Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2019 | Apr. 23, 2019 | |
Document and Entity Information | ||
Entity Registrant Name | INCYTE CORP | |
Entity Central Index Key | 0000879169 | |
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2019 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 214,438,549 | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q1 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 | [1] |
Current assets: | |||
Cash and cash equivalents | $ 1,299,704 | $ 1,163,980 | |
Marketable securities—available-for-sale | 281,320 | 274,343 | |
Accounts receivable | 244,081 | 307,598 | |
Inventory | 7,129 | 6,967 | |
Prepaid expenses and other current assets | 72,266 | 79,366 | |
Total current assets | 1,904,500 | 1,832,254 | |
Restricted cash and investments | 995 | 1,006 | |
Long term investments | 120,188 | 99,199 | |
Inventory | 3,876 | 3,438 | |
Property and equipment, net | 338,331 | 319,751 | |
Other intangible assets, net | 209,980 | 215,364 | |
Goodwill | 155,593 | 155,593 | |
Other assets, net | 20,698 | 19,157 | |
Total assets | 2,754,161 | 2,645,762 | |
Current liabilities: | |||
Accounts payable | 70,363 | 103,827 | |
Accrued compensation | 48,522 | 60,176 | |
Interest payable | 89 | 29 | |
Accrued and other current liabilities | 211,302 | 229,401 | |
Acquisition-related contingent consideration | 34,239 | 31,844 | |
Total current liabilities | 364,515 | 425,277 | |
Convertible senior notes | 17,647 | 17,434 | |
Acquisition-related contingent consideration | 252,761 | 255,157 | |
Other liabilities | 33,671 | 21,927 | |
Total liabilities | 668,594 | 719,795 | |
Stockholders' equity: | |||
Preferred stock, $0.001 par value; 5,000,000 shares authorized; none issued or outstanding as of March 31, 2019 and December 31, 2018 | |||
Common stock, $0.001 par value; 400,000,000 shares authorized; 214,320,605 and 213,274,660 shares issued and outstanding as of March 31, 2019 and December 31, 2018, respectively | 214 | 213 | |
Additional paid-in capital | 3,869,952 | 3,813,678 | |
Accumulated other comprehensive loss | (9,247) | (10,165) | |
Accumulated deficit | (1,775,352) | (1,877,759) | |
Total stockholders' equity | 2,085,567 | 1,925,967 | |
Total liabilities and stockholders' equity | $ 2,754,161 | $ 2,645,762 | |
[1] | The condensed consolidated balance sheet at December 31, 2018 has been derived from the audited financial statements at that date. |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Mar. 31, 2019 | Dec. 31, 2018 |
CONDENSED CONSOLIDATED BALANCE SHEETS | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
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) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 400,000,000 | 400,000,000 |
Common stock, shares issued | 214,320,605 | 213,274,660 |
Common stock, shares outstanding | 214,320,605 | 213,274,660 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Revenues: | ||
Total revenues | $ 497,857 | $ 382,282 |
Costs and expenses: | ||
Cost of product revenues (including definite-lived intangible amortization) | 22,588 | 18,106 |
Research and development | 270,545 | 303,103 |
Selling, general and administrative | 123,983 | 121,498 |
Change in fair value of contingent consideration | 6,671 | 6,685 |
Total costs and expenses | 423,787 | 449,392 |
Income (loss) from operations | 74,070 | (67,110) |
Other income (expense), net | 9,373 | 4,462 |
Interest expense | (335) | (385) |
Unrealized gain on long term investments | 20,989 | 22,679 |
Income (loss) before provision for income taxes | 104,097 | (40,354) |
Provision for income taxes | 1,785 | 786 |
Net income (loss) | $ 102,312 | $ (41,140) |
Net income (loss) per share: | ||
Basic | $ 0.48 | $ (0.19) |
Diluted | $ 0.47 | $ (0.19) |
Shares used in computing net income (loss) per share: | ||
Basic | 214,065 | 211,681 |
Diluted | 217,061 | 211,681 |
Product revenues, net | ||
Revenues: | ||
Total revenues | $ 396,249 | $ 334,505 |
Product royalty revenues | ||
Revenues: | ||
Total revenues | 61,608 | 47,716 |
Other revenues | ||
Revenues: | ||
Total revenues | $ 61 | |
Milestone revenues | ||
Revenues: | ||
Total revenues | $ 40,000 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) | ||
Net income (loss) | $ 102,312 | $ (41,140) |
Other comprehensive income (loss) | ||
Foreign currency translation | 126 | 35 |
Unrealized gain (loss) on marketable securities, net of tax | 681 | (505) |
Defined benefit pension obligations, net of tax | 111 | 111 |
Other comprehensive income (loss) | 918 | (359) |
Comprehensive income (loss) | $ 103,230 | $ (41,499) |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY - USD ($) $ in Thousands | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit | Total | |
Increase (Decrease) in Stockholders' Equity | ||||||
Adoption of ASU | ASU 2016-01 | $ (2,753) | $ 2,753 | ||||
Balances at Dec. 31, 2017 | $ 211 | $ 3,627,433 | (7,010) | (1,990,005) | $ 1,630,629 | |
Increase (Decrease) in Stockholders' Equity | ||||||
Issuance of shares of Common Stock upon exercise of stock options and settlement of employee restricted stock units | 1 | 2,575 | 2,576 | |||
Issuance of shares of Common Stock for services rendered | 87 | 87 | ||||
Issuance of shares of Common Stock upon conversion of Convertible Senior Notes | 27 | 27 | ||||
Stock compensation | 36,224 | 36,224 | ||||
Other comprehensive income (loss) | (359) | (359) | ||||
Net income (loss) | (41,140) | (41,140) | ||||
Balances at Mar. 31, 2018 | 212 | 3,666,346 | (10,122) | (2,028,392) | 1,628,044 | |
Increase (Decrease) in Stockholders' Equity | ||||||
Adoption of ASU | ASU No. 2016-02 | 95 | 95 | ||||
Balances at Dec. 31, 2018 | 213 | 3,813,678 | (10,165) | (1,877,759) | 1,925,967 | [1] |
Increase (Decrease) in Stockholders' Equity | ||||||
Issuance of shares of Common Stock upon exercise of stock options and settlement of employee restricted stock units | 1 | 15,480 | 15,481 | |||
Issuance of shares of Common Stock for services rendered | 104 | 104 | ||||
Stock compensation | 40,690 | 40,690 | ||||
Other comprehensive income (loss) | 918 | 918 | ||||
Net income (loss) | 102,312 | 102,312 | ||||
Balances at Mar. 31, 2019 | $ 214 | $ 3,869,952 | $ (9,247) | $ (1,775,352) | $ 2,085,567 | |
[1] | The condensed consolidated balance sheet at December 31, 2018 has been derived from the audited financial statements at that date. |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (Parenthetical) - shares | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Issuance of shares of Common Stock upon exercise of stock options and restricted stock units | 1,044,745 | 623,709 |
Issuance of shares of Common Stock for services rendered | 1,200 | 1,032 |
Convertible Senior Notes 0.375 Percent Due 2018 | ||
Issuance of shares of Common Stock upon conversion of convertible senior notes | 539 |
CONDENSED CONSOLIDATED STATEM_5
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Cash flows from operating activities: | ||
Net income (loss) | $ 102,312 | $ (41,140) |
Adjustments to reconcile net income (loss) to net cash provided by operating activities: | ||
Depreciation and amortization | 13,891 | 13,424 |
Stock-based compensation | 40,592 | 36,224 |
Other, net | 104 | 87 |
Unrealized gain on long term investments | (20,989) | (22,679) |
Change in fair value of contingent consideration | 6,671 | 6,685 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 63,517 | 46,109 |
Prepaid expenses and other assets | 5,559 | (18,922) |
Inventory | (600) | 1,879 |
Accounts payable | (33,464) | 6,444 |
Accrued and other liabilities | (21,930) | (7,273) |
Net cash provided by operating activities | 155,663 | 20,838 |
Cash flows from investing activities: | ||
Purchase of long term investments | (8,937) | |
Capital expenditures | (18,267) | (12,590) |
Purchases of marketable securities | (34,574) | (38,033) |
Sale and maturities of marketable securities | 28,278 | 31,032 |
Net cash used in investing activities | (24,563) | (28,528) |
Cash flows from financing activities: | ||
Proceeds from issuance of common stock under stock plans | 15,481 | 2,595 |
Payment of finance lease liabilities | (195) | |
Payment of contingent consideration | (10,799) | |
Net cash provided by financing activities | 4,487 | 2,595 |
Effect of exchange rates on cash, cash equivalents, restricted cash and investments | 126 | 35 |
Net increase (decrease) in cash, cash equivalents, restricted cash and investments | 135,713 | (5,060) |
Cash, cash equivalents, restricted cash and investments at beginning of period | 1,164,986 | 900,434 |
Cash, cash equivalents, restricted cash and investments at end of period | 1,300,699 | 895,374 |
Supplemental Schedule of Cash Flow Information | ||
Income taxes paid | 448 | 52 |
Unpaid purchases of property and equipment | 8,414 | |
Leased assets obtained in exchange for new operating lease liabilities | 932 | |
Leased assets obtained in exchange for new finance lease liabilities | $ 645 | |
Convertible Senior Notes 0.375 Percent Due 2018 | ||
Supplemental Schedule of Cash Flow Information | ||
Reclassification to common stock and additional paid in capital in connection with conversions of 0.375% convertible senior notes due 2018 | $ 27 |
CONDENSED CONSOLIDATED STATEM_6
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Parenthetical) | Mar. 31, 2018 |
Convertible Senior Notes 0.375 Percent Due 2018 | |
Interest rate of debt (as a percent) | 0.375% |
Organization and business
Organization and business | 3 Months Ended |
Mar. 31, 2019 | |
Organization and business | |
Organization and business | 1. Organization and business Incyte Corporation (including its subsidiaries, “Incyte,” “we,” “us,” or “our”) is a biopharmaceutical company focused on developing and commercializing proprietary therapeutics. Our portfolio includes compounds in various stages, ranging from preclinical to late stage development, and commercialized products JAKAFI® (ruxolitinib) and ICLUSIG® (ponatinib). Our operations are treated as one operating segment. |
Summary of significant accounti
Summary of significant accounting policies | 3 Months Ended |
Mar. 31, 2019 | |
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, 2019, the condensed consolidated statements of operations, comprehensive income (loss), stockholders’ equity, and cash flows for the three months ended March 31, 2019 and 2018, 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, 2018 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, 2018. Principles of Consolidation. The condensed consolidated financial statements include the accounts of Incyte Corporation and our wholly owned subsidiaries. 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. 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 U.S. dollars are reflected as a component of other comprehensive income (loss). Transaction gains and losses are recorded in other income (expense), net, in the condensed consolidated statements of operations. 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, and trade receivables 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 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 and money market funds that meet certain guidelines. Our receivables mainly relate to our product sales of JAKAFI, ICLUSIG and collaborative agreements with pharmaceutical companies. We have not experienced any significant credit losses on cash, cash equivalents, marketable securities, or trade receivables to date and do not require collateral on receivables. Cash and Cash Equivalents. Cash and cash equivalents are held in 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. Our marketable securities consist of investments in corporate debt securities and U.S. government securities that 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’ equity. 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 other income (expense), net on the condensed consolidated statements of operations. The cost of securities sold is based on the specific identification method. Accounts Receivable. As of March 31, 2019 and December 31, 2018, we had a de minimis 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 and net realizable value with cost determined under the specific identification method and may consist of raw materials, work in process and finished goods. JAKAFI raw materials and work-in-process inventory is not subject to expiration and the shelf life of finished goods inventory is 36 months from the start of manufacturing of the finished goods. ICLUSIG raw materials and work-in-process inventory is not subject to expiration and finished goods inventory has a shelf life of 24 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 ongoing evaluation of the entities with which we have variable interests, such as equity ownership, in order to identify entities (i) that 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, 2019, there were no entities in which we held a variable interest which we determined to be VIEs. Long Term Investments. Our long term investments consist of equity investments in common stock of publicly-held companies with whom we have entered into collaboration and license agreements. We classify all of our equity investments in common stock of publicly-held companies as long term investments on the condensed consolidated balance sheets. Our equity investments are accounted for at fair value using readily determinable pricing available on a securities exchange on the condensed consolidated balance sheets. All changes in fair value are reported in the condensed consolidated statements of operations as an unrealized gain (loss) on long term investments. In assessing whether we exercise significant influence over any of the companies in which we hold equity investments, 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. Currently, none of our equity investments in publicly-held companies are considered relationships in which we are able to assert control. Property and Equipment, net. Property and equipment, net 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. Leasehold improvements are amortized over the shorter of the estimated useful life of the assets or lease term. Lease Accounting. The new accounting standard for leases, Accounting Standard Codification (“ASC”) 842, Leases, was adopted for the fiscal year beginning on January 1, 2019. Per the new standard, all leases with a lease term greater than 12 months, regardless of lease type classification, are recorded as an obligation on the balance sheet with a corresponding right-of-use asset. Under the prior leasing standard, only contracts assessed as capital leases were recorded on the balance sheet. Both finance and operating leases are reflected as liabilities on the commencement date of the lease based on the present value of the lease payments to be made over the lease term. The current lease liabilities are reflected in accrued and other current liabilities and the noncurrent lease liabilities are reflected in other liabilities on the condensed consolidated balance sheet. Right-of-use assets are valued at the initial measurement of the lease liability, plus any initial direct costs or rent prepayments and reduced by any lease incentives and any deferred lease payments. These assets are recorded in property and equipment, net on the condensed consolidated balance sheet and are amortized over the lease term. For operating leases, the expense recognition is similar to that of operating leases under ASC 840, with a single lease cost recognized on a straight-line basis. For finance leases, the expense recognition is similar to that of capital leases under ASC 840, with separate amortization and interest expense, with higher interest expense in the earlier periods of a lease. Leases with an initial term of 12 months or less are not recorded on the balance sheet and we recognize lease expense for these leases on a straight-line basis over the term of the lease. In determining whether a contract contains a lease, asset and service agreements are assessed at onset and upon modification for criteria of specifically identified assets, control and economic benefit. Other Intangible Assets, net. Other intangible assets, net consist of licensed intellectual property rights acquired in business combinations, which are reported at acquisition date fair value, less accumulated amortization. Intangible assets with finite lives are amortized over their estimated useful lives using the straight-line method. Impairment of Long-Lived Assets. Long-lived assets with finite lives are tested for impairment whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. If indicators of impairment are present, the asset is tested for recoverability by comparing the carrying value of the asset to the related estimated undiscounted future cash flows expected to be derived from the asset. If the expected cash flows are less than the carrying value of the asset, then the asset is considered to be impaired and its carrying value is written down to fair value, based on the related estimated discounted future cash flows. Goodwill. Goodwill is calculated as the difference between the acquisition date fair value of the consideration transferred and the values assigned to the assets acquired and liabilities assumed. Goodwill is not amortized but is tested for impairment at the reporting unit level at least annually as of October 1 or when a triggering event occurs that could indicate a potential impairment by assessing qualitative factors or performing a quantitative analysis in determining whether it is more likely than not that the fair value of net assets are below their carrying amounts. A reporting unit is the same as, or one level below, an operating segment. Our operations are currently comprised of a single, entity wide reporting unit. We completed our most recent annual impairment assessment as of October 1, 2018 and determined that the carrying value of our goodwill was not impaired. 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. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more-likely-than-not that some portion or all of the deferred tax assets will not be realized. We recognize the tax benefit from an uncertain tax position only if it is more-likely-than-not that the position will be sustained upon examination by the taxing authorities, including resolutions of any related appeals or litigation processes, based on the technical merits of the position. The tax benefit that is recorded for these positions is measured at the largest amount of benefit that is greater than 50 percent likely of being realized upon ultimate settlement. We adjust the level of the liability to reflect any subsequent changes in the relevant facts surrounding the uncertain positions. Any interest and penalties on uncertain tax positions are included within the tax provision. 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 presented as a direct deduction from the carrying amount of the long-term debt liability, consistent with debt discounts, 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 other income (expense), net over the useful life of the related capital assets. Such amounts are recorded in other liabilities on the condensed consolidated balance sheets. Net Income (Loss) Per Share. Our basic and diluted net income (loss) per share is calculated by dividing the net income (loss) by the weighted average number of shares of common stock outstanding during all periods presented. Options to purchase stock, restricted stock units, performance stock units 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 that are classified as available-for-sale, foreign currency translation gains or losses and defined benefit pension obligations. Revenue Recognition. The new accounting standard for the recognition of revenue, ASC 606, Revenue from Contracts with Customers , was adopted for the fiscal year beginning on January 1, 2018. Per the new standard, revenue-generating contracts are assessed to identify distinct performance obligations, allocating transaction prices to those performance obligations, and criteria for satisfaction of a performance obligation. The new standard allows for recognition of revenue only when we have satisfied a performance obligation through transferring control of the promised good or service to a customer. Control, in this instance, may mean the ability to prevent other entities from directing the use of, and receiving benefit from, a good or service. The standard indicates that an entity must determine at contract inception whether it will transfer control of a promised good or service over time or satisfy the performance obligation at a point in time through analysis of the following criteria: (i) the entity has a present right to payment, (ii) the customer has legal title, (iii) the customer has physical possession, (iv) the customer has the significant risks and rewards of ownership and (v) the customer has accepted the asset. We assess collectability based primarily on the customer’s payment history and on the creditworthiness of the customer. Overall, the adoption of the new standard did not significantly alter our methodology for recognition of revenue. Product Revenues Our product revenues consist of U.S. sales of JAKAFI and European sales of ICLUSIG. Product revenues are recognized once we satisfy the performance obligation at a point in time under the revenue recognition criteria as described above. In November 2011, we began shipping JAKAFI to our customers in the U.S., which include specialty pharmacies and wholesalers. In June 2016, we acquired the right to and began shipping ICLUSIG to our customers in the European Union and certain other jurisdictions, which include retail pharmacies, hospital pharmacies and distributors. We recognize revenues for product received by our customers net of allowances for customer credits, including estimated rebates, chargebacks, discounts, returns, distribution service fees, patient assistance programs, and government rebates, such as Medicare Part D coverage gap reimbursements in the U.S. At March 31, 2019 and December 31, 2018, $69.4 million and $44.8 million, respectively, of accrued sales allowances were included in accrued and other current liabilities on the condensed consolidated balance sheets. Product shipping and handling costs are included in cost of product revenues. Customer Credits: Our customers are offered various forms of consideration, including allowances, service fees and prompt payment discounts. We expect our 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 and Discounts: Allowances for rebates include mandated discounts under the Medicaid Drug Rebate Program in the U.S. and mandated discounts in Europe in markets where government-sponsored healthcare systems are the primary payers for healthcare. 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 launches. Our estimates for expected utilization of rebates are based on data received from our 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 certain contracted customers, which currently consist primarily of group purchasing organizations, Public Health Service institutions, non-profit clinics, and Federal government entities purchasing via the Federal Supply Schedule, purchase directly from our wholesalers. Contracted customers generally purchase the product at a discounted price. The wholesalers, in turn, charges back to us the difference between the price initially paid by the wholesalers and the discounted price paid by the contracted customers. In addition to actual chargebacks received we maintain an accrual for chargebacks based on the estimated contractual discounts on the inventory levels on hand in our distribution channel. If actual future chargebacks vary from these 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 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. Royalty revenues on commercial sales for baricitinib (marketed as OLUMIANT) by Eli Lilly and Company (“Lilly”) are based on net sales of licensed products in licensed territories as provided by Lilly. We recognize royalty revenues in the period the sales occur. Cost of Product Revenues Cost of product revenues includes all JAKAFI related product costs as well as ICLUSIG related product costs. The acquired ICLUSIG inventories were recorded at fair value less costs to sell in connection with our June 2016 acquisition of ARIAD Pharmaceuticals (Luxembourg) S.à.r.l., since renamed Incyte Biosciences Luxembourg S.à.r.l. (the “Acquisition”). In addition, cost of product revenues include low single-digit royalties under our collaboration and license agreement to Novartis on all future sales of JAKAFI in the United States. Subsequent to the Acquisition on June 1, 2016, cost of product revenues also includes the amortization of our licensed intellectual property for ICLUSIG using the straight-line method over the estimated useful life of 12.5 years. Milestone and Contract Revenues Our license agreements, which fall within the scope of ASC 606, Revenue from Contracts with Customers, include distinct drug compound out-licensing, collection of upfront payments, milestones or royalty revenues from a counterparty, and provision of commercially available products to suppliers. Our agreements often include contractual milestones, which typically relate to the achievement of pre-specified development, regulatory and commercialization events outside of our control, such as regulatory approval of a compound, first patient dosing or achievement of sales-based thresholds. For such cases, we believe that revenue related to these events should not be recognized until the milestone has been achieved. Some contracts form collaborative arrangements of various types with third-parties. We assess whether the nature of the arrangement is within the scope of ASC 808, Collaborative Arrangements , in conjunction with the new revenue guidance to determine the nature of the performance obligations and associated transaction prices. A collaborative relationship may exist when we participate in an activity or process with another party, such as performance of research and development services or the exchange of intellectual property for use in clinical trials, when both parties share in the risks and rewards that result from the activity or participate and govern contract activities through a joint steering committee. 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 U.S. Food and Drug Administration (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 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 that are subject to cliff vesting are recognized as compensation expense over the requisite service period using the straight-line attribution method, and the fair value of RSUs that are subject to graded vesting are recognized as compensation expense over the requisite service period using the accelerated 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, which we assess as of the end of each reporting period. Once a pe |
Revenues
Revenues | 3 Months Ended |
Mar. 31, 2019 | |
Revenues | |
Revenues | 3. Revenues As discussed in Note 2, ASC 606, Revenue from Contracts with Customers , was adopted for the fiscal year beginning on January 1, 2018. Per the new standard, revenue-generating contracts are assessed to identify distinct performance obligations, allocating transaction prices to those performance obligations, and criteria for satisfaction of a performance obligation. The new standard allows for recognition of revenue only when we have satisfied a performance obligation through transferring control of the promised good or service to a customer. The standard indicates that an entity must determine at contract inception whether it will transfer control of a promised good or service over time or satisfy the performance obligation at a point in time through analysis of the following criteria: (i) the entity has a present right to payment, (ii) the customer has legal title, (iii) the customer has physical possession, (iv) the customer has the significant risks and rewards of ownership and (v) the customer has accepted the asset. The new standard was applied to contracts for which performance had not been completed as of the date of adoption. For those contracts that were modified prior to the date of adoption, we reflected the aggregate effect of those modifications when determining the appropriate accounting under the new standard. The effect of applying this practical expedient did not result in material differences. Overall, the adoption of the new standard did not significantly alter our methodology for recognition of revenue. The following table presents our disaggregated revenue for the periods presented (in thousands). Three Months Ended March 31, 2019 2018 JAKAFI revenues, net $ 375,611 $ 313,720 ICLUSIG revenues, net 20,638 20,785 Total product revenues, net 396,249 334,505 JAKAVI product royalty revenues 45,571 41,337 OLUMIANT product royalty revenues 16,037 6,379 Total product royalty revenues 61,608 47,716 Milestone and contract revenues 40,000 — Other revenues — 61 Total revenues $ 497,857 $ 382,282 For further information on our revenue-generating contracts, refer to our license agreements footnote. |
Fair value of financial instrum
Fair value of financial instruments | 3 Months Ended |
Mar. 31, 2019 | |
Fair value of financial instruments. | |
Fair value of financial instruments | 4. 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. Recurring Fair Value Measurements Our marketable securities consist of investments in corporate debt securities and U.S. government securities that are classified as available-for-sale. At March 31, 2019 and December 31, 2018, our Level 2 corporate debt and U.S. government securities were valued using readily available pricing sources which utilize market observable inputs, including the current interest rate and other characteristics for similar types of investments. Our long term investments classified as Level 1 were valued using their respective closing stock prices on The Nasdaq Stock Market. Our policy is to recognize transfers into and transfers out of fair value hierarchy levels as of the end of the reporting period. There were no transfers out of or in to hierarchy levels during the three months ended March 31, 2019. The following fair value hierarchy table presents information about each major category of our financial assets measured at fair value on a recurring basis (in thousands): Fair Value Measurement at Reporting Date Using: Quoted Prices in Significant Other Significant Active Markets for Observable Unobservable Identical Assets Inputs Inputs Balance as of (Level 1) (Level 2) (Level 3) March 31, 2019 Cash and cash equivalents $ 1,299,704 $ — $ — $ 1,299,704 Debt securities (corporate and government) — 281,320 — 281,320 Long term investments (Note 9) 120,188 — — 120,188 Total assets $ 1,419,892 $ 281,320 $ — $ 1,701,212 Fair Value Measurement at Reporting Date Using: Quoted Prices in Significant Other Significant Active Markets for Observable Unobservable Identical Assets Inputs Inputs Balance as of (Level 1) (Level 2) (Level 3) December 31, 2018 Cash and cash equivalents $ 1,163,980 $ — $ — $ 1,163,980 Debt securities (corporate and government) — 274,343 — 274,343 Long term investment (Note 9) 99,199 — — 99,199 Total assets $ 1,263,179 $ 274,343 $ — $ 1,537,522 The following fair value hierarchy table presents information about each major category of our financial liabilities measured at fair value on a recurring basis as (in thousands): Fair Value Measurement at Reporting Date Using: Quoted Prices in Significant Other Significant Active Markets for Observable Unobservable Identical Assets Inputs Inputs Balance as of (Level 1) (Level 2) (Level 3) March 31, 2019 Acquisition-related contingent consideration $ — $ — $ 287,000 $ 287,000 Total liabilities $ — $ — $ 287,000 $ 287,000 Fair Value Measurement at Reporting Date Using: Quoted Prices in Significant Other Significant Active Markets for Observable Unobservable Identical Assets Inputs Inputs Balance as of (Level 1) (Level 2) (Level 3) December 31, 2018 Acquisition-related contingent consideration $ — $ — $ 287,001 $ 287,001 Total liabilities $ — $ — $ 287,001 $ 287,001 The following is a rollforward of our Level 3 liabilities (in thousands): Balance at January 1, 2019 $ 287,001 Contingent consideration earned during the period but not yet paid (6,672) Change in fair value of contingent consideration 6,671 Balance at March 31, 2019 $ 287,000 The fair value of the contingent consideration was determined using an income approach based on projected ICLUSIG revenues in the European Union and other countries for the approved third line treatment and discount rates. The fair value of the contingent consideration is remeasured each reporting period, with changes in fair value recorded in the condensed consolidated statements of operations. The change in fair value of the contingent consideration during the three months ended March 31, 2019 was due primarily to the passage of time as there were no other significant changes in the key assumptions during the period. We make payments to Takeda quarterly based on the royalties or any additional milestone payments earned in the previous quarter. At March 31, 2019 and December 31, 2018, contingent consideration earned but not yet paid was $6.7 million and $13.2 million, respectively. Royalties earned in the first quarter of 2019 of $6.7 million were included in accrued and other current liabilities at March 31, 2019. Royalties earned in the third quarter of 2018 of $6.7 million were included in accounts payable and the royalties earned in the fourth quarter of 2018 of $6.5 million were included in accrued and other current liabilities at December 31, 2018. The following is a summary of our marketable security portfolio (in thousands): Net Amortized Unrealized Estimated Cost Losses Fair Value March 31, 2019 Debt securities (corporate and government) $ 281,701 $ (381) $ 281,320 December 31, 2018 Debt securities (corporate and government) $ 275,405 $ (1,062) $ 274,343 Our debt securities generally have contractual maturity dates of between 12 to 18 months. |
Concentration of credit risk
Concentration of credit risk | 3 Months Ended |
Mar. 31, 2019 | |
Concentration of credit risk | |
Concentration of credit risk | 5. Concentration of credit risk In December 2009, we entered into a license, development and commercialization agreement with Lilly. In November 2009, we entered into a collaboration and license agreement with Novartis. In December 2018, we entered into a research collaboration and licensing agreement with Innovent Biologics, Inc. (“Innovent”). The concentration of credit risk related to our collaborative partners is as follows: Percentage of Total Milestone and Contract Revenues for the Three Months Ended March 31, 2019 2018 Collaboration Partner A — % — % Collaboration Partner B — % — % Collaboration Partner C 100 % — % Collaboration Partners A, B and C comprised, in aggregate, 26% and 42% of the accounts receivable balance as of March 31, 2019 and December 31, 2018, respectively. In November 2011, we began commercialization and distribution of JAKAFI to a number of customers. Our product revenues are concentrated in a number of these customers. The concentration of credit risk related to our JAKAFI product revenues is as follows: Percentage of Total Net Product Revenues for the Three Months Ended March 31, 2019 2018 Customer A 18 % 22 % Customer B 15 % 13 % Customer C 16 % 14 % Customer D 12 % 11 % We are exposed to risks associated with extending credit to customers related to the sale of products. Customers A, B, C and D comprised, in aggregate, 37% and 30% of the accounts receivable balance as of March 31, 2019 and December 31, 2018, respectively. The concentration of credit risk relating to ICLUSIG product revenues or accounts receivable is not significant. |
Inventory
Inventory | 3 Months Ended |
Mar. 31, 2019 | |
Inventory | |
Inventory | 6. Inventory Our inventory balance consists of the following (in thousands): March 31, December 31, 2019 2018 Raw materials $ 1,822 $ 481 Work-in-process 4,097 3,488 Finished goods 5,086 6,436 11,005 10,405 Inventories-current 7,129 6,967 Inventories-noncurrent $ 3,876 $ 3,438 Inventories, stated at the lower of cost and net realizable value, consist of raw materials, work in process and finished goods. At March 31, 2019, $7.1 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, 2019, $3.9 million of inventory was classified as noncurrent on the condensed consolidated balance sheets as we did not expect this inventory to be consumed for commercial use within the next twelve months. We obtain some inventory components from a limited number of suppliers due to technology, availability, price, quality or other considerations. The loss of a supplier, the deterioration of our relationship with a supplier, or any unilateral violation of the contractual terms under which we are supplied components by a supplier could adversely affect our total revenues and gross margins. |
Property and equipment, net
Property and equipment, net | 3 Months Ended |
Mar. 31, 2019 | |
Property and equipment, net | |
Property and equipment, net | 7. Property and equipment, net Property and equipment, net consists of the following (in thousands): March 31, December 31, 2019 2018 Office equipment $ 15,199 $ 16,955 Laboratory equipment 63,339 61,697 Computer equipment 58,389 55,436 Land 10,068 10,122 Building and leasehold improvements 213,529 213,196 Operating lease right-of-use assets 24,334 — Finance lease right-of-use assets 2,332 — Construction in progress 64,598 65,576 451,788 422,982 Less accumulated depreciation and amortization (113,457) (103,231) Property and equipment, net $ 338,331 $ 319,751 In February 2018, we signed an agreement to rent a building in Morges, Switzerland for an initial term of 15 years, with multiple options to extend for an additional 20 years. The building will undergo extensive renovations prior to our occupation and, when completed, will serve as our new European headquarters. The new building will consist of approximately 100,000 square feet of office space. This building will allow for consolidation of our European operations that are currently located in Geneva and Lausanne, Switzerland. Building permits were granted by the local government authorities in September 2018, and construction activity began immediately thereafter. We are responsible for a portion of the renovation and construction costs, and anticipate taking possession of the building and construction activities beginning in July 2019. As of March 31, 2019, we have recorded approximately $2.0 million in on site preparation, design and construction costs. In July 2018, we signed an agreement to purchase land located within Y-PARC, Switzerland’s largest technology park in Yverdon. The land was purchased, in cash, for $4.8 million. Upon this parcel, we plan on constructing a large molecule production facility. Construction activity commenced in July 2018 and as of March 31, 2019, we have recorded approximately $55.8 million in costs for construction, ground preparation and architectural and engineering studies. We currently anticipate the facility to be completed in the second half of 2020. As stated in Note 2, in January 2019, we adopted ASC 842, Leases, which changed the accounting and reporting of our lease activity. Although we do not have significant lease activity, we are the lessee of several contracts, including those to secure fleet vehicles, buildings and IT equipment. Our lease agreements do not contain any material residual value guarantees or restrictive covenants. Some of our building leases include options to renew for additional periods of up to five years and the exercise of these options is at our discretion. Our current lease liabilities are reflected in accrued and other current liabilities and our noncurrent lease liabilities are reflected in other liabilities on the condensed consolidated balance sheets. As of March 31, 2019 our lease liabilities are as follows (in thousands): Current Operating lease liabilities $ 10,245 Finance lease liabilities 815 Noncurrent Operating lease liabilities 12,629 Finance lease liabilities 723 Total lease liabilities $ 24,412 The cash paid for amounts included in the measurement of our operating lease liabilities as of March 31, 2019 was $2.8 million in operating cash flows. The cash paid for amounts included in the measurement of our finance lease liabilities as of March 31, 2019 was $0.2 million in financing cash flows. The maturity of our lease liabilities are as follows (in thousands): Operating Finance Remainder of 2019 $ 8,793 $ 886 2020 6,339 556 2021 4,242 195 2022 2,265 — 2023 1,602 — After 2023 1,429 — Total lease cash payments $ 24,670 $ 1,637 Less: discount 1,796 99 Present value of lease liabilities $ 22,874 $ 1,538 As of March 31, 2019, our finance and operating leases had a weighted average lease term of approximately 2.0 and 4.4 years, respectively. The discount rate of our leases is an approximation of an estimated incremental borrowing rate and is dependent upon the term and economics of each agreement. The weighted average discount rate of our operating leases and finance leases is approximately 4.7% and 6.6%, respectively. For the three months ended March 31, 2019, we incurred approximately $3.6 million of expense related to our operating leases, approximately $0.2 million of amortization on our finance lease right-of-use assets and a de minimis amount of interest expense on our finance lease liabilities. Rent expense for the three months ended March 31, 2018 was $3.3 million. For the three months ended March 31, 2019, the cost of our short term leases with a term less than 12 months was de minimis. |
Intangible assets and goodwill
Intangible assets and goodwill | 3 Months Ended |
Mar. 31, 2019 | |
Intangible assets and goodwill | |
Intangible assets and goodwill | 8. Intangible assets and goodwill Intangible Assets, Net The components of intangible assets were as follows (in thousands, except for useful life): Balance at March 31, 2019 Balance at December 31, 2018 Weighted- Gross Net Gross Net Average Useful Carrying Accumulated Carrying Carrying Accumulated Carrying Lives (Years) Amount Amortization Amount Amount Amortization Amount Finite-lived intangible assets: Licensed IP 12.5 $ 271,000 $ 61,020 $ 209,980 $ 271,000 $ 55,636 $ 215,364 Estimated aggregate amortization expense based on the current carrying value of amortizable intangible assets is as follows (in thousands): Remainder of 2019 2020 2021 2022 2023 Thereafter Amortization expense $ 16,155 $ 21,536 $ 21,536 $ 21,536 $ 21,536 $ 107,681 Goodwill There were no changes to the carrying amount of goodwill for the three months ended March 31, 2019. |
License agreements
License agreements | 3 Months Ended |
Mar. 31, 2019 | |
License agreements | |
License agreements | 9. 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 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. In April 2016, we amended this agreement to provide that Novartis has exclusive research, development and commercialization rights outside of the United States to ruxolitinib (excluding topical formulations) in the graft-versus-host-disease (“GVHD”) field. We became eligible to receive up to $75.0 million of additional potential development and regulatory milestones relating to GVHD. Exclusive of the upfront payment of $150.0 million received in 2009 and the immediate milestone of $60.0 million earned in 2010, we have recognized and received in the aggregate $132.0 million for the achievement of development milestones, $215.0 million for the achievement of regulatory milestones and $120.0 million for the achievement of sales milestones through March 31, 2019. In 2018, under this agreement, we recognized a $60.0 million sales milestone for Novartis achieving annual net sales of a JAK licensed product of $900.0 million. In 2017, we recognized a $40.0 million sales milestone for Novartis achieving annual net sales of a JAK licensed product of $600.0 million and a $25.0 million development milestone based on the formal initiation by Novartis of a Phase III clinical trial evaluating ruxolitinib in GVHD. In 2016, we recognized a $5.0 million payment in exchange for the development and commercialization rights to ruxolitinib in GVHD outside of the United States and a $40.0 million regulatory milestone for the reimbursement of JAKAVI in Europe for the treatment of patients with polycythemia vera. In 2015, we recognized a $5.0 million development milestone based on the formal initiation by Novartis of a Phase II clinical trial evaluating capmatinib for a third indication, 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, a $15.0 million regulatory milestone for the approval of JAKAVI in Japan for the treatment of patients with polycythemia vera, and a $20.0 million sales milestone for Novartis achieving annual net sales of a JAK licensed product of $300.0 million. In 2014, we recognized a $60.0 million regulatory milestone related to reimbursement of JAKAVI in Europe, 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 a $25.0 million development milestone based on the formal initiation by Novartis of a Phase II clinical trial evaluating capmatinib. In 2012, we recognized a $40.0 million regulatory milestone for the achievement of a predefined milestone for the European Union regulatory approval of JAKAVI. In 2011, we recognized a $15.0 million development milestone 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 for the approval of JAKAFI in the United States. In 2010, we recognized $50.0 million in development milestones for the initiation of the global Phase III trial, RESPONSE, in patients with polycythemia vera. We determined that each of these milestones were 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, and tiered, worldwide royalties on future capmatinib net sales that range from 12% to 14%. Since the achievement of the $60.0 million regulatory milestone related to reimbursement of JAKAVI in Europe in September 2014, 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, 2019 and 2018, such royalties payable to Novartis on net sales within the United States totaled $13.4 million and $10.4 million, respectively, and are reflected in cost of product revenues on the condensed consolidated statements of operations. At March 31, 2019 and December 31, 2018, $13.4 million and $18.6 million, respectively, of accrued royalties payable to Novartis were included in accrued and other current liabilities on the condensed consolidated balance sheets. 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 also 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 (i) the expiration of the last valid claim of the licensed patent rights covering the licensed product in the relevant country, (ii) the expiration of regulatory exclusivity for the licensed product in such country and (iii) 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. We determined that there were two deliverables under the agreement: (i) the ex-U.S. license for ruxolitinib and (ii) our obligations in connection with our participation on the joint development committee for myelofibrosis and polycythemia vera/essential thrombocythemia. We concluded that these deliverables should be accounted for as a single unit of accounting and the $150.0 million upfront payment received in December 2009 and the immediate $60.0 million milestone payment received in January 2010 should be recognized on a straight-line basis through December 2013, when we estimated we would complete our obligations in connection with our participation on the joint development committee for myelofibrosis and polycythemia vera, our estimated performance period under the agreement. We completed this substantive performance obligation related to this arrangement in December 2013. 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 are recorded net against the related research and development expenses. At March 31, 2019 and December 31, 2018, $0.5 million and $0.7 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, 2019 and 2018 were net of $0.6 million and $0.5 million, respectively, of costs reimbursed by Novartis. Milestone and contract revenue under the Novartis agreement for the three months ended March 31, 2019 and 2018 was $0.0 million. Product royalty revenue related to Novartis net sales of JAKAVI outside of the United States for the three months ended March 31, 2019 and 2018 was $45.6 million and $41.3 million, respectively. At March 31, 2019 and December 31, 2018, $45.6 million and $55.4 million, respectively, of product royalties were included in accounts receivable on the condensed consolidated balance sheets. Lilly - Baricitinib 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. Exclusive of the upfront payment of $90.0 million received in 2009, we have recognized and received, in aggregate, $149.0 million for the achievement of development milestones and $235.0 million for the achievement of regulatory milestones through March 31, 2019. In January 2016, Lilly submitted an NDA to the FDA and a Marketing Authorization Application (MAA) to the European Medicines Agency for baricitinib as treatment for rheumatoid arthritis. In February 2017, we and Lilly announced that the European Commission approved baricitinib as OLUMIANT for the treatment of moderate-to-severe rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to, one or more disease-modifying antirheumatic drugs. In July 2017, Japan's Ministry of Health, Labor and Welfare granted marketing approval for OLUMIANT for the treatment of rheumatoid arthritis in patients with inadequate response to standard-of-care therapies. In June 2018, the FDA approved the 2mg dose of OLUMIANT for the treatment of adults with moderately-to-severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor inhibitor therapies. In 2018, under this agreement, we recognized a $20.0 million development milestone for the first patient treated in the systemic lupus erythematosus Phase III program for baricitinib and a $100.0 million regulatory milestone for the FDA approval of the 2mg dose of OLUMIANT (baricitinib) for the treatment of adults with moderately-to-severely active rheumatoid arthritis. In 2017, we recognized a $30.0 million development milestone for the first patient treated in the atopic dermatitis Phase III program for baricitinib, $15.0 million regulatory milestone for the approval of baricitinib for the treatment of rheumatoid arthritis by Japan’s Ministry of Health, Labor and Welfare and a $65.0 million regulatory milestone for the approval of baricitinib for the treatment of moderate-to-severe rheumatoid arthritis in adult patients by the European Commission. In 2016, we recognized a $35.0 million regulatory milestone for the submission of an NDA to the FDA for the approval of oral once-daily baricitinib for the treatment of moderate-to-severe rheumatoid arthritis and a $20.0 million regulatory milestone for the submission of a Marketing Authorization Application to the European Medicines Agency for the approval of oral once-daily baricitinib for the treatment of moderate-to-severe rheumatoid arthritis. In 2012, we recognized a $50.0 million development milestone for the initiation of the rheumatoid arthritis Phase III program for baricitinib. In 2010, we recognized a $30.0 million development milestone 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 for the Phase IIb clinical trial initiation of baricitinib for the treatment of rheumatoid arthritis. We determined that each of these milestones were substantive as their achievement required substantive efforts by us and was at risk until the milestones were ultimately achieved. We retained options to co-develop our JAK1/JAK2 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, including post-launch studies required by a regulatory authority. 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. For indications that we elect not to co-develop, we would receive tiered, double-digit royalty payments on future global net sales with rates ranging up to 20% if the product is successfully commercialized. 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. We previously had retained an option to co-promote products in the United States but, in March 2016, we waived our co-promotion option as part of an amendment to the agreement. In July 2010, we elected to co-develop baricitinib with Lilly in rheumatoid arthritis and became 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, including post-launch studies required by a regulatory authority. We subsequently elected to co-develop baricitinib with Lilly in psoriatic arthritis, atopic dermatitis, alopecia areata, systemic lupus erythematosus and axial spondyloarthritis and were responsible for funding 30% of future global development costs for those indications through regulatory approval, including post-launch studies required by a regulatory authority. In April 2019, we elected to end additional co-funding of the development of baricitinib effective as of January 1, 2019. We will continue to receive royalties on global net sales of OLUMIANT, pursuant to the terms in the Lilly agreement, as described above. Research and development expenses recorded under the Lilly agreement representing 30% of the global development costs for baricitinib for the treatment of rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, alopecia areata, systemic lupus erythematosus and axial spondyloarthritis for the three months ended March 31, 2019 and 2018 were $0.0 million and $12.5 million, respectively. At March 31, 2019 and December 31, 2018, a total of $0.0 million and $23.1 million, respectively, of such costs were included in accrued and other liabilities on the condensed consolidated balance sheets. 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 (i) the expiration of the last valid claim of the licensed patent rights covering the licensed product in the relevant country, (ii) the expiration of regulatory exclusivity for the licensed product in such country and (iii) 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. We completed our substantive performance obligation related to this arrangement in December 2016. Milestone and contract revenue under the Lilly agreement for the three months ended March 31, 2019 and 2018 was $0.0 million. Product royalty revenue related to Lilly global net sales of OLUMIANT for the three months ended March 31, 2019 and 2018 was $16.0 million and $6.4 million, respectively. At March 31, 2019 and December 31, 2018, $16.2 million and $14.0 million, respectively, of product royalties were included in accounts receivable on the condensed consolidated balance sheets. Lilly - Ruxolitinib In March 2016, we entered into an amendment to the agreement with Lilly that amended the non-compete provision of the agreement to allow us to engage in the development and commercialization of ruxolitinib in the GVHD field. We paid Lilly an upfront payment of $35.0 million and Lilly is eligible to receive up to $40.0 million in additional regulatory milestone payments relating to ruxolitinib in the GVHD field. Agenus In January 2015, we entered into a License, Development and Commercialization Agreement with Agenus Inc. and its wholly-owned subsidiary, 4-Antibody AG, (now known as Agenus Switzerland Inc.), 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’ antibody discovery platforms. 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. Upon closing of the agreement, we paid Agenus total consideration of $60.0 million. In February 2017, we and Agenus amended this agreement (the “Amended Agreement”). Under the terms of the Amended 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, and in November 2015, three more targets were added. 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 are responsible for all costs associated with discovery, preclinical, clinical development and commercialization activities. The programs relating to GITR and OX40 and two of the undisclosed targets were profit-share programs until February 2017, while the other targets currently under collaboration are royalty-bearing programs. The Amended Agreement converted the programs relating to GITR and OX40 to royalty-bearing programs and removed from the collaboration the profit-share programs relating to the two undisclosed targets, with one reverting to us and one reverting to Agenus. Should any of those removed programs be successfully developed by a party, the other party will be eligible to receive the same milestone payments as the royalty-bearing programs and royalties at a 15% rate on global net sales. There are currently no profit-share programs. For each royalty-bearing product other than GITR and OX40, Agenus will be eligible to receive tiered royalties on global net sales ranging from 6% to 12%. For GITR and OX40, Agenus will be eligible to receive 15% royalties on global net sales. Under the Amended Agreement, we paid Agenus $20.0 million in accelerated milestones relating to the clinical development of the GITR and OX40 programs, which was recorded in research and development expense. Agenus is eligible to receive up to an additional $510.0 million in future contingent development, regulatory and commercialization milestones across all programs in the collaboration. The agreement may be terminated by us for convenience upon 12 months’ notice and may also be terminated under certain other circumstances, including material breach. In June 2018, we recorded a $5.0 million development milestone due to Agenus for the LAG-3 program and in September 2018 we recorded a $5.0 million development milestone due to Agenus for the TIM-3 program. In connection with the Amended Agreement, we also agreed to purchase 10.0 million shares of Agenus Inc. common stock for an aggregate purchase price of $60.0 million in cash, or $6.00 per share. We completed the purchase of the shares on February 14, 2017, when the closing price on The Nasdaq Stock Market for Agenus Inc. shares was $4.40 per share. The shares we acquired were not registered under the Securities Act of 1933 on the purchase date and were subject to certain security specific restrictions for a period of time, and accordingly, we estimated a discount for lack of marketability on the shares on the issuance date of $4.5 million, which resulted in a net fair value of the shares on the issuance date of $39.5 million. Therefore, of the total consideration paid of $60.0 million, $39.5 million was allocated to our stock purchase in Agenus Inc. and was recorded within long term investments and $20.5 million was allocated to research and development expense. 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. From the date of our initial stock purchase in February 2015 and up to the date of our second stock purchase in February 2017, we owned between 9% and 11% of the outstanding shares of Agenus Inc. common stock. As a result of our February 2017 stock purchase, we owned approximately 13% of the outstanding shares of Agenus Inc. common stock as of March 31, 2019. We concluded that we have the ability to exercise significant influence, but not control, over Agenus Inc. based primarily on our ownership interest, the fact that we have been the largest Agenus stockholder since the date of our initial stock purchase, 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, 2019 and 2018, we recorded an unrealized gain of $10.5 million and $25.8 million, respectively, based on the change in fair value of Agenus Inc.’s common stock during these periods. The fair market value of our long term investment in Agenus Inc. at March 31, 2019 and December 31, 2018 was $52.6 million and $42.3 million, respectively. For the three months ended December 31, 2018, Agenus reported within its Form 10-K total revenues of approximately $6.5 million and net loss of approximately $48.8 million within their consolidated financial statements. Research and development expenses for the three months ended March 31, 2019 and 2018 also included $10.2 million and $1.9 million, respectively, of development costs incurred pursuant to the Agenus arrangement. At March 31, 2019 and December 31, 2018, a total of $4.7 million and $2.3 million, respectively, of such costs were included in accrued and other liabilities on the condensed consolidated balance sheets. Merus In December 2016, we entered into a Collaboration and License Agreement with Merus N.V. (“Merus”). Under this agreement, which became effective in January 2017, the parties have agreed to collaborate with respect to the research, discovery and development of bispecific antibodies utilizing Merus’ technology platform. The collaboration encompasses up to eleven independent programs. The most advanced collaboration program is MCLA-145, a bispecific antibody targeting PD-L1 and CD137, for which we received exclusive development and commercialization rights outside of the United States. Merus retained exclusive development and commercialization rights in the United States to MCLA-145. Each party will share equally the costs of mutually agreed global development activities for MCLA-145, and fund itself any independent development activities in its territory. Merus will be responsible for commercializing MCLA-145 in the United States and we will be responsible for commercializing it outside of the United States. In addition to receiving rights to MCLA-145 outside of the United States, we received worldwide exclusive development and commercialization rights to up to ten additional programs. Of these ten additional programs, Merus retained the option, subject to certain conditions, to co-fund development of up to two such programs. If Merus exercises its co-funding option for a program, Merus would be responsible for funding 35% of the associated future global development costs and, for certain of such programs, would be responsible for reimbursing us for certain development costs incurred prior to the option exercise. Merus will also have the right to participate in a specified proportion of detailing activities in the United States for one of those co-developed programs. All costs related to the co-funded collaboration programs are subject to joint research and development plans and overseen by a joint development committee, but we will have final determination as to such plans in cases of dispute. We will be responsible for all research, development and commercialization costs relating to all other programs. In February 2017, we paid Merus an upfront non-refundable payment of $120.0 million. For each program as to which Merus does not have commercialization or development co-funding rights, Merus will be eligible to receive up to $100.0 million in future contingent development and regulatory milestones, and up to $250.0 million in commercialization milestones as well as tiered royalties ranging from 6% to 10% of global net sales. For each program as to which Merus exercises its option to co-fund development, Merus will be eligible to receive a 50% share of profits (or sustain 50% of any losses) in the United States and be eligible to receive tiered royalties ranging from 6% to 10% of net sales of products outside of the United States. If Merus opts to cease co-funding a program as to which it exercised its co-development option, then Merus will no longer receive a share of profits in the United States but will be eligible to receive the same milestones from the co-funding termination date and the same tiered royalties described above with respect to programs where Merus does not have a right to co-fund development and, depending on the stage at which Merus chose to cease co-funding development costs, Merus will be eligible to receive additional royalties ranging up to 4% of net sales in the United States. For MCLA-145, we and Merus will each be eligible to receive tiered royalties on net sales in the other party’s territory at rates ranging from 6% to 10%. The Merus agreement will continue on a program-by-program basis until we have 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. The agreement may be terminated in its entirety or on a program-by-program basis by us for convenience. The agreement may also be terminated by either party under certain other circumstances, including material breach, as set forth in the agreement. If the agreement is terminated with respect to one or more programs, all rights in the terminated programs revert to Merus, subject to payment to us of a reverse royalty of up to 4% on sales of future products, if Merus elects to pursue development and commercialization of products arising from the terminated programs. In addition, in December 2016, we entered into a Share Subscription Agreement with Merus, pursuant to which we agreed to purchase 3.2 million common shares of Merus for an aggregate purchase price of $80.0 million in cash, or $25.00 per share. We agreed to certain standstill provisions whereby we are obligated to refrain from taking certain actions with respect to Merus or Merus’ common shares during a period ending on the earliest of (i) three years from the closing date of our share purchase, (ii) the date Merus publicly announces any merger or similar business combination or another party announces an intention to acquire a substantial portion of Merus’ securities, and (iii) the termination of the Collaboration and License Agreement. The standstill provisions are subject to certain exceptions, including an exception that allows us to maintain our percentage ownership following equity financings by Merus. We also agreed, subject to limited exceptions, not to sell or otherwise transfer any of our Merus shares for a period, referred to as the Lock-Up Period, ending on the earlier of 18 months after the closing date of the sale of the Shares or the end of the standstill period. In addition, if the standstill period has not been terminated earlier upon the occurrence of certain events, for a period of three years after the Lock-Up Period, we will be restricted from selling or otherwise transferring more than one-third of our Merus shares during any 12-month period or 10% of our Merus shares during any three-month period, unless Merus consents otherwise. We have further agreed that during the standstill period, we will vote all of our Merus shares in accordance with the recommendation of a majority of Merus’ supervisory board. However, we may vote our Merus shares at our own discretion for certain extraordinary matters, including a change in control of Merus. Merus has agreed to customary resale registration rights with respect to our Merus shares; however, any such resales will be subject to the Lock-Up Period and volume limitations on sale and transfer described above. We completed the purchase of the shares on January 23, 2017 when the closing price on The Nasdaq Stock Market for Merus shares was $24.50 per share. The shares we acquired were not registered under the Securities Act of 1933 on the purchase date and were subject to certain security specific restrictions for a period of time, and accordingly, we estimated a discount for lack of marketability on the shares on the issuance date of $5.6 million, which resulted in a net fair value of the shares on the issuance date of $72.8 million. Of the total consideration paid of $80.0 million, $72.8 million was allocated to our stock purchase in Merus and was recorded as a long term investment and $7.2 million was allocated to research and development expense. The fair market value of our total long term investment in Merus at March 31, 2019 and December 31, 2018 was $47.3 million and $44.8 million, respectively. We have concluded Merus is not a VIE because it has sufficient equity to finance its activ |
Stock compensation
Stock compensation | 3 Months Ended |
Mar. 31, 2019 | |
Stock compensation | |
Stock compensation | 10. Stock compensation We recorded $40.6 million and $36.2 million, respectively, of stock compensation expense on the condensed consolidated statements of operations for the three months ended March 31, 2019 and 2018. For the three months ended March 31, 2019, we capitalized $0.1 million of stock compensation expense as part of the cost of an asset. Stock compensation expense included within our condensed consolidated statements of operations included research and development expense of $27.4 million and $24.2 million, respectively, for the three months ended March 31, 2019 and 2018. Stock compensation expense included within our condensed consolidated statements of operations also included selling, general and administrative expense of $13.0 million and $12.0 million for the three months ended March 31, 2019 and 2018, respectively. Stock compensation expense included within our condensed consolidated statements of operations also included cost of product revenues of $0.2 million for the three months ended March 31, 2019. 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 Options Employee Stock Purchase Plan For the Three Months Ended March 31, 2019 2018 2019 2018 Average risk-free interest rates 2.51 % 2.42 % 2.27 % 2.26 % Average expected life (in years) 5.33 5.53 0.25 0.25 Volatility 45 % 45 % 34 % 36 % Weighted-average fair value (in dollars) 31.50 41.59 13.31 18.17 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. Nonemployee awards are measured on the grant date by estimating the fair value of the equity instruments to be issued using the expected term, similar to our employee awards. Option activity under the 2010 Stock Plan was as follows: Shares Subject to Outstanding Options Shares Available Weighted Average for Grant Shares Exercise Price Balance at December 31, 2018 6,477,577 12,285,159 $ 74.39 Options granted (2,271,592) 2,271,592 $ 72.81 Options exercised — (849,870) $ 25.38 Options cancelled 315,321 (315,321) $ 89.29 Balance at March 31, 2019 4,521,306 13,391,560 $ 76.88 In July 2016, we revised the terms of our annual stock option grants to provide that new option grants would generally have a 10-year term and vest over four years, with 25% vesting after one year and the remainder vesting in 36 equal monthly installments. Previously, our option grants generally had 7-year terms and vested over three years, with 33% vesting after one year and the remainder vesting in 24 equal monthly installments. RSU award and PSU 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, 2018 545,751 2,043,337 $ 80.35 RSUs granted (165,251) 165,251 $ 73.69 PSUs achieved (44,940) 44,940 $ 65.76 RSUs cancelled 55,591 (55,591) $ 89.46 PSUs cancelled 9,889 (9,889) $ 67.32 RSUs released — (213,604) $ 89.38 Balance at March 31, 2019 401,040 1,974,444 $ 78.29 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. Each RSU granted prior to July 2016 was subject to cliff vesting after three years. In July 2016, we revised the terms of our RSU grants to provide that the awards will vest 25% annually over four years. 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, 2019, a cumulative total of 333,334 RSUs granted to Mr. Hoppenot had vested and were released, leaving 66,666 RSUs outstanding. In June 2018, we granted 190,000 RSUs and 446,500 PSUs under long term incentive plans with performance and/or service-based milestones with graded and/or cliff vesting over three to four years. For one of the long term incentive plans, under which 106,500 PSUs were granted, the actual number of shares of our common stock into which each PSU may convert are subject to a multiplier of up to 267% based on the level at which the performance conditions are achieved. Compensation expense for the performance-based awards is recorded over the estimated service period for each milestone when the performance conditions are deemed probable of achievement. For the period ended March 31, 2019, the stock compensation expense recorded during the period was for service-based awards and performance conditions deemed probable of achievement and/or achieved. For PSUs containing performance conditions which were not deemed probable of achievement at March 31, 2019, no stock compensation expense was recognized. In July 2018, we granted 77,243 PSUs to executives with performance milestones and graded vesting over four years. The shares of our common stock into which each PSU may convert is subject to a multiplier up to 150% based on the level at which the performance condition is achieved. Compensation expense for the performance-based awards is recorded over the estimated service period when the performance condition is deemed probable of achievement. The actual number of shares of our common stock into which each PSU converted was at a multiplier of 83% based on the performance condition being achieved as of December 31, 2018. Based on our historical experience of employee turnover, we have assumed an annualized forfeiture rate of 5% for our options, RSUs and PSUs. 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, 2019, was $133.9 million, which is expected to be recognized over the weighted average period of approximately 1.7 years. Total compensation cost of RSUs granted but not yet vested, as of March 31, 2019, was $59.6 million, which is expected to be recognized over the weighted average period of approximately 1.6 years. Total compensation cost of PSUs granted but not yet vested, as of March 31, 2019, was $27.7 million, which is expected to be recognized over the weighted average period of 2.7 years, should the underlying performance conditions be deemed probable of achievement. |
Accrued and other current liabi
Accrued and other current liabilities | 3 Months Ended |
Mar. 31, 2019 | |
Accrued and other current liabilities | |
Accrued and other current liabilities | 11. Accrued and other current liabilities Accrued and other current liabilities at March 31, 2019 and December 31, 2018 consisted of the following (in thousands): March 31, December 31, 2019 2018 Royalties $ 20,077 $ 25,087 Clinical related costs 65,874 98,607 Sales allowances 69,359 44,770 Construction in progress 16,087 7,673 Financing lease liability — 18,696 Other current liabilities 39,905 34,568 Total accrued and other current liabilities $ 211,302 $ 229,401 |
Debt
Debt | 3 Months Ended |
Mar. 31, 2019 | |
Debt | |
Debt | 12. Debt The components of the convertible notes are as follows (in thousands): Carrying Amount, Interest Rates March 31, December 31, Debt March 31, 2019 Maturities 2019 2018 1.25% Convertible Senior Notes due 2020 1.25 % $ 17,647 $ 17,434 17,647 17,434 Less current portion — — $ 17,647 $ 17,434 The carrying amount and fair value of our convertible notes are as follows (in thousands): March 31, 2019 December 31, 2018 Carrying Carrying Amount Fair Value Amount Fair Value 1.25% Convertible Senior Notes due 2020 $ 17,647 $ 32,048 $ 17,434 $ 25,073 $ 17,647 $ 32,048 $ 17,434 $ 25,073 The fair value of the 1.25% Convertible Senior Notes due 2020 (the “2020 Notes”) is based on data from readily available pricing sources which utilize market observable inputs and other characteristics for similar types of instruments, and, therefore, is classified within Level 2 in the fair value hierarchy. Prior to May 14, 2014, the 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 2020 Notes are convertible prior to the close of business on the business day immediately preceding May 15, 2020 only under the following circumstances: (i) 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 2020 Notes on each applicable trading day; (ii) 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 the 2020 Notes 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 2020 Notes on each such trading day; or (iii) upon the occurrence of specified corporate events. On or after May 15, 2020 until the close of business on the second scheduled trading day immediately preceding the relevant maturity date, the 2020 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, 2019, the 2020 Notes became convertible through at least June 30, 2019, based on meeting the conversion criteria related to the sale price of our common stock during the calendar quarter ended March 31, 2019 as described in (i) above. The 2020 Notes are reflected in long term liabilities on the condensed consolidated balance sheet as of March 31, 2019 as management’s intent is to settle any conversions of the 2020 Notes during this period in shares of our common stock. |
Employee benefit plans
Employee benefit plans | 3 Months Ended |
Mar. 31, 2019 | |
Employee benefit plans | |
Employee benefit plans | 13. Employee benefit plans Defined Contribution Plans We have a defined contribution plan qualified under Section 401(k) of the Internal Revenue Code covering all U.S. employees and defined contribution plans for other Incyte employees in Europe. Employees may contribute a portion of their compensation, which is then matched by us, subject to certain limitations. Defined contribution expense for the three months ended March 31, 2019 and 2018 was $2.9 million and $2.7 million, respectively. Defined Benefit Pension Plans We have defined benefit pension plans for our employees in Europe which provide benefits to employees upon retirement, death or disability. The assets of the pension plans are held in collective investment accounts represented by the cash surrender value of an insurance policy and are classified as Level 2 within the fair value hierarchy. The net periodic benefit cost was as follows (in thousands): Three Months Ended March 31, 2019 2018 Service cost $ 1,263 $ 1,079 Interest cost 84 71 Expected return on plan assets (60) (50) Amortization of prior service cost 45 45 Amortization of actuarial losses 66 66 Net periodic benefit cost $ 1,398 $ 1,211 The components of net periodic benefit cost other than the service cost component are included in other income (expense), net on the condensed consolidated statements of operations. We expect to contribute a total of $3.5 million to the pension plans in 2019 inclusive of the amounts contributed to the plan during the current period. As of March 31, 2019 and December 31, 2018, $15.8 million and $15.7 million, respectively, of accrued pension obligation is recorded in other long term liabilities on the condensed consolidated balance sheets. |
Income taxes
Income taxes | 3 Months Ended |
Mar. 31, 2019 | |
Income taxes | |
Income taxes | 14. Income taxes For the three months ended March 31, 2019 and 2018, we recorded income tax expense of approximately $1.8 million and $0.8 million, respectively. The change in tax expense for the three months ended March 31, 2019 was primarily driven by the difference in projected annual operating income or loss compared to our actual results as well as the recognition of certain discrete items in the current period. As of March 31, 2019, a full valuation allowance continues to be recorded against our U.S. and Swiss net deferred tax assets. This position is based on an analysis of positive and negative evidence, including analyzing three-year cumulative pre-tax income or loss, projections of future taxable income as well as other quantitative and qualitative information. The balance of our unrecognized tax benefits (including penalties and interest) increased by approximately $0.4 million during the three months ended March 31, 2019, of which only $0.1 million was recorded as an increase to noncurrent other liabilities on the condensed consolidated balance sheet. The increase is primarily driven by unrecognized tax benefits related to current year operations and research and development tax credits. |
Net income (loss) per share
Net income (loss) per share | 3 Months Ended |
Mar. 31, 2019 | |
Net income (loss) per share | |
Net income (loss) per share | 15. Net income (loss) per share Net income (loss) per share was calculated as follows for the periods indicated below: Three Months Ended March 31, (in thousands, except per share data) 2019 2018 Basic Net Income (Loss) Per Share Basic net income (loss) $ 102,312 $ (41,140) Weighted average common shares outstanding 214,065 211,681 Basic net income (loss) per share $ 0.48 $ (0.19) Diluted Net Income (Loss) Per Share Diluted net income (loss) $ 102,312 $ (41,140) Weighted average common shares outstanding 214,065 211,681 Dilutive stock options and RSUs 2,996 — Weighted average shares used to compute diluted net income (loss) per share 217,061 211,681 Diluted net income (loss) per share $ 0.47 $ (0.19) The potential common shares that were excluded from the diluted net income (loss) per share computation are as follows: Three Months Ended March 31, 2019 2018 Outstanding stock options and awards 9,318,013 13,104,711 Common shares issuable upon conversion of the 2018 Notes — 148,836 Common shares issuable upon conversion of the 2020 Notes 368,939 368,939 Total potential common shares excluded from diluted net income (loss) per share computation 9,686,952 13,622,486 |
Contingencies
Contingencies | 3 Months Ended |
Mar. 31, 2019 | |
Contingencies | |
Contingencies | 16. Contingencies In December 2018, we received a civil investigative demand from the U.S. Department of Justice for documents and information relating to our speaker programs and patient assistance programs, including our support of non-profit organizations that provide financial assistance to eligible patients. We are cooperating with this inquiry. Given that the investigation is still ongoing and that we have not yet been made aware of the substance of any civil claims, we cannot predict the outcome of the investigation, the timing of the ultimate resolution of this matter, or reasonably estimate the possible range of loss, if any, that may result from this matter. Accordingly, no reserve has been made with respect to this matter as of March 31, 2019. |
Summary of significant accoun_2
Summary of significant accounting policies (Policies) | 3 Months Ended |
Mar. 31, 2019 | |
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, 2019, the condensed consolidated statements of operations, comprehensive income (loss), stockholders’ equity, and cash flows for the three months ended March 31, 2019 and 2018, 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, 2018 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, 2018. |
Principles of Consolidation | Principles of Consolidation. The condensed consolidated financial statements include the accounts of Incyte Corporation and our wholly owned subsidiaries. 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. 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 U.S. dollars are reflected as a component of other comprehensive income (loss). Transaction gains and losses are recorded in other income (expense), net, in the condensed consolidated statements of operations. |
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, and trade receivables 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 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 and money market funds that meet certain guidelines. Our receivables mainly relate to our product sales of JAKAFI, ICLUSIG and collaborative agreements with pharmaceutical companies. We have not experienced any significant credit losses on cash, cash equivalents, marketable securities, or trade receivables to date and do not require collateral on receivables. |
Cash and Cash Equivalents | Cash and Cash Equivalents. Cash and cash equivalents are held in 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. Our marketable securities consist of investments in corporate debt securities and U.S. government securities that 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’ equity. 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 other income (expense), net on the condensed consolidated statements of operations. The cost of securities sold is based on the specific identification method. |
Accounts Receivable | Accounts Receivable. As of March 31, 2019 and December 31, 2018, we had a de minimis 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 and net realizable value with cost determined under the specific identification method and may consist of raw materials, work in process and finished goods. JAKAFI raw materials and work-in-process inventory is not subject to expiration and the shelf life of finished goods inventory is 36 months from the start of manufacturing of the finished goods. ICLUSIG raw materials and work-in-process inventory is not subject to expiration and finished goods inventory has a shelf life of 24 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 ongoing evaluation of the entities with which we have variable interests, such as equity ownership, in order to identify entities (i) that 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, 2019, there were no entities in which we held a variable interest which we determined to be VIEs. |
Long Term Equity Investments | Long Term Investments. Our long term investments consist of equity investments in common stock of publicly-held companies with whom we have entered into collaboration and license agreements. We classify all of our equity investments in common stock of publicly-held companies as long term investments on the condensed consolidated balance sheets. Our equity investments are accounted for at fair value using readily determinable pricing available on a securities exchange on the condensed consolidated balance sheets. All changes in fair value are reported in the condensed consolidated statements of operations as an unrealized gain (loss) on long term investments. In assessing whether we exercise significant influence over any of the companies in which we hold equity investments, 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. Currently, none of our equity investments in publicly-held companies are considered relationships in which we are able to assert control. |
Property and Equipment | Property and Equipment, net. Property and equipment, net 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. Leasehold improvements are amortized over the shorter of the estimated useful life of the assets or lease term. |
Lease Accounting | Lease Accounting. The new accounting standard for leases, Accounting Standard Codification (“ASC”) 842, Leases, was adopted for the fiscal year beginning on January 1, 2019. Per the new standard, all leases with a lease term greater than 12 months, regardless of lease type classification, are recorded as an obligation on the balance sheet with a corresponding right-of-use asset. Under the prior leasing standard, only contracts assessed as capital leases were recorded on the balance sheet. Both finance and operating leases are reflected as liabilities on the commencement date of the lease based on the present value of the lease payments to be made over the lease term. The current lease liabilities are reflected in accrued and other current liabilities and the noncurrent lease liabilities are reflected in other liabilities on the condensed consolidated balance sheet. Right-of-use assets are valued at the initial measurement of the lease liability, plus any initial direct costs or rent prepayments and reduced by any lease incentives and any deferred lease payments. These assets are recorded in property and equipment, net on the condensed consolidated balance sheet and are amortized over the lease term. For operating leases, the expense recognition is similar to that of operating leases under ASC 840, with a single lease cost recognized on a straight-line basis. For finance leases, the expense recognition is similar to that of capital leases under ASC 840, with separate amortization and interest expense, with higher interest expense in the earlier periods of a lease. Leases with an initial term of 12 months or less are not recorded on the balance sheet and we recognize lease expense for these leases on a straight-line basis over the term of the lease. In determining whether a contract contains a lease, asset and service agreements are assessed at onset and upon modification for criteria of specifically identified assets, control and economic benefit. |
Other Intangible Assets, net | Other Intangible Assets, net. Other intangible assets, net consist of licensed intellectual property rights acquired in business combinations, which are reported at acquisition date fair value, less accumulated amortization. Intangible assets with finite lives are amortized over their estimated useful lives using the straight-line method. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets. Long-lived assets with finite lives are tested for impairment whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. If indicators of impairment are present, the asset is tested for recoverability by comparing the carrying value of the asset to the related estimated undiscounted future cash flows expected to be derived from the asset. If the expected cash flows are less than the carrying value of the asset, then the asset is considered to be impaired and its carrying value is written down to fair value, based on the related estimated discounted future cash flows. |
Goodwill | Goodwill. Goodwill is calculated as the difference between the acquisition date fair value of the consideration transferred and the values assigned to the assets acquired and liabilities assumed. Goodwill is not amortized but is tested for impairment at the reporting unit level at least annually as of October 1 or when a triggering event occurs that could indicate a potential impairment by assessing qualitative factors or performing a quantitative analysis in determining whether it is more likely than not that the fair value of net assets are below their carrying amounts. A reporting unit is the same as, or one level below, an operating segment. Our operations are currently comprised of a single, entity wide reporting unit. We completed our most recent annual impairment assessment as of October 1, 2018 and determined that the carrying value of our goodwill was not impaired. |
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. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more-likely-than-not that some portion or all of the deferred tax assets will not be realized. We recognize the tax benefit from an uncertain tax position only if it is more-likely-than-not that the position will be sustained upon examination by the taxing authorities, including resolutions of any related appeals or litigation processes, based on the technical merits of the position. The tax benefit that is recorded for these positions is measured at the largest amount of benefit that is greater than 50 percent likely of being realized upon ultimate settlement. We adjust the level of the liability to reflect any subsequent changes in the relevant facts surrounding the uncertain positions. Any interest and penalties on uncertain tax positions are included within the tax provision. |
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 presented as a direct deduction from the carrying amount of the long-term debt liability, consistent with debt discounts, 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 other income (expense), net over the useful life of the related capital assets. Such amounts are recorded in other liabilities on the condensed consolidated balance sheets. |
Net Income (Loss) Per Share | Net Income (Loss) Per Share. Our basic and diluted net income (loss) per share is calculated by dividing the net income (loss) by the weighted average number of shares of common stock outstanding during all periods presented. Options to purchase stock, restricted stock units, performance stock units 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 that are classified as available-for-sale, foreign currency translation gains or losses and defined benefit pension obligations. |
Revenue Recognition | Revenue Recognition. The new accounting standard for the recognition of revenue, ASC 606, Revenue from Contracts with Customers , was adopted for the fiscal year beginning on January 1, 2018. Per the new standard, revenue-generating contracts are assessed to identify distinct performance obligations, allocating transaction prices to those performance obligations, and criteria for satisfaction of a performance obligation. The new standard allows for recognition of revenue only when we have satisfied a performance obligation through transferring control of the promised good or service to a customer. Control, in this instance, may mean the ability to prevent other entities from directing the use of, and receiving benefit from, a good or service. The standard indicates that an entity must determine at contract inception whether it will transfer control of a promised good or service over time or satisfy the performance obligation at a point in time through analysis of the following criteria: (i) the entity has a present right to payment, (ii) the customer has legal title, (iii) the customer has physical possession, (iv) the customer has the significant risks and rewards of ownership and (v) the customer has accepted the asset. We assess collectability based primarily on the customer’s payment history and on the creditworthiness of the customer. Overall, the adoption of the new standard did not significantly alter our methodology for recognition of revenue. Product Revenues Our product revenues consist of U.S. sales of JAKAFI and European sales of ICLUSIG. Product revenues are recognized once we satisfy the performance obligation at a point in time under the revenue recognition criteria as described above. In November 2011, we began shipping JAKAFI to our customers in the U.S., which include specialty pharmacies and wholesalers. In June 2016, we acquired the right to and began shipping ICLUSIG to our customers in the European Union and certain other jurisdictions, which include retail pharmacies, hospital pharmacies and distributors. We recognize revenues for product received by our customers net of allowances for customer credits, including estimated rebates, chargebacks, discounts, returns, distribution service fees, patient assistance programs, and government rebates, such as Medicare Part D coverage gap reimbursements in the U.S. At March 31, 2019 and December 31, 2018, $69.4 million and $44.8 million, respectively, of accrued sales allowances were included in accrued and other current liabilities on the condensed consolidated balance sheets. Product shipping and handling costs are included in cost of product revenues. Customer Credits: Our customers are offered various forms of consideration, including allowances, service fees and prompt payment discounts. We expect our 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 and Discounts: Allowances for rebates include mandated discounts under the Medicaid Drug Rebate Program in the U.S. and mandated discounts in Europe in markets where government-sponsored healthcare systems are the primary payers for healthcare. 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 launches. Our estimates for expected utilization of rebates are based on data received from our 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 certain contracted customers, which currently consist primarily of group purchasing organizations, Public Health Service institutions, non-profit clinics, and Federal government entities purchasing via the Federal Supply Schedule, purchase directly from our wholesalers. Contracted customers generally purchase the product at a discounted price. The wholesalers, in turn, charges back to us the difference between the price initially paid by the wholesalers and the discounted price paid by the contracted customers. In addition to actual chargebacks received we maintain an accrual for chargebacks based on the estimated contractual discounts on the inventory levels on hand in our distribution channel. If actual future chargebacks vary from these 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 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. Royalty revenues on commercial sales for baricitinib (marketed as OLUMIANT) by Eli Lilly and Company (“Lilly”) are based on net sales of licensed products in licensed territories as provided by Lilly. We recognize royalty revenues in the period the sales occur. Cost of Product Revenues Cost of product revenues includes all JAKAFI related product costs as well as ICLUSIG related product costs. The acquired ICLUSIG inventories were recorded at fair value less costs to sell in connection with our June 2016 acquisition of ARIAD Pharmaceuticals (Luxembourg) S.à.r.l., since renamed Incyte Biosciences Luxembourg S.à.r.l. (the “Acquisition”). In addition, cost of product revenues include low single-digit royalties under our collaboration and license agreement to Novartis on all future sales of JAKAFI in the United States. Subsequent to the Acquisition on June 1, 2016, cost of product revenues also includes the amortization of our licensed intellectual property for ICLUSIG using the straight-line method over the estimated useful life of 12.5 years. Milestone and Contract Revenues Our license agreements, which fall within the scope of ASC 606, Revenue from Contracts with Customers, include distinct drug compound out-licensing, collection of upfront payments, milestones or royalty revenues from a counterparty, and provision of commercially available products to suppliers. Our agreements often include contractual milestones, which typically relate to the achievement of pre-specified development, regulatory and commercialization events outside of our control, such as regulatory approval of a compound, first patient dosing or achievement of sales-based thresholds. For such cases, we believe that revenue related to these events should not be recognized until the milestone has been achieved. Some contracts form collaborative arrangements of various types with third-parties. We assess whether the nature of the arrangement is within the scope of ASC 808, Collaborative Arrangements , in conjunction with the new revenue guidance to determine the nature of the performance obligations and associated transaction prices. A collaborative relationship may exist when we participate in an activity or process with another party, such as performance of research and development services or the exchange of intellectual property for use in clinical trials, when both parties share in the risks and rewards that result from the activity or participate and govern contract activities through a joint steering committee. 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 U.S. Food and Drug Administration (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 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 and Long-term Incentive Plans | 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 that are subject to cliff vesting are recognized as compensation expense over the requisite service period using the straight-line attribution method, and the fair value of RSUs that are subject to graded vesting are recognized as compensation expense over the requisite service period using the accelerated 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, which we assess as of the end of each reporting period. Once a performance condition is considered probable, we record compensation expense based on the portion of the service period elapsed to date with respect to that award, with a cumulative catch-up, net of estimated forfeitures, and recognize any remaining compensation expense, if any, over the remaining requisite service period using the straight-line attribution method for PSUs that are subject to cliff vesting and using the accelerated attribution method for PSUs that are subject to graded vesting. Long term Incentive Plans. We have long term incentive plans which provide eligible employees with the opportunity to receive performance and service-based incentive compensation, which may be comprised of cash, stock options, restricted stock units and/or performance shares. The payment of cash and the grant or vesting of equity may be contingent upon the achievement of pre-determined regulatory, sales and internal performance milestones. |
Acquisition-Related Contingent Consideration | Acquisition-Related Contingent Consideration. Acquisition-related contingent consideration, which consists of our future royalty and certain potential milestone obligations to Takeda Pharmaceutical Company Limited, which acquired ARIAD (“Takeda”), is recorded on the acquisition date at the estimated fair value of the obligation, in accordance with the acquisition method of accounting. The fair value measurement is based on significant inputs that are unobservable in the market and thus represents a Level 3 measurement. The fair value of the acquisition-related contingent consideration is remeasured each reporting period, with changes in fair value recorded in the condensed consolidated statements of operations. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In February 2016, the Financial Accounting Standards Board (“FASB”) issued ASC 842, Leases, that requires lessees to recognize assets and liabilities on the balance sheet for most leases including operating leases. Additionally, the FASB issued clarifying guidance to the topic in ASUs No. 2018-10, No. 2018-11, No. 2018-20 and No. 2019-01 which clarified certain aspects of the new leases standard and provided an optional transition method. The guidance requires that the lessees classify leases as either a finance or operating lease and lessors classify all leases as sales-type, direct financing or operating leases. The statement of operations presentation and expense recognition for lessees for finance leases is similar to that of capital leases under ASC 840, with separate interest and amortization expense with higher interest expense in the earlier periods of a lease. For operating leases, the statement of operations presentation and expense recognition is similar to that of operating leases under ASC 840, with a single lease cost recognized on a straight-line basis. We implemented a third-party information technology application to facilitate activities for the new accounting and disclosure requirements and implemented new internal control procedures to support the new accounting and reporting processes associated with adopting the guidance. We elected the package of practical expedients and adopted utilizing the optional transition method as defined within ASU No. 2018-11. Accordingly, prior periods will not be restated to reflect the adopted standard. For lease agreements entered into or reassessed after the adoption of ASC 842, we combine lease and nonlease components. We did not elect the hindsight expedient. As a result of adoption on January 1, 2019, we recorded $23.6 million of lease right-of-use assets, $23.7 million of lease liabilities and an adjustment to retained earnings of $0.1 million. In addition, our capital lease assets and liabilities are now classified as finance lease right-of-use assets and liabilities. The capital asset and financing liability of $18.7 million recorded in 2018 related to the Morges office building and construction, described more fully in Note 7, was derecognized upon adoption. In accordance with the transition provisions in ASC 842, we reassessed the Morges lease as of the adoption date and we concluded that we did not have control of the construction project at that time. We will reassess the Morges lease for lease accounting and classification at the point in time in which we take possession of the leased asset, which is anticipated to occur in the second half of 2019. The adoption of the standard did not materially impact our consolidated net income and had no impact on our consolidated cash flows. In June 2016, the FASB issued ASU No. 2016-13, “Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments.” This guidance applies to all entities and impacts how entities account for credit losses for most financial assets and other instruments. For available-for-sale debt securities, entities will be required to recognize an allowance for credit losses rather than a reduction to the carrying value of the asset. For trade receivables, loans and held-to-maturity debt securities, entities will be required to estimate lifetime expected credit losses. This guidance is effective for fiscal years beginning after December 15, 2019 and interim periods therein. Early adoption is permitted for annual periods beginning after December 15, 2018 and interim periods therein. We are currently analyzing the impact of ASU No. 2016-13 on the condensed consolidated financial statements . In June 2018, the FASB issued ASU No. 2018-07, “Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting.” This guidance expanded the scope of ASC 718 to include share-based payments granted to nonemployees in exchange for goods or services and supersedes the guidance in ASC 505-50. Under this new standard, nonemployee awards are measured on the grant date by estimating the fair value of the equity instruments to be issued rather than the fair value of the goods or services received. Entities may use the expected term when estimating the fair value of a nonemployee option or elect to use the contractual term as the expected term, on an award-by-award basis. The cumulative effect of the transition adjustment is to be recorded as an adjustment to retained earnings as of the beginning of the annual period of adoption. We adopted this standard for the period beginning January 1, 2019 and concluded there to be no change in our previous accounting for nonemployee awards and no impact on our condensed consolidated financial statements. In August 2018, the FASB issued ASU No. 2018-14, “Compensation – Retirement Benefits – Defined Benefit Plans – General,” an update to Subtopic ASC 715-20. The guidance amended year-end disclosure requirements related to defined benefit pension plans, and does not affect interim disclosures. The guidance is effective for fiscal years ending after December 15, 2020, and is permitted for early adoption. The standard is to be applied on a retrospective basis. Incyte sponsors defined benefit plans for employees located in Europe. We are currently analyzing the impact of ASU No. 2018-14 on the condensed consolidated financial statements . In August 2018, the FASB issued ASU No. 2018-15, “Intangibles – Goodwill and Other – Internal-Use Software,” an update to Subtopic ASC 350-40. The guidance directs accounting for service contracts for cloud computing arrangements to follow guidance within ASC 350-40 to determine capitalization of implementation costs. The guidance is effective for fiscal years beginning after December 15, 2019, and is permitted for early adoption. The standard may be applied on either a retrospective or prospective basis. We are currently analyzing the impact of ASU No. 2018-15 on the condensed consolidated financial statements. In August 2018, the SEC issued a final rule Release No. 33-10532, “Disclosure Update and Simplification,” to amend certain disclosure requirements now seen as redundant, duplicative, overlapping, outdated or superseded in wake of recent accounting pronouncements. The amended rules became effective November 5, 2018. We analyzed the release in preparation of this Form 10-Q, which resulted in the additional disclosure of changes to stockholders’ equity during interim periods, as presented within this Form 10-Q within the condensed consolidated statements of stockholders’ equity. We note that many of the amended requirements under this Release are not applicable to the Company, as we do not make dividend payments to stockholders, currently report our activities under a single business segment, and already provided all other significant disclosure requirements. In November 2018, the FASB issued ASU No. 2018-18, “Collaborative Arrangements (Topic 808): Clarifying the Interaction Between Topic 808 and Topic 606.” The guidance clarifies the interactions between Topic 808 and Topic 606, including clarifications on revenue recognition, unit of account, and reporting disclosure requirements. The guidance is effective for fiscal years beginning after December 15, 2019, and is permitted for early adoption. The standard is to be applied on a retrospective basis to the date of the initial application of Topic 606. We utilize collaborative arrangements as described in our license agreements footnote and are currently analyzing the impact of ASU No. 2018-18 on the condensed consolidated financial statements. |
Revenues (Tables)
Revenues (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Revenues | |
Schedule of disaggregated revenue | The following table presents our disaggregated revenue for the periods presented (in thousands). Three Months Ended March 31, 2019 2018 JAKAFI revenues, net $ 375,611 $ 313,720 ICLUSIG revenues, net 20,638 20,785 Total product revenues, net 396,249 334,505 JAKAVI product royalty revenues 45,571 41,337 OLUMIANT product royalty revenues 16,037 6,379 Total product royalty revenues 61,608 47,716 Milestone and contract revenues 40,000 — Other revenues — 61 Total revenues $ 497,857 $ 382,282 |
Fair value of financial instr_2
Fair value of financial instruments (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Fair value of financial instruments. | |
Schedule of fair value of assets measured on recurring basis | The following fair value hierarchy table presents information about each major category of our financial assets measured at fair value on a recurring basis (in thousands): Fair Value Measurement at Reporting Date Using: Quoted Prices in Significant Other Significant Active Markets for Observable Unobservable Identical Assets Inputs Inputs Balance as of (Level 1) (Level 2) (Level 3) March 31, 2019 Cash and cash equivalents $ 1,299,704 $ — $ — $ 1,299,704 Debt securities (corporate and government) — 281,320 — 281,320 Long term investments (Note 9) 120,188 — — 120,188 Total assets $ 1,419,892 $ 281,320 $ — $ 1,701,212 Fair Value Measurement at Reporting Date Using: Quoted Prices in Significant Other Significant Active Markets for Observable Unobservable Identical Assets Inputs Inputs Balance as of (Level 1) (Level 2) (Level 3) December 31, 2018 Cash and cash equivalents $ 1,163,980 $ — $ — $ 1,163,980 Debt securities (corporate and government) — 274,343 — 274,343 Long term investment (Note 9) 99,199 — — 99,199 Total assets $ 1,263,179 $ 274,343 $ — $ 1,537,522 |
Schedule of fair value of liabilities measured on recurring basis | The following fair value hierarchy table presents information about each major category of our financial liabilities measured at fair value on a recurring basis as (in thousands): Fair Value Measurement at Reporting Date Using: Quoted Prices in Significant Other Significant Active Markets for Observable Unobservable Identical Assets Inputs Inputs Balance as of (Level 1) (Level 2) (Level 3) March 31, 2019 Acquisition-related contingent consideration $ — $ — $ 287,000 $ 287,000 Total liabilities $ — $ — $ 287,000 $ 287,000 Fair Value Measurement at Reporting Date Using: Quoted Prices in Significant Other Significant Active Markets for Observable Unobservable Identical Assets Inputs Inputs Balance as of (Level 1) (Level 2) (Level 3) December 31, 2018 Acquisition-related contingent consideration $ — $ — $ 287,001 $ 287,001 Total liabilities $ — $ — $ 287,001 $ 287,001 |
Schedule of roll forward of Level 3 liabilities | The following is a rollforward of our Level 3 liabilities (in thousands): Balance at January 1, 2019 $ 287,001 Contingent consideration earned during the period but not yet paid (6,672) Change in fair value of contingent consideration 6,671 Balance at March 31, 2019 $ 287,000 |
Summary of marketable securities portfolio | The following is a summary of our marketable security portfolio (in thousands): Net Amortized Unrealized Estimated Cost Losses Fair Value March 31, 2019 Debt securities (corporate and government) $ 281,701 $ (381) $ 281,320 December 31, 2018 Debt securities (corporate and government) $ 275,405 $ (1,062) $ 274,343 |
Concentration of credit risk (T
Concentration of credit risk (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Concentration of credit risk | |
Schedule of concentration of credit risk related to collaborative partners | In December 2018, we entered into a research collaboration and licensing agreement with Innovent Biologics, Inc. (“Innovent”). The concentration of credit risk related to our collaborative partners is as follows: Percentage of Total Milestone and Contract Revenues for the Three Months Ended March 31, 2019 2018 Collaboration Partner A — % — % Collaboration Partner B — % — % Collaboration Partner C 100 % — % |
Schedule of concentration of credit risk related to specialty pharmacy customers | The concentration of credit risk related to our JAKAFI product revenues is as follows: Percentage of Total Net Product Revenues for the Three Months Ended March 31, 2019 2018 Customer A 18 % 22 % Customer B 15 % 13 % Customer C 16 % 14 % Customer D 12 % 11 % |
Inventory (Tables)
Inventory (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Inventory | |
Schedule of inventory | Our inventory balance consists of the following (in thousands): March 31, December 31, 2019 2018 Raw materials $ 1,822 $ 481 Work-in-process 4,097 3,488 Finished goods 5,086 6,436 11,005 10,405 Inventories-current 7,129 6,967 Inventories-noncurrent $ 3,876 $ 3,438 |
Property and equipment, net (Ta
Property and equipment, net (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Property and equipment, net | |
Schedule of property and equipment, net | Property and equipment, net consists of the following (in thousands): March 31, December 31, 2019 2018 Office equipment $ 15,199 $ 16,955 Laboratory equipment 63,339 61,697 Computer equipment 58,389 55,436 Land 10,068 10,122 Building and leasehold improvements 213,529 213,196 Operating lease right-of-use assets 24,334 — Finance lease right-of-use assets 2,332 — Construction in progress 64,598 65,576 451,788 422,982 Less accumulated depreciation and amortization (113,457) (103,231) Property and equipment, net $ 338,331 $ 319,751 |
Summary of lease liability | As of March 31, 2019 our lease liabilities are as follows (in thousands): Current Operating lease liabilities $ 10,245 Finance lease liabilities 815 Noncurrent Operating lease liabilities 12,629 Finance lease liabilities 723 Total lease liabilities $ 24,412 |
Summary of maturity of our lease liabilities | The maturity of our lease liabilities are as follows (in thousands): Operating Finance Remainder of 2019 $ 8,793 $ 886 2020 6,339 556 2021 4,242 195 2022 2,265 — 2023 1,602 — After 2023 1,429 — Total lease cash payments $ 24,670 $ 1,637 Less: discount 1,796 99 Present value of lease liabilities $ 22,874 $ 1,538 |
Intangible assets and goodwill
Intangible assets and goodwill (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Intangible assets and goodwill | |
Schedule of intangible assets, net | The components of intangible assets were as follows (in thousands, except for useful life): Balance at March 31, 2019 Balance at December 31, 2018 Weighted- Gross Net Gross Net Average Useful Carrying Accumulated Carrying Carrying Accumulated Carrying Lives (Years) Amount Amortization Amount Amount Amortization Amount Finite-lived intangible assets: Licensed IP 12.5 $ 271,000 $ 61,020 $ 209,980 $ 271,000 $ 55,636 $ 215,364 |
Schedule of estimated aggregate amortization expense | Estimated aggregate amortization expense based on the current carrying value of amortizable intangible assets is as follows (in thousands): Remainder of 2019 2020 2021 2022 2023 Thereafter Amortization expense $ 16,155 $ 21,536 $ 21,536 $ 21,536 $ 21,536 $ 107,681 |
Stock compensation (Tables)
Stock compensation (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Stock compensation | |
Schedule of valuation assumptions used for valuation of fair value of stock compensation granted | 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 Options Employee Stock Purchase Plan For the Three Months Ended March 31, 2019 2018 2019 2018 Average risk-free interest rates 2.51 % 2.42 % 2.27 % 2.26 % Average expected life (in years) 5.33 5.53 0.25 0.25 Volatility 45 % 45 % 34 % 36 % Weighted-average fair value (in dollars) 31.50 41.59 13.31 18.17 |
Schedule of option activity under the 2010 Stock Plan | Option activity under the 2010 Stock Plan was as follows: Shares Subject to Outstanding Options Shares Available Weighted Average for Grant Shares Exercise Price Balance at December 31, 2018 6,477,577 12,285,159 $ 74.39 Options granted (2,271,592) 2,271,592 $ 72.81 Options exercised — (849,870) $ 25.38 Options cancelled 315,321 (315,321) $ 89.29 Balance at March 31, 2019 4,521,306 13,391,560 $ 76.88 |
Schedule of RSU award and PSU activity under the 2010 Stock Plan | RSU award and PSU 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, 2018 545,751 2,043,337 $ 80.35 RSUs granted (165,251) 165,251 $ 73.69 PSUs achieved (44,940) 44,940 $ 65.76 RSUs cancelled 55,591 (55,591) $ 89.46 PSUs cancelled 9,889 (9,889) $ 67.32 RSUs released — (213,604) $ 89.38 Balance at March 31, 2019 401,040 1,974,444 $ 78.29 |
Accrued and other current lia_2
Accrued and other current liabilities (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Accrued and other current liabilities | |
Schedule of accrued and other current liabilities | Accrued and other current liabilities at March 31, 2019 and December 31, 2018 consisted of the following (in thousands): March 31, December 31, 2019 2018 Royalties $ 20,077 $ 25,087 Clinical related costs 65,874 98,607 Sales allowances 69,359 44,770 Construction in progress 16,087 7,673 Financing lease liability — 18,696 Other current liabilities 39,905 34,568 Total accrued and other current liabilities $ 211,302 $ 229,401 |
Debt (Tables)
Debt (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Debt | |
Schedule of components of convertible notes | The components of the convertible notes are as follows (in thousands): Carrying Amount, Interest Rates March 31, December 31, Debt March 31, 2019 Maturities 2019 2018 1.25% Convertible Senior Notes due 2020 1.25 % $ 17,647 $ 17,434 17,647 17,434 Less current portion — — $ 17,647 $ 17,434 |
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, 2019 December 31, 2018 Carrying Carrying Amount Fair Value Amount Fair Value 1.25% Convertible Senior Notes due 2020 $ 17,647 $ 32,048 $ 17,434 $ 25,073 $ 17,647 $ 32,048 $ 17,434 $ 25,073 |
Employee benefit plans (Tables)
Employee benefit plans (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Employee benefit plans | |
Schedule of net periodic benefit cost | The net periodic benefit cost was as follows (in thousands): Three Months Ended March 31, 2019 2018 Service cost $ 1,263 $ 1,079 Interest cost 84 71 Expected return on plan assets (60) (50) Amortization of prior service cost 45 45 Amortization of actuarial losses 66 66 Net periodic benefit cost $ 1,398 $ 1,211 |
Net income (loss) per share (Ta
Net income (loss) per share (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Net income (loss) per share | |
Schedule of calculation of net income (loss) per share | Net income (loss) per share was calculated as follows for the periods indicated below: Three Months Ended March 31, (in thousands, except per share data) 2019 2018 Basic Net Income (Loss) Per Share Basic net income (loss) $ 102,312 $ (41,140) Weighted average common shares outstanding 214,065 211,681 Basic net income (loss) per share $ 0.48 $ (0.19) Diluted Net Income (Loss) Per Share Diluted net income (loss) $ 102,312 $ (41,140) Weighted average common shares outstanding 214,065 211,681 Dilutive stock options and RSUs 2,996 — Weighted average shares used to compute diluted net income (loss) per share 217,061 211,681 Diluted net income (loss) per share $ 0.47 $ (0.19) |
Schedule of antidilutive securities excluded from the computation of earnings per share | The potential common shares that were excluded from the diluted net income (loss) per share computation are as follows: Three Months Ended March 31, 2019 2018 Outstanding stock options and awards 9,318,013 13,104,711 Common shares issuable upon conversion of the 2018 Notes — 148,836 Common shares issuable upon conversion of the 2020 Notes 368,939 368,939 Total potential common shares excluded from diluted net income (loss) per share computation 9,686,952 13,622,486 |
Organization and business (Deta
Organization and business (Details) | 3 Months Ended |
Mar. 31, 2019segment | |
Organization and Business | |
Number of operating segments | 1 |
Summary of significant accoun_3
Summary of significant accounting policies - Narrative 1 (Details) | 3 Months Ended |
Mar. 31, 2019itemissuerinstrument | |
Concentrations of Credit Risk | |
Number of issuer to which company limits the amount of credit exposure other than US Government guaranteed securities | issuer | 1 |
Number of financial investment to which company limits the amount of credit exposure other than US Government guaranteed securities | instrument | 1 |
Variable Interest Entities | |
Number of entities in which variable interest held | item | 0 |
JAKAFI | |
Inventory | |
Shelf life for finished goods inventory, maximum | 36 months |
ICLUSIG | |
Inventory | |
Shelf life for finished goods inventory, maximum | 24 months |
Summary of significant accoun_4
Summary of significant accounting policies - Revenue Recognition (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2019 | Dec. 31, 2018 | |
Revenue recognition | ||
Accrued sales allowances | $ 69.4 | $ 44.8 |
Percentage of Medicare Part D insurance coverage gap mandate to be funded by manufacturers | 50.00% | |
ICLUSIG | ||
Revenue recognition | ||
Amortization period | 12 years 6 months |
Summary of significant accoun_5
Summary of significant accounting policies - Recent Accounting Pronouncements (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Jan. 01, 2019 | Dec. 31, 2018 | |
Recent Accounting Pronouncements | ||||
Operating lease liabilities | $ 22,874 | |||
Financing lease liabilities | 1,538 | |||
Retained earnings | $ (1,775,352) | $ (1,877,759) | [1] | |
Capital lease obligation | 18,696 | |||
Office Building in Morges, Switzerland | Building and leasehold improvements | ||||
Recent Accounting Pronouncements | ||||
Capital lease asset | 18,700 | |||
Capital lease obligation | $ 18,700 | |||
ASU No. 2016-02 | Restatement Adjustment | ||||
Recent Accounting Pronouncements | ||||
Financing lease assets | $ 23,600 | |||
Financing lease liabilities | 23,700 | |||
Retained earnings | $ 100 | |||
[1] | The condensed consolidated balance sheet at December 31, 2018 has been derived from the audited financial statements at that date. |
Revenues (Details)
Revenues (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Revenues | ||
Total revenues | $ 497,857 | $ 382,282 |
Product revenues, net | ||
Revenues | ||
Total revenues | 396,249 | 334,505 |
JAKAFI | ||
Revenues | ||
Total revenues | 375,611 | 313,720 |
ICLUSIG | ||
Revenues | ||
Total revenues | 20,638 | 20,785 |
Product royalty revenues | ||
Revenues | ||
Total revenues | 61,608 | 47,716 |
JAKAVI Royalty Revenues | ||
Revenues | ||
Total revenues | 45,571 | 41,337 |
OLUMIANT Royalty Revenues | ||
Revenues | ||
Total revenues | 16,037 | 6,379 |
Milestone and contract revenues | ||
Revenues | ||
Total revenues | $ 40,000 | |
Other revenues | ||
Revenues | ||
Total revenues | $ 61 |
Fair value of financial instr_3
Fair value of financial instruments - Fair value on a recurring basis (Details) (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | ||||
Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Dec. 31, 2018 | |||
Fair value of financial instruments | ||||||
Assets transfers from Level 1 to Level 2 | $ 0 | |||||
Assets transfers from Level 2 to Level 1 | 0 | |||||
Assets transfers into Level 3 | 0 | |||||
Assets transfers out of Level 3 | 0 | |||||
Liabilities transfers from Level 1 to Level 2 | 0 | |||||
Liabilities transfers from Level 2 to Level 1 | 0 | |||||
Liabilities transfers into Level 3 | 0 | |||||
Liabilities transfers out of Level 3 | 0 | |||||
Long term investments | 120,188 | $ 99,199 | [1] | $ 99,199 | [1] | |
ARIAD | ||||||
Roll forward of Level 3 liabilities | ||||||
Contingent consideration earned during the period but not yet paid | (6,700) | (13,200) | ||||
ARIAD | Account payable | ||||||
Roll forward of Level 3 liabilities | ||||||
Contingent consideration earned during the period but not yet paid | $ (6,700) | |||||
ARIAD | Accrued and other current liabilities | ||||||
Roll forward of Level 3 liabilities | ||||||
Contingent consideration earned during the period but not yet paid | (6,700) | (6,500) | ||||
Level 3 | Fair Value | ||||||
Roll forward of Level 3 liabilities | ||||||
Balance at the beginning of the period | 287,001 | |||||
Contingent consideration earned during the period but not yet paid | (6,672) | |||||
Change in fair value of contingent consideration | 6,671 | |||||
Balance at the end of the period | 287,000 | 287,001 | 287,001 | |||
Recurring | Fair Value | ||||||
Fair value of financial instruments | ||||||
Cash and cash equivalents | 1,299,704 | 1,163,980 | 1,163,980 | |||
Debt securities (corporate and government) | 281,320 | 274,343 | 274,343 | |||
Long term investments | 120,188 | 99,199 | 99,199 | |||
Total assets | 1,701,212 | 1,537,522 | 1,537,522 | |||
Acquisition-related contingent consideration | 287,000 | 287,001 | 287,001 | |||
Total liabilities | 287,000 | 287,001 | 287,001 | |||
Recurring | Level 1 | ||||||
Fair value of financial instruments | ||||||
Cash and cash equivalents | 1,299,704 | 1,163,980 | 1,163,980 | |||
Long term investments | 120,188 | 99,199 | 99,199 | |||
Total assets | 1,419,892 | 1,263,179 | 1,263,179 | |||
Recurring | Level 2 | ||||||
Fair value of financial instruments | ||||||
Debt securities (corporate and government) | 281,320 | 274,343 | 274,343 | |||
Total assets | 281,320 | 274,343 | 274,343 | |||
Recurring | Level 3 | ||||||
Fair value of financial instruments | ||||||
Acquisition-related contingent consideration | 287,000 | 287,001 | 287,001 | |||
Total liabilities | $ 287,000 | $ 287,001 | $ 287,001 | |||
[1] | The condensed consolidated balance sheet at December 31, 2018 has been derived from the audited financial statements at that date. |
Fair value of financial instr_4
Fair value of financial instruments - Marketable securities portfolio (Details) (Details) - Debt securities (corporate and government) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Dec. 31, 2018 | |
Summary of marketable security portfolio | ||
Amortized Cost | $ 281,701 | $ 275,405 |
Net Unrealized Losses | (381) | (1,062) |
Estimated Fair Value | $ 281,320 | $ 274,343 |
Minimum | ||
Summary of marketable security portfolio | ||
Contractual maturity dates | 12 months | |
Maximum | ||
Summary of marketable security portfolio | ||
Contractual maturity dates | 18 months |
Concentration of credit risk (D
Concentration of credit risk (Details) | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | |
Milestone Revenues | Customer Concentration Risk | Collaboration Partner C | |||
Concentration of risk | |||
Percentage of concentration risk | 100.00% | ||
Net Product Revenues | Customer Concentration Risk | Customer A | |||
Concentration of risk | |||
Percentage of concentration risk | 18.00% | 22.00% | |
Net Product Revenues | Customer Concentration Risk | Customer B | |||
Concentration of risk | |||
Percentage of concentration risk | 15.00% | 13.00% | |
Net Product Revenues | Customer Concentration Risk | Customer C | |||
Concentration of risk | |||
Percentage of concentration risk | 16.00% | 14.00% | |
Net Product Revenues | Customer Concentration Risk | Customer D | |||
Concentration of risk | |||
Percentage of concentration risk | 12.00% | 11.00% | |
Accounts Receivable | Credit Concentration Risk | Collaboration Partner A, B and C | |||
Concentration of risk | |||
Percentage of concentration risk | 26.00% | 42.00% | |
Accounts Receivable | Credit Concentration Risk | Customer A, B, C and D | |||
Concentration of risk | |||
Percentage of concentration risk | 37.00% | 30.00% |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 | |
Inventory | |||
Raw materials | $ 1,822 | $ 481 | |
Work-in-process | 4,097 | 3,488 | |
Finished goods | 5,086 | 6,436 | |
Total inventories | 11,005 | 10,405 | |
Inventories - current | 7,129 | 6,967 | [1] |
Inventories-noncurrent | $ 3,876 | $ 3,438 | [1] |
[1] | The condensed consolidated balance sheet at December 31, 2018 has been derived from the audited financial statements at that date. |
Property and equipment, net - P
Property and equipment, net - Property and equipment, net (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 | |
Property and equipment, net | |||
Property and Equipment, gross | $ 451,788 | $ 422,982 | |
Less accumulated depreciation and amortization | (113,457) | (103,231) | |
Property and Equipment, net | 338,331 | 319,751 | [1] |
Office equipment | |||
Property and equipment, net | |||
Property and Equipment, gross | 15,199 | 16,955 | |
Laboratory equipment | |||
Property and equipment, net | |||
Property and Equipment, gross | 63,339 | 61,697 | |
Computer equipment | |||
Property and equipment, net | |||
Property and Equipment, gross | 58,389 | 55,436 | |
Land | |||
Property and equipment, net | |||
Property and Equipment, gross | 10,068 | 10,122 | |
Building and leasehold improvements | |||
Property and equipment, net | |||
Property and Equipment, gross | 213,529 | 213,196 | |
Operating lease right-of-use assets | |||
Property and equipment, net | |||
Property and Equipment, gross | 24,334 | ||
Finance lease right-of-use assets | |||
Property and equipment, net | |||
Property and Equipment, gross | 2,332 | ||
Construction in Progress | |||
Property and equipment, net | |||
Property and Equipment, gross | $ 64,598 | $ 65,576 | |
[1] | The condensed consolidated balance sheet at December 31, 2018 has been derived from the audited financial statements at that date. |
Property and equipment, net - N
Property and equipment, net - Narrative (Details) $ in Thousands | 1 Months Ended | |||
Jul. 31, 2018USD ($) | Feb. 28, 2018ft² | Mar. 31, 2019USD ($) | Dec. 31, 2018USD ($) | |
Property and equipment, net | ||||
Costs for architectural and engineering studies and initial ground preparation | $ 451,788 | $ 422,982 | ||
Land | ||||
Property and equipment, net | ||||
Costs for architectural and engineering studies and initial ground preparation | 10,068 | 10,122 | ||
Construction in Progress | ||||
Property and equipment, net | ||||
Costs for architectural and engineering studies and initial ground preparation | 64,598 | 65,576 | ||
Building and leasehold improvements | ||||
Property and equipment, net | ||||
Costs for architectural and engineering studies and initial ground preparation | 213,529 | $ 213,196 | ||
Office Building in Morges, Switzerland | Construction in Progress | ||||
Property and equipment, net | ||||
Site preparation, design and construction costs | 2,000 | |||
Office Building in Morges, Switzerland | Building and leasehold improvements | ||||
Property and equipment, net | ||||
Initial term of agreement to rent | 15 years | |||
Renewal term of agreement to rent | 20 years | |||
Pending Land and Building Acquisition | Office Building in Morges, Switzerland | Building and leasehold improvements | ||||
Property and equipment, net | ||||
Square footage | ft² | 100,000 | |||
Pending Land and Building Acquisition | Land in Y-PARC, Switzerland's largest technology park, Yverdon | Land | ||||
Property and equipment, net | ||||
Purchase price | $ 4,800 | |||
Pending Land and Building Acquisition | Land in Y-PARC, Switzerland's largest technology park, Yverdon | Construction in Progress | ||||
Property and equipment, net | ||||
Costs for architectural and engineering studies and initial ground preparation | $ 55,800 |
Property and equipment, net - L
Property and equipment, net - Lease and maturity of lease liabilities (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Lease liabilities | ||
Operating lease liabilities, current | $ 10,245 | |
Finance lease liabilities, current | 815 | |
Operating lease liabilities, noncurrent | 12,629 | |
Finance lease liabilities, noncurrent | 723 | |
Total lease liabilities | 24,412 | |
Cash paid for operating lease liabilities | 2,800 | |
Cash paid for financing lease liabilities in financing cash flows | 195 | |
Maturity of our operating lease liabilities | ||
Remainder of 2019 | 8,793 | |
2020 | 6,339 | |
2021 | 4,242 | |
2022 | 2,265 | |
2023 | 1,602 | |
After 2023 | 1,429 | |
Total lease cash payments | 24,670 | |
Less: discount | 1,796 | |
Present value of lease liabilities | 22,874 | |
Maturity of our finance lease liabilities | ||
Remainder of 2019 | 886 | |
2020 | 556 | |
2021 | 195 | |
Total lease cash payments | 1,637 | |
Less: discount | 99 | |
Present value of lease liabilities | $ 1,538 | |
Weighted average lease term, finance leases | 2 years | |
Weighted average lease term, operating leases | 4 years 4 months 24 days | |
Weighted average discount rate, operating leases | 4.70% | |
Weighted average discount rate, finance leases | 6.60% | |
Expense related to our operating leases | $ 3,600 | |
Amortization on our finance lease right-of-use assets | $ 200 | |
Rent expense | $ 3,300 |
Intangible assets and goodwil_2
Intangible assets and goodwill (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Dec. 31, 2018 | |
Amortization Expense | ||
Remainder of 2019 | $ 16,155 | |
2020 | 21,536 | |
2021 | 21,536 | |
2022 | 21,536 | |
2023 | 21,536 | |
Thereafter | 107,681 | |
Changes to carrying amount of goodwill | ||
Changes to the carry amount of goodwill | $ 0 | |
Licensed IP | ||
Intangible assets | ||
Weighted Average Useful Lives (Years) | 12 years 6 months | |
Finite-lived intangible assets: | ||
Gross Carrying Amount | $ 271,000 | $ 271,000 |
Accumulated Amortization | 61,020 | 55,636 |
Net Carrying Amount | $ 209,980 | $ 215,364 |
License agreements - Novartis (
License agreements - Novartis (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | 113 Months Ended | |||||||||||||
Apr. 30, 2016USD ($) | Sep. 30, 2014USD ($) | Jan. 31, 2010USD ($) | Dec. 31, 2009USD ($) | Nov. 30, 2009USD ($)item | Mar. 31, 2019USD ($) | Mar. 31, 2018USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | Dec. 31, 2013USD ($) | Dec. 31, 2012USD ($) | Dec. 31, 2011USD ($) | Dec. 31, 2010USD ($) | Mar. 31, 2019USD ($) | |
License agreements | |||||||||||||||||
Revenues | $ 497,857 | $ 382,282 | |||||||||||||||
JAKAFI | |||||||||||||||||
License agreements | |||||||||||||||||
Revenues | 375,611 | 313,720 | |||||||||||||||
Novartis | |||||||||||||||||
License agreements | |||||||||||||||||
Upfront and immediate milestone payment to be received under license agreement | $ 210,000 | ||||||||||||||||
Upfront payment received under license agreement | $ 150,000 | ||||||||||||||||
Immediate milestone payment received under license agreement | $ 60,000 | ||||||||||||||||
Number of deliverables under license agreement | item | 2 | ||||||||||||||||
Reimbursable costs recorded as deferred revenue | $ 10,900 | ||||||||||||||||
Reimbursable costs included in accounts receivable | 500 | $ 700 | $ 500 | ||||||||||||||
Research and development expenses reimbursed | 600 | 500 | |||||||||||||||
Product royalties in accounts receivable | 45,600 | 55,400 | 45,600 | ||||||||||||||
Novartis | Pre-specified Events | Maximum | |||||||||||||||||
License agreements | |||||||||||||||||
Upfront and immediate milestone payment to be received under license agreement | $ 1,200,000 | ||||||||||||||||
Novartis | Development Milestones | |||||||||||||||||
License agreements | |||||||||||||||||
Amount recognized and received for the achievement of a predefined milestone | 132,000 | ||||||||||||||||
Novartis | Development Milestones | Phase III | |||||||||||||||||
License agreements | |||||||||||||||||
Amount recognized and received for the achievement of a predefined milestone | $ 50,000 | ||||||||||||||||
Novartis | Development Milestones | Maximum | |||||||||||||||||
License agreements | |||||||||||||||||
Upfront and immediate milestone payment to be received under license agreement | 174,000 | ||||||||||||||||
Novartis | Regulatory Milestones | |||||||||||||||||
License agreements | |||||||||||||||||
Amount recognized and received for the achievement of a predefined milestone | 215,000 | ||||||||||||||||
Novartis | Regulatory Milestones | Maximum | |||||||||||||||||
License agreements | |||||||||||||||||
Upfront and immediate milestone payment to be received under license agreement | 495,000 | ||||||||||||||||
Novartis | Commercialization Milestones | |||||||||||||||||
License agreements | |||||||||||||||||
Amount recognized and received for the achievement of a predefined milestone | 120,000 | ||||||||||||||||
Novartis | Commercialization Milestones | Maximum | |||||||||||||||||
License agreements | |||||||||||||||||
Upfront and immediate milestone payment to be received under license agreement | $ 500,000 | ||||||||||||||||
Novartis | Development and Commercialization Milestones | |||||||||||||||||
License agreements | |||||||||||||||||
Revenues | 0 | 0 | |||||||||||||||
Novartis | LY3009104 | Development Milestones | |||||||||||||||||
License agreements | |||||||||||||||||
Amount recognized and received for the achievement of a predefined milestone | $ 5,000 | $ 7,000 | $ 25,000 | $ 15,000 | |||||||||||||
Novartis | GVHD | Development Milestones | Phase III | |||||||||||||||||
License agreements | |||||||||||||||||
Amount recognized and received for the achievement of a predefined milestone | $ 25,000 | ||||||||||||||||
Novartis | GVHD | Development and Regulatory Milestones | Maximum | |||||||||||||||||
License agreements | |||||||||||||||||
Upfront and immediate milestone payment to be received under license agreement | $ 75,000 | ||||||||||||||||
Novartis | GVHD | Development and Commercialization Milestones | |||||||||||||||||
License agreements | |||||||||||||||||
Amount recognized and received for the achievement of a predefined milestone | $ 5,000 | ||||||||||||||||
Novartis | JAKAFI | U.S. | |||||||||||||||||
License agreements | |||||||||||||||||
Royalties payable on net sales | 13,400 | 10,400 | |||||||||||||||
Royalties payable | 13,400 | 18,600 | $ 13,400 | ||||||||||||||
Novartis | JAKAFI | Regulatory Milestones | U.S. | |||||||||||||||||
License agreements | |||||||||||||||||
Amount recognized and received for the achievement of a predefined milestone | $ 10,000 | ||||||||||||||||
Novartis | JAKAVI | |||||||||||||||||
License agreements | |||||||||||||||||
Revenues | $ 45,600 | $ 41,300 | |||||||||||||||
Novartis | JAKAVI | Minimum | |||||||||||||||||
License agreements | |||||||||||||||||
Royalty payments on future global net sales (as a percent) | 12.00% | ||||||||||||||||
Novartis | JAKAVI | Maximum | |||||||||||||||||
License agreements | |||||||||||||||||
Royalty payments on future global net sales (as a percent) | 14.00% | ||||||||||||||||
Novartis | JAKAVI | Regulatory Milestones | Europe | |||||||||||||||||
License agreements | |||||||||||||||||
Amount recognized and received for the achievement of a predefined milestone | $ 60,000 | $ 40,000 | 25,000 | 60,000 | $ 40,000 | ||||||||||||
Novartis | JAKAVI | Regulatory Milestones | JAPAN | |||||||||||||||||
License agreements | |||||||||||||||||
Amount recognized and received for the achievement of a predefined milestone | 15,000 | $ 25,000 | |||||||||||||||
Novartis | JAKAVI | Commercialization Milestones | |||||||||||||||||
License agreements | |||||||||||||||||
Amount recognized and received for the achievement of a predefined milestone | 60,000 | 40,000 | 20,000 | ||||||||||||||
Revenues | $ 900,000 | $ 600,000 | $ 300,000 |
License agreements - Lilly (Det
License agreements - Lilly (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | 112 Months Ended | ||||||||
Mar. 31, 2016 | Jul. 31, 2010 | Dec. 31, 2009 | Jun. 30, 2019 | Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2012 | Dec. 31, 2010 | Mar. 31, 2019 | |
License agreements | ||||||||||||
Research and Development Expense | $ 270,545 | $ 303,103 | ||||||||||
Revenues | 497,857 | 382,282 | ||||||||||
Product royalty revenues | ||||||||||||
License agreements | ||||||||||||
Revenues | 61,608 | 47,716 | ||||||||||
Eli Lilly | ||||||||||||
License agreements | ||||||||||||
Upfront payment received under license agreement | $ 90,000 | |||||||||||
Product royalties in accounts receivable | $ 16,200 | $ 14,000 | $ 16,200 | |||||||||
Eli Lilly | Maximum | ||||||||||||
License agreements | ||||||||||||
Associated future global development costs from the initiation of a Phase IIb trial, if elected to co-develop (as a percentage) | 20.00% | |||||||||||
Eli Lilly | Phase IIB | ||||||||||||
License agreements | ||||||||||||
Funding of future development costs (as a percent) | 30.00% | 30.00% | 30.00% | |||||||||
Research and Development Expense | $ 0 | 12,500 | ||||||||||
Accrued and other liabilities | 0 | 23,100 | 0 | |||||||||
Eli Lilly | Pre-specified Events | Maximum | ||||||||||||
License agreements | ||||||||||||
Upfront and immediate milestone payment to be received under license agreement | 665,000 | |||||||||||
Eli Lilly | Development Milestones | ||||||||||||
License agreements | ||||||||||||
Amount recognized and received for the achievement of a predefined milestone | 20,000 | $ 30,000 | 149,000 | |||||||||
Eli Lilly | Development Milestones | Maximum | ||||||||||||
License agreements | ||||||||||||
Upfront and immediate milestone payment to be received under license agreement | 150,000 | |||||||||||
Eli Lilly | Development Milestones | Phase III | ||||||||||||
License agreements | ||||||||||||
Amount recognized and received for the achievement of a predefined milestone | $ 50,000 | |||||||||||
Eli Lilly | Development Milestones | Phase IIA | ||||||||||||
License agreements | ||||||||||||
Amount recognized and received for the achievement of a predefined milestone | $ 30,000 | |||||||||||
Eli Lilly | Development Milestones | Phase IIB | ||||||||||||
License agreements | ||||||||||||
Amount recognized and received for the achievement of a predefined milestone | $ 19,000 | |||||||||||
Eli Lilly | Regulatory Milestones | ||||||||||||
License agreements | ||||||||||||
Amount recognized and received for the achievement of a predefined milestone | $ 100,000 | $ 235,000 | ||||||||||
Eli Lilly | Regulatory Milestones | JAPAN | ||||||||||||
License agreements | ||||||||||||
Amount recognized and received for the achievement of a predefined milestone | 15,000 | |||||||||||
Eli Lilly | Regulatory Milestones | U.S. | ||||||||||||
License agreements | ||||||||||||
Amount recognized and received for the achievement of a predefined milestone | $ 35,000 | |||||||||||
Eli Lilly | Regulatory Milestones | Europe | ||||||||||||
License agreements | ||||||||||||
Amount recognized and received for the achievement of a predefined milestone | $ 65,000 | $ 20,000 | ||||||||||
Eli Lilly | Regulatory Milestones | Maximum | ||||||||||||
License agreements | ||||||||||||
Upfront and immediate milestone payment to be received under license agreement | 365,000 | |||||||||||
Eli Lilly | Commercialization Milestones | Maximum | ||||||||||||
License agreements | ||||||||||||
Upfront and immediate milestone payment to be received under license agreement | $ 150,000 | |||||||||||
Eli Lilly | Development and Commercialization Milestones | ||||||||||||
License agreements | ||||||||||||
Revenues | 0 | 0 | ||||||||||
Eli Lilly | GVHD | ||||||||||||
License agreements | ||||||||||||
Upfront payment under license agreement | $ 35,000 | |||||||||||
Additional milestone payments under the license agreement | $ 40,000 | |||||||||||
Eli Lilly | Product royalty revenues | ||||||||||||
License agreements | ||||||||||||
Revenues | $ 16,000 | $ 6,400 |
License agreements - Agenus (De
License agreements - Agenus (Details) $ / shares in Units, $ in Thousands, shares in Millions | Feb. 14, 2017USD ($)$ / shares | Feb. 01, 2017USD ($)$ / sharesshares | Feb. 28, 2017USD ($) | Nov. 30, 2015item | Feb. 28, 2015 | Jan. 31, 2015item | Mar. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Mar. 31, 2018USD ($) | Mar. 31, 2017USD ($) | Sep. 30, 2018USD ($) | Jun. 30, 2018USD ($) | |
License agreements | |||||||||||||
Long term investment | $ 120,188 | $ 99,199 | [1] | ||||||||||
Research and development expense | 270,545 | $ 303,103 | |||||||||||
Unrealized gain (loss) on long term investments | 20,989 | 22,679 | |||||||||||
Current assets | 1,904,500 | 1,832,254 | [1] | ||||||||||
Current liabilities | 364,515 | 425,277 | [1] | ||||||||||
Cash and cash equivalents | $ 1,299,704 | 1,163,980 | [1] | ||||||||||
Agenus | |||||||||||||
License agreements | |||||||||||||
Number of program targets | item | 3 | 4 | |||||||||||
Royalty payments on future global net sales (as a percent) | 15.00% | ||||||||||||
Period of notice for termination of license agreement | 12 months | ||||||||||||
Agenus | Development, Regulatory and Commercialization Milestones | Minimum | |||||||||||||
License agreements | |||||||||||||
Royalty payments on future global net sales (as a percent) | 6.00% | ||||||||||||
Agenus | Development, Regulatory and Commercialization Milestones | Maximum | |||||||||||||
License agreements | |||||||||||||
Royalty payments on future global net sales (as a percent) | 12.00% | ||||||||||||
Additional milestone payments under the license agreement | $ 510,000 | ||||||||||||
Agenus | Development Milestones | |||||||||||||
License agreements | |||||||||||||
Upfront payment under license agreement | $ 20,000 | ||||||||||||
Additional milestone payments under the license agreement | $ 5,000 | $ 5,000 | |||||||||||
Agenus | |||||||||||||
License agreements | |||||||||||||
Long term investment | $ 52,600 | 42,300 | |||||||||||
Research and development expense | $ 10,200 | 1,900 | |||||||||||
Shares owned following stock purchase (as a percent) | 11.00% | 9.00% | |||||||||||
Ownership percentage (as a percent) | 13.00% | ||||||||||||
Unrealized gain (loss) on long term investments | $ 10,500 | $ 25,800 | |||||||||||
Total revenues | 6,500 | ||||||||||||
Net income (loss) | 48,800 | ||||||||||||
Agenus | Accrued and other liabilities | |||||||||||||
License agreements | |||||||||||||
Accrued and other liabilities | $ 4,700 | $ 2,300 | |||||||||||
Agenus | Stock purchase agreement | |||||||||||||
License agreements | |||||||||||||
Purchase of common stock under Stock Purchase Agreement (in shares ) | shares | 10 | ||||||||||||
Purchase price of common stock | $ 60,000 | ||||||||||||
Per share price | $ / shares | $ 4.40 | $ 6 | |||||||||||
Discount for lack of marketability | $ 4,500 | ||||||||||||
Fair value of shares on the issuance date | 39,500 | ||||||||||||
Total consideration paid | $ 60,000 | ||||||||||||
Long term investment | $ 39,500 | ||||||||||||
Research and development expense | $ 20,500 | ||||||||||||
[1] | The condensed consolidated balance sheet at December 31, 2018 has been derived from the audited financial statements at that date. |
License agreements - Merus (Det
License agreements - Merus (Details) $ / shares in Units, $ in Thousands, € in Millions, shares in Millions | Jan. 23, 2017USD ($)$ / shares | Feb. 28, 2017USD ($) | Jan. 31, 2017USD ($)item | Dec. 31, 2016USD ($)$ / sharesshares | Mar. 31, 2019USD ($) | Dec. 31, 2018EUR (€) | Mar. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2018USD ($) | |
License agreements | ||||||||||
Long term investment | $ 120,188 | $ 99,199 | [1] | |||||||
Research and development expense | 270,545 | $ 303,103 | ||||||||
Unrealized gain (loss) on long term investments | 20,989 | 22,679 | ||||||||
Current assets | 1,904,500 | 1,832,254 | [1] | |||||||
Current liabilities | 364,515 | 425,277 | [1] | |||||||
Merus | ||||||||||
License agreements | ||||||||||
Number of independent programs | item | 11 | |||||||||
Number of preclinical discovery programs | item | 2 | |||||||||
Number of programs under the resulting products are co-funded for development | item | 1 | |||||||||
Associated future global development costs , if elected to co-develop (as a percent) | 35.00% | |||||||||
Upfront payment under license agreement | $ 120,000 | |||||||||
Research and development expense | 2,600 | 2,400 | ||||||||
Merus | Accrued and other liabilities | ||||||||||
License agreements | ||||||||||
Accrued and other liabilities | 2,500 | 2,900 | ||||||||
Merus | U.S. | ||||||||||
License agreements | ||||||||||
Profit sharing (as a percent) | 50.00% | |||||||||
Percentage of profit (losses) | 50.00% | |||||||||
Merus | Minimum | ||||||||||
License agreements | ||||||||||
Royalty payments on future global net sales (as a percent) | 6.00% | |||||||||
Merus | Minimum | U.S. | ||||||||||
License agreements | ||||||||||
Royalty payments on future global net sales (as a percent) | 6.00% | |||||||||
Merus | Minimum | Non-U.S. | ||||||||||
License agreements | ||||||||||
Royalty payments on future global net sales (as a percent) | 6.00% | |||||||||
Merus | Maximum | ||||||||||
License agreements | ||||||||||
Number of additional preclinical discovery programs | item | 10 | |||||||||
Royalty payments on future global net sales (as a percent) | 10.00% | |||||||||
Percentage of reverse royalty | 4.00% | |||||||||
Merus | Maximum | U.S. | ||||||||||
License agreements | ||||||||||
Royalty payments on future global net sales (as a percent) | 10.00% | |||||||||
Percentage of additional royalties | 4.00% | |||||||||
Merus | Maximum | Non-U.S. | ||||||||||
License agreements | ||||||||||
Royalty payments on future global net sales (as a percent) | 10.00% | |||||||||
Merus | Maximum | Development and Regulatory Milestones | ||||||||||
License agreements | ||||||||||
Additional milestone payments under the license agreement | $ 100,000 | |||||||||
Merus | Maximum | Commercialization Milestones | ||||||||||
License agreements | ||||||||||
Additional milestone payments under the license agreement | $ 250,000 | |||||||||
Merus | ||||||||||
License agreements | ||||||||||
Total revenues | € | € 8.5 | |||||||||
Net income (loss) | € | € (0.5) | |||||||||
Merus | Stock purchase agreement | ||||||||||
License agreements | ||||||||||
Purchase of common stock under Stock Purchase Agreement (in shares ) | shares | 3.2 | |||||||||
Purchase price of common stock | $ 80,000 | |||||||||
Per share price | $ / shares | $ 24.50 | $ 25 | ||||||||
Lock-up period | 18 months | |||||||||
Standstill period | 3 years | |||||||||
Percentage of total shares allowed to sell during any 12-month period (as a percent) | 33.00% | |||||||||
Percentage of total shares allowed to sell during any three-month period (as a percent) | 10.00% | |||||||||
Discount for lack of marketability | $ 5,600 | |||||||||
Fair value of shares on the issuance date | 72,800 | |||||||||
Total consideration paid | $ 80,000 | |||||||||
Long term investment | $ 72,800 | |||||||||
Research and development expense | $ 7,200 | |||||||||
Fair market value of our long term investments | $ 47,300 | $ 44,800 | ||||||||
Ownership percentage (as a percent) | 14.00% | |||||||||
Unrealized gain (loss) on long term investments | $ 2,500 | $ (2,800) | ||||||||
[1] | The condensed consolidated balance sheet at December 31, 2018 has been derived from the audited financial statements at that date. |
License agreements - Calithera
License agreements - Calithera (Details) - USD ($) $ / shares in Units, $ in Thousands, shares in Millions | Jan. 01, 2018 | Jan. 30, 2017 | Mar. 31, 2017 | Jan. 31, 2017 | Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2018 | Jan. 01, 2017 | |
License agreements | ||||||||||
Long term investment | $ 120,188 | $ 99,199 | [1] | |||||||
Research and development expense | 270,545 | $ 303,103 | ||||||||
Net income | 102,312 | (41,140) | ||||||||
Unrealized gain (loss) on long term investments | 20,989 | 22,679 | ||||||||
Calithera | ||||||||||
License agreements | ||||||||||
Funding of future development costs (as a percent) | 70.00% | |||||||||
Upfront payment made under license agreement | $ 45,000 | |||||||||
Potential milestone payments to be made with profit sharing in effect | 430,000 | |||||||||
Potential milestone payments to be made with profit sharing terminated | $ 750,000 | |||||||||
Milestone payment made under license agreement | $ 12,000 | |||||||||
Research and development expense | 4,600 | 2,600 | ||||||||
Calithera | Accrued and other liabilities | ||||||||||
License agreements | ||||||||||
Accrued and other liabilities | 3,200 | |||||||||
Calithera | U.S. | ||||||||||
License agreements | ||||||||||
Percentage of profit (losses) | 60.00% | |||||||||
Calithera | Other Comprehensive Income | ||||||||||
License agreements | ||||||||||
Unrealized gain (loss) on long term investments | 4,700 | $ (3,500) | ||||||||
Calithera | Calithera | Accrued and other liabilities | ||||||||||
License agreements | ||||||||||
Accrued and other liabilities | 2,600 | |||||||||
Calithera | Stock purchase agreement | ||||||||||
License agreements | ||||||||||
Purchase of common stock under Stock Purchase Agreement (in shares ) | 1.7 | |||||||||
Purchase price of common stock | $ 8,000 | |||||||||
Per share price | $ 6.75 | $ 4.65 | ||||||||
Fair market value of our long term investments | $ 11,600 | $ 11,600 | $ 6,900 | |||||||
Total consideration paid | 53,000 | |||||||||
Upfront license fees | 45,000 | |||||||||
Stock purchase price | $ 8,000 | |||||||||
Long term investment | $ 11,600 | |||||||||
Research and development expense | $ 41,400 | |||||||||
Ownership percentage (as a percent) | 4.00% | |||||||||
Calithera | ASU 2016-01 | ||||||||||
License agreements | ||||||||||
Net income | $ 2,800 | |||||||||
[1] | The condensed consolidated balance sheet at December 31, 2018 has been derived from the audited financial statements at that date. |
License agreements - MacroGenic
License agreements - MacroGenics (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | ||||
Nov. 30, 2018 | Sep. 30, 2018 | Dec. 31, 2017 | Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | |
License agreements | ||||||
Research and development | $ 270,545 | $ 303,103 | ||||
MacroGenics | ||||||
License agreements | ||||||
Upfront payment under license agreement | $ 150,000 | |||||
Research and development | $ 5,000 | $ 10,000 | 9,400 | $ 6,500 | ||
MacroGenics | Accrued and other liabilities | ||||||
License agreements | ||||||
Accrued and other liabilities | $ 4,400 | $ 3,200 | ||||
Minimum | MacroGenics | ||||||
License agreements | ||||||
Royalty payments on future global net sales (as a percent) | 15.00% | |||||
Maximum | MacroGenics | ||||||
License agreements | ||||||
Royalty payments on future global net sales (as a percent) | 24.00% | |||||
Development and Regulatory Milestones | Maximum | MacroGenics | ||||||
License agreements | ||||||
Additional milestone payments under the license agreement | $ 420,000 | |||||
Commercialization Milestones | Maximum | MacroGenics | ||||||
License agreements | ||||||
Additional milestone payments under the license agreement | $ 330,000 |
License agreements - Syros (Det
License agreements - Syros (Details) $ / shares in Units, $ in Thousands, shares in Millions | Jan. 08, 2018USD ($)$ / shares | Jan. 01, 2018USD ($)$ / sharesshares | Jan. 31, 2018USD ($)item$ / sharesshares | Mar. 31, 2019USD ($) | Mar. 31, 2018USD ($) | Dec. 31, 2018USD ($) | |
License agreements | |||||||
Long term investment | $ 120,188 | $ 99,199 | [1] | ||||
Research and development expense | 270,545 | $ 303,103 | |||||
Unrealized gain (loss) on long term investments | 20,989 | 22,679 | |||||
Syros Pharmaceuticals, Inc. | |||||||
License agreements | |||||||
Number of program targets | item | 7 | ||||||
Upfront payment under license agreement | $ 10,000 | ||||||
Fair market value of our long term investments | $ 8,600 | 5,200 | |||||
Ownership percentage (as a percent) | 3.00% | ||||||
Unrealized gain (loss) on long term investments | $ 3,300 | $ 3,200 | |||||
Syros Pharmaceuticals, Inc. | Stock purchase agreement | |||||||
License agreements | |||||||
Purchase of common stock under Stock Purchase Agreement (in shares ) | shares | 0.8 | ||||||
Purchase price of common stock | $ 10,000 | ||||||
Per share price | $ / shares | $ 9.77 | $ 12.61 | |||||
Lock-up period | 12 months | ||||||
Discount for lack of marketability | $ 100 | ||||||
Fair value of shares on the issuance date | $ 7,600 | ||||||
Long term investment | 7,600 | ||||||
Research and development expense | 2,400 | ||||||
Syros Pharmaceuticals, Inc. | Amended stock purchase agreement | |||||||
License agreements | |||||||
Purchase of common stock under Stock Purchase Agreement (in shares ) | shares | 0.1 | ||||||
Purchase price of common stock | $ 1,400 | ||||||
Per share price | $ / shares | $ 9.55 | ||||||
Long term investment | $ 1,400 | ||||||
Syros Pharmaceuticals, Inc. | Maximum | |||||||
License agreements | |||||||
Target selection and option exercise fee payment | $ 54,000 | ||||||
Syros Pharmaceuticals, Inc. | Development and Regulatory Milestones | Maximum | |||||||
License agreements | |||||||
Additional milestone payments under the license agreement | 50,000 | ||||||
Syros Pharmaceuticals, Inc. | Commercialization Milestones | Maximum | |||||||
License agreements | |||||||
Additional milestone payments under the license agreement | $ 65,000 | ||||||
[1] | The condensed consolidated balance sheet at December 31, 2018 has been derived from the audited financial statements at that date. |
License agreements - Innovent (
License agreements - Innovent (Details) - Innovent $ in Millions | 1 Months Ended | |
Jan. 31, 2019USD ($) | Dec. 31, 2018USD ($)item | |
License agreements | ||
Upfront and immediate milestone payment to be received under license agreement | $ 40 | |
Product candidates | item | 3 | |
Regulatory Milestones | Maximum | ||
License agreements | ||
Upfront and immediate milestone payment to be received under license agreement | $ 20 | |
Development and Regulatory Milestones | Maximum | ||
License agreements | ||
Upfront and immediate milestone payment to be received under license agreement | 129 | |
Commercialization Milestones | Maximum | ||
License agreements | ||
Upfront and immediate milestone payment to be received under license agreement | $ 202.5 |
Stock compensation (Details)
Stock compensation (Details) - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Stock compensation | ||
Stock compensation expense | $ 40.6 | $ 36.2 |
Stock Compensation Expense Capitalized | $ 0.1 | |
Weighted-average fair value assumptions | ||
Valuation method | Black-Scholes valuation model | |
Dividend yield (as a percent) | 0.00% | |
Research and Development Expense [Member] | ||
Stock compensation | ||
Stock compensation expense | $ 27.4 | 24.2 |
Selling, General and Administrative Expenses [Member] | ||
Stock compensation | ||
Stock compensation expense | 13 | $ 12 |
Cost of product revenues | ||
Stock compensation | ||
Stock compensation expense | $ 0.2 | |
Employee Stock | ||
Weighted-average fair value assumptions | ||
Average risk-free interest rates (as a percent) | 2.27% | 2.26% |
Average expected life (in years) | 3 months | 3 months |
Volatility (as a percent) | 34.00% | 36.00% |
Weighted-average fair value (in dollars per share) | $ 13.31 | $ 18.17 |
Stock Options | ||
Weighted-average fair value assumptions | ||
Average risk-free interest rates (as a percent) | 2.51% | 2.42% |
Average expected life (in years) | 5 years 3 months 29 days | 5 years 6 months 11 days |
Volatility (as a percent) | 45.00% | 45.00% |
Weighted-average fair value (in dollars per share) | $ 31.50 | $ 41.59 |
Unrecognized compensation | ||
Unrecognized compensation cost for nonvested option (in dollars) | $ 133.9 | |
Vesting period of recognition of the unrecognized compensation cost of nonvested awards | 1 year 8 months 12 days | |
Restricted Stock Units (RSUs) | ||
Unrecognized compensation | ||
Unrecognized compensation cost for nonvested option (in dollars) | $ 59.6 | |
Vesting period of recognition of the unrecognized compensation cost of nonvested awards | 1 year 7 months 6 days | |
Performance Stock Units (PSUs) | ||
Unrecognized compensation | ||
Unrecognized compensation cost for nonvested option (in dollars) | $ 27.7 | |
Vesting period of recognition of the unrecognized compensation cost of nonvested awards | 2 years 8 months 12 days |
Stock compensation - Option act
Stock compensation - Option activity (Details) - Stock Options - $ / shares | 1 Months Ended | 3 Months Ended | 6 Months Ended |
Jul. 31, 2016 | Mar. 31, 2019 | Jun. 30, 2016 | |
Shares Available For Grant | |||
Outstanding at the beginning of the period (in shares) | 6,477,577 | ||
Options granted (in shares) | (2,271,592) | ||
Options cancelled (in shares) | 315,321 | ||
Outstanding at the end of the period (in shares) | 4,521,306 | ||
Shares Subject to Outstanding Options, Shares | |||
Outstanding at the beginning of the period (in shares) | 12,285,159 | ||
Options granted (in shares) | 2,271,592 | ||
Options exercised (in shares) | (849,870) | ||
Options cancelled (in shares) | (315,321) | ||
Outstanding at the end of the period (in shares) | 13,391,560 | ||
Shares Subject to Outstanding Options, Weighted Average Exercise Price | |||
Outstanding at the beginning of the period (in dollars per share) | $ 74.39 | ||
Options granted (in dollars per share) | 72.81 | ||
Options exercised (in dollars per share) | 25.38 | ||
Options cancelled (in dollars per share) | 89.29 | ||
Outstanding at the end of the period (in dollars per share) | $ 76.88 | ||
Termination period | 10 years | 7 years | |
Vesting period | 4 years | 3 years | |
Vesting after one year | |||
Shares Subject to Outstanding Options, Weighted Average Exercise Price | |||
Vesting period | 1 year | 1 year | |
Vesting Percentage | 25.00% | 33.00% | |
Remainder vesting | |||
Shares Subject to Outstanding Options, Weighted Average Exercise Price | |||
Vesting period | 36 months | 24 months |
Stock compensation - RSU and PS
Stock compensation - RSU and PSU award activity (Details) - $ / shares | 1 Months Ended | 3 Months Ended | |
Jul. 31, 2018 | Jun. 30, 2018 | Mar. 31, 2019 | |
Restricted Stock Units (RSUs) | |||
Shares Available For Grant | |||
Shares Available for Grant Beginning Balance (in shares) | 545,751 | ||
Granted (in shares) | (165,251) | ||
Cancelled (in shares) | 55,591 | ||
Shares Available for Grant Ending Balance (in shares) | 401,040 | ||
Shares Subject to Outstanding Options, Shares | |||
Outstanding at the beginning of the period (in shares) | 2,043,337 | ||
Granted (in shares) | 190,000,000 | 165,251 | |
Cancelled (in shares) | (55,591) | ||
Released (in shares) | (213,604) | ||
Outstanding at the end of the period (in shares) | 1,974,444 | ||
Shares Subject to Outstanding Options, Weighted Average Exercise Price | |||
Outstanding at the beginning of the period (in dollars per share) | $ 80.35 | ||
Granted (in dollars per share) | 73.69 | ||
Cancelled (in dollars per share) | 89.46 | ||
Released (in dollars per share) | 89.38 | ||
Outstanding at the end of the period (in dollars per share) | $ 78.29 | ||
Performance Stock Units (PSUs) | |||
Shares Available For Grant | |||
Achieved (in shares) | (44,940) | ||
Cancelled (in shares) | 9,889 | ||
Shares Subject to Outstanding Options, Shares | |||
Granted (in shares) | 77,243 | 446,500,000 | |
Achieved (in shares) | 44,940 | ||
Cancelled (in shares) | (9,889) | ||
Shares Subject to Outstanding Options, Weighted Average Exercise Price | |||
Achieved (in dollars per share) | $ 65.76 | ||
Cancelled (in dollars per share) | $ 67.32 |
Stock compensation - RSU and _2
Stock compensation - RSU and PSU Narrative (Details) - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||
Jul. 31, 2018 | Jun. 30, 2018 | Jul. 31, 2016 | Jan. 31, 2014 | Mar. 31, 2019 | Mar. 31, 2018 | Jun. 30, 2016 | Dec. 31, 2018 | |
Stock Compensation Plans | ||||||||
Allocated Share-based Compensation Expense | $ 40.6 | $ 36.2 | ||||||
Assumed annualized forfeiture rate (as a percent) | 5.00% | |||||||
Stock Options | ||||||||
Stock Compensation Plans | ||||||||
Vesting period | 4 years | 3 years | ||||||
Restricted Stock Units (RSUs) | ||||||||
Stock Compensation Plans | ||||||||
Number of shares awarded for each RSU (in shares) | 1 | |||||||
Percentage of units vesting at the end of each calendar year (as a percent) | 25.00% | |||||||
Vesting period | 4 years | |||||||
Granted (in shares) | 190,000,000 | 165,251 | ||||||
Outstanding (in shares) | 401,040 | 545,751 | ||||||
Service period | 3 years | |||||||
Restricted Stock Units (RSUs) | President And Chief Executive Officer | ||||||||
Stock Compensation Plans | ||||||||
Percentage of units vesting at the end of each calendar year (as a percent) | 16.70% | |||||||
Granted (in shares) | 400,000 | |||||||
Vested (in shares) | 333,334 | |||||||
Outstanding (in shares) | 66,666 | |||||||
Performance Stock Units (PSUs) | ||||||||
Stock Compensation Plans | ||||||||
Vesting period | 4 years | |||||||
Multiplier conversion rate of units into common stock (as a percent) | 150.00% | |||||||
Granted (in shares) | 77,243 | 446,500,000 | ||||||
Multiplying factor | 83.00% | |||||||
Performance Stock Units (PSUs) | Minimum | ||||||||
Stock Compensation Plans | ||||||||
Vesting period | 3 years | |||||||
Performance Stock Units (PSUs) | Maximum | ||||||||
Stock Compensation Plans | ||||||||
Vesting period | 4 years | |||||||
Performance Stock Units (PSUs) | Long term incentive plan | ||||||||
Stock Compensation Plans | ||||||||
Granted (in shares) | 106,500 | |||||||
Performance Stock Units (PSUs) | Long term incentive plan | Maximum | ||||||||
Stock Compensation Plans | ||||||||
Multiplier conversion rate of units into common stock (as a percent) | 267.00% |
Accrued and other current lia_3
Accrued and other current liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 | |
Accrued and Other Current Liabilities | |||
Royalties | $ 20,077 | $ 25,087 | |
Clinical related costs | 65,874 | 98,607 | |
Sales allowances | 69,359 | 44,770 | |
Construction in progress | 16,087 | 7,673 | |
Finance lease liabilities | 18,696 | ||
Operating lease liabilities | 10,245 | ||
Other current liabilities | 39,905 | 34,568 | |
Total accrued and other current liabilities | $ 211,302 | $ 229,401 | [1] |
[1] | The condensed consolidated balance sheet at December 31, 2018 has been derived from the audited financial statements at that date. |
Debt - Components of convertibl
Debt - Components of convertible notes (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 | |
Convertible Notes | |||
Convertible senior notes noncurrent | $ 17,647 | $ 17,434 | [1] |
Carrying Amount | |||
Convertible Notes | |||
Convertible senior notes | 17,647 | 17,434 | |
Convertible senior notes noncurrent | $ 17,647 | 17,434 | |
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 | Carrying Amount | |||
Convertible Notes | |||
Convertible senior notes | $ 17,647 | $ 17,434 | |
[1] | The condensed consolidated balance sheet at December 31, 2018 has been derived from the audited financial statements at that date. |
Debt - Carrying amount and Fair
Debt - Carrying amount and Fair Value (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Carrying Amount | ||
Convertible Notes | ||
Convertible senior notes | $ 17,647 | $ 17,434 |
Fair Value | ||
Convertible Notes | ||
Convertible senior notes | $ 32,048 | 25,073 |
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 | Carrying Amount | ||
Convertible Notes | ||
Convertible senior notes | $ 17,647 | 17,434 |
Convertible Senior Notes 1.25 Percent Due 2020 | Fair Value | ||
Convertible Notes | ||
Convertible senior notes | $ 32,048 | $ 25,073 |
Debt - Narrative (Details)
Debt - Narrative (Details) | 3 Months Ended | |
Mar. 31, 2019item | Mar. 31, 2018shares | |
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 | |
Number of consecutive trading days before five consecutive business days during the note measurement period | 5 | |
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% | |
Number of scheduled trading days preceding relevant maturity date at which Notes are convertible regardless of other circumstances | 2 days | |
Convertible Senior Notes 0.375 Percent Due 2018 | ||
Convertible Notes | ||
Interest rate of debt (as a percent) | 0.375% | |
Common stock issued in exchange of notes (in shares) | shares | 539 | |
Convertible Senior Notes 1.25 Percent Due 2020 | ||
Convertible Notes | ||
Interest rate of debt (as a percent) | 1.25% |
Employee benefit plans - Define
Employee benefit plans - Defined Contribution Plan (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Employee benefit plans | ||
Defined contribution expense | $ 2.9 | $ 2.7 |
Employee benefit plans - Period
Employee benefit plans - Periodic Benefit Cost (Details) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | |
Employee benefit plans | |||
Employer Service cost | $ 1,263 | $ 1,079 | |
Interest cost | 84 | 71 | |
Expected return on plan assets | (60) | (50) | |
Amortization of prior service cost | 45 | 45 | |
Amortization of actuarial losses | 66 | 66 | |
Net periodic benefit cost | $ 1,398 | $ 1,211 | |
Location of costs excluding the service component | us-gaap:OtherNonoperatingIncomeExpense | us-gaap:OtherNonoperatingIncomeExpense | |
Expected contributions | $ 3,500 | ||
Accrued pension obligation | $ 15,800 | $ 15,700 |
Income taxes (Details)
Income taxes (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Income taxes | ||
Income tax (benefit) expense | $ 1,785 | $ 786 |
Increase in unrecognized tax benefits | 400 | |
Additions related to prior periods tax positions | $ 100 |
Net income (loss) per share (De
Net income (loss) per share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Basic Net Income (Loss) Per Share | ||
Basic net income (loss) | $ 102,312 | $ (41,140) |
Weighted average common shares outstanding | 214,065,000 | 211,681,000 |
Basic net income (loss) per share | $ 0.48 | $ (0.19) |
Diluted Net Income (Loss) Per Share | ||
Diluted net income (loss) | $ 102,312 | $ (41,140) |
Weighted average common shares outstanding | 214,065,000 | 211,681,000 |
Dilutive stock options and RSU’s | 2,996,000 | |
Weighted average shares used to compute diluted net income (loss) per share | 217,061,000 | 211,681,000 |
Diluted net income (loss) per share | $ 0.47 | $ (0.19) |
Anti-dilutive securities | ||
Potential common shares excluded from diluted net loss per share computation | 9,686,952 | 13,622,486 |
Stock Options | ||
Anti-dilutive securities | ||
Potential common shares excluded from diluted net loss per share computation | 9,318,013 | 13,104,711 |
Convertible Senior Notes 0.375 Percent Due 2018 | ||
Anti-dilutive securities | ||
Potential common shares excluded from diluted net loss per share computation | 148,836 | |
Convertible Senior Notes 1.25 Percent Due 2020 | ||
Anti-dilutive securities | ||
Potential common shares excluded from diluted net loss per share computation | 368,939 | 368,939 |