Document And Entity Information
Document And Entity Information | 9 Months Ended |
Sep. 30, 2017shares | |
Document and Entity Information [Abstract] | |
Entity Registrant Name | INTERCEPT PHARMACEUTICALS INC |
Entity Central Index Key | 1,270,073 |
Current Fiscal Year End Date | --12-31 |
Entity Filer Category | Large Accelerated Filer |
Trading Symbol | icpt |
Entity Common Stock, Shares Outstanding | 25,102,079 |
Document Type | 10-Q |
Amendment Flag | false |
Document Period End Date | Sep. 30, 2017 |
Document Fiscal Period Focus | Q3 |
Document Fiscal Year Focus | 2,017 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Current assets: | ||
Cash and cash equivalents | $ 120,244 | $ 43,675 |
Investment securities, available-for-sale | 372,506 | 645,710 |
Accounts receivable, net | 14,487 | 9,126 |
Prepaid expenses and other current assets | 14,278 | 9,354 |
Total current assets | 521,515 | 707,865 |
Fixed assets, net | 18,141 | 11,295 |
Inventory, net | 3,897 | 2,279 |
Security deposits | 16,873 | 17,814 |
Total assets | 560,426 | 739,253 |
Current liabilities: | ||
Accounts payable, accrued expenses and other liabilities | 82,070 | 65,551 |
Short-term interest payable | 3,737 | 7,267 |
Short-term portion of deferred revenue | 1,782 | 5,694 |
Total current liabilities | 87,589 | 78,512 |
Long-term liabilities: | ||
Long-term debt | 351,984 | 341,356 |
Long-term other liabilities | 6,068 | |
Long-term portion of deferred revenue | 3,118 | 4,453 |
Total liabilities | 448,759 | 424,321 |
Stockholders' equity: | ||
Preferred stock par value $0.001 per share; 5,000,000 shares authorized; none outstanding as of September 30, 2017 and December 31, 2016, respectively | ||
Common stock par value $0.001 per share; 45,000,000 shares authorized; 25,102,079 and 24,819,918 shares issued and outstanding as of September 30, 2017 and December 31, 2016, respectively | 25 | 25 |
Additional paid-in capital | 1,470,545 | 1,426,168 |
Accumulated other comprehensive loss, net | (632) | (2,801) |
Accumulated deficit | (1,358,271) | (1,108,460) |
Total stockholders' equity | 111,667 | 314,932 |
Total liabilities and stockholders' equity | $ 560,426 | $ 739,253 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2017 | Dec. 31, 2016 |
Statement Of Financial Position [Abstract] | ||
Preferred stock, par or stated value per share | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, authorized | 45,000,000 | 45,000,000 |
Common stock, shares, issued | 25,102,079 | 24,819,918 |
Common stock, shares, outstanding | 25,102,079 | 24,819,918 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Income Statement [Abstract] | ||||
Product revenue, net | $ 40,889 | $ 4,732 | $ 91,933 | $ 4,807 |
Licensing revenue | 445 | 445 | 1,336 | 6,336 |
Total revenue | 41,334 | 5,177 | 93,269 | 11,143 |
Operating expenses: | ||||
Cost of sales | 172 | 548 | ||
Selling, general and administrative | 61,356 | 52,802 | 189,363 | 197,382 |
Research and development | 45,977 | 35,411 | 134,001 | 102,292 |
Total operating expenses | 107,505 | 88,213 | 323,912 | 299,674 |
Operating loss | (66,171) | (83,036) | (230,643) | (288,531) |
Other income (expense): | ||||
Interest expense | (7,354) | (7,065) | (21,840) | (7,065) |
Other income, net | 924 | 1,286 | 3,388 | 2,807 |
Total other income (expense) | (6,430) | (5,779) | (18,452) | (4,258) |
Net loss | $ (72,601) | $ (88,815) | $ (249,095) | $ (292,789) |
Net Loss Per Share [Abstract] | ||||
Net loss per share, basic and diluted (in dollars per share) | $ (2.89) | $ (3.59) | $ (9.96) | $ (11.90) |
Weighted average shares outstanding, basic and diluted | 25,104 | 24,738 | 25,021 | 24,614 |
Condensed Consolidated Stateme5
Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Comprehensive Loss: | ||||
Net loss | $ (72,601) | $ (88,815) | $ (249,095) | $ (292,789) |
Unrealized holding gains (losses) arising during the period | 409 | (1,073) | 1,114 | 966 |
Reclassification for recognized losses on marketable investment securities during the period | (52) | |||
Net unrealized gains (losses) on marketable investment securities | 409 | (1,073) | 1,114 | 914 |
Foreign currency translation adjustments | 488 | (691) | 1,055 | (1,585) |
Comprehensive loss | $ (71,704) | $ (90,579) | $ (246,926) | $ (293,460) |
Condensed Consolidated Stateme6
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Cash flows from operating activities: | ||
Net loss | $ (249,095) | $ (292,789) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 41,584 | 27,041 |
Amortization of investment premium | 2,777 | 3,736 |
Amortization of deferred financing costs | 1,052 | 326 |
Depreciation | 3,256 | 2,187 |
Accretion of debt discount | 9,576 | 3,001 |
Realized gain on investments | 52 | |
Changes in operating assets: | ||
Prepaid expenses and other current assets | (4,924) | (984) |
Accounts receivable | (5,361) | |
Inventory | (1,618) | |
Security deposits | (1,803) | |
Changes in operating liabilities: | ||
Accounts payable, accrued expenses, and other current liabilities | 16,519 | 1,699 |
Long-term other liabilities | 6,068 | |
Interest payable | (3,530) | 3,738 |
Deferred revenue | (5,247) | 817 |
Net cash used in operating activities | (188,943) | (252,979) |
Cash flows from investing activities: | ||
Purchases of investment securities | (127,002) | (443,323) |
Refund of security deposits | 941 | |
Sales of investment securities | 398,543 | 361,019 |
Purchases of equipment, leasehold improvements, and furniture and fixtures | (10,102) | (4,005) |
Net cash provided by (used in) investing activities | 262,380 | (86,309) |
Cash flows from financing activities: | ||
Payments for capped call transactions and associated costs | (38,364) | |
Proceeds from issuance of Convertible Notes, net of issuance costs | 447,715 | |
Proceeds from exercise of options, net | 2,077 | 4,429 |
Net cash provided by financing activities | 2,077 | 413,780 |
Effect of exchange rate changes | 1,055 | (2,018) |
Net increase in cash and cash equivalents | 76,569 | 72,474 |
Cash and cash equivalents - beginning of period | 43,675 | 32,742 |
Cash and cash equivalents - end of period | $ 120,244 | $ 105,216 |
Overview of Business
Overview of Business | 9 Months Ended |
Sep. 30, 2017 | |
Overview of Business and Basis of Presentation [Abstract] | |
Overview of Business | 1. Overview of Business Intercept Pharmaceuticals, Inc. (“Intercept” or the “Company”) is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat non-viral, progressive liver diseases, including primary biliary cholangitis (“PBC”), nonalcoholic steatohepatitis (“NASH”), primary sclerosing cholangitis (“PSC”) and biliary atresia. Founded in 2002 in New York, Intercept now has operations in the United States, Europe and Canada. |
Basis of Presentation
Basis of Presentation | 9 Months Ended |
Sep. 30, 2017 | |
Overview of Business and Basis of Presentation [Abstract] | |
Basis of Presentation | 2. Basis of Presentation The Company’s financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). All intercompany accounts and transactions have been eliminated. Certain information that is normally required by U.S. GAAP has been condensed or omitted in accordance with rules and regulations of the Securities and Exchange Commission (“SEC”). Operating results for the three and nine months ended September 30, 2017 are not necessarily indicative of the results that may be expected for any future period or for the year ending December 31, 2017. In the opinion of management, these unaudited condensed consolidated financial statements include all normal and recurring adjustments considered necessary for a fair presentation of these interim unaudited condensed consolidated financial statements. These unaudited condensed consolidated financial statements should be read in conjunction with the Company's audited consolidated financial statements and the notes thereto for the year ended December 31, 2016 , included in the Company’s 2016 Annual Report on Form 10-K filed with the SEC. Certain reclassifications have been made to prior period amounts in the Company’s unaudited condensed consolidated statements of operations to conform to the current period presentation. The Company reclassified certain medical affairs costs of $8.4 million and $20.3 million from research and development expense to selling, general and administrative expense on the unaudited condensed consolidated statements of operations during the three and nine months ended September 30, 2016. Use of Estimates The preparation of these unaudited consolidated condensed financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, expenses, revenues and related disclosures. Significant estimates include: clinical trial accruals, revenues and share-based compensation expense. The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances. Actual results may differ from those estimates or assumptions . |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2017 | |
Summary of Significant Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 3. Summary of Significant Accounting Policies The Company’s significant accounting policies are described in Note 3 of Notes to Consolidated Financial Statements included in its Annual Report on Form 10-K for the year ended December 31, 2016 . Revenue Recognition Product Revenue, Net Revenue is recognized when the four basic criteria of revenue recognition are met: (1) persuasive evidence that an arrangement exists; (2) delivery has occurred or services have been rendered; (3) the fee is fixed or determinable; and (4) collectability is reasonably assured. When the revenue recognition criteria are not met, we defer the recognition of revenue by recording deferred revenue on the balance sheet until such time that all criteria are met. The Company commenced its commercial launch of Ocaliva ® (obeticholic acid or “OCA”) for the treatment of PBC in the United States in June 2016. In December 2016, the European Commission granted conditional approval for the treatment of PBC and the Company commenced launch in January of 2017. In May 2017, Health Canada granted a conditional approval for the treatment of PBC and the Company commenced launch in July of 2017. The Company sells Ocaliva to a limited number of specialty pharmacies which dispense the product directly to patients. The specialty pharmacies are referred to as the Company’s customers. The Company provides the right of return to its customers for unopened product for a limited time before and after its expiration date. Prior to July 2017, given the Company’s limited sales history for Ocaliva and the inherent uncertainties in estimating product returns, the Company determined that the shipments of Ocaliva made to its customers did not meet the criteria for revenue recognition at the time of shipment. Accordingly, the Company recognized revenue when the product was sold through by its customers, provided all other revenue recognition criteria were met. The Company invoiced its customers upon shipment of Ocaliva to them and recorded accounts receivable, with a corresponding liability for deferred revenue equal to the gross invoice price. The Company then recognized revenue when Ocaliva was sold through as specialty pharmacies dispensed product directly to the patients (sell-through basis). The Company re-evaluated its revenue recognition policy in the third quarter of 2017, which included the accumulation and review of customer related transactions since the Company’s commercial launch in the second quarter of 2016. The Company now believes it has accumulated sufficient data to reasonably estimate product returns and, therefore, it will now effectively recognize revenue at the time of shipment to its customers (sell-in basis). During the third quarter of 2017, the Company recorded an adjustment related to this change in estimate to recognize previously deferred revenue. The net effect was an increase in net sales of Ocaliva of $4.1 million for the three and nine months ended September 30, 2017. The Company also established a new reserve of $0.7 million during the third quarter of 2017 related to future returns from its customers under its various contracts. The Company recognized net sales of Ocaliva of $40.9 million and $4.7 million for the three months ended September 30, 2017 and 2016, respectively, and $91.9 million and $4.8 million for the nine months ended September 30, 2017 and 2016, respectively. The Company has written contracts with each of its customers and delivery occurs when the customer receives Ocaliva. The Company evaluates the creditworthiness of each of its customers to determine whether collection is reasonably assured. In order to conclude that the price is fixed and determinable, the Company must be able to (i) calculate its gross product revenues from the sales to its customers and (ii) reasonably estimate its net product revenues. The Company calculates gross product revenues based on the wholesale acquisition cost that the Company charges its customers for Ocaliva. The Company estimates its net product revenues by deducting from its gross product revenues (i) trade allowances, such as invoice discounts for prompt payment and customer fees, (ii) estimated government rebates and discounts related to Medicare, Medicaid and other government programs, and (iii) estimated costs of incentives offered to certain indirect customers including patients. Recent Accounting Pronouncements In May 2014, the Financial Accounting Standards Board (“ FASB”) issued ASU 2014-09, Revenue from Contracts with Customers (“ASU 2014-09”). ASU 2014-09 supersedes the revenue recognition requirements of FASB ASC Topic 605, Revenue Recognition and most industry-specific guidance throughout the ASC, resulting in the creation of FASB ASC Topic 606, Revenue from Contracts with Customers. ASU 2014-09 requires entities to recognize revenue in a way that depicts the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled to in exchange for those goods or services. This ASU provides alternative methods of adoption. In August 2015, the FASB issued ASU 2015-14, Revenue from Contracts with Customers, Deferral of the Effective Date (“ASU 2015-14”). ASU 2015-14 defers the effective date of ASU 2014-09 by one year to December 15, 2017 for fiscal years, and interim periods within those years, beginning after that date and permits early adoption of the standard, but not before the original effective date for fiscal years beginning after December 15, 2016. In March 2016, the FASB issued ASU 2016-08, Revenue from Contracts with Customers, Principal versus Agent Considerations (Reporting Revenue Gross versus Net) (“ASU 2016-08”) clarifying the implementation guidance on principal versus agent considerations. Specifically, an entity is required to determine whether the nature of a promise is to provide the specified good or service itself (that is, the entity is a principal) or to arrange for the good or service to be provided to the customer by the other party (that is, the entity is an agent). The determination influences the timing and amount of revenue recognition. In April 2016, the FASB issued ASU 2016-10, Revenue from Contracts with Customers, Identifying Performance Obligations and Licensing, clarifying the implementation guidance on identifying performance obligations and licensing. Specifically, the amendments reduce the cost and complexity of identifying promised goods or services and improves the guidance for determining whether promises are separately identifiable. The amendments also provide implementation guidance on determining whether an entity’s promise to grant a license provides a customer with either a right to use the entity’s intellectual property (which is satisfied at a point in time) or a right to access the entity’s intellectual property (which is satisfied over time). The effective date and transition requirements for ASU 2016-08 and ASU 2016-10 are the same as the effective date and transition requirements for ASU 2014-09. The Company is currently evaluating which transition approach it will utilize and the impact of adopting ASU 2014-09, ASU 2016-08 and ASU 2016-10 on its consolidated financial statements and related disclosures. The Company continues to execute on its implementation plan for ASC 606 and its assessment of the impact that adoption will have on the Company’s consolidated financial statements; specifically, as it relates to different revenue streams within a given contract and the impact adoption of ASC 606 could have on the Company’s financial statement disclosures. The Company will adopt Topic 606 in the first quarter of 2018 using the modified retrospective method which consists of applying and recognizing the cumulative effect of Topic 606 at the date of initial application and providing certain additional disclosures as defined per Topic 606. The Company is in the process of reviewing variable consideration, potential disclosures, and our method of adoption to complete our evaluation of the impact on our consolidated financial statements prior to the end of 2017. In addition, we continue to monitor additional changes, modifications, clarifications or interpretations undertaken by the FASB, which may impact our current conclusions. On August 27, 2014, the FASB issued ASU 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (“ASU 2014-15”), which requires an entity to evaluate whether conditions or events, in the aggregate, raise substantial doubt about the entity’s ability to continue as a going concern for one year from the date the financial statements are issued or are available to be issued. The guidance became effective January 1, 2017. The Company adopted ASU No. 2014-15 on January 1, 2017, and its adoption did not have a material impact on the Company’s financial statements . In January 2016, FASB issued ASU 2016-01, Recognition and Measurement of Financial Assets and Financial Liabilities (“ASU 2016-01”) . ASU 2016-01 requires equity investments to be measured at fair value with changes in fair value recognized in net income; simplifies the impairment assessment of equity investments without readily determinable fair values by requiring a qualitative assessment to identify impairment; eliminates the requirement for public business entities to disclose the method(s) and significant assumptions used to estimate the fair value that is required to be disclosed for financial instruments measured at amortized cost on the balance sheet; requires public business entities to use the exit price notion when measuring the fair value of financial instruments for disclosure purposes; requires an entity to present separately in other comprehensive income the portion of the total change in the fair value of a liability resulting from a change in the instrument-specific credit risk when the entity has elected to measure the liability at fair value in accordance with the fair value option for financial instruments; requires separate presentation of financial assets and financial liabilities by measurement category and form of financial assets on the balance sheet or the accompanying notes to the financial statements and clarifies that an entity should evaluate the need for a valuation allowance on a deferred tax asset related to available-for-sale securities in combination with the entity’s other deferred tax assets. ASU 2016-01 is effective for financial statements issued for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years. The Company is currently evaluating the impact that the adoption of ASU 2016-01 will have on its consolidated financial statements and related disclosures. In February 2016, the FASB issued ASU 2016-02, Leases (“ASU 2016-02”) which supersedes Topic 840, Leases. ASU 2016-02 requires lessees to recognize a right-of-use asset and a lease liability on their balance sheets for all the leases with terms greater than twelve months. Based on certain criteria, leases will be classified as either financing or operating, with classification affecting the pattern of expense recognition in the income statement. For leases with a term of twelve months or less, a lessee is permitted to make an accounting policy election by class of underlying asset not to recognize lease assets and lease liabilities. If a lessee makes this election, it should recognize lease expense for such leases generally on a straight-line basis over the lease term. ASU 2016-02 is effective for fiscal years beginning after December 15, 2018, and interim periods within those years, with early adoption permitted. In transition, lessees and lessors are required to recognize and measure leases at the beginning of the earliest period presented using a modified retrospective approach. The modified retrospective approach includes a number of optional practical expedients primarily focused on leases that commenced before the effective date of Topic 842, including continuing to account for leases that commence before the effective date in accordance with previous guidance, unless the lease is modified. The Company is evaluating the impact of the adoption of the standard on its consolidated financial statements and related disclosures. In March 2016, the FASB issued ASU 2016-09, Improvements to Employee Share-Based Payment Accounting (“ASU 2016-09”) which is intended to improve the accounting for share-based payment transactions as part of the FASB’s simplification initiative. The ASU changes certain aspects of the accounting for share-based payment award transactions, including: (1) accounting for income taxes; (2) classification of excess tax benefits on the statement of cash flows; (3) forfeitures; (4) minimum statutory tax withholding requirements; and (5) classification of employee taxes paid on the statement of cash flows when an employer withholds shares for tax withholding purposes. The ASU is effective for fiscal years beginning after December 15, 2016, and interim periods within those years for public business entities. The Company adopted ASU 2016-09 during the first quarter of 2017. In connection with the adoption of this ASU, the Company elected to account for forfeitures as they occur and applied this change in accounting policy on a modified retrospective basis. As a result, the Company recorded a cumulative-effect adjustment to retained earnings which resulted in an increase to accumulated deficit of $0.7 million with an offsetting increase to additional paid-in capital (zero net total equity impact) as of the date of adoption, related to additional stock compensation expense that would have been recognized on unvested outstanding options unadjusted for estimated forfeitures. As a result of this guidance, the Company also recorde d $58.7 million of additional deferred tax assets, which are fully offset by a valuation allowance. Other provisions of ASU 2016-09 had no impact on the Company’s consolidated financial statements. In May 2017, the FASB issued ASU 2017-09, Compensation—Stock Compensation (Topic 718): Scope of Modification Accounting, which clarifies when to account for a change to the terms or conditions of a share-based payment award as a modification. Under the new guidance, modification accounting is required only if the fair value, the vesting conditions, or the classification of the award (as equity or liability) changes as a result of the change in terms or conditions. It is effective prospectively for the annual period ending December 31, 2018 and interim periods within that annual period. Early adoption is permitted. The Company is evaluating the impact of adoption of the standard on the consolidated financial statements and related disclosures, but does not expect it to have a significant impact. In July 2017, the FASB issued ASU 2017-11, Earnings Per Share (Topic 260), Distinguishing Liabilities from Equity (Topic 480) and Derivatives and Hedging (Topic 815): I. Accounting for Certain Financial Instruments with Down Round Features; II. Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception, (ASU 2017-11). Part I of this update addresses the complexity of accounting for certain financial instruments with down round features. Down round features are features of certain equity-linked instruments (or embedded features) that result in the strike price being reduced on the basis of the pricing of future equity offerings. Current accounting guidance creates cost and complexity for entities that issue financial instruments (such as warrants and convertible instruments) with down round features that require fair value measurement of the entire instrument or conversion option. Part II of this update addresses the difficulty of navigating Topic 480, Distinguishing Liabilities from Equity, because of the existence of extensive pending content in the FASB Accounting Standards Codification. This pending content is the result of the indefinite deferral of accounting requirements about mandatorily redeemable financial instruments of certain nonpublic entities and certain mandatorily redeemable noncontrolling interests. The amendments in Part II of this update do not have an accounting effect. This ASU is effective for fiscal years, and interim periods within those years, beginning after December 15, 2018. The Company is currently assessing the potential impact of adopting ASU 2017-11 on its financial statements and related disclosures , but does not expect it to have a significant impact . |
Significant Agreements
Significant Agreements | 9 Months Ended |
Sep. 30, 2017 | |
Significant Agreements [Abstract] | |
Significant Agreements | 4. Significant Agreements Sumitomo Dainippon Pharma Co, Ltd. (Sumitomo Dainippon) In March 2011, the Company entered into an exclusive license agreement with Sumitomo Dainippon to research, develop and commercialize OCA as a therapeutic for the treatment of PBC and NASH in Japan and China (excluding Taiwan). Under the terms of the license agreement, the Company received an up-front payment from Sumitomo Dainippon of $15.0 million and may be eligible to receive additional milestone payments of up to an aggregate of approximately $30.0 million in development milestones based on the initiation or completion of clinical trials, $70.0 million in regulatory approval milestones and $200.0 million in sales milestones. The regulatory approval milestones include $15.0 million for receiving marketing approval of OCA for NASH in Japan, $10.0 million for receiving marketing approval of OCA for NASH in China, and $5.0 million for receiving marketing approval of OCA for PBC in the United States, which was achieved upon the FDA approval of Ocaliva for the treatment of PBC in May 2016. As of September 30, 2017 , the Company had achieved $6.0 million of the development milestones under its collaboration agreement with Sumitomo Dainippon. The sales milestones are based on aggregate sales amounts of OCA in the Sumitomo Dainippon territory and include $5.0 million for achieving net sales of $50.0 million, $10.0 million for achieving net sales of $100.0 million, $20.0 million for achieving net sales of $200.0 million, $40.0 million for achieving net sales of $400.0 million and $120.0 million for achieving net sales of $1.2 billion. The Company has determined that each potential future development, regulatory and sales milestone is substantive. In May 2014, Sumitomo Dainippon exercised its option under the license agreement to add Korea as part of its licensed territories and paid the Company a $1.0 million up-front fee. Sumitomo Dainippon has the option to add several other Asian countries to its territory to pursue OCA for additional indications. Sumitomo Dainippon will be responsible for the costs of developing and commercializing OCA in its territories. Sumitomo Dainippon is also required to make royalty payments ranging from the tens to the twenties in percent based on net sales of OCA products in the Sumitomo Dainippon territory. The Company evaluated the license agreement with Sumitomo Dainippon and determined that it is a revenue arrangement with multiple deliverables, or performance obligations. The Company’s substantive performance obligations under this license include an exclusive license to its technology, technical and scientific support to the development plan and participation on a joint steering committee. The Company determined that these performance obligations represent a single unit of accounting, since, initially, the license does not have stand-alone value to Sumitomo Dainippon without the Company’s technical expertise and steering committee participation during the development of OCA. This development period is currently estimated as continuing through June 2020 and, as such, the up-front payment and payments made in respect of the Korea option are being recognized ratably over this period. During the three months ended September 30, 2017 and 2016 , the Company recorded licensing revenue of approximately $0 .4 million and $0.4 million, respectively. During the nine months ended September 30, 2017 and 2016 , the Company recorded licensing revenue of approximately $1.3 million and $6.3 million, respectively. |
Cash, Cash Equivalents and Inve
Cash, Cash Equivalents and Investments | 9 Months Ended |
Sep. 30, 2017 | |
Cash, Cash Equivalents, and Investments [Abstract] | |
Cash, Cash Equivalents, and Investments | 5. Cash, Cash Equivalents and Investments The following table summarizes the Company’s cash, cash equivalents and investments as of September 30, 2017 and December 31, 2016 : As of September 30, 2017 Gross Gross Unrealized Unrealized Amortized Cost Gains Losses Fair Value (In thousands) Cash and cash equivalents: Cash and money market funds $ 120,244 $ - $ - $ 120,244 Investment securities: Commercial paper 11,468 - (4) 11,464 Corporate debt securities 342,252 1 (433) 341,820 U.S. government and agency securities 19,248 - (26) 19,222 Total investments 372,968 1 (463) 372,506 Total cash, cash equivalents and investments $ 493,212 $ 1 $ (463) $ 492,750 As of December 31, 2016 Gross Gross Unrealized Unrealized Amortized Cost Gains Losses Fair Value (In thousands) Cash and cash equivalents: Cash and money market funds $ 43,675 $ - $ - $ 43,675 Investment securities: Commercial paper 66,185 - (71) 66,114 Corporate debt securities 554,847 14 (1,443) 553,418 U.S. government and agency securities 26,254 - (76) 26,178 Total investments 647,286 14 (1,590) 645,710 Total cash, cash equivalents and investments $ 690,961 $ 14 $ (1,590) $ 689,385 As of September 30, 2017 , the Company held a total o f forty eight position s t hat w ere in a continuous unrealized loss position for more than twelve months. The Company has determined that the unrealized losses are deemed to be temporary impairments as of September 30, 2017 . The Company believes that the unrealized losses generally are caused by increases in the risk premiums required by market participants rather than an adverse change in cash flows or a fundamental weakness in the credit quality of the issuer or underlying assets. Because the Company has the ability and intent to hold these investments until a recovery of fair value, which may be maturity, it does not consider the investment s to be other-than-temporarily impaired at September 30, 2017 . |
Fixed Assets, Net
Fixed Assets, Net | 9 Months Ended |
Sep. 30, 2017 | |
Fixed Assets, Net [Abstract] | |
Fixed Assets, Net | 6. Fixed Assets, Net Fixed assets are stated at cost and depreciated or amortized using the straight-line method based on useful lives as follows: Useful lives (Years) September 30, 2017 December 31, 2016 (In thousands) Office equipment and software 3 $ 5,044 $ 4,942 Leasehold improvements Over life of lease 15,280 6,668 Furniture and fixtures 7 5,250 4,202 Subtotal 25,574 15,812 Less: accumulated depreciation (7,433) (4,517) Fixed assets, net $ 18,141 $ 11,295 |
Inventory, Net
Inventory, Net | 9 Months Ended |
Sep. 30, 2017 | |
Inventory, Net [Abstract] | |
Inventory, Net | 7. Inventory, Net Inventories are stated at the lower of cost or market. Inventories consist of the following: September 30, 2017 December 31, 2016 (In thousands) Work-in-process $ 3,717 $ 2,207 Finished goods 180 72 Inventory, net $ 3,897 $ 2,279 |
Accounts Payable, Accrued Expen
Accounts Payable, Accrued Expenses and Other Liabilities | 9 Months Ended |
Sep. 30, 2017 | |
Accounts Payable, Accrued Expenses and Other Liabilities [Abstract] | |
Accounts Payable, Accrued Expenses and Other Liabilities | 8. Accounts Payable, Accrued Expenses and Other Liabilities Accounts payable, accrued expenses and other liabilities consisted of the following: September 30, 2017 December 31, 2016 (In thousands) Accounts payable $ 10,053 $ 6,722 Accrued contracted services 44,244 35,429 Accrued employee compensation 18,720 19,287 Other liabilities 9,053 4,113 Accounts payable, accrued expenses and other liabilities $ 82,070 $ 65,551 |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2017 | |
Fair Value Measurements [Abstract] | |
Fair Value Measurements | 7 9. Fair Value Measurements The carrying amounts of the Company’s receivables and payables approximate their fair value due to their short maturities. Accounting principles provide guidance for using fair value to measure assets and liabilities. The guidance includes a three-level hierarchy of valuation techniques used to measure fair value, defined as follows: · Unadjusted Quoted Prices — The fair value of an asset or liability is based on unadjusted quoted prices in active markets for identical assets or liabilities (Level 1). · Pricing Models with Significant Observable Inputs — The fair value of an asset or liability is based on information derived from either an active market quoted price, which may require further adjustment based on the attributes of the financial asset or liability being measured, or an inactive market transaction (Level 2). · Pricing Models with Significant Unobservable Inputs — The fair value of an asset or liability is primarily based on internally derived assumptions surrounding the timing and amount of expected cash flows for the financial instrument. Therefore, these assumptions are unobservable in either an active or inactive market (Level 3). The Company considers an active market as one in which transactions for the asset or liability occur with sufficient frequency and volume to provide pricing information on an ongoing basis. Conversely, the Company views an inactive market as one in which there are few transactions for the asset or liability, the prices are not current, or price quotations vary substantially either over time or among market makers. Where appropriate, non-performance risk, or that of a counterparty, is considered in determining the fair values of liabilities and assets, respectively. The Company’s cash deposits and money market funds are classified within Level 1 of the fair value hierarchy because they are valued using bank balances or quoted market prices. Investments are classified as Level 2 instruments based on market pricing and other observable inputs. Financial assets carried at fair value are classified in the tables below in one of the three categories described above: Fair Value Measurements Using Total Level 1 Level 2 Level 3 (In thousands) September 30, 2017 Assets: Money market funds (included in cash and cash equivalents) $ 37,426 $ 37,426 $ - $ - Available for sale securities: Commercial paper 11,464 - 11,464 - Corporate debt securities 341,820 - 341,820 - U.S. government and agency securities 19,222 - 19,222 - Total financial assets: $ 409,932 $ 37,426 $ 372,506 $ - December 31, 2016 Assets: Money market funds (included in cash and cash equivalents) $ 11,755 $ 11,755 $ - $ - Available for sale securities: Commercial paper 66,114 - 66,114 - Corporate debt securities 553,418 - 553,418 - U.S. government and agency securities 26,178 - 26,178 - Total financial assets $ 657,465 $ 11,755 $ 645,710 $ - The estimated fair value of marketable debt securities (commercial paper, corporate debt securities and U.S. government and agency securities), by contractual maturity, are as follows: Fair Value as of September 30, 2017 December 31, 2016 (In thousands) Due in one year or less $ 344,852 $ 456,184 Due after 1 year through 5 years 27,654 189,526 Total investments in debt securities $ 372,506 $ 645,710 Actual maturities may differ from contractual maturities because issuers may have the right to call or prepay obligations without call or prepayment penalties. |
Long-Term Debt
Long-Term Debt | 9 Months Ended |
Sep. 30, 2017 | |
Long-Term Debt [Abstract] | |
Long-Term Debt | 10. Long-Term Debt Debt, net of discounts and deferred financing costs, consists of the following: September 30, 2017 December 31, 2016 (In thousands) Long-term debt $ 351,984 $ 341,356 Less current portion - - Long-term debt outstanding $ 351,984 $ 341,356 On July 6, 2016, the Company issued $460.0 million aggregate principal amount of the 3.25% convertible senior notes due 2023 (“Convertible Notes”). The Company received net proceeds of $447.6 million after deducting underwriting discounts and estimated offering expenses of approximately $12.4 million. The Company used approximately $38.4 million of the net proceeds from the offering to fund the payment of the cost of the capped call transactions that were entered into in connection with the issuance of the Convertible Notes. The Convertible Notes are senior unsecured obligations of the Company. Interest is payable semi-annually on January 1 and July 1 of each year, beginning on January 1, 2017. The Convertible Notes mature on July 1, 2023 , unless earlier repurchased, redeemed or converted. The Convertible Notes are convertible at the option of holders, under certain circumstances and during certain periods, into cash, shares of the Company’s common stock or a combination of cash and shares of the Company’s common stock, at the Company’s election. The initial conversion rate of the Convertible Notes is 5.0358 shares of the Company’s common stock per $1,000 principal amount of Convertible Notes, which is equivalent to an initial conversion price of approximately $198.58 per share of the Company’s common stock. The conversion rate is subject to adjustment upon the occurrence of certain events. The Company may redeem for cash all or part of the Convertible Notes, at its option, on or after July 6, 2021 , under certain circumstances at a redemption price equal to 100% of the principal amount of the Convertible Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. The capped call transactions are expected generally to reduce the potential dilution upon conversion of the Convertible Notes in the event that the market price per share of the Company’s common stock, as measured under the terms of the capped call transactions, is greater than the strike price of the capped call transactions, which initially corresponds to the conversion price of the Convertible Notes, and is subject to anti-dilution adjustments generally similar to those applicable to the conversion rate of the Convertible Notes. The cap price of the capped call transactions is initially $262.2725 per share, and is subject to certain adjustments under the terms of the capped call transactions. If, however, the market price per share of the Company’s common stock, as measured under the terms of the capped call transactions, exceeds the cap price of the capped call transactions, there would nevertheless be dilution upon conversion of the Convertible Notes to the extent that such market price exceeds the cap price of the capped call transactions. In accordance with ASC Subtopic 470-20, the Company used an effective interest rate of 8.4% to determine the liability component of the Convertible Notes. This resulted in the recognition of $334.4 million as the liability component of the Convertible Notes and the recognition of the residual $113.2 million as the debt discount with a corresponding increase to additional paid-in capital for the equity component of the Convertible Notes. Interest expense was $7.4 million and $7.1 million for the three months ended September 30, 2017 and 2016 , respectively, and $21.8 million and $7.1 million for the nine months ended September 30, 2017 and 2016 , respectively, related to the Convertible Notes. Accrued interest on the Convertible Notes was approximately $3.7 million and $7.3 million as of September 30, 2017 and December 31, 2016 , respectively. The Company recorded debt issuance costs of $12.4 million, which are being amortized using the effective interest method. As of September 30, 2017 , $10.7 million of debt issuance costs are recorded on the unaudited condensed consolidated balance sheet in Long-Term Debt, in accordance with ASU 2015-03. As of September 30, 2017 , the Company had outstanding borrowings of $460.0 million related to the Convertible Notes. |
Product Revenue, Net
Product Revenue, Net | 9 Months Ended |
Sep. 30, 2017 | |
Product Revenue, Net [Abstract] | |
Product Revenue, Net | 11. Product Revenue, Net The Company recognized net sales of Ocaliva of $ 40.9 million and $ 4.7 million for the three months ended September 30, 2017 and 2016 , respectively, and $ 91.9 million and $ 4.8 million for the nine months ended September 30, 2017 and 2016 , respectively. The table below summarizes consolidated product revenue, net by region: Three Months Ended September 30, Nine Months Ended September 30, 2017 2016 2017 2016 (In thousands) Product revenue, net: U.S. $ 36,176 $ 4,732 $ 83,829 $ 4,807 ex-U.S. 4,713 - 8,104 - Total product revenue, net $ 40,889 $ 4,732 $ 91,933 $ 4,807 |
Stock Compensation
Stock Compensation | 9 Months Ended |
Sep. 30, 2017 | |
Stock Compensation [Abstract] | |
Stock Compensation | 12. Stock Compensation The 2012 Equity Incentive Plan (“2012 Plan”) became effective upon the pricing of the initial public offering in October 2012. At the same time, the 2003 Stock Incentive Plan (“2003 Plan”) was terminated and 555,843 shares available under the 2003 Plan were added to the 2012 Plan. On January 1, 2017, the number of shares reserved for issuance under the 2012 Plan was increased by 993,558 shares, as a result of the automatic increase in shares reserved pursuant to the terms thereof. The estimated fair value of the options that have been granted under the 2003 and 2012 Plans is determined utilizing the Black-Scholes option-pricing model at the date of grant. The fair value of restricted stock units (“RSUs”) and restricted stock awards (“RSAs”) that have been granted under the 2012 Plan is determined utilizing the closing stock price on the date of grant. The following table summarizes stock option activity during the nine months ended September 30, 2017 : Weighted Average Number Weighted Remaining Aggregate of Shares Average Contractual Intrinsic Value (In thousands) Exercise Price Term (years) (In thousands) Outstanding at December 31, 2016 1,553 $ 117.80 7.4 $ 48,308 Granted 499 $ 113.27 - $ - Exercised (85) $ 24.36 - $ - Cancelled/forfeited (103) $ 141.78 - $ - Expired (53) $ 214.69 - $ - Outstanding at September 30, 2017 1,811 $ 116.76 7.3 $ 15,118 Expected to vest 1,811 $ 116.76 7.3 $ 15,118 Exercisable 914 $ 102.08 6.0 $ 15,115 As of September 30, 2017 , there was approximate ly $54.2 m illion of total unrecognized compensation expense related to the unvested stock options shown in the table above, which is expected to be recognized over a weighted average period of 2.5 years. The fair value of the Company's option awards were estimated using the assumptions below: Nine Months Ended September 30, 2017 2016 Volatility 60.9 - 65.4% 59.6 - 65.6% Expected term (in years) 6.0 - 9.9 6.0 - 10.0 Risk-free rate 1.8 - 2.4% 1.1 - 1.8% Expected dividend yield —% —% The following table summarizes the aggregate RSU and RSA activity during the nine months ended September 30, 2017 : Weighted Number of Average Fair Awards Value (In thousands) Non-vested shares outstanding, December 31, 2016 381 $ 136.89 Granted 262 $ 113.41 Vested (133) $ 135.92 Forfeited (46) $ 134.77 Non-vested shares outstanding, September 30, 2017 464 $ 124.11 As of September 30, 2017 , there was approximately $46.9 million of total unrecognized compensation expense related to unvested RSUs and RSAs, which is expected to be recognized over a weighted average period of 2.6 ye ars. The Company accounts for forfeitures when they occur. Ultimately, the actual expense recognized over the vesting period will be for only those shares that vest. When performance based grants are issued, the Company recognizes no expense until achievement of the performance requirement is deemed probable. Stock-based compensation expense has been reported in our statements of operations as follows: Three Months Ended September 30, Nine Months Ended September 30, 2017 2016 2017 2016 (In thousands) Selling, general and administrative $ 9,449 $ 7,207 $ 28,338 $ 14,191 Research and development 3,788 5,337 13,246 12,850 Total stock-based compensation $ 13,237 $ 12,544 $ 41,584 $ 27,041 |
Net Loss Per Share
Net Loss Per Share | 9 Months Ended |
Sep. 30, 2017 | |
Net Loss Per Share [Abstract] | |
Net Loss Per Share | 13. Net Loss Per Share The following table presents the historical computation of basic and diluted net loss per share: Three Months Ended September 30, Nine Months Ended September 30, 2017 2016 2017 2016 (In thousands, except per share amounts) Historical net loss per share Numerator: Net loss attributable to common stockholders $ (72,601) $ (88,815) $ (249,095) $ (292,789) Denominator: Weighted average shares used in calculating net loss per share - basic and diluted 25,104 24,738 25,021 24,614 Net loss per share: Basic and diluted $ (2.89) $ (3.59) $ (9.96) $ (11.90) The following potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding: Three Months Ended September 30, Nine Months Ended September 30, 2017 2016 2017 2016 (In thousands) Convertible Notes 2,316 - 2,316 - Options 1,811 1,594 1,811 1,594 Restricted stock units 464 388 464 388 Total 4,591 1,982 4,591 1,982 |
Basis of Presentation (Policy)
Basis of Presentation (Policy) | 9 Months Ended |
Sep. 30, 2017 | |
Overview of Business and Basis of Presentation [Abstract] | |
Use of Estimates | Use of Estimates The preparation of these unaudited consolidated condensed financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, expenses, revenues and related disclosures. Significant estimates include: clinical trial accruals, revenues and share-based compensation expense. The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances. Actual results may differ from those estimates or assumptions |
Cash, Cash Equivalents and In21
Cash, Cash Equivalents and Investments (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Cash, Cash Equivalents, and Investments [Abstract] | |
Schedule of Available-for-sale Securities Reconciliation | The following table summarizes the Company’s cash, cash equivalents and investments as of September 30, 2017 and December 31, 2016 : As of September 30, 2017 Gross Gross Unrealized Unrealized Amortized Cost Gains Losses Fair Value (In thousands) Cash and cash equivalents: Cash and money market funds $ 120,244 $ - $ - $ 120,244 Investment securities: Commercial paper 11,468 - (4) 11,464 Corporate debt securities 342,252 1 (433) 341,820 U.S. government and agency securities 19,248 - (26) 19,222 Total investments 372,968 1 (463) 372,506 Total cash, cash equivalents and investments $ 493,212 $ 1 $ (463) $ 492,750 As of December 31, 2016 Gross Gross Unrealized Unrealized Amortized Cost Gains Losses Fair Value (In thousands) Cash and cash equivalents: Cash and money market funds $ 43,675 $ - $ - $ 43,675 Investment securities: Commercial paper 66,185 - (71) 66,114 Corporate debt securities 554,847 14 (1,443) 553,418 U.S. government and agency securities 26,254 - (76) 26,178 Total investments 647,286 14 (1,590) 645,710 Total cash, cash equivalents and investments $ 690,961 $ 14 $ (1,590) $ 689,385 |
Fixed Assets, Net (Tables)
Fixed Assets, Net (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Fixed Assets, Net [Abstract] | |
Fixed Assets, Net | Fixed assets are stated at cost and depreciated or amortized using the straight-line method based on useful lives as follows: Useful lives (Years) September 30, 2017 December 31, 2016 (In thousands) Office equipment and software 3 $ 5,044 $ 4,942 Leasehold improvements Over life of lease 15,280 6,668 Furniture and fixtures 7 5,250 4,202 Subtotal 25,574 15,812 Less: accumulated depreciation (7,433) (4,517) Fixed assets, net $ 18,141 $ 11,295 |
Inventory (Tables)
Inventory (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Inventory, Net [Abstract] | |
Schedule of Inventory | Inventories are stated at the lower of cost or market. Inventories consist of the following: September 30, 2017 December 31, 2016 (In thousands) Work-in-process $ 3,717 $ 2,207 Finished goods 180 72 Inventory, net $ 3,897 $ 2,279 |
Accounts Payable, Accrued Exp24
Accounts Payable, Accrued Expenses and Other Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Accounts Payable, Accrued Expenses and Other Liabilities [Abstract] | |
Schedule of Accounts Payable and Accrued Liabilities | Accounts payable, accrued expenses and other liabilities consisted of the following: September 30, 2017 December 31, 2016 (In thousands) Accounts payable $ 10,053 $ 6,722 Accrued contracted services 44,244 35,429 Accrued employee compensation 18,720 19,287 Other liabilities 9,053 4,113 Accounts payable, accrued expenses and other liabilities $ 82,070 $ 65,551 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Fair Value Measurements [Abstract] | |
Fair Value, Marketable Securities Measured on Recurring and Nonrecurring Basis | Financial assets carried at fair value are classified in the tables below in one of the three categories described above: Fair Value Measurements Using Total Level 1 Level 2 Level 3 (In thousands) September 30, 2017 Assets: Money market funds (included in cash and cash equivalents) $ 37,426 $ 37,426 $ - $ - Available for sale securities: Commercial paper 11,464 - 11,464 - Corporate debt securities 341,820 - 341,820 - U.S. government and agency securities 19,222 - 19,222 - Total financial assets: $ 409,932 $ 37,426 $ 372,506 $ - December 31, 2016 Assets: Money market funds (included in cash and cash equivalents) $ 11,755 $ 11,755 $ - $ - Available for sale securities: Commercial paper 66,114 - 66,114 - Corporate debt securities 553,418 - 553,418 - U.S. government and agency securities 26,178 - 26,178 - Total financial assets $ 657,465 $ 11,755 $ 645,710 $ - |
Schedule of Available for Sale Securities Debt Maturities | Fair Value Measurements Using Total Level 1 Level 2 Level 3 (In thousands) September 30, 2017 Assets: Money market funds (included in cash and cash equivalents) $ 37,426 $ 37,426 $ - $ - Available for sale securities: Commercial paper 11,464 - 11,464 - Corporate debt securities 341,820 - 341,820 - U.S. government and agency securities 19,222 - 19,222 - Total financial assets: $ 409,932 $ 37,426 $ 372,506 $ - December 31, 2016 Assets: Money market funds (included in cash and cash equivalents) $ 11,755 $ 11,755 $ - $ - Available for sale securities: Commercial paper 66,114 - 66,114 - Corporate debt securities 553,418 - 553,418 - U.S. government and agency securities 26,178 - 26,178 - Total financial assets $ 657,465 $ 11,755 $ 645,710 $ - The estimated fair value of marketable debt securities (commercial paper, corporate debt securities and U.S. government and agency securities), by contractual maturity, are as follows: Fair Value as of September 30, 2017 December 31, 2016 (In thousands) Due in one year or less $ 344,852 $ 456,184 Due after 1 year through 5 years 27,654 189,526 Total investments in debt securities $ 372,506 $ 645,710 |
Long-Term Debt (Tables)
Long-Term Debt (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Long-Term Debt [Abstract] | |
Schedule of Long-term Debt Instruments | Debt, net of discounts and deferred financing costs, consists of the following: September 30, 2017 December 31, 2016 (In thousands) Long-term debt $ 351,984 $ 341,356 Less current portion - - Long-term debt outstanding $ 351,984 $ 341,356 |
Product Revenue, Net (Tables)
Product Revenue, Net (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Product Revenue, Net [Abstract] | |
Schedule of Product Revenue, Net | The table below summarizes consolidated product revenue, net by region: Three Months Ended September 30, Nine Months Ended September 30, 2017 2016 2017 2016 (In thousands) Product revenue, net: U.S. $ 36,176 $ 4,732 $ 83,829 $ 4,807 ex-U.S. 4,713 - 8,104 - Total product revenue, net $ 40,889 $ 4,732 $ 91,933 $ 4,807 |
Stock Compensation (Tables)
Stock Compensation (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Stock Compensation [Abstract] | |
Schedule of Share Based Compensation Stock Options Activities | The following table summarizes stock option activity during the nine months ended September 30, 2017 : Weighted Average Number Weighted Remaining Aggregate of Shares Average Contractual Intrinsic Value (In thousands) Exercise Price Term (years) (In thousands) Outstanding at December 31, 2016 1,553 $ 117.80 7.4 $ 48,308 Granted 499 $ 113.27 - $ - Exercised (85) $ 24.36 - $ - Cancelled/forfeited (103) $ 141.78 - $ - Expired (53) $ 214.69 - $ - Outstanding at September 30, 2017 1,811 $ 116.76 7.3 $ 15,118 Expected to vest 1,811 $ 116.76 7.3 $ 15,118 Exercisable 914 $ 102.08 6.0 $ 15,115 |
Schedule of Share Based Compensation Arrangement By Share Based Payment Award Grants in Period Fair Value Assumptions | The fair value of the Company's option awards were estimated using the assumptions below: Nine Months Ended September 30, 2017 2016 Volatility 60.9 - 65.4% 59.6 - 65.6% Expected term (in years) 6.0 - 9.9 6.0 - 10.0 Risk-free rate 1.8 - 2.4% 1.1 - 1.8% Expected dividend yield —% —% |
Schedule of Share-based Compensation, Restricted Stock Units Award Activity | The following table summarizes the aggregate RSU and RSA activity during the nine months ended September 30, 2017 : Weighted Number of Average Fair Awards Value (In thousands) Non-vested shares outstanding, December 31, 2016 381 $ 136.89 Granted 262 $ 113.41 Vested (133) $ 135.92 Forfeited (46) $ 134.77 Non-vested shares outstanding, September 30, 2017 464 $ 124.11 |
Schedule of Stock Based Compensation Expense | Stock-based compensation expense has been reported in our statements of operations as follows: Three Months Ended September 30, Nine Months Ended September 30, 2017 2016 2017 2016 (In thousands) Selling, general and administrative $ 9,449 $ 7,207 $ 28,338 $ 14,191 Research and development 3,788 5,337 13,246 12,850 Total stock-based compensation $ 13,237 $ 12,544 $ 41,584 $ 27,041 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Net Loss Per Share [Abstract] | |
Schedule of Calculation of Numerator and Denominator in Earnings Per Share | The following table presents the historical computation of basic and diluted net loss per share: Three Months Ended September 30, Nine Months Ended September 30, 2017 2016 2017 2016 (In thousands, except per share amounts) Historical net loss per share Numerator: Net loss attributable to common stockholders $ (72,601) $ (88,815) $ (249,095) $ (292,789) Denominator: Weighted average shares used in calculating net loss per share - basic and diluted 25,104 24,738 25,021 24,614 Net loss per share: Basic and diluted $ (2.89) $ (3.59) $ (9.96) $ (11.90) |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | The following potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding: Three Months Ended September 30, Nine Months Ended September 30, 2017 2016 2017 2016 (In thousands) Convertible Notes 2,316 - 2,316 - Options 1,811 1,594 1,811 1,594 Restricted stock units 464 388 464 388 Total 4,591 1,982 4,591 1,982 |
Basis of Presentation (Narrativ
Basis of Presentation (Narrative) (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended |
Sep. 30, 2016 | Sep. 30, 2016 | |
Overview of Business and Basis of Presentation [Abstract] | ||
Amount reclassifed from research and development expense to selling, general and administrative expense | $ 8.4 | $ 20.3 |
Summary of Significant Accoun31
Summary of Significant Accounting Policies (Narrative) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2017 | Mar. 31, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | Dec. 31, 2016 | |
Product revenue, Ocaliva | $ 40,889 | $ 4,732 | $ 91,933 | $ 4,807 | ||
Additional paid-in capital | 1,470,545 | 1,470,545 | $ 1,426,168 | |||
Ocaliva [Member] | ||||||
Reserves related to future returns | 700 | |||||
Product revenue, Ocaliva | 40,900 | $ 4,700 | 91,900 | $ 4,800 | ||
Ocaliva [Member] | Adjustment to Recognition of Previously Deferred Revenue [Member] | ||||||
Product revenue, Ocaliva | $ 4,100 | $ 4,100 | ||||
Accounting Standards Update 2016-09 [Member] | ||||||
Increase to Accumulated Deficit | $ 700 | |||||
Additional paid-in capital | 700 | |||||
Deferred tax assets | $ 58,700 |
Significant Agreements (Narrati
Significant Agreements (Narrative) (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||
May 31, 2014 | Mar. 31, 2011 | Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | Dec. 31, 2016 | |
Significant Agreements [Line Items] | |||||||
License arrangement, deferred revenue, recognized | $ 400 | $ 400 | $ 1,300 | $ 6,300 | |||
Security deposit | 16,873 | 16,873 | $ 17,814 | ||||
Licensing revenue | $ 445 | $ 445 | 1,336 | $ 6,336 | |||
Nonsoftware License Arrangement [Member] | Dainippon Sumitomo Pharma Co Ltd [Member] | |||||||
Significant Agreements [Line Items] | |||||||
Development milestone reached | $ 6,000 | ||||||
Nonsoftware License Arrangement [Member] | Up-front Payment [Member] | Dainippon Sumitomo Pharma Co Ltd [Member] | |||||||
Significant Agreements [Line Items] | |||||||
License agreement payment | $ 15,000 | ||||||
Nonsoftware License Arrangement [Member] | Additional Development Receivable [Member] | Dainippon Sumitomo Pharma Co Ltd [Member] | |||||||
Significant Agreements [Line Items] | |||||||
Contingent arrangement receivable amount | 30,000 | ||||||
Nonsoftware License Arrangement [Member] | Additional Regulatory Approval Receivable [Member] | Dainippon Sumitomo Pharma Co Ltd [Member] | |||||||
Significant Agreements [Line Items] | |||||||
Contingent arrangement receivable amount | 70,000 | ||||||
Nonsoftware License Arrangement [Member] | Additional Sales Receivable [Member] | Dainippon Sumitomo Pharma Co Ltd [Member] | |||||||
Significant Agreements [Line Items] | |||||||
Contingent arrangement receivable amount | 200,000 | ||||||
Japan [Member] | Nonsoftware License Arrangement [Member] | Additional Regulatory Approval Receivable [Member] | Dainippon Sumitomo Pharma Co Ltd [Member] | |||||||
Significant Agreements [Line Items] | |||||||
Contingent arrangement receivable amount | 15,000 | ||||||
China [Member] | Nonsoftware License Arrangement [Member] | Additional Regulatory Approval Receivable [Member] | Dainippon Sumitomo Pharma Co Ltd [Member] | |||||||
Significant Agreements [Line Items] | |||||||
Contingent arrangement receivable amount | 10,000 | ||||||
United States [Member] | Nonsoftware License Arrangement [Member] | Additional Regulatory Approval Receivable [Member] | Dainippon Sumitomo Pharma Co Ltd [Member] | |||||||
Significant Agreements [Line Items] | |||||||
Contingent arrangement receivable amount | 5,000 | ||||||
Korea [Member] | Nonsoftware License Arrangement [Member] | Up-front Payment [Member] | Dainippon Sumitomo Pharma Co Ltd [Member] | |||||||
Significant Agreements [Line Items] | |||||||
License agreement payment | $ 1,000 | ||||||
Criteria One [Member] | Nonsoftware License Arrangement [Member] | Dainippon Sumitomo Pharma Co Ltd [Member] | |||||||
Significant Agreements [Line Items] | |||||||
Contingent arrangement receivable amount | 5,000 | ||||||
License arrangement, milestone benchmark | 50,000 | ||||||
Criteria Two [Member] | Nonsoftware License Arrangement [Member] | Dainippon Sumitomo Pharma Co Ltd [Member] | |||||||
Significant Agreements [Line Items] | |||||||
Contingent arrangement receivable amount | 10,000 | ||||||
License arrangement, milestone benchmark | 100,000 | ||||||
Criteria Three [Member] | Nonsoftware License Arrangement [Member] | Dainippon Sumitomo Pharma Co Ltd [Member] | |||||||
Significant Agreements [Line Items] | |||||||
Contingent arrangement receivable amount | 20,000 | ||||||
License arrangement, milestone benchmark | 200,000 | ||||||
Criteria Four [Member] | Nonsoftware License Arrangement [Member] | Dainippon Sumitomo Pharma Co Ltd [Member] | |||||||
Significant Agreements [Line Items] | |||||||
Contingent arrangement receivable amount | 40,000 | ||||||
License arrangement, milestone benchmark | 400,000 | ||||||
Criteria Five [Member] | Nonsoftware License Arrangement [Member] | Dainippon Sumitomo Pharma Co Ltd [Member] | |||||||
Significant Agreements [Line Items] | |||||||
Contingent arrangement receivable amount | 120,000 | ||||||
License arrangement, milestone benchmark | $ 1,200,000 |
Cash, Cash Equivalents and In33
Cash, Cash Equivalents and Investments (Schedule of Available-for-sale Securities Reconciliation) (Details) $ in Thousands | Sep. 30, 2017USD ($)security | Dec. 31, 2016USD ($) |
Investments: | ||
Total investments, Amortized Cost | $ 372,968 | $ 647,286 |
Total cash and cash equivalents and investments, Amortized Cost | 493,212 | 690,961 |
Total investments, Gross Unrealized Gains | 1 | 14 |
Total cash and cash equivalents and investments, Gross Unrealized Gains | 1 | 14 |
Total investments, Gross Unrealized Losses | (463) | (1,590) |
Total cash and cash equivalents and investments, Gross Unrealized Losses | (463) | (1,590) |
Total investments, Fair Value | 372,506 | 645,710 |
Total cash and cash equivalents and investments, Fair Value | $ 492,750 | 689,385 |
Available-for-sale, Securities in Unrealized Loss Positions, Qualitative Disclosure, Number of Positions, Greater than or Equal to One Year | security | 48 | |
Commercial Paper [Member] | ||
Investments: | ||
Total investments, Amortized Cost | $ 11,468 | 66,185 |
Total investments, Gross Unrealized Losses | (4) | (71) |
Total investments, Fair Value | 11,464 | 66,114 |
Corporate Debt Securities [Member] | ||
Investments: | ||
Total investments, Amortized Cost | 342,252 | 554,847 |
Total investments, Gross Unrealized Gains | 1 | 14 |
Total investments, Gross Unrealized Losses | (433) | (1,443) |
Total investments, Fair Value | 341,820 | 553,418 |
US Government Agencies Debt Securities [Member] | ||
Investments: | ||
Total investments, Amortized Cost | 19,248 | 26,254 |
Total investments, Gross Unrealized Losses | (26) | (76) |
Total investments, Fair Value | 19,222 | 26,178 |
Cash and Money Market Funds [Member] | ||
Cash and cash equivalents: | ||
Cash and Cash Equivalents, Amortized Cost | 120,244 | 43,675 |
Cash and cash equivalents, Fair Value | $ 120,244 | $ 43,675 |
Fixed Assets, Net (Fixed Assets
Fixed Assets, Net (Fixed Assets Stated at Cost) (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2017 | Dec. 31, 2016 | |
Fixed assets | $ 25,574 | $ 15,812 |
Less: accumulated depreciation | (7,433) | (4,517) |
Fixed assets, net | 18,141 | 11,295 |
Office Equipment [Member] | ||
Fixed assets | $ 5,044 | 4,942 |
Property, Plant and Equipment, Useful Life | 3 years | |
Leasehold Improvements [Member] | ||
Fixed assets | $ 15,280 | 6,668 |
Property, Plant and Equipment, Estimated Useful Lives | Over life of lease | |
Furniture and Fixtures [Member] | ||
Fixed assets | $ 5,250 | $ 4,202 |
Property, Plant and Equipment, Useful Life | 7 years |
Inventory (Schedule of Inventor
Inventory (Schedule of Inventory) (Details) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Inventory, Net [Abstract] | ||
Work-in-process | $ 3,717 | $ 2,207 |
Finished goods | 180 | 72 |
Inventory, net | $ 3,897 | $ 2,279 |
Accounts Payable, Accrued Exp36
Accounts Payable, Accrued Expenses and Other Liabilities (Schedule of Accounts Payable and Accrued Liabilities) (Details) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Accounts Payable, Accrued Expenses and Other Liabilities [Abstract] | ||
Accounts payable | $ 10,053 | $ 6,722 |
Accured contracted services | 44,244 | 35,429 |
Accrued employee compensation | 18,720 | 19,287 |
Other liabilities | 9,053 | 4,113 |
Accounts payable, accrued expenses and other liabilities | $ 82,070 | $ 65,551 |
Fair Value Measurements (Fair V
Fair Value Measurements (Fair Value, Marketable Securities Measured on Recurring and Nonrecurring Basis) (Details) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Available-For-Sale Securities, Fair Value Disclosure | $ 372,506 | $ 645,710 |
Total financial assets | 409,932 | 657,465 |
Fair Value, Inputs, Level 1 [Member] | ||
Total financial assets | 37,426 | 11,755 |
Fair Value, Inputs, Level 2 [Member] | ||
Total financial assets | 372,506 | 645,710 |
Fair Value, Inputs, Level 3 [Member] | ||
Total financial assets | ||
Money Market Funds [Member] | ||
Cash and cash equivalents, fair value disclosure | 37,426 | 11,755 |
Money Market Funds [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Cash and cash equivalents, fair value disclosure | 37,426 | 11,755 |
Money Market Funds [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Cash and cash equivalents, fair value disclosure | ||
Commercial Paper [Member] | ||
Available-For-Sale Securities, Fair Value Disclosure | 11,464 | 66,114 |
Commercial Paper [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Available-For-Sale Securities, Fair Value Disclosure | 11,464 | 66,114 |
Commercial Paper [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Available-For-Sale Securities, Fair Value Disclosure | ||
Corporate Debt Securities [Member] | ||
Available-For-Sale Securities, Fair Value Disclosure | 341,820 | 553,418 |
Corporate Debt Securities [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Available-For-Sale Securities, Fair Value Disclosure | 341,820 | 553,418 |
Corporate Debt Securities [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Available-For-Sale Securities, Fair Value Disclosure | ||
US Government Agencies Debt Securities [Member] | ||
Available-For-Sale Securities, Fair Value Disclosure | 19,222 | 26,178 |
US Government Agencies Debt Securities [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Available-For-Sale Securities, Fair Value Disclosure | 19,222 | 26,178 |
US Government Agencies Debt Securities [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Available-For-Sale Securities, Fair Value Disclosure |
Fair Value Measurements (Schedu
Fair Value Measurements (Schedule of Available for Sale Securities Debt Maturities) (Details) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Total investments in debt securities | $ 372,506 | $ 645,710 |
Debt Securities [Member] | ||
Due in one year or less | 344,852 | 456,184 |
Due after 1 year through 5 years | 27,654 | 189,526 |
Total investments in debt securities | $ 372,506 | $ 645,710 |
Long-Term Debt (Narrative) (Det
Long-Term Debt (Narrative) (Details) | Jul. 06, 2016USD ($)$ / shares | Sep. 30, 2017USD ($) | Sep. 30, 2016USD ($) | Sep. 30, 2017USD ($) | Sep. 30, 2016USD ($) | Dec. 31, 2016USD ($) |
Proceeds from convertible debt | $ 447,715,000 | |||||
Payments for capped call transactions and associated costs | $ 38,400,000 | 38,364,000 | ||||
Long-term debt | $ 351,984,000 | $ 351,984,000 | $ 341,356,000 | |||
Interest expense | 7,354,000 | $ 7,065,000 | 21,840,000 | 7,065,000 | ||
Amortization of debt issuance costs | $ 12,400,000 | |||||
Convertible Senior Notes 3.25% [Member] | Convertible Debt [Member] | ||||||
Debt instrument, convertible, terms of conversion feature | The Convertible Notes are senior unsecured obligations of the Company. Interest is payable semi-annually on January 1 and July 1 of each year, beginning on January 1, 2017. The Convertible Notes mature on July 1, 2023, unless earlier repurchased, redeemed or converted. The Convertible Notes are convertible at the option of holders, under certain circumstances and during certain periods, into cash, shares of the Company's common stock or a combination of cash and shares of the Company's common stock, at the Company's election. The initial conversion rate of the Convertible Notes is 5.0358 shares of the Company's common stock per $1,000 principal amount of Convertible Notes, which is equivalent to an initial conversion price of approximately $198.58 per share of the Company's common stock. The conversion rate is subject to adjustment upon the occurrence of certain events. The Company may redeem for cash all or part of the Convertible Notes, at its option, on or after July 6, 2021, under certain circumstances at a redemption price equal to 100% of the principal amount of the Convertible Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. | |||||
Debt instrument, maturity date, description | The Convertible Notes mature on July 1, 2023, unless earlier repurchased, redeemed or converted. | |||||
Debt instrument, maturity date | Jul. 1, 2023 | |||||
Debt instrument, face amount | $ 460,000,000 | |||||
Debt instrument, interest rate, stated percentage | 3.25% | |||||
Proceeds from convertible debt | $ 447,600,000 | |||||
Debt issuance costs | $ 12,400,000 | 10,700,000 | $ 10,700,000 | |||
Debt instrument, convertible, conversion ratio | 5.0358 | |||||
Debt instrument, convertible, type of equity security | common stock | |||||
Debt instrument, convertible, conversion price | $ / shares | $ 198.58 | |||||
Debt instrument, convertible, earliest date | Jul. 6, 2021 | |||||
Debt instrument, redemption price, percentage | 100.00% | |||||
Cap price of capped call transaction | $ / shares | $ 262.2725 | |||||
Debt instrument liability component effective interest rate | 8.40% | |||||
Long-term debt | $ 334,400,000 | |||||
Convertible debt, outstanding | 460,000,000 | $ 460,000,000 | ||||
Debt instrument, unamortized discount, noncurrent | $ 113,200,000 | |||||
Interest expense | 7,400,000 | $ 7,100,000 | 21,800,000 | $ 7,100,000 | ||
Interest payable, current | $ 3,700,000 | $ 3,700,000 | $ 7,300,000 |
Long-Term Debt (Schedule of Lon
Long-Term Debt (Schedule of Long-term Debt Instruments) (Details) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Long-Term Debt [Abstract] | ||
Long-term Debt, Total | $ 351,984 | $ 341,356 |
Less current portion | ||
Long-term debt outstanding | $ 351,984 | $ 341,356 |
Product Revenue, Net (Narrative
Product Revenue, Net (Narrative) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Product Revenue, Net [Abstract] | ||||
Product revenue, net | $ 40,889 | $ 4,732 | $ 91,933 | $ 4,807 |
Product Revenue, Net (Schedule
Product Revenue, Net (Schedule of Product Revenue, Net) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Product revenue, net | $ 40,889 | $ 4,732 | $ 91,933 | $ 4,807 |
Product [Member] | ||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Product revenue, net | 40,889 | 4,732 | 91,933 | 4,807 |
Product [Member] | United States [Member] | ||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Product revenue, net | 36,176 | $ 4,732 | 83,829 | $ 4,807 |
Product [Member] | Non-US [Member] | ||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Product revenue, net | $ 4,713 | $ 8,104 |
Stock Compensation (Narrative)
Stock Compensation (Narrative) (Details) - USD ($) $ in Millions | Jan. 02, 2017 | Oct. 31, 2012 | Sep. 30, 2017 |
Share-based compensation not yet recognized, options | $ 54.2 | ||
2012 Stock Plan [Member] | |||
Additional shares available | 993,558 | 555,843 | |
Stock Options [Member] | |||
Share-based compensation not yet recognized, period | 2 years 6 months | ||
Restricted Stock [Member] | |||
Share-based compensation not yet recognized, other than options | $ 46.9 | ||
Share-based compensation not yet recognized, period | 2 years 7 months 6 days |
Stock Compensation (Schedule of
Stock Compensation (Schedule of Share Based Compensation Stock Options Activities) (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2017 | Dec. 31, 2016 | |
Stock Compensation [Abstract] | ||
Beginning Outstanding, Number of Shares | 1,553 | |
Granted - Number of Shares | 499 | |
Exercised - Number of Shares | (85) | |
Forfeited - Number of Shares | (103) | |
Expired - Number of Shares | (53) | |
Ending Outstanding, Number of Shares | 1,811 | 1,553 |
Expected to vest - Number of shares | 1,811 | |
Exercisable - Number of Shares | 914 | |
Beginning Outstanding, Weighted Average Exercise Price | $ 117.80 | |
Granted - Weighted Average Exercise Price | 113.27 | |
Exercised - Weighted Average Exercise Price | 24.36 | |
Forfeited - Weighted Average Exercise Price | 141.78 | |
Expired - Weighted Average Exercise Price | 214.69 | |
Ending Outstanding, Weighted Average Exercise Price | 116.76 | $ 117.80 |
Expected to vest - Weighted Average Exercise Price | 116.76 | |
Exercisable - Weighted Average Exercise Price | $ 102.08 | |
Options Outstanding - Weighted Average Remaining Life | 7 years 3 months 19 days | 7 years 4 months 24 days |
Expected to vest - Weighted Average Remaining Term | 7 years 3 months 19 days | |
Exercisable - Weighted Average Remaining Term | 6 years | |
Options Outstanding - Aggregate Intrinsic Value | $ 15,118 | $ 48,308 |
Expected to vest - Aggregate Intrinsic Value | 15,118 | |
Exercisable - Aggregate Intrinsic Value | $ 15,115 |
Stock Compensation (Schedule 45
Stock Compensation (Schedule of Share Based Compensation Arrangement By Share Based Payment Award Grants in Period Fair Value Assumptions) (Details) - Stock Options [Member] | 9 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Fair value assumption method used | Black-Scholes option-pricing model | |
Volatility, minimum | 60.90% | 59.60% |
Volatility, maximum | 65.40% | 65.60% |
Risk-free interest rate, minimum | 1.80% | 1.10% |
Risk-free interest rate, maximum | 2.40% | 1.80% |
Expected dividend yield | ||
Minimum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (in years) | 6 years | 6 years |
Maximum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (in years) | 9 years 10 months 25 days | 10 years |
Stock Compensation (Schedule 46
Stock Compensation (Schedule of Share-based Compensation, Restricted Stock Units and Award Activity) (Details) shares in Thousands | 9 Months Ended |
Sep. 30, 2017$ / sharesshares | |
Stock Compensation [Abstract] | |
Outstanding, December 31, 2016 | shares | 381 |
Granted - Shares | shares | 262 |
Vested - Shares | shares | (133) |
Forfeited - Shares | shares | (46) |
Outstanding, September 30, 2017 | shares | 464 |
Outstanding - Weighted Average Fair Value, December 31, 2016 | $ / shares | $ 136.89 |
Granted - Weighted Average Fair Value | $ / shares | 113.41 |
Vested - Weighted Average Fair Value | $ / shares | 135.92 |
Forfeited - Weighted Average Fair Value | $ / shares | 134.77 |
Outstanding - Weighted Average Fair Value, September 30, 2017 | $ / shares | $ 124.11 |
Stock Compensation (Schedule 47
Stock Compensation (Schedule of Stock Based Compensation Expense) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Allocated stock-based compensation | $ 13,237 | $ 12,544 | $ 41,584 | $ 27,041 |
Selling, General and Administrative Expenses [Member] | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Allocated stock-based compensation | 9,449 | 7,207 | 28,338 | 14,191 |
Research and Development Expense [Member] | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Allocated stock-based compensation | $ 3,788 | $ 5,337 | $ 13,246 | $ 12,850 |
Net Loss Per Share (Schedule of
Net Loss Per Share (Schedule of Calculation of Numerator and Denominator in Earnings Per Share) (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Numerator: | ||||
Net loss attributable to common stockholders | $ (72,601) | $ (88,815) | $ (249,095) | $ (292,789) |
Denominator: | ||||
Weighted average shares used in calculating net loss per share - basic and diluted | 25,104 | 24,738 | 25,021 | 24,614 |
Net loss per share, basic and diluted (in dollars per share) | $ (2.89) | $ (3.59) | $ (9.96) | $ (11.90) |
Net Loss Per Share (Schedule 49
Net Loss Per Share (Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share) (Details) - shares shares in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Antidilutive securities excluded from computation of earnings per share, amount | 4,591 | 1,982 | 4,591 | 1,982 |
Convertible Notes [Member] | ||||
Antidilutive securities excluded from computation of earnings per share, amount | 2,316 | 2,316 | ||
Stock Options [Member] | ||||
Antidilutive securities excluded from computation of earnings per share, amount | 1,811 | 1,594 | 1,811 | 1,594 |
Restricted Stock Units (RSUs) [Member] | ||||
Antidilutive securities excluded from computation of earnings per share, amount | 464 | 388 | 464 | 388 |