Document_and_Entity_Informatio
Document and Entity Information | 3 Months Ended | |
Mar. 31, 2015 | Apr. 23, 2015 | |
Document and Entity Information | ||
Entity Registrant Name | INCYTE CORP | |
Entity Central Index Key | 879169 | |
Document Type | 10-Q | |
Document Period End Date | 31-Mar-15 | |
Amendment Flag | FALSE | |
Current Fiscal Year End Date | -19 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 179,042,841 | |
Document Fiscal Year Focus | 2015 | |
Document Fiscal Period Focus | Q1 |
CONDENSED_CONSOLIDATED_BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS (USD $) | Mar. 31, 2015 | Dec. 31, 2014 | |
In Thousands, unless otherwise specified | |||
Current assets: | |||
Cash and cash equivalents | $421,822 | $452,297 | [1] |
Marketable securities-available-for-sale | 163,602 | 147,966 | [1] |
Restricted investments | 500 | 500 | [1] |
Accounts receivable | 69,604 | 57,933 | [1] |
Inventory | 2,414 | 358 | [1] |
Deferred income taxes | 6,025 | 19,641 | [1] |
Prepaid expenses and other current assets | 28,178 | 20,519 | [1] |
Total current assets | 692,145 | 699,214 | [1] |
Restricted investments | 13,875 | 14,000 | [1] |
Long term investments | 39,829 | ||
Inventory | 17,021 | 19,078 | [1] |
Property and equipment, net | 80,667 | 81,790 | [1] |
Other assets, net | 19,087 | 15,987 | [1] |
Total assets | 862,624 | 830,069 | [1] |
Current liabilities: | |||
Accounts payable | 26,586 | 24,462 | [1] |
Accrued compensation | 24,324 | 34,422 | [1] |
Interest payable | 4,443 | 1,841 | [1] |
Accrued and other current liabilities | 70,048 | 62,270 | [1] |
Deferred revenue-collaborative agreements | 12,857 | 12,880 | [1] |
Convertible senior notes | 87,337 | 85,640 | [1] |
Total current liabilities | 225,595 | 221,515 | [1] |
Convertible senior notes | 610,210 | 603,478 | [1] |
Other liabilities | 52,910 | 54,552 | [1] |
Deferred income taxes | 6,025 | 19,641 | [1] |
Deferred revenue-collaborative agreements | 9,297 | 12,511 | [1] |
Total liabilities | 904,037 | 911,697 | [1] |
Stockholders' deficit: | |||
Preferred stock, $0.001 par value; 5,000,000 shares authorized; none issued or outstanding as of March 31, 2015 and December 31, 2014 | [1] | ||
Common stock, $0.001 par value; 400,000,000 shares authorized; 173,386,941 and 170,876,619 shares issued and outstanding as of March 31, 2015 and December 31, 2014, respectively | 173 | 171 | [1] |
Additional paid-in capital | 1,760,033 | 1,701,904 | [1] |
Accumulated other comprehensive income | 2,258 | 1,815 | [1] |
Accumulated deficit | -1,803,877 | -1,785,518 | [1] |
Total stockholders' deficit | -41,413 | -81,628 | [1] |
Total liabilities and stockholders' deficit | $862,624 | $830,069 | [1] |
[1] | The condensed consolidated balance sheet at December 31, 2014 has been derived from the audited financial statements at that date. |
CONDENSED_CONSOLIDATED_BALANCE1
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
CONDENSED CONSOLIDATED BALANCE SHEETS | ||
Preferred stock, par value (in dollars per share) | $0.00 | $0.00 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $0.00 | $0.00 |
Common stock, shares authorized | 400,000,000 | 400,000,000 |
Common stock, shares issued | 173,386,941 | 170,876,619 |
Common stock, shares outstanding | 173,386,941 | 170,876,619 |
CONDENSED_CONSOLIDATED_STATEME
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (USD $) | 3 Months Ended | |
In Thousands, except Per Share data, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 |
Revenues: | ||
Product revenues, net | $115,330 | $69,651 |
Product royalty revenues | 15,673 | 9,826 |
Contract revenues | 28,214 | 10,214 |
Other revenues | 58 | 101 |
Total revenues | 159,275 | 89,792 |
Costs and expenses: | ||
Cost of product revenues | 2,974 | 168 |
Research and development | 118,365 | 75,585 |
Selling, general and administrative | 44,871 | 36,974 |
Total costs and expenses | 166,210 | 112,727 |
Loss from operations | -6,935 | -22,935 |
Interest and other income, net | 1,630 | 735 |
Interest expense | -12,687 | -11,443 |
Debt exchange expense on senior note conversions | -265 | |
Loss before provision for income taxes | -17,992 | -33,908 |
Provision for income taxes | 367 | 49 |
Net loss | ($18,359) | ($33,957) |
Basic and diluted net loss per share (in dollars per share) | ($0.11) | ($0.21) |
Shares used in computing basic and diluted net loss per share( in shares) | 172,070 | 165,357 |
CONDENSED_CONSOLIDATED_STATEME1
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (USD $) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 |
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS | ||
Net loss | ($18,359) | ($33,957) |
Other comprehensive income: | ||
Unrealized gains on restricted investments and marketable securities, net of tax | 443 | 47 |
Other comprehensive income | 443 | 47 |
Comprehensive loss | ($17,916) | ($33,910) |
CONDENSED_CONSOLIDATED_STATEME2
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (USD $) | 3 Months Ended | ||
In Thousands, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 | |
Cash flows from operating activities: | |||
Net loss | ($18,359) | ($33,957) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization of debt discounts | 11,835 | 9,623 | |
Stock-based compensation | 17,558 | 15,347 | |
Debt exchange expense on senior note conversions | 265 | ||
Excess tax provision (benefit) from stock based compensation | -3,833 | 31 | |
Changes in operating assets and liabilities: | |||
Accounts receivable | -11,671 | -11,020 | |
Prepaid expenses and other assets | -194 | -4,899 | |
Inventory | 1 | -506 | |
Accounts payable | 2,124 | -1,152 | |
Accrued and other liabilities | 1,190 | -2,208 | |
Deferred revenue - collaborative agreements | -3,237 | -3,218 | |
Net cash used in operating activities | -4,586 | -31,694 | |
Cash flows from investing activities: | |||
Long term investment | -39,829 | ||
Capital expenditures | -3,553 | -2,663 | |
Purchases of marketable securities | -34,467 | -45,114 | |
Maturities of marketable securities | 19,274 | 90 | |
Net cash used in investing activities | -58,575 | -47,687 | |
Cash flows from financing activities: | |||
Release of restricted investments | 125 | ||
Proceeds from issuance of common stock under stock plans | 29,180 | 44,833 | |
Direct financing arrangement repayments | -452 | ||
Excess tax provision (benefit) from stock based compensation | 3,833 | -31 | |
Cash paid in connection with exchange of 4.75% convertible senior notes due 2015 | -265 | ||
Net cash provided by financing activities | 32,686 | 44,537 | |
Net decrease in cash and cash equivalents | -30,475 | -34,844 | |
Cash and cash equivalents at beginning of period | 452,297 | [1] | 471,429 |
Cash and cash equivalents at end of period | 421,822 | 436,585 | |
Supplemental Schedule of Cash Flow Information | |||
Interest paid | 839 | ||
Incomes taxes paid | 13 | ||
Convertible Senior Notes 4.75 Percent Due 2015 | |||
Supplemental Schedule of Cash Flow Information | |||
Reclassification to additional paid in capital in connection with exchange of 4.75% convertible senior notes due 2015 | $4,446 | ||
[1] | The condensed consolidated balance sheet at December 31, 2014 has been derived from the audited financial statements at that date. |
CONDENSED_CONSOLIDATED_STATEME3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Parenthetical) (Convertible Senior Notes 4.75 Percent Due 2015) | Mar. 31, 2015 | Mar. 31, 2014 |
Convertible Senior Notes 4.75 Percent Due 2015 | ||
Interest rate of debt (as a percent) | 4.75% | 4.75% |
Organization_and_business
Organization and business | 3 Months Ended |
Mar. 31, 2015 | |
Organization and business | |
Organization and business | |
1.Organization and business | |
Incyte Corporation (“Incyte,” “we,” “us,” or “our”) is a biopharmaceutical company focused on developing and commercializing proprietary therapeutics, primarily for oncology. Our pipeline includes compounds in various stages, ranging from preclinical to late stage development, and a commercialized product, JAKAFI® (ruxolitinib). Our operations are treated as one operating segment. | |
Summary_of_significant_account
Summary of significant accounting policies | 3 Months Ended |
Mar. 31, 2015 | |
Summary of significant accounting policies | |
Summary of significant accounting policies | |
2.Summary of significant accounting policies | |
Basis of presentation | |
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. The condensed consolidated balance sheet as of March 31, 2015 and the condensed consolidated statements of operations, comprehensive loss and cash flows for the three months ended March 31, 2015 and 2014, are unaudited, but include all adjustments, consisting only of normal recurring adjustments, which we consider necessary for a fair presentation of the financial position, operating results and cash flows for the periods presented. The condensed consolidated balance sheet at December 31, 2014 has been derived from audited financial statements. | |
Although we believe that the disclosures in these financial statements are adequate to make the information presented not misleading, certain information and footnote information normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) have been condensed or omitted pursuant to the rules and regulations of the Securities and Exchange Commission. | |
Results for any interim period are not necessarily indicative of results for any future interim period or for the entire year. The accompanying financial statements should be read in conjunction with the financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2014. | |
Principles of Consolidation. The condensed consolidated financial statements include the accounts of Incyte Corporation and our wholly owned subsidiaries, including Incyte Holdings Corporation, Incyte International Holdings Sarl, and Incyte Europe Sarl. All inter-company accounts, transactions, and profits have been eliminated in consolidation. | |
Foreign Currency Translation. Operations in non-U.S. entities are recorded in the functional currency of each entity. For financial reporting purposes, the functional currency of an entity is determined by a review of the source of an entity’s most predominant cash flows. The results of operations for any non-U.S. dollar functional currency entities are translated from functional currencies into U.S. dollars using the average currency rate during each month, which approximates the results that would be obtained using actual currency rates on the dates of individual transactions. Assets and liabilities are translated using currency rates at the end of the period. Adjustments resulting from translating the financial statements of our foreign entities that use their local currency as the functional currency into the U.S. dollars are reflected as a component of other comprehensive income (loss). Transaction gains and losses are recorded in interest and other income, net in the condensed consolidated statements of operations. To date, both the translation gains or losses in other comprehensive income and the transaction gains or losses in interest and other income, net have been immaterial. | |
Use of Estimates. The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates. | |
Concentrations of Credit Risk. Cash, cash equivalents, marketable securities, trade receivables and restricted investments are financial instruments which potentially subject us to concentrations of credit risk. The estimated fair value of financial instruments approximates the carrying value based on available market information. We primarily invest our excess available funds in notes and bills issued by the U.S. government and its agencies and corporate debt securities and, by policy, limit the amount of credit exposure to any one issuer and to any one type of investment, other than securities issued or guaranteed by the U.S. government. Our receivables mainly relate to our product sales of JAKAFI and collaborative agreements with pharmaceutical companies. We have not experienced any significant credit losses on cash, cash equivalents, marketable securities, trade receivables or restricted investments to date and do not require collateral on receivables. | |
Cash and Cash Equivalents. Cash and cash equivalents are held in U.S. banks or in custodial accounts with banks. Cash equivalents are defined as all liquid investments and money market funds with maturity from date of purchase of 90 days or less that are readily convertible into cash. | |
Marketable Securities—Available-for-Sale. All marketable securities are classified as available-for-sale. Available-for-sale securities are carried at fair value, based on quoted market prices and observable inputs, with unrealized gains and losses, net of tax, reported as a separate component of stockholders’ deficit. We classify marketable securities that are available for use in current operations as current assets on the condensed consolidated balance sheets. Realized gains and losses and declines in value judged to be other than temporary for available-for-sale securities are included in “Interest and other income, net.” The cost of securities sold is based on the specific identification method. | |
Accounts Receivable. As of March 31, 2015 and December 31, 2014, we had no allowance for doubtful accounts. We provide an allowance for doubtful accounts based on experience and specifically identified risks. Accounts receivable are carried at fair value and charged off against the allowance for doubtful accounts when we determine that recovery is unlikely and we cease collection efforts. | |
Inventory. Inventories are determined at the lower of cost or market value with cost determined under the specific identification method and may consist of raw materials, work in process and finished goods. We began capitalizing inventory in mid-November 2011 once the U.S. Food and Drug Administration (“FDA”) approved JAKAFI as the related costs were expected to be recoverable through the commercialization of the product. Costs incurred prior to approval of JAKAFI have been recorded as research and development expense in our statements of operations. As a result, cost of product revenues for the next 18 to 21 months will reflect a lower average per unit cost of materials. | |
The raw materials and work-in-process inventory is not subject to expiration and the shelf life for finished goods inventory is 36 months from the start of manufacturing of the finished goods. We evaluate for potential excess inventory by analyzing current and future product demand relative to the remaining product shelf life. We build demand forecasts by considering factors such as, but not limited to, overall market potential, market share, market acceptance and patient usage. We classify inventory as current on the condensed consolidated balance sheets when we expect inventory to be consumed for commercial use within the next twelve months. | |
Variable Interest Entities. We perform an initial and on-going evaluation of the entities with which we have variable interests, such as equity ownership, in order to identify entities that (i) do not have sufficient equity investment at risk to permit the entity to finance its activities without additional subordinated financial support or (ii) in which the equity investors lack an essential characteristic of a controlling financial interest as variable interest entities (“VIE” or “VIEs”). If an entity is identified as a VIE, we perform an assessment to determine whether we have both (i) the power to direct activities that most significantly impact the VIE’s economic performance and (ii) have the obligation to absorb losses from or the right to receive benefits of the VIE that could potentially be significant to the VIE. If both of these criteria are satisfied, we are identified as the primary beneficiary of the VIE. As of March 31, 2015, there were no entities in which we held a variable interest which we determined to be VIEs. | |
Equity Method Investments. In circumstances where we have the ability to exercise significant influence over the operating and financial policies of a company in which we have an investment, the investment is accounted for either (i) under the equity method of accounting or (ii) at fair value by electing the fair value option under U.S. GAAP. In assessing whether we exercise significant influence, we consider the nature and magnitude of our investment, any voting and protective rights we hold, any participation in the governance of the other company, and other relevant factors such as the presence of a collaboration or other business relationship. Under the equity method of accounting, we record within our results of operations our share of income or loss of the investee company. Under the fair value option, our investment is carried at fair value and all changes in fair value are reported in our results of operations. | |
Property and Equipment. Property and equipment is stated at cost, less accumulated depreciation and amortization. Depreciation is recorded using the straight-line method over the estimated useful lives of the respective assets (generally three to five years). Leasehold improvements are amortized over the shorter of the estimated useful life of the assets or lease term. | |
Management continually reviews the estimated useful lives of technologically sensitive equipment and believes that those estimates appropriately reflect the current useful life of our assets. In the event that a currently unknown significantly advanced technology became commercially available, we would re-evaluate the value and estimated useful lives of our existing equipment, possibly having a material impact on the financial statements. | |
Lease Accounting. We account for operating leases by recording rent expense on a straight-line basis over the expected life of the lease, commencing on the date we gain possession of leased property. We include tenant improvement allowances and rent holidays received from landlords and the effect of any rent escalation clauses as adjustments to straight-line rent expense over the expected life of the lease. | |
Capital leases are reflected as a liability at the inception of the lease based on the present value of the minimum lease payments or, if lower, the fair value of the property. Assets under capital leases are recorded in property and equipment, net on the condensed consolidated balance sheets and depreciated in a manner similar to other property and equipment. | |
Certain construction projects may be accounted for as direct financing arrangements, whereby we record, over the construction period, the full cost of the asset in property and equipment, net on the condensed consolidated balance sheets. A corresponding liability is also recorded, net of leasehold improvements paid for by us, and is amortized over the expected lease term through monthly rental payments using the effective interest method. | |
Income Taxes. We account for income taxes using the asset and liability approach which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the carrying amount of assets and liabilities for financial reporting purposes and amounts reportable for income tax purposes. In addition, we follow the guidance related to accounting for uncertainty in income taxes. This guidance creates a single model to address uncertainty in tax positions and clarifies the accounting for income taxes by prescribing the minimum recognition threshold a tax position is required to meet before it is recognized in the financial statements. | |
Financing Costs Related to Long-term Debt. Costs associated with obtaining long-term debt are deferred and amortized over the term of the related debt using the effective interest method. Such costs are included in other assets, net on the condensed consolidated balance sheets. | |
Grant Accounting. Grant amounts received from government agencies for operations are deferred and are amortized into income over the service period of the grant. Grant amounts received for purchases of capital assets are deferred and amortized into interest and other income, net over the useful life of the related capital assets. Such amounts are recorded in other liabilities on the condensed consolidated balance sheets. | |
Net Loss Per Share. Our basic and diluted losses per share are calculated by dividing the net loss by the weighted average number of shares of common stock outstanding during all periods presented. Options to purchase stock and shares issuable upon the conversion of convertible debt are included in diluted earnings per share calculations, unless the effects are anti-dilutive. | |
Accumulated Other Comprehensive Income (Loss). Accumulated other comprehensive income (loss) consists of unrealized gains or losses on marketable securities and restricted cash and investments. | |
Revenue Recognition. Revenues are recognized when (1) persuasive evidence of an arrangement exists, (2) delivery has occurred or services have been rendered, (3) the price is fixed or determinable and (4) collectability is reasonably assured. Revenues are deferred for fees received before earned or until no further obligations exist. We exercise judgment in determining that collectability is reasonably assured or that services have been delivered in accordance with the arrangement. We assess whether the fee is fixed or determinable based on the payment terms associated with the transaction and whether the sales price is subject to refund or adjustment. We assess collectability based primarily on the customer’s payment history and on the creditworthiness of the customer. | |
Product Revenues | |
Our product revenues consist of U.S. sales of JAKAFI and are recognized once we meet all four revenue recognition criteria described above. In November 2011, we began shipping JAKAFI to our specialty pharmacy customers, which in turn dispense JAKAFI to patients in fulfillment of prescriptions. | |
We recognize revenues for product received by our specialty pharmacy customers net of allowances for customer credits, including estimated rebates, chargebacks, discounts, returns, distribution service fees, patient assistance programs, and Medicare Part D coverage gap reimbursements. Product shipping and handling costs are included in cost of product revenues. | |
Customer Credits: Our specialty pharmacy customers are offered various forms of consideration, including allowances, service fees and prompt payment discounts. We expect our specialty pharmacy customers will earn prompt payment discounts and, therefore, we deduct the full amount of these discounts from total product sales when revenues are recognized. Service fees are also deducted from total product sales as they are earned. | |
Rebates: Allowances for rebates include mandated discounts under the Medicaid Drug Rebate Program. Rebate amounts are based upon contractual agreements or legal requirements with public sector (e.g. Medicaid) benefit providers. Rebates are amounts owed after the final dispensing of the product to a benefit plan participant and are based upon contractual agreements or legal requirements with public sector benefit providers. The accrual for rebates is based on statutory discount rates and expected utilization as well as historical data we have accumulated since product launch. Our estimates for expected utilization of rebates are based on data received from our specialty pharmacy customers. Rebates are generally invoiced and paid in arrears so that the accrual balance consists of an estimate of the amount expected to be incurred for the current quarter’s activity, plus an accrual balance for known prior quarters’ unpaid rebates. If actual future rebates vary from estimates, we may need to adjust prior period accruals, which would affect revenue in the period of adjustment. | |
Chargebacks: Chargebacks are discounts that occur when contracted customers purchase directly from a specialty pharmacy, or an intermediary distributor. Contracted customers, which currently consist primarily of Public Health Service institutions, non-profit clinics, and Federal government entities purchasing via the Federal Supply Schedule, generally purchase the product at a discounted price. The specialty pharmacy or distributor, in turn, charges back to us the difference between the price initially paid by the specialty pharmacy or distributor and the discounted price paid to the specialty pharmacy or distributor by the customer. The accrual for chargebacks is based on the estimated contractual discounts on the inventory levels on hand in our distribution channel. If actual future chargebacks vary from estimates, we may need to adjust prior period accruals, which would affect revenue in the period of adjustment. | |
Medicare Part D Coverage Gap: Medicare Part D prescription drug benefit mandates manufacturers to fund 50% of the Medicare Part D insurance coverage gap for prescription drugs sold to eligible patients. Our estimates for the expected Medicare Part D coverage gap are based on historical invoices received and in part from data received from our specialty pharmacy customers. Funding of the coverage gap is generally invoiced and paid in arrears so that the accrual balance consists of an estimate of the amount expected to be incurred for the current quarter’s activity, plus an accrual balance for known prior quarters. If actual future funding varies from estimates, we may need to adjust prior period accruals, which would affect revenue in the period of adjustment. | |
Co-payment Assistance: Patients who have commercial insurance and meet certain eligibility requirements may receive co-payment assistance. We accrue a liability for co-payment assistance based on actual program participation and estimates of program redemption using data provided by third-party administrators. | |
Product Royalty Revenues | |
Royalty revenues on commercial sales for ruxolitinib (marketed as JAKAVI® outside the United States) by Novartis Pharmaceutical International Ltd. (“Novartis”) are based on net sales of licensed products in licensed territories as provided by Novartis. We recognize royalty revenues in the period the sales occur. | |
Cost of Product Revenues | |
Cost of product revenues includes all JAKAFI related costs that are recoverable through the commercialization of the product. Beginning in October 2014, we became obligated to pay tiered, low single digit royalties under our collaboration and license agreement to Novartis on all future sales of JAKAFI in the United States which are included in cost of product revenues. | |
Contract and License Revenues | |
Under agreements involving multiple deliverables, services and/or rights to use assets that we entered into prior to January 1, 2011, the multiple elements are divided into separate units of accounting when certain criteria are met, including whether the delivered items have stand-alone value to the customer and whether there is objective and reliable evidence of the fair value of the undelivered items. When separate units of accounting exist, consideration is allocated among the separate elements based on their respective fair values. The determination of fair value of each element is based on objective evidence from historical sales of the individual elements by us to other customers. If such evidence of fair value for each undelivered element of the arrangement does not exist, all revenue from the arrangement is deferred until such time that evidence of fair value for each undelivered element does exist or until all elements of the arrangement are delivered. When elements are specifically tied to a separate earnings process, revenue is recognized when the specific performance obligation tied to the element is completed. When revenues for an element are not specifically tied to a separate earnings process, they are recognized ratably over the term of the agreement. We assess whether a substantive milestone exists at the inception of our agreements. For all milestones within our arrangements that are considered substantive, we recognize revenue upon the achievement of the associated milestone. If a milestone is not considered substantive, we would recognize the applicable milestone payment over the remaining period of performance under the arrangement. As of March 31, 2015, all remaining potential milestones under our collaborative arrangements are considered substantive. | |
On January 1, 2011, updated guidance on the recognition of revenues for agreements with multiple deliverables became effective and applies to any agreements we may enter into on or after January 1, 2011. This updated guidance (i) relates to whether multiple deliverables exist, how the deliverables in a revenue arrangement should be separated and how the consideration should be allocated; (ii) requires companies to allocate revenues in an arrangement using estimated selling prices of deliverables if a vendor does not have vendor-specific objective evidence or third-party evidence of selling price; and (iii) eliminates the use of the residual method and requires companies to allocate revenues using the relative selling price method. During the three months ended March 31, 2015 and 2014, we did not enter into any agreements that are subject to this updated guidance. If we enter into an agreement with multiple deliverables after January 1, 2011 or amend existing agreements, this updated guidance could have a material effect on our financial statements. | |
Our collaborations often include contractual milestones, which typically relate to the achievement of pre-specified development, regulatory and commercialization events. These three categories of milestone events reflect the three stages of the life-cycle of our drugs, which we describe in more detail in the following paragraphs. | |
The regulatory review and approval process, which includes preclinical testing and clinical trials of each drug candidate, is lengthy, expensive and uncertain. Securing approval by the FDA requires the submission of extensive preclinical and clinical data and supporting information to the FDA for each indication to establish a drug candidate’s safety and efficacy. The approval process takes many years, requires the expenditure of substantial resources, involves post-marketing surveillance and may involve ongoing requirements for post-marketing studies. Before commencing clinical investigations of a drug candidate in humans, we must submit an Investigational New Drug application (“IND”), which must be reviewed by the FDA. | |
The steps generally required before a drug may be marketed in the United States include preclinical laboratory tests, animal studies and formulation studies, submission to the FDA of an IND for human clinical testing, performance of adequate and well-controlled clinical trials in three phases, as described below, to establish the safety and efficacy of the drug for each indication, submission of a new drug application (“NDA”) or biologics license application (“BLA”) to the FDA for review and FDA approval of the NDA or BLA. | |
Similar requirements exist within foreign regulatory agencies as well. The time required satisfying the FDA requirements or similar requirements of foreign regulatory agencies may vary substantially based on the type, complexity and novelty of the product or the targeted disease. | |
Preclinical testing includes laboratory evaluation of product pharmacology, drug metabolism, and toxicity, which includes animal studies, to assess potential safety and efficacy as well as product chemistry, stability, formulation, development, and testing. The results of the preclinical tests, together with manufacturing information and analytical data, are submitted to the FDA as part of an IND. The FDA may raise safety concerns or questions about the conduct of the clinical trials included in the IND, and any of these concerns or questions must be resolved before clinical trials can proceed. We cannot be sure that submission of an IND will result in the FDA allowing clinical trials to commence. Clinical trials involve the administration of the investigational drug or the marketed drug to human subjects under the supervision of qualified investigators and in accordance with good clinical practices regulations covering the protection of human subjects. Clinical trials typically are conducted in three sequential phases, but the phases may overlap or be combined. Phase I usually involves the initial introduction of the investigational drug into healthy volunteers to evaluate its safety, dosage tolerance, absorption, metabolism, distribution and excretion. Phase II usually involves clinical trials in a limited patient population to evaluate dosage tolerance and optimal dosage, identify possible adverse effects and safety risks, and evaluate and gain preliminary evidence of the efficacy of the drug for specific indications. Phase III clinical trials usually further evaluate clinical efficacy and safety by testing the drug in its final form in an expanded patient population, providing statistical evidence of efficacy and safety, and providing an adequate basis for labeling. We cannot guarantee that Phase I, Phase II or Phase III testing will be completed successfully within any specified period of time, if at all. Furthermore, we, the institutional review board for a trial, or the FDA may suspend clinical trials at any time on various grounds, including a finding that the subjects or patients are being exposed to an unacceptable health risk. | |
Generally, the milestone events contained in our collaboration agreements coincide with the progression of our drugs from development, to regulatory approval and then to commercialization. The process of successfully discovering a new development candidate, having it approved and successfully commercialized is highly uncertain. As such, the milestone payments we may earn from our partners involve a significant degree of risk to achieve. Therefore, as a drug candidate progresses through the stages of its life-cycle, the value of the drug candidate generally increases. | |
Research and Development Costs. Our policy is to expense research and development costs as incurred. We often contract with clinical research organizations (“CROs”) to facilitate, coordinate and perform agreed upon research and development of a new drug. To ensure that research and development costs are expensed as incurred, we record monthly accruals for clinical trials and preclinical testing costs based on the work performed under the contract. | |
These CRO contracts typically call for the payment of fees for services at the initiation of the contract and/or upon the achievement of certain clinical trial milestones. In the event that we prepay CRO fees, we record the prepayment as a prepaid asset and amortize the asset into research and development expense over the period of time the contracted research and development services are performed. Most professional fees, including project and clinical management, data management, monitoring, and medical writing fees are incurred throughout the contract period. These professional fees are expensed based on their percentage of completion at a particular date. Our CRO contracts generally include pass through fees. Pass through fees include, but are not limited to, regulatory expenses, investigator fees, travel costs, and other miscellaneous costs, including shipping and printing fees. We expense the costs of pass through fees under our CRO contracts as they are incurred, based on the best information available to us at the time. The estimates of the pass through fees incurred are based on the amount of work completed for the clinical trial and are monitored through correspondence with the CROs, internal reviews and a review of contractual terms. The factors utilized to derive the estimates include the number of patients enrolled, duration of the clinical trial, estimated patient attrition, screening rate and length of the dosing regimen. CRO fees incurred to set up the clinical trial are expensed during the setup period. Under our clinical trial collaboration agreements and clinical trial agreements, we may be reimbursed for certain development costs incurred. Such costs are recorded as a reduction of research and development expense in the period in which the related expense is incurred. | |
Stock Compensation. Share-based payment transactions with employees, which include stock options, restricted stock units (“RSUs”) and performance shares (“PSUs”), are recognized as compensation expense over the requisite service period based on their estimated fair values as well as expected forfeiture rates. The stock compensation process requires significant judgment and the use of estimates, particularly surrounding Black-Scholes assumptions such as stock price volatility over the option term and expected option lives, as well as expected forfeiture rates and the probability of PSUs vesting. The fair value of stock options, which are subject to graded vesting, are recognized as compensation expense over the requisite service period using the accelerated attribution method. The fair value of RSUs, which are generally subject to cliff vesting, are recognized as compensation expense over the requisite service period using the straight line attribution method. The fair value of PSUs are recognized as compensation expense beginning at the time in which the performance conditions are deemed probable of achievement, over the remaining requisite service period. We recorded $17.6 million and $15.3 million of stock compensation expense on our condensed consolidated statements of operations for the three months ended March 31, 2015 and 2014, respectively. | |
Recent Accounting Pronouncements | |
In August 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-15, “Presentation of Financial Statements—Going Concern”, to provide guidance on management’s responsibility in evaluating whether there is substantial doubt about a company’s ability to continue as a going concern and about related footnote disclosures. For each reporting period, management will be required to evaluate whether there are conditions or events that raise substantial doubt about a company’s ability to continue as a going concern within one year from the date the financial statements are issued. This guidance is effective for the annual period ending after December 15, 2016, and for annual periods and interim periods thereafter. Early application is permitted. We do not believe the pending adoption of ASU No. 2014-15 will have a material impact on our condensed consolidated financial statements. | |
In May 2014, the FASB issued ASU No. 2014-09, “Revenue from Contracts with Customers,” which provides a five step approach to be applied to all contracts with customers. ASU No. 2014-09 also requires expanded disclosures about revenue recognition. On April 1, 2015, the FASB proposed to extend the effective date of ASU No. 2014-09 from reporting periods beginning after December 15, 2016 to reporting periods beginning after December 15, 2017. Early adoption is permitted for reporting periods beginning after December 15, 2016. Once the proposal is formally issued, the public will have 30 days to comment, after which the proposal will be decided upon. We are currently analyzing the impact of ASU No. 2014-09 on our results of operations and, at this time, we are unable to determine the impact on the new standard, if any, on our condensed consolidated financial statements. | |
Fair_value_of_financial_instru
Fair value of financial instruments | 3 Months Ended | |||||||||||||
Mar. 31, 2015 | ||||||||||||||
Fair value of financial instruments. | ||||||||||||||
Fair value of financial instruments | ||||||||||||||
3.Fair value of financial instruments | ||||||||||||||
FASB accounting guidance defines fair value as the price that would be received to sell an asset or paid to transfer a liability (“the exit price”) in an orderly transaction between market participants at the measurement date. The standard outlines a valuation framework and creates a fair value hierarchy in order to increase the consistency and comparability of fair value measurements and the related disclosures. In determining fair value we use quoted prices and observable inputs. Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of us. The fair value hierarchy is broken down into three levels based on the source of inputs as follows: | ||||||||||||||
Level 1—Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities. | ||||||||||||||
Level 2—Valuations based on observable inputs and quoted prices in active markets for similar assets and liabilities. | ||||||||||||||
Level 3—Valuations based on inputs that are unobservable and models that are significant to the overall fair value measurement. | ||||||||||||||
Our marketable securities consist of investments in U.S. government agencies, corporate debt securities and non-agency mortgage-backed securities that are classified as available-for-sale. | ||||||||||||||
At March 31, 2015 and December 31, 2014, our Level 2 corporate debt securities and mortgage-backed securities are valued using readily available pricing sources which utilize market observable inputs, including the current interest rate and other characteristics for similar types of instruments. | ||||||||||||||
The following fair value hierarchy table presents information about each major category of our financial assets and liabilities measured at fair value on a recurring basis as of March 31, 2015 (in thousands): | ||||||||||||||
Fair Value Measurement at Reporting Date Using: | ||||||||||||||
Quoted Prices in | Significant Other | Significant | Balance as of | |||||||||||
Active Markets for | Observable | Unobservable | March 31, 2015 | |||||||||||
Identical Assets | Inputs | Inputs | ||||||||||||
(Level 1) | (Level 2) | (Level 3) | ||||||||||||
Cash and cash equivalents | $ | 421,822 | $ | — | $ | — | $ | 421,822 | ||||||
Corporate debt securities | — | 160,180 | — | 160,180 | ||||||||||
Long term investment (Note 7) | 39,829 | — | — | 39,829 | ||||||||||
Mortgage-backed securities | — | 3,422 | — | 3,422 | ||||||||||
Total assets | $ | 461,651 | $ | 163,602 | $ | — | $ | 625,253 | ||||||
The following fair value hierarchy table presents information about each major category of our financial assets measured at fair value on a recurring basis as of December 31, 2014 (in thousands): | ||||||||||||||
Fair Value Measurement at Reporting Date Using: | ||||||||||||||
Quoted Prices in | Significant Other | Significant | Balance as of | |||||||||||
Active Markets for | Observable | Unobservable | December 31, 2014 | |||||||||||
Identical Assets | Inputs | Inputs | ||||||||||||
(Level 1) | (Level 2) | (Level 3) | ||||||||||||
Cash and cash equivalents | $ | 452,297 | $ | — | $ | — | $ | 452,297 | ||||||
Corporate debt securities | — | 144,402 | — | 144,402 | ||||||||||
Mortgage-backed securities | — | 3,564 | — | 3,564 | ||||||||||
Total assets | $ | 452,297 | $ | 147,966 | $ | — | $ | 600,263 | ||||||
The following is a summary of our marketable security portfolio as of March 31, 2015 and December 31, 2014, respectively. | ||||||||||||||
Amortized | Net | Net | Estimated | |||||||||||
Cost | Unrealized | Unrealized | Fair Value | |||||||||||
Gains | Losses | |||||||||||||
(in thousands) | ||||||||||||||
March 31, 2015 | ||||||||||||||
Corporate debt securities | $ | 160,008 | $ | 172 | $ | — | $ | 160,180 | ||||||
Mortgage backed securities | 1,330 | 2,092 | — | 3,422 | ||||||||||
$ | 161,338 | $ | 2,264 | $ | — | $ | 163,602 | |||||||
December 31, 2014 | ||||||||||||||
Corporate debt securities | $ | 144,684 | $ | — | $ | (282 | ) | $ | 144,402 | |||||
Mortgage backed securities | 1,461 | 2,103 | — | 3,564 | ||||||||||
$ | 146,145 | $ | 2,103 | $ | (282 | ) | $ | 147,966 | ||||||
Our corporate debt securities generally have contractual maturity dates of between 12 to 18 months. Because of the potential for prepayment on mortgage-backed securities, they are not categorized by contractual maturity. | ||||||||||||||
Concentration_of_Credit_Risk
Concentration of Credit Risk | 3 Months Ended | |||||
Mar. 31, 2015 | ||||||
Concentration of Credit Risk | ||||||
Concentration of Credit Risk | ||||||
4.Concentration of Credit Risk | ||||||
In December 2009, we entered into a license, development and commercialization agreement with Eli Lilly and Company (“Lilly”). In November 2009, we entered into a collaboration and license agreement with Novartis. The concentration of credit risk related to our collaborative partners is as follows: | ||||||
Percentage of Total | ||||||
Contract Revenues for the | ||||||
Three Months Ended, | ||||||
March 31, | ||||||
2015 | 2014 | |||||
Collaboration Partner A | 89 | % | 68 | % | ||
Collaboration Partner B | 11 | % | 32 | % | ||
Collaboration Partner A and Collaboration Partner B comprised in the aggregate 23% and 26% of the accounts receivable balance as of March 31, 2015 and December 31, 2014, respectively. | ||||||
In November 2011, we began commercialization and distribution of JAKAFI to a number of specialty pharmacies. Our product revenues are concentrated in a number of specialty pharmacy customers. The concentration of credit risk related to our specialty pharmacy customers is as follows: | ||||||
Percentage of Total Net | ||||||
Product Revenues for the | ||||||
Three Months Ended, | ||||||
March 31, | ||||||
2015 | 2014 | |||||
Customer A | 28 | % | 29 | % | ||
Customer B | 20 | % | 21 | % | ||
Customer C | 13 | % | 11 | % | ||
Customer D | 8 | % | 9 | % | ||
We are exposed to risks associated with extending credit to specialty pharmacy customers related to the sale of products. Customer A, Customer B, Customer C and Customer D comprised in the aggregate 69% and 54% of the accounts receivable balance as of March 31, 2015 and December 31, 2014, respectively. | ||||||
Inventory
Inventory | 3 Months Ended | |||||||
Mar. 31, 2015 | ||||||||
Inventory | ||||||||
Inventory | ||||||||
5.Inventory | ||||||||
Our inventory balance consists of the following: | ||||||||
March 31, | December 31, | |||||||
2015 | 2014 | |||||||
(in thousands) | ||||||||
Raw materials | $ | 500 | $ | 591 | ||||
Work-in-process | 16,521 | 18,487 | ||||||
Finished goods | 2,414 | 358 | ||||||
19,435 | 19,436 | |||||||
Inventories—current | 2,414 | 358 | ||||||
Inventories—non-current | $ | 17,021 | $ | 19,078 | ||||
Inventories, stated at the lower of cost or market, consist of raw materials, work in process and finished goods. At March 31, 2015, $2.4 million of inventory was classified as current on the condensed consolidated balance sheet as we expect this inventory to be consumed for commercial use within the next twelve months. At March 31, 2015, $17.0 million of inventory was classified as non-current on the condensed consolidated balance sheet as we did not expect this inventory to be consumed for commercial use within the next twelve months. We obtain a number of inventory components from single source suppliers due to technology, availability, price, quality or other considerations. The loss of a single source supplier, the deterioration of its relationship with a single source supplier, or any unilateral violation of the contractual terms under which we are supplied components by a single source supplier could adversely affect our total revenues and gross margins. | ||||||||
The raw materials and work-in-process inventory is not subject to expiration and the shelf life for finished goods inventory is 36 months from the start of manufacturing of the finished goods. We evaluate for potential excess inventory by analyzing current and future product demand relative to the remaining product shelf life. We build demand forecasts by considering factors such as, but not limited to, overall market potential, market share, market acceptance and patient usage. | ||||||||
Property_and_Equipment
Property and Equipment | 3 Months Ended | |||||||
Mar. 31, 2015 | ||||||||
Property and Equipment | ||||||||
Property and Equipment | ||||||||
6.Property and Equipment | ||||||||
Property and equipment consists of the following: | ||||||||
March 31, | December 31, | |||||||
2015 | 2014 | |||||||
(in thousands) | ||||||||
Office equipment | $ | 6,223 | $ | 6,090 | ||||
Laboratory equipment | 27,053 | 26,800 | ||||||
Computer equipment | 19,775 | 18,648 | ||||||
Building and leasehold improvements | 64,862 | 64,926 | ||||||
117,913 | 116,464 | |||||||
Less accumulated depreciation and amortization | (37,246 | ) | (34,674 | ) | ||||
$ | 80,667 | $ | 81,790 | |||||
In 2013, we entered into a lease agreement for a new corporate headquarters, which consists of approximately 190,000 square feet of laboratory and office space located in Wilmington, Delaware. The term of this lease is 15 years from the date of commencement. The construction of the facility was completed and the lease commenced on October 1, 2014 with a monthly lease rate of $0.5 million for the first 10 years of the lease and with the monthly lease rate increasing annually during the last five years of lease. | ||||||||
We are accounting for the lease as a direct financing arrangement whereby over the construction period, we recorded the value of the facility (consisting of the estimated fair value of the existing shell, plus construction costs incurred) as a capital asset, with a corresponding lease liability, net of build out costs paid for by us during the construction period. The lease liability will be amortized over the term of the lease using the effective interest method. In addition, we have posted a $15.0 million letter of credit for the facility lease for the benefit of the landlord, which is collateralized by a restricted investments account for the same amount. This amount was recorded as restricted investments on the condensed consolidated balance sheets and will be reduced over a period of time during the duration of the lease. The letter of credit could be subject to accelerated reductions if we meet certain pre-defined financial targets. Restricted investments on the condensed consolidated balance sheets at March 31, 2015 and December 31, 2014 were $14.4 million and $14.5 million, respectively. | ||||||||
License_agreements
License agreements | 3 Months Ended |
Mar. 31, 2015 | |
License agreements | |
License agreements | |
7.License agreements | |
Novartis | |
In November 2009, we entered into a Collaboration and License Agreement with Novartis. Under the terms of the agreement, Novartis received exclusive development and commercialization rights outside of the United States to our JAK inhibitor ruxolitinib and certain back-up compounds for hematologic and oncology indications, including all hematological malignancies, solid tumors and myeloproliferative diseases. We retained exclusive development and commercialization rights to JAKAFI (ruxolitinib) in the United States and in certain other indications. Novartis also received worldwide exclusive development and commercialization rights to our c-MET inhibitor compound capmatinib and certain back-up compounds in all indications. We retained options to co-develop and to co-promote capmatinib in the United States. | |
Under this agreement, we received an upfront payment and immediate milestone payment totaling $210.0 million and were initially eligible to receive up to $1.2 billion in milestone payments across multiple indications upon the achievement of pre-specified events, including up to $174.0 million for the achievement of development milestones, up to $495.0 million for the achievement of regulatory milestones and up to $500.0 million for the achievement of commercialization milestones. As of March 31, 2015, we have recognized in the aggregate $97.0 million for the achievement of development milestones and $160.0 million for the achievement of regulatory milestones. | |
During the three months ended March 31, 2015, under this agreement, we recognized and received a $25.0 million regulatory milestone triggered by the Committee for Medicinal Products for Human Use of the European Medicines Agency adopting a positive opinion for JAKAVI (ruxolitinib) for the treatment of adult patients with polycythemia vera who are resistant to or intolerant of hydroxyurea. In 2014, we recognized and received a $60.0 million regulatory milestone related to reimbursement of JAKAVI (ruxolitinib) in Europe, recognized and received a $25.0 million regulatory milestone for the approval of JAKAVI in Japan for the treatment of patients with myelofibrosis and a $7.0 million development milestone based on the formal initiation by Novartis of a Phase II clinical trial evaluating capmatinib in non-small cell lung cancer. In 2013, we recognized and received a $25.0 million development milestone payment under this agreement based on the formal initiation by Novartis of a Phase II clinical trial evaluating capmatinib. In 2012, we recognized and received a $40.0 million regulatory milestone payment under this agreement for the achievement of a predefined milestone for the European Union regulatory approval of JAKAVI. In 2011, we recognized and received a $15.0 million development milestone payment under this agreement for the achievement of a predefined milestone in the Phase I dose-escalation trial for capmatinib in patients with solid tumors and a $10.0 million regulatory milestone payment for the approval of JAKAFI in the United States. We determined the 2015, 2014, 2013, 2012 and 2011 milestones to be substantive as their achievement required substantive efforts by us and was at risk until the milestones were ultimately achieved. We also are eligible to receive tiered, double-digit royalties ranging from the upper-teens to the mid-twenties on future JAKAVI net sales outside of the United States. Since the achievement of the $60.0 million regulatory milestone related to reimbursement of JAKAVI in Europe, we are obligated to pay to Novartis tiered royalties in the low single digits on future JAKAFI net sales within the United States. During the three months ended March 31, 2015, such royalties payable to Novartis on net sales within the United States totaled $2.5 million and are reflected in cost of product revenues on the condensed consolidated statement of operations. Each company is responsible for costs relating to the development and commercialization of ruxolitinib in its respective territories, with costs of collaborative studies shared equally. Novartis is now responsible for all costs relating to the development and commercialization of capmatinib. | |
The Novartis agreement will continue on a program-by-program basis until Novartis has no royalty payment obligations with respect to such program or, if earlier, the termination of the agreement or any program in accordance with the terms of the agreement. Royalties are payable by Novartis on a product-by-product and country-by-country basis until the latest to occur of (1) the expiration of the last valid claim of the licensed patent rights covering the licensed product in the relevant country, (2) the expiration of regulatory exclusivity for the licensed product in such country and (3) a specified period from first commercial sale in such country of the licensed product by Novartis or its affiliates or sublicensees. The agreement may be terminated in its entirety or on a program-by-program basis by Novartis for convenience. The agreement may also be terminated by either party under certain other circumstances, including material breach. | |
At December 31, 2009, we recorded $10.9 million of reimbursable costs incurred prior to the effective date of the agreement as deferred revenue on the consolidated balance sheet. These costs were recognized on a straight line basis through December 2013 consistent with the aforementioned upfront and milestone payments. Future reimbursable costs incurred after the effective date of the agreement with Novartis will be recorded net against the related research and development expenses. At March 31, 2015 and December 31, 2014, $0.5 million and $0.3 million, respectively, of reimbursable costs were included in accounts receivable on the condensed consolidated balance sheets. Research and development expenses for the three months ended March 31, 2015 and 2014 were net of $0.5 million and $1.1 million, respectively, of costs reimbursed by Novartis. | |
Contract revenue under the Novartis agreement was $25.0 million and $7.0 million for the three months ended March 31, 2015 and 2014, respectively. In addition, for the three months ended March 31, 2015 and 2014, respectively, we recorded $15.7 million and $9.8 million of product royalty revenues related to Novartis net sales of JAKAVI outside of the United States. At March 31, 2015 and December 31, 2014, $15.8 million and $14.8 million, respectively, of product royalties were included in accounts receivable on the condensed consolidated balance sheets. | |
Lilly | |
In December 2009, we entered into a License, Development and Commercialization Agreement with Lilly. Under the terms of the agreement, Lilly received exclusive worldwide development and commercialization rights to our JAK inhibitor baricitinib, and certain back-up compounds for inflammatory and autoimmune diseases. We received an upfront payment of $90.0 million, and were initially eligible to receive up to $665.0 million in substantive milestone payments across multiple indications upon the achievement of pre-specified events, including up to $150.0 million for the achievement of development milestones, up to $365.0 million for the achievement of regulatory milestones and up to $150.0 million for the achievement of commercialization milestones. As of March 31, 2015, we have recognized and received in the aggregate $99.0 million for the achievement of development milestones. | |
In 2012, we recognized a $50.0 million development milestone under this agreement for the achievement of a predefined milestone for the initiation of the rheumatoid arthritis Phase III program for baricitinib. In 2010, we recognized and received a $30.0 million development milestone payment based upon the initial three month data in the Phase IIa clinical trial of baricitinib for the treatment of rheumatoid arthritis and a $19.0 million development milestone payment for the Phase IIb clinical trial initiation of baricitinib for the treatment of rheumatoid arthritis. We determined the 2012 and 2010 milestones to be substantive as their achievement required substantive efforts by us and was at risk until the milestones were ultimately achieved. We also could receive tiered, double-digit royalty payments on future global net sales with rates ranging up to 20% if the product is successfully commercialized. | |
We retained options to co-develop our JAK inhibitors with Lilly on a compound-by-compound and indication-by-indication basis. Lilly is responsible for all costs relating to the development and commercialization of the compounds unless we elect to co-develop any compounds or indications. If we elect to co-develop any compounds and/or indications, we would be responsible for funding 30% of the associated future global development costs from the initiation of a Phase IIb trial through regulatory approval. We would receive an incremental royalty rate increase across all tiers resulting in effective royalty rates ranging up to the high twenties on potential future global net sales for compounds and/or indications that we elect to co-develop. We also retained an option to co-promote products in the United States. In July 2010, we elected to co-develop baricitinib with Lilly in rheumatoid arthritis and we are responsible for funding 30% of the associated future global development costs for this indication from the initiation of the Phase IIb trial through regulatory approval. Research and development expenses recorded under the Lilly agreement representing 30% of the global development costs for baricitinib for the treatment of rheumatoid arthritis were $11.6 million and $14.0 million for the three months ended March 31, 2015 and 2014, respectively. We have retained certain mechanisms to give us cost protection as baricitinib advances in clinical development. We can defer our portion of co-development study costs by indication if they exceed a predetermined level. This deferment would be credited against future milestones or royalties and we would still be eligible for the full incremental royalties related to the co-development option. In addition, even if we have started co-development funding for any indication, we can at any time opt out and stop future co-development cost sharing. If we elect to do this we would still be eligible for our base royalties plus an incremental pro-rated royalty commensurate with our contribution to the total co-development cost for those indications for which we co-funded. The Lilly agreement will continue until Lilly no longer has any royalty payment obligations or, if earlier, the termination of the agreement in accordance with its terms. Royalties are payable by Lilly on a product-by-product and country- by-country basis until the latest to occur of (1) the expiration of the last valid claim of the licensed patent rights covering the licensed product in the relevant country, (2) the expiration of regulatory exclusivity for the licensed product in such country and (3) a specified period from first commercial sale in such country of the licensed product by Lilly or its affiliates or sublicensees. The agreement may be terminated by Lilly for convenience, and may also be terminated under certain other circumstances, including material breach. | |
We determined that there were two deliverables under the agreement: (i) the worldwide license and (ii) our obligations in connection with a co-development option. We concluded that these deliverables should be accounted for as a single unit of accounting and the $90.0 million upfront payment should be recognized on a straight line basis as revenue through December 2016, our estimated performance period under the agreement. | |
Contract revenue under the Lilly agreement was $3.2 million for the three months ended March 31, 2015 and 2014. | |
Agenus | |
In January 2015, we entered into a License, Development and Commercialization Agreement with Agenus Inc. and its wholly owned subsidiary, 4 Antibody AG, which we collectively refer to as Agenus. Under this agreement, the parties have agreed to collaborate on the discovery of novel immuno therapeutics using Agenus’ proprietary Retrocyte Display antibody discovery platform. The agreement became effective on February 18, 2015, upon the expiration of the waiting period under the Hart Scott Rodino Antitrust Improvements Act of 1976 (“HSR Act”). | |
Under the terms of this agreement, we received exclusive worldwide development and commercialization rights to four checkpoint modulators directed against GITR, OX40, LAG-3 and TIM-3. In addition to the initial four program targets, we and Agenus have the option to jointly nominate and pursue additional targets within the framework of the collaboration. These targets may be designated profit share programs, where all costs and profits are shared equally by us and Agenus, or royalty bearing programs, where we will be responsible for all costs associated with discovery, preclinical activities, clinical development and commercialization activities. The programs relating to GITR and OX40 are profit share programs and the programs relating to LAG-3 and TIM-3 are royalty bearing programs. For each royalty bearing product, Agenus will be eligible to receive up to $155 million in future contingent development, regulatory and commercialization milestones as well as tiered royalties on global net sales ranging from 6% to 12%. For each profit share product, Agenus will be eligible to receive up to $20 million in future contingent development milestones. Additionally, Agenus retains co-promotion participation rights in the United States on any profit share product. For each royalty bearing product, Agenus has reserved the right to elect to co fund 30% of development costs for a commensurate increase in royalties. The agreement may be terminated by us for convenience and may also be terminated under certain other circumstances, including material breach. | |
In January 2015, we also entered into a Stock Purchase Agreement with Agenus Inc. pursuant to which we agreed to purchase, subject to expiration of the waiting period under the HSR Act, approximately 7.76 million shares of Agenus Inc. common stock for an aggregate purchase price of $35.0 million in cash, or approximately $4.51 per share. We completed the purchase of the shares on February 18, 2015. On February 18, 2015 the closing price of Agenus Inc. common shares on The NASDAQ Stock Market was $5.13 per share and, therefore, the value of the 7.76 million shares acquired by us was $39.8 million. We have agreed not to dispose of any of the shares of common stock for a period of 12 months and Agenus Inc. has agreed to certain registration rights with respect to the shares of common stock. | |
Upon closing of the Agenus transaction on February 18, 2015, we paid total consideration of $60.0 million to Agenus Inc. Of the $60.0 million, $39.8 million was allocated to our stock purchase in Agenus Inc. and was recorded as a long term investment on the condensed consolidated balance sheets and $20.2 million was allocated to research and development expense on the condensed consolidated statement of operations. | |
At the February 18, 2015 closing date and at March 31, 2015, we have concluded Agenus Inc. is not a VIE because it has sufficient equity to finance its activities without additional subordinated financial support and its at-risk equity holders have the characteristics of a controlling financial interest. We own approximately 11% of the outstanding shares of Agenus Inc. common stock and conclude that we have the ability to exercise significant influence, but not control, over Agenus Inc. based primarily on our ownership interest, the level of intra-entity transactions between us and Agenus related to development expenses, as well as other qualitative factors. We have elected the fair value option to account for our long term investment in Agenus Inc. whereby the investment is marked to market through earnings in each reporting period. We believe the fair value option to be the most appropriate accounting method to account for securities in publicly held collaborators for which we have significant influence. For the three months ended March 31, 2015, there was no gain or loss recorded as the market price of Agenus Inc.’s common stock at March 31, 2015 was consistent with the fair value on the acquisition date of the investment. | |
Research and development expenses for the three months ended March 31, 2015, also included $1.8 million of development costs incurred pursuant to the Agenus arrangement. Such costs were included in accrued and other liabilities on the condensed consolidated balance sheets as of March 31, 2015. | |
Stock_compensation
Stock compensation | 3 Months Ended | |||||||||
Mar. 31, 2015 | ||||||||||
Stock compensation | ||||||||||
Stock compensation | ||||||||||
8.Stock compensation | ||||||||||
We recorded $17.6 million and $15.3 million of stock compensation expense on our condensed consolidated statements of operations for the three months ended March 31, 2015 and 2014, respectively. Stock compensation expense included within our condensed consolidated statements of operations included research and development expense of $10.3 million and $8.3 million for the three months ended March 31, 2015 and 2014, respectively. Stock compensation expense included within our condensed consolidated statements of operations also included selling, general and administrative expense of $7.3 million and $7.0 million for the three months ended March 31, 2015 and 2014, respectively. | ||||||||||
We utilized the Black-Scholes valuation model for estimating the fair value of the stock compensation granted, with the following weighted-average assumptions: | ||||||||||
Employee Stock | Employee Stock | |||||||||
Options For the | Purchase Plan For the | |||||||||
Three Months | Three Months | |||||||||
Ended | Ended | |||||||||
March 31, | March 31, | |||||||||
2015 | 2014 | 2015 | 2014 | |||||||
Average risk-free interest rates | 1.35 | % | 1.18 | % | 0.56 | % | 0.44 | % | ||
Average expected life (in years) | 5.05 | 4.47 | 0.25 | 0.25 | ||||||
Volatility | 50 | % | 50 | % | 38 | % | 52 | % | ||
Weighted-average fair value (in dollars) | 32.59 | 26.52 | 9.56 | 8.65 | ||||||
The risk-free interest rate is derived from the U.S. Federal Reserve rate in effect at the time of grant. The expected life calculation is based on the observed and expected time to the exercise of options by our employees based on historical exercise patterns for similar type options. Expected volatility is based on the historical volatility of our common stock over the period commensurate with the expected life of the options. A dividend yield of zero is assumed based on the fact that we have never paid cash dividends and have no present intention to pay cash dividends. | ||||||||||
Option activity under the 2010 Stock Plan was as follows: | ||||||||||
Shares Subject to | ||||||||||
Outstanding Options | ||||||||||
Shares Available | Shares | Weighted Average | ||||||||
for Grant | Exercise Price | |||||||||
Balance at December 31, 2014 | 5,399,816 | 14,655,043 | $ | 21.96 | ||||||
Options granted | (1,622,520 | ) | 1,622,520 | $ | 74.03 | |||||
Options exercised | — | (2,478,752 | ) | $ | 15.91 | |||||
Options cancelled | 74,169 | (74,169 | ) | $ | 42.21 | |||||
Balance at March 31, 2015 | 3,851,465 | 13,724,642 | $ | 29.1 | ||||||
RSU and PSU award activity under the 2010 Stock Plan was as follows: | ||||||||||
Shares Subject to | ||||||||||
Shares Available | Outstanding Awards | |||||||||
for Grant | Shares | Grant Date Value | ||||||||
Balance at December 31, 2014 | 1,001,523 | 398,477 | — | |||||||
RSUs granted | (175,338 | ) | 175,338 | $ | 74.08 | |||||
PSUs granted | — | — | — | |||||||
RSUs cancelled | 5,074 | (5,074 | ) | $ | 64.74 | |||||
PSUs cancelled | — | — | — | |||||||
Balance at March 31, 2015 | 831,259 | 568,741 | — | |||||||
In January 2014, we began granting RSUs and PSUs to our employees at the share price on the date of grant. Each RSU represents the right to acquire one share of our common stock. We granted a total of 175,338 RSUs during the three months ended March 31, 2015 which will cliff vest in three years and will be recognized as stock compensation expense over this period. Also, in January 2014, Hervé Hoppenot, our President and Chief Executive Officer, was granted a one-time grant of 400,000 RSUs outside of our 2010 Stock Incentive Plan. Vesting of the RSUs will be subject to Mr. Hoppenot’s continued employment on the applicable vesting dates, with one-sixth of the RSUs vesting at the end of each of the calendar years 2014 through 2019, subject to earlier acceleration of vesting upon the occurrence of certain events in accordance with the terms of his employment agreement. As of March 31, 2015, a total of 66,666 RSUs granted to Mr. Hoppenot vested and were released leaving 333,334 RSUs outstanding. | ||||||||||
At March 31, 2015, we have only recognized stock compensation expense relating to performance conditions of the outstanding PSUs that are deemed probable of achievement at that date. For PSUs containing performance conditions which have not been deemed probable of achievement at March 31, 2015, no stock compensation expense has been recognized for these awards. The actual number of shares of our common stock into which each PSU may convert are subject to a multiplier of up to 125% based on the level at which the performance conditions are achieved. | ||||||||||
Based on our historical experience of employee turnover, we have assumed an annualized forfeiture rate of 5% for our options, PSUs and RSUs. Under the true-up provisions of the stock compensation guidance, we will record additional expense if the actual forfeiture rate is lower than we estimated, and will record a recovery of prior expense if the actual forfeiture is higher than we estimated. | ||||||||||
Total compensation cost of options granted but not yet vested, as of March 31, 2015, was $58.1 million, which is expected to be recognized over the weighted average period of 3.0 years. Total compensation cost of RSUs granted but not yet vested, as of March 31, 2015, was $31.8 million, which is expected to be recognized over the weighted average period of 3.0 years. Total compensation cost of PSUs granted but not yet vested, as of March 31, 2015, was $0.7 million, which is expected to be recognized over the weighted average period of 3.0 years, should the underlying performance conditions be deemed probable of achievement. | ||||||||||
Debt
Debt | 3 Months Ended | |||||||||||||
Mar. 31, 2015 | ||||||||||||||
Debt | ||||||||||||||
Debt | ||||||||||||||
9.Debt | ||||||||||||||
The components of the convertible notes are as follows (in thousands): | ||||||||||||||
Carrying Amount | ||||||||||||||
Debt | Interest Rates | Maturities | March 31, | December 31, | ||||||||||
March 31, 2015 | 2015 | 2014 | ||||||||||||
4.75% Convertible Senior Notes due 2015 | 4.75 | % | 2015 | $ | 87,337 | $ | 85,640 | |||||||
0.375% Convertible Senior Notes due 2018 | 0.375 | % | 2018 | 318,292 | 314,752 | |||||||||
1.25% Convertible Senior Notes due 2020 | 1.25 | % | 2020 | 291,918 | 288,726 | |||||||||
697,547 | 689,118 | |||||||||||||
Less current portion | 87,337 | 85,640 | ||||||||||||
$ | 610,210 | $ | 603,478 | |||||||||||
The carrying amount and fair value of our convertible notes are as follows (in thousands): | ||||||||||||||
March 31, 2015 | December 31, 2014 | |||||||||||||
Carrying | Fair Value | Carrying | Fair Value | |||||||||||
Amount | Amount | |||||||||||||
4.75% Convertible Senior Notes due 2015 | $ | 87,337 | $ | 947,148 | $ | 85,640 | $ | 755,143 | ||||||
0.375% Convertible Senior Notes due 2018 | 318,292 | 682,500 | 314,752 | 560,156 | ||||||||||
1.25% Convertible Senior Notes due 2020 | 291,918 | 695,861 | 288,726 | 577,736 | ||||||||||
$ | 697,547 | $ | 2,325,509 | $ | 689,118 | $ | 1,893,035 | |||||||
The fair values of the 4.75% Convertible Senior Notes due 2015 (the “2015 Notes”), the 0.375% Convertible Senior Notes due 2018 (the “2018 Notes”) and the 1.25% Convertible Senior Notes due 2020 (the “2020 Notes”) are based on data from readily available pricing sources which utilize market observable inputs and other characteristics for similar types of instruments, and, therefore, these convertible senior notes are classified within Level 2 in the fair value hierarchy. | ||||||||||||||
Prior to May 14, 2014, the 2018 and 2020 Notes were not convertible except in connection with a make whole fundamental change, as defined in the respective indentures. Beginning on, and including, May 15, 2014, the 2018 and 2020 Notes are convertible prior to the close of business on the business day immediately preceding May 15, 2018, in the case of the 2018 Notes, and May 15, 2020, in the case of the 2020 Notes, only under the following circumstances: (1) during any calendar quarter commencing after the calendar quarter ending on March 31, 2014 (and only during such calendar quarter), if the last reported sale price of our common stock for at least 20 trading days (whether or not consecutive) during a period of 30 consecutive trading days ending on the last trading day of the immediately preceding calendar quarter is greater than or equal to 130% of the conversion price for the 2018 Notes or 2020 Notes, as applicable, on each applicable trading day; (2) during the five business day period after any five consecutive trading day period (the “measurement period”) in which the trading price per $1,000 principal amount of 2018 Notes or 2020 Notes, as applicable, for each trading day of the measurement period was less than 98% of the product of the last reported sale price of our common stock and the conversion rate for the 2018 Notes or 2020 Notes, as applicable, on each such trading day; or (3) upon the occurrence of specified corporate events. On or after May 15, 2018, in the case of the 2018 Notes, and May 15, 2020, in the case of the 2020 Notes, until the close of business on the second scheduled trading day immediately preceding the relevant maturity date, the Notes are convertible at any time, regardless of the foregoing circumstances. Upon conversion we will pay or deliver, as the case may be, cash, shares of common stock or a combination of cash and shares of common stock, at our election. | ||||||||||||||
On April 1, 2015, the 2018 Notes and 2020 Notes became convertible through at least June 30, 2015, based on the meeting the conversion criteria related to the sale price of our common stock during the calendar quarter ended March 31, 2015 as described in (1) above. Management’s intent is to settle any conversions of 2018 Notes or 2020 Notes during this period in shares of our common stock and, therefore, the 2018 Notes and 2020 Notes are reflected in long term liabilities on the condensed consolidated balance sheet at March 31, 2015. | ||||||||||||||
During April 2015, certain holders of the 2015 Notes converted a total of $46.9 million in aggregate principal amount of the 2015 Notes for the shares of our common stock into which the 2015 Notes were convertible, aggregating 5.3 million shares. | ||||||||||||||
Income_Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2015 | |
Income Taxes | |
Income Taxes | |
10.Income taxes | |
In January 2015, we licensed certain intellectual property rights related to our non-partnered clinical programs to our wholly-owned subsidiary in Switzerland. Although the license of intellectual property rights did not result in any gain or loss in the condensed consolidated statements of operations, the transaction generated a taxable gain in the U.S, and we are utilizing available federal and state net operating loss carryforwards to offset the majority of this gain. Any taxes incurred related to intercompany transactions are treated as prepaid tax in our condensed consolidated balance sheets and amortized to income tax expense over the life of the intellectual property. Any cash taxes anticipated to be paid related to this intercompany transaction are immaterial. | |
Net_loss_per_share
Net loss per share | 3 Months Ended | |||||
Mar. 31, 2015 | ||||||
Net loss per share | ||||||
Net loss per share | ||||||
11.Net loss per share | ||||||
For all periods presented, both basic and diluted net loss per common share are computed by dividing the net loss by the number of weighted average common shares outstanding during the period. Stock options and potential common shares issuable upon conversion of the 2015 Notes, 2018 Notes and 2020 Notes were excluded from the computation of diluted net loss per share, as their share effect was anti-dilutive for all periods presented. | ||||||
The potential common shares that were excluded from the diluted net loss per share computation are as follows: | ||||||
Three Months Ended | ||||||
March 31, | ||||||
2015 | 2014 | |||||
Outstanding stock awards | 14,626,717 | 18,027,392 | ||||
Common shares issuable upon conversion of 4.75% Convertible Senior Notes due 2015 | 10,353,076 | 10,441,728 | ||||
Common shares issuable upon conversion of 0.375% Convertible Senior Notes due 2018 | 7,245,263 | 7,245,263 | ||||
Common shares issuable upon conversion of 1.25% Convertible Senior Notes due 2020 | 7,245,263 | 7,245,263 | ||||
Total potential common shares excluded from diluted net loss per share computation | 39,470,319 | 42,959,646 | ||||
Summary_of_significant_account1
Summary of significant accounting policies (Policies) | 3 Months Ended |
Mar. 31, 2015 | |
Summary of significant accounting policies | |
Basis of presentation | |
Basis of presentation | |
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. The condensed consolidated balance sheet as of March 31, 2015 and the condensed consolidated statements of operations, comprehensive loss and cash flows for the three months ended March 31, 2015 and 2014, are unaudited, but include all adjustments, consisting only of normal recurring adjustments, which we consider necessary for a fair presentation of the financial position, operating results and cash flows for the periods presented. The condensed consolidated balance sheet at December 31, 2014 has been derived from audited financial statements. | |
Although we believe that the disclosures in these financial statements are adequate to make the information presented not misleading, certain information and footnote information normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) have been condensed or omitted pursuant to the rules and regulations of the Securities and Exchange Commission. | |
Results for any interim period are not necessarily indicative of results for any future interim period or for the entire year. The accompanying financial statements should be read in conjunction with the financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2014. | |
Principles of Consolidation | |
Principles of Consolidation. The condensed consolidated financial statements include the accounts of Incyte Corporation and our wholly owned subsidiaries, including Incyte Holdings Corporation, Incyte International Holdings Sarl, and Incyte Europe Sarl. All inter-company accounts, transactions, and profits have been eliminated in consolidation. | |
Foreign Currency Translation | |
Foreign Currency Translation. Operations in non-U.S. entities are recorded in the functional currency of each entity. For financial reporting purposes, the functional currency of an entity is determined by a review of the source of an entity’s most predominant cash flows. The results of operations for any non-U.S. dollar functional currency entities are translated from functional currencies into U.S. dollars using the average currency rate during each month, which approximates the results that would be obtained using actual currency rates on the dates of individual transactions. Assets and liabilities are translated using currency rates at the end of the period. Adjustments resulting from translating the financial statements of our foreign entities that use their local currency as the functional currency into the U.S. dollars are reflected as a component of other comprehensive income (loss). Transaction gains and losses are recorded in interest and other income, net in the condensed consolidated statements of operations. To date, both the translation gains or losses in other comprehensive income and the transaction gains or losses in interest and other income, net have been immaterial. | |
Use of Estimates | |
Use of Estimates. The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates. | |
Concentrations of Credit Risk | |
Concentrations of Credit Risk. Cash, cash equivalents, marketable securities, trade receivables and restricted investments are financial instruments which potentially subject us to concentrations of credit risk. The estimated fair value of financial instruments approximates the carrying value based on available market information. We primarily invest our excess available funds in notes and bills issued by the U.S. government and its agencies and corporate debt securities and, by policy, limit the amount of credit exposure to any one issuer and to any one type of investment, other than securities issued or guaranteed by the U.S. government. Our receivables mainly relate to our product sales of JAKAFI and collaborative agreements with pharmaceutical companies. We have not experienced any significant credit losses on cash, cash equivalents, marketable securities, trade receivables or restricted investments to date and do not require collateral on receivables. | |
Cash and Cash Equivalents | |
Cash and Cash Equivalents. Cash and cash equivalents are held in U.S. banks or in custodial accounts with banks. Cash equivalents are defined as all liquid investments and money market funds with maturity from date of purchase of 90 days or less that are readily convertible into cash. | |
Marketable Securities-Available-for-Sale | |
Marketable Securities—Available-for-Sale. All marketable securities are classified as available-for-sale. Available-for-sale securities are carried at fair value, based on quoted market prices and observable inputs, with unrealized gains and losses, net of tax, reported as a separate component of stockholders’ deficit. We classify marketable securities that are available for use in current operations as current assets on the condensed consolidated balance sheets. Realized gains and losses and declines in value judged to be other than temporary for available-for-sale securities are included in “Interest and other income, net.” The cost of securities sold is based on the specific identification method. | |
Accounts Receivable | |
Accounts Receivable. As of March 31, 2015 and December 31, 2014, we had no allowance for doubtful accounts. We provide an allowance for doubtful accounts based on experience and specifically identified risks. Accounts receivable are carried at fair value and charged off against the allowance for doubtful accounts when we determine that recovery is unlikely and we cease collection efforts. | |
Inventory | |
Inventory. Inventories are determined at the lower of cost or market value with cost determined under the specific identification method and may consist of raw materials, work in process and finished goods. We began capitalizing inventory in mid-November 2011 once the U.S. Food and Drug Administration (“FDA”) approved JAKAFI as the related costs were expected to be recoverable through the commercialization of the product. Costs incurred prior to approval of JAKAFI have been recorded as research and development expense in our statements of operations. As a result, cost of product revenues for the next 18 to 21 months will reflect a lower average per unit cost of materials. | |
The raw materials and work-in-process inventory is not subject to expiration and the shelf life for finished goods inventory is 36 months from the start of manufacturing of the finished goods. We evaluate for potential excess inventory by analyzing current and future product demand relative to the remaining product shelf life. We build demand forecasts by considering factors such as, but not limited to, overall market potential, market share, market acceptance and patient usage. We classify inventory as current on the condensed consolidated balance sheets when we expect inventory to be consumed for commercial use within the next twelve months. | |
Variable Interest Entities | |
Variable Interest Entities. We perform an initial and on-going evaluation of the entities with which we have variable interests, such as equity ownership, in order to identify entities that (i) do not have sufficient equity investment at risk to permit the entity to finance its activities without additional subordinated financial support or (ii) in which the equity investors lack an essential characteristic of a controlling financial interest as variable interest entities (“VIE” or “VIEs”). If an entity is identified as a VIE, we perform an assessment to determine whether we have both (i) the power to direct activities that most significantly impact the VIE’s economic performance and (ii) have the obligation to absorb losses from or the right to receive benefits of the VIE that could potentially be significant to the VIE. If both of these criteria are satisfied, we are identified as the primary beneficiary of the VIE. As of March 31, 2015, there were no entities in which we held a variable interest which we determined to be VIEs. | |
Equity Method Investments | |
Equity Method Investments. In circumstances where we have the ability to exercise significant influence over the operating and financial policies of a company in which we have an investment, the investment is accounted for either (i) under the equity method of accounting or (ii) at fair value by electing the fair value option under U.S. GAAP. In assessing whether we exercise significant influence, we consider the nature and magnitude of our investment, any voting and protective rights we hold, any participation in the governance of the other company, and other relevant factors such as the presence of a collaboration or other business relationship. Under the equity method of accounting, we record within our results of operations our share of income or loss of the investee company. Under the fair value option, our investment is carried at fair value and all changes in fair value are reported in our results of operations. | |
Property and Equipment | |
Property and Equipment. Property and equipment is stated at cost, less accumulated depreciation and amortization. Depreciation is recorded using the straight-line method over the estimated useful lives of the respective assets (generally three to five years). Leasehold improvements are amortized over the shorter of the estimated useful life of the assets or lease term. | |
Management continually reviews the estimated useful lives of technologically sensitive equipment and believes that those estimates appropriately reflect the current useful life of our assets. In the event that a currently unknown significantly advanced technology became commercially available, we would re-evaluate the value and estimated useful lives of our existing equipment, possibly having a material impact on the financial statements. | |
Lease Accounting | |
Lease Accounting. We account for operating leases by recording rent expense on a straight-line basis over the expected life of the lease, commencing on the date we gain possession of leased property. We include tenant improvement allowances and rent holidays received from landlords and the effect of any rent escalation clauses as adjustments to straight-line rent expense over the expected life of the lease. | |
Capital leases are reflected as a liability at the inception of the lease based on the present value of the minimum lease payments or, if lower, the fair value of the property. Assets under capital leases are recorded in property and equipment, net on the condensed consolidated balance sheets and depreciated in a manner similar to other property and equipment. | |
Certain construction projects may be accounted for as direct financing arrangements, whereby we record, over the construction period, the full cost of the asset in property and equipment, net on the condensed consolidated balance sheets. A corresponding liability is also recorded, net of leasehold improvements paid for by us, and is amortized over the expected lease term through monthly rental payments using the effective interest method. | |
Income Taxes | |
Income Taxes. We account for income taxes using the asset and liability approach which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the carrying amount of assets and liabilities for financial reporting purposes and amounts reportable for income tax purposes. In addition, we follow the guidance related to accounting for uncertainty in income taxes. This guidance creates a single model to address uncertainty in tax positions and clarifies the accounting for income taxes by prescribing the minimum recognition threshold a tax position is required to meet before it is recognized in the financial statements. | |
Financing Costs Related to Long-term Debt | |
Financing Costs Related to Long-term Debt. Costs associated with obtaining long-term debt are deferred and amortized over the term of the related debt using the effective interest method. Such costs are included in other assets, net on the condensed consolidated balance sheets. | |
Grant Accounting | |
Grant Accounting. Grant amounts received from government agencies for operations are deferred and are amortized into income over the service period of the grant. Grant amounts received for purchases of capital assets are deferred and amortized into interest and other income, net over the useful life of the related capital assets. Such amounts are recorded in other liabilities on the condensed consolidated balance sheets. | |
Net Loss Per Share | |
Net Loss Per Share. Our basic and diluted losses per share are calculated by dividing the net loss by the weighted average number of shares of common stock outstanding during all periods presented. Options to purchase stock and shares issuable upon the conversion of convertible debt are included in diluted earnings per share calculations, unless the effects are anti-dilutive. | |
Accumulated Other Comprehensive Income (Loss) | |
Accumulated Other Comprehensive Income (Loss). Accumulated other comprehensive income (loss) consists of unrealized gains or losses on marketable securities and restricted cash and investments. | |
Revenue Recognition | |
Revenue Recognition. Revenues are recognized when (1) persuasive evidence of an arrangement exists, (2) delivery has occurred or services have been rendered, (3) the price is fixed or determinable and (4) collectability is reasonably assured. Revenues are deferred for fees received before earned or until no further obligations exist. We exercise judgment in determining that collectability is reasonably assured or that services have been delivered in accordance with the arrangement. We assess whether the fee is fixed or determinable based on the payment terms associated with the transaction and whether the sales price is subject to refund or adjustment. We assess collectability based primarily on the customer’s payment history and on the creditworthiness of the customer. | |
Product Revenues | |
Our product revenues consist of U.S. sales of JAKAFI and are recognized once we meet all four revenue recognition criteria described above. In November 2011, we began shipping JAKAFI to our specialty pharmacy customers, which in turn dispense JAKAFI to patients in fulfillment of prescriptions. | |
We recognize revenues for product received by our specialty pharmacy customers net of allowances for customer credits, including estimated rebates, chargebacks, discounts, returns, distribution service fees, patient assistance programs, and Medicare Part D coverage gap reimbursements. Product shipping and handling costs are included in cost of product revenues. | |
Customer Credits: Our specialty pharmacy customers are offered various forms of consideration, including allowances, service fees and prompt payment discounts. We expect our specialty pharmacy customers will earn prompt payment discounts and, therefore, we deduct the full amount of these discounts from total product sales when revenues are recognized. Service fees are also deducted from total product sales as they are earned. | |
Rebates: Allowances for rebates include mandated discounts under the Medicaid Drug Rebate Program. Rebate amounts are based upon contractual agreements or legal requirements with public sector (e.g. Medicaid) benefit providers. Rebates are amounts owed after the final dispensing of the product to a benefit plan participant and are based upon contractual agreements or legal requirements with public sector benefit providers. The accrual for rebates is based on statutory discount rates and expected utilization as well as historical data we have accumulated since product launch. Our estimates for expected utilization of rebates are based on data received from our specialty pharmacy customers. Rebates are generally invoiced and paid in arrears so that the accrual balance consists of an estimate of the amount expected to be incurred for the current quarter’s activity, plus an accrual balance for known prior quarters’ unpaid rebates. If actual future rebates vary from estimates, we may need to adjust prior period accruals, which would affect revenue in the period of adjustment. | |
Chargebacks: Chargebacks are discounts that occur when contracted customers purchase directly from a specialty pharmacy, or an intermediary distributor. Contracted customers, which currently consist primarily of Public Health Service institutions, non-profit clinics, and Federal government entities purchasing via the Federal Supply Schedule, generally purchase the product at a discounted price. The specialty pharmacy or distributor, in turn, charges back to us the difference between the price initially paid by the specialty pharmacy or distributor and the discounted price paid to the specialty pharmacy or distributor by the customer. The accrual for chargebacks is based on the estimated contractual discounts on the inventory levels on hand in our distribution channel. If actual future chargebacks vary from estimates, we may need to adjust prior period accruals, which would affect revenue in the period of adjustment. | |
Medicare Part D Coverage Gap: Medicare Part D prescription drug benefit mandates manufacturers to fund 50% of the Medicare Part D insurance coverage gap for prescription drugs sold to eligible patients. Our estimates for the expected Medicare Part D coverage gap are based on historical invoices received and in part from data received from our specialty pharmacy customers. Funding of the coverage gap is generally invoiced and paid in arrears so that the accrual balance consists of an estimate of the amount expected to be incurred for the current quarter’s activity, plus an accrual balance for known prior quarters. If actual future funding varies from estimates, we may need to adjust prior period accruals, which would affect revenue in the period of adjustment. | |
Co-payment Assistance: Patients who have commercial insurance and meet certain eligibility requirements may receive co-payment assistance. We accrue a liability for co-payment assistance based on actual program participation and estimates of program redemption using data provided by third-party administrators. | |
Product Royalty Revenues | |
Royalty revenues on commercial sales for ruxolitinib (marketed as JAKAVI® outside the United States) by Novartis Pharmaceutical International Ltd. (“Novartis”) are based on net sales of licensed products in licensed territories as provided by Novartis. We recognize royalty revenues in the period the sales occur. | |
Cost of Product Revenues | |
Cost of product revenues includes all JAKAFI related costs that are recoverable through the commercialization of the product. Beginning in October 2014, we became obligated to pay tiered, low single digit royalties under our collaboration and license agreement to Novartis on all future sales of JAKAFI in the United States which are included in cost of product revenues. | |
Contract and License Revenues | |
Under agreements involving multiple deliverables, services and/or rights to use assets that we entered into prior to January 1, 2011, the multiple elements are divided into separate units of accounting when certain criteria are met, including whether the delivered items have stand-alone value to the customer and whether there is objective and reliable evidence of the fair value of the undelivered items. When separate units of accounting exist, consideration is allocated among the separate elements based on their respective fair values. The determination of fair value of each element is based on objective evidence from historical sales of the individual elements by us to other customers. If such evidence of fair value for each undelivered element of the arrangement does not exist, all revenue from the arrangement is deferred until such time that evidence of fair value for each undelivered element does exist or until all elements of the arrangement are delivered. When elements are specifically tied to a separate earnings process, revenue is recognized when the specific performance obligation tied to the element is completed. When revenues for an element are not specifically tied to a separate earnings process, they are recognized ratably over the term of the agreement. We assess whether a substantive milestone exists at the inception of our agreements. For all milestones within our arrangements that are considered substantive, we recognize revenue upon the achievement of the associated milestone. If a milestone is not considered substantive, we would recognize the applicable milestone payment over the remaining period of performance under the arrangement. As of March 31, 2015, all remaining potential milestones under our collaborative arrangements are considered substantive. | |
On January 1, 2011, updated guidance on the recognition of revenues for agreements with multiple deliverables became effective and applies to any agreements we may enter into on or after January 1, 2011. This updated guidance (i) relates to whether multiple deliverables exist, how the deliverables in a revenue arrangement should be separated and how the consideration should be allocated; (ii) requires companies to allocate revenues in an arrangement using estimated selling prices of deliverables if a vendor does not have vendor-specific objective evidence or third-party evidence of selling price; and (iii) eliminates the use of the residual method and requires companies to allocate revenues using the relative selling price method. During the three months ended March 31, 2015 and 2014, we did not enter into any agreements that are subject to this updated guidance. If we enter into an agreement with multiple deliverables after January 1, 2011 or amend existing agreements, this updated guidance could have a material effect on our financial statements. | |
Our collaborations often include contractual milestones, which typically relate to the achievement of pre-specified development, regulatory and commercialization events. These three categories of milestone events reflect the three stages of the life-cycle of our drugs, which we describe in more detail in the following paragraphs. | |
The regulatory review and approval process, which includes preclinical testing and clinical trials of each drug candidate, is lengthy, expensive and uncertain. Securing approval by the FDA requires the submission of extensive preclinical and clinical data and supporting information to the FDA for each indication to establish a drug candidate’s safety and efficacy. The approval process takes many years, requires the expenditure of substantial resources, involves post-marketing surveillance and may involve ongoing requirements for post-marketing studies. Before commencing clinical investigations of a drug candidate in humans, we must submit an Investigational New Drug application (“IND”), which must be reviewed by the FDA. | |
The steps generally required before a drug may be marketed in the United States include preclinical laboratory tests, animal studies and formulation studies, submission to the FDA of an IND for human clinical testing, performance of adequate and well-controlled clinical trials in three phases, as described below, to establish the safety and efficacy of the drug for each indication, submission of a new drug application (“NDA”) or biologics license application (“BLA”) to the FDA for review and FDA approval of the NDA or BLA. | |
Similar requirements exist within foreign regulatory agencies as well. The time required satisfying the FDA requirements or similar requirements of foreign regulatory agencies may vary substantially based on the type, complexity and novelty of the product or the targeted disease. | |
Preclinical testing includes laboratory evaluation of product pharmacology, drug metabolism, and toxicity, which includes animal studies, to assess potential safety and efficacy as well as product chemistry, stability, formulation, development, and testing. The results of the preclinical tests, together with manufacturing information and analytical data, are submitted to the FDA as part of an IND. The FDA may raise safety concerns or questions about the conduct of the clinical trials included in the IND, and any of these concerns or questions must be resolved before clinical trials can proceed. We cannot be sure that submission of an IND will result in the FDA allowing clinical trials to commence. Clinical trials involve the administration of the investigational drug or the marketed drug to human subjects under the supervision of qualified investigators and in accordance with good clinical practices regulations covering the protection of human subjects. Clinical trials typically are conducted in three sequential phases, but the phases may overlap or be combined. Phase I usually involves the initial introduction of the investigational drug into healthy volunteers to evaluate its safety, dosage tolerance, absorption, metabolism, distribution and excretion. Phase II usually involves clinical trials in a limited patient population to evaluate dosage tolerance and optimal dosage, identify possible adverse effects and safety risks, and evaluate and gain preliminary evidence of the efficacy of the drug for specific indications. Phase III clinical trials usually further evaluate clinical efficacy and safety by testing the drug in its final form in an expanded patient population, providing statistical evidence of efficacy and safety, and providing an adequate basis for labeling. We cannot guarantee that Phase I, Phase II or Phase III testing will be completed successfully within any specified period of time, if at all. Furthermore, we, the institutional review board for a trial, or the FDA may suspend clinical trials at any time on various grounds, including a finding that the subjects or patients are being exposed to an unacceptable health risk. | |
Generally, the milestone events contained in our collaboration agreements coincide with the progression of our drugs from development, to regulatory approval and then to commercialization. The process of successfully discovering a new development candidate, having it approved and successfully commercialized is highly uncertain. As such, the milestone payments we may earn from our partners involve a significant degree of risk to achieve. Therefore, as a drug candidate progresses through the stages of its life-cycle, the value of the drug candidate generally increases. | |
Research and Development Costs | |
Research and Development Costs. Our policy is to expense research and development costs as incurred. We often contract with clinical research organizations (“CROs”) to facilitate, coordinate and perform agreed upon research and development of a new drug. To ensure that research and development costs are expensed as incurred, we record monthly accruals for clinical trials and preclinical testing costs based on the work performed under the contract. | |
These CRO contracts typically call for the payment of fees for services at the initiation of the contract and/or upon the achievement of certain clinical trial milestones. In the event that we prepay CRO fees, we record the prepayment as a prepaid asset and amortize the asset into research and development expense over the period of time the contracted research and development services are performed. Most professional fees, including project and clinical management, data management, monitoring, and medical writing fees are incurred throughout the contract period. These professional fees are expensed based on their percentage of completion at a particular date. Our CRO contracts generally include pass through fees. Pass through fees include, but are not limited to, regulatory expenses, investigator fees, travel costs, and other miscellaneous costs, including shipping and printing fees. We expense the costs of pass through fees under our CRO contracts as they are incurred, based on the best information available to us at the time. The estimates of the pass through fees incurred are based on the amount of work completed for the clinical trial and are monitored through correspondence with the CROs, internal reviews and a review of contractual terms. The factors utilized to derive the estimates include the number of patients enrolled, duration of the clinical trial, estimated patient attrition, screening rate and length of the dosing regimen. CRO fees incurred to set up the clinical trial are expensed during the setup period. Under our clinical trial collaboration agreements and clinical trial agreements, we may be reimbursed for certain development costs incurred. Such costs are recorded as a reduction of research and development expense in the period in which the related expense is incurred. | |
Stock Compensation | |
Stock Compensation. Share-based payment transactions with employees, which include stock options, restricted stock units (“RSUs”) and performance shares (“PSUs”), are recognized as compensation expense over the requisite service period based on their estimated fair values as well as expected forfeiture rates. The stock compensation process requires significant judgment and the use of estimates, particularly surrounding Black-Scholes assumptions such as stock price volatility over the option term and expected option lives, as well as expected forfeiture rates and the probability of PSUs vesting. The fair value of stock options, which are subject to graded vesting, are recognized as compensation expense over the requisite service period using the accelerated attribution method. The fair value of RSUs, which are generally subject to cliff vesting, are recognized as compensation expense over the requisite service period using the straight line attribution method. The fair value of PSUs are recognized as compensation expense beginning at the time in which the performance conditions are deemed probable of achievement, over the remaining requisite service period. We recorded $17.6 million and $15.3 million of stock compensation expense on our condensed consolidated statements of operations for the three months ended March 31, 2015 and 2014, respectively. | |
Recent Accounting Pronouncements | |
Recent Accounting Pronouncements | |
In August 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-15, “Presentation of Financial Statements—Going Concern”, to provide guidance on management’s responsibility in evaluating whether there is substantial doubt about a company’s ability to continue as a going concern and about related footnote disclosures. For each reporting period, management will be required to evaluate whether there are conditions or events that raise substantial doubt about a company’s ability to continue as a going concern within one year from the date the financial statements are issued. This guidance is effective for the annual period ending after December 15, 2016, and for annual periods and interim periods thereafter. Early application is permitted. We do not believe the pending adoption of ASU No. 2014-15 will have a material impact on our condensed consolidated financial statements. | |
In May 2014, the FASB issued ASU No. 2014-09, “Revenue from Contracts with Customers,” which provides a five step approach to be applied to all contracts with customers. ASU No. 2014-09 also requires expanded disclosures about revenue recognition. On April 1, 2015, the FASB proposed to extend the effective date of ASU No. 2014-09 from reporting periods beginning after December 15, 2016 to reporting periods beginning after December 15, 2017. Early adoption is permitted for reporting periods beginning after December 15, 2016. Once the proposal is formally issued, the public will have 30 days to comment, after which the proposal will be decided upon. We are currently analyzing the impact of ASU No. 2014-09 on our results of operations and, at this time, we are unable to determine the impact on the new standard, if any, on our condensed consolidated financial statements. | |
Fair_value_of_financial_instru1
Fair value of financial instruments (Tables) | 3 Months Ended | |||||||||||||
Mar. 31, 2015 | ||||||||||||||
Fair value of financial instruments. | ||||||||||||||
Schedule of fair value of assets and liabilities measured on recurring basis | ||||||||||||||
The following fair value hierarchy table presents information about each major category of our financial assets and liabilities measured at fair value on a recurring basis as of March 31, 2015 (in thousands): | ||||||||||||||
Fair Value Measurement at Reporting Date Using: | ||||||||||||||
Quoted Prices in | Significant Other | Significant | Balance as of | |||||||||||
Active Markets for | Observable | Unobservable | March 31, 2015 | |||||||||||
Identical Assets | Inputs | Inputs | ||||||||||||
(Level 1) | (Level 2) | (Level 3) | ||||||||||||
Cash and cash equivalents | $ | 421,822 | $ | — | $ | — | $ | 421,822 | ||||||
Corporate debt securities | — | 160,180 | — | 160,180 | ||||||||||
Long term investment (Note 7) | 39,829 | — | — | 39,829 | ||||||||||
Mortgage-backed securities | — | 3,422 | — | 3,422 | ||||||||||
Total assets | $ | 461,651 | $ | 163,602 | $ | — | $ | 625,253 | ||||||
The following fair value hierarchy table presents information about each major category of our financial assets measured at fair value on a recurring basis as of December 31, 2014 (in thousands): | ||||||||||||||
Fair Value Measurement at Reporting Date Using: | ||||||||||||||
Quoted Prices in | Significant Other | Significant | Balance as of | |||||||||||
Active Markets for | Observable | Unobservable | December 31, 2014 | |||||||||||
Identical Assets | Inputs | Inputs | ||||||||||||
(Level 1) | (Level 2) | (Level 3) | ||||||||||||
Cash and cash equivalents | $ | 452,297 | $ | — | $ | — | $ | 452,297 | ||||||
Corporate debt securities | — | 144,402 | — | 144,402 | ||||||||||
Mortgage-backed securities | — | 3,564 | — | 3,564 | ||||||||||
Total assets | $ | 452,297 | $ | 147,966 | $ | — | $ | 600,263 | ||||||
Summary of marketable securities portfolio | ||||||||||||||
Amortized | Net | Net | Estimated | |||||||||||
Cost | Unrealized | Unrealized | Fair Value | |||||||||||
Gains | Losses | |||||||||||||
(in thousands) | ||||||||||||||
March 31, 2015 | ||||||||||||||
Corporate debt securities | $ | 160,008 | $ | 172 | $ | — | $ | 160,180 | ||||||
Mortgage backed securities | 1,330 | 2,092 | — | 3,422 | ||||||||||
$ | 161,338 | $ | 2,264 | $ | — | $ | 163,602 | |||||||
December 31, 2014 | ||||||||||||||
Corporate debt securities | $ | 144,684 | $ | — | $ | (282 | ) | $ | 144,402 | |||||
Mortgage backed securities | 1,461 | 2,103 | — | 3,564 | ||||||||||
$ | 146,145 | $ | 2,103 | $ | (282 | ) | $ | 147,966 | ||||||
Concentration_of_Credit_Risk_T
Concentration of Credit Risk (Tables) | 3 Months Ended | |||||
Mar. 31, 2015 | ||||||
Concentration of Credit Risk | ||||||
Schedule of concentration of credit risk related to collaborative partners | ||||||
Percentage of Total | ||||||
Contract Revenues for the | ||||||
Three Months Ended, | ||||||
March 31, | ||||||
2015 | 2014 | |||||
Collaboration Partner A | 89 | % | 68 | % | ||
Collaboration Partner B | 11 | % | 32 | % | ||
Schedule of concentration of credit risk related to specialty pharmacy customers | ||||||
Percentage of Total Net | ||||||
Product Revenues for the | ||||||
Three Months Ended, | ||||||
March 31, | ||||||
2015 | 2014 | |||||
Customer A | 28 | % | 29 | % | ||
Customer B | 20 | % | 21 | % | ||
Customer C | 13 | % | 11 | % | ||
Customer D | 8 | % | 9 | % | ||
Inventory_Tables
Inventory (Tables) | 3 Months Ended | |||||||
Mar. 31, 2015 | ||||||||
Inventory | ||||||||
Schedule of inventory | ||||||||
March 31, | December 31, | |||||||
2015 | 2014 | |||||||
(in thousands) | ||||||||
Raw materials | $ | 500 | $ | 591 | ||||
Work-in-process | 16,521 | 18,487 | ||||||
Finished goods | 2,414 | 358 | ||||||
19,435 | 19,436 | |||||||
Inventories—current | 2,414 | 358 | ||||||
Inventories—non-current | $ | 17,021 | $ | 19,078 | ||||
Property_and_Equipment_Tables
Property and Equipment (Tables) | 3 Months Ended | |||||||
Mar. 31, 2015 | ||||||||
Property and Equipment | ||||||||
Schedule of property and equipment | ||||||||
March 31, | December 31, | |||||||
2015 | 2014 | |||||||
(in thousands) | ||||||||
Office equipment | $ | 6,223 | $ | 6,090 | ||||
Laboratory equipment | 27,053 | 26,800 | ||||||
Computer equipment | 19,775 | 18,648 | ||||||
Building and leasehold improvements | 64,862 | 64,926 | ||||||
117,913 | 116,464 | |||||||
Less accumulated depreciation and amortization | (37,246 | ) | (34,674 | ) | ||||
$ | 80,667 | $ | 81,790 | |||||
Stock_compensation_Tables
Stock compensation (Tables) | 3 Months Ended | |||||||||
Mar. 31, 2015 | ||||||||||
Stock compensation | ||||||||||
Schedule of valuation assumptions used for valuation of fair value of stock compensation granted | ||||||||||
Employee Stock | Employee Stock | |||||||||
Options For the | Purchase Plan For the | |||||||||
Three Months | Three Months | |||||||||
Ended | Ended | |||||||||
March 31, | March 31, | |||||||||
2015 | 2014 | 2015 | 2014 | |||||||
Average risk-free interest rates | 1.35 | % | 1.18 | % | 0.56 | % | 0.44 | % | ||
Average expected life (in years) | 5.05 | 4.47 | 0.25 | 0.25 | ||||||
Volatility | 50 | % | 50 | % | 38 | % | 52 | % | ||
Weighted-average fair value (in dollars) | 32.59 | 26.52 | 9.56 | 8.65 | ||||||
Schedule of option activity under the 2010 Stock Plan | ||||||||||
Shares Subject to | ||||||||||
Outstanding Options | ||||||||||
Shares Available | Shares | Weighted Average | ||||||||
for Grant | Exercise Price | |||||||||
Balance at December 31, 2014 | 5,399,816 | 14,655,043 | $ | 21.96 | ||||||
Options granted | (1,622,520 | ) | 1,622,520 | $ | 74.03 | |||||
Options exercised | — | (2,478,752 | ) | $ | 15.91 | |||||
Options cancelled | 74,169 | (74,169 | ) | $ | 42.21 | |||||
Balance at March 31, 2015 | 3,851,465 | 13,724,642 | $ | 29.1 | ||||||
Schedule of RSU and PSU award activity under the 2010 Stock Plan | ||||||||||
Shares Subject to | ||||||||||
Shares Available | Outstanding Awards | |||||||||
for Grant | Shares | Grant Date Value | ||||||||
Balance at December 31, 2014 | 1,001,523 | 398,477 | — | |||||||
RSUs granted | (175,338 | ) | 175,338 | $ | 74.08 | |||||
PSUs granted | — | — | — | |||||||
RSUs cancelled | 5,074 | (5,074 | ) | $ | 64.74 | |||||
PSUs cancelled | — | — | — | |||||||
Balance at March 31, 2015 | 831,259 | 568,741 | — | |||||||
Debt_Tables
Debt (Tables) | 3 Months Ended | |||||||||||||
Mar. 31, 2015 | ||||||||||||||
Debt | ||||||||||||||
Schedule of components of convertible notes | ||||||||||||||
The components of the convertible notes are as follows (in thousands): | ||||||||||||||
Carrying Amount | ||||||||||||||
Debt | Interest Rates | Maturities | March 31, | December 31, | ||||||||||
March 31, 2015 | 2015 | 2014 | ||||||||||||
4.75% Convertible Senior Notes due 2015 | 4.75 | % | 2015 | $ | 87,337 | $ | 85,640 | |||||||
0.375% Convertible Senior Notes due 2018 | 0.375 | % | 2018 | 318,292 | 314,752 | |||||||||
1.25% Convertible Senior Notes due 2020 | 1.25 | % | 2020 | 291,918 | 288,726 | |||||||||
697,547 | 689,118 | |||||||||||||
Less current portion | 87,337 | 85,640 | ||||||||||||
$ | 610,210 | $ | 603,478 | |||||||||||
Schedule of carrying amount and fair value of convertible notes | ||||||||||||||
The carrying amount and fair value of our convertible notes are as follows (in thousands): | ||||||||||||||
March 31, 2015 | December 31, 2014 | |||||||||||||
Carrying | Fair Value | Carrying | Fair Value | |||||||||||
Amount | Amount | |||||||||||||
4.75% Convertible Senior Notes due 2015 | $ | 87,337 | $ | 947,148 | $ | 85,640 | $ | 755,143 | ||||||
0.375% Convertible Senior Notes due 2018 | 318,292 | 682,500 | 314,752 | 560,156 | ||||||||||
1.25% Convertible Senior Notes due 2020 | 291,918 | 695,861 | 288,726 | 577,736 | ||||||||||
$ | 697,547 | $ | 2,325,509 | $ | 689,118 | $ | 1,893,035 | |||||||
Net_loss_per_share_Tables
Net loss per share (Tables) | 3 Months Ended | |||||
Mar. 31, 2015 | ||||||
Net loss per share | ||||||
Schedule of antidilutive securities excluded from the computation of earnings per share | ||||||
Three Months Ended | ||||||
March 31, | ||||||
2015 | 2014 | |||||
Outstanding stock awards | 14,626,717 | 18,027,392 | ||||
Common shares issuable upon conversion of 4.75% Convertible Senior Notes due 2015 | 10,353,076 | 10,441,728 | ||||
Common shares issuable upon conversion of 0.375% Convertible Senior Notes due 2018 | 7,245,263 | 7,245,263 | ||||
Common shares issuable upon conversion of 1.25% Convertible Senior Notes due 2020 | 7,245,263 | 7,245,263 | ||||
Total potential common shares excluded from diluted net loss per share computation | 39,470,319 | 42,959,646 | ||||
Organization_and_business_Deta
Organization and business (Details) | 3 Months Ended |
Mar. 31, 2015 | |
segment | |
Organization and business | |
Number of operating segments | 1 |
Summary_of_significant_account2
Summary of significant accounting policies (Details) (USD $) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2015 | Dec. 31, 2014 |
instrument | ||
issuer | ||
item | ||
Concentrations of Credit Risk | ||
Number of issuer to which company limits the amount of credit exposure other than US Government guaranteed securities | 1 | |
Number of financial investment to which company limits the amount of credit exposure other than US Government guaranteed securities | 1 | |
Accounts Receivable | ||
Allowance for doubtful accounts | $0 | $0 |
Inventory | ||
Shelf life for finished goods inventory, maximum | 36 months | |
Variable Interest Entities | ||
Number of entities in which variable interest held | 0 | |
Minimum [Member] | ||
Property and Equipment | ||
Estimated useful life | 3 years | |
Maximum [Member] | ||
Property and Equipment | ||
Estimated useful life | 5 years |
Summary_of_significant_account3
Summary of significant accounting policies (Details 2) (USD $) | 3 Months Ended | |
In Millions, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 |
item | ||
category | ||
Revenue Recognition | ||
Percentage of Medicare Part D insurance coverage gap mandate to be funded by manufacturers | 50.00% | |
Categories of milestone events, number | 3 | |
Number of stages of life-cycle drugs | 3 | |
Stock-Based Compensation | ||
Stock-based compensation expense | $17.60 | $15.30 |
Fair_value_of_financial_instru2
Fair value of financial instruments (Details) (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
In Thousands, unless otherwise specified | ||
Fair value of financial instruments | ||
Long term investment (Note 7) | $39,829 | |
Fair Value, Measurements, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Fair value of financial instruments | ||
Cash and cash equivalents | 421,822 | 452,297 |
Long term investment (Note 7) | 39,829 | |
Total assets | 461,651 | 452,297 |
Fair Value, Measurements, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Fair value of financial instruments | ||
Corporate debt securities | 160,180 | 144,402 |
Mortgage backed securities | 3,422 | 3,564 |
Total assets | 163,602 | 147,966 |
Fair Value, Measurements, Recurring [Member] | Estimate of Fair Value Measurement [Member] | ||
Fair value of financial instruments | ||
Cash and cash equivalents | 421,822 | 452,297 |
Corporate debt securities | 160,180 | 144,402 |
Long term investment (Note 7) | 39,829 | |
Mortgage backed securities | 3,422 | 3,564 |
Total assets | $625,253 | $600,263 |
Fair_value_of_financial_instru3
Fair value of financial instruments (Details 2) (USD $) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2015 | Dec. 31, 2014 |
Summary of marketable security portfolio | ||
Amortized Cost | 161,338 | $146,145 |
Net Unrealized Gains | 2,264 | 2,103 |
Net Unrealized Losses | -282 | |
Estimated Fair Value | 163,602 | 147,966 |
Corporate Debt Securities [Member] | ||
Summary of marketable security portfolio | ||
Amortized Cost | 160,008 | 144,684 |
Net Unrealized Gains | 172 | |
Net Unrealized Losses | -282 | |
Estimated Fair Value | 160,180 | 144,402 |
Corporate Debt Securities [Member] | Minimum [Member] | ||
Summary of marketable security portfolio | ||
Contractual maturity dates | 12 months | |
Corporate Debt Securities [Member] | Maximum [Member] | ||
Summary of marketable security portfolio | ||
Contractual maturity dates | 18 months | |
Collateralized Mortgage Backed Securities [Member] | ||
Summary of marketable security portfolio | ||
Amortized Cost | 1,330 | 1,461 |
Net Unrealized Gains | 2,092 | 2,103 |
Estimated Fair Value | 3,422 | $3,564 |
Concentration_of_Credit_Risk_D
Concentration of Credit Risk (Details) | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2015 | Mar. 31, 2014 | Dec. 31, 2014 | |
Contract Revenues [Member] | Customer Concentration Risk [Member] | Collaboration Partner A [Member] | |||
Concentration of risk | |||
Percentage of concentration risk | 89.00% | 68.00% | |
Contract Revenues [Member] | Customer Concentration Risk [Member] | Collaboration Partner B [Member] | |||
Concentration of risk | |||
Percentage of concentration risk | 11.00% | 32.00% | |
Sales Revenue Goods Services Net [Member] | Customer Concentration Risk [Member] | Customer A [Member] | |||
Concentration of risk | |||
Percentage of concentration risk | 28.00% | 29.00% | |
Sales Revenue Goods Services Net [Member] | Customer Concentration Risk [Member] | Customer B [Member] | |||
Concentration of risk | |||
Percentage of concentration risk | 20.00% | 21.00% | |
Sales Revenue Goods Services Net [Member] | Customer Concentration Risk [Member] | Customer C [Member] | |||
Concentration of risk | |||
Percentage of concentration risk | 13.00% | 11.00% | |
Sales Revenue Goods Services Net [Member] | Customer Concentration Risk [Member] | Customer D [Member] | |||
Concentration of risk | |||
Percentage of concentration risk | 8.00% | 9.00% | |
Accounts Receivable [Member] | Credit Concentration Risk [Member] | Collaboration Partner A and B [Member] | |||
Concentration of risk | |||
Percentage of concentration risk | 23.00% | 26.00% | |
Accounts Receivable [Member] | Credit Concentration Risk [Member] | Customer A B C and D [Member] | |||
Concentration of risk | |||
Percentage of concentration risk | 69.00% | 54.00% |
Inventory_Details
Inventory (Details) (USD $) | 3 Months Ended | ||
In Thousands, unless otherwise specified | Mar. 31, 2015 | Dec. 31, 2014 | |
Inventory | |||
Raw materials | $500 | $591 | |
Work-in-process | 16,521 | 18,487 | |
Finished goods | 2,414 | 358 | |
Total inventories | 19,435 | 19,436 | |
Inventories - current | 2,414 | 358 | [1] |
Inventories - non -current | $17,021 | $19,078 | [1] |
Shelf life for finished goods inventory, maximum | 36 months | ||
[1] | The condensed consolidated balance sheet at December 31, 2014 has been derived from the audited financial statements at that date. |
Property_and_Equipment_Details
Property and Equipment (Details) (USD $) | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2015 | Dec. 31, 2013 | Dec. 31, 2014 | ||
sqft | ||||
Property and Equipment | ||||
Property and Equipment, gross | $117,913,000 | $116,464,000 | ||
Less accumulated depreciation and amortization | -37,246,000 | -34,674,000 | ||
Property and Equipment, net | 80,667,000 | 81,790,000 | [1] | |
Area of laboratory and office building on lease (in square feet) | 190,000 | |||
Term of lease | 15 years | |||
Minimum monthly lease rental | 500,000 | |||
Initial term of lease over which minimum lease rent is required to be payable | 10 years | |||
Last term of lease | 5 years | |||
Letter of credit for posted for lease facility | 15,000,000 | |||
Restricted investments | 14,400,000 | 14,500,000 | ||
Office Equipment [Member] | ||||
Property and Equipment | ||||
Property and Equipment, gross | 6,223,000 | 6,090,000 | ||
Laboratory Equipment [Member] | ||||
Property and Equipment | ||||
Property and Equipment, gross | 27,053,000 | 26,800,000 | ||
Computer Equipment [Member] | ||||
Property and Equipment | ||||
Property and Equipment, gross | 19,775,000 | 18,648,000 | ||
Building And Leasehold Improvements [Member] | ||||
Property and Equipment | ||||
Property and Equipment, gross | $64,862,000 | $64,926,000 | ||
[1] | The condensed consolidated balance sheet at December 31, 2014 has been derived from the audited financial statements at that date. |
License_agreements_Details
License agreements (Details) (USD $) | 3 Months Ended | 1 Months Ended | 65 Months Ended | 12 Months Ended | 1 Months Ended | 64 Months Ended | 12 Months Ended | |||||
Mar. 31, 2015 | Mar. 31, 2014 | Nov. 30, 2009 | Mar. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2011 | Dec. 31, 2012 | Jul. 31, 2010 | Dec. 31, 2009 | Mar. 31, 2015 | Dec. 31, 2010 | |
item | ||||||||||||
License agreements | ||||||||||||
Contract revenues | $28,214,000 | $10,214,000 | ||||||||||
Product royalty revenues | 15,673,000 | 9,826,000 | ||||||||||
Novartis | ||||||||||||
License agreements | ||||||||||||
Upfront and immediate milestone payment to be received under license agreement | 210,000,000 | |||||||||||
Product royalties | 15,800,000 | 15,800,000 | 14,800,000 | 15,800,000 | ||||||||
Reimbursable costs recorded as deferred revenue | 10,900,000 | |||||||||||
Reimbursable costs included in accounts receivable | 500,000 | 500,000 | 300,000 | 500,000 | ||||||||
Research and development expenses reimbursed | 500,000 | 1,100,000 | ||||||||||
Contract revenues | 25,000,000 | 7,000,000 | ||||||||||
Novartis | UNITED STATES | ||||||||||||
License agreements | ||||||||||||
Royalties Payable | 2,500,000 | 2,500,000 | 2,500,000 | |||||||||
Novartis | Pre-specified Events [Member] | Maximum [Member] | ||||||||||||
License agreements | ||||||||||||
Upfront and immediate milestone payment to be received under license agreement | 1,200,000,000 | |||||||||||
Novartis | Development Milestones | ||||||||||||
License agreements | ||||||||||||
Amount recognized and received for the achievement of a predefined milestone | 97,000,000 | |||||||||||
Novartis | Development Milestones | Maximum [Member] | ||||||||||||
License agreements | ||||||||||||
Upfront and immediate milestone payment to be received under license agreement | 174,000,000 | |||||||||||
Novartis | Regulatory Milestones [Member] | ||||||||||||
License agreements | ||||||||||||
Amount recognized and received for the achievement of a predefined milestone | 160,000,000 | |||||||||||
Novartis | Regulatory Milestones [Member] | Maximum [Member] | ||||||||||||
License agreements | ||||||||||||
Upfront and immediate milestone payment to be received under license agreement | 495,000,000 | |||||||||||
Novartis | Commercialization Milestones [Member] | Maximum [Member] | ||||||||||||
License agreements | ||||||||||||
Upfront and immediate milestone payment to be received under license agreement | 500,000,000 | |||||||||||
Novartis | LY3009104 [Member] | Development Milestones | ||||||||||||
License agreements | ||||||||||||
Amount recognized and received for the achievement of a predefined milestone | 7,000,000 | 25,000,000 | 15,000,000 | |||||||||
Novartis | JAKAFI [Member] | ||||||||||||
License agreements | ||||||||||||
Product royalty revenues | 15,700,000 | 9,800,000 | ||||||||||
Novartis | JAKAFI [Member] | Regulatory Milestones [Member] | ||||||||||||
License agreements | ||||||||||||
Amount recognized and received for the achievement of a predefined milestone | 10,000,000 | |||||||||||
Novartis | JAKAFI [Member] | Regulatory Milestones [Member] | Europe | ||||||||||||
License agreements | ||||||||||||
Amount recognized and received for the achievement of a predefined milestone | 25,000,000 | 60,000,000 | 40,000,000 | |||||||||
Novartis | JAKAFI [Member] | Regulatory Milestones [Member] | JAPAN | ||||||||||||
License agreements | ||||||||||||
Amount recognized and received for the achievement of a predefined milestone | 25,000,000 | |||||||||||
Eli Lilly | ||||||||||||
License agreements | ||||||||||||
Number of deliverables under license agreement | 2 | |||||||||||
Upfront payment received under license agreement | 90,000,000 | |||||||||||
Research and development expenses reimbursed | 11,600,000 | 14,000,000 | ||||||||||
Contract revenues | 3,200,000 | 3,200,000 | ||||||||||
Associated future global development costs from the initiation of a Phase IIb trial, if elected to co-develop, percentage | 30.00% | 30.00% | 30.00% | 30.00% | ||||||||
Eli Lilly | Maximum [Member] | ||||||||||||
License agreements | ||||||||||||
Range of royalty payments on future global net sales (as a percent) | 20.00% | |||||||||||
Eli Lilly | Pre-specified Events [Member] | Maximum [Member] | ||||||||||||
License agreements | ||||||||||||
Upfront and immediate milestone payment to be received under license agreement | 665,000,000 | |||||||||||
Eli Lilly | Development Milestones | ||||||||||||
License agreements | ||||||||||||
Amount recognized and received for the achievement of a predefined milestone | 99,000,000 | |||||||||||
Eli Lilly | Development Milestones | Maximum [Member] | ||||||||||||
License agreements | ||||||||||||
Upfront and immediate milestone payment to be received under license agreement | 150,000,000 | |||||||||||
Eli Lilly | Development Milestones | Phase Three [Member] | ||||||||||||
License agreements | ||||||||||||
Amount recognized and received for the achievement of a predefined milestone | 50,000,000 | |||||||||||
Eli Lilly | Development Milestones | Phase Two A [Member] | ||||||||||||
License agreements | ||||||||||||
Amount recognized and received for the achievement of a predefined milestone | 30,000,000 | |||||||||||
Eli Lilly | Development Milestones | Phase Two B [Member] | ||||||||||||
License agreements | ||||||||||||
Amount recognized and received for the achievement of a predefined milestone | 19,000,000 | |||||||||||
Eli Lilly | Regulatory Milestones [Member] | Maximum [Member] | ||||||||||||
License agreements | ||||||||||||
Upfront and immediate milestone payment to be received under license agreement | 365,000,000 | |||||||||||
Eli Lilly | Commercialization Milestones [Member] | Maximum [Member] | ||||||||||||
License agreements | ||||||||||||
Upfront and immediate milestone payment to be received under license agreement | $150,000,000 |
License_agreements_Details_2
License agreements (Details 2) (USD $) | 3 Months Ended | 0 Months Ended | 1 Months Ended | |
Share data in Millions, except Per Share data, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 | Feb. 18, 2015 | Jan. 31, 2015 |
License agreements | ||||
Long term investments | $39,829,000 | |||
Research and development expense | 118,365,000 | 75,585,000 | ||
Agenus | ||||
License agreements | ||||
Acquisition of outstanding voting stock of Agenus (as a percent) | 11.00% | |||
Gain or loss recorded | 0 | |||
Research and development expense | 1,800,000 | |||
Agenus | Development Regulatory and Commercialization Milestones | ||||
License agreements | ||||
Reserved right to elect to co-fund of development costs (as a percent) | 30.00% | |||
Agenus | Development Regulatory and Commercialization Milestones | Minimum [Member] | ||||
License agreements | ||||
Range of royalty payments on future global net sales (as a percent) | 6.00% | |||
Agenus | Development Regulatory and Commercialization Milestones | Maximum [Member] | ||||
License agreements | ||||
Future contingent milestone payment | 155,000,000 | |||
Range of royalty payments on future global net sales (as a percent) | 12.00% | |||
Agenus | Development Milestones | Maximum [Member] | ||||
License agreements | ||||
Future contingent milestone payment | 20,000,000 | |||
Agenus | Stock purchase agreement | ||||
License agreements | ||||
Purchase of common stock under Stock Purchase Agreement (in shares ) | 7.76 | |||
Purchase price of common stock under Stock Purchase Agreement | 39,800,000 | 35,000,000 | ||
Per share price of common stock under Stock Purchase Agreement | $5.13 | $4.51 | ||
Minimum period for holding common stock of Agenus | 12 months | |||
Total consideration paid | 60,000,000 | |||
Long term investments | 39,800,000 | |||
Research and development expense | $20,200,000 |
Stock_compensation_Details
Stock compensation (Details) (USD $) | 3 Months Ended | |
Mar. 31, 2015 | Mar. 31, 2014 | |
Stock compensation | ||
Stock compensation expense | $17,600,000 | $15,300,000 |
Weighted-average fair value assumptions | ||
Valuation method | Black-Scholes valuation model | |
Dividend yield (as a percent) | 0.00% | |
Assumed annualized forfeiture rate (as a percent) | 5.00% | |
Research and Development Expense [Member] | ||
Stock compensation | ||
Stock compensation expense | 10,300,000 | 8,300,000 |
Selling, General and Administrative Expenses [Member] | ||
Stock compensation | ||
Stock compensation expense | 7,300,000 | 7,000,000 |
Employee Stock Option [Member] | ||
Weighted-average fair value assumptions | ||
Average risk-free interest rates (as a percent) | 1.35% | 1.18% |
Average expected life (in years) | 5 years 18 days | 4 years 5 months 19 days |
Volatility (as a percent) | 50.00% | 50.00% |
Weighted-average fair value (in dollars per share) | $32.59 | $26.52 |
Unrecognized compensation | ||
Unrecognized compensation cost for nonvested option (in dollars) | 58,100,000 | |
Vesting period of recognition of the unrecognized compensation cost of nonvested awards | 3 years | |
Employee Stock [Member] | ||
Weighted-average fair value assumptions | ||
Average risk-free interest rates (as a percent) | 0.56% | 0.44% |
Average expected life (in years) | 3 months | 3 months |
Volatility (as a percent) | 38.00% | 52.00% |
Weighted-average fair value (in dollars per share) | $9.56 | $8.65 |
Restricted Stock Units (RSUs) [Member] | ||
Unrecognized compensation | ||
Unrecognized compensation cost for nonvested option (in dollars) | 31,800,000 | |
Vesting period of recognition of the unrecognized compensation cost of nonvested awards | 3 years | |
Performance Shares [Member] | ||
Stock compensation | ||
Stock compensation expense | 0 | |
Unrecognized compensation | ||
Unrecognized compensation cost for nonvested option (in dollars) | $700,000 | |
Vesting period of recognition of the unrecognized compensation cost of nonvested awards | 3 years |
Stock_compensation_Details_2
Stock compensation (Details 2) (Employee Stock Option [Member], USD $) | 3 Months Ended |
Mar. 31, 2015 | |
Employee Stock Option [Member] | |
Shares Available For Grant | |
Outstanding at the beginning of the period (in shares) | 5,399,816 |
Options granted (in shares) | -1,622,520 |
Options cancelled (in shares) | 74,169 |
Outstanding at the end of the period (in shares) | 3,851,465 |
Number Outstanding | |
Outstanding at the beginning of the period (in shares) | 14,655,043 |
Options granted (in shares) | 1,622,520 |
Options exercised (in shares) | -2,478,752 |
Options cancelled (in shares) | -74,169 |
Outstanding at the end of the period (in shares) | 13,724,642 |
Weighted Average Exercise Price per share | |
Outstanding at the beginning of the period (in dollars per share) | $21.96 |
Options granted (in dollars per share) | $74.03 |
Options exercised (in dollars per share) | $15.91 |
Options cancelled (in dollars per share) | $42.21 |
Outstanding at the end of the period (in dollars per share) | $29.10 |
Stock_compensation_Details_3
Stock compensation (Details 3) (USD $) | 3 Months Ended | 1 Months Ended | |
In Thousands, except Share data, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 | Jan. 31, 2014 |
Stock Compensation Plans | |||
Stock compensation expense | $17,600 | $15,300 | |
Restricted Stock Units (RSUs) [Member] | |||
Stock Compensation Plans | |||
Number of shares awarded for each RSU (in shares) | 1 | ||
Granted (in shares) | 175,338 | ||
Cliff vesting period | 3 years | ||
Share-based Compensation Arrangement by Share-based Payment Award, Shares Available for Grant [Roll Forward] | |||
Shares Available for Grant Beginning Balance (in shares) | 1,001,523 | ||
Granted (in shares) | -175,338 | ||
Cancelled (in shares) | 5,074 | ||
Shares Available for Grant Ending Balance (in shares) | 831,259 | ||
Number Outstanding | |||
Outstanding at the beginning of the period (in shares) | 398,477 | ||
Granted (in shares) | 175,338 | ||
Outstanding (in shares) | 831,259 | ||
Cancelled (in shares) | -5,074 | ||
Outstanding at the end of the period (in shares) | 568,741 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Additional Disclosures [Abstract] | |||
Granted (in dollars per share) | $74.08 | ||
Cancelled (in dollars per share) | $64.74 | ||
Restricted Stock Units (RSUs) [Member] | President And Chief Executive Officer Member | |||
Stock Compensation Plans | |||
Granted (in shares) | 400,000 | ||
Percentage of units vesting at the end of each calendar year (as a percent) | 16.70% | ||
Share-based Compensation Arrangement by Share-based Payment Award, Shares Available for Grant [Roll Forward] | |||
Cancelled (in shares) | 66,666 | ||
Shares Available for Grant Ending Balance (in shares) | 333,334 | ||
Number Outstanding | |||
Granted (in shares) | 400,000 | ||
Outstanding (in shares) | 333,334 | ||
Performance Shares [Member] | |||
Stock Compensation Plans | |||
Stock compensation expense | $0 | ||
Performance Shares [Member] | Maximum [Member] | |||
Stock Compensation Plans | |||
Multiplier conversion rate of units into common stock (as a percent) | 125.00% |
Debt_Details
Debt (Details) (USD $) | 1 Months Ended | 12 Months Ended | |||
Share data in Millions, unless otherwise specified | Apr. 30, 2015 | Dec. 31, 2014 | Mar. 31, 2015 | Mar. 31, 2014 | |
Convertible Notes | |||||
Convertible senior notes | 603,478,000 | [1] | $610,210,000 | ||
Reported Value Measurement [Member] | |||||
Convertible Notes | |||||
Long-term debt, Current Maturities | 689,118,000 | 697,547,000 | |||
Less current portion | 85,640,000 | 87,337,000 | |||
Long-term debt, noncurrent | 603,478,000 | 610,210,000 | |||
Convertible senior notes | 689,118,000 | 697,547,000 | |||
Estimate of Fair Value Measurement [Member] | |||||
Convertible Notes | |||||
Convertible senior notes | 1,893,035,000 | 2,325,509,000 | |||
Convertible Senior Notes 4.75 Percent Due 2015 | |||||
Convertible Notes | |||||
Interest rate of debt (as a percent) | 4.75% | 4.75% | |||
Aggregate principal amount of notes exchanged | 46,900,000 | ||||
Common stock issued in exchange of notes (in shares) | 5.3 | ||||
Convertible Senior Notes 4.75 Percent Due 2015 | Reported Value Measurement [Member] | |||||
Convertible Notes | |||||
Convertible senior notes | 85,640,000 | 87,337,000 | |||
Convertible Senior Notes 4.75 Percent Due 2015 | Estimate of Fair Value Measurement [Member] | |||||
Convertible Notes | |||||
Convertible senior notes | 755,143,000 | 947,148,000 | |||
Convertible Senior Notes 0.375 Percent Due 2018 and Convertible Senior Notes 1.25 Percent Due 2020 | |||||
Convertible Notes | |||||
Number of days within 30 consecutive trading days in which the price of the entity's common stock must exceed the conversion price for the notes to be converted | 20 days | ||||
Number of consecutive trading days during which the closing price of the entity's common stock must exceed the conversion price for at least 20 days in order for the notes to be convertible | 30 days | ||||
Percentage of the closing sales price of common stock that the conversion price must exceed in order for the notes to be convertible (as a percent) | 130.00% | ||||
Number of consecutive business days immediately after any five consecutive trading day period during the note measurement period | 5 days | ||||
Number of consecutive trading days before five consecutive business days during the note measurement period | 5 days | ||||
Conversion ratio, principal amount of note | 1,000 | ||||
Percentage of the trading price to the product of the last reported sale price of the common stock and the conversion rate, maximum (as a percent) | 98.00% | ||||
Convertible Senior Notes 0.375 Percent Due 2018 | |||||
Convertible Notes | |||||
Interest rate of debt (as a percent) | 0.38% | ||||
Convertible Senior Notes 0.375 Percent Due 2018 | Reported Value Measurement [Member] | |||||
Convertible Notes | |||||
Convertible senior notes | 314,752,000 | 318,292,000 | |||
Convertible Senior Notes 0.375 Percent Due 2018 | Estimate of Fair Value Measurement [Member] | |||||
Convertible Notes | |||||
Convertible senior notes | 560,156,000 | 682,500,000 | |||
Convertible Senior Notes 1.25 Percent Due 2020 | |||||
Convertible Notes | |||||
Interest rate of debt (as a percent) | 1.25% | ||||
Convertible Senior Notes 1.25 Percent Due 2020 | Reported Value Measurement [Member] | |||||
Convertible Notes | |||||
Convertible senior notes | 288,726,000 | 291,918,000 | |||
Convertible Senior Notes 1.25 Percent Due 2020 | Estimate of Fair Value Measurement [Member] | |||||
Convertible Notes | |||||
Convertible senior notes | 577,736,000 | $695,861,000 | |||
[1] | The condensed consolidated balance sheet at December 31, 2014 has been derived from the audited financial statements at that date. |
Net_loss_per_share_Details
Net loss per share (Details) | 3 Months Ended | |
Mar. 31, 2015 | Mar. 31, 2014 | |
Anti-dilutive securities | ||
Potential common shares excluded from diluted net loss per share computation | 39,470,319 | 42,959,646 |
Employee Stock Option [Member] | ||
Anti-dilutive securities | ||
Potential common shares excluded from diluted net loss per share computation | 14,626,717 | 18,027,392 |
Convertible Senior Notes 4.75 Percent Due 2015 | ||
Anti-dilutive securities | ||
Potential common shares excluded from diluted net loss per share computation | 10,353,076 | 10,441,728 |
Interest rate of debt (as a percent) | 4.75% | |
Convertible Senior Notes 0.375 Percent Due 2018 | ||
Anti-dilutive securities | ||
Potential common shares excluded from diluted net loss per share computation | 7,245,263 | 7,245,263 |
Interest rate of debt (as a percent) | 0.38% | |
Convertible Senior Notes 1.25 Percent Due 2020 | ||
Anti-dilutive securities | ||
Potential common shares excluded from diluted net loss per share computation | 7,245,263 | 7,245,263 |
Interest rate of debt (as a percent) | 1.25% |