Summary Of Significant Accounting Policies (Policy) | 9 Months Ended |
Sep. 30, 2014 |
Summary Of Significant Accounting Policies [Abstract] | ' |
Revenue Recognition | ' |
Revenue Recognition |
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We recognize revenue primarily from the sale of PROVENGE. Revenue from the sale of PROVENGE is recorded net of product returns and estimated price discounts, including rebates and chargebacks offered pursuant to mandatory federal and state government programs and to members of Group Purchasing Organizations (“GPOs”) with which we have contracts. Revenue from sales of PROVENGE is recognized upon confirmed product delivery to and issuance of a product release form to the physician. Product returns are limited to those instances in which the physician receives the product, but does not infuse the product prior to expiry, either due to timing or the failure of the product to meet specifications and pass site inspection. Due to the limited usable life of PROVENGE of approximately 18 hours from the completion of the manufacturing process to patient infusion, actual return information is known and credited against sales in the month incurred. |
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PROVENGE sales are direct to physician; however, we have entered into distribution agreements with several credit-worthy third-party wholesalers (the “Wholesalers”) whereby we manufacture and ship the product direct to the physician and transfer the sale of PROVENGE to the Wholesalers. Under the distribution agreements, the Wholesalers assume all bad debt risk from the physician or institution; therefore no allowance for bad debt is recorded. Under the terms of the distribution agreements, our return policy allows for the return of product that has expired or has a defect prior to delivery, product that is damaged during delivery and product that cannot be infused because it does not otherwise meet specified requirements. |
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Our product is subject to certain required pricing discounts via rebates and/or chargebacks pursuant to mandatory federal and state government programs and, accordingly, revenue recognition requires estimates of rebates and chargebacks. |
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We have agreements with the Centers for Medicare and Medicaid Services providing for a rebate on sales to eligible Medicaid patients. The physician purchases our product at full price, and then receives reimbursement from the applicable state. The state, in turn, invoices us for the amount of the Medicaid rebate. Estimated rebates payable under Medicaid are recognized in the same period that the related revenue is recognized, resulting in a reduction in product revenue, and are classified as other accrued liabilities until paid. Our estimate of rebates payable is based on historical claim information. Medicaid rebates were not material for each period presented. |
We also have agreements with the Public Health Service (“PHS”) and Federal Supply Schedule (“FSS”) customers, including the Department of Veteran Affairs and the Department of Defense, providing for a chargeback on sales to eligible providers. Chargebacks occur when a contracted physician purchases our product at fixed contract prices that are lower than the price we charge the Wholesalers. Each Wholesaler, in turn, charges us back for the difference between the price initially paid by the Wholesaler and the contract price paid to the Wholesaler by the physician. These chargebacks are estimated and recorded in the period that the related revenue is recognized, resulting in a reduction in product revenue and trade accounts receivable. The following is a roll forward of the chargebacks reserve associated with the PHS and FSS programs: |
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| Nine Months Ended September 30, |
| 2014 | | 2013 |
| (In thousands) |
Beginning balance, January 1 | $ | 3,540 | | $ | 3,107 |
Current provision related to sales made in current period | | 14,037 | | | 10,426 |
Adjustments | | -1,807 | | | -2,128 |
Payments/credits | | -12,097 | | | -8,399 |
Balance at September 30 | $ | 3,673 | | $ | 3,006 |
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We have entered into agreements with certain GPOs that contract for the purchase of PROVENGE on behalf of their members and provide contract administration services. Eligible members of the GPOs purchase PROVENGE at contracted prices through a chargeback. These chargebacks are estimated and recorded in the period that the related revenue is recognized, resulting in a reduction in product revenue and trade accounts receivable. The following is a roll forward of the chargebacks reserve associated with the GPO programs: |
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| Nine Months Ended September 30, |
| 2014 | | 2013 |
| (In thousands) |
Beginning balance, January 1 | $ | 1,590 | | $ | 182 |
Current provision related to sales made in current period | | 12,751 | | | 5,204 |
Payments/credits | | -13,268 | | | -4,739 |
Balance at September 30 | $ | 1,073 | | $ | 647 |
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Eligible members of the GPOs may also be entitled to receive a rebate on eligible purchases of PROVENGE at the end of each quarter. Estimated rebates and administrative fees payable to GPOs are recognized in the same period that the related revenue is recognized, resulting in a reduction in product revenue, and are classified as other accrued liabilities until paid. Our estimate of rebates payable is based upon information we gather related to sales to eligible GPO members. The following is a roll forward of the accrued GPO rebates and administrative fees balance: |
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| Nine Months Ended September 30, |
| 2014 | | 2013 |
| (In thousands) |
Beginning balance, January 1 | $ | 1,788 | | $ | 1,950 |
Current provision related to sales made in current period | | 5,912 | | | 4,682 |
Payments/credits | | -5,908 | | | -5,054 |
Balance at September 30 | $ | 1,792 | | $ | 1,578 |
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Restricted Cash | ' |
Restricted Cash |
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Restricted cash, as further discussed in Note 13 – Commitment and Contingencies, represents a reserve account for the commitment to purchase antigen used in the manufacture of PROVENGE. |
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Inventory | ' |
Inventory |
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Inventories are determined at the lower of cost or market value with cost determined under the specific identification method. |
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We periodically evaluate inventory for impairment by considering factors such as expiry, obsolescence and net realizable value. We review inventory for expiry risk by evaluating current and future product demand relative to inventory life. We expect to realize the carrying value of inventory. |
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In addition, if we determine that events and circumstances indicate that inventory may not meet required quality specifications, we will record an impairment. |
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Restructuring Expenses | ' |
Restructuring Expenses |
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We record a liability for costs associated with an exit or disposal activity at fair value in the period in which the liability is incurred. Employee termination benefits are accrued when the obligation is probable and estimable. Employee termination benefits are expensed at the date the employee is notified unless the employee must provide future service in excess of 60 days, in which case such benefits are expensed ratably over the future service period. For contract termination costs, we record a liability upon the later of the contract termination date or the date we cease using the rights conveyed by the contract. |
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Impairment Of Long-Lived Assets | ' |
Impairment of Long-Lived Assets |
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We periodically evaluate the carrying value of long-lived assets when events and circumstances indicate that the carrying amount of an asset may not be recovered. When evaluating long-lived assets for impairment, we compare the carrying value of the asset to the asset's estimated undiscounted future cash flows. Impairment is recorded if the estimated future cash flows are less than the carrying value of the asset. The impairment loss recognized, if any, is the excess of the asset’s carrying value over the fair value of the long-lived asset. The determination of fair value of the assets evaluated for impairment requires the use of judgmental assumptions surrounding the amount and timing of future cash flows and the highest and best use of the assets. |
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On November 10, 2014, we and the Debtor Subsidiaries filed voluntary petitions for relief under Chapter 11 of Title 11 of the Bankruptcy Code in the Bankruptcy Court for the District of Delaware. Our plan to file these voluntary petitions for relief under Chapter 11 of the Bankruptcy Code was deemed to be an indicator of impairment. As a result, we undertook an impairment analysis of our long-lived assets that we intend to sell through the competitive process contemplated under each of the Plan Support Agreements (the “PSAs”) entered into with certain holders (collectively, the “Supporting Noteholders”) of the 2016 Notes and compared the carrying value of these assets to the asset’s undiscounted future cash flows. Refer to Note 14 – Subsequent Events for further discussion on the Chapter 11 Cases and the PSAs. |
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As described in Note 1, given the nature of the bankruptcy process, realization of assets and liquidation of liabilities are subject to significant uncertainty. A sale of assets or other transaction could or will materially change the amounts and classifications reported in the unaudited consolidated financial statements, which do not give effect to any adjustments, to the carrying value of assets or amounts of liabilities that might be necessary as a consequence of confirmation of a Chapter 11 plan or a sale of assets. Our determination of the cash flows used to support the recoverability of these assets requires us to estimate future revenue growth, costs of operations and the fair value of consideration that may be realized in respect of the assets through such competitive process, which requires significant management judgment. The estimates we used to forecast the future operating results are consistent with the plans and estimates that we use to manage our business. Significant assumptions utilized in this analysis as of September 30, 2014 included maintaining current unit sale volumes, continuing to implement cost reduction measures and the ability to obtain consideration in excess of the book value of the assets to be sold at auction. The result of this analysis indicated that impairment was not required as of September 30, 2014. |
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Accounting For Stock-Based Compensation | ' |
Accounting for Stock-Based Compensation |
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Stock-based compensation cost is estimated at the grant date based on the award’s fair value and is recognized on the accelerated method as expense over the requisite service period. The fair value of stock options granted and stock issued under the Employee Stock Purchase Plan is calculated using the Black-Scholes-Merton (“BSM”) option pricing model. The BSM model requires various judgmental assumptions regarding volatility and expected option life. If any of the assumptions used in the BSM model change significantly, stock-based compensation expense for new awards may differ materially from that recorded for existing awards. |
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Restricted stock awards generally vest and are expensed over two- to four-year periods. We have granted restricted stock awards and options with certain performance conditions to certain executive officers and key employees. At each reporting date, we evaluate whether achievement of the performance conditions is probable. Compensation expense is recorded over the appropriate service period based upon our assessment of accomplishing each performance provision or the occurrence of other events which may have caused the awards or options to accelerate and vest. |
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In the second quarter of 2013, we granted cash-settled stock appreciation rights with a two-year vest period to certain employees. These awards are classified as liabilities and are measured at fair value at each reporting date, with fair value being determined using the BSM model. |
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Stock-based compensation accounting also requires the estimate of forfeiture rates. In 2014 and 2013, we increased our estimated forfeiture rates based on historical data, resulting in cumulative catch-up adjustments to decrease stock-based compensation expense and net loss by $4.9 million and $5.8 million for the nine months ended September 30, 2014 and 2013, respectively. These adjustments decreased basic and diluted net loss per share by $0.03 and $0.04 for the nine months ended September 30, 2014 and 2013, respectively. |
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Net Loss Per Share | ' |
Net Loss Per Share |
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Basic net loss per share is calculated by dividing net loss by the weighted average number of common shares outstanding. The calculation of diluted net loss per share excludes all outstanding stock options, unvested restricted stock and shares issuable upon potential conversion of the 2016 Notes in the three and nine months ended September 30, 2014 and 2013 and the 4.75% Convertible Senior Subordinated Notes due 2014 (the “2014 Notes”) in the three and nine months ended September 30, 2013 because all such securities are anti-dilutive: accordingly, diluted net loss per share is the same as basic net loss per share. For the three and nine months ended September 30, 2014 and 2013, the computation of diluted net loss per share excluded 17.8 million shares and 22.9 million shares, respectively. |
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Comprehensive Loss | ' |
Comprehensive Loss |
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Comprehensive loss includes charges and credits to stockholders’ deficit that are not the result of transactions with stockholders. Comprehensive loss consisted of net loss plus changes in unrealized gain or loss on investments for the three and nine months ended September 30, 2014 and 2013. |
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Loss Contingencies | ' |
Loss Contingencies |
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A loss contingency is recorded if it is probable that an asset has been impaired or a liability has been incurred and the amount of the loss can be reasonably estimated. We evaluate, among other factors, the probability of an unfavorable outcome and our ability to reasonably estimate the amount of the ultimate loss. Loss contingencies that we determine to be reasonably possible, but not probable, are disclosed but not recorded. Changes in these estimates could materially affect our financial position and results of operations. |
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Recent Accounting Pronouncements | ' |
Recent Accounting Pronouncements |
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In July 2013, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update 2013-11 (“ASU 2013-11”), Presentation of an Unrecognized Tax Benefit When a Net Operating Loss Carryforward, a Similar Tax Loss, or a Tax Credit Carryforward Exists. This standard requires that an unrecognized tax benefit, or a portion of an unrecognized tax benefit, be presented as a reduction of a deferred tax asset for an NOL carryforward, a similar tax loss, or a tax credit carryforward. If certain exception conditions exist, an entity should present an unrecognized tax benefit in the financial statements as a liability and should not net the unrecognized tax benefit with a deferred tax asset. The adoption of ASU 2013-11 on January 1, 2014 did not have a material impact on our financial position, results of operations or cash flows. |
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In May 2014, the FASB issued Accounting Standards Update 2014-09 (“ASU No. 2014-09”), Revenue from Contracts with Customers, which supersedes the guidance 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. ASU 2014-09 is effective for annual reporting periods beginning after December 15, 2016, including interim periods within that reporting period, and is to be applied retrospectively, with early application not permitted. We are evaluating the new standard, but do not at this time expect this standard to have a material impact on our consolidated financial statements. |
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In August 2014, the FASB issued Accounting Standards Update 2014-15 (“ASU 2014-15”), Presentation of Financial Statements—Going Concern: Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern. ASU 2014-15 requires an entity's management to evaluate whether there are conditions or events that raise substantial doubt about the entity's ability to continue as a going concern within one year after the date that the financial statements are issued. Public entities are required to apply ASU 2014-15 for annual reporting periods ending after December 15, 2016, and interim periods thereafter. Early application is permitted. We are evaluating the impact of ASU 2014-15. |
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For a more detailed listing of our significant accounting policies, see Note 2 of the consolidated financial statements included in the 2013 Form 10-K. |
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