Document_and_Entity_Informatio
Document and Entity Information | 3 Months Ended | |
Mar. 31, 2014 | 5-May-14 | |
Document Information [Line Items] | ' | ' |
Document Type | '10-Q | ' |
Amendment Flag | 'false | ' |
Document Period End Date | 31-Mar-14 | ' |
Document Fiscal Year Focus | '2014 | ' |
Document Fiscal Period Focus | 'Q1 | ' |
Trading Symbol | 'CORT | ' |
Entity Registrant Name | 'CORCEPT THERAPEUTICS INC | ' |
Entity Central Index Key | '0001088856 | ' |
Current Fiscal Year End Date | '--12-31 | ' |
Entity Filer Category | 'Accelerated Filer | ' |
Entity Common Stock, Shares Outstanding | ' | 100,893,846 |
CONDENSED_BALANCE_SHEETS
CONDENSED BALANCE SHEETS (USD $) | Mar. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Current assets: | ' | ' |
Cash and cash equivalents | $43,618 | $54,877 |
Trade receivables | 1,922 | 1,428 |
Inventory | 1,127 | 1,096 |
Prepaid expenses and other current assets | 1,453 | 910 |
Total current assets | 48,120 | 58,311 |
Strategic inventory | 4,330 | 4,450 |
Property and equipment, net of accumulated depreciation | 285 | 203 |
Other assets | 96 | 113 |
Total assets | 52,831 | 63,077 |
Current liabilities: | ' | ' |
Accounts payable | 3,666 | 2,381 |
Accrued clinical expenses | 3,380 | 3,288 |
Other accrued liabilities | 1,271 | 1,301 |
Long-term obligation - current portion | 6,896 | 5,743 |
Deferred revenue | 29 | 25 |
Total current liabilities | 15,242 | 12,738 |
Long-term obligation, net of current portion | 28,218 | 29,322 |
Commitments | ' | ' |
Stockholders' equity: | ' | ' |
Preferred stock, par value $0.001 per share, 10,000 shares authorized and no shares outstanding at March 31, 2014 and December 31, 2013 | ' | ' |
Common stock, par value $0.001 per share, 280,000 shares authorized and 100,689 and 99,849 shares issued and outstanding at March 31, 2014 and December 31, 2013, respectively | 101 | 100 |
Additional paid-in capital | 315,817 | 313,534 |
Accumulated deficit | -306,547 | -292,617 |
Total stockholders' equity | 9,371 | 21,017 |
Total liabilities and stockholders' equity | $52,831 | $63,077 |
CONDENSED_BALANCE_SHEETS_Paren
CONDENSED BALANCE SHEETS (Parenthetical) (USD $) | Mar. 31, 2014 | Dec. 31, 2013 |
In Thousands, except Per Share data, unless otherwise specified | ||
Preferred stock, par value | $0.00 | $0.00 |
Preferred stock, shares authorized | 10,000 | 10,000 |
Preferred stock, shares outstanding | ' | ' |
Common stock, par value | $0.00 | $0.00 |
Common stock, shares authorized | 280,000 | 280,000 |
Common stock, shares issued | 100,689 | 99,849 |
Common stock, shares outstanding | 100,689 | 99,849 |
CONDENSED_STATEMENTS_OF_COMPRE
CONDENSED STATEMENTS OF COMPREHENSIVE LOSS (Unaudited) (USD $) | 3 Months Ended | |
In Thousands, except Per Share data, unless otherwise specified | Mar. 31, 2014 | Mar. 31, 2013 |
Product sales, net | $4,405 | $1,717 |
Operating expenses: | ' | ' |
Cost of sales | 174 | 20 |
Research and development | 7,285 | 4,257 |
Selling, general and administrative | 9,805 | 8,383 |
Total operating expenses | 17,264 | 12,660 |
Loss from operations | -12,859 | -10,943 |
Interest and other expense | -1,071 | -1,141 |
Net loss and comprehensive loss | ($13,930) | ($12,084) |
Basic and diluted net loss per share | ($0.14) | ($0.12) |
Weighted average shares outstanding used in computing basic and diluted net loss per share | 100,521 | 99,814 |
CONDENSED_STATEMENTS_OF_CASH_F
CONDENSED STATEMENTS OF CASH FLOWS (Unaudited) (USD $) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2014 | Mar. 31, 2013 |
Operating activities | ' | ' |
Net loss | ($13,930) | ($12,084) |
Adjustments to reconcile net loss to net cash used in operations: | ' | ' |
Stock-based compensation | 1,378 | 1,310 |
Accretion of interest expense | 1,044 | 1,115 |
Amortization of debt financing costs | 8 | 11 |
Depreciation and amortization of property and equipment | 28 | 14 |
Changes in operating assets and liabilities: | ' | ' |
Trade receivables | -494 | -586 |
Inventory | 89 | -13 |
Prepaid expenses and other current assets | -543 | 48 |
Other assets | 9 | -3 |
Accounts payable | 1,285 | -1,541 |
Accrued clinical expenses | 92 | -260 |
Other accrued liabilities | -30 | 375 |
Deferred revenue | 4 | 60 |
Net cash used in operating activities | -11,060 | -11,554 |
Investing activities | ' | ' |
Purchases of property and equipment | -110 | -18 |
Cash used in investing activities | -110 | -18 |
Financing activities | ' | ' |
Proceeds from issuance of common stock and warrants, net of issuance costs | 906 | ' |
Payments related to long-term obligation | -995 | ' |
Net cash used in financing activities | -89 | ' |
Net decrease in cash and cash equivalents | -11,259 | -11,572 |
Cash and cash equivalents, at beginning of period | 54,877 | 93,032 |
Cash and cash equivalents, at end of period | $43,618 | $81,460 |
Basis_of_Presentation_and_Summ
Basis of Presentation and Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2014 | |
Basis of Presentation and Summary of Significant Accounting Policies | ' |
1. Basis of Presentation and Summary of Significant Accounting Policies | |
Description of Business and Basis of Presentation | |
Corcept Therapeutics Incorporated was incorporated in the state of Delaware in May 1998, and our 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, psychiatric and oncologic 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 II (GR-II), 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 in the United States 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-II 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. | |
The accompanying unaudited condensed balance sheet as of March 31, 2014 and the condensed statements of comprehensive loss and condensed statements of cash flows for the three-month periods ended March 31, 2014 and 2013 have been prepared in accordance with U.S. generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair presentation have been included. Operating results for the three-month period ended March 31, 2014 are not necessarily indicative of the results that may be expected for the year ending December 31, 2014 or any other period. These financial statements and notes should be read in conjunction with the financial statements for the year ended December 31, 2013 included in our Annual Report on Form 10-K. The accompanying balance sheet as of December 31, 2013 has been derived from audited financial statements at that date. | |
Use of Estimates | |
The preparation of financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ materially from those estimates. | |
We evaluate our estimates and assumptions on an ongoing basis, including those related to our reserves for chargebacks and rebates, patient assistance, potential product returns and 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 capped royalty obligation, 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. As of March 31, 2014 and December 31, 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 institutions 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 experienced no loss or lack of access to cash and cash equivalents in our operating or investment accounts during the three-month periods ended March 31, 2014 and 2013. | |
We are exposed to credit risk in regard to our trade receivables with this risk being 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 will record a reserve 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 March 31, 2014, we had one tablet manufacturer for Korlym with an operational facility – AAI Pharma Services Corp. (AAI). AAI was approved by the FDA in November 2012 for the manufacture of our commercial tablets, subject to the successful manufacture of validation batches. The manufacture of these batches began in April 2014. 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 manufacturers 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 placed orders for additional quantities of mifepristone API and Korlym tablets, which are now in inventory. | |
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 and the obligation under our Financing Agreement with Biopharma Secured Debt Fund II Sub, S.àr.l (Biopharma). | |
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 Korlym. | |
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 and 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-II antagonists (Covered Products) and (ii) net Covered Product revenues earned in the calendar quarter ending June 30, 2013 and thereafter (together, Korlym Receipts), until such time as we have paid Biopharma a total of $45.0 million. | |
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. Actual payment amounts will be based on Korlym Receipts over the term of the Financing Agreement but in no event will the total amount paid to Biopharma exceed $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 March 31, 2014. | |
See Note 4, Long-term Obligation, for additional information regarding this agreement. | |
Net Product Sales | |
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. Korlym is not available in retail pharmacies. As of July 1, 2013, we began using Dohmen Life Science Services. (Dohmen), formerly known as Centric Health Resources, Inc., 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 provide cash donations to a non-profit third party organization that supports 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 as net product revenues sales of Korlym tablets 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 and distributor fees, (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. We also offered them 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, we ceased incurring a prompt-payment discount to our specialty pharmacy. | |
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) information obtained from our vendors regarding 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 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: Because sales through Dohmen, our specialty pharmacy, are made to individual patients who do not have the right to return the product, our exposure to product returns is now 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 as inventory following approval by the FDA in February 2012. Prior to receiving FDA approval for Korlym, we expensed all costs related to the manufacturing of the product as incurred; we classified these costs as research and development expense. A portion of the product manufactured prior to FDA approval is available for us to use commercially. | |
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 efforts to prosecute and defend those submissions and the development of second-generation compounds, as well as research and development-related overhead expenses. We also 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 fair value-based measurement of the award at the grant date as determined utilizing the Black-Scholes option valuation model. For service-based awards, we recognize expense over the requisite service period. | |
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 6 for a detailed discussion of stock-based compensation expense. |
Fair_Value_of_Financial_Instru
Fair Value of Financial Instruments | 3 Months Ended |
Mar. 31, 2014 | |
Fair Value of Financial Instruments | ' |
2. Fair Value of Financial Instruments | |
As of March 31, 2014 and December 31, 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 $42.7 million and $52.9 million as of March 31, 2014 and December 31, 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 March 31, 2014 and December 31, 2013 were in active markets and valued based upon their quoted prices. |
Composition_of_Certain_Balance
Composition of Certain Balance Sheet Items | 3 Months Ended | ||||||||
Mar. 31, 2014 | |||||||||
Composition of Certain Balance Sheet Items | ' | ||||||||
3. Composition of Certain Balance Sheet Items | |||||||||
Inventory | |||||||||
The composition of inventory was as follows: | |||||||||
March 31, | December 31, | ||||||||
2014 | 2013 | ||||||||
(in thousands) | |||||||||
Raw materials | $ | 4,373 | $ | 4,318 | |||||
Work in progress | 11 | 2 | |||||||
Finished goods | 1,073 | 1,226 | |||||||
Total inventory | 5,457 | 5,546 | |||||||
Less strategic inventory classified as non-current | (4,330 | ) | (4,450 | ) | |||||
Total inventory classified as current | $ | 1,127 | $ | 1,096 | |||||
The finished goods inventory as of March 31, 2014 and December 31, 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 had 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. | |||||||||
Other Accrued Liabilities | |||||||||
Other accrued liabilities consisted of the following: | |||||||||
March 31, | December 31, | ||||||||
2014 | 2013 | ||||||||
(in thousands) | |||||||||
Accrued compensation | $ | 527 | $ | 466 | |||||
Professional fees | 176 | 369 | |||||||
Commercialization costs | 258 | 288 | |||||||
Government rebates | 141 | 40 | |||||||
Legal fees | 62 | 110 | |||||||
Other | 107 | 28 | |||||||
$ | 1,271 | $ | 1,301 | ||||||
LongTerm_Obligation
Long-Term Obligation | 3 Months Ended | ||||||||
Mar. 31, 2014 | |||||||||
Long-Term Obligation | ' | ||||||||
4. Long-Term Obligation | |||||||||
As discussed in Note 1, Basis of Presentation and Summary of Significant Accounting Policies, Long-term Obligation, in August 2012, we entered into a Financing Agreement with Biopharma under which we received $30.0 million from Biopharma. In return, we are obligated to make payments, calculated as a percentage of our net sales of Korlym, any future mifepristone-based products, our selective GR-II 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. Through March 31, 2014, we made aggregate payments to Biopharma in the amount of $2.0 million, with an additional payment in the amount of $1.0 million made in April 2014. | |||||||||
Under the terms of the Financing Agreement, our payments are entirely 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 payments as follows: | |||||||||
• | 20 percent of our net product sales of Covered Products, beginning with the calendar quarter ended June 30, 2013, subject to quarterly payment caps of $3.0 million during 2014, and $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, (EBITDA) 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. 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 $1.0 million for the three-month period ended March 31, 2014, $1.1 million for the same period ended March 31, 2013 and total accreted interest of $7.1 million for the period from August 2012 through March 31, 2014, is calculated based on the internal interest rate to Biopharma that would result from these assumed payment streams. 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. 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. | |||||||||
The carrying value of the long-term obligation was $35.1 million as of March 31, 2014 and December 31, 2013. The long-term obligation, including accrued 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 March 31, 2014 and December 31, 2013, utilizing the payment assumptions discussed above. | |||||||||
March 31, | December 31, | ||||||||
2014 | 2013 | ||||||||
(in thousands) | |||||||||
Total repayment obligation | $ | 45,000 | $ | 45,000 | |||||
Less interest to be accreted in future periods | (7,866 | ) | (8,910 | ) | |||||
Less payments made | (2,020 | ) | (1,025 | ) | |||||
Less current portion | (6,896 | ) | (5,743 | ) | |||||
Long-term obligation, net of current portion | $ | 28,218 | $ | 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 March 31, 2014 and December 31, 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 two years and the 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 March 31, 2014 and December 31, 2013, the unamortized issuance costs were $80,000 and $87,000, respectively, and are included in other assets on our balance sheets. |
Significant_Agreements
Significant Agreements | 3 Months Ended |
Mar. 31, 2014 | |
Significant Agreements | ' |
5. Significant Agreements | |
Pharmaceutical Manufacturing Agreement | |
In March 2014, we entered into a 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 certain minimum percentage of our mifepristone requirements from PCAS, the amount of which will be variable depending on future needs. The initial term of the agreement is five years from March 20, 2014, with an automatic extension of one year unless either party gives 12 months’ prior written notice to the other that it does not want such an extension. We have the right to terminate the agreement if PCAS is unable to manufacture the product for a consecutive nine-month period. | |
Clinical Trial Agreement | |
In March 2014, we entered into an agreement with Quotient Clinical Limited, a clinical research organization (CRO), for a Phase 1 study of 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. |
Stock_Option_Plans
Stock Option Plans | 3 Months Ended | ||||||||
Mar. 31, 2014 | |||||||||
Stock Option Plans | ' | ||||||||
6. 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 Incentive Award Plan (the 2012 Plan). | |||||||||
On February 6, 2014, our Board of Directors authorized an increase of 3,993,300 shares in the number of shares available for issuance 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. | |||||||||
During the three-month period ended March 31, 2014, we issued an aggregate of 840,000 shares of our common stock upon the exercise of stock options. | |||||||||
The following table provides a summary of non-cash stock-based compensation. | |||||||||
Three Months Ended | |||||||||
March 31, | |||||||||
2014 | 2013 | ||||||||
(in thousands) | |||||||||
Research and development | $ | 162 | $ | 148 | |||||
Selling, general and administrative | 1,216 | 1,162 | |||||||
Total non-cash stock-based compensation | $ | 1,378 | $ | 1,310 | |||||
Net_Loss_Per_Share
Net Loss Per Share | 3 Months Ended | ||||||||
Mar. 31, 2014 | |||||||||
Net Loss Per Share | ' | ||||||||
7. 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 stock 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. | |||||||||
March 31, | |||||||||
2014 | 2013 | ||||||||
(in thousands) | |||||||||
Stock options outstanding | 14,675 | 14,141 | |||||||
Warrants outstanding | 8,574 | 8,904 | |||||||
Total | 23,249 | 23,045 | |||||||
Subsequent_Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2014 | |
Subsequent Events | ' |
8. Subsequent Events | |
Tablet Manufacturing Agreement | |
On April 7, 2014, we entered into a manufacturing agreement with AAI Pharma Services Corp. (AAI) under which AAI will manufacture and package Korlym tablets. The initial term of this agreement is a period of three years from April 7, 2014, with consecutive automatic extensions of two years unless either party gives written notice - in the case of AAI, 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 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. |
Basis_of_Presentation_and_Summ1
Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2014 | |
Description of Business and Basis of Presentation | ' |
Description of Business and Basis of Presentation | |
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, psychiatric and oncologic 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 II (GR-II), 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 in the United States 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-II 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. | |
The accompanying unaudited condensed balance sheet as of March 31, 2014 and the condensed statements of comprehensive loss and condensed statements of cash flows for the three-month periods ended March 31, 2014 and 2013 have been prepared in accordance with U.S. generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair presentation have been included. Operating results for the three-month period ended March 31, 2014 are not necessarily indicative of the results that may be expected for the year ending December 31, 2014 or any other period. These financial statements and notes should be read in conjunction with the financial statements for the year ended December 31, 2013 included in our Annual Report on Form 10-K. The accompanying balance sheet as of December 31, 2013 has been derived from audited financial statements at that date. | |
Use of Estimates | ' |
Use of Estimates | |
The preparation of financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ materially from those estimates. | |
We evaluate our estimates and assumptions on an ongoing basis, including those related to our reserves for chargebacks and rebates, patient assistance, potential product returns and 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 capped royalty obligation, 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. As of March 31, 2014 and December 31, 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 institutions 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 experienced no loss or lack of access to cash and cash equivalents in our operating or investment accounts during the three-month periods ended March 31, 2014 and 2013. | |
We are exposed to credit risk in regard to our trade receivables with this risk being 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 will record a reserve 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 March 31, 2014, we had one tablet manufacturer for Korlym with an operational facility – AAI Pharma Services Corp. (AAI). AAI was approved by the FDA in November 2012 for the manufacture of our commercial tablets, subject to the successful manufacture of validation batches. The manufacture of these batches began in April 2014. 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 manufacturers 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 placed orders for additional quantities of mifepristone API and Korlym tablets, which are now in inventory. | |
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 and the obligation under our Financing Agreement with Biopharma Secured Debt Fund II Sub, S.àr.l (Biopharma). | |
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 Korlym. | |
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 and 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-II antagonists (Covered Products) and (ii) net Covered Product revenues earned in the calendar quarter ending June 30, 2013 and thereafter (together, Korlym Receipts), until such time as we have paid Biopharma a total of $45.0 million. | |
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. Actual payment amounts will be based on Korlym Receipts over the term of the Financing Agreement but in no event will the total amount paid to Biopharma exceed $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 March 31, 2014. | |
See Note 4, Long-term Obligation, for additional information regarding this agreement. | |
Net Product Sales | ' |
Net Product Sales | |
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. Korlym is not available in retail pharmacies. As of July 1, 2013, we began using Dohmen Life Science Services. (Dohmen), formerly known as Centric Health Resources, Inc., 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 provide cash donations to a non-profit third party organization that supports 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 as net product revenues sales of Korlym tablets 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 and distributor fees, (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. We also offered them 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, we ceased incurring a prompt-payment discount to our specialty pharmacy. | |
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) information obtained from our vendors regarding 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 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: Because sales through Dohmen, our specialty pharmacy, are made to individual patients who do not have the right to return the product, our exposure to product returns is now 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 as inventory following approval by the FDA in February 2012. Prior to receiving FDA approval for Korlym, we expensed all costs related to the manufacturing of the product as incurred; we classified these costs as research and development expense. A portion of the product manufactured prior to FDA approval is available for us to use commercially. | |
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 efforts to prosecute and defend those submissions and the development of second-generation compounds, as well as research and development-related overhead expenses. We also 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 fair value-based measurement of the award at the grant date as determined utilizing the Black-Scholes option valuation model. For service-based awards, we recognize expense over the requisite service period. | |
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 6 for a detailed discussion of stock-based compensation expense. |
Composition_of_Certain_Balance1
Composition of Certain Balance Sheet Items (Tables) | 3 Months Ended | ||||||||
Mar. 31, 2014 | |||||||||
Composition of Inventory | ' | ||||||||
The composition of inventory was as follows: | |||||||||
March 31, | December 31, | ||||||||
2014 | 2013 | ||||||||
(in thousands) | |||||||||
Raw materials | $ | 4,373 | $ | 4,318 | |||||
Work in progress | 11 | 2 | |||||||
Finished goods | 1,073 | 1,226 | |||||||
Total inventory | 5,457 | 5,546 | |||||||
Less strategic inventory classified as non-current | (4,330 | ) | (4,450 | ) | |||||
Total inventory classified as current | $ | 1,127 | $ | 1,096 | |||||
Other Accrued Liabilities | ' | ||||||||
Other accrued liabilities consisted of the following: | |||||||||
March 31, | December 31, | ||||||||
2014 | 2013 | ||||||||
(in thousands) | |||||||||
Accrued compensation | $ | 527 | $ | 466 | |||||
Professional fees | 176 | 369 | |||||||
Commercialization costs | 258 | 288 | |||||||
Government rebates | 141 | 40 | |||||||
Legal fees | 62 | 110 | |||||||
Other | 107 | 28 | |||||||
$ | 1,271 | $ | 1,301 | ||||||
LongTerm_Obligation_Tables
Long-Term Obligation (Tables) | 3 Months Ended | ||||||||
Mar. 31, 2014 | |||||||||
Summary of Payment Obligations under Financing Agreement | ' | ||||||||
The following table provides a summary of the payment obligations under the Financing Agreement as of March 31, 2014 and December 31, 2013, utilizing the payment assumptions discussed above. | |||||||||
March 31, | December 31, | ||||||||
2014 | 2013 | ||||||||
(in thousands) | |||||||||
Total repayment obligation | $ | 45,000 | $ | 45,000 | |||||
Less interest to be accreted in future periods | (7,866 | ) | (8,910 | ) | |||||
Less payments made | (2,020 | ) | (1,025 | ) | |||||
Less current portion | (6,896 | ) | (5,743 | ) | |||||
Long-term obligation, net of current portion | $ | 28,218 | $ | 29,322 | |||||
Stock_Option_Plans_Tables
Stock Option Plans (Tables) | 3 Months Ended | ||||||||
Mar. 31, 2014 | |||||||||
Summary of Non-Cash Stock-Based Compensation | ' | ||||||||
The following table provides a summary of non-cash stock-based compensation. | |||||||||
Three Months Ended | |||||||||
March 31, | |||||||||
2014 | 2013 | ||||||||
(in thousands) | |||||||||
Research and development | $ | 162 | $ | 148 | |||||
Selling, general and administrative | 1,216 | 1,162 | |||||||
Total non-cash stock-based compensation | $ | 1,378 | $ | 1,310 | |||||
Net_Loss_Per_Share_Tables
Net Loss Per Share (Tables) | 3 Months Ended | ||||||||
Mar. 31, 2014 | |||||||||
Securities Outstanding that could Potentially Dilute Per Share Data | ' | ||||||||
The following table presents information on securities outstanding as of the end of each period that could potentially dilute the per share data in the future. | |||||||||
March 31, | |||||||||
2014 | 2013 | ||||||||
(in thousands) | |||||||||
Stock options outstanding | 14,675 | 14,141 | |||||||
Warrants outstanding | 8,574 | 8,904 | |||||||
Total | 23,249 | 23,045 | |||||||
Basis_of_Presentation_and_Summ2
Basis of Presentation and Summary of Significant Accounting Policies - Additional Information (Detail) (USD $) | 3 Months Ended | 6 Months Ended | 1 Months Ended | 3 Months Ended | ||
Mar. 31, 2014 | Jun. 30, 2013 | Aug. 31, 2012 | Mar. 31, 2014 | Mar. 31, 2014 | Aug. 31, 2012 | |
Segment | Financing Agreement with Biopharma | Minimum | Maximum | Maximum | ||
Vendor | Financing Agreement with Biopharma | |||||
Accounting Policies [Line Items] | ' | ' | ' | ' | ' | ' |
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. | ' | ' | ' | ' | ' |
Credit losses against trade receivables | $0 | ' | ' | ' | ' | ' |
Number of manufacturer | 1 | ' | ' | ' | ' | ' |
Property and equipment, estimated useful life | ' | ' | ' | '3 years | '5 years | ' |
Debt issuance date | ' | ' | 2-Aug-12 | ' | ' | ' |
Proceeds from issuance of long-term obligation, net of cash paid for issuance costs | ' | ' | 30,000,000 | ' | ' | ' |
Total amount to be paid related to debt | ' | ' | ' | ' | ' | $45,000,000 |
Payment terms for discount on sales of Korlym sales | ' | '30 days | ' | ' | ' | ' |
Number of operating segment | 1 | ' | ' | ' | ' | ' |
Fair_Value_of_Financial_Instru1
Fair Value of Financial Instruments - Additional Information (Detail) (Level 1, Money market funds, USD $) | Mar. 31, 2014 | Dec. 31, 2013 |
In Millions, unless otherwise specified | ||
Level 1 | Money market funds | ' | ' |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ' | ' |
Money market fund, fair value | $42.70 | $52.90 |
Composition_of_Inventory_Detai
Composition of Inventory (Detail) (USD $) | Mar. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Inventory [Line Items] | ' | ' |
Raw materials | $4,373 | $4,318 |
Work in progress | 11 | 2 |
Finished goods | 1,073 | 1,226 |
Total inventory | 5,457 | 5,546 |
Less strategic inventory classified as non-current | -4,330 | -4,450 |
Total inventory classified as current | $1,127 | $1,096 |
Other_Accrued_Liabilities_Deta
Other Accrued Liabilities (Detail) (USD $) | Mar. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Other Liabilities [Line Items] | ' | ' |
Accrued compensation | $527 | $466 |
Professional fees | 176 | 369 |
Commercialization costs | 258 | 288 |
Government rebates | 141 | 40 |
Legal fees | 62 | 110 |
Other | 107 | 28 |
Other accrued liabilities | $1,271 | $1,301 |
Longterm_Obligation_Additional
Long-term Obligation - Additional Information (Detail) (USD $) | 3 Months Ended | 1 Months Ended | 3 Months Ended | 12 Months Ended | 19 Months Ended | 1 Months Ended | 3 Months Ended | 3 Months Ended | ||||||||
Mar. 31, 2014 | Mar. 31, 2013 | Dec. 31, 2013 | Dec. 31, 2012 | Aug. 31, 2012 | Mar. 31, 2014 | Dec. 31, 2013 | Mar. 31, 2014 | Apr. 30, 2014 | Aug. 31, 2012 | Mar. 31, 2014 | Aug. 31, 2012 | Mar. 31, 2014 | Mar. 31, 2014 | Mar. 31, 2014 | Aug. 31, 2012 | |
Financing Agreement with Biopharma | Financing Agreement with Biopharma | Financing Agreement with Biopharma | Financing Agreement with Biopharma | Financing Agreement with Biopharma | Financing Agreement with Biopharma | Maximum | Maximum | Maximum | Maximum | Maximum | Minimum | |||||
Subsequent Events | Cash Required Under Debt Covenants | Financing Agreement with Biopharma | Financing Agreement with Biopharma | Financing Agreement with Biopharma | Financing Agreement with Biopharma | Financing Agreement with Biopharma | Financing Agreement with Biopharma | |||||||||
Quarterly Payment During 2014 | Quarterly Payment During 2015 | Quarterly Payment During 2016 and Later | Cash Required Under Debt Covenants | |||||||||||||
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 | 995,000 | ' | ' | ' | ' | 2,020,000 | 1,025,000 | ' | 1,000,000 | ' | ' | ' | ' | ' | ' | ' |
Payment obligation based on a percentage of net product sales | ' | ' | ' | ' | ' | 20.00% | ' | ' | ' | ' | 50.00% | ' | ' | ' | ' | ' |
Quarterly payment amount cap | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 3,000,000 | 3,750,000 | 0 | ' |
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, (EBITDA) for the four calendar quarters preceding such incurrence and, in each case, fail to cure within the applicable cure period. | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
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 $50.0 million after such payment. | ' | ' | ' | ' | ' | ' |
Cash and cash equivalents | 43,618,000 | 81,460,000 | 54,877,000 | 93,032,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 50,000,000 |
Accretion of interest expense | 1,044,000 | 1,115,000 | ' | ' | ' | ' | ' | 7,100,000 | ' | ' | ' | ' | ' | ' | ' | ' |
Long term debt carrying value | ' | ' | ' | ' | ' | 35,100,000 | 35,100,000 | 35,100,000 | ' | ' | ' | ' | ' | ' | ' | ' |
Issuance costs capitalized | ' | ' | ' | ' | ' | 140,000 | ' | 140,000 | ' | ' | ' | ' | ' | ' | ' | ' |
Unamortized issuance cost | ' | ' | ' | ' | ' | $80,000 | $87,000 | $80,000 | ' | ' | ' | ' | ' | ' | ' | ' |
Summary_of_Payment_Obligations
Summary of Payment Obligations under Financing Agreement (Detail) (USD $) | 3 Months Ended | 12 Months Ended |
In Thousands, unless otherwise specified | Mar. 31, 2014 | Dec. 31, 2013 |
Debt Instrument [Line Items] | ' | ' |
Total repayment obligation | $45,000 | $45,000 |
Less interest to be accreted in future periods | -7,866 | -8,910 |
Less payments made | -995 | ' |
Less current portion | -6,896 | -5,743 |
Long-term obligation, net of current portion | 28,218 | 29,322 |
Financing Agreement with Biopharma | ' | ' |
Debt Instrument [Line Items] | ' | ' |
Less payments made | ($2,020) | ($1,025) |
Significant_Agreements_Additio
Significant Agreements - Additional Information (Detail) (USD $) | 3 Months Ended |
In Millions, unless otherwise specified | Mar. 31, 2014 |
Pharmaceutical Manufacturing Agreement | ' |
Debt And Credit Agreements [Line Items] | ' |
Agreement description | 'In March 2014, we entered into a long-term manufacturing and supply agreement with PCAS for the manufacture of mifepristone, the active pharmaceutical agreement in KorlymB.. We have agreed to purchase a certain minimum percentage of our mifepristone requirements from PCAS, the amount of which will be variable depending on future needs. The initial term of the agreement is five years from March 20, 2014, with an automatic extension of one year unless either party gives 12 monthsb prior written notice to the other that it does not want such 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 | 'Five years |
Agreement termination, written notice period | '12 months |
Agreement extension notice period | 'The initial term of the agreement is five years from March 20, 2014, with an automatic extension of one year unless either party gives 12 months' prior written notice to the other that it does not want such an extension. |
Clinical Trial Agreement | ' |
Debt And Credit Agreements [Line Items] | ' |
Total commitment under agreement | 2.6 |
Stock_Option_Plans_Additional_
Stock Option Plans - Additional Information (Detail) | 3 Months Ended | |
Mar. 31, 2014 | Dec. 31, 2013 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' |
Common shares to be issued upon exercise of options | 840,000 | ' |
2012 Equity Incentive Award Plan | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' |
Number of additional shares authorized for issuance | 3,993,300 | ' |
Increase in shares available for issuance percentage on common stock outstanding | ' | 4.00% |
Summary_of_NonCash_StockBased_
Summary of Non-Cash Stock-Based Compensation (Detail) (USD $) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2014 | Mar. 31, 2013 |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ' | ' |
Non-cash stock-based compensation expense | $1,378 | $1,310 |
Research and development | ' | ' |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ' | ' |
Non-cash stock-based compensation expense | 162 | 148 |
Selling, general and administrative | ' | ' |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ' | ' |
Non-cash stock-based compensation expense | $1,216 | $1,162 |
Securities_Outstanding_that_co
Securities Outstanding that could Potentially Dilute Per Share Data (Detail) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2014 | Mar. 31, 2013 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ' | ' |
Securities outstanding that could potentially dilute per share data | 23,249 | 23,045 |
Options | ' | ' |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ' | ' |
Securities outstanding that could potentially dilute per share data | 14,675 | 14,141 |
Warrants | ' | ' |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ' | ' |
Securities outstanding that could potentially dilute per share data | 8,574 | 8,904 |
Subsequent_Events_Additional_I
Subsequent Events - Additional Information (Detail) (Subsequent Events) | 0 Months Ended |
Apr. 07, 2014 | |
Subsequent Events | ' |
Subsequent Event [Line Items] | ' |
Initial agreement period | 'Three years |
Agreement termination, written notice period | '18 months |
Agreement extension notice period | 'The initial term of this agreement is a period of three years from April 7, 2014, with consecutive automatic extensions of two years unless either party gives written notice - in the case of AAI, 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. |