Document And Entity Information
Document And Entity Information - shares | 3 Months Ended | |
Mar. 31, 2019 | Apr. 30, 2019 | |
Entity Information [Line Items] | ||
Entity Registrant Name | Amneal Pharmaceuticals, Inc. | |
Trading Symbol | AMRX | |
Entity Central Index Key | 0001723128 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q1 | |
Amendment Flag | false | |
Entity Emerging Growth Company | false | |
Entity Small Business | false | |
Common Class A | ||
Entity Information [Line Items] | ||
Entity Common Stock, Shares Outstanding | 115,564,250 | |
Common Class B | ||
Entity Information [Line Items] | ||
Entity Common Stock, Shares Outstanding | 170,940,707 | |
Common Class B-1 | ||
Entity Information [Line Items] | ||
Entity Common Stock, Shares Outstanding | 12,328,767 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Income Statement [Abstract] | ||
Net revenue | $ 446,120 | $ 275,189 |
Cost of goods sold | 309,743 | 130,594 |
Cost of goods sold impairment charges | 53,297 | 0 |
Gross profit | 83,080 | 144,595 |
Selling, general and administrative | 84,436 | 25,121 |
Research and development | 53,858 | 44,209 |
In-process research and development impairment charges | 22,787 | 0 |
Intellectual property legal development expenses | 4,166 | 4,576 |
Acquisition, transaction-related and integration expenses | 6,032 | 7,135 |
Restructuring and other charges | 6,161 | 0 |
Operating (loss) income | (94,360) | 63,554 |
Other (expense) income: | ||
Interest expense, net | (43,281) | (21,051) |
Foreign exchange (loss) gain, net | (5,464) | 8,565 |
Gain on sale of international business | 8,818 | 0 |
Other income, net | 1,107 | 948 |
Total other expense, net | (38,820) | (11,538) |
(Loss) income before income taxes | (133,180) | 52,016 |
(Benefit from) provision for income taxes | (8,428) | 364 |
Net (loss) income | (124,752) | 51,652 |
Less: Net income attributable to Amneal Pharmaceuticals LLC pre-Combination | 0 | (51,535) |
Less: Net loss (income) attributable to non-controlling interests | 76,871 | (117) |
Net loss attributable to Amneal Pharmaceuticals, Inc. | $ (47,881) | $ 0 |
Net loss per share attributable to Amneal Pharmaceuticals, Inc.'s common stockholders: | ||
Class A and Class B-1 basic and diluted (in dollars per share) | $ (0.37) | |
Weighted-average common shares outstanding: | ||
Class A and Class B-1 basic and diluted (in shares) | 127,687 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss/Income - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Statement of Other Comprehensive Income [Abstract] | ||
Net (loss) income | $ (124,752) | $ 51,652 |
Less: Net income attributable to Amneal Pharmaceuticals LLC pre-Combination | 0 | (51,535) |
Less: Net loss (income) attributable to non-controlling interests | 76,871 | (117) |
Net loss attributable to Amneal Pharmaceuticals, Inc. | (47,881) | 0 |
Other comprehensive income (loss): | ||
Foreign currency translation adjustments arising during the period | 5,236 | (9,957) |
Less: Reclassification of foreign currency translation adjustment included in net loss | 3,373 | 0 |
Foreign currency translation adjustments, net | 8,609 | (9,957) |
Less: Other comprehensive loss attributable to Amneal Pharmaceuticals LLC pre-Combination | 0 | 9,957 |
Less: Other comprehensive loss attributable to non-controlling interests | (4,927) | 0 |
Other comprehensive income attributable to Amneal Pharmaceuticals, Inc. | 3,682 | 0 |
Comprehensive loss attributable to Amneal Pharmaceuticals, Inc. | $ (44,199) | $ 0 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 63,946 | $ 213,394 |
Restricted cash | 2,797 | 5,385 |
Trade accounts receivable, net | 640,212 | 481,495 |
Inventories | 448,294 | 457,219 |
Prepaid expenses and other current assets | 111,563 | 128,321 |
Related party receivables | 1,156 | 830 |
Total current assets | 1,267,968 | 1,286,644 |
Property, plant and equipment, net | 514,414 | 544,146 |
Goodwill | 421,640 | 426,226 |
Intangible assets, net | 1,591,158 | 1,654,969 |
Deferred tax asset, net | 382,941 | 373,159 |
Operating lease right-of-use assets | 80,803 | |
Other assets | 62,422 | 67,592 |
Total assets | 4,384,586 | 4,352,736 |
Current liabilities: | ||
Accounts payable and accrued expenses | 558,750 | 514,440 |
Current portion of long-term debt, net | 21,445 | 21,449 |
Related party payables | 2,928 | 17,695 |
Total current liabilities | 599,530 | 553,850 |
Long-term debt, net | 2,625,152 | 2,630,598 |
Deferred income taxes | 0 | 1,178 |
Liabilities under tax receivable agreement | 193,499 | 192,884 |
Other liabilities | 37,723 | 38,780 |
Total long-term liabilities | 2,985,275 | 2,902,523 |
Commitments and contingencies (Notes 5, 11 and 13) | ||
Stockholders' Equity | ||
Preferred stock, $0.01 par value, 2,000 shares authorized; none issued at both March 31, 2019 and December 31, 2018 | 0 | 0 |
Additional paid-in capital | 537,159 | 530,438 |
Stockholders' accumulated deficit | (63,844) | (20,920) |
Accumulated other comprehensive loss | (4,099) | (7,755) |
Total Amneal Pharmaceuticals, Inc. stockholders' equity | 472,205 | 504,750 |
Non-controlling interests | 327,576 | 391,613 |
Total stockholders' equity | 799,781 | 896,363 |
Total liabilities and stockholders' equity | 4,384,586 | 4,352,736 |
Common Class A | ||
Stockholders' Equity | ||
Common stock | 1,156 | 1,151 |
Common Class B | ||
Stockholders' Equity | ||
Common stock | 1,710 | 1,713 |
Common Class B-1 | ||
Stockholders' Equity | ||
Common stock | 123 | 123 |
Excluding Related Party | ||
Current assets: | ||
Operating lease right-of-use assets | 63,238 | |
Current liabilities: | ||
Current portion of operating lease liabilities | 13,173 | |
Operating lease liabilities | 51,200 | |
Related Party | ||
Current assets: | ||
Operating lease right-of-use assets | 17,565 | |
Financing lease right-of-use assets - related party | 63,240 | |
Current liabilities: | ||
Current portion of operating lease liabilities | 2,217 | |
Current portion of operating and financing lease liabilities - related party | 3,234 | |
Current portion of financing obligation - related party | 266 | |
Operating lease liabilities | 15,445 | |
Financing lease liabilities - related party | 62,256 | |
Financing obligation - related party | $ 0 | $ 39,083 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2019 | Dec. 31, 2018 |
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized (in shares) | 2,000,000 | 2,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Common Class A | ||
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized (in shares) | 900,000,000 | 900,000,000 |
Common stock, shares issued (in shares) | 115,564,000 | 115,047,000 |
Common stock, shares outstanding (in shares) | 115,564,000 | 115,047,000 |
Common Class B | ||
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized (in shares) | 300,000,000 | 300,000,000 |
Common stock, shares issued (in shares) | 170,941,000 | 171,261,000 |
Common stock, shares outstanding (in shares) | 170,941,000 | 171,261,000 |
Common Class B-1 | ||
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized (in shares) | 18,000,000 | 18,000,000 |
Common stock, shares issued (in shares) | 12,329,000 | 12,329,000 |
Common stock, shares outstanding (in shares) | 12,329,000 | 12,329,000 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Cash flows from operating activities: | ||
Net (loss) income | $ (124,752) | $ 51,652 |
Adjustments to reconcile net (loss) income to net cash (used in) provided by operating activities: | ||
Depreciation and amortization | 48,868 | 14,751 |
Amortization of Levothyroxine Transition Agreement asset | 36,393 | 0 |
Unrealized foreign currency loss (gain) | 6,490 | (8,327) |
Amortization of debt issuance costs | 1,601 | 1,170 |
Gain on sale of international business | (8,818) | 0 |
Intangible asset impairment charges | 76,084 | 0 |
Deferred tax benefit | (9,884) | (512) |
Stock-based compensation expense | 4,347 | 0 |
Inventory provision | 15,650 | 2,845 |
Other operating charges and credits, net | 1,109 | (3,431) |
Changes in assets and liabilities: | ||
Trade accounts receivable, net | (165,012) | 4,981 |
Inventories | (14,180) | (47,589) |
Prepaid expenses, other current assets and other assets | 22,657 | 1,491 |
Related party receivables | (314) | 5,215 |
Accounts payable, accrued expenses and other liabilities | 695 | 15,325 |
Related party payables | 656 | (10,542) |
Net cash (used in) provided by operating activities | (108,410) | 27,029 |
Cash flows from investing activities: | ||
Purchases of property, plant and equipment | (17,988) | (19,499) |
Cash sold with international business | (3,478) | 0 |
Net cash used in investing activities | (21,466) | (19,499) |
Cash flows from financing activities: | ||
Payments of principal on debt and capital leases | (6,750) | (3,543) |
Proceeds from exercise of stock options | 1,010 | 0 |
Capital contribution from non-controlling interest | 0 | 360 |
Acquisition of non-controlling interest | (2,011) | 0 |
Tax distribution to non-controlling interest | (13,494) | 0 |
Distributions to members | 0 | (30,000) |
Payments of principal on financing lease - related party | (619) | |
Net cash used in financing activities | (21,864) | (33,246) |
Effect of foreign exchange rate on cash | (296) | 411 |
Net decrease in cash, cash equivalents, and restricted cash | (152,036) | (25,305) |
Cash, cash equivalents, and restricted cash - beginning of period | 218,779 | 77,922 |
Cash, cash equivalents, and restricted cash - end of period | 66,743 | 52,617 |
Cash and cash equivalents | 63,946 | 48,224 |
Restricted cash - end of period | 2,797 | 4,393 |
Supplemental disclosure of cash flow information: | ||
Cash paid for interest | 40,032 | 18,843 |
Cash received (paid) for income taxes | 9,713 | (1,510) |
Supplemental disclosure of non-cash investing and financing activity: | ||
Distribution to members | 0 | 8,562 |
Receivable from the sale of international business | 35,837 | 0 |
Payable for acquisition of product rights and licenses | 50,000 | 5,000 |
Related Party | ||
Cash flows from financing activities: | ||
Payments of principal on financing lease - related party | (619) | |
Payments of financing obligation - related party | $ 0 | $ (63) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity / Members’ Deficit - USD ($) shares in Thousands, $ in Thousands | Total | Members' Equity | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive (Loss) Income | Non-Controlling Interests | Common StockCommon Class A | Common StockCommon Class B | Common StockCommon Class B-1 |
Members' equity beginning balance at Dec. 31, 2017 | $ (375,582) | $ 2,716 | $ 8,562 | $ (382,785) | $ (14,232) | $ 10,157 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||
Net (loss) income | 51,652 | 51,535 | 117 | ||||||
Capital contribution from non-controlling interest | 360 | 360 | |||||||
Distributions to members | (38,562) | (8,562) | (30,000) | ||||||
Foreign currency translation adjustments arising during the period | (9,957) | (9,957) | |||||||
Members' equity ending balance at Mar. 31, 2018 | (368,819) | $ 2,716 | 0 | (357,980) | (24,189) | 10,634 | |||
Shares beginning balance (in shares) at Dec. 31, 2018 | 115,047 | 171,261 | 12,329 | ||||||
Stockholders' equity beginning balance at Dec. 31, 2018 | 896,363 | 530,438 | (20,920) | (7,755) | 391,613 | $ 1,151 | $ 1,713 | $ 123 | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||
Net (loss) income | (124,752) | (47,881) | (76,871) | ||||||
Foreign currency translation adjustments arising during the period | 5,236 | 2,238 | 2,998 | ||||||
Stock-based compensation | 4,347 | 4,347 | |||||||
Exercise of stock options (in shares) | 197 | ||||||||
Exercise of stock options | 1,010 | 748 | (7) | 267 | $ 2 | ||||
Redemption of Class B Common Stock (in shares) | (320) | (320) | |||||||
Redemption of Class B Common Stock | 223 | 1,124 | (19) | (882) | $ 3 | $ (3) | |||
Tax distribution | (82) | (82) | |||||||
Reclassification of foreign currency translation adjustment included in net loss | 3,373 | 1,444 | 1,929 | ||||||
Other | 502 | 502 | |||||||
Shares ending balance (in shares) at Mar. 31, 2019 | 115,564 | 170,941 | 12,329 | ||||||
Stockholders' equity ending balance at Mar. 31, 2019 | $ 799,781 | $ 537,159 | $ (63,844) | $ (4,099) | $ 327,576 | $ 1,156 | $ 1,710 | $ 123 |
Nature of Operations
Nature of Operations | 3 Months Ended |
Mar. 31, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Operations | Nature of Operations Amneal Pharmaceuticals, Inc., formerly known as Atlas Holdings, Inc. (the "Company"), was formed along with its wholly owned subsidiary, K2 Merger Sub Corporation, a Delaware corporation ("Merger Sub"), on October 4, 2017, for the purpose of facilitating the combination of Impax Laboratories, Inc. (now Impax Laboratories, LLC), a Delaware corporation then listed on the Nasdaq Stock Market ("Impax") and Amneal Pharmaceuticals LLC, a Delaware limited liability company ("Amneal"). Amneal was formed in 2002 and operates through various subsidiaries. Amneal is a vertically integrated developer, manufacturer, and seller of generic pharmaceutical products. Amneal’s pharmaceutical research includes analytical and formulation development and stability. Amneal has operations in the United States, Switzerland, India, and Ireland, and certain other countries, primarily in Western Europe. Amneal divested its operations in the United Kingdom on March 30, 2019 . For additional information, refer to Note 3. Acquisitions and Divestitures . Amneal sells to wholesalers, distributors, hospitals, chain pharmacies and individual pharmacies, either directly or indirectly. On October 17, 2017, Amneal, Impax, the Company and Merger Sub entered into the Business Combination Agreement, as amended on November 21, 2017 and December 16, 2017 (the "BCA"). On May 4, 2018, pursuant to the BCA, Impax and Amneal combined the generics and specialty pharmaceutical business of Impax with the generic drug development and manufacturing business of Amneal to create the Company as a new generics and specialty pharmaceutical company, through the following transactions (together, the "Combination," and the closing of the Combination, the "Closing"): (i) Merger Sub merged with and into Impax, with Impax surviving as a direct wholly owned subsidiary of the Company, (ii) each share of Impax’s common stock, par value $0.01 per share ("Impax Common Stock"), issued and outstanding immediately prior to the Closing, other than Impax Common Stock held by Impax in treasury, by the Company or by any of their respective subsidiaries, was converted into the right to receive one fully paid and non-assessable share of Class A common stock of the Company, par value $0.01 per share ("Class A Common Stock"), (iii) Impax converted to a Delaware limited liability company, (iv) the Company contributed to Amneal all of the Company’s equity interests in Impax, in exchange for Amneal common units ("Amneal Common Units"), (v) the Company issued an aggregate number of shares of Class B common stock of the Company, par value $0.01 per share ("Class B Common Stock," and collectively, with the Class A Common Stock and Class B-1 common stock of the Company, par value $0.01 , ("Class B-1 Common Stock"), the "Company Common Stock" to APHC Holdings, LLC, (formerly Amneal Holdings, LLC), the parent entity of Amneal as of the Closing ("Holdings"), and (vi) the Company became the managing member of Amneal. Immediately upon the Closing, holders of Impax Common Stock prior to the Closing collectively held approximately 25% of the Company and Holdings held a majority interest in the Company with an effective voting interest of approximately 75% on a fully diluted and as converted basis through its ownership of Class B Common Stock. Holdings also held a corresponding number of Amneal Common Units, which entitled it to approximately 75% of the economic interests in the combined businesses of Impax and Amneal. The Company held an interest in Amneal of approximately 25% and became its managing member. In connection with the Combination, on May 4, 2018, Holdings entered into definitive purchase agreements which provided for a private placement of certain shares of Class A Common Stock and Class B-1 Common Stock (the "PIPE Investment") with select institutional investors (the "PIPE Investors"). Pursuant to the terms of the purchase agreements, upon the Closing, Holdings exercised its right to cause the Company to redeem approximately 15% of its ownership interests in the Company in exchange for 34.5 million shares of Class A Common Stock and 12.3 million unregistered shares of Class B-1 Common Stock (the "Redemption"). The shares of Class A Common Stock and Class B-1 Common Stock received in the Redemption were sold immediately following the Closing by Holdings to the PIPE Investors at a per share purchase price of $18.25 for gross proceeds of $855 million . Following the PIPE Investment, the PIPE Investors owned collectively approximately 15% of the Company Common Stock on a fully diluted and as converted basis. On May 4, 2018, Holdings also caused Amneal to redeem (the "Closing Date Redemption") 6.9 million of Amneal Common Units held by Holdings for a like number of shares of Class A Common Stock, for future distribution to certain direct and indirect members of Holdings who were or are employees of the Company and to whom were previously issued (prior to the Closing) profit participation units ("PPUs") in Amneal. As a result of the PIPE Investment and Closing Date Redemption, the voting and economic interest of approximately 75% held by Holdings immediately upon Closing was reduced by approximately 18% . The overall interest percentage held by non-controlling interest holders upon the consummation of the Combination, PIPE Investment and Closing Date Redemption was approximately 57% . As of both December 31, 2018 and March 31, 2019 , the overall interest percentage held by non-controlling interest holders was approximately 57% . O n July 5, 2018, Holdings distributed to its members all Amneal Common Units and shares of Class B Common Stock held by Holdings. As a result, as of March 31, 2019 , Holdings did no t hold any equity interest in Amneal or the Company. The Company is a holding company, whose principal assets are Amneal Common Units. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Basis of Presentation The accompanying unaudited consolidated financial statements should be read in conjunction with Amneal’s annual audited financial statements for the year ended December 31, 2018 included in the Company’s 2018 Annual Report on Form 10-K. Certain information and footnote disclosures normally included in annual financial statements have been omitted from the accompanying unaudited consolidated financial statements. In the opinion of management, the accompanying unaudited consolidated financial statements contain all adjustments, consisting of only normal recurring adjustments, necessary for a fair statement of the Company's financial position as of March 31, 2019 , the results of its operations and its comprehensive loss, changes in stockholders' equity and cash flows for the three months ended March 31, 2019 and 2018 . The consolidated balance sheet data at December 31, 2018 was derived from the Company's audited annual financial statements, but does not include all disclosures required by accounting principles generally accepted in the United States. The accounting policies of the Company are set forth in Note 2. Summary of Significant Accounting Policies contained in the Company’s 2018 Annual Report on Form 10-K, except for the impact of the adoption of new accounting standards discussed under Recently Adopted Accounting Pronouncements . Use of Estimates The preparation of financial statements, which are prepared in accordance with generally accepted accounting principles in the United States, requires the Company's management to make estimates and assumptions that affect the reported financial position at the date of the financial statements and the reported results of operations during the reporting period. Such estimates and assumptions affect the reported amounts of assets, liabilities, revenues and expenses, and disclosure of contingent assets and liabilities in the consolidated financial statements and accompanying notes. The following are some, but not all, of such estimates: the determination of chargebacks, sales returns, rebates, bill backs, allowances for accounts receivable, accrued liabilities, stock-based compensation, valuation of inventory balances, the determination of useful lives for product rights, allowances for deferred tax assets and the assessment of expected cash flows used in evaluating goodwill and other long-lived assets for impairment. Actual results could differ from those estimates. Reclassifications Certain prior period balances have been reclassified to conform to the current period presentation. Recently Adopted Accounting Pronouncements Leases In February 2016, the Financial Accounting Standards Board ("FASB") issued ASU 2016-02, Leases, which was subsequently supplemented by clarifying guidance (collectively, "Topic 842") to improve financial reporting of leasing transactions. Topic 842 requires a lessee to recognize most leases, including those classified as operating, on its balance sheets as right of use ("ROU") assets and lease liabilities and requires disclose of additional key information about leases. The Company elected to apply the modified retrospective transition provisions of Topic 842 on January 1, 2019, the date of adoption. In addition, the Company elected the package of practical expedients permitted under the transition guidance within the new standard. This allowed the Company to carry forward historical lease classifications. Adoption of this standard resulted in the recording of operating lease ROU assets and operating lease liabilities of $85 million and $86 million , respectively. The transition guidance of Topic 842 also required the Company to de-recognize the build to suit accounting associated with a related party lease for integrated manufacturing and office space and recognize that transaction as a financing lease as of January 1, 2019. The resulting de-recognition reduced leasehold improvements and a financing obligation by $24 million and $39 million , respectively, and increased non-controlling interests and stockholders' accumulated deficit, net of income taxes, by $9 million and $5 million , respectively. The arrangement was then recognized as a financing lease with an ROU asset and lease liability of $64 million on January 1, 2019. Leases with related parties, the details of which are described in Note 15. Related Party Transactions, are presented separately in the Company's balance sheets. The adoption of Topic 842 did not have a material impact on the Company's consolidated statements of operations. ROU assets and lease liabilities for reporting periods beginning on or after January 1, 2019 are presented under the new guidance, while prior periods amounts were not adjusted and continue to be reported in accordance with previous guidance. All significant lease arrangements after January 1, 2019 are recognized as ROU assets and lease liabilities at lease commencement. ROU assets represent the Company's right to use an underlying asset for the lease term and lease liabilities represent its obligation to make lease payments arising from the lease. ROU assets and liabilities are recognized at the commencement date based on the present value of the future lease payments using the Company's incremental borrowing rate, which is updated quarterly. Operating lease expense is recognized on a straight-line basis over the lease term. At each balance sheet date, operating and financing lease liabilities continue to represent the present value of the future payments. Financing lease ROU assets are expensed using the straight-line method, unless another basis is more representative of the pattern of economic benefit, to lease expense. Interest on financing lease liabilities is recognized in interest expense. Leases with an initial term of 12 months or less (short-term leases) are not recognized in the balance sheet and the related lease payments are recognized as incurred over the lease term. The Company separates lease and non-lease components. A portion of the Company's real estate leases are subject to periodic changes in the Consumer Price Index ("CPI"). The changes to the CPI are treated as variable lease payments and recognized in the period in which the obligation for those payments was incurred. For further details regarding the Company's leases, refer to Note 11. Leases . Financial Instruments In January 2016, the FASB issued ASU 2016-01, Financial Instruments—Overall (Subtopic 825-10), Recognition and Measurement of Financial Assets and Financial Liabilities , which addresses certain aspects of recognition, measurement, presentation, and disclosure of financial instruments. The Company adopted ASU 2016-01 as of January 1, 2019 and it did not have a material impact on the Company's consolidated financial statements. Recently Issued Accounting Pronouncements In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 82): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement, which modifies the disclosure requirements on fair value measurement. The guidance is effective for annual periods beginning after December 15, 2019 and interim periods within those annual periods, and early adoption is permitted. The Company is evaluating the impact of this new guidance on its consolidated financial statements. In January 2017, the FASB issued ASU 2017-04, Intangibles—Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment that eliminates the requirement to calculate the implied fair value of goodwill (i.e., Step 2 of today’s goodwill impairment test) to measure a goodwill impairment charge. Instead, entities will record an impairment charge based on the excess of a reporting unit’s carrying amount over its fair value (i.e., measure the charge based on today’s Step 1). The standard will be applied prospectively and is effective for the Company’s annual and interim impairment tests performed in periods beginning after December 15, 2019. Early adoption is permitted for annual and interim goodwill impairment testing dates after January 1, 2017. The Company is evaluating the impact of this new guidance on its consolidated financial statements. In June 2016, the FASB issued ASU 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments , guidance that changes the impairment model for most financial assets including trade receivables and certain other instruments that are not measured at fair value through net income. The standard will replace today’s "incurred loss" approach with an "expected loss" model for instruments measured at amortized cost and require entities to record allowances for available-for-sale debt securities rather than reduce the carrying amount, as they do today under the other-than-temporary impairment model. It also simplifies the accounting model for purchased credit-impaired debt securities and loans. Entities will apply the standard’s provisions as a cumulative effect adjustment to retained earnings as of the beginning of the first reporting period in which the guidance is effective. The guidance is effective for the Company for the annual period beginning after December 15, 2019. The Company is evaluating the impact of this new guidance on its consolidated financial statements. |
Acquisitions and Divestitures
Acquisitions and Divestitures | 3 Months Ended |
Mar. 31, 2019 | |
Business Combinations [Abstract] | |
Acquisitions and Divestitures | Acquisitions and Divestitures Acquisitions Impax Acquisition On May 4, 2018, the Company completed the Combination, as described in Note 1. Nature of Operations . For the three months ended March 31, 2018 , transaction costs associated with the Impax acquisition of $7 million were recorded in acquisition, transaction-related and integration expenses ( no ne for the three months ended March 31, 2019 ). The Impax acquisition was accounted for under the acquisition method of accounting, with Amneal as the accounting acquirer of Impax. Amneal was identified as the accounting acquirer because: (i) Amneal exchanged Amneal Common Units with the Company for the Company’s interest in Impax, (ii) Holdings held a majority interest in the Company with an effective voting interest of approximately 75% on a fully diluted and as converted basis through their ownership of Class B Common Stock, and (iii) a majority of the directors on the Company's current board of directors were designated by Holdings. As such, the cost to acquire Impax was allocated to the respective assets acquired and liabilities assumed based on their estimated fair values as of the closing date of the Combination. The measurement of the consideration transferred by Amneal for its interest in Impax is based on the fair value of the equity interest that Amneal would have had to issue to give the Impax shareholders the same percentage equity interest in the Company, which is equal to approximately 25% of Amneal, on May 4, 2018. However, the fair value of Impax's common stock was used to calculate the consideration for the Combination because Impax's common stock had a quoted market price and the Combination involved only the exchange of equity. The purchase price, net of cash acquired, is calculated as follows (in thousands, except share amount and price per share): Fully diluted Impax share number (1) 73,288,792 Closing quoted market price of an Impax common share on May 4, 2018 $ 18.30 Equity consideration - subtotal $ 1,341,185 Add: Fair value of Impax stock options as of May 4, 2018 (2) 22,610 Total equity consideration 1,363,795 Add: Extinguishment of certain Impax obligations, including accrued and unpaid interest 320,290 Less: Cash acquired (37,907 ) Purchase price, net of cash acquired $ 1,646,178 (1) Represents shares of Impax Common Stock issued and outstanding immediately prior to the Combination. (2) Represents the fair value of 3.0 million fully vested Impax stock options valued using the Black-Scholes options pricing model. The following is a summary of the preliminary purchase price allocation for the Impax acquisition (in thousands): Preliminary Fair Values Trade accounts receivable, net $ 211,762 Inventories 183,088 Prepaid expenses and other current assets 91,430 Property, plant and equipment 87,472 Goodwill 399,988 Intangible assets 1,574,929 Other 55,790 Total assets acquired 2,604,459 Accounts payable 47,912 Accrued expenses and other current liabilities 277,176 Long-term debt 599,400 Other long-term liabilities 33,793 Total liabilities assumed 958,281 Net assets acquired $ 1,646,178 Intangible Assets The acquired intangible assets are being amortized over their estimated useful lives as follows (in thousands): Preliminary Fair Values Weighted-Average Useful Life (Years) Marketed product rights $ 1,045,617 12.9 In addition to the amortizable intangible assets noted above, $529 million was allocated to in-process research and development ("IPR&D"), which is currently not subject to amortization. The estimated fair value of the IPR&D and identifiable intangible assets was determined using the "income approach," which is a valuation technique that provides an estimate of the fair value of an asset based on market participant expectations of the cash flows an asset would generate over its remaining useful life. The assumptions, including the expected projected cash flows, utilized in the preliminary purchase price allocation and in determining the purchase price were based on management's best estimates as of the closing date of the Combination on May 4, 2018. Some of the more significant assumptions inherent in the development of those asset valuations include the estimated net cash flows for each year for each asset or product (including net revenues, cost of sales, research and development costs, selling and marketing costs and working capital / contributory asset charges), the appropriate discount rate to select in order to measure the risk inherent in each future cash flow stream, the assessment of each asset’s life cycle, the potential regulatory and commercial success risks, competitive trends impacting the asset and each cash flow stream, as well as other factors. No assurances can be given that the underlying assumptions used to prepare the discounted cash flow analysis will not change. For these and other reasons, actual results may vary significantly from estimated results. Goodwill Of the total goodwill acquired in connection with the Impax acquisition, approximately $359 million has been allocated to the Company’s Specialty segment and approximately $41 million has been allocated to the Generics segment. Goodwill is calculated as the excess of the consideration transferred over the net assets recognized and represents the expected revenue and cost synergies of the combined company. Factors that contributed to the Company’s recognition of goodwill include the Company’s intent to expand its generic and specialty product portfolios and to acquire certain benefits from the Impax product pipelines, in addition to the anticipated synergies that the Company expects to generate from the acquisition. The Company makes an initial allocation of the purchase price at the date of acquisition based upon its understanding of the fair value of the acquired assets and assumed liabilities. The Company obtains this information during due diligence and through other sources. In the months after closing, as the Company obtains additional information about these assets and liabilities and learns more about the newly acquired business, it is able to refine the estimates of fair value and more accurately allocate the purchase price. Only items identified as of the acquisition date are considered for subsequent adjustment. The Company is continuing to evaluate certain pre-acquisition contingencies associated with the Impax acquisition. The Company will make appropriate adjustments to the purchase price allocation prior to completion of the measurement period, as required. Unaudited Pro Forma Information The unaudited pro forma combined results of operations for the three months ended March 31, 2018 (assuming the closing of the Combination occurred on January 1, 2017) are as follows (in thousands): Three Months Ended March 31, 2018 Net revenue $ 417,544 Net loss (74,077 ) Net loss attributable to Amneal Pharmaceuticals, Inc. $ (8,595 ) The pro forma results have been prepared for comparative purposes only and are not necessarily indicative of the actual results of operations had the closing of the Combination taken place on January 1, 2018. Furthermore, the pro forma results do not purport to project the future results of operations of the Company. The unaudited pro forma information reflects primarily the following non-recurring adjustments (all of which were adjusted for the applicable tax impact): • Adjustments to costs of goods sold related to the inventory acquired; and • Adjustments to selling, general and administrative expense related to transaction costs directly attributable to the transactions. UK Divestiture On March 30, 2019 , Amneal sold 100% of the stock of its Creo Pharma Holding Limited subsidiary, which comprised the Company's entire operations in the United Kingdom, to AI Sirona (Luxembourg) Acquisition S.a.r.l ("AI Sirona") for cash consideration of $36 million which was received in April 2019. The carrying value of the net assets sold was $22 million , including intangible assets of $7 million and goodwill of $5 million . As a result of the sale, Amneal recognized a pre-tax gain of $9 million , inclusive of transaction costs and the recognition of accumulated foreign currency translation adjustment losses of $3 million , within gain on sale of international business for the three months ended March 31, 2019 . As part of the disposition, Amneal entered into a supply and license agreement with AI Sirona to supply certain products for a period of up to two years . |
Revenue Recognition
Revenue Recognition | 3 Months Ended |
Mar. 31, 2019 | |
Revenue from Contract with Customer [Abstract] | |
Revenue Recognition | Revenue Recognition Performance Obligations The Company’s performance obligation is the supply of finished pharmaceutical products to its customers. The Company’s customers consist primarily of major wholesalers, retail pharmacies, managed care organizations, purchasing co-ops, hospitals, government agencies and pharmaceutical companies. The Company’s customer contracts generally consist of both a master agreement, which is signed by the Company and its customer, and a customer submitted purchase order, which is governed by the terms and conditions of the master agreement. Customers purchase product by direct channel sales from the Company or by indirect channel sales through various distribution channels. Revenue is recognized when the Company transfers control of its products to the customer, which typically occurs at a point-in-time, upon delivery. Substantially all of the Company’s net revenues relate to products which are transferred to the customer at a point-in-time. The Company offers standard payment terms to its customers and has elected the practical expedient to not adjust the promised amount of consideration for the effects of a significant financing, since the period between when the Company transfers the product to the customer and when the customer pays for that product is one year or less. Taxes collected from customers relating to product sales and remitted to governmental authorities are excluded from revenues. The consideration amounts due from customers as a result of product sales are subject to variable consideration, as described further below. The Company offers standard product warranties which provide assurance that the product will function as expected and in accordance with specifications. Customers cannot purchase warranties separately and these warranties do not give rise to a separate performance obligation. The Company permits the return of product under certain circumstances, mainly upon product expiration, instances of shipping errors or where product is damaged in transit. The Company accrues for the customer’s right to return as part of its variable consideration. See below for further details. Variable Consideration The Company includes an estimate of variable consideration in its transaction price at the time of sale, when control of the product transfers to the customer. Variable consideration includes but is not limited to: chargebacks, rebates, group purchasing organization ("GPO") fees, prompt payment (cash) discounts, consideration payable to the customer, billbacks, Medicaid and other government pricing programs, price protection and shelf stock adjustments, sales returns, and profit shares. The Company assesses whether or not an estimate of its variable consideration is constrained and has determined that the constraint does not apply, since it is probable that a significant reversal in the amount of cumulative revenue will not occur in the future when the uncertainty associated with the variable consideration is subsequently resolved. The Company’s estimates for variable consideration are adjusted as required at each reporting period for specific known developments that may result in a change in the amount of total consideration it expects to receive. Chargebacks In the case an indirect customer purchases product from their preferred wholesaler instead of directly from the Company, and the contract price charged to the indirect customer is lower than the wholesaler pricing, the Company pays the direct customer (wholesaler) a chargeback for the price differential. The Company estimates its chargeback accrual based on its estimates of the level of inventory of its products in the distribution channel that remain subject to chargebacks and historical chargeback rates. The estimate of the level of products in the distribution channel is based primarily on data provided by key customers. Rebates The Company pays fixed or volume-based rebates to its customers based on a fixed amount, fixed percentage of product sales or based on the achievement of a specified level of purchases. The Company’s rebate accruals are based on actual net sales, contractual rebate rates negotiated with customers, and expected purchase volumes / corresponding tiers based on actual sales to date and forecasted amounts. Group Purchasing Organization Fees The Company pays fees to GPOs for administrative services that the GPOs perform in connection with the purchases of product by the GPO participants who are the Company’s customers. The Company’s GPO fee accruals are based on actual net sales, contractual fee rates negotiated with GPOs and the mix of the products in the distribution channel that remain subject to GPO fees. Prompt Payment (Cash) Discounts The Company provides customers with prompt payment discounts which may result in adjustments to the price that is invoiced for the product transferred, in the case that payments are made within a defined period. The Company’s prompt payment discount accruals are based on actual net sales and contractual discount rates. Consideration Payable to the Customer The Company pays administrative and service fees to its customers based on a fixed percentage of the product price. These fees are not in exchange for a distinct good or service and therefore are recognized as a reduction of the transaction price. The Company accrues for these fees based on actual net sales, contractual fee rates negotiated with the customer and the mix of the products in the distribution channel that remain subject to fees. Billbacks In the case an indirect customer purchases product from their preferred wholesaler instead of directly from the Company, and the contract price charged to the indirect customer is higher than contractual pricing, the Company pays the indirect customer a billback for the price differential. The Company estimates its billback accrual based on its estimates of the level of inventory of its products in the distribution channel that remain subject to billbacks and historical billback rates. The estimate of the level of products in the distribution channel is based primarily on data provided by key customers. Medicaid and Other Government Pricing Programs The Company complies with required rebates mandated by law under Medicaid and other government pricing programs. The Company estimates its government pricing accruals based on monthly sales, historical experience of claims submitted by the various states and jurisdictions, historical rates and estimated lag time of the rebate invoices. Price Protection and Shelf Stock Adjustments The Company provides customers with price protection and shelf stock adjustments which may result in an adjustment to the price charged for the product transferred, based on differences between old and new prices which may be applied to the customer’s on-hand inventory at the time of the price change. The Company accrues for these adjustments when its expected value of an adjustment is greater than zero, based on contractual pricing, actual net sales, accrual rates based on historical average rates, and estimates of the level of inventory of its products in the distribution channel that remain subject to these adjustments. The estimate of the level of products in the distribution channel is based primarily on data provided by key customers. Sales Returns The Company permits the return of product under certain circumstances, mainly upon product expiration, instances of shipping errors or where product is damaged in transit, and occurrences of product recalls. The Company’s product returns accrual is primarily based on estimates of future product returns based generally on actual net sales, estimates of the level of inventory of its products in the distribution channel that remain subject to returns, estimated lag time of returns and historical return rates. The estimate of the level of products in the distribution channel is based primarily on data provided by key customers. Profit Shares For certain product sale arrangements, the Company earns a profit share upon the customer’s sell-through of the product purchased from the Company. The Company estimates its profit shares based on actual net sales, estimates of the level of inventory of its products in the distribution channel that remain subject to profit shares, and historical rates of profit shares earned. The estimate of the level of products in the distribution channel is based primarily on data provided by key customers. Concentration of Revenue The Company's three largest customers account for approximately 79% of total gross sales of products for the three months ended March 31, 2019 and 80% for the three months ended March 31, 2018 . Significant Products The Company generally consolidates net revenue by "product family," meaning that it consolidates net revenue from products containing the same active ingredient(s) irrespective of dosage strength, delivery method or packaging size. The Company's significant product families, as determined based on net revenue, and their percentage of the Company's consolidated net revenue for each of the three months ended March 31, 2019 and 2018 are set forth below (in thousands, except for percentages): Segment Product Family Three Months Ended March 31, 2019 $ % Generics Levothyroxine Sodium $ 48,994 11% Specialty Rytary® family 28,828 6% Generics Diclofenac Sodium Gel 23,467 5% Generics Yuvafem-Estradiol 18,739 4% Generics Epinephrine Auto-Injector family (generic Adrenaclick®) $ 15,195 3% Segment Product Family Three Months Ended March 31, 2018 $ % Generics Oseltamivir $ 42,567 15% Generics Yuvafem-Estradiol 19,267 7% Generics Diclofenac Sodium Gel 20,276 7% Generics Aspirin; Dipyridamole ER Capsul 17,022 6% Generics Atovaquone $ 8,334 3% A rollforward of the major categories of sales-related deductions for the three months ended March 31, 2019 is as follows (in thousands): Contract Charge-backs and Sales Volume Allowances Cash Discount Allowances Accrued Returns Allowance Accrued Medicaid and Commercial Rebates Balance at December 31, 2018 $ 829,596 $ 36,157 $ 154,503 $ 74,202 Provision related to sales recorded in the period 1,105,531 35,172 17,125 36,105 Credits/payments issued during the period (1,191,605 ) (19,440 ) (25,588 ) (28,565 ) Balance at March 31, 2019 $ 743,522 $ 51,889 $ 146,040 $ 81,742 |
Alliance and Collaboration
Alliance and Collaboration | 3 Months Ended |
Mar. 31, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Alliance and Collaboration | Alliance and Collaboration The Company has entered into several alliance, collaboration, license, distribution and similar agreements with respect to certain of its products and services with third-party pharmaceutical companies. The consolidated statements of operations include revenue recognized under agreements the Company has entered into to develop marketing and/or distribution relationships with its partners to fully leverage the technology platform and revenue recognized under development agreements which generally obligate the Company to provide research and development services over multiple periods. The Company's significant arrangements are discussed below. Levothyroxine License and Supply Agreement; Transition Agreement On August 16, 2018 , the Company entered into a license and supply agreement with Jerome Stevens Pharmaceuticals, Inc. ("JSP") for levothyroxine sodium tablets ("Levothyroxine"). This agreement designated the Company as JSP's exclusive commercial partner for Levothyroxine in the U.S. market for a 10-year term commencing on March 22, 2019. Under this license and supply agreement with JSP, the Company accrued the up-front license payment of $50 million on March 22, 2019 , which was paid in April 2019. The agreement also provides for the Company to pay a profit share to JSP based on net profits of the Company's sales of Levothyroxine, after considering product costs. On November 9, 201 8, the Company entered into a transition agreement ("Transition Agreement") with Lannett Company (“Lannett”) and JSP. Under the terms of the Transition Agreement, the Company assumed the distribution and marketing of Levothyroxine from Lannett beginning December 1, 2018 through March 22, 2019, ahead of the commencement date of the license and supply agreement with JSP described above. In accordance with the terms of the Transition Agreement, the Company made $47 million of non-refundable payments to Lannett. For the three months ended March 31, 2019 and the year ended December 31, 2018 , $37 million and $ 10 million , respectively, were expensed to cost of goods sold, as the Company sold Levothyroxine. As of December 31, 2018 , the Company had a $4 million transition contract liability, which was fully settled in February 2019. Biosimilar Licensing and Supply Agreement On May 7, 2018, the Company entered into a licensing and supply agreement, with Mabxience S.L., for its biosimilar candidate for Avastin® (bevacizumab). The Company will be the exclusive partner in the U.S. market. The Company will pay development and regulatory milestone payments as well as commercial milestone payments on reaching pre-agreed sales targets in the market to Mabxience, up to $72 million . For the three months ended March 31, 2019 , the Company expensed a milestone payment of $1 million to research and development expense. There were no milestone payments expensed for the three months ended March 31, 2018 . Distribution, License, Development and Supply Agreement with AstraZeneca UK Limited In January 2012, Impax entered into an agreement with AstraZeneca UK Limited ("AstraZeneca") to distribute branded products under the terms of a distribution, license, development and supply Agreement (the "AZ Agreement"). The parties subsequently entered into a First Amendment to the AZ Agreement dated May 31, 2016 (as amended, the "AZ Amendment"). Under the terms of the AZ Agreement, AstraZeneca granted to Impax an exclusive license to commercialize the tablet, orally disintegrating tablet and nasal spray formulations of Zomig® (zolmitriptan) products for the treatment of migraine headaches in the United States and in certain U.S. territories, except during an initial transition period when AstraZeneca fulfilled all orders of Zomig® products on Impax’s behalf and AstraZeneca paid to Impax the gross profit on such Zomig® products. Pursuant to the AZ Amendment, under certain conditions, and depending on the nature and terms of the study agreed to with the FDA, Impax agreed to conduct, at its own expense, the juvenile toxicity study and pediatric study required by the FDA under the Pediatric Research Equity Act ("PREA") for approval of the nasal formulation of Zomig ® for the acute treatment of migraine in pediatric patients ages six through eleven years old, as further described in the study protocol mutually agreed to by the parties (the "PREA Study"). In consideration for Impax conducting the PREA Study at its own expense, the AZ Amendment provides for the total royalty payments payable by Impax to AstraZeneca on net sales of Zomig ® products under the AZ Agreement to be reduced by an aggregate amount of $30 million to be received in quarterly amounts specified in the Amendment beginning from the quarter ended June 30, 2016 and through the quarter ended December 31, 2020 . In the event the royalty reduction amounts exceed the royalty payments payable by Impax to AstraZeneca pursuant to the AZ Agreement in any given quarter, AstraZeneca will be required to pay Impax an amount equal to the difference between the royalty reduction amount and the royalty payment payable by Impax to AstraZeneca. Impax’s commitment to perform the PREA Study may be terminated, without penalty, under certain circumstances as set forth in the AZ Amendment. The Company recognizes the amounts received from AstraZeneca for the PREA Study as a reduction to research and development expense. In May 2013, Impax’s exclusivity period for branded Zomig® tablets and orally disintegrating tablets expired and Impax launched authorized generic versions of those products in the United States. As discussed above, pursuant to the AZ Amendment, the total royalty payments payable by Impax to AstraZeneca on net sales of Zomig ® products under the AZ Agreement is reduced by certain specified amounts beginning from the quarter ended June 30, 2016 and through the quarter ended December 31, 2020 , with such reduced royalty amounts totaling an aggregate amount of $30 million . The Company recorded cost of sales for royalties under this agreement of $4 million for the three months ended March 31, 2019 . |
Restructuring and Other Charges
Restructuring and Other Charges | 3 Months Ended |
Mar. 31, 2019 | |
Restructuring and Related Activities [Abstract] | |
Restructuring and Other Charges | Restructuring and Other Charges During the second quarter of 2018, in connection with the Combination, the Company committed to a restructuring plan to achieve cost savings. The Company expects to integrate its operations and reduce its combined cost structure through workforce reductions that eliminate duplicative positions and the consolidation of certain administrative, manufacturing and research and development facilities. In connection with this plan, the Company announced on May 10, 2018 that it intended to close its Hayward, California based operations (collectively these actions comprise the "Plan"). The following table sets forth the components of the Company's restructuring and other charges (in thousands): Three Months Ended March 31, 2019 Employee restructuring separation charges (1) $ 2,318 Other employee severance charges 3,843 Total restructuring and other charges $ 6,161 (1) Employee restructuring separation charges include the cost of benefits provided pursuant to the Company's severance programs for employees impacted by the Plan at the Company's Hayward, CA facility and other facilities. The charges related to restructuring impacted segment earnings as follows (in thousands): Three Months Ended March 31, 2019 Generics $ 996 Specialty 178 Corporate 1,144 Total employee restructuring separation charges $ 2,318 The following table shows the change in the employee separation-related liability associated with the Company's restructuring programs, which is included in accounts payable and accrued expenses (in thousands): Employee Restructuring Balance at December 31, 2018 $ 22,112 Charges to income 2,318 Payments (12,069 ) Balance at March 31, 2019 $ 12,361 |
Loss per Share
Loss per Share | 3 Months Ended |
Mar. 31, 2019 | |
Earnings Per Share [Abstract] | |
Loss per Share | Loss per Share Basic loss per share of Class A Common Stock and Class B-1 Common Stock is computed by dividing net loss attributable to Amneal Pharmaceuticals, Inc. by the weighted-average number of shares of Class A Common Stock and Class B-1 Common Stock outstanding during the period. Diluted loss per share of Class A Common Stock and Class B-1 Common Stock is computed by dividing net loss attributable to Amneal Pharmaceuticals, Inc. by the weighted-average number of shares of Class A Common Stock and Class B-1 Common Stock outstanding, adjusted to give effect to potentially dilutive securities. The following table sets forth reconciliations of the numerators and denominators used to compute basic and diluted loss per share of Class A Common Stock and Class B-1 Common Stock (in thousands, except per share amounts): Three Months Ended March 31, 2019 Numerator: Net loss attributable to Amneal Pharmaceuticals, Inc. $ (47,881 ) Denominator: Weighted-average shares of Class A Common Stock and Class B-1 Common Stock outstanding - basic and diluted 127,687 Net loss per share attributable to Amneal Pharmaceuticals, Inc.'s common stockholders: Class A and Class B-1 basic and diluted $ (0.37 ) The allocation of net loss to the holders of shares of Class A Common Stock and Class B-1 Common Stock began following the closing of the Combination on May 4, 2018. Therefore, loss per share has not been presented for the three months ended March 31, 2018. Shares of the Company's Class B Common Stock do not share in the earnings or losses of the Company and, therefore, are not participating securities. As such, separate presentation of basic and diluted earnings per share of Class B Common Stock under the two-class method has not been presented. The following table presents potentially dilutive securities excluded from the computations of diluted earnings per share of Class A Common Stock and Class B-1 Common Stock (in thousands): Three Months Ended March 31, 2019 Stock options (1) 8,400 Restricted stock units (1) 3,282 Performance stock units (1) 520 Shares of Class B Common Stock (2) 171,041 (1) Excluded from the computation of diluted loss per share of Class A Common Stock and Class B-1 Common Stock because the effect of their inclusion would have been anti-dilutive since there was a net loss attributable to the Company for the three months ended March 31, 2019 . (2) Shares of Class B Common Stock are considered potentially dilutive shares of Class A Common Stock and Class B-1 Common Stock. Shares of Class B Common Stock have been excluded from the computations of diluted earnings per share of Class A Common Stock and Class B-1 Common Stock because the effect of their inclusion would have been anti-dilutive under the if-converted method. |
Income taxes
Income taxes | 3 Months Ended |
Mar. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Income taxes | Income taxes As a result of the Combination (refer to Note 1. Nature of Operations ), the Company became the sole managing member of Amneal, with Amneal being the accounting predecessor for accounting purposes. The operations of Amneal are conducted through a limited liability company that is treated as a partnership for U.S. federal and most applicable state and local income tax purposes. As a partnership, Amneal is not subject to U.S. federal and certain state and local income taxes. Any taxable income or loss generated by Amneal is passed through to and included in the taxable income or loss of its members, including the Company, on a pro rata basis subject to applicable tax regulations. The Company is subject to U.S. federal income taxes, in addition to state and local income taxes with respect to its allocable share of any taxable income or loss of Amneal, as well as any stand-alone income or loss generated by the Company. Amneal provides for income taxes in the various foreign jurisdictions in which it operates. The Company records a valuation allowance against its deferred tax assets to reduce the net carrying value to an amount that it believes is more likely than not to be realized. As of March 31, 2019, management concluded, based on the weight of all available positive and negative evidence, those deferred tax assets recorded as a result of the Combination are more likely than not to be realized. As such, no additional valuation allowance was recognized. In connection with the Combination, the Company entered into a tax receivable agreement (“TRA”) for which it is generally required to pay the other holders of Amneal Common Units 85% of the applicable tax savings, if any, in U.S. federal and state income tax that it is deemed to realize as a result of certain tax attributes of their Amneal Common Units sold to the Company (or exchanged in a taxable sale) and that are created as a result of (i) the sales of their Amneal Common Units for shares of Class A common stock and (ii) tax benefits attributable to payments made under the TRA (including imputed interest). In connection with the exchanges which occurred during the three months ended March 31, 2019 , the Company recorded an additional TRA liability of $0.6 million . The Company's TRA liability payable was $193 million as of both March 31, 2019 and December 31, 2018 . Such amounts will be paid when such deferred tax assets are realized as a reduction to income taxes due or payable. The Company’s benefit from income taxes and effective tax rate were $8 million and 6.3% , respectively, for the three months ended March 31, 2019 . The Company's provision for income taxes and effective tax rate were $0.4 million and 0.7% , respectively, for the three months ended March 31, 2018 . The change in income taxes is primarily due to the change in the Company's legal structure subsequent to the Combination. Prior to the Combination, as a limited liability company, income taxes were only provided for the international subsidiaries as all domestic taxes flowed to the members. Subsequent to May 4, 2018, domestic income taxes were also provided for the Company's allocable share of income or losses from Amneal at the prevailing U.S. federal, state, and local corporate income tax rates. The change in income tax expense is also associated with the year-over-year decline in pre-tax income. The decline in pre-tax income was primarily attributable to $76 million in impairment charges on intangible assets and $6 million in restructuring and other charges associated with severance benefits. The Company and its subsidiaries file income tax returns in the U.S. federal, and various state, local and foreign jurisdictions. The Company is not currently under income tax audit in any jurisdiction, and it will file its first income tax returns for the period ended December 31, 2018. Impax's federal tax filings for the 2015, 2016 and 2017 tax years are currently under audit. The IRS statute of limitations is open for the 2015, 2016 and 2017 tax years for Impax. If there were adjustments to the attributes of Impax, they could impact the carryforward losses at the Company, which is the successor in interest to Impax. The Amneal partnership was audited for the tax year ended December 31, 2015 without any adjustments to taxable income. Income tax returns are generally subject to examination for a period of 3 years in the U.S. The statute of limitations for the 2016 and 2017 tax years will, therefore, expire no earlier than 2020. However, any adjustments to the 2016 or 2017 tax years would be pre-transaction when the Company had no ownership interest in Amneal. Under the partnership income tax regulations and audit guidelines, the Company is not responsible for any hypothetical pre-transaction income tax liabilities which pass through to the owners as of the year of any potential income tax adjustment. Neither the Company nor any of its other affiliates is currently under audit for state income tax. |
Trade Accounts Receivable, Net
Trade Accounts Receivable, Net | 3 Months Ended |
Mar. 31, 2019 | |
Receivables [Abstract] | |
Trade Accounts Receivable, Net | Trade Accounts Receivable, Net Trade accounts receivable, net is comprised of the following (in thousands): March 31, 2019 December 31, 2018 Gross accounts receivable $ 1,438,296 $ 1,349,588 Allowance for doubtful accounts (2,673 ) (2,340 ) Contract charge-backs and sales volume allowances (743,522 ) (829,596 ) Cash discount allowances (51,889 ) (36,157 ) Subtotal (798,084 ) (868,093 ) Trade accounts receivable, net $ 640,212 $ 481,495 Receivables from customers representing 10% or more of the Company’s gross trade accounts receivable reflected three customers at March 31, 2019 , equal to 33% , 29% , and 22% , respectively. Receivables from customers representing 10% or more of the Company’s gross trade accounts receivable reflected three customers at December 31, 2018 , equal to 30% , 28% , and 24% , respectively. |
Inventories
Inventories | 3 Months Ended |
Mar. 31, 2019 | |
Inventory Disclosure [Abstract] | |
Inventories | Inventories Inventories, net of reserves, are comprised of the following (in thousands): March 31, 2019 December 31, 2018 Raw materials $ 182,590 $ 181,654 Work in process 57,729 54,152 Finished goods 207,975 221,413 Total inventories $ 448,294 $ 457,219 |
Leases
Leases | 3 Months Ended |
Mar. 31, 2019 | |
Leases [Abstract] | |
Leases | Leases The majority of the Company's operating and financing lease portfolio consists of corporate offices, manufacturing sites, warehouse space, research and development facilities and manufacturing equipment. The Company's leases have remaining lease terms of 1 year to 25 years . Rent expense for the three months ended March 31, 2019 and 2018 was $7 million and $2 million , respectively. The components of total lease costs were as follows (in thousands): Three Months Ended March 31, 2019 Operating lease cost (1) $ 5,940 Finance lease cost: Amortization of right-of-use assets 652 Interest on lease liabilities 1,124 Total finance lease cost 1,776 Total lease cost $ 7,716 (1) Includes variable and short-term lease costs. Supplemental balance sheet information related to the Company's leases was as follows (in thousands): Operating leases March 31, 2019 Operating lease right-of-use assets $ 63,238 Operating lease right-of-use assets - related party 17,565 Total operating lease right-of-use assets $ 80,803 Operating lease liabilities $ 51,200 Operating lease liabilities - related party 15,445 Current portion of operating lease liabilities 13,173 Current portion of operating and financing lease liabilities - related party 2,217 Total operating lease liabilities $ 82,035 Financing leases Financing lease right of use assets - related party $ 63,240 Financing lease liabilities - related party $ 62,256 Current portion of operating and financing lease liabilities - related party 1,017 Total financing lease liabilities $ 63,273 Supplemental cash flow information related to leases was as follows (in thousands): Three Months Ended March 31, 2019 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from finance leases $ 750 Operating cash flows from operating leases 4,897 Financing cash flows from finance leases 619 Non-cash activity: Right-of-use assets obtained in exchange for new operating lease liabilities $ 360 The table below reflects the weighted average remaining lease term and weighted average discount rate for our operating and finance leases as of March 31, 2019 . March 31, 2019 Weighted average remaining lease term - operating leases 6 years Weighted average remaining lease term - finance leases 24 years Weighted average discount rate - operating leases 5.9% Weighted average discount rate - finance leases 7.1% Maturities of lease liabilities as of March 31, 2019 were as follows (in thousands): Operating Leases Financing Leases 2019 (1) $ 15,000 $ 4,105 2020 19,824 5,474 2021 18,354 5,474 2022 10,169 5,474 2023 10,050 5,474 Thereafter 26,939 106,740 Total lease payments 100,336 132,741 Less: Imputed interest (18,301 ) (69,468 ) Total $ 82,035 $ 63,273 (1) Excludes the three months ended March 31, 2019. As disclosed in our 2018 Annual Report on Form 10-K, under the previous lease accounting standard, the table below reflects the future minimum lease payments, including reasonably assured renewals, due under non-cancelable leases and a financing obligation as of December 31, 2018 (in thousands): Operating Leases Financing Obligation 2019 $ 25,885 $ 5,474 2020 12,071 5,474 2021 11,105 5,474 2022 10,329 5,474 2023 10,043 5,474 Thereafter 28,128 107,196 Total lease payments 97,561 134,566 Less: Imputed interest — (95,217 ) Total $ 97,561 $ 39,349 For additional information regarding lease transactions between related parties, refer to Note 15. Related Party Transactions. |
Leases | Leases The majority of the Company's operating and financing lease portfolio consists of corporate offices, manufacturing sites, warehouse space, research and development facilities and manufacturing equipment. The Company's leases have remaining lease terms of 1 year to 25 years . Rent expense for the three months ended March 31, 2019 and 2018 was $7 million and $2 million , respectively. The components of total lease costs were as follows (in thousands): Three Months Ended March 31, 2019 Operating lease cost (1) $ 5,940 Finance lease cost: Amortization of right-of-use assets 652 Interest on lease liabilities 1,124 Total finance lease cost 1,776 Total lease cost $ 7,716 (1) Includes variable and short-term lease costs. Supplemental balance sheet information related to the Company's leases was as follows (in thousands): Operating leases March 31, 2019 Operating lease right-of-use assets $ 63,238 Operating lease right-of-use assets - related party 17,565 Total operating lease right-of-use assets $ 80,803 Operating lease liabilities $ 51,200 Operating lease liabilities - related party 15,445 Current portion of operating lease liabilities 13,173 Current portion of operating and financing lease liabilities - related party 2,217 Total operating lease liabilities $ 82,035 Financing leases Financing lease right of use assets - related party $ 63,240 Financing lease liabilities - related party $ 62,256 Current portion of operating and financing lease liabilities - related party 1,017 Total financing lease liabilities $ 63,273 Supplemental cash flow information related to leases was as follows (in thousands): Three Months Ended March 31, 2019 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from finance leases $ 750 Operating cash flows from operating leases 4,897 Financing cash flows from finance leases 619 Non-cash activity: Right-of-use assets obtained in exchange for new operating lease liabilities $ 360 The table below reflects the weighted average remaining lease term and weighted average discount rate for our operating and finance leases as of March 31, 2019 . March 31, 2019 Weighted average remaining lease term - operating leases 6 years Weighted average remaining lease term - finance leases 24 years Weighted average discount rate - operating leases 5.9% Weighted average discount rate - finance leases 7.1% Maturities of lease liabilities as of March 31, 2019 were as follows (in thousands): Operating Leases Financing Leases 2019 (1) $ 15,000 $ 4,105 2020 19,824 5,474 2021 18,354 5,474 2022 10,169 5,474 2023 10,050 5,474 Thereafter 26,939 106,740 Total lease payments 100,336 132,741 Less: Imputed interest (18,301 ) (69,468 ) Total $ 82,035 $ 63,273 (1) Excludes the three months ended March 31, 2019. As disclosed in our 2018 Annual Report on Form 10-K, under the previous lease accounting standard, the table below reflects the future minimum lease payments, including reasonably assured renewals, due under non-cancelable leases and a financing obligation as of December 31, 2018 (in thousands): Operating Leases Financing Obligation 2019 $ 25,885 $ 5,474 2020 12,071 5,474 2021 11,105 5,474 2022 10,329 5,474 2023 10,043 5,474 Thereafter 28,128 107,196 Total lease payments 97,561 134,566 Less: Imputed interest — (95,217 ) Total $ 97,561 $ 39,349 For additional information regarding lease transactions between related parties, refer to Note 15. Related Party Transactions. |
Fair Value Measurements of Fina
Fair Value Measurements of Financial Instruments | 3 Months Ended |
Mar. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements of Financial Instruments | Fair Value Measurements of Financial Instruments Fair value is the exit price that would be received to sell an asset or paid to transfer a liability. Fair value is a market-based measurement that should be determined using assumptions that market participants would use in pricing an asset or liability. Valuation techniques used to measure fair value should maximize the use of observable inputs and minimize the use of unobservable inputs. To measure fair value, the Company uses the following fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable: Level 1 – Quoted prices in active markets for identical assets or liabilities. Level 2 – Inputs other than Level 1 that are observable for the asset or liability, either directly or indirectly, such as quoted prices for similar assets and liabilities in active markets; quoted prices for identical or similar assets or liabilities in markets that are not active; or other inputs that are observable or can be corroborated by observable market data by correlation or other means. Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. Value is determined using pricing models, discounted cash flow methodologies, or similar techniques and also includes instruments for which the determination of fair value requires significant judgment or estimation. Assets and Liabilities Measured at Fair Value on a Recurring Basis The Company evaluates its financial assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level of classification for each reporting period. The following table sets forth the Company’s financial assets and liabilities that were measured at fair value on a recurring basis as of March 31, 2019 and December 31, 2018 (in thousands): Fair Value Measurement Based on March 31, 2019 Total Quoted Prices in Active Markets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Assets Deferred Compensation Plan asset (1) $ 42,718 $ — $ 42,718 $ — Liabilities Deferred Compensation Plan liabilities (1) $ 27,073 $ — $ 27,073 $ — December 31, 2018 Assets Deferred Compensation Plan asset (1) $ 40,101 $ — $ 40,101 $ — Liabilities Deferred Compensation Plan liabilities (1) $ 27,978 $ — $ 27,978 $ — (1) The deferred compensation plan liabilities are non-current liabilities recorded at the value of the amount owed to the plan participants, with changes in value recognized as compensation expense. The calculation of the deferred compensation plan obligation is derived from observable market data by reference to hypothetical investments selected by the participants and is included in other long-term liabilities. The Company invests participant contributions in corporate-owned life insurance policies, for which the cash surrender value is included in other non-current assets. There were no transfers between levels in the fair value hierarchy during the three months ended March 31, 2019 . Assets and Liabilities Not Measured at Fair Value on a Recurring Basis The carrying amounts of cash, accounts receivable and accounts payable approximate their fair values due to the short-term maturity of these instruments. The $2.7 billion term loan under the Company’s senior credit agreement entered into on May 4, 2018 (the "Term Loan") falls into the Level 2 category within the fair value level hierarchy. The fair value was determined using market data for valuation. The fair value of the Term Loan at March 31, 2019 and December 31, 2018 was approximately $2.7 billion and $2.5 billion , respectively. Assets and Liabilities Measured at Fair Value on a Non-Recurring Basis There were no non-recurring fair value measurements during the three months ended March 31, 2019 and 2018 . |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Commitments Commercial Manufacturing, Collaboration, License, and Distribution Agreements The Company continues to seek to enhance its product line and develop a balanced portfolio of differentiated products through product acquisitions and in-licensing. Accordingly, the Company, in certain instances, may be contractually obligated to make potential future development, regulatory, and commercial milestone, royalty and/or profit sharing payments in conjunction with collaborative agreements or acquisitions that the Company has entered into with third parties. The Company has also licensed certain technologies or intellectual property from various third parties. The Company is generally required to make upfront payments as well as other payments upon successful completion of regulatory or sales milestones. The agreements generally permit the Company to terminate the agreement with no significant continuing obligation. The Company could be required to make significant payments pursuant to these arrangements. These payments are contingent upon the occurrence of certain future events and, given the nature of these events, it is unclear when, if ever, the Company may be required to pay such amounts. Further, the timing of any future payment is not reasonably estimable. Contingencies Legal Proceedings The Company's legal proceedings are complex, constantly evolving and subject to uncertainty. As such, the Company cannot predict the outcome or impact of the legal proceedings set forth below. And the Company is subject to legal proceedings that are not set forth below. While the Company believes it has valid claims and/or defenses to the matters described below, the nature of litigation is unpredictable, and the outcome of the following proceedings could include damages, fines, penalties and injunctive or administrative remedies. For any proceedings where losses are probable and reasonably capable of estimation, the Company accrues for a potential loss. While these accruals have been deemed reasonable by the Company’s management, the assessment process relies heavily on estimates and assumptions that may ultimately prove inaccurate or incomplete. Additionally, unforeseen circumstances or events may lead the Company to subsequently change its estimates and assumptions. Unless otherwise indicated below, the Company is at this time unable to estimate the possible loss, if any, associated with such litigation. The Company currently intends to vigorously prosecute and/or defend these proceedings as appropriate. From time to time, however, the Company may settle or otherwise resolve these matters on terms and conditions that it believes to be in its best interest. Resolution of any or all claims, legal proceedings or investigations could have a material adverse effect on the Company's results of operations and/or cash flow in any given accounting period, or on the Company's overall financial condition. Additionally, the Company manufactures and derives a portion of its revenue from the sale of pharmaceutical products in the opioid class of drugs, and may therefore face claims arising from the regulation and/or consumption of such products. Although the outcome and costs of the asserted and unasserted claims is difficult to predict, based on the information presently known to management, the Company does not currently expect the ultimate liability, if any, for such matters to have a material adverse effect on its business, financial condition, results of operations, or cash flows. Medicaid Reimbursement Accrual The Company is required to provide pricing information to state agencies that administer federal Medicaid programs. Certain state agencies have alleged that manufacturers have reported improper pricing information, which allegedly caused them to overpay reimbursement costs. Reserves are periodically established by the Company for any potential claims or settlements of overpayment. Although the Company intends to vigorously defend against any such claims, it had a reserve of $15 million at both March 31, 2019 and December 31, 2018 . The ultimate settlement of any potential liability for such claims may be higher or lower than estimated. Patent Litigation There is substantial litigation in the pharmaceutical, biological, and biotechnology industries with respect to the manufacture, use, and sale of new products which are the subject of conflicting patent and intellectual property claims. One or more patents often cover the brand name products for which the Company is developing generic versions and the Company typically has patent rights covering the Company’s branded products. Under federal law, when a drug developer files an Abbreviated New Drug Application ("ANDA") for a generic drug seeking approval before expiration of a patent which has been listed with the FDA as covering the brand name product, the developer must certify its product will not infringe the listed patent(s) and/or the listed patent is invalid or unenforceable (commonly referred to as a "Paragraph IV" certification). Notices of such certification must be provided to the patent holder, who may file a suit for patent infringement within 45 days of the patent holder’s receipt of such notice. If the patent holder files suit within the 45-day period, the FDA can review and tentatively approve the ANDA, but generally is prevented from granting final marketing approval of the product until a final judgment in the action has been rendered in favor of the generic drug developer, or 30 months from the date the notice was received, whichever is sooner. The Company’s Generic segment is typically subject to patent infringement litigation brought by branded pharmaceutical manufacturers in connection with the Company’s Paragraph IV certifications seeking an order delaying the approval of the Company’s ANDA until expiration of the patent(s) at issue in the litigation. Likewise, the Company’s Specialty segment is currently involved in patent infringement litigation against generic drug manufacturers that have filed Paragraph IV certifications to market their generic drugs prior to expiration of the Company’s patents at issue in the litigation. The uncertainties inherent in patent litigation make the outcome of such litigation difficult to predict. For the Company’s Generics segment, the potential consequences in the event of an unfavorable outcome in such litigation include delaying launch of its generic products until patent expiration. If the Company were to launch its generic product prior to successful resolution of a patent litigation, the Company could be liable for potential damages measured by the profits lost by the branded product manufacturer rather than the profits earned by the Company if it is found to infringe a valid, enforceable patent, or enhanced treble damages in cases of willful infringement. For the Company’s Specialty segment, an unfavorable outcome may significantly accelerate generic competition ahead of expiration of the patents covering the Company’s branded products. All such litigation typically involves significant expense. The Company is generally responsible for all of the patent litigation fees and costs associated with current and future products not covered by its alliance and collaboration agreements. The Company has agreed to share legal expenses with respect to third-party and Company products under the terms of certain of the alliance and collaboration agreements. The Company records the costs of patent litigation as expense in the period when incurred for products it has developed, as well as for products which are the subject of an alliance or collaboration agreement with a third-party. Patent Defense Matters Otsuka Pharmaceutical Co. Ltd. v. Amneal Pharmaceuticals LLC, et. al. (Aripiprazole) In March 2015, Otsuka Pharmaceutical Co. Ltd. filed suit against Amneal in the U.S. District Court for the District of New Jersey alleging patent infringement based on the filing of Amneal’s ANDA for a generic alternative to Otsuka’s Abilify® tablet product. In 2016, the District Court granted Amneal’s motion to dismiss several of the patents in suit. The Court of Appeals for the Federal Circuit affirmed the dismissal with respect to one such patent and Otsuka did not appeal the District Court’s decision with respect to the other patents. At this time one patent remains in the suit and the District Court has not yet set a trial date with respect to that patent. Amneal, like numerous other generic manufacturers, has launched its generic version of Otsuka’s Abilify® "at-risk," prior to trial on the remaining patent-in-suit, and continues to sell the product. Patent Infringement Matters Impax Laboratories, LLC. v. Zydus Pharmaceuticals USA, Inc. and Cadila Healthcare Ltd. (Rytary ® ) On December 21, 2017, Impax filed suit against Zydus Pharmaceuticals USA, Inc. and Cadila Healthcare Ltd. (collectively, "Zydus") in the United States District Court for the District of New Jersey, alleging infringement of U.S. Patent No. 9,089,608, based on the filing of Zydus’s ANDA relating to carbidopa and levodopa extended release capsules, generic to Rytary ® . Zydus answered the complaint on April 27, 2018, asserting counterclaims of non-infringement and invalidity of U.S. Pat. Nos. 7,094,427; 8,377,474; 8,454,998; 8,557,283; and 9,089,607. Impax answered Zydus’s counterclaims on June 1, 2018. Zydus filed a motion for judgment on the pleadings regarding its counterclaims. On November 29, 2018, the Court granted Zydus’s motion for judgment as to its counterclaims. A case schedule has been set with trial anticipated in February 2020. Other Litigation Related to the Company’s Business Opana ER® FTC Antitrust Suit On February 25, 2014, Impax received a Civil Investigative Demand (“CID”) from the Federal Trade Commission (“FTC”) concerning its investigation into the drug Opana® ER and its generic equivalents. On March 30, 2016, the FTC filed a complaint against Impax, Endo Pharmaceuticals Inc. ("Endo"), and others in the United States District Court for the Eastern District of Pennsylvania, alleging that Impax and Endo violated antitrust laws when they entered into a June 2010 co-promotion and development agreement and a June 2010 settlement agreement that resolved patent litigation in connection with the submission of Impax’s ANDA for generic original Opana® ER. In July 2016, the defendants filed a motion to dismiss the complaint, and a motion to sever the claims regarding Opana® ER from claims with respect to a separate settlement agreement that was challenged by the FTC. On October 20, 2016, the Court granted the motion to sever, formally terminating the suit against Impax, with an order that the FTC re-file no later than November 3, 2016 and dismissed the motion to dismiss as moot. On October 25, 2016, the FTC filed a notice of voluntary dismissal. On January 19, 2017, the FTC filed a Part 3 Administrative complaint against Impax with similar allegations regarding Impax’s June 2010 settlement agreement with Endo that resolved patent litigation in connection with the submission of Impax’s ANDA for generic original Opana® ER. Impax filed its answer to the Administrative Complaint on February 7, 2017. Trial concluded on November 15, 2017. On May 11, 2018, the Administrative Law Judge ruled in favor of Impax and dismissed the case in its entirety. The government appealed this ruling to the FTC. On March 28, 2019, the FTC issued an Opinion & Order reversing the Administrative Law Judge’s initial dismissal decision. The FTC found that Impax had violated Section 5 of the FTC Act by engaging in an unfair method of competition, and accordingly entered an order enjoining Impax from entering into anticompetitive reverse patent settlements (or agreements with other generic original Opana® ER manufacturers) and requiring Impax to maintain an antitrust compliance program. The Company intends to appeal. Opana ER® Antitrust Litigation From June 2014 to April 2015, 14 complaints styled as class actions on behalf of direct purchasers and indirect purchasers (also known as end-payors) and several separate individual complaints on behalf of certain direct purchasers (the “opt-out plaintiffs”) were filed against the manufacturer of the brand drug Opana ER® and Impax. The direct purchaser plaintiffs comprise Value Drug Company; Meijer Inc. The end-payor plaintiffs comprise the Fraternal Order of Police, Miami Lodge 20, Insurance Trust Fund; Wisconsin Masons’ Health Care Fund; Massachusetts Bricklayers; Pennsylvania Employees Benefit Trust Fund; International Union of Operating Engineers, Local 138 Welfare Fund; Louisiana Health Service & Indemnity Company d/b/a Blue Cross and Blue Shield of Louisiana; Kim Mahaffay; and Plumbers & Pipefitters Local 178 Health & Welfare Trust Fund. The opt-out plaintiffs comprise Walgreen Co.; The Kroger Co.; Safeway, Inc.; HEB Grocery Company L.P.; Albertson’s LLC; Rite Aid Corporation; Rite Aid Hdqtrs. Corp.; and CVS Pharmacy, Inc. On December 12, 2014, the United States Judicial Panel on Multidistrict Litigation (the "JPML") ordered the pending class actions transferred to the Northern District of Illinois for coordinated pretrial proceedings, as In Re Opana ER Antitrust Litigation (MDL No. 2580). (Actions subsequently filed in other jurisdictions also were transferred by the JPML to the Northern District of Illinois to be coordinated or consolidated with the coordinated proceedings, and the District Court likewise has consolidated the opt-out plaintiffs’ actions with the direct purchaser class actions for pretrial purposes.) In each case, the complaints allege that Endo engaged in an anticompetitive scheme by, among other things, entering into an anticompetitive settlement agreement with Impax to delay generic competition of Opana ER® and in violation of state and federal antitrust laws. Plaintiffs seek, among other things, unspecified monetary damages and equitable relief, including disgorgement and restitution. Discovery, including expert discovery, is ongoing. On March 25, 2019, plaintiffs filed motions for class certification and opening expert reports. Defendants’ oppositions to class certification and rebuttal expert reports are due to be filed by August 8, 2019. No trial date has been scheduled. The Company believes it has substantial meritorious defenses to the claims asserted with respect to the litigation. However, any adverse outcome could negatively affect the Company and could have a material adverse effect on the Company's results of operations, cash flows and/or overall financial condition. Sergeants Benevolent Association Health & Welfare Fund v. Actavis, PLC, et. al. In August 2015, a complaint styled as a class action was filed against Forest Laboratories (a subsidiary of Actavis plc) and numerous generic drug manufacturers, including Amneal, in the United States District Court for the Southern District of New York involving patent litigation settlement agreements between Forest Laboratories and the generic drug manufacturers concerning generic versions of Forest’s Namenda IR product. The complaint (as amended on February 12, 2016) asserts federal and state antitrust claims on behalf of indirect purchasers, who allege in relevant part that during the class period they indirectly purchased Namenda® IR or its generic equivalents in various states at higher prices than they would have absent the defendants’ allegedly unlawful anticompetitive conduct. Plaintiffs seek, among other things, unspecified monetary damages and equitable relief, including disgorgement and restitution. On September 13, 2016, the Court stayed the indirect purchaser plaintiffs’ claims pending factual development or resolution of claims brought in a separate, related complaint by direct purchasers (in which the Company is not a defendant). On September 10, 2018, the Court lifted the stay, referred the case to the assigned Magistrate Judge for supervision of supplemental, non-duplicative discovery in advance of mediation to be scheduled in 2019. The parties thereafter participated in supplemental discovery, as well as supplemental motion-to-dismiss briefing. On December 26, 2018, the Court granted in part and denied in part motions to dismiss the indirect purchaser plaintiffs’ claims. On January 7, 2019, Amneal, its relevant co-defendants, and the indirect purchaser plaintiffs informed the Magistrate Judge that they had agreed to mediation, which occurred in April 2019. The Company has reached a settlement in principle with plaintiffs, subject to execution of definitive documentation. The amount of the settlement is not expected to be material to the Company's consolidated financial statements. Attorney General of the State of Connecticut Interrogatories and Subpoena Duces Tecum On July 14, 2014, Impax received a subpoena and interrogatories (the "Subpoena") from the State of Connecticut Attorney General ("Connecticut AG") concerning its investigation into sales of Impax's generic product, digoxin. According to the Connecticut AG, the investigation is to determine whether anyone engaged in a contract, combination or conspiracy in restraint of trade or commerce which has the effect of (i) fixing, controlling or maintaining prices or (ii) allocating or dividing customers or territories relating to the sale of digoxin in violation of Connecticut state antitrust law. The Company has produced documents and information in response to the Subpoena. To the knowledge of the Company, no proceedings by the Connecticut AG have been initiated against the Company at this time. However, no assurance can be given as to the timing or outcome of this investigation. United States Department of Justice Investigations On November 6, 2014, Impax disclosed that one of its sales representatives received a grand jury subpoena from the Antitrust Division of the United States Department of Justice (the "DOJ"). In connection with this same investigation, on March 13, 2015, Impax received a grand jury subpoena from the DOJ requesting the production of information and documents regarding the sales, marketing, and pricing of certain generic prescription medications. In particular, the DOJ’s investigation currently focuses on four generic medications: digoxin tablets, terbutaline sulfate tablets, prilocaine/lidocaine cream, and calcipotriene topical solution. The Company has been cooperating and intends to continue cooperating with the investigation. However, no assurance can be given as to the timing or outcome of the investigation. On April 30, 2018, Impax received a CID from the Civil Division of the DOJ (the "Civil Division"). The CID requests the production of information and documents regarding the pricing and sale of Impax’s pharmaceuticals and Impax’s interactions with other generic pharmaceutical manufacturers. According to the CID, the investigation concerns allegations that generic pharmaceutical manufacturers, including Impax, engaged in market allocation and price-fixing agreements, paid illegal remuneration, and caused false claims to be submitted to the Federal government. The Company has been cooperating and intends to continue cooperating with the Civil Division’s investigation. However, no assurance can be given as to the timing or outcome of the investigation. Texas State Attorney General Civil Investigative Demand On May 27, 2014, a CID was served on Amneal by the Office of the Attorney General for the state of Texas (the "Texas AG") relating to products distributed by Amneal under a specific Amneal labeler code. Shortly thereafter, Amneal received a second CID with respect to the same products sold by Interpharm Holding, Inc. ("Interpharm"), the assets of which had been acquired by Amneal in June 2008. Amneal completed its production of the direct and indirect sales transaction data in connection with the products at issue and provided this information to the Texas AG in November 2015. In May 2016, the Texas AG delivered two settlement demands to Amneal in connection with alleged overpayments made by the State of Texas for such products under its Medicaid programs. For the Amneal and Interpharm products at issue, the Texas AG’s initial demand was for an aggregate total of $36 million based on $16 million in alleged overpayments. After analyzing the Texas AG’s demand, Amneal raised certain questions regarding the methodology used in the Texas AG’s overpayment calculations, including the fact that the calculations treated all pharmacy claims after 2012 for the products at issue as claims for over-the-counter ("OTC") drugs, even though the products were prescription pharmaceuticals. This had the effect of increasing the alleged overpayment because the dispensing fee for OTC drugs was lower than that for prescription drugs. Therefore, the Texas AG’s calculations were derived by subtracting a lower (and incorrect) OTC dispensing fee from the higher (and correct) prescription dispensing fee. The Texas AG later acknowledged this discrepancy. In March 2019, the Texas AG provided Amneal with a re-calculation of the alleged overpayment, and Amneal is in discussions with the Texas AG. In Re Generic Pharmaceuticals Pricing Antitrust Litigation Between March 2016 and January 2019, numerous complaints styled as antitrust class actions on behalf of direct purchasers and indirect purchasers (or end-payors) and several separate individual complaints on behalf of certain direct and indirect purchasers (the “opt-out plaintiffs”) have been filed against manufacturers of generic digoxin, lidocaine/prilocaine, glyburide-metformin, and metronidazole, including Impax. The end-payor plaintiffs comprise Plaintiff International Union of Operating Engineers Local 30 Benefits Fund; Tulsa Firefighters Health and Welfare Trust; NECA-IBEW Welfare Trust Fund; Pipe Trade Services MN; Edward Carpinelli; Fraternal Order of Police, Miami Lodge 20, Insurance Trust Fund; Nina Diamond; UFCW Local 1500 Welfare Fund; Minnesota Laborers Health and Welfare Fund; The City of Providence, Rhode Island; Philadelphia Federation of Teachers Health and Welfare Fund; United Food & Commercial Workers and Employers Arizona Health and Welfare Trust; Ottis McCrary; Plumbers & Pipefitters Local 33 Health and Welfare Fund; Plumbers & Pipefitters Local 178 Health and Welfare Trust Fund; Unite Here Health; Valerie Velardi; and Louisiana Health Service Indemnity Company. The direct purchaser plaintiffs comprise KPH Healthcare Services, Inc. a/k/a Kinney Drugs, Inc.; Rochester Drug Co-Operative, Inc.; César Castillo, Inc.; Ahold USA, Inc.; and FWK Holdings, L.L.C. The opt-out plaintiffs comprise The Kroger Co.; Albertsons Companies, LLC; H.E. Butt Grocery Company L.P.; Humana Inc.; and United Healthcare Services, Inc. On April 6, 2017, the JPML ordered the consolidation of all civil actions involving allegations of antitrust conspiracies in the generic pharmaceutical industry regarding 18 generic drugs in the Eastern District of Pennsylvania, as In Re Generic Pharmaceuticals Pricing Antitrust Litigation (MDL No. 2724). Consolidated class action complaints were filed on August 15, 2017 for each of the 18 drugs; Impax is named as a defendant in the 2 complaints respecting digoxin and lidocaine-prilocaine. Impax also is a defendant in the class action complaint filed with the MDL court on June 22, 2018 by certain direct purchasers of glyburide-metformin and metronidazole. Each of the various complaints alleges a conspiracy to fix, maintain, stabilize, and/or raise prices, rig bids, and allocate markets or customers for the particular drug products at issue. Plaintiffs seek, among other things, unspecified monetary damages and equitable relief, including disgorgement and restitution. On October 16, 2018, the Court denied Impax and its co-defendants’ motion to dismiss the digoxin complaint. On February 15, 2019, the Court granted in part and denied in part defendants’ motions to dismiss various state antitrust, consumer protection, and unjust enrichment claims brought by two classes of indirect purchasers in the digoxin action. The Court dismissed seven state law claims in the end-payor plaintiffs’ complaint and six state law claims in the indirect reseller plaintiffs’ complaint. Motions to dismiss the glyburide-metformin and metronidazole complaint, as well as 2 of the complaints filed by certain opt-out plaintiffs, were filed February 21, 2019. On March 11, 2019, the Court issued an order approving a stipulation withdrawing the direct purchaser plaintiffs’ glyburide-metformin claims against Impax. Document discovery otherwise is proceeding. In May 2019, the Company received letters from the State Attorneys General for South Carolina and Massachusetts providing notice that those states intend to pursue claims against the Company for alleged violations of federal and state antitrust and consumer protection laws relating to generic drug pricing. The Company believes it has substantial meritorious defenses to the claims asserted with respect to the litigation. However, any adverse outcome could negatively affect the Company and could have a material adverse effect on the Company's results of operations, cash flows and/or overall financial condition. Prescription Opioid Litigation The Company and certain of its affiliates have been named as defendants in various matters relating to the promotion and sale of prescription opioid pain relievers. The Company is aware that other individuals and states and political subdivisions are filing comparable actions against, among others, manufacturers and parties that have promoted and sold prescription opioid pain relievers, and additional suits may be filed. The complaints, asserting claims under provisions of different state and Federal law, generally contend that the defendants allegedly engaged in improper marketing of opioids, and seek a variety of remedies, including restitution, civil penalties, disgorgement of profits, treble damages, attorneys’ fees and injunctive relief. None of the complaints specifies the exact amount of damages at issue. The Company and its affiliates that are defendants in the various lawsuits deny all allegations asserted in these complaints and have filed or intend to file motions to dismiss where possible. Each of the opioid-related matters described below is in its early stages. The Company intends to continue to vigorously defend these cases. In light of the inherent uncertainties of civil litigation, the Company is not in a position to predict the likelihood of an unfavorable outcome or provide an estimate of the amount or range of potential loss in the event of an unfavorable outcome in any of these matters. On August 17, 2017, plaintiff Linda Hughes, as the mother of Nathan Hughes, decedent, filed a complaint in Missouri state court naming Amneal Pharmaceuticals of New York LLC, Impax, five other pharmaceutical company defendants, and three healthcare provider defendants. Plaintiff alleges that use of defendants’ opioid medications caused the death of her son, Nathan Hughes. The complaint alleges causes of action against Amneal and Impax for strict product liability, negligent product liability, violation of Missouri Merchandising Practices Act and fraudulent misrepresentation. The case was removed to federal court on September 18, 2017. It was transferred to the United States District Court for the Northern District of Ohio on February 2, 2018 and is part of the multidistrict litigation pending as In Re National Prescription Opiate Litigation, MDL No. 2804 (the “MDL”). Plaintiff has filed a motion to remand the case to Missouri state court. That motion remains pending before the MDL court. All activity in the case is stayed by order of the MDL court. On March 15, 2018, plaintiff Scott Ellington, purporting to represent the State of Arkansas, more than sixty counties and a dozen cities, filed a complaint in Arkansas state court naming Gemini Laboratories, LLC and fifty-one other pharmaceutical companies as defendants. Plaintiffs allege that Gemini and the other pharmaceutical company defendants improperly marketed, sold, and distributed opioid medications and failed to adequately warn about the risks of those medications. Plaintiffs allege causes of actions against Gemini and the other pharmaceutical company defendants for negligence and nuisance and alleged violations of multiple Arkansas statutes. Plaintiffs request past damages and restitution for monies allegedly spent by the State of Arkansas and the county and city plaintiffs for “extraordinary and additional services” for responding to what plaintiffs term the “Arkansas Opioid Epidemic.” Plaintiffs also seek prospective damages to allow them to “comprehensively intervene in the Arkansas Opioid Epidemic,” punitive and treble damages as provided by law, and their costs and fees. The complaint does not include any specific damage amounts. Gemini filed a general denial and, on June 28, 2018, it joined the other pharmaceutical company defendants in moving to dismiss plaintiffs’ complaint. On January 29, 2019, the Court granted without prejudice Gemini’s motion to dismiss and dismissed Gemini from the litigation on March 22, 2019. On March 27, 2018, plaintiff American Resources Insurance Company, Inc. filed a complaint in the United States District Court for the Southern District of Alabama against Amneal Pharmaceuticals of New York, LLC, Amneal Pharmaceuticals LLC, Impax, the Impax Generics Division, and thirty-five other pharmaceutical company defendants. Plaintiff seeks certification of a class of insurers that since January 1, 2010, allegedly have been wrongfully required to: (i) reimburse for prescription opioids that allegedly were promoted, sold, and distributed illegally and improperly by the pharmaceutical company defendants; and (ii) incur costs for treatment of overdoses of opioid medications, misuse of those medications, or addiction to them. The complaint seeks compensatory and punitive damages, but plaintiff’s complaint does not include any allegation of specific damage amounts. On or about May 2, 2018, the case was transferred to the MDL. All activity in the case is stayed by order of the MDL court. On May 30, 2018, plaintiff William J. Comstock filed a complaint in Washington state court against Amneal Pharmaceuticals of New York, LLC, and four other pharmaceutical company defendants. Plaintiff alleges he became addicted to opioid medications manufactured and sold by the pharmaceutical company defendants, which plaintiff contends caused him to experience opioid-induced psychosis, prolonged hospitalizations, pain, and suffering. Plaintiff asserts causes of action against Amneal and the other pharmaceutical company defendants for negligence, fraudulent misrepresentation, and violations of the Washington Consumer Protection Act. On July 12, 2018, Amneal and other defendants removed the case to the United States District Court for the Eastern District of Washington. On August 17, 2018, the case was transferred to the MDL. All activity in the case is stayed by order of the MDL court. On June 18, 2018, a Subpoena and CID issued by the Office of the Attorney General of Kentucky, Office of Consumer Protection was served on Amneal. The CID contains eleven requests for production of documents pertaining to opioid medications manufactured and/or sold by Amneal, or for which Amneal holds an Abbreviated New Drug Application. The Company is evaluating the CID and has been in communication with the Office of the Attorney General about the scope of the CID, the response to the CID, and the timing of the response. It is unknown if the Office of the Attorney General will pursue any claim or file a lawsuit against Amneal. On July 9, 2018, the Muscogee (Creek) Nation filed a First Amended Complaint in its case pending in the MDL against the Company and 55 other defendants consisting of pharmaceutical companies, wholesalers, distributors, and pharmacies. Plaintiff alleges it has been damaged by the Company and the other pharmaceutical company defendants as a result of alleged improper marketing, including off-label marketing, failure to adequately warn of the risks of opioid medications, and failure to properly monitor and control diversion of opioid medications within the Nation. The case has been designated as a bellwether motion to dismiss case for the MDL, meaning it is a test case for arguments directed at the complaints filed by Indian tribes in the MDL cases. On August 31, 2018, the Company moved to dismiss the First Amended Complaint, and also joined in separate motions to dismiss filed by differen |
Segment Information
Segment Information | 3 Months Ended |
Mar. 31, 2019 | |
Segment Reporting [Abstract] | |
Segment Information | Segment Information The Company has two reportable segments, the Generics segment and the Specialty segment. Generics develops, manufactures and commercializes complex oral solids, injectables, ophthalmics, liquids, topicals, softgels, inhalation products and transdermals across a broad range of therapeutic categories. The Company's retail and institutional portfolio contains approximately 200 product families, many of which represent difficult-to-manufacture products or products that have a high barrier-to-entry, such as oncologics, anti-infectives and supportive care products for healthcare providers. Specialty delivers proprietary medicines to the U.S. market. The Company offers a growing portfolio in core therapeutic categories including central nervous system disorders, endocrinology, parasitic infections and other therapeutic areas. Our specialty products are marketed through skilled specialty sales and marketing teams, who call on neurologists, movement disorder specialists, endocrinologists and primary care physicians in key markets throughout the U.S. Specialty also has a number of product candidates that are in varying stages of development. The Company’s chief operating decision maker evaluates the financial performance of the Company’s segments based upon segment operating income (loss). Items below income (loss) from operations are not reported by segment, since they are excluded from the measure of segment profitability reviewed by the Company’s chief operating decision maker. Additionally, general and administrative expenses, certain selling expenses, certain litigation settlements, and non-operating income and expenses are included in "Corporate and Other." The Company does not report balance sheet information by segment since it is not reviewed by the Company’s chief operating decision maker. The tables below present segment information reconciled to total Company financial results, with segment operating income or loss including gross profit less direct selling expenses, research and development expenses, and other operating expenses to the extent specifically identified by segment (in thousands): Three Months Ended March 31, 2019 Generics Specialty Corporate Total Net revenue $ 382,477 $ 63,643 $ — $ 446,120 Cost of goods sold 278,878 30,865 — 309,743 Cost of goods sold impairment charges 53,297 — — 53,297 Gross profit 50,302 32,778 — 83,080 Selling, general and administrative 24,148 21,327 38,961 84,436 Research and development 50,151 3,707 — 53,858 In-process research and development impairment charges 22,787 — — 22,787 Intellectual property legal development expenses 3,121 1,045 — 4,166 Other operating expenses 4,678 2,062 5,453 12,193 Operating (loss) income $ (54,583 ) $ 4,637 $ (44,414 ) $ (94,360 ) Three Months Ended March 31, 2018 Generics Specialty Corporate Total Net revenue $ 275,189 $ — $ — $ 275,189 Cost of goods sold 130,594 — — 130,594 Gross profit 144,595 — — 144,595 Selling, general and administrative 11,203 — 13,918 25,121 Research and development 44,209 — — 44,209 Intellectual property legal development expenses 4,576 — — 4,576 Other operating expenses — — 7,135 7,135 Operating income (loss) $ 84,607 $ — $ (21,053 ) $ 63,554 |
Related Party Transactions
Related Party Transactions | 3 Months Ended |
Mar. 31, 2019 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Related Party Transactions The Company has various business agreements with certain third-party companies in which there is some common ownership and/or management between those entities, on the one hand, and the Company, on the other hand. The Company has no direct ownership or management in any of such related party companies. The related party relationships that generated income and/ or expense in the respective reporting periods are described below. Financing Lease/Financing Obligation - Related Party The Company has a financing lease for two buildings located in Long Island, New York, that are used as an integrated manufacturing and office facility. For annual payments required under the terms of the non-cancelable lease agreement over the next five years and thereafter, refer to Note 11. Leases . Kanan, LLC Kanan, LLC ("Kanan") is an independent real estate company which owns Amneal’s manufacturing facilities located at 65 Readington Road, Branchburg, New Jersey, 131 Chambers Brook Road, Branchburg, New Jersey and 1 New England Avenue, Piscataway, New Jersey. Amneal leases these facilities from Kanan under two separate triple-net lease agreements that expire in 2027 and 2031, respectively, at an annual rental cost of approximately $2 million combined, subject to CPI rent escalation adjustments as provided in the lease agreements. Rent expense paid to the related party for both of the three months ended March 31, 2019 and 2018 was $0.5 million . Asana Biosciences, LLC Asana Biosciences, LLC (“Asana”) is an early stage drug discovery and research and development company focusing on several therapeutic areas, including oncology, pain and inflammation. Amneal provided research and development services to Asana under a development and manufacturing agreement. The total amount of income earned from this arrangement for the three months ended March 31, 2019 was $0.3 million ( no ne in 2018). Industrial Real Estate Holdings NY, LLC Industrial Real Estate Holdings NY, LLC ("IRE") is an independent real estate management entity which, among other activities, is the landlord of Amneal’s leased manufacturing facility located at 75 Adams Avenue, Hauppauge, New York. The lease expires in March 2021. Rent expense paid to the related party for both the three months ended March 31, 2019 and 2018 was $0.3 million . Kashiv BioSciences LLC Kashiv BioSciences, LLC ("Kashiv") is an independent contract development organization focused primarily on the development of 505(b) (2) NDA products. Amneal has various business agreements with Kashiv. In May 2013, Amneal entered into a sublease agreement with Kashiv for a portion of one of its research and development facilities. The sublease automatically renews annually if not terminated and has an annual base rent of $2 million . On January 15, 2018, Amneal and Kashiv entered into an Assignment and Assumption of Lease Agreement. The lease was assigned to Kashiv, and Amneal was relieved of all obligations. Rental income from the related party sublease for the three months ending March 31, 2018 was $0.4 million ( no ne in 2019). Amneal has also entered into various development and commercialization arrangements with Kashiv to collaborate on the development and commercialization of certain generic pharmaceutical products. The total reimbursable expenses associated with these arrangements for the period ended March 31, 2019 was $0.8 million ( no ne in 2018). Kashiv receives a percentage of net profits with respect to Amneal’s sales of these products. The total profit share paid to Kashiv for the three months ended March 31, 2019 and 2018 was $0.7 million and $0.4 million , respectively. At March 31, 2019 and December 31, 2018 payables of approximately $1 million and $0.8 million , respectively, were due to the related party for royalty-related transactions. In June 2017, Amneal and Kashiv entered a product acquisition and royalty stream purchase agreement. The aggregate purchase price was $25 million on the closing, which has been paid, plus two potential future $5 million earn outs related to the Estradiol Product. The contingent earn outs were to be recorded in the period in which they are earned. The first and second $5 million earn outs were recognized in March 2018 and June 2018, respectively, as an increase to the cost of the Estradiol product intangible asset and will be amortized on a straight-line basis over the remaining life of the Estradiol intangible asset. The first earn out was paid in July 2018 and the second earn out was paid in September 2018. Pursuant to a product development agreement, Amneal and Kashiv agreed to collaborate on the development and commercialization of Oxycodone HCI ER Oral Tablets. Under the agreement, this product is owned by Kashiv, with Amneal acting as the exclusive marketing partner and as Kashiv’s agent for filing the product ANDA. Under the agreement, Amneal was also responsible for assuming control of and managing all aspects of the patent litigation arising from the filing of the ANDA, including selecting counsel and settling such proceeding (subject to Kashiv’s consent). In December 2017, Amneal and Kashiv terminated the product development agreement and pursuant to the termination and settlement of the agreement, Kashiv agreed to pay Amneal $8 million , an amount equal to the legal costs incurred by Amneal related to the defense of the ANDA. The cash payment was received in February 2018. Adello Biologics, LLC Adello is an independent clinical stage company engaged in the development of biosimilar pharmaceutical products. Amneal and Adello are parties to a master services agreement pursuant to which, from time to time, Amneal provides human resources and product quality assurance services on behalf of Adello. The parties are also party to a license agreement for parking spaces in Piscataway, NJ. The total amount of net expense paid to Adello from these agreements for the three months ended and March 31, 2018 was $0.1 million ( no ne in 2019). In March 2017, Amneal entered into a product development agreement with Adello. The collaboration extended the remaining development process to Adello for a complex generic product, while Amneal retained its commercial rights upon approval. Pursuant to the agreement, Adello paid Amneal $10 million for reimbursement of past development costs, which Amneal deferred as a liability and will pay royalties upon commercialization. In October 2017, Amneal and Adello terminated their product development agreement pursuant to which Amneal and Adello had been collaborating to develop and commercialize Glatiramer Acetate products. Pursuant to the termination agreement, Amneal owed Adello $11 million for the up-front payment plus interest. This amount was paid in January 2018. On October 1, 2017, Amneal and Adello entered into a license and commercialization agreement pursuant to which the parties have agreed to cooperate with respect to certain development activities in connection with two biologic pharmaceutical products. In addition, under the agreement, Adello has appointed Amneal as its exclusive marketing partner for such products in the United States. In connection with the agreement, Amneal paid an upfront amount of $2 million in October 2017 which was recorded within research and development expenses. The agreement also provides for potential future milestone payments to Adello. In October 2017, Amneal purchased a building from Adello in Ireland to further support its inhalation dosage form. Amneal issued a promissory note for 13 million euros ( $15 million based on exchange rate as of December 31, 2017 ) which accrues interest at a rate of 2% per annum, due on or before July 1, 2019. The promissory note was paid in full in the second quarter of 2018. PharmaSophia, LLC PharmaSophia, LLC ("PharmaSophia") is a joint venture formed by Nava Pharma, LLC ("Nava") and Oakwood Laboratories, LLC for the purpose of developing certain products. Currently PharmaSophia is actively developing two injectable products. PharmaSophia and Nava are parties to a research and development agreement pursuant to which Nava provides research and development services to PharmaSophia. Nava subcontracted this obligation to Amneal, entering into a subcontract research and development services agreement pursuant to which Amneal provides research and development services to Nava in connection with the products being developed by PharmaSophia. The total amount of income earned from these agreements for the three months ended March 31, 2019 and 2018 was $0.3 million and $0.1 million , respectively. At March 31, 2019 and December 31, 2018 receivables of $0.4 million and $0.1 million , respectively, were due from the related party. Gemini Laboratories, LLC Prior to the Company's acquisition of Gemini in May 2018, Amneal and Gemini were parties to various agreements. Total gross profit earned from the sale of inventory to Gemini for the three months ended March 31, 2018 was $0.1 million . The total profit share paid by Gemini for the three months ended March 31, 2018 was $4 million . Tax Distributions Under the terms of the Limited Liability Company Agreement, Amneal is obligated to make tax distributions to its members, which are also holders of non-controlling interests in the Company. For further details, refer to Note 19. Stockholders' Equity/ Members' Deficit contained in the Company's 2018 Annual Report on Form 10-K. Non-Controlling Interests During December 2018, the Company acquired the non-controlling interests in one of Amneal's non-public subsidiaries for approximately $3 million . As of December 31, 2018 , the Company recorded a $3 million related party payable for this transaction of which $1 million remained outstanding as of March 31, 2019 . |
Goodwill and Intangible Assets
Goodwill and Intangible Assets | 3 Months Ended |
Mar. 31, 2019 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Goodwill and Intangible Assets | Goodwill and Intangible Assets The changes in goodwill for the three months ended March 31, 2019 and for the year ended December 31, 2018 were as follows (in thousands): March 31, 2019 December 31, 2018 Balance, beginning of period $ 426,226 $ 26,444 Goodwill acquired during the period — 401,488 Goodwill divested during the period (4,697 ) — Currency translation 111 (1,706 ) Balance, end of period $ 421,640 $ 426,226 As of March 31, 2019 , $360 million and $61 million of goodwill was allocated to the Specialty and Generics segment, respectively. As of December 31, 2018 , $360 million and $66 million of goodwill was allocated to the Specialty and Generics segment, respectively. For the three months ended March 31, 2019 , goodwill divested was associated with the sale of the Company's operations in the United Kingdom. For the year ended December 31, 2018 , goodwill acquired was associated with the Impax and Gemini acquisitions. Refer to Note 3. Acquisitions and Divestitures for additional information about the acquisition of Impax and the divestiture of the Company's operations in the United Kingdom. Intangible assets at March 31, 2019 and December 31, 2018 are comprised of the following (in thousands): March 31, 2019 December 31, 2018 Weighted-Average Amortization Period (in years) Cost Accumulated Amortization Net Cost Accumulated Amortization Net Amortizing intangible assets: Product rights 11.9 $ 1,269,576 $ (109,732 ) $ 1,159,844 $ 1,282,011 $ (88,081 ) $ 1,193,930 Customer relationships — — — 7,005 (1,955 ) 5,050 Other intangible assets 10.7 3,072 (901 ) 2,171 5,620 (1,561 ) 4,059 Total $ 1,272,648 $ (110,633 ) $ 1,162,015 $ 1,294,636 $ (91,597 ) $ 1,203,039 In-process research and development 429,143 — 429,143 451,930 — 451,930 Total intangible assets $ 1,701,791 $ (110,633 ) $ 1,591,158 $ 1,746,566 $ (91,597 ) $ 1,654,969 The Company evaluated assets for potential impairment by comparing estimated future undiscounted net cash flows to the carrying amount of the asset. For the three months ended March 31, 2019 , the Company recognized a total of $76 million of intangible asset impairment charges, of which $53 million was recognized in cost of goods sold and $23 million was recognized in research and development expense. The impairment charges primarily related to four products, two of which are currently marketed products and two of which are IPR&D products, all acquired as part of the Combination. For the currently marketed products, the impairment charges were the result of significant price erosion during the first quarter of 2019, without an offsetting increase in customer demand, resulting in significantly lower than expected future cash flows. For one IPR&D product, the impairment charge was the result of increased competition at launch resulting in significantly lower than expected future cash flows. For the other IPR&D product, the impairment charge was the result of a strategic decision to no longer pursue approval of the product. During the three months ended March 31, 2019 , the Company recognized a $50 million product rights intangible asset and a corresponding liability for the exclusive rights to sell Levothyroxine in the U.S. market under a license and supply agreement with JSP. Refer to Note 5. Alliance and Collaboration for additional information. For the three months ended March 31, 2019 , included in the Company's divested United Kingdom operations were a net customer relationship intangible asset and a net trade name intangible asset of $5 million and $2 million , respectively. Refer to Note 3. Acquisitions and Divestitures for additional information. Amortization expense related to intangible assets recognized is as follows (in thousands): Three Months 2019 2018 Amortization $ 30,963 $ 1,760 The following table presents future amortization expense for the next five years and thereafter, excluding $429 million of IPR&D intangible assets (in thousands): Future Amortization Remainder of 2019 $ 90,200 2020 136,898 2021 153,738 2022 152,413 2023 128,244 2024 120,244 Thereafter 380,278 Total $ 1,162,015 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
Use of Estimates | Use of Estimates The preparation of financial statements, which are prepared in accordance with generally accepted accounting principles in the United States, requires the Company's management to make estimates and assumptions that affect the reported financial position at the date of the financial statements and the reported results of operations during the reporting period. Such estimates and assumptions affect the reported amounts of assets, liabilities, revenues and expenses, and disclosure of contingent assets and liabilities in the consolidated financial statements and accompanying notes. The following are some, but not all, of such estimates: the determination of chargebacks, sales returns, rebates, bill backs, allowances for accounts receivable, accrued liabilities, stock-based compensation, valuation of inventory balances, the determination of useful lives for product rights, allowances for deferred tax assets and the assessment of expected cash flows used in evaluating goodwill and other long-lived assets for impairment. Actual results could differ from those estimates. |
Recently Adopted and Recently Issued Accounting Pronouncements | Recently Adopted Accounting Pronouncements Leases In February 2016, the Financial Accounting Standards Board ("FASB") issued ASU 2016-02, Leases, which was subsequently supplemented by clarifying guidance (collectively, "Topic 842") to improve financial reporting of leasing transactions. Topic 842 requires a lessee to recognize most leases, including those classified as operating, on its balance sheets as right of use ("ROU") assets and lease liabilities and requires disclose of additional key information about leases. The Company elected to apply the modified retrospective transition provisions of Topic 842 on January 1, 2019, the date of adoption. In addition, the Company elected the package of practical expedients permitted under the transition guidance within the new standard. This allowed the Company to carry forward historical lease classifications. Adoption of this standard resulted in the recording of operating lease ROU assets and operating lease liabilities of $85 million and $86 million , respectively. The transition guidance of Topic 842 also required the Company to de-recognize the build to suit accounting associated with a related party lease for integrated manufacturing and office space and recognize that transaction as a financing lease as of January 1, 2019. The resulting de-recognition reduced leasehold improvements and a financing obligation by $24 million and $39 million , respectively, and increased non-controlling interests and stockholders' accumulated deficit, net of income taxes, by $9 million and $5 million , respectively. The arrangement was then recognized as a financing lease with an ROU asset and lease liability of $64 million on January 1, 2019. Leases with related parties, the details of which are described in Note 15. Related Party Transactions, are presented separately in the Company's balance sheets. The adoption of Topic 842 did not have a material impact on the Company's consolidated statements of operations. ROU assets and lease liabilities for reporting periods beginning on or after January 1, 2019 are presented under the new guidance, while prior periods amounts were not adjusted and continue to be reported in accordance with previous guidance. All significant lease arrangements after January 1, 2019 are recognized as ROU assets and lease liabilities at lease commencement. ROU assets represent the Company's right to use an underlying asset for the lease term and lease liabilities represent its obligation to make lease payments arising from the lease. ROU assets and liabilities are recognized at the commencement date based on the present value of the future lease payments using the Company's incremental borrowing rate, which is updated quarterly. Operating lease expense is recognized on a straight-line basis over the lease term. At each balance sheet date, operating and financing lease liabilities continue to represent the present value of the future payments. Financing lease ROU assets are expensed using the straight-line method, unless another basis is more representative of the pattern of economic benefit, to lease expense. Interest on financing lease liabilities is recognized in interest expense. Leases with an initial term of 12 months or less (short-term leases) are not recognized in the balance sheet and the related lease payments are recognized as incurred over the lease term. The Company separates lease and non-lease components. A portion of the Company's real estate leases are subject to periodic changes in the Consumer Price Index ("CPI"). The changes to the CPI are treated as variable lease payments and recognized in the period in which the obligation for those payments was incurred. For further details regarding the Company's leases, refer to Note 11. Leases . Financial Instruments In January 2016, the FASB issued ASU 2016-01, Financial Instruments—Overall (Subtopic 825-10), Recognition and Measurement of Financial Assets and Financial Liabilities , which addresses certain aspects of recognition, measurement, presentation, and disclosure of financial instruments. The Company adopted ASU 2016-01 as of January 1, 2019 and it did not have a material impact on the Company's consolidated financial statements. Recently Issued Accounting Pronouncements In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 82): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement, which modifies the disclosure requirements on fair value measurement. The guidance is effective for annual periods beginning after December 15, 2019 and interim periods within those annual periods, and early adoption is permitted. The Company is evaluating the impact of this new guidance on its consolidated financial statements. In January 2017, the FASB issued ASU 2017-04, Intangibles—Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment that eliminates the requirement to calculate the implied fair value of goodwill (i.e., Step 2 of today’s goodwill impairment test) to measure a goodwill impairment charge. Instead, entities will record an impairment charge based on the excess of a reporting unit’s carrying amount over its fair value (i.e., measure the charge based on today’s Step 1). The standard will be applied prospectively and is effective for the Company’s annual and interim impairment tests performed in periods beginning after December 15, 2019. Early adoption is permitted for annual and interim goodwill impairment testing dates after January 1, 2017. The Company is evaluating the impact of this new guidance on its consolidated financial statements. In June 2016, the FASB issued ASU 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments , guidance that changes the impairment model for most financial assets including trade receivables and certain other instruments that are not measured at fair value through net income. The standard will replace today’s "incurred loss" approach with an "expected loss" model for instruments measured at amortized cost and require entities to record allowances for available-for-sale debt securities rather than reduce the carrying amount, as they do today under the other-than-temporary impairment model. It also simplifies the accounting model for purchased credit-impaired debt securities and loans. Entities will apply the standard’s provisions as a cumulative effect adjustment to retained earnings as of the beginning of the first reporting period in which the guidance is effective. The guidance is effective for the Company for the annual period beginning after December 15, 2019. The Company is evaluating the impact of this new guidance on its consolidated financial statements. |
Revenue Recognition | Revenue Recognition Performance Obligations The Company’s performance obligation is the supply of finished pharmaceutical products to its customers. The Company’s customers consist primarily of major wholesalers, retail pharmacies, managed care organizations, purchasing co-ops, hospitals, government agencies and pharmaceutical companies. The Company’s customer contracts generally consist of both a master agreement, which is signed by the Company and its customer, and a customer submitted purchase order, which is governed by the terms and conditions of the master agreement. Customers purchase product by direct channel sales from the Company or by indirect channel sales through various distribution channels. Revenue is recognized when the Company transfers control of its products to the customer, which typically occurs at a point-in-time, upon delivery. Substantially all of the Company’s net revenues relate to products which are transferred to the customer at a point-in-time. The Company offers standard payment terms to its customers and has elected the practical expedient to not adjust the promised amount of consideration for the effects of a significant financing, since the period between when the Company transfers the product to the customer and when the customer pays for that product is one year or less. Taxes collected from customers relating to product sales and remitted to governmental authorities are excluded from revenues. The consideration amounts due from customers as a result of product sales are subject to variable consideration, as described further below. The Company offers standard product warranties which provide assurance that the product will function as expected and in accordance with specifications. Customers cannot purchase warranties separately and these warranties do not give rise to a separate performance obligation. The Company permits the return of product under certain circumstances, mainly upon product expiration, instances of shipping errors or where product is damaged in transit. The Company accrues for the customer’s right to return as part of its variable consideration. See below for further details. Variable Consideration The Company includes an estimate of variable consideration in its transaction price at the time of sale, when control of the product transfers to the customer. Variable consideration includes but is not limited to: chargebacks, rebates, group purchasing organization ("GPO") fees, prompt payment (cash) discounts, consideration payable to the customer, billbacks, Medicaid and other government pricing programs, price protection and shelf stock adjustments, sales returns, and profit shares. The Company assesses whether or not an estimate of its variable consideration is constrained and has determined that the constraint does not apply, since it is probable that a significant reversal in the amount of cumulative revenue will not occur in the future when the uncertainty associated with the variable consideration is subsequently resolved. The Company’s estimates for variable consideration are adjusted as required at each reporting period for specific known developments that may result in a change in the amount of total consideration it expects to receive. Chargebacks In the case an indirect customer purchases product from their preferred wholesaler instead of directly from the Company, and the contract price charged to the indirect customer is lower than the wholesaler pricing, the Company pays the direct customer (wholesaler) a chargeback for the price differential. The Company estimates its chargeback accrual based on its estimates of the level of inventory of its products in the distribution channel that remain subject to chargebacks and historical chargeback rates. The estimate of the level of products in the distribution channel is based primarily on data provided by key customers. Rebates The Company pays fixed or volume-based rebates to its customers based on a fixed amount, fixed percentage of product sales or based on the achievement of a specified level of purchases. The Company’s rebate accruals are based on actual net sales, contractual rebate rates negotiated with customers, and expected purchase volumes / corresponding tiers based on actual sales to date and forecasted amounts. Group Purchasing Organization Fees The Company pays fees to GPOs for administrative services that the GPOs perform in connection with the purchases of product by the GPO participants who are the Company’s customers. The Company’s GPO fee accruals are based on actual net sales, contractual fee rates negotiated with GPOs and the mix of the products in the distribution channel that remain subject to GPO fees. Prompt Payment (Cash) Discounts The Company provides customers with prompt payment discounts which may result in adjustments to the price that is invoiced for the product transferred, in the case that payments are made within a defined period. The Company’s prompt payment discount accruals are based on actual net sales and contractual discount rates. Consideration Payable to the Customer The Company pays administrative and service fees to its customers based on a fixed percentage of the product price. These fees are not in exchange for a distinct good or service and therefore are recognized as a reduction of the transaction price. The Company accrues for these fees based on actual net sales, contractual fee rates negotiated with the customer and the mix of the products in the distribution channel that remain subject to fees. Billbacks In the case an indirect customer purchases product from their preferred wholesaler instead of directly from the Company, and the contract price charged to the indirect customer is higher than contractual pricing, the Company pays the indirect customer a billback for the price differential. The Company estimates its billback accrual based on its estimates of the level of inventory of its products in the distribution channel that remain subject to billbacks and historical billback rates. The estimate of the level of products in the distribution channel is based primarily on data provided by key customers. Medicaid and Other Government Pricing Programs The Company complies with required rebates mandated by law under Medicaid and other government pricing programs. The Company estimates its government pricing accruals based on monthly sales, historical experience of claims submitted by the various states and jurisdictions, historical rates and estimated lag time of the rebate invoices. Price Protection and Shelf Stock Adjustments The Company provides customers with price protection and shelf stock adjustments which may result in an adjustment to the price charged for the product transferred, based on differences between old and new prices which may be applied to the customer’s on-hand inventory at the time of the price change. The Company accrues for these adjustments when its expected value of an adjustment is greater than zero, based on contractual pricing, actual net sales, accrual rates based on historical average rates, and estimates of the level of inventory of its products in the distribution channel that remain subject to these adjustments. The estimate of the level of products in the distribution channel is based primarily on data provided by key customers. Sales Returns The Company permits the return of product under certain circumstances, mainly upon product expiration, instances of shipping errors or where product is damaged in transit, and occurrences of product recalls. The Company’s product returns accrual is primarily based on estimates of future product returns based generally on actual net sales, estimates of the level of inventory of its products in the distribution channel that remain subject to returns, estimated lag time of returns and historical return rates. The estimate of the level of products in the distribution channel is based primarily on data provided by key customers. Profit Shares For certain product sale arrangements, the Company earns a profit share upon the customer’s sell-through of the product purchased from the Company. The Company estimates its profit shares based on actual net sales, estimates of the level of inventory of its products in the distribution channel that remain subject to profit shares, and historical rates of profit shares earned. The estimate of the level of products in the distribution channel is based primarily on data provided by key customers. |
Acquisitions and Divestitures (
Acquisitions and Divestitures (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Business Combinations [Abstract] | |
Schedule of Purchase Price, Net of Cash Acquired | The purchase price, net of cash acquired, is calculated as follows (in thousands, except share amount and price per share): Fully diluted Impax share number (1) 73,288,792 Closing quoted market price of an Impax common share on May 4, 2018 $ 18.30 Equity consideration - subtotal $ 1,341,185 Add: Fair value of Impax stock options as of May 4, 2018 (2) 22,610 Total equity consideration 1,363,795 Add: Extinguishment of certain Impax obligations, including accrued and unpaid interest 320,290 Less: Cash acquired (37,907 ) Purchase price, net of cash acquired $ 1,646,178 (1) Represents shares of Impax Common Stock issued and outstanding immediately prior to the Combination. (2) Represents the fair value of 3.0 million fully vested Impax stock options valued using the Black-Scholes options pricing model. |
Schedule of Purchase Price Allocation | The following is a summary of the preliminary purchase price allocation for the Impax acquisition (in thousands): Preliminary Fair Values Trade accounts receivable, net $ 211,762 Inventories 183,088 Prepaid expenses and other current assets 91,430 Property, plant and equipment 87,472 Goodwill 399,988 Intangible assets 1,574,929 Other 55,790 Total assets acquired 2,604,459 Accounts payable 47,912 Accrued expenses and other current liabilities 277,176 Long-term debt 599,400 Other long-term liabilities 33,793 Total liabilities assumed 958,281 Net assets acquired $ 1,646,178 |
Schedule of Acquired Intangible Assets | The acquired intangible assets are being amortized over their estimated useful lives as follows (in thousands): Preliminary Fair Values Weighted-Average Useful Life (Years) Marketed product rights $ 1,045,617 12.9 |
Schedule of Business Acquisition Pro Forma Data | The unaudited pro forma combined results of operations for the three months ended March 31, 2018 (assuming the closing of the Combination occurred on January 1, 2017) are as follows (in thousands): Three Months Ended March 31, 2018 Net revenue $ 417,544 Net loss (74,077 ) Net loss attributable to Amneal Pharmaceuticals, Inc. $ (8,595 ) |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Revenue from Contract with Customer [Abstract] | |
Schedules of Concentration of Risk | The Company's significant product families, as determined based on net revenue, and their percentage of the Company's consolidated net revenue for each of the three months ended March 31, 2019 and 2018 are set forth below (in thousands, except for percentages): Segment Product Family Three Months Ended March 31, 2019 $ % Generics Levothyroxine Sodium $ 48,994 11% Specialty Rytary® family 28,828 6% Generics Diclofenac Sodium Gel 23,467 5% Generics Yuvafem-Estradiol 18,739 4% Generics Epinephrine Auto-Injector family (generic Adrenaclick®) $ 15,195 3% Segment Product Family Three Months Ended March 31, 2018 $ % Generics Oseltamivir $ 42,567 15% Generics Yuvafem-Estradiol 19,267 7% Generics Diclofenac Sodium Gel 20,276 7% Generics Aspirin; Dipyridamole ER Capsul 17,022 6% Generics Atovaquone $ 8,334 3% |
Schedule of Major Categories of Sales-Related Deductions | A rollforward of the major categories of sales-related deductions for the three months ended March 31, 2019 is as follows (in thousands): Contract Charge-backs and Sales Volume Allowances Cash Discount Allowances Accrued Returns Allowance Accrued Medicaid and Commercial Rebates Balance at December 31, 2018 $ 829,596 $ 36,157 $ 154,503 $ 74,202 Provision related to sales recorded in the period 1,105,531 35,172 17,125 36,105 Credits/payments issued during the period (1,191,605 ) (19,440 ) (25,588 ) (28,565 ) Balance at March 31, 2019 $ 743,522 $ 51,889 $ 146,040 $ 81,742 |
Restructuring and Other Charg_2
Restructuring and Other Charges (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Restructuring and Related Activities [Abstract] | |
Restructuring and Related Costs | The following table sets forth the components of the Company's restructuring and other charges (in thousands): Three Months Ended March 31, 2019 Employee restructuring separation charges (1) $ 2,318 Other employee severance charges 3,843 Total restructuring and other charges $ 6,161 (1) Employee restructuring separation charges include the cost of benefits provided pursuant to the Company's severance programs for employees impacted by the Plan at the Company's Hayward, CA facility and other facilities. The charges related to restructuring impacted segment earnings as follo |
Schedule of Restructuring Reserve | The following table shows the change in the employee separation-related liability associated with the Company's restructuring programs, which is included in accounts payable and accrued expenses (in thousands): Employee Restructuring Balance at December 31, 2018 $ 22,112 Charges to income 2,318 Payments (12,069 ) Balance at March 31, 2019 $ 12,361 |
Loss per Share (Tables)
Loss per Share (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Earnings Per Share [Abstract] | |
Schedule of Earnings Per Share, Basic and Diluted | The following table sets forth reconciliations of the numerators and denominators used to compute basic and diluted loss per share of Class A Common Stock and Class B-1 Common Stock (in thousands, except per share amounts): Three Months Ended March 31, 2019 Numerator: Net loss attributable to Amneal Pharmaceuticals, Inc. $ (47,881 ) Denominator: Weighted-average shares of Class A Common Stock and Class B-1 Common Stock outstanding - basic and diluted 127,687 Net loss per share attributable to Amneal Pharmaceuticals, Inc.'s common stockholders: Class A and Class B-1 basic and diluted $ (0.37 ) |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | The following table presents potentially dilutive securities excluded from the computations of diluted earnings per share of Class A Common Stock and Class B-1 Common Stock (in thousands): Three Months Ended March 31, 2019 Stock options (1) 8,400 Restricted stock units (1) 3,282 Performance stock units (1) 520 Shares of Class B Common Stock (2) 171,041 (1) Excluded from the computation of diluted loss per share of Class A Common Stock and Class B-1 Common Stock because the effect of their inclusion would have been anti-dilutive since there was a net loss attributable to the Company for the three months ended March 31, 2019 . (2) Shares of Class B Common Stock are considered potentially dilutive shares of Class A Common Stock and Class B-1 Common Stock. Shares of Class B Common Stock have been excluded from the computations of diluted earnings per share of Class A Common Stock and Class B-1 Common Stock because the effect of their inclusion would have been anti-dilutive under the if-converted method. |
Trade Accounts Receivable, Net
Trade Accounts Receivable, Net (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Receivables [Abstract] | |
Schedule of Trade Accounts Receivable, Net | Trade accounts receivable, net is comprised of the following (in thousands): March 31, 2019 December 31, 2018 Gross accounts receivable $ 1,438,296 $ 1,349,588 Allowance for doubtful accounts (2,673 ) (2,340 ) Contract charge-backs and sales volume allowances (743,522 ) (829,596 ) Cash discount allowances (51,889 ) (36,157 ) Subtotal (798,084 ) (868,093 ) Trade accounts receivable, net $ 640,212 $ 481,495 |
Inventories (Tables)
Inventories (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory, Current | Inventories, net of reserves, are comprised of the following (in thousands): March 31, 2019 December 31, 2018 Raw materials $ 182,590 $ 181,654 Work in process 57,729 54,152 Finished goods 207,975 221,413 Total inventories $ 448,294 $ 457,219 |
Schedule of Inventory, Noncurrent | Inventories, net of reserves, are comprised of the following (in thousands): March 31, 2019 December 31, 2018 Raw materials $ 182,590 $ 181,654 Work in process 57,729 54,152 Finished goods 207,975 221,413 Total inventories $ 448,294 $ 457,219 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Leases [Abstract] | |
Schedule of Components of Lease Costs / Supplemental Cash Flow Information | The components of total lease costs were as follows (in thousands): Three Months Ended March 31, 2019 Operating lease cost (1) $ 5,940 Finance lease cost: Amortization of right-of-use assets 652 Interest on lease liabilities 1,124 Total finance lease cost 1,776 Total lease cost $ 7,716 (1) Includes variable and short-term lease costs. Supplemental cash flow information related to leases was as follows (in thousands): Three Months Ended March 31, 2019 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from finance leases $ 750 Operating cash flows from operating leases 4,897 Financing cash flows from finance leases 619 Non-cash activity: Right-of-use assets obtained in exchange for new operating lease liabilities $ 360 |
Schedule of Supplemental Balance Sheet Information | Supplemental balance sheet information related to the Company's leases was as follows (in thousands): Operating leases March 31, 2019 Operating lease right-of-use assets $ 63,238 Operating lease right-of-use assets - related party 17,565 Total operating lease right-of-use assets $ 80,803 Operating lease liabilities $ 51,200 Operating lease liabilities - related party 15,445 Current portion of operating lease liabilities 13,173 Current portion of operating and financing lease liabilities - related party 2,217 Total operating lease liabilities $ 82,035 Financing leases Financing lease right of use assets - related party $ 63,240 Financing lease liabilities - related party $ 62,256 Current portion of operating and financing lease liabilities - related party 1,017 Total financing lease liabilities $ 63,273 |
Schedule of Lease Term and Discount Rate Information | The table below reflects the weighted average remaining lease term and weighted average discount rate for our operating and finance leases as of March 31, 2019 . March 31, 2019 Weighted average remaining lease term - operating leases 6 years Weighted average remaining lease term - finance leases 24 years Weighted average discount rate - operating leases 5.9% Weighted average discount rate - finance leases 7.1% |
Schedule of Operating Lease Maturities, After Adopting 842 | Maturities of lease liabilities as of March 31, 2019 were as follows (in thousands): Operating Leases Financing Leases 2019 (1) $ 15,000 $ 4,105 2020 19,824 5,474 2021 18,354 5,474 2022 10,169 5,474 2023 10,050 5,474 Thereafter 26,939 106,740 Total lease payments 100,336 132,741 Less: Imputed interest (18,301 ) (69,468 ) Total $ 82,035 $ 63,273 (1) Excludes the three months ended March 31, 2019. |
Schedule of Finance Lease Maturities, After Adopting 842 | Maturities of lease liabilities as of March 31, 2019 were as follows (in thousands): Operating Leases Financing Leases 2019 (1) $ 15,000 $ 4,105 2020 19,824 5,474 2021 18,354 5,474 2022 10,169 5,474 2023 10,050 5,474 Thereafter 26,939 106,740 Total lease payments 100,336 132,741 Less: Imputed interest (18,301 ) (69,468 ) Total $ 82,035 $ 63,273 (1) Excludes the three months ended March 31, 2019. |
Schedule of Operating Lease Maturities, Before Adopting 842 | As disclosed in our 2018 Annual Report on Form 10-K, under the previous lease accounting standard, the table below reflects the future minimum lease payments, including reasonably assured renewals, due under non-cancelable leases and a financing obligation as of December 31, 2018 (in thousands): Operating Leases Financing Obligation 2019 $ 25,885 $ 5,474 2020 12,071 5,474 2021 11,105 5,474 2022 10,329 5,474 2023 10,043 5,474 Thereafter 28,128 107,196 Total lease payments 97,561 134,566 Less: Imputed interest — (95,217 ) Total $ 97,561 $ 39,349 |
Schedule of Finance Lease Maturities, Before Adopting 842 | As disclosed in our 2018 Annual Report on Form 10-K, under the previous lease accounting standard, the table below reflects the future minimum lease payments, including reasonably assured renewals, due under non-cancelable leases and a financing obligation as of December 31, 2018 (in thousands): Operating Leases Financing Obligation 2019 $ 25,885 $ 5,474 2020 12,071 5,474 2021 11,105 5,474 2022 10,329 5,474 2023 10,043 5,474 Thereafter 28,128 107,196 Total lease payments 97,561 134,566 Less: Imputed interest — (95,217 ) Total $ 97,561 $ 39,349 |
Fair Value Measurements of Fi_2
Fair Value Measurements of Financial Instruments (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Assets and Liabilities Measured at Fair Value on a Recurring Basis | The following table sets forth the Company’s financial assets and liabilities that were measured at fair value on a recurring basis as of March 31, 2019 and December 31, 2018 (in thousands): Fair Value Measurement Based on March 31, 2019 Total Quoted Prices in Active Markets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Assets Deferred Compensation Plan asset (1) $ 42,718 $ — $ 42,718 $ — Liabilities Deferred Compensation Plan liabilities (1) $ 27,073 $ — $ 27,073 $ — December 31, 2018 Assets Deferred Compensation Plan asset (1) $ 40,101 $ — $ 40,101 $ — Liabilities Deferred Compensation Plan liabilities (1) $ 27,978 $ — $ 27,978 $ — (1) The deferred compensation plan liabilities are non-current liabilities recorded at the value of the amount owed to the plan participants, with changes in value recognized as compensation expense. The calculation of the deferred compensation plan obligation is derived from observable market data by reference to hypothetical investments selected by the participants and is included in other long-term liabilities. The Company invests participant contributions in corporate-owned life insurance policies, for which the cash surrender value is included in other non-current assets. |
Segment Information (Tables)
Segment Information (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Segment Reporting [Abstract] | |
Schedule of Segment Reporting Information, by Segment | The tables below present segment information reconciled to total Company financial results, with segment operating income or loss including gross profit less direct selling expenses, research and development expenses, and other operating expenses to the extent specifically identified by segment (in thousands): Three Months Ended March 31, 2019 Generics Specialty Corporate Total Net revenue $ 382,477 $ 63,643 $ — $ 446,120 Cost of goods sold 278,878 30,865 — 309,743 Cost of goods sold impairment charges 53,297 — — 53,297 Gross profit 50,302 32,778 — 83,080 Selling, general and administrative 24,148 21,327 38,961 84,436 Research and development 50,151 3,707 — 53,858 In-process research and development impairment charges 22,787 — — 22,787 Intellectual property legal development expenses 3,121 1,045 — 4,166 Other operating expenses 4,678 2,062 5,453 12,193 Operating (loss) income $ (54,583 ) $ 4,637 $ (44,414 ) $ (94,360 ) Three Months Ended March 31, 2018 Generics Specialty Corporate Total Net revenue $ 275,189 $ — $ — $ 275,189 Cost of goods sold 130,594 — — 130,594 Gross profit 144,595 — — 144,595 Selling, general and administrative 11,203 — 13,918 25,121 Research and development 44,209 — — 44,209 Intellectual property legal development expenses 4,576 — — 4,576 Other operating expenses — — 7,135 7,135 Operating income (loss) $ 84,607 $ — $ (21,053 ) $ 63,554 |
Goodwill and Intangible Assets
Goodwill and Intangible Assets (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Goodwill | The changes in goodwill for the three months ended March 31, 2019 and for the year ended December 31, 2018 were as follows (in thousands): March 31, 2019 December 31, 2018 Balance, beginning of period $ 426,226 $ 26,444 Goodwill acquired during the period — 401,488 Goodwill divested during the period (4,697 ) — Currency translation 111 (1,706 ) Balance, end of period $ 421,640 $ 426,226 |
Schedule of Indefinite-Lived Intangible Assets | Intangible assets at March 31, 2019 and December 31, 2018 are comprised of the following (in thousands): March 31, 2019 December 31, 2018 Weighted-Average Amortization Period (in years) Cost Accumulated Amortization Net Cost Accumulated Amortization Net Amortizing intangible assets: Product rights 11.9 $ 1,269,576 $ (109,732 ) $ 1,159,844 $ 1,282,011 $ (88,081 ) $ 1,193,930 Customer relationships — — — 7,005 (1,955 ) 5,050 Other intangible assets 10.7 3,072 (901 ) 2,171 5,620 (1,561 ) 4,059 Total $ 1,272,648 $ (110,633 ) $ 1,162,015 $ 1,294,636 $ (91,597 ) $ 1,203,039 In-process research and development 429,143 — 429,143 451,930 — 451,930 Total intangible assets $ 1,701,791 $ (110,633 ) $ 1,591,158 $ 1,746,566 $ (91,597 ) $ 1,654,969 |
Schedule of Finite-Lived Intangible Assets | Intangible assets at March 31, 2019 and December 31, 2018 are comprised of the following (in thousands): March 31, 2019 December 31, 2018 Weighted-Average Amortization Period (in years) Cost Accumulated Amortization Net Cost Accumulated Amortization Net Amortizing intangible assets: Product rights 11.9 $ 1,269,576 $ (109,732 ) $ 1,159,844 $ 1,282,011 $ (88,081 ) $ 1,193,930 Customer relationships — — — 7,005 (1,955 ) 5,050 Other intangible assets 10.7 3,072 (901 ) 2,171 5,620 (1,561 ) 4,059 Total $ 1,272,648 $ (110,633 ) $ 1,162,015 $ 1,294,636 $ (91,597 ) $ 1,203,039 In-process research and development 429,143 — 429,143 451,930 — 451,930 Total intangible assets $ 1,701,791 $ (110,633 ) $ 1,591,158 $ 1,746,566 $ (91,597 ) $ 1,654,969 |
Finite-lived Intangible Assets Amortization Expense | Amortization expense related to intangible assets recognized is as follows (in thousands): Three Months 2019 2018 Amortization $ 30,963 $ 1,760 |
Schedule of Finite-Lived Intangible Assets, Future Amortization Expense | The following table presents future amortization expense for the next five years and thereafter, excluding $429 million of IPR&D intangible assets (in thousands): Future Amortization Remainder of 2019 $ 90,200 2020 136,898 2021 153,738 2022 152,413 2023 128,244 2024 120,244 Thereafter 380,278 Total $ 1,162,015 |
Nature of Operations - Narrativ
Nature of Operations - Narrative (Details) - USD ($) $ / shares in Units, shares in Millions, $ in Millions | May 04, 2018 | Mar. 31, 2019 | Dec. 31, 2018 |
Class of Stock [Line Items] | |||
Shares repurchased percentage | 15.00% | ||
Private Placement | |||
Class of Stock [Line Items] | |||
Sale of stock price per share (in dollars per share) | $ 18.25 | ||
Gross proceeds from stock issuance | $ 855 | ||
Holdings | |||
Class of Stock [Line Items] | |||
Ownership percentage by noncontrolling owners | 57.00% | 57.00% | 57.00% |
Holdings | Private Placement And PPU Holders Distribution | |||
Class of Stock [Line Items] | |||
Decrease in noncontrolling ownership interest percentage | 18.00% | ||
Impax Acquisition | Holdings | |||
Class of Stock [Line Items] | |||
Ownership percentage by noncontrolling owners | 75.00% | 0.00% | |
Ownership percentage by parent | 25.00% | ||
Impax Common Stock Holders | Impax Acquisition | |||
Class of Stock [Line Items] | |||
Shareholder ownership percentage | 25.00% | ||
Amneal Holdings, LLC | Impax Acquisition | |||
Class of Stock [Line Items] | |||
Shareholder ownership percentage | 75.00% | ||
PIPE Investors | |||
Class of Stock [Line Items] | |||
Shareholder ownership percentage | 15.00% | ||
Common Class A | |||
Class of Stock [Line Items] | |||
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 | $ 0.01 |
Stock conversion ratio | 1 | ||
Common Class A | Private Placement | |||
Class of Stock [Line Items] | |||
Sale of stock, number of shares issued in transaction (in shares) | 34.5 | ||
Common Class A | PPU Holders Distribution | |||
Class of Stock [Line Items] | |||
Sale of stock, number of shares issued in transaction (in shares) | 6.9 | ||
Common Class B | |||
Class of Stock [Line Items] | |||
Common stock, par value (in dollars per share) | $ 0.01 | 0.01 | 0.01 |
Common Class B-1 | |||
Class of Stock [Line Items] | |||
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 | $ 0.01 |
Common Class B-1 | Private Placement | |||
Class of Stock [Line Items] | |||
Sale of stock, number of shares issued in transaction (in shares) | 12.3 | ||
Impax Laboratories, LLC | |||
Class of Stock [Line Items] | |||
Common stock, par value (in dollars per share) | $ 0.01 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Narrative (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Jan. 01, 2019 | Dec. 31, 2018 |
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||
Operating lease right-of-use assets | $ 80,803 | $ 85,000 | |
Lease liabilities | 82,035 | 86,000 | |
De-recognition, leasehold improvements, adopting ASU | (514,414) | $ (544,146) | |
Increase in non-controlling interests, net of income taxes | 327,576 | 391,613 | |
Increase in stockholders' accumulated deficit, net of income taxes | (63,844) | (20,920) | |
Finance lease, ROU asset | 64,000 | ||
Finance lease liability | 63,273 | 64,000 | |
Accounting Standards Update 2016-02 | |||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||
Increase in non-controlling interests, net of income taxes | 9,000 | ||
Increase in stockholders' accumulated deficit, net of income taxes | 5,000 | ||
Accounting Standards Update 2016-02 | Leasehold improvements | |||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||
De-recognition, leasehold improvements, adopting ASU | 24,000 | ||
Related Party | |||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||
Operating lease right-of-use assets | 17,565 | ||
De-recognition reduction, financing obligation, adopting ASU | 0 | $ (39,083) | |
Finance lease, ROU asset | $ 63,240 | ||
Related Party | Accounting Standards Update 2016-02 | |||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||
De-recognition reduction, financing obligation, adopting ASU | $ 39,000 |
Acquisitions and Divestitures -
Acquisitions and Divestitures - Narrative (Details) - USD ($) | Mar. 30, 2019 | May 04, 2018 | Apr. 30, 2019 | Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2017 |
Business Acquisition [Line Items] | |||||||
Goodwill | $ 421,640,000 | $ 426,226,000 | $ 26,444,000 | ||||
Loss on sale | (8,818,000) | $ 0 | |||||
Disposal Group, Disposed of by Sale, Not Discontinued Operations | Creo Pharma Holding Limited | |||||||
Business Acquisition [Line Items] | |||||||
Ownership percentage sold | 100.00% | ||||||
Carrying value, net assets | $ 22,000,000 | ||||||
Carrying value, intangible assets sold | 7,000,000 | ||||||
Carrying value, goodwill | $ 5,000,000 | ||||||
Loss on sale | (9,000,000) | ||||||
Loss on disposition of business, release of foreign currency translation adjustments | 3,000,000 | ||||||
Disposal Group, Disposed of by Sale, Not Discontinued Operations | Creo Pharma Holding Limited | Subsequent Event | |||||||
Business Acquisition [Line Items] | |||||||
Cash consideration, subsidiary | $ 36,000,000 | ||||||
Specialty | |||||||
Business Acquisition [Line Items] | |||||||
Goodwill | 360,000,000 | 360,000,000 | |||||
Generics | |||||||
Business Acquisition [Line Items] | |||||||
Goodwill | 61,000,000 | $ 66,000,000 | |||||
AI Sirona | Disposal Group, Disposed of by Sale, Not Discontinued Operations | Creo Pharma Holding Limited | |||||||
Business Acquisition [Line Items] | |||||||
Supply agreement period | 2 years | ||||||
Impax Acquisition | |||||||
Business Acquisition [Line Items] | |||||||
Acquisition, transaction-related and integration expenses | 0 | $ 7,000,000 | |||||
Measurement consideration transferred, fair value equity interest, percentage | 25.00% | ||||||
Indefinite-lived intangible assets acquired | $ 529,000,000 | ||||||
Goodwill | 399,988,000 | ||||||
Impax Acquisition | Specialty | |||||||
Business Acquisition [Line Items] | |||||||
Goodwill | 359,000,000 | ||||||
Impax Acquisition | Generics | |||||||
Business Acquisition [Line Items] | |||||||
Goodwill | $ 41,000,000 | ||||||
Impax Acquisition | Amneal Holdings, LLC | |||||||
Business Acquisition [Line Items] | |||||||
Shareholder ownership percentage | 75.00% |
Acquisitions and Divestitures_2
Acquisitions and Divestitures - Payments to Acquire Business (Details) - Impax Acquisition $ / shares in Units, $ in Thousands | May 04, 2018USD ($)$ / sharesshares |
Business Acquisition [Line Items] | |
Fully diluted Impax share number (in shares) | shares | 73,288,792 |
Closing quoted market price of an Impax common share on May 4, 2018 (in dollars per share) | $ / shares | $ 18.3 |
Equity consideration - subtotal | $ 1,341,185 |
Add: Fair value of Impax stock options as of May 4, 2018 | 22,610 |
Total equity consideration | 1,363,795 |
Add: Extinguishment of certain Impax obligations, including accrued and unpaid interest | 320,290 |
Less: Cash acquired | (37,907) |
Purchase price, net of cash acquired | $ 1,646,178 |
Number of shares issued (in shares) | shares | 3,000,000 |
Acquisitions and Divestitures_3
Acquisitions and Divestitures - Assets Acquired and Liabilities Assumed (Details) - USD ($) | 3 Months Ended | |||
Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Business Acquisition [Line Items] | ||||
Goodwill | $ 421,640,000 | $ 426,226,000 | $ 26,444,000 | |
Impax Acquisition | ||||
Business Combinations [Abstract] | ||||
Acquisition, transaction-related and integration expenses | 0 | $ 7,000,000 | ||
Business Acquisition [Line Items] | ||||
Trade accounts receivable, net | 211,762,000 | |||
Inventories | 183,088,000 | |||
Prepaid expenses and other current assets | 91,430,000 | |||
Property, plant and equipment | 87,472,000 | |||
Goodwill | 399,988,000 | |||
Intangible assets | 1,574,929,000 | |||
Other | 55,790,000 | |||
Total assets acquired | 2,604,459,000 | |||
Accounts payable | 47,912,000 | |||
Accrued expenses and other current liabilities | 277,176,000 | |||
Long-term debt | 599,400,000 | |||
Other long-term liabilities | 33,793,000 | |||
Total liabilities assumed | 958,281,000 | |||
Net assets acquired | $ 1,646,178,000 |
Acquisitions and Divestitures_4
Acquisitions and Divestitures - Acquired Intangible Assets (Details) - Impax Acquisition $ in Thousands | May 04, 2018USD ($) |
Acquired Finite-Lived Intangible Assets [Line Items] | |
Preliminary Fair Values | $ 1,045,617 |
Weighted-Average Useful Life | 12 years 10 months 24 days |
Acquisitions and Divestitures_5
Acquisitions and Divestitures - Pro Forma (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2018USD ($) | |
Business Combinations [Abstract] | |
Net revenue | $ 417,544 |
Net loss | (74,077) |
Net loss attributable to Amneal Pharmaceuticals, Inc. | $ (8,595) |
Revenue Recognition - Narrative
Revenue Recognition - Narrative (Details) - customer | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | |
Concentration Risk [Line Items] | |||
Concentration risk, number of largest customers | 3 | 3 | |
Sales Revenue, Gross | Three Largest Customers | Customer Concentration Risk | |||
Concentration Risk [Line Items] | |||
Concentration risk percentage | 79.00% | 80.00% |
Revenue Recognition - Revenue b
Revenue Recognition - Revenue by Product Family (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Disaggregation of Revenue [Line Items] | ||
Net revenue | $ 446,120 | $ 275,189 |
Levothyroxine Sodium | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 48,994 | |
Rytary® family | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 28,828 | |
Diclofenac Sodium Gel | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 23,467 | 20,276 |
Yuvafem-Estradiol | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 18,739 | 19,267 |
Epinephrine Auto-Injector family (generic Adrenaclick®) | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | $ 15,195 | |
Oseltamivir | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 42,567 | |
Aspirin; Dipyridamole ER Capsul | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | 17,022 | |
Atovaquone | ||
Disaggregation of Revenue [Line Items] | ||
Net revenue | $ 8,334 | |
Revenue from Contract with Customer | Product Concentration Risk | Levothyroxine Sodium | ||
Disaggregation of Revenue [Line Items] | ||
Concentration risk percentage | 11.00% | |
Revenue from Contract with Customer | Product Concentration Risk | Rytary® family | ||
Disaggregation of Revenue [Line Items] | ||
Concentration risk percentage | 6.00% | |
Revenue from Contract with Customer | Product Concentration Risk | Diclofenac Sodium Gel | ||
Disaggregation of Revenue [Line Items] | ||
Concentration risk percentage | 5.00% | 7.00% |
Revenue from Contract with Customer | Product Concentration Risk | Yuvafem-Estradiol | ||
Disaggregation of Revenue [Line Items] | ||
Concentration risk percentage | 4.00% | 7.00% |
Revenue from Contract with Customer | Product Concentration Risk | Epinephrine Auto-Injector family (generic Adrenaclick®) | ||
Disaggregation of Revenue [Line Items] | ||
Concentration risk percentage | 3.00% | |
Revenue from Contract with Customer | Product Concentration Risk | Oseltamivir | ||
Disaggregation of Revenue [Line Items] | ||
Concentration risk percentage | 15.00% | |
Revenue from Contract with Customer | Product Concentration Risk | Aspirin; Dipyridamole ER Capsul | ||
Disaggregation of Revenue [Line Items] | ||
Concentration risk percentage | 6.00% | |
Revenue from Contract with Customer | Product Concentration Risk | Atovaquone | ||
Disaggregation of Revenue [Line Items] | ||
Concentration risk percentage | 3.00% |
Revenue Recognition - Major Cat
Revenue Recognition - Major Categories of Sales-Related Deductions (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2019USD ($) | |
Contract Charge-backs and Sales Volume Allowances | |
SEC Schedule, 12-09, Valuation and Qualifying Accounts Disclosure [Line Items] | |
Balance, Beginning of Period | $ 829,596 |
Provision related to sales recorded in the period | 1,105,531 |
Credits/payments issued during the period | (1,191,605) |
Balance, End of Period | 743,522 |
Cash Discount Allowances | |
SEC Schedule, 12-09, Valuation and Qualifying Accounts Disclosure [Line Items] | |
Balance, Beginning of Period | 36,157 |
Provision related to sales recorded in the period | 35,172 |
Credits/payments issued during the period | (19,440) |
Balance, End of Period | 51,889 |
Accrued Returns Allowance | |
SEC Schedule, 12-09, Valuation and Qualifying Accounts Disclosure [Line Items] | |
Balance, Beginning of Period | 154,503 |
Provision related to sales recorded in the period | 17,125 |
Credits/payments issued during the period | (25,588) |
Balance, End of Period | 146,040 |
Accrued Medicaid and Commercial Rebates | |
SEC Schedule, 12-09, Valuation and Qualifying Accounts Disclosure [Line Items] | |
Balance, Beginning of Period | 74,202 |
Provision related to sales recorded in the period | 36,105 |
Credits/payments issued during the period | (28,565) |
Balance, End of Period | $ 81,742 |
Alliance and Collaboration - Na
Alliance and Collaboration - Narrative (Details) - USD ($) | Aug. 16, 2018 | May 07, 2018 | Jun. 30, 2016 | Apr. 30, 2019 | Feb. 28, 2019 | Mar. 31, 2019 | Mar. 31, 2018 | Mar. 22, 2019 | Dec. 31, 2018 |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Expensed to cost of goods sold | $ 309,743,000 | $ 130,594,000 | |||||||
Transition contract liability | 558,750,000 | $ 514,440,000 | |||||||
Research and development | 53,858,000 | 44,209,000 | |||||||
JSP License And Commercialization Agreement | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Collaborative arrangement term | 10 years | ||||||||
Accrued up-front license contingent payment | $ 50,000,000 | ||||||||
JSP License And Commercialization Agreement | Subsequent Event | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Payment of up-front license contingent payment | $ 50,000,000 | ||||||||
JSP And Lannett Company Transition Agreement | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Payment of non-refundable payment | $ 4,000,000 | 47,000,000 | |||||||
Expensed to cost of goods sold | 37,000,000 | 10,000,000 | |||||||
Transition contract liability | $ 4,000,000 | ||||||||
Biosimilar Licensing and Supply Agreement | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Collaborative arrangement maximum contingent payments amount | $ 72,000,000 | ||||||||
Research and development | 1,000,000 | $ 0 | |||||||
Astra Zeneca | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Collaborative arrangement reduced royalty | $ 30,000,000 | ||||||||
Astra Zeneca | Royalty | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Expensed to cost of goods sold | $ 4,000,000 |
Restructuring and Other Charg_3
Restructuring and Other Charges - Restructuring Charges (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Restructuring Cost and Reserve [Line Items] | ||
Employee restructuring separation charges | $ 6,161 | $ 0 |
Employee restructuring separation charges | ||
Restructuring Cost and Reserve [Line Items] | ||
Employee restructuring separation charges | 2,318 | |
Severance charges | ||
Restructuring Cost and Reserve [Line Items] | ||
Employee restructuring separation charges | 2,318 | |
Other employee severance charges | 3,843 | |
Severance charges | Corporate | ||
Restructuring Cost and Reserve [Line Items] | ||
Employee restructuring separation charges | 1,144 | |
Severance charges | Generics | Operating Segments | ||
Restructuring Cost and Reserve [Line Items] | ||
Employee restructuring separation charges | 996 | |
Severance charges | Specialty | Operating Segments | ||
Restructuring Cost and Reserve [Line Items] | ||
Employee restructuring separation charges | $ 178 |
Restructuring and Other Charg_4
Restructuring and Other Charges - Restructuring Rollforward (Details) - Employee Restructuring $ in Thousands | 3 Months Ended |
Mar. 31, 2019USD ($) | |
Restructuring Reserve [Roll Forward] | |
Beginning balance | $ 22,112 |
Charges to income | 2,318 |
Payments | (12,069) |
Ending balance | $ 12,361 |
Loss per Share - Computation of
Loss per Share - Computation of Basic and Diluted Earnings per Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Numerator: | ||
Net loss attributable to Amneal Pharmaceuticals, Inc. | $ (47,881) | $ 0 |
Denominator: | ||
Weighted-average shares of Class A Common Stock and Class B-1 Common Stock outstanding - basic and diluted (in shares) | 127,687 | |
Net loss per share attributable to Amneal Pharmaceuticals, Inc.'s common stockholders: | ||
Class A and Class B-1 basic (in dollars per share) | $ (0.37) |
Loss per Share - Securities Exc
Loss per Share - Securities Excluded from Diluted Earnings per Share Computation (Details) shares in Thousands | 3 Months Ended |
Mar. 31, 2019shares | |
Common Class B | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |
Potentially dilutive securities excluded from earnings per share (in shares) | 171,041 |
Stock options | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |
Potentially dilutive securities excluded from earnings per share (in shares) | 8,400 |
Restricted stock units | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |
Potentially dilutive securities excluded from earnings per share (in shares) | 3,282 |
Performance stock units | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |
Potentially dilutive securities excluded from earnings per share (in shares) | 520 |
Income taxes - Narrative (Detai
Income taxes - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |||
Additional liabilities under tax receivable agreement | $ 600 | ||
Liabilities under tax receivable agreement | 193,499 | $ 192,884 | |
Income tax (benefit) provision | $ (8,428) | $ 364 | |
Effective tax rate, percent | 6.30% | 0.70% | |
Impairment charges on intangible assets | $ 76,000 | ||
Restructuring and other charges | $ 6,161 | $ 0 |
Trade Accounts Receivable, Ne_2
Trade Accounts Receivable, Net - Schedule of Trade Accounts Receivable, Net (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Receivables [Abstract] | ||
Gross accounts receivable | $ 1,438,296 | $ 1,349,588 |
Allowance for doubtful accounts | (2,673) | (2,340) |
Contract charge-backs and sales volume allowances | (743,522) | (829,596) |
Cash discount allowances | (51,889) | (36,157) |
Subtotal | (798,084) | (868,093) |
Trade accounts receivable, net | $ 640,212 | $ 481,495 |
Trade Accounts Receivable, Ne_3
Trade Accounts Receivable, Net - Narrative (Details) - customer | 3 Months Ended | 12 Months Ended |
Mar. 31, 2019 | Dec. 31, 2018 | |
Concentration Risk [Line Items] | ||
Concentration risk, number of customers | 3 | 3 |
Customer Concentration Risk | Accounts Receivable | Customer A | ||
Concentration Risk [Line Items] | ||
Concentration risk percentage | 33.00% | 30.00% |
Customer Concentration Risk | Accounts Receivable | Customer B | ||
Concentration Risk [Line Items] | ||
Concentration risk percentage | 29.00% | 28.00% |
Customer Concentration Risk | Accounts Receivable | Customer C | ||
Concentration Risk [Line Items] | ||
Concentration risk percentage | 22.00% | 24.00% |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 182,590 | $ 181,654 |
Work in process | 57,729 | 54,152 |
Finished goods | 207,975 | 221,413 |
Total inventories | $ 448,294 | $ 457,219 |
Leases - Narrative (Details)
Leases - Narrative (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Lessee, Lease, Description [Line Items] | ||
Operating and finance lease, rent expense | $ 7 | $ 2 |
Minimum | ||
Lessee, Lease, Description [Line Items] | ||
Operating and finance lease term | 1 year | |
Maximum | ||
Lessee, Lease, Description [Line Items] | ||
Operating and finance lease term | 25 years |
Leases - Components of Total Le
Leases - Components of Total Lease Costs (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2019USD ($) | |
Leases [Abstract] | |
Operating lease cost | $ 5,940 |
Finance lease cost: | |
Amortization of right-of-use assets | 652 |
Interest on lease liabilities | 1,124 |
Total finance lease cost | 1,776 |
Total lease cost | $ 7,716 |
Leases - Supplemental Balance S
Leases - Supplemental Balance Sheet Information (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Jan. 01, 2019 |
Operating leases | ||
Operating lease right-of-use assets | $ 80,803 | $ 85,000 |
Total operating lease liabilities | 82,035 | 86,000 |
Financing leases | ||
Financing lease right-of-use assets - related party | 64,000 | |
Total financing lease liabilities | 63,273 | $ 64,000 |
Excluding Related Party | ||
Operating leases | ||
Operating lease right-of-use assets | 63,238 | |
Operating lease liabilities | 51,200 | |
Current portion of operating lease liabilities | 13,173 | |
Related Party | ||
Operating leases | ||
Operating lease right-of-use assets | 17,565 | |
Operating lease liabilities | 15,445 | |
Current portion of operating lease liabilities | 2,217 | |
Financing leases | ||
Financing lease right-of-use assets - related party | 63,240 | |
Financing lease liabilities - related party | 62,256 | |
Current portion of financing obligation - related party | $ 1,017 |
Leases - Supplemental Cash Flow
Leases - Supplemental Cash Flow Information (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2019USD ($) | |
Cash paid for amounts included in the measurement of lease liabilities: | |
Operating cash flows from finance leases | $ 750 |
Operating cash flows from operating leases | 4,897 |
Financing cash flows from finance leases | 619 |
Non-cash activity: | |
Right-of-use assets obtained in exchange for new operating lease liabilities | $ 360 |
Leases - Term and Discount Rate
Leases - Term and Discount Rate Information (Details) | Mar. 31, 2019 |
Leases [Abstract] | |
Weighted average remaining lease term - operating leases | 6 years |
Weighted average remaining lease term - finance leases | 24 years |
Weighted average discount rate - operating leases | 5.90% |
Weighted average discount rate - finance leases | 7.10% |
Leases - Lease Maturities, Afte
Leases - Lease Maturities, After Adopting 842 (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Jan. 01, 2019 |
Operating Leases | ||
2019 | $ 15,000 | |
2020 | 19,824 | |
2021 | 18,354 | |
2022 | 10,169 | |
2023 | 10,050 | |
Thereafter | 26,939 | |
Total lease payments | 100,336 | |
Less: Imputed interest | (18,301) | |
Total | 82,035 | $ 86,000 |
Financing Leases | ||
2019 | 4,105 | |
2020 | 5,474 | |
2021 | 5,474 | |
2022 | 5,474 | |
2023 | 5,474 | |
Thereafter | 106,740 | |
Total lease payments | 132,741 | |
Less: Imputed interest | (69,468) | |
Total | $ 63,273 | $ 64,000 |
Leases - Lease Maturities, Befo
Leases - Lease Maturities, Before Adopting 842 (Details) $ in Thousands | Dec. 31, 2018USD ($) |
Operating Leases | |
2019 | $ 25,885 |
2020 | 12,071 |
2021 | 11,105 |
2022 | 10,329 |
2023 | 10,043 |
Operating Leases, Future Minimum Payments, Due Thereafter | 28,128 |
Total | 97,561 |
Financing Obligation | |
2019 | 5,474 |
2020 | 5,474 |
2021 | 5,474 |
2022 | 5,474 |
2023 | 5,474 |
Thereafter | 107,196 |
Total lease payments | 134,566 |
Less: Imputed interest | (95,217) |
Total | $ 39,349 |
Fair Value Measurements of Fi_3
Fair Value Measurements of Financial Instruments - Assets and Liabilities Measured at Fair Value (Details) - Recurring - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Deferred Compensation Plan asset | $ 42,718 | $ 40,101 |
Deferred Compensation Plan liabilities | 27,073 | 27,978 |
Quoted Prices in Active Markets (Level 1) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Deferred Compensation Plan asset | 0 | 0 |
Deferred Compensation Plan liabilities | 0 | 0 |
Significant Other Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Deferred Compensation Plan asset | 42,718 | 40,101 |
Deferred Compensation Plan liabilities | 27,073 | 27,978 |
Significant Unobservable Inputs (Level 3) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Deferred Compensation Plan asset | 0 | 0 |
Deferred Compensation Plan liabilities | $ 0 | $ 0 |
Fair Value Measurements of Fi_4
Fair Value Measurements of Financial Instruments - Narrative (Details) - USD ($) $ in Billions | Mar. 31, 2019 | Dec. 31, 2018 |
Term Loan | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Long-term debt fair value | $ 2.7 | $ 2.5 |
Commitments and Contingencies -
Commitments and Contingencies - Narrative (Details) $ in Millions | Mar. 16, 2019complaint | Mar. 15, 2019defendent | Mar. 14, 2019defendent | Feb. 15, 2019claim | Feb. 07, 2019defendent | Jan. 23, 2019defendent | Dec. 03, 2018defendent | Oct. 04, 2018defendent | Aug. 24, 2018defendent | Jul. 18, 2018defendent | Jul. 09, 2018defendent | Jun. 18, 2018request | May 30, 2018defendent | Mar. 27, 2018defendent | Mar. 15, 2018companydefendent | Aug. 17, 2017companydefendent | Apr. 06, 2017drugcomplaint | Mar. 31, 2019USD ($)defendent | May 31, 2016USD ($)settlement_demand | Mar. 31, 2019USD ($)defendent | Nov. 30, 2018defendent | Apr. 30, 2015complaint | Feb. 21, 2019complaint | Dec. 31, 2018USD ($) | Feb. 15, 2017litigation |
Loss Contingencies [Line Items] | |||||||||||||||||||||||||
Medicaid reimbursement reserve | $ | $ 15 | $ 15 | $ 15 | ||||||||||||||||||||||
Opana ER | |||||||||||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||||||||||
Number of complaints styled as class actions | 14 | ||||||||||||||||||||||||
Texas State Attorney General Civil Investigative Demand | |||||||||||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||||||||||
Number of settlement demands | settlement_demand | 2 | ||||||||||||||||||||||||
Damages sought, initial demand aggregate total | $ | $ 36 | ||||||||||||||||||||||||
Alleged overpayments | $ | $ 16 | ||||||||||||||||||||||||
Generic Digoxin and Doxycycline Antitrust Litigation | |||||||||||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||||||||||
Number of generic drugs included in consolidation of civil actions | drug | 18 | ||||||||||||||||||||||||
Digoxin And Lidocaine-prilocaine Litigation | |||||||||||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||||||||||
Number of complaints styled as class actions | 2 | ||||||||||||||||||||||||
Number of complaints filed by opt-out plaintiffs | 2 | ||||||||||||||||||||||||
Digoxin And Lidocaine-prilocaine Litigation | End-Payor Plaintiff | |||||||||||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||||||||||
Number of claims dismissed | claim | 7 | ||||||||||||||||||||||||
Digoxin And Lidocaine-prilocaine Litigation | Indirect Reseller Plaintiff | |||||||||||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||||||||||
Number of claims dismissed | claim | 6 | ||||||||||||||||||||||||
Opiod Medications Litigation | |||||||||||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||||||||||
Number of defendants | defendent | 29 | 31 | 20 | 18 | 32 | 45 | 18 | 41 | 55 | 4 | 35 | 51 | 5 | 39 | 37 | 37 | |||||||||
Number of healthcare provider defendants | company | 3 | ||||||||||||||||||||||||
Number of counties filing a complaint (more than) | company | 60 | ||||||||||||||||||||||||
Number of cities filing a complaint | company | 12 | ||||||||||||||||||||||||
Number of CID requests | request | 11 | ||||||||||||||||||||||||
Number of additional complaints | 424 | ||||||||||||||||||||||||
Teva VS Impax Laboratories, Inc. | |||||||||||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||||||||||
Number of litigations | litigation | 2 |
Segment Information - Narrative
Segment Information - Narrative (Details) | 3 Months Ended |
Mar. 31, 2019segmentproduct | |
Segment Reporting [Abstract] | |
Number of reportable segments | segment | 2 |
Number of product families | product | 200 |
Segment Information - Schedules
Segment Information - Schedules of Segment Information (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Segment Reporting Information [Line Items] | ||
Net revenue | $ 446,120 | $ 275,189 |
Cost of goods sold | 309,743 | 130,594 |
Cost of goods sold impairment charges | 53,297 | 0 |
Gross profit | 83,080 | 144,595 |
Selling, general and administrative | 84,436 | 25,121 |
Research and development | 53,858 | 44,209 |
In-process research and development impairment charges | 22,787 | 0 |
Intellectual property legal development expenses | 4,166 | 4,576 |
Other operating expenses | 12,193 | 7,135 |
Operating (loss) income | (94,360) | 63,554 |
Operating Segments | Generics | ||
Segment Reporting Information [Line Items] | ||
Net revenue | 382,477 | 275,189 |
Cost of goods sold | 278,878 | 130,594 |
Cost of goods sold impairment charges | 53,297 | |
Gross profit | 50,302 | 144,595 |
Selling, general and administrative | 24,148 | 11,203 |
Research and development | 50,151 | 44,209 |
In-process research and development impairment charges | 22,787 | |
Intellectual property legal development expenses | 3,121 | 4,576 |
Other operating expenses | 4,678 | 0 |
Operating (loss) income | (54,583) | 84,607 |
Operating Segments | Specialty | ||
Segment Reporting Information [Line Items] | ||
Net revenue | 63,643 | 0 |
Cost of goods sold | 30,865 | 0 |
Cost of goods sold impairment charges | 0 | |
Gross profit | 32,778 | 0 |
Selling, general and administrative | 21,327 | 0 |
Research and development | 3,707 | 0 |
In-process research and development impairment charges | 0 | |
Intellectual property legal development expenses | 1,045 | 0 |
Other operating expenses | 2,062 | 0 |
Operating (loss) income | 4,637 | 0 |
Corporate and Other | ||
Segment Reporting Information [Line Items] | ||
Net revenue | 0 | 0 |
Cost of goods sold | 0 | 0 |
Cost of goods sold impairment charges | 0 | |
Gross profit | 0 | 0 |
Selling, general and administrative | 38,961 | 13,918 |
Research and development | 0 | 0 |
In-process research and development impairment charges | 0 | |
Intellectual property legal development expenses | 0 | 0 |
Other operating expenses | 5,453 | 7,135 |
Operating (loss) income | $ (44,414) | $ (21,053) |
Related Party Transactions - Na
Related Party Transactions - Narrative (Details) € in Millions | 1 Months Ended | 3 Months Ended | 12 Months Ended | 25 Months Ended | |||||||
Dec. 31, 2018USD ($) | Jun. 30, 2018USD ($) | Dec. 31, 2017USD ($) | Oct. 31, 2017USD ($) | Jun. 30, 2017USD ($)payment | Mar. 31, 2017USD ($) | Mar. 31, 2019USD ($)lease_agreement | Mar. 31, 2018USD ($) | Dec. 31, 2018USD ($) | Mar. 31, 2018USD ($) | Oct. 31, 2017EUR (€) | |
Related Party Transaction [Line Items] | |||||||||||
Related party receivables | $ 830,000 | $ 1,156,000 | $ 830,000 | ||||||||
Payments to acquire non-controlling interests of non-public subsidiaries | 3,000,000 | ||||||||||
Related party payables | 17,695,000 | 2,928,000 | 17,695,000 | ||||||||
Subsidiary of Common Parent | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Related party payables | 3,000,000 | $ 1,000,000 | 3,000,000 | ||||||||
Kanan, LLC | Related Party | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Number of lease agreements | lease_agreement | 2 | ||||||||||
Kanan, LLC | Related Party | Annual Rental Cost | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Amounts of transaction with related party | $ 2,000,000 | ||||||||||
Kanan, LLC | Related Party | Rent Expense | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Expenses from transactions with related party | 500,000 | $ 500,000 | |||||||||
Asana Biosciences, LLC | Related Party | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Income from related parties | 300,000 | 0 | |||||||||
Industrial Real Estate Holdings NY, LLC | Related Party | Rent Expense | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Expenses from transactions with related party | 300,000 | 300,000 | |||||||||
Kashiv Pharmaceuticals LLC | Related Party | Annual Base Rent | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Amounts of transaction with related party | 2,000,000 | ||||||||||
Kashiv Pharmaceuticals LLC | Related Party | Rental Income | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Income from related parties | 0 | 400,000 | |||||||||
Kashiv Pharmaceuticals LLC | Related Party | Profit Share On Various Arrangements | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Expenses from transactions with related party | 700,000 | 400,000 | |||||||||
Kashiv Pharmaceuticals LLC | Related Party | Product Acquisition And Royalty Stream Purchase Agreement | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Amounts of transaction with related party | $ 25,000,000 | ||||||||||
Number of earn out payments | payment | 2 | ||||||||||
Kashiv Pharmaceuticals LLC | Related Party | Product Acquisition And Royalty Stream Purchase Agreement, Earn-out Payment | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Amounts of transaction with related party | $ 5,000,000 | ||||||||||
Kashiv Pharmaceuticals LLC | Related Party | Legal Cost Reimbursement | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Amounts of transaction with related party | $ 8,000,000 | ||||||||||
Kashiv BioSciences LLC | Related Party | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Related parties payable | 800,000 | 1,000,000 | 800,000 | ||||||||
Kashiv BioSciences LLC | Related Party | Development And Commercialization Reimbursable Expense | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Amounts of transaction with related party | 800,000 | 0 | |||||||||
Kashiv BioSciences LLC | Related Party | Product Acquisition And Royalty Stream Purchase Agreement, Earn-out Payment One | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Amounts of transaction with related party | $ 5,000,000 | $ 5,000,000 | |||||||||
Adello Biologics, LLC | Related Party | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Related parties payable | $ 11,000,000 | ||||||||||
Face amount of related party notes receivable | $ 15,000,000 | € 13 | |||||||||
Interest rate on related party notes receivable | 2.00% | 2.00% | |||||||||
Adello Biologics, LLC | Related Party | Human Resource And Product Quality Assurance Services And License Agreement Expense | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Expenses from transactions with related party | 0 | 100,000 | |||||||||
Adello Biologics, LLC | Related Party | Reimbursement Of Past Development Costs | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Expenses from transactions with related party | $ 10,000,000 | ||||||||||
Adello Biologics, LLC | Related Party | License And Commercialization Agreement Up Front Payment | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Expenses from transactions with related party | $ 2,000,000 | ||||||||||
PharmaSophia, LLC | Related Party | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Income from related parties | 300,000 | 100,000 | |||||||||
Related party receivables | $ 100,000 | $ 400,000 | $ 100,000 | ||||||||
Gemini Laboratories, LLC | Related Party | Profit Share On Various Arrangements | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Income from related parties | 4,000,000 | ||||||||||
Gemini Laboratories, LLC | Related Party | Gross Profit From Sale Of Inventory | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Income from related parties | $ 100,000 |
Goodwill and Intangible Asset_2
Goodwill and Intangible Assets - Schedule of Goodwill (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2019 | Dec. 31, 2018 | |
Goodwill [Roll Forward] | ||
Balance, beginning of period | $ 426,226 | $ 26,444 |
Goodwill acquired during the period | 0 | 401,488 |
Goodwill divested during the period | (4,697) | 0 |
Currency translation | 111 | (1,706) |
Balance, end of period | $ 421,640 | $ 426,226 |
Goodwill and Intangible Asset_3
Goodwill and Intangible Assets - Narrative (Details) | 3 Months Ended | ||||
Mar. 31, 2019USD ($)product | Mar. 30, 2019USD ($) | Mar. 22, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | |
Goodwill [Line Items] | |||||
Goodwill | $ 421,640,000 | $ 426,226,000 | $ 26,444,000 | ||
Cost of goods sold impairment charges | 76,000,000 | ||||
In-process research and development | 429,143,000 | 451,930,000 | |||
Disposal Group, Disposed of by Sale, Not Discontinued Operations | Creo Pharma Holding Limited | |||||
Goodwill [Line Items] | |||||
Carrying value, intangible assets sold | $ 7,000,000 | ||||
JSP License And Commercialization Agreement | |||||
Goodwill [Line Items] | |||||
Accrued up-front license contingent payment | $ 50,000,000 | ||||
Specialty | |||||
Goodwill [Line Items] | |||||
Goodwill | 360,000,000 | 360,000,000 | |||
Generics | |||||
Goodwill [Line Items] | |||||
Goodwill | 61,000,000 | $ 66,000,000 | |||
Cost of goods sold impairment charges | $ 76,000,000 | ||||
Intangible assets impairment, number of products related to | product | 4 | ||||
Generics | Cost of goods sold | |||||
Goodwill [Line Items] | |||||
Cost of goods sold impairment charges | $ 53,000,000 | ||||
Generics | Research and development | |||||
Goodwill [Line Items] | |||||
Cost of goods sold impairment charges | 23,000,000 | ||||
Product rights | JSP License And Commercialization Agreement | |||||
Goodwill [Line Items] | |||||
Accrued up-front license contingent payment | $ 50,000,000 | ||||
Customer relationships | Disposal Group, Disposed of by Sale, Not Discontinued Operations | Creo Pharma Holding Limited | |||||
Goodwill [Line Items] | |||||
Carrying value, intangible assets sold | 5,000,000 | ||||
Trade Names | Disposal Group, Disposed of by Sale, Not Discontinued Operations | Creo Pharma Holding Limited | |||||
Goodwill [Line Items] | |||||
Carrying value, intangible assets sold | $ 2,000,000 |
Goodwill and Intangible Asset_4
Goodwill and Intangible Assets - Intangible Assets (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Dec. 31, 2018 | |
Finite-Lived Intangible Assets, Net [Abstract] | ||
Cost | $ 1,272,648 | $ 1,294,636 |
Accumulated Amortization | (110,633) | (91,597) |
Net | 1,162,015 | 1,203,039 |
In-process research and development | 429,143 | 451,930 |
Intangible assets, cost | 1,701,791 | 1,746,566 |
Intangible assets, net | $ 1,591,158 | 1,654,969 |
Product rights | ||
Finite-Lived Intangible Assets, Net [Abstract] | ||
Weighted-Average Amortization Period (in years) | 11 years 10 months 24 days | |
Cost | $ 1,269,576 | 1,282,011 |
Accumulated Amortization | (109,732) | (88,081) |
Net | $ 1,159,844 | 1,193,930 |
Customer relationships | ||
Finite-Lived Intangible Assets, Net [Abstract] | ||
Weighted-Average Amortization Period (in years) | ||
Cost | $ 0 | 7,005 |
Accumulated Amortization | 0 | (1,955) |
Net | $ 0 | 5,050 |
Other intangible assets | ||
Finite-Lived Intangible Assets, Net [Abstract] | ||
Weighted-Average Amortization Period (in years) | 10 years 8 months 12 days | |
Cost | $ 3,072 | 5,620 |
Accumulated Amortization | (901) | (1,561) |
Net | $ 2,171 | $ 4,059 |
Goodwill and Intangible Asset_5
Goodwill and Intangible Assets - Amortization Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Amortization | $ 30,963 | $ 1,760 |
Goodwill and Intangible Asset_6
Goodwill and Intangible Assets - Future Amortization Expense (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Finite-Lived Intangible Assets, Amortization Expense, Maturity Schedule [Abstract] | ||
Remainder of 2019 | $ 90,200 | |
2020 | 136,898 | |
2021 | 153,738 | |
2022 | 152,413 | |
2023 | 128,244 | |
2024 | 120,244 | |
Thereafter | 380,278 | |
Net | $ 1,162,015 | $ 1,203,039 |
Uncategorized Items - amrx-2019
Label | Element | Value |
Cumulative Effect of New Accounting Principle in Period of Adoption | us-gaap_CumulativeEffectOfNewAccountingPrincipleInPeriodOfAdoption | $ 3,270,000 |
Cumulative Effect of New Accounting Principle in Period of Adoption | us-gaap_CumulativeEffectOfNewAccountingPrincipleInPeriodOfAdoption | 13,561,000 |
Noncontrolling Interest [Member] | ||
Cumulative Effect of New Accounting Principle in Period of Adoption | us-gaap_CumulativeEffectOfNewAccountingPrincipleInPeriodOfAdoption | 8,604,000 |
Retained Earnings [Member] | ||
Cumulative Effect of New Accounting Principle in Period of Adoption | us-gaap_CumulativeEffectOfNewAccountingPrincipleInPeriodOfAdoption | 3,270,000 |
Cumulative Effect of New Accounting Principle in Period of Adoption | us-gaap_CumulativeEffectOfNewAccountingPrincipleInPeriodOfAdoption | $ 4,957,000 |