Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2018 | Jul. 31, 2018 | |
Document And Entity Information [Abstract] | ||
Entity Registrant Name | ACORDA THERAPEUTICS INC | |
Entity Central Index Key | 1,008,848 | |
Document Type | 10-Q | |
Document Period End Date | Jun. 30, 2018 | |
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 | 47,483,813 | |
Document Fiscal Year Focus | 2,018 | |
Document Fiscal Period Focus | Q2 | |
Trading Symbol | ACOR |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Jun. 30, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash and cash equivalents | $ 243,345,000 | $ 307,068,000 |
Restricted cash | 221,000 | 410,000 |
Short term investments | 148,371,000 | 0 |
Trade accounts receivable, net of allowances of $1,783 and $845, as of June 30, 2018 and December 31, 2017, respectively | 64,360,000 | 81,403,000 |
Prepaid expenses | 15,101,000 | 13,333,000 |
Finished goods inventory held by the Company | 21,147,000 | 37,501,000 |
Other current assets | 2,007,000 | 1,983,000 |
Total current assets | 494,552,000 | 441,698,000 |
Property and equipment, net of accumulated depreciation | 42,524,000 | 36,669,000 |
Goodwill | 284,100,000 | 286,611,000 |
Intangible assets, net of accumulated amortization | 428,762,000 | 430,603,000 |
Non-current portion of deferred cost of license revenue | 1,638,000 | |
Other assets | 678,000 | 750,000 |
Total assets | 1,250,616,000 | 1,197,969,000 |
Current liabilities: | ||
Accounts payable | 15,400,000 | 27,367,000 |
Accrued expenses and other current liabilities | 97,761,000 | 100,128,000 |
Current portion of deferred license revenue | 9,057,000 | |
Current portion of loans payable | 629,000 | 645,000 |
Current portion of liability related to sale of future royalties | 7,081,000 | 6,763,000 |
Total current liabilities | 120,871,000 | 143,960,000 |
Convertible senior notes (due 2021) | 313,679,000 | 308,805,000 |
Non-current portion of acquired contingent consideration | 109,174,000 | 112,722,000 |
Non-current portion of deferred license revenue | 23,398,000 | |
Non-current portion of loans payable | 24,698,000 | 25,670,000 |
Deferred tax liability | 37,586,000 | 22,459,000 |
Non-current portion of liability related to sale of future royalties | 26,102,000 | 29,025,000 |
Other non-current liabilities | 11,871,000 | 11,943,000 |
Commitments and contingencies | ||
Stockholders’ equity: | ||
Preferred stock, $0.001 par value. Authorized 20,000,000 shares at June 30, 2018 and December 31, 2017; no shares issued as of June 30, 2018 and December 31, 2017, respectively | ||
Common stock, $0.001 par value. Authorized 80,000,000 shares at June 30, 2018 and December 31, 2017; issued 47,223,027 and 46,441,428 shares, including those held in treasury, as of June 30, 2018 and December 31, 2017, respectively | 47,000 | 46,000 |
Treasury stock at cost (79,275 shares at June 30, 2018 and 16,151 shares at December 31, 2017) | (1,976,000) | (389,000) |
Additional paid-in capital | 993,292,000 | 968,580,000 |
Accumulated deficit | (389,527,000) | (455,108,000) |
Accumulated other comprehensive income | 4,799,000 | 6,858,000 |
Total stockholders’ equity | 606,635,000 | 519,987,000 |
Total liabilities and stockholders’ equity | $ 1,250,616,000 | $ 1,197,969,000 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Jun. 30, 2018 | Dec. 31, 2017 |
Statement Of Financial Position [Abstract] | ||
Trade accounts receivable, allowances (in dollars) | $ 1,783 | $ 845 |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, Authorized shares | 20,000,000 | 20,000,000 |
Preferred stock, issued shares | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, Authorized shares | 80,000,000 | 80,000,000 |
Common stock, issued shares | 47,223,027 | 46,441,428 |
Treasury stock, shares | 79,275 | 16,151 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Revenues: | ||||
Total net revenues | $ 153,302 | $ 139,438 | $ 259,467 | $ 258,824 |
Costs and expenses: | ||||
Cost of sales | 31,094 | 29,665 | 52,444 | 54,848 |
Cost of license revenue | 159 | 317 | ||
Research and development | 25,910 | 51,184 | 56,470 | 97,677 |
Selling, general and administrative | 44,263 | 49,334 | 91,864 | 101,359 |
Changes in fair value of acquired contingent consideration | (7,000) | 6,400 | (800) | 17,200 |
Total operating expenses | 94,267 | 136,742 | 199,978 | 271,401 |
Operating income (loss) | 59,035 | 2,696 | 59,489 | (12,577) |
Other (expense) income, net: | ||||
Interest and amortization of debt discount expense | (5,414) | (5,460) | (10,911) | (9,603) |
Interest income | 910 | 35 | 1,236 | 73 |
Realized (loss) gain on foreign currency transactions | (2) | 4 | (7) | (440) |
Other income | 24 | 24 | ||
Total other expense, net | (4,482) | (5,421) | (9,658) | (9,970) |
Income (loss) before taxes | 54,553 | (2,725) | 49,831 | (22,547) |
Provision for income taxes | (8,356) | (5,471) | (11,833) | (4,552) |
Net income (loss) | $ 46,197 | $ (8,196) | $ 37,998 | $ (27,099) |
Net income (loss) per share—basic | $ 0.99 | $ (0.18) | $ 0.82 | $ (0.59) |
Net income (loss) per share—diluted | $ 0.98 | $ (0.18) | $ 0.81 | $ (0.59) |
Weighted average common shares outstanding used in computing net income (loss) per share—basic | 46,799 | 45,943 | 46,546 | 45,876 |
Weighted average common shares outstanding used in computing net income (loss) per share—diluted | 47,201 | 45,943 | 46,974 | 45,876 |
Net Product Revenues | ||||
Revenues: | ||||
Total net revenues | $ 150,412 | $ 132,756 | $ 253,415 | $ 245,349 |
Royalty Revenues | ||||
Revenues: | ||||
Total net revenues | $ 2,890 | 4,418 | $ 6,052 | 8,946 |
License Revenue | ||||
Revenues: | ||||
Total net revenues | $ 2,264 | $ 4,529 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Income (Loss) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Statement Of Income And Comprehensive Income [Abstract] | ||||
Net income (loss) | $ 46,197 | $ (8,196) | $ 37,998 | $ (27,099) |
Other comprehensive income (loss), net of tax: | ||||
Foreign currency translation adjustment | (4,529) | 10,170 | (1,982) | 12,572 |
Unrealized income (loss) on available for sale debt securities | 15 | (77) | ||
Other comprehensive (loss) income, net of tax | (4,514) | 10,170 | (2,059) | 12,572 |
Comprehensive income (loss) | $ 41,683 | $ 1,974 | $ 35,939 | $ (14,527) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2018 | Jun. 30, 2017 | |
Cash flows from operating activities: | ||
Net income (loss) | $ 37,998 | $ (27,099) |
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: | ||
Share-based compensation expense | 11,112 | 18,616 |
Amortization of net premiums and discounts on investments | (78) | |
Amortization of debt discount and debt issuance costs | 7,973 | 6,365 |
Depreciation and amortization expense | 6,648 | 11,723 |
Change in acquired contingent consideration obligation | (800) | 17,200 |
Unrealized foreign currency transaction loss | 247 | |
Non-cash royalty revenue | (5,326) | |
Deferred tax provision (benefit) | 12,633 | (1,618) |
Changes in assets and liabilities: | ||
Decrease (increase) in accounts receivable | 17,042 | (3,325) |
(Increase) decrease in prepaid expenses and other current assets | (1,640) | 3,805 |
Decrease (increase) in inventory | 16,355 | (778) |
Decrease in non-current portion of deferred cost of license revenue | 317 | |
Decrease (increase) in other assets | 17 | (3,924) |
Decrease in accounts payable, accrued expenses and other current liabilities | (17,036) | (32,229) |
Decrease in non-current portion of deferred license revenue | (4,529) | |
Increase in other non-current liabilities | 61 | 69 |
Net cash provided by (used in) operating activities | 84,959 | (15,160) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (10,793) | (8,747) |
Purchases of intangible assets | (162) | (207) |
Purchases of investments | (148,371) | |
Net cash used in investing activities | (159,326) | (8,954) |
Cash flows from financing activities: | ||
Proceeds from issuance of common stock and option exercises | 12,727 | 5,474 |
Refund of deposit for purchase of noncontrolling interest | 2,722 | |
Purchase of treasury stock | (1,587) | (60) |
Repayment of loans payable | (656) | (2,409) |
Net cash provided by financing activities | 10,484 | 5,727 |
Effect of exchange rate changes on cash, cash equivalents and restricted cash | (84) | 906 |
Net decrease in cash, cash equivalents and restricted cash | (63,967) | (17,481) |
Cash, cash equivalents and restricted cash at beginning of period | 308,039 | 158,871 |
Cash, cash equivalents and restricted cash at end of period | 244,072 | 141,390 |
Supplemental disclosure: | ||
Cash paid for interest | 3,045 | 3,047 |
Cash paid for taxes | $ 13,554 | $ 7,682 |
Organization and Business Activ
Organization and Business Activities | 6 Months Ended |
Jun. 30, 2018 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Organization and Business Activities | (1) Organization and Business Activities Acorda Therapeutics, Inc. (“Acorda” or the “Company”) is a biopharmaceutical company focused on developing therapies that restore function and improve the lives of people with neurological disorders. The accompanying unaudited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (GAAP) for interim financial information, Accounting Standards Codification (ASC) Topic 270-10 and with the instructions to Form 10-Q. Accordingly, these financial statements do not include all of the information and footnotes required by GAAP for complete financial statements. In management’s opinion, all adjustments considered necessary for a fair presentation have been included in the interim periods presented and all adjustments are of a normal recurring nature. The Company has evaluated subsequent events through the date of this filing. Operating results for the three and six-month periods ended June 30, 2018 are not necessarily indicative of the results that may be expected for the year ending December 31, 2018. When used in these notes, the terms “Acorda” or “the Company” mean Acorda Therapeutics, Inc. The December 31, 2017 consolidated balance sheet data was derived from audited financial statements, but does not include all disclosures required by GAAP. You should read these unaudited interim condensed consolidated financial statements in conjunction with the consolidated financial statements and footnotes included in the Company's Annual Report on Form 10-K, as amended by Amendment No. 1 on Form 10-K/A, for the year ended December 31, 2017. Certain reclassifications were made to prior period amounts in the consolidated financial statements and accompanying notes to conform with the current year presentation due to the adoption of ASU 2016-18 “Statement of Cash Flows” and Topic 230: Restricted Cash. See Note 2. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2018 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | (2) Summary of Significant Accounting Policies Our critical accounting policies are detailed in our Annual Report on Form 10-K, as amended by Amendment No. 1 on Form 10-K/A, for the year ended December 31, 2017. Effective January 1, 2018, the Company adopted ASU 2014-09, “Revenue from Contracts with Customers” (Topic 606), ASU 2016-01, “Financial Instruments - Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities”, ASU 2016-15 “Statement of Cash Flows” (Topic 230): Classification of Certain Cash Receipts and Cash Payments, ASU 2016-18 “Statement of Cash Flows” (Topic 230): Restricted Cash , ASU 2017-01, “Business Combinations” (Topic 805): Clarifying the Definition of a Business, and ASU 2017-09, “Compensation – Stock Compensation” (Topic 718): Scope of Modification Accounting and ASU 2017-01 Revenue Recognition On January 1, 2018, we adopted the new accounting standard ASC 606, “Revenue from Contracts with Customers” (Topic 606) (“ASC 606”) and the related amendments to all contracts with customers that were not completed as of the date of adoption using the modified retrospective method. ASC 606 supersedes prior revenue guidance under ASC 605 “Revenue Recognition” (“ASC 605”) and requires entities to recognize revenue to depict the transfer of promised goods or services to customers at an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The Company completed its assessment of the new guidance and evaluated the new requirements as applied to its existing revenue contracts not completed as of the date of initial application. As a result of the assessment, with the exception of the changes to our recognition of license revenue as further described below, the Company determined that adoption of the new standard did not have a significant impact on its revenue recognition methodology. In accordance with ASC 606, the Company recognizes revenue when the customer obtains control of a promised good or service, in an amount that reflects the consideration to which the Company expects to be entitled in exchange for the good or service. The Company determined that the revenue recognition methodology for the deferred license revenue changed as a result of the adoption of ASC 606. License revenue recorded by the Company prior to January 1, 2018 related exclusively to the recognition of the upfront payment received from Biogen upon the execution of the License and Collaboration agreement that granted Biogen an exclusive non sub-licensable license to sell Fampyra outside of the U.S. License revenue recorded prior to January 1, 2018 was recognized under ASC 605 on a pro rata basis as the Company’s obligations were satisfied throughout the duration of the license and collaboration agreement. As of January 1, 2018, the Company adopted ASC 606 which changed the Company’s determination of its distinct performance obligations resulting in an acceleration of the recognition of the revenue in the arrangement. The material performance obligations were completed prior to January 1, 2018, and as a result, the Company recognized its previously deferred revenue as a cumulative effect adjustment The cumulative effect of applying ASC 606 to the company’s consolidated balance sheet was as follows: (In thousands) Balance as of December 31, 2017 Net Adjustments Balance as of January 1, 2018 Assets Other current assets $ 1,983 $ (634 ) $ 1,349 Non-current portion of deferred cost of license revenue 1,638 (1,638 ) — Total Assets $ 1,197,969 $ (2,272 ) $ 1,195,697 Liabilities Current portion of deferred license revenue $ 9,057 $ (9,057 ) $ — Non-current portion of deferred license revenue 23,398 (23,398 ) — Deferred tax liability 22,459 2,600 25,059 Accumulated deficit (455,108 ) 27,583 (427,525 ) Total liabilities and stockholders' equity $ 1,197,969 $ (2,272 ) $ 1,195,697 The impact of the adoption of ASC 606 on the Company’s consolidated balance sheet as of June 30, 2018 was as follows: (In thousands) Balance as of June 30, 2018 Prior to Adoption of ASC 606 Net Adjustments Balance as of June 30, 2018 as Reported Under ASC 606 Assets Other current assets $ 2,641 $ (634 ) $ 2,007 Non-current portion of deferred cost of license revenue 1,320 (1,320 ) — Total Assets $ 1,252,570 $ (1,954 ) $ 1,250,616 Liabilities Current portion of deferred license revenue $ 9,057 $ (9,057 ) $ — Non-current portion of deferred license revenue 18,870 (18,870 ) — Deferred tax liability 34,986 2,600 37,586 Accumulated deficit (412,900 ) 23,373 (389,527 ) Total liabilities and stockholders' equity $ 1,252,570 $ (1,954 ) $ 1,250,616 The impact of the adoption of ASC 606 on the Company’s consolidated statement of operations for the three-month period ended June 30, 2018 was as follows: (In thousands) Three-Month Period Ended June 30, 2018 Balance Prior to Adoption of ASC 606 Effect of Change Three-Month Period Ended June 30, 2018 Balance as Reported Under ASC 606 License revenue $ 2,264 $ (2,264 ) $ — Cost of license revenue 159 (159 ) — Operating income (loss) $ 61,140 $ (2,105 ) $ 59,035 Net income (loss) $ 48,302 $ (2,105 ) $ 46,197 Net income (loss) per share—basic $ 1.03 $ (0.04 ) $ 0.99 Net income (loss) per share—diluted $ 1.02 $ (0.04 ) $ 0.98 The impact of the adoption of ASC 606 on the Company’s consolidated statement of operations for the six-month period ended June 30, 2018 was as follows: (In thousands) Six-Month Period Ended June 30, 2018 Balance Prior to Adoption of ASC 606 Effect of Change Six-Month Period Ended June 30, 2018 Balance as Reported Under ASC 606 License revenue $ 4,528 $ (4,528 ) $ — Cost of license revenue 318 (318 ) — Operating income (loss) $ 63,699 $ (4,210 ) $ 59,489 Net income (loss) $ 42,208 $ (4,210 ) $ 37,998 Net income (loss) per share—basic $ 0.91 $ (0.09 ) $ 0.82 Net income (loss) per share—diluted $ 0.90 $ (0.09 ) $ 0.81 ASC 606 did not have an aggregate impact on the Company’s net cash provided by operating activities. ASC 606 outlines a five-step process for recognizing revenue from contracts with customers: i) identify the contract with the customer, ii) identify the performance obligations in the contract, (iii) determine the transaction price, iv) allocate the transaction price to the separate performance obligations in the contract, and (v) recognize revenue associated with the performance obligations as they are satisfied. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. Once a contract is determined to be within the scope of ASC 606, the Company determines the performance obligations that are distinct. The Company recognizes as revenues the amount of the transaction price that is allocated to each respective performance obligation when the performance obligation is satisfied or as it is satisfied. Generally, the Company's performance obligations are transferred to customers at a point in time, typically upon receipt of the product by the customer. ASC 606 requires entities to record a contract asset when a performance obligation has been satisfied or partially satisfied, but the amount of consideration has not yet been received because the receipt of the consideration is conditioned on something other than the passage of time. ASC 606 also requires an entity to present a revenue contract as a contract liability in instances when a customer pays consideration, or an entity has a right to an amount of consideration that is unconditional (e.g. receivable), before the entity transfers a good or service to the customer. We currently do not have any contract assets. We recognize contract liabilities when a customer pays an upfront deposit upon contract execution for future obligations to be performed by us. As of June 30, 2018, we had contract liability in the amount of $5.5 million which reflects an upfront deposit paid by a customer upon contract execution for future obligations to be performed by us. The amount is currently reported in accrued expenses and other current liabilities in the Balance Sheet. If the contract is canceled, these upfront deposits are refundable only if certain obligations have not been performed by us. We did not have any contract liability as of December 31, 2017. Product Revenue, Net Net revenue from product sales is recognized at the transaction price when the customer obtains control of the Company’s products, which occurs at a point in time, typically upon receipt of the product by the customer. The Company’s products are sold primarily to a network of specialty providers which are contractually obligated to hold no more than an agreed upon number of days of inventory. The Company’s payment terms are between 30 to 34 days. The Company’s net revenues represent total revenues adjusted for discounts and allowances, including estimated cash discounts, chargebacks, rebates, returns, Discounts and Allowances Revenue from product sales are recorded at the transaction price, which includes estimates for discounts and allowances for which reserves are established and includes cash discounts, chargebacks, rebates, returns, copay assistance, data fees and wholesaler fees for services Discounts and allowances are recorded following shipment of product and the appropriate reserves are credited. These reserves are classified as reductions of accounts receivable (if the amount is payable to the Customer and right of offset exists) or a current liability (if the amount is payable to a party other than a Customer). These allowances are established by management as its best estimate based on historical experience and data points available and are adjusted to reflect known changes in the factors that impact such reserves. Allowances for customer credits, chargebacks, rebates, data fees and wholesaler fees for services, returns, and discounts are established based on contractual terms with customers and analyses of historical usage of these items. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known. The nature of our allowances and accruals requiring critical estimates, and the specific considerations it uses in estimating their amounts are as follows: Government Chargebacks and Rebates: We contract for Medicaid and other U.S. Federal government programs to allow for our products to remain eligible for reimbursement under these programs. For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap for whom the Company will owe an additional liability under the Medicare Part D program. Based upon our contracts and the most recent experience with respect to sales through each of these channels, we provide an allowance for chargebacks and rebates. We monitor the sales trends and adjust the chargeback and rebate percentages on a regular basis to reflect the most recent chargebacks and rebate experience. The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for product that has been recognized as revenue, but remains in the distribution channel inventories at the end of each reporting period. Managed Care Contract Rebates: We contract with various managed care organizations including health insurance companies and pharmacy benefit managers. These contracts stipulate that rebates and, in some cases, administrative fees, are paid to these organizations provided our product is placed on a specific tier on the organization’s drug formulary. Based upon our contracts and the most recent experience with respect to sales through managed care channels, we provide an allowance for managed care contract rebates. We monitor the sales trends and adjust the allowance on a regular basis to reflect the most recent rebate experience. The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for product that has been recognized as revenue, but remains in the distribution channel inventories at the end of each reporting period. Copay Mitigation Rebates: We offer copay mitigation to commercially insured patients who have coverage for our products (in accordance with applicable law) and are responsible for a cost share. Based upon our contracts and the most recent experience with respect to actual copay assistance provided, we provide an allowance for copay mitigation rebates. We monitor the sales trends and adjust the rebate percentages on a regular basis to reflect the most recent rebate experience. Cash Discounts: We sell directly to our network of specialty pharmacies, Kaiser and ASD Specialty Healthcare, Inc. We generally provide invoice discounts for prompt payment for our products. We estimate our cash discounts based on the terms offered to our customers. Discounts are estimated based on rates that are explicitly stated in the Company’s contracts as it is expected they will take the discount and are recorded as a reduction of revenue at the time of product shipment when product revenue is recognized. We adjust estimates based on actual activity as necessary. Product Returns: We either offer customers no return except for products damaged in shipping or consistent with industry practice, a limited right of return based on the product’s expiration date. The Company estimates the amount of its product sales that may be returned by its customers and records this estimate as a reduction of revenue in the period the related product revenue is recognized. The company currently estimates product return liabilities using historical sales information and inventory remaining in the distribution channel. Data Fees and Fees for Service Payable to Specialty Pharmacies: We have contracted with certain specialty pharmacies to obtain transactional data related to our products in order to develop a better understanding of our selling channel as well as patient activity and utilization by the Medicaid program and other government agencies and managed care organizations. We pay a variable fee to the specialty pharmacies to provide us the data. We also pay the specialty pharmacies a flat fee in exchange for providing distribution and inventory management services, including the provision of inventory management data to the Company. We estimate our fee for service accruals and allowances based on sales to each specialty pharmacy and the applicable contracted rate. Royalty Revenue Royalty revenue recorded by the Company relates exclusively to the Company’s License and Collaboration agreement with Biogen which provides for ongoing royalties based on sales of Fampyra outside of the U.S. The Company recognizes revenue for royalties under ASC 606, which provides revenue recognition constraints by requiring the recognition of revenue at the later of the following: 1) sale or usage of the products or 2) satisfaction of the performance obligations. The Company has satisfied its performance obligations and therefore recognizes royalty revenue when the sales to which the royalties relate are completed. Milestone Revenue Milestone revenue relates to the License and Collaboration agreement with Biogen which provides for milestone payments for the achievement of certain regulatory and sales milestones during the term of the agreement. Regulatory milestones are contingent upon the approval of Fampyra for new indications outside of the U.S. Sales milestones are contingent upon the achievement of certain net sales targets for Fampyra sales outside of the U.S. The Company recognizes milestone revenue under ASC 606, which provides constraints for entities to recognize milestone revenue which is deemed to be variable by requiring the Company to estimate the amount of consideration to which it is entitled in exchange for transferring the promised goods or services to a customer. The Company recognizes an estimate of revenue to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the milestone is achieved. For regulatory milestones, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the Company’s control or the licensee’s control, such as regulatory approvals, are generally not considered probable of being achieved until those approvals are received. The following table disaggregates our revenue by major source (in thousands): Three-month period ended June 30, 2018 Three-month period ended June 30, 2017 Six-month period ended June 30, 2018 Six-month period ended June 30, 2017 Revenues: Net product revenues $ 150,412 $ 132,756 $ 253,415 $ 245,349 Royalty revenues 2,890 4,418 6,052 8,946 License revenue — 2,264 — 4,529 Total net revenues $ 153,302 $ 139,438 $ 259,467 $ 258,824 Foreign Currency Translation The functional currency of operations outside the United States of America is deemed to be the currency of the local country, unless otherwise determined that the United States dollar would serve as a more appropriate functional currency given the economic operations of the entity. Accordingly, the assets and liabilities of the Company’s foreign subsidiary, Biotie, are translated into United States dollars using the period-end exchange rate; income and expense items are translated using the average exchange rate during the period; and equity transactions are translated at historical rates. Cumulative translation adjustments are reflected as a separate component of equity. Foreign currency transaction losses and gains are recognized in the period incurred and are reported as other (expense) income, net in the statement of operations. Segment and Geographic Information The Company is managed and operated as one business which is focused on developing therapies that restore function and improve the lives of people with neurological disorders. The entire business is managed by a single management team that reports to the Chief Executive Officer. The Company does not operate separate lines of business with respect to any of its products or product candidates and the Company does not prepare discrete financial information with respect to separate products or product candidates or by location. Accordingly, the Company views its business as one reportable operating segment. Net product revenues reported to date are derived from the sales of Ampyra and Qutenza in the U.S. Subsequent Events Subsequent events are defined as those events or transactions that occur after the balance sheet date, but before the financial statements are filed with the Securities and Exchange Commission. The Company completed an evaluation of the impact of any subsequent events through the date these financial statements were issued, and determined the following subsequent events required disclosure in these financial statements. On August 3, 2018, we reported the following updates on the Ampyra ANDA litigation with the three generic drug manufacturers that remain a party to the litigation: We have entered into a conditioned settlement agreement with Mylan Pharmaceuticals Inc. and affiliates, and as a result of the settlement agreement, Mylan will be permitted to market its generic version of Ampyra in the U.S. sometime in 2025 or earlier under certain circumstances; we have signed an interim agreement with Teva Pharmaceuticals USA, Inc., that addresses the period of time until August 31, 2018 (and potentially until the appellate court issues a decision on the merits); and we have signed an interim agreement with West-Ward Pharmaceuticals International Limited and Hikma Pharmaceuticals USA Inc., successors to Roxane Laboratories, Inc., that addresses the period of time until the appellate court issues a decision on the merits. The terms of the settlement agreement and interim agreements are otherwise confidential. Accounting Pronouncements Adopted As noted above, in May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update 2014-09, “Revenue from Contracts with Customers” (Topic 606) (ASU 2014-09). This new standard replaced all previous U.S. GAAP guidance on this topic and eliminated all industry-specific guidance. The new standard requires the application of a five-step model to determine the amount and timing of revenue to be recognized. The underlying principle is that revenue is to be recognized for the transfer of goods or services to customers that reflects the amount of consideration that the Company expects to be entitled to in exchange for those goods or services. The Company adopted the new standard effective January 1, 2018 using the modified retrospective transition method. See discussion of the adoption above in Revenue Recognition In November 2016, the FASB issued Accounting Standards Update ASU 2016-18 “Statement of Cash Flows” (Topic 230); Restricted Cash (ASU 2016-18), which defines new requirements for the presentation of restricted cash and restricted cash equivalents in the statement of cash flows. The amendments in this ASU require retrospective application to each period presented. The Company adopted this guidance effective January 1, 2018 retrospectively. This ASU requires the entities to present statement of cash flows in a manner such that it reconciles beginning and ending totals of cash, cash equivalents, restricted cash or restricted cash equivalents. Also, when cash, cash equivalents, restricted cash or restricted cash equivalents are presented in more than one line item within the statement of financial position, an entity should, for each period that a statement of financial position is presented, present on the face of the statement of cash flows or disclose in the notes to the financial statements, the line items and amounts of cash, cash equivalents, and restricted cash or restricted cash equivalents reported within the statement of financial position. The amounts, disaggregated by the line item in which they appear within the statement of financial position, shall sum to the total amount of cash, cash equivalents, and restricted cash or restricted cash equivalents at the end of the corresponding period shown in the statement of cash flows. The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the statement of financial position that sum to the total of the same amounts shown in the statement of cash flows: Six-month period ended June 30, 2018 Six-month period ended June 30, 2017 (In thousands) Beginning of period End of period Beginning of period End of period Cash and cash equivalents $ 307,068 $ 243,345 $ 158,537 $ 141,135 Restricted cash 410 221 79 — Restricted cash included in Other assets 561 506 255 255 Total Cash, cash equivalents and restricted cash per statement of cash flows $ 308,039 $ 244,072 $ 158,871 $ 141,390 Amounts included in restricted cash represent those amounts required to be set aside to cover the Company’s self-funded employee health insurance. Restricted cash included in other assets on the statement of financial position relates to cash collateralized standby letters of credit in connection with obligations under facility leases, which is included with other assets in the consolidated balance sheet due to the long-term nature of the letters of credit. In June 2018, the FASB issued ASU 2018-07, which simplifies the accounting for share-based payments granted to nonemployees for goods and services. Under the ASU, most of the guidance on such payments to nonemployees would be aligned with the requirements for share-based payments granted to employees. Currently, share-based payment arrangements with employees are accounted for under ASC 718, while nonemployee share-based payments issued for goods and services are accounted for under ASC 505-50. ASC 505-50, before the amendments, differed significantly from ASC 718. However, FASB concluded that awards granted to employees are economically similar to awards granted to nonemployees and therefore two different accounting models were not justified. This ASU is effective for fiscal years beginning after December 15, 2018, and interim periods therein with early adoption permitted. The Company early adopted this guidance beginning June 1, 2018. The adoption of this guidance did not have an impact on its consolidated financial statements. Accounting Pronouncements Not Yet Adopted In February 2016, the FASB issued Accounting Standards Update 2016-02, “Leases” (Topic 842). The main objective of this update is to increase transparency and comparability among organizations by recognizing lease assets and lease liabilities on the balance sheet and disclosing key information about leasing arrangements. This ASU is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. The Company has implemented a process to identify its outstanding lease portfolio and is currently evaluating its outstanding leases to determine the impact the new standard will have on its financial statements. In January 2017, the FASB issued Accounting Standards Update 2017-04, “Intangibles – Goodwill and Other” (Topic 350): Simplifying the Test for Goodwill Impairment (ASU 2017-04). This new standard simplifies how an entity is required to test goodwill for impairment by eliminating Step 2 from the goodwill impairment test. ASU 2017-04 allows for prospective application and is effective for fiscal years beginning after December 15, 2019, and interim periods therein with early adoption permitted for interim or annual goodwill impairment tests performed on testing dates after January 1, 2017. The Company is currently evaluating whether it will adopt this guidance early. The Company does not expect the adoption of this guidance to have a significant impact on its consolidated financial statements. In February 2018, the FASB issued Accounting Standards Update 2018-02, ‘Income Statement—Reporting Comprehensive Income’ (Topic 220): Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income (ASU 2018-02). This new standard provides entities with an option to reclassify stranded tax effects within AOCI to retained earnings in each period in which the effect of the change in the U.S. federal corporate income tax rate in the Tax Cuts and Jobs Act (or portion thereof) is recorded. ASC 740-10-35-4 requires that deferred tax assets and liabilities should be adjusted to account for any changes in tax laws or rates within the period that the enactment of these changes occurs and any adjustments to flow through income from continuing operations. Since the adjustments due to the Tax Cuts and Jobs Act are required to flow through income from continuing operations, the tax effects of items within accumulated other comprehensive income known now as “stranded tax effects,” do not reflect the appropriate tax rate. As such, FASB issued ASU 2018-02, in order to address these stranded income tax effects. The new standard requires entities to disclose the following: • A description of the accounting policy for releasing income tax effects from AOCI; • Whether they elect to reclassify the stranded income tax effects from the Tax Cuts and Jobs Act, and • Information about the other income tax effects that are reclassified. The ASU is effective for all entities for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years with early adoption permitted. The Company is currently evaluating the impact it may have on its consolidated financial statements. In March 2018, the FASB issued Accounting Standards Update 2018-05, “Amendments to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin (SAB) No. 118’. The ASU adds seven paragraphs to ASC 740, Income Taxes, that contain SEC guidance related to SAB 118 (codified as SEC SAB Topic 5.EE, “Income Tax Accounting Implications of the Tax Cuts and Jobs Act”), which provides guidance for companies that are not able to complete their accounting for the income tax effects of the Tax Cuts and Jobs Act in the period of enactment which is the period that includes December 22, 2017. The measurement period should not extend beyond one year from the enactment date. The Company is currently evaluating the impact the adoption of this guidance may have on its consolidated financial statements. |
Share-based Compensation
Share-based Compensation | 6 Months Ended |
Jun. 30, 2018 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Share-based Compensation | (3) Share-based Compensation During the three‑month periods ended June 30, 2018 and 2017, the Company recognized share-based compensation expense of $5.2 million and $11.7 million, respectively. During the six‑month periods ended June 30, 2018 and 2017, the Company recognized share-based compensation expense of $11.1 million and $19.6 million, respectively. Activity in options and restricted stock during the six-month period ended June 30, 2018 and related balances outstanding as of that date are reflected below. The weighted average fair value per share of options granted to employees for the three-month periods ended June 30, 2018 and 2017 were approximately $14.32 and $7.24, respectively The weighted average fair value per share of options granted to employees for the six-month periods ended June 30, 2018 and 2017 were approximately $12.84 and $10.75, respectively. The following table summarizes share-based compensation expense included within the consolidated statements of operations: For the three-month period ended June 30, For the six-month period ended June 30, (In millions) 2018 2017 2018 2017 Research and development expense $ 1.5 $ 3.8 $ 3.2 $ 6.4 Selling, general and administrative expense 3.7 7.9 7.9 13.2 Total $ 5.2 $ 11.7 $ 11.1 $ 19.6 A summary of share-based compensation activity for the six-month period ended June 30, 2018 is presented below: Stock Option Activity Number of Shares (In Weighted Average Exercise Price Weighted Average Remaining Contractual Term Intrinsic Value (In Balance at January 1, 2018 8,930 $ 29.46 Granted 705 25.12 Cancelled (401 ) 27.26 Exercised (638 ) 21.18 Balance at June 30, 2018 8,596 $ 29.82 5.9 $ 19,315 Vested and expected to vest at June 30, 2018 8,545 $ 29.85 5.9 $ 19,096 Vested and exercisable at June 30, 2018 6,669 $ 30.51 5.1 $ 13,284 Restricted Stock and Performance Stock Unit Activity (In thousands) Restricted Stock and Performance Stock Units Number of Shares Nonvested at January 1, 2018 697 Granted — Vested (143 ) Forfeited (106 ) Nonvested at June 30, 2018 448 Unrecognized compensation cost for unvested stock options, restricted stock awards and performance stock units as of June 30, 2018 totaled $30.3 million and is expected to be recognized over a weighted average period of approximately 1.8 years. During the three‑month period ended June 30, 2018, the Company repurchased 16,339 shares of common stock at an average price of $23.58 per share or approximately $0.4 million. During the six‑month period ended June 30, 2018, the Company repurchased 63,124 shares of common stock at an average price of $25.15 per share or approximately $1.6 million. The share repurchase consists primarily of common stock withheld to cover the tax liability in connection with the settlement of vested restricted stock units and stock options that were exercised in the three and six-month period ended June 30, 2018. |
Earnings (Loss) Per Share
Earnings (Loss) Per Share | 6 Months Ended |
Jun. 30, 2018 | |
Earnings Per Share [Abstract] | |
Earnings (Loss) Per Share | (4) Earnings (Loss) Per Share The following table sets forth the computation of basic and diluted earnings (loss) per share for the three and six-month periods ended June 30, 2018 and 2017: (In thousands, except per share data) Three-month period ended June 30, 2018 Three-month period ended June 30, 2017 Six-month period ended June 30, 2018 Six-month period ended June 30, 2017 Basic and diluted Net income (loss) $ 46,197 $ (8,196 ) $ 37,998 $ (27,099 ) Weighted average common shares outstanding used in computing net income (loss) per share—basic 46,799 45,943 46,546 45,876 Plus: net effect of dilutive stock options and restricted common shares 402 — 428 — Weighted average common shares outstanding used in computing net income (loss) per share—diluted 47,201 45,943 46,974 45,876 Net income (loss) per share—basic $ 0.99 $ (0.18 ) $ 0.82 $ (0.59 ) Net income (loss) per share—diluted $ 0.98 $ (0.18 ) $ 0.81 $ (0.59 ) Securities that could potentially be dilutive are excluded from the computation of diluted earnings per share when a loss from continuing operations exists or when the exercise price exceeds the average closing price of the Company’s common stock during the period, because their inclusion would result in an anti-dilutive effect on per share amounts. The following amounts were not included in the calculation of net income (loss) per diluted share because their effects were anti-dilutive: (In thousands) Three-month period ended June 30, 2018 Three-month period ended June 30, 2017 Six-month period ended June 30, 2018 Six-month period ended June 30, 2017 Denominator Stock options and restricted common shares 7,356 10,197 7,660 9,672 Additionally, the impact of the convertible debt was determined to be anti-dilutive and excluded from the calculation of net income (loss) per diluted share for the three and six-month periods ended June 30, 2018 and 2017. |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2018 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | (5) Income Taxes The Company’s effective income tax rate differs from the U.S. statutory rate principally due to state taxes, Federal research and development tax credits, jurisdictions with pretax losses for which no tax benefit can be recognized, changes in the valuation allowance and the effects of share based compensation which are recorded discretely in the quarters in which they occur. For the three-month periods ended June 30, 2018 and 2017, the Company recorded a provision of $8.4 million and $5.5 million for income taxes, respectively. The effective income tax rates for the Company for the three-month periods ended June 30, 2018 and 2017 were 15.3% and (200.8%), respectively. The variance in the effective tax rates for the three-month period ended June 30, 2018 as compared to the three-month period ended June 30, 2017 was due primarily to differences in pre-tax book income between the periods, the decrease in the federal statutory tax rate as a result of tax reform, the valuation allowance recorded on deferred tax assets for which no tax benefit can be recognized, state taxes, and the reduction in the research & development tax credit. For the six-month periods ended June 30, 2018 and 2017, the Company recorded a provision of $11.8 million and $4.6 million for income taxes, respectively. The effective income tax rates for the Company for the six-month periods ended June 30, 2018 and 2017 were 23.9% and (20.2%), respectively. The variance in the effective tax rates for the six-month period ended June 30, 2018 as compared to the six-month period ended June 30, 2017 was due primarily to differences in pre-tax book income between the periods, the decrease in the federal statutory tax rate as a result of tax reform, the valuation allowance recorded on deferred tax assets for which no tax benefit can be recognized, state taxes, and the reduction in the research & development tax credit. The Company continues to evaluate the realizability of its deferred tax assets and liabilities on a quarterly basis and will adjust such amounts in light of changing facts and circumstances including, but not limited to, future projections of taxable income, tax legislation, rulings by relevant tax authorities, the progress of ongoing tax audits and the regulatory approval of products currently under development. Any changes to the valuation allowance or deferred tax assets and liabilities in the future would impact the Company's income taxes. The Tax Cuts and Jobs Act of 2017 (the “Act”) was enacted on December 22, 2017. The Act reduces the U.S. federal corporate tax rate from 35% to 21% effective for tax years beginning after December 31, 2017, requires companies to pay a one-time transition tax on earnings of certain foreign subsidiaries that were previously deferred and includes a variety of other changes. On December 22, 2017, Staff Accounting Bulletin No. 118 (“SAB 118”) was issued to address the application of U.S. GAAP in situations when a registrant does not have the necessary information available, prepared, or analyzed (including computations) in reasonable detail to complete the accounting for certain income tax effects of the Act. For the three and six- month periods ended June 30, 2018, the Company has not completed its accounting for the tax effects of the enactment of the Act; however, in certain cases, we have made a reasonable estimate of the effects on our existing deferred tax balances. In other cases, we have not been able to make a reasonable estimate and continue to account for those items based on our existing accounting under ASC 740, Income Taxes, and the provisions of the tax laws that were in effect immediately prior to the enactment. T he Company has not obtained additional information affecting the provisional amounts initially recorded. Additional work is still necessary for a more detailed analysis of the Company's deferred tax assets and liabilities and its historical foreign earnings as w ell as potential correlative adjustments. Any subsequent adjustment to these amounts will be recorded to current tax expense The Internal Revenue Service completed its examination of the Company’s US income tax return for 2015 in the second quarter of 2018 with no material impact. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2018 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | (6) Fair Value Measurements The following table presents information about the Company’s assets and liabilities measured at fair value on a recurring basis as of June 30, 2018 and December 31, 2017 and indicates the fair value hierarchy of the valuation techniques utilized to determine such fair value. In general, fair values determined by Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities. Fair values determined by Level 2 inputs utilize data points that are observable, such as quoted prices, interest rates, exchange rates and yield curves. Fair values determined by Level 3 inputs utilize unobservable data points for the asset or liability. The Company’s Level 1 assets consist of time deposits and investments in a Treasury money market fund. The Company’s level 2 assets consist of investments in corporate bonds and commercial paper which are categorized as short-term investments for investments with original maturities between three months and one year. The Company’s Level 3 liabilities represent acquired contingent consideration related to the acquisition of Civitas and are valued using a probability weighted discounted cash flow valuation approach. No changes in valuation techniques occurred during the three or six-month periods ended June 30, 2018. The estimated fair values of all of our financial instruments approximate their carrying values at June 30, 2018, except for the fair value of the Company’s convertible senior notes, which was approximately $336.3 million as of June 30, 2018. The Company estimates the fair value of its notes utilizing market quotations for the debt (Level 2). (In thousands) Level 1 Level 2 Level 3 June 30, 2018 Assets Carried at Fair Value: Cash equivalents $ 11,381 $ — $ — Short-term investments — 148,371 — Liabilities Carried at Fair Value: Acquired contingent consideration — — 112,200 December 31, 2017 Assets Carried at Fair Value: Cash equivalents $ 9,163 $ — $ — Liabilities Carried at Fair Value: Acquired contingent consideration — — 113,000 The following table presents additional information about liabilities measured at fair value on a recurring basis and for which the Company utilizes Level 3 inputs to determine fair value. Acquired contingent consideration (In thousands) Three-month period ended June 30, 2018 Three-month period ended June 30, 2017 Six-month period ended June 30, 2018 Six-month period ended June 30, 2017 Acquired contingent consideration: Balance, beginning of period $ 119,200 $ 82,900 $ 113,000 $ 72,100 Fair value change to contingent consideration included in the statement of operations (7,000 ) 6,400 (800 ) 17,200 Balance, end of period $ 112,200 $ 89,300 $ 112,200 $ 89,300 • The Company estimates the fair value of its acquired contingent consideration using a probability weighted discounted cash flow valuation approach based on estimated future sales expected from Inbrija (levodopa inhalation powder) our most advanced development program Inbrija Inbrija The acquired contingent consideration is classified as a Level 3 liability as its valuation requires substantial judgment and estimation of factors that are not currently observable in the market. If different assumptions were used for the various inputs to the valuation approach, including but not limited to, assumptions involving probability adjusted sales estimates for Inbrija |
Investments
Investments | 6 Months Ended |
Jun. 30, 2018 | |
Investments Debt And Equity Securities [Abstract] | |
Investments | (7) Investments The Company has determined that all of its investments are classified as available-for-sale. Available-for-sale debt securities are carried at fair value with interest on these investments included in interest income and are recorded based primarily on quoted market prices. Available-for-sale investments consisted of the following at June 30, 2018: Gross Gross Estimated Amortized Unrealized Unrealized Fair (In thousands) Cost Gains Losses Value Short Term Investments $ 148,448 $ 8 $ (85 ) $ 148,371 Short-term investments with maturities of three months or less from date of purchase have been classified as cash equivalents, and amounted to approximately $11.4 million as of June 30, 2018. Short-term investments have original maturities of greater than 3 months but less than 1 year and amounted to approximately $148.4 million as of June 30, 2018. The aggregate fair value of short-term investments in an unrealized loss position amounted to approximately $114.1 million as of June 30, 2018. The Company held no short-term investments at December 31, 2017. Short-term investments at June 30, 2018 primarily consisted of high-grade commercial paper and corporate bonds. Long-term investments have original maturities of greater than 1 year. There were no investments classified as long-term at June 30, 2018 or December 31, 2017. The Company has determined that there were no other-than-temporary declines in the fair values of its investments as of June 30, 2018 as the Company does not intend to sell its investments and it is not more likely than not that the Company will be required to sell its investments prior to the recovery of its amortized cost basis. Unrealized holding gains and losses, which relate to debt instruments, are reported within accumulated other comprehensive income (AOCI) in the statements of comprehensive income. The changes in AOCI associated with the unrealized holding losses on available-for-sale investments during the six-month period ended June 30, 2018, were as follows (in thousands): (In thousands) Net Unrealized Gains (Losses) on Marketable Securities Balance at December 31, 2017 $ — Other comprehensive loss before reclassifications (170 ) Amounts reclassified from accumulated other comprehensive income — Net current period other comprehensive loss (170 ) Balance at June 30, 2018 $ (170 ) |
Liability Related to Sale of Fu
Liability Related to Sale of Future Royalties | 6 Months Ended |
Jun. 30, 2018 | |
Deferred Revenue Disclosure [Abstract] | |
Liability Related to Sale of Future Royalties | (8) Liability Related to Sale of Future Royalties As of October 1, 2017, the Company completed a royalty purchase agreement with HealthCare Royalty Partners The Company maintained the rights under the license and collaboration agreement with Biogen, therefore, the Royalty Agreement has been accounted for as a liability that will be amortized using the effective interest method over the life of the arrangement, in accordance with the relevant accounting guidance. The Company recorded the receipt of the $40 million payment from HCRP and established a corresponding liability in the amount of $40 million, net of transaction costs of approximately $2.2 million. The net liability is classified between the current and non-current portion of liability related to sale of future royalties in the consolidated balance sheets based on the recognition of the interest and principal payments to be received by HCRP in the next 12 months from the financial statement reporting date. The total net royalties to be paid, less the net proceeds received will be recorded to interest expense using the effective interest method over the life of the Royalty Agreement. The Company will estimate the payments to be made to HCRP over the term of the Agreement based on forecasted royalties and will calculate the interest rate required to discount such payments back to the liability balance. Over the course of the Royalty Agreement, the actual interest rate will be affected by the amount and timing of net royalty revenue recognized and changes in forecasted revenue. On a quarterly basis, the Company will reassess the effective interest rate and adjust the rate prospectively as necessary. The Company recognized non-cash royalty revenue of approximately $2.5 million, non-cash interest expense of approximately $1.1 million and debt discount amortization costs of approximately $0.2 million for the three-month period ended June 30, 2018. The Company recognized non-cash royalty revenue of approximately $5.3 million, non-cash interest expense of approximately $2.3 million and debt discount amortization costs of approximately $0.4 million for the six-month period ended June 30, 2018. The interest and debt discount amortization expense is reflected as interest and amortization of debt discount expense in the Statement of Operations. (In thousands) Three-month period ended June 30, 2018 Six-month period ended June 30, 2018 Liability related to sale of future royalties - beginning balance $ 34,395 $ 35,788 Deferred transaction costs recognized 198 401 Non-cash royalty revenue payable to HCRP (2,544 ) (5,326 ) Non-cash interest expense recognized 1,134 2,320 Liability related to sale of future royalties - ending balance $ 33,183 $ 33,183 |
Convertible Senior Notes
Convertible Senior Notes | 6 Months Ended |
Jun. 30, 2018 | |
Debt Disclosure [Abstract] | |
Convertible Senior Notes | (9) Convertible Senior Notes On June 17, 2014, the Company issued $345 million aggregate principal amount of 1.75% Convertible Senior Notes due 2021 (the Notes) in an underwritten public offering. The net proceeds from the offering were $337.5 million after deducting the Underwriter’s discount and offering expenses paid by the Company. The Notes are convertible 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, under certain circumstances as outlined in the indenture, based on an initial conversion rate, subject to adjustment, of 23.4968 shares per $1,000 principal amount of Notes (representing an initial conversion price of approximately $42.56 per share). The Company may not redeem the Notes prior to June 20, 2017. The Company may redeem for cash all or part of the Notes, at the Company’s option, on or after June 20, 2017, under certain circumstances as outlined in the indenture. The Company pays 1.75% interest per annum on the principal amount of the Notes, payable semiannually in arrears in cash on June 15 and December 15 of each year. The Notes will mature on June 15, 2021. If the Company undergoes a “fundamental change” (as defined in the Indenture), subject to certain conditions, holders may require the Company to repurchase for cash all or part of their Notes in principal amounts of $1,000 or an integral multiple thereof. The Indenture contains customary terms and covenants and events of default. If an event of default (other than certain events of bankruptcy, insolvency or reorganization involving the Company) occurs and is continuing, the Trustee by notice to the Company, or the holders of at least 25% in principal amount of the outstanding Notes by notice to the Company and the Trustee, may declare 100% of the principal of and accrued and unpaid interest, if any, on all the Notes to be due and payable. Upon such a declaration of acceleration, such principal and accrued and unpaid interest, if any, will be due and payable immediately. Upon the occurrence of certain events of bankruptcy, insolvency or reorganization involving the Company, 100% of the principal and accrued and unpaid interest, if any, on all of the Notes will become due and payable automatically. Notwithstanding the foregoing, the Indenture provides that, to the extent the Company elects and for up to 270 days, the sole remedy for an event of default relating to certain failures by the Company to comply with certain reporting covenants in the Indenture consists exclusively of the right to receive additional interest on the Notes. The Notes will be senior unsecured obligations and will rank equally with all of the Company’s existing and future senior debt and senior to any of the Company’s subordinated debt. The Notes will be structurally subordinated to all existing or future indebtedness and other liabilities (including trade payables) of the Company’s subsidiaries and will be effectively subordinated to the Company’s existing or future secured indebtedness to the extent of the value of the collateral. The Indenture does not limit the amount of debt that the Company or its subsidiaries may incur. In accounting for the issuance of the Notes, the Company separated the Notes into liability and equity components. The carrying amount of the liability component was calculated by measuring the fair value of a similar liability that does not have an associated convertible feature. The carrying amount of the equity component representing the conversion option was determined by deducting the fair value of the liability component from the par value of the Notes as a whole. The equity component is not re-measured as long as it continues to meet the conditions for equity classification. The outstanding note balance as of June 30, 2018 and December 31, 2017 consisted of the following: (In thousands) June 30,2018 December 31, 2017 Liability component: Principal $ 345,000 $ 345,000 Less: debt discount and debt issuance costs, net (31,321 ) (36,195 ) Net carrying amount $ 313,679 $ 308,805 Equity component $ 61,195 $ 61,195 In connection with the issuance of the Notes, the Company incurred approximately $7.5 million of debt issuance costs, which primarily consisted of underwriting, legal and other professional fees, and allocated these costs to the liability and equity components based on the allocation of the proceeds. Of the total $7.5 million of debt issuance costs, $1.3 million were allocated to the equity component and recorded as a reduction to additional paid-in capital and $6.2 million were allocated to the liability component and recorded as a reduction in the carrying amount of the debt liability on the balance sheet. The portion allocated to the liability component is amortized to interest expense over the expected life of the Notes using the effective interest method. As of June 30, 2018, the remaining contractual life of the Notes is approximately 3.0 years. The effective interest rate on the liability component was approximately 4.8% for the period from the date of issuance through June 30, 2018. The following table sets forth total interest expense recognized related to the Notes for the three and six months ended June 30, 2018 and 2017: (In thousands) Three-month period ended June 30, 2018 Three-month period ended June 30, 2017 Six-month period ended June 30, 2018 Six-month period ended June 30, 2017 Contractual interest expense $ 1,509 $ 1,509 $ 3,019 $ 3,019 Amortization of debt issuance costs 227 216 451 430 Amortization of debt discount 2,225 2,122 4,423 4,219 Total interest expense $ 3,961 $ 3,847 $ 7,893 $ 7,668 |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | (10) Commitments and Contingencies The Company is currently party to various legal proceedings which are principally patent litigation matters. The Company has assessed such legal proceedings and does not believe that it is probable that a liability has been incurred or that the amount of any potential liability or range of losses can be reasonably estimated. As a result, the Company did not record any loss contingencies for any of these matters. Litigation expenses are expensed as incurred. Refer to Note 2 subsequent events for further details. |
Summary of Significant Accoun17
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2018 | |
Accounting Policies [Abstract] | |
Revenue Recognition | Revenue Recognition On January 1, 2018, we adopted the new accounting standard ASC 606, “Revenue from Contracts with Customers” (Topic 606) (“ASC 606”) and the related amendments to all contracts with customers that were not completed as of the date of adoption using the modified retrospective method. ASC 606 supersedes prior revenue guidance under ASC 605 “Revenue Recognition” (“ASC 605”) and requires entities to recognize revenue to depict the transfer of promised goods or services to customers at an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The Company completed its assessment of the new guidance and evaluated the new requirements as applied to its existing revenue contracts not completed as of the date of initial application. As a result of the assessment, with the exception of the changes to our recognition of license revenue as further described below, the Company determined that adoption of the new standard did not have a significant impact on its revenue recognition methodology. In accordance with ASC 606, the Company recognizes revenue when the customer obtains control of a promised good or service, in an amount that reflects the consideration to which the Company expects to be entitled in exchange for the good or service. The Company determined that the revenue recognition methodology for the deferred license revenue changed as a result of the adoption of ASC 606. License revenue recorded by the Company prior to January 1, 2018 related exclusively to the recognition of the upfront payment received from Biogen upon the execution of the License and Collaboration agreement that granted Biogen an exclusive non sub-licensable license to sell Fampyra outside of the U.S. License revenue recorded prior to January 1, 2018 was recognized under ASC 605 on a pro rata basis as the Company’s obligations were satisfied throughout the duration of the license and collaboration agreement. As of January 1, 2018, the Company adopted ASC 606 which changed the Company’s determination of its distinct performance obligations resulting in an acceleration of the recognition of the revenue in the arrangement. The material performance obligations were completed prior to January 1, 2018, and as a result, the Company recognized its previously deferred revenue as a cumulative effect adjustment The cumulative effect of applying ASC 606 to the company’s consolidated balance sheet was as follows: (In thousands) Balance as of December 31, 2017 Net Adjustments Balance as of January 1, 2018 Assets Other current assets $ 1,983 $ (634 ) $ 1,349 Non-current portion of deferred cost of license revenue 1,638 (1,638 ) — Total Assets $ 1,197,969 $ (2,272 ) $ 1,195,697 Liabilities Current portion of deferred license revenue $ 9,057 $ (9,057 ) $ — Non-current portion of deferred license revenue 23,398 (23,398 ) — Deferred tax liability 22,459 2,600 25,059 Accumulated deficit (455,108 ) 27,583 (427,525 ) Total liabilities and stockholders' equity $ 1,197,969 $ (2,272 ) $ 1,195,697 The impact of the adoption of ASC 606 on the Company’s consolidated balance sheet as of June 30, 2018 was as follows: (In thousands) Balance as of June 30, 2018 Prior to Adoption of ASC 606 Net Adjustments Balance as of June 30, 2018 as Reported Under ASC 606 Assets Other current assets $ 2,641 $ (634 ) $ 2,007 Non-current portion of deferred cost of license revenue 1,320 (1,320 ) — Total Assets $ 1,252,570 $ (1,954 ) $ 1,250,616 Liabilities Current portion of deferred license revenue $ 9,057 $ (9,057 ) $ — Non-current portion of deferred license revenue 18,870 (18,870 ) — Deferred tax liability 34,986 2,600 37,586 Accumulated deficit (412,900 ) 23,373 (389,527 ) Total liabilities and stockholders' equity $ 1,252,570 $ (1,954 ) $ 1,250,616 The impact of the adoption of ASC 606 on the Company’s consolidated statement of operations for the three-month period ended June 30, 2018 was as follows: (In thousands) Three-Month Period Ended June 30, 2018 Balance Prior to Adoption of ASC 606 Effect of Change Three-Month Period Ended June 30, 2018 Balance as Reported Under ASC 606 License revenue $ 2,264 $ (2,264 ) $ — Cost of license revenue 159 (159 ) — Operating income (loss) $ 61,140 $ (2,105 ) $ 59,035 Net income (loss) $ 48,302 $ (2,105 ) $ 46,197 Net income (loss) per share—basic $ 1.03 $ (0.04 ) $ 0.99 Net income (loss) per share—diluted $ 1.02 $ (0.04 ) $ 0.98 The impact of the adoption of ASC 606 on the Company’s consolidated statement of operations for the six-month period ended June 30, 2018 was as follows: (In thousands) Six-Month Period Ended June 30, 2018 Balance Prior to Adoption of ASC 606 Effect of Change Six-Month Period Ended June 30, 2018 Balance as Reported Under ASC 606 License revenue $ 4,528 $ (4,528 ) $ — Cost of license revenue 318 (318 ) — Operating income (loss) $ 63,699 $ (4,210 ) $ 59,489 Net income (loss) $ 42,208 $ (4,210 ) $ 37,998 Net income (loss) per share—basic $ 0.91 $ (0.09 ) $ 0.82 Net income (loss) per share—diluted $ 0.90 $ (0.09 ) $ 0.81 ASC 606 did not have an aggregate impact on the Company’s net cash provided by operating activities. ASC 606 outlines a five-step process for recognizing revenue from contracts with customers: i) identify the contract with the customer, ii) identify the performance obligations in the contract, (iii) determine the transaction price, iv) allocate the transaction price to the separate performance obligations in the contract, and (v) recognize revenue associated with the performance obligations as they are satisfied. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. Once a contract is determined to be within the scope of ASC 606, the Company determines the performance obligations that are distinct. The Company recognizes as revenues the amount of the transaction price that is allocated to each respective performance obligation when the performance obligation is satisfied or as it is satisfied. Generally, the Company's performance obligations are transferred to customers at a point in time, typically upon receipt of the product by the customer. ASC 606 requires entities to record a contract asset when a performance obligation has been satisfied or partially satisfied, but the amount of consideration has not yet been received because the receipt of the consideration is conditioned on something other than the passage of time. ASC 606 also requires an entity to present a revenue contract as a contract liability in instances when a customer pays consideration, or an entity has a right to an amount of consideration that is unconditional (e.g. receivable), before the entity transfers a good or service to the customer. We currently do not have any contract assets. We recognize contract liabilities when a customer pays an upfront deposit upon contract execution for future obligations to be performed by us. As of June 30, 2018, we had contract liability in the amount of $5.5 million which reflects an upfront deposit paid by a customer upon contract execution for future obligations to be performed by us. The amount is currently reported in accrued expenses and other current liabilities in the Balance Sheet. If the contract is canceled, these upfront deposits are refundable only if certain obligations have not been performed by us. We did not have any contract liability as of December 31, 2017. Product Revenue, Net Net revenue from product sales is recognized at the transaction price when the customer obtains control of the Company’s products, which occurs at a point in time, typically upon receipt of the product by the customer. The Company’s products are sold primarily to a network of specialty providers which are contractually obligated to hold no more than an agreed upon number of days of inventory. The Company’s payment terms are between 30 to 34 days. The Company’s net revenues represent total revenues adjusted for discounts and allowances, including estimated cash discounts, chargebacks, rebates, returns, Discounts and Allowances Revenue from product sales are recorded at the transaction price, which includes estimates for discounts and allowances for which reserves are established and includes cash discounts, chargebacks, rebates, returns, copay assistance, data fees and wholesaler fees for services Discounts and allowances are recorded following shipment of product and the appropriate reserves are credited. These reserves are classified as reductions of accounts receivable (if the amount is payable to the Customer and right of offset exists) or a current liability (if the amount is payable to a party other than a Customer). These allowances are established by management as its best estimate based on historical experience and data points available and are adjusted to reflect known changes in the factors that impact such reserves. Allowances for customer credits, chargebacks, rebates, data fees and wholesaler fees for services, returns, and discounts are established based on contractual terms with customers and analyses of historical usage of these items. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known. The nature of our allowances and accruals requiring critical estimates, and the specific considerations it uses in estimating their amounts are as follows: Government Chargebacks and Rebates: We contract for Medicaid and other U.S. Federal government programs to allow for our products to remain eligible for reimbursement under these programs. For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap for whom the Company will owe an additional liability under the Medicare Part D program. Based upon our contracts and the most recent experience with respect to sales through each of these channels, we provide an allowance for chargebacks and rebates. We monitor the sales trends and adjust the chargeback and rebate percentages on a regular basis to reflect the most recent chargebacks and rebate experience. The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for product that has been recognized as revenue, but remains in the distribution channel inventories at the end of each reporting period. Managed Care Contract Rebates: We contract with various managed care organizations including health insurance companies and pharmacy benefit managers. These contracts stipulate that rebates and, in some cases, administrative fees, are paid to these organizations provided our product is placed on a specific tier on the organization’s drug formulary. Based upon our contracts and the most recent experience with respect to sales through managed care channels, we provide an allowance for managed care contract rebates. We monitor the sales trends and adjust the allowance on a regular basis to reflect the most recent rebate experience. The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for product that has been recognized as revenue, but remains in the distribution channel inventories at the end of each reporting period. Copay Mitigation Rebates: We offer copay mitigation to commercially insured patients who have coverage for our products (in accordance with applicable law) and are responsible for a cost share. Based upon our contracts and the most recent experience with respect to actual copay assistance provided, we provide an allowance for copay mitigation rebates. We monitor the sales trends and adjust the rebate percentages on a regular basis to reflect the most recent rebate experience. Cash Discounts: We sell directly to our network of specialty pharmacies, Kaiser and ASD Specialty Healthcare, Inc. We generally provide invoice discounts for prompt payment for our products. We estimate our cash discounts based on the terms offered to our customers. Discounts are estimated based on rates that are explicitly stated in the Company’s contracts as it is expected they will take the discount and are recorded as a reduction of revenue at the time of product shipment when product revenue is recognized. We adjust estimates based on actual activity as necessary. Product Returns: We either offer customers no return except for products damaged in shipping or consistent with industry practice, a limited right of return based on the product’s expiration date. The Company estimates the amount of its product sales that may be returned by its customers and records this estimate as a reduction of revenue in the period the related product revenue is recognized. The company currently estimates product return liabilities using historical sales information and inventory remaining in the distribution channel. Data Fees and Fees for Service Payable to Specialty Pharmacies: We have contracted with certain specialty pharmacies to obtain transactional data related to our products in order to develop a better understanding of our selling channel as well as patient activity and utilization by the Medicaid program and other government agencies and managed care organizations. We pay a variable fee to the specialty pharmacies to provide us the data. We also pay the specialty pharmacies a flat fee in exchange for providing distribution and inventory management services, including the provision of inventory management data to the Company. We estimate our fee for service accruals and allowances based on sales to each specialty pharmacy and the applicable contracted rate. Royalty Revenue Royalty revenue recorded by the Company relates exclusively to the Company’s License and Collaboration agreement with Biogen which provides for ongoing royalties based on sales of Fampyra outside of the U.S. The Company recognizes revenue for royalties under ASC 606, which provides revenue recognition constraints by requiring the recognition of revenue at the later of the following: 1) sale or usage of the products or 2) satisfaction of the performance obligations. The Company has satisfied its performance obligations and therefore recognizes royalty revenue when the sales to which the royalties relate are completed. Milestone Revenue Milestone revenue relates to the License and Collaboration agreement with Biogen which provides for milestone payments for the achievement of certain regulatory and sales milestones during the term of the agreement. Regulatory milestones are contingent upon the approval of Fampyra for new indications outside of the U.S. Sales milestones are contingent upon the achievement of certain net sales targets for Fampyra sales outside of the U.S. The Company recognizes milestone revenue under ASC 606, which provides constraints for entities to recognize milestone revenue which is deemed to be variable by requiring the Company to estimate the amount of consideration to which it is entitled in exchange for transferring the promised goods or services to a customer. The Company recognizes an estimate of revenue to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the milestone is achieved. For regulatory milestones, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the Company’s control or the licensee’s control, such as regulatory approvals, are generally not considered probable of being achieved until those approvals are received. The following table disaggregates our revenue by major source (in thousands): Three-month period ended June 30, 2018 Three-month period ended June 30, 2017 Six-month period ended June 30, 2018 Six-month period ended June 30, 2017 Revenues: Net product revenues $ 150,412 $ 132,756 $ 253,415 $ 245,349 Royalty revenues 2,890 4,418 6,052 8,946 License revenue — 2,264 — 4,529 Total net revenues $ 153,302 $ 139,438 $ 259,467 $ 258,824 |
Foreign Currency Translation | Foreign Currency Translation The functional currency of operations outside the United States of America is deemed to be the currency of the local country, unless otherwise determined that the United States dollar would serve as a more appropriate functional currency given the economic operations of the entity. Accordingly, the assets and liabilities of the Company’s foreign subsidiary, Biotie, are translated into United States dollars using the period-end exchange rate; income and expense items are translated using the average exchange rate during the period; and equity transactions are translated at historical rates. Cumulative translation adjustments are reflected as a separate component of equity. Foreign currency transaction losses and gains are recognized in the period incurred and are reported as other (expense) income, net in the statement of operations. |
Segment and Geographic Information | Segment and Geographic Information The Company is managed and operated as one business which is focused on developing therapies that restore function and improve the lives of people with neurological disorders. The entire business is managed by a single management team that reports to the Chief Executive Officer. The Company does not operate separate lines of business with respect to any of its products or product candidates and the Company does not prepare discrete financial information with respect to separate products or product candidates or by location. Accordingly, the Company views its business as one reportable operating segment. Net product revenues reported to date are derived from the sales of Ampyra and Qutenza in the U.S. |
Subsequent Events | Subsequent Events Subsequent events are defined as those events or transactions that occur after the balance sheet date, but before the financial statements are filed with the Securities and Exchange Commission. The Company completed an evaluation of the impact of any subsequent events through the date these financial statements were issued, and determined the following subsequent events required disclosure in these financial statements. On August 3, 2018, we reported the following updates on the Ampyra ANDA litigation with the three generic drug manufacturers that remain a party to the litigation: We have entered into a conditioned settlement agreement with Mylan Pharmaceuticals Inc. and affiliates, and as a result of the settlement agreement, Mylan will be permitted to market its generic version of Ampyra in the U.S. sometime in 2025 or earlier under certain circumstances; we have signed an interim agreement with Teva Pharmaceuticals USA, Inc., that addresses the period of time until August 31, 2018 (and potentially until the appellate court issues a decision on the merits); and we have signed an interim agreement with West-Ward Pharmaceuticals International Limited and Hikma Pharmaceuticals USA Inc., successors to Roxane Laboratories, Inc., that addresses the period of time until the appellate court issues a decision on the merits. The terms of the settlement agreement and interim agreements are otherwise confidential. |
Accounting Pronouncements Adopted | Accounting Pronouncements Adopted As noted above, in May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update 2014-09, “Revenue from Contracts with Customers” (Topic 606) (ASU 2014-09). This new standard replaced all previous U.S. GAAP guidance on this topic and eliminated all industry-specific guidance. The new standard requires the application of a five-step model to determine the amount and timing of revenue to be recognized. The underlying principle is that revenue is to be recognized for the transfer of goods or services to customers that reflects the amount of consideration that the Company expects to be entitled to in exchange for those goods or services. The Company adopted the new standard effective January 1, 2018 using the modified retrospective transition method. See discussion of the adoption above in Revenue Recognition In November 2016, the FASB issued Accounting Standards Update ASU 2016-18 “Statement of Cash Flows” (Topic 230); Restricted Cash (ASU 2016-18), which defines new requirements for the presentation of restricted cash and restricted cash equivalents in the statement of cash flows. The amendments in this ASU require retrospective application to each period presented. The Company adopted this guidance effective January 1, 2018 retrospectively. This ASU requires the entities to present statement of cash flows in a manner such that it reconciles beginning and ending totals of cash, cash equivalents, restricted cash or restricted cash equivalents. Also, when cash, cash equivalents, restricted cash or restricted cash equivalents are presented in more than one line item within the statement of financial position, an entity should, for each period that a statement of financial position is presented, present on the face of the statement of cash flows or disclose in the notes to the financial statements, the line items and amounts of cash, cash equivalents, and restricted cash or restricted cash equivalents reported within the statement of financial position. The amounts, disaggregated by the line item in which they appear within the statement of financial position, shall sum to the total amount of cash, cash equivalents, and restricted cash or restricted cash equivalents at the end of the corresponding period shown in the statement of cash flows. The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the statement of financial position that sum to the total of the same amounts shown in the statement of cash flows: Six-month period ended June 30, 2018 Six-month period ended June 30, 2017 (In thousands) Beginning of period End of period Beginning of period End of period Cash and cash equivalents $ 307,068 $ 243,345 $ 158,537 $ 141,135 Restricted cash 410 221 79 — Restricted cash included in Other assets 561 506 255 255 Total Cash, cash equivalents and restricted cash per statement of cash flows $ 308,039 $ 244,072 $ 158,871 $ 141,390 Amounts included in restricted cash represent those amounts required to be set aside to cover the Company’s self-funded employee health insurance. Restricted cash included in other assets on the statement of financial position relates to cash collateralized standby letters of credit in connection with obligations under facility leases, which is included with other assets in the consolidated balance sheet due to the long-term nature of the letters of credit. In June 2018, the FASB issued ASU 2018-07, which simplifies the accounting for share-based payments granted to nonemployees for goods and services. Under the ASU, most of the guidance on such payments to nonemployees would be aligned with the requirements for share-based payments granted to employees. Currently, share-based payment arrangements with employees are accounted for under ASC 718, while nonemployee share-based payments issued for goods and services are accounted for under ASC 505-50. ASC 505-50, before the amendments, differed significantly from ASC 718. However, FASB concluded that awards granted to employees are economically similar to awards granted to nonemployees and therefore two different accounting models were not justified. This ASU is effective for fiscal years beginning after December 15, 2018, and interim periods therein with early adoption permitted. The Company early adopted this guidance beginning June 1, 2018. The adoption of this guidance did not have an impact on its consolidated financial statements. |
Accounting Pronouncements Not Yet Adopted | Accounting Pronouncements Not Yet Adopted In February 2016, the FASB issued Accounting Standards Update 2016-02, “Leases” (Topic 842). The main objective of this update is to increase transparency and comparability among organizations by recognizing lease assets and lease liabilities on the balance sheet and disclosing key information about leasing arrangements. This ASU is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. The Company has implemented a process to identify its outstanding lease portfolio and is currently evaluating its outstanding leases to determine the impact the new standard will have on its financial statements. In January 2017, the FASB issued Accounting Standards Update 2017-04, “Intangibles – Goodwill and Other” (Topic 350): Simplifying the Test for Goodwill Impairment (ASU 2017-04). This new standard simplifies how an entity is required to test goodwill for impairment by eliminating Step 2 from the goodwill impairment test. ASU 2017-04 allows for prospective application and is effective for fiscal years beginning after December 15, 2019, and interim periods therein with early adoption permitted for interim or annual goodwill impairment tests performed on testing dates after January 1, 2017. The Company is currently evaluating whether it will adopt this guidance early. The Company does not expect the adoption of this guidance to have a significant impact on its consolidated financial statements. In February 2018, the FASB issued Accounting Standards Update 2018-02, ‘Income Statement—Reporting Comprehensive Income’ (Topic 220): Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income (ASU 2018-02). This new standard provides entities with an option to reclassify stranded tax effects within AOCI to retained earnings in each period in which the effect of the change in the U.S. federal corporate income tax rate in the Tax Cuts and Jobs Act (or portion thereof) is recorded. ASC 740-10-35-4 requires that deferred tax assets and liabilities should be adjusted to account for any changes in tax laws or rates within the period that the enactment of these changes occurs and any adjustments to flow through income from continuing operations. Since the adjustments due to the Tax Cuts and Jobs Act are required to flow through income from continuing operations, the tax effects of items within accumulated other comprehensive income known now as “stranded tax effects,” do not reflect the appropriate tax rate. As such, FASB issued ASU 2018-02, in order to address these stranded income tax effects. The new standard requires entities to disclose the following: • A description of the accounting policy for releasing income tax effects from AOCI; • Whether they elect to reclassify the stranded income tax effects from the Tax Cuts and Jobs Act, and • Information about the other income tax effects that are reclassified. The ASU is effective for all entities for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years with early adoption permitted. The Company is currently evaluating the impact it may have on its consolidated financial statements. In March 2018, the FASB issued Accounting Standards Update 2018-05, “Amendments to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin (SAB) No. 118’. The ASU adds seven paragraphs to ASC 740, Income Taxes, that contain SEC guidance related to SAB 118 (codified as SEC SAB Topic 5.EE, “Income Tax Accounting Implications of the Tax Cuts and Jobs Act”), which provides guidance for companies that are not able to complete their accounting for the income tax effects of the Tax Cuts and Jobs Act in the period of enactment which is the period that includes December 22, 2017. The measurement period should not extend beyond one year from the enactment date. The Company is currently evaluating the impact the adoption of this guidance may have on its consolidated financial statements. |
Summary of Significant Accoun18
Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Disaggregation of Revenue | The following table disaggregates our revenue by major source (in thousands): Three-month period ended June 30, 2018 Three-month period ended June 30, 2017 Six-month period ended June 30, 2018 Six-month period ended June 30, 2017 Revenues: Net product revenues $ 150,412 $ 132,756 $ 253,415 $ 245,349 Royalty revenues 2,890 4,418 6,052 8,946 License revenue — 2,264 — 4,529 Total net revenues $ 153,302 $ 139,438 $ 259,467 $ 258,824 |
Reconciliation of Cash, Cash Equivalents and Restricted Cash | The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the statement of financial position that sum to the total of the same amounts shown in the statement of cash flows: Six-month period ended June 30, 2018 Six-month period ended June 30, 2017 (In thousands) Beginning of period End of period Beginning of period End of period Cash and cash equivalents $ 307,068 $ 243,345 $ 158,537 $ 141,135 Restricted cash 410 221 79 — Restricted cash included in Other assets 561 506 255 255 Total Cash, cash equivalents and restricted cash per statement of cash flows $ 308,039 $ 244,072 $ 158,871 $ 141,390 |
ASC 606 | |
Cumulative Effect and Impact of Adoption of ASC 606 on Consolidated Balance Sheet And Consolidated Statement Of Operations | The cumulative effect of applying ASC 606 to the company’s consolidated balance sheet was as follows: (In thousands) Balance as of December 31, 2017 Net Adjustments Balance as of January 1, 2018 Assets Other current assets $ 1,983 $ (634 ) $ 1,349 Non-current portion of deferred cost of license revenue 1,638 (1,638 ) — Total Assets $ 1,197,969 $ (2,272 ) $ 1,195,697 Liabilities Current portion of deferred license revenue $ 9,057 $ (9,057 ) $ — Non-current portion of deferred license revenue 23,398 (23,398 ) — Deferred tax liability 22,459 2,600 25,059 Accumulated deficit (455,108 ) 27,583 (427,525 ) Total liabilities and stockholders' equity $ 1,197,969 $ (2,272 ) $ 1,195,697 The impact of the adoption of ASC 606 on the Company’s consolidated balance sheet as of June 30, 2018 was as follows: (In thousands) Balance as of June 30, 2018 Prior to Adoption of ASC 606 Net Adjustments Balance as of June 30, 2018 as Reported Under ASC 606 Assets Other current assets $ 2,641 $ (634 ) $ 2,007 Non-current portion of deferred cost of license revenue 1,320 (1,320 ) — Total Assets $ 1,252,570 $ (1,954 ) $ 1,250,616 Liabilities Current portion of deferred license revenue $ 9,057 $ (9,057 ) $ — Non-current portion of deferred license revenue 18,870 (18,870 ) — Deferred tax liability 34,986 2,600 37,586 Accumulated deficit (412,900 ) 23,373 (389,527 ) Total liabilities and stockholders' equity $ 1,252,570 $ (1,954 ) $ 1,250,616 The impact of the adoption of ASC 606 on the Company’s consolidated statement of operations for the three-month period ended June 30, 2018 was as follows: (In thousands) Three-Month Period Ended June 30, 2018 Balance Prior to Adoption of ASC 606 Effect of Change Three-Month Period Ended June 30, 2018 Balance as Reported Under ASC 606 License revenue $ 2,264 $ (2,264 ) $ — Cost of license revenue 159 (159 ) — Operating income (loss) $ 61,140 $ (2,105 ) $ 59,035 Net income (loss) $ 48,302 $ (2,105 ) $ 46,197 Net income (loss) per share—basic $ 1.03 $ (0.04 ) $ 0.99 Net income (loss) per share—diluted $ 1.02 $ (0.04 ) $ 0.98 The impact of the adoption of ASC 606 on the Company’s consolidated statement of operations for the six-month period ended June 30, 2018 was as follows: (In thousands) Six-Month Period Ended June 30, 2018 Balance Prior to Adoption of ASC 606 Effect of Change Six-Month Period Ended June 30, 2018 Balance as Reported Under ASC 606 License revenue $ 4,528 $ (4,528 ) $ — Cost of license revenue 318 (318 ) — Operating income (loss) $ 63,699 $ (4,210 ) $ 59,489 Net income (loss) $ 42,208 $ (4,210 ) $ 37,998 Net income (loss) per share—basic $ 0.91 $ (0.09 ) $ 0.82 Net income (loss) per share—diluted $ 0.90 $ (0.09 ) $ 0.81 |
Share-based Compensation (Table
Share-based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Schedule of Share-based Compensation Expense | The following table summarizes share-based compensation expense included within the consolidated statements of operations: For the three-month period ended June 30, For the six-month period ended June 30, (In millions) 2018 2017 2018 2017 Research and development expense $ 1.5 $ 3.8 $ 3.2 $ 6.4 Selling, general and administrative expense 3.7 7.9 7.9 13.2 Total $ 5.2 $ 11.7 $ 11.1 $ 19.6 |
Schedule of Stock Option Activity | A summary of share-based compensation activity for the six-month period ended June 30, 2018 is presented below: Number of Shares (In Weighted Average Exercise Price Weighted Average Remaining Contractual Term Intrinsic Value (In Balance at January 1, 2018 8,930 $ 29.46 Granted 705 25.12 Cancelled (401 ) 27.26 Exercised (638 ) 21.18 Balance at June 30, 2018 8,596 $ 29.82 5.9 $ 19,315 Vested and expected to vest at June 30, 2018 8,545 $ 29.85 5.9 $ 19,096 Vested and exercisable at June 30, 2018 6,669 $ 30.51 5.1 $ 13,284 |
Restricted Stock and Performance Stock Unit | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Schedule of Restricted Stock and Performance Stock Unit Activity | (In thousands) Restricted Stock and Performance Stock Units Number of Shares Nonvested at January 1, 2018 697 Granted — Vested (143 ) Forfeited (106 ) Nonvested at June 30, 2018 448 |
Earnings (Loss) Per Share (Tabl
Earnings (Loss) Per Share (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Earnings Per Share [Abstract] | |
Schedule of computation of basic and diluted earnings (loss) per share | The following table sets forth the computation of basic and diluted earnings (loss) per share for the three and six-month periods ended June 30, 2018 and 2017: (In thousands, except per share data) Three-month period ended June 30, 2018 Three-month period ended June 30, 2017 Six-month period ended June 30, 2018 Six-month period ended June 30, 2017 Basic and diluted Net income (loss) $ 46,197 $ (8,196 ) $ 37,998 $ (27,099 ) Weighted average common shares outstanding used in computing net income (loss) per share—basic 46,799 45,943 46,546 45,876 Plus: net effect of dilutive stock options and restricted common shares 402 — 428 — Weighted average common shares outstanding used in computing net income (loss) per share—diluted 47,201 45,943 46,974 45,876 Net income (loss) per share—basic $ 0.99 $ (0.18 ) $ 0.82 $ (0.59 ) Net income (loss) per share—diluted $ 0.98 $ (0.18 ) $ 0.81 $ (0.59 ) |
Schedule of antidilutive securities excluded from calculation of net income (loss) per diluted share | The following amounts were not included in the calculation of net income (loss) per diluted share because their effects were anti-dilutive: (In thousands) Three-month period ended June 30, 2018 Three-month period ended June 30, 2017 Six-month period ended June 30, 2018 Six-month period ended June 30, 2017 Denominator Stock options and restricted common shares 7,356 10,197 7,660 9,672 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Schedule of Assets and Liabilities Measured at Fair Value on a Recurring Basis | (In thousands) Level 1 Level 2 Level 3 June 30, 2018 Assets Carried at Fair Value: Cash equivalents $ 11,381 $ — $ — Short-term investments — 148,371 — Liabilities Carried at Fair Value: Acquired contingent consideration — — 112,200 December 31, 2017 Assets Carried at Fair Value: Cash equivalents $ 9,163 $ — $ — Liabilities Carried at Fair Value: Acquired contingent consideration — — 113,000 |
Contingent consideration liability | |
Schedule of Contingent Liabilities | (In thousands) Three-month period ended June 30, 2018 Three-month period ended June 30, 2017 Six-month period ended June 30, 2018 Six-month period ended June 30, 2017 Acquired contingent consideration: Balance, beginning of period $ 119,200 $ 82,900 $ 113,000 $ 72,100 Fair value change to contingent consideration included in the statement of operations (7,000 ) 6,400 (800 ) 17,200 Balance, end of period $ 112,200 $ 89,300 $ 112,200 $ 89,300 |
Investments (Tables)
Investments (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Investments Debt And Equity Securities [Abstract] | |
Schedule of Available-for-Sale Securities | The Company has determined that all of its investments are classified as available-for-sale. Available-for-sale debt securities are carried at fair value with interest on these investments included in interest income and are recorded based primarily on quoted market prices. Available-for-sale investments consisted of the following at June 30, 2018: Gross Gross Estimated Amortized Unrealized Unrealized Fair (In thousands) Cost Gains Losses Value Short Term Investments $ 148,448 $ 8 $ (85 ) $ 148,371 |
Schedule of Changes in Accumulated Other Comprehensive (Loss) Income | The changes in AOCI associated with the unrealized holding losses on available-for-sale investments during the six-month period ended June 30, 2018, were as follows (in thousands): (In thousands) Net Unrealized Gains (Losses) on Marketable Securities Balance at December 31, 2017 $ — Other comprehensive loss before reclassifications (170 ) Amounts reclassified from accumulated other comprehensive income — Net current period other comprehensive loss (170 ) Balance at June 30, 2018 $ (170 ) |
Liability Related to Sale of 23
Liability Related to Sale of Future Royalties (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Deferred Revenue Disclosure [Abstract] | |
Schedule of Activity Within Liability Related to Sale of Future Royalties | (In thousands) Three-month period ended June 30, 2018 Six-month period ended June 30, 2018 Liability related to sale of future royalties - beginning balance $ 34,395 $ 35,788 Deferred transaction costs recognized 198 401 Non-cash royalty revenue payable to HCRP (2,544 ) (5,326 ) Non-cash interest expense recognized 1,134 2,320 Liability related to sale of future royalties - ending balance $ 33,183 $ 33,183 |
Convertible Senior Notes (Table
Convertible Senior Notes (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Debt Disclosure [Abstract] | |
Summary of Outstanding Note Balances | The outstanding note balance as of June 30, 2018 and December 31, 2017 consisted of the following: (In thousands) June 30,2018 December 31, 2017 Liability component: Principal $ 345,000 $ 345,000 Less: debt discount and debt issuance costs, net (31,321 ) (36,195 ) Net carrying amount $ 313,679 $ 308,805 Equity component $ 61,195 $ 61,195 |
Schedule of Interest Expense Recognized Related to the Notes | The following table sets forth total interest expense recognized related to the Notes for the three and six months ended June 30, 2018 and 2017: (In thousands) Three-month period ended June 30, 2018 Three-month period ended June 30, 2017 Six-month period ended June 30, 2018 Six-month period ended June 30, 2017 Contractual interest expense $ 1,509 $ 1,509 $ 3,019 $ 3,019 Amortization of debt issuance costs 227 216 451 430 Amortization of debt discount 2,225 2,122 4,423 4,219 Total interest expense $ 3,961 $ 3,847 $ 7,893 $ 7,668 |
Summary of Significant Accoun25
Summary of Significant Accounting Policies - Additional Information (Details) $ in Thousands | 6 Months Ended | ||
Jun. 30, 2018USD ($)Segment | Jan. 01, 2018USD ($) | Dec. 31, 2017USD ($) | |
Revenue Recognition | |||
Accumulated deficit | $ (389,527) | $ (455,108) | |
Contract liability | $ 5,500 | ||
Segment and Geographic Information | |||
Number of operating segments | Segment | 1 | ||
Number of reportable operating segments | Segment | 1 | ||
Minimum | |||
Revenue Recognition | |||
Product revenue payment term | 30 days | ||
Maximum | |||
Revenue Recognition | |||
Product revenue payment term | 34 days | ||
ASC 606 | |||
Revenue Recognition | |||
Accumulated deficit | $ (427,525) | ||
ASC 606 | Net Adjustments | |||
Revenue Recognition | |||
Accumulated deficit | $ 23,373 | $ 27,583 |
Summary of Significant Accoun26
Summary of Significant Accounting Policies - Cumulative Effect and Impact of Adoption of ASC 606 on Consolidated Balance Sheet (Details) - USD ($) $ in Thousands | Jun. 30, 2018 | Jan. 01, 2018 | Dec. 31, 2017 |
Assets | |||
Other current assets | $ 2,007 | $ 1,983 | |
Non-current portion of deferred cost of license revenue | 1,638 | ||
Total Assets | 1,250,616 | 1,197,969 | |
Liabilities | |||
Current portion of deferred license revenue | 9,057 | ||
Non-current portion of deferred license revenue | 23,398 | ||
Deferred tax liability | 37,586 | 22,459 | |
Accumulated deficit | (389,527) | (455,108) | |
Total liabilities and stockholders' equity | 1,250,616 | $ 1,197,969 | |
ASC 606 | |||
Assets | |||
Other current assets | $ 1,349 | ||
Total Assets | 1,195,697 | ||
Liabilities | |||
Deferred tax liability | 25,059 | ||
Accumulated deficit | (427,525) | ||
Total liabilities and stockholders' equity | 1,195,697 | ||
ASC 606 | Net Adjustments | |||
Assets | |||
Other current assets | (634) | (634) | |
Non-current portion of deferred cost of license revenue | (1,320) | (1,638) | |
Total Assets | (1,954) | (2,272) | |
Liabilities | |||
Current portion of deferred license revenue | (9,057) | (9,057) | |
Non-current portion of deferred license revenue | (18,870) | (23,398) | |
Deferred tax liability | 2,600 | 2,600 | |
Accumulated deficit | 23,373 | 27,583 | |
Total liabilities and stockholders' equity | (1,954) | $ (2,272) | |
ASC 606 | Prior to Adoption of ASC 606 | |||
Assets | |||
Other current assets | 2,641 | ||
Non-current portion of deferred cost of license revenue | 1,320 | ||
Total Assets | 1,252,570 | ||
Liabilities | |||
Current portion of deferred license revenue | 9,057 | ||
Non-current portion of deferred license revenue | 18,870 | ||
Deferred tax liability | 34,986 | ||
Accumulated deficit | (412,900) | ||
Total liabilities and stockholders' equity | $ 1,252,570 |
Summary of Significant Accoun27
Summary of Significant Accounting Policies - Impact of Adoption of ASC 606 on Consolidated Statement of Operations (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | ||||
License revenue | $ 153,302 | $ 139,438 | $ 259,467 | $ 258,824 |
Cost of license revenue | 31,094 | 29,665 | 52,444 | 54,848 |
Operating income (loss) | 59,035 | 2,696 | 59,489 | (12,577) |
Net income (loss) | $ 46,197 | $ (8,196) | $ 37,998 | $ (27,099) |
Net income (loss) per share—basic | $ 0.99 | $ (0.18) | $ 0.82 | $ (0.59) |
Net income (loss) per share—diluted | $ 0.98 | $ (0.18) | $ 0.81 | $ (0.59) |
License Revenue | ||||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | ||||
License revenue | $ 2,264 | $ 4,529 | ||
ASC 606 | Prior to Adoption of ASC 606 | ||||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | ||||
Operating income (loss) | $ 61,140 | $ 63,699 | ||
Net income (loss) | $ 48,302 | $ 42,208 | ||
Net income (loss) per share—basic | $ 1.03 | $ 0.91 | ||
Net income (loss) per share—diluted | $ 1.02 | $ 0.90 | ||
ASC 606 | Net Adjustments | ||||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | ||||
Operating income (loss) | $ (2,105) | $ (4,210) | ||
Net income (loss) | $ (2,105) | $ (4,210) | ||
Net income (loss) per share—basic | $ (0.04) | $ (0.09) | ||
Net income (loss) per share—diluted | $ (0.04) | $ (0.09) | ||
ASC 606 | License Revenue | Prior to Adoption of ASC 606 | ||||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | ||||
License revenue | $ 2,264 | $ 4,528 | ||
Cost of license revenue | 159 | 318 | ||
ASC 606 | License Revenue | Net Adjustments | ||||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | ||||
License revenue | (2,264) | (4,528) | ||
Cost of license revenue | $ (159) | $ (318) |
Summary of Significant Accoun28
Summary of Significant Accounting Policies - Disaggregation of Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Disaggregation Of Revenue [Line Items] | ||||
Total net revenues | $ 153,302 | $ 139,438 | $ 259,467 | $ 258,824 |
Net Product Revenues | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total net revenues | 150,412 | 132,756 | 253,415 | 245,349 |
Royalty Revenues | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total net revenues | $ 2,890 | 4,418 | $ 6,052 | 8,946 |
License Revenue | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total net revenues | $ 2,264 | $ 4,529 |
Summary of Significant Accoun29
Summary of Significant Accounting Policies - Reconciliation of Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Jun. 30, 2018 | Dec. 31, 2017 | Jun. 30, 2017 | Dec. 31, 2016 |
Accounting Policies [Abstract] | ||||
Cash and cash equivalents | $ 243,345 | $ 307,068 | $ 141,135 | $ 158,537 |
Restricted cash | 221 | 410 | 79 | |
Restricted cash included in Other assets | $ 506 | $ 561 | $ 255 | $ 255 |
Restricted cash, noncurrent, statement of financial position [extensible list] | us-gaap:OtherAssetsNoncurrent | us-gaap:OtherAssetsNoncurrent | us-gaap:OtherAssetsNoncurrent | us-gaap:OtherAssetsNoncurrent |
Total Cash, cash equivalents and restricted cash per statement of cash flows | $ 244,072 | $ 308,039 | $ 141,390 | $ 158,871 |
Share-based Compensation - Addi
Share-based Compensation - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ||||
Share-based compensation expense recognized | $ 5.2 | $ 11.7 | $ 11.1 | $ 19.6 |
Weighted average fair value of options granted (in dollars per share) | $ 14.32 | $ 7.24 | $ 12.84 | $ 10.75 |
Share based compensation, other disclosures | ||||
Total unrecognized compensation costs related to unvested stock options and restricted stock awards that the company expects to recognize | $ 30.3 | $ 30.3 | ||
Weighted average period | 1 year 9 months 18 days | |||
Repurchases of common stock, shares | 16,339 | 63,124 | ||
Average price of common stock per share | $ 23.58 | $ 25.15 | ||
Repurchases of common stock | $ 0.4 | $ 1.6 |
Share-based Compensation - Sche
Share-based Compensation - Schedule of Share-based Compensation Expense (Details) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Share-based compensation expense recognized | $ 5.2 | $ 11.7 | $ 11.1 | $ 19.6 |
Research and development expense | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Share-based compensation expense recognized | 1.5 | 3.8 | 3.2 | 6.4 |
Selling, general, and administrative expense | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Share-based compensation expense recognized | $ 3.7 | $ 7.9 | $ 7.9 | $ 13.2 |
Share-based Compensation - Sc32
Share-based Compensation - Schedule of Stock Options Activity (Details) $ / shares in Units, shares in Thousands, $ in Thousands | 6 Months Ended |
Jun. 30, 2018USD ($)$ / sharesshares | |
Stock Option Activity | |
Beginning balance (in shares) | shares | 8,930 |
Granted (in shares) | shares | 705 |
Cancelled (in shares) | shares | (401) |
Exercised (in shares) | shares | (638) |
Ending balance (in shares) | shares | 8,596 |
Vested and expected to vest at the end of the period | shares | 8,545 |
Vested and exercisable at the end of the period | shares | 6,669 |
Weighted Average Exercise Price | |
Balance at the beginning of the period (in dollars per share) | $ / shares | $ 29.46 |
Granted (in dollars per share) | $ / shares | 25.12 |
Cancelled (in dollars per share) | $ / shares | 27.26 |
Exercised (in dollars per share) | $ / shares | 21.18 |
Balance at the end of the period (in dollars per share) | $ / shares | 29.82 |
Vested and expected to vest at the end of the period (in dollars per share) | $ / shares | 29.85 |
Vested and exercisable at the end of the period (in dollars per share) | $ / shares | $ 30.51 |
Weighted Average Remaining Contractual Term | |
Balance at the end of the period | 5 years 10 months 24 days |
Vested and expected to vest at the end of the period | 5 years 10 months 24 days |
Vested and exercisable at the end of the period | 5 years 1 month 6 days |
Intrinsic Value | |
Balance at the end of the period | $ | $ 19,315 |
Vested and expected to vest at the end of the period | $ | 19,096 |
Vested and exercisable at the end of the period | $ | $ 13,284 |
Share-based Compensation - Sc33
Share-based Compensation - Schedule of Restricted Stock and Performance Stock Unit Activity (Details) - Restricted Stock and Performance Stock Unit shares in Thousands | 6 Months Ended |
Jun. 30, 2018shares | |
Restricted Stock and Performance Stock Units | |
Nonvested at the beginning of the period (in shares) | 697 |
Granted (in shares) | 0 |
Vested (in shares) | (143) |
Forfeited (in shares) | (106) |
Nonvested at the end of the period (in shares) | 448 |
Earnings (Loss) Per Share - Sch
Earnings (Loss) Per Share - Schedule of Computation of Basic and Diluted Earnings (Loss) Per Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Basic and diluted | ||||
Net income (loss) | $ 46,197 | $ (8,196) | $ 37,998 | $ (27,099) |
Weighted average common shares outstanding used in computing net income (loss) per share—basic | 46,799 | 45,943 | 46,546 | 45,876 |
Plus: net effect of dilutive stock options and restricted common shares | 402 | 428 | ||
Weighted average common shares outstanding used in computing net income (loss) per share—diluted | 47,201 | 45,943 | 46,974 | 45,876 |
Net income (loss) per share—basic | $ 0.99 | $ (0.18) | $ 0.82 | $ (0.59) |
Net income (loss) per share—diluted | $ 0.98 | $ (0.18) | $ 0.81 | $ (0.59) |
Earnings (Loss) Per Share - S35
Earnings (Loss) Per Share - Schedule of Antidilutive Securities Excluded from Calculation of Net Income (Loss) Per Diluted Share (Details) - shares shares in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Stock options and restricted common shares | ||||
Antidilutive Securities | ||||
Anti-dilutive securities excluded from computation of loss per share (in shares) | 7,356 | 10,197 | 7,660 | 9,672 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | Dec. 31, 2017 | |
Reconciliation of statutory federal income tax rate to effective income tax rate | |||||
Provision for income taxes | $ 8,356 | $ 5,471 | $ 11,833 | $ 4,552 | |
Effective income tax rate (as a percent) | 15.30% | (200.80%) | 23.90% | (20.20%) | |
US federal corporate tax rate | 21.00% | 35.00% |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) | Jun. 30, 2018USD ($) |
Fair Value Liabilities Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | |
Milestone payment, minimum (as a percent) | 26.30% |
Milestone payment, maximum (as a percent) | 85.00% |
Milestone payment, minimum | $ 0 |
Milestone payment, maximum | 60,900,000 |
Level 2 | |
Fair Value Liabilities Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | |
Convertible senior notes | $ 336,300,000 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Assets and Liabilities Measured at Fair Value on a Recurring Basis (Details) - USD ($) | Jun. 30, 2018 | Dec. 31, 2017 |
Assets Carried at Fair Value: | ||
Short-term investments | $ 148,371,000 | $ 0 |
Liabilities Carried at Fair Value: | ||
Acquired contingent consideration | 109,174,000 | 112,722,000 |
Level 1 | Recurring basis | ||
Assets Carried at Fair Value: | ||
Cash equivalents | 11,381,000 | 9,163,000 |
Level 2 | Recurring basis | ||
Assets Carried at Fair Value: | ||
Short-term investments | 148,371,000 | |
Level 3 | Recurring basis | ||
Liabilities Carried at Fair Value: | ||
Acquired contingent consideration | $ 112,200,000 | |
Acquired contingent consideration | $ 113,000,000 |
Fair Value Measurements - Sch39
Fair Value Measurements - Schedule of Contingent Liabilities (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Assets and liabilities measured at fair value on a recurring basis utilizing Level 3 inputs | ||||
Balance, beginning of period | $ 119,200 | $ 82,900 | $ 113,000 | $ 72,100 |
Fair value change to contingent consideration included in the statement of operations | (7,000) | 6,400 | (800) | 17,200 |
Balance, end of period | $ 112,200 | $ 89,300 | $ 112,200 | $ 89,300 |
Investments - Schedule of Avail
Investments - Schedule of Available-for-Sale Securities (Details) - Short Term Investments $ in Thousands | Jun. 30, 2018USD ($) |
Schedule Of Available For Sale Securities [Line Items] | |
Amortized Cost | $ 148,448 |
Gross Unrealized Gains | 8 |
Gross Unrealized Losses | (85) |
Estimated Fair Value | $ 148,371 |
Investments - Additional Inform
Investments - Additional Information (Details) - USD ($) | Jun. 30, 2018 | Dec. 31, 2017 |
Schedule Of Available For Sale Securities [Line Items] | ||
Long-term Investments | $ 0 | $ 0 |
Short-term investments | 148,371,000 | $ 0 |
Short-term investments classified as cash equivalents | 11,400,000 | |
Short Term Investments | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Fair value of short-term investments in an unrealized loss position | $ 114,100,000 |
Investments - Schedule of Chang
Investments - Schedule of Changes in Accumulated Other Comprehensive (loss) Income (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Accumulated Other Comprehensive Income Loss [Line Items] | ||||
Balance at December 31, 2017 | $ 6,858 | |||
Net current period other comprehensive loss | $ (4,514) | $ 10,170 | (2,059) | $ 12,572 |
Balance at June 30, 2018 | 4,799 | 4,799 | ||
Net Unrealized Gains (Losses) on Marketable Securities | ||||
Accumulated Other Comprehensive Income Loss [Line Items] | ||||
Other comprehensive loss before reclassifications | (170) | |||
Net current period other comprehensive loss | (170) | |||
Balance at June 30, 2018 | $ (170) | $ (170) |
Liability Related to Sale of 43
Liability Related to Sale of Future Royalties - Additional Information (Details) - USD ($) $ in Thousands | Oct. 01, 2017 | Jun. 30, 2018 | Jun. 30, 2018 |
Liability Related To Sale Of Future Royalties [Line Items] | |||
Non-cash royalty revenue | $ 5,326 | ||
Royalty Purchase Agreement | |||
Liability Related To Sale Of Future Royalties [Line Items] | |||
Payment from royalties | $ 40,000 | ||
Royalty liability | 40,000 | ||
Net of transaction costs | $ 2,200 | $ (198) | (401) |
Non-cash royalty revenue | 2,544 | 5,326 | |
Non-cash interest expense | 1,134 | 2,320 | |
Debt discount amortization costs | $ 200 | $ 400 |
Liability Related to Sale of 44
Liability Related to Sale of Future Royalties - Schedule of Activity Within Liability Related to Sale of Future Royalties (Details) - USD ($) $ in Thousands | Oct. 01, 2017 | Jun. 30, 2018 | Jun. 30, 2018 |
Liability Related To Sale Of Future Royalties [Line Items] | |||
Non-cash royalty revenue payable to HCRP | $ (5,326) | ||
Royalty Purchase Agreement | |||
Liability Related To Sale Of Future Royalties [Line Items] | |||
Liability related to sale of future royalties - beginning balance | $ 34,395 | 35,788 | |
Deferred transaction costs recognized | $ (2,200) | 198 | 401 |
Non-cash royalty revenue payable to HCRP | (2,544) | (5,326) | |
Non-cash interest expense recognized | 1,134 | 2,320 | |
Liability related to sale of future royalties - ending balance | $ 33,183 | $ 33,183 |
Convertible Senior Notes - Addi
Convertible Senior Notes - Additional Information (Details) - Notes $ / shares in Units, $ in Thousands | Jun. 17, 2014USD ($) | Jun. 30, 2018USD ($)$ / shares | Dec. 31, 2017USD ($) |
Debt Instrument [Line Items] | |||
Interest rate (as a percent) | 1.75% | ||
Net proceeds from offering, after deducting Underwriter's discount and estimated offering expenses payable | $ 337,500 | ||
Principal | $ 345,000 | $ 345,000 | $ 345,000 |
Notes maturity date | Jun. 15, 2021 | ||
Notes frequency of periodic payment | semiannually in arrears in cash | ||
Period to comply with covenants | 270 days | ||
Debt issuance costs | $ 7,500 | ||
Debt issuance costs allocated to equity component | 1,300 | ||
Debt issuance costs allocated to liability component | $ 6,200 | ||
Remaining contractual life | 3 years | ||
Effective interest rate on liability component (as a percent) | 4.80% | ||
Debt Conversion Terms upon Occurrence of Certain Fundamental Company Changes | |||
Debt Instrument [Line Items] | |||
Principal amount of Notes or an integral multiple thereof in which holder may repurchase the Notes | $ 1,000 | ||
Debt Conversion Event Term | |||
Debt Instrument [Line Items] | |||
Minimum percentage of aggregate principal amount held by bondholders to declare notes due and payable | 25.00% | ||
In event of default arising out of certain bankruptcy events, percentage of principal amount due and payable | 100.00% | ||
Convertible Debt Holder | |||
Debt Instrument [Line Items] | |||
Initial conversion rate of common stock | 23.4968 | ||
Initial conversion price of convertible notes into common stock (in dollars per share) | $ / shares | $ 42.56 |
Convertible Senior Notes - Summ
Convertible Senior Notes - Summary of Outstanding Note Balances (Details) - Notes - USD ($) $ in Thousands | Jun. 30, 2018 | Dec. 31, 2017 | Jun. 17, 2014 |
Debt Instrument [Line Items] | |||
Principal | $ 345,000 | $ 345,000 | $ 345,000 |
Less: debt discount and debt issuance costs, net | (31,321) | (36,195) | |
Net carrying amount | 313,679 | 308,805 | |
Equity component | $ 61,195 | $ 61,195 |
Convertible Senior Notes - Sche
Convertible Senior Notes - Schedule of Interest Expense Recognized Related to the Notes (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Debt Instrument [Line Items] | ||||
Total interest expense | $ 5,414 | $ 5,460 | $ 10,911 | $ 9,603 |
Notes | ||||
Debt Instrument [Line Items] | ||||
Contractual interest expense | 1,509 | 1,509 | 3,019 | 3,019 |
Amortization of debt issuance costs | 227 | 216 | 451 | 430 |
Amortization of debt discount | 2,225 | 2,122 | 4,423 | 4,219 |
Total interest expense | $ 3,961 | $ 3,847 | $ 7,893 | $ 7,668 |