Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2017 | Nov. 06, 2017 | |
Document and Entity Information [Abstract] | ||
Entity Registrant Name | MEDICINES CO /DE | |
Entity Central Index Key | 1,113,481 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2017 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2,017 | |
Document Fiscal Period Focus | Q3 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 72,897,295 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Current assets: | ||
Cash and cash equivalents | $ 166,734 | $ 541,835 |
Available for sale securities | 42,168 | 0 |
Accounts receivable, net of allowances of approximately $6.7 million and $2.9 million at September 30, 2017 and December 31, 2016, respectively | 7,793 | 22,087 |
Inventory, net | 67,169 | 70,898 |
Prepaid expenses and other current assets | 13,974 | 19,133 |
Total current assets | 297,838 | 653,953 |
Fixed assets, net | 18,022 | 30,961 |
Indefinite-lived intangible assets | 0 | 253,620 |
Finite-lived intangible assets, net | 285,965 | 361,601 |
Goodwill | 255,629 | 255,629 |
Restricted cash | 5,048 | 5,032 |
Contingent purchase price from sale of businesses | 143,700 | 143,700 |
Other assets | 778 | 715 |
Total assets | 1,006,980 | 1,705,211 |
Current liabilities: | ||
Accounts payable | 11,698 | 28,450 |
Accrued expenses | 81,246 | 88,524 |
Current portion of contingent purchase price | 28,700 | 55,000 |
Convertible senior notes | 0 | 53,749 |
Deferred revenue | 7,269 | 18,902 |
Total current liabilities | 128,913 | 244,625 |
Contingent purchase price | 34,183 | 82,289 |
Convertible senior notes | 642,655 | 623,584 |
Deferred tax liabilities | 0 | 89,992 |
Other liabilities | 13,174 | 11,705 |
Total liabilities | 818,925 | 1,052,195 |
Equity component of currently redeemable convertible senior notes | 0 | 1,033 |
Stockholders’ equity: | ||
Preferred stock, $1.00 par value per share, 5,000,000 shares authorized; no shares issued and outstanding | 0 | 0 |
Common stock, $0.001 par value per share, 187,500,000 authorized; 75,791,437 issued and 72,778,294 outstanding at September 30, 2017 and 73,212,545 issued and 71,019,563 outstanding at December 31, 2016 | 76 | 73 |
Additional paid-in capital | 1,362,040 | 1,256,890 |
Treasury stock, at cost; 3,013,143 and 2,192,982 shares at September 30, 2017 and December 31, 2016, respectively | (90,016) | (50,000) |
Accumulated deficit | (1,079,096) | (548,983) |
Accumulated other comprehensive loss | (4,949) | (5,479) |
Total The Medicines Company stockholders’ equity | 188,055 | 652,501 |
Non-controlling interest in joint venture | 0 | (518) |
Total stockholders’ equity | 188,055 | 651,983 |
Total liabilities and stockholders’ equity | 1,006,980 | 1,705,211 |
Product licenses, net | ||
Current assets: | ||
Finite-lived intangible assets, net | 0 | 26,987 |
Developed product rights, net | ||
Current assets: | ||
Finite-lived intangible assets, net | 285,965 | 334,614 |
In-process research & development | ||
Current assets: | ||
Indefinite-lived intangible assets | $ 0 | $ 253,620 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Millions | Sep. 30, 2017 | Dec. 31, 2016 |
Current assets: | ||
Allowances for accounts receivable | $ 6.7 | $ 2.9 |
Stockholders’ equity: | ||
Preferred stock, par value (USD per share) | $ 1 | $ 1 |
Preferred stock, shares authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (USD per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 187,500,000 | 187,500,000 |
Common stock, shares, issued (in shares) | 75,791,437 | 73,212,545 |
Common stock, shares outstanding (in shares) | 72,778,294 | 71,019,563 |
Treasury stock, shares (in shares) | 3,013,143 | 2,192,982 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Income Statement [Abstract] | ||||
Net product revenues | $ 10,935 | $ 18,843 | $ 38,135 | $ 80,542 |
Royalty revenues | 5,936 | 18,756 | 21,694 | 62,094 |
Total net revenues | 16,871 | 37,599 | 59,829 | 142,636 |
Operating expenses: | ||||
Cost of product revenues | 9,601 | 20,777 | 39,436 | 54,804 |
Asset impairment charges | 0 | 0 | 329,097 | 0 |
Research and development | 45,838 | 23,537 | 117,337 | 94,595 |
Selling, general and administrative | 47,198 | 69,022 | 159,980 | 242,478 |
Total operating expenses | 102,637 | 113,336 | 645,850 | 391,877 |
Loss from operations | (85,766) | (75,737) | (586,021) | (249,241) |
Co-promotion and license income | 769 | 757 | 2,283 | 3,073 |
Gain on sale of assets | 0 | 0 | 0 | 288,301 |
Loss on extinguishment of debt | 0 | 0 | 0 | (5,380) |
Interest expense | (11,886) | (12,089) | (36,898) | (32,198) |
Other income | 71 | 865 | 916 | 741 |
(Loss) income from continuing operations before income taxes | (96,812) | (86,204) | (619,720) | 5,296 |
Benefit (provision) for income taxes | 66,637 | (163) | 89,607 | (220) |
Net (loss) income from continuing operations | (30,175) | (86,367) | (530,113) | 5,076 |
Income (loss) from discontinued operations, net of tax | 0 | 96 | 0 | (1,390) |
Net (loss) income | (30,175) | (86,271) | (530,113) | 3,686 |
Net loss attributable to non-controlling interest | 0 | 13 | 0 | 50 |
Net (loss) income attributable to The Medicines Company | (30,175) | (86,258) | (530,113) | 3,736 |
Amounts attributable to The Medicines Company: | ||||
Net (loss) income from continuing operations | (30,175) | (86,354) | (530,113) | 5,126 |
Income (loss) from discontinued operations, net of tax | 0 | 96 | 0 | (1,390) |
Net (loss) income attributable to The Medicines Company | $ (30,175) | $ (86,258) | $ (530,113) | $ 3,736 |
Basic (loss) earnings per common share attributable to The Medicines Company: | ||||
(Loss) earnings from continuing operations (USD per share) | $ (0.42) | $ (1.23) | $ (7.39) | $ 0.07 |
Loss from discontinued operations (USD per share) | 0 | 0 | 0 | (0.02) |
Basic (loss) earnings per share (USD per share) | (0.42) | (1.23) | (7.39) | 0.05 |
Diluted (loss) earnings per common share attributable to The Medicines Company: | ||||
(Loss) earnings from continuing operations (USD per share) | (0.42) | (1.23) | (7.39) | 0.07 |
Loss from discontinued operations (USD per share) | 0 | 0 | 0 | (0.02) |
Diluted (loss) earnings per share (USD per share) | $ (0.42) | $ (1.23) | $ (7.39) | $ 0.05 |
Weighted average number of common shares outstanding: | ||||
Basic (shares) | 72,286 | 70,194 | 71,763 | 69,711 |
Diluted (shares) | 72,286 | 70,194 | 71,763 | 72,920 |
Condensed Consolidated Stateme5
Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Statement of Comprehensive Income [Abstract] | ||||
Net (loss) income | $ (30,175) | $ (86,271) | $ (530,113) | $ 3,686 |
Other comprehensive income (loss): | ||||
Foreign currency translation adjustment | 487 | (70) | 527 | 208 |
Unrealized gain on available for sale securities | 10 | 0 | 3 | 0 |
Amounts reclassified from accumulated other comprehensive income | 0 | 0 | 0 | (9,665) |
Other comprehensive income (loss) | 497 | (70) | 530 | (9,457) |
Comprehensive loss | (29,678) | (86,341) | (529,583) | (5,771) |
Less: comprehensive loss attributable to non-controlling interest | 0 | 13 | 0 | 50 |
Comprehensive loss attributable to The Medicines Company | $ (29,678) | $ (86,328) | $ (529,583) | $ (5,721) |
Condensed Consolidated Stateme6
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Cash flows from operating activities: | ||
Net (loss) income | $ (530,113) | $ 3,686 |
Adjustments to reconcile net (loss) income to net cash used in operating activities: | ||
Depreciation and amortization | 17,674 | 22,517 |
Asset impairment charges | 329,097 | 0 |
Amortization of debt discount | 20,325 | 19,392 |
Unrealized foreign currency transaction losses (gains), net | 1,276 | (125) |
Stock compensation expense | 24,078 | 24,541 |
Gain on sale of businesses | 0 | (289,305) |
Loss on disposal of fixed assets | 72 | 1 |
Deferred tax benefit | (89,992) | (1,661) |
Extinguishment of debt | 0 | 5,380 |
Reserve for excess or obsolete inventory | 1,797 | 7,350 |
Changes in contingent purchase price | (11,788) | 13,573 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 14,476 | 24,125 |
Inventory, net | 1,976 | (14,077) |
Prepaid expenses and other current assets | 5,886 | 1,907 |
Accounts payable | (16,898) | (17,265) |
Accrued expenses | (5,245) | (49,110) |
Deferred revenue | (11,707) | (5,761) |
Payments on contingent purchase price | (52,499) | 0 |
Other liabilities | (3,189) | (6,153) |
Net cash used in operating activities | (304,774) | (260,985) |
Cash flows from investing activities: | ||
Purchases of fixed assets | (4,525) | (920) |
Purchases of available for sale securities | (131,560) | 0 |
Proceeds from maturities and sales of available for sale securities | 89,344 | 0 |
Payments for intangible assets | 0 | (10,000) |
Proceeds from sale of businesses | 0 | 437,875 |
Change in restricted cash | 10 | (3,660) |
Net cash (used in) provided by investing activities | (46,731) | 423,295 |
Cash flows from financing activities: | ||
Proceeds from issuances of common stock, net | 40,708 | 27,404 |
Payments on contingent purchase price | (10,119) | (7,921) |
Proceeds from the issuance of convertible senior notes | 0 | 402,500 |
Repayments of convertible senior notes | (55,000) | (323,225) |
Purchase of capped call transactions related to convertible senior notes | 0 | (33,931) |
Proceeds from settlement of bond hedges related to convertible senior notes | 0 | 100,459 |
Settlement of warrants | 0 | (87,874) |
Debt and equity issuance costs | 0 | (11,725) |
Purchase of shares of non-controlling interest | (167) | 0 |
Net cash (used in) provided by financing activities | (24,578) | 65,687 |
Effect of exchange rate changes on cash | 982 | (814) |
(Decrease) increase in cash and cash equivalents | (375,101) | 227,183 |
Cash and cash equivalents at beginning of period | 541,835 | 373,173 |
Cash and cash equivalents at end of period | 166,734 | 600,356 |
Supplemental disclosure of cash flow information: | ||
Interest paid | 22,561 | 11,891 |
Non-cash investing and financing activities | ||
Issuance of common stock upon conversion of convertible notes | 32,018 | 0 |
Receipt of common stock upon settlement of 2017 Note hedge | 40,015 | 0 |
Issuance of common stock upon the exercise of the 2017 Warrants | $ 887 | $ 0 |
Nature of Business
Nature of Business | 9 Months Ended |
Sep. 30, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Business | Nature of Business The Medicines Company is a global biopharmaceutical company focused on saving lives, alleviating suffering and contributing to the economics of healthcare. The Company markets Angiomax ® (bivalirudin), Minocin ® (minocycline) for injection and Orbactiv ® (oritavancin), and in August 2017 the U.S. Food and Drug Administration (FDA) approved the new drug application for Vabomere ™ (meropenem and vaborbactam). The Company also has a pipeline of products in development, including inclisiran and early stage antibiotic candidates targeting multi-drug resistant bacteria. The Company has the right to develop, manufacture and commercialize inclisiran under its collaboration agreement with Alnylam Pharmaceuticals, Inc. (Alnylam). The Company believes that its products and products in development possess favorable attributes that competitive products do not provide, can satisfy unmet medical needs and offer, or in the case of its products in development have the potential to offer, improved performance. On November 3, 2015, the Company announced that it was in the process of evaluating its operations with a goal of unlocking stockholder value. In particular, the Company stated its current intention was to explore strategies for optimizing the Company’s capital structure and liquidity position and to narrow the Company’s operational focus by strategically separating non-core businesses and products in order to generate non-dilutive cash and reduce associated cash burn and capital requirements. On February 1, 2016, the Company completed the sale of its hemostasis portfolio, consisting of PreveLeak (surgical sealant), Raplixa (fibrin sealant) and Recothrom Thrombin topical (Recombinant) (the Hemostasis Business), to wholly owned subsidiaries of Mallinckrodt plc (collectively, Mallinckrodt) pursuant to the purchase and sale agreement dated December 18, 2015 between the Company and Mallinckrodt. At completion of the sale, the Company received approximately $174.1 million in cash from Mallinckrodt, and may receive up to an additional $235.0 million in the aggregate following the achievement of certain specified calendar year net sales milestones with respect to net sales of PreveLeak and Raplixa. The financial results of the Hemostasis Business were classified to discontinued operations for the three and nine months ended September 30, 2016 presented in the Company’s condensed consolidated financial statements. See Note 16 , “Discontinued Operations,” for further details. On June 21, 2016, the Company completed the sale of three non-core cardiovascular products, Cleviprex (clevidipine) injectable emulsion, Kengreal (cangrelor) and rights to Argatroban for Injection (collectively the Non-Core ACC Products) and related assets, to Chiesi USA, Inc. (Chiesi USA) and its parent company Chiesi Farmaceutici S.p.A. (Chiesi) pursuant to the purchase and sale agreement dated May 9, 2016 by and among the Company, Chiesi and Chiesi USA. At the completion of the sale, the Company received approximately $263.8 million in cash, which included the value of product inventory, and may receive up to an additional $480.0 million in the aggregate following the achievement of certain specified calendar year net sales milestones with respect to net sales of each of Cleviprex and Kengreal. As part of the transaction, the Company sublicensed to Chiesi all of its rights to Cleviprex and Kengreal under the Company’s license from AstraZeneca. Subsequent to the completion of the sale, these sublicenses from the Company to Chiesi were terminated, Chiesi purchased from AstraZeneca all or substantially all of AstraZeneca’s assets relating to Cleviprex and Kengreal, the parties released certain claims against one another, and the Company paid Chiesi $7.5 million . See Note 15 , “Dispositions,” for further details. Consistent with the Company’s intentions announced in November 2015, in January 2017 the Company announced that it was seeking opportunities to partner or divest Ionsys and is exploring alternatives for monetizing, in whole or in part, the Company’s infectious disease business. Although the Company continues to seek a partnership or divestiture transaction for Ionsys, on June 1, 2017 the Company voluntarily discontinued and withdrew Ionsys from the market in the United States and ceased related commercialization activities, effective June 19, 2017, with the New Drug Application for Ionsys remaining open to December 31, 2017. Concurrent with this market withdrawal, the Company commenced implementation of a workforce reduction, which resulted in the reduction of 57 employees, representing approximately 15% of the Company’s workforce. In the second quarter of 2017, the Company recorded a pre-tax charge of approximately $276.9 million associated with the discontinuation and market withdrawal of Ionsys in the United States market, of which $268.1 million was a non-cash impairment charge (including a write-off of inventory) and $8.8 million relates to cash severance and other exit costs. The non-cash impairment charge includes $11.4 million to reduce the carrying amount of the fixed assets associated with Ionsys to an estimated fair value of zero . The Company has also discontinued and withdrawn Ionsys in the European market. Until October 2017, the Company had an exclusive license with SymBio Pharmaceuticals Ltd. (SymBio) to develop and commercialize Ionsys in Japan. That agreement terminated in connection with a legal dispute with SymBio, as described in Part II, Item 1. Legal Proceedings of this Quarterly Report on Form 10-Q. The following table presents the impact the discontinuation and market withdrawal of Ionsys had on the Company’s statement of operations for the nine months ended September 30, 2017 (amounts in thousands): Operating expenses: Cost of product revenue $ 8,458 Asset impairment charges 264,097 Research and development 1,032 Selling, general and administrative 3,331 Total operating expenses 276,918 Loss from operations (276,918 ) (Loss) income from continuing operations before income taxes (276,918 ) Benefit (provision) for income taxes — Net (loss) income from continuing operations $ (276,918 ) In August 2017, the Company announced that it discontinued the clinical development program for MDCO-700, an investigational anesthetic agent. In connection with this decision, the Company’s condensed consolidated statement of operations for the nine months ended September 30, 2017 includes the following non-cash adjustments that were recorded during the second quarter of 2017: $65.0 million of asset impairment charges to in-process research and development (IPR&D) acquired from Annovation, a $14.7 million decrease in the carrying value of the contingent purchase price to an estimated fair value of zero , and a $23.0 million benefit for income taxes due to a reduction in the Company’s recorded valuation allowance against its deferred tax assets as a result of the impairment charge. |
Significant Accounting Policies
Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2017 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies | Significant Accounting Policies The Company’s significant accounting policies are described in Note 2, “Significant Accounting Policies,” in the notes to the audited consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016 (the 2016 Form 10-K). Basis of Presentation The accompanying condensed consolidated financial statements are unaudited and have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) for interim financial information and with the instructions to Form 10-Q. Accordingly, they do not include all the information and footnotes required by GAAP for complete financial statements. In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all adjustments, consisting solely of normal recurring adjustments, considered necessary for a fair presentation of the Company’s financial position, results of operations, comprehensive loss , and cash flows for the periods presented. The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly owned and majority owned subsidiaries. All significant intercompany balances and transactions have been eliminated in consolidation. The Company recorded net loss attributable to non-controlling interest in the Company’s condensed consolidated financial statements equal to the percentage of ownership interest retained in the respective operations by the non-controlling parties for the three and nine months ended September 30, 2016 . The Company has no unconsolidated subsidiaries. The Company’s results of operations for the three and nine months ended September 30, 2017 are not necessarily indicative of the results that may be expected from the Company for the entire fiscal year or any other quarter of the fiscal year ending December 31, 2017 . These unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements included in the 2016 Form 10-K. Going Concern Due to the introduction of generic competition against Angiomax and the divestiture of certain of the Company’s non-core products, the Company’s revenues generated from product sales have declined significantly since 2014. Revenues are expected to continue to decline as generic competition for Angiomax increases. The Company has incurred net losses and negative cash flows from operations since 2014 and has an accumulated deficit of $1,079.1 million as of September 30, 2017. The Company expects to incur significant expenses and operating losses for the foreseeable future as it continues to develop, seek regulatory approval for and commercially launch its products and products in development, including inclisiran and Vabomere. The Company believes that its existing cash and cash equivalents and available for sale securities of approximately $208.9 million as of September 30, 2017, together with the cash flows it generates from product sales, will not be sufficient to satisfy the Company’s anticipated operating and other funding requirements for the next twelve months from November 9, 2017 (the date of filing this Form 10-Q). Because the Company expects to continue to incur negative cash flows from operations, the Company will need to raise additional funds through asset sales, including asset sales of products or businesses that generate a material portion of the Company’s revenues, engage in other strategic transactions, sell additional equity or debt securities, or seek additional financing through other arrangements in order to meet the Company’s anticipated operating and other funding requirements for the next twelve months. There can be no assurances that asset sales or public or private financings may be available in amounts or on terms acceptable to the Company, if at all. The Company’s ability to obtain additional equity or debt financing may be limited by market conditions. If the Company were unable to consummate asset sales, obtain additional financing or otherwise increase its cash resources, it may be required to delay, reduce the scope of, or eliminate one or more of its planned research, development or commercialization activities. Due to these uncertainties, there is substantial doubt about the Company’s ability to continue as a going concern. The unaudited condensed consolidated financial statements as of September 30, 2017 have been prepared under the assumption that the Company will continue as a going concern and do not include any adjustments that might result from the outcome of the uncertainty discussed above. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, costs, expenses and accumulated other comprehensive loss that are reported in the condensed consolidated financial statements and accompanying disclosures. Actual results may be different. Revenue Recognition The Company’s revenue recognition accounting policy is described in Note 2 of the notes to the consolidated financial statements included in the 2016 Form 10-K. Effective as of September 1, 2017, the Company modified its revenue recognition accounting policy with respect to product sales of Orbactiv and branded Angiomax as follows: Product Sales for Orbactiv and branded Angiomax. Prior to September 1, 2017, the Company recognized sales from Orbactiv under a deferred revenue model as it did not have sufficient information to develop estimates of expected returns and other adjustments to gross revenue. As a result of the entrance of generic products in the marketplace beginning in the third quarter of 2015, the Company could not reasonably estimate its chargebacks with respect to branded Angiomax between July 1, 2015 and August 30, 2017, and sales of branded Angiomax in the United States were also recognized under a deferred revenue model during that period. Under the deferred revenue model, the Company did not recognize revenue upon product shipment of Orbactiv and branded Angiomax to Integrated Commercialization Solutions (ICS). Instead, upon product shipment, the Company invoiced ICS, recorded deferred revenue at gross invoice sales price, classified the cost basis of the product held by ICS as finished goods inventory held by others and included such cost basis amount within prepaid expenses and other current assets on the consolidated balance sheets. The Company recognized revenue when hospitals purchased the products and the transaction consideration became fixed or determinable. Beginning September 1, 2017, the Company has sufficient market information to reasonably estimate its chargebacks, returns and other adjustments to gross revenues associated with Orbactiv and branded Angiomax and recognizes sales upon shipment to ICS. This change in estimate did not materially impact net product revenues or cost of product revenues for the three and nine months ended September 30, 2017 , and is not expected to materially impact net product revenues or costs of product revenues in future periods. Contingencies The Company may be, from time to time, a party to various disputes and claims arising from normal business activities. The Company continually assesses litigation to determine if an unfavorable outcome would lead to a probable loss or reasonably possible loss which could be estimated. In accordance with the guidance of the Financial Accounting Standards Board (FASB) on accounting for loss contingencies, the Company accrues for all contingencies at the earliest date at which the Company deems it probable that a liability has been incurred and the amount of such liability can be reasonably estimated. If the estimate of a probable loss is a range and no amount within the range is more likely than another, the Company accrues the minimum of the range. In the cases where the Company believes that a reasonably possible loss exists, the Company discloses the facts and circumstances of the litigation, including an estimable range, if possible. Research and Development Research and development costs are expensed as incurred. Clinical study costs are accrued over the service periods specified in the contracts and adjusted as necessary based upon an ongoing review of the level of effort and costs actually incurred. Payments for a product license prior to regulatory approval of the product and payments for milestones achieved prior to regulatory approval of the product are expensed in the period incurred as research and development. Milestone payments that do not represent payments of contingent purchase price from business combinations that are made in connection with regulatory approvals are capitalized and amortized to cost of revenue over the remaining useful life of the asset. The Company performs research and development for U.S. government agencies under a cost-reimbursable contract in which the Company is reimbursed for direct costs incurred plus allowable indirect costs. The Company recognizes the reimbursements under research contracts when a contract has been executed, the contract price is fixed or determinable, delivery of services or products has occurred, and collection of the contract price is reasonably assured. The reimbursements are classified as an offset to research and development expenses. Payments received in advance of work performed are deferred. The Company recorded reductions of research and development expenses of $4.4 million and $3.4 million for the three months ended September 30, 2017 and 2016 , respectively, and $8.3 million and $11.9 million for the nine months ended September 30, 2017 and 2016 , respectively, in the accompanying condensed consolidated statements of operations. Contingent Purchase Price From Sale of Business The Company has contingent assets for certain specified calendar year net sales milestones as part of the sale of the Hemostasis Business to Mallinckrodt and the Non-Core ACC Products to Chiesi, which in each case are reflected as contingent purchase price from sale of businesses on the accompany condensed consolidated balance sheets. The Company will recognize any increases in the carrying amount or impairments of the contingent purchase price if and when the milestones are achieved or determined to have no value. The Company noted no indicators of impairment on the carrying amount of the contingent assets. In addition, the Company determined that the fair values of these contingent payments to be received from Mallinckrodt and Chiesi are not readily determinable at September 30, 2017, as the estimated future net sales of each of the respective products are determined by the future actions of Mallinckrodt and Chiesi, respectively. Recent Accounting Pronouncements In May 2014, the FASB issued a comprehensive new revenue recognition Accounting Standards Update (ASU), “Revenue from Contracts with Customers (Topic 606)” (ASU No. 2014-09). ASU No. 2014-09 provides guidance to clarify the principles for recognizing revenue. This guidance includes the required steps to achieve the core principle that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. In August 2015, the FASB deferred the effective date of the revenue recognition guidance to reporting periods beginning after December 15, 2017. Early adoption of the standard is permitted but not before the original effective date, which was for reporting periods beginning after December 15, 2016. The FASB has further amended guidance related to recording revenue on a gross versus a net basis and on identifying performance obligations and licensing. The FASB has also revised certain SEC guidance primarily related to ASC Topic 815, “Derivatives and Hedging,” and has issued additional improvements and practical expedients to the standard. The Company, has analyzed the impacts of ASU No. 2014-09 on its revenue streams, specifically focusing on its product revenues, including its arrangement with Sandoz Inc. (Sandoz) to sell in the United States an authorized generic version of Angiomax (bivalirudin), and its collaboration agreements. The Company’s assessment included a review of current accounting policies and practices to identify potential differences that would result from applying the guidance. Currently, the Company uses a deferred revenue model for sales of its authorized generic version of Angiomax (bivalirudin) as the price is not fixed or determinable and recognizes royalty revenue on an accrual basis in the period in which Sandoz reports sales to its customers. The Company currently records revenue recognized from sales of bivalirudin to Sandoz in both net product revenues and royalty revenues in its consolidated statements of operations. Under the new standard, the promise to provide bivalirudin to Sandoz and the promise to provide exclusivity to Sandoz to distribute bivalirudin in the United States will constitute one performance obligation; as a result, under the new standard, revenue recognized from sales of bivalirudin to Sandoz will be recorded solely in net product revenues in the Company’s consolidated statements of operations upon transfer of control of product to Sandoz. The transaction price will reflect the amount the Company expects to be entitled to in connection with the sale of bivalirudin to Sandoz, which will include an estimate of the variable amount of the consideration subject to the constraint that it must be probable that a significant reversal of revenue will not occur. This may result in revenue being recognized earlier provided the Company can reliably estimate the ultimate price expected to be realized from Sandoz’s customer. The Company does not expect the adoption of the guidance to have a material impact on revenue recognized related to its collaboration agreements. The Company will continue to assess new customer contracts throughout 2017 and any impact the standard will have on its processes, systems and controls. While the Company’s assessment of the impacts of ASU No. 2014-09 is still in process, the adoption of the guidance is not expected to have a material impact on the Company’s consolidated financial statements. However, the Company will be required to provide additional disclosures in the notes to the consolidated financial statements upon adoption. The Company currently intends to adopt the standard using the modified retrospective method. In January 2016 the FASB issued ASU No. 2016-01, “Financial Instruments - Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities” (ASU No. 2016-01). ASU No. 2016-01 amends certain aspects of accounting and disclosure requirements of financial instruments, including the requirement that equity investments with readily determinable fair values be measured at fair value with changes in fair value recognized in a company’s results of operations. The new standard does not apply to investments accounted for under the equity method of accounting or those that result in consolidation of the investee. Equity investments that do not have readily determinable fair values may be measured at fair value or at cost minus impairment adjusted for changes in observable prices. A financial liability that is measured at fair value in accordance with the fair value option is required to be presented separately in other comprehensive income for the portion of the total change in the fair value resulting from change in the instrument-specific credit risk. In addition, a valuation allowance should be evaluated on deferred tax assets related to available-for-sale debt securities in combination with other deferred tax assets. ASU No. 2016-01 will be effective for public companies for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2017. Based on current investment holdings, the Company does not believe the adoption of this standard is expected to have a material impact the consolidated balance sheets and statements of operations. In February 2016, the FASB issued ASU No. 2016-02, “Leases (Topic 842)” (ASU No. 2016-02). ASU No. 2016-02 will require organizations that lease assets with lease terms of more than 12 months to recognize assets and liabilities for the rights and obligations created by those leases on their balance sheets. The ASU will also require new qualitative and quantitative disclosures to help investors and other financial statement users better understand the amount, timing, and uncertainty of cash flows arising from leases. ASU No. 2016-02 will be effective for public companies for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2018, with early adoption permitted. The Company expects to adopt this guidance when effective and is currently evaluating the effect that the updated standard will have on its consolidated financial statements and related disclosures. In March 2016, the FASB issued ASU No. 2016-09, “Compensation - Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting” (ASU No. 2016-09). This ASU makes several modifications to Topic 718 related to the accounting for forfeitures, employer tax withholding on share-based compensation, and the financial statement presentation of excess tax benefits or deficiencies. ASU No. 2016-09 also clarifies the statement of cash flows presentation for certain components of share-based awards. On January 1, 2017, the Company adopted ASU No. 2016-09 and has elected to continue its determination of compensation costs recognized in each period based upon an estimate of expected future forfeitures. Upon the settlement of awards during the nine months ended September 30, 2017, the Company recorded excess tax benefits of $5.2 million but was unable to recognize any benefit due to the establishment of a valuation allowance on its net operating loss carry forward deferred tax assets. The Company does not expect to be able to recognize any benefit related to additional excess tax benefits recorded throughout 2017. There was no net impact on the Company’s opening accumulated deficit upon application of this guidance using the modified retrospective transition method as the total cumulative-effect adjustment for previously deferred excess tax benefits was offset by a related change in the valuation allowance. The other amended requirements of ASU No. 2016-09 did not have a material impact on the Company’s condensed consolidated financial statements and related disclosures. In August 2016, the FASB issued ASU No. 2016-15, “Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments” (ASU No. 2016-15). This guidance clarifies how certain cash receipts and payments should be presented in the statement of cash flows and is effective for interim and annual reporting periods beginning after December 15, 2017, with early adoption permitted. The Company does not believe that this guidance will have a material impact on the consolidated financial statements and related disclosures. In November 2016, the FASB issued ASU 2016-18, “Statement of Cash Flows (Topic 230): Restricted Cash” (ASU No. 2016-18). This amends the guidance in ASC 230, including providing additional guidance related to transfers between cash and restricted cash and how entities present, in their statement of cash flows, the cash receipts and cash payments that directly affect the restricted cash accounts. ASU 2016-18 is effective for annual reporting periods beginning after December 15, 2017, and interim periods within those years, with early adoption permitted. The Company does not believe that this guidance will have an impact on the consolidated financial statements and related disclosures. In January 2017, the FASB issued ASU 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business, which clarifies the definition of a business with the objective of adding guidance to assist entities with evaluating whether transactions should be accounted for as acquisitions (or disposals) of assets or businesses. ASU 2017-01 is effective for annual reporting periods beginning after December 15, 2017, and interim periods within those years, with early adoption permitted. The Company will apply the guidance to applicable transactions after the adoption date. The impact on the Company’s consolidated financial statements will depend on the facts and circumstances of any specific future transactions. In January 2017, the FASB issued ASU 2017-04, Intangibles-Goodwill and Other, Simplifying the Test for Goodwill Impairment, which eliminates Step 2 from the goodwill impairment test. Under the revised test, an entity should perform its annual, or interim, goodwill impairment test by comparing the fair value of a reporting unit with its carrying amount. An entity should recognize an impairment charge for the amount by which the carrying amount exceeds the reporting unit’s fair value; however, the loss recognized should not exceed the total amount of goodwill allocated to that reporting unit. This ASU is effective for any interim or annual impairment tests for fiscal years beginning after December 15, 2019, with early adoption permitted. The Company does not believe that this guidance will have an impact on the consolidated financial statements and related disclosures. |
Stock Compensation Expense
Stock Compensation Expense | 9 Months Ended |
Sep. 30, 2017 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock Compensation Expense | Stock Compensation Expense The Company recorded stock compensation expense of approximately $7.9 million and $8.1 million for the three months ended September 30, 2017 and 2016 , respectively, and $24.1 million and $24.7 million for the nine months ended September 30, 2017 and 2016 , respectively. As of September 30, 2017 , there was approximately $35.3 million of total unrecognized compensation costs related to non-vested share-based employee compensation arrangements granted under the Company’s equity compensation plans. The Company expects to recognize those costs over a weighted average period of 1.3 years. During the nine months ended September 30, 2017 and 2016 , the Company issued a total of 1,754,744 and 1,322,091 , respectively, of shares of its common stock upon the exercise of stock options, grants of restricted stock, and purchases under the Company’s 2010 employee stock purchase plan (ESPP). Cash received from the exercise of stock options and purchases through the ESPP during the nine months ended September 30, 2017 and 2016 was $40.7 million and $27.4 million , respectively, and is included within the financing activities section of the accompanying condensed consolidated statements of cash flows. |
(Loss) Earnings Per Share
(Loss) Earnings Per Share | 9 Months Ended |
Sep. 30, 2017 | |
Earnings Per Share [Abstract] | |
(Loss) Earnings Per Share | (Loss) Earnings Per Share Basic (loss) earnings per share is computed by dividing consolidated net loss attributable to The Medicines Company by the weighted average number of shares of common stock outstanding during the period, excluding unvested restricted common shares. The potentially dilutive effect of the Company’s stock options, unvested restricted common stock, stock purchase warrants, and convertible senior notes due 2017 (which matured on June 1, 2017) and 2022 on earnings per share is computed under the treasury stock method. In addition, the Company analyzes the potential dilutive effect of the convertible senior notes due 2023 on earnings per share under the “if converted” method, in which it is assumed that the outstanding security converts into common stock at the beginning of the period. For periods of net income when the effects are not anti-dilutive, diluted earnings per share is computed by dividing the net income attributable to The Medicines Company by the weighted average number of shares outstanding and the impact of all potential dilutive common shares, consisting primarily of stock options, unvested restricted common stock, shares issuable upon conversion of convertible senior notes due 2017, 2022 and 2023 and stock purchase warrants. For periods of net loss from continuing operations, diluted loss per share is calculated similar to basic loss per share as the effect of including all potentially dilutive common share equivalents is anti-dilutive. Due to the periods of net loss from continuing operations attributable to The Medicines Company, the calculation of diluted loss per share for the three and nine months ended September 30, 2017 excluded 10,703,826 and 13,312,289 , respectively, of potentially dilutive stock options, warrants, restricted common shares, and shares issuable upon conversion of the 2017, 2022 and 2023 Notes as their inclusion would have an anti-dilutive effect. The calculation of diluted loss per share for the three and nine months ended September 30, 2016 excluded 3,930,938 and 3,109,274 , respectively, of potentially dilutive stock options, stock purchase warrants, restricted common shares, and shares issuable upon conversion of the 2017, 2022 and 2023 Notes as their inclusion would have an anti-dilutive effect. |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2017 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes For the three months ended September 30, 2017 and 2016, the Company recorded a benefit for income taxes of $66.6 million and a provision for income taxes of $0.2 million , respectively. The worldwide effective income tax rates for the Company for the three months ended September 30, 2017 and 2016 was 68.83% and (0.2)% , respectively. For the nine months ended September 30, 2017 and 2016, the Company recorded a benefit for income taxes of $89.6 million and a provision for income taxes of $0.2 million , respectively. The worldwide effective income tax rates for the Company for the nine months ended September 30, 2017 and 2016 was 14.5% and 4.1% , respectively. For the three and nine months ended September 30, 2017 , the Company’s benefit for income taxes is primarily attributable to a reduction in the Company’s recorded valuation allowance against its deferred tax assets as a result of the commencement of amortization of IPR&D associated with Vabomere upon approval by the FDA, which resulted in a discrete benefit of $66.7 million , and the impairment of IPR&D associated with MDCO-700, which resulted in a discrete benefit of $23.0 million . For further details regarding the approval of Vabomere and impairment of IPR&D associated with MDCO-700 see Note 9, “Intangible Assets and Goodwill.” The Company considers all available evidence, both positive and negative, to determine whether, based on the weight of that evidence, a valuation allowance is needed to reduce its deferred tax assets to the amount that is more likely than not to be realized. The Company placed significant weight on the fact that the Company expects to be in a cumulative net book loss for the three-year period ending December 31, 2017 in recording valuation allowances on substantial portions of its deferred tax assets as of September 30, 2017 . The Company will continue to evaluate its ability to realize its deferred tax assets on a periodic 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 additional changes to the valuation allowance recorded on deferred tax assets in the future would impact the Company’s income taxes. |
Cash and Cash Equivalents and A
Cash and Cash Equivalents and Available for Sale Securities | 9 Months Ended |
Sep. 30, 2017 | |
Investments, Debt and Equity Securities [Abstract] | |
Cash and Cash Equivalents and Available for Sale Securities | Cash and Cash Equivalents and Available for Sale Securities The Company considers all highly liquid investments purchased with original maturities at the date of purchase of three months or less to be cash equivalents. At September 30, 2017 and December 31, 2016 , the Company had cash and cash equivalents of $166.7 million and $541.8 million , respectively, which consisted of cash of $152.0 million and $485.7 million , and money market funds with original maturities of less than three months of $14.7 million and $56.1 million at September 30, 2017 and December 31, 2016 , respectively. At September 30, 2017 , the Company held available for sale securities with a fair value totaling $42.2 million . These available for sale securities consist of corporate debt securities and asset backed securities. At September 30, 2017 , all of the $42.2 million of available for sale securities are due within one year. The Company evaluates securities with unrealized losses to determine whether such losses are other than temporary. Available for sale securities, including carrying value and estimated fair values, are summarized as follows: As of September 30, 2017 Amortized Cost Fair Value Unrealized Gain (in thousands) Asset backed securities 8,192 8,192 — Corporate debt securities 33,973 33,976 3 Total $ 42,165 $ 42,168 $ 3 The Company does not intend to sell its corporate debt securities and it is not more likely than not that the Company will be required to sell its corporate debt securities before recovery of their amortized cost basis, which may be maturity. Restricted Cash The Company had restricted cash of $5.0 million at September 30, 2017 and December 31, 2016 , respectively, which included $3.7 million and $1.0 million reserved for an outstanding letter of credit associated with foreign taxes and the Company’s lease for the office space in Parsippany, New Jersey, respectively, at both September 30, 2017 and December 31, 2016 , respectively. These funds are invested in certificates of deposit. The letter of credit for the Company’s lease for the office space in Parsippany, New Jersey permits draws by the landlord to cure defaults by the Company. In addition, as a result of the acquisition of Targanta Therapeutics Corporation (Targanta) in 2009, the Company had restricted cash of $0.1 million at both September 30, 2017 and December 31, 2016 , in the form of a guaranteed investment certificate collateralizing an available credit facility. The Company also had restricted cash of $0.2 million at September 30, 2017 and December 31, 2016 , respectively, related to certain foreign tender requirements. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2017 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements The Company applies a fair value framework in order to measure and disclose its financial assets and liabilities. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The fair value hierarchy requires an entity to maximize the use of observable inputs, where available, and minimize the use of unobservable inputs when measuring fair value. There are three levels of inputs that may be used to measure fair value: Level 1 Quoted prices in active markets for identical assets or liabilities. The Company’s Level 1 assets consist of money market investments. Level 2 Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Fair values are determined by utilizing quoted prices for similar assets and liabilities in active markets or other market observable inputs such as interest rates and yield curves. The Company’s Level 2 assets consist of U.S. government debt, corporate debt securities and asset back securities. Level 3 Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The Company’s Level 3 assets and liabilities consist of the contingent purchase prices associated with the Company’s business combinations, respectively. The fair value of certain development or regulatory milestone based contingent purchase prices was determined in a discounted cash flow framework by probability weighting the future contractual payment with management's assessment of the likelihood of achieving these milestones and present valuing them using a risk-adjusted discount rate. Certain sales milestone based payments were determined in a discounted cash flow framework where risk-adjusted revenue scenarios were estimated using Monte Carlo simulation models to compute contractual payments which were present valued using a risk-adjusted discount rate. Financial assets and liabilities measured at fair value on a recurring basis Financial assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the asset or liability. Except for the Company’s Level 2 liabilities which are discussed in Note 10 , “Convertible Senior Notes,” the following table sets forth the Company’s assets and liabilities that are measured at fair value on a recurring basis at September 30, 2017 and December 31, 2016 , by level, within the fair value hierarchy: As of September 30, 2017 As of December 31, 2016 Assets and Liabilities Quoted Prices In Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Balance as of September 30, 2017 Quoted Prices In Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Balance as of December 31, 2016 (in thousands) Assets: Cash equivalents $ 14,686 $ — $ 14,686 $ 56,097 $ — $ — $ 56,097 Available for sale securities — 42,168 — 42,168 $ — $ — $ — — Total assets at fair value $ 14,686 $ 42,168 $ — $ 56,854 $ 56,097 $ — $ — $ 56,097 Liabilities: Contingent purchase price $ — $ — $ 62,884 $ 62,884 $ — $ — $ 137,289 $ 137,289 Total liabilities at fair value $ — $ — $ 62,884 $ 62,884 $ — $ — $ 137,289 $ 137,289 Level 3 disclosures The Company measures contingent purchase price at fair value based on significant inputs not observable in the market, which causes it to be classified as a Level 3 measurement within the fair value hierarchy. The valuation of contingent purchase price uses assumptions and estimates the Company believes would be made by a market participant in making the same valuation. The Company assesses these assumptions and estimates on an on-going basis as additional data impacting the assumptions and estimates are obtained. Changes in the fair value of contingent purchase price related to updated assumptions and estimates are recognized within selling, general and administrative expenses in the accompanying condensed consolidated statements of operations. The contingent purchase price may change significantly as additional data is obtained, impacting the Company’s assumptions regarding probabilities of successful achievement of related milestones used to estimate the fair value of the liability. In evaluating this information, considerable judgment is required to interpret the market data used to develop the assumptions and estimates. The estimates of fair value may not be indicative of the amounts that could be realized in a current market exchange. Accordingly, the use of different market assumptions and/or different valuation techniques may have a material effect on the estimated fair value amounts, and such changes could materially impact the Company’s results of operations in future periods. The following table provides quantitative information associated with the fair value measurements of the Company’s Level 3 liabilities: Fair Value as of Valuation Technique Unobservable Input Range (Weighted Average) (in thousands) Targanta: Contingent purchase price $ 1,584 Probability-adjusted discounted cash flow Probability of success 5% Period in which milestone is expected to be achieved 2021 Discount rate 11% Rempex: Contingent purchase price: Event-based milestones $ 47,200 Probability-adjusted discounted cash flow Probabilities of successes 18% - 90% (71%) Period in which milestones are expected to be achieved 2018 - 2024 Discount rate 4.4% - 7.3% Contingent purchase price: Sales-based milestones $ 14,100 Risk-adjusted revenue simulation Probabilities of successes 15% - 85% (72%) Period in which milestones are expected to be achieved 2020 - 2022 Discount rate 5.5% - 6.7% Fair Value as of Valuation Technique Unobservable Input Range (Weighted Average) (in thousands) Targanta: Contingent purchase price $ 5,857 Probability-adjusted discounted cash flow Probability of success 20% Period in which milestone is expected to be achieved 2021 Discount rate 11% Incline: Contingent purchase price $ 1,269 Probability-adjusted discounted cash flow Probabilities of successes 5% Period in which milestones are expected to be achieved 2019 Discount rate 18% Rempex: Contingent purchase price: Event-based milestones $ 95,800 Probability-adjusted discounted cash flow Probabilities of successes 18% - 95% (78%) Period in which milestones are expected to be achieved 2017 - 2024 Discount rate 5.2% - 8.5% Contingent purchase price: Sales-based milestones $ 20,300 Risk-adjusted revenue simulation Probabilities of successes 16% - 65% (56%) Period in which milestones are expected to be achieved 2018 - 2022 Discount rate 6.6% - 8.2% Annovation: Contingent purchase price $ 14,063 Probability-adjusted discounted cash flow Probabilities of successes 9% - 50% (34%) Period in which milestones are expected to be achieved 2018 - 2031 Discount rate 6.0% - 10.0% The fair value of the contingent purchase price represents the fair value of the Company’s liability for all potential payments under the Company’s acquisition agreements for Targanta, Incline Therapeutics, Inc. (Incline), Rempex Pharmaceuticals, Inc. (Rempex) and Annovation BioPharma, Inc. (Annovation). During the first quarter of 2017, the Company made a $20.0 million payment to the former equity holders of Rempex upon acceptance of the NDA for Vabomere. During the third quarter of 2017, the Company made a $40.0 million payment to the former equity holders of Rempex upon approval of Vabomere in the United States. There were no other changes to the potential future payments under the Company’s acquisition agreements. As of September 30, 2017, the remaining potential future payments to the former equity holders of Rempex and Targanta were $224.7 million and $49.4 million , respectively. The remaining potential future payments under the Company’s acquisition agreements do not include payments of $175.8 million (which includes $86.3 million to the former equity holders of Incline and Annovation and $89.5 million to other third parties) related to the Ionsys product, which was discontinued and withdrawn in the United States in June 2017 and which has also been discontinued in Europe, and the MDCO-700 development program, which the Company discontinued in August 2017. The significant unobservable inputs used in the fair value measurement of the Company’s contingent purchase prices are the probabilities of successful achievement of development, regulatory, and sales milestones that would trigger payments under the Targanta, Incline, Rempex and Annovation agreements, probabilities as to the periods in which the milestones are expected to be achieved and discount rates. Significant changes in any of the probabilities of success or periods in which milestones will be achieved would result in a significantly higher or lower fair value measurement. The changes in fair value of the Company’s Level 3 contingent purchase price during the three and nine months ended September 30, 2017 and 2016 were as follows: Three Months Ended Nine Months Ended 2017 2016 2017 2016 (in thousands) Balance at beginning of period $ 111,171 $ 118,571 $ 137,289 $ 123,757 Payments (40,616 ) (1,564 ) (62,618 ) (8,811 ) Fair value adjustments to contingent purchase prices included in net loss (7,672 ) 12,403 (11,788 ) 14,464 Balance at end of period $ 62,883 $ 129,410 $ 62,883 $ 129,410 For the three and nine months ended September 30, 2017 and 2016 , changes in the carrying value of the contingent purchase price obligations resulted from changes in the fair value of the contingent consideration due to either the passage of time, changes in discount rates, changes in probabilities of success, or milestone payments. This includes a decrease of $14.7 million in the carrying value of the contingent purchase price to an estimated fair value of zero as a result of the Company’s decision to discontinue the clinical development program for MDCO-700 in August 2017. See Note 1 , “Nature of Business,” for further details. No other changes in valuation techniques or inputs occurred during the three and nine months ended September 30, 2017 and 2016 . |
Inventory
Inventory | 9 Months Ended |
Sep. 30, 2017 | |
Inventory Disclosure [Abstract] | |
Inventory | Inventory The major classes of inventory were as follows: September 30, December 31, (in thousands) Raw materials $ 57,818 $ 56,962 Work-in-progress 4,615 12,033 Finished goods 4,736 1,903 Total $ 67,169 $ 70,898 The Company reviews inventory, including inventory purchase commitments, for slow moving or obsolete amounts based on expected product sales volume and provides reserves against the carrying amount of inventory as appropriate. If annual volume is less than expected, the Company may be required to make additional allowances for excess or obsolete inventory in the future. |
Intangible Assets and Goodwill
Intangible Assets and Goodwill | 9 Months Ended |
Sep. 30, 2017 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Assets and Goodwill | Intangible Assets and Goodwill The following table sets forth the carrying amounts and accumulated amortization of the Company’s intangible assets: As of September 30, 2017 As of December 31, 2016 Gross Carrying Amount Accumulated Amortization Net Carrying Amount Gross Carrying Amount Accumulated Amortization Net Carrying Amount (in thousands) Amortizable intangible assets: Product licenses (1) $ — $ — $ — $ 30,000 $ (3,013 ) $ 26,987 Developed product rights (2) 309,180 (23,215 ) 285,965 370,560 (35,946 ) 334,614 Total amortizable intangible assets 309,180 (23,215 ) 285,965 400,560 (38,959 ) 361,601 Intangible assets not subject to amortization: In-process research and development $ — $ — $ — $ 253,620 $ — $ 253,620 Total intangible assets not subject to amortization — — — 253,620 — 253,620 Total intangible assets $ 309,180 $ (23,215 ) $ 285,965 $ 654,180 $ (38,959 ) $ 615,221 _______________________________________ (1) The Company amortizes intangible assets related to the product licenses over their expected useful lives. (2) The Company amortizes intangible assets related to developed product rights over the remaining life of the patents. In the third quarter of 2017, the Company reclassified $188.6 million of IPR&D assets to developed product rights due to the approval of Vabomere in the United States and commenced amortization over its estimated useful life. The Company recognized amortization expense of approximately $3.1 million and $6.5 million for the three months ended September 30, 2017 and 2016 , respectively, and approximately $11.6 million and $19.3 million during the nine months ended September 30, 2017 and 2016 , respectively, related to its intangible assets. The Company expects amortization expense related to its intangible assets to be approximately $5.4 million for the last three months of 2017 . The Company expects annual amortization expense related to its intangible assets to be approximately $21.4 million , $21.4 million , $21.4 million , $21.4 million and $21.4 million for the years ending December 31, 2018 , 2019 , 2020 , 2021 and 2022 , respectively, with the balance of $173.6 million being amortized thereafter. The Company records amortization expense in cost of revenue in the accompanying condensed consolidated statements of operations. In the second quarter of 2017 the Company recorded impairment charges of $226.5 million and $26.2 million to reduce the unamortized carrying amounts of the developed product rights and product licenses, respectively, associated with Ionsys to their estimated fair values of zero which is a Level 3 fair value measurement, as a result of the discontinuation and market withdrawal of Ionsys which became effective on June 19, 2017. In the second quarter of 2017, the Company recorded impairment charges of $65.0 million to reduce the carrying amount of the in-process research and development associated with MDCO-700 to an estimated fair value of zero , which is a Level 3 fair value measurement, in connection with management’s decision to discontinue the MDCO-700 trials. These impairment charges were recorded in asset impairment charges in the accompanying condensed consolidated statements of operations. See Note 1 , “Nature of Business,” for further details and Note 7, “Fair Value Measurements,” for definitions of hierarchy levels. There were no changes in the carrying amount of goodwill for the nine months ended September 30, 2017 . |
Convertible Senior Notes
Convertible Senior Notes | 9 Months Ended |
Sep. 30, 2017 | |
Debt Disclosure [Abstract] | |
Convertible Senior Notes | Convertible Senior Notes Convertible Senior Notes Due 2023 In June 2016, the Company issued, at par value, $402.5 million aggregate principal amount of 2.75% convertible senior notes due 2023 (the “2023 Notes”). The 2023 Notes bear cash interest at a rate of 2.75% per year, payable semi-annually on January 15 and July 15 of each year, beginning on January 15, 2017. The 2023 Notes will mature on July 15, 2023. The net proceeds to the Company from the offering were $390.8 million after deducting the initial purchasers’ discounts and commissions and the offering expenses payable by the Company. The 2023 Notes are governed by an indenture (the “2023 Notes Indenture”) with Wells Fargo Bank, National Association, a national banking association, as trustee (the “2023 Notes Trustee”). The 2023 Notes are senior unsecured obligations of the Company and will rank senior in right of payment to the Company’s future indebtedness that is expressly subordinated in right of payment to the 2023 Notes; equal in right of payment to the Company’s existing and future unsecured indebtedness that is not so subordinated; effectively junior in right of payment to any of the Company’s secured indebtedness to the extent of the value of the assets securing such indebtedness; and structurally junior to all existing and future indebtedness and other liabilities (including trade payables) incurred by the Company’s subsidiaries. Holders may convert their 2023 Notes at their option at any time prior to the close of business on the business day immediately preceding April 15, 2023 only under the following circumstances: • during any calendar quarter commencing on or after September 30, 2016 (and only during such calendar quarter), if the last reported sale price of the Company’s common stock for at least 20 trading days (whether or not consecutive) during a period of 30 consecutive trading days ending on the last trading day of the immediately preceding calendar quarter is greater than or equal to 130% of the conversion price on each applicable trading day; • during the five business day period after any five consecutive trading day period (the ‘‘measurement period’’) in which the trading price (as defined in the 2023 Notes Indenture) per $1,000 principal amount of notes for each trading day of the measurement period was less than 98% of the product of the last reported sale price of the Company’s common stock and the conversion rate on each such trading day; • during any period after the Company has issued notice of redemption until the close of business on the scheduled trading day immediately preceding the relevant redemption date; or • upon the occurrence of specified corporate events. On or after April 15, 2023, until the close of business on the second scheduled trading day immediately preceding the maturity date, holders may convert their 2023 Notes at any time, regardless of the foregoing circumstances. Upon conversion, the Company will pay or deliver, as the case may be, cash, shares of the Company’s common stock or a combination thereof, at the Company’s option, based upon a daily conversion value calculated on a proportionate basis for each trading day in a 50 trading day observation period (as more fully described in the 2023 Notes Indenture). The conversion rate for the 2023 Notes was initially, and remains, 20.4198 shares of the Company’s common stock per $1,000 principal amount of the 2023 Notes, which is equivalent to an initial conversion price of approximately $48.97 per share of the Company’s common stock. The Company may not redeem the 2023 Notes prior to July 15, 2020. The Company may redeem for cash all or any portion of the 2023 Notes, at its option, on or after July 15, 2020 if the last reported sale price of its common stock has been at least 130% of the conversion price then in effect on the last trading day of, and for at least 19 other trading days (whether or not consecutive) during, any 30 consecutive trading day period ending on, and including, the trading day immediately preceding the date on which the Company provides notice of redemption, at a redemption price equal to 100% of the principal amount of the 2023 Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. No redemption date may be designated that falls on or after the 52 nd scheduled trading date prior to maturity. No sinking fund is provided for the 2023 Notes, which means that the Company is not required to redeem or retire the 2023 Notes periodically. If the Company undergoes a fundamental change (as defined in the 2023 Notes Indenture), subject to certain conditions, holders of the 2023 Notes may require the Company to repurchase for cash all or part of their 2023 Notes at a repurchase price equal to 100% of the principal amount of the 2023 Notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date. The 2023 Notes Indenture governing the 2023 Notes contains customary events of default with respect to the 2023 Notes, including that upon certain events of default (including the Company’s failure to make any payment of principal or interest on the 2023 Notes when due and payable) occurring and continuing, the 2023 Notes Trustee by notice to the Company, or the holders of at least 25% in principal amount of the outstanding 2023 Notes by notice to the Company and the 2023 Notes Trustee, may, and the 2023 Notes Trustee at the request of such holders (subject to the provisions of the 2023 Notes Indenture) shall, declare 100% of the principal of and accrued and unpaid interest, if any, on all the 2023 Notes to be due and payable. In case of certain events of bankruptcy, insolvency or reorganization, involving the Company or a significant subsidiary, 100% of the principal of and accrued and unpaid interest on the 2023 Notes will automatically become due and payable. Upon such a declaration of acceleration, such principal and accrued and unpaid interest, if any, will be due and payable immediately. In accounting for the issuance of the 2023 Notes, the Company separated the 2023 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 2023 Notes as a whole. The excess of the principal amount of the liability component over its carrying amount, referred to as the debt discount, is amortized to interest expense over the seven -year term of the 2023 Notes. The equity component is not re-measured as long as it continues to meet the conditions for equity classification. The equity component related to the 2023 Notes is $101.0 million and is recorded in additional paid-in capital on the accompanying condensed consolidated balance sheet. In accounting for the transaction costs related to the issuance of the 2023 Notes, the Company allocated the total costs incurred to the liability and equity components of the 2023 Notes based on their relative values. Transaction costs attributable to the liability component are amortized to interest expense over the seven -year term of the 2023 Notes, and transaction costs attributable to the equity component are netted with the equity components in stockholders’ equity. Additionally, the Company initially recorded a net deferred tax liability of $33.5 million in connection with the 2023 Notes. The 2023 Notes consist of the following: Liability component September 30, 2017 December 31, 2016 (in thousands) Principal $ 402,500 $ 402,500 Less: Debt discount, net (1) (93,778 ) (103,162 ) Net carrying amount $ 308,722 $ 299,338 _______________________________________ (1) Included in the accompanying condensed consolidated balance sheets within convertible senior notes (due 2023) and amortized to interest expense over the remaining life of the 2023 Notes using the effective interest rate method. The fair value of the 2023 Notes was approximately $424.3 million as of September 30, 2017 . The Company estimates the fair value of its 2023 Notes utilizing market quotations for debt that have quoted prices in active markets. Since the 2023 Notes do not trade on a daily basis in an active market, the fair value estimates are based on market observable inputs based on borrowing rates currently available for debt with similar terms and average maturities, which are classified as Level 2 measurements within the fair value hierarchy. See Note 7 , “Fair Value Measurements,” for definitions of hierarchy levels. As of September 30, 2017 , the remaining contractual life of the 2023 Notes is approximately 5.8 years. The following table sets forth total interest expense recognized related to the 2023 Notes: Three Months Ended September 30, Nine Months Ended September 30, 2017 2016 2017 2016 (in thousands) (in thousands) Contractual interest expense $ 2,767 $ 2,777 $ 8,293 $ 3,381 Amortization of debt discount 3,205 2,923 9,384 3,650 Total $ 5,972 $ 5,700 $ 17,677 $ 7,031 Effective interest rate of the liability component 7.5 % 7.5 % 7.5 % 7.5 % Capped call transactions In June 2016, the Company entered into capped call transactions with certain counterparties of the 2023 Notes or their respective affiliates or other financial institutions. The Company used approximately $33.9 million of the net proceeds from the offering to pay the cost of the capped call transactions, which is included as a net reduction to additional paid-in capital on the accompanying condensed consolidated balance sheet. The capped call transactions are expected to reduce the potential dilution with respect to shares of the Company’s common stock upon any conversion of the 2023 Notes and/or offset any cash payments the Company is required to make in excess of the principal amount of converted 2023 Notes, as the case may be, if the market price of the Company’s common stock is then greater than the strike price of the capped call transactions. Such reduction of potential dilution or offset of cash payments is subject to a cap based on the cap price of the capped call transactions. The cap price of the capped calls is currently $64.68 . For any conversions of the 2023 Notes prior to the close of business on the 52 nd scheduled trading day immediately preceding the stated maturity date of the 2023 Notes, including without limitation upon an acquisition of the Company or similar business combination, a corresponding portion of the capped calls will be terminated. Upon such termination, the portion of the capped calls being terminated will be settled at fair value (subject to certain limitations), as determined by the counterparties to the capped calls and no payments will be due from the Company to such counterparties. The capped calls expire on the earlier of (i) the last day on which any Convertible Securities remain outstanding and (ii) the second “Scheduled Trading Day” (as defined in the 2023 Notes Indenture) immediately preceding the “Maturity Date” (as defined in the 2023 Notes Indenture). Convertible Senior Notes Due 2022 The 2022 Notes bear cash interest at a rate of 2.5% per year, payable semi-annually on January 15 and July 15 of each year, beginning on July 15, 2015. The 2022 Notes will mature on January 15, 2022. The net proceeds to the Company from the offering were $387.2 million after deducting the initial purchasers’ discounts and commissions and the offering expenses payable by the Company. The 2022 Notes are governed by an indenture (the “2022 Notes Indenture”) with Wells Fargo Bank, National Association, a national banking association, as trustee (the “2022 Notes Trustee”). The 2022 Notes are senior unsecured obligations of the Company and will rank senior in right of payment to the Company’s future indebtedness that is expressly subordinated in right of payment to the 2022 Notes; equal in right of payment to the Company’s existing and future unsecured indebtedness that is not so subordinated; effectively junior in right of payment to any of the Company’s secured indebtedness to the extent of the value of the assets securing such indebtedness; and structurally junior to all existing and future indebtedness and other liabilities (including trade payables) incurred by the Company’s subsidiaries. Holders may convert their 2022 Notes at their option at any time prior to the close of business on the business day immediately preceding October 15, 2021 only under the following circumstances: • during any calendar quarter commencing on or after March 31, 2015 (and only during such calendar quarter), if the last reported sale price of the Company’s common stock for at least 20 trading days (whether or not consecutive) during a period of 30 consecutive trading days ending on the last trading day of the immediately preceding calendar quarter is greater than or equal to 130% of the conversion price on each applicable trading day; • during the five business day period after any five consecutive trading day period (the measurement period) in which the trading price (as defined in the 2022 Notes Indenture) per $1,000 principal amount of 2022 Notes for each trading day of the measurement period was less than 98% of the product of the last reported sale price of the Company’s common stock and the conversion rate on each such trading day; • during any period after the Company has issued notice of redemption until the close of business on the scheduled trading day immediately preceding the relevant redemption date; or • upon the occurrence of specified corporate events. During the first quarter of 2017 , the conditional conversion feature of the 2022 Notes was triggered based on the trading price of the Company’s common stock during the first quarter of 2017, and the holders were entitled to convert the 2022 Notes through June 30, 2017. In any period when holders of the 2022 Notes are eligible to exercise their conversion option, the liability component related to the 2022 Notes is classified as current and the difference between (1) the amount of cash deliverable upon conversion (i.e., par value of debt) and (2) the carrying value of the liability component is classified as mezzanine (temporary) equity, as the Company is required to settle the aggregate principal amount of the notes in cash. If in any future period the conversion threshold requirements of the 2022 Notes are not met, then the liability component of the 2022 Notes will be classified as non-current and the difference between (1) the amount of cash deliverable upon conversion (i.e., par value of debt) and (2) the carrying value of the debt component will be reclassified from mezzanine equity to permanent equity, and will continue to be reported as permanent equity for any period in which the debt is not currently convertible. During the second quarter of 2017 an immaterial amount of the 2022 Notes were submitted for conversion. On July 1, 2017, the conditional conversion feature of the 2022 Notes was no longer triggered based on the trading price of the Company’s common stock. On or after October 15, 2021, until the close of business on the second scheduled trading day immediately preceding the maturity date, holders may convert their 2022 Notes at any time, regardless of the circumstances described above. Upon conversion, the Company will pay cash up to the aggregate principal amount of the 2022 Notes to be converted and deliver shares of its common stock in respect of the remainder, if any, of its conversion obligation in excess of the aggregate principal amount of 2022 Notes being converted, subject to a daily share cap. The conversion rate for the 2022 Notes was initially, and remains, 29.8806 shares of the Company’s common stock per $1,000 principal amount of the 2022 Notes, which is equivalent to an initial conversion price of approximately $33.47 per share of the Company’s common stock. The Company may not redeem the 2022 Notes prior to January 15, 2019. The Company may redeem for cash all or any portion of the 2022 Notes, at its option, on or after January 15, 2019 if the last reported sale price of its common stock has been at least 130% of the conversion price then in effect on the last trading day of, and for at least 19 other trading days (whether or not consecutive) during any 30 consecutive trading day period ending on, and including, the trading day immediately preceding the date on which the Company provides notice of redemption, at a redemption price equal to 100% of the principal amount of the 2022 Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. No sinking fund is provided for the 2022 Notes, which means that the Company is not required to redeem or retire the 2022 Notes periodically. If the Company undergoes a “fundamental change” (as defined in the Indenture governing the 2022 Notes Indenture), subject to certain conditions, holders of the 2022 Notes may require the Company to repurchase for cash all or part of their 2022 Notes at a repurchase price equal to 100% of the principal amount of the 2022 Notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date. The 2022 Notes Indenture contains customary events of default with respect to the 2022 Notes, including that upon certain events of default (including the Company’s failure to make any payment of principal or interest on the 2022 Notes when due and payable) occurring and continuing, the 2022 Notes Trustee by notice to the Company, or the holders of at least 25% in principal amount of the outstanding 2022 Notes by notice to the Company and the 2022 Notes Trustee, may, and the 2022 Notes Trustee at the request of such holders (subject to the provisions of the 2022 Notes Indenture) shall, declare 100% of the principal of and accrued and unpaid interest, if any, on all the 2022 Notes to be due and payable. In case of certain events of bankruptcy, insolvency or reorganization, involving the Company or a significant subsidiary, 100% of the principal of and accrued and unpaid interest on the 2022 Notes will automatically become due and payable. Upon such a declaration of acceleration, such principal and accrued and unpaid interest, if any, will be due and payable immediately. In accounting for the issuance of the 2022 Notes, the Company separated the 2022 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 2022 Notes as a whole. The excess of the principal amount of the liability component over its carrying amount, referred to as the debt discount, is amortized to interest expense over the seven -year term of the 2022 Notes. The equity component is not re-measured as long as it continues to meet the conditions for equity classification. The equity component related to the 2022 Notes was $88.9 million and was recorded in additional paid-in capital on the accompanying condensed consolidated balance sheets. In accounting for the transaction costs related to the issuance of the 2022 Notes, the Company allocated the total costs incurred to the liability and equity components of the 2022 Notes based on their relative values. Transaction costs attributable to the liability component are amortized to interest expense over the seven -year term of the 2022 Notes, and transaction costs attributable to the equity component are netted with the equity components in stockholders’ equity. Additionally, the Company initially recorded a net deferred tax liability of $31.8 million in connection with the 2022 Notes. The 2022 Notes consist of the following: Liability component September 30, 2017 December 31, 2016 (in thousands) Principal $ 399,997 $ 400,000 Less: Debt discount, net (1) (66,064 ) (75,754 ) Net carrying amount $ 333,933 $ 324,246 _______________________________________ (1) Included in the accompanying condensed consolidated balance sheets within convertible senior notes (due 2022) and amortized to interest expense over the remaining life of the 2022 Notes using the effective interest rate method. The fair value of the 2022 Notes was approximately $504.7 million as of September 30, 2017 . The Company estimates the fair value of its 2022 Notes utilizing market quotations for debt that have quoted prices in active markets. Since the 2022 Notes do not trade on a daily basis in an active market, the fair value estimates are based on market observable inputs based on borrowing rates currently available for debt with similar terms and average maturities, which are classified as Level 2 measurements within the fair value hierarchy. See Note 7 , “Fair Value Measurements,” for definitions of hierarchy levels. As of September 30, 2017 , the remaining contractual life of the 2022 Notes is approximately 4.3 years. The following table sets forth total interest expense recognized related to the 2022 Notes: Three Months Ended September 30, Nine Months Ended September 30, 2017 2016 2017 2016 (in thousands) (in thousands) Contractual interest expense $ 2,500 $ 2,500 $ 7,500 $ 7,500 Amortization of debt discount 3,298 3,078 9,690 9,043 Total $ 5,798 $ 5,578 $ 17,190 $ 16,543 Effective interest rate of the liability component 6.5 % 6.5 % 6.5 % 6.5 % Convertible Senior Notes Due 2017 In June 2012, the Company issued, at par value, $275.0 million aggregate principal amount of 1.375% convertible senior notes due June 1, 2017 (the “2017 Notes”). The net proceeds to the Company from the offering were $266.2 million after deducting the initial purchasers’ discounts and commissions and the offering expenses payable by the Company. The 2017 Notes were senior unsecured obligations of the Company and paid cash interest at a rate of 1.375% per year, payable semi-annually on June 1 and December 1 of each year. The conversion rate for the 2017 Notes was 35.8038 shares of the Company’s common stock per $1,000 principal amount of the 2017 Notes, which is equivalent to an initial conversion price of $27.93 per share of the Company’s common stock. In June 2016, the Company used approximately $323.2 million of the net proceeds of the 2023 Notes to repurchase $220.0 million in aggregate principal amount of the 2017 Notes in privately negotiated transactions effected through the initial purchasers of the 2017 Notes. As part of the June 2016 repurchase of the 2017 Notes, the Company settled a proportionate amount of outstanding bond hedges and warrants related to the 2017 Notes for a net cash receipt of $12.6 million . The Company recorded a loss of $5.4 million on the extinguishment of debt during the three months ended June 30, 2016 and accounted for the difference of $108.7 million between the consideration transferred to the holder and the fair value of the liability component of the 2017 Notes as a reduction of additional paid-in capital on the accompany condensed consolidated balance sheet. The 2017 Notes that remained outstanding after the 2016 repurchase matured on June 1, 2017. In connection with the maturity of the 2017 Notes, the holders converted substantially all of the outstanding principal amount of the 2017 Notes, the Company paid cash to the converting 2017 Note holders equal to $55.4 million in respect of principal, interest and fractional shares on the 2017 Notes to be converted and delivered 819,901 shares of the Company’s common stock. The 2017 Notes consist of the following: Liability component September 30, 2017 December 31, 2016 (in thousands) Principal $ — $ 55,000 Less: Debt discount, net (1) — (1,251 ) Net carrying amount $ — $ 53,749 _______________________________________ (1) Included in the accompanying condensed consolidated balance sheets within convertible senior notes (due 2017) and amortized to interest expense over the remaining life of the 2017 Notes using the effective interest rate method. The following table sets forth total interest expense recognized related to the 2017 Notes: Three Months Ended September 30, Nine Months Ended September 30, 2017 2016 2017 2016 (in thousands) (in thousands) Contractual interest expense $ — $ 189 $ 315 $ 1,912 Amortization of debt discount — 621 1,251 6,699 Total $ — $ 810 $ 1,566 $ 8,611 Effective interest rate of the liability component 6.02 % 6.02 % 6.02 % 6.02 % Note Hedges In June 2012, the Company paid an aggregate amount of $58.2 million for the 2017 Note Hedges, which was recorded as a reduction of additional paid-in-capital in stockholders’ equity. As part of the June 2016 repurchase of $220.0 million in aggregate principal amount of the 2017 Notes, the Company settled the related hedges and received cash of approximately $100.5 million . The remaining 2017 Note Hedges covered approximately two million shares of the Company’s common stock, subject to anti-dilution adjustments substantially similar to those applicable to the 2017 Notes, had a strike price that corresponded to the initial conversion price of the 2017 Notes, and were exercisable upon conversion of the 2017 Notes. The 2017 Note Hedges were separate transactions entered into by the Company with the 2017 Hedge Counterparties and were not part of the terms of the 2017 Notes or the 2017 Warrants. Holders of the 2017 Notes and 2017 Warrants did not have any rights with respect to the 2017 Note Hedges. On June 1, 2017, in connection with the maturity of the 2017 Notes, the Company redeemed the 2017 Note Hedges and received from the Note Hedge counterparties approximately 820,000 shares at a weighted average price of $48.79 per share. The redemption offset the dilution with respect to shares of the Company’s common stock issued upon the conversion of the 2017 Notes. The shared delivered to the Company in connection with the redemption of the 2017 Notes Hedges are held by the Company as treasury shares. Warrants In June 2012, the Company received aggregate proceeds of $38.4 million from the sale of warrants to the 2017 Hedge Counterparties, which the Company recorded as additional paid-in-capital in stockholders’ equity. The 2017 Warrants are separate transactions entered into by the Company with the 2017 Hedge Counterparties and are not part of the terms of the 2017 Notes or 2017 Note Hedges. Holders of the 2017 Notes and 2017 Note Hedges did not have any rights with respect to the 2017 Warrants. The 2017 Warrants also meet the definition of a derivative. Because the 2017 Warrants are indexed to the Company’s common stock and are recorded in equity in the Company’s condensed consolidated balance sheets, the 2017 Warrants are exempt from the scope and fair value provisions related to accounting for derivative instruments. As part of the June 2016 repurchase of $220.0 million in aggregate principal amount of the 2017 Notes, the Company paid $87.9 million to settle the related warrants. The remaining 2017 Warrants, which continued to remain outstanding after the maturity of the 2017 Notes, are to purchase up to approximately two million shares of the Company’s common stock, subject to customary anti-dilution adjustments, at a strike price of $34.20 per share. The 2017 Warrants will have a dilutive effect with respect to the Company’s common stock to the extent that the market price per share of the Company’s common stock, as measured under the terms of the 2017 Warrants, exceeds the applicable strike price. The warrants will be net-settled, provided that subject to certain conditions the Company may elect to settle all of the 2017 Warrants in cash. The 2017 Warrants expired beginning in August 2017 and will continue to expire on a series of expiration dates through December 2017. During the three months ended September 30, 2017 , the holders of the 2017 Warrants exercised 443,070 warrants on a net basis and as a result the Company issued 24,217 shares of common stock. The Company has 1,427,679 warrants outstanding as of September 30, 2017 . |
Accumulated Other Comprehensive
Accumulated Other Comprehensive Loss | 9 Months Ended |
Sep. 30, 2017 | |
Equity [Abstract] | |
Accumulated Other Comprehensive Loss | Accumulated Other Comprehensive Loss The following tables provide a reconciliation of the components of accumulated other comprehensive loss , net of tax, attributable to The Medicines Company for the three and nine months ended September 30, 2017 and 2016 : Three Months Ended September 30, 2017 2016 Foreign currency translation adjustment Unrealized loss on available for sale securities Total Foreign currency translation adjustment Unrealized loss on available for sale securities Total (in thousands) Balance at beginning of period $ (5,439 ) $ (7 ) $ (5,446 ) $ (5,414 ) $ — $ (5,414 ) Other comprehensive loss before reclassifications 487 10 497 (70 ) — (70 ) Total other comprehensive loss 487 10 497 (70 ) — (70 ) Balance at end of period $ (4,952 ) $ 3 $ (4,949 ) $ (5,484 ) $ — $ (5,484 ) Nine Months Ended September 30, 2017 2016 Foreign currency translation adjustment Unrealized loss on available for sale securities Total Foreign currency translation adjustment Unrealized gain (loss) on available for sale securities Total (in thousands) Balance at beginning of period $ (5,479 ) $ — $ (5,479 ) $ 3,924 $ 49 $ 3,973 Other comprehensive income before reclassifications 527 3 530 208 — 208 Amounts reclassified from accumulated other comprehensive income (1) (2) — — — (9,616 ) (49 ) (9,665 ) Total other comprehensive (loss) income 527 3 530 (9,408 ) (49 ) (9,457 ) Balance at end of period $ (4,952 ) $ 3 $ (4,949 ) $ (5,484 ) $ — $ (5,484 ) _______________________________________ (1) Amounts were reclassified to other income in the accompanying condensed consolidated statements of operations. There is generally no tax impact related to foreign currency translation adjustments, as earnings are considered permanently reinvested. In addition, there were no material tax impacts related to unrealized gains or losses on available for sale securities in the periods presented. (2) See Note 16 , “Discontinued Operations,” for a discussion of this reclass of foreign currency translation adjustment. |
Segment and Geographic Informat
Segment and Geographic Information | 9 Months Ended |
Sep. 30, 2017 | |
Segment Reporting [Abstract] | |
Segment and Geographic Information | Segment and Geographic Information The Company manages its business and operations as one segment and is focused on advancing the treatment of acute and intensive care patients through the delivery of innovative, cost-effective medicines to the worldwide hospital marketplace. The Company allocates resources and assesses financial performance on a consolidated basis. Revenues reported below are derived primarily from sales of Angiomax in the United States, including royalty revenue from Sandoz. The geographic segment information provided below is classified based on the major geographic regions in which the Company operates. Long-lived assets are comprised of the Company’s noncurrent assets. Three Months Ended September 30, Nine Months Ended September 30, 2017 2016 2017 2016 ($ in thousands) Net revenues: United States $ 15,460 91.6 % $ 35,662 94.8 % $ 55,062 92.0 % $ 133,273 93.3 % Europe 1,208 7.2 % 1,726 4.6 % 4,355 7.3 % 7,544 5.3 % Rest of world 203 1.2 % 211 0.6 % 412 0.7 % 1,819 1.4 % Total net revenues $ 16,871 100 % $ 37,599 100.0 % $ 59,829 100.0 % $ 142,636 100.0 % September 30, 2017 December 31, 2016 ($ in thousands) Long-lived assets: United States $ 708,309 99.9 % $ 1,047,098 99.6 % Europe 833 0.1 % 4,160 0.4 % Total long-lived assets $ 709,142 100.0 % $ 1,051,258 100.0 % |
Contingencies
Contingencies | 9 Months Ended |
Sep. 30, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
Contingencies | Contingencies The Company may be, from time to time, a party to various disputes and claims arising from normal business activities. The Company accrues for loss contingencies when available information indicates that it is probable that a liability has been incurred and the amount of such loss can be reasonably estimated. In the cases where the Company believes that a reasonably possible loss exists, the Company discloses the facts and circumstances of the litigation, including an estimable range, if possible. The Company is currently party to the legal proceedings described in Part II, Item 1, Legal Proceedings, of this Quarterly Report on Form 10-Q, which include patent litigation matters and litigation related to a license agreement. 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 can be reasonably estimated. As a result, the Company did not record a loss contingency related to any of these legal proceedings. Particularly with respect to the litigation related to a license agreement, the Company is presently unable to predict the outcome of such lawsuit or to reasonably estimate the possible loss, or range of potential losses, if any, related to such lawsuit. While it is not possible to determine the outcome of the matters described in Part II, Item 1, Legal Proceedings, of this Quarterly Report on Form 10-Q, the Company believes that the resolution of all such matters could have a material adverse effect on its financial condition or results of operations and cash flows. |
Restructuring
Restructuring | 9 Months Ended |
Sep. 30, 2017 | |
Restructuring and Related Activities [Abstract] | |
Restructuring | Restructuring On June 1, 2017, the Company voluntarily discontinued and withdrew Ionsys from the market in the United States and ceased related commercialization activities, effective June 19, 2017, with the New Drug Application for Ionsys remaining open to December 31, 2017. Concurrent with this market withdrawal, the Company commenced implementation of a workforce reduction, which resulted in the reduction of 57 employees, representing approximately 15% of the Company’s workforce. The Company recorded a pre-tax charge of approximately $276.9 million associated with the discontinuation and market withdrawal of Ionsys in the United States market, of which $268.1 million was a non-cash impairment charge (including a write-off of inventory), $5.8 million relates to cash severance and $3.0 million relates to other exit costs. The Company has also discontinued Ionsys in the European market. The impacted employees are eligible to receive severance payments in specified amounts, health benefits and outplacement services. The Company has and will record these charges in cost of goods sold, research and development and selling, general and administrative expenses based on responsibilities of the impacted employees. The following table sets forth details regarding the activities described above during the nine months ended September 30, 2017 : Balance as of January 1, 2017 Expenses, Net Cash Noncash Balance as of September 30, 2017 (in thousands) Employee severance and other personnel benefits: $ — $ 5.9 $ (5.1 ) $ (0.1 ) $ 0.7 |
Dispositions
Dispositions | 9 Months Ended |
Sep. 30, 2017 | |
Discontinued Operations and Disposal Groups [Abstract] | |
Dispositions | Dispositions On June 21, 2016, the Company completed the sale of its Non-Core ACC Products pursuant to the purchase and sale agreement dated May 9, 2016 by and among the Company, Chiesi USA and Chiesi. At the completion of the sale, the Company received approximately $263.8 million in cash, which included the value of product inventory, and may receive up to an additional $480.0 million in the aggregate following the achievement of certain specified calendar year net sales milestones with respect to net sales of each of Cleviprex and Kengreal. The following table presents the consideration received, major classes of assets sold and the gain recognized on the sale of the Non-Core ACC Products: (in thousands) Sale price: Cash $ 263,807 Contingent purchase price from sale of business 65,700 Total sale price 329,507 Assets: Inventory 2,184 Intangibles 5,210 Goodwill 33,812 Total assets sold 41,206 Gain on sale of business $ 288,301 The Company recognized a gain on sale of business of approximately $288.3 million for the nine months ended September 30, 2016 in continuing operations. Disposition related costs during 2016 of approximately $7.9 million for advisory, legal and regulatory fees incurred in connection with the sale of the Non-Core ACC Products were recorded in selling, general and administrative expenses. See Note 7, “Fair Value Measurements,” for further details on the contingent purchase price from sale of businesses. Discontinued Operations Sale of Hemostasis Business On February 1, 2016, the Company completed the sale of its Hemostasis Business to Mallinckrodt pursuant to the purchase and sale agreement dated December 18, 2015 between the Company and Mallinckrodt. At the completion of the sale, the Company received approximately $174.1 million in cash from Mallinckrodt, and may receive up to an additional $235.0 million in the aggregate following the achievement of certain specified calendar year net sales milestones with respect to net sales of PreveLeak and Raplixa. Financial results of the Hemostasis Business are presented as “ Income (loss) from discontinued operations, net of tax ” on the accompanying condensed consolidated statements of operations for the three and nine months ended September 30, 2016 . The following table presents key financial results of the Hemostasis Business included in “ Income (loss) from discontinued operations, net of tax ” for the three and nine months ended September 30, 2016 : Three Months Ended Nine Months Ended September 30, 2016 2016 Net product revenues $ 28 $ 78 Operating expenses: Cost of product revenue (9 ) 1,695 Research and development (15 ) 104 Selling, general and administrative (44 ) 634 Total operating expenses (68 ) 2,433 Income (loss) from operations 96 (2,355 ) Gain from sale of business — 1,004 Other expense, net — (39 ) Income (loss) from discontinued operations before income taxes 96 (1,390 ) Benefit for income taxes — — Income (loss) from discontinued operations, net of tax $ 96 $ (1,390 ) Cumulative translation adjustment (“CTA”) gains or losses of foreign subsidiaries related to divested businesses are reclassified into income once the liquidation of the respective foreign subsidiaries is substantially complete. At the completion of the sale of the Hemostasis Business, the Company reclassified $9.6 million , net of tax, of CTA gains from accumulated comprehensive loss to the Company’s results of discontinued operations. Of this amount, $8.4 million was included in the impairment loss recorded to reduce the Hemostasis Business disposal group’s carrying value to its estimated fair value, less costs to sell as of December 31, 2015 and $1.2 million was included in “Gain from sale of business” for the nine months ended September 30, 2016 . |
Discontinued Operations
Discontinued Operations | 9 Months Ended |
Sep. 30, 2017 | |
Discontinued Operations and Disposal Groups [Abstract] | |
Discontinued Operations | Dispositions On June 21, 2016, the Company completed the sale of its Non-Core ACC Products pursuant to the purchase and sale agreement dated May 9, 2016 by and among the Company, Chiesi USA and Chiesi. At the completion of the sale, the Company received approximately $263.8 million in cash, which included the value of product inventory, and may receive up to an additional $480.0 million in the aggregate following the achievement of certain specified calendar year net sales milestones with respect to net sales of each of Cleviprex and Kengreal. The following table presents the consideration received, major classes of assets sold and the gain recognized on the sale of the Non-Core ACC Products: (in thousands) Sale price: Cash $ 263,807 Contingent purchase price from sale of business 65,700 Total sale price 329,507 Assets: Inventory 2,184 Intangibles 5,210 Goodwill 33,812 Total assets sold 41,206 Gain on sale of business $ 288,301 The Company recognized a gain on sale of business of approximately $288.3 million for the nine months ended September 30, 2016 in continuing operations. Disposition related costs during 2016 of approximately $7.9 million for advisory, legal and regulatory fees incurred in connection with the sale of the Non-Core ACC Products were recorded in selling, general and administrative expenses. See Note 7, “Fair Value Measurements,” for further details on the contingent purchase price from sale of businesses. Discontinued Operations Sale of Hemostasis Business On February 1, 2016, the Company completed the sale of its Hemostasis Business to Mallinckrodt pursuant to the purchase and sale agreement dated December 18, 2015 between the Company and Mallinckrodt. At the completion of the sale, the Company received approximately $174.1 million in cash from Mallinckrodt, and may receive up to an additional $235.0 million in the aggregate following the achievement of certain specified calendar year net sales milestones with respect to net sales of PreveLeak and Raplixa. Financial results of the Hemostasis Business are presented as “ Income (loss) from discontinued operations, net of tax ” on the accompanying condensed consolidated statements of operations for the three and nine months ended September 30, 2016 . The following table presents key financial results of the Hemostasis Business included in “ Income (loss) from discontinued operations, net of tax ” for the three and nine months ended September 30, 2016 : Three Months Ended Nine Months Ended September 30, 2016 2016 Net product revenues $ 28 $ 78 Operating expenses: Cost of product revenue (9 ) 1,695 Research and development (15 ) 104 Selling, general and administrative (44 ) 634 Total operating expenses (68 ) 2,433 Income (loss) from operations 96 (2,355 ) Gain from sale of business — 1,004 Other expense, net — (39 ) Income (loss) from discontinued operations before income taxes 96 (1,390 ) Benefit for income taxes — — Income (loss) from discontinued operations, net of tax $ 96 $ (1,390 ) Cumulative translation adjustment (“CTA”) gains or losses of foreign subsidiaries related to divested businesses are reclassified into income once the liquidation of the respective foreign subsidiaries is substantially complete. At the completion of the sale of the Hemostasis Business, the Company reclassified $9.6 million , net of tax, of CTA gains from accumulated comprehensive loss to the Company’s results of discontinued operations. Of this amount, $8.4 million was included in the impairment loss recorded to reduce the Hemostasis Business disposal group’s carrying value to its estimated fair value, less costs to sell as of December 31, 2015 and $1.2 million was included in “Gain from sale of business” for the nine months ended September 30, 2016 . |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2017 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events On October 25, 2017, the Company announced its intention to commence a series of workforce reductions, independent of the potential divestiture of the Company’s infectious disease business (the “Workforce Reductions”), to improve efficiencies and better align its costs and structure. As a result of the Workforce Reductions and the potential infectious disease business divestiture, the Company plans to reduce its personnel to less than 60 employees. Upon signing release agreements, affected employees will receive the Company’s severance package, including reduction payments and fully paid health care coverage and outplacement services for six months to a year. The Company expects to substantially implement the Workforce Reductions in December 2017. The Company expects to record, in the aggregate, charges of approximately $13 million to $18 million associated with the Workforce Reductions, which will be recognized beginning in the fourth quarter of 2017 and through the second quarter of 2018. Substantially all of these charges are expected to represent cash expenditures. In addition to the Workforce Reductions, additional restructuring charges are expected to be incurred but cannot be estimated at this time. |
Significant Accounting Polici24
Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2017 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying condensed consolidated financial statements are unaudited and have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) for interim financial information and with the instructions to Form 10-Q. Accordingly, they do not include all the information and footnotes required by GAAP for complete financial statements. In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all adjustments, consisting solely of normal recurring adjustments, considered necessary for a fair presentation of the Company’s financial position, results of operations, comprehensive loss , and cash flows for the periods presented. The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly owned and majority owned subsidiaries. All significant intercompany balances and transactions have been eliminated in consolidation. The Company recorded net loss attributable to non-controlling interest in the Company’s condensed consolidated financial statements equal to the percentage of ownership interest retained in the respective operations by the non-controlling parties for the three and nine months ended September 30, 2016 . The Company has no unconsolidated subsidiaries. The Company’s results of operations for the three and nine months ended September 30, 2017 are not necessarily indicative of the results that may be expected from the Company for the entire fiscal year or any other quarter of the fiscal year ending December 31, 2017 . These unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements included in the 2016 Form 10-K. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, costs, expenses and accumulated other comprehensive loss that are reported in the condensed consolidated financial statements and accompanying disclosures. Actual results may be different. |
Revenue Recognition | Revenue Recognition The Company’s revenue recognition accounting policy is described in Note 2 of the notes to the consolidated financial statements included in the 2016 Form 10-K. Effective as of September 1, 2017, the Company modified its revenue recognition accounting policy with respect to product sales of Orbactiv and branded Angiomax as follows: Product Sales for Orbactiv and branded Angiomax. Prior to September 1, 2017, the Company recognized sales from Orbactiv under a deferred revenue model as it did not have sufficient information to develop estimates of expected returns and other adjustments to gross revenue. As a result of the entrance of generic products in the marketplace beginning in the third quarter of 2015, the Company could not reasonably estimate its chargebacks with respect to branded Angiomax between July 1, 2015 and August 30, 2017, and sales of branded Angiomax in the United States were also recognized under a deferred revenue model during that period. Under the deferred revenue model, the Company did not recognize revenue upon product shipment of Orbactiv and branded Angiomax to Integrated Commercialization Solutions (ICS). Instead, upon product shipment, the Company invoiced ICS, recorded deferred revenue at gross invoice sales price, classified the cost basis of the product held by ICS as finished goods inventory held by others and included such cost basis amount within prepaid expenses and other current assets on the consolidated balance sheets. The Company recognized revenue when hospitals purchased the products and the transaction consideration became fixed or determinable. Beginning September 1, 2017, the Company has sufficient market information to reasonably estimate its chargebacks, returns and other adjustments to gross revenues associated with Orbactiv and branded Angiomax and recognizes sales upon shipment to ICS. |
Contingencies | Contingencies The Company may be, from time to time, a party to various disputes and claims arising from normal business activities. The Company continually assesses litigation to determine if an unfavorable outcome would lead to a probable loss or reasonably possible loss which could be estimated. In accordance with the guidance of the Financial Accounting Standards Board (FASB) on accounting for loss contingencies, the Company accrues for all contingencies at the earliest date at which the Company deems it probable that a liability has been incurred and the amount of such liability can be reasonably estimated. If the estimate of a probable loss is a range and no amount within the range is more likely than another, the Company accrues the minimum of the range. In the cases where the Company believes that a reasonably possible loss exists, the Company discloses the facts and circumstances of the litigation, including an estimable range, if possible. |
Research and Development | Research and Development Research and development costs are expensed as incurred. Clinical study costs are accrued over the service periods specified in the contracts and adjusted as necessary based upon an ongoing review of the level of effort and costs actually incurred. Payments for a product license prior to regulatory approval of the product and payments for milestones achieved prior to regulatory approval of the product are expensed in the period incurred as research and development. Milestone payments that do not represent payments of contingent purchase price from business combinations that are made in connection with regulatory approvals are capitalized and amortized to cost of revenue over the remaining useful life of the asset. The Company performs research and development for U.S. government agencies under a cost-reimbursable contract in which the Company is reimbursed for direct costs incurred plus allowable indirect costs. The Company recognizes the reimbursements under research contracts when a contract has been executed, the contract price is fixed or determinable, delivery of services or products has occurred, and collection of the contract price is reasonably assured. The reimbursements are classified as an offset to research and development expenses. Payments received in advance of work performed are deferred. |
Contingent Purchase Price From Sale of Business | Contingent Purchase Price From Sale of Business The Company has contingent assets for certain specified calendar year net sales milestones as part of the sale of the Hemostasis Business to Mallinckrodt and the Non-Core ACC Products to Chiesi, which in each case are reflected as contingent purchase price from sale of businesses on the accompany condensed consolidated balance sheets. The Company will recognize any increases in the carrying amount or impairments of the contingent purchase price if and when the milestones are achieved or determined to have no value. The Company noted no indicators of impairment on the carrying amount of the contingent assets. In addition, the Company determined that the fair values of these contingent payments to be received from Mallinckrodt and Chiesi are not readily determinable at September 30, 2017, as the estimated future net sales of each of the respective products are determined by the future actions of Mallinckrodt and Chiesi, respectively. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In May 2014, the FASB issued a comprehensive new revenue recognition Accounting Standards Update (ASU), “Revenue from Contracts with Customers (Topic 606)” (ASU No. 2014-09). ASU No. 2014-09 provides guidance to clarify the principles for recognizing revenue. This guidance includes the required steps to achieve the core principle that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. In August 2015, the FASB deferred the effective date of the revenue recognition guidance to reporting periods beginning after December 15, 2017. Early adoption of the standard is permitted but not before the original effective date, which was for reporting periods beginning after December 15, 2016. The FASB has further amended guidance related to recording revenue on a gross versus a net basis and on identifying performance obligations and licensing. The FASB has also revised certain SEC guidance primarily related to ASC Topic 815, “Derivatives and Hedging,” and has issued additional improvements and practical expedients to the standard. The Company, has analyzed the impacts of ASU No. 2014-09 on its revenue streams, specifically focusing on its product revenues, including its arrangement with Sandoz Inc. (Sandoz) to sell in the United States an authorized generic version of Angiomax (bivalirudin), and its collaboration agreements. The Company’s assessment included a review of current accounting policies and practices to identify potential differences that would result from applying the guidance. Currently, the Company uses a deferred revenue model for sales of its authorized generic version of Angiomax (bivalirudin) as the price is not fixed or determinable and recognizes royalty revenue on an accrual basis in the period in which Sandoz reports sales to its customers. The Company currently records revenue recognized from sales of bivalirudin to Sandoz in both net product revenues and royalty revenues in its consolidated statements of operations. Under the new standard, the promise to provide bivalirudin to Sandoz and the promise to provide exclusivity to Sandoz to distribute bivalirudin in the United States will constitute one performance obligation; as a result, under the new standard, revenue recognized from sales of bivalirudin to Sandoz will be recorded solely in net product revenues in the Company’s consolidated statements of operations upon transfer of control of product to Sandoz. The transaction price will reflect the amount the Company expects to be entitled to in connection with the sale of bivalirudin to Sandoz, which will include an estimate of the variable amount of the consideration subject to the constraint that it must be probable that a significant reversal of revenue will not occur. This may result in revenue being recognized earlier provided the Company can reliably estimate the ultimate price expected to be realized from Sandoz’s customer. The Company does not expect the adoption of the guidance to have a material impact on revenue recognized related to its collaboration agreements. The Company will continue to assess new customer contracts throughout 2017 and any impact the standard will have on its processes, systems and controls. While the Company’s assessment of the impacts of ASU No. 2014-09 is still in process, the adoption of the guidance is not expected to have a material impact on the Company’s consolidated financial statements. However, the Company will be required to provide additional disclosures in the notes to the consolidated financial statements upon adoption. The Company currently intends to adopt the standard using the modified retrospective method. In January 2016 the FASB issued ASU No. 2016-01, “Financial Instruments - Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities” (ASU No. 2016-01). ASU No. 2016-01 amends certain aspects of accounting and disclosure requirements of financial instruments, including the requirement that equity investments with readily determinable fair values be measured at fair value with changes in fair value recognized in a company’s results of operations. The new standard does not apply to investments accounted for under the equity method of accounting or those that result in consolidation of the investee. Equity investments that do not have readily determinable fair values may be measured at fair value or at cost minus impairment adjusted for changes in observable prices. A financial liability that is measured at fair value in accordance with the fair value option is required to be presented separately in other comprehensive income for the portion of the total change in the fair value resulting from change in the instrument-specific credit risk. In addition, a valuation allowance should be evaluated on deferred tax assets related to available-for-sale debt securities in combination with other deferred tax assets. ASU No. 2016-01 will be effective for public companies for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2017. Based on current investment holdings, the Company does not believe the adoption of this standard is expected to have a material impact the consolidated balance sheets and statements of operations. In February 2016, the FASB issued ASU No. 2016-02, “Leases (Topic 842)” (ASU No. 2016-02). ASU No. 2016-02 will require organizations that lease assets with lease terms of more than 12 months to recognize assets and liabilities for the rights and obligations created by those leases on their balance sheets. The ASU will also require new qualitative and quantitative disclosures to help investors and other financial statement users better understand the amount, timing, and uncertainty of cash flows arising from leases. ASU No. 2016-02 will be effective for public companies for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2018, with early adoption permitted. The Company expects to adopt this guidance when effective and is currently evaluating the effect that the updated standard will have on its consolidated financial statements and related disclosures. In March 2016, the FASB issued ASU No. 2016-09, “Compensation - Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting” (ASU No. 2016-09). This ASU makes several modifications to Topic 718 related to the accounting for forfeitures, employer tax withholding on share-based compensation, and the financial statement presentation of excess tax benefits or deficiencies. ASU No. 2016-09 also clarifies the statement of cash flows presentation for certain components of share-based awards. On January 1, 2017, the Company adopted ASU No. 2016-09 and has elected to continue its determination of compensation costs recognized in each period based upon an estimate of expected future forfeitures. Upon the settlement of awards during the nine months ended September 30, 2017, the Company recorded excess tax benefits of $5.2 million but was unable to recognize any benefit due to the establishment of a valuation allowance on its net operating loss carry forward deferred tax assets. The Company does not expect to be able to recognize any benefit related to additional excess tax benefits recorded throughout 2017. There was no net impact on the Company’s opening accumulated deficit upon application of this guidance using the modified retrospective transition method as the total cumulative-effect adjustment for previously deferred excess tax benefits was offset by a related change in the valuation allowance. The other amended requirements of ASU No. 2016-09 did not have a material impact on the Company’s condensed consolidated financial statements and related disclosures. In August 2016, the FASB issued ASU No. 2016-15, “Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments” (ASU No. 2016-15). This guidance clarifies how certain cash receipts and payments should be presented in the statement of cash flows and is effective for interim and annual reporting periods beginning after December 15, 2017, with early adoption permitted. The Company does not believe that this guidance will have a material impact on the consolidated financial statements and related disclosures. In November 2016, the FASB issued ASU 2016-18, “Statement of Cash Flows (Topic 230): Restricted Cash” (ASU No. 2016-18). This amends the guidance in ASC 230, including providing additional guidance related to transfers between cash and restricted cash and how entities present, in their statement of cash flows, the cash receipts and cash payments that directly affect the restricted cash accounts. ASU 2016-18 is effective for annual reporting periods beginning after December 15, 2017, and interim periods within those years, with early adoption permitted. The Company does not believe that this guidance will have an impact on the consolidated financial statements and related disclosures. In January 2017, the FASB issued ASU 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business, which clarifies the definition of a business with the objective of adding guidance to assist entities with evaluating whether transactions should be accounted for as acquisitions (or disposals) of assets or businesses. ASU 2017-01 is effective for annual reporting periods beginning after December 15, 2017, and interim periods within those years, with early adoption permitted. The Company will apply the guidance to applicable transactions after the adoption date. The impact on the Company’s consolidated financial statements will depend on the facts and circumstances of any specific future transactions. In January 2017, the FASB issued ASU 2017-04, Intangibles-Goodwill and Other, Simplifying the Test for Goodwill Impairment, which eliminates Step 2 from the goodwill impairment test. Under the revised test, an entity should perform its annual, or interim, goodwill impairment test by comparing the fair value of a reporting unit with its carrying amount. An entity should recognize an impairment charge for the amount by which the carrying amount exceeds the reporting unit’s fair value; however, the loss recognized should not exceed the total amount of goodwill allocated to that reporting unit. This ASU is effective for any interim or annual impairment tests for fiscal years beginning after December 15, 2019, with early adoption permitted. The Company does not believe that this guidance will have an impact on the consolidated financial statements and related disclosures. |
Earnings Per Share | Basic (loss) earnings per share is computed by dividing consolidated net loss attributable to The Medicines Company by the weighted average number of shares of common stock outstanding during the period, excluding unvested restricted common shares. The potentially dilutive effect of the Company’s stock options, unvested restricted common stock, stock purchase warrants, and convertible senior notes due 2017 (which matured on June 1, 2017) and 2022 on earnings per share is computed under the treasury stock method. In addition, the Company analyzes the potential dilutive effect of the convertible senior notes due 2023 on earnings per share under the “if converted” method, in which it is assumed that the outstanding security converts into common stock at the beginning of the period. For periods of net income when the effects are not anti-dilutive, diluted earnings per share is computed by dividing the net income attributable to The Medicines Company by the weighted average number of shares outstanding and the impact of all potential dilutive common shares, consisting primarily of stock options, unvested restricted common stock, shares issuable upon conversion of convertible senior notes due 2017, 2022 and 2023 and stock purchase warrants. For periods of net loss from continuing operations, diluted loss per share is calculated similar to basic loss per share as the effect of including all potentially dilutive common share equivalents is anti-dilutive. |
Fair Value Measurements | The Company applies a fair value framework in order to measure and disclose its financial assets and liabilities. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The fair value hierarchy requires an entity to maximize the use of observable inputs, where available, and minimize the use of unobservable inputs when measuring fair value. There are three levels of inputs that may be used to measure fair value: Level 1 Quoted prices in active markets for identical assets or liabilities. The Company’s Level 1 assets consist of money market investments. Level 2 Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Fair values are determined by utilizing quoted prices for similar assets and liabilities in active markets or other market observable inputs such as interest rates and yield curves. The Company’s Level 2 assets consist of U.S. government debt, corporate debt securities and asset back securities. Level 3 Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The Company’s Level 3 assets and liabilities consist of the contingent purchase prices associated with the Company’s business combinations, respectively. The fair value of certain development or regulatory milestone based contingent purchase prices was determined in a discounted cash flow framework by probability weighting the future contractual payment with management's assessment of the likelihood of achieving these milestones and present valuing them using a risk-adjusted discount rate. Certain sales milestone based payments were determined in a discounted cash flow framework where risk-adjusted revenue scenarios were estimated using Monte Carlo simulation models to compute contractual payments which were present valued using a risk-adjusted discount rate. |
Segments | The Company manages its business and operations as one segment and is focused on advancing the treatment of acute and intensive care patients through the delivery of innovative, cost-effective medicines to the worldwide hospital marketplace. The Company allocates resources and assesses financial performance on a consolidated basis. |
Nature of Business (Tables)
Nature of Business (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Discontinuation and Market Withdrawal | The following table presents the impact the discontinuation and market withdrawal of Ionsys had on the Company’s statement of operations for the nine months ended September 30, 2017 (amounts in thousands): Operating expenses: Cost of product revenue $ 8,458 Asset impairment charges 264,097 Research and development 1,032 Selling, general and administrative 3,331 Total operating expenses 276,918 Loss from operations (276,918 ) (Loss) income from continuing operations before income taxes (276,918 ) Benefit (provision) for income taxes — Net (loss) income from continuing operations $ (276,918 ) The following table presents the consideration received, major classes of assets sold and the gain recognized on the sale of the Non-Core ACC Products: (in thousands) Sale price: Cash $ 263,807 Contingent purchase price from sale of business 65,700 Total sale price 329,507 Assets: Inventory 2,184 Intangibles 5,210 Goodwill 33,812 Total assets sold 41,206 Gain on sale of business $ 288,301 The following table presents key financial results of the Hemostasis Business included in “ Income (loss) from discontinued operations, net of tax ” for the three and nine months ended September 30, 2016 : Three Months Ended Nine Months Ended September 30, 2016 2016 Net product revenues $ 28 $ 78 Operating expenses: Cost of product revenue (9 ) 1,695 Research and development (15 ) 104 Selling, general and administrative (44 ) 634 Total operating expenses (68 ) 2,433 Income (loss) from operations 96 (2,355 ) Gain from sale of business — 1,004 Other expense, net — (39 ) Income (loss) from discontinued operations before income taxes 96 (1,390 ) Benefit for income taxes — — Income (loss) from discontinued operations, net of tax $ 96 $ (1,390 ) |
Cash and Cash Equivalents and26
Cash and Cash Equivalents and Available for Sale Securities (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Investments, Debt and Equity Securities [Abstract] | |
Available for sale Securities | Available for sale securities, including carrying value and estimated fair values, are summarized as follows: As of September 30, 2017 Amortized Cost Fair Value Unrealized Gain (in thousands) Asset backed securities 8,192 8,192 — Corporate debt securities 33,973 33,976 3 Total $ 42,165 $ 42,168 $ 3 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Fair Value Disclosures [Abstract] | |
Assets and Liabilities Measured at Fair Value on Recurring Basis | Except for the Company’s Level 2 liabilities which are discussed in Note 10 , “Convertible Senior Notes,” the following table sets forth the Company’s assets and liabilities that are measured at fair value on a recurring basis at September 30, 2017 and December 31, 2016 , by level, within the fair value hierarchy: As of September 30, 2017 As of December 31, 2016 Assets and Liabilities Quoted Prices In Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Balance as of September 30, 2017 Quoted Prices In Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Balance as of December 31, 2016 (in thousands) Assets: Cash equivalents $ 14,686 $ — $ 14,686 $ 56,097 $ — $ — $ 56,097 Available for sale securities — 42,168 — 42,168 $ — $ — $ — — Total assets at fair value $ 14,686 $ 42,168 $ — $ 56,854 $ 56,097 $ — $ — $ 56,097 Liabilities: Contingent purchase price $ — $ — $ 62,884 $ 62,884 $ — $ — $ 137,289 $ 137,289 Total liabilities at fair value $ — $ — $ 62,884 $ 62,884 $ — $ — $ 137,289 $ 137,289 |
Fair Value Inputs, Quantitative Information | The following table provides quantitative information associated with the fair value measurements of the Company’s Level 3 liabilities: Fair Value as of Valuation Technique Unobservable Input Range (Weighted Average) (in thousands) Targanta: Contingent purchase price $ 1,584 Probability-adjusted discounted cash flow Probability of success 5% Period in which milestone is expected to be achieved 2021 Discount rate 11% Rempex: Contingent purchase price: Event-based milestones $ 47,200 Probability-adjusted discounted cash flow Probabilities of successes 18% - 90% (71%) Period in which milestones are expected to be achieved 2018 - 2024 Discount rate 4.4% - 7.3% Contingent purchase price: Sales-based milestones $ 14,100 Risk-adjusted revenue simulation Probabilities of successes 15% - 85% (72%) Period in which milestones are expected to be achieved 2020 - 2022 Discount rate 5.5% - 6.7% Fair Value as of Valuation Technique Unobservable Input Range (Weighted Average) (in thousands) Targanta: Contingent purchase price $ 5,857 Probability-adjusted discounted cash flow Probability of success 20% Period in which milestone is expected to be achieved 2021 Discount rate 11% Incline: Contingent purchase price $ 1,269 Probability-adjusted discounted cash flow Probabilities of successes 5% Period in which milestones are expected to be achieved 2019 Discount rate 18% Rempex: Contingent purchase price: Event-based milestones $ 95,800 Probability-adjusted discounted cash flow Probabilities of successes 18% - 95% (78%) Period in which milestones are expected to be achieved 2017 - 2024 Discount rate 5.2% - 8.5% Contingent purchase price: Sales-based milestones $ 20,300 Risk-adjusted revenue simulation Probabilities of successes 16% - 65% (56%) Period in which milestones are expected to be achieved 2018 - 2022 Discount rate 6.6% - 8.2% Annovation: Contingent purchase price $ 14,063 Probability-adjusted discounted cash flow Probabilities of successes 9% - 50% (34%) Period in which milestones are expected to be achieved 2018 - 2031 Discount rate 6.0% - 10.0% |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation | The changes in fair value of the Company’s Level 3 contingent purchase price during the three and nine months ended September 30, 2017 and 2016 were as follows: Three Months Ended Nine Months Ended 2017 2016 2017 2016 (in thousands) Balance at beginning of period $ 111,171 $ 118,571 $ 137,289 $ 123,757 Payments (40,616 ) (1,564 ) (62,618 ) (8,811 ) Fair value adjustments to contingent purchase prices included in net loss (7,672 ) 12,403 (11,788 ) 14,464 Balance at end of period $ 62,883 $ 129,410 $ 62,883 $ 129,410 |
Inventory (Tables)
Inventory (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | The major classes of inventory were as follows: September 30, December 31, (in thousands) Raw materials $ 57,818 $ 56,962 Work-in-progress 4,615 12,033 Finished goods 4,736 1,903 Total $ 67,169 $ 70,898 |
Intangible Assets and Goodwill
Intangible Assets and Goodwill (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Finite-Lived Intangible Assets by Major Class | The following table sets forth the carrying amounts and accumulated amortization of the Company’s intangible assets: As of September 30, 2017 As of December 31, 2016 Gross Carrying Amount Accumulated Amortization Net Carrying Amount Gross Carrying Amount Accumulated Amortization Net Carrying Amount (in thousands) Amortizable intangible assets: Product licenses (1) $ — $ — $ — $ 30,000 $ (3,013 ) $ 26,987 Developed product rights (2) 309,180 (23,215 ) 285,965 370,560 (35,946 ) 334,614 Total amortizable intangible assets 309,180 (23,215 ) 285,965 400,560 (38,959 ) 361,601 Intangible assets not subject to amortization: In-process research and development $ — $ — $ — $ 253,620 $ — $ 253,620 Total intangible assets not subject to amortization — — — 253,620 — 253,620 Total intangible assets $ 309,180 $ (23,215 ) $ 285,965 $ 654,180 $ (38,959 ) $ 615,221 _______________________________________ (1) The Company amortizes intangible assets related to the product licenses over their expected useful lives. (2) The Company amortizes intangible assets related to developed product rights over the remaining life of the patents. |
Schedule of Indefinite-lived Intangible Assets by Major Class | The following table sets forth the carrying amounts and accumulated amortization of the Company’s intangible assets: As of September 30, 2017 As of December 31, 2016 Gross Carrying Amount Accumulated Amortization Net Carrying Amount Gross Carrying Amount Accumulated Amortization Net Carrying Amount (in thousands) Amortizable intangible assets: Product licenses (1) $ — $ — $ — $ 30,000 $ (3,013 ) $ 26,987 Developed product rights (2) 309,180 (23,215 ) 285,965 370,560 (35,946 ) 334,614 Total amortizable intangible assets 309,180 (23,215 ) 285,965 400,560 (38,959 ) 361,601 Intangible assets not subject to amortization: In-process research and development $ — $ — $ — $ 253,620 $ — $ 253,620 Total intangible assets not subject to amortization — — — 253,620 — 253,620 Total intangible assets $ 309,180 $ (23,215 ) $ 285,965 $ 654,180 $ (38,959 ) $ 615,221 _______________________________________ (1) The Company amortizes intangible assets related to the product licenses over their expected useful lives. (2) The Company amortizes intangible assets related to developed product rights over the remaining life of the patents. |
Convertible Senior Notes (Table
Convertible Senior Notes (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Debt Disclosure [Abstract] | |
Schedule of Debt | The 2017 Notes consist of the following: Liability component September 30, 2017 December 31, 2016 (in thousands) Principal $ — $ 55,000 Less: Debt discount, net (1) — (1,251 ) Net carrying amount $ — $ 53,749 _______________________________________ (1) Included in the accompanying condensed consolidated balance sheets within convertible senior notes (due 2017) and amortized to interest expense over the remaining life of the 2017 Notes using the effective interest rate method. The 2022 Notes consist of the following: Liability component September 30, 2017 December 31, 2016 (in thousands) Principal $ 399,997 $ 400,000 Less: Debt discount, net (1) (66,064 ) (75,754 ) Net carrying amount $ 333,933 $ 324,246 _______________________________________ (1) Included in the accompanying condensed consolidated balance sheets within convertible senior notes (due 2022) and amortized to interest expense over the remaining life of the 2022 Notes using the effective interest rate method. The 2023 Notes consist of the following: Liability component September 30, 2017 December 31, 2016 (in thousands) Principal $ 402,500 $ 402,500 Less: Debt discount, net (1) (93,778 ) (103,162 ) Net carrying amount $ 308,722 $ 299,338 _______________________________________ (1) Included in the accompanying condensed consolidated balance sheets within convertible senior notes (due 2023) and amortized to interest expense over the remaining life of the 2023 Notes using the effective interest rate method. |
Schedule of Interest Expense | The following table sets forth total interest expense recognized related to the 2023 Notes: Three Months Ended September 30, Nine Months Ended September 30, 2017 2016 2017 2016 (in thousands) (in thousands) Contractual interest expense $ 2,767 $ 2,777 $ 8,293 $ 3,381 Amortization of debt discount 3,205 2,923 9,384 3,650 Total $ 5,972 $ 5,700 $ 17,677 $ 7,031 Effective interest rate of the liability component 7.5 % 7.5 % 7.5 % 7.5 % The following table sets forth total interest expense recognized related to the 2017 Notes: Three Months Ended September 30, Nine Months Ended September 30, 2017 2016 2017 2016 (in thousands) (in thousands) Contractual interest expense $ — $ 189 $ 315 $ 1,912 Amortization of debt discount — 621 1,251 6,699 Total $ — $ 810 $ 1,566 $ 8,611 Effective interest rate of the liability component 6.02 % 6.02 % 6.02 % 6.02 % The following table sets forth total interest expense recognized related to the 2022 Notes: Three Months Ended September 30, Nine Months Ended September 30, 2017 2016 2017 2016 (in thousands) (in thousands) Contractual interest expense $ 2,500 $ 2,500 $ 7,500 $ 7,500 Amortization of debt discount 3,298 3,078 9,690 9,043 Total $ 5,798 $ 5,578 $ 17,190 $ 16,543 Effective interest rate of the liability component 6.5 % 6.5 % 6.5 % 6.5 % |
Accumulated Other Comprehensi31
Accumulated Other Comprehensive Loss (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Equity [Abstract] | |
Schedule of Accumulated Other Comprehensive Loss | The following tables provide a reconciliation of the components of accumulated other comprehensive loss , net of tax, attributable to The Medicines Company for the three and nine months ended September 30, 2017 and 2016 : Three Months Ended September 30, 2017 2016 Foreign currency translation adjustment Unrealized loss on available for sale securities Total Foreign currency translation adjustment Unrealized loss on available for sale securities Total (in thousands) Balance at beginning of period $ (5,439 ) $ (7 ) $ (5,446 ) $ (5,414 ) $ — $ (5,414 ) Other comprehensive loss before reclassifications 487 10 497 (70 ) — (70 ) Total other comprehensive loss 487 10 497 (70 ) — (70 ) Balance at end of period $ (4,952 ) $ 3 $ (4,949 ) $ (5,484 ) $ — $ (5,484 ) Nine Months Ended September 30, 2017 2016 Foreign currency translation adjustment Unrealized loss on available for sale securities Total Foreign currency translation adjustment Unrealized gain (loss) on available for sale securities Total (in thousands) Balance at beginning of period $ (5,479 ) $ — $ (5,479 ) $ 3,924 $ 49 $ 3,973 Other comprehensive income before reclassifications 527 3 530 208 — 208 Amounts reclassified from accumulated other comprehensive income (1) (2) — — — (9,616 ) (49 ) (9,665 ) Total other comprehensive (loss) income 527 3 530 (9,408 ) (49 ) (9,457 ) Balance at end of period $ (4,952 ) $ 3 $ (4,949 ) $ (5,484 ) $ — $ (5,484 ) _______________________________________ (1) Amounts were reclassified to other income in the accompanying condensed consolidated statements of operations. There is generally no tax impact related to foreign currency translation adjustments, as earnings are considered permanently reinvested. In addition, there were no material tax impacts related to unrealized gains or losses on available for sale securities in the periods presented. (2) See Note 16 , “Discontinued Operations,” for a discussion of this reclass of foreign currency translation adjustment. |
Segment and Geographic Inform32
Segment and Geographic Information (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Segment Reporting [Abstract] | |
Reconciliation of Revenue from Segments to Consolidated | The geographic segment information provided below is classified based on the major geographic regions in which the Company operates. Long-lived assets are comprised of the Company’s noncurrent assets. Three Months Ended September 30, Nine Months Ended September 30, 2017 2016 2017 2016 ($ in thousands) Net revenues: United States $ 15,460 91.6 % $ 35,662 94.8 % $ 55,062 92.0 % $ 133,273 93.3 % Europe 1,208 7.2 % 1,726 4.6 % 4,355 7.3 % 7,544 5.3 % Rest of world 203 1.2 % 211 0.6 % 412 0.7 % 1,819 1.4 % Total net revenues $ 16,871 100 % $ 37,599 100.0 % $ 59,829 100.0 % $ 142,636 100.0 % |
Reconciliation of Assets from Segment to Consolidated | September 30, 2017 December 31, 2016 ($ in thousands) Long-lived assets: United States $ 708,309 99.9 % $ 1,047,098 99.6 % Europe 833 0.1 % 4,160 0.4 % Total long-lived assets $ 709,142 100.0 % $ 1,051,258 100.0 % |
Restructuring (Tables)
Restructuring (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Restructuring and Related Activities [Abstract] | |
Restructuring Activity | The following table sets forth details regarding the activities described above during the nine months ended September 30, 2017 : Balance as of January 1, 2017 Expenses, Net Cash Noncash Balance as of September 30, 2017 (in thousands) Employee severance and other personnel benefits: $ — $ 5.9 $ (5.1 ) $ (0.1 ) $ 0.7 |
Dispositions (Tables)
Dispositions (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Discontinued Operations and Disposal Groups [Abstract] | |
Major Classes of Assets Sold and Gain Recognized | The following table presents the impact the discontinuation and market withdrawal of Ionsys had on the Company’s statement of operations for the nine months ended September 30, 2017 (amounts in thousands): Operating expenses: Cost of product revenue $ 8,458 Asset impairment charges 264,097 Research and development 1,032 Selling, general and administrative 3,331 Total operating expenses 276,918 Loss from operations (276,918 ) (Loss) income from continuing operations before income taxes (276,918 ) Benefit (provision) for income taxes — Net (loss) income from continuing operations $ (276,918 ) The following table presents the consideration received, major classes of assets sold and the gain recognized on the sale of the Non-Core ACC Products: (in thousands) Sale price: Cash $ 263,807 Contingent purchase price from sale of business 65,700 Total sale price 329,507 Assets: Inventory 2,184 Intangibles 5,210 Goodwill 33,812 Total assets sold 41,206 Gain on sale of business $ 288,301 The following table presents key financial results of the Hemostasis Business included in “ Income (loss) from discontinued operations, net of tax ” for the three and nine months ended September 30, 2016 : Three Months Ended Nine Months Ended September 30, 2016 2016 Net product revenues $ 28 $ 78 Operating expenses: Cost of product revenue (9 ) 1,695 Research and development (15 ) 104 Selling, general and administrative (44 ) 634 Total operating expenses (68 ) 2,433 Income (loss) from operations 96 (2,355 ) Gain from sale of business — 1,004 Other expense, net — (39 ) Income (loss) from discontinued operations before income taxes 96 (1,390 ) Benefit for income taxes — — Income (loss) from discontinued operations, net of tax $ 96 $ (1,390 ) |
Discontinued Operations (Tables
Discontinued Operations (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Discontinued Operations and Disposal Groups [Abstract] | |
Discontinued Operations | The following table presents the impact the discontinuation and market withdrawal of Ionsys had on the Company’s statement of operations for the nine months ended September 30, 2017 (amounts in thousands): Operating expenses: Cost of product revenue $ 8,458 Asset impairment charges 264,097 Research and development 1,032 Selling, general and administrative 3,331 Total operating expenses 276,918 Loss from operations (276,918 ) (Loss) income from continuing operations before income taxes (276,918 ) Benefit (provision) for income taxes — Net (loss) income from continuing operations $ (276,918 ) The following table presents the consideration received, major classes of assets sold and the gain recognized on the sale of the Non-Core ACC Products: (in thousands) Sale price: Cash $ 263,807 Contingent purchase price from sale of business 65,700 Total sale price 329,507 Assets: Inventory 2,184 Intangibles 5,210 Goodwill 33,812 Total assets sold 41,206 Gain on sale of business $ 288,301 The following table presents key financial results of the Hemostasis Business included in “ Income (loss) from discontinued operations, net of tax ” for the three and nine months ended September 30, 2016 : Three Months Ended Nine Months Ended September 30, 2016 2016 Net product revenues $ 28 $ 78 Operating expenses: Cost of product revenue (9 ) 1,695 Research and development (15 ) 104 Selling, general and administrative (44 ) 634 Total operating expenses (68 ) 2,433 Income (loss) from operations 96 (2,355 ) Gain from sale of business — 1,004 Other expense, net — (39 ) Income (loss) from discontinued operations before income taxes 96 (1,390 ) Benefit for income taxes — — Income (loss) from discontinued operations, net of tax $ 96 $ (1,390 ) |
Nature of Business (Details)
Nature of Business (Details) | Jun. 19, 2017USD ($)position | Jun. 21, 2016USD ($)product | Feb. 01, 2016USD ($) | Sep. 30, 2017USD ($) | Jun. 30, 2017USD ($) | Sep. 30, 2016USD ($) | Sep. 30, 2017USD ($) | Sep. 30, 2016USD ($) | Dec. 31, 2016USD ($) |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||||||
Proceeds from sale of businesses | $ 0 | $ 437,875,000 | |||||||
Contingent purchase price from sale of businesses | $ 143,700,000 | 143,700,000 | $ 143,700,000 | ||||||
Restructuring, Settlement and Impairment Provisions [Abstract] | |||||||||
Impairment charge | 0 | $ 0 | 329,097,000 | 0 | |||||
Severance and other exits costs | $ 5,800,000 | ||||||||
Long-lived assets | $ 709,142,000 | 709,142,000 | $ 1,051,258,000 | ||||||
Decrease in fair value of contingent consideration | 11,788,000 | $ (13,573,000) | |||||||
Discontinued operations, disposed of by sale | Hemostasis Business | |||||||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||||||
Proceeds from sale of businesses | $ 174,100,000 | ||||||||
Contingent purchase price from sale of businesses | $ 235,000,000 | ||||||||
Not discontinued operations, disposed of by sale | Non-Core ACC Products | |||||||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||||||
Proceeds from sale of businesses | $ 263,807,000 | ||||||||
Contingent purchase price from sale of businesses | $ 480,000,000 | ||||||||
Number of products sold | product | 3 | ||||||||
Payment for release of claims | $ 7,500,000 | ||||||||
Not discontinued operations, discontinuation and market withdrawal | Ionsys | |||||||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||||||
Number of positions eliminated | position | 57 | ||||||||
Percent of workforce eliminated | 15.00% | ||||||||
Restructuring, Settlement and Impairment Provisions [Abstract] | |||||||||
Impairment, severance and other employee costs | $ 276,900,000 | ||||||||
Impairment charge | 268,100,000 | ||||||||
Severance and other exits costs | 8,800,000 | ||||||||
Impairment of fixed assets | 11,400,000 | ||||||||
Long-lived assets | 0 | ||||||||
Not discontinued operations, discontinuation and market withdrawal | MDCO-700 | |||||||||
Restructuring, Settlement and Impairment Provisions [Abstract] | |||||||||
Decrease in fair value of contingent consideration | 14,700,000 | ||||||||
Contingent consideration, carrying value | 0 | ||||||||
Income tax benefit, disposition | 23,000,000 | $ 23,000,000 | |||||||
Not discontinued operations, discontinuation and market withdrawal | MDCO-700 | In-process research & development | |||||||||
Restructuring, Settlement and Impairment Provisions [Abstract] | |||||||||
Impairment of indefinite-lived intangible assets | $ 65,000,000 |
Nature of Business - Discontinu
Nature of Business - Discontinuation and Market Withdrawal (Details) - Ionsys - Not discontinued operations, discontinuation and market withdrawal $ in Thousands | 9 Months Ended |
Sep. 30, 2017USD ($) | |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |
Cost of product revenue | $ 8,458 |
Asset impairment charges | 264,097 |
Research and development | 1,032 |
Selling, general and administrative | 3,331 |
Total operating expenses | 276,918 |
Income (loss) from operations | (276,918) |
(Loss) income from continuing operations before income taxes | (276,918) |
Benefit (provision) for income taxes | 0 |
Net (loss) income from continuing operations | $ (276,918) |
Significant Accounting Polici38
Significant Accounting Policies (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | Dec. 31, 2016 | |
Debt Instrument [Line Items] | |||||
Accumulated deficit | $ 1,079,096 | $ 1,079,096 | $ 548,983 | ||
Cash and cash equivalents, and available for sale securities | 208,900 | 208,900 | |||
Reimbursement revenue | $ 4,400 | $ 3,400 | 8,300 | $ 11,900 | |
Accounting Standards Update 2016-09 | |||||
Debt Instrument [Line Items] | |||||
Excess tax benefits related to share-based compensation | $ 5,200 |
Stock Compensation Expense (Det
Stock Compensation Expense (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ||||
Recorded share-based compensation expense | $ 7.9 | $ 8.1 | $ 24.1 | $ 24.7 |
Total unrecognized compensation costs related to non-vested share-based compensation | $ 35.3 | $ 35.3 | ||
Period for recognition | 1 year 4 months 6 days | |||
Common stock issued during period for exercise of stock options, restricted stock grants, and purchases under ESPP (shares) | 1,754,744 | 1,322,091 | ||
Cash received from exercise of stock options and purchases through the ESPP | $ 40.7 | $ 27.4 |
(Loss) Earnings Per Share (Deta
(Loss) Earnings Per Share (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Earnings Per Share [Abstract] | ||||
Antidilutive shares excluded from computation of diluted loss per share (in shares) | 10,703,826 | 3,930,938 | 13,312,289 | 3,109,274 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2017 | Jun. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Income Tax Disclosure [Abstract] | |||||
Benefit (provision) for income taxes | $ 66,637 | $ (163) | $ 89,607 | $ (220) | |
Effective income tax rate | 68.83% | (0.20%) | 14.50% | 4.10% | |
Discrete tax benefit | $ 66,700 | $ 66,700 | |||
Not discontinued operations, discontinuation and market withdrawal | MDCO-700 | |||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||
Income tax benefit, disposition | $ 23,000 | $ 23,000 |
Cash and Cash Equivalents and42
Cash and Cash Equivalents and Available for Sale Securities - Additional Information (Details) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 | Sep. 30, 2016 | Dec. 31, 2015 |
Cash and Cash Equivalents [Line Items] | ||||
Cash and cash equivalents | $ 166,734 | $ 541,835 | $ 600,356 | $ 373,173 |
Cash | 152,000 | 485,700 | ||
Available for sale Securities | ||||
Fair value of available for sale securities | 42,168 | |||
Available for sale securities | 42,168 | 0 | ||
Restricted Cash | ||||
Restricted cash | 5,048 | 5,032 | ||
Restricted cash, letter of credit - foreign taxes | 3,700 | 3,700 | ||
Restricted cash, letter of credit - lease agreement | 1,000 | 1,000 | ||
Restricted cash, guaranteed investment certificate for collateralizing an available credit facility | 100 | 100 | ||
Restricted cash, foreign tender requirements | 200 | 200 | ||
Money market funds | ||||
Cash and Cash Equivalents [Line Items] | ||||
Cash equivalents | $ 14,700 | $ 56,100 |
Cash and Cash Equivalents and43
Cash and Cash Equivalents and Available for Sale Securities - Available for Sale Securities (Details) $ in Thousands | Sep. 30, 2017USD ($) |
Schedule of Available-for-sale Securities [Line Items] | |
Amortized Cost | $ 42,165 |
Fair Value | 42,168 |
Unrealized Gain | 3 |
Asset backed securities | |
Schedule of Available-for-sale Securities [Line Items] | |
Amortized Cost | 8,192 |
Fair Value | 8,192 |
Unrealized Gain | 0 |
Corporate debt securities | |
Schedule of Available-for-sale Securities [Line Items] | |
Amortized Cost | 33,973 |
Fair Value | 33,976 |
Unrealized Gain | $ 3 |
Fair Value Measurements - Asset
Fair Value Measurements - Assets and Liabilities Measured at Fair Value on Recurring Basis (Details) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Liabilities: | ||
Contingent purchase price | $ 34,183 | $ 82,289 |
Fair Value, Measurements, Recurring | ||
Assets: | ||
Cash equivalents | 14,686 | 56,097 |
Available for sale securities | 42,168 | 0 |
Total assets at fair value | 56,854 | 56,097 |
Liabilities: | ||
Contingent purchase price | 62,884 | 137,289 |
Total liabilities at fair value | 62,884 | 137,289 |
Fair Value, Measurements, Recurring | Quoted Prices In Active Markets for Identical Assets (Level 1) | ||
Assets: | ||
Cash equivalents | 14,686 | 56,097 |
Available for sale securities | 0 | 0 |
Total assets at fair value | 14,686 | 56,097 |
Liabilities: | ||
Contingent purchase price | 0 | 0 |
Total liabilities at fair value | 0 | 0 |
Fair Value, Measurements, Recurring | Significant Other Observable Inputs (Level 2) | ||
Assets: | ||
Cash equivalents | 0 | |
Available for sale securities | 42,168 | 0 |
Total assets at fair value | 42,168 | 0 |
Liabilities: | ||
Contingent purchase price | 0 | 0 |
Total liabilities at fair value | 0 | 0 |
Fair Value, Measurements, Recurring | Significant Unobservable Inputs (Level 3) | ||
Assets: | ||
Cash equivalents | 0 | 0 |
Available for sale securities | 0 | 0 |
Total assets at fair value | 0 | 0 |
Liabilities: | ||
Contingent purchase price | 62,884 | 137,289 |
Total liabilities at fair value | $ 62,884 | $ 137,289 |
Fair Value Measurements - Fair
Fair Value Measurements - Fair Value Inputs, Quantitative Information (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2017 | Dec. 31, 2016 | |
Fair Value Inputs, Assets, Quantitative Information [Line Items] | ||
Contingent purchase price | $ 34,183 | $ 82,289 |
Targanta | ||
Fair Value Inputs, Assets, Quantitative Information [Line Items] | ||
Contingent purchase price | $ 1,584 | $ 5,857 |
Targanta | Probability-adjusted discounted cash flow | ||
Fair Value Inputs, Assets, Quantitative Information [Line Items] | ||
Probability of success | 5.00% | 20.00% |
Discount rate | 11.00% | 11.00% |
Incline | ||
Fair Value Inputs, Assets, Quantitative Information [Line Items] | ||
Contingent purchase price | $ 1,269 | |
Incline | Probability-adjusted discounted cash flow | ||
Fair Value Inputs, Assets, Quantitative Information [Line Items] | ||
Discount rate | 18.00% | |
Incline | Minimum | Probability-adjusted discounted cash flow | ||
Fair Value Inputs, Assets, Quantitative Information [Line Items] | ||
Probability of success | 5.00% | |
Rempex | Event-based milestones | ||
Fair Value Inputs, Assets, Quantitative Information [Line Items] | ||
Contingent purchase price | $ 47,200 | $ 95,800 |
Rempex | Event-based milestones | Probability-adjusted discounted cash flow | ||
Fair Value Inputs, Assets, Quantitative Information [Line Items] | ||
Probability of success | 71.00% | 78.00% |
Rempex | Event-based milestones | Minimum | Probability-adjusted discounted cash flow | ||
Fair Value Inputs, Assets, Quantitative Information [Line Items] | ||
Probability of success | 18.00% | 18.00% |
Discount rate | 4.40% | 5.20% |
Rempex | Event-based milestones | Maximum | Probability-adjusted discounted cash flow | ||
Fair Value Inputs, Assets, Quantitative Information [Line Items] | ||
Probability of success | 90.00% | 95.00% |
Discount rate | 7.30% | 8.50% |
Rempex | Sales-based Milestones | ||
Fair Value Inputs, Assets, Quantitative Information [Line Items] | ||
Contingent purchase price | $ 14,100 | $ 20,300 |
Rempex | Sales-based Milestones | Risk-adjusted revenue simulation | ||
Fair Value Inputs, Assets, Quantitative Information [Line Items] | ||
Probability of success | 72.00% | 56.00% |
Rempex | Sales-based Milestones | Minimum | Risk-adjusted revenue simulation | ||
Fair Value Inputs, Assets, Quantitative Information [Line Items] | ||
Probability of success | 15.00% | 16.00% |
Discount rate | 5.50% | 6.60% |
Rempex | Sales-based Milestones | Maximum | Risk-adjusted revenue simulation | ||
Fair Value Inputs, Assets, Quantitative Information [Line Items] | ||
Probability of success | 85.00% | 65.00% |
Discount rate | 6.70% | 8.20% |
Annovation | ||
Fair Value Inputs, Assets, Quantitative Information [Line Items] | ||
Contingent purchase price | $ 14,063 | |
Annovation | Probability-adjusted discounted cash flow | ||
Fair Value Inputs, Assets, Quantitative Information [Line Items] | ||
Probability of success | 34.00% | |
Annovation | Minimum | Probability-adjusted discounted cash flow | ||
Fair Value Inputs, Assets, Quantitative Information [Line Items] | ||
Probability of success | 9.00% | |
Discount rate | 6.00% | |
Annovation | Maximum | Probability-adjusted discounted cash flow | ||
Fair Value Inputs, Assets, Quantitative Information [Line Items] | ||
Probability of success | 50.00% | |
Discount rate | 10.00% |
Fair Value Measurements - Level
Fair Value Measurements - Level 3 Contingent Purchase Price (Details) - Contingent Purchase Price Liability - Fair Value, Measurements, Recurring - Significant Unobservable Inputs (Level 3) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||||
Balance at beginning of period | $ 111,171 | $ 118,571 | $ 137,289 | $ 123,757 |
Payments | (40,616) | (1,564) | (62,618) | (8,811) |
Fair value adjustments to contingent purchase prices included in net loss | (7,672) | 12,403 | (11,788) | 14,464 |
Balance at end of period | $ 62,883 | $ 129,410 | $ 62,883 | $ 129,410 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Sep. 30, 2017 | Sep. 30, 2016 | |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||
Decrease in fair value of contingent consideration | $ 11,788,000 | $ (13,573,000) | |||
Ionsys and MDCO-700 | Not discontinued operations, discontinuation and market withdrawal | |||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||
Contingent consideration related to discontinued products | $ 175,800,000 | 175,800,000 | |||
MDCO-700 | Not discontinued operations, discontinuation and market withdrawal | |||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||
Contingent consideration, carrying value | $ 0 | ||||
Decrease in fair value of contingent consideration | $ 14,700,000 | ||||
Rempex | |||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||
Payment of contingent purchase price | 40,000,000 | $ 20,000,000 | |||
Contingent consideration, carrying value | 224,700,000 | 224,700,000 | |||
Targanta | |||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||
Contingent consideration, carrying value | 49,400,000 | 49,400,000 | |||
Incline and Annovation | Ionsys and MDCO-700 | Not discontinued operations, discontinuation and market withdrawal | |||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||
Contingent consideration related to discontinued products | 86,300,000 | 86,300,000 | |||
Series of Individually Immaterial Business Acquisitions | Ionsys and MDCO-700 | Not discontinued operations, discontinuation and market withdrawal | |||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||
Contingent consideration related to discontinued products | $ 89,500,000 | $ 89,500,000 |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 57,818 | $ 56,962 |
Work-in-progress | 4,615 | 12,033 |
Finished goods | 4,736 | 1,903 |
Total | $ 67,169 | $ 70,898 |
Intangible Assets and Goodwil49
Intangible Assets and Goodwill - Intangible Assets (Details) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Acquired Finite-Lived Intangible Assets [Line Items] | ||
Amortizable intangible assets, Gross Carrying Amount | $ 309,180 | $ 400,560 |
Amortizable intangible assets, Accumulated Amortization and Other Charges | (23,215) | (38,959) |
Amortizable intangible assets, Net Carrying Amount | 285,965 | 361,601 |
In-process research & development | 0 | 253,620 |
Intangible Assets, Gross Carrying Amount | 309,180 | 654,180 |
Intangible Assets, Net Carrying Amount | 285,965 | 615,221 |
In-process research & development | ||
Acquired Finite-Lived Intangible Assets [Line Items] | ||
In-process research & development | 0 | 253,620 |
Product licenses | ||
Acquired Finite-Lived Intangible Assets [Line Items] | ||
Amortizable intangible assets, Gross Carrying Amount | 0 | 30,000 |
Amortizable intangible assets, Accumulated Amortization and Other Charges | 0 | (3,013) |
Amortizable intangible assets, Net Carrying Amount | 0 | 26,987 |
Developed product rights | ||
Acquired Finite-Lived Intangible Assets [Line Items] | ||
Amortizable intangible assets, Gross Carrying Amount | 309,180 | 370,560 |
Amortizable intangible assets, Accumulated Amortization and Other Charges | (23,215) | (35,946) |
Amortizable intangible assets, Net Carrying Amount | $ 285,965 | $ 334,614 |
Intangible Assets and Goodwil50
Intangible Assets and Goodwill - Additional Information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2017 | Jun. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | Dec. 31, 2016 | |
Goodwill and Intangible Assets Disclosure [Abstract] | ||||||
Amortization of intangible assets | $ 3,100,000 | $ 6,500,000 | $ 11,600,000 | $ 19,300,000 | ||
Future amortization expense, remainder of fiscal year | 5,400,000 | 5,400,000 | ||||
Future amortization expense, 2018 | 21,400,000 | 21,400,000 | ||||
Future amortization expense, 2019 | 21,400,000 | 21,400,000 | ||||
Future amortization expense, 2020 | 21,400,000 | 21,400,000 | ||||
Future amortization expense, 2021 | 21,400,000 | 21,400,000 | ||||
Future amortization expense, 2022 | 21,400,000 | 21,400,000 | ||||
Future amortization expense, thereafter | 173,600,000 | 173,600,000 | ||||
Finite-Lived Intangible Assets [Line Items] | ||||||
Finite-lived intangible assets, net | 285,965,000 | 285,965,000 | $ 361,601,000 | |||
Indefinite-lived intangible assets | 0 | 0 | 253,620,000 | |||
Increase (decrease) in carrying amount of goodwill | 0 | |||||
In-process research & development | ||||||
Finite-Lived Intangible Assets [Line Items] | ||||||
Reclassification of IPR&D assets | (188,600,000) | |||||
Indefinite-lived intangible assets | 0 | 0 | 253,620,000 | |||
Developed product rights, net | ||||||
Finite-Lived Intangible Assets [Line Items] | ||||||
Finite-lived intangible assets, net | 285,965,000 | 285,965,000 | 334,614,000 | |||
Product licenses, net | ||||||
Finite-Lived Intangible Assets [Line Items] | ||||||
Finite-lived intangible assets, net | $ 0 | $ 0 | $ 26,987,000 | |||
Not discontinued operations, discontinuation and market withdrawal | Ionsys | Developed product rights, net | ||||||
Finite-Lived Intangible Assets [Line Items] | ||||||
Impairment of finite-lived intangible assets | $ 226,500,000 | |||||
Not discontinued operations, discontinuation and market withdrawal | Ionsys | Product licenses, net | ||||||
Finite-Lived Intangible Assets [Line Items] | ||||||
Impairment of finite-lived intangible assets | 26,200,000 | |||||
Not discontinued operations, discontinuation and market withdrawal | MDCO-700 | In-process research & development | ||||||
Finite-Lived Intangible Assets [Line Items] | ||||||
Impairment of indefinite-lived intangible assets | 65,000,000 | |||||
Indefinite-lived intangible assets | 0 | |||||
Not discontinued operations, discontinuation and market withdrawal | MDCO-700 | Product licenses, net | ||||||
Finite-Lived Intangible Assets [Line Items] | ||||||
Finite-lived intangible assets, net | $ 0 |
Convertible Senior Notes - Due
Convertible Senior Notes - Due 2023 (Details) | Jun. 30, 2017$ / shares | Jun. 30, 2016USD ($)day$ / shares | Sep. 30, 2017USD ($) | Sep. 30, 2016USD ($) | Sep. 30, 2017USD ($) | Sep. 30, 2016USD ($) | Dec. 31, 2016USD ($) |
Interest expense | |||||||
Amortization of debt discount | $ 20,325,000 | $ 19,392,000 | |||||
Convertible Senior Notes Due 2023 | Senior Notes | |||||||
Debt Instrument [Line Items] | |||||||
Principal | $ 402,500,000 | $ 402,500,000 | 402,500,000 | $ 402,500,000 | |||
Interest rate | 2.75% | ||||||
Proceeds from offering | $ 390,800,000 | ||||||
Trading days | day | 20 | ||||||
Redemption consecutive trading period | 30 days | ||||||
Redemption stock price conversion threshold (greater than or equal to) | 130.00% | ||||||
Consecutive measurement period | 5 days | ||||||
Percent of trading price (less than) | 98.00% | ||||||
Consecutive trading days | day | 50 | ||||||
Conversion ratio | 0.0204198 | ||||||
Conversion price (USD per share) | $ / shares | $ 48.97 | ||||||
Redemption trading period | 19 days | ||||||
Percent of principal amount plus accrued and unpaid interest | 100.00% | ||||||
Debt default principal amount percentage | 25.00% | ||||||
Debt instrument, term | 7 years | ||||||
Carrying amount, equity component | $ 101,000,000 | ||||||
Net deferred tax liabilities | 33,500,000 | ||||||
Liability component | |||||||
Principal | 402,500,000 | 402,500,000 | 402,500,000 | 402,500,000 | |||
Less: Debt discount, net | (93,778,000) | (93,778,000) | (103,162,000) | ||||
Net carrying amount | 308,722,000 | $ 308,722,000 | $ 299,338,000 | ||||
Remaining contractual life | 5 years 9 months 18 days | ||||||
Interest expense | |||||||
Contractual interest expense | 2,767,000 | $ 2,777,000 | $ 8,293,000 | 3,381,000 | |||
Amortization of debt discount | 3,205,000 | 2,923,000 | 9,384,000 | 3,650,000 | |||
Total | $ 5,972,000 | $ 5,700,000 | $ 17,677,000 | $ 7,031,000 | |||
Effective interest rate of the liability component | 7.50% | 7.50% | 7.50% | 7.50% | |||
Convertible Senior Notes Due 2023 | Senior Notes | Call Option | |||||||
Interest expense | |||||||
Payment of cost of capped call transactions | $ 33,900,000 | ||||||
Cap price (USD per share) | $ / shares | $ 64.68 | ||||||
Convertible Senior Notes Due 2023 | Senior Notes | Significant Other Observable Inputs (Level 2) | |||||||
Liability component | |||||||
Fair value of Notes | $ 424,300,000 | $ 424,300,000 |
Convertible Senior Notes - Du52
Convertible Senior Notes - Due 2022 (Details) | Mar. 31, 2015USD ($)day$ / shares | Sep. 30, 2017USD ($) | Sep. 30, 2016USD ($) | Sep. 30, 2017USD ($) | Sep. 30, 2016USD ($) | Dec. 31, 2016USD ($) |
Interest expense | ||||||
Amortization of debt discount | $ 20,325,000 | $ 19,392,000 | ||||
Senior Notes | Convertible Senior Notes Due 2022 | ||||||
Debt Instrument [Line Items] | ||||||
Interest rate | 2.50% | |||||
Proceeds from offering | $ 387,200,000 | |||||
Trading days | day | 20 | |||||
Redemption consecutive trading period | 30 days | |||||
Redemption stock price conversion threshold (greater than or equal to) | 130.00% | |||||
Consecutive measurement period | 5 days | |||||
Percent of trading price (less than) | 98.00% | |||||
Conversion ratio | 0.0298806 | |||||
Conversion price (USD per share) | $ / shares | $ 33.47 | |||||
Redemption trading period | 19 days | |||||
Percent of principal amount plus accrued and unpaid interest | 100.00% | |||||
Debt default principal amount percentage | 25.00% | |||||
Debt instrument, term | 7 years | |||||
Carrying amount, equity component | $ 88,900,000 | |||||
Net deferred tax liabilities | $ 31,800,000 | |||||
Liability component | ||||||
Principal | $ 399,997,000 | $ 399,997,000 | $ 400,000,000 | |||
Less: Debt discount, net | (66,064,000) | (66,064,000) | (75,754,000) | |||
Net carrying amount | 333,933,000 | $ 333,933,000 | $ 324,246,000 | |||
Remaining contractual life | 4 years 3 months 18 days | |||||
Interest expense | ||||||
Contractual interest expense | 2,500,000 | $ 2,500,000 | $ 7,500,000 | 7,500,000 | ||
Amortization of debt discount | 3,298,000 | 3,078,000 | 9,690,000 | 9,043,000 | ||
Total | $ 5,798,000 | $ 5,578,000 | $ 17,190,000 | $ 16,543,000 | ||
Effective interest rate of the liability component | 6.50% | 6.50% | 6.50% | 6.50% | ||
Senior Notes | Convertible Senior Notes Due 2022 | Significant Other Observable Inputs (Level 2) | ||||||
Liability component | ||||||
Fair value of Notes | $ 504,700,000 | $ 504,700,000 |
Convertible Senior Notes - Du53
Convertible Senior Notes - Due 2017 (Details) | Jun. 01, 2017USD ($)shares | Jun. 30, 2016USD ($) | Jun. 30, 2012USD ($)$ / shares | Sep. 30, 2017USD ($) | Sep. 30, 2016USD ($) | Jun. 30, 2016USD ($) | Sep. 30, 2017USD ($) | Sep. 30, 2016USD ($) | Dec. 31, 2016USD ($) |
Debt Instrument [Line Items] | |||||||||
Repayments of convertible senior notes | $ 55,000,000 | $ 323,225,000 | |||||||
Extinguishment of debt | $ 0 | $ 0 | 0 | 5,380,000 | |||||
Interest expense | |||||||||
Amortization of debt discount | 20,325,000 | 19,392,000 | |||||||
Senior Notes | Convertible Senior Notes Due 2017 | |||||||||
Debt Instrument [Line Items] | |||||||||
Principal | $ 275,000,000 | 0 | 0 | $ 55,000,000 | |||||
Interest rate | 1.375% | ||||||||
Proceeds from offering | $ 266,200,000 | ||||||||
Conversion ratio | 0.0358038 | ||||||||
Conversion price (USD per share) | $ / shares | $ 27.93 | ||||||||
Repayments of convertible senior notes | $ 55,400,000 | $ 323,200,000 | |||||||
Debt, aggregate principal amount repurchased | 220,000,000 | $ 220,000,000 | |||||||
Cash receipt for settlement of outstanding bond hedges and warrants | $ 12,600,000 | ||||||||
Extinguishment of debt | 5,400,000 | ||||||||
Reduction of additional paid-in capital for difference between consideration transferred and fair value of liability component | $ 108,700,000 | ||||||||
Issuance of stock upon note conversion (in shares) | shares | 819,901 | ||||||||
Liability component | |||||||||
Principal | $ 275,000,000 | 0 | 0 | 55,000,000 | |||||
Less: Debt discount, net | 0 | 0 | (1,251,000) | ||||||
Net carrying amount | 0 | 0 | $ 53,749,000 | ||||||
Interest expense | |||||||||
Contractual interest expense | 0 | 189,000 | 315,000 | 1,912,000 | |||||
Amortization of debt discount | 0 | 621,000 | 1,251,000 | 6,699,000 | |||||
Total | $ 0 | $ 810,000 | $ 1,566,000 | $ 8,611,000 | |||||
Effective interest rate of the liability component | 6.02% | 6.02% | 6.02% | 6.02% |
Convertible Senior Notes - Note
Convertible Senior Notes - Note Hedges (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | Jun. 01, 2017 | Jun. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | Jun. 30, 2012 |
Debt Instrument [Line Items] | |||||
Proceeds from settlement of bond hedges related to convertible senior notes | $ 0 | $ 100,459 | |||
Senior Notes | Convertible Senior Notes Due 2017 | |||||
Debt Instrument [Line Items] | |||||
Debt, aggregate principal amount repurchased | $ 220,000 | ||||
Proceeds from settlement of bond hedges related to convertible senior notes | $ 100,500 | ||||
Interest Rate Contract | |||||
Debt Instrument [Line Items] | |||||
Aggregate amount of hedge | $ 58,200 | ||||
Common stock exercisable upon conversion (in shares) | 2,000 | ||||
Common stock received upon settlement (in shares) | 820 | ||||
Weighted average price of common stock received upon settlement (in dollars per share) | $ 48.79 |
Convertible Senior Notes - Warr
Convertible Senior Notes - Warrants (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2012 | Sep. 30, 2017 | Sep. 30, 2017 | Sep. 30, 2016 | |
Debt Instrument [Line Items] | |||||
Settlement of warrants | $ 0 | $ 87,874 | |||
Senior Notes | Convertible Senior Notes Due 2017 | |||||
Debt Instrument [Line Items] | |||||
Debt, aggregate principal amount repurchased | $ 220,000 | ||||
2017 Warrants | |||||
Debt Instrument [Line Items] | |||||
Proceeds from sale of warrants | $ 38,400 | ||||
Settlement of warrants | $ 87,900 | ||||
Common stock exercisable upon conversion (in shares) | 2,000,000 | ||||
Exercise price of warrants (in dollars per share) | $ 34.20 | ||||
Warrants exercised (in shares) | 443,070 | ||||
Common stock, shares, issued (in shares) | 24,217 | ||||
Warrants outstanding (in shares) | 1,427,679 | 1,427,679 |
Accumulated Other Comprehensi56
Accumulated Other Comprehensive Loss (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Accumulated Other Comprehensive Loss [Roll Forward] | ||||
Balance at beginning of period | $ 651,983,000 | |||
Other comprehensive income before reclassifications | $ 497,000 | $ (70,000) | 530,000 | $ 208,000 |
Amounts reclassified from accumulated other comprehensive income | 0 | (9,665,000) | ||
Other comprehensive income (loss) | 497,000 | (70,000) | 530,000 | (9,457,000) |
Balance at end of period | 188,055,000 | 188,055,000 | ||
Unrealized gains and losses on available-for-sale securities, tax impact | 0 | 0 | ||
AOCI Including Portion Attributable to Noncontrolling Interest [Member] | ||||
Accumulated Other Comprehensive Loss [Roll Forward] | ||||
Balance at beginning of period | (5,446,000) | (5,414,000) | (5,479,000) | 3,973,000 |
Balance at end of period | (4,949,000) | (5,484,000) | (4,949,000) | (5,484,000) |
Foreign currency translation adjustment | ||||
Accumulated Other Comprehensive Loss [Roll Forward] | ||||
Balance at beginning of period | (5,439,000) | (5,414,000) | (5,479,000) | 3,924,000 |
Other comprehensive income before reclassifications | 487,000 | (70,000) | 527,000 | 208,000 |
Amounts reclassified from accumulated other comprehensive income | 0 | (9,616,000) | ||
Other comprehensive income (loss) | 487,000 | (70,000) | 527,000 | (9,408,000) |
Balance at end of period | (4,952,000) | (5,484,000) | (4,952,000) | (5,484,000) |
Unrealized gain (loss) on available for sale securities | ||||
Accumulated Other Comprehensive Loss [Roll Forward] | ||||
Balance at beginning of period | (7,000) | 0 | 0 | 49,000 |
Other comprehensive income before reclassifications | 10,000 | 0 | 3,000 | 0 |
Amounts reclassified from accumulated other comprehensive income | 0 | (49,000) | ||
Other comprehensive income (loss) | 10,000 | 0 | 3,000 | (49,000) |
Balance at end of period | $ 3,000 | $ 0 | $ 3,000 | $ 0 |
Segment and Geographic Inform57
Segment and Geographic Information (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2017USD ($) | Sep. 30, 2016USD ($) | Sep. 30, 2017USD ($)segment | Sep. 30, 2016USD ($) | Dec. 31, 2016USD ($) | |
Revenues from External Customers and Long-Lived Assets [Line Items] | |||||
Number of operating segments | segment | 1 | ||||
Net revenue | $ 16,871 | $ 37,599 | $ 59,829 | $ 142,636 | |
Percentage of revenue by geographic segments | 100.00% | 100.00% | 100.00% | 100.00% | |
Long-lived assets | $ 709,142 | $ 709,142 | $ 1,051,258 | ||
Percentage of long-lived assets by geographic segments | 100.00% | 100.00% | 100.00% | ||
United States | |||||
Revenues from External Customers and Long-Lived Assets [Line Items] | |||||
Net revenue | $ 15,460 | $ 35,662 | $ 55,062 | $ 133,273 | |
Percentage of revenue by geographic segments | 91.60% | 94.80% | 92.00% | 93.30% | |
Long-lived assets | $ 708,309 | $ 708,309 | $ 1,047,098 | ||
Percentage of long-lived assets by geographic segments | 99.90% | 99.90% | 99.60% | ||
Europe | |||||
Revenues from External Customers and Long-Lived Assets [Line Items] | |||||
Net revenue | $ 1,208 | $ 1,726 | $ 4,355 | $ 7,544 | |
Percentage of revenue by geographic segments | 7.20% | 4.60% | 7.30% | 5.30% | |
Long-lived assets | $ 833 | $ 833 | $ 4,160 | ||
Percentage of long-lived assets by geographic segments | 0.10% | 0.10% | 0.40% | ||
Rest of world | |||||
Revenues from External Customers and Long-Lived Assets [Line Items] | |||||
Net revenue | $ 203 | $ 211 | $ 412 | $ 1,819 | |
Percentage of revenue by geographic segments | 1.20% | 0.60% | 0.70% | 1.40% |
Restructuring (Details)
Restructuring (Details) $ in Thousands | Jun. 19, 2017USD ($)position | Sep. 30, 2017USD ($) | Jun. 30, 2017USD ($) | Sep. 30, 2016USD ($) | Sep. 30, 2017USD ($) | Sep. 30, 2016USD ($) |
Restructuring, Settlement and Impairment Provisions [Abstract] | ||||||
Impairment charge | $ 0 | $ 0 | $ 329,097 | $ 0 | ||
Severance and other exits costs | $ 5,800 | |||||
Other exit costs | $ 3,000 | |||||
Restructuring Reserve [Roll Forward] | ||||||
Balance | 0 | |||||
Expenses, Net | 5,900 | |||||
Cash | (5,100) | |||||
Noncash | (100) | |||||
Balance | $ 700 | $ 700 | ||||
Ionsys | Not discontinued operations, discontinuation and market withdrawal | ||||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||||
Number of positions eliminated | position | 57 | |||||
Percent of workforce eliminated | 15.00% | |||||
Restructuring, Settlement and Impairment Provisions [Abstract] | ||||||
Impairment, severance and other employee costs | $ 276,900 | |||||
Impairment charge | 268,100 | |||||
Severance and other exits costs | $ 8,800 |
Dispositions - Major Classes of
Dispositions - Major Classes of Assets Sold and Gain Recognized (Details) - USD ($) $ in Thousands | Jun. 21, 2016 | Sep. 30, 2017 | Sep. 30, 2016 |
Sale price: | |||
Cash | $ 0 | $ 437,875 | |
Non-Core ACC Products | Not discontinued operations, disposed of by sale | |||
Sale price: | |||
Cash | $ 263,807 | ||
Contingent purchase price from sale of business | 65,700 | ||
Total sale price | 329,507 | ||
Assets: | |||
Inventory | 2,184 | ||
Intangibles | 5,210 | ||
Goodwill | 33,812 | ||
Total assets sold | 41,206 | ||
Gain on sale of business | $ 288,301 |
Dispositions - Additional Infor
Dispositions - Additional Information (Details) - USD ($) $ in Thousands | Jun. 21, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | Dec. 31, 2016 |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||||
Proceeds from sale of businesses | $ 0 | $ 437,875 | ||||
Potential contingent proceeds from sale | $ 143,700 | 143,700 | $ 143,700 | |||
Gain on sale of assets | $ 0 | $ 0 | $ 0 | $ 288,301 | ||
Non-Core ACC Products | Not discontinued operations, disposed of by sale | ||||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||||
Proceeds from sale of businesses | $ 263,807 | |||||
Potential contingent proceeds from sale | $ 480,000 | |||||
Gain on sale of assets | $ 288,300 | |||||
Disposition related costs | $ 7,900 |
Discontinued Operations - Key F
Discontinued Operations - Key Financial Results and Assets and Liabilities Held for Sale (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Disposal Group, Including Discontinued Operation, Income Statement Disclosures [Abstract] | ||||
Income (loss) from discontinued operations, net of tax | $ 0 | $ 96 | $ 0 | $ (1,390) |
Hemostasis Business | Discontinued operations, disposed of by sale | ||||
Disposal Group, Including Discontinued Operation, Income Statement Disclosures [Abstract] | ||||
Net product revenues | 28 | 78 | ||
Cost of product revenue | (9) | 1,695 | ||
Research and development | (15) | 104 | ||
Selling, general and administrative | (44) | 634 | ||
Total operating expenses | (68) | 2,433 | ||
Income (loss) from operations | 96 | (2,355) | ||
Gain from sale of business | 0 | 1,004 | ||
Other expense, net | 0 | (39) | ||
Income (loss) from discontinued operations before income taxes | 96 | (1,390) | ||
Benefit for income taxes | 0 | 0 | ||
Income (loss) from discontinued operations, net of tax | $ 96 | $ (1,390) |
Discontinued Operations - Addit
Discontinued Operations - Additional Information (Details) - USD ($) $ in Thousands | Feb. 01, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | Dec. 31, 2015 | Dec. 31, 2016 |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||
Proceeds from sale of businesses | $ 0 | $ 437,875 | |||
Contingent purchase price from sale of businesses | 143,700 | $ 143,700 | |||
Amounts reclassified from accumulated other comprehensive income | 0 | 9,665 | |||
Foreign currency translation adjustment | |||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||
Amounts reclassified from accumulated other comprehensive income | $ 0 | 9,616 | |||
Foreign currency translation adjustment | Impairment charges | |||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||
Amounts reclassified from accumulated other comprehensive income | $ 8,400 | ||||
Foreign currency translation adjustment | Gain from sale of business | |||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||
Amounts reclassified from accumulated other comprehensive income | $ 1,200 | ||||
Hemostasis Business | Discontinued operations, disposed of by sale | |||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||
Proceeds from sale of businesses | $ 174,100 | ||||
Contingent purchase price from sale of businesses | 235,000 | ||||
Hemostasis Business | Discontinued operations, disposed of by sale | Foreign currency translation adjustment | |||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||
Amounts reclassified from accumulated other comprehensive income | $ 9,600 |
Subsequent Events (Details)
Subsequent Events (Details) - Subsequent events $ in Millions | Oct. 25, 2017USD ($)Employee |
Subsequent Event [Line Items] | |
Number of personnel after restructuring (employees) | Employee | 60 |
Minimum | |
Subsequent Event [Line Items] | |
Workforce reductions, expected cost | $ 13 |
Maximum | |
Subsequent Event [Line Items] | |
Workforce reductions, expected cost | $ 18 |