred to as Covered Products) and any upfront, milestone or other contingent payments with respect to Covered Products. Biopharma’s right to receive payments will expire once it has received cumulative payments of $45.0 million. We have made aggregate payments to Biopharma in the amount of $5.9 million through December 31, 2014, with an additional payment in the amount of $1.9 million made in February 2015. | ||||||
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, subject to quarterly payment caps of $3.75 million during 2015. There is no quarterly cap on payments with respect to net product sales in 2016 and later. | |||||
· | 20 percent of payments received for upfront, milestone or other contingent fees under co-promotion and out-license agreements for Covered Products (without application of quarterly caps). | |||||
· | 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 this 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. | ||||||
The cash payment of $30.0 million received from Biopharma was recorded as a long-term obligation at issuance in August 2012. As discussed in Note 1, Basis of Presentation and Summary of Significant Accounting Policies, Long-term Obligation, we make estimates of the timing of payments during the term of this agreement for purposes of calculating the expected rate of return to Biopharma, the accretion of related interest expense and the current portion of our obligation. Interest expense of $3.7 million and $4.4 million for the years ended December 31, 2014 and 2013, respectively, and total accreted interest of $9.8 million for the period from August 16, 2012, the date of funding of the Financing Agreement, through December 31, 2014, was calculated based on the internal interest rate to Biopharma that would result from these assumed payment streams. The timing of payment amounts will be based on actual Korlym Receipts recorded in the financial statements over the term of this agreement and may differ from these estimates. While changes in the timing of Korlym revenue may affect the timing of recognition of interest expense and the split between the current and long-term portions of the obligation at any balance sheet date, the aggregate amount to be repaid to Biopharma is fixed at $45.0 million. | ||||||
The carrying value of the long-term obligation was $33.9 million and $35.1 million as of December 31, 2014 and December 31, 2013, respectively. The long-term obligation, including accreted interest, is presented on the balance sheet in two components; the Long-term obligation - current portion, which equates to the estimated amount due under the agreement to be paid within twelve months following the balance sheet date, and the remaining amount, which is included in Long-term obligation, net of current portion. | ||||||
The following table provides a summary of the payment obligations under the Financing Agreement as of December 31, 2014 and 2013, utilizing the payment assumptions discussed above. | ||||||
December 31, | December 31, | |||||
2014 | 2013 | |||||
(in thousands) | ||||||
Total repayment obligation | $ | 45,000 | $ | 45,000 | ||
Less interest to be accreted in future periods | -5,232 | -8,910 | ||||
Less payments made | -5,881 | -1,025 | ||||
Less current portion | -9,424 | -5,743 | ||||
Long-term obligation, net of current portion | $ | 24,463 | $ | 29,322 | ||
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, 2014 and 2013. 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 revenues and an estimated cost of capital. Management’s estimate of the future product revenues is subject to significant uncertainty due to the fact that Korlym has been available for less than three years and there is an extended time period associated with the Financing Agreement. | ||||||
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, 2014, the unamortized issuance costs were $58,000, and are included in other assets on our balance sheet. | ||||||
Lease_Obligations
Lease Obligations | 12 Months Ended |
Dec. 31, 2014 | |
Lease Obligations [Abstract] | |
Lease Obligations | 6. Lease Obligations |
In May 2014, we exercised our option to extend the lease for our office space through December 2015. At December 31, 2014, the remaining minimum rental payments under this operating lease were $631,000. | |
Through December 31, 2014, we have entered into operating leases for automobiles provided to our sales force and medical science liaisons. The leases are for periods of three years each. At December 31, 2014, the remaining obligation for base rental payments under these leases was $180,000. | |
Rent expense amounted to $609,000, $428,000 and $360,000, for the years ended December 31, 2014, 2013 and 2012, respectively. | |
Related_Party_Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2014 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 7. Related Party Transactions |
See discussion below in Note 8, Preferred Stock and Stockholders’ Equity, under the caption Common Stock, regarding the sale of securities in March 2012 to various investors, including members of our board of directors and related entities. | |
Preferred_Stock_and_Stockholde
Preferred Stock and Stockholders' Equity | 12 Months Ended | ||||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||||
Preferred Stock and Stockholders' Equity [Abstract] | |||||||||||||||||||
Preferred Stock and Stockholders' Equity | 8. Preferred Stock and Stockholders’ Equity | ||||||||||||||||||
Preferred Stock | |||||||||||||||||||
The 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, 2014 and 2013, we had no outstanding shares of preferred stock. | |||||||||||||||||||
Common Stock | |||||||||||||||||||
Significant stock transactions | |||||||||||||||||||
There were no transactions relating to the sale and issuance of common stock or the exercise and issuance of warrants during the two years ended December 31, 2014 and 2013, other than the exercise of a warrant in May 2014 that had been issued in a private placement in March 2008 (the March 2008 Financing). This warrant was exercised on a cashless net-exercise basis, wherein the investor surrendered a warrant for 529,567 shares in exchange for the issuance of 164,666 shares of common stock. The following paragraphs describe significant transactions relating to the sale and issuance of common stock and the exercise and issuance of warrants during the year ended December 31, 2012. Information regarding the issuance of common stock upon the exercise of stock options is discussed below under the caption, Stock Option Plans. | |||||||||||||||||||
Transactions during 2012 | |||||||||||||||||||
On March 29, 2012, we issued 4.2 million shares of our common stock upon the exercise of warrants that we had issued in a private placement transaction in April 2010 at an exercise price of $2.96 per share and sold new warrants to the same investors to purchase 4.2 million shares of common stock at an exercise price of $4.05 per share. The new warrants are exercisable through March 29, 2015. We generated net proceeds in these transactions of $12.8 million, after the deduction of issuance costs. Venture capital funds, trusts and other entities affiliated with members of our Board of Directors purchased 40 percent of the securities sold in this transaction, with the remainder being purchased by other qualified investors. | |||||||||||||||||||
On July 6, 2012, we sold 11.0 million shares of our common stock in an underwritten public offering at a price to the public of $4.49 per share, generating net proceeds of $46.1 million after deducting expenses of the offering. | |||||||||||||||||||
During the year ended December 31, 2012, investors exercised additional warrants for the purchase of our common stock with exercise prices ranging from $1.66 to $2.96 per share. As a result, we issued an aggregate of 216,000 shares of common stock and generated aggregate proceeds of $470,000. | |||||||||||||||||||
Registration Rights related to March 2008 Financing | |||||||||||||||||||
In March 2008, we sold 8.9 million shares of our common stock and warrants to purchase 4.5 million shares of our common stock in the March 2008 Financing. The registration rights agreement covering securities issued in the March 2008 Financing provides that if we do not fulfill certain of our obligations under the registration rights agreement, we will be required to pay liquidated damages to the holders of the shares and warrants. We filed the registration statement covering the resale of the shares sold and shares underlying the warrants sold in this transaction with the Securities and Exchange Commission (SEC) on April 11, 2008, and it was declared effective by the SEC on November 10, 2008. During 2008, we recorded $1.3 million in liquidated damages to other non-operating expense because of the delay in the effectiveness of the registration statement, which represented 5% of the purchase price. No separate contingent obligation has been recorded since that time as no additional liquidated damages have become probable of payment. | |||||||||||||||||||
No dividends have been declared or paid by us. | |||||||||||||||||||
Shares of common stock reserved for future issuance as of December 31, 2014 are as follows: | |||||||||||||||||||
Common stock: | (in thousands) | ||||||||||||||||||
Exercise of outstanding options | 14,704 | ||||||||||||||||||
Exercise of warrants | 8,044 | ||||||||||||||||||
Shares available for grant under stock option plans | 7,546 | ||||||||||||||||||
30,294 | |||||||||||||||||||
On February 18, 2015, our Board of Directors authorized an increase of 4.1 million shares in the number of shares available under the 2012 Incentive Award Plan (the 2012 Plan), which was equivalent to 4% of the shares of our common stock outstanding as of December 31, 2014, pursuant to the terms of the 2012 Plan. | |||||||||||||||||||
Stock Option Plans | |||||||||||||||||||
We have three stock option plans – the 2000 Stock Option Plan (the 2000 Plan), the 2004 Equity Incentive Plan (the 2004 Plan) and the 2012 Plan. As of December 31, 2014, all option grants under the 2000 Plan were fully vested and have either been exercised or expired at the end of their contractual life. | |||||||||||||||||||
In 2004, our board of directors and stockholders approved the 2004 Plan, which became effective upon the completion of our Initial Public Offering (IPO), after which time, no additional options have been or will be issued under the 2000 Plan. 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 2000 Plan and 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 6, 2014, our board of directors authorized an increase of 4.0 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, 2013, pursuant to the terms of the 2012 Plan. As of December 31, 2014, 7.5 million shares remained available for future grants under the 2012 Plan. See the discussion above under Common Stock regarding an additional increase to the shares available for grant under the 2012 Plan that was authorized by the Board of Directors in February 2015. | |||||||||||||||||||
Option activity during 2012, 2013 and 2014 | |||||||||||||||||||
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 thousands) | (in thousands) | (in years) | (in thousands) | ||||||||||||||||
Balance at December 31, 2011 | 2,251 | 10,308 | $ | 2.86 | |||||||||||||||
Increase in shares authorized for grant | 3,369 | — | — | ||||||||||||||||
Shares granted | -1,695 | 1,695 | $ | 3.26 | |||||||||||||||
Shares exercised | — | -165 | $ | 1.91 | |||||||||||||||
Shares expired under 2000 Plan | 11 | -93 | $ | 7 | |||||||||||||||
Shares cancelled and forfeited under 2004 and 2012 Plans | 119 | -119 | $ | 3.26 | |||||||||||||||
Balance at December 31, 2012 | 4,055 | 11,626 | $ | 2.9 | |||||||||||||||
Increase in shares authorized for grant | 3,992 | — | — | ||||||||||||||||
Shares granted | -3,565 | 3,565 | $ | 1.98 | |||||||||||||||
Shares exercised | — | -35 | $ | 1.58 | |||||||||||||||
Shares cancelled and forfeited | 444 | -444 | $ | 4.58 | |||||||||||||||
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 | 6.22 | $ | 10,424 | ||||||||||||
Options exercisable at December 31, 2014 | 10,489 | $ | 2.67 | 5.29 | $ | 7,866 | |||||||||||||
Options fully vested and expected to vest at December 31, 2014 | 14,704 | $ | 2.62 | 6.22 | $ | 10,424 | |||||||||||||
The total intrinsic value of options exercised during the years ended December 31, 2014, 2013 and 2012 was $3.0 million, $55,000 and $303,000, 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, 2014, 2013 and 2012 was $4.6 million, $5.0 million and $5.0 million, respectively. | |||||||||||||||||||
The following is a summary of options outstanding and options exercisable at December 31, 2014. | |||||||||||||||||||
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 | 4,885 | 5 | $ | 1.49 | $ | 7,355 | 3,907 | $ | 1.42 | $ | 6,156 | ||||
$ | 2.01 | - | $ | 3 | 4,779 | 7.4 | $ | 2.36 | 3,069 | 2,678 | $ | 2.36 | 1,710 | ||||||
$ | 3.01 | - | $ | 4.5 | 4,844 | 6.5 | $ | 3.92 | — | 3,709 | $ | 4.08 | — | ||||||
$ | 4.51 | - | $ | 5.7 | 196 | 0.5 | $ | 5.02 | — | 195 | $ | 5.02 | — | ||||||
14,704 | 6.2 | $ | 2.62 | $ | 10,424 | 10,489 | $ | 2.67 | $ | 7,866 | |||||||||
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, 2014. The aggregate intrinsic value is the difference between our closing stock price on December 31, 2014 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, | |||||||||||||||||||
2014 | 2013 | 2012 | |||||||||||||||||
Weighted-average assumptions for stock options granted: | |||||||||||||||||||
Risk-free interest rate | 1.80% | 1.76% | 1.06% | ||||||||||||||||
Expected term | 6 | years | 8.3 | years | 6.7 | years | |||||||||||||
Expected volatility of stock price | 79.00% | 83.90% | 86.60% | ||||||||||||||||
Dividend rate | 0% | 0% | 0% | ||||||||||||||||
Weighted average grant date fair value-based measurement | $ | 1.77 | $ | 1.54 | $ | 2.41 | |||||||||||||
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 apply a forfeiture rate of zero in our stock option expense calculations as we have a limited employee base and have experienced minimal turnover. When an employee terminates, we will record a change in accounting estimate that represents the difference between the expense recorded in the financial statements and the expense that would have been recorded based upon the rights to options that vested during the individual’s service as an employee. | |||||||||||||||||||
Summary of compensation expense related to options to employees and directors | |||||||||||||||||||
We recognized compensation expense of $4.7 million, $5.1 million and $5.1 million, related to options to employees and directors during the years ended December 31, 2014, 2013, and 2012, respectively. The data for the year ended December 31, 2012 include $1.3 million of expense related to performance-based option awards to officers that vested upon the FDA approval of Korlym in February 2012, which is classified as selling, general and administrative expense. | |||||||||||||||||||
As of December 31, 2014, we had $7.1 million of unrecognized compensation expense for employee and director options outstanding as of that date, which had a remaining weighted-average vesting period of 2.5 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. For options with performance-based vesting criteria, we recognize expense based on the minimum number of shares that will vest over time as the criteria are met based on the Black-Scholes valuation of the vested shares. | |||||||||||||||||||
We recorded charges to expense for non-employee stock options of $470,000, $127,000 and $208,000 for the years ended December 31, 2014, 2013 and 2012, respectively. | |||||||||||||||||||
As of December 31, 2014, there are three awards outstanding to non-employees with an aggregate total of 149,000 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, | |||||||||||||||||||
2014 | 2013 | 2012 | |||||||||||||||||
(in thousands) | |||||||||||||||||||
Research and development expense | $ | 723 | $ | 618 | $ | 546 | |||||||||||||
Selling, general and administrative expense | 4,478 | 4,578 | 4,764 | ||||||||||||||||
Total | $ | 5,201 | $ | 5,196 | $ | 5,310 | |||||||||||||
Warrants | |||||||||||||||||||
Outstanding warrants at December 31, 2014 were as follows: | |||||||||||||||||||
Number of | Exercise | Expiration | |||||||||||||||||
Shares | Price | Date | |||||||||||||||||
(in thousands) | |||||||||||||||||||
March 2008 Financing | 3,842 | $ | 2.77 | 3/24/15 | |||||||||||||||
March 2012 Warrant Exchange | 4,202 | $ | 4.05 | 3/29/15 | |||||||||||||||
Total warrants outstanding | 8,044 | ||||||||||||||||||
All of our warrants may be exercised for cash at any time up to the expiration dates noted in the table above. In these instances, the number of shares issued will be equal to the number of warrant shares shown on each respective warrant. | |||||||||||||||||||
The warrants issued under the March 2008 Financing may be exercised pursuant to a cashless net-exercise, whereby the exercise cost is satisfied through a reduction in the number of shares to be issued. In a net-exercise, the number of shares to be issued would be based on the differential between the market value of our common stock at the time of the exercise and the exercise price of the shares underlying the original warrant. The warrants issued under the March 2012 Warrant Exchange do not contain a net-exercise provision. | |||||||||||||||||||
Net_Loss_Per_Share
Net Loss Per Share | 12 Months Ended | |||||
Dec. 31, 2014 | ||||||
Net Loss Per Share [Abstract] | ||||||
Net Loss Per Share | 9. Net Loss Per Share | |||||
Basic and diluted net loss per share is computed by dividing the net loss by the weighted-average number of common shares outstanding during the period. The computation of net loss per share for each period, including the number of weighted-average shares outstanding, is shown on the face of the statements of comprehensive loss. | ||||||
We have excluded the impact of common stock equivalents relating to shares underlying outstanding options and warrants from the calculation of diluted net loss per common share because all such securities are antidilutive for all periods presented. | ||||||
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, | ||||||
2014 | 2013 | 2012 | ||||
(in thousands) | ||||||
Stock options outstanding | 14,704 | 14,712 | 11,626 | |||
Warrants outstanding | 8,044 | 8,574 | 8,904 | |||
Total | 22,748 | 23,286 | 20,530 | |||
Income_Taxes
Income Taxes | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Income Taxes [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, | |||||||||
2014 | 2013 | ||||||||
Deferred tax assets: | (in thousands) | ||||||||
Federal and state net operating losses | $ | 65,012 | $ | 55,955 | |||||
Capitalized research and patent costs | 25,567 | 23,395 | |||||||
Research credits | 22,789 | 21,252 | |||||||
Biopharma Financing Agreement | 13,296 | 13,021 | |||||||
Stock-based compensation costs | 6,410 | 5,398 | |||||||
Other | 2,995 | 1,148 | |||||||
Total deferred tax assets | 136,069 | 120,169 | |||||||
Valuation allowance | -136,069 | -120,169 | |||||||
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, $15.9 million and $14.0 million, respectively, for the years ended December 31, 2014, 2013 and 2012, respectively. | |||||||||
At December 31, 2014, we had net operating loss carryforwards available to offset any future taxable income that we may generate for federal income tax purposes of $167.8 million, which expire in the years 2019 through 2034; California net operating loss carryforwards of $131.0 million, which expire in the years 2015 through 2034 and net operating losses carryforwards from other states of $18.8 million, which expire in the years 2024 through 2034. Our federal and state net operating loss carryforwards as of December 31, 2014 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, 2014. | |||||||||
We also had federal and California research tax credits of $21.0 million and $2.6 million, respectively. The federal research credits will expire in the years 2019 through 2033 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. | |||||||||
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. | |||||||||
The following table presents a reconciliation from the statutory federal income tax rate to the effective rate. | |||||||||
Year ended December 31, | |||||||||
2014 | 2013 | 2012 | |||||||
(in thousands) | |||||||||
U.S. federal taxes (benefit) at statutory rate | $ | -10,670 | $ | -15,644 | $ | -12,936 | |||
Unutilized net operating loss | 11,002 | 16,181 | 13,853 | ||||||
Unutilized research credits | -1,308 | -1,515 | -2,190 | ||||||
Non-deductible offset of Orphan Drug Credit | 249 | 383 | 827 | ||||||
Non-deductible stock based compensation | 673 | 567 | 404 | ||||||
Other | 54 | 28 | 42 | ||||||
Total | $ | — | $ | — | $ | — | |||
Commitments
Commitments | 12 Months Ended |
Dec. 31, 2014 | |
Commitments [Abstract] | |
Commitments | 11. Commitments |
We have entered into a number of agreements to conduct clinical trials and pre-clinical studies for further development of our lead product, Korlym, and our proprietary, selective GR antagonists. See the discussion in Note 2, Significant Agreements, for further discussion regarding the commitments under these 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
Quarterly Financial Data | 12 Months Ended | |||||||||||
Dec. 31, 2014 | ||||||||||||
Quarterly Financial Data [Abstract] | ||||||||||||
Quarterly Financial Data | 12. Quarterly Financial Data (Unaudited) | |||||||||||
The following table is in thousands, except per share amounts: | ||||||||||||
Quarter Ended | 31-Mar | 30-Jun | 30-Sep | 31-Dec | ||||||||
2014 | ||||||||||||
Product sales, net | $ | 4,405 | $ | 5,851 | $ | 7,282 | $ | 9,013 | ||||
Gross profit on product sales | 4,231 | 5,636 | 7,047 | 8,755 | ||||||||
Net loss | -13,930 | -7,552 | -6,006 | -3,895 | ||||||||
Basic and diluted net loss per share | -0.14 | -0.07 | -0.06 | -0.04 | ||||||||
2013 | ||||||||||||
Product sales, net | $ | 1,717 | $ | 1,891 | $ | 2,634 | $ | 4,115 | ||||
Gross profit on product sales | 1,697 | 1,868 | 2,594 | 4,055 | ||||||||
Net loss | -12,084 | -11,897 | -10,906 | -11,124 | ||||||||
Basic and diluted net loss per share | -0.12 | -0.12 | -0.11 | -0.11 | ||||||||
Basis_of_Presentation_and_Summ1
Basis of Presentation and Summary of Significant Accounting Policies (Policy) | 12 Months Ended |
Dec. 31, 2014 | |
Basis of Presentation and Summary of Significant Accounting Policies [Abstract] | |
Description of Business | Description of Business |
Corcept Therapeutics Incorporated was incorporated in the state of Delaware in May 1998, and our facilities are located in Menlo Park, California. Corcept is a pharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of severe metabolic, oncologic and psychiatric disorders. Since our inception, we have been developing our lead product, Korlym®. Mifepristone, the active ingredient in Korlym, is a potent competitive antagonist of the glucocorticoid receptor (GR), which means that it competitively blocks the effects of cortisol throughout the body at one of its two receptors. In February 2012, the United States Food and Drug Administration (FDA) approved Korlym (mifepristone) 300 mg Tablets as a once-daily oral medication for treatment of hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing’s syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery. We released Korlym for sale in the United States in April 2012. In December 2013, we initiated a study of mifepristone for the treatment of triple-negative breast cancer. In addition, we have discovered and patented three series of novel selective GR antagonists. Unless otherwise stated, all references in these financial statements to “we,” “us,” “our,” “Corcept,” the “Company,” “our company” and similar designations refer to Corcept Therapeutics Incorporated. | |
Use of Estimates | Use of Estimates |
The preparation of financial statements in conformity with U.S. generally accepted accounting principles requires management to use assumptions and make estimates to form judgments 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 our reserves for chargebacks and rebates, patient assistance, potential product returns, excess/obsolete inventories, allowances for doubtful accounts, accruals of clinical and preclinical expenses, contingent liabilities, and the timing of payments with respect to our long-term financing agreement, which determine its effective interest rate. We base our estimates on relevant experience and on other specific assumptions that we believe are reasonable. | |
We update our assumptions and estimates on a recurring basis as new information becomes available. Any changes in estimates are recorded in the period of the change. | |
Cash and Cash Equivalents | Cash and Cash Equivalents |
We invest our cash in bank deposits, money market accounts, corporate debt securities and obligations of the U.S. government and U.S. government sponsored entities. 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, which approximates cost and, as of December 31, 2014 and 2013, all of our funds were invested in cash and cash equivalents that consist of a money market fund maintained at a major U.S. financial institution. | |
Credit Risks and Concentrations | Credit Risks and Concentrations |
We have a concentration of credit risk related to our cash and cash equivalents. We are exposed to credit risk in the event of default by the financial institution holding these funds or by the entity or entities that issued the securities held by the fund to the extent of the amount recorded on our balance sheet. We mitigate this risk by investing in a money market fund that invests primarily in short-term U.S. Treasury notes and bills. We have never experienced a loss or lack of access to cash and cash equivalents in our operating or investment accounts. | |
Since the commercialization of Korlym in April 2012, we have been exposed to credit risk in regard to our trade receivables. From the launch of Korlym through June 30, 2013, 97% of our sales were to one specialty pharmacy customer, from whom we have fully collected all receivables. As discussed in Note 2, Significant Agreements – Commercial Agreements, in mid-2013 we transitioned all of our specialty pharmacy business to a new provider, Dohmen Life Science Services (Dohmen), formerly known as Centric Health Resources, Inc.. Among other services, Dohmen 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 of our product. As of December 31, 2014, we had one tablet manufacturer for Korlym– AAI Pharma Services Corp. (AAI). 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. | |
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, for example, 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, not an entity-specific measurement, and a fair value measurement should therefore be based on the assumptions that market participants would use in pricing the asset or liability. | |
No assets or liabilities in our financial statements are required to be reported at fair value other than our cash equivalents. | |
Trade Receivables | Trade Receivables |
Trade receivables are recorded net of customer allowances for co-pay assistance, doubtful accounts and sales returns. See the discussion below under “Net Product Sales” regarding the methods for estimation of these allowances and sales returns. We determine our allowance for doubtful accounts based on existing contractual payment terms, actual payment patterns of our customers and individual customer circumstances. To date, we have determined that an allowance for uncollectible trade receivables is not required. | |
Inventory | Inventory |
We consider regulatory approval of product candidates to be uncertain, and product manufactured prior to regulatory approval may not be sold unless regulatory approval is obtained. We expense the manufacturing costs for product candidates incurred prior to regulatory approval as research and development expense as we incur them. When regulatory approval of a product is obtained, we begin capitalizing manufacturing costs related to the approved product into inventory, provided such product is produced by a facility the FDA has approved to manufacture the commercial product. | |
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 analyze our inventory levels quarterly and write down inventory that has become obsolete or has a cost basis in excess of its expected net realizable value, as well as any inventory quantities in excess of expected requirements. Any expired inventory is disposed of and the related costs are recognized as cost of sales in the statement of comprehensive loss. | |
Inventory amounts that are not expected to be consumed within twelve months following the balance sheet date are classified as strategic inventory, a noncurrent asset. | |
Property and Equipment | Property and Equipment |
We state property and equipment at cost less accumulated depreciation. Property and equipment are depreciated using the straight-line method over the estimated useful lives of the assets, ranging from three to five years. | |
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 was recorded as a long-term obligation at issuance. We are obligated to make payments calculated as a percentage of (i) any licensing or other contingent payments arising from Korlym and any other products containing mifepristone or any of our proprietary selective GR antagonists (Covered Products) and (ii) net Covered Product revenues earned in the calendar quarter ended June 30, 2013 and thereafter (together, Korlym Receipts), until such time as we have paid Biopharma a total of $45.0 million. | |
Interest expense related to the Financing Agreement is calculated based on the internal interest rate to Biopharma that would result from these assumed payment streams. | |
The accounting for the Financing Agreement requires us to make certain estimates and assumptions, including the timing of royalty payments due to Biopharma, the expected rate of return to Biopharma, the split between current and long-term portions of the obligation and the accretion of related interest expense. Korlym has only been marketed since April 2012 and the magnitude and timing of Korlym revenue is difficult to predict. Therefore, these estimates and assumptions are subject to significant variability and are likely to change as we gain experience marketing Korlym, which will result in changes in our classification of the current and long-term portions of the amounts payable pursuant to the Financing Agreement, as well as the internal rate of return paid to Biopharma and the accretion of interest expense related to this obligation. The amount of our payment with respect to each quarter will be based on Korlym Receipts recorded in that quarter and may differ from our estimates. While changes in timing of Korlym revenue may affect the timing of recognition of interest expense and the split between the current and long-term portions of the obligation at any balance sheet date, the aggregate amount to be repaid to Biopharma is fixed at $45.0 million. | |
The amount shown as the current portion of the obligation is an estimate of the total amount under the Financing Agreement that would be paid to Biopharma within 12 months following December 31, 2014. | |
See Note 6, Long-Term Obligation, for additional information regarding this agreement. | |
Net Product Sales | Net Product Sales |
Korlym is not available in retail pharmacies. From our initial launch in April 2012 through June 30, 2013, we sold Korlym primarily to a specialty pharmacy and a specialty distributor, which subsequently resold Korlym to patients and healthcare providers. As of July 1, 2013, we began using Dohmen as our specialty pharmacy. Dohmen operates on a consignment basis, without carrying any Korlym inventory. Accordingly, all of our sales through Dohmen are made directly to patients. | |
We recognize product revenues 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 product 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. | |
We make cash donations to a non-profit third party organization that provides patients who meet certain eligibility requirements with financial assistance for the treatment of Cushing's syndrome, which treatment may include Korlym. We do not include in net product revenues sales of Korlym tablets to uninsured patients funded through this source. | |
We calculate gross product revenues based on the price that we charge our customers. We estimate our net product revenues by deducting from our gross product revenues (a) trade allowances, such as discounts for prompt payment, (b) estimated government rebates and chargebacks, (c) reserves for expected product returns and (d) estimated costs of our patient co-pay assistance program. We initially record estimates for these deductions at the time we recognize the gross revenue. We update our estimates on a recurring basis as new information becomes available. | |
Trade Allowances: Through June 30, 2013, we offered our specialty pharmacy and specialty distributor customers a discount on Korlym sales for payment within 30 days and a small discount for providing data services. We expected these customers to earn these discounts and, accordingly, deducted them in full from gross product revenues and trade receivables at the time we recognized such revenues. Beginning in the third quarter of 2013, with the change in our sales model discussed above, we ceased incurring a prompt-payment discount on product sold through our specialty pharmacy and the cost of data services is now recorded as operating expense. | |
Rebates and Chargebacks: We contract with Medicaid and other government programs so that Korlym will be eligible for purchase by, or qualify for partial or full reimbursement from, such government programs. We estimate the rebates and chargebacks that we are obligated to provide to government programs and deduct these estimated amounts from our gross product sales at the time the revenues are recognized. We base our estimates of these rebates and chargebacks upon (i) the discount amounts applicable to government-funded programs and (ii) the percentage of sales by our customers to patients who are covered by entities or programs that are eligible for such rebates and chargebacks. | |
Allowances for Patient Co-pay Assistance Program: We provide financial assistance to eligible patients whose insurance policies require them to pay high deductibles and co-pays. We estimate the cost of assistance to be provided under this program by applying our actual experience regarding such assistance to our estimate of the percentage of our sales in the period that will be provided to patients covered by the program. | |
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. | |
Because our sales through Dohmen, our specialty pharmacy, which represents the majority of our sales from July 1, 2015 forward, are made to individual patients who do not have the right to return the product, our exposure to product returns is limited to the specialty distributor channel and is not expected to be material. | |
Cost of Sales | Cost of Sales |
Cost of sales includes the cost of product (the cost to manufacture Korlym, which includes material, third-party manufacturing costs and indirect personnel and other overhead costs) based on units for which revenue is recognized in the current period, as well as costs of stability testing, logistics and distribution of the product. We began capitalizing Korlym production costs and the cost to acquire mifepristone, the active ingredient (API) in Korlym, as inventory following approval by the FDA in February 2012. Prior to receiving FDA approval for Korlym, we expensed all such costs when incurred as research and development expense. A portion of the product manufactured and the API acquired prior to FDA approval was available for commercial use. As of December 31, 2014, the majority of this pre-approval material has been consumed and the cost of sales for 2015 and future years will include the full cost of the product. | |
Research and Development | Research and Development |
Research and development expenses consist of costs incurred for research and development activities that we sponsor. These costs include direct expenses, such as the cost of clinical trials, pre-clinical studies, manufacturing development, preparations for submissions to the FDA and other regulatory bodies and efforts to prosecute and defend those submissions and the development of second-generation compounds, as well as research and development-related overhead expenses. We expense as incurred nonrefundable payments to third parties and our cost of acquiring technologies and materials used in research and development that have no alternative future use. | |
We base our cost accruals for clinical trials, research and preclinical activities 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 concerns the discovery, development and commercialization of pharmaceutical products. | |
Stock-Based Compensation | Stock-Based Compensation |
Stock-based compensation for employee and director options | |
We account for stock-based compensation related to option grants to employees and directors under the fair value method, based on the value of the award at the grant date as determined using the Black-Scholes option valuation model. For service-based awards, we recognize expense over the requisite service period. For options with performance-based vesting criteria, we begin to recognize expense when we believe there is a high degree of probability (i.e., greater than 70%) of achieving the vesting criteria. | |
Stock-based compensation expense related to non-employees | |
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. For service-based awards, we recognize expense over the requisite service period. For options with performance-based vesting criteria, we recognize expense based on the minimum number of shares that will vest over time as the criteria are met based on the Black-Scholes valuation of the vested shares. | |
See Note 8 for a detailed discussion of stock-based compensation expense. | |
Income Taxes | Income Taxes |
We determine deferred tax assets and liabilities based on the differences between the financial reporting and tax bases of assets and liabilities, measured using the enacted tax rates that will be in effect when the differences are expected to reverse. A valuation allowance is recorded when it is more likely than not that the deferred tax asset will not be realized. | |
No amounts have been recognized as interest or penalties on income tax related matters. The determination of an accounting policy as to the classification of such costs has been deferred until such time as any such costs are incurred. | |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements |
In May 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2014-09, Revenue from Contracts with Customers. ASU 2014-09 supersedes the revenue recognition requirements in Revenue Recognition (Topic 605), and requires entities to recognize revenue in a way that depicts 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 applying this new guidance to contracts within its scope, an entity will: (1) identify the contract(s) with a customer, (2) identify the performance obligation in the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations in the contract, and (5) recognize revenue when (or as) the entity satisfies a performance obligation. Additionally, this new guidance will require significantly expanded revenue recognition disclosures. This guidance, which will become effective for us as of January 1, 2017, is to be applied retrospectively. Early application is not permitted. We are currently evaluating the new standard, but do not anticipate a material impact to our financial statements once implemented. | |
In August 2014, the FASB issued ASU No. 2014-15, Disclosure of Uncertainties about an Entity's Ability to Continue as a Going Concern, which requires an entity to evaluate whether conditions or events, in the aggregate, raise substantial doubt about the entity's ability to continue as a going concern for one year from the date the financial statements are issued or are available to be issued. The guidance will become effective January 1, 2017. The adoption of ASU 2014-15 is not expected to have an impact on our financial statements. | |
Composition_of_Certain_Balance1
Composition of Certain Balance Sheet Items (Tables) | 12 Months Ended | |||||
Dec. 31, 2014 | ||||||
Composition of Certain Balance Sheet Items [Abstract] | ||||||
Composition of Inventory | ||||||
December 31, | December 31, | |||||
2014 | 2013 | |||||
(in thousands) | ||||||
Raw materials | $ | 3,595 | $ | 4,318 | ||
Work in progress | 15 | 2 | ||||
Finished goods | 1,687 | 1,226 | ||||
Total inventory | 5,297 | 5,546 | ||||
Less strategic inventory classified as non-current | -4,090 | -4,450 | ||||
Total inventory classified as current | $ | 1,207 | $ | 1,096 | ||
Property and Equipment | ||||||
December 31, | ||||||
2014 | 2013 | |||||
(in thousands) | ||||||
Furniture and equipment | $ | 253 | $ | 183 | ||
Vehicles | 65 | 38 | ||||
Software | 193 | 116 | ||||
Leasehold improvements | 14 | 14 | ||||
525 | 351 | |||||
Less: accumulated depreciation | -289 | -148 | ||||
$ | 236 | $ | 203 | |||
Other Accrued Liabilities | ||||||
December 31, | ||||||
2014 | 2013 | |||||
(in thousands) | ||||||
Accrued compensation | $ | 564 | $ | 466 | ||
Professional fees | 330 | 369 | ||||
Commercialization costs | 556 | 288 | ||||
Government rebates | 275 | 40 | ||||
Legal fees | 120 | 110 | ||||
Other | 31 | 28 | ||||
$ | 1,876 | $ | 1,301 | |||
LongTerm_Obligation_Tables
Long-Term Obligation (Tables) | 12 Months Ended | |||||
Dec. 31, 2014 | ||||||
Long-Term Obligation [Abstract] | ||||||
Summary of Payment Obligations under Financing Agreement | ||||||
December 31, | December 31, | |||||
2014 | 2013 | |||||
(in thousands) | ||||||
Total repayment obligation | $ | 45,000 | $ | 45,000 | ||
Less interest to be accreted in future periods | -5,232 | -8,910 | ||||
Less payments made | -5,881 | -1,025 | ||||
Less current portion | -9,424 | -5,743 | ||||
Long-term obligation, net of current portion | $ | 24,463 | $ | 29,322 | ||
Preferred_Stock_and_Stockholde1
Preferred Stock and Stockholders' Equity (Tables) | 12 Months Ended | ||||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||||
Preferred Stock and Stockholders' Equity [Abstract] | |||||||||||||||||||
Shares of Common Stock Reserved for Future Issuance | |||||||||||||||||||
Common stock: | (in thousands) | ||||||||||||||||||
Exercise of outstanding options | 14,704 | ||||||||||||||||||
Exercise of warrants | 8,044 | ||||||||||||||||||
Shares available for grant under stock option plans | 7,546 | ||||||||||||||||||
30,294 | |||||||||||||||||||
Summary of 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 thousands) | (in thousands) | (in years) | (in thousands) | ||||||||||||||||
Balance at December 31, 2011 | 2,251 | 10,308 | $ | 2.86 | |||||||||||||||
Increase in shares authorized for grant | 3,369 | — | — | ||||||||||||||||
Shares granted | -1,695 | 1,695 | $ | 3.26 | |||||||||||||||
Shares exercised | — | -165 | $ | 1.91 | |||||||||||||||
Shares expired under 2000 Plan | 11 | -93 | $ | 7 | |||||||||||||||
Shares cancelled and forfeited under 2004 and 2012 Plans | 119 | -119 | $ | 3.26 | |||||||||||||||
Balance at December 31, 2012 | 4,055 | 11,626 | $ | 2.9 | |||||||||||||||
Increase in shares authorized for grant | 3,992 | — | — | ||||||||||||||||
Shares granted | -3,565 | 3,565 | $ | 1.98 | |||||||||||||||
Shares exercised | — | -35 | $ | 1.58 | |||||||||||||||
Shares cancelled and forfeited | 444 | -444 | $ | 4.58 | |||||||||||||||
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 | 6.22 | $ | 10,424 | ||||||||||||
Options exercisable at December 31, 2014 | 10,489 | $ | 2.67 | 5.29 | $ | 7,866 | |||||||||||||
Options fully vested and expected to vest at December 31, 2014 | 14,704 | $ | 2.62 | 6.22 | $ | 10,424 | |||||||||||||
Summary of Options Outstanding and Exercisable | |||||||||||||||||||
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 | 4,885 | 5 | $ | 1.49 | $ | 7,355 | 3,907 | $ | 1.42 | $ | 6,156 | ||||
$ | 2.01 | - | $ | 3 | 4,779 | 7.4 | $ | 2.36 | 3,069 | 2,678 | $ | 2.36 | 1,710 | ||||||
$ | 3.01 | - | $ | 4.5 | 4,844 | 6.5 | $ | 3.92 | — | 3,709 | $ | 4.08 | — | ||||||
$ | 4.51 | - | $ | 5.7 | 196 | 0.5 | $ | 5.02 | — | 195 | $ | 5.02 | — | ||||||
14,704 | 6.2 | $ | 2.62 | $ | 10,424 | 10,489 | $ | 2.67 | $ | 7,866 | |||||||||
Summary of Weighted-Average Assumptions and Resultant Fair Value-Based Measurements for Options Granted to Employees and Directors | |||||||||||||||||||
Year Ended December 31, | |||||||||||||||||||
2014 | 2013 | 2012 | |||||||||||||||||
Weighted-average assumptions for stock options granted: | |||||||||||||||||||
Risk-free interest rate | 1.80% | 1.76% | 1.06% | ||||||||||||||||
Expected term | 6 | years | 8.3 | years | 6.7 | years | |||||||||||||
Expected volatility of stock price | 79.00% | 83.90% | 86.60% | ||||||||||||||||
Dividend rate | 0% | 0% | 0% | ||||||||||||||||
Weighted average grant date fair value-based measurement | $ | 1.77 | $ | 1.54 | $ | 2.41 | |||||||||||||
Summary of Non-Cash Stock-Based Compensation by Financial Statement Classification | |||||||||||||||||||
Year ended December 31, | |||||||||||||||||||
2014 | 2013 | 2012 | |||||||||||||||||
(in thousands) | |||||||||||||||||||
Research and development expense | $ | 723 | $ | 618 | $ | 546 | |||||||||||||
Selling, general and administrative expense | 4,478 | 4,578 | 4,764 | ||||||||||||||||
Total | $ | 5,201 | $ | 5,196 | $ | 5,310 | |||||||||||||
Warrants Outstanding | |||||||||||||||||||
Number of | Exercise | Expiration | |||||||||||||||||
Shares | Price | Date | |||||||||||||||||
(in thousands) | |||||||||||||||||||
March 2008 Financing | 3,842 | $ | 2.77 | 3/24/15 | |||||||||||||||
March 2012 Warrant Exchange | 4,202 | $ | 4.05 | 3/29/15 | |||||||||||||||
Total warrants outstanding | 8,044 | ||||||||||||||||||
Net_Loss_Per_Share_Tables
Net Loss Per Share (Tables) | 12 Months Ended | |||||
Dec. 31, 2014 | ||||||
Net Loss Per Share [Abstract] | ||||||
Securities Outstanding that could Potentially Dilute Per Share Data | ||||||
December 31, | ||||||
2014 | 2013 | 2012 | ||||
(in thousands) | ||||||
Stock options outstanding | 14,704 | 14,712 | 11,626 | |||
Warrants outstanding | 8,044 | 8,574 | 8,904 | |||
Total | 22,748 | 23,286 | 20,530 | |||
Income_Taxes_Tables
Income Taxes (Tables) | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Income Taxes [Abstract] | |||||||||
Significant Components of Deferred Tax Assets | |||||||||
December 31, | |||||||||
2014 | 2013 | ||||||||
Deferred tax assets: | (in thousands) | ||||||||
Federal and state net operating losses | $ | 65,012 | $ | 55,955 | |||||
Capitalized research and patent costs | 25,567 | 23,395 | |||||||
Research credits | 22,789 | 21,252 | |||||||
Biopharma Financing Agreement | 13,296 | 13,021 | |||||||
Stock-based compensation costs | 6,410 | 5,398 | |||||||
Other | 2,995 | 1,148 | |||||||
Total deferred tax assets | 136,069 | 120,169 | |||||||
Valuation allowance | -136,069 | -120,169 | |||||||
Net deferred tax assets | $ | — | $ | — | |||||
Reconciliation of Statutory Federal Income Tax Rate to Effective Rate | |||||||||
Year ended December 31, | |||||||||
2014 | 2013 | 2012 | |||||||
(in thousands) | |||||||||
U.S. federal taxes (benefit) at statutory rate | $ | -10,670 | $ | -15,644 | $ | -12,936 | |||
Unutilized net operating loss | 11,002 | 16,181 | 13,853 | ||||||
Unutilized research credits | -1,308 | -1,515 | -2,190 | ||||||
Non-deductible offset of Orphan Drug Credit | 249 | 383 | 827 | ||||||
Non-deductible stock based compensation | 673 | 567 | 404 | ||||||
Other | 54 | 28 | 42 | ||||||
Total | $ | — | $ | — | $ | — | |||
Quarterly_Financial_Data_Table
Quarterly Financial Data (Tables) | 12 Months Ended | |||||||||||
Dec. 31, 2014 | ||||||||||||
Quarterly Financial Data [Abstract] | ||||||||||||
Quarterly Financial Data | ||||||||||||
Quarter Ended | 31-Mar | 30-Jun | 30-Sep | 31-Dec | ||||||||
2014 | ||||||||||||
Product sales, net | $ | 4,405 | $ | 5,851 | $ | 7,282 | $ | 9,013 | ||||
Gross profit on product sales | 4,231 | 5,636 | 7,047 | 8,755 | ||||||||
Net loss | -13,930 | -7,552 | -6,006 | -3,895 | ||||||||
Basic and diluted net loss per share | -0.14 | -0.07 | -0.06 | -0.04 | ||||||||
2013 | ||||||||||||
Product sales, net | $ | 1,717 | $ | 1,891 | $ | 2,634 | $ | 4,115 | ||||
Gross profit on product sales | 1,697 | 1,868 | 2,594 | 4,055 | ||||||||
Net loss | -12,084 | -11,897 | -10,906 | -11,124 | ||||||||
Basic and diluted net loss per share | -0.12 | -0.12 | -0.11 | -0.11 | ||||||||
Basis_of_Presentation_and_Summ2
Basis of Presentation and Summary of Significant Accounting Policies (Narrative) (Details) (USD $) | 12 Months Ended | 15 Months Ended | 1 Months Ended |
In Millions, unless otherwise specified | Dec. 31, 2014 | Jun. 30, 2013 | Aug. 31, 2012 |
segment | |||
item | |||
Accounting Policies [Line Items] | |||
Date of incorporation | 31-May-98 | ||
Entity incorporated, State | Delaware | ||
Additional cash and cash equivalents, description | We consider all highly liquid investments purchased with maturities of three months or less from the date of purchase to be cash equivalents. | ||
Number of manufacturers | 1 | ||
Payment terms for discount on sales of Korlym sales | 30 days | ||
Number of operating segments | 1 | ||
Financing Agreement with Biopharma [Member] | |||
Accounting Policies [Line Items] | |||
Debt issuance date | 2-Aug-12 | ||
Proceeds from issuance of long-term obligation, net of cash paid for issuance costs | $30 | ||
Cumulative payments to be made under financing agreement | 45 | ||
Specialty Pharmacy [Member] | |||
Accounting Policies [Line Items] | |||
Percentage of sales to one specialty pharmacy customers | 97.00% | ||
Number of customers | 1 | ||
Minimum [Member] | |||
Accounting Policies [Line Items] | |||
Property and equipment, estimated useful life | 3 years | ||
Probability percentage for achieving performance-based vesting criteria for expense recognition | 70.00% | ||
Maximum [Member] | |||
Accounting Policies [Line Items] | |||
Property and equipment, estimated useful life | 5 years | ||
Maximum [Member] | Financing Agreement with Biopharma [Member] | |||
Accounting Policies [Line Items] | |||
Cumulative payments to be made under financing agreement | $45 |
Significant_Agreements_Narrati
Significant Agreements (Narrative) (Details) (USD $) | 12 Months Ended | 1 Months Ended | 6 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Oct. 31, 1999 | Jun. 30, 2013 | |
Debt And Credit Agreements [Line Items] | |||||
Cost incurred under the agreement | $18,372,000 | $20,470,000 | $14,074,000 | ||
Stanford License Agreement [Member] | |||||
Debt And Credit Agreements [Line Items] | |||||
Issuance of common stock in conjunction with a license agreement | 30,000 | ||||
Stanford License Agreement [Member] | Annual Payment [Member] | |||||
Debt And Credit Agreements [Line Items] | |||||
Royalty payments to be made | 50,000 | ||||
CuraScript Specialty Pharmacy [Member] | |||||
Debt And Credit Agreements [Line Items] | |||||
Agreement termination date | 20-Jul-13 | ||||
Return reserve for inventory | 300,000 | ||||
Centric Health Resources, Inc. [Member] | |||||
Debt And Credit Agreements [Line Items] | |||||
Agreement description | In May 2013, we entered into a services agreement with Dohmen to provide exclusive specialty pharmacy and patient services programs for Korlym beginning JulyB 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. | ||||
Initial agreement period | 3 years | ||||
Agreement termination, written notice period | 180 days | ||||
Agreement extension notice period | 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. | ||||
Agreement with PCAS [Member] | |||||
Debt And Credit Agreements [Line Items] | |||||
Agreement description | In March 2014, we entered into a new long-term manufacturing and supply agreement with PCAS for the manufacture of mifepristone, the active pharmaceutical agreement 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. | ||||
Initial agreement period | 5 years | ||||
Automatic extension period | 1 year | ||||
Agreement termination, written notice period | 12 months | ||||
Right to terminate agreement if unable to manufacture product, period | 9 months | ||||
Agreement with AAI Pharma [Member] | |||||
Debt And Credit Agreements [Line Items] | |||||
Initial agreement period | 3 years | ||||
Automatic extension period | 2 years | ||||
Agreement termination, written notice period | 12 months | ||||
Termination notice period for manufacturer | 18 months | ||||
Right to terminate agreement if unable to manufacture product, period | 4 months | ||||
Ockham Development Group Inc. [Member] | |||||
Debt And Credit Agreements [Line Items] | |||||
Commitment amount related to service agreement | 2,900,000 | ||||
Cost incurred under the agreement | 1,000,000 | ||||
Quotient Clinical Limited [Member] | |||||
Debt And Credit Agreements [Line Items] | |||||
Agreement description | In March 2014, we entered into an agreement with Quotient Clinical Limited, a clinical research organization, to assist in the management and conduct of our Phase 1 study of CORT125134, one of our new compounds. The total commitment under the agreement is approximately $2.6 million, which is expected to be expended over approximately a 1-year period. Approximately $1.5B million of the costs under this agreement were incurred through DecemberB 31, 2014, with the remainder to be incurred over the course of the trial. | ||||
Initial agreement period | 1 year | ||||
Commitment amount related to service agreement | 2,600,000 | ||||
Cost incurred under the agreement | $1,500,000 |
Fair_Value_of_Financial_Instru1
Fair Value of Financial Instruments (Narrative) (Details) (Level 1 [Member], Money Market Fund [Member], USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Millions, unless otherwise specified | ||
Level 1 [Member] | Money Market Fund [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Money market fund, fair value | $21.90 | $52.90 |
Composition_of_Certain_Balance2
Composition of Certain Balance Sheet Items (Composition of Inventory) (Details) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Composition of Certain Balance Sheet Items [Abstract] | ||
Raw materials | $3,595 | $4,318 |
Work in progress | 15 | 2 |
Finished goods | 1,687 | 1,226 |
Total inventory | 5,297 | 5,546 |
Less strategic inventory classified as non-current | -4,090 | -4,450 |
Total inventory classified as current | $1,207 | $1,096 |
Composition_of_Certain_Balance3
Composition of Certain Balance Sheet Items (Property and Equipment) (Details) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Other Liabilities [Line Items] | ||
Property and equipment | $525 | $351 |
Less: accumulated depreciation | -289 | -148 |
Property and equipment net | 236 | 203 |
Furniture and Equipment [Member] | ||
Other Liabilities [Line Items] | ||
Property and equipment | 253 | 183 |
Vehicles [Member] | ||
Other Liabilities [Line Items] | ||
Property and equipment | 65 | 38 |
Software [Member] | ||
Other Liabilities [Line Items] | ||
Property and equipment | 193 | 116 |
Leasehold Improvements [Member] | ||
Other Liabilities [Line Items] | ||
Property and equipment | $14 | $14 |
Composition_of_Certain_Balance4
Composition of Certain Balance Sheet Items (Other Accrued Liabilities) (Details) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Composition of Certain Balance Sheet Items [Abstract] | ||
Accrued compensation | $564 | $466 |
Professional fees | 330 | 369 |
Commercialization costs | 556 | 288 |
Government rebates | 275 | 40 |
Legal fees | 120 | 110 |
Other | 31 | 28 |
Other accrued liabilities | $1,876 | $1,301 |
LongTerm_Obligation_Narrative_
Long-Term Obligation (Narrative) (Details) (USD $) | 12 Months Ended | 1 Months Ended | 28 Months Ended | 1 Months Ended | |||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Aug. 31, 2012 | Dec. 31, 2014 | Feb. 28, 2015 | Dec. 31, 2011 | |
Debt Instrument [Line Items] | |||||||
Aggregate payments to long-term obligations | $4,856,000 | $1,025,000 | |||||
Cash and cash equivalents | 24,248,000 | 54,877,000 | 93,032,000 | 24,248,000 | 39,635,000 | ||
Accretion of interest expense | 3,678,000 | 4,410,000 | 1,680,000 | ||||
Financing Agreement with Biopharma [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Proceeds from issuance of long-term obligation, net of cash paid for issuance costs | 30,000,000 | ||||||
Cumulative payments to be made under financing agreement | 45,000,000 | ||||||
Aggregate payments to long-term obligations | 5,900,000 | ||||||
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% | |||||
Increase in percentage used to calculate long term payment obligations, description | 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. | ||||||
Interest expense on long-term obligation | 3,700,000 | 4,400,000 | |||||
Accretion of interest expense | 9,800,000 | ||||||
Long term debt carrying value | 33,900,000 | 35,100,000 | 33,900,000 | ||||
Issuance costs capitalized | 140,000 | 140,000 | |||||
Unamortized issuance cost | 58,000 | 58,000 | |||||
Financing Agreement with Biopharma [Member] | Subsequent Events [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Aggregate payments to long-term obligations | 1,900,000 | ||||||
Financing Agreement with Biopharma [Member] | Cash Required Under Debt Covenants [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Debt covenant, description | 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 $50.0B million after such payment. | ||||||
Minimum [Member] | Financing Agreement with Biopharma [Member] | Cash Required Under Debt Covenants [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Cash and cash equivalents | 50,000,000 | ||||||
Maximum [Member] | Financing Agreement with Biopharma [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Cumulative payments to be made under financing agreement | 45,000,000 | ||||||
Payment obligation based on a percentage of net product sales | 50.00% | ||||||
Maximum [Member] | Financing Agreement with Biopharma [Member] | Quarterly Payment During 2015 [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Quarterly payment amount cap | 3,750,000 | ||||||
Maximum [Member] | Financing Agreement with Biopharma [Member] | Quarterly Payment During 2016 and Later [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Quarterly payment amount cap | $0 |
LongTerm_Obligation_Summary_of
Long-Term Obligation (Summary of Payment Obligations under Financing Agreement) (Details) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Long-Term Obligation [Abstract] | ||
Total repayment obligation | $45,000 | $45,000 |
Less interest to be accreted in future periods | -5,232 | -8,910 |
Less payments made | -5,881 | -1,025 |
Less current portion | -9,424 | -5,743 |
Long-term obligation, net of current portion | $24,463 | $29,322 |
Lease_Obligations_Narrative_De
Lease Obligations (Narrative) (Details) (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Operating Leased Assets [Line Items] | |||
Rent expenses | $609,000 | $428,000 | $360,000 |
Office Space [Member] | |||
Operating Leased Assets [Line Items] | |||
Minimum rental payment for lease | 631,000 | ||
Automobiles [Member] | |||
Operating Leased Assets [Line Items] | |||
Minimum rental payment for lease | $180,000 | ||
Term of leases | 3 years |
Preferred_Stock_and_Stockholde2
Preferred Stock and Stockholders' Equity (Narrative) (Details) (USD $) | 0 Months Ended | 1 Months Ended | 12 Months Ended | 0 Months Ended | 1 Months Ended | ||||||
Jul. 06, 2012 | 31-May-14 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2008 | Feb. 18, 2015 | Feb. 06, 2014 | Mar. 29, 2012 | Apr. 30, 2010 | Dec. 31, 2011 | |
item | |||||||||||
Shareholders Equity [Line Items] | |||||||||||
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | |||||||||
Preferred stock, par value | $0.00 | $0.00 | |||||||||
Preferred stock, shares outstanding | 0 | 0 | |||||||||
Common stock shares issued upon exercise of warrants | 164,666 | ||||||||||
Warrant exercised on a cashless net-exercise basis | 529,567 | ||||||||||
Common stock, shares issued | 11,000,000 | ||||||||||
Common stock, price per share | $4.49 | ||||||||||
Net sales from sale of common stock | $46,100,000 | ||||||||||
Liquidated damages to other non-operating expense | 1,300,000 | ||||||||||
Percentage of liquidated damages | 5.00% | ||||||||||
Number of additional shares authorized for issuance | 3,993,000 | 3,992,000 | 3,369,000 | ||||||||
Number of stock option plans | 3 | ||||||||||
Number of shares issuable | 10,489,000 | ||||||||||
Shares available for future grants | 7,546,000 | 4,926,000 | 4,055,000 | 2,251,000 | |||||||
Total intrinsic value of options exercised | 3,000,000 | 55,000 | 303,000 | ||||||||
Fair value of options vested | 4,600,000 | 5,000,000 | 5,000,000 | ||||||||
Forfeiture rate, stock option expense | 0.00% | ||||||||||
Non-cash stock-based compensation expense | 5,201,000 | 5,196,000 | 5,310,000 | ||||||||
Unrecognized compensation expense | 7,100,000 | ||||||||||
Unrecognized compensation expense, weighted-average vesting period | 2 years 6 months | ||||||||||
Common shares to be issued upon exercise of options | 1,381,000 | 35,000 | 165,000 | ||||||||
2012 Equity Incentive Award Plan [Member] | |||||||||||
Shareholders Equity [Line Items] | |||||||||||
Increase in shares available for issuance based on percentage of common stock outstanding | 4.00% | 4.00% | |||||||||
Shares available for future grants | 7,500,000 | 5,300,000 | |||||||||
Minimum [Member] | 2004 Equity Incentive Plan [Member] | |||||||||||
Shareholders Equity [Line Items] | |||||||||||
Exercise price as percentage of fair value of common stock | 100.00% | ||||||||||
Stock options, vesting period | 1 year | ||||||||||
Minimum [Member] | 2012 Stock Option Plan [Member] | |||||||||||
Shareholders Equity [Line Items] | |||||||||||
Exercise price as percentage of fair value of common stock | 100.00% | ||||||||||
Stock options, vesting period | 1 year | ||||||||||
Maximum [Member] | 2004 Equity Incentive Plan [Member] | |||||||||||
Shareholders Equity [Line Items] | |||||||||||
Stock options, vesting period | 5 years | ||||||||||
Maximum [Member] | 2012 Stock Option Plan [Member] | |||||||||||
Shareholders Equity [Line Items] | |||||||||||
Stock options, vesting period | 4 years | ||||||||||
Non-employee [Member] | |||||||||||
Shareholders Equity [Line Items] | |||||||||||
Number of awards outstanding | 3 | ||||||||||
Non-cash stock-based compensation expense | 470,000 | 127,000 | 208,000 | ||||||||
Unvested shares | 149,000 | ||||||||||
Subsequent Events [Member] | 2012 Equity Incentive Award Plan [Member] | |||||||||||
Shareholders Equity [Line Items] | |||||||||||
Number of additional shares authorized for issuance | 4,100,000 | 4,000,000 | |||||||||
Employee And Director Stock Option [Member] | |||||||||||
Shareholders Equity [Line Items] | |||||||||||
Non-cash stock-based compensation expense | 5,100,000 | 5,100,000 | |||||||||
Performance Based Option [Member] | Employee And Director Stock Option [Member] | |||||||||||
Shareholders Equity [Line Items] | |||||||||||
Non-cash stock-based compensation expense | 1,300,000 | ||||||||||
Warrants [Member] | |||||||||||
Shareholders Equity [Line Items] | |||||||||||
Common stock shares issued upon exercise of warrants | 216,000 | ||||||||||
Proceeds from warrant exercises | 470,000 | ||||||||||
Warrants [Member] | Minimum [Member] | |||||||||||
Shareholders Equity [Line Items] | |||||||||||
Exercise price of warrants | $1.66 | ||||||||||
Warrants [Member] | Maximum [Member] | |||||||||||
Shareholders Equity [Line Items] | |||||||||||
Exercise price of warrants | $2.96 | ||||||||||
April 2010 Private Placement [Member] | |||||||||||
Shareholders Equity [Line Items] | |||||||||||
Common stock shares issued upon exercise of warrants | 4,200,000 | 4,200,000 | |||||||||
Exercise price of warrants | $2.96 | ||||||||||
April 2010 and March 2012 Private Placements [Member] | |||||||||||
Shareholders Equity [Line Items] | |||||||||||
Proceeds from warrant exercises and issuance of new warrants | $12,800,000 | ||||||||||
March 2012 Private Placement [Member] | |||||||||||
Shareholders Equity [Line Items] | |||||||||||
Latest date warrants can be exercised | 29-Mar-15 | ||||||||||
Private Placement [Member] | |||||||||||
Shareholders Equity [Line Items] | |||||||||||
Exercise price of warrants | $4.05 | ||||||||||
Warrants issued and outstanding | 4,500,000 | ||||||||||
Stock and warrants issued during period | 8,900,000 | ||||||||||
Related Parties [Member] | March 2012 Private Placement [Member] | |||||||||||
Shareholders Equity [Line Items] | |||||||||||
Percentage of securities sold to related parties | 40.00% |
Preferred_Stock_and_Stockholde3
Preferred Stock and Stockholders' Equity (Shares of Common Stock Reserved for Future Issuance) (Details) | Dec. 31, 2014 |
In Thousands, unless otherwise specified | |
Shareholders Equity [Line Items] | |
Shares of common stock reserved for future issuance | 30,294 |
Stock Options [Member] | |
Shareholders Equity [Line Items] | |
Shares of common stock reserved for future issuance | 14,704 |
Warrants [Member] | |
Shareholders Equity [Line Items] | |
Shares of common stock reserved for future issuance | 8,044 |
Shares Available for Grant Under Stock Option Plans [Member] | |
Shareholders Equity [Line Items] | |
Shares of common stock reserved for future issuance | 7,546 |
Preferred_Stock_and_Stockholde4
Preferred Stock and Stockholders' Equity (Summary of Stock Plan Activity) (Details) (USD $) | 12 Months Ended | ||
In Thousands, except Per Share data, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Shares Available For Future Grant | |||
Beginning balance | 4,926 | 4,055 | 2,251 |
Increase in shares authorized for grant | 3,993 | 3,992 | 3,369 |
Shares granted | -2,140 | -3,565 | -1,695 |
Shares cancelled and forfeited | 767 | 444 | |
Ending balance | 7,546 | 4,926 | 4,055 |
Shares Subject to Options Outstanding | |||
Beginning balance | 14,712 | 11,626 | 10,308 |
Shares granted | 2,140 | 3,565 | 1,695 |
Shares exercised | -1,381 | -35 | -165 |
Shares cancelled and forfeited | -767 | -444 | |
Ending balance | 14,704 | 14,712 | 11,626 |
Options exercisable | 10,489 | ||
Options fully vested and expected to vest | 14,704 | ||
Outstanding Options, Weighted- Average Exercise Price | |||
Beginning balance | $2.63 | $2.90 | $2.86 |
Shares granted | $2.62 | $1.98 | $3.26 |
Shares exercised | $1.34 | $1.58 | $1.91 |
Shares cancelled and forfeited | $5.03 | $4.58 | |
Ending balance | $2.62 | $2.63 | $2.90 |
Options exercisable | $2.67 | ||
Options fully vested and expected to vest | $2.62 | ||
Outstanding Options, Weighted Average Remaining Contractual Life | |||
Weighted average remaining contractual life | 6 years 2 months 19 days | ||
Weighted average remaining contractual life, Options exercisable | 5 years 3 months 15 days | ||
Weighted average remaining contractual life, Options fully vested and expected to vest | 6 years 2 months 19 days | ||
Outstanding Options, Aggregate Intrinsic Value | |||
Aggregate Intrinsic Value | $10,424 | ||
Options exercisable | 7,866 | ||
Options fully vested and expected to vest | $10,424 | ||
2000 Stock Option Plan [Member] | |||
Shares Available For Future Grant | |||
Shares expired | 11 | ||
Shares Subject to Options Outstanding | |||
Shares expired | -93 | ||
Outstanding Options, Weighted- Average Exercise Price | |||
Shares expired | $7 | ||
2004 and 2012 Plans [Member] | |||
Shares Available For Future Grant | |||
Shares cancelled and forfeited | 119 | ||
Shares Subject to Options Outstanding | |||
Shares cancelled and forfeited | -119 | ||
Outstanding Options, Weighted- Average Exercise Price | |||
Shares cancelled and forfeited | $3.26 |
Preferred_Stock_and_Stockholde5
Preferred Stock and Stockholders' Equity (Summary of Options Outstanding and Exercisable) (Details) (USD $) | 12 Months Ended | |||
In Thousands, except Per Share data, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||||
Options Outstanding, Number of Shares | 14,704 | 14,712 | 11,626 | 10,308 |
Options Outstanding, Weighted Average Remaining Contractual Life (in years) | 6 years 2 months 19 days | |||
Options Outstanding, Weighted Average Exercise Price | $2.62 | $2.63 | $2.90 | $2.86 |
Options Outstanding, Aggregate Intrinsic Value | $10,424 | |||
Options Exercisable, Number of Shares | 10,489 | |||
Options Exercisable, Weighted Average Exercise Price | $2.67 | |||
Options Exercisable, Aggregate Intrinsic Value | 7,866 | |||
$0.96 - $ 2.00 [Member] | ||||
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 | 4,885 | |||
Options Outstanding, Weighted Average Remaining Contractual Life (in years) | 5 years | |||
Options Outstanding, Weighted Average Exercise Price | $1.49 | |||
Options Outstanding, Aggregate Intrinsic Value | 7,355 | |||
Options Exercisable, Number of Shares | 3,907 | |||
Options Exercisable, Weighted Average Exercise Price | $1.42 | |||
Options Exercisable, Aggregate Intrinsic Value | 6,156 | |||
$2.01 - $ 3.00 [Member] | ||||
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 | 4,779 | |||
Options Outstanding, Weighted Average Remaining Contractual Life (in years) | 7 years 4 months 24 days | |||
Options Outstanding, Weighted Average Exercise Price | $2.36 | |||
Options Outstanding, Aggregate Intrinsic Value | 3,069 | |||
Options Exercisable, Number of Shares | 2,678 | |||
Options Exercisable, Weighted Average Exercise Price | $2.36 | |||
Options Exercisable, Aggregate Intrinsic Value | $1,710 | |||
$3.01 - $ 4.50 [Member] | ||||
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 | $4.50 | |||
Options Outstanding, Number of Shares | 4,844 | |||
Options Outstanding, Weighted Average Remaining Contractual Life (in years) | 6 years 6 months | |||
Options Outstanding, Weighted Average Exercise Price | $3.92 | |||
Options Exercisable, Number of Shares | 3,709 | |||
Options Exercisable, Weighted Average Exercise Price | $4.08 | |||
$4.51 - $ 5.70 [Member] | ||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||||
Exercise Price Of Options, minimum | $4.51 | |||
Exercise Price Of Options, Maximum | $5.70 | |||
Options Outstanding, Number of Shares | 196 | |||
Options Outstanding, Weighted Average Remaining Contractual Life (in years) | 6 months | |||
Options Outstanding, Weighted Average Exercise Price | $5.02 | |||
Options Exercisable, Number of Shares | 195 | |||
Options Exercisable, Weighted Average Exercise Price | $5.02 |
Preferred_Stock_and_Stockholde6
Preferred Stock and Stockholders' Equity (Summary of Weighted-Average Assumptions and Resultant Fair Value-Based Measurements for Options Granted to Employees and Directors) (Details) (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Weighted-average assumptions for stock options granted: | |||
Risk-free interest rate | 1.80% | 1.76% | 1.06% |
Expected term | 6 years | 8 years 3 months 18 days | 6 years 8 months 12 days |
Expected volatility of stock price | 79.00% | 83.90% | 86.60% |
Dividend rate | 0.00% | 0.00% | 0.00% |
Weighted average grant date fair value-based measurement | $1.77 | $1.54 | $2.41 |
Preferred_Stock_and_Stockholde7
Preferred Stock and Stockholders' Equity (Summary of Non-Cash Stock-Based Compensation by Financial Statement Classification) (Details) (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Non-cash stock-based compensation expense | $5,201,000 | $5,196,000 | $5,310,000 |
Research and Development Expense [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Non-cash stock-based compensation expense | 723,000 | 618,000 | 546,000 |
Selling, General and Administrative Expense [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Non-cash stock-based compensation expense | $4,478,000 | $4,578,000 | $4,764,000 |
Preferred_Stock_and_Stockholde8
Preferred Stock and Stockholders' Equity (Warrants Outstanding) (Details) (USD $) | 12 Months Ended |
Dec. 31, 2014 | |
Class of Warrant or Right [Line Items] | |
Number of shares | $8,044,000 |
March 2008 Financing [Member] | |
Class of Warrant or Right [Line Items] | |
Number of shares | 3,842,000 |
Exercise Price | $2.77 |
Expiration Date | 24-Mar-15 |
March 2012 Warrant Exchange [Member] | |
Class of Warrant or Right [Line Items] | |
Number of shares | $4,202,000 |
Exercise Price | $4.05 |
Expiration Date | 29-Mar-15 |
Net_Loss_Per_Share_Details
Net Loss Per Share (Details) | 12 Months Ended | ||
In Thousands, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Securities outstanding that could potentially dilute per share data | 22,748 | 23,286 | 20,530 |
Stock Options [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Securities outstanding that could potentially dilute per share data | 14,704 | 14,712 | 11,626 |
Warrants [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Securities outstanding that could potentially dilute per share data | 8,044 | 8,574 | 8,904 |
Income_Taxes_Narrative_Details
Income Taxes - (Narrative) (Details) (USD $) | 12 Months Ended | ||
In Millions, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Income Taxes [Line Items] | |||
Increase in valuation allowance | $15.90 | $15.90 | $14 |
Federal [Member] | |||
Income Taxes [Line Items] | |||
Net operating loss carryforwards | 167.8 | ||
Federal [Member] | Minimum [Member] | |||
Income Taxes [Line Items] | |||
Net operating loss carryforwards, expiration year | 2019 | ||
Federal [Member] | Maximum [Member] | |||
Income Taxes [Line Items] | |||
Net operating loss carryforwards, expiration year | 2034 | ||
California State [Member] | |||
Income Taxes [Line Items] | |||
Net operating loss carryforwards | 131 | ||
California State [Member] | Minimum [Member] | |||
Income Taxes [Line Items] | |||
Net operating loss carryforwards, expiration year | 2015 | ||
California State [Member] | Maximum [Member] | |||
Income Taxes [Line Items] | |||
Net operating loss carryforwards, expiration year | 2034 | ||
Other States [Member] | |||
Income Taxes [Line Items] | |||
Net operating loss carryforwards | 18.8 | ||
Other States [Member] | Minimum [Member] | |||
Income Taxes [Line Items] | |||
Net operating loss carryforwards, expiration year | 2024 | ||
Other States [Member] | Maximum [Member] | |||
Income Taxes [Line Items] | |||
Net operating loss carryforwards, expiration year | 2034 | ||
Research Tax Credit Carryforward [Member] | Federal [Member] | |||
Income Taxes [Line Items] | |||
Research and development tax credits | 21 | ||
Research Tax Credit Carryforward [Member] | Federal [Member] | Minimum [Member] | |||
Income Taxes [Line Items] | |||
Research and development tax credit, expiration year | 2019 | ||
Research Tax Credit Carryforward [Member] | Federal [Member] | Maximum [Member] | |||
Income Taxes [Line Items] | |||
Research and development tax credit, expiration year | 2033 | ||
Research Tax Credit Carryforward [Member] | California State [Member] | |||
Income Taxes [Line Items] | |||
Research and development tax credits | $2.60 |
Income_Taxes_Significant_Compo
Income Taxes (Significant Components of Deferred Tax Assets) (Details) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Deferred tax assets: | ||
Federal and state net operating losses | $65,012 | $55,955 |
Capitalized research and patent costs | 25,567 | 23,395 |
Research credits | 22,789 | 21,252 |
Biopharma Financing Agreement | 13,296 | 13,021 |
Stock-based compensation costs | 6,410 | 5,398 |
Other | 2,995 | 1,148 |
Total deferred tax assets | 136,069 | 120,169 |
Valuation allowance | -136,069 | -120,169 |
Net deferred tax assets |
Income_Taxes_Reconciliation_of
Income Taxes (Reconciliation of Statutory Federal Income Tax Rate to Effective Rate) (Details) (USD $) | 12 Months Ended | ||
In Thousands, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Income Taxes [Abstract] | |||
U.S. federal taxes (benefit) at statutory rate | ($10,670) | ($15,644) | ($12,936) |
Unutilized, net operating loss | 11,002 | 16,181 | 13,853 |
Unutilized research credits | -1,308 | -1,515 | -2,190 |
Non-deductible offset of Orphan Drug Credit | 249 | 383 | 827 |
Non-deductible stock based compensation | 673 | 567 | 404 |
Other | 54 | 28 | 42 |
Total |
Commitments_Narrative_Details
Commitments (Narrative) (Details) (USD $) | Dec. 31, 2014 |
Commitments [Abstract] | |
Losses for contingent liability | $0 |
Quarterly_Financial_Data_Detai
Quarterly Financial Data (Details) (USD $) | 3 Months Ended | 12 Months Ended | |||||||||
In Thousands, except Per Share data, unless otherwise specified | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2013 | Sep. 30, 2013 | Jun. 30, 2013 | Mar. 31, 2013 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Quarterly Financial Data [Abstract] | |||||||||||
Product sales, net | $9,013 | $7,282 | $5,851 | $4,405 | $4,115 | $2,634 | $1,891 | $1,717 | $26,551 | $10,357 | $3,307 |
Gross profit on product sales | 8,755 | 7,047 | 5,636 | 4,231 | 4,055 | 2,594 | 1,868 | 1,697 | |||
Net loss | ($3,895) | ($6,006) | ($7,552) | ($13,930) | ($11,124) | ($10,906) | ($11,897) | ($12,084) | ($31,383) | ($46,011) | ($38,048) |
Basic and diluted net loss per share | ($0.04) | ($0.06) | ($0.07) | ($0.14) | ($0.11) | ($0.11) | ($0.12) | ($0.12) | ($0.31) | ($0.46) | ($0.41) |