Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Feb. 25, 2019 | Jun. 29, 2018 | |
Document and Entity Information | |||
Entity Registrant Name | AMAG PHARMACEUTICALS INC. | ||
Entity Central Index Key | 792,977 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Filer Category | Large Accelerated Filer | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2018 | ||
Document Fiscal Year Focus | 2,018 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Emerging Growth Company | false | ||
Entity Small Business | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 664.2 | ||
Entity Common Stock, Shares Outstanding | 34,713,130 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash and cash equivalents | $ 253,256 | $ 162,855 |
Marketable securities | 140,915 | 136,593 |
Accounts receivable, net | 75,347 | 91,460 |
Inventories | 26,691 | 34,443 |
Prepaid and other current assets | 18,961 | 11,009 |
Note receivable | 10,000 | 0 |
Assets held for sale | 0 | 45,508 |
Total current assets | 525,170 | 481,868 |
Property and equipment, net | 7,521 | 7,904 |
Goodwill | 422,513 | 422,513 |
Intangible assets, net | 217,033 | 375,479 |
Deferred tax assets | 1,260 | 47,120 |
Restricted cash | 495 | 495 |
Other long-term assets | 1,467 | 266 |
Assets held for sale, net of current portion | 0 | 564,711 |
Total assets | 1,175,459 | 1,900,356 |
Current liabilities: | ||
Accounts payable | 14,487 | 7,717 |
Accrued expenses | 129,537 | 166,732 |
Current portion of convertible notes, net | 21,276 | 0 |
Current portion of acquisition-related contingent consideration | 144 | 49,399 |
Liabilities held for sale | 0 | 53,870 |
Total current liabilities | 165,444 | 277,718 |
Long-term liabilities: | ||
Long-term debt, net | 0 | 466,291 |
Convertible notes, net | 261,933 | 268,392 |
Acquisition-related contingent consideration | 215 | 686 |
Other long-term liabilities | 1,212 | 1,204 |
Liabilities held for sale, net of current portion | 0 | 95,821 |
Total liabilities | 428,804 | 1,110,112 |
Commitments and Contingencies (Note P) | ||
Stockholders’ equity: | ||
Preferred stock, par value $0.01 per share, 2,000,000 shares authorized; none issued | 0 | 0 |
Common stock, par value $0.01 per share, 117,500,000 shares authorized; 34,606,760 and 34,083,112 shares issued and outstanding at December 31, 2018 and December 31, 2017, respectively | 346 | 341 |
Additional paid-in capital | 1,292,736 | 1,271,628 |
Accumulated other comprehensive loss | (3,985) | (3,908) |
Accumulated deficit | (542,442) | (477,817) |
Total stockholders’ equity | 746,655 | 790,244 |
Total liabilities and stockholders’ equity | $ 1,175,459 | $ 1,900,356 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2018 | Dec. 31, 2017 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 2,000,000 | 2,000,000 |
Preferred stock, shares issued | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 117,500,000 | 117,500,000 |
Common stock, shares issued | 34,606,760 | 34,083,112 |
Common stock, shares outstanding | 34,606,760 | 34,083,112 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Revenues: | |||
Revenues | $ 474,002 | $ 495,769 | $ 432,487 |
Costs and expenses: | |||
Cost of product sales | 215,892 | 161,349 | 96,314 |
Research and development expenses | 44,846 | 75,017 | 65,561 |
Acquired in-process research and development | 32,500 | 65,845 | 0 |
Selling, general and administrative expenses | 227,810 | 178,151 | 169,468 |
Impairment of intangible assets | 0 | 319,246 | 15,724 |
Restructuring expenses | 0 | 0 | 341 |
Total costs and expenses | 521,048 | 799,608 | 347,408 |
Operating (loss) income | (47,046) | (303,839) | 85,079 |
Other income (expense): | |||
Interest expense | (51,971) | (68,382) | (73,153) |
Loss on debt extinguishment | (35,922) | (10,926) | 0 |
Interest and dividend income | 5,328 | 2,810 | 3,149 |
Other (expense) income | (74) | (70) | 189 |
Total other expense, net | (82,639) | (76,568) | (69,815) |
(Loss) income from continuing operations before income taxes | (129,685) | (380,407) | 15,264 |
Income tax expense (benefit) | 39,654 | (175,254) | 13,171 |
Net (loss) income from continuing operations | (169,339) | (205,153) | 2,093 |
Discontinued operations: | |||
Income (loss) from discontinued operations | 18,873 | 10,313 | (6,209) |
Gain on sale of CBR business | 87,076 | 0 | 0 |
Income tax expense (benefit) | 2,371 | 4,388 | (1,633) |
Net income (loss) from discontinued operations | 103,578 | 5,925 | (4,576) |
Net loss | $ (65,761) | $ (199,228) | $ (2,483) |
Basic net (loss) income per share: | |||
(Loss) income from continuing operations (in dollars per share) | $ (4.92) | $ (5.88) | $ 0.06 |
Income (loss) from discontinued operations (in dollars per share) | 3.01 | 0.17 | (0.13) |
Total (in dollars per share) | (1.91) | (5.71) | (0.07) |
Diluted net (loss) income per share: | |||
(Loss) income from continuing operations (in dollars per share) | (4.92) | (5.88) | 0.06 |
Income (loss) from discontinued operations (in dollars per share) | 3.01 | 0.17 | (0.13) |
Total (in dollars per share) | $ (1.91) | $ (5.71) | $ (0.07) |
Weighted average shares outstanding used to compute net (loss) income per share: | |||
Basic (in shares) | 34,394 | 34,907 | 34,346 |
Diluted (in shares) | 34,394 | 34,907 | 34,833 |
Product | |||
Revenues: | |||
Revenues | $ 473,852 | $ 495,645 | $ 432,170 |
Product and Service, Other | |||
Revenues: | |||
Revenues | $ 150 | $ 124 | $ 317 |
CONSOLIDATED STATEMENTS OF COMP
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Statement of Comprehensive Income [Abstract] | |||
Net loss | $ (65,761) | $ (199,228) | $ (2,483) |
Unrealized (losses) gains on marketable securities: | |||
Holding (losses) gains arising during period, net of tax | (77) | (70) | 261 |
Reclassification adjustment for gains (losses) included in net (loss) income, net of tax | 0 | 0 | 106 |
Net unrealized (losses) gains on securities | (77) | (70) | 367 |
Total comprehensive loss | $ (65,838) | $ (199,298) | $ (2,116) |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2015 | 34,733,117 | ||||
Beginning balance at Dec. 31, 2015 | $ 932,264 | $ 347 | $ 1,233,786 | $ (4,205) | $ (297,664) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock under employee stock purchase plan (in shares) | 79,324 | ||||
Issuance of common stock under employee stock purchase plan | 1,468 | $ 1 | 1,467 | ||
Net shares issued in connection with the exercise of stock options and vesting of restricted stock units, net of withholdings (in shares) | 355,450 | ||||
Net shares issued in connection with the exercise of stock options and vesting of restricted stock units, net of withholdings | 230 | $ 3 | 227 | ||
Repurchase of common stock pursuant to the 2016 share repurchase program (in shares) | (831,744) | ||||
Repurchase of common stock pursuant to the 2016 share repurchase program | (20,000) | $ (8) | (19,992) | ||
Non-cash equity-based compensation | 22,543 | 22,543 | |||
Unrealized losses on securities, net of tax | 367 | 367 | |||
Net loss | (2,483) | (2,483) | |||
Ending balance (in shares) at Dec. 31, 2016 | 34,336,147 | ||||
Ending balance at Dec. 31, 2016 | 934,389 | $ 343 | 1,238,031 | (3,838) | (300,147) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Settlement of warrants | 323 | 323 | |||
Equity component of the 2022 Convertible Notes, net of issuance costs and taxes | 43,236 | 43,236 | |||
Equity component of debt repurchase | (27,988) | (27,988) | |||
Shares issued in connection with Endoceutics License Agreement (in shares) | 600,000 | ||||
Shares issued in connection with Endoceutics License Agreement | $ 13,500 | $ 6 | 13,494 | ||
Repurchase and retirement of common stock pursuant to the 2016 Share Repurchase Program (in shares) | (1,366,266) | (1,366,266) | |||
Repurchase and retirement of common stock pursuant to the 2016 Share Repurchase Program | $ (19,467) | $ (14) | (19,453) | ||
Issuance of common stock under employee stock purchase plan (in shares) | 120,580 | ||||
Issuance of common stock under employee stock purchase plan | 1,594 | $ 1 | 1,593 | ||
Net shares issued in connection with the exercise of stock options and vesting of restricted stock units, net of withholdings (in shares) | 392,651 | ||||
Net shares issued in connection with the exercise of stock options and vesting of restricted stock units, net of withholdings | (1,267) | $ 5 | (1,272) | ||
Non-cash equity-based compensation | 23,664 | 23,664 | |||
Unrealized losses on securities, net of tax | (70) | (70) | |||
Net loss | $ (199,228) | (199,228) | |||
Ending balance (in shares) at Dec. 31, 2017 | 34,083,112 | 34,083,112 | |||
Ending balance at Dec. 31, 2017 | $ 790,244 | $ 341 | 1,271,628 | (3,908) | (477,817) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock under employee stock purchase plan (in shares) | 59,872 | ||||
Issuance of common stock under employee stock purchase plan | 918 | $ 1 | 917 | ||
Net shares issued in connection with the exercise of stock options and vesting of restricted stock units, net of withholdings (in shares) | 463,776 | ||||
Net shares issued in connection with the exercise of stock options and vesting of restricted stock units, net of withholdings | 279 | $ 4 | 275 | ||
Non-cash equity-based compensation | 19,916 | 19,916 | |||
Unrealized losses on securities, net of tax | (77) | (77) | |||
Net loss | $ (65,761) | (65,761) | |||
Ending balance (in shares) at Dec. 31, 2018 | 34,606,760 | 34,606,760 | |||
Ending balance at Dec. 31, 2018 | $ 746,655 | $ 346 | $ 1,292,736 | $ (3,985) | $ (542,442) |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Cash flows from operating activities: | |||
Net loss | $ (65,761) | $ (199,228) | $ (2,483) |
Adjustments to reconcile net loss to net cash provided by operating activities: | |||
Depreciation and amortization | 172,223 | 155,538 | 99,886 |
Impairment of intangible assets | 0 | 319,246 | 19,663 |
Provision for bad debt expense | 678 | 3,852 | 3,209 |
Amortization of premium/discount on purchased securities | 87 | 302 | 624 |
(Gain) loss on disposal of fixed assets | (99) | 265 | 0 |
Non-cash equity-based compensation expense | 19,916 | 23,664 | 22,543 |
Non-cash IPR&D expense | 0 | 945 | 0 |
Loss on debt extinguishment | 35,922 | 10,926 | 0 |
Amortization of debt discount and debt issuance costs | 15,658 | 14,395 | 12,105 |
(Gain) loss on sale of investments, net | (1) | 70 | 38 |
Change in fair value of contingent consideration | (49,607) | (47,686) | 25,683 |
Deferred income taxes | 41,166 | (178,421) | 7,279 |
Gain on sale of the CBR business | (87,076) | 0 | 0 |
Transaction costs | (14,111) | 0 | 0 |
Changes in operating assets and liabilities: | |||
Accounts receivable, net | 16,995 | (14,978) | (9,906) |
Inventories | 4,722 | (2,331) | (2,355) |
Receivable from collaboration | 0 | 0 | 428 |
Prepaid and other current assets | (6,097) | (2,222) | 4,095 |
Accounts payable and accrued expenses | (32,568) | 16,834 | 49,037 |
Deferred revenues | 8,658 | 17,080 | 24,522 |
Payment of contingent consideration in excess of acquisition date fair value | 0 | (10,432) | (8,116) |
Other assets and liabilities | 95 | (1,223) | (30) |
Net cash provided by operating activities | 60,800 | 106,596 | 246,222 |
Cash flows from investing activities: | |||
Proceeds from sales or maturities of marketable securities | 85,342 | 294,957 | 127,479 |
Purchase of marketable securities | (89,956) | (127,249) | (194,723) |
Acquisition of Intrarosa intangible asset | 0 | (55,800) | 0 |
Proceeds from the sale of the CBR business | 519,303 | 0 | 0 |
Note receivable | (10,000) | ||
Note receivable | 0 | 0 | |
Capital expenditures | (2,534) | (8,988) | (5,460) |
Net cash provided by (used in) investing activities | 502,155 | 102,920 | (72,704) |
Cash flows from financing activities: | |||
Long-term debt principal payments | (475,000) | (353,125) | (17,502) |
Proceeds from 2022 Convertible Notes | 0 | 320,000 | 0 |
Payments to repurchase 2019 Convertible Notes | 0 | (191,730) | 0 |
Payment of premium on debt extinguishment | (28,054) | (625) | 0 |
Proceeds to settle warrants | 0 | 323 | 0 |
Payment of convertible debt issuance costs | 0 | (9,553) | 0 |
Payment of contingent consideration | (119) | (39,793) | (92,130) |
Payments for repurchases of common stock | 0 | (19,466) | (20,000) |
Proceeds from the exercise of common stock options | 3,881 | 3,021 | 3,885 |
Payments of employee tax withholding related to equity-based compensation | (2,682) | (2,696) | (2,171) |
Net cash used in financing activities | (501,974) | (293,644) | (127,918) |
Net increase (decrease) in cash, cash equivalents and restricted cash | 60,981 | (84,128) | 45,600 |
Cash, cash equivalents and restricted cash at beginning of the year | 192,770 | 276,898 | 231,298 |
Cash, cash equivalents and restricted cash at end of the year | 253,751 | 192,770 | 276,898 |
Supplemental data of cash flow information: | |||
Cash paid for taxes | 5,345 | 5,296 | 5,309 |
Cash paid for interest | 48,757 | 56,959 | 62,381 |
Non-cash investing and financing activities: | |||
Fair value of common stock issued in connection with the acquisition of the Intrarosa intangible asset | 13,500 | ||
Endoceutics, Inc. | |||
Non-cash investing and financing activities: | |||
Fair value of common stock issued in connection with the acquisition of the Intrarosa intangible asset | 0 | 12,555 | 0 |
Contingent consideration accrued for the acquisition of the Intrarosa intangible asset | $ 0 | $ 9,300 | $ 0 |
Description of Business
Description of Business | 12 Months Ended |
Dec. 31, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business | DESCRIPTION OF BUSINESS AMAG Pharmaceuticals, Inc., a Delaware corporation, was founded in 1981. We are a pharmaceutical company focused on bringing innovative products to patients with unmet medical needs by leveraging our development and commercial expertise to invest in and grow our pharmaceutical products across a range of therapeutic areas. Our currently marketed products support the health of patients in the areas of maternal and women’s health, anemia management and cancer supportive care, including Feraheme ® (ferumoxytol injection) for intravenous use, Makena ® (hydroxyprogesterone caproate injection), Intrarosa ® (prasterone) vaginal inserts and MuGard ® Mucoadhesive Oral Wound Rinse. In addition to our marketed products, our portfolio includes three product candidates, Vyleesi™ (bremelanotide), which is being developed for the treatment of hypoactive sexual desire disorder (“HSDD”) in pre-menopausal women, AMAG-423 (digoxin immune fab (ovine)), which is being studied for the treatment of severe preeclampsia, and ciraparantag, which is being studied as an anticoagulant reversal agent. We acquired ciraparantag through our acquisition of Perosphere Pharmaceuticals Inc (“Perosphere”), which was completed on January 16, 2019. See Note W, “ Subsequent Events ” for further details on the Perosphere acquisition. On August 6, 2018, we completed the sale of our wholly-owned subsidiary, CBR Acquisition Holdings Corp, and the Cord Blood Registry ® (“CBR”) business to GI Partners (“GI”), a private equity investment firm, pursuant to the June 14, 2018 Stock Purchase Agreement between us and affiliates of GI. We received $519.3 million in cash at closing and recognized a gain of $87.1 million on the sale during the year ended December 31, 2018. Since August 2015, we had provided services related to the preservation of umbilical cord blood stem cell and cord tissue units operated through CBR. For additional information, see Note C, “ Discontinued Operations and Held for Sale ” . We are subject to risks common to companies in the pharmaceutical industry including, but not limited to (as such risks pertain to our business) our ability to successfully commercialize our products, intense competition, including from generic products; maintaining and defending the proprietary nature of our technology; our dependence upon third-party manufacturers and our potential inability to obtain raw or other materials and impacts of supply shortages; our reliance on and the extent of reimbursement from third parties for the use of our products, including the impact of generic competitors, Makena’s high Medicaid reimbursement concentration and the limited level of reimbursement for Intrarosa; our ability to expand our product portfolio through business development transactions; the approval of our product candidates and our ability to commercialize such products, if approved; employee retention and our ability to manage our expanded product portfolio; potential litigation, including securities and product liability suits; our ability to work effectively and collaboratively with our licensors and partners; our reliance on other third parties in our business, including to conduct our clinical trials and undertake our product and distribution; our ability to attract and retain key employees; our potential failure to comply with federal and state healthcare fraud and abuse laws, marketing disclosure laws, or other federal and state laws and regulations and potential civil or criminal penalties as a result thereof; uncertainties regarding reporting and payment obligations under government pricing programs; post-approval commitments for Makena and Feraheme; our ability to comply with data protection laws and regulations; the impact of disruptions to our information technology systems; our level of and ability to repay our indebtedness; our access to sufficient capital; the availability of net operating loss carryforwards and other tax assets; potential differences between actual future results and the estimates or assumptions used by us in preparation of our consolidated financial statements, including goodwill and intangible assets; the volatility of our stock price; the potential fluctuation of our operating results; and provisions in our charter, by-laws and certain contracts that discourage an acquisition of our company. Throughout this Annual Report on Form 10-K, AMAG Pharmaceuticals, Inc. and our consolidated subsidiaries are collectively referred to as “the Company,” “AMAG,” “we,” “us,” or “our.” |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation and Principles of Consolidation The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the U.S. (“GAAP”) and include the accounts of our wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. As of June 30, 2018, our CBR business met all of the conditions to be classified as held for sale and represented a discontinued operation, as we considered the disposal of the CBR business to be a strategic shift that would have a major effect on our operations and financial results. All assets and liabilities associated with CBR were therefore classified as assets and liabilities held for sale in our consolidated balance sheets for 2017. Further, all historical operating results for CBR are reflected within discontinued operations in the consolidated statements of operations for all periods presented. For additional information, see Note C, “ Discontinued Operations and Held for Sale. ” Use of Estimates and Assumptions The preparation of consolidated financial statements in conformity with GAAP requires management to make certain estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, and the related disclosure of contingent assets and liabilities. The most significant estimates and assumptions are used to determine amounts and values of, but are not limited to: revenue recognition related to product sales revenue; product sales allowances and accruals; allowance for doubtful accounts; marketable securities; inventory; acquisition date fair value and subsequent fair value estimates used to assess impairment of long-lived assets, including goodwill, in-process research and development (“IPR&D”) and other intangible assets; contingent consideration; debt obligations; certain accrued liabilities, including clinical trial accruals; income taxes, inclusive of valuation allowances, and equity-based compensation expense. Actual results could differ materially from those estimates. Cash and Cash Equivalents Cash and cash equivalents consist principally of cash held in commercial bank accounts, money market funds and U.S. Treasury securities having an original maturity of less than three months at the date of acquisition. We consider all highly liquid marketable securities with a maturity of three months or less as of the acquisition date to be cash equivalents. At December 31, 2018 and 2017 , substantially all of our cash and cash equivalents were held in either commercial bank accounts or money market funds. Marketable Securities We account for and classify our marketable securities as either “available-for-sale,” “held-to-maturity,” or “trading debt securities,” in accordance with the accounting guidance related to the accounting and classification of certain investments in marketable securities. The determination of the appropriate classification by us is based primarily on management’s ability and intent to sell the debt security at the time of purchase. As of December 31, 2018 and 2017 , all of our marketable securities were classified as available-for-sale. Available-for-sale securities are those securities which we view as available for use in current operations, if needed. We generally classify our available-for-sale securities as short-term investments, even though the stated maturity date may be one year or more beyond the current balance sheet date. Available-for-sale marketable securities are stated at fair value with their unrealized gains and losses included in accumulated other comprehensive income (loss) within the consolidated statements of stockholders’ equity, until such gains and losses are realized in other income (expense) within the consolidated statements of operations or until an unrealized loss is considered other-than-temporary. We recognize other-than-temporary impairments of our marketable securities when there is a decline in fair value below the amortized cost basis and if (a) we have the intent to sell the security or (b) it is more likely than not that we will be required to sell the security prior to recovery of its amortized cost basis. If either of these conditions is met, we recognize the difference between the amortized cost basis of the security and its fair value at the impairment measurement date in our consolidated statements of operations. If neither of these conditions is met, we must perform additional analysis to evaluate whether the unrealized loss is associated with the creditworthiness of the issuer of the security rather than other factors, such as interest rates or market factors. If we determine from this analysis that we do not expect to receive cash flows sufficient to recover the entire amortized cost of the security, a credit loss exists, the impairment is considered other-than-temporary and is recognized in our consolidated statements of operations. Inventory Inventory is stated at the lower of cost or net realizable value, with approximate cost being determined on a first-in, first-out basis. Prior to initial approval from the U.S. Food and Drug Administration (the “FDA”) or other regulatory agencies, we expense costs relating to the production of inventory in the period incurred, unless we believe regulatory approval and subsequent commercialization of the product candidate is probable and we expect the future economic benefit from sales of the product to be realized, at which point we capitalize the costs as inventory. We assess the costs capitalized prior to regulatory approval each quarter for indicators of impairment, such as a reduced likelihood of approval. We expense costs associated with clinical trial material as research and development expense. On a quarterly basis, we analyze our inventory levels to determine whether we have any obsolete, expired, or excess inventory. If any inventory is expected to expire prior to being sold, has a cost basis in excess of its net realizable value, is in excess of expected sales requirements as determined by internal sales forecasts, or fails to meet commercial sale specifications, the inventory is written-down through a charge to cost of product sales. The determination of whether inventory costs will be realizable requires estimates by management of future expected inventory requirements, based on sales forecasts. Once packaged, our products have a shelf-life ranging from three to five years . As a result of comparison to internal sales forecasts, we expect to fully realize the carrying value of our finished goods inventory. If actual market conditions are less favorable than those projected by management, inventory write-downs may be required. Charges for inventory write-downs are not reversed if it is later determined that the product is saleable. Restricted Cash We classified $0.5 million of our cash as restricted cash, a non-current asset on the balance sheet, as of December 31, 2018 and 2017 . This amount represented the security deposit delivered to the landlord of our Waltham, Massachusetts headquarters. Concentrations and Significant Customer Information Financial instruments which potentially subject us to concentrations of credit risk consist principally of cash and cash equivalents, marketable securities, and accounts receivable. We currently hold our excess cash primarily in institutional money market funds, corporate debt securities, U.S. treasury and government agency securities, commercial paper and certificates of deposit. As of December 31, 2018 , we did not have a material concentration in any single investment. Our operations are located entirely within the U.S. We focus primarily on developing, manufacturing, and commercializing our products and product candidates. The following table sets forth customers who represented 10% or more of our total revenues for 2018 , 2017 and 2016 : Years Ended December 31, 2018 2017 2016 AmerisourceBergen Drug Corporation 27% 26% 27% McKesson Corporation 26% 24% 14% Caremark, LLC < 10% < 10% 10% Our net accounts receivable primarily represent amounts due for products sold directly to wholesalers, distributors, specialty pharmacies and our authorized generic partner. Accounts receivable for our products are recorded net of reserves for estimated chargeback obligations, prompt payment discounts and any allowance for doubtful accounts. As part of our credit management policy, we perform ongoing credit evaluations of our customers, and we generally do not require collateral. If the financial condition of any of our significant product sales customers was to deteriorate and result in an impairment of its ability to make payments owed to us, an allowance for doubtful accounts may be required which could have a material effect on earnings in the period of any such adjustment. We did not experience any significant bad debts and have not established an allowance for doubtful accounts as of December 31, 2018 and 2017 . At December 31, 2018 and 2017 , three and two customers, respectively, accounted for 10% or more of our accounts receivable balance, representing approximately 73% and 57% in the aggregate of our total accounts receivable, respectively. We are currently dependent on a single supplier for Feraheme drug substance (produced in two separate facilities) as well as for drug substance and final packaging services for Intrarosa. In addition, we currently have a single supplier for our auto-injector product. We have been and may continue to be exposed to a significant loss of revenue from the sale of our products in the event that our suppliers and/or manufacturers are not able to fulfill demand for any reason. Property and Equipment, Net Property and equipment are recorded at cost and depreciated when placed into service using the straight-line method based on their estimated useful lives as follows: Useful Life Computer equipment and software 5 Years Furniture and fixtures 5 Years Leasehold improvements Lesser of Lease or Asset Life Laboratory and production equipment 5 Years / 8 Years Costs for capital assets not yet placed in service are capitalized on our balance sheets and will be depreciated in accordance with the above guidelines once placed into service. Costs for maintenance and repairs are expensed as incurred. Upon sale or other disposition of property and equipment, the cost and related depreciation are removed from the accounts and any resulting gain or loss is charged to our consolidated statements of operations. Long-lived assets to be held and used are evaluated for impairment whenever events or changes in circumstances indicate that the carrying value of the asset may not be recoverable. Determination of recoverability is based on an estimate of undiscounted future cash flows resulting from the use of the asset and its eventual disposition. In the event such cash flows are not expected to be sufficient to recover the carrying amount of the assets, the assets are written down to their estimated fair values. Assets classified as held for sale are no longer subject to depreciation and are recorded at the lower of carrying value or estimated net realizable value. Business Combinations and Asset Acquisitions The purchase price allocation for business combinations requires extensive use of accounting estimates and judgments to allocate the purchase price to the identifiable tangible and intangible assets acquired and liabilities assumed based on their respective fair values. Under Accounting Standards Update (“ASU”) No. 2017-01, “ Business Combinations (Topic 805): Clarifying the Definition of a Business (“2017-01”), we first determine whether substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or a group of similar identifiable assets. If this threshold is met, the single asset or group of assets, as applicable, is not a business. We account for acquired businesses using the acquisition method of accounting, under which the total purchase price of an acquisition is allocated to the net tangible and identifiable intangible assets acquired and liabilities assumed based on their estimated fair values as of the acquisition date. Acquisition-related costs are expensed as incurred. Any excess of the consideration transferred over the estimated fair values of the identifiable net assets acquired is recorded as goodwill. The purchase price allocations are initially prepared on a preliminary basis and are subject to change as additional information becomes available concerning the fair value and tax basis of the assets acquired and liabilities assumed. Any adjustments to the purchase price allocations are made as soon as practicable but no later than one year from the acquisition date. Acquired inventory is recorded at its fair value, which may require a step-up adjustment to recognize the inventory at its expected net realizable value. The inventory step-up is recorded to cost of product sales in our consolidated statements of operations when related inventory is sold, and we record step-up costs associated with clinical trial material as research and development expense. Acquisition-Related Contingent Consideration Contingent consideration arising from a business combination is included as part of the purchase price and is recognized at its estimated fair value as of the acquisition date. Subsequent to the acquisition date, we measure contingent consideration arrangements at fair value for each period until the contingency is resolved. These changes in fair value are recognized in selling, general and administrative expenses in our consolidated statements of operations. Changes in fair values reflect new information about the likelihood of the payment of the contingent consideration and the passage of time. For asset acquisitions, we record contingent consideration for obligations we consider to be probable and estimable and these liabilities are not adjusted to fair value. Goodwill We test goodwill at the reporting unit level for impairment on an annual basis and between annual tests if events and circumstances indicate it is more likely than not that the fair value of a reporting unit is less than its carrying value. Events that could indicate impairment and trigger an interim impairment assessment include, but are not limited to, an adverse change in current economic and market conditions, including a significant prolonged decline in market capitalization, a significant adverse change in legal factors, unexpected adverse business conditions, and an adverse action or assessment by a regulator. Our annual impairment test date is October 31. We have determined that we operate in a single operating segment and have a single reporting unit. In performing our goodwill impairment tests during 2018 and 2017 , we utilized the approach prescribed under Accounting Standards Codification (“ASC”) 350, as amended by ASU 2017-04, Intangibles - Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment (“ASU 2017-04”), which requires that an entity 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. For additional information, see Note I, “ Goodwill and Intangible Assets, Net. ” Intangible Assets We amortize our intangible assets that have finite lives based on either the straight-line method, or if reliably determinable, based on the pattern in which the economic benefit of the asset is expected to be utilized. When such facts and circumstances exist, management compares the projected undiscounted future cash flows associated with the asset over its estimated useful life against the carrying amount. The impairment loss, if any, is measured as the excess of the carrying amount of the asset over its fair value. If we acquire a business as defined under applicable accounting standards, then the acquired IPR&D is capitalized as an intangible asset. If we acquire an asset or a group of assets that do not meet the definition of a business, then the acquired IPR&D is expensed on its acquisition date. Future costs to develop these assets are recorded to research and development expense as they are incurred. Acquired IPR&D represents the fair value assigned to research and development assets that we acquire and have not been completed at the acquisition date. The fair value of IPR&D acquired in a business combination is capitalized on our consolidated balance sheets at the acquisition-date fair value and is determined by estimating the costs to develop the technology into commercially viable products, estimating the resulting revenue from the projects, and discounting the projected net cash flows to present value. IPR&D is not amortized, but rather is reviewed for impairment on an annual basis or more frequently if indicators of impairment are present, until the project is completed or abandoned. If we determine that IPR&D becomes impaired or is abandoned, the carrying value is written down to its fair value with the related impairment charge recognized in our consolidated statement of operations in the period in which the impairment occurs. Upon successful completion of each project and launch of the product, we will make a separate determination of the estimated useful life of the IPR&D intangible asset and the related amortization will be recorded as an expense prospectively over its estimated useful life. The projected discounted cash flow models used to estimate our IPR&D reflect significant assumptions regarding the estimates a market participant would make in order to evaluate a drug development asset, including the following: • Probability of successfully completing clinical trials and obtaining regulatory approval; • Market size, market growth projections, and market share; • Estimates regarding the timing of and the expected costs to advance our clinical programs to commercialization; • Estimates of future cash flows from potential product sales; and • A discount rate. Additionally, to the extent we acquire other indefinite-lived intangible assets through our business combinations, these assets are reviewed for impairment on an annual basis or more frequently if indicators of impairment are present. If we determine that the asset becomes impaired, the carrying value is written down to its fair value with the related impairment charge recognized in our consolidated statements of operations in the period in which the impairment occurs. Patents We expense all patent-related costs in selling, general and administrative expenses as incurred. Revenue Recognition Effective January 1, 2018, we adopted ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”), using the modified retrospective transition method. We recognized the cumulative effect of applying the new revenue standard to all contracts with customers that were not completed as of January 1, 2018 as an adjustment of $1.1 million to the opening balance of stockholders’ equity at the beginning of 2018. The adjustment recorded was for incremental contract acquisition costs related to the CBR business. The comparative information has not been restated and continues to be reported under the accounting standards in effect for the periods presented. This standard applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, certain collaboration arrangements and financial instruments. ASC 606 also impacts certain other areas, such as the accounting for costs to obtain or fulfill a contract. The standard also requires disclosure of the nature, amount, timing, and uncertainty of revenue and cash flows arising from contracts with customers. The adoption of ASC 606 did not have an impact on the amount of reported revenues with respect to our product revenue. See Note D, “ Revenue Recognition ” for additional information. Research and Development Expenses Research and development expenses include both external and internal expenses. External expenses primarily include costs of clinical trials and fees paid to contract research organizations (“CROs”), clinical supply and manufacturing expenses, regulatory filing fees, consulting and professional fees as well as other general costs related to the execution of research and development activities. Internal expenses primarily include compensation of employees engaged in research and development activities. Research and development expenses are expensed as incurred. Manufacturing costs are generally expensed as incurred until a product has received the necessary initial regulatory approval. Advertising Costs Advertising costs are expensed as incurred and included in selling, general and administrative expenses in our consolidated statements of operations. Advertising costs, including promotional expenses, costs related to trade shows and print media advertising space were $29.8 million , $9.1 million and $4.9 million for the years ended December 31, 2018 , 2017 and 2016 , respectively. Equity-Based Compensation Equity-based compensation cost is generally measured at the estimated grant date fair value and recorded to expense over the requisite service period, which is generally the vesting period. Because equity-based compensation expense is based on awards ultimately expected to vest, we must make certain judgments about whether employees, officers, directors, consultants and advisers will complete the requisite service period, and reduce the compensation expense being recognized for estimated forfeitures. Forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Forfeitures are estimated based upon historical experience and adjusted for unusual events such as corporate restructurings, which can result in higher than expected turnover and forfeitures. If factors change and we employ different assumptions in future periods, the compensation expense that we record in the future may differ significantly from what we have recorded in the current period. We estimate the fair value of equity-based compensation involving stock options based on the Black-Scholes option pricing model. This model requires the input of several factors such as the expected option term, the expected risk-free interest rate over the expected option term, the expected volatility of our stock price over the expected option term and the expected dividend yield over the expected option term and are subject to various assumptions. The fair value of awards calculated using the Black-Scholes option pricing model is generally amortized on a straight-line basis over the requisite service period, and is recognized based on the proportionate amount of the requisite service period that has been rendered during each reporting period. We estimate the fair value of our restricted stock units (“RSUs”) whose vesting is contingent upon market conditions, such as total shareholder return, using the Monte-Carlo simulation model. The fair value of RSUs where vesting is contingent upon market conditions is amortized based upon the estimated derived service period. The fair value of RSUs granted to our employees and directors whose vesting is dependent on future service is determined based upon the quoted closing market price per share on the date of grant, adjusted for estimated forfeitures. We believe our valuation methodologies are appropriate for estimating the fair value of the equity awards we grant to our employees and directors. Our equity award valuations are estimates and may not be reflective of actual future results or amounts ultimately realized by recipients of these grants. These amounts are subject to future quarterly adjustments based upon a variety of factors, which include, but are not limited to, changes in estimated forfeiture rates and the issuance of new equity-based awards. Income Taxes We use the asset and liability method of accounting for deferred income taxes. Under this method, deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. A deferred tax asset is established for the expected future benefit of net operating loss (“NOL”) and credit carryforwards. Deferred tax assets and liabilities are measured using enacted rates in effect for the year in which those temporary differences are expected to be recovered or settled. A valuation allowance against net deferred tax assets is required if, based on available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. Significant judgments, estimates and assumptions regarding future events, such as the amount, timing and character of income, deductions and tax credits, are required in the determination of our provision for income taxes and whether valuation allowances are required against deferred tax assets. In evaluating our ability to recover our deferred tax assets, we consider all available evidence, both positive and negative, including the existence of taxable temporary differences, our past operating results, the existence of cumulative income in the most recent fiscal years, changes in the business in which we operate and our forecast of future taxable income. In determining future taxable income, we are responsible for assumptions utilized including the amount of state and federal operating income, the reversal of temporary differences and the implementation of feasible and prudent tax planning strategies. These assumptions require significant judgment about the forecasts of future taxable income. As of December 31, 2018 , we have established a valuation allowance on our net deferred tax assets other than refundable alternative minimum tax (“AMT”) credits to the extent that our existing taxable temporary differences would not be available as a source of income to realize the benefits of those deferred tax assets. We account for uncertain tax positions using a “more-likely-than-not” threshold for recognizing and resolving uncertain tax positions. The evaluation of uncertain tax positions is based on factors that include, but are not limited to, changes in tax law, the measurement of tax positions taken or expected to be taken in tax returns, the effective settlement of matters subject to audit, new audit activity, and changes in facts or circumstances related to a tax position. We evaluate uncertain tax positions on a quarterly basis and adjust the level of the liability to reflect any subsequent changes in the relevant facts surrounding the uncertain positions. Any changes to these estimates, based on the actual results obtained and/or a change in assumptions, could impact our income tax provision in future periods. Interest and penalty charges, if any, related to unrecognized tax benefits would be classified as a provision for income tax in our consolidated statement of operations. Comprehensive Loss Our comprehensive loss consists of net loss and other comprehensive loss. Other comprehensive loss includes changes in equity that are excluded from net loss, which for all periods presented in these consolidated financial statements related to unrealized holding gains and losses on available-for-sale marketable securities, net of tax. Basic and Diluted Net (Loss) Income per Share We compute basic net (loss) income per share by dividing net (loss) income by the weighted average number of common shares outstanding during the relevant period. Diluted net (loss) income per common share has been computed by dividing net (loss) income by the diluted number of common shares outstanding during the period. Except where the result would be antidilutive to net income, diluted net income per common share would be computed assuming the impact of the conversion of the 2.5% convertible senior notes due in 2019 (the “2019 Convertible Notes”) and the 3.25% convertible senior notes due in 2022 (the “2022 Convertible Notes”), the exercise of outstanding stock options, the vesting of RSUs, and the exercise of warrants. We have a choice to settle the conversion obligation of our 2022 Convertible Notes and the 2019 Convertible Notes (together, the “Convertible Notes”) in cash, shares or any combination of the two. Our policy is to settle the principal balance of the Convertible Notes in cash. As such, we apply the treasury stock method to these securities and the dilution related to the conversion premium, if any, of the Convertible Notes is included in the calculation of diluted weighted-average shares outstanding to the extent each issuance is dilutive based on the average stock price during each reporting period being greater than the conversion price of the respective Convertible Notes. The dilutive effect of the warrants, stock options and RSUs has been calculated using the treasury stock method. The components of basic and diluted net (loss) income per share for 2018 , 2017 and 2016 were as follows (in thousands, except per share data): Years Ended December 31, 2018 2017 2016 Net (loss) income from continuing operations $ (169,339 ) $ (205,153 ) $ 2,093 Net income (loss) from discontinued operations 103,578 5,925 (4,576 ) Weighted average common shares outstanding 34,394 34,907 34,346 Effect of dilutive securities: Stock options and RSUs — — 487 Shares used in calculating dilutive net loss per share 34,394 34,907 34,833 Basic net (loss) income per share: (Loss) income from continuing operations $ (4.92 ) $ (5.88 ) $ 0.06 Income (loss) from discontinued operations 3.01 0.17 (0.13 ) Total $ (1.91 ) $ (5.71 ) $ (0.07 ) Diluted net (loss) income per share: (Loss) income from continuing operations $ (4.92 ) $ (5.88 ) $ 0.06 Income (loss) from discontinued operations 3.01 0.17 (0.13 ) Total $ (1.91 ) $ (5.71 ) $ (0.07 ) The following table sets forth the potential common shares issuable upon the exercise of outstanding options, the purchase of shares under our employee stock purchase plan, the vesting of RSUs, the exercise of warrants (prior to consideration of the treasury stock method), and the conversion of the Convertible Notes, which were excluded from our computation of diluted net (loss) income per share because their inclusion would have been anti-dilutive (in thousands): Years Ended December 31, 2018 2017 2016 Options to purchase shares of common stock 3,797 3,531 2,590 Shares of common stock issuable upon the vesting of RSUs 1,129 1,070 613 Warrants 1,008 1,008 7,382 2022 Convertible Notes 11,695 11,695 — 2019 Convertible Notes 790 790 7,382 Shares of common stock under employee stock purchase plan 81 — — 36 Total 18,500 18,094 18,003 In connection with the issuance of the 2019 Convertible Notes, in February 2014, we entered into convertible bond hedges with certain financial institutions. The convertible bond hedges are not included for purposes of calculating the number of diluted shares outstanding, as their effect would be anti-dilutive. The convertible bond hedges are generally expected, but not guaranteed, to reduce the potential dilution and/or offset the cash payments we are required to make upon conversion of the remaining 2019 Convertible Notes. During 2018 and 2017 , the average common stock price was below the exercise price of the warrants and during 2016 , the average common stock price was above the exercise price of the warrants. Reclassification Certain prior period amounts have been reclassified to conform to the current year presentation. Business Segments We have determined that we conduct our operations in one business segment: the manufacture, development and commercialization of products for use in treating various conditions, with a focus on maternal and women’s health and anemia management. Long-lived assets consist entirely of property and equipment and are located in the U.S. for all periods presented. |
Discontinued Operations and Hel
Discontinued Operations and Held For Sale | 12 Months Ended |
Dec. 31, 2018 | |
Discontinued Operations and Disposal Groups [Abstract] | |
Discontinued Operations and Held For Sale | DISCONTINUED OPERATIONS AND HELD FOR SALE On August 6, 2018, we completed the sale of our CBR business to GI Partners pursuant to the CBR Purchase Agreement. We received $519.3 million in cash at closing and recognized a gain of $87.1 million on the sale during the year ended December 31, 2018 . Although we are providing limited transitional services related to GI for certain agreed-upon sales and marketing, technology, human resources and finance functions for several months post-closing, we do not expect to have any (and have not had any) significant involvement in the operations of the CBR business following the close of the sale. We determined that the sale of CBR represented a strategic shift that would have a major effect on our business and therefore met the criteria for classification as discontinued operations at June 30, 2018. All historical operating results for CBR were reflected within discontinued operations in the consolidated statements of operations for all periods presented. Further, all assets and liabilities associated with CBR were classified as assets and liabilities held for sale in our consolidated balance sheets for the historical period presented. Assets and liabilities held for sale were reflected separately in our consolidated balance sheets and were comprised of the following as of December 31, 2018 and 2017 (in thousands): December 31, 2018 2017 Assets Current assets: Cash $ — $ 29,259 Accounts receivable, net — 12,042 Inventories (raw materials) — 2,913 Prepaid and other current assets — 1,294 Total current assets held for sale — 45,508 Property, plant and equipment, net — 18,092 Intangible assets, net — 328,991 Goodwill — 216,971 Other long-term assets — 496 Restricted cash — 161 Total long-term assets held for sale — 564,711 Liabilities Current liabilities: Accounts payable — 2,618 Accrued expenses — 8,758 Deferred revenues, short term — 42,494 Total current liabilities held for sale — 53,870 Deferred revenues, long-term — 24,387 Deferred tax liabilities — 71,046 Other long-term liabilities — 388 Total long-term liabilities held for sale $ — $ 95,821 The results of operations of the CBR business were classified as discontinued operations for all periods presented in our consolidated financial statements. The following is a summary of net income (loss) from discontinued operations for the years ended December 31, 2018 , 2017 and 2016 : Years Ended December 31, 2018 2017 2016 Service revenues, net $ 71,217 $ 114,177 $ 99,604 Costs and expenses: Cost of services 12,559 21,817 20,575 Research and development expenses — — 523 Selling, general and administrative expenses 39,899 81,782 80,402 Impairment of intangible assets — — 3,939 Restructuring expenses — — 374 Total costs and expenses 52,458 103,599 105,813 Operating income (loss) 18,759 10,578 (6,209 ) Other income (expense) 114 (265 ) — Income (loss) from discontinued operations 18,873 10,313 (6,209 ) Gain on sale of CBR business 87,076 — — Income tax expense (benefit) 2,371 4,388 (1,633 ) Net income (loss) from discontinued operations $ 103,578 $ 5,925 $ (4,576 ) The cash flows related to discontinued operations have not been segregated and are included in the Consolidated Statements of Cash Flows. For the years ended December 31, 2018 and 2017 , capital expenditures related to the CBR business were $1.6 million and $4.9 million , respectively. Depreciation and amortization expense related to the CBR business for the same periods was $8.4 million and $21.7 million , respectively. Excluding the gain of $87.1 million recognized on the sale of the CBR business and the related transaction expenses of $14.1 million presented in the Consolidated Statements of Cash Flows for the year ended December 31, 2018 , there were no other significant operating or investing non-cash items related to the CBR business for either period presented. |
Revenue Recognition
Revenue Recognition | 12 Months Ended |
Dec. 31, 2018 | |
Revenue from Contract with Customer [Abstract] | |
Revenue Recognition | REVENUE RECOGNITION On January 1, 2018, we adopted ASC 606 applying the modified retrospective transition method to all contracts that were not completed as of January 1, 2018. Results for reporting periods beginning after January 1, 2018 are presented under ASC 606, while prior period amounts are not adjusted and continue to be reported under the accounting standards in effect for prior periods. There was no impact to revenue for the year ended December 31, 2018 as a result of adoption. Under ASC 606, we recognize revenue when our customer obtains control of promised goods or services in an amount that reflects the consideration which we expect to receive in exchange for those goods or services. To determine revenue recognition for arrangements that we determine are within the scope of ASC 606, we perform the following five steps: a. Identify the contract(s) with a customer; b. Identify the performance obligations in the contract; c. Determine the transaction price; d. Allocate the transaction price to the performance obligations in the contract; and e. Recognize revenue when (or as) the performance obligations are satisfied. We only apply the five step model to contracts when it is probable that we will collect the consideration we are entitled to in exchange for the goods or services we transfer to the customer. At contract inception, if the contract is determined to be within the scope of ASC 606, we assess the goods or services promised within each contract, determine those that are performance obligations, and assess whether each promised good or service is distinct. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Our major sources of revenue during the reporting periods were product revenues from Makena (including both our branded and unbranded products), Feraheme and Intrarosa. The adoption of ASC 606 did not have an impact on the pattern or timing of recognition of our product revenue, as the majority of our product revenue continues to be recognized when the customer takes control of our product. Revenue and Allowances The following table provides information about disaggregated revenue by products for the years ended December 31, 2018 , 2017 and 2016 (in thousands): Years Ended December 31, 2018 2017 2016 Product sales, net Makena $ 322,265 $ 387,158 $ 334,050 Feraheme 135,001 105,930 97,058 Intrarosa 16,218 1,816 — MuGard 368 741 1,062 Total $ 473,852 $ 495,645 $ 432,170 Total gross product sales were offset by product sales allowances and accruals for the years ended December 31, 2018 , 2017 and 2016 as follows (in thousands): Years Ended December 31, 2018 2017 2016 Gross product sales $ 974,330 $ 920,061 $ 748,839 Provision for product sales allowances and accruals: Contractual adjustments 387,540 310,588 229,686 Governmental rebates 112,938 113,828 86,983 Total 500,478 424,416 316,669 Product sales, net $ 473,852 $ 495,645 $ 432,170 The following table summarizes the product revenue allowance and accrual activity for the years ended December 31, 2018 , 2017 and 2016 (in thousands): Contractual Governmental Adjustments Rebates Total Balance at January 1, 2016 $ 30,177 $ 25,767 $ 55,944 Current provisions relating to sales in current year 224,894 93,035 317,929 Adjustments relating to sales in prior years (2,348 ) (6,052 ) (8,400 ) Payments/returns relating to sales in current year (181,150 ) (41,636 ) (222,786 ) Payments/returns relating to sales in prior years (23,973 ) (19,715 ) (43,688 ) Balance at December 31, 2016 47,600 51,399 98,999 Current provisions relating to sales in current year 314,537 112,167 426,704 Adjustments relating to sales in prior years (3,949 ) 1,661 (2,288 ) Payments/returns relating to sales in current year (253,545 ) (61,569 ) (315,114 ) Payments/returns relating to sales in prior years (42,479 ) (53,060 ) (95,539 ) Balance at December 31, 2017 62,164 50,598 112,762 Provisions related to current period sales 389,861 105,034 494,895 Adjustments related to prior period sales (2,330 ) 7,903 5,573 Payments/returns relating to current period sales (333,694 ) (75,920 ) (409,614 ) Payments/returns relating to prior period sales (58,802 ) (58,501 ) (117,303 ) Balance at December 31, 2018 $ 57,199 $ 29,114 $ 86,313 We receive payments from customers based upon contractual billing schedules; accounts receivable are recorded when the right to consideration becomes unconditional. Performance Obligations and Product Revenue At contract inception, we assess the goods promised in our contracts with customers and identify a performance obligation for each promise to transfer to the customer a good (or bundle of goods) that is distinct. To identify the performance obligations, we consider all of the goods promised in the contract regardless of whether they are explicitly stated or are implied by customary business practices. We determined that the following distinct goods represent separate performance obligations: • Supply of Makena (branded and unbranded) product • Supply of Feraheme product • Supply of Intrarosa product We principally sell our products to wholesalers, specialty distributors, specialty pharmacies and other customers, including our authorized generic partner (collectively, “Customers”), who purchase products directly from us. Our Customers subsequently resell the products to healthcare providers and patients. In addition to distribution agreements with Customers, we enter into arrangements with healthcare providers and payers that provide for government-mandated and/or privately-negotiated rebates, chargebacks and discounts with respect to the purchase of our products. For the majority of our Customers, we transfer control at the point in time when the goods are delivered. In instances when we perform shipping and handling activities, these are considered fulfillment activities, and accordingly, the costs are accrued when the related revenue is recognized. Taxes collected from Customers and remitted to governmental authorities are excluded from revenues. Variable Consideration Under ASC 606, we are required to make estimates of the net sales price, including estimates of variable consideration (such as rebates, chargebacks, discounts, copay assistance and other deductions), and recognize the estimated amount as revenue, when we transfer control of the product to our customers. In addition, we estimate variable consideration related to our share of net distributable profits from our authorized generic partner. Variable consideration must be determined using either an “expected value” or a “most likely amount” method. We record product revenues net of certain allowances and accruals in our consolidated statements of operations. Product sales allowances and accruals are primarily comprised of both direct and indirect fees, discounts and rebates and provisions for estimated product returns. Direct fees, discounts and rebates are contractual fees and price adjustments payable to Customers that purchase products directly from us. Indirect fees, discounts and rebates are contractual price adjustments payable to healthcare providers and organizations, such as certain physicians, clinics, hospitals, group purchasing organizations (“GPOs”), and dialysis organizations that typically do not purchase products directly from us but rather from wholesalers and specialty distributors. Consideration payable to a Customer, or other parties that purchase goods from a Customer, are considered to be a reduction of the transaction price, and therefore, of revenue. Product sales allowances and accruals are based on definitive contractual agreements or legal requirements (such as laws and regulations to provide mandatory discounts for sales to government entities) related to the purchase and/or utilization of the product by these entities and are recorded in the same period that the related revenue is recognized. We use the expected value method for estimating variable consideration. We estimate product sales allowances and accruals using either historical, actual and/or other data, including estimated patient usage, applicable contractual rebate rates, contract performance by the benefit providers, other current contractual and statutory requirements, historical market data based upon experience of our products and other products similar to them, specific known market events and trends such as competitive pricing and new product introductions, current and forecasted Customer buying patterns and inventory levels, and the shelf life of our products. As part of this evaluation, we also review changes to federal and other legislation, changes to rebate contracts, changes in the level of discounts, and changes in product sales trends. Although allowances and accruals are recorded at the time of product sale, rebates are typically paid out in arrears, one to three months after the sale. The estimate of variable consideration, which is included in the transaction price, may be constrained and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved in a future period. Estimating variable consideration and the related constraint requires the use of significant management judgment and actual amounts of consideration ultimately received may differ from our estimates. If actual results in the future vary from our estimates, we will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known. No amounts were constrained as of December 31, 2018 . Discounts We typically offer a 2% prompt payment discount to certain customers as an incentive to remit payment in accordance with the stated terms of the invoice, generally 30 days . Because we anticipate that those customers who are offered this discount will take advantage of the discount, 100% of the prompt payment discount at the time of sale is accrued for eligible customers, based on the gross amount of each invoice. We adjust the accrual quarterly to reflect actual experience. Chargebacks Chargeback reserves represent the estimated obligations resulting from the difference between the prices at which we sell our products to wholesalers and the sales price ultimately paid to wholesalers under fixed price contracts by third-party payers, including governmental agencies. The chargeback estimates are determined based on actual product sales data and forecasted customer buying patterns. Actual chargeback amounts are determined at the time of resale to the qualified healthcare provider, and we generally issue credits for such amounts within several weeks of receiving notification from the wholesaler. Estimated chargeback amounts are recorded at the time of sale and adjusted quarterly to reflect actual experience. Distributor/Wholesaler and Group Purchasing Organization Fees Fees under arrangements with distributors and wholesalers are usually based upon units of product purchased during the prior month or quarter and are usually paid by us within several weeks of the receipt of an invoice from the wholesaler or distributor, as the case may be. Fees under arrangements with GPOs are usually based upon member purchases during the prior quarter and are generally billed by the GPO within 30 days after period end. In accordance with ASC 606, since the consideration given to the Customer is not for a distinct good or service, the consideration is a reduction of the transaction price of the vendor’s products or services. We have included these fees in contractual adjustments in the table above. We generally pay such amounts within several weeks of the receipt of an invoice from the distributor, wholesaler or GPO. Accordingly, we accrue the estimated fee due at the time of sale, based on the contracted price invoiced to the Customer. We adjust the accrual quarterly to reflect actual experience. Product Returns Consistent with industry practice, we generally offer wholesalers, specialty distributors and other customers a limited right to return our products based on the product’s expiration date. The current shelf-lives or time between manufacture and expiration for products in our portfolio range from three to five years . Product returns are estimated based on the historical return patterns and known or expected changes in the marketplace. We track actual returns by individual production lots. Returns on lots eligible for credits under our returned goods policy are monitored and compared with historical return trends and rates. We expect that wholesalers and healthcare providers will not stock significant inventory due to the cost of the product, the expense to store our products, and/or that our products are readily available for distribution. We record an estimate of returns at the time of sale. If necessary, our estimated rate of returns may be adjusted for actual return experience as it becomes available and for known or expected changes in the marketplace. There were no material adjustments to our reserve for product returns during the years ended December 31, 2018 , 2017 or 2016 . To date, our product returns have been relatively limited; however, returns experience may change over time. We may be required to make future adjustments to our product returns estimate, which would result in a corresponding change to our net product sales in the period of adjustment and could be significant. Sales Rebates We contract with various private payer organizations, primarily pharmacy benefit managers, for the payment of rebates with respect to utilization of our products. We determine our estimates for rebates, if applicable, based on actual product sales data and our historical product claims experience. Rebate amounts generally are invoiced quarterly and are paid in arrears, and we expect to pay such amounts within several weeks of notification by the provider. We regularly assess our reserve balance and the rate at which we accrue for claims against product sales. If we determine in future periods that our actual rebate experience is not indicative of expected claims, if actual claims experience changes, or if other factors affect estimated claims rates, we may be required to adjust our current accumulated reserve estimate, which would affect net product sales in the period of the adjustment and could be significant. Governmental Rebates Governmental rebates relate to our reimbursement arrangements with state Medicaid programs. We determine our estimates for Medicaid rebates, if applicable, based on actual product sales data and our historical product claims experience. In estimating these reserves, we provide for a Medicaid rebate associated with both those expected instances where Medicaid will act as the primary insurer as well as in those instances where we expect Medicaid will act as the secondary insurer. Rebate amounts generally are invoiced quarterly and are paid in arrears, and we expect to pay such amounts within several weeks of notification by the Medicaid or provider entity. We regularly assess our Medicaid reserve balance and the rate at which we accrue for claims against product sales. If we determine in future periods that our actual rebate experience is not indicative of expected claims, if actual claims experience changes, or if other factors affect estimated claims rates, we may be required to adjust our current Medicaid accumulated reserve estimate, which would affect net product sales in the period of the adjustment and could be significant. Other Discounts Other discounts which we offer include voluntary patient assistance programs, such as copay assistance programs, which are intended to provide financial assistance to qualified commercially insured patients with prescription drug copayments required by payers. The calculation of the accrual for copay assistance is based on an estimate of claims and the cost per claim that we expect to receive associated with product that has been recognized as revenue. |
Marketable Securities
Marketable Securities | 12 Months Ended |
Dec. 31, 2018 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable Securities | MARKETABLE SECURITIES As of December 31, 2018 and 2017 , our marketable securities consisted of securities classified as available-for-sale in accordance with accounting standards which provide guidance related to accounting and classification of certain investments in marketable securities. The following is a summary of our marketable securities as of December 31, 2018 and 2017 (in thousands): December 31, 2018 Gross Gross Estimated Amortized Unrealized Unrealized Fair Description of Securities: Cost Gains Losses Value Short-term investments:* Corporate debt securities $ 51,184 $ — $ (236 ) $ 50,948 U.S. treasury and government agency securities 7,647 — (34 ) 7,613 Commercial paper 3,995 — — 3,995 Certificates of deposit 12,000 — — 12,000 Total short-term investments 74,826 — (270 ) 74,556 Long-term investments:** Corporate debt securities 62,530 52 (433 ) 62,149 U.S. treasury and government agency securities 2,742 — (32 ) 2,710 Certificates of deposit 1,500 — — 1,500 Total long-term investments 66,772 52 (465 ) 66,359 Total investments $ 141,598 $ 52 $ (735 ) $ 140,915 December 31, 2017 Gross Gross Estimated Amortized Unrealized Unrealized Fair Description of Securities: Cost Gains Losses Value Short-term investments:* Corporate debt securities $ 57,257 $ — $ (68 ) $ 57,189 U.S. treasury and government agency securities 1,999 — (13 ) 1,986 Commercial paper 1,999 — — 1,999 Certificates of deposit 9,151 — — 9,151 Total short-term investments 70,406 — (81 ) 70,325 Long-term investments:** Corporate debt securities 59,282 1 (320 ) 58,963 U.S. treasury and government agency securities 7,381 — (76 ) 7,305 Total long-term investments 66,663 1 (396 ) 66,268 Total investments $ 137,069 $ 1 $ (477 ) $ 136,593 * Represents marketable securities with a remaining maturity of less than one year. ** Represents marketable securities with a remaining maturity of one to three years classified as short-term on our consolidated balance sheets. Impairments and Unrealized Gains and Losses on Marketable Securities We did no t recognize any other-than-temporary impairment losses in our consolidated statements of operations related to our marketable securities during 2018 , 2017 and 2016 . We considered various factors, including the length of time that each security was in a realized loss position and our ability and intent to hold these securities until recovery of their amortized cost basis occurs. As of December 31, 2018 , we have no material losses in an unrealized loss position for more than one year. Future events may occur, or additional information may become available, which may cause us to identify credit losses where we do not expect to receive cash flows sufficient to recover the entire amortized cost basis of a security and may necessitate the recording of future realized losses on securities in our portfolio. Significant losses in the estimated fair values of our marketable securities could have a material adverse effect on our earnings in future periods. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2018 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | FAIR VALUE MEASUREMENTS We apply the provisions of ASC Topic 820, Fair Value Measurements (“ASC 820”) for our financial assets and liabilities that are re-measured and reported at fair value each reporting period and our nonfinancial assets and liabilities that are re-measured and reported at fair value on a non-recurring basis. Fair value is the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. When determining fair value, we consider the principal or most advantageous market in which it would transact and consider assumptions that market participants would use when pricing the asset or liability. ASC 820 establishes a three-level valuation hierarchy for disclosure of fair value measurements. Financial assets and liabilities are categorized within the valuation hierarchy based upon the lowest level of input that is significant to the measurement of fair value. The three levels of the hierarchy are defined as follows: • Level 1- Inputs to the valuation methodology are quoted market prices for identical assets or liabilities. • Level 2 - Inputs to the valuation methodology are other observable inputs, including quoted market prices for similar assets or liabilities and market-corroborated inputs. • Level 3 - Inputs to the valuation methodology are unobservable inputs based on management’s best estimate of inputs market participants would use in pricing the asset or liability at the measurement date, including assumptions about risk. The following tables represent the fair value hierarchy as of December 31, 2018 and 2017 , for those assets and liabilities that we measure at fair value on a recurring basis (in thousands): Fair Value Measurements at December 31, 2018 Using: Total Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Assets: Cash equivalents $ 71,568 $ 71,568 $ — $ — Corporate debt securities 113,097 — 113,097 — U.S. treasury and government agency securities 10,323 — 10,323 — Commercial paper 3,995 — 3,995 — Certificates of deposit 13,500 — 13,500 — Total Assets $ 212,483 $ 71,568 $ 140,915 $ — Liabilities: Contingent consideration - Lumara Health $ — $ — $ — $ — Contingent consideration - MuGard 359 — — 359 Total Liabilities $ 359 $ — $ — $ 359 Fair Value Measurements at December 31, 2017 Using: Total Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Assets: Cash equivalents $ 4,591 $ 4,591 $ — $ — Corporate debt securities 116,152 — 116,152 — U.S. treasury and government agency securities 9,291 — 9,291 — Commercial paper 1,999 — 1,999 — Certificates of deposit 9,151 — 9,151 — Total Assets $ 141,184 $ 4,591 $ 136,593 $ — Liabilities: Contingent consideration - Lumara Health $ 49,187 $ — $ — $ 49,187 Contingent consideration - MuGard 898 — — 898 Total Liabilities $ 50,085 $ — $ — $ 50,085 Marketable securities Our cash equivalents are classified as Level 1 assets under the fair value hierarchy as these assets have been valued using quoted market prices in active markets and do not have any restrictions on redemption. Our marketable securities are classified as Level 2 assets under the fair value hierarchy as these assets were primarily determined from independent pricing services, which normally derive security prices from recently reported trades for identical or similar securities, making adjustments based upon other significant observable market transactions. At the end of each reporting period, we perform quantitative and qualitative analysis of prices received from third parties to determine whether prices are reasonable estimates of fair value. After completing our analysis, we did not adjust or override any fair value measurements provided by our pricing services as of December 31, 2018 or 2017 . In addition, there were no transfers or reclassifications of any securities between Level 1 and Level 2 during 2018 or 2017 . Contingent consideration In accordance with GAAP, for asset acquisitions, we record contingent consideration for obligations we consider to be probable and estimable and these liabilities are not adjusted to fair value. As of December 31, 2018 , no contingent consideration was recorded in accrued expenses. As of December 31, 2017 , $10.0 million of contingent consideration was recorded in accrued expenses and was paid to Endoceutics in April 2018 on the first anniversary of the closing of the license agreement between us and Endoceutics. We recorded contingent consideration related to the November 2014 acquisition of Lumara Health Inc. (“Lumara Health”) for our Makena product and related to our June 2013 license agreement for MuGard ® Mucoadhesive Oral Wound Rinse (the “MuGard License Agreement”) with Abeona Therapeutics, Inc. (“Abeona”), under which we acquired the U.S. commercial rights for the management of oral mucositis and stomatitis (the “MuGard Rights”). The fair value measurements of contingent consideration obligations and the related intangible assets arising from business combinations are classified as Level 3 assets under the fair value hierarchy as these assets have been valued using unobservable inputs. These inputs include: (a) the estimated amount and timing of projected cash flows; (b) the probability of the achievement of the factors on which the contingency is based; and (c) the risk-adjusted discount rate used to present value the probability-weighted cash flows. Significant increases or decreases in any of those inputs in isolation could result in a significantly lower or higher fair value measurement. The following table presents a reconciliation of contingent consideration obligations related to the acquisition of Lumara Health and the MuGard Rights (in thousands): Balance as of January 1, 2017 $ 147,995 Payments made (50,224 ) Adjustments to fair value of contingent consideration (47,686 ) Balance as of December 31, 2017 $ 50,085 Payments made (119 ) Adjustments to fair value of contingent consideration (49,607 ) Balance as of December 31, 2018 $ 359 During 2018 , we reduced the fair value of our contingent consideration liability by approximately $49.6 million , primarily based on actual Makena net sales to date and our expectations for future performance, which indicated that achievement of future milestones is not probable. This adjustment was based on our estimates, which are reliant on a number of external factors as well as the exercise of judgment. The $47.7 million adjustment to the fair value of the contingent consideration liability in 2017 was primarily due to a decrease to the Makena contingent consideration based on a revision of our long-term forecast of total projected net Makena sales, which impacted both the amount and timing of future milestone payments. In addition, during 2017 , we paid a $50.0 million sales milestone to the former stockholders of Lumara Health and a $0.2 million royalty payment for MuGard. The fair value of the contingent milestone payments payable by us to the former stockholders of Lumara Health was determined based on our probability-adjusted discounted cash flows estimated to be realized from the net sales of Makena from December 1, 2014 through December 31, 2019. The fair value of the contingent royalty payments payable by us to Abeona under the MuGard License Agreement was determined based on various market factors, including an analysis of estimated sales using a discount rate of approximately 14% as of December 31, 2018 . In addition, as of December 31, 2018 , we estimated that the undiscounted royalty amounts we could pay under the MuGard License Agreement, based on current projections, may range from $0.3 million to $0.6 million over the remainder of the ten year period, which commenced on June 6, 2013, the acquisition date, which is our best estimate of the period over which we expect the majority of the asset’s cash flows to be derived. We believe the estimated fair values of the contingent payments associated with Lumara Health and the MuGard Rights are based on reasonable assumptions, however, our actual results may vary significantly from the estimated results. Debt We estimate the fair value of our debt obligations by using quoted market prices obtained from third-party pricing services, which is classified as a Level 2 input. As of December 31, 2018 , the estimated fair value of the 2022 Convertible Notes and the 2019 Convertible Notes was $294.8 million and $20.9 million , respectively, which differed from their carrying values. As of December 31, 2017 , the estimated fair value of our 2023 Senior Notes (as defined below), the 2022 Convertible Notes and the 2019 Convertible Notes was $463.7 million , $282.9 million and $21.6 million , respectively, which differed from their carrying values. See Note R, “ Debt, ” for additional information on our debt obligations. |
Inventories
Inventories | 12 Months Ended |
Dec. 31, 2018 | |
Inventory Disclosure [Abstract] | |
Inventories | INVENTORIES Our major classes of inventories were as follows as of December 31, 2018 and 2017 (in thousands): December 31, 2018 2017 Raw materials $ 9,388 $ 9,505 Work in process 5,932 4,146 Finished goods 11,371 20,792 Total inventories $ 26,691 $ 34,443 |
Property and Equipment, Net
Property and Equipment, Net | 12 Months Ended |
Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, Net | PROPERTY AND EQUIPMENT, NET Property and equipment, net consisted of the following as of December 31, 2018 and 2017 (in thousands): December 31, 2018 2017 Computer equipment and software $ 1,637 $ 1,401 Furniture and fixtures 1,737 1,442 Leasehold improvements 2,938 2,938 Laboratory and production equipment 6,000 654 Construction in progress 420 5,068 12,732 11,503 Less: accumulated depreciation (5,211 ) (3,599 ) Property and equipment, net $ 7,521 $ 7,904 During 2018 , 2017 and 2016 , depreciation expense was $1.6 million , $1.2 million , and $0.9 million , respectively. |
Goodwill and Intangible Assets,
Goodwill and Intangible Assets, Net | 12 Months Ended |
Dec. 31, 2018 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Goodwill and Intangible Assets, Net | GOODWILL AND INTANGIBLE ASSETS, NET Goodwill Our $422.5 million goodwill balance represents goodwill of the continuing business following the goodwill allocation required by the CBR transaction discussed in Note C, “Discontinued Operations and Held for Sale.” We determined that CBR met the definition of a business and as a result, in accordance with ASC 350 - Intangibles - Goodwill and Other (“ASC 350”), allocated goodwill on a relative fair value basis between CBR and the continuing business for the purposes of determining the carrying value of CBR. As of December 31, 2018 , we had no accumulated impairment losses related to goodwill. We test goodwill at the reporting unit level for impairment on an annual basis and between annual tests if events and circumstances indicate it is more likely than not that the fair value of a reporting unit is less than its carrying value. Events that could indicate impairment and trigger an interim impairment assessment include, but are not limited to, an adverse change in current economic and market conditions, including a significant prolonged decline in market capitalization, a significant adverse change in legal factors, unexpected adverse business conditions, and an adverse action or assessment by a regulator. Our annual impairment test date is October 31. We have determined that we operate in a single operating segment and have a single reporting unit. In performing our goodwill impairment tests during 2018 and 2017 , we utilized the approach prescribed under ASC 350, as amended by ASU 2017-04 which requires that an entity 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. When we perform any goodwill impairment test, the estimated fair value of our reporting unit is determined using an income approach that utilizes a discounted cash flow (“DCF”) model or a market approach, when appropriate, which assesses our market capitalization as adjusted for a control premium, or a combination thereof. The DCF model is based upon expected future after-tax operating cash flows of the reporting unit discounted to a present value using a risk-adjusted discount rate. Estimates of future cash flows require management to make significant assumptions concerning (i) future operating performance, including future sales, long-term growth rates, operating margins, variations in the amount and timing of cash flows and the probability of achieving the estimated cash flows (ii) the probability of regulatory approvals, and (iii) future economic conditions, all of which may differ from actual future cash flows. These assumptions are based on significant inputs not observable in the market and thus represent Level 3 measurements within the fair value hierarchy. The discount rate, which is intended to reflect the risks inherent in future cash flow projections, used in the DCF model, is based on estimates of the weighted average cost of capital (“WACC”) of market participants relative to our reporting unit. Financial and credit market volatility can directly impact certain inputs and assumptions used to develop the WACC. Any changes in these assumptions may affect our fair value estimate and the result of an impairment test. We believe the discount rates and other inputs and assumptions are consistent with those that a market participant would use. In addition, in order to assess the reasonableness of the fair value of our reporting unit as calculated under the DCF model, we also compare the reporting unit’s fair value to our market capitalization and calculate an implied control premium (the excess sum of the reporting unit’s fair value over its market capitalization). We evaluate the implied control premium by comparing it to control premiums of recent comparable market transactions, as applicable. Throughout 2017 , at points during 2018 and as of December 31, 2018 and 2017 , our market capitalization was lower than our stockholders’ equity, or book value. We believe that a market participant buyer would be required to pay a control premium for our business that would cover the difference between our market capitalization and our book value. As described in the accounting guidance for evaluating long-lived assets for impairment, an entity’s fair value may include a control premium in addition to the quoted market price to determine the fair value of a single reporting unit entity, as an acquiring entity is often willing to pay more for equity securities that give it a controlling interest than an investor would pay for a number of equity securities representing less than a controlling interest. This accounting guidance also indicates that the quoted market price of an individual security need not be the sole measurement basis of the fair value of a single reporting unit. 2018 Impairment Testing Results During the second quarter of 2018 , in conjunction with the goodwill allocation required by the CBR transaction and in accordance with ASC 350, we performed a goodwill impairment test to assess whether there were indicators that its fair value was less than its carrying value. As a result of this evaluation, we determined that there was no impairment of goodwill at June 30, 2018. On October 31, 2018 (the “measurement date”), we conducted our 2018 annual goodwill impairment test using a market approach to estimate the fair value of our reporting unit as of the measurement date. We considered our market capitalization, as adjusted for a control premium, to be one indicator of the fair value of our reporting unit. On October 31, 2018, our stock price closed at $21.50 per share, resulting in a market capitalization of approximately $742 million , which was below the carrying amount of our reporting unit as of the measurement date, resulting in an implied control premium of 2% . In the days following our October 31, 2018 annual testing date, our stock price declined, largely in response to our November 1, 2018 earnings release and Company update. This decline resulted in a market capitalization of approximately $633 million on November 5, 2018, resulting in an implied control premium of 20% . During the third quarter of 2018 , we obtained an updated control premium analysis that benchmarked average control premiums paid in prior merger and acquisition transactions among biotechnology and pharmaceutical companies. The analysis indicated that control premiums vary depending on facts and circumstances for each transaction. The range of control premiums observed was between 39% and 96% , with a median of 71% . Management believes that using this market approach of assessing reasonable control premiums provided a sufficient basis to assess whether the fair value of our reporting unit, including a range of reasonable control premiums, was above its carrying amount. Incorporating control premiums in this range to our October 31, 2018 market capitalization of $742 million resulted in a fair value which was at least 36% greater (at the low end of the range) than the carrying amount of our net assets as of October 31, 2018. As a result of this review, we determined that there was no impairment of our goodwill at October 31, 2018. Between October 31, 2018 and December 31, 2018 , our stock price continued to fluctuate, with a median closing stock price of $17.84 per share for the period from November 1, 2018 through December 31, 2018 . The median closing stock price of $17.84 per share resulted in a market capitalization of approximately $617 million , which as compared to the $747 million carrying amount of our reporting unit at December 31, 2018 resulted in an implied control premium of 21% . Incorporating the range of control premiums obtained from the control premium study used in our annual goodwill impairment test at October 31, 2018 to the calculated market capitalization of $617 million resulted in a fair value which was at least 15% greater (at the low end of the range) than the carrying amount of our net assets as of December 31, 2018 . Using the closing stock price of $15.19 per share on December 31, 2018 results in an implied control premium of 41% . This implied control premium is within the range of control premiums observed. As a result of this review, we determined that there was no impairment of our goodwill between our annual goodwill impairment test date and December 31, 2018 . In addition, we determined that there were no other indicators of impairment through December 31, 2018 requiring further assessment. 2017 Impairment Testing Results During the third quarter of 2017 , we determined that the significant reduction in the long-term forecasted cash flows of our largest product, Makena, which led to a $319.2 million impairment of the Makena base technology intangible asset, was an indicator that an interim impairment test of goodwill was necessary at September 30, 2017. We performed a quantitative goodwill impairment test at September 30, 2017 in accordance with ASU 2017-04, to both assess whether a goodwill impairment existed and if so, the amount of the impairment loss. We considered our market capitalization, as adjusted for a control premium, to be one indicator of the fair value of our reporting unit. On September 30, 2017, our stock price closed at $18.45 , resulting in a market capitalization of approximately $653.0 million , which was 18% below the carrying amount of the reporting unit as of September 30, 2017. During the third quarter of 2017, we obtained a control premium analysis which benchmarked average control premiums paid in prior merger and acquisition transactions among biotechnology and pharmaceutical companies. The analysis indicated that control premiums vary depending on facts and circumstances for each transaction. The range of control premiums observed was between 30% and 83% , with a mean of 64% . Management believes that using this market approach of assessing reasonable control premiums provided a sufficient basis to assess whether the fair value of our reporting unit, including a range of reasonable control premiums, was above its carrying amount as of September 30, 2017. Incorporating control premiums in this range to our September 30, 2017 market capitalization of $653.0 million resulted in a fair value which was at least 6% greater (at the low end of the range) than the carrying amount of our net assets as of September 30, 2017. As a result of this review, we determined that there was no impairment of our goodwill at September 30, 2017. On October 31, 2017 (the “measurement date”), we conducted our 2017 annual goodwill impairment test using an income approach, specifically a DCF model, and a market approach to estimate the fair value of our reporting unit as of the measurement date. We used a range of discount rates between 10.0% and 19.5% across our commercial products and product candidates, which resulted in a weighted average discount rate of 13.6% to determine the fair value of our reporting unit. We believe the discount rate and other inputs and assumptions are consistent with those that a market participant would use. In addition, we believe we utilized reasonable estimates and assumptions about future revenues, cost projections, and cash flows as of the measurement date. As a corroborating step in our 2017 annual impairment assessment, we compared our implied control premium, as determined by the difference between the fair value of our reporting unit as estimated by our DCF analysis and our market capitalization, to control premiums of recent comparable market transactions. The results indicated that the implied control premium was within the range of control premiums observed in prior merger and acquisition transactions among biotechnology and pharmaceutical companies. We believe that using this market approach further corroborated our DCF fair value assessment at October 31, 2017. As a result of our DCF analysis, we determined that the fair value of our reporting unit exceeded its carrying value by 18% and as such, no impairment was recorded as of October 31, 2017. In performing a sensitivity analysis, had we increased the weighted average discount rate by 1% , the fair value of the reporting unit would have still exceeded the carrying value. In addition, we determined that there were no other indicators of impairment through December 31, 2017 requiring further assessment. Assumptions related to revenue, growth rates and operating margin are based on management’s annual and ongoing forecasting, budgeting and planning processes and represent our best estimate of the future results of operations across the company as of that point in time. These estimates are subject to many assumptions, such as the economic environment in which our reporting unit operates, expectations of regulatory approval of our products in development or under review with the FDA, demand for our products and competitor actions. If we were to apply different assumptions, or if the outcome of regulatory or other developments, or actual demand for our products and competitor actions, are inconsistent with our assumptions, our estimated discounted future cash flows and the resulting estimated fair value of our reporting unit would increase or decrease, and could result in the fair value of our reporting unit being less than its carrying value in an impairment test. Intangible Assets December 31, 2018 December 31, 2017 Cost Accumulated Amortization Impairments Net Cost Accumulated Amortization Impairments Net Amortizable intangible assets: Makena base technology $ 797,100 $ 400,495 $ 319,246 $ 77,359 $ 797,100 $ 255,754 $ 319,246 $ 222,100 Makena auto-injector developed technology 79,100 6,952 — 72,148 — — — — Intrarosa developed technology 77,655 10,129 — 67,526 77,655 3,376 — 74,279 953,855 417,576 319,246 217,033 874,755 259,130 319,246 296,379 Indefinite-lived intangible assets: Makena IPR&D — — — — 79,100 — — 79,100 Total intangible assets $ 953,855 $ 417,576 $ 319,246 $ 217,033 $ 953,855 $ 259,130 $ 319,246 $ 375,479 The Makena base technology and IPR&D intangible assets were acquired in November 2014 in connection with our acquisition of Lumara Health. During the first quarter of 2018, following the FDA approval of Makena for administration via a pre-filled subcutaneous auto-injector (the “Makena auto-injector”), we reclassified the Makena IPR&D as the Makena auto-injector developed technology and placed it into service. Amortization of the Makena auto-injector developed technology is being recognized on a straight-line basis over 8.8 years . During the third quarter of 2017, we received new information from a variety of sources, including from external consulting firms and our authorized generic partner, regarding the potential competitive landscape for the Makena intramuscular (“IM”) product (the “Makena IM product”) upon loss of orphan drug exclusivity in February 2018. The information received from one of our external consulting firms included competitive intelligence information, which indicated that several generic manufacturers had either likely filed an Abbreviated New Drug Application (“ANDA”) with the FDA in the third quarter of 2017 or were likely to file an ANDA in the fourth quarter of 2017. During the third quarter of 2017, we also began negotiations with our own authorized generic partner and gained industry insight into how the competitive landscape of the market might evolve once multiple generics entered. This information, combined with continued progress on our own authorized generic strategy, was incorporated into our revised long-range revenue forecasts for the Makena IM product during the third quarter of 2017. This new information received in the third quarter, altered our previous assumptions, including the potential number of generic entrants and potential timing of entry following the loss of its orphan drug exclusivity, which significantly impacted our long-term revenue forecast for the Makena IM product. We determined that the revised long-term forecast resulting from the information received in the third quarter of 2017 constituted a triggering event with respect to our Makena base technology intangible asset, which relates solely to the Makena IM product. We estimated that the sum of the undiscounted projected cash flows of the Makena IM product was less than the carrying value of the corresponding intangible asset. Therefore, we reassessed the fair value of the Makena base technology intangible asset using an income approach, a Level 3 measurement technique. We determined that as of September 30, 2017, the fair value of the Makena base technology intangible asset was less than the carrying value and accordingly, we recorded an impairment charge of $319.2 million , which was recorded within a separate operating expense line item in our consolidated statements of operations. Amortization of the Makena base technology asset is being recognized using an economic consumption model. Prior to the third quarter of 2017, this asset was being amortized over 20 years from the acquisition date, which we believed was an appropriate amortization period. During the third quarter of 2017, we reassessed the remaining useful life of the Makena base technology intangible asset. Based on the revised long-term forecast for the Makena IM product, we believe that the substantive period of revenue from the Makena IM asset will be through 2024 and thus concluded that seven years is an appropriate amortization period based on its revised estimated remaining economic life. Accordingly, we prospectively adjusted the remaining useful life of the Makena base technology intangible asset to seven years. Further, during the third and fourth quarters of 2017, we evaluated our Makena IPR&D intangible asset, which is related to the Makena auto-injector, for impairment and concluded that its fair value was greater than its carrying value, and therefore it was not impaired. The Intrarosa developed technology was acquired in April 2017 from Endoceutics. Amortization of the Intrarosa developed technology is being recognized on a straight line basis over 11.5 years. The MuGard Rights were acquired from Abeona in June 2013. Amortization of the MuGard Rights was being recognized using an economic consumption model over ten years from the acquisition date, which represented our best estimate of the period over which we expected the majority of the asset’s cash flows to be derived. During 2016, based on our determination that the fair value of the net MuGard Rights intangible asset was below its book value, we recorded an impairment charge for the full $15.7 million net intangible asset. As of December 31, 2018 , the weighted average remaining amortization period for our finite-lived intangible assets was approximately 7.5 years. Total amortization expense for 2018 , 2017 and 2016 , was $158.4 million , $130.4 million and $72.3 million , respectively. Amortization expense for the Makena base technology, Intrarosa developed technology, and the MuGard Rights is recorded in cost of product sales in our consolidated statements of operations. We expect amortization expense related to our finite-lived intangible assets to be as follows (in thousands): Period Estimated Amortization Expense Year Ending December 31, 2019 $ 41,891 Year Ending December 31, 2020 37,123 Year Ending December 31, 2021 31,022 Year Ending December 31, 2022 27,972 Year Ending December 31, 2023 18,207 Thereafter 60,818 Total $ 217,033 |
Current and Long-Term Liabiliti
Current and Long-Term Liabilities | 12 Months Ended |
Dec. 31, 2018 | |
Payables and Accruals [Abstract] | |
Current and Long-Term Liabilities | CURRENT AND LONG-TERM LIABILITIES Accrued Expenses Accrued expenses consisted of the following as of December 31, 2018 and 2017 (in thousands): December 31, 2018 2017 Commercial rebates, fees and returns $ 80,520 $ 101,852 Professional, license, and other fees and expenses 23,242 23,657 Salaries, bonuses, and other compensation 22,482 15,882 Interest expense 1,067 13,525 Intrarosa-related license fees — 10,000 Accrued research and development 2,226 1,816 Total accrued expenses $ 129,537 $ 166,732 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | INCOME TAXES For the years ended December 31, 2018 , 2017 , and 2016 , all of our profit or loss before income taxes was from U.S. operations. The income tax expense (benefit) consisted of the following (in thousands): Years Ended December 31, 2018 2017 2016 Current: Federal $ (1,136 ) $ 2,162 $ — State 1,469 5,358 4,169 Total current $ 333 $ 7,520 $ 4,169 Deferred: Federal $ 42,886 $ (172,048 ) $ 11,208 State (3,565 ) (10,726 ) (2,206 ) Total deferred $ 39,321 $ (182,774 ) $ 9,002 Total income tax expense (benefit) $ 39,654 $ (175,254 ) $ 13,171 The reconciliation of the statutory U.S. federal income tax rate to our effective income tax rate from continuing operations was as follows: Years Ended December 31, 2018 2017 2016 Statutory U.S. federal tax rate 21.0 % 35.0 % 35.0 % State taxes, net of federal benefit 4.7 3.3 5.4 Impact of 2017 tax reform on deferred tax balance — 4.6 — Equity-based compensation expense (1.5 ) (0.8 ) 16.2 Contingent consideration 7.2 4.4 41.5 Other permanent items, net (1.4 ) (0.5 ) 11.9 Tax credits 6.2 0.7 (19.2 ) Write-down of acquired state net operating losses — — 67.7 Valuation allowance (67.4 ) (0.8 ) (68.3 ) Other, net 0.6 0.2 (3.9 ) Effective tax rate (30.6 )% 46.1 % 86.3 % For the year ended December 31, 2018 , we recognized income tax expense of $39.7 million , representing an effective tax rate of (30.6)% . The difference between the expected statutory federal tax rate of 21.0% and the effective tax rate of (30.6)% for the year ended December 31, 2018 , was primarily attributable to the establishment of a valuation allowance on net deferred tax assets other than refundable AMT credits, the impact of non-deductible stock compensation and other non-deductible expenses, partially offset by a benefit from contingent consideration associated with Lumara Health, state income taxes and orphan drug tax credits. We have established a valuation allowance on our deferred tax assets other than refundable credits to the extent that our existing taxable temporary differences would not be available as a source of income to realize the benefits of those deferred tax assets. The valuation allowance on our deferred tax assets, other than refundable AMT credits, increased during the year ended December 31, 2018 primarily because the deferred tax liabilities associated with the CBR business, which was reclassified to discontinued operations and sold during the year ended December 31, 2018, are no longer available as a source of income to realize the benefits of the net deferred tax assets. On December 22, 2017, the Tax Cuts and Jobs Act (the “2017 Tax Act”), was enacted. The 2017 Tax Act includes significant changes to the U.S. corporate income tax system, including a reduction of the federal corporate income tax rate from 35.0% to 21.0% , effective January 1, 2018. Deferred tax assets and liabilities are measured using enacted rates in effect for the year in which those temporary differences are expected to be recovered or settled. As a result of the reduction in the federal tax rate from 35.0% to 21.0% , we revalued our ending net deferred tax liabilities at December 31, 2017 and recognized a provisional $17.6 million tax benefit. On December 22, 2017, the SEC staff issued Staff Accounting Bulletin No. 118 (“SAB 118”), which allowed us to record provisional amounts for the impact of the 2017 Tax Act during a measurement period which is similar to the measurement period used when accounting for business combinations. During the year ended December 31, 2018, we completed our accounting for the enactment date income tax effects of the 2017 Tax Act in accordance with SAB 118 and recorded immaterial adjustments as a result. For the year ended December 31, 2017 , we recognized an income tax benefit of $175.3 million representing an effective tax rate of 46.1% . The difference between the expected statutory federal tax rate of 35.0% and the 46.1% effective tax rate for 2017 was primarily attributable to the impact of the 2017 federal tax reform legislation, as discussed above, contingent consideration associated with Lumara Health, federal research and orphan drug tax credits generated during the year, and the impact of state income taxes, partially offset by equity-based compensation expenses and an increase to our valuation allowance. For the year ended December 31, 2016 , we recognized income tax expense of $13.2 million representing an effective tax rate of 86.3% . The difference between the statutory tax rate and the effective tax rate was primarily attributable to the impact of contingent consideration associated with Lumara Health, equity-based compensation expenses and other permanent items, including meals and entertainment expense, officer compensation and Makena-related expenses, partially offset by the benefit of the federal research and development and orphan drug tax credits generated during the year. The effective tax rate for the year ended December 31, 2016 reflected the significance of these permanent differences in relation to the pre-tax income for the year ended December 31, 2016. As a result of state tax planning during 2016, we analyzed the acquired state net operating losses (“NOLs”) and determined that a significant portion were not utilizable and should be written down. This write-down was offset with a decrease in the valuation allowance as we had previously determined that it was more likely than not that these NOLs would not be utilized. Deferred tax assets and deferred tax liabilities are recognized based on temporary differences between the financial reporting and tax basis of assets and liabilities using future enacted rates. A valuation allowance is recorded against deferred tax assets if it is more likely than not that some or all of the deferred tax assets will not be realized. The components of our deferred tax assets and liabilities were as follows (in thousands): December 31, 2018 2017 Assets Net operating loss carryforwards $ 46,888 $ 60,308 Tax credit carryforwards 24,290 15,577 Capital loss carryforwards 20,896 — Interest expense carryforwards 4,318 — Equity-based compensation expense 5,931 5,873 Capitalized research & development 4,635 7,872 Intangible assets 12,565 — Reserves 2,683 3,342 Contingent consideration 87 1,406 Other 5,389 5,971 Valuation allowance (113,278 ) (4,740 ) Liabilities Property, plant and equipment depreciation (614 ) (198 ) Intangible assets and inventory — (32,406 ) Debt instruments (12,489 ) (15,744 ) Other (41 ) (141 ) Net deferred tax assets $ 1,260 $ 47,120 The valuation allowance increased by approximately $108.5 million for the year ended December 31, 2018 . We have established a valuation allowance on our deferred tax assets other than refundable AMT credits to the extent that our existing taxable temporary differences would not be available as a source of income to realize the benefits of those deferred tax assets. Our valuation allowance on our deferred tax assets, other than refundable AMT credits, increased during the year ended December 31, 2018 , primarily because the deferred tax liabilities associated with the CBR business, which was reclassified to discontinued operations and sold during 2018, are no longer available as a source of income to realize the benefits of the net deferred tax assets. At December 31, 2018 , we had federal and state NOL carryforwards of approximately $199.0 million and $92.9 million , respectively, of which $123.1 million and $16.6 million federal and state NOL carryforwards, were acquired as part of the Lumara Health transaction, respectively. The federal and state NOLs expire at various dates through 2038 . We have federal tax credits of approximately $23.4 million to offset future tax liabilities of which $2.3 million were acquired as part of the Lumara Health transaction. We have state tax credits of $1.2 million to offset future tax liabilities. These federal and state tax credits will expire periodically through 2038 if not utilized. We have a capital loss carryforward of $90.5 million from the sale of the CBR business that can only be used to offset future capital gains and expires in 2023. Our interest expense carryforward is $17.8 million , which may be carried forward indefinitely. Utilization of our NOLs, interest expense carryforwards, and research and development (“R&D”) credit carryforwards may be subject to a substantial annual limitation due to ownership change limitations that have occurred previously or that could occur in the future in accordance with Section 382 of the Internal Revenue Code of 1986 (“Section 382”) as well as similar state provisions. These ownership changes may limit the amount of NOLs and interest expense carryforwards that can be utilized annually to offset future taxable income and may limit the amounts of R&D credit carryforwards that can be utilized annually to offset taxes. In general, an ownership change as defined by Section 382 results from transactions increasing the ownership of certain shareholders or public groups in the stock of a corporation by more than 50% over a three -year period. Since our formation, we have raised capital through the issuance of capital stock on several occasions. These financings, combined with the purchasing shareholders’ subsequent disposition of those shares, could result in a change of control, as defined by Section 382. We conducted an analysis under Section 382 to determine if historical changes in ownership through December 31, 2018 , based upon publicly available information as of December 31, 2018 , would limit or otherwise restrict our ability to utilize these NOLs, interest expense, and R&D credit carryforwards. As a result of this analysis, we do not believe there are any significant limitations on our ability to utilize these carryforwards. The NOLs and tax credits acquired from Lumara health are subject to restrictions under Section 382. These restricted NOLs and credits may be utilized subject to an annual limitation. We identified two ownership changes associated with the attributes acquired as part of the Lumara Health transaction and determined these attributes are subject to an annual limitation. Future changes in ownership after December 31, 2018 could affect the limitation in future years and any limitation may result in expiration of a portion of the NOL or R&D credit carryforwards before utilization. Unrecognized tax benefits represent uncertain tax positions for which reserves have been established. A reconciliation of our changes in unrecognized tax benefits is as follows (in thousands): Years Ended December 31, 2018 2017 2016 Unrecognized tax benefits at the beginning of the year $ 10,560 $ 13,020 $ 12,695 Additions based on tax positions related to the current year 12 574 300 Additions for tax positions from prior years 608 340 69 Subtractions for federal tax reform — (3,296 ) — Subtractions for tax positions from prior years — (78 ) (44 ) Unrecognized tax benefits at the end of the year $ 11,180 $ 10,560 $ 13,020 The amount of unrecognized tax benefits that would impact the effective tax rate if recognized is immaterial, as the majority of our uncertain tax positions relate to NOL and credit carryforwards, which, if recognized, are currently expected to require a full valuation allowance. Our unrecognized tax benefits as of December 31, 2018 increased by $0.6 million as compared to December 31, 2017 primarily due to tax reserves established on R&D tax credits. Our unrecognized tax benefits as of December 31, 2017 decreased by $2.5 million as compared to December 31, 2016 primarily due to the change in the federal tax rate, which reduced the future value of our federal NOLs and the corresponding value of the unrecognized tax benefits related to those NOLs. This decrease was partially offset by tax reserves established on R&D tax credits. Our unrecognized tax benefits as of December 31, 2016 increased by $0.3 million as compared to December 31, 2015 primarily due to tax reserves established on R&D tax credits. We have recorded minimal interest or penalties on unrecognized tax benefits since inception. We recognize both accrued interest and penalties related to unrecognized tax benefits in income tax expense. We do not expect our unrecognized tax benefits to change significantly in the next 12 months . The statute of limitations for assessment by the Internal Revenue Service (the “IRS”) and most state tax authorities is closed for tax years prior to December 31, 2015, although carryforward attributes that were generated prior to tax year 2015 may still be adjusted upon examination by the IRS or state tax authorities if they either have been or will be used in a future period. We file income tax returns in the U.S. federal and various state jurisdictions. There are currently no federal audits in progress. We have two state audits in progress. We do not expect these audits to result in any material impact. |
Accumulated Other Comprehensive
Accumulated Other Comprehensive Loss | 12 Months Ended |
Dec. 31, 2018 | |
Equity [Abstract] | |
Accumulated Other Comprehensive Loss | ACCUMULATED OTHER COMPREHENSIVE LOSS The following table summarizes the changes in the accumulated balances of other comprehensive loss associated with unrealized (losses) gains on securities during 2018 , 2017 and 2016 (in thousands): December 31, 2018 2017 2016 Beginning balance $ (3,908 ) $ (3,838 ) $ (4,205 ) Other comprehensive loss before reclassifications (77 ) (70 ) 261 Reclassification adjustment for gains included in net loss — — 106 Ending balance $ (3,985 ) $ (3,908 ) $ (3,838 ) |
Equity-Based Compensation
Equity-Based Compensation | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Equity-Based Compensation | EQUITY-BASED COMPENSATION We currently maintain three equity compensation plans, namely our Fourth Amended and Restated 2007 Equity Incentive Plan, as amended (the “2007 Plan”), the Lumara Health Inc. Amended and Restated 2013 Incentive Compensation Plan (the “Lumara Health 2013 Plan”) and our 2015 Employee Stock Purchase Plan (“2015 ESPP”). All outstanding stock options granted under each of our equity compensation plans other than our 2015 ESPP (discussed below) have an exercise price equal to the closing price of a share of our common stock on the grant date. During the fourth quarter of 2017, the then outstanding awards under our Amended and Restated 2000 Stock Plan (the “2000 Plan”) expired. Our 2007 Plan was originally approved by our stockholders in November 2007, and succeeded our 2000 Plan, which has expired and under which no further grants may be made. Any shares that remained available for issuance under the 2000 Plan as of the date of adoption of the 2007 Plan were included in the number of shares that were issued under the 2007 Plan. In addition, any shares subject to outstanding awards granted under the 2000 Plan that expired or terminated for any reason prior to exercise were added to the total number of shares of our stock available for issuance under the 2007 Plan. In June 2018, at our annual meeting of stockholders, our stockholders approved an amendment to our 2007 Plan to, among other things, increase the number of shares of our common stock available for issuance thereunder by 1,043,000 shares. The alloted number of shares available for issuance under the 2007 Plan was 10,537,365 as of December 31, 2018 and there were 2,548,513 shares remaining available for future issuance under the 2007 Plan. As of December 31, 2018 , all outstanding options under the 2007 Plan have either a seven or ten -year term. In November 2014, we assumed the Lumara Health 2013 Plan in connection with the acquisition of Lumara Health. The total number of shares issuable pursuant to awards under this plan as of the effective date of the acquisition and after taking into account any adjustments as a result of the acquisition, was 200,000 shares. As of December 31, 2018 , there were 18,242 shares remaining available for issuance under the Lumara Health 2013 Plan, which are available for grants to certain employees, officers, directors, consultants, and advisers of AMAG and our subsidiaries who are newly-hired or who previously performed services for Lumara Health. All outstanding options under the Lumara Health 2013 Plan have a ten -year term. The 2007 Plan and the Lumara Health 2013 Plan provide for the grant of stock options, RSUs, restricted stock, stock, stock appreciation rights and other equity interests in our company. We generally issue common stock from previously authorized but unissued shares to satisfy option exercises and RSU awards. The terms and conditions of each award are determined by our Board of Directors (the “Board”) or the Compensation Committee of our Board. The terms and conditions of each award assumed in the acquisition of Lumara Health were previously determined by Lumara Health prior to being assumed in connection with the acquisition, subject to applicable adjustments made in connection with such acquisition. In May 2015, our stockholders approved our 2015 ESPP, which authorizes the issuance of up to 200,000 shares of our common stock to eligible employees. In June 2018, at our annual meeting of stockholders, our stockholders approved an amendment to our 2015 ESPP to increase the maximum number of shares of our common stock that will be made available for sale thereunder by 500,000 shares. The terms of the 2015 ESPP permit eligible employees to purchase shares (subject to certain plan and tax limitations) in semi-annual offerings through payroll deductions of up to an annual maximum of 10% of the employee’s “compensation” as defined in the 2015 ESPP. Shares are purchased at a price equal to 85% of the fair market value of our common stock on either the first or last business day of the offering period, whichever is lower. Plan periods consist of six -month periods typically commencing June 1 and ending November 30 and commencing December 1 and ending May 31. As of December 31, 2018 , 259,776 shares have been issued under our 2015 ESPP. During 2018 , we also granted equity through inducement grants outside of our equity compensation plans to certain employees to induce them to accept employment with us (collectively, “Inducement Grants”). The options were granted at an exercise price equal to the fair market value of a share of our common stock on the respective grant dates and will be exercisable in four equal annual installments beginning on the first anniversary of the respective grant dates. The RSU grants will vest in three equal annual installments beginning on the first anniversary of the respective grant dates. The foregoing grants were made pursuant to inducement grants outside of our stockholder approved equity plans as permitted under the NASDAQ Stock Market listing rules. We assessed the terms of these awards and determined there was no possibility that we would have to settle these awards in cash and therefore, equity accounting was applied. Stock Options The following table summarizes stock option activity during 2018 : 2007 Equity 2013 Lumara Inducement Plan Equity Plan Grants Total Outstanding at December 31, 2017 2,590,373 125,536 815,450 3,531,359 Granted 1,047,087 35,400 102,393 1,184,880 Exercised (150,789 ) (2,812 ) — (153,601 ) Expired or terminated (704,885 ) (33,674 ) (107,500 ) (846,059 ) Outstanding at December 31, 2018 2,781,786 124,450 810,343 3,716,579 Restricted Stock Units The following table summarizes RSU activity during 2018 : 2007 Equity 2013 Lumara Inducement Plan Equity Plan Grants Total Outstanding at December 31, 2017 966,623 11,611 91,541 1,069,775 Granted 766,869 1,600 48,418 816,887 Vested (375,470 ) (10,650 ) (52,164 ) (438,284 ) Expired or terminated (316,881 ) (460 ) (2,502 ) (319,843 ) Outstanding at December 31, 2018 1,041,141 2,101 85,293 1,128,535 In March 2018 and February 2017, we granted RSUs under our 2007 Plan to certain members of our senior management covering a maximum of 206,250 and 191,250 shares of common stock, respectively. These performance-based RSUs will vest, if at all, on March 1, 2021 and February 22, 2020, respectively, based on our total shareholder return (“TSR”) performance measured against the median TSR of a defined group of companies over a three -year period. As of December 31, 2018 , the maximum shares of common stock that may be issued under these awards was 188,250 and 153,750 , respectively. The maximum aggregate total fair value of these RSUs is $3.5 million and $3.1 million , respectively, which is being recognized as expense over a period of three years from the date of grant, net of any estimated and actual forfeitures. Equity-based compensation expense Equity-based compensation expense for 2018 , 2017 and 2016 consisted of the following (in thousands): Years Ended December 31, 2018 2017 2016 Cost of product sales $ 802 $ 884 $ 511 Research and development 2,533 3,225 3,475 Selling, general and administrative 16,614 16,187 15,590 Total equity-based compensation expense 19,949 20,296 19,576 Income tax effect — (6,188 ) (5,696 ) After-tax effect of equity-based compensation expense $ 19,949 $ 14,108 $ 13,880 We reduce the compensation expense being recognized to account for estimated forfeitures, which we estimate based primarily on historical experience, adjusted for unusual events such as corporate restructurings, which may result in higher than expected turnover and forfeitures. Under current accounting guidance, forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. The following table summarizes the weighted average assumptions we utilized for purposes of valuing grants of options to our employees and non-employee directors: Years Ended December 31, 2018 2017 2016 Non-Employee Non-Employee Non-Employee Employees Directors Employees Directors Employees Directors Risk free interest rate (%) 2.75 2.70 1.86 1.61 1.32 1.10 Expected volatility (%) 57 59 53 57 49 54 Expected option term (years) 5.0 4.0 5.0 4.0 5.0 3.0 Dividend yield none none none none none none Risk free interest rates utilized are based upon published U.S. Treasury yields at the date of the grant for the expected option term. During 2018 , 2017 and 2016 , we estimated our expected stock price volatility by using the historical volatility of our own common stock price over the prior period equivalent to our expected option term, in order to better reflect expected future volatility. To compute the expected option term, we analyze historical exercise experience as well as expected stock option exercise patterns. The following table summarizes details regarding stock options granted under our equity incentive plans for the year ended December 31, 2018 : December 31, 2018 Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term Aggregate Intrinsic Value Outstanding at beginning of year 3,531,359 $ 28.27 7.2 $ — Granted 1,184,880 21.14 — — Exercised (153,601 ) 19.26 — — Expired and/or forfeited (846,059 ) 35.13 — — Outstanding at end of year 3,716,579 $ 24.81 7.3 $ 694 Outstanding at end of year - vested and unvested expected to vest 3,601,519 $ 24.92 7.2 $ 690 Exercisable at end of year 1,928,239 $ 27.26 5.8 $ 515 The weighted average grant date fair value of stock options granted during 2018 , 2017 and 2016 was $10.76 , $ 9.52 and $10.63 , respectively. A total of 604,886 stock options vested during 2018 . The aggregate intrinsic value of options exercised during 2018 , 2017 and 2016 , excluding purchases made pursuant to our 2015 ESPP, measured as of the exercise date, was approximately $0.6 million , $0.4 million and $1.5 million , respectively. The intrinsic value of a stock option is the amount by which the fair market value of the underlying stock on a specific date exceeds the exercise price of the common stock option. The following table summarizes details regarding RSUs granted under our equity incentive plans for the year ended December 31, 2018 : December 31, 2018 Restricted Stock Units Weighted Average Grant Date Fair Value Outstanding at beginning of year 1,069,775 $ 26.07 Granted 816,887 22.32 Vested (438,284 ) 28.25 Forfeited (319,843 ) 22.86 Outstanding at end of year 1,128,535 $ 23.42 Outstanding at end of year and expected to vest 1,060,647 $ 23.40 The weighted average grant date fair value of RSUs granted during 2018 , 2017 and 2016 was $22.32 , $24.18 and $22.28 , respectively. The total fair value of RSUs that vested during 2018 , 2017 and 2016 was $12.4 million , $12.3 million and $9.1 million , respectively. At December 31, 2018 , the amount of unrecorded equity-based compensation expense for both option and RSU awards, attributable to future periods was approximately $32.7 million . Of this amount, $16.2 million was associated with stock options and is expected to be amortized on a straight-line basis to expense over a weighted average period of approximately 2.7 years, $12.6 million was associated with RSUs and is expected to be amortized on a straight-line basis to expense over a weighted average period of approximately 1.8 years, and $3.9 million was associated with performance-based RSUs and is expected to be amortized on a straight-line basis to expense over a weighted average period of approximately 1.8 years. Such amounts will be amortized primarily to research and development or selling, general and administrative expense. These future estimates are subject to change based upon a variety of future events, which include, but are not limited to, changes in estimated forfeiture rates, employee turnover, and the issuance of new stock options and other equity-based awards. |
Employee Savings Plan
Employee Savings Plan | 12 Months Ended |
Dec. 31, 2018 | |
Retirement Benefits [Abstract] | |
Employee Savings Plan | EMPLOYEE SAVINGS PLAN We provide a 401(k) Plan to our employees by which they may defer compensation for income tax purposes under Section 401(k) of the Internal Revenue Code. Each employee may elect to defer a percentage of his or her salary up to a specified maximum. As of December 31, 2018 our 401(k) Plan provided, among other things, for a company contribution of 4% of each employee’s combined salary and certain other compensation for the plan year. Contributions by us to the 401(k) Plan are not taxable to employees until withdrawn from the 401(k) Plan and contributions are deductible by us when made. The amount of our company contribution for the 401(k) Plan was $4.0 million , $2.3 million and $1.6 million for 2018 , 2017 and 2016 , respectively. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2018 | |
Equity [Abstract] | |
Stockholders' Equity | STOCKHOLDERS’ EQUITY In January 2016, we announced that our Board authorized a program to repurchase up to $60.0 million in shares of our common stock. The repurchase program does not have an expiration date and may be suspended for periods or discontinued at any time. Under the program, we may purchase our stock from time to time at the discretion of management in the open market or in privately negotiated transactions. The number of shares repurchased and the timing of the purchases will depend on a number of factors, including share price, trading volume and general market conditions, along with working capital requirements, general business conditions and other factors. We may also from time to time establish a trading plan under Rule 10b5-1 of the Securities and Exchange Act of 1934 to facilitate purchases of our shares under this program. During 2018 , we did not repurchase shares of common stock under this program. During 2017 , we repurchased and retired 1,366,266 shares of common stock under this repurchase program for $19.5 million , at an average purchase price of $14.27 per share. As of December 31, 2018 and 2017 , $20.5 million remains available for the repurchase of shares under the program. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | COMMITMENTS AND CONTINGENCIES Commitments Our long-term contractual obligations include commitments and estimated purchase obligations entered into in the normal course of business. These include commitments related to our facility and vehicle leases, purchases of inventory, debt obligations, and other purchase obligations. Lease Obligations In June 2013, we entered into a lease agreement with BP Bay Colony LLC (the “Landlord”) for the lease of certain real property located at 1100 Winter Street, Waltham, Massachusetts (the “Waltham Premises”) for use as our principal executive offices. The initial term of the lease was five years and two months with one five -year extension term at our option. We have entered into several amendments to the original lease to add additional space and to extend the term of the original lease to April 2021. In addition to base rent, we are also required to pay a proportionate share of the Landlord’s operating costs. The Landlord agreed to pay for certain agreed-upon improvements to the Waltham Premises and we agreed to pay for any increased costs due to changes by us to the agreed-upon plans. We record all tenant improvements paid by us as leasehold improvements and amortize these improvements over the shorter of the estimated useful life of the improvement or the remaining life of the initial lease term. Amortization of leasehold improvements is included in depreciation expense. In addition, in connection with our facility lease for the Waltham Premises, the Landlord held a security deposit of $0.5 million in the form of an irrevocable letter of credit which is classified on our balance sheet as a long-term asset as of December 31, 2018 and 2017 . We also lease vehicles for our sales employees under a Master Agreement with Enterprise FM Trust. Each vehicle is leased for a three year term, commencing on the delivery date. Rent expense, net of deferred rent amortization, for our leases was $5.1 million , $3.0 million , and $1.6 million for 2018 , 2017 and 2016 , respectively. Future minimum payments under our non-cancelable leases as of December 31, 2018 are as follows (in thousands): Period Future Minimum Lease Payments Year Ending December 31, 2019 $ 5,119 Year Ending December 31, 2020 4,075 Year Ending December 31, 2021 1,034 Year Ending December 31, 2022 — Year Ending December 31, 2023 — Total $ 10,228 Purchase Obligations Purchase obligations primarily represent minimum purchase commitments for inventory. As of December 31, 2018 , our minimum purchase commitments totaled $ 88.7 million . Contingent Consideration Related to Business Combinations In connection with our acquisition of Lumara Health in November 2014, we agreed to pay up to $350.0 million based on the achievement of certain sales milestones, of which $150.0 million has been paid to date. During 2018, we reversed the accrual for a $50.0 million milestone payment based on actual Makena net sales to date and our expectations for future performance, which indicated that achievement of the future milestone was not probable. As we update our analysis in future periods, actual results may vary significantly from the estimated results, which are reliant on a number of external factors as well as the exercise of judgment. Contingent Regulatory and Commercial Milestone Payments In connection with the Endoceutics License Agreement, we are required to pay Endoceutics certain sales milestone payments, including a first sales milestone payment of $15.0 million , which would be triggered when Intrarosa annual net U.S. sales exceed $150.0 million and a second milestone payment of $30.0 million , which would be triggered when annual net U.S. sales of Intrarosa exceed $300.0 million . If annual net U.S. sales of Intrarosa exceed $500.0 million , there are additional sales milestone payments totaling up to $850.0 million , which would be triggered at various sales thresholds. We are also obligated to pay tiered royalties to Endoceutics equal to a percentage of net U.S. sales of Intrarosa ranging from mid-teens for calendar year net sales up to $150.0 million to mid twenty percent for any calendar year net sales that exceed $ 1.0 billion for the commercial life of Intrarosa, with deductions (a) after the later of (i) the expiration date of the last to expire of a licensed patent containing a valid patent claim or (ii) 10 years after the first commercial sale of Intrarosa for the treatment of vulvar and vaginal atrophy (“VVA”) or female sexual dysfunction (“FSD”) in the U.S. (as applicable), (b) for generic competition and (c) for third-party payments, subject to an aggregate cap on such deductions of royalties otherwise payable to Endoceutics. In connection with the license agreement we entered into with Palatin Technologies, Inc. (“Palatin”) in January 2017 (the “Palatin License Agreement”), we are required to pay Palatin up to $380.0 million in regulatory and commercial milestone payments, of which $20.0 million was paid in 2018 following the acceptance by the FDA of our New Drug Application (“NDA”) for Vyleesi. As of December 31, 2018, the remaining potential milestone payments include $60.0 million upon FDA approval of Vyleesi and up to $300.0 million of aggregate sales milestone payments upon the achievement of certain annual net sales over the course of the license. We are also obligated to pay Palatin tiered royalties on annual net sales of Vyleesi and any other products containing Vyleesi (collectively “the Vyleesi Products”), on a product-by-product basis, in the Palatin Territory, as defined below, ranging from the high-single digits to the low double-digits. In September 2018, we exercised our option to acquire the global rights to AMAG-423 pursuant to an option agreement entered into in July 2015 with Velo, the terms of which were amended at the time of exercise. Under the terms of the agreement, we paid Velo an upfront option exercise fee of $12.5 million and are obligated to pay Velo a $30.0 million milestone payment upon FDA approval of AMAG-423. In addition, we are obligated to pay sales milestone payments to Velo of up to $240.0 million in the aggregate, triggered at various annual net sales thresholds between $300.0 million and $900.0 million and low-single digit royalties based on net sales. Further, we have assumed additional obligations under a previous agreement entered into by Velo with a third-party, including a $5.0 million milestone payment upon regulatory approval and $10.0 million following the first commercial sale of AMAG-423, payable in quarterly installments as a percentage of quarterly gross commercial sales until the obligation is met. We are also obligated to pay the third-party low-single digit royalties based on net sales. In connection with a development and license agreement (the “Antares License Agreement”) with Antares Pharma, Inc. (“Antares”), we are required to pay royalties to Antares on net sales of the Makena auto-injector commencing on the launch of the Makena auto-injector in a particular country until the Makena auto-injector is no longer sold or offered for sale in such country or the Antares License Agreement is terminated (the “Antares Royalty Term”). The royalty rates range from high single digit to low double digits and are tiered based on levels of net sales of the Makena auto-injector and decrease after the expiration of licensed patents or where there are generic equivalents to the Makena auto-injector being sold in a particular country. Antares is also entitled to sales-based milestone payments upon the achievement of certain annual net sales. Employment Arrangements We have entered into employment agreements or other arrangements with most of our executive officers and certain other employees, which provide for the continuation of salary and certain benefits and, in certain instances, the acceleration of the vesting of certain equity awards to such individuals in the event that the individual is terminated other than for cause, as defined in the applicable employment agreements or arrangements. Indemnification Obligations As permitted under Delaware law, pursuant to our certificate of incorporation, by-laws and agreements with all of our current directors, executive officers, and certain of our employees, we are obligated to indemnify such individuals for certain events or occurrences while the officer, director or employee is, or was, serving at our request in such capacity. The maximum potential amount of future payments we could be required to make under these indemnification obligations is not capped. Our director and officer insurance policy limits our initial exposure and our policy provides significant coverage. As a result, we believe the estimated fair value of these indemnification obligations is likely to be immaterial. We are also a party to a number of other agreements entered into in the ordinary course of business, which contain typical provisions and which obligate us to indemnify the other parties to such agreements upon the occurrence of certain events. Such indemnification obligations are usually in effect from the date of execution of the applicable agreement for a period equal to the applicable statute of limitations. Our aggregate maximum potential future liability under such indemnification provisions is uncertain. We have not incurred any expenses as a result of such indemnification provisions during the years ended December 31, 2018 , 2017 or 2016 . Accordingly, we have determined that the estimated aggregate fair value of our potential liabilities under such indemnification provisions is not significant, and we have not recorded any liability related to such indemnification. Contingencies Legal Proceedings We accrue a liability for legal contingencies when we believe that it is both probable that a liability has been incurred and that we can reasonably estimate the amount of the loss. We review these accruals and adjust them to reflect ongoing negotiations, settlements, rulings, advice of legal counsel and other relevant information. To the extent new information is obtained and our views on the probable outcomes of claims, suits, assessments, investigations or legal proceedings change, changes in our accrued liabilities would be recorded in the period in which such determination is made. For certain matters referenced below, the liability is not probable or the amount cannot be reasonably estimated and, therefore, accruals have not been made. In addition, in accordance with the relevant authoritative guidance, for any matters in which the likelihood of material loss is at least reasonably possible, we will provide disclosure of the possible loss or range of loss. If a reasonable estimate cannot be made, however, we will provide disclosure to that effect. We expense legal costs as they are incurred. Sandoz Patent Infringement Lawsuit In March 2016, we initiated a patent infringement suit regarding an Abbreviated New Drug Application submitted to the FDA by Sandoz Inc. (“Sandoz”) requesting approval to engage in commercial manufacture, use and sale of a generic version of ferumoxytol. On March 23, 2018, we and Sandoz entered a stipulation of dismissal in the United States District Court for the District of New Jersey pursuant to a settlement agreement that dismissed and resolved this action. According to the terms of the settlement, if Sandoz receives FDA approval by a certain date, Sandoz may launch its generic version of Feraheme on July 15, 2021, or earlier under certain circumstances customary for settlement agreements of this nature. Sandoz will pay a royalty on the sales of its generic version of Feraheme to us until the expiration of the last Feraheme patent listed in the Orange Book. If Sandoz is unable to secure approval by such date, Sandoz will launch an authorized generic version of Feraheme on July 15, 2022 for up to twelve months. Sandoz’s right to distribute, and our obligation to supply, the authorized generic product shall be in accordance with standard commercial terms and profit splits. Other On July 20, 2015, the Federal Trade Commission (the “FTC”) notified us that it is conducting an investigation into whether Lumara Health or its predecessor engaged in unfair methods of competition with respect to Makena or any hydroxyprogesterone caproate product. The FTC noted in its letter that the existence of the investigation does not indicate that the FTC has concluded that Lumara Health or its predecessor has violated the law and we believe that our contracts and practices comply with relevant law and policy, including the federal Drug Quality and Security Act (the “DQSA”), which was enacted in November 2013, and public statements from and enforcement actions by the FDA regarding its implementation of the DQSA. We have provided the FTC with a response providing a brief overview of the DQSA for context, which we believe was helpful, including: (a) how the statute outlined that large-scale compounding of products that are copies or near-copies of FDA-approved drugs (like Makena) is not in the interests of public safety; (b) our belief that the DQSA has had a significant impact on the compounding of hydroxyprogesterone caproate; and (c) how our contracts with former compounders allow those compounders to continue to serve physicians and patients with respect to supplying medically necessary alternative/altered forms of hydroxyprogesterone caproate. We believe we have fully cooperated with the FTC and we have had no further interactions with the FTC on this matter since we provided our response to the FTC in August 2015. On or about April 6, 2016, we received Notice of a Lawsuit and Request to Waive Service of a Summons in a case entitled Plumbers’ Local Union No. 690 Health Plan v. Actavis Group et. al. (“Plumbers’ Union”), which was filed in the Court of Common Pleas of Philadelphia County, First Judicial District of Pennsylvania and, after removal to federal court, is now pending in the United States District Court for the Eastern District of Pennsylvania (Civ. Action No. 16-65-AB). Thereafter, we were also made aware of a related complaint entitled Delaware Valley Health Care Coalition v. Actavis Group et. al. (“Delaware Valley”), which was filed with the Court of Common Pleas of Philadelphia County, First Judicial District of Pennsylvania District Court of Pennsylvania (Case ID: 160200806). The complaints name K-V Pharmaceutical Company (“KV”) (Lumara Health’s predecessor company), certain of its successor entities, subsidiaries and affiliate entities (the “Subsidiaries”), along with a number of other pharmaceutical companies. We acquired Lumara Health in November 2014, a year after KV emerged from bankruptcy protection, at which time it, along with its then existing subsidiaries, became our wholly-owned subsidiary. We have not been served with process or waived service of summons in either case. The actions are being brought alleging unfair and deceptive trade practices with regard to certain pricing practices that allegedly resulted in certain payers overpaying for certain of KV’s generic products. On July 21, 2016, the Plaintiff in the Plumbers’ Union case dismissed KV with prejudice to refiling and on October 6, 2016, all claims against the Subsidiaries were dismissed without prejudice. We are in discussions with Plaintiff’s counsel to similarly dismiss all claims in the Delaware Valley case. Because the Delaware Valley case is in the earliest stages and we have not been served with process in this case, we are currently unable to predict the outcome or reasonably estimate the range of potential loss associated with this matter, if any. We may periodically become subject to other legal proceedings and claims arising in connection with ongoing business activities, including claims or disputes related to patents that have been issued or that are pending in the field of research on which we are focused. Other than the above actions, we are not aware of any material claims against us as of December 31, 2018 or 2017 . |
Collaboration, License and Othe
Collaboration, License and Other Strategic Agreements | 12 Months Ended |
Dec. 31, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Collaboration, License and Other Strategic Agreements | COLLABORATION, LICENSE AND OTHER STRATEGIC AGREEMENTS Our commercial strategy includes expanding our portfolio through the in-license or acquisition of additional pharmaceutical products or companies, including revenue-generating commercial products and development assets. As of December 31, 2018 , we were a party to the following collaborations: Velo As described above in Note P, “ Commitments and Contingencies, ” in September 2018, we exercised our option to acquire the global rights to the AMAG-423 program, which we accounted for as an asset acquisition under ASU No. 2017-01 . Prasco In December 2017, we entered into a Distribution and Supply Agreement (the “Prasco Agreement”) with Prasco, LLC (“Prasco”), under which Prasco was granted an exclusive, non-sublicensable, nontranferable license to purchase, distribute and sell a generic version of Makena in the U.S. (the “Makena authorized generic”). In July 2018, Prasco launched the Makena authorized generic of both the single-dose and multi-dose intramuscular injections. Under the Prasco Agreement, we are responsible for the manufacture and supply of the Makena authorized generic to be sold to Prasco at a predetermined supply price. Prasco is also required to pay us a certain percentage of the net distributable profits from the sale of the Makena authorized generic. We account for revenue recognized under the Prasco Agreement in accordance with ASC 606. Pursuant to the terms of the Prasco Agreement, in certain circumstances we have reimbursed and may be required to reimburse Prasco for additional penalties incurred by Prasco if we fail to supply a certain percentage of product ordered by Prasco in a prespecified timeframe. The Prasco Agreement expires on July 2, 2022, which term will be automatically extended thereafter for additional one year periods, unless canceled by us or Prasco within an agreed upon notice period. The Prasco Agreement is subject to early termination by us for convenience after a certain period of time or if Prasco is subject to a change of control or by either party for, among other things, uncured breach by or bankruptcy of the other party, lack of commercial viability or FDA notice, or by mutual agreement. Antares We are party to the Antares License Agreement, which grants us an exclusive, worldwide, royalty-bearing license, with the right to sublicense, to certain intellectual property rights, including know-how, patents and trademarks, to develop, use, sell, offer for sale and import and export the Makena auto-injector. Under the terms of the Antares License Agreement, as amended in March 2018, we are responsible for the clinical development and preparation, submission and maintenance of all regulatory applications in each country where we desire to market and sell the Makena auto-injector, including the U.S. We are required to pay royalties to Antares on net sales of the Makena auto-injector for the Antares Royalty Term. The royalty rates range from high single digit to low double digits and are tiered based on levels of net sales of the Makena auto-injector and decrease after the expiration of licensed patents or where there are generic equivalents to the Makena auto-injector being sold in a particular country. In addition, we are required to pay Antares sales milestone payments upon the achievement of certain annual net sales. The Antares License Agreement terminates at the end of the Antares Royalty Term, but is subject to early termination by us for convenience and by either party upon an uncured breach by or bankruptcy of the other party. In March 2018, the Antares License Agreement was amended to, among other things, transfer the agreement to AMAG from our subsidiary, amend certain confidentiality provisions, and to provide for co-termination with the Antares Manufacturing Agreement (described below). We are also party to a Manufacturing Agreement with Antares (the “Antares Manufacturing Agreement”) that sets forth the terms and conditions pursuant to which Antares agreed to sell to us on an exclusive basis, and we agreed to purchase, the fully packaged Makena auto-injector for commercial distribution. Antares remains responsible for the manufacture and supply of the device components and assembly of the Makena auto-injector. We are responsible for the supply of the drug to be used in the assembly of the finished auto-injector product. The Antares Manufacturing Agreement terminates at the expiration or earlier termination of the Antares License Agreement, but is subject to early termination by us for certain supply failure situations, and by either party upon an uncured breach by or bankruptcy of the other party or our permanent cessation of commercialization of the Makena auto-injector for efficacy or safety reasons. Endoceutics In February 2017, we entered into the Endoceutics License Agreement with Endoceutics. Pursuant to the Endoceutics License Agreement, Endoceutics granted us the right to develop and commercialize pharmaceutical products containing dehydroepiandrosterone (“DHEA”), including Intrarosa, at dosage strengths of 13 mg or less per dose and formulated for intravaginal delivery, excluding any combinations with other active pharmaceutical ingredients, in the U.S. for the treatment of VVA and FSD. The transactions contemplated by the Endoceutics License Agreement closed on April 3, 2017. We accounted for the Endoceutics License Agreement as an asset acquisition under ASU 2017-01 . Upon the closing of the Endoceutics License Agreement, we made an upfront payment of $50.0 million and issued 600,000 shares of unregistered common stock to Endoceutics, which had a value of $13.5 million , as measured on April 3, 2017, the date of closing. In addition, we paid Endoceutics $10.0 million in the third quarter of 2017 upon the delivery by Endoceutics of Intrarosa launch quantities and $10.0 million in 2018 following the first anniversary of the closing. In the second quarter of 2017, we recorded a total of $83.5 million of consideration, of which $77.7 million was allocated to the Intrarosa developed technology intangible asset and $5.8 million was recorded as IPR&D expense based on their relative fair values. In addition, we also pay tiered royalties to Endoceutics equal to a percentage of net sales of Intrarosa in the U.S. ranging from mid-teens for calendar year net sales up to $150.0 million to mid twenty percent for any calendar year net sales that exceed $1.0 billion for the commercial life of Intrarosa, with deductions (a) after the later of (i) the expiration date of the last to expire of a licensed patent containing a valid patent claim or (ii) 10 years after the first commercial sale of Intrarosa for the treatment of VVA or FSD in the U.S. (as applicable), (b) for generic competition and (c) for third-party payments, subject to an aggregate cap on such deductions of royalties otherwise payable to Endoceutics. Endoceutics is also eligible to receive certain sales milestone payments, including a first sales milestone payment of $15.0 million , which would be triggered when Intrarosa annual net U.S. sales exceed $150.0 million , and a second milestone payment of $30.0 million , which would be triggered when annual net U.S. sales of Intrarosa exceed $300.0 million . If annual net U.S. sales of Intrarosa exceed $500.0 million , there are additional sales milestone payments totaling up to $850.0 million , which would be triggered at various sales thresholds. In the third quarter of 2017, Endoceutics initiated a clinical study with Intrarosa for the treatment of HSDD in post-menopausal women, which is now fully enrolled. Upon review of the full data set, it will be determined whether to continue to pursue an additional clinical trial to support an eventual filing with the FDA for an HSDD indication. We have agreed to share the direct costs related to such studies based upon a negotiated allocation with us funding up to $20.0 million , of which we have paid approximately $6.0 million . We have the exclusive right to commercialize Intrarosa for the treatment of VVA and FSD in the U.S., subject to the terms of the Endoceutics License Agreement. We have agreed to use commercially reasonable efforts to market, promote and otherwise commercialize Intrarosa for the treatment of VVA and, if approved, FSD in the U.S. Endoceutics has the right to directly conduct additional commercialization activities for Intrarosa for the treatment of VVA and FSD in the U.S. and has the right to conduct activities related generally to the field of intracrinology, in each case, subject to our review and approval and our right to withhold approval in certain instances. Each party’s commercialization activities and budget are described in a commercialization plan, which is updated annually. In April 2017, we entered into an exclusive commercial supply agreement with Endoceutics pursuant to which Endoceutics, itself or through affiliates or contract manufacturers, agreed to manufacture and supply Intrarosa to us (the “Endoceutics Supply Agreement”) and is our exclusive supplier of Intrarosa in the U.S., subject to certain rights for us to manufacture and supply Intrarosa in the event of a cessation notice or supply failure (as such terms are defined in the Endoceutics Supply Agreement). Under the Endoceutics Supply Agreement, Endoceutics has agreed to maintain at all times a second source supplier for the manufacture of DHEA and the drug product and to identify, validate and transfer manufacturing intellectual property to the second source supplier by April 2019. The Endoceutics Supply Agreement will generally remain in effect until the termination of the Endoceutics License Agreement. The Endoceutics License Agreement expires on the date of expiration of all royalty obligations due thereunder unless earlier terminated in accordance with the Endoceutics License Agreement. Palatin In January 2017, we entered into the Palatin License Agreement with Palatin under which we acquired (a) an exclusive license in all countries of North America (the “Palatin Territory”), with the right to grant sub-licenses, to research, develop and commercialize the Vyleesi Products, an investigational product designed to be a treatment for HSDD in pre-menopausal women, (b) a worldwide non-exclusive license, with the right to grant sub-licenses, to manufacture the Vyleesi Products, and (c) a non-exclusive license in all countries outside the Palatin Territory, with the right to grant sub-licenses, to research and develop (but not commercialize) the Vyleesi Products. The transaction closed in February 2017 and was accounted for as an asset acquisition under ASU 2017-01. Under the terms of the Palatin License Agreement, in February 2017 we paid Palatin $60.0 million as a one-time upfront payment and subject to agreed-upon deductions reimbursed Palatin approximately $25.0 million for reasonable, documented, out-of-pocket expenses incurred by Palatin in connection with the development and regulatory activities necessary to submit an NDA in the U.S. for Vyleesi for the treatment of HSDD in pre-menopausal women. During 2017, we fulfilled these payment obligations to Palatin. The $60.0 million upfront payment made in February 2017 to Palatin was recorded as IPR&D expense as the product candidate had not received regulatory approval. In June 2018, our NDA submission to the FDA for Vyleesi was accepted, which triggered a $20.0 million milestone payment, which we paid in the second quarter of 2018 and recorded as an IPR&D expense in the first quarter of 2018 when acceptance was deemed probable. In addition, the Palatin License Agreement requires us to make contingent payments of (a) $60.0 million upon FDA approval of Vyleesi, and (b) up to $300.0 million of aggregate sales milestone payments upon the achievement of certain annual net sales milestones over the course of the license. The first sales milestone payment of $25.0 million will be triggered when Vyleesi annual net sales exceed $250.0 million . We are also obligated to pay Palatin tiered royalties on annual net sales in North America of the Vyleesi Products, on a product-by-product basis, in the Palatin Territory ranging from the high-single digits to the low double-digits. The royalties will expire on a product-by-product and country-by-country basis upon the latest to occur of (a) the earliest date on which there are no valid claims of Palatin patent rights covering such Vyleesi Product in such country, (b) the expiration of the regulatory exclusivity period for such Vyleesi Product in such country and (c) 10 years following the first commercial sale of such Vyleesi Product in such country. These royalties are subject to reduction in the event that: (x) we must license additional third-party intellectual property in order to develop, manufacture or commercialize a Vyleesi Product or (y) generic competition occurs with respect to a Vyleesi Product in a given country, subject to an aggregate cap on such deductions of royalties otherwise payable to Palatin. After the expiration of the applicable royalties for any Vyleesi Product in a given country, the license for such Vyleesi Product in such country would become a fully paid-up, royalty-free, perpetual and irrevocable license. The Palatin License Agreement expires on the date of expiration of all royalty obligations due thereunder, unless earlier terminated in accordance with the Palatin License Agreement. Abeona In June 2013, we entered into the MuGard License Agreement under which Abeona granted us an exclusive, royalty-bearing license, with the right to grant sublicenses, to certain intellectual property rights, including know-how, patents and trademarks, to use, import, offer for sale, sell, manufacture and commercialize MuGard in the U.S. and its territories and possessions (the “MuGard Territory”) for the management of oral mucositis/stomatitis (that may be caused by radiotherapy and/or chemotherapy) and all types of oral wounds (mouth sores and injuries), including certain ulcers/canker sores and traumatic ulcers, such as those caused by oral surgery or ill-fitting dentures or braces. In consideration for the license, we paid Abeona an upfront license fee of $3.3 million in June 2013. We are required to pay royalties to Abeona on net sales of MuGard in the MuGard Territory until the later of (a) the expiration of the licensed patents or (b) the tenth anniversary of the first commercial sale of MuGard in the MuGard Territory (the “MuGard Royalty Term”). These tiered, double-digit royalty rates decrease after the expiration of the licensed patents. After the expiration of the MuGard Royalty Term, the license shall become a fully paid-up, royalty-free and perpetual license in the MuGard Territory. Abeona remains responsible for the manufacture of MuGard and we have entered into a quality agreement and a supply agreement under which we purchase MuGard inventory from them. Our inventory purchases are at the price actually paid by Abeona to purchase it from a third-party plus a mark-up to cover administration, handling and overhead. Abeona is responsible for maintenance of the licensed patents at its own expense, and we retain the first right to enforce any licensed patent against third-party infringement. The MuGard License Agreement terminates at the end of the MuGard Royalty Term, but is subject to early termination by us for convenience and by either party upon an uncured breach by or bankruptcy of the other party. |
Debt
Debt | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
Debt | DEBT Our outstanding debt obligations as of December 31, 2018 and December 31, 2017 consisted of the following (in thousands): December 31, 2018 2017 2023 Senior Notes $ — $ 466,291 2022 Convertible Notes 261,933 248,194 2019 Convertible Notes 21,276 20,198 Total long-term debt 283,209 734,683 Less: current maturities 21,276 — Long-term debt, net of current maturities $ 261,933 $ 734,683 2023 Senior Notes In August 2015, in connection with the CBR acquisition, we completed a private placement of $500 million aggregate principal amount of 7.875% Senior Notes due 2023 (the “2023 Senior Notes”). The 2023 Senior Notes were issued pursuant to an Indenture, dated as of August 17, 2015 (the “Indenture”), by and among us, certain of our subsidiaries acting as guarantors of the 2023 Senior Notes and Wilmington Trust, National Association, as trustee. In October 2017, we repurchased $25.0 million of the 2023 Senior Notes in a privately negotiated transaction, resulting in a loss on extinguishment of debt of $1.1 million . In September 2018, we repurchased the remaining $475.0 million of the 2023 Senior Notes at a premium of $28.1 million using the proceeds from the CBR sale, which resulted in a loss on extinguishment of debt of $35.9 million , inclusive of the premium paid. Convertible Notes The outstanding balances of our Convertible Notes as of December 31, 2018 consisted of the following (in thousands): 2022 Convertible Notes 2019 Convertible Notes Total Liability component: Principal $ 320,000 $ 21,417 $ 341,417 Less: debt discount and issuance costs, net 58,067 141 58,208 Net carrying amount $ 261,933 $ 21,276 $ 283,209 Gross equity component $ 72,576 $ 9,905 $ 82,481 In accordance with accounting guidance for debt with conversion and other options, we separately account for the liability and equity components of our Convertible Notes by allocating the proceeds between the liability component and the embedded conversion option (the “Equity Component”) due to our ability to settle the Convertible Notes in cash, common stock or a combination of cash and common stock, at our option. The carrying amount of the liability components was calculated by measuring the fair value of a similar liability that does not have an associated convertible feature. The allocation was performed in a manner that reflected our non-convertible debt borrowing rate for similar debt. The Equity Component of the Convertible Notes was recognized as a debt discount and represents the difference between the proceeds from the issuance of the Convertible Notes and the fair value of the liability of the Convertible Notes on their respective dates of issuance. The excess of the principal amount of the liability component over its carrying amount (the “Debt Discount”) is amortized to interest expense using the effective interest method over five years. The Equity Component is not remeasured as long as it continues to meet the conditions for equity classification. 2022 Convertible Notes In the second quarter of 2017, we issued $320.0 million aggregate principal amount of convertible senior notes due in 2022 (the “2022 Convertible Notes”) and received net proceeds of $310.4 million from the sale of the 2022 Convertible Notes, after deducting fees and expenses of $9.6 million . The approximately $9.6 million of debt issuance costs primarily consisted of underwriting, legal and other professional fees, and allocated these costs to the liability and equity components based on the allocation of the proceeds. Of the total $9.6 million of debt issuance costs, $2.2 million was allocated to the Equity Component and recorded as a reduction to additional paid-in capital and $7.4 million was allocated to the liability component and is now recorded as a reduction of the 2022 Convertible Notes in our consolidated balance sheet. The portion allocated to the liability component is amortized to interest expense using the effective interest method over five years. The 2022 Convertible Notes are governed by the terms of an indenture between us, as issuer, and Wilmington Trust, National Association, as the trustee. The 2022 Convertible Notes are senior unsecured obligations and bear interest at a rate of 3.25% per year, payable semi-annually in arrears on June 1 and December 1 of each year, beginning on December 1, 2017. The 2022 Convertible Notes will mature on June 1, 2022 , unless earlier repurchased or converted. Upon conversion of the 2022 Convertible Notes, such 2022 Convertible Notes will be convertible into, at our election, cash, shares of our common stock, or a combination thereof, at a conversion rate of 36.5464 shares of common stock per $1,000 principal amount of the 2022 Convertible Notes, which corresponds to an initial conversion price of approximately $27.36 per share of our common stock. The conversion rate is subject to adjustment from time to time upon the occurrence of certain events, including, but not limited to, the issuance of stock dividends and payment of cash dividends. At any time prior to the close of business on the business day immediately preceding March 1, 2022, holders may convert their 2022 Convertible Notes at their option only under the following circumstances: 1) during any calendar quarter (and only during such calendar quarter) commencing after the calendar quarter ending September 30, 2017, if the last reported sale price of our common stock for at least 20 trading days (whether or not consecutive) during a period of 30 consecutive trading days ending on the last trading day of the immediately preceding calendar quarter is greater than or equal to 130% of the conversion price on each applicable trading day; 2) during the five business day period after any five consecutive trading day period (the “measurement period”) in which the trading price per $1,000 principal amount of the 2022 Convertible Notes for each trading day of the measurement period was less than 98% of the product of the last reported sale price of our common stock and the conversion rate on each such trading day; or 3) upon the occurrence of specified corporate events. On or after March 1, 2022, until the close of business on the business day immediately preceding the maturity date, holders may convert all or any portion of their 2022 Convertible Notes, in multiples of $1,000 principal amount, at the option of the holder regardless of the foregoing circumstances. The 2022 Convertible Notes were not convertible as of December 31, 2018 . We determined the expected life of the debt was equal to the five -year term on the 2022 Convertible Notes. The effective interest rate on the liability component was 9.49% for the period from the date of issuance through December 31, 2018 . As of December 31, 2018 , the “if-converted value” did not exceed the remaining principal amount of the 2022 Convertible Notes. 2019 Convertible Notes In February 2014, we issued $200.0 million aggregate principal amount of the 2019 Convertible Notes. We received net proceeds of $193.3 million from the sale of the 2019 Convertible Notes, after deducting fees and expenses of $6.7 million . We used $14.1 million of the net proceeds from the sale of the 2019 Convertible Notes to pay the cost of the convertible bond hedges, as described below (after such cost was partially offset by the proceeds to us from the sale of warrants in the warrant transactions described below). In May 2017 and September 2017, we entered into privately negotiated transactions with certain investors to repurchase approximately $158.9 million and $19.6 million , respectively, aggregate principal amount of the 2019 Convertible Notes for an aggregate repurchase price of approximately $171.3 million and $21.4 million , respectively, including accrued interest. Pursuant to ASC Topic 470, Debt (“ASC 470”), the accounting for the May 2017 repurchase of the 2019 Convertible Notes was evaluated on a creditor-by-creditor basis with regard to the 2022 Convertible Notes to determine modification versus extinguishment accounting. We concluded that the May 2017 repurchase of the 2019 Convertible Notes should be accounted for as an extinguishment and we recorded a debt extinguishment gain of $0.2 million related to the difference between the consideration paid, the fair value of the liability component and carrying values at the repurchase date. As a result of the September 2017 repurchase of the 2019 Convertible Notes, we recorded a debt extinguishment loss of $0.3 million related to the difference between the consideration paid, the fair value of the liability component and carrying value at the repurchase date. The 2019 Convertible Notes are governed by the terms of an indenture between us, as issuer, and Wilmington Trust, National Association, as the trustee. The 2019 Convertible Notes are senior unsecured obligations and bear interest at a rate of 2.5% per year, payable semi-annually in arrears on February 15 and August 15 of each year. The 2019 Convertible Notes will mature on February 15, 2019 unless earlier repurchased or converted. Upon conversion of the remaining 2019 Convertible Notes, such 2019 Convertible Notes will be convertible into, at our election, cash, shares of our common stock, or a combination thereof, at a conversion rate of 36.9079 shares of common stock per $1,000 principal amount of the 2019 Convertible Notes, which corresponds to an initial conversion price of approximately $27.09 per share of our common stock. The conversion rate is subject to adjustment from time to time upon the occurrence of certain events, including, but not limited to, the issuance of stock dividends and payment of cash dividends. On or after May 15, 2018 until the close of business on the second scheduled trading day immediately preceding the maturity date, holders may convert all or any portion of their 2019 Convertible Notes, in multiples of $1,000 principal amount, at the option of the holder, regardless of the foregoing circumstances. The 2019 Convertible Notes were convertible as of December 31, 2018 . We determined the expected life of the debt was equal to the five -year term of the 2019 Convertible Notes. The effective interest rate on the liability component was 7.79% for the period from the date of issuance through December 31, 2018 . As of December 31, 2018 , the “if-converted value” did not exceed the remaining principal amount of the 2019 Convertible Notes. Convertible Notes Interest Expense The following table sets forth total interest expense recognized related to the Convertible Notes during 2018 , 2017 , and 2016 (in thousands): Years Ended December 31, 2018 2017 2016 Contractual interest expense $ 10,935 $ 8,961 $ 5,000 Amortization of debt issuance costs 1,403 1,275 1,072 Amortization of debt discount 13,414 11,071 7,544 Total interest expense $ 25,752 $ 21,307 $ 13,616 Convertible Bond Hedge and Warrant Transactions In connection with the pricing of the 2019 Convertible Notes and in order to reduce the potential dilution to our common stock and/or offset cash payments due upon conversion of the 2019 Convertible Notes, in February 2014 we entered into convertible bond hedge transactions and separate warrant transactions of our common stock underlying the aggregate principal amount of the 2019 Convertible Notes with certain financial institutions (the “call spread counterparties”). In connection with the May 2017 and September 2017 repurchases of the 2019 Convertible Notes, as discussed above, we entered into agreements with the call spread counterparties to terminate a portion of the then existing convertible bond hedge transactions in an amount corresponding to the amount of such 2019 Convertible Notes repurchased and to terminate a portion of the then-existing warrant transactions. As of December 31, 2018 , the remaining bond hedge transactions covered approximately 0.8 million shares of our common stock underlying the remaining $21.4 million principal amount of the 2019 Convertible Notes. The convertible bond hedges have an exercise price of approximately $27.09 per share, subject to adjustment upon certain events, and are exercisable when and if the 2019 Convertible Notes are converted. If upon conversion of the 2019 Convertible Notes, the price of our common stock is above the exercise price of the convertible bond hedges, the call spread counterparties will deliver shares of our common stock and/or cash with an aggregate value approximately equal to the difference between the price of our common stock at the conversion date and the exercise price, multiplied by the number of shares of our common stock related to the convertible bond hedges being exercised. The convertible bond hedges were separate transactions entered into by us and were not part of the terms of the 2019 Convertible Notes or the warrants, discussed below. Holders of the 2019 Convertible Notes will not have any rights with respect to the convertible bond hedges. As of December 31, 2018 , the remaining warrant transactions covered approximately 1.0 million shares of our common stock underlying the remaining $21.4 million principal amount of the 2019 Convertible Notes. The initial exercise price of the warrants is $34.12 per share, subject to adjustment upon certain events, which was 70% above the last reported sale price of our common stock of $20.07 on February 11, 2014. The warrants would separately have a dilutive effect to the extent that the market value per share of our common stock, as measured under the terms of the warrants, exceeds the applicable exercise price of the warrants. The warrants were issued to the call spread counterparties pursuant to the exemption from registration set forth in Section 4(a)(2) of the Securities Act of 1933, as amended. As part of the May 2017 agreements to partially terminate the bond hedge and warrant transactions, we received approximately $0.3 million , which we recorded as a net increase to additional paid-in capital during 2017. 2015 Term Loan Facility In August 2015, we entered into a credit agreement with a group of lenders, including Jefferies Finance LLC as administrative and collateral agent, that provided us with, among other things, a six -year $350.0 million term loan facility, under which we borrowed the full amount (the “2015 Term Loan Facility”). The 2015 Term Loan Facility included an annual mandatory prepayment of the debt in an amount equal to 50% of our excess cash flow (as defined in the 2015 Term Loan Facility) as measured on an annual basis, beginning with the year ended December 31, 2016. We prepaid $3.0 million of the debt in April 2017. In May 2017, we repaid the remaining $321.8 million of outstanding borrowings and accrued interest of the 2015 Term Loan Facility and, in accordance with ASC 470, recognized a $9.7 million loss on debt extinguishment. Future Payments Future annual principal payments on our long-term debt as of December 31, 2018 were as follows (in thousands): Period Future Annual Principal Payments Year Ending December 31, 2019 $ 21,417 Year Ending December 31, 2020 — Year Ending December 31, 2021 — Year Ending December 31, 2022 320,000 Thereafter — Total $ 341,417 |
Consolidated Quarterly Financia
Consolidated Quarterly Financial Data - Unaudited | 12 Months Ended |
Dec. 31, 2018 | |
Condensed Financial Information Disclosure [Abstract] | |
Consolidated Quarterly Financial Data - Unaudited | CONSOLIDATED QUARTERLY FINANCIAL DATA - UNAUDITED The following tables provide unaudited consolidated quarterly financial data for 2018 and 2017 (in thousands, except per share data): March 31, 2018 June 30, 2018 September 30, 2018 December 31, 2018 Total revenues $ 117,387 $ 146,254 $ 122,238 $ 88,122 Gross profit 53,475 69,478 75,749 59,406 Operating expenses (2) 104,239 27,591 95,084 78,241 Net loss from continuing operations $ (58,098 ) $ (25,817 ) $ (64,678 ) $ (20,746 ) Net income (loss) from discontinued operations $ 3,856 $ 5,736 $ 95,517 $ (1,531 ) Net (loss) income $ (54,242 ) $ (20,081 ) $ 30,839 $ (22,277 ) Basic net (loss) income per share: Loss from continuing operations $ (1.70 ) $ (0.75 ) $ (1.88 ) $ (0.60 ) Income (loss) from discontinued operations 0.11 0.17 2.77 (0.04 ) Total $ (1.59 ) $ (0.58 ) $ 0.89 $ (0.64 ) Diluted net (loss) income per share: Loss from continuing operations $ (1.70 ) $ (0.75 ) $ (1.88 ) $ (0.60 ) Income (loss) from discontinued operations 0.11 0.17 2.77 (0.04 ) Total $ (1.59 ) $ (0.58 ) $ 0.89 $ (0.64 ) March 31, 2017 June 30, 2017 September 30, 2017 December 31, 2017 Total revenues $ 112,541 $ 130,371 $ 124,331 $ 128,525 Gross profit (loss) (1) 84,968 98,270 (226,000 ) 57,938 Operating expenses (3) 125,112 95,003 28,236 70,663 Net (loss) income from continuing operations $ (35,925 ) $ (14,252 ) $ (155,713 ) $ 738 Net (loss) income from discontinued operations $ (635 ) $ 186 $ 3,652 $ 2,722 Net (loss) income $ (36,560 ) $ (14,066 ) $ (152,061 ) $ 3,460 Basic net (loss) income per share: (Loss) income from continuing operations $ (1.04 ) $ (0.41 ) $ (4.41 ) $ 0.02 (Loss) income from discontinued operations (0.02 ) 0.01 0.10 0.08 Total $ (1.06 ) $ (0.40 ) $ (4.31 ) $ 0.10 Diluted net (loss) income per share: (Loss) income from continuing operations $ (1.04 ) $ (0.41 ) $ (4.41 ) $ 0.02 (Loss) income from discontinued operations (0.02 ) 0.01 0.10 0.08 Total $ (1.06 ) $ (0.40 ) $ (4.31 ) $ 0.10 The sum of quarterly (loss) income per share totals differ from annual (loss) income per share totals due to rounding. (1) Gross profit (loss) for the third quarter of 2017 included an impairment charge of $319.2 million relating to the Makena base technology intangible asset. (2) Operating expenses for the second quarter of 2018 include the reversal of $49.8 million relating to the fair value of a contingent consideration liability that was no longer expected to be paid. (3) Operating expenses for the first quarter of 2017 include $60.0 million of acquired IPR&D expense related to the one-time upfront payment under the terms of the Palatin License Agreement. Operating expenses for the third quarter of 2017 include the reversal of $49.9 million relating to the fair value of a contingent consideration liability that was no longer expected to be paid. |
Valuation And Qualifying Accoun
Valuation And Qualifying Accounts (In Thousands) | 12 Months Ended |
Dec. 31, 2018 | |
SEC Schedule, 12-09, Valuation and Qualifying Accounts [Abstract] | |
Valuation And Qualifying Accounts (In Thousands) | VALUATION AND QUALIFYING ACCOUNTS (IN THOUSANDS) Balance at Beginning of Period Additions (2) Deductions Charged to Reserves Balance at End of Period Year ended December 31, 2018: Accounts receivable allowances (1) $ 12,060 $ 229,509 $ (232,026 ) $ 9,543 Rebates, fees and returns reserves (2) $ 100,702 $ 270,959 $ (294,891 ) $ 76,770 Valuation allowance for deferred tax assets (3) $ 4,740 $ 108,562 $ (24 ) $ 113,278 Year ended December 31, 2017: Accounts receivable allowances (1) $ 9,533 $ 168,945 $ (166,418 ) $ 12,060 Rebates, fees and returns reserves (2) $ 89,466 $ 255,471 $ (244,235 ) $ 100,702 Valuation allowance for deferred tax assets (3) $ 1,429 $ 3,875 $ (564 ) $ 4,740 Year ended December 31, 2016: Accounts receivable allowances (1) $ 10,783 $ 122,792 $ (124,042 ) $ 9,533 Rebates, fees and returns reserves (2) $ 45,162 $ 186,941 $ (142,637 ) $ 89,466 Valuation allowance for deferred tax assets (3) $ 11,859 $ 632 $ (11,062 ) $ 1,429 ________________________ (1) Accounts receivable allowances represent discounts and other chargebacks related to the provision of our product sales. (2) Additions to rebates, fees and returns reserves are recorded as a reduction of revenues. (3) As of December 31, 2018 , we have established a valuation allowance on our net deferred tax assets other than refundable AMT credits. At December 31, 2017, our valuation allowance related primarily to certain of our state NOL and credit carryforwards. At December 31, 2016, our valuation allowance related primarily to our federal capital loss carryforward and our state NOL and credit carryforwards acquired from Lumara Health. |
Recently Issued and Proposed Ac
Recently Issued and Proposed Accounting Pronouncements | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Changes and Error Corrections [Abstract] | |
Recently Issued and Proposed Accounting Pronouncements | RECENTLY ISSUED AND PROPOSED ACCOUNTING PRONOUNCEMENTS From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that are adopted by us as of the specified effective date. In August 2018, the FASB issued ASU No. 2018-13, Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement (“ASU 2018-13”). This standard eliminates, adds and modifies certain disclosure requirements for fair value measurements as part of its disclosure framework project. ASU 2018-13 is effective for annual reporting periods beginning after December 15, 2019 and interim periods within those annual periods and early adoption is permitted. We are currently evaluating the impact of our adoption of ASU 2018-13 on our consolidated financial statements. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). This standard requires entities to measure all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions and reasonable and supportable forecasts. ASU 2016-13 is effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years and early adoption is permitted. We are currently evaluating the impact of our adoption of ASU 2016-13 in our consolidated financial statements. In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) . This statement requires entities to recognize on its balance sheet assets and liabilities associated with the rights and obligations created by leases with terms greater than twelve months. This update is effective for annual reporting periods beginning after December 15, 2018, which for us is the period beginning January 1, 2019. During the fourth quarter of 2018, we finalized our assessments over the impact that these new standards will have on our consolidated results of operations, financial position and disclosures and are finalizing our accounting policies. As of December 31, 2018, we have not identified any accounting changes that would impact our results of operations or cash flows. However, we expect to recognize material right-of-use assets and lease liabilities related to our operating lease commitments. We currently plan to adopt this standard using the “modified retrospective approach” and follow the related transition option that allows for application of the transition provisions of the standard at the beginning of the period of adoption. In addition, we currently plan to utilize the package of available transition practical expedients. There are also certain considerations related to internal control over financial reporting that are associated with implementing Topic 842. We are evaluating our internal control framework over leases to identify any changes that may need to be made in response to the new guidance. In addition, financial statement disclosures under the new guidance in Topic 842 will be expanded in comparison to the disclosure requirements under the current guidance. We will have completed the design and implementation of the appropriate controls to obtain and disclose the information required under Topic 842 in our first quarter of 2019. |
Recently Adopted Accounting Pro
Recently Adopted Accounting Pronouncements (Notes) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Changes and Error Corrections [Abstract] | |
Recently Adopted Accounting Pronouncements | RECENTLY ADOPTED ACCOUNTING PRONOUNCEMENTS In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606) , which superseded all existing revenue recognition requirements, including most industry specific guidance. The FASB subsequently issued a number of amendments to ASU 2014-09 that have the same effective date and transition date (collectively, “ASC 606”). We adopted ASC 606 on January 1, 2018 using the modified retrospective transition method. See Note D, “Revenue Recognition” for additional information. In November 2016, the FASB issued ASU No. 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash (“ASU 2016-18”).which requires amounts generally described as restricted cash and restricted cash equivalents to be included with cash and cash equivalents when reconciling beginning-of-period and end-of-period total amounts shown on the statement of cash flows. We adopted the standard on January 1, 2018 using the retrospective approach and modified the presentation of our consolidated statements of cash flows in accordance with the standard. The adoption of ASU 2016-18 did not have a material impact on our consolidated financial statements. 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 2016-15”).This standard clarifies certain aspects of the statement of cash flows, including the classification of debt prepayment or debt extinguishment costs or other debt instruments with coupon interest rates that are insignificant in relation to the effective interest rate of the borrowing, contingent consideration payments made after a business combination, proceeds from the settlement of insurance claims, proceeds from the settlement of corporate owned life insurance policies, distributions received from equity method investees and beneficial interests in securitization transactions. This new standard also clarifies that an entity should determine each separately identifiable source of use within the cash receipts and payments on the basis of the nature of the underlying cash flows. In situations in which cash receipts and payments have aspects of more than one class of cash flows and cannot be separated by source or use, the appropriate classification should depend on the activity that is likely to be the predominant source or use of cash flows for the item. We adopted the standard on January 1, 2018 using the retrospective approach. ASU 2016-15 did not have a material effect on our consolidated financial statements upon adoption. 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 2016-01”). This standard 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 our results of operations. This 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. We adopted the standard on January 1, 2018 using the modified retrospective approach. The adoption of ASU 2016-01 did not have an impact on our consolidated financial statements. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2018 | |
Subsequent Events [Abstract] | |
Subsequent Events | SUBSEQUENT EVENTS Acquisition of Perosphere Pharmaceuticals Inc. On January 16, 2019, we acquired Perosphere through the merger of our wholly-owned subsidiary, Magellan Merger Sub, Inc., a Delaware corporation (“Merger Sub”), with and into Perosphere, with Perosphere continuing as the surviving entity and our wholly-owned subsidiary (the “Merger”). The acquisition enhances our development pipeline by adding an innovative clinical asset to our portfolio and leveraging our expertise in hematology. As a result of the acquisition of Perosphere, we acquired the global rights to ciraparantag, an anticoagulant reversal agent, which is being investigated for patients treated with novel oral anticoagulants or low molecular weight heparin when reversal of the anticoagulant effect of these products is needed for emergency surgery, urgent procedures or due to life-threatening or uncontrolled bleeding. In addition, provided certain clinical milestones are met, the Phase 3 program for ciraparantag will be partially funded under an existing clinical trial collaboration agreement, as amended, with a global pharmaceutical company, under which we may receive certain payments anticipated in 2019 and 2020 related to ciraparantag for use as an anticoagulant reversal agent to reverse the effects of Savaysa ® (edoxaban) and low molecular weight heparin. The Merger was completed pursuant to the Agreement and Plan of Merger (the “Perosphere Agreement”), dated as of December 12, 2018, by and among, inter alia, AMAG and Perosphere. Pursuant to the Perosphere Agreement, we paid, at closing, an upfront purchase price (the “Upfront Merger Consideration”) of approximately $50.0 million , approximately $40.0 million of which was funded from our available cash and approximately $10.0 million of which was deemed paid in connection with the cancellation of a convertible note in the principal amount of $10.0 million issued to us by Perosphere in October 2018. The purchase price is subject to customary post-closing adjustments under the Perosphere Agreement. In addition to the Upfront Merger Consideration, AMAG used available cash to repay $12.0 million of Perosphere’s term loan indebtedness and assumed approximately $6.2 million of Perosphere’s other liabilities. Under and subject to the terms and conditions set forth in the Perosphere Agreement, we are obligated to pay future contingent consideration of up to an aggregate of $365.0 million (the “Milestone Payments”), including (a) up to an aggregate of $140.0 million that becomes payable conditioned upon the achievement of specified regulatory milestones for ciraparantag (the “Regulatory Milestone Payments”), including a $40.0 million milestone payment conditioned upon approval by the European Medicines Agency and (b) up to an aggregate of $225.0 million that becomes payable conditioned upon the achievement of specified sales milestones (the “Sales Milestone Payments”). If the final label approved for ciraparantag in the U.S. includes a boxed warning, the Regulatory Milestone Payments shall no longer be payable, and any previously paid Regulatory Milestone Payments shall be credited against 50% of any future Milestone Payment that otherwise becomes payable. The first Sales Milestone Payment of $20.0 million will be payable conditioned upon annual net sales of ciraparantag of at least $100.0 million . We are unable to provide preliminary estimates of asset and liability values as the valuation of the assets acquired and liabilities assumed is in progress. 2019 Restructuring In February 2019, we completed a restructuring to combine our women’s health and maternal health sales forces into one integrated sales team, which will promote both Intrarosa and Makena. Approximately 110 employees were displaced through this workforce reduction. We expect to record a one-time restructuring charge of approximately $6.0 million primarily related to severance and related benefits in the first quarter of 2019 and expect the activities to be completed by the end of the first quarter of 2019. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Basis of Presentation | The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the U.S. (“GAAP”) and include the accounts of our wholly-owned subsidiaries. |
Principles of Consolidation | All intercompany balances and transactions have been eliminated in consolidation. |
Use of Estimates and Assumptions | Use of Estimates and Assumptions The preparation of consolidated financial statements in conformity with GAAP requires management to make certain estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, and the related disclosure of contingent assets and liabilities. The most significant estimates and assumptions are used to determine amounts and values of, but are not limited to: revenue recognition related to product sales revenue; product sales allowances and accruals; allowance for doubtful accounts; marketable securities; inventory; acquisition date fair value and subsequent fair value estimates used to assess impairment of long-lived assets, including goodwill, in-process research and development (“IPR&D”) and other intangible assets; contingent consideration; debt obligations; certain accrued liabilities, including clinical trial accruals; income taxes, inclusive of valuation allowances, and equity-based compensation expense. Actual results could differ materially from those estimates. |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash and cash equivalents consist principally of cash held in commercial bank accounts, money market funds and U.S. Treasury securities having an original maturity of less than three months at the date of acquisition. We consider all highly liquid marketable securities with a maturity of three months or less as of the acquisition date to be cash equivalents. |
Marketable Securities | Marketable Securities We account for and classify our marketable securities as either “available-for-sale,” “held-to-maturity,” or “trading debt securities,” in accordance with the accounting guidance related to the accounting and classification of certain investments in marketable securities. The determination of the appropriate classification by us is based primarily on management’s ability and intent to sell the debt security at the time of purchase. As of December 31, 2018 and 2017 , all of our marketable securities were classified as available-for-sale. Available-for-sale securities are those securities which we view as available for use in current operations, if needed. We generally classify our available-for-sale securities as short-term investments, even though the stated maturity date may be one year or more beyond the current balance sheet date. Available-for-sale marketable securities are stated at fair value with their unrealized gains and losses included in accumulated other comprehensive income (loss) within the consolidated statements of stockholders’ equity, until such gains and losses are realized in other income (expense) within the consolidated statements of operations or until an unrealized loss is considered other-than-temporary. We recognize other-than-temporary impairments of our marketable securities when there is a decline in fair value below the amortized cost basis and if (a) we have the intent to sell the security or (b) it is more likely than not that we will be required to sell the security prior to recovery of its amortized cost basis. If either of these conditions is met, we recognize the difference between the amortized cost basis of the security and its fair value at the impairment measurement date in our consolidated statements of operations. If neither of these conditions is met, we must perform additional analysis to evaluate whether the unrealized loss is associated with the creditworthiness of the issuer of the security rather than other factors, such as interest rates or market factors. If we determine from this analysis that we do not expect to receive cash flows sufficient to recover the entire amortized cost of the security, a credit loss exists, the impairment is considered other-than-temporary and is recognized in our consolidated statements of operations. |
Inventory | Inventory Inventory is stated at the lower of cost or net realizable value, with approximate cost being determined on a first-in, first-out basis. Prior to initial approval from the U.S. Food and Drug Administration (the “FDA”) or other regulatory agencies, we expense costs relating to the production of inventory in the period incurred, unless we believe regulatory approval and subsequent commercialization of the product candidate is probable and we expect the future economic benefit from sales of the product to be realized, at which point we capitalize the costs as inventory. We assess the costs capitalized prior to regulatory approval each quarter for indicators of impairment, such as a reduced likelihood of approval. We expense costs associated with clinical trial material as research and development expense. On a quarterly basis, we analyze our inventory levels to determine whether we have any obsolete, expired, or excess inventory. If any inventory is expected to expire prior to being sold, has a cost basis in excess of its net realizable value, is in excess of expected sales requirements as determined by internal sales forecasts, or fails to meet commercial sale specifications, the inventory is written-down through a charge to cost of product sales. The determination of whether inventory costs will be realizable requires estimates by management of future expected inventory requirements, based on sales forecasts. Once packaged, our products have a shelf-life ranging from three to five years . As a result of comparison to internal sales forecasts, we expect to fully realize the carrying value of our finished goods inventory. If actual market conditions are less favorable than those projected by management, inventory write-downs may be required. Charges for inventory write-downs are not reversed if it is later determined that the product is saleable. |
Restricted Cash | Restricted Cash We classified $0.5 million of our cash as restricted cash, a non-current asset on the balance sheet, as of December 31, 2018 and 2017 . This amount represented the security deposit delivered to the landlord of our Waltham, Massachusetts headquarters. |
Concentrations and Significant Customer Information | Concentrations and Significant Customer Information Financial instruments which potentially subject us to concentrations of credit risk consist principally of cash and cash equivalents, marketable securities, and accounts receivable. We currently hold our excess cash primarily in institutional money market funds, corporate debt securities, U.S. treasury and government agency securities, commercial paper and certificates of deposit. Our operations are located entirely within the U.S. We focus primarily on developing, manufacturing, and commercializing our products and product candidates. Our net accounts receivable primarily represent amounts due for products sold directly to wholesalers, distributors, specialty pharmacies and our authorized generic partner. Accounts receivable for our products are recorded net of reserves for estimated chargeback obligations, prompt payment discounts and any allowance for doubtful accounts. As part of our credit management policy, we perform ongoing credit evaluations of our customers, and we generally do not require collateral. If the financial condition of any of our significant product sales customers was to deteriorate and result in an impairment of its ability to make payments owed to us, an allowance for doubtful accounts may be required which could have a material effect on earnings in the period of any such adjustment. We are currently dependent on a single supplier for Feraheme drug substance (produced in two separate facilities) as well as for drug substance and final packaging services for Intrarosa. In addition, we currently have a single supplier for our auto-injector product. We have been and may continue to be exposed to a significant loss of revenue from the sale of our products in the event that our suppliers and/or manufacturers are not able to fulfill demand for any reason. |
Property and Equipment, Net | Property and Equipment, Net Property and equipment are recorded at cost and depreciated when placed into service using the straight-line method based on their estimated useful lives as follows: Useful Life Computer equipment and software 5 Years Furniture and fixtures 5 Years Leasehold improvements Lesser of Lease or Asset Life Laboratory and production equipment 5 Years / 8 Years Costs for capital assets not yet placed in service are capitalized on our balance sheets and will be depreciated in accordance with the above guidelines once placed into service. Costs for maintenance and repairs are expensed as incurred. Upon sale or other disposition of property and equipment, the cost and related depreciation are removed from the accounts and any resulting gain or loss is charged to our consolidated statements of operations. Long-lived assets to be held and used are evaluated for impairment whenever events or changes in circumstances indicate that the carrying value of the asset may not be recoverable. Determination of recoverability is based on an estimate of undiscounted future cash flows resulting from the use of the asset and its eventual disposition. In the event such cash flows are not expected to be sufficient to recover the carrying amount of the assets, the assets are written down to their estimated fair values. Assets classified as held for sale are no longer subject to depreciation and are recorded at the lower of carrying value or estimated net realizable value. |
Business Combinations, Asset Acquisitions and Acquisition-Related Contingent Consideration | Business Combinations and Asset Acquisitions The purchase price allocation for business combinations requires extensive use of accounting estimates and judgments to allocate the purchase price to the identifiable tangible and intangible assets acquired and liabilities assumed based on their respective fair values. Under Accounting Standards Update (“ASU”) No. 2017-01, “ Business Combinations (Topic 805): Clarifying the Definition of a Business (“2017-01”), we first determine whether substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or a group of similar identifiable assets. If this threshold is met, the single asset or group of assets, as applicable, is not a business. We account for acquired businesses using the acquisition method of accounting, under which the total purchase price of an acquisition is allocated to the net tangible and identifiable intangible assets acquired and liabilities assumed based on their estimated fair values as of the acquisition date. Acquisition-related costs are expensed as incurred. Any excess of the consideration transferred over the estimated fair values of the identifiable net assets acquired is recorded as goodwill. The purchase price allocations are initially prepared on a preliminary basis and are subject to change as additional information becomes available concerning the fair value and tax basis of the assets acquired and liabilities assumed. Any adjustments to the purchase price allocations are made as soon as practicable but no later than one year from the acquisition date. Acquired inventory is recorded at its fair value, which may require a step-up adjustment to recognize the inventory at its expected net realizable value. The inventory step-up is recorded to cost of product sales in our consolidated statements of operations when related inventory is sold, and we record step-up costs associated with clinical trial material as research and development expense. Acquisition-Related Contingent Consideration Contingent consideration arising from a business combination is included as part of the purchase price and is recognized at its estimated fair value as of the acquisition date. Subsequent to the acquisition date, we measure contingent consideration arrangements at fair value for each period until the contingency is resolved. These changes in fair value are recognized in selling, general and administrative expenses in our consolidated statements of operations. Changes in fair values reflect new information about the likelihood of the payment of the contingent consideration and the passage of time. For asset acquisitions, we record contingent consideration for obligations we consider to be probable and estimable and these liabilities are not adjusted to fair value. |
Goodwill | Goodwill We test goodwill at the reporting unit level for impairment on an annual basis and between annual tests if events and circumstances indicate it is more likely than not that the fair value of a reporting unit is less than its carrying value. Events that could indicate impairment and trigger an interim impairment assessment include, but are not limited to, an adverse change in current economic and market conditions, including a significant prolonged decline in market capitalization, a significant adverse change in legal factors, unexpected adverse business conditions, and an adverse action or assessment by a regulator. Our annual impairment test date is October 31. We have determined that we operate in a single operating segment and have a single reporting unit. In performing our goodwill impairment tests during 2018 and 2017 , we utilized the approach prescribed under Accounting Standards Codification (“ASC”) 350, as amended by ASU 2017-04, Intangibles - Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment (“ASU 2017-04”), which requires that an entity 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. For additional information, see Note I, “ Goodwill and Intangible Assets, Net. ” |
Intangible Assets | Intangible Assets We amortize our intangible assets that have finite lives based on either the straight-line method, or if reliably determinable, based on the pattern in which the economic benefit of the asset is expected to be utilized. When such facts and circumstances exist, management compares the projected undiscounted future cash flows associated with the asset over its estimated useful life against the carrying amount. The impairment loss, if any, is measured as the excess of the carrying amount of the asset over its fair value. If we acquire a business as defined under applicable accounting standards, then the acquired IPR&D is capitalized as an intangible asset. If we acquire an asset or a group of assets that do not meet the definition of a business, then the acquired IPR&D is expensed on its acquisition date. Future costs to develop these assets are recorded to research and development expense as they are incurred. Acquired IPR&D represents the fair value assigned to research and development assets that we acquire and have not been completed at the acquisition date. The fair value of IPR&D acquired in a business combination is capitalized on our consolidated balance sheets at the acquisition-date fair value and is determined by estimating the costs to develop the technology into commercially viable products, estimating the resulting revenue from the projects, and discounting the projected net cash flows to present value. IPR&D is not amortized, but rather is reviewed for impairment on an annual basis or more frequently if indicators of impairment are present, until the project is completed or abandoned. If we determine that IPR&D becomes impaired or is abandoned, the carrying value is written down to its fair value with the related impairment charge recognized in our consolidated statement of operations in the period in which the impairment occurs. Upon successful completion of each project and launch of the product, we will make a separate determination of the estimated useful life of the IPR&D intangible asset and the related amortization will be recorded as an expense prospectively over its estimated useful life. The projected discounted cash flow models used to estimate our IPR&D reflect significant assumptions regarding the estimates a market participant would make in order to evaluate a drug development asset, including the following: • Probability of successfully completing clinical trials and obtaining regulatory approval; • Market size, market growth projections, and market share; • Estimates regarding the timing of and the expected costs to advance our clinical programs to commercialization; • Estimates of future cash flows from potential product sales; and • A discount rate. Additionally, to the extent we acquire other indefinite-lived intangible assets through our business combinations, these assets are reviewed for impairment on an annual basis or more frequently if indicators of impairment are present. If we determine that the asset becomes impaired, the carrying value is written down to its fair value with the related impairment charge recognized in our consolidated statements of operations in the period in which the impairment occurs. |
Patents | Patents We expense all patent-related costs in selling, general and administrative expenses as incurred. |
Revenue Recognition | Revenue Recognition Effective January 1, 2018, we adopted ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”), using the modified retrospective transition method. We recognized the cumulative effect of applying the new revenue standard to all contracts with customers that were not completed as of January 1, 2018 as an adjustment of $1.1 million to the opening balance of stockholders’ equity at the beginning of 2018. The adjustment recorded was for incremental contract acquisition costs related to the CBR business. The comparative information has not been restated and continues to be reported under the accounting standards in effect for the periods presented. This standard applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, certain collaboration arrangements and financial instruments. ASC 606 also impacts certain other areas, such as the accounting for costs to obtain or fulfill a contract. The standard also requires disclosure of the nature, amount, timing, and uncertainty of revenue and cash flows arising from contracts with customers. The adoption of ASC 606 did not have an impact on the amount of reported revenues with respect to our product revenue. We receive payments from customers based upon contractual billing schedules; accounts receivable are recorded when the right to consideration becomes unconditional. Performance Obligations and Product Revenue At contract inception, we assess the goods promised in our contracts with customers and identify a performance obligation for each promise to transfer to the customer a good (or bundle of goods) that is distinct. To identify the performance obligations, we consider all of the goods promised in the contract regardless of whether they are explicitly stated or are implied by customary business practices. We determined that the following distinct goods represent separate performance obligations: • Supply of Makena (branded and unbranded) product • Supply of Feraheme product • Supply of Intrarosa product We principally sell our products to wholesalers, specialty distributors, specialty pharmacies and other customers, including our authorized generic partner (collectively, “Customers”), who purchase products directly from us. Our Customers subsequently resell the products to healthcare providers and patients. In addition to distribution agreements with Customers, we enter into arrangements with healthcare providers and payers that provide for government-mandated and/or privately-negotiated rebates, chargebacks and discounts with respect to the purchase of our products. For the majority of our Customers, we transfer control at the point in time when the goods are delivered. In instances when we perform shipping and handling activities, these are considered fulfillment activities, and accordingly, the costs are accrued when the related revenue is recognized. Taxes collected from Customers and remitted to governmental authorities are excluded from revenues. Variable Consideration Under ASC 606, we are required to make estimates of the net sales price, including estimates of variable consideration (such as rebates, chargebacks, discounts, copay assistance and other deductions), and recognize the estimated amount as revenue, when we transfer control of the product to our customers. In addition, we estimate variable consideration related to our share of net distributable profits from our authorized generic partner. Variable consideration must be determined using either an “expected value” or a “most likely amount” method. We record product revenues net of certain allowances and accruals in our consolidated statements of operations. Product sales allowances and accruals are primarily comprised of both direct and indirect fees, discounts and rebates and provisions for estimated product returns. Direct fees, discounts and rebates are contractual fees and price adjustments payable to Customers that purchase products directly from us. Indirect fees, discounts and rebates are contractual price adjustments payable to healthcare providers and organizations, such as certain physicians, clinics, hospitals, group purchasing organizations (“GPOs”), and dialysis organizations that typically do not purchase products directly from us but rather from wholesalers and specialty distributors. Consideration payable to a Customer, or other parties that purchase goods from a Customer, are considered to be a reduction of the transaction price, and therefore, of revenue. Product sales allowances and accruals are based on definitive contractual agreements or legal requirements (such as laws and regulations to provide mandatory discounts for sales to government entities) related to the purchase and/or utilization of the product by these entities and are recorded in the same period that the related revenue is recognized. We use the expected value method for estimating variable consideration. We estimate product sales allowances and accruals using either historical, actual and/or other data, including estimated patient usage, applicable contractual rebate rates, contract performance by the benefit providers, other current contractual and statutory requirements, historical market data based upon experience of our products and other products similar to them, specific known market events and trends such as competitive pricing and new product introductions, current and forecasted Customer buying patterns and inventory levels, and the shelf life of our products. As part of this evaluation, we also review changes to federal and other legislation, changes to rebate contracts, changes in the level of discounts, and changes in product sales trends. Although allowances and accruals are recorded at the time of product sale, rebates are typically paid out in arrears, one to three months after the sale. The estimate of variable consideration, which is included in the transaction price, may be constrained and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved in a future period. Estimating variable consideration and the related constraint requires the use of significant management judgment and actual amounts of consideration ultimately received may differ from our estimates. If actual results in the future vary from our estimates, we will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known. No amounts were constrained as of December 31, 2018 . Discounts We typically offer a 2% prompt payment discount to certain customers as an incentive to remit payment in accordance with the stated terms of the invoice, generally 30 days . Because we anticipate that those customers who are offered this discount will take advantage of the discount, 100% of the prompt payment discount at the time of sale is accrued for eligible customers, based on the gross amount of each invoice. We adjust the accrual quarterly to reflect actual experience. Chargebacks Chargeback reserves represent the estimated obligations resulting from the difference between the prices at which we sell our products to wholesalers and the sales price ultimately paid to wholesalers under fixed price contracts by third-party payers, including governmental agencies. The chargeback estimates are determined based on actual product sales data and forecasted customer buying patterns. Actual chargeback amounts are determined at the time of resale to the qualified healthcare provider, and we generally issue credits for such amounts within several weeks of receiving notification from the wholesaler. Estimated chargeback amounts are recorded at the time of sale and adjusted quarterly to reflect actual experience. Distributor/Wholesaler and Group Purchasing Organization Fees Fees under arrangements with distributors and wholesalers are usually based upon units of product purchased during the prior month or quarter and are usually paid by us within several weeks of the receipt of an invoice from the wholesaler or distributor, as the case may be. Fees under arrangements with GPOs are usually based upon member purchases during the prior quarter and are generally billed by the GPO within 30 days after period end. In accordance with ASC 606, since the consideration given to the Customer is not for a distinct good or service, the consideration is a reduction of the transaction price of the vendor’s products or services. We have included these fees in contractual adjustments in the table above. We generally pay such amounts within several weeks of the receipt of an invoice from the distributor, wholesaler or GPO. Accordingly, we accrue the estimated fee due at the time of sale, based on the contracted price invoiced to the Customer. We adjust the accrual quarterly to reflect actual experience. Product Returns Consistent with industry practice, we generally offer wholesalers, specialty distributors and other customers a limited right to return our products based on the product’s expiration date. The current shelf-lives or time between manufacture and expiration for products in our portfolio range from three to five years . Product returns are estimated based on the historical return patterns and known or expected changes in the marketplace. We track actual returns by individual production lots. Returns on lots eligible for credits under our returned goods policy are monitored and compared with historical return trends and rates. We expect that wholesalers and healthcare providers will not stock significant inventory due to the cost of the product, the expense to store our products, and/or that our products are readily available for distribution. We record an estimate of returns at the time of sale. If necessary, our estimated rate of returns may be adjusted for actual return experience as it becomes available and for known or expected changes in the marketplace. There were no material adjustments to our reserve for product returns during the years ended December 31, 2018 , 2017 or 2016 . To date, our product returns have been relatively limited; however, returns experience may change over time. We may be required to make future adjustments to our product returns estimate, which would result in a corresponding change to our net product sales in the period of adjustment and could be significant. Sales Rebates We contract with various private payer organizations, primarily pharmacy benefit managers, for the payment of rebates with respect to utilization of our products. We determine our estimates for rebates, if applicable, based on actual product sales data and our historical product claims experience. Rebate amounts generally are invoiced quarterly and are paid in arrears, and we expect to pay such amounts within several weeks of notification by the provider. We regularly assess our reserve balance and the rate at which we accrue for claims against product sales. If we determine in future periods that our actual rebate experience is not indicative of expected claims, if actual claims experience changes, or if other factors affect estimated claims rates, we may be required to adjust our current accumulated reserve estimate, which would affect net product sales in the period of the adjustment and could be significant. Governmental Rebates Governmental rebates relate to our reimbursement arrangements with state Medicaid programs. We determine our estimates for Medicaid rebates, if applicable, based on actual product sales data and our historical product claims experience. In estimating these reserves, we provide for a Medicaid rebate associated with both those expected instances where Medicaid will act as the primary insurer as well as in those instances where we expect Medicaid will act as the secondary insurer. Rebate amounts generally are invoiced quarterly and are paid in arrears, and we expect to pay such amounts within several weeks of notification by the Medicaid or provider entity. We regularly assess our Medicaid reserve balance and the rate at which we accrue for claims against product sales. If we determine in future periods that our actual rebate experience is not indicative of expected claims, if actual claims experience changes, or if other factors affect estimated claims rates, we may be required to adjust our current Medicaid accumulated reserve estimate, which would affect net product sales in the period of the adjustment and could be significant. Other Discounts Other discounts which we offer include voluntary patient assistance programs, such as copay assistance programs, which are intended to provide financial assistance to qualified commercially insured patients with prescription drug copayments required by payers. The calculation of the accrual for copay assistance is based on an estimate of claims and the cost per claim that we expect to receive associated with product that has been recognized as revenue. Under ASC 606, we recognize revenue when our customer obtains control of promised goods or services in an amount that reflects the consideration which we expect to receive in exchange for those goods or services. To determine revenue recognition for arrangements that we determine are within the scope of ASC 606, we perform the following five steps: a. Identify the contract(s) with a customer; b. Identify the performance obligations in the contract; c. Determine the transaction price; d. Allocate the transaction price to the performance obligations in the contract; and e. Recognize revenue when (or as) the performance obligations are satisfied. We only apply the five step model to contracts when it is probable that we will collect the consideration we are entitled to in exchange for the goods or services we transfer to the customer. At contract inception, if the contract is determined to be within the scope of ASC 606, we assess the goods or services promised within each contract, determine those that are performance obligations, and assess whether each promised good or service is distinct. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Our major sources of revenue during the reporting periods were product revenues from Makena (including both our branded and unbranded products), Feraheme and Intrarosa. The adoption of ASC 606 did not have an impact on the pattern or timing of recognition of our product revenue, as the majority of our product revenue continues to be recognized when the customer takes control of our product. |
Research and Development Expenses | Research and Development Expenses Research and development expenses include both external and internal expenses. External expenses primarily include costs of clinical trials and fees paid to contract research organizations (“CROs”), clinical supply and manufacturing expenses, regulatory filing fees, consulting and professional fees as well as other general costs related to the execution of research and development activities. Internal expenses primarily include compensation of employees engaged in research and development activities. Research and development expenses are expensed as incurred. Manufacturing costs are generally expensed as incurred until a product has received the necessary initial regulatory approval. |
Advertising Costs | Advertising Costs Advertising costs are expensed as incurred and included in selling, general and administrative expenses in our consolidated statements of operations. |
Equity-Based Compensation | Equity-Based Compensation Equity-based compensation cost is generally measured at the estimated grant date fair value and recorded to expense over the requisite service period, which is generally the vesting period. Because equity-based compensation expense is based on awards ultimately expected to vest, we must make certain judgments about whether employees, officers, directors, consultants and advisers will complete the requisite service period, and reduce the compensation expense being recognized for estimated forfeitures. Forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Forfeitures are estimated based upon historical experience and adjusted for unusual events such as corporate restructurings, which can result in higher than expected turnover and forfeitures. If factors change and we employ different assumptions in future periods, the compensation expense that we record in the future may differ significantly from what we have recorded in the current period. We estimate the fair value of equity-based compensation involving stock options based on the Black-Scholes option pricing model. This model requires the input of several factors such as the expected option term, the expected risk-free interest rate over the expected option term, the expected volatility of our stock price over the expected option term and the expected dividend yield over the expected option term and are subject to various assumptions. The fair value of awards calculated using the Black-Scholes option pricing model is generally amortized on a straight-line basis over the requisite service period, and is recognized based on the proportionate amount of the requisite service period that has been rendered during each reporting period. We estimate the fair value of our restricted stock units (“RSUs”) whose vesting is contingent upon market conditions, such as total shareholder return, using the Monte-Carlo simulation model. The fair value of RSUs where vesting is contingent upon market conditions is amortized based upon the estimated derived service period. The fair value of RSUs granted to our employees and directors whose vesting is dependent on future service is determined based upon the quoted closing market price per share on the date of grant, adjusted for estimated forfeitures. We believe our valuation methodologies are appropriate for estimating the fair value of the equity awards we grant to our employees and directors. Our equity award valuations are estimates and may not be reflective of actual future results or amounts ultimately realized by recipients of these grants. These amounts are subject to future quarterly adjustments based upon a variety of factors, which include, but are not limited to, changes in estimated forfeiture rates and the issuance of new equity-based awards. |
Income Taxes | Income Taxes We use the asset and liability method of accounting for deferred income taxes. Under this method, deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. A deferred tax asset is established for the expected future benefit of net operating loss (“NOL”) and credit carryforwards. Deferred tax assets and liabilities are measured using enacted rates in effect for the year in which those temporary differences are expected to be recovered or settled. A valuation allowance against net deferred tax assets is required if, based on available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. Significant judgments, estimates and assumptions regarding future events, such as the amount, timing and character of income, deductions and tax credits, are required in the determination of our provision for income taxes and whether valuation allowances are required against deferred tax assets. In evaluating our ability to recover our deferred tax assets, we consider all available evidence, both positive and negative, including the existence of taxable temporary differences, our past operating results, the existence of cumulative income in the most recent fiscal years, changes in the business in which we operate and our forecast of future taxable income. In determining future taxable income, we are responsible for assumptions utilized including the amount of state and federal operating income, the reversal of temporary differences and the implementation of feasible and prudent tax planning strategies. These assumptions require significant judgment about the forecasts of future taxable income. As of December 31, 2018 , we have established a valuation allowance on our net deferred tax assets other than refundable alternative minimum tax (“AMT”) credits to the extent that our existing taxable temporary differences would not be available as a source of income to realize the benefits of those deferred tax assets. We account for uncertain tax positions using a “more-likely-than-not” threshold for recognizing and resolving uncertain tax positions. The evaluation of uncertain tax positions is based on factors that include, but are not limited to, changes in tax law, the measurement of tax positions taken or expected to be taken in tax returns, the effective settlement of matters subject to audit, new audit activity, and changes in facts or circumstances related to a tax position. We evaluate uncertain tax positions on a quarterly basis and adjust the level of the liability to reflect any subsequent changes in the relevant facts surrounding the uncertain positions. Any changes to these estimates, based on the actual results obtained and/or a change in assumptions, could impact our income tax provision in future periods. Interest and penalty charges, if any, related to unrecognized tax benefits would be classified as a provision for income tax in our consolidated statement of operations. |
Comprehensive Loss | Comprehensive Loss Our comprehensive loss consists of net loss and other comprehensive loss. Other comprehensive loss includes changes in equity that are excluded from net loss, which for all periods presented in these consolidated financial statements related to unrealized holding gains and losses on available-for-sale marketable securities, net of tax. |
Basic and Diluted Net (Loss) Income per Share | Basic and Diluted Net (Loss) Income per Share We compute basic net (loss) income per share by dividing net (loss) income by the weighted average number of common shares outstanding during the relevant period. Diluted net (loss) income per common share has been computed by dividing net (loss) income by the diluted number of common shares outstanding during the period. Except where the result would be antidilutive to net income, diluted net income per common share would be computed assuming the impact of the conversion of the 2.5% convertible senior notes due in 2019 (the “2019 Convertible Notes”) and the 3.25% convertible senior notes due in 2022 (the “2022 Convertible Notes”), the exercise of outstanding stock options, the vesting of RSUs, and the exercise of warrants. We have a choice to settle the conversion obligation of our 2022 Convertible Notes and the 2019 Convertible Notes (together, the “Convertible Notes”) in cash, shares or any combination of the two. Our policy is to settle the principal balance of the Convertible Notes in cash. As such, we apply the treasury stock method to these securities and the dilution related to the conversion premium, if any, of the Convertible Notes is included in the calculation of diluted weighted-average shares outstanding to the extent each issuance is dilutive based on the average stock price during each reporting period being greater than the conversion price of the respective Convertible Notes. The dilutive effect of the warrants, stock options and RSUs has been calculated using the treasury stock method. |
Business Segments | Business Segments We have determined that we conduct our operations in one business segment: the manufacture, development and commercialization of products for use in treating various conditions, with a focus on maternal and women’s health and anemia management. Long-lived assets consist entirely of property and equipment and are located in the U.S. for all periods presented. |
Fair Value Measurements | We apply the provisions of ASC Topic 820, Fair Value Measurements (“ASC 820”) for our financial assets and liabilities that are re-measured and reported at fair value each reporting period and our nonfinancial assets and liabilities that are re-measured and reported at fair value on a non-recurring basis. Fair value is the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. When determining fair value, we consider the principal or most advantageous market in which it would transact and consider assumptions that market participants would use when pricing the asset or liability. ASC 820 establishes a three-level valuation hierarchy for disclosure of fair value measurements. Financial assets and liabilities are categorized within the valuation hierarchy based upon the lowest level of input that is significant to the measurement of fair value. The three levels of the hierarchy are defined as follows: • Level 1- Inputs to the valuation methodology are quoted market prices for identical assets or liabilities. • Level 2 - Inputs to the valuation methodology are other observable inputs, including quoted market prices for similar assets or liabilities and market-corroborated inputs. • Level 3 - Inputs to the valuation methodology are unobservable inputs based on management’s best estimate of inputs market participants would use in pricing the asset or liability at the measurement date, including assumptions about risk. |
Recently Issued and Proposed Accounting Pronouncements and Recently Adopted Accounting Pronouncements | RECENTLY ISSUED AND PROPOSED ACCOUNTING PRONOUNCEMENTS From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that are adopted by us as of the specified effective date. In August 2018, the FASB issued ASU No. 2018-13, Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement (“ASU 2018-13”). This standard eliminates, adds and modifies certain disclosure requirements for fair value measurements as part of its disclosure framework project. ASU 2018-13 is effective for annual reporting periods beginning after December 15, 2019 and interim periods within those annual periods and early adoption is permitted. We are currently evaluating the impact of our adoption of ASU 2018-13 on our consolidated financial statements. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). This standard requires entities to measure all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions and reasonable and supportable forecasts. ASU 2016-13 is effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years and early adoption is permitted. We are currently evaluating the impact of our adoption of ASU 2016-13 in our consolidated financial statements. In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) . This statement requires entities to recognize on its balance sheet assets and liabilities associated with the rights and obligations created by leases with terms greater than twelve months. This update is effective for annual reporting periods beginning after December 15, 2018, which for us is the period beginning January 1, 2019. During the fourth quarter of 2018, we finalized our assessments over the impact that these new standards will have on our consolidated results of operations, financial position and disclosures and are finalizing our accounting policies. As of December 31, 2018, we have not identified any accounting changes that would impact our results of operations or cash flows. However, we expect to recognize material right-of-use assets and lease liabilities related to our operating lease commitments. We currently plan to adopt this standard using the “modified retrospective approach” and follow the related transition option that allows for application of the transition provisions of the standard at the beginning of the period of adoption. In addition, we currently plan to utilize the package of available transition practical expedients. There are also certain considerations related to internal control over financial reporting that are associated with implementing Topic 842. We are evaluating our internal control framework over leases to identify any changes that may need to be made in response to the new guidance. In addition, financial statement disclosures under the new guidance in Topic 842 will be expanded in comparison to the disclosure requirements under the current guidance. We will have completed the design and implementation of the appropriate controls to obtain and disclose the information required under Topic 842 in our first quarter of 2019. RECENTLY ADOPTED ACCOUNTING PRONOUNCEMENTS In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606) , which superseded all existing revenue recognition requirements, including most industry specific guidance. The FASB subsequently issued a number of amendments to ASU 2014-09 that have the same effective date and transition date (collectively, “ASC 606”). We adopted ASC 606 on January 1, 2018 using the modified retrospective transition method. See Note D, “Revenue Recognition” for additional information. In November 2016, the FASB issued ASU No. 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash (“ASU 2016-18”).which requires amounts generally described as restricted cash and restricted cash equivalents to be included with cash and cash equivalents when reconciling beginning-of-period and end-of-period total amounts shown on the statement of cash flows. We adopted the standard on January 1, 2018 using the retrospective approach and modified the presentation of our consolidated statements of cash flows in accordance with the standard. The adoption of ASU 2016-18 did not have a material impact on our consolidated financial statements. 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 2016-15”).This standard clarifies certain aspects of the statement of cash flows, including the classification of debt prepayment or debt extinguishment costs or other debt instruments with coupon interest rates that are insignificant in relation to the effective interest rate of the borrowing, contingent consideration payments made after a business combination, proceeds from the settlement of insurance claims, proceeds from the settlement of corporate owned life insurance policies, distributions received from equity method investees and beneficial interests in securitization transactions. This new standard also clarifies that an entity should determine each separately identifiable source of use within the cash receipts and payments on the basis of the nature of the underlying cash flows. In situations in which cash receipts and payments have aspects of more than one class of cash flows and cannot be separated by source or use, the appropriate classification should depend on the activity that is likely to be the predominant source or use of cash flows for the item. We adopted the standard on January 1, 2018 using the retrospective approach. ASU 2016-15 did not have a material effect on our consolidated financial statements upon adoption. 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 2016-01”). This standard 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 our results of operations. This 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. We adopted the standard on January 1, 2018 using the modified retrospective approach. The adoption of ASU 2016-01 did not have an impact on our consolidated financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Schedule of customers representing greater than 10% of revenues/accounts receivable balances | The following table sets forth customers who represented 10% or more of our total revenues for 2018 , 2017 and 2016 : Years Ended December 31, 2018 2017 2016 AmerisourceBergen Drug Corporation 27% 26% 27% McKesson Corporation 26% 24% 14% Caremark, LLC < 10% < 10% 10% |
Schedule of property and equipment estimated useful lives | Property and equipment are recorded at cost and depreciated when placed into service using the straight-line method based on their estimated useful lives as follows: Useful Life Computer equipment and software 5 Years Furniture and fixtures 5 Years Leasehold improvements Lesser of Lease or Asset Life Laboratory and production equipment 5 Years / 8 Years Property and equipment, net consisted of the following as of December 31, 2018 and 2017 (in thousands): December 31, 2018 2017 Computer equipment and software $ 1,637 $ 1,401 Furniture and fixtures 1,737 1,442 Leasehold improvements 2,938 2,938 Laboratory and production equipment 6,000 654 Construction in progress 420 5,068 12,732 11,503 Less: accumulated depreciation (5,211 ) (3,599 ) Property and equipment, net $ 7,521 $ 7,904 |
Schedule of components of basic and diluted net income (loss) per share | The components of basic and diluted net (loss) income per share for 2018 , 2017 and 2016 were as follows (in thousands, except per share data): Years Ended December 31, 2018 2017 2016 Net (loss) income from continuing operations $ (169,339 ) $ (205,153 ) $ 2,093 Net income (loss) from discontinued operations 103,578 5,925 (4,576 ) Weighted average common shares outstanding 34,394 34,907 34,346 Effect of dilutive securities: Stock options and RSUs — — 487 Shares used in calculating dilutive net loss per share 34,394 34,907 34,833 Basic net (loss) income per share: (Loss) income from continuing operations $ (4.92 ) $ (5.88 ) $ 0.06 Income (loss) from discontinued operations 3.01 0.17 (0.13 ) Total $ (1.91 ) $ (5.71 ) $ (0.07 ) Diluted net (loss) income per share: (Loss) income from continuing operations $ (4.92 ) $ (5.88 ) $ 0.06 Income (loss) from discontinued operations 3.01 0.17 (0.13 ) Total $ (1.91 ) $ (5.71 ) $ (0.07 ) |
Schedule of anti-dilutive securities from computation of diluted net (loss) income per share | The following table sets forth the potential common shares issuable upon the exercise of outstanding options, the purchase of shares under our employee stock purchase plan, the vesting of RSUs, the exercise of warrants (prior to consideration of the treasury stock method), and the conversion of the Convertible Notes, which were excluded from our computation of diluted net (loss) income per share because their inclusion would have been anti-dilutive (in thousands): Years Ended December 31, 2018 2017 2016 Options to purchase shares of common stock 3,797 3,531 2,590 Shares of common stock issuable upon the vesting of RSUs 1,129 1,070 613 Warrants 1,008 1,008 7,382 2022 Convertible Notes 11,695 11,695 — 2019 Convertible Notes 790 790 7,382 Shares of common stock under employee stock purchase plan 81 — — 36 Total 18,500 18,094 18,003 |
Discontinued Operations and H_2
Discontinued Operations and Held For Sale (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Discontinued Operations and Disposal Groups [Abstract] | |
Discontinued operations held for sale | Assets and liabilities held for sale were reflected separately in our consolidated balance sheets and were comprised of the following as of December 31, 2018 and 2017 (in thousands): December 31, 2018 2017 Assets Current assets: Cash $ — $ 29,259 Accounts receivable, net — 12,042 Inventories (raw materials) — 2,913 Prepaid and other current assets — 1,294 Total current assets held for sale — 45,508 Property, plant and equipment, net — 18,092 Intangible assets, net — 328,991 Goodwill — 216,971 Other long-term assets — 496 Restricted cash — 161 Total long-term assets held for sale — 564,711 Liabilities Current liabilities: Accounts payable — 2,618 Accrued expenses — 8,758 Deferred revenues, short term — 42,494 Total current liabilities held for sale — 53,870 Deferred revenues, long-term — 24,387 Deferred tax liabilities — 71,046 Other long-term liabilities — 388 Total long-term liabilities held for sale $ — $ 95,821 The results of operations of the CBR business were classified as discontinued operations for all periods presented in our consolidated financial statements. The following is a summary of net income (loss) from discontinued operations for the years ended December 31, 2018 , 2017 and 2016 : Years Ended December 31, 2018 2017 2016 Service revenues, net $ 71,217 $ 114,177 $ 99,604 Costs and expenses: Cost of services 12,559 21,817 20,575 Research and development expenses — — 523 Selling, general and administrative expenses 39,899 81,782 80,402 Impairment of intangible assets — — 3,939 Restructuring expenses — — 374 Total costs and expenses 52,458 103,599 105,813 Operating income (loss) 18,759 10,578 (6,209 ) Other income (expense) 114 (265 ) — Income (loss) from discontinued operations 18,873 10,313 (6,209 ) Gain on sale of CBR business 87,076 — — Income tax expense (benefit) 2,371 4,388 (1,633 ) Net income (loss) from discontinued operations $ 103,578 $ 5,925 $ (4,576 ) |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Revenue from Contract with Customer [Abstract] | |
Disaggregated revenue | The following table provides information about disaggregated revenue by products for the years ended December 31, 2018 , 2017 and 2016 (in thousands): Years Ended December 31, 2018 2017 2016 Product sales, net Makena $ 322,265 $ 387,158 $ 334,050 Feraheme 135,001 105,930 97,058 Intrarosa 16,218 1,816 — MuGard 368 741 1,062 Total $ 473,852 $ 495,645 $ 432,170 Total gross product sales were offset by product sales allowances and accruals for the years ended December 31, 2018 , 2017 and 2016 as follows (in thousands): Years Ended December 31, 2018 2017 2016 Gross product sales $ 974,330 $ 920,061 $ 748,839 Provision for product sales allowances and accruals: Contractual adjustments 387,540 310,588 229,686 Governmental rebates 112,938 113,828 86,983 Total 500,478 424,416 316,669 Product sales, net $ 473,852 $ 495,645 $ 432,170 |
Product revenue allowance and accrual activity | The following table summarizes the product revenue allowance and accrual activity for the years ended December 31, 2018 , 2017 and 2016 (in thousands): Contractual Governmental Adjustments Rebates Total Balance at January 1, 2016 $ 30,177 $ 25,767 $ 55,944 Current provisions relating to sales in current year 224,894 93,035 317,929 Adjustments relating to sales in prior years (2,348 ) (6,052 ) (8,400 ) Payments/returns relating to sales in current year (181,150 ) (41,636 ) (222,786 ) Payments/returns relating to sales in prior years (23,973 ) (19,715 ) (43,688 ) Balance at December 31, 2016 47,600 51,399 98,999 Current provisions relating to sales in current year 314,537 112,167 426,704 Adjustments relating to sales in prior years (3,949 ) 1,661 (2,288 ) Payments/returns relating to sales in current year (253,545 ) (61,569 ) (315,114 ) Payments/returns relating to sales in prior years (42,479 ) (53,060 ) (95,539 ) Balance at December 31, 2017 62,164 50,598 112,762 Provisions related to current period sales 389,861 105,034 494,895 Adjustments related to prior period sales (2,330 ) 7,903 5,573 Payments/returns relating to current period sales (333,694 ) (75,920 ) (409,614 ) Payments/returns relating to prior period sales (58,802 ) (58,501 ) (117,303 ) Balance at December 31, 2018 $ 57,199 $ 29,114 $ 86,313 |
Marketable Securities (Tables)
Marketable Securities (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Investments, Debt and Equity Securities [Abstract] | |
Summary of marketable securities | The following is a summary of our marketable securities as of December 31, 2018 and 2017 (in thousands): December 31, 2018 Gross Gross Estimated Amortized Unrealized Unrealized Fair Description of Securities: Cost Gains Losses Value Short-term investments:* Corporate debt securities $ 51,184 $ — $ (236 ) $ 50,948 U.S. treasury and government agency securities 7,647 — (34 ) 7,613 Commercial paper 3,995 — — 3,995 Certificates of deposit 12,000 — — 12,000 Total short-term investments 74,826 — (270 ) 74,556 Long-term investments:** Corporate debt securities 62,530 52 (433 ) 62,149 U.S. treasury and government agency securities 2,742 — (32 ) 2,710 Certificates of deposit 1,500 — — 1,500 Total long-term investments 66,772 52 (465 ) 66,359 Total investments $ 141,598 $ 52 $ (735 ) $ 140,915 December 31, 2017 Gross Gross Estimated Amortized Unrealized Unrealized Fair Description of Securities: Cost Gains Losses Value Short-term investments:* Corporate debt securities $ 57,257 $ — $ (68 ) $ 57,189 U.S. treasury and government agency securities 1,999 — (13 ) 1,986 Commercial paper 1,999 — — 1,999 Certificates of deposit 9,151 — — 9,151 Total short-term investments 70,406 — (81 ) 70,325 Long-term investments:** Corporate debt securities 59,282 1 (320 ) 58,963 U.S. treasury and government agency securities 7,381 — (76 ) 7,305 Total long-term investments 66,663 1 (396 ) 66,268 Total investments $ 137,069 $ 1 $ (477 ) $ 136,593 * Represents marketable securities with a remaining maturity of less than one year. ** Represents marketable securities with a remaining maturity of one to three years classified as short-term on our consolidated balance sheets. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Fair Value Disclosures [Abstract] | |
Schedule of assets and liabilities measured at fair value on a recurring basis | The following tables represent the fair value hierarchy as of December 31, 2018 and 2017 , for those assets and liabilities that we measure at fair value on a recurring basis (in thousands): Fair Value Measurements at December 31, 2018 Using: Total Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Assets: Cash equivalents $ 71,568 $ 71,568 $ — $ — Corporate debt securities 113,097 — 113,097 — U.S. treasury and government agency securities 10,323 — 10,323 — Commercial paper 3,995 — 3,995 — Certificates of deposit 13,500 — 13,500 — Total Assets $ 212,483 $ 71,568 $ 140,915 $ — Liabilities: Contingent consideration - Lumara Health $ — $ — $ — $ — Contingent consideration - MuGard 359 — — 359 Total Liabilities $ 359 $ — $ — $ 359 Fair Value Measurements at December 31, 2017 Using: Total Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Assets: Cash equivalents $ 4,591 $ 4,591 $ — $ — Corporate debt securities 116,152 — 116,152 — U.S. treasury and government agency securities 9,291 — 9,291 — Commercial paper 1,999 — 1,999 — Certificates of deposit 9,151 — 9,151 — Total Assets $ 141,184 $ 4,591 $ 136,593 $ — Liabilities: Contingent consideration - Lumara Health $ 49,187 $ — $ — $ 49,187 Contingent consideration - MuGard 898 — — 898 Total Liabilities $ 50,085 $ — $ — $ 50,085 |
Schedule of reconciliation of contingent consideration obligations | The following table presents a reconciliation of contingent consideration obligations related to the acquisition of Lumara Health and the MuGard Rights (in thousands): Balance as of January 1, 2017 $ 147,995 Payments made (50,224 ) Adjustments to fair value of contingent consideration (47,686 ) Balance as of December 31, 2017 $ 50,085 Payments made (119 ) Adjustments to fair value of contingent consideration (49,607 ) Balance as of December 31, 2018 $ 359 |
Inventories (Tables)
Inventories (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Inventory Disclosure [Abstract] | |
Schedule of major classes of inventories | Our major classes of inventories were as follows as of December 31, 2018 and 2017 (in thousands): December 31, 2018 2017 Raw materials $ 9,388 $ 9,505 Work in process 5,932 4,146 Finished goods 11,371 20,792 Total inventories $ 26,691 $ 34,443 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |
Schedule of property equipment, net | Property and equipment are recorded at cost and depreciated when placed into service using the straight-line method based on their estimated useful lives as follows: Useful Life Computer equipment and software 5 Years Furniture and fixtures 5 Years Leasehold improvements Lesser of Lease or Asset Life Laboratory and production equipment 5 Years / 8 Years Property and equipment, net consisted of the following as of December 31, 2018 and 2017 (in thousands): December 31, 2018 2017 Computer equipment and software $ 1,637 $ 1,401 Furniture and fixtures 1,737 1,442 Leasehold improvements 2,938 2,938 Laboratory and production equipment 6,000 654 Construction in progress 420 5,068 12,732 11,503 Less: accumulated depreciation (5,211 ) (3,599 ) Property and equipment, net $ 7,521 $ 7,904 |
Goodwill and Intangible Asset_2
Goodwill and Intangible Assets, Net (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of amortizable intangible assets | December 31, 2018 December 31, 2017 Cost Accumulated Amortization Impairments Net Cost Accumulated Amortization Impairments Net Amortizable intangible assets: Makena base technology $ 797,100 $ 400,495 $ 319,246 $ 77,359 $ 797,100 $ 255,754 $ 319,246 $ 222,100 Makena auto-injector developed technology 79,100 6,952 — 72,148 — — — — Intrarosa developed technology 77,655 10,129 — 67,526 77,655 3,376 — 74,279 953,855 417,576 319,246 217,033 874,755 259,130 319,246 296,379 Indefinite-lived intangible assets: Makena IPR&D — — — — 79,100 — — 79,100 Total intangible assets $ 953,855 $ 417,576 $ 319,246 $ 217,033 $ 953,855 $ 259,130 $ 319,246 $ 375,479 |
Schedule of indefinite-lived intangible assets | December 31, 2018 December 31, 2017 Cost Accumulated Amortization Impairments Net Cost Accumulated Amortization Impairments Net Amortizable intangible assets: Makena base technology $ 797,100 $ 400,495 $ 319,246 $ 77,359 $ 797,100 $ 255,754 $ 319,246 $ 222,100 Makena auto-injector developed technology 79,100 6,952 — 72,148 — — — — Intrarosa developed technology 77,655 10,129 — 67,526 77,655 3,376 — 74,279 953,855 417,576 319,246 217,033 874,755 259,130 319,246 296,379 Indefinite-lived intangible assets: Makena IPR&D — — — — 79,100 — — 79,100 Total intangible assets $ 953,855 $ 417,576 $ 319,246 $ 217,033 $ 953,855 $ 259,130 $ 319,246 $ 375,479 |
Schedule of expected future annual amortization expense related to intangible assets | We expect amortization expense related to our finite-lived intangible assets to be as follows (in thousands): Period Estimated Amortization Expense Year Ending December 31, 2019 $ 41,891 Year Ending December 31, 2020 37,123 Year Ending December 31, 2021 31,022 Year Ending December 31, 2022 27,972 Year Ending December 31, 2023 18,207 Thereafter 60,818 Total $ 217,033 |
Current and Long-Term Liabili_2
Current and Long-Term Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Payables and Accruals [Abstract] | |
Schedule of accrued expenses | Accrued expenses consisted of the following as of December 31, 2018 and 2017 (in thousands): December 31, 2018 2017 Commercial rebates, fees and returns $ 80,520 $ 101,852 Professional, license, and other fees and expenses 23,242 23,657 Salaries, bonuses, and other compensation 22,482 15,882 Interest expense 1,067 13,525 Intrarosa-related license fees — 10,000 Accrued research and development 2,226 1,816 Total accrued expenses $ 129,537 $ 166,732 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Schedule of income tax expense (benefit) | The income tax expense (benefit) consisted of the following (in thousands): Years Ended December 31, 2018 2017 2016 Current: Federal $ (1,136 ) $ 2,162 $ — State 1,469 5,358 4,169 Total current $ 333 $ 7,520 $ 4,169 Deferred: Federal $ 42,886 $ (172,048 ) $ 11,208 State (3,565 ) (10,726 ) (2,206 ) Total deferred $ 39,321 $ (182,774 ) $ 9,002 Total income tax expense (benefit) $ 39,654 $ (175,254 ) $ 13,171 |
Schedule of reconciliation of the statutory U.S. federal income tax rate to the entity's effective income tax rate | The reconciliation of the statutory U.S. federal income tax rate to our effective income tax rate from continuing operations was as follows: Years Ended December 31, 2018 2017 2016 Statutory U.S. federal tax rate 21.0 % 35.0 % 35.0 % State taxes, net of federal benefit 4.7 3.3 5.4 Impact of 2017 tax reform on deferred tax balance — 4.6 — Equity-based compensation expense (1.5 ) (0.8 ) 16.2 Contingent consideration 7.2 4.4 41.5 Other permanent items, net (1.4 ) (0.5 ) 11.9 Tax credits 6.2 0.7 (19.2 ) Write-down of acquired state net operating losses — — 67.7 Valuation allowance (67.4 ) (0.8 ) (68.3 ) Other, net 0.6 0.2 (3.9 ) Effective tax rate (30.6 )% 46.1 % 86.3 % |
Schedule of components of the entity's deferred tax assets and liabilities | The components of our deferred tax assets and liabilities were as follows (in thousands): December 31, 2018 2017 Assets Net operating loss carryforwards $ 46,888 $ 60,308 Tax credit carryforwards 24,290 15,577 Capital loss carryforwards 20,896 — Interest expense carryforwards 4,318 — Equity-based compensation expense 5,931 5,873 Capitalized research & development 4,635 7,872 Intangible assets 12,565 — Reserves 2,683 3,342 Contingent consideration 87 1,406 Other 5,389 5,971 Valuation allowance (113,278 ) (4,740 ) Liabilities Property, plant and equipment depreciation (614 ) (198 ) Intangible assets and inventory — (32,406 ) Debt instruments (12,489 ) (15,744 ) Other (41 ) (141 ) Net deferred tax assets $ 1,260 $ 47,120 |
Summary of income tax contingencies | A reconciliation of our changes in unrecognized tax benefits is as follows (in thousands): Years Ended December 31, 2018 2017 2016 Unrecognized tax benefits at the beginning of the year $ 10,560 $ 13,020 $ 12,695 Additions based on tax positions related to the current year 12 574 300 Additions for tax positions from prior years 608 340 69 Subtractions for federal tax reform — (3,296 ) — Subtractions for tax positions from prior years — (78 ) (44 ) Unrecognized tax benefits at the end of the year $ 11,180 $ 10,560 $ 13,020 |
Accumulated Other Comprehensi_2
Accumulated Other Comprehensive Loss (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Equity [Abstract] | |
Schedule of changes in accumulated other comprehensive loss associated with unrealized (losses) gains on securities | The following table summarizes the changes in the accumulated balances of other comprehensive loss associated with unrealized (losses) gains on securities during 2018 , 2017 and 2016 (in thousands): December 31, 2018 2017 2016 Beginning balance $ (3,908 ) $ (3,838 ) $ (4,205 ) Other comprehensive loss before reclassifications (77 ) (70 ) 261 Reclassification adjustment for gains included in net loss — — 106 Ending balance $ (3,985 ) $ (3,908 ) $ (3,838 ) |
Equity-Based Compensation (Tabl
Equity-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Summary of details regarding stock options granted under equity incentive plans | The following table summarizes details regarding stock options granted under our equity incentive plans for the year ended December 31, 2018 : December 31, 2018 Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term Aggregate Intrinsic Value Outstanding at beginning of year 3,531,359 $ 28.27 7.2 $ — Granted 1,184,880 21.14 — — Exercised (153,601 ) 19.26 — — Expired and/or forfeited (846,059 ) 35.13 — — Outstanding at end of year 3,716,579 $ 24.81 7.3 $ 694 Outstanding at end of year - vested and unvested expected to vest 3,601,519 $ 24.92 7.2 $ 690 Exercisable at end of year 1,928,239 $ 27.26 5.8 $ 515 The following table summarizes stock option activity during 2018 : 2007 Equity 2013 Lumara Inducement Plan Equity Plan Grants Total Outstanding at December 31, 2017 2,590,373 125,536 815,450 3,531,359 Granted 1,047,087 35,400 102,393 1,184,880 Exercised (150,789 ) (2,812 ) — (153,601 ) Expired or terminated (704,885 ) (33,674 ) (107,500 ) (846,059 ) Outstanding at December 31, 2018 2,781,786 124,450 810,343 3,716,579 |
Summary of details regarding restricted stock units granted under equity incentive plans | The following table summarizes details regarding RSUs granted under our equity incentive plans for the year ended December 31, 2018 : December 31, 2018 Restricted Stock Units Weighted Average Grant Date Fair Value Outstanding at beginning of year 1,069,775 $ 26.07 Granted 816,887 22.32 Vested (438,284 ) 28.25 Forfeited (319,843 ) 22.86 Outstanding at end of year 1,128,535 $ 23.42 Outstanding at end of year and expected to vest 1,060,647 $ 23.40 The following table summarizes RSU activity during 2018 : 2007 Equity 2013 Lumara Inducement Plan Equity Plan Grants Total Outstanding at December 31, 2017 966,623 11,611 91,541 1,069,775 Granted 766,869 1,600 48,418 816,887 Vested (375,470 ) (10,650 ) (52,164 ) (438,284 ) Expired or terminated (316,881 ) (460 ) (2,502 ) (319,843 ) Outstanding at December 31, 2018 1,041,141 2,101 85,293 1,128,535 |
Schedule of equity-based compensation expense | Equity-based compensation expense for 2018 , 2017 and 2016 consisted of the following (in thousands): Years Ended December 31, 2018 2017 2016 Cost of product sales $ 802 $ 884 $ 511 Research and development 2,533 3,225 3,475 Selling, general and administrative 16,614 16,187 15,590 Total equity-based compensation expense 19,949 20,296 19,576 Income tax effect — (6,188 ) (5,696 ) After-tax effect of equity-based compensation expense $ 19,949 $ 14,108 $ 13,880 |
Schedule of share-based payment award, stock options, valuation assumptions | The following table summarizes the weighted average assumptions we utilized for purposes of valuing grants of options to our employees and non-employee directors: Years Ended December 31, 2018 2017 2016 Non-Employee Non-Employee Non-Employee Employees Directors Employees Directors Employees Directors Risk free interest rate (%) 2.75 2.70 1.86 1.61 1.32 1.10 Expected volatility (%) 57 59 53 57 49 54 Expected option term (years) 5.0 4.0 5.0 4.0 5.0 3.0 Dividend yield none none none none none none |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Maturity schedule by fiscal year, operating leases | Future minimum payments under our non-cancelable leases as of December 31, 2018 are as follows (in thousands): Period Future Minimum Lease Payments Year Ending December 31, 2019 $ 5,119 Year Ending December 31, 2020 4,075 Year Ending December 31, 2021 1,034 Year Ending December 31, 2022 — Year Ending December 31, 2023 — Total $ 10,228 |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
Schedule of outstanding debt obligations | Our outstanding debt obligations as of December 31, 2018 and December 31, 2017 consisted of the following (in thousands): December 31, 2018 2017 2023 Senior Notes $ — $ 466,291 2022 Convertible Notes 261,933 248,194 2019 Convertible Notes 21,276 20,198 Total long-term debt 283,209 734,683 Less: current maturities 21,276 — Long-term debt, net of current maturities $ 261,933 $ 734,683 |
Schedule of outstanding convertible debt | The outstanding balances of our Convertible Notes as of December 31, 2018 consisted of the following (in thousands): 2022 Convertible Notes 2019 Convertible Notes Total Liability component: Principal $ 320,000 $ 21,417 $ 341,417 Less: debt discount and issuance costs, net 58,067 141 58,208 Net carrying amount $ 261,933 $ 21,276 $ 283,209 Gross equity component $ 72,576 $ 9,905 $ 82,481 |
Schedule of total interest expense recognized related to the convertible notes | The following table sets forth total interest expense recognized related to the Convertible Notes during 2018 , 2017 , and 2016 (in thousands): Years Ended December 31, 2018 2017 2016 Contractual interest expense $ 10,935 $ 8,961 $ 5,000 Amortization of debt issuance costs 1,403 1,275 1,072 Amortization of debt discount 13,414 11,071 7,544 Total interest expense $ 25,752 $ 21,307 $ 13,616 |
Schedule of maturities of long-term debt | Future annual principal payments on our long-term debt as of December 31, 2018 were as follows (in thousands): Period Future Annual Principal Payments Year Ending December 31, 2019 $ 21,417 Year Ending December 31, 2020 — Year Ending December 31, 2021 — Year Ending December 31, 2022 320,000 Thereafter — Total $ 341,417 |
Consolidated Quarterly Financ_2
Consolidated Quarterly Financial Data - Unaudited (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Condensed Financial Information Disclosure [Abstract] | |
Condensed Quarterly Income Statement | The following tables provide unaudited consolidated quarterly financial data for 2018 and 2017 (in thousands, except per share data): March 31, 2018 June 30, 2018 September 30, 2018 December 31, 2018 Total revenues $ 117,387 $ 146,254 $ 122,238 $ 88,122 Gross profit 53,475 69,478 75,749 59,406 Operating expenses (2) 104,239 27,591 95,084 78,241 Net loss from continuing operations $ (58,098 ) $ (25,817 ) $ (64,678 ) $ (20,746 ) Net income (loss) from discontinued operations $ 3,856 $ 5,736 $ 95,517 $ (1,531 ) Net (loss) income $ (54,242 ) $ (20,081 ) $ 30,839 $ (22,277 ) Basic net (loss) income per share: Loss from continuing operations $ (1.70 ) $ (0.75 ) $ (1.88 ) $ (0.60 ) Income (loss) from discontinued operations 0.11 0.17 2.77 (0.04 ) Total $ (1.59 ) $ (0.58 ) $ 0.89 $ (0.64 ) Diluted net (loss) income per share: Loss from continuing operations $ (1.70 ) $ (0.75 ) $ (1.88 ) $ (0.60 ) Income (loss) from discontinued operations 0.11 0.17 2.77 (0.04 ) Total $ (1.59 ) $ (0.58 ) $ 0.89 $ (0.64 ) March 31, 2017 June 30, 2017 September 30, 2017 December 31, 2017 Total revenues $ 112,541 $ 130,371 $ 124,331 $ 128,525 Gross profit (loss) (1) 84,968 98,270 (226,000 ) 57,938 Operating expenses (3) 125,112 95,003 28,236 70,663 Net (loss) income from continuing operations $ (35,925 ) $ (14,252 ) $ (155,713 ) $ 738 Net (loss) income from discontinued operations $ (635 ) $ 186 $ 3,652 $ 2,722 Net (loss) income $ (36,560 ) $ (14,066 ) $ (152,061 ) $ 3,460 Basic net (loss) income per share: (Loss) income from continuing operations $ (1.04 ) $ (0.41 ) $ (4.41 ) $ 0.02 (Loss) income from discontinued operations (0.02 ) 0.01 0.10 0.08 Total $ (1.06 ) $ (0.40 ) $ (4.31 ) $ 0.10 Diluted net (loss) income per share: (Loss) income from continuing operations $ (1.04 ) $ (0.41 ) $ (4.41 ) $ 0.02 (Loss) income from discontinued operations (0.02 ) 0.01 0.10 0.08 Total $ (1.06 ) $ (0.40 ) $ (4.31 ) $ 0.10 The sum of quarterly (loss) income per share totals differ from annual (loss) income per share totals due to rounding. (1) Gross profit (loss) for the third quarter of 2017 included an impairment charge of $319.2 million relating to the Makena base technology intangible asset. (2) Operating expenses for the second quarter of 2018 include the reversal of $49.8 million relating to the fair value of a contingent consideration liability that was no longer expected to be paid. (3) Operating expenses for the first quarter of 2017 include $60.0 million of acquired IPR&D expense related to the one-time upfront payment under the terms of the Palatin License Agreement. Operating expenses for the third quarter of 2017 include the reversal of $49.9 million relating to the fair value of a contingent consideration liability that was no longer expected to be paid. |
Valuation And Qualifying Acco_2
Valuation And Qualifying Accounts (In Thousands) (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
SEC Schedule, 12-09, Valuation and Qualifying Accounts [Abstract] | |
Schedule of Valuation and Qualifying Accounts | Balance at Beginning of Period Additions (2) Deductions Charged to Reserves Balance at End of Period Year ended December 31, 2018: Accounts receivable allowances (1) $ 12,060 $ 229,509 $ (232,026 ) $ 9,543 Rebates, fees and returns reserves (2) $ 100,702 $ 270,959 $ (294,891 ) $ 76,770 Valuation allowance for deferred tax assets (3) $ 4,740 $ 108,562 $ (24 ) $ 113,278 Year ended December 31, 2017: Accounts receivable allowances (1) $ 9,533 $ 168,945 $ (166,418 ) $ 12,060 Rebates, fees and returns reserves (2) $ 89,466 $ 255,471 $ (244,235 ) $ 100,702 Valuation allowance for deferred tax assets (3) $ 1,429 $ 3,875 $ (564 ) $ 4,740 Year ended December 31, 2016: Accounts receivable allowances (1) $ 10,783 $ 122,792 $ (124,042 ) $ 9,533 Rebates, fees and returns reserves (2) $ 45,162 $ 186,941 $ (142,637 ) $ 89,466 Valuation allowance for deferred tax assets (3) $ 11,859 $ 632 $ (11,062 ) $ 1,429 ________________________ (1) Accounts receivable allowances represent discounts and other chargebacks related to the provision of our product sales. (2) Additions to rebates, fees and returns reserves are recorded as a reduction of revenues. (3) As of December 31, 2018 , we have established a valuation allowance on our net deferred tax assets other than refundable AMT credits. At December 31, 2017, our valuation allowance related primarily to certain of our state NOL and credit carryforwards. At December 31, 2016, our valuation allowance related primarily to our federal capital loss carryforward and our state NOL and credit carryforwards acquired from Lumara Health. |
Description of Business (Detail
Description of Business (Details) $ in Thousands | Aug. 06, 2018USD ($) | Dec. 31, 2018USD ($)product_candidate | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||
Number of product candidates | product_candidate | 3 | |||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||
Gain on sale of CBR business | $ 87,076 | $ 0 | $ 0 | |
CBR business | Discontinued Operations, Held-for-sale or Disposed of by Sale | ||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||
Cash consideration for sale of wholly-owned subsidiary | $ 519,300 | |||
Gain on sale of CBR business | $ 87,100 | $ 87,076 | $ 0 | $ 0 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Inventory (Details) | 12 Months Ended |
Dec. 31, 2018 | |
Minimum | |
Inventory [Line Items] | |
Shelf-life | 3 years |
Maximum | |
Inventory [Line Items] | |
Shelf-life | 5 years |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Restricted Cash (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Accounting Policies [Abstract] | ||
Restricted cash | $ 495 | $ 495 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Customers Who Represent 10% or More of Total Revenues or Accounts Receivable Balances (Details) - facility | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Sales Revenue, Goods, Net | Customer Concentration Risk | AmerisourceBergen Drug Corporation | |||
Concentrations and Significant Customer Information | |||
Concentration risk, including less than and more than 10% (percent) | 27.00% | 26.00% | 27.00% |
Sales Revenue, Goods, Net | Customer Concentration Risk | McKesson Corporation | |||
Concentrations and Significant Customer Information | |||
Concentration risk, including less than and more than 10% (percent) | 26.00% | 24.00% | 14.00% |
Sales Revenue, Goods, Net | Customer Concentration Risk | Caremark, LLC | |||
Concentrations and Significant Customer Information | |||
Concentration risk, including less than and more than 10% (percent) | 10.00% | 10.00% | 10.00% |
Accounts Receivable | Customer Concentration Risk | Three Customers | |||
Concentrations and Significant Customer Information | |||
Concentration risk, including less than and more than 10% (percent) | 73.00% | ||
Accounts Receivable | Customer Concentration Risk | Two Customers | |||
Concentrations and Significant Customer Information | |||
Concentration risk, including less than and more than 10% (percent) | 57.00% | ||
Feraheme | |||
Concentrations and Significant Customer Information | |||
Number of production facilities | 2 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Property and Equipment, Net (Details) | 12 Months Ended |
Dec. 31, 2018 | |
Computer equipment and software | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives | 5 years |
Furniture and fixtures | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives | 5 years |
Laboratory and production equipment | Minimum | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives | 5 years |
Laboratory and production equipment | Maximum | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives | 8 years |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Revenue Recognition (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Jan. 01, 2018 | Dec. 31, 2017 | Jan. 01, 2017 | Dec. 31, 2016 | Dec. 31, 2015 |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||
Cumulative effect of new accounting principle in period of adoption | $ 21,558 | |||||
Stockholders' equity | $ 746,655 | $ 790,244 | $ 934,389 | $ 932,264 | ||
Accounting Standards Update 2014-09 | ||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||
Cumulative effect of new accounting principle in period of adoption | $ 1,136 | |||||
Accumulated Deficit | ||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||
Cumulative effect of new accounting principle in period of adoption | $ 21,558 | |||||
Stockholders' equity | $ (542,442) | $ (477,817) | $ (300,147) | $ (297,664) | ||
Accumulated Deficit | Accounting Standards Update 2014-09 | ||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||
Cumulative effect of new accounting principle in period of adoption | $ 1,136 |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies - Advertising Costs (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Accounting Policies [Abstract] | |||
Advertising costs | $ 29.8 | $ 9.1 | $ 4.9 |
Summary of Significant Accou_10
Summary of Significant Accounting Policies - Basic and Diluted Net (Loss) Income per Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 12 Months Ended | ||||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Feb. 28, 2014 | |
Debt Instrument [Line Items] | ||||||||||||
Net (loss) income from continuing operations | $ (20,746) | $ (64,678) | $ (25,817) | $ (58,098) | $ 738 | $ (155,713) | $ (14,252) | $ (35,925) | $ (169,339) | $ (205,153) | $ 2,093 | |
Net income (loss) from discontinued operations | $ (1,531) | $ 95,517 | $ 5,736 | $ 3,856 | $ 2,722 | $ 3,652 | $ 186 | $ (635) | $ 103,578 | $ 5,925 | $ (4,576) | |
Weighted average common shares outstanding (in shares) | 34,394 | 34,907 | 34,346 | |||||||||
Effect of dilutive securities: | ||||||||||||
Stock options and RSUs (in shares) | 0 | 0 | 487 | |||||||||
Shares used in calculating dilutive net loss per share (in shares) | 34,394 | 34,907 | 34,833 | |||||||||
Basic net (loss) income per share: | ||||||||||||
(Loss) income from continuing operations (in dollars per share) | $ (0.60) | $ (1.88) | $ (0.75) | $ (1.70) | $ 0.02 | $ (4.41) | $ (0.41) | $ (1.04) | $ (4.92) | $ (5.88) | $ 0.06 | |
Income (loss) from discontinued operations (in dollars per share) | (0.04) | 2.77 | 0.17 | 0.11 | 0.08 | 0.10 | 0.01 | (0.02) | 3.01 | 0.17 | (0.13) | |
Total (in dollars per share) | (0.64) | 0.89 | (0.58) | (1.59) | 0.10 | (4.31) | (0.40) | (1.06) | (1.91) | (5.71) | (0.07) | |
Diluted net (loss) income per share: | ||||||||||||
(Loss) income from continuing operations (in dollars per share) | (0.60) | (1.88) | (0.75) | (1.70) | 0.02 | (4.41) | (0.41) | (1.04) | (4.92) | (5.88) | 0.06 | |
Income (loss) from discontinued operations (in dollars per share) | (0.04) | 2.77 | 0.17 | 0.11 | 0.08 | 0.10 | 0.01 | (0.02) | 3.01 | 0.17 | (0.13) | |
Total (in dollars per share) | $ (0.64) | $ 0.89 | $ (0.58) | $ (1.59) | $ 0.10 | $ (4.31) | $ (0.40) | $ (1.06) | $ (1.91) | $ (5.71) | $ (0.07) | |
Convertible Debt | Convertible Notes Due 2019 | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Interest rate | 2.50% | |||||||||||
Convertible Debt | 2022 Convertible Notes | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Interest rate | 3.25% | 3.25% | 3.25% |
Summary of Significant Accou_11
Summary of Significant Accounting Policies - Schedule of Anti-dilutive Securities excluded from Computation of Earnings per Share (Details) - shares shares in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Anti-dilutive securities (shares) | 18,500 | 18,094 | 18,003 |
Options to purchase shares of common stock | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Anti-dilutive securities (shares) | 3,797 | 3,531 | 2,590 |
Shares of common stock issuable upon the vesting of RSUs | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Anti-dilutive securities (shares) | 1,129 | 1,070 | 613 |
Warrants | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Anti-dilutive securities (shares) | 1,008 | 1,008 | 7,382 |
Shares of common stock under employee stock purchase plan | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Anti-dilutive securities (shares) | 81 | 0 | 36 |
2022 Convertible Notes | Convertible Debt Securities | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Anti-dilutive securities (shares) | 11,695 | 11,695 | 0 |
2019 Convertible Notes | Convertible Debt Securities | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Anti-dilutive securities (shares) | 790 | 790 | 7,382 |
Summary of Significant Accou_12
Summary of Significant Accounting Policies - Business Segments (Details) | 12 Months Ended |
Dec. 31, 2018business_segment | |
Accounting Policies [Abstract] | |
Number of business segments | 1 |
Discontinued Operations and H_3
Discontinued Operations and Held For Sale - Narrative (Details) - USD ($) $ in Thousands | Aug. 06, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||
Gain on sale of CBR business | $ 87,076 | $ 0 | $ 0 | |
Transaction expenses | 14,111 | 0 | 0 | |
Discontinued Operations, Held-for-sale or Disposed of by Sale | CBR business | ||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||
Cash consideration for sale of wholly-owned subsidiary | $ 519,300 | |||
Gain on sale of CBR business | $ 87,100 | 87,076 | 0 | $ 0 |
Capital expenditures | 1,600 | 4,900 | ||
Depreciation and amortization expense | $ 8,400 | $ 21,700 |
Discontinued Operations and H_4
Discontinued Operations and Held For Sale - Assets and Liabilities Held For Sale (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Current assets: | ||
Total current assets held for sale | $ 0 | $ 45,508 |
Total long-term assets held for sale | 0 | 564,711 |
Current liabilities: | ||
Total current liabilities held for sale | 0 | 53,870 |
Total long-term liabilities held for sale | 0 | 95,821 |
CBR business | Discontinued Operations, Held-for-sale or Disposed of by Sale | ||
Current assets: | ||
Cash | 0 | 29,259 |
Accounts receivable, net | 0 | 12,042 |
Inventories (raw materials) | 0 | 2,913 |
Prepaid and other current assets | 0 | 1,294 |
Total current assets held for sale | 0 | 45,508 |
Property, plant and equipment, net | 0 | 18,092 |
Intangible assets, net | 0 | 328,991 |
Goodwill | 0 | 216,971 |
Other long-term assets | 0 | 496 |
Restricted cash | 0 | 161 |
Total long-term assets held for sale | 0 | 564,711 |
Current liabilities: | ||
Accounts payable | 0 | 2,618 |
Accrued expenses | 0 | 8,758 |
Deferred revenues, short term | 0 | 42,494 |
Total current liabilities held for sale | 0 | 53,870 |
Deferred revenues, long-term | 0 | 24,387 |
Deferred tax liabilities | 0 | 71,046 |
Other long-term liabilities | 0 | 388 |
Total long-term liabilities held for sale | $ 0 | $ 95,821 |
Discontinued Operations and H_5
Discontinued Operations and Held For Sale - Summary of Net Income (Loss) (Details) - USD ($) $ in Thousands | Aug. 06, 2018 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Costs and expenses: | ||||||||||||
Income (loss) from discontinued operations | $ 18,873 | $ 10,313 | $ (6,209) | |||||||||
Gain on sale of CBR business | 87,076 | 0 | 0 | |||||||||
Income tax expense (benefit) | 2,371 | 4,388 | (1,633) | |||||||||
Net income (loss) from discontinued operations | $ (1,531) | $ 95,517 | $ 5,736 | $ 3,856 | $ 2,722 | $ 3,652 | $ 186 | $ (635) | 103,578 | 5,925 | (4,576) | |
CBR business | Discontinued Operations, Held-for-sale or Disposed of by Sale | ||||||||||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||||||||||
Service revenues, net | 71,217 | 114,177 | 99,604 | |||||||||
Costs and expenses: | ||||||||||||
Cost of services | 12,559 | 21,817 | 20,575 | |||||||||
Research and development expenses | 0 | 0 | 523 | |||||||||
Selling, general and administrative expenses | 39,899 | 81,782 | 80,402 | |||||||||
Impairment of intangible assets | 0 | 0 | 3,939 | |||||||||
Restructuring expenses | 0 | 0 | 374 | |||||||||
Total costs and expenses | 52,458 | 103,599 | 105,813 | |||||||||
Operating income (loss) | 18,759 | 10,578 | (6,209) | |||||||||
Other income (expense) | 114 | (265) | 0 | |||||||||
Income (loss) from discontinued operations | 18,873 | 10,313 | (6,209) | |||||||||
Gain on sale of CBR business | $ 87,100 | 87,076 | 0 | 0 | ||||||||
Income tax expense (benefit) | 2,371 | 4,388 | (1,633) | |||||||||
Net income (loss) from discontinued operations | $ 103,578 | $ 5,925 | $ (4,576) |
Revenue Recognition - Disaggreg
Revenue Recognition - Disaggregated Revenue By Major Products (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Disaggregation of Revenue [Line Items] | |||||||||||
Revenues | $ 88,122 | $ 122,238 | $ 146,254 | $ 117,387 | $ 128,525 | $ 124,331 | $ 130,371 | $ 112,541 | $ 474,002 | $ 495,769 | $ 432,487 |
Makena | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Revenues | 322,265 | 387,158 | 334,050 | ||||||||
Feraheme | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Revenues | 135,001 | 105,930 | 97,058 | ||||||||
Intrarosa | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Revenues | 16,218 | 1,816 | 0 | ||||||||
MuGard | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Revenues | 368 | 741 | 1,062 | ||||||||
Product | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Revenues | $ 473,852 | $ 495,645 | $ 432,170 |
Revenue Recognition - Total Gro
Revenue Recognition - Total Gross Product (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Provision for product sales allowances and accruals: | |||||||||||
Product sales, net | $ 88,122 | $ 122,238 | $ 146,254 | $ 117,387 | $ 128,525 | $ 124,331 | $ 130,371 | $ 112,541 | $ 474,002 | $ 495,769 | $ 432,487 |
Product | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Gross product sales | 974,330 | 920,061 | 748,839 | ||||||||
Provision for product sales allowances and accruals: | |||||||||||
Contractual adjustments | 387,540 | 310,588 | 229,686 | ||||||||
Governmental rebates | 112,938 | 113,828 | 86,983 | ||||||||
Total | 500,478 | 424,416 | 316,669 | ||||||||
Product sales, net | $ 473,852 | $ 495,645 | $ 432,170 |
Revenue Recognition - Product R
Revenue Recognition - Product Revenue Allowance and Accrual Activity (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Contractual Adjustments | |||
Balance at Beginning of Period | $ 62,164 | $ 47,600 | $ 30,177 |
Provisions related to current period sales | 389,861 | 314,537 | 224,894 |
Adjustments related to prior period sales | (2,330) | (3,949) | (2,348) |
Payments/returns relating to current period sales | (333,694) | (253,545) | (181,150) |
Payments/returns relating to prior period sales | (58,802) | (42,479) | (23,973) |
Balance at End of Period | 57,199 | 62,164 | 47,600 |
Governmental Rebates | |||
Balance at Beginning of Period | 50,598 | 51,399 | 25,767 |
Provisions related to current period sales | 105,034 | 112,167 | 93,035 |
Adjustments related to prior period sales | 7,903 | 1,661 | (6,052) |
Payments/returns relating to current period sales | (75,920) | (61,569) | (41,636) |
Payments/returns relating to prior period sales | (58,501) | (53,060) | (19,715) |
Balance at End of Period | 29,114 | 50,598 | 51,399 |
Revenue, Allowance [Roll Forward] | |||
Balance at Beginning of Period | 112,762 | 98,999 | 55,944 |
Provisions related to current period sales | 494,895 | 426,704 | 317,929 |
Adjustments related to prior period sales | 5,573 | (2,288) | (8,400) |
Payments/returns relating to current period sales | (409,614) | (315,114) | (222,786) |
Payments/returns relating to prior period sales | (117,303) | (95,539) | (43,688) |
Balance at End of Period | $ 86,313 | $ 112,762 | $ 98,999 |
Revenue Recognition - Additiona
Revenue Recognition - Additional Information (Details) | 12 Months Ended |
Dec. 31, 2018 | |
Disaggregation of Revenue [Line Items] | |
Discount percentage | 2.00% |
Standard payment term | 30 days |
Percentage of discount accrued at time of sale | 100.00% |
GPO billing period | 30 days |
Minimum | |
Disaggregation of Revenue [Line Items] | |
Rebate payment term | 1 month |
Product return term | 3 years |
Maximum | |
Disaggregation of Revenue [Line Items] | |
Rebate payment term | 3 months |
Product return term | 5 years |
Marketable Securities (Details)
Marketable Securities (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Short-term investments: | |||
Amortized Cost, short-term investments | $ 74,826,000 | $ 70,406,000 | |
Gross Unrealized Gains, short-term investments | 0 | 0 | |
Gross Unrealized Losses, short-term investments | (270,000) | (81,000) | |
Estimated Fair Value, short-term investments | 74,556,000 | 70,325,000 | |
Long-term investments: | |||
Amortized Cost, long-term investments | 66,772,000 | 66,663,000 | |
Gross Unrealized Gains, long-term investments | 52,000 | 1,000 | |
Gross Unrealized Losses, long-term investments | (465,000) | (396,000) | |
Estimated Fair Value, long-term investments | 66,359,000 | 66,268,000 | |
Total investments | |||
Amortized Cost, total | 141,598,000 | 137,069,000 | |
Gross Unrealized Gains, total | 52,000 | 1,000 | |
Gross Unrealized Losses, total | (735,000) | (477,000) | |
Estimated Fair Value, total | 140,915,000 | 136,593,000 | |
Other-than-temporary impairment losses | 0 | 0 | $ 0 |
Corporate debt securities | |||
Short-term investments: | |||
Amortized Cost, short-term investments | 51,184,000 | 57,257,000 | |
Gross Unrealized Gains, short-term investments | 0 | 0 | |
Gross Unrealized Losses, short-term investments | (236,000) | (68,000) | |
Estimated Fair Value, short-term investments | 50,948,000 | 57,189,000 | |
Long-term investments: | |||
Amortized Cost, long-term investments | 62,530,000 | 59,282,000 | |
Gross Unrealized Gains, long-term investments | 52,000 | 1,000 | |
Gross Unrealized Losses, long-term investments | (433,000) | (320,000) | |
Estimated Fair Value, long-term investments | 62,149,000 | 58,963,000 | |
U.S. treasury and government agency securities | |||
Short-term investments: | |||
Amortized Cost, short-term investments | 7,647,000 | 1,999,000 | |
Gross Unrealized Gains, short-term investments | 0 | 0 | |
Gross Unrealized Losses, short-term investments | (34,000) | (13,000) | |
Estimated Fair Value, short-term investments | 7,613,000 | 1,986,000 | |
Long-term investments: | |||
Amortized Cost, long-term investments | 2,742,000 | 7,381,000 | |
Gross Unrealized Gains, long-term investments | 0 | 0 | |
Gross Unrealized Losses, long-term investments | (32,000) | (76,000) | |
Estimated Fair Value, long-term investments | 2,710,000 | 7,305,000 | |
Commercial paper | |||
Short-term investments: | |||
Amortized Cost, short-term investments | 3,995,000 | 1,999,000 | |
Gross Unrealized Gains, short-term investments | 0 | 0 | |
Gross Unrealized Losses, short-term investments | 0 | 0 | |
Estimated Fair Value, short-term investments | 3,995,000 | 1,999,000 | |
Certificates of deposit | |||
Short-term investments: | |||
Amortized Cost, short-term investments | 12,000,000 | 9,151,000 | |
Gross Unrealized Gains, short-term investments | 0 | 0 | |
Gross Unrealized Losses, short-term investments | 0 | 0 | |
Estimated Fair Value, short-term investments | 12,000,000 | $ 9,151,000 | |
Long-term investments: | |||
Amortized Cost, long-term investments | 1,500,000 | ||
Gross Unrealized Gains, long-term investments | 0 | ||
Gross Unrealized Losses, long-term investments | 0 | ||
Estimated Fair Value, long-term investments | $ 1,500,000 |
Fair Value Measurements - Asset
Fair Value Measurements - Assets and Liabilities Measured at Fair Value on a Recurring Basis (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | ||
Jun. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | |
Fair value, measurements, recurring | ||||
Assets: | ||||
Cash equivalents | $ 71,568 | $ 4,591 | ||
Total Assets | 212,483 | 141,184 | ||
Liabilities: | ||||
Total Liabilities | 359 | 50,085 | ||
Fair value, measurements, recurring | Lumara Health Inc. | ||||
Liabilities: | ||||
Contingent consideration | 0 | 49,187 | ||
Fair value, measurements, recurring | MuGard | ||||
Liabilities: | ||||
Contingent consideration | 359 | 898 | ||
Fair value, measurements, recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||||
Assets: | ||||
Cash equivalents | 71,568 | 4,591 | ||
Total Assets | 71,568 | 4,591 | ||
Liabilities: | ||||
Total Liabilities | 0 | 0 | ||
Fair value, measurements, recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | Lumara Health Inc. | ||||
Liabilities: | ||||
Contingent consideration | 0 | 0 | ||
Fair value, measurements, recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | MuGard | ||||
Liabilities: | ||||
Contingent consideration | 0 | 0 | ||
Fair value, measurements, recurring | Significant Other Observable Inputs (Level 2) | ||||
Assets: | ||||
Cash equivalents | 0 | 0 | ||
Total Assets | 140,915 | 136,593 | ||
Liabilities: | ||||
Total Liabilities | 0 | 0 | ||
Fair value, measurements, recurring | Significant Other Observable Inputs (Level 2) | Lumara Health Inc. | ||||
Liabilities: | ||||
Contingent consideration | 0 | 0 | ||
Fair value, measurements, recurring | Significant Other Observable Inputs (Level 2) | MuGard | ||||
Liabilities: | ||||
Contingent consideration | 0 | 0 | ||
Fair value, measurements, recurring | Significant Unobservable Inputs (Level 3) | ||||
Assets: | ||||
Cash equivalents | 0 | 0 | ||
Total Assets | 0 | 0 | ||
Liabilities: | ||||
Total Liabilities | 359 | 50,085 | ||
Fair value, measurements, recurring | Significant Unobservable Inputs (Level 3) | Lumara Health Inc. | ||||
Liabilities: | ||||
Contingent consideration | 0 | 49,187 | ||
Fair value, measurements, recurring | Significant Unobservable Inputs (Level 3) | MuGard | ||||
Liabilities: | ||||
Contingent consideration | 359 | 898 | ||
Corporate debt securities | Fair value, measurements, recurring | ||||
Assets: | ||||
Available-for-sale securities | 113,097 | 116,152 | ||
Corporate debt securities | Fair value, measurements, recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||||
Assets: | ||||
Available-for-sale securities | 0 | 0 | ||
Corporate debt securities | Fair value, measurements, recurring | Significant Other Observable Inputs (Level 2) | ||||
Assets: | ||||
Available-for-sale securities | 113,097 | 116,152 | ||
Corporate debt securities | Fair value, measurements, recurring | Significant Unobservable Inputs (Level 3) | ||||
Assets: | ||||
Available-for-sale securities | 0 | 0 | ||
U.S. treasury and government agency securities | Fair value, measurements, recurring | ||||
Assets: | ||||
Available-for-sale securities | 10,323 | 9,291 | ||
U.S. treasury and government agency securities | Fair value, measurements, recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||||
Assets: | ||||
Available-for-sale securities | 0 | 0 | ||
U.S. treasury and government agency securities | Fair value, measurements, recurring | Significant Other Observable Inputs (Level 2) | ||||
Assets: | ||||
Available-for-sale securities | 10,323 | 9,291 | ||
U.S. treasury and government agency securities | Fair value, measurements, recurring | Significant Unobservable Inputs (Level 3) | ||||
Assets: | ||||
Available-for-sale securities | 0 | 0 | ||
Commercial paper | Fair value, measurements, recurring | ||||
Assets: | ||||
Available-for-sale securities | 3,995 | 1,999 | ||
Commercial paper | Fair value, measurements, recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||||
Assets: | ||||
Available-for-sale securities | 0 | 0 | ||
Commercial paper | Fair value, measurements, recurring | Significant Other Observable Inputs (Level 2) | ||||
Assets: | ||||
Available-for-sale securities | 3,995 | 1,999 | ||
Commercial paper | Fair value, measurements, recurring | Significant Unobservable Inputs (Level 3) | ||||
Assets: | ||||
Available-for-sale securities | 0 | 0 | ||
Certificates of deposit | Fair value, measurements, recurring | ||||
Assets: | ||||
Available-for-sale securities | 13,500 | 9,151 | ||
Certificates of deposit | Fair value, measurements, recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||||
Assets: | ||||
Available-for-sale securities | 0 | 0 | ||
Certificates of deposit | Fair value, measurements, recurring | Significant Other Observable Inputs (Level 2) | ||||
Assets: | ||||
Available-for-sale securities | 13,500 | 9,151 | ||
Certificates of deposit | Fair value, measurements, recurring | Significant Unobservable Inputs (Level 3) | ||||
Assets: | ||||
Available-for-sale securities | 0 | 0 | ||
Contingent Consideration | ||||
Fair value of assets and liabilities measured on a recurring basis | ||||
Adjustments to fair value of contingent consideration | $ 49,800 | $ 49,900 | $ (49,607) | $ (47,686) |
Fair Value Measurements - Conti
Fair Value Measurements - Contingent Consideration (Details) | 3 Months Ended | 12 Months Ended | |||
Jun. 30, 2018USD ($) | Sep. 30, 2017USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||||
Contingent consideration accrued | $ 129,537,000 | $ 166,732,000 | |||
Reconciliation of contingent consideration obligations related to acquisitions | |||||
Royalty payment | 119,000 | 39,793,000 | $ 92,130,000 | ||
Endoceutics License Agreement | |||||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||||
Contingent consideration accrued | 0 | 10,000,000 | |||
MuGard | |||||
Reconciliation of contingent consideration obligations related to acquisitions | |||||
Royalty payment | 200,000 | ||||
Estimated undiscounted royalty amounts payable, minimum | 300,000 | ||||
Estimated undiscounted royalty amounts payable, maximum | $ 600,000 | ||||
Period over which estimated undiscounted royalty amounts could be paid | 10 years | ||||
Contingent Consideration | |||||
Reconciliation of contingent consideration obligations related to acquisitions | |||||
Balance | $ 50,085,000 | 147,995,000 | |||
Payments made | (119,000) | (50,224,000) | |||
Adjustments to fair value of contingent consideration | $ 49,800,000 | $ 49,900,000 | (49,607,000) | (47,686,000) | |
Balance | $ 359,000 | 50,085,000 | $ 147,995,000 | ||
Lumara Health | |||||
Reconciliation of contingent consideration obligations related to acquisitions | |||||
Payment of contingent consideration | $ 50,000,000 | ||||
Measurement Input, Discount Rate | MuGard | |||||
Reconciliation of contingent consideration obligations related to acquisitions | |||||
Discount rate | 0.14 |
Fair Value Measurements - Debt
Fair Value Measurements - Debt (Details) - Significant Other Observable Inputs (Level 2) - USD ($) $ in Millions | Dec. 31, 2018 | Dec. 31, 2017 |
Senior Notes | 2023 Senior Notes | ||
Debt | ||
Fair value of debt | $ 463.7 | |
Convertible Debt | 2022 Convertible Notes | ||
Debt | ||
Fair value of debt | $ 294.8 | 282.9 |
Convertible Debt | 2019 Convertible Notes | ||
Debt | ||
Fair value of debt | $ 20.9 | $ 21.6 |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 9,388 | $ 9,505 |
Work in process | 5,932 | 4,146 |
Finished goods | 11,371 | 20,792 |
Total inventories | $ 26,691 | $ 34,443 |
Property and Equipment, Net (De
Property and Equipment, Net (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Property, Plant and Equipment [Line Items] | |||
Property and equipment, gross | $ 12,732 | $ 11,503 | |
Less: accumulated depreciation | (5,211) | (3,599) | |
Property and equipment, net | 7,521 | 7,904 | |
Depreciation expense | 1,600 | 1,200 | $ 900 |
Computer equipment and software | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, gross | 1,637 | 1,401 | |
Furniture and fixtures | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, gross | 1,737 | 1,442 | |
Leasehold improvements | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, gross | 2,938 | 2,938 | |
Laboratory and production equipment | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, gross | 6,000 | 654 | |
Construction in progress | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, gross | $ 420 | $ 5,068 |
Goodwill and Intangible Asset_3
Goodwill and Intangible Assets, Net - Goodwill - Narrative (Details) | Dec. 31, 2018USD ($)$ / shares | Nov. 05, 2018USD ($) | Oct. 31, 2018USD ($)$ / shares | Oct. 31, 2017USD ($) | Sep. 30, 2017USD ($)$ / shares | Dec. 31, 2018USD ($)$ / shares | Jun. 30, 2018USD ($) | Dec. 31, 2018USD ($)$ / shares | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Sep. 30, 2018 | Feb. 11, 2014$ / shares |
Goodwill [Line Items] | ||||||||||||
Goodwill | $ 422,513,000 | $ 422,513,000 | $ 422,513,000 | $ 422,513,000 | ||||||||
Accumulated impairment losses | $ 0 | $ 0 | $ 0 | |||||||||
Share price (in dollars per share) | $ / shares | $ 15.19 | $ 21.50 | $ 18.45 | $ 15.19 | $ 15.19 | $ 20.07 | ||||||
Market capitalization | $ 633,000,000 | $ 742,000,000 | $ 653,000,000 | $ 617,000,000 | ||||||||
Fair value percentage below carrying amount, reporting unit | 41.00% | 20.00% | 2.00% | 18.00% | 21.00% | |||||||
Fair value percentage above carrying amount, net assets | 15.00% | 36.00% | 6.00% | |||||||||
Goodwill, impairment | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | |||||||
Share price, median (in dollars per share) | $ / shares | $ 17.84 | |||||||||||
Reporting unit, carrying amount | $ 747,000,000 | $ 747,000,000 | 747,000,000 | |||||||||
Impairment of intangible assets | $ 0 | $ 319,246,000 | $ 15,724,000 | |||||||||
Fair value percentage above carrying amount, reporting unit | 18.00% | |||||||||||
Fair value inputs, discount rate, sensitivity analysis of one percent | 1.00% | |||||||||||
Measurement Input, Control Premium | ||||||||||||
Goodwill [Line Items] | ||||||||||||
Reporting unit, measurement input, median | 0.71 | |||||||||||
Measurement Input, Control Premium | Minimum | ||||||||||||
Goodwill [Line Items] | ||||||||||||
Reporting unit, measurement input | 0.30 | 0.39 | ||||||||||
Measurement Input, Control Premium | Maximum | ||||||||||||
Goodwill [Line Items] | ||||||||||||
Reporting unit, measurement input | 0.83 | |||||||||||
Measurement Input, Control Premium | Weighted Average | ||||||||||||
Goodwill [Line Items] | ||||||||||||
Reporting unit, measurement input | 0.64 | |||||||||||
Measurement Input, Discount Rate | Minimum | ||||||||||||
Goodwill [Line Items] | ||||||||||||
Reporting unit, measurement input | 0.100 | |||||||||||
Measurement Input, Discount Rate | Maximum | ||||||||||||
Goodwill [Line Items] | ||||||||||||
Reporting unit, measurement input | 0.195 | 0.96 | ||||||||||
Measurement Input, Discount Rate | Weighted Average | ||||||||||||
Goodwill [Line Items] | ||||||||||||
Reporting unit, measurement input | 0.136 |
Goodwill and Intangible Asset_4
Goodwill and Intangible Assets, Net - Schedule of Intangible Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Finite-Lived Intangible Assets [Line Items] | ||
Cost | $ 953,855 | $ 874,755 |
Accumulated Amortization | 417,576 | 259,130 |
Impairments | 319,246 | 319,246 |
Total | 217,033 | 296,379 |
Total intangible assets | ||
Cost | 953,855 | 953,855 |
Impairments | 319,246 | 319,246 |
Net | 217,033 | 375,479 |
Makena | Developed technology rights | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 797,100 | 797,100 |
Accumulated Amortization | 400,495 | 255,754 |
Impairments | 319,246 | 319,246 |
Total | 77,359 | 222,100 |
Makena auto-injector developed technology | Developed technology rights | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 79,100 | 0 |
Accumulated Amortization | 6,952 | 0 |
Impairments | 0 | 0 |
Total | 72,148 | 0 |
Intrarosa | Developed technology rights | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 77,655 | 77,655 |
Accumulated Amortization | 10,129 | 3,376 |
Impairments | 0 | 0 |
Total | 67,526 | 74,279 |
Makena IPR&D | ||
Indefinite-lived Intangible Assets [Line Items] | ||
Cost | 0 | 79,100 |
Impairments | 0 | 0 |
Net | $ 0 | $ 79,100 |
Goodwill and Intangible Asset_5
Goodwill and Intangible Assets, Net - Intangible Assets - Narrative (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||
Apr. 30, 2017 | Jun. 30, 2013 | Sep. 30, 2018 | Sep. 30, 2017 | Jun. 30, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Finite-Lived Intangible Assets [Line Items] | ||||||||
Expected useful life | 7 years 6 months 18 days | |||||||
Impairment of intangible assets | $ 0 | $ 319,246 | $ 15,724 | |||||
Amortization of intangible assets | $ 158,400 | $ 130,400 | 72,300 | |||||
MuGard Rights | ||||||||
Finite-Lived Intangible Assets [Line Items] | ||||||||
Expected useful life | 10 years | |||||||
Impairment of intangible assets | $ 15,700 | |||||||
Makena auto-injector developed technology | Developed technology rights | ||||||||
Finite-Lived Intangible Assets [Line Items] | ||||||||
Expected useful life | 8 years 9 months 18 days | |||||||
Makena | Developed technology rights | ||||||||
Finite-Lived Intangible Assets [Line Items] | ||||||||
Expected useful life | 7 years | 20 years | 7 years | |||||
Impairment of intangible assets | $ 319,200 | |||||||
Intrarosa | Developed technology rights | ||||||||
Finite-Lived Intangible Assets [Line Items] | ||||||||
Expected useful life | 11 years 6 months |
Goodwill and Intangible Asset_6
Goodwill and Intangible Assets, Net - Amortization Expense (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Estimated Amortization Expense | ||
Year Ending December 31, 2019 | $ 41,891 | |
Year Ending December 31, 2020 | 37,123 | |
Year Ending December 31, 2021 | 31,022 | |
Year Ending December 31, 2022 | 27,972 | |
Year Ending December 31, 2023 | 18,207 | |
Thereafter | 60,818 | |
Total | $ 217,033 | $ 296,379 |
Current and Long-Term Liabili_3
Current and Long-Term Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Accrued Expenses | ||
Commercial rebates, fees and returns | $ 80,520 | $ 101,852 |
Professional, license, and other fees and expenses | 23,242 | 23,657 |
Salaries, bonuses, and other compensation | 22,482 | 15,882 |
Interest expense | 1,067 | 13,525 |
Intrarosa-related license fees | 0 | 10,000 |
Accrued research and development | 2,226 | 1,816 |
Total accrued expenses | $ 129,537 | $ 166,732 |
Income Taxes - Schedule of Inco
Income Taxes - Schedule of Income Tax Expense (Benefit) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Current: | |||
Federal | $ (1,136) | $ 2,162 | $ 0 |
State | 1,469 | 5,358 | 4,169 |
Total current | 333 | 7,520 | 4,169 |
Deferred: | |||
Federal | 42,886 | (172,048) | 11,208 |
State | (3,565) | (10,726) | (2,206) |
Total deferred | 39,321 | (182,774) | 9,002 |
Total income tax expense (benefit) | $ 39,654 | $ (175,254) | $ 13,171 |
Income Taxes - Income Tax Recon
Income Taxes - Income Tax Reconciliation (Details) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |||
Statutory U.S. federal tax rate | 21.00% | 35.00% | 35.00% |
State taxes, net of federal benefit | 4.70% | 3.30% | 5.40% |
Impact of 2017 tax reform on deferred tax balance | 0.00% | 4.60% | 0.00% |
Equity-based compensation expense | (1.50%) | (0.80%) | 16.20% |
Contingent consideration | 7.20% | 4.40% | 41.50% |
Other permanent items, net | (1.40%) | (0.50%) | 11.90% |
Tax credits | 6.20% | 0.70% | (19.20%) |
Write-down of acquired state net operating losses | 0.00% | 0.00% | 67.70% |
Valuation allowance | (67.40%) | (0.80%) | (68.30%) |
Other, net | 0.60% | 0.20% | (3.90%) |
Effective tax rate | (30.60%) | 46.10% | 86.30% |
Income Taxes - Narrative (Detai
Income Taxes - Narrative (Details) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018USD ($)state_auditownership_change | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | |
Tax Credit Carryforward [Line Items] | |||
Income tax expense (benefit) | $ 39,654 | $ (175,254) | $ 13,171 |
Effective tax rate | (30.60%) | 46.10% | 86.30% |
Statutory U.S. federal tax rate | 21.00% | 35.00% | 35.00% |
Tax cuts and jobs act, provisional tax benefit | $ 17,600 | ||
Increase in valuation allowance | $ 108,500 | ||
Increase (decrease) in unrecognized tax benefits | $ 600 | $ (2,500) | $ 300 |
Number of state audits in progress | state_audit | 2 | ||
Lumara Health Inc. | |||
Tax Credit Carryforward [Line Items] | |||
Number of ownership changes | ownership_change | 2 | ||
Domestic Tax Authority | |||
Tax Credit Carryforward [Line Items] | |||
Operating loss carryforwards | $ 199,000 | ||
Tax credit carryforward, amount | 23,400 | ||
Domestic Tax Authority | Lumara Health Inc. | |||
Tax Credit Carryforward [Line Items] | |||
Operating loss carryforwards | 123,100 | ||
Tax credit carryforward, amount | 2,300 | ||
State and Local Jurisdiction | |||
Tax Credit Carryforward [Line Items] | |||
Operating loss carryforwards | 92,900 | ||
Tax credit carryforward, amount | 1,200 | ||
State and Local Jurisdiction | Lumara Health Inc. | |||
Tax Credit Carryforward [Line Items] | |||
Operating loss carryforwards | 16,600 | ||
Capital Loss Carryforward | Discontinued Operations, Held-for-sale or Disposed of by Sale | CBR business | |||
Tax Credit Carryforward [Line Items] | |||
Tax credit carryforward, amount | 90,500 | ||
Interest Expense Carryforward | |||
Tax Credit Carryforward [Line Items] | |||
Tax credit carryforward, amount | $ 17,800 |
Income Taxes - Deferred Tax Com
Income Taxes - Deferred Tax Components (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Assets | ||
Net operating loss carryforwards | $ 46,888 | $ 60,308 |
Tax credit carryforwards | 24,290 | 15,577 |
Capital loss carryforwards | 20,896 | 0 |
Interest expense carryforwards | 4,318 | 0 |
Equity-based compensation expense | 5,931 | 5,873 |
Capitalized research & development | 4,635 | 7,872 |
Intangible assets | 12,565 | 0 |
Reserves | 2,683 | 3,342 |
Contingent consideration | 87 | 1,406 |
Other | 5,389 | 5,971 |
Valuation allowance | (113,278) | (4,740) |
Liabilities | ||
Property, plant and equipment depreciation | (614) | (198) |
Intangible assets and inventory | 0 | (32,406) |
Debt instruments | (12,489) | (15,744) |
Other | (41) | (141) |
Net deferred tax assets | $ 1,260 | $ 47,120 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Uncertain Tax Positions (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | |||
Unrecognized tax benefits at the beginning of the year | $ 10,560 | $ 13,020 | $ 12,695 |
Additions based on tax positions related to the current year | 12 | 574 | 300 |
Additions for tax positions from prior years | 608 | 340 | 69 |
Subtractions for federal tax reform | 0 | (3,296) | 0 |
Subtractions for tax positions from prior years | 0 | (78) | (44) |
Unrecognized tax benefits at the end of the year | $ 11,180 | $ 10,560 | $ 13,020 |
Accumulated Other Comprehensi_3
Accumulated Other Comprehensive Loss (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
AOCI Attributable to Parent, Net of Tax | |||
Beginning balance | $ 790,244 | $ 934,389 | $ 932,264 |
Other comprehensive loss before reclassifications | (77) | (70) | 261 |
Reclassification adjustment for gains included in net loss | 0 | 0 | 106 |
Ending balance | 746,655 | 790,244 | 934,389 |
Accumulated Other Comprehensive Income (Loss) | |||
AOCI Attributable to Parent, Net of Tax | |||
Beginning balance | (3,908) | (3,838) | (4,205) |
Ending balance | $ (3,985) | $ (3,908) | $ (3,838) |
Equity-Based Compensation - Nar
Equity-Based Compensation - Narrative (Details) $ / shares in Units, $ in Millions | 1 Months Ended | 12 Months Ended | ||||
Jun. 30, 2018shares | May 31, 2015shares | Dec. 31, 2018USD ($)plan$ / sharesshares | Dec. 31, 2017USD ($)$ / shares | Dec. 31, 2016USD ($)$ / shares | Nov. 30, 2014shares | |
Equity compensation plans | ||||||
Number of equity compensation plans | plan | 3 | |||||
Options granted in period (in dollars per share) | $ / shares | $ 10.76 | $ 9.52 | $ 10.63 | |||
Options vested in period (shares) | 604,886 | |||||
Value of options exercised in period | $ | $ 0.6 | $ 0.4 | $ 1.5 | |||
Compensation cost not yet recognized | $ | 32.7 | |||||
Compensation cost not yet recognized, associated with stock options | $ | $ 16.2 | |||||
RSUs | ||||||
Equity compensation plans | ||||||
Compensation expense, period for recognition | 1 year 9 months 18 days | |||||
RSUs granted (in dollars per share) | $ / shares | $ 22.32 | $ 24.18 | $ 22.28 | |||
Value of RSUs vested during period | $ | $ 12.4 | $ 12.3 | $ 9.1 | |||
Compensation cost not yet recognized | $ | $ 12.6 | |||||
Performance Restricted Stock Units (RSUs) | ||||||
Equity compensation plans | ||||||
Compensation expense, period for recognition | 1 year 9 months | |||||
Compensation cost not yet recognized | $ | $ 3.9 | |||||
Employee and Non Employee Director Stock Option | ||||||
Equity compensation plans | ||||||
Compensation expense, period for recognition | 2 years 8 months | |||||
2000 Equity Plan | ||||||
Equity compensation plans | ||||||
Remaining number of shares available for future grants | 0 | |||||
2007 Equity Plan | ||||||
Equity compensation plans | ||||||
Remaining number of shares available for future grants | 2,548,513 | |||||
Additional common stock for issuance (shares) | 1,043,000 | |||||
Shares authorized for issuance | 10,537,365 | |||||
2007 Equity Plan | Minimum | ||||||
Equity compensation plans | ||||||
Offering period term | 7 years | |||||
2007 Equity Plan | Maximum | ||||||
Equity compensation plans | ||||||
Offering period term | 10 years | |||||
2007 Equity Plan | Performance Restricted Stock Units (RSUs) | ||||||
Equity compensation plans | ||||||
Award vesting period | 3 years | |||||
Compensation expense, period for recognition | 3 years | |||||
2013 Lumara Equity Plan | ||||||
Equity compensation plans | ||||||
Remaining number of shares available for future grants | 18,242 | |||||
Shares authorized for issuance | 200,000 | |||||
Offering period term | 10 years | |||||
2015 ESPP | ||||||
Equity compensation plans | ||||||
Additional common stock for issuance (shares) | 500,000 | |||||
Shares authorized for issuance | 200,000 | |||||
Annual maximum percentage of employee compensation available for ESPP share purchases | 10.00% | |||||
Purchase price per share as a percentage of fair market value of common stock on the first or last day of the plan period | 85.00% | |||||
Stock offering period | 6 months | |||||
Shares issued | 259,776 | |||||
Inducement Grants | Employee Stock Option | ||||||
Equity compensation plans | ||||||
Award vesting period | 4 years | |||||
Inducement Grants | RSUs | ||||||
Equity compensation plans | ||||||
Award vesting period | 3 years |
Equity-Based Compensation - Act
Equity-Based Compensation - Activity Related to Plans (Details) - USD ($) $ in Millions | 1 Months Ended | 12 Months Ended | |
Mar. 31, 2018 | Feb. 28, 2017 | Dec. 31, 2018 | |
Stock Options | |||
Beginning balance (shares) | 3,531,359 | ||
Granted (shares) | 1,184,880 | ||
Exercised (shares) | (153,601) | ||
Expired or terminated (shares) | (846,059) | ||
Ending balance (shares) | 3,716,579 | ||
2007 Equity Plan | |||
Stock Options | |||
Beginning balance (shares) | 2,590,373 | ||
Granted (shares) | 1,047,087 | ||
Exercised (shares) | (150,789) | ||
Expired or terminated (shares) | (704,885) | ||
Ending balance (shares) | 2,781,786 | ||
Restricted Stock Units | |||
Remaining number of shares available for future grants | 2,548,513 | ||
2013 Lumara Equity Plan | |||
Stock Options | |||
Beginning balance (shares) | 125,536 | ||
Granted (shares) | 35,400 | ||
Exercised (shares) | (2,812) | ||
Expired or terminated (shares) | (33,674) | ||
Ending balance (shares) | 124,450 | ||
Restricted Stock Units | |||
Remaining number of shares available for future grants | 18,242 | ||
Inducement Grants | |||
Stock Options | |||
Beginning balance (shares) | 815,450 | ||
Granted (shares) | 102,393 | ||
Exercised (shares) | 0 | ||
Expired or terminated (shares) | (107,500) | ||
Ending balance (shares) | 810,343 | ||
RSUs | |||
Restricted Stock Units | |||
Outstanding at beginning of year (shares) | 1,069,775 | ||
Granted (shares) | 816,887 | ||
Vested (shares) | (438,284) | ||
Expired or terminated (in shares) | (319,843) | ||
Outstanding at end of year (shares) | 1,128,535 | ||
Compensation expense, period for recognition | 1 year 9 months 18 days | ||
RSUs | 2007 Equity Plan | |||
Restricted Stock Units | |||
Outstanding at beginning of year (shares) | 966,623 | ||
Granted (shares) | 766,869 | ||
Vested (shares) | (375,470) | ||
Expired or terminated (in shares) | (316,881) | ||
Outstanding at end of year (shares) | 1,041,141 | ||
RSUs | 2013 Lumara Equity Plan | |||
Restricted Stock Units | |||
Outstanding at beginning of year (shares) | 11,611 | ||
Granted (shares) | 1,600 | ||
Vested (shares) | (10,650) | ||
Expired or terminated (in shares) | (460) | ||
Outstanding at end of year (shares) | 2,101 | ||
RSUs | Inducement Grants | |||
Restricted Stock Units | |||
Outstanding at beginning of year (shares) | 91,541 | ||
Granted (shares) | 48,418 | ||
Vested (shares) | (52,164) | ||
Expired or terminated (in shares) | (2,502) | ||
Outstanding at end of year (shares) | 85,293 | ||
Award vesting period | 3 years | ||
Performance Restricted Stock Units (RSUs) | |||
Restricted Stock Units | |||
Compensation expense, period for recognition | 1 year 9 months | ||
Performance Restricted Stock Units (RSUs) | 2007 Equity Plan | |||
Restricted Stock Units | |||
Granted (shares) | 206,250 | 191,250 | |
Award vesting period | 3 years | ||
Compensation expense, period for recognition | 3 years | ||
March 2018 | Performance Restricted Stock Units (RSUs) | 2007 Equity Plan | |||
Restricted Stock Units | |||
Granted (shares) | 188,250 | ||
Fair value, performance- based RSUs | $ 3.5 | ||
February 2017 | Performance Restricted Stock Units (RSUs) | 2007 Equity Plan | |||
Restricted Stock Units | |||
Remaining number of shares available for future grants | 153,750 | ||
Fair value, performance- based RSUs | $ 3.1 |
Equity-Based Compensation - Equ
Equity-Based Compensation - Equity-Based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Equity-based compensation expense | |||
Total equity-based compensation expense | $ 19,949 | $ 20,296 | $ 19,576 |
Income tax effect | 0 | (6,188) | (5,696) |
After-tax effect of equity-based compensation expense | 19,949 | 14,108 | 13,880 |
Cost of product sales | |||
Equity-based compensation expense | |||
Total equity-based compensation expense | 802 | 884 | 511 |
Research and development | |||
Equity-based compensation expense | |||
Total equity-based compensation expense | 2,533 | 3,225 | 3,475 |
Selling, general and administrative | |||
Equity-based compensation expense | |||
Total equity-based compensation expense | $ 16,614 | $ 16,187 | $ 15,590 |
Equity-Based Compensation - Wei
Equity-Based Compensation - Weighted-Average Fair Value Assumptions, Stock Option Activity (Details) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Employee Stock Option | |||
Equity compensation plans | |||
Risk free interest rate (%) | 2.75% | 1.86% | 1.32% |
Expected volatility (%) | 57.00% | 53.00% | 49.00% |
Expected option term (years) | 5 years | 5 years | 5 years |
Dividend yield | 0.00% | 0.00% | 0.00% |
Non Employee Directors | |||
Equity compensation plans | |||
Risk free interest rate (%) | 2.70% | 1.61% | 1.10% |
Expected volatility (%) | 59.00% | 57.00% | 54.00% |
Expected option term (years) | 4 years | 4 years | 3 years |
Dividend yield | 0.00% | 0.00% | 0.00% |
Equity-Based Compensation - Sch
Equity-Based Compensation - Schedule of Stock-based Compensation (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Options | ||
Beginning balance (shares) | 3,531,359 | |
Granted (shares) | 1,184,880 | |
Exercised (shares) | (153,601) | |
Expired and/or forfeited (shares) | (846,059) | |
Ending balance (shares) | 3,716,579 | 3,531,359 |
Outstanding at end of year - vested and unvested expected to vest (shares) | 3,601,519 | |
Exercisable at end of year (shares) | 1,928,239 | |
Weighted Average Exercise Price | ||
Beginning balance (in dollars per share) | $ 28.27 | |
Granted (in dollars per share) | 21.14 | |
Exercised (in dollars per share) | 19.26 | |
Expired and/or forfeited (in dollars per share) | 35.13 | |
Ending balance (in dollars per share) | 24.81 | $ 28.27 |
Outstanding at end of year - vested and unvested expected to vest (in dollars per share) | 24.92 | |
Exercisable at end of year (in dollars per share) | $ 27.26 | |
Stock Option Activity, Additional Disclosures | ||
Weighted Average Remaining Contractual Term, Outstanding | 7 years 3 months 18 days | 7 years 2 months 12 days |
Weighted Average Remaining Contractual Term, Outstanding at end of year - vested and unvested expected to vest | 7 years 2 months 12 days | |
Weighted Average Remaining Contractual Term, Exercisable at end of year | 5 years 9 months 18 days | |
Aggregate Intrinsic Value, Outstanding at end of year | $ 694 | |
Aggregate Intrinsic Value, Outstanding at end of year, vested and unvested expected to vest | 690 | |
Aggregate Intrinsic Value, Exercisable at end of year | $ 515 |
Equity-Based Compensation - S_2
Equity-Based Compensation - Schedule of RSUs Granted (Details) - RSUs - $ / shares | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Restricted Stock Units | |||
Outstanding at beginning of year (shares) | 1,069,775 | ||
Granted (shares) | 816,887 | ||
Vested (shares) | (438,284) | ||
Forfeited (shares) | (319,843) | ||
Outstanding at end of year (shares) | 1,128,535 | 1,069,775 | |
Outstanding at end of year and expected to vest (shares) | 1,060,647 | ||
Weighted Average Grant Date Fair Value | |||
Beginning balance (in dollars per share) | $ 26.07 | ||
Granted (in dollars per share) | 22.32 | $ 24.18 | $ 22.28 |
Vested (in dollars per share) | 28.25 | ||
Forfeitures (in dollars per share) | 22.86 | ||
Ending balance (in dollars per share) | 23.42 | $ 26.07 | |
Outstanding at end of year and expected to vest (in dollars per share) | $ 23.40 |
Employee Savings Plan (Details)
Employee Savings Plan (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Defined Contribution Plan Disclosure [Line Items] | |||
Employer matching contribution (percent) | 4.00% | ||
Cost recognized | $ 4 | $ 2.3 | $ 1.6 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2018 | Jan. 31, 2016 | |
Equity [Abstract] | |||
Share repurchase program, authorized amount (in shares) | $ 60,000,000 | ||
Common stock repurchased and retired (in shares) | 1,366,266 | ||
Stock repurchased and retired during period, value | $ 19,467,000 | ||
Average share price (in dollars per share) | $ 14.27 | ||
Available for repurchase of shares | $ 20,500,000 |
Commitments and Contingencies -
Commitments and Contingencies - Narrative (Details) $ in Thousands | Apr. 03, 2017USD ($) | Sep. 30, 2018USD ($) | Feb. 28, 2017USD ($) | Sep. 30, 2013extension_term | Jun. 30, 2018USD ($) | Sep. 30, 2017USD ($) | Mar. 31, 2017USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Dec. 31, 2018USD ($) | Nov. 30, 2014USD ($) | Jun. 30, 2013 |
Commitments | |||||||||||||
Option to extend, number | extension_term | 1 | ||||||||||||
Extension term | 5 years | ||||||||||||
Security deposit | $ 495 | $ 495 | $ 495 | ||||||||||
Operating leases, rent expense, net | 5,100 | 3,000 | $ 1,600 | ||||||||||
Remaining minimum purchase commitments | 88,700 | 88,700 | |||||||||||
Payments for contingent consideration | 119 | 39,793 | 92,130 | ||||||||||
Lumara Health Inc. | |||||||||||||
Commitments | |||||||||||||
Additional merger consideration | $ 350,000 | ||||||||||||
Contingent consideration | 50,000 | 50,000 | |||||||||||
First Milestone | Lumara Health Inc. | |||||||||||||
Commitments | |||||||||||||
Payments for contingent consideration | 150,000 | ||||||||||||
Endoceutics, Inc. | |||||||||||||
Commitments | |||||||||||||
Future contingent payments (up to) | 0 | 9,300 | $ 0 | 0 | |||||||||
Payments related to collaborative arrangement | $ 50,000 | ||||||||||||
Palatin Technologies, Inc. | |||||||||||||
Commitments | |||||||||||||
Payments related to collaborative arrangement | $ 60,000 | $ 60,000 | |||||||||||
Velo Bio, LLC | |||||||||||||
Commitments | |||||||||||||
Payments related to collaborative arrangement | $ 12,500 | ||||||||||||
Velo Bio, LLC | Regulatory Milestone Achievement, U.S.Food and Drug Administration Approval | |||||||||||||
Commitments | |||||||||||||
Future contingent payments (up to) | 30,000 | ||||||||||||
Velo Bio, LLC | Annual Sales Milestone Achievements | |||||||||||||
Commitments | |||||||||||||
Future contingent payments (up to) | 240,000 | ||||||||||||
Velo Bio, LLC | Annual Sales Milestone Achievements | Minimum | |||||||||||||
Commitments | |||||||||||||
Sales milestone targets | 300,000 | ||||||||||||
Velo Bio, LLC | Annual Sales Milestone Achievements | Maximum | |||||||||||||
Commitments | |||||||||||||
Sales milestone targets | 900,000 | ||||||||||||
Velo Bio, LLC | Regulatory Milestone Achievement | |||||||||||||
Commitments | |||||||||||||
Future contingent payments (up to) | 5,000 | ||||||||||||
Velo Bio, LLC | Commercial Milestone Payments | |||||||||||||
Commitments | |||||||||||||
Future contingent payments (up to) | $ 10,000 | ||||||||||||
Letter of Credit | |||||||||||||
Commitments | |||||||||||||
Security deposit | 500 | $ 500 | 500 | ||||||||||
Intrarosa | Endoceutics, Inc. | |||||||||||||
Commitments | |||||||||||||
Payments related to collaborative arrangement | $ 6,000 | ||||||||||||
Intrarosa | Endoceutics, Inc. | First Sales Milestone Achievement | |||||||||||||
Commitments | |||||||||||||
Future contingent payments (up to) | 15,000 | 15,000 | 15,000 | ||||||||||
Potential milestone payment, triggering event, sales | 150,000 | 150,000 | |||||||||||
Intrarosa | Endoceutics, Inc. | Second Sales Milestone Achievement | |||||||||||||
Commitments | |||||||||||||
Future contingent payments (up to) | 30,000 | 30,000 | 30,000 | ||||||||||
Potential milestone payment, triggering event, sales | 300,000 | 300,000 | |||||||||||
Intrarosa | Endoceutics, Inc. | Third Sales Milestone Achievement | |||||||||||||
Commitments | |||||||||||||
Future contingent payments (up to) | 850,000 | 850,000 | 850,000 | ||||||||||
Potential milestone payment, triggering event, sales | 500,000 | 500,000 | |||||||||||
Intrarosa | Endoceutics, Inc. | Tiered Royalties | |||||||||||||
Commitments | |||||||||||||
Potential milestone payment, triggering event, sales | $ 150,000 | $ 150,000 | |||||||||||
Royalty percentage, maximum | 25.00% | 25.00% | |||||||||||
Net sales threshold, future contingent payments | $ 1,000,000 | $ 1,000,000 | |||||||||||
Period after first commercial sale | 10 years | 10 years | |||||||||||
Vyleesi Products | Palatin Technologies, Inc. | First Sales Milestone Achievement | |||||||||||||
Commitments | |||||||||||||
Future contingent payments (up to) | 25,000 | ||||||||||||
Potential milestone payment, triggering event, sales | $ 250,000 | ||||||||||||
Vyleesi Products | Palatin Technologies, Inc. | Tiered Royalties | |||||||||||||
Commitments | |||||||||||||
Period after first commercial sale | 10 years | ||||||||||||
Vyleesi Products | Palatin Technologies, Inc. | Regulatory and Commercial Milestone Payments | |||||||||||||
Commitments | |||||||||||||
Future contingent payments (up to) | $ 380,000 | 380,000 | |||||||||||
Vyleesi Products | Palatin Technologies, Inc. | Regulatory Milestone Achievement, Acceptance by U.S.Food And Drug Administration of New Drug Application | |||||||||||||
Commitments | |||||||||||||
Payments related to collaborative arrangement | $ 20,000 | 20,000 | |||||||||||
Vyleesi Products | Palatin Technologies, Inc. | Regulatory Milestone Achievement, U.S.Food and Drug Administration Approval | |||||||||||||
Commitments | |||||||||||||
Future contingent payments (up to) | $ 60,000 | 60,000 | 60,000 | ||||||||||
Vyleesi Products | Palatin Technologies, Inc. | Achievement of Certain Annual Sales Milestones Over Course of License Agreement | |||||||||||||
Commitments | |||||||||||||
Future contingent payments (up to) | $ 300,000 | $ 300,000 | $ 300,000 | ||||||||||
Lease Agreement, BP Bay Colony LLC | |||||||||||||
Commitments | |||||||||||||
Term of contract | 5 years 2 months | ||||||||||||
Master Agreement, Enterprise FM Trust | |||||||||||||
Commitments | |||||||||||||
Term of contract | 3 years | 3 years |
Commitments and Contingencies_2
Commitments and Contingencies - Operating Leases, Fiscal Year Maturity Schedule (Details) $ in Thousands | Dec. 31, 2018USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
Year Ending December 31, 2019 | $ 5,119 |
Year Ending December 31, 2020 | 4,075 |
Year Ending December 31, 2021 | 1,034 |
Year Ending December 31, 2022 | 0 |
Year Ending December 31, 2023 | 0 |
Total | $ 10,228 |
Collaboration, License and Ot_2
Collaboration, License and Other Strategic Agreements (Details) - USD ($) $ in Thousands | Apr. 03, 2017 | Feb. 28, 2017 | Jun. 30, 2013 | Jun. 30, 2018 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Collaborative Agreements | ||||||||||
Shares issued in connection with Endoceutics License Agreement | $ 13,500 | |||||||||
Endoceutics, Inc. | ||||||||||
Collaborative Agreements | ||||||||||
Payments related to collaborative arrangement | $ 50,000 | |||||||||
Number of shares issued under arrangement | 600,000 | |||||||||
Shares issued in connection with Endoceutics License Agreement | $ 13,500 | $ 0 | 12,555 | $ 0 | ||||||
Future contingent payments (up to) | 0 | $ 9,300 | $ 0 | |||||||
Consideration recorded | $ 83,500 | |||||||||
IPR&D expense | 5,800 | |||||||||
Palatin Technologies, Inc. | ||||||||||
Collaborative Agreements | ||||||||||
Payments related to collaborative arrangement | $ 60,000 | $ 60,000 | ||||||||
Out-of-pocket expenses (up to) | $ 25,000 | |||||||||
Abeona Therapeutics Inc. | ||||||||||
Collaborative Agreements | ||||||||||
Payments related to collaborative arrangement | $ 3,300 | |||||||||
Intrarosa | Endoceutics, Inc. | ||||||||||
Collaborative Agreements | ||||||||||
Payments related to collaborative arrangement | $ 6,000 | |||||||||
Out-of-pocket expenses (up to) | 20,000 | |||||||||
Intrarosa | Endoceutics, Inc. | Developed technology rights | ||||||||||
Collaborative Agreements | ||||||||||
Finite-lived intangible assets | $ 77,700 | |||||||||
Intrarosa | Endoceutics, Inc. | Delivery of Intrarosa Launch Quantities | ||||||||||
Collaborative Agreements | ||||||||||
Payments related to collaborative arrangement | $ 10,000 | |||||||||
Intrarosa | Endoceutics, Inc. | First Anniversary of Closing | ||||||||||
Collaborative Agreements | ||||||||||
Future contingent payments (up to) | 10,000 | |||||||||
Intrarosa | Endoceutics, Inc. | Tiered Royalties | ||||||||||
Collaborative Agreements | ||||||||||
Potential milestone payment, triggering event, sales | $ 150,000 | $ 150,000 | ||||||||
Royalty percentage, maximum | 25.00% | 25.00% | ||||||||
Net sales threshold, future contingent payments | $ 1,000,000 | $ 1,000,000 | ||||||||
Period after first commercial sale | 10 years | 10 years | ||||||||
Intrarosa | Endoceutics, Inc. | First Sales Milestone Achievement | ||||||||||
Collaborative Agreements | ||||||||||
Future contingent payments (up to) | $ 15,000 | $ 15,000 | ||||||||
Potential milestone payment, triggering event, sales | 150,000 | 150,000 | ||||||||
Intrarosa | Endoceutics, Inc. | Second Sales Milestone Achievement | ||||||||||
Collaborative Agreements | ||||||||||
Future contingent payments (up to) | 30,000 | 30,000 | ||||||||
Potential milestone payment, triggering event, sales | 300,000 | 300,000 | ||||||||
Intrarosa | Endoceutics, Inc. | Third Sales Milestone Achievement | ||||||||||
Collaborative Agreements | ||||||||||
Future contingent payments (up to) | 850,000 | 850,000 | ||||||||
Potential milestone payment, triggering event, sales | $ 500,000 | 500,000 | ||||||||
Vyleesi Products | Palatin Technologies, Inc. | Tiered Royalties | ||||||||||
Collaborative Agreements | ||||||||||
Period after first commercial sale | 10 years | |||||||||
Vyleesi Products | Palatin Technologies, Inc. | First Sales Milestone Achievement | ||||||||||
Collaborative Agreements | ||||||||||
Future contingent payments (up to) | $ 25,000 | |||||||||
Potential milestone payment, triggering event, sales | 250,000 | |||||||||
Vyleesi Products | Palatin Technologies, Inc. | Regulatory Milestone Achievement, Acceptance by U.S.Food And Drug Administration of New Drug Application | ||||||||||
Collaborative Agreements | ||||||||||
Payments related to collaborative arrangement | $ 20,000 | 20,000 | ||||||||
Vyleesi Products | Palatin Technologies, Inc. | Regulatory Milestone Achievement, U.S.Food and Drug Administration Approval | ||||||||||
Collaborative Agreements | ||||||||||
Future contingent payments (up to) | 60,000 | 60,000 | ||||||||
Vyleesi Products | Palatin Technologies, Inc. | Achievement of Certain Annual Sales Milestones Over Course of License Agreement | ||||||||||
Collaborative Agreements | ||||||||||
Future contingent payments (up to) | $ 300,000 | $ 300,000 |
Debt - Schedule of Outstanding
Debt - Schedule of Outstanding Debt Obligations (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Debt Instrument [Line Items] | ||
Net carrying amount | $ 283,209 | $ 734,683 |
Less: current maturities | 21,276 | 0 |
Long-term debt, net of current maturities | 261,933 | 734,683 |
Senior Notes | 2023 Senior Notes | ||
Debt Instrument [Line Items] | ||
Net carrying amount | 0 | 466,291 |
Convertible Debt | ||
Debt Instrument [Line Items] | ||
Net carrying amount | 283,209 | |
Convertible Debt | 2022 Convertible Notes | ||
Debt Instrument [Line Items] | ||
Net carrying amount | 261,933 | 248,194 |
Convertible Debt | 2019 Convertible Notes | ||
Debt Instrument [Line Items] | ||
Net carrying amount | $ 21,276 | $ 20,198 |
Debt - 2023 Senior Notes (Detai
Debt - 2023 Senior Notes (Details) - USD ($) | 1 Months Ended | 12 Months Ended | ||||
Sep. 30, 2018 | Oct. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Aug. 31, 2015 | |
Debt Instrument [Line Items] | ||||||
Loss on debt extinguishment | $ 35,922,000 | $ 10,926,000 | $ 0 | |||
Payment of premium on debt extinguishment | $ (28,054,000) | $ (625,000) | $ 0 | |||
Senior Notes | 2023 Senior Notes | ||||||
Debt Instrument [Line Items] | ||||||
Principal amount of debt at time of issuance | $ 500,000,000 | |||||
Interest rate | 7.875% | |||||
Repurchased amount | $ 475,000,000 | $ 25,000,000 | ||||
Loss on debt extinguishment | 35,900,000 | $ 1,100,000 | ||||
Payment of premium on debt extinguishment | $ (28,100,000) |
Debt - Outstanding Convertible
Debt - Outstanding Convertible Note Balances (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Liability component: | ||
Principal | $ 341,417 | |
Net carrying amount | 283,209 | $ 734,683 |
Convertible Debt | ||
Liability component: | ||
Principal | 341,417 | |
Less: debt discount and issuance costs, net | 58,208 | |
Net carrying amount | 283,209 | |
Gross equity component | 82,481 | |
2022 Convertible Notes | Convertible Debt | ||
Liability component: | ||
Principal | 320,000 | |
Less: debt discount and issuance costs, net | 58,067 | |
Net carrying amount | 261,933 | 248,194 |
Gross equity component | 72,576 | |
2019 Convertible Notes | Convertible Debt | ||
Liability component: | ||
Principal | 21,417 | |
Less: debt discount and issuance costs, net | 141 | |
Net carrying amount | 21,276 | $ 20,198 |
Gross equity component | $ 9,905 |
Debt - Convertible Notes (Detai
Debt - Convertible Notes (Details) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||
Sep. 30, 2017USD ($) | May 31, 2017USD ($) | Feb. 28, 2014USD ($)$ / shares | Jun. 30, 2017USD ($)day$ / shares | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | |
Debt Instrument [Line Items] | |||||||
Net proceeds from issuance of convertible debt | $ 0 | $ 320,000,000 | $ 0 | ||||
Payment of convertible debt issuance costs | 0 | 9,553,000 | 0 | ||||
Gain (loss) on debt extinguishment | $ (35,922,000) | $ (10,926,000) | $ 0 | ||||
Convertible Debt | |||||||
Debt Instrument [Line Items] | |||||||
Period of amortization of debt discount to interest expense using effective interest method (years) | 5 years | ||||||
2022 Convertible Notes | Convertible Debt | |||||||
Debt Instrument [Line Items] | |||||||
Period of amortization of debt discount to interest expense using effective interest method (years) | 5 years | ||||||
Principal amount of debt at time of issuance | $ 320,000,000 | ||||||
Net proceeds from issuance of convertible debt | 310,400,000 | ||||||
Payment of convertible debt issuance costs | 9,600,000 | ||||||
Debt issuance costs | 9,600,000 | ||||||
Debt issuance costs allocated to equity component | 2,200,000 | ||||||
Debt issuance costs allocated to the liability component | $ 7,400,000 | ||||||
Interest rate | 3.25% | 3.25% | |||||
Debt conversion ratio | 0.0365464 | ||||||
Initial conversion price of convertible notes into common stock (USD per share) | $ / shares | $ 27.36 | ||||||
Debt term | 5 years | ||||||
Effective interest rate | 9.49% | ||||||
2019 Convertible Notes | Convertible Debt | |||||||
Debt Instrument [Line Items] | |||||||
Principal amount of debt at time of issuance | $ 200,000,000 | ||||||
Net proceeds from issuance of convertible debt | 193,300,000 | ||||||
Debt issuance costs | $ 6,700,000 | ||||||
Interest rate | 2.50% | ||||||
Debt conversion ratio | 0.0369079 | ||||||
Initial conversion price of convertible notes into common stock (USD per share) | $ / shares | $ 27.09 | ||||||
Debt term | 5 years | ||||||
Effective interest rate | 7.79% | ||||||
Proceeds used to pay the cost of the bond hedges (after such cost was partially offset by proceeds from the sale of warrants) | $ 14,100,000 | ||||||
Repurchased amount | $ 19,600,000 | $ 158,900,000 | |||||
Repurchase price | 21,400,000 | 171,300,000 | |||||
Gain (loss) on debt extinguishment | $ (300,000) | $ 200,000 | |||||
Debt Instrument, Conversion, Period One | 2022 Convertible Notes | Convertible Debt | |||||||
Debt Instrument [Line Items] | |||||||
Trading period | day | 20 | ||||||
Consecutive trading period | day | 30 | ||||||
Closing sales price of the entity's common stock that the conversion price must exceed or be equal in order for the notes to be convertible | 130.00% | ||||||
Debt Instrument, Conversion, Period Two | 2022 Convertible Notes | Convertible Debt | |||||||
Debt Instrument [Line Items] | |||||||
Consecutive trading period | day | 5 | ||||||
Closing sales price of the entity's common stock that the conversion price must exceed or be equal in order for the notes to be convertible | 98.00% | ||||||
Number of consecutive business days after any five consecutive trading day period during the note measurement period | day | 5 |
Debt - Schedule of Total Intere
Debt - Schedule of Total Interest Expense Recognized Related to the Convertible Notes (Details) - Convertible Debt - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Debt Instrument [Line Items] | |||
Contractual interest expense | $ 10,935 | $ 8,961 | $ 5,000 |
Amortization of debt issuance costs | 1,403 | 1,275 | 1,072 |
Amortization of debt discount | 13,414 | 11,071 | 7,544 |
Total interest expense | $ 25,752 | $ 21,307 | $ 13,616 |
Debt - Convertible Bond Hedge a
Debt - Convertible Bond Hedge and Warrant Transactions (Details) - USD ($) $ / shares in Units, $ in Thousands, shares in Millions | 1 Months Ended | 12 Months Ended | ||||||
May 31, 2017 | Feb. 28, 2014 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Oct. 31, 2018 | Sep. 30, 2017 | Feb. 11, 2014 | |
Debt Instrument [Line Items] | ||||||||
Exercise price (in dollars per share) | $ 27.09 | |||||||
Initial exercise price (in dollars per share) | $ 34.12 | |||||||
Exercise price above last reported sale price of common stock | 70.00% | |||||||
Sale price of common stock (in dollars per share) | $ 15.19 | $ 21.50 | $ 18.45 | $ 20.07 | ||||
Proceeds to settle warrants | $ 300 | $ 0 | $ 323 | $ 0 | ||||
Bond Option | ||||||||
Debt Instrument [Line Items] | ||||||||
Common stock covered under convertible bond hedge/warrants (in shares) | 0.8 | |||||||
Warrants | ||||||||
Debt Instrument [Line Items] | ||||||||
Common stock covered under convertible bond hedge/warrants (in shares) | 1 | |||||||
Convertible Notes Due 2019 | Convertible Debt | ||||||||
Debt Instrument [Line Items] | ||||||||
Remaining principal amount of convertible notes | $ 21,400 |
Debt - 2015 Term Loan Facility
Debt - 2015 Term Loan Facility (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | ||||
May 31, 2017 | Apr. 30, 2017 | Aug. 31, 2015 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Debt Instrument [Line Items] | ||||||
Loss on debt extinguishment | $ 35,922 | $ 10,926 | $ 0 | |||
Line of Credit | 2015 Term Loan Facility | ||||||
Debt Instrument [Line Items] | ||||||
Debt term | 6 years | |||||
Maximum borrowing capacity | $ 350,000 | |||||
Annual mandatory prepayment of debt as a percentage of excess cash flow | 50.00% | |||||
Repayment of debt | $ 321,800 | $ 3,000 | ||||
Loss on debt extinguishment | $ 9,700 |
Debt - Future Payments (Details
Debt - Future Payments (Details) $ in Thousands | Dec. 31, 2018USD ($) |
Future Annual Principal Payments | |
Year Ending December 31, 2019 | $ 21,417 |
Year Ending December 31, 2020 | 0 |
Year Ending December 31, 2021 | 0 |
Year Ending December 31, 2022 | 320,000 |
Thereafter | 0 |
Total | $ 341,417 |
Consolidated Quarterly Financ_3
Consolidated Quarterly Financial Data - Unaudited (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||||||
Feb. 28, 2017 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Condensed Financial Information Disclosure [Abstract] | ||||||||||||
Total revenues | $ 88,122 | $ 122,238 | $ 146,254 | $ 117,387 | $ 128,525 | $ 124,331 | $ 130,371 | $ 112,541 | $ 474,002 | $ 495,769 | $ 432,487 | |
Gross profit | 59,406 | 75,749 | 69,478 | 53,475 | 57,938 | (226,000) | 98,270 | 84,968 | ||||
Operating expenses | 78,241 | 95,084 | 27,591 | 104,239 | 70,663 | 28,236 | 95,003 | 125,112 | ||||
Net (loss) income from continuing operations | (20,746) | (64,678) | (25,817) | (58,098) | 738 | (155,713) | (14,252) | (35,925) | (169,339) | (205,153) | 2,093 | |
Net (loss) income from discontinued operations | (1,531) | 95,517 | 5,736 | 3,856 | 2,722 | 3,652 | 186 | (635) | 103,578 | 5,925 | (4,576) | |
Net loss | $ (22,277) | $ 30,839 | $ (20,081) | $ (54,242) | $ 3,460 | $ (152,061) | $ (14,066) | $ (36,560) | $ (65,761) | $ (199,228) | $ (2,483) | |
Basic net (loss) income per share: | ||||||||||||
(Loss) income from continuing operations (in dollars per share) | $ (0.60) | $ (1.88) | $ (0.75) | $ (1.70) | $ 0.02 | $ (4.41) | $ (0.41) | $ (1.04) | $ (4.92) | $ (5.88) | $ 0.06 | |
(Loss) income from discontinued operations (in dollars per share) | (0.04) | 2.77 | 0.17 | 0.11 | 0.08 | 0.10 | 0.01 | (0.02) | 3.01 | 0.17 | (0.13) | |
Total (in dollars per share) | (0.64) | 0.89 | (0.58) | (1.59) | 0.10 | (4.31) | (0.40) | (1.06) | (1.91) | (5.71) | (0.07) | |
Diluted net (loss) income per share: | ||||||||||||
(Loss) income from continuing operations (in dollars per share) | (0.60) | (1.88) | (0.75) | (1.70) | 0.02 | (4.41) | (0.41) | (1.04) | (4.92) | (5.88) | 0.06 | |
Income (loss) from discontinued operations (in dollars per share) | (0.04) | 2.77 | 0.17 | 0.11 | 0.08 | 0.10 | 0.01 | (0.02) | 3.01 | 0.17 | (0.13) | |
Total (in dollars per share) | $ (0.64) | $ 0.89 | $ (0.58) | $ (1.59) | $ 0.10 | $ (4.31) | $ (0.40) | $ (1.06) | $ (1.91) | $ (5.71) | $ (0.07) | |
Condensed Financial Statements, Captions [Line Items] | ||||||||||||
Impairment of intangible assets | $ 0 | $ 319,246 | $ 15,724 | |||||||||
Makena | ||||||||||||
Condensed Financial Information Disclosure [Abstract] | ||||||||||||
Total revenues | 322,265 | 387,158 | $ 334,050 | |||||||||
Makena | Developed technology rights | ||||||||||||
Condensed Financial Statements, Captions [Line Items] | ||||||||||||
Impairment of intangible assets | $ 319,200 | |||||||||||
Contingent Consideration | ||||||||||||
Condensed Financial Statements, Captions [Line Items] | ||||||||||||
Adjustments to fair value of contingent consideration | $ 49,800 | $ 49,900 | $ (49,607) | $ (47,686) | ||||||||
Palatin Technologies, Inc. | ||||||||||||
Condensed Financial Statements, Captions [Line Items] | ||||||||||||
Upfront payment | $ 60,000 | $ 60,000 |
Valuation And Qualifying Acco_3
Valuation And Qualifying Accounts (In Thousands) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Accounts receivable allowances | |||
Valuation Allowance for Impairment of Recognized Servicing Assets [Roll Forward] | |||
Balance at Beginning of Period | $ 12,060 | $ 9,533 | $ 10,783 |
Additions | 229,509 | 168,945 | 122,792 |
Deductions Charged to Reserves | (232,026) | (166,418) | (124,042) |
Balance at End of Period | 9,543 | 12,060 | 9,533 |
Rebates, fees and returns reserves | |||
Valuation Allowance for Impairment of Recognized Servicing Assets [Roll Forward] | |||
Balance at Beginning of Period | 100,702 | 89,466 | 45,162 |
Additions | 270,959 | 255,471 | 186,941 |
Deductions Charged to Reserves | (294,891) | (244,235) | (142,637) |
Balance at End of Period | 76,770 | 100,702 | 89,466 |
Valuation allowance for deferred tax assets | |||
Valuation Allowance for Impairment of Recognized Servicing Assets [Roll Forward] | |||
Balance at Beginning of Period | 4,740 | 1,429 | 11,859 |
Additions | 108,562 | 3,875 | 632 |
Deductions Charged to Reserves | (24) | (564) | (11,062) |
Balance at End of Period | $ 113,278 | $ 4,740 | $ 1,429 |
Subsequent Events (Details)
Subsequent Events (Details) | Jan. 16, 2019USD ($) | Feb. 28, 2019employee | Mar. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) |
Subsequent Event [Line Items] | ||||||
Payment for debt extinguishment | $ 28,054,000 | $ 625,000 | $ 0 | |||
Restructuring charges | $ 0 | $ 0 | $ 341,000 | |||
Subsequent Event | ||||||
Subsequent Event [Line Items] | ||||||
Number of positions eliminated | employee | 110 | |||||
Subsequent Event | Perosphere Pharmaceuticals Inc. | ||||||
Subsequent Event [Line Items] | ||||||
Upfront purchase price | $ 50,000,000 | |||||
Cash consideration | 40,000,000 | |||||
Other liabilities | 6,200,000 | |||||
Additional merger consideration | 365,000,000 | |||||
Subsequent Event | Perosphere Convertible Note | Convertible Debt | ||||||
Subsequent Event [Line Items] | ||||||
Principal amount of debt at time of issuance | 10,000,000 | |||||
Subsequent Event | Perosphere Convertible Note | Convertible Debt | Perosphere Pharmaceuticals Inc. | ||||||
Subsequent Event [Line Items] | ||||||
Cancellation of convertible note | 10,000,000 | |||||
Subsequent Event | Perosphere Term Loan | Line of Credit | Perosphere Pharmaceuticals Inc. | ||||||
Subsequent Event [Line Items] | ||||||
Payment for debt extinguishment | 12,000,000 | |||||
Subsequent Event | Regulatory Milestone Achievement | Perosphere Pharmaceuticals Inc. | ||||||
Subsequent Event [Line Items] | ||||||
Additional merger consideration | $ 140,000,000 | |||||
Credited percentage | 50.00% | |||||
Subsequent Event | Milestone Achievement, Approval By European Medicines Agency | Perosphere Pharmaceuticals Inc. | ||||||
Subsequent Event [Line Items] | ||||||
Additional merger consideration | $ 40,000,000 | |||||
Subsequent Event | Sales Milestones Achievement | Perosphere Pharmaceuticals Inc. | ||||||
Subsequent Event [Line Items] | ||||||
Additional merger consideration | 225,000,000 | |||||
Subsequent Event | First Sales Milestone Achievement | Perosphere Pharmaceuticals Inc. | ||||||
Subsequent Event [Line Items] | ||||||
Contingent consideration, milestone payment | 20,000,000 | |||||
Triggering event, threshold amount (at least) | $ 100,000,000 | |||||
Scenario, Forecast | ||||||
Subsequent Event [Line Items] | ||||||
Restructuring charges | $ 6,000,000 |