Summary Of Significant Accounting Policies (Policy) | 9 Months Ended |
Sep. 30, 2013 |
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 (“CMS”) providing for a rebate on sales to eligible Medicaid patients. For sales of our product 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 gross 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”), providing for a chargeback on sales to PHS-eligible providers, 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 patients. 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 gross product revenue and trade accounts receivable. |
The following is a roll forward of our chargebacks reserve associated with the PHS and FSS programs: |
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| Nine Months Ended September 30, |
| 2013 | | 2012 |
| (in thousands) |
Beginning balance, January 1 | $ | 3,107 | | $ | 7,065 |
Current provision related to sales made in current period | | 10,426 | | | 12,837 |
Current provision related to sales made in prior periods | | — | | | 50 |
Adjustments | | -2,128 | | | — |
Payments/credits | | -8,399 | | | -13,394 |
Balance at September 30 | $ | 3,006 | | $ | 6,558 |
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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. Beginning in July of 2012, 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 gross product revenue and trade accounts receivable. We recorded chargebacks related to the GPOs of $2.4 million and $5.2 million for the three and nine months ended September 30, 2013, respectively, and $0.1 million for each of the three and nine months ended September 30, 2012. |
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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 gross 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 of our product to eligible GPO members. The following is a roll forward of our accrued GPO rebates and administrative fees balance: |
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| Nine Months Ended September 30, |
| 2013 | | 2012 |
| (in thousands) |
Beginning balance, January 1 | $ | 1,950 | | $ | 885 |
Current provision related to sales made in current period | | 4,682 | | | 5,719 |
Current provision related to sales made in prior periods | | — | | | 57 |
Payments/credits | | -5,054 | | | -4,734 |
Balance at September 30 | $ | 1,578 | | $ | 1,927 |
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Inventory | ' |
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Inventory |
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Inventories are determined at the lower of cost or market value with cost determined under the specific identification method. We began capitalizing raw material inventory in mid-April 2009, in anticipation of the potential approval for marketing of PROVENGE in the first half of 2010. At this time, our expectation of future benefits became sufficiently high to justify capitalization of these costs, as regulatory approval was considered probable and the related costs were expected to be recoverable through the commercialization of the product. Costs incurred prior to mid-April 2009 were recorded as research and development expense in the statements of operations, which resulted in zero-cost inventory. |
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For the nine months ended September 30, 2012, we used $4.7 million of zero-cost inventory; no zero-cost inventory remained on hand as of June 30, 2012. As a result, cost of product revenue reflects a lower average per unit cost of raw material in the first half of 2012. |
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Restructuring And Contract Termination Expenses | ' |
Restructuring and Contract Termination 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. Refer to Note 12 – Restructuring and Contract Termination for details of restructuring expenses recorded in the third quarter of 2013 and Note 14 – Subsequent Events for additional actions that will be implemented in the fourth quarter of 2013. |
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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 to be held and used 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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The long-lived assets at our manufacturing facilities in Atlanta, Georgia and in Orange County, California represent our most significant long-lived assets and have an average remaining estimated useful life of approximately 7.5 years. Our determination of the cash flows used to support the recoverability of these assets requires us to estimate future revenue growth and costs of operations, requiring significant management judgments. 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, 2013 included maintaining our current revenue levels and successfully implementing the cost reduction measures as further discussed in Note 14 – Subsequent Events. The recoverability test is particularly sensitive to our estimates of future revenue and operating expenses. For example, in our recoverability analysis as of September 30, 2013, a decrease in our revenue assumptions for future periods of less than 2%, without a corresponding decrease in operating expenses, would have indicated that the undiscounted cash flows were insufficient to recover the carrying value of our facility assets. In this analysis, the undiscounted cash flows exceeded the current net book value of our facility assets by 10%. Although we believe that our current underlying assumptions supporting this assessment are reasonable, if actual product revenues do not meet the levels we have forecasted or if we do not achieve the reductions in operating expense we have forecasted, we may be required to update the assumptions in our impairment analysis. Such updates to this analysis may impact the recoverability of these assets, which may result in a material charge to our statement of operations. |
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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 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. We determine the fair value of awards under our Employee Stock Purchase Plan using the BSM model. |
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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 expense also requires the estimate of forfeiture rates. In the first and second quarters of 2013, we adjusted our estimated forfeiture rates based on historical forfeiture data, resulting in cumulative catch-up adjustments to decrease stock-based compensation expense and net loss by $5.8 million for the nine months ended September 30, 2013. These adjustments decreased basic and diluted net loss per share by $0.04 for the nine months ended September 30, 2013. |
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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. For the calculation of diluted net loss per share, we have excluded all outstanding stock options, unvested restricted stock and shares issuable upon potential conversion of the 2.875% Convertible Senior Notes due 2016 (the “2016 Notes”) and the 4.75% Convertible Senior Subordinated Notes due 2014 (the “2014 Notes”) from the calculation because all such securities are anti-dilutive, and accordingly, our diluted net loss per shares is the same as basic net loss per share. For the three and nine months ended September 30, 2013 and 2012, the computation of diluted net loss per share excluded 22.9 million shares and 23.1 million shares, respectively. |
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Comprehensive Income (Loss) | ' |
Comprehensive Income (Loss) |
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Comprehensive income (loss) includes charges and credits to stockholders’ equity that are not the result of transactions with stockholders. Our comprehensive loss consisted of net loss plus changes in unrealized gain or loss on investments for the three and nine months ended September 30, 2013 and 2012. |
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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 make a reasonable estimate of 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 February 2013, the Financial Accounting Standards Board (the “FASB”) issued an Accounting Standards Update which requires companies to provide information about the amounts reclassified from accumulated other comprehensive income to net income by component. In addition, companies are required to present, either on the face of the statements of operations or in the notes to the financial statements, significant amounts reclassified from accumulated other comprehensive income by statement of operations line item. There were no reclassifications from accumulated other comprehensive income to net income for the three and nine months ended September 30, 2013. |
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In June 2013, the FASB ratified Emerging Issues Task Force (“EITF”) Issue 13-C, “Presentation of an Unrecognized Tax Benefit When a Net Operating Loss Carryforward, a Similar Tax Loss, or a Tax Credit Carryforward Exists,” which concludes that an unrecognized tax benefit should be presented as a reduction of a deferred tax asset when settlement in this manner is available under the tax law. We will adopt this amendment as of January 2014, and do not believe it will have any impact on our financial position, results of operations or cash flows. |
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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 2012 Form 10-K. |
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