Notes to Consolidated Financial Statements
(unaudited)
1. Nature of Operations
Amneal Pharmaceuticals, Inc. (the “Company”) is a pharmaceutical company specializing in developing, manufacturing, marketing and distributing high-value generic and branded specialty pharmaceutical products across a broad array of dosage forms and therapeutic areas. The Company operates principally in the United States, India, and Ireland, and sells to wholesalers, distributors, hospitals, chain pharmacies and individual pharmacies, either directly or indirectly. The Company is a holding company, whose principal assets are common units (“Amneal Common Units”) of Amneal Pharmaceuticals, LLC (“Amneal”).
In 2018, Amneal completed the acquisition of Impax Laboratories, Inc. (“Impax”), a generic and specialty pharmaceutical company. In 2020, Amneal acquired a 65.1% controlling interest in both AvKARE Inc., a Tennessee corporation now a limited liability company (“AvKARE, LLC”), and Dixon-Shane, LLC d/b/a R&S Northeast LLC, a Kentucky limited liability company (“R&S”) (collectively, the “Rondo Acquisitions”). AvKARE, LLC is one of the largest private label providers of generic pharmaceuticals in the U.S. federal agency sector, primarily focused on serving the Department of Defense and the Department of Veterans Affairs. R&S is a national pharmaceutical wholesaler focused primarily on offering 340b-qualified entities products to provide consistency in care and pricing.
The group of investors, together with their affiliates and certain assignees, who owned Amneal when it was a private company (the “Members”) held 50.1% of Amneal Common Units and the Company held the remaining 49.9% as of September 30, 2022.
2. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying unaudited consolidated financial statements, which are prepared in accordance with generally accepted accounting principles in the United States of America, should be read in conjunction with the Company’s annual audited financial statements for the year ended December 31, 2021 included in the Company’s 2021 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 September 30, 2022, cash flows for the nine months ended September 30, 2022 and 2021 and the results of its operations, its comprehensive income (loss) and its changes in stockholders’ equity for the three and nine months ended September 30, 2022 and 2021. The consolidated balance sheet data at December 31, 2021 was derived from the Company’s audited annual financial statements, but does not include all disclosures required by generally accepted accounting principles in the United States of America.
Except for the updates included in this note, the accounting policies of the Company are set forth in Note 2. Summary of Significant Accounting Policies contained in the Company’s 2021 Annual Report on Form 10-K.
Use of Estimates
The preparation of financial statements 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, billbacks, valuation of intangible and other assets acquired in business combinations, allowances for accounts receivable, accrued liabilities, initial and subsequent valuation of contingent consideration recognized in business combinations, stock-based compensation, valuation of inventory balances, the determination of useful lives for product rights 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 Accounting Pronouncements
Government Assistance (Topic 832): Disclosures by Business Entities About Government Assistance
In November 2021, the FASB issued ASU 2021-10, Government Assistance (Topic 832), Disclosures by Business Entities About Government Assistance, which requires entities to provide disclosures on material government assistance transactions for annual reporting periods. The disclosures include information around the nature of the assistance, the related accounting policies used to account for government assistance, the effect of government assistance on the entity’s financial statements, and any significant terms and conditions of the agreements, including commitments and contingencies. The new standard is effective for the Company’s annual disclosures as of and for the year ending December 31, 2022, with early adoption permissible. The Company elected to adopt this guidance during the quarter ended June 30, 2022 in connection with the recognition of cash incentive related to the India Production Linked Incentive Scheme for the Pharmaceutical Sector (“PLI Scheme”). Refer to Note 19. Government Grants, for additional information.
Recently Issued Accounting Pronouncements
In March 2020, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2020-04, Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting, which provides elective amendments for entities that have contracts, hedging relationships and other transactions that reference LIBOR or another reference rate expected to be discontinued because of reference rate reform. These amendments are effective immediately and may be applied prospectively to contract modifications made and hedging relationships entered into or evaluated on or before December 31, 2022. In January 2021, the FASB issued ASU 2021-01, Reference Rate Reform (Topic 848), to expand and clarify the scope of Topic 848 to include derivative instruments on discounting transactions. The amendments in this ASU are effective in the same timeframe as ASU 2020-04. The Company is currently evaluating the impact this guidance will have on its consolidated financial statements.
In October 2021, the FASB issued ASU 2021-08, Business Combinations (Topic 805): Accounting for Contract Assets and Contract Liabilities from Contracts with Customers, which requires entities to recognize and measure contract assets and contract liabilities acquired in a business combination in accordance with Topic 606, Revenue from Contracts with Customers. The update will generally result in an entity recognizing contract assets and contract liabilities at amounts consistent with those recorded by the acquiree immediately before the acquisition date rather than at fair value. The new standard is effective on a prospective basis for fiscal years beginning after December 15, 2022, with early adoption permitted. The Company does not expect this standard to have a material impact on its consolidated financial statements.
Reclassification
The prior period balance related to liabilities for legal proceedings of $58.0 million, formerly included in accounts payable and accrued expenses as of December 31, 2021, has been reclassified to the balance sheet caption current portion of liabilities for legal matters to conform to the current period presentation in the consolidated balance sheets.
3. Acquisitions
Saol Baclofen Franchise Acquisition
On December 30, 2021, the Company entered into an asset purchase agreement with certain entities affiliated with Saol International Limited (collectively, “Saol”), a private specialty pharmaceutical company, pursuant to which it agreed to acquire Saol’s baclofen franchise, including Lioresal®, LYVISPAH™, and a pipeline product under development (the “Saol Acquisition”). The Saol Acquisition expands the Company’s commercial institutional and specialty portfolio in neurology while adding commercial infrastructure in advance of its entry into the biosimilar institutional market. The transaction closed on February 9, 2022.
Consideration for the Saol Acquisition included $84.7 million, paid at closing with cash on hand, and contingent royalty payments based on annual net sales for certain acquired assets, beginning in 2023. Cash paid at closing included $1.1 million for inventory acquired in excess of the normalized level, as defined in the asset purchase agreement (working capital adjustment).
For the nine months ended September 30, 2022, the Company incurred $0.1 million in transaction costs associated with the Saol Acquisition, which was recorded in acquisition, transaction-related and integration expenses (none for the three months ended September 30, 2022).
The Saol Acquisition was accounted for under the acquisition method of accounting, with Amneal as the accounting acquirer. The purchase price was calculated as follows (in thousands):
| | | | | |
Cash | $ | 84,714 | |
Contingent consideration (royalties) (1) | 8,796 | |
Fair value of consideration transferred | $ | 93,510 | |
(1)The estimated fair value of contingent consideration on the acquisition date was $8.8 million and was based on significant Level 3 inputs that were not observable in the market. Key assumptions included the discount rate, projected year of payments and expected net product sales. Refer to Note 10. Fair Value Measurements, for additional information on the methodology and determination of this liability.
The following is a summary of the purchase price allocation for the Saol Acquisition (in thousands):
| | | | | |
| Final Fair Values as of February 9, 2022 |
Inventory | $ | 2,162 | |
Prepaid expenses and other current assets | 98 | |
Goodwill | 7,553 | |
Intangible assets | 83,815 | |
Total assets acquired | 93,628 | |
Accounts payable and accrued expenses | 118 | |
Fair value of consideration transferred | $ | 93,510 | |
The acquired intangible assets are being amortized over their estimated useful lives as follows (in thousands):
| | | | | | | | | | | |
| Final Fair Value | | Weighted-Average Useful Life (in years) |
Marketed product rights | $ | 83,815 | | | 11.6 |
The estimated fair value of the 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 purchase price allocation and in determining the purchase price were based on management's best estimates as of the closing date of the Saol Acquisition on February 9, 2022.
Some of the more significant assumptions inherent in the development of those asset valuations included the estimated net cash flows for each year for each asset (including net revenues, cost of sales, 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. The underlying assumptions used to prepare the discounted cash flow analysis may change; accordingly, for these and other reasons, actual results may vary significantly from estimated results.
Goodwill is calculated as the excess of the consideration transferred over the net assets recognized. Of the total goodwill acquired in connection with the Saol Acquisition, $5.2 million was allocated to the Company’s Generics segment and $2.4 million was allocated to the Company’s Specialty segment.
From the acquisition date of February 9, 2022 to September 30, 2022, the Saol Acquisition contributed net revenue and an operating loss of $14.9 million and $4.6 million, respectively. For the three months ended September 30, 2022, the Saol Acquisition contributed net revenue and an operating loss of $5.6 million and $2.6 million, respectively.
Puniska Healthcare Pvt. Ltd.
On November 2, 2021, the Company entered into a definitive agreement to acquire Puniska Healthcare Pvt. Ltd. (“Puniska”), a privately held manufacturer of parenteral and injectable drugs in India, and land in a transaction valued at $93.0 million (the “Puniska Acquisition”). Upon execution of the agreement, the Company paid $72.9 million with cash on hand for approximately 74% of the equity interests of Puniska. Upon approval of the transaction by the government of India in March 2022, the Company paid, with cash on hand, an additional $1.7 million for the remaining 26% of the equity interests of Puniska (included in redeemable non-controlling interests in the Company’s consolidated balance sheet as of December 31, 2021) and $14.2 million for the satisfaction of a preexisting payable to the sellers (included in related party payables-short term in the Company’s consolidated balance sheet as of December 31, 2021). During December 2021, the Company paid $4.3 million with cash on hand for land associated with the Puniska Acquisition.
There were no transaction costs associated with the Puniska Acquisition for the three and nine months ended September 30, 2022.
The Puniska Acquisition, excluding the land acquired in December 2021, was accounted for under the acquisition method of accounting, with Amneal as the accounting acquirer. The preliminary purchase price was calculated as follows (in thousands):
| | | | | |
Cash (1) | $ | 72,880 | |
Payable to sellers (2) | 14,162 | |
Fair value of consideration transferred | $ | 87,042 | |
(1) Cash includes the payment made upon execution of the agreement.
(2) Due to the short-term nature of the payable to the sellers, the principal amount approximates fair value.
The following is a summary of the preliminary purchase price allocation for the Puniska Acquisition (in thousands):
| | | | | |
| Preliminary Fair Values as of November 2, 2021 |
Cash | $ | 165 | |
Trade accounts receivable, net | 232 | |
Inventories | 1,092 | |
Prepaid expenses and other current assets | 4,473 |
Property, plant and equipment | 53,423 |
Goodwill | 30,091 |
Operating lease-right-of-use assets | 234 |
Other assets | 1,303 |
Total assets acquired | 91,013 |
Accounts payable and accrued expenses | 1,732 |
Operating lease liabilities | 234 |
Other long-term liabilities | 263 |
Total liabilities assumed | 2,229 | |
Redeemable non-controlling interests | 1,742 |
Fair value of consideration transferred | $ | 87,042 | |
Goodwill is calculated as the excess of the consideration transferred and fair value of the redeemable non-controlling interests over the net assets recognized. All of the goodwill acquired in connection with the Puniska Acquisition was allocated to the Company’s Generics segment.
Kashiv Specialty Pharmaceuticals, LLC Acquisition
On January 11, 2021, the Company and Kashiv Biosciences, LLC (a related party, see Note 15. Related Party Transactions) (“Kashiv”) entered into a definitive agreement for Amneal to acquire a 98% interest in Kashiv Specialty Pharmaceuticals, LLC
(“KSP”), a subsidiary of Kashiv focused on the development of innovative drug delivery platforms, novel 505(b)(2) drugs and complex generics (the “KSP Acquisition”).
On April 2, 2021, the Company completed the KSP Acquisition. Under the terms of the transaction, the cash portion of the consideration was $104.5 million, comprised of a purchase price of $100.1 million (including initial and deferred consideration) and a working capital adjustment of $4.4 million. The initial cash purchase price was funded by cash on hand. For further detail of the purchase price, refer to the table below.
Transaction costs associated with the KSP Acquisition were $3.1 million for the nine months ended September 30, 2021 and were included in acquisition, transaction-related and integration expenses (none for the three months ended September 30, 2021 and for the three and nine months ended September 30, 2022).
The KSP Acquisition was accounted for under the acquisition method of accounting, with Amneal as the accounting acquirer.
The purchase price was calculated as follows (in thousands):
| | | | | |
Cash, including working capital payments | $ | 74,440 | |
Deferred consideration (1) | 30,099 | |
Contingent consideration (regulatory milestones) (2) | 500 | |
Contingent consideration (royalties) (2) | 5,200 | |
Settlement of Amneal trade accounts payable due to KSP (3) | (7,117) | |
Fair value consideration transferred | $ | 103,122 | |
(1)The deferred consideration was stated at the fair value estimate of $30.1 million, which is the $30.5 million contractually stated amount less a $0.4 million discount. The deferred consideration consisted of $30.0 million, which the Company paid in January 2022 and $0.5 million, which the Company paid during the three months ending September 30, 2022. As the deferred consideration is non-interest bearing, the Company, using guideline companies and market borrowings with comparable risk profiles, discounted the deferred consideration at 1.7% over the period from April 2, 2021 to the maturity dates, for a fair value of $30.1 million on the date of acquisition. This discount was amortized to interest expense over the life of the deferred consideration utilizing the effective interest rate method.
(2) Kashiv is eligible to receive up to an additional $8.0 million in contingent payments upon the achievement of certain regulatory milestones and potential royalty payments from high single-digits to mid double-digits, depending on the amount of aggregate annual net sales for certain future pharmaceutical products. The estimated fair value of contingent consideration on the acquisition date was $5.7 million, based on significant Level 3 inputs that were not observable in the market. Key assumptions included the discount rate, probability of achievement of milestones, projected year of payments and expected net product sales. Refer to Note 10. Fair Value Measurements, for additional information on the methodology and determination of this liability.
(3) Represented trade accounts payable due to KSP that were effectively settled upon closing of the KSP Acquisition.
The following is a summary of the purchase price allocation for the KSP Acquisition (in thousands):
| | | | | |
| Final Fair Values as of April 2, 2021 |
Cash | $ | 112 | |
Restricted cash | 500 | |
Prepaid expenses and other current assets | 381 | |
Property, plant and equipment | 5,375 | |
Goodwill | 43,530 | |
Intangible assets | 56,400 | |
Operating lease right-of-use assets | 9,367 | |
Total assets acquired | 115,665 | |
Accounts payable and accrued expenses | 1,239 | |
Operating lease liability | 9,177 | |
Related party payable | 127 | |
Total liabilities assumed | 10,543 | |
Non-controlling interests | 2,000 | |
Fair value of consideration transferred | $ | 103,122 | |
Total acquired intangible assets of $56.4 million were comprised of marketed product rights of $29.4 million and in-process research and development (“IPR&D”) of $27.0 million.
The acquired intangible assets are being amortized over their estimated useful lives as follows (in thousands):
| | | | | | | | | | | |
| Fair Value | | Weighted-Average Useful Life (in years) |
Marketed product rights | $ | 29,400 | | | 5.9 |
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 purchase price allocation and in determining the purchase price were based on management’s best estimates as of the closing date of the KSP Acquisition on April 2, 2021.
Some of the more significant assumptions inherent in the development of those asset valuations included the estimated net cash flows for each year for each asset or product (including net revenues, cost of sales, R&D, 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. The underlying assumptions used to prepare the discounted cash flow analysis may change; accordingly, for these and other reasons, actual results may vary significantly from estimated results.
Goodwill is calculated as the excess of the consideration transferred and fair value of the non-controlling interests over the net assets recognized. Of the total goodwill acquired in connection with the KSP Acquisition, $40.8 million was allocated to the Company’s Generics segment and $2.7 million was allocated to the Company’s Specialty segment.
4. Revenue Recognition
The Company recognizes revenue in accordance with ASC 606, Revenue from Contracts with Customers. Revenue is recognized when the Company transfers control of its products to the customer, which typically occurs at a point-in-time, either upon shipment or delivery. Substantially all of the Company’s net revenues relate to products which are transferred to the customer at a point-in-time.
Concentration of Revenue
The following table summarizes revenues from each of our customers which individually accounted for 10% or more of our total net revenue:
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2022 | | 2021 | | 2022 | | 2021 |
Customer A | 21 | % | | 18 | % | | 20 | % | | 21 | % |
Customer B | 17 | % | | 20 | % | | 17 | % | | 20 | % |
Customer C | 23 | % | | 25 | % | | 23 | % | | 24 | % |
Customer D | 9 | % | | 9 | % | | 11 | % | | 10 | % |
Disaggregated Revenue
The Company's significant therapeutic classes for its Generics and Specialty segments and sales channels for its AvKARE segment, as determined based on net revenue for the three and nine months ended September 30, 2022 and 2021, are set forth below (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended September 30, | | Nine Months Ended September 30, |
| | 2022 | | 2021 | | 2022 | | 2021 |
Generics | | | | | | | |
| Anti-Infective | $ | 4,957 | | | $ | 9,406 | | | $ | 16,768 | | | $ | 24,996 | |
| Hormonal/ Allergy | 119,726 | | | 107,614 | | | 334,403 | | | 325,971 | |
| Antiviral (1) | 5,782 | | | 9,762 | | | 17,649 | | | 1,560 | |
| Central Nervous System | 96,877 | | | 91,263 | | | 286,789 | | | 294,182 | |
| Cardiovascular System | 28,926 | | | 35,692 | | | 84,422 | | | 107,137 | |
| Gastroenterology | 17,129 | | | 17,172 | | | 51,280 | | | 56,333 | |
| Oncology | 12,240 | | | 21,203 | | | 47,872 | | | 73,683 | |
| Metabolic Disease/Endocrine | 9,276 | | | 12,893 | | | 30,497 | | | 26,331 | |
| Respiratory | 8,720 | | | 8,233 | | | 26,503 | | | 26,874 | |
| Dermatology | 17,327 | | | 14,860 | | | 48,741 | | | 42,556 | |
| Other therapeutic classes | 29,101 | | | 18,983 | | | 86,790 | | | 39,857 | |
| International and other | 205 | | | 46 | | | 1,194 | | | 592 | |
| Total Generics net revenue | 350,266 | | | 347,127 | | | 1,032,908 | | | 1,020,072 | |
Specialty | | | | | | | |
| Hormonal/ Allergy | 22,012 | | | 16,422 | | | 65,751 | | | 49,230 | |
| Central Nervous System | 61,785 | | | 68,869 | | | 185,309 | | | 201,710 | |
| Other therapeutic classes | 5,687 | | | 7,454 | | | 20,511 | | | 26,371 | |
| Total Specialty net revenue | 89,484 | | | 92,745 | | | 271,571 | | | 277,311 | |
AvKARE | | | | | | | |
| Distribution | 66,057 | | | 48,048 | | | 190,560 | | | 141,863 | |
| Government Label | 26,000 | | | 29,898 | | | 72,739 | | | 90,142 | |
| Institutional | 8,297 | | | 7,873 | | | 20,672 | | | 18,832 | |
| Other | 5,453 | | | 2,902 | | | 14,095 | | | 8,553 | |
| Total AvKARE net revenue | 105,807 | | | 88,721 | | | 298,066 | | | 259,390 | |
| Total net revenue | $ | 545,557 | | | $ | 528,593 | | | $ | 1,602,545 | | | $ | 1,556,773 | |
(1) Antiviral net revenue for the nine months ended September 30, 2021 reflected lower demand and increased returns activity for Oseltamivir (generic Tamiflu®) above historical levels due to decreased influenza activity during the onset of the COVID-19 pandemic.
A rollforward of the major categories of sales-related deductions for the nine months ended September 30, 2022 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, 2021 | $ | 503,902 | | | $ | 23,642 | | | $ | 161,978 | | | $ | 85,737 | |
Provision related to sales recorded in the period | 2,389,025 | | | 79,658 | | | 61,052 | | | 90,308 | |
Credits/payments issued during the period | (2,517,447) | | | (81,342) | | | (77,616) | | | (96,379) | |
Balance at September 30, 2022 | $ | 375,480 | | | $ | 21,958 | | | $ | 145,414 | | | $ | 79,666 | |
5. 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.
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 supply agreement was subsequently amended on March 2, 2021 and the licensing agreement was amended on March 4, 2021. Pursuant to the agreement, the Company will be the exclusive partner in the U.S. market and 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 $78.3 million. For the nine months ended September 30, 2021, the Company recognized $9.5 million of research and development expense under this agreement (none for the three months ended September 30, 2021 and the three and nine months ended September 30, 2022).
On April 13, 2022, the Food and Drug Administration (“FDA”) approved the Company’s biologics license application for bevacizumab-maly, a biosimilar referencing Avastin®. In connection with this regulatory approval and associated activity, the Company incurred milestones of $26.5 million during the nine months ended September 30, 2022 (none during the three months ended September 30, 2022). The milestones, of which $10.0 million was paid during the three months ended June 30, 2022 and $16.5 million was paid during the three months ended September 30, 2022, have been capitalized as product rights intangible assets and will be amortized to cost of sales over their estimated useful lives of 7 years.
Agreements with Kashiv Biosciences, LLC
For details on the Company’s related party agreements with Kashiv, refer to Note 15. Related Party Transactions in this Form 10-Q and the Company’s 2021 Annual Report on Form 10-K.
6. (Loss) Earnings per Share
Basic (loss) earnings per share of the Company’s class A common stock is computed by dividing net (loss) income attributable to Amneal Pharmaceuticals, Inc. by the weighted-average number of shares of class A common stock outstanding during the period. Diluted (loss) earnings per share of class A common stock is computed by dividing net (loss) income attributable to Amneal Pharmaceuticals, Inc. by the weighted-average number of shares of class A 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) earnings per share of class A common stock (in thousands, except per share amounts):
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2022 | | 2021 | | 2022 | | 2021 |
Numerator: | | | | | | | |
Net (loss) income attributable to Amneal Pharmaceuticals, Inc. | $ | (2,689) | | | $ | (4,237) | | | $ | (125,653) | | | $ | 17,001 | |
Denominator: | | | | | | | |
Weighted-average shares outstanding - basic | 151,393 | | | 149,290 | | | 150,765 | | | 148,771 | |
Effect of dilutive securities: | | | | | | | |
Stock options | — | | | — | | | — | | | 785 | |
Restricted stock units | — | | | — | | | — | | | 2,099 | |
Weighted-average shares outstanding - diluted | 151,393 | | | 149,290 | | | 150,765 | | | 151,655 | |
Net (loss) earnings per share attributable to Amneal Pharmaceuticals, Inc.’s class A common stockholders: | | | | | | | |
Basic | $ | (0.02) | | | $ | (0.03) | | | $ | (0.83) | | | $ | 0.11 | |
Diluted | $ | (0.02) | | | $ | (0.03) | | | $ | (0.83) | | | $ | 0.11 | |
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 (loss) 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 (loss) earnings per share of class A common stock (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, | |
| 2022 | | 2021 | | | 2022 | | 2021 | |
Stock options | 2,728 | | (1) | 3,102 | | (1) | | 2,728 | | (1) | 347 | | (3) |
Restricted stock units | 10,874 | | (1) | 8,171 | | (1) | | 10,874 | | (1) | — | | |
Performance stock units | 7,266 | | (1) | 5,184 | | (1) | | 7,266 | | (1) | 5,184 | | (4) |
Shares of class B common stock | 152,117 | | (2) | 152,117 | | (2) | | 152,117 | | (2) | 152,117 | | (2) |
(1)Excluded from the computation of diluted earnings per share of class A common stock because the effect of their inclusion would have been anti-dilutive since there was a net loss attributable to the Company during the period.
(2)Shares of class B common stock are considered potentially dilutive shares of class A common stock. Shares of class B common stock have been excluded from the computations of diluted (loss) earnings per share because the effect of their inclusion would have been anti-dilutive under the if-converted method.
(3)Excluded from the computation of diluted earnings per share of class A common stock because the exercise price of the stock options exceeded the average market price of the class A common stock during the period (out-of-the-money).
(4)Excluded from the computation of diluted earnings per share of class A common stock because the performance vesting conditions were not met during the period.
7. Income Taxes
For the three months ended September 30, 2022, the Company’s provision for income taxes and effective tax rates were $4.6 million and 209.6%, respectively, compared to $4.0 million and (198.2)%, respectively, for the three months ended September 30, 2021. The period-over-period change in the provision for income taxes was primarily related to a change in the mix of foreign income.
For the nine months ended September 30, 2022, the Company’s provision for income taxes and effective tax rates were $8.5 million and (3.5)%, respectively, compared to $7.1 million and 14.8%, respectively, for the nine months ended September 30, 2021. The period-over-period change in the provision for income taxes was primarily related to a change in the mix of foreign income and a discrete benefit as a result of the completion of an Internal Revenue Service examination and Joint Committee review of the 2012-2018 federal income tax returns, which enabled the Company to recognize previously unrecognized tax benefits.
As of September 30, 2019, the Company established a valuation allowance based upon all available objective and verifiable evidence both positive and negative, including historical levels of pre-tax income (loss) both on a consolidated basis and tax reporting entity basis, legislative developments, expectations and risks associated with estimates of future pre-tax income, and prudent and feasible tax planning strategies. The Company estimated that as of September 30, 2019, it had generated a cumulative consolidated three-year pre-tax loss, which continued as of December 31, 2021. As a result of the initial September 30, 2019 and December 31, 2021 analyses, the Company determined that it remained more likely than not that it would not realize the benefits of its gross deferred tax assets (“DTAs”) and, therefore, maintained its valuation allowance. As of December 31, 2021, this valuation allowance was $416.6 million, and it reduced the carrying value of these gross DTAs, net of the impact of the reversal of taxable temporary differences, to zero. As of September 30, 2022, based on its evaluation of available positive and negative evidence, the Company has maintained its position with respect to the valuation allowance.
The Company entered into a tax receivable agreement (“TRA”) for which it is generally required to pay the 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. In conjunction with the valuation allowance recorded on the DTAs at September 30, 2019, the Company reversed the TRA liability.
The projection of future taxable income involves significant judgment. Actual taxable income may differ from the Company’s estimates, which could significantly impact the timing of the recognition of the contingent liability under the TRA. As noted above, the Company has determined it is more-likely-than-not it will be unable to utilize all of its DTAs subject to the TRA; therefore, as of September 30, 2022, the Company has not recognized the contingent liability under the TRA related to the tax savings it may realize from common units sold or exchanged. If utilization of these DTAs becomes more likely than not in the future, at such time, Amneal will recognize a liability under the TRA as a result of basis adjustments under Internal Revenue Code Section 754. As of both September 30, 2022 and December 31, 2021, the contingent liability associated with the TRA was approximately $206.3 million.
The timing and amount of any payments under the TRA may vary depending upon a number of factors, including the timing and number of Amneal Common Units sold or exchanged for the Company's class A common stock, the price of the Company's class A common stock on the date of sale or exchange, the timing and amount of the Company's taxable income, and the tax rate in effect at the time of realization of the Company's taxable income (the TRA liability is determined based on a percentage of the corporate tax savings from the use of the TRA's attributes). Further sales or exchanges occurring subsequent to September 30, 2022 could result in future Amneal tax deductions and obligations to pay 85% of such benefits to the holders of Amneal Common Units. These obligations could be incremental to and substantially larger than the approximate $206.3 million contingent liability as of September 30, 2022 described above. Under certain conditions, such as a change of control or other early termination event, the Company could be obligated to make TRA payments in advance of tax benefits being realized. Payments could also be in excess of the tax savings that the Company may ultimately realize.
Any future recognition of these TRA liabilities will be recorded through charges in the Company’s consolidated statements of operations. However, if the tax attributes are not utilized in future years, it is reasonably possible no amounts would be paid under the TRA. Should the Company determine that a DTA with a valuation allowance is realizable in a subsequent period, the related valuation allowance will be reversed and if a resulting TRA payment is determined to be probable, a corresponding TRA liability will be recorded.
The U.S. federal government has recently signed into law the Inflation Reduction Act of 2022 (the “IRA”) which, among other things, imposes a minimum “book” tax on certain large corporations and creates a new excise tax on stock repurchases made by certain publicly traded corporations after December 31, 2022. Although the Company continues to evaluate the impact of the IRA on its consolidated financial statements as it awaits further guidance, the Company does not currently expect a material impact.
8. Trade Accounts Receivable, Net
Trade accounts receivable, net was comprised of the following (in thousands):
| | | | | | | | | | | |
| September 30, 2022 | | December 31, 2021 |
Gross accounts receivable | $ | 1,028,124 | | | $ | 1,191,792 | |
Allowance for credit losses | (1,949) | | | (1,665) | |
Contract charge-backs and sales volume allowances | (375,480) | | | (503,902) | |
Cash discount allowances | (21,958) | | | (23,642) | |
Subtotal | (399,387) | | | (529,209) | |
Trade accounts receivable, net | $ | 628,737 | | | $ | 662,583 | |
Concentration of Receivables
Trade accounts receivable from customers representing 10% or more of the Company’s total trade accounts receivable were as follows:
| | | | | | | | | | | |
| September 30, 2022 | | December 31, 2021 |
Customer A | 35 | % | | 37 | % |
Customer B | 20 | % | | 24 | % |
Customer C | 28 | % | | 25 | % |
9. Inventories
Inventories were comprised of the following (in thousands):
| | | | | | | | | | | |
| September 30, 2022 | | December 31, 2021 |
Raw materials | $ | 220,030 | | | $ | 214,508 | |
Work in process | 76,161 | | | 47,802 | |
Finished goods | 247,667 | | | 227,079 | |
Total inventories | $ | 543,858 | | | $ | 489,389 | |
10. Fair Value Measurements
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 September 30, 2022 and December 31, 2021 (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | Fair Value Measurement Based on |
September 30, 2022 | | Total | | Quoted Prices in Active Markets (Level 1) | | Significant Other Observable Inputs (Level 2) | | Significant Unobservable Inputs (Level 3) |
Assets | | | | | | | | |
Interest rate swap asset (1) | | $ | 88,860 | | | $ | — | | | $ | 88,860 | | | $ | — | |
Liabilities | | | | | | | | |
Deferred compensation plan liabilities (2) | | $ | 9,558 | | | $ | — | | | $ | 9,558 | | | $ | — | |
Contingent consideration liabilities (3) | | $ | 13,201 | | | $ | — | | | $ | — | | | $ | 13,201 | |
| | | | | | | | |
December 31, 2021 | | | | | | | | |
Liabilities | | | | | | | | |
Interest rate swap liability (1) | | $ | 11,473 | | | $ | — | | | $ | 11,473 | | | $ | — | |
Deferred compensation plan liabilities (2) | | $ | 13,883 | | | $ | — | | | $ | 13,883 | | | $ | — | |
Contingent consideration liability (3) | | $ | 5,900 | | | $ | — | | | $ | — | | | $ | 5,900 | |
(1)The fair value measurement of the Company’s interest rate swap classified within Level 2 of the fair value hierarchy is a model-derived valuation as of a given date in which all significant inputs are observable in active markets including certain financial information and certain assumptions regarding past, present, and future market conditions. Refer to Note 11. Financial Instruments for information on the Company's interest rate swap.
(2)These liabilities are 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.
(3)The fair value measurement of contingent consideration liabilities has been classified as Level 3 recurring liabilities as the valuations require judgment and estimation of factors that are not currently observable in the market. If different assumptions were used for various inputs, the estimated fair values could be higher or lower than what the Company determined. As of September 30, 2022, the contingent consideration liability associated with the Saol Acquisition included $0.4 million recorded in accounts payable and accrued expenses and $7.9 million recorded in other-longer term liabilities. As of September 30, 2022 and December 31, 2021, the contingent consideration liability associated with the KSP Acquisition was valued at approximately $4.9 million and $5.9 million, respectively, and recorded within related party payables - long term. Refer to Note 3. Acquisitions for additional information related to contingent consideration associated with the KSP Acquisition and the Saol Acquisition.
There were no transfers between levels in the fair value hierarchy during the nine months ended September 30, 2022.
Contingent consideration
On April 2, 2021, the Company completed the KSP Acquisition, which provides for contingent milestone payments of up to an aggregate of $8.0 million (undiscounted) upon the achievement of certain regulatory milestones, as well as contingent royalty payments that are tiered depending on the aggregate annual net sales for certain future pharmaceutical products.
On February 9, 2022, the Company completed the Saol Acquisition, which provides for contingent royalty payments that are tiered depending on the aggregate annual net sales for certain pharmaceutical products, beginning in 2023.
The following table provides a reconciliation of the contingent consideration liability measured at fair value on a recurring basis using significant unobservable inputs (Level 3) (in thousands):
| | | | | | | | | | | | | | |
| | | | | | |
| | Nine Months Ended September 30, 2022 | | Year Ended December 31, 2021 | | |
Balance, beginning of period | | $ | 5,900 | | | $ | — | | | |
Addition due to the Saol Acquisition | | 8,796 | | | — | | | |
Addition due to the KSP Acquisition | | — | | | 5,700 | | | |
Change in fair value during the period | | (1,495) | | | 200 | | | |
Balance, end of period | | $ | 13,201 | | | $ | 5,900 | | | |
The fair value measurement of the contingent consideration liabilities were determined based on significant unobservable inputs, including the discount rate, estimated probabilities of success, timing of achieving specified regulatory milestones and the estimated amount of future sales of the acquired products. The contingent consideration liabilities were estimated by applying a probability-weighted expected payment model for contingent milestone payments and Monte Carlo simulation models for contingent royalty payments, which were then discounted to present value. Changes to the fair values of the contingent consideration liabilities can result from changes to one or a number of the aforementioned inputs. If different assumptions were used for various inputs, the estimated fair value could be higher or lower than what the Company determined.
The following table summarizes the significant unobservable inputs used in the fair value measurement of our contingent consideration liabilities as of September 30, 2022:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Contingent Consideration Liability | | Fair Value as of September 30, 2022 (in thousands) | | Unobservable input | | Range | | Weighted Average(1) |
Regulatory Milestones (KSP Acquisition) | | $420 | | Discount rate | | 9.2% | - | 9.9% | | 9.3% |
| | Probability of payment | | 1.8% | - | 20.0% | | 17.0% |
| | Projected year of payment | | 2024 | - | 2027 | | 2024 |
Royalties (KSP Acquisition) | | $4,500 | | Discount rate | | 13.5% | - | 13.5% | | 13.5% |
| | Probability of payment | | 1.8% | - | 20.0% | | 17.8% |
| | Projected year of payment | | 2024 | - | 2032 | | 2029 |
Royalties (Saol Acquisition) | | $8,281 | | Discount rate | | 17.3% | - | 17.3% | | 17.3% |
| | Projected year of payment | | 2023 | - | 2033 | | 2025 |
| | | | | | | | | | |
| | | | | | | | | | |
(1) Unobservable inputs were weighted by the relative fair value of each product candidate acquired.
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 Term Loan, as defined in Note 17. Debt in the Company’s 2021 Annual Report on Form 10-K, is in 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 September 30, 2022 was approximately $2.1 billion as compared to approximately $2.6 billion at December 31, 2021.
The Rondo Term Loan, as defined in Note 17. Debt in the Company’s 2021 Annual Report on Form 10-K, is in the Level 2 category within the fair value level hierarchy. The fair value of the Rondo Term Loan at September 30, 2022 and December 31, 2021 was $80.8 million and $139.0 million, respectively.
The Sellers Notes are in the Level 2 category within the fair value level hierarchy. The fair value of the Sellers Notes at September 30, 2022 and December 31, 2021 was $38.7 million and $38.0 million, respectively.
Refer to Note 17. Debt in our 2021 Annual Report on Form 10-K for detailed information about our indebtedness, including definitions of terms.
Assets and Liabilities Measured at Fair Value on a Non-Recurring Basis
There were no non-recurring fair value measurements during the nine months ended September 30, 2022 and 2021.
11. Financial Instruments
The Company uses an interest rate swap to manage its exposure to market risks for changes in interest rates.
Interest Rate Risk
Interest income earned on cash and cash equivalents may fluctuate as interest rates change; however, due to their relatively short maturities, the Company does not hedge these assets or their investment cash flows because the impact of interest rate risk is not material. The Company is exposed to interest rate risk on its debt obligations. The Company's debt obligations consist of variable-rate and fixed-rate debt instruments. The Company's primary objective is to achieve the lowest overall cost of funding while managing the variability in cash outflows within an acceptable range. In order to achieve this objective, the Company has entered into an interest rate swap on the Term Loan.
Interest Rate Derivative – Cash Flow Hedge
The interest rate swap involves the periodic exchange of payments without the exchange of underlying principal or notional amounts. In October 2019, the Company entered into an interest rate lock agreement for a total notional amount of $1.3 billion to hedge part of the Company's interest rate exposure associated with the variability in future cash flows from changes in the one-month LIBOR associated with the Term Loan.
As of September 30, 2022, the total gain, net of income taxes, related to the Company’s cash flow hedge was $88.9 million, of which $44.0 million was recognized in accumulated other comprehensive income and $44.9 million was recognized in non-controlling interests.
A summary of the fair values of derivative instruments in the consolidated balance sheets was as follows (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | September 30, 2022 | | December 31, 2021 |
Derivatives Designated as Hedging Instruments | | Balance Sheet Classification | | Fair Value | | Balance Sheet Classification | | Fair Value |
Variable-to-fixed interest rate swap | | Other assets | | $ | 88,860 | | | Other long-term liabilities | | $ | 11,473 | |
12. Goodwill and Other Intangible Assets
The changes in goodwill for the nine months ended September 30, 2022 and for the year ended December 31, 2021 were as follows (in thousands):
| | | | | | | | | | | |
| September 30, 2022 | | December 31, 2021 |
Balance, beginning of period | $ | 593,017 | | | $ | 522,814 | |
Goodwill acquired during the period | 7,553 | | | 70,584 | |
Adjustment during the period for Puniska Acquisition | 3,075 | | | — | |
Currency translation | (4,141) | | | (381) | |
Balance, end of period | $ | 599,504 | | | $ | 593,017 | |
As of September 30, 2022, $366.3 million, $163.7 million, and $69.5 million of goodwill was allocated to the Specialty, Generics, and AvKARE segments, respectively. As of December 31, 2021, $363.9 million, $159.6 million, and $69.5 million of goodwill was allocated to the Specialty, Generics, and AvKARE segments, respectively. For the nine months ended September 30, 2022, goodwill acquired during the period was associated with the Saol Acquisition. For the year ended December 31, 2021, goodwill acquired during the period was associated with the Puniska Acquisition and the KSP Acquisition. Refer to Note 3. Acquisitions for additional information.
Intangible assets at September 30, 2022 and December 31, 2021 were comprised of the following (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| September 30, 2022 | | December 31, 2021 |
| Weighted-Average Amortization Period (in years) | | Cost | | Accumulated Amortization | | Net | | Cost | | Accumulated Amortization | | Net |
Amortizing intangible assets: | | | | | | | | | | | | | |
Product rights | 7.7 | | $ | 1,240,071 | | | $ | (547,330) | | | $ | 692,741 | | | $ | 1,122,612 | | | $ | (436,902) | | | $ | 685,710 | |
Other intangible assets | 4.3 | | 133,800 | | | (72,961) | | | 60,839 | | | 133,800 | | | (58,013) | | | 75,787 | |
Subtotal | | | $ | 1,373,871 | | | $ | (620,291) | | | $ | 753,580 | | | $ | 1,256,412 | | | $ | (494,915) | | | $ | 761,497 | |
In-process research and development | | | 405,425 | | | — | | | 405,425 | | | 405,425 | | | — | | | 405,425 | |
Total intangible assets | | | $ | 1,779,296 | | | $ | (620,291) | | | $ | 1,159,005 | | | $ | 1,661,837 | | | $ | (494,915) | | | $ | 1,166,922 | |
During the nine months ended September 30, 2022, the Company recognized $83.8 million of marketed product rights intangible assets associated with the purchase price allocation of the Saol Acquisition. During the nine months ended September 30, 2021, the Company recognized $56.4 million of intangible assets associated with the purchase price allocation of the KSP Acquisition, consisting of $29.4 million of marketed product rights and $27.0 million of IPR&D. Product rights are amortized to cost of goods sold over their estimated useful lives. Refer to Note 3. Acquisitions for additional information on the purchase price allocation associated with the Saol Acquisition and the final purchase price allocation associated with the KSP Acquisition.
Amortization expense related to intangible assets was as follows (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2022 | | 2021 | | 2022 | | 2021 |
Amortization | $ | 44,545 | | | $ | 43,809 | | | $ | 127,446 | | | $ | 129,001 | |
The following table presents future amortization expense for the next five years and thereafter, excluding $405.4 million of IPR&D intangible assets (in thousands):
| | | | | |
| Future Amortization |
Remainder of 2022 | $ | 45,498 | |
2023 | 161,613 | |
2024 | 158,692 | |
2025 | 120,790 | |
2026 | 71,891 | |
Thereafter | 195,096 | |
Total | $ | 753,580 | |
The Company reviews intangible assets with finite lives for recoverability whenever events or changes in circumstances indicate that the carrying amount of the assets may not be fully recoverable. Indefinite-lived intangible assets, including IPR&D, are tested for impairment if impairment indicators arise and, at a minimum, annually.
For the three and nine months ended September 30, 2022, the Company recognized $0.7 million and $5.8 million, respectively, of intangible asset impairment charges, which were recognized in cost of goods sold impairment charges. The impairment charge for the three months ended September 30, 2022 was related to a product that is no longer expected to be sold to a key customer, and therefore the asset is not expected to be recoverable. The impairment charges for the nine months ended September 30, 2022 relates to the aforementioned charge, and a marketed product that experienced significant price erosion without an offsetting increase in customer demand, resulting in significantly lower than expected future margins.
For the three months ended September 30, 2021, the Company recognized $0.7 million of intangible asset impairments, which were recognized in cost of goods sold impairment charges. The impairment charges were related to two marketed products, which experienced significant price erosion during 2021.
For the nine months ended September 30, 2021, the Company recognized $1.4 million of intangible asset impairment charges, of which $0.7 million was recognized in cost of goods sold impairment charges and $0.7 million was recognized in in-process research and development impairment charges. The cost of goods sold impairment charges were related to the two aforementioned marketed products and the in-process research and development impairment charges related to one IPR&D product, which experienced a delay in its estimated launch date.
13. 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 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. Refer to Note 5. Alliance and Collaboration for additional information. Certain of these arrangements are with related parties. Refer to Note 15. Related Party Transactions for additional information.
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 its significant legal proceedings which are set forth below. 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. While the Company believes it has meritorious claims and/or defenses to the matters described below (and intends to vigorously prosecute and defend them), the nature and cost of litigation is unpredictable, and an unfavorable outcome of such 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 a potential loss. When the Company has a probable loss for which a reasonable estimate of the liability is a range of losses and no amount within that range is a better estimate than any other amount, the Company records the loss at the low end of the range. 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 unable at this time to estimate the possible loss or the range of loss, if any, associated with such legal proceedings and claims. Any such claims, proceedings, investigations or litigation, regardless of the merits, might result in substantial costs to defend or settle, borrowings under our debt agreements, restrictions on product use or sales, or otherwise harm our business. The ultimate resolution of any or all claims, legal proceedings or investigations are inherently uncertain and difficult to predict, could differ materially from our estimates and could have a material adverse effect on the Company's results of operations and/or cash flows in any given accounting period, or on the Company's overall financial condition. 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. An insurance recovery, if any, is recorded in the period in which it is probable the recovery will be realized.
Charges (insurance recoveries) related to legal matters, net were comprised of the following (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2022 | | 2021 | | 2022 | | 2021 |
Opana ER® antitrust litigation | $ | — | | | $ | — | | | $ | 262,837 | | | $ | — | |
Securities class action - Cambridge Retirement System v. Amneal | — | | | 19,000 | | | (15,500) | | | 19,000 | |
Galeas v. Amneal | — | | | — | | | 1,200 | | | — | |
Other | 285 | | | — | | | 1,299 | | | — | |
Total | $ | 285 | | | $ | 19,000 | | | $ | 249,836 | | | $ | 19,000 | |
Liabilities for legal matters were comprised of the following (in thousands):
| | | | | | | | | | | |
Matter | September 30, 2022 | | December 31, 2021 |
Opana ER® Antitrust Litigation(1) | $ | 173,000 | | | $ | — | |
Opana ER® Antitrust Litigation - Accrued Interest | 937 | | | — | |
Securities Class Action - Fleming v. Impax(2) | — | | | 33,000 | |
Securities Class Action - Cambridge Retirement System v. Amneal(2) | — | | | 25,000 | |
Galeas vs. Amneal | 1,200 | | | — | |
Other | 957 | | | — | |
Current portion of liabilities for legal matters | $ | 176,094 | | | $ | 58,000 | |
| | | |
Opana ER® Antitrust Litigation | $ | 50,000 | | | $ | — | |
Imputed interest | (1,743) | | | — | |
Accrued interest | 468 | | | — | |
Long-term portion of liabilities for legal matters (included in other long-term liabilities) | $ | 48,725 | | | $ | — | |
(1) During June 2022 and July 2022, the Company paid $100.0 million and $15.0 million, respectively, into a settlement escrow account, of which $73.0 million remains as of September 30, 2022 after payment of $42.0 million in court-approved claims from the escrow account to certain plaintiffs during July 2022.
(2) During July 2022 and August 2022, respectively, the securities class actions Fleming v. Impax and Cambridge Retirement System v. Amneal were settled for $33.0 million and $25.0 million, respectively, upon final approval by the court.
As of September 30, 2022, the remaining payments associated with the Opana ER® antitrust litigation settlement agreements and the Preliminary Settlement Agreements (as defined below) are as follows:
| | | | | | | | |
| | Amount Due |
December 2022 | | $ | 16,056 | |
January 2023 | | 83,944 | |
January 2024 | | 50,000 | |
| | 150,000 | |
Add: Escrow account balance as of September 30, 2022 | | 73,000 | |
Undiscounted liability as of September 30, 2022 | | $ | 223,000 | |
3% interest is payable on the amounts due in December 2022, January 2023, and January 2024. The Company includes the interest accrual on these amounts as a component of the current portion of liabilities for legal matters. Additional interest of 2.7% was imputed on the $50.0 million long-term liability due in January 2024, resulting in an initial discount of $2.2 million, which will be amortized to interest expense over the life of the liability using the effective interest method.
As noted above, payments made with respect to litigation that has not been finally settled are recorded as escrow deposit assets. Upon final approval by the court, escrow deposit assets funded by the Company and its insurers will be used to satisfy the associated accrued liabilities. Refer to Note 17. Prepaid Expenses and Other Current Assets for additional information on settlement escrow deposits.
Refer to the respective discussions below for additional information on the significant matters in the tables above.
Medicaid Reimbursement and Price Reporting Matters
The Company is required to provide pricing information to state agencies, including 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. Other agencies have alleged that manufacturers have failed to timely file required reports concerning pricing information. Liabilities are periodically established by the Company for any potential claims or settlements of overpayment. The Company intends to vigorously defend against any such claims. 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 Generics 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.
When a drug developer files an Abbreviated Biologics License Application (“aBLA”) seeking approval to manufacture and market a biosimilar product, there are also procedures in place to resolve patent disputes early in the process if the parties choose to do so. To engage these legal provisions, an aBLA filer must produce a copy of the aBLA and relevant manufacturing information to the reference drug manufacturer shortly after the FDA accepts the aBLA for filing. This triggers what is termed the “patent dance” and begins a series of exchanges that will ultimately define the scope of a resulting patent litigation related to the product that is the subject of the aBLA. Notably, 60 days after receiving the aBLA and manufacturing information, the Biologics Application sponsor must provide a list of patents that are potentially infringed by the aBLA product. Within 60 days of receiving that list, the aBLA filer must provide its positions of why the disclosed patents are invalid or will not be infringed by the aBLA product. The patent owner can then respond to the non-infringement and invalidity positions, and the parties will negotiate the scope of litigation related to the disclosed patents. This “patent dance” is optional, but can provide certainty regarding the scope of litigation and can be valuable in settlement negotiations. If the parties do not resolve the dispute over the course of the “patent dance”, the case will proceed to patent litigation. There is no stay of FDA approval for biosimilar products, providing opportunities for the aBLA filer to launch while litigation is pending, which need to be carefully assessed.
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 the 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 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 Matter
Biogen International GMBH, et al. v. Amneal Pharmaceuticals LLC, et al. (Dimethyl Fumarate)
In June 2017, Biogen International GMBH (“Biogen”) filed suit against Amneal and various other generic manufacturers in the United States District Court for the District of Delaware (“D. Del.”) alleging patent infringement based on the filing of ANDAs by Amneal and others for generic alternatives to Biogen’s Tecfidera® (dimethyl fumarate) capsules product (Biogen International GMBH, et al. v. Amneal Pharmaceuticals LLC, et al., No. 1:17-cv-00823-MN). Biogen also filed suit in June 2017 against Mylan Pharmaceuticals Inc. (“Mylan”) in the United States District Court for the Northern District of West Virginia (“N.D. W. Va.”) relating to Mylan’s own ANDA for Tecfidera®. On June 18, 2020, the N.D. W. Va. court issued an
order finding the sole Biogen patent at issue invalid. Biogen appealed the order (the “Mylan Appeal”) to the United States Court of Appeals for the Federal Circuit (the “Federal Circuit”). On September 22, 2020, the D. Del. court entered judgment in favor of the defendants (including Amneal), adopting the finding of invalidity made by the N.D. W. Va. court. Biogen appealed the D. Del. Order (“the Amneal Consolidated Appeal”).
Amneal, like Mylan and several other generic manufacturers, launched its generic dimethyl fumarate capsule products “at-risk,” pending the outcome of Biogen’s appeal of the N.D. W. Va. order.
On November 30, 2021, the Federal Circuit affirmed the N.D. W. Va. court’s order that Biogen’s patent is invalid: on March 23, 2022, issued a mandate in the Mylan Appeal as to the invalidity of the patent; and on June 16, 2022, Biogen filed a cert petition with the Supreme Court of the United States (the “U.S. Supreme Court”) which was denied on October 3, 2022. On October 31, 2022, the Federal Circuit dismissed Biogen’s consolidated appeals.
Other Litigation Related to the Company’s Business
Opana ER® FTC Matters
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 settlement agreement that resolved patent litigation in connection with the submission of Impax’s ANDA for generic original Opana® ER. In October 2016, the Court granted Impax’s motion to sever, formally terminating the suit against Impax. In January 2017, the FTC filed a Part 3 Administrative Complaint against Impax with similar allegations regarding the 2010 settlement. Following trial, in May 2018, the Administrative Law Judge ruled in favor of Impax and dismissed the Complaint in its entirety. FTC Complaint Counsel appealed the decision to the full Commission, and in March 2019, the FTC issued an Opinion & Order reversing the Administrative Law Judge’s decision. The Opinion & Order did not provide for any monetary damages but prevented Impax from entering into future agreements containing certain terms. Impax filed a Petition for Review of the FTC’s Opinion & Order with the United States Court of Appeals for the Fifth Circuit, and on April 13, 2021, the Fifth Circuit issued a decision denying Impax’s Petition for Review, effectively affirming the FTC’s Opinion & Order. On September 10, 2021, Impax filed a petition for writ of certiorari in the U.S. Supreme Court, which was denied in December 2021.
On July 12, 2019, the Company received a CID from the FTC concerning an August 2017 settlement agreement between Impax and Endo, which resolved a subsequent patent infringement and breach of contract dispute between the parties regarding the above-referenced June 2010 settlement agreement related to Opana® ER. The Company cooperated with the FTC regarding the CID. On January 25, 2021, the FTC filed a complaint against Endo, Impax and Amneal in the United States District Court for the District of Columbia, alleging that the 2017 settlement violated antitrust laws. In April 2021, the Company filed a motion to dismiss the FTC’s complaint, which the District Court granted on March 24, 2022. The FTC appealed the District Court’s decision in May 2022, which appeal remains pending. The Company believes it has strong defenses to the FTC’s allegations and intends to vigorously defend the action, however, no assurance can be given as to the timing or outcome of the litigation.
Opana ER® Antitrust Litigation
From June 2014 to April 2015, several complaints styled as class actions on behalf of direct purchasers and indirect purchasers (or end-payors) and several separate individual complaints on behalf of certain direct purchasers (the “opt-out plaintiffs”) of Opana ER® were filed against Endo and Impax.
In December 2014, the United States Judicial Panel on Multidistrict Litigation (the “JPML”) transferred the actions to the United States District Court for the Northern District of Illinois (“N.D. Ill.”) for coordinated pretrial proceedings, as In Re: Opana ER Antitrust Litigation (MDL No. 2580) (“MDL”). 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.
In June 2022, Impax entered into a preliminary settlement agreement with the class of direct purchasers that, if all conditions are satisfied, would result in the resolution of substantially all the direct purchasers’ and individual complainants’ underlying claims and lawsuits in the MDL. At the same time, Impax entered into a settlement agreement with individual complainants that resolved all of their claims and lawsuits in the MDL. Subsequently, Impax entered into a separate preliminary settlement agreement with the class of indirect purchasers that, if all conditions are satisfied, would result in the resolution of substantially all the indirect purchasers’ underlying claims and lawsuits in the MDL. The preliminary settlement agreements are referred to herein collectively as the “Preliminary Settlement Agreements,” and the direct purchaser plaintiffs, indirect purchaser plaintiffs,
and individual complainants are referred to herein collectively as “the Plaintiffs.” On November 3, 2022, the N.D. Ill. approved the direct purchasers’ settlement.
Pursuant to the settlement agreements, the Company has agreed to pay a total of $265.0 million between 2022 and mid-January 2024 to resolve substantially all the Plaintiffs’ claims. 3% interest is due on $150.0 million payable between December 2022 and mid-January 2024. The settlement agreements are not an admission of liability or fault by Impax, the Company or its subsidiaries, and with respect to the Preliminary Settlement Agreements between Impax and the purported classes of (i) direct purchaser plaintiffs and (ii) indirect purchaser plaintiffs, they are subject to court approval. Upon satisfaction of the relevant pre-conditions, including but not limited to court approval of the final settlement agreements, substantially all the claims and lawsuits in the litigation will have been resolved. During the nine months ended September 30, 2022, the Company recorded a pre-tax charge of $262.8 million associated with the settlement agreements and the Preliminary Settlement Agreements. Imputed interest of $2.2 million will be recognized to interest expense during the payment period.
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. Plaintiff seeks, among other things, unspecified monetary damages, and equitable relief, including disgorgement and restitution. On September 13, 2016, the Court stayed the indirect purchaser plaintiff’s 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 and 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 plaintiff’s claims. On January 7, 2019, Amneal, its relevant co-defendants, and the indirect purchaser plaintiff informed the Magistrate Judge that they had agreed to mediation, which occurred in April 2019. In June 2019, the Company reached a settlement with the plaintiff, subject to Court approval. On September 10, 2019, the Court entered an order preliminarily approving the settlement and indefinitely staying the case as to the settling defendants (including the Company), until the disposition of the claims against the non-settling defendants. The remaining defendants have recently settled with the plaintiff. All parties will file proposed materials seeking final approval of the settlements and to finally resolve the case on November 8, 2022, after which time the settlement will be subject to final approval from the Court. The amount of the settlement was not 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 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 concerned whether anyone engaged in a contract, combination, or conspiracy in restraint of trade or commerce which had the effect of (i) fixing, controlling, or maintaining prices or (ii) allocating or dividing customers or territories relating to the sale of digoxin. Impax cooperated in the investigation and produced documents and information in response to the subpoena in 2014 and 2015. 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”). 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 four generic prescription medications. Impax has cooperated in the investigation and produced documents and information in response to the subpoenas from 2014 to 2016. 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 interactions with other generic pharmaceutical manufacturers regarding whether generic pharmaceutical manufacturers engaged in market allocation and price-fixing agreements, paid illegal remuneration, and caused false claims to be submitted to the federal government.
Impax has cooperated with the Civil Division’s investigation. However, no assurance can be given as to the timing or outcome of the investigation.
In Re Generic Pharmaceuticals Pricing Antitrust Litigation
Since March 2016, multiple putative antitrust class action complaints have been filed on behalf of direct purchasers, indirect purchasers (or end-payors), and indirect resellers, as well as individual complaints on behalf of certain direct and indirect purchasers, and municipalities (the “opt-out plaintiffs”) against manufacturers of generic drugs, including Impax and the Company. The complaints allege a conspiracy to fix, maintain, stabilize, and/or raise prices, rig bids, and allocate markets or customers for various generic drugs in violation of federal and state antitrust and consumer protection laws. Plaintiffs seek unspecified monetary damages and equitable relief, including disgorgement and restitution. The lawsuits have been consolidated in an MDL in the United States District Court for the Eastern District of Pennsylvania (In re Generic Pharmaceuticals Pricing Antitrust Litigation, No. 2724, (E.D. Pa.)).
On May 10, 2019, Attorneys General of 43 States and the Commonwealth of Puerto Rico filed a complaint in the United States District Court for the District of Connecticut against various manufacturers and individuals, including the Company, alleging a conspiracy to fix, maintain, stabilize, and/or raise prices, rig bids, and allocate markets or customers for multiple generic drugs. On November 1, 2019, the State Attorneys General filed an Amended Complaint on behalf of nine additional states and territories. On June 10, 2020, Attorneys General of 46 States, the Commonwealth of Puerto Rico, the Commonwealth of the Northern Mariana Islands, the Territory of Guam, the U.S. Virgin Islands, and the District of Columbia filed a new complaint against various manufacturers and individuals, including the Company, alleging a conspiracy to fix prices, rig bids, and allocate markets or customers for additional generic drugs. Plaintiff States seek unspecified monetary damages and penalties and equitable relief, including disgorgement and restitution. On September 9, 2021, the State Attorneys General filed an Amended Complaint on behalf of California in addition to the original Plaintiff States. On March 30, 2022, the State of Alabama voluntarily dismissed all its claims in the May 10, 2019 and June 10, 2020 actions against all defendants, including the Company, without prejudice. These lawsuits have been incorporated into MDL No. 2724. Fact and document discovery in MDL No. 2724 are proceeding. In May 2021, the court issued a revised order designating certain plaintiffs’ complaints regarding two generic drug products to proceed as bellwether cases, along with the Plaintiff States’ June 10, 2020, complaint involving the Company. No final scheduling order has yet been issued for this matter.
On June 3, 2020, the Company and Impax were also named in a putative class action complaint filed in the Federal Court of Canada in Toronto, Ontario against numerous generic pharmaceutical manufacturers, on behalf of a putative class of individuals who purchased generic drugs in the private sector from 2012 to the present (Kathryn Eaton v. Teva Canada Limited, et. al., No. T-607-20). The complaint alleges price fixing, among other claims. On August 23, 2022, plaintiff filed a second amended complaint. The case has otherwise not progressed to date.
Prescription Opioid Litigation
The Company and certain of its affiliates have been named as defendants in various matters filed in state and federal courts relating to the sale of prescription opioid pain relievers. Plaintiffs in these actions include state Attorneys General, county and municipal governments, hospitals, Indian tribes, pension funds, third-party payors, and individuals. Plaintiffs seek unspecified monetary damages and other forms of relief based on various causes of action, including negligence, public nuisance, unjust enrichment, and civil conspiracy, as well as alleged violations of the Racketeer Influenced and Corrupt Organizations Act (“RICO”), state and federal controlled substances laws and other statutes. All cases involving the Company also name other manufacturers, distributors and retail pharmacies as defendants, and there are numerous other cases involving allegations relating to prescription opioid pain relievers against other manufacturers, distributors, and retail pharmacies in which the Company and its affiliates are not named.
Nearly all cases pending in federal district courts have been consolidated for pre-trial proceedings in an MDL in the United States District Court for the Northern District of Ohio (In re: National Prescription Opiate Litigation, Case No. 17-mdl-2804). There are approximately 915 cases in the MDL in which the Company or its affiliates have been named as defendants. The Company is also named in approximately 119 state court cases pending in eleven states. The Company has filed motions to dismiss in many of these cases. No firm trial dates have been set except in Alabama (July 24, 2023). The Company is not involved in the September 2022 trial in New Mexico previously reported because of the tentative settlement the Company reached with the New Mexico Attorney General in May 2022 to resolve the New Mexico Attorney General’s claims against the Company. The Company anticipates a final determination regarding approval to be made following the trial as to the plaintiff’s claims against the non-settling defendants.
On August 3, 2022, the Company and certain of its affiliates were named as defendants in a Complaint filed in Tennessee state court, along with numerous other manufacturers, distributors, retailers, and healthcare providers, in which it is alleged the defendants are liable in civil damages to six minors who allegedly were born with neonatal abstinence syndrome (“NAS”) allegedly as a result of their biological mothers’ alleged use of diverted prescription opioid medications. The plaintiffs’ claim against each defendant in that case requires plaintiffs to prove by clear and convincing evidence that the defendant intentionally participated in Tennessee in that state’s illegal drug market as defined in the Tennessee Drug Dealer Liability Act. The Company intends to file a motion to dismiss the complaint. The Company also was named in two NAS cases in West Virginia state court which have been consolidated with other West Virginia state court NAS cases before the West Virginia Mass Litigation Panel (“WV MLP”). All NAS cases before the WV MLP have been stayed through December 30, 2022. On November 1, 2022, the Company entered into a preliminary settlement agreement to resolve all pending litigation brought by West Virginia political subdivisions.
Securities Class Actions
On April 17, 2017, New York Hotel Trades Council & Hotel Association of New York City, Inc. Pension Fund filed an amended putative class action complaint in the United States District Court for the Northern District of California against Impax and four former Impax officers alleging violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 (Fleming v. Impax Laboratories Inc., et al., No. 4:16-cv-6557-HSG). Plaintiff alleges that Impax (1) concealed collusion with competitors to fix the price of the generic drug digoxin; (2) concealed anticipated erosion in the price of generic drug diclofenac; and (3) overstated the value of the generic drug budesonide. In June 2021, Plaintiffs (New York Hotel Trades Council & Hotel Association of New York City, Inc. Pension Fund, and Sheet Metal Workers’ Pension Fund of Southern California, Arizona and Nevada, who had filed various motions to intervene as a plaintiff in the case) and defendants reached a tentative agreement to settle all claims in the case for $33.0 million, subject to certain terms and conditions and subject to court approval. The district court entered an order granting preliminary approval of the settlement on November 22, 2021 and held a fairness hearing on March 31, 2022. On July 15, 2022, the district court entered an order granting final approval of the settlement. On July 21, 2022, a stipulated final judgment was entered, effectively terminating this matter before the district court. The settlement was fully covered by insurance and was paid from an escrow account (refer to Note 17. Prepaid Expenses and Other Current Assets for amounts deposited into a settlement escrow account).
On December 18, 2019, Cambridge Retirement System filed a putative class action complaint in the Superior Court of New Jersey, Somerset County against the Company and certain current or former officers alleging violations of Sections 11, 12(a)(2) and 15 of the Securities Act of 1933 (Cambridge Retirement System v. Amneal Pharmaceuticals, Inc., et al., No. SOM-L-1701-19). Plaintiffs allege that the May 7, 2018, amended registration statement and prospectus issued in connection with the Amneal/Impax business combination was materially false and/or misleading because it failed to disclose that Amneal allegedly engaged in anticompetitive conduct to fix generic drug prices. Plaintiffs filed a motion for class certification on October 30, 2020, and in April 2021 filed a second amended complaint including similar allegations regarding a November 2017 registration statement and prospectus issued in connection with the Amneal/Impax business combination. In February 2022, the parties reached a tentative agreement to settle the claims, subject to, among other things, the negotiation and court approval of a definitive settlement agreement. On March 28, 2022, the parties executed a settlement agreement for $25.0 million. On April 29, 2022, the court preliminarily approved the settlement. On August 16, 2022, the court gave final approval to the settlement. For the nine months ended September 30, 2022, the Company recorded insurance recoveries of $15.5 million related to this case. The final settlement for $25.0 million was paid from an escrow account which was funded both by insurance recoveries of $15.5 million and cash paid by the Company of $9.5 million (refer to Note 17. Prepaid Expenses and Other Current Assets for amounts deposited into a settlement escrow account).
United States Department of Justice / Drug Enforcement Administration Subpoenas
On July 7, 2017, Amneal Pharmaceuticals of New York, LLC received an administrative subpoena issued by the Long Island, NY District Office of the Drug Enforcement Administration (the “DEA”) requesting information related to compliance with certain recordkeeping and reporting requirements. On or about April 12, 2019 and May 28, 2019, the Company received grand jury subpoenas from the U.S. Attorney’s Office for the Eastern District of New York (the “USAO”) relating to similar topics concerning the Company’s suspicious order monitoring program and its compliance with the Controlled Substances Act. The Company is cooperating with the USAO in responding to the subpoenas and has entered civil and criminal amended tolling agreements with the USAO through approximately November 14, 2022. It is not currently possible to determine the exact outcome of these investigations.
On March 14, 2019, Amneal received a subpoena (the “Subpoena”) from the U.S. Attorney’s Office for the Southern District of Florida. The Subpoena requests information and documents generally related to the marketing, sale, and distribution of
oxymorphone. The Company has cooperated and produced documents in response to the Subpoena. However, no assurance can be given as to the timing or outcome of the underlying investigation.
On October 7, 2019, Amneal received a subpoena from the New York State Department of Financial Services seeking documents and information related to sales of opioid products in the state of New York. The Company is cooperating with the request and providing responsive information. It is not currently possible to determine the exact outcome of this investigation.
Ranitidine Litigation
The Company and its affiliates have been named as defendants, along with numerous other pharmaceutical manufacturers, wholesale distributors, and retail pharmacy chains, in In re Zantac/Ranitidine NDMA Litigation (MDL No. 2924), pending in the Southern District of Florida. Plaintiffs allege that defendants failed to disclose and/or concealed the alleged inherent presence of N-Nitrosodimethylamine (or “NDMA”) in brand-name Zantac® or generic ranitidine and the alleged associated risk of cancer. Consolidated groups of (a) personal injury plaintiffs, (b) economic loss/medical monitoring class action plaintiffs, and (c) third-party payor plaintiffs have each filed master complaints against brand and generic pharmaceutical manufacturers, distributors, retailers, and repackagers of ranitidine-containing products. The Company or its affiliates have been named in the three master complaints and approximately 313 personal injury short form complaints. On December 31, 2020, the Court dismissed in full the three master complaints against the generic manufacturers, including the Company and its affiliates, with leave to file amended complaints on certain claims relating to manufacturing, storage, and transportation. Plaintiffs filed amended complaints in February 2021, and Defendants filed various motions to dismiss the amended complaints in March 2021. On July 8, 2021, the MDL dismissed all claims against the generic drug manufacturers, including the Company and its affiliates, without leave to file further amended complaints. Plaintiffs have appealed the MDL court’s dismissal to the 11th Circuit Court of Appeals, which has consolidated the appeals of the personal injury cases. The 11th Circuit Court of Appeals has not established a briefing schedule yet in personal injury cases appeals.
On June 18, 2020, Amneal was named in a lawsuit filed in New Mexico brought by the New Mexico Attorney General alleging claims of public nuisance, negligence, and violations of consumer protection laws against various brand and generic manufacturers and store-brand distributors of Zantac®/Ranitidine. Plaintiff seeks unspecified compensatory and punitive damages, as well as abatement, medical monitoring, restitution, and injunctive relief. The Company filed a motion to dismiss on May 17, 2021, and filed a notice of supplemental authority based on the MDL court’s July 2021 dismissal order. The Court denied the motion on August 17, 2021. The Company filed a motion to dismiss based on lack of personal jurisdiction on January 26, 2022. On September 22, 2022, the Court ordered the parties to participate in 90 days of reciprocal jurisdictional discovery.
On November 12, 2020, Amneal was named in a public nuisance and consumer protection lawsuit filed in state court in Baltimore, Maryland, on behalf of the Mayor and City Council of Baltimore. Defendants removed the case to federal court and on April 1, 2021, the case was remanded to state court. On August 23, 2021, the Company filed a motion to dismiss, which was granted.
On October 1, 2021, Amneal and Amneal Pharmaceuticals of New York, LLC, were named as defendants in two Pennsylvania state court complaints, along with twenty-five other defendants, including brand-name manufacturers, generic manufacturers, and one Pennsylvania-based pharmacy. The complaint track cases are being coordinated in the Philadelphia County Court of Common Pleas with other Pennsylvania ranitidine cases in which the Company is not a party under what is known as a Mass Tort Program (MTP). The Complaints track the dismissed master personal injury complaint from the MDL and were removed and subsequently transferred to the MDL on November 9, 2021. The cases were remanded to Pennsylvania state court on April 22, 2022. The Company filed preliminary objections in one case on May 18, 2022, which remain pending, and intends to file preliminary objections in the second case following a coordinated briefing schedule. Amneal entities have been named in three additional cases filed on September 27, 2022, each of which will be part of the MTP.
In a lawsuit filed on February 8, 2022 by Gary Ross in Illinois state court, Amneal and Amneal Pharmaceuticals of New York, LLC, were named as defendants, along with twenty other defendants, including brand-name manufacturers, generic manufacturers, and retailers in which plaintiff claimed personal injury from use of ranitidine. The generic drug manufacturers filed a motion to dismiss in that case on March 28, 2022 which remains pending. On March 1, 2022, plaintiff Barbara Martin filed a lawsuit in Illinois state court naming Amneal, Amneal Pharmaceuticals of New York, LLC, and Amneal Pharmaceuticals, Inc., along with seven other defendants, including brand-name manufacturers, generic manufacturers, and retailers. Plaintiff has attempted to serve only Amneal Pharmaceuticals of New York, LLC. The Company filed a motion to dismiss on May 6, 2022. In addition, the Company and/or its affiliates, as well as multiple other defendants including other generic drug manufacturers, have been named as defendants in six multi-plaintiff cases filed in three different Illinois counties
in which plaintiffs allege injuries in the form of various cancers from the use of ranitidine. At the appropriate time, the Company intends to file motions to dismiss in those cases.
The Company and/or its affiliates, as well as multiple other defendants including other generic drug manufacturers, have been named in seven multi-plaintiff cases filed in California during August and September 2022, in which plaintiffs allege injuries in the form of various cancers from the use of ranitidine. At the appropriate time, the Company intends to file motions to dismiss in those cases.
On September 26, 2022, Amneal Pharmaceuticals of New York, LLC was named as one of multiple defendants in a single-plaintiff case filed in Suffolk County, New York, alleging injuries in the form of bladder cancer from the use of ranitidine. At the appropriate time, the Company intends to file a motion to dismiss.
Metformin Litigation
Amneal and AvKARE, Inc. were named as defendants, along with numerous other manufacturers, retail pharmacies, and wholesalers, in several putative class action lawsuits pending in the United States District Court for the District of New Jersey (“D.N.J.”), consolidated as In Re Metformin Marketing and Sales Practices Litigation (No. 2:20-cv-02324-MCA-MAH). The lawsuits all allege that defendants made and sold to putative class members generic metformin products that were “adulterated” or “contaminated” with NDMA.
An economic loss complaint filed on behalf of consumers and third-party payors who purchased or paid or made reimbursements for metformin alleges that plaintiffs suffered economic losses in connection with their purchases or reimbursements due to the purported contamination. On May 20, 2021, the Court granted Defendants’ motion to dismiss the economic loss complaint, and Plaintiffs filed an amended complaint on June 21, 2021. Defendants again moved to dismiss, and on March 30, 2022, the Court granted in part and denied in part Defendants’ second motion to dismiss. Plaintiffs filed a second amended complaint on May 6, 2022. Defendants again moved to dismiss on June 3, 2022, and briefing is complete. Initial limited discovery took place, but further discovery has been stayed pending the outcome of the third motion to dismiss. Additionally, medical monitoring class action complaints were filed on behalf of consumers who consumed allegedly contaminated metformin allege “cellular damage, genetic harm, and/or are at an increased risk of developing cancer” and seek medical monitoring, including evaluation and treatment. These cases are currently stayed.
On March 29, 2021, a plaintiff filed a complaint in the United States District Court for the Middle District of Alabama asserting claims against manufacturers of Valsartan, Losartan, and Metformin based on the alleged presence of nitrosamines in those products. The only allegations against Amneal concern Metformin. (Davis v. Camber Pharmaceuticals, Inc., et al., C.A. No. 2:21-00254 (M.D. Ala.) (the “Davis Action”)). On May 5, 2021, the JPML transferred the Davis Action into the In re: Valsartan, Losartan, and Irbesartan Products Liability Litigation multi-district litigation for pretrial proceedings.
On October 29, 2021, three plaintiffs filed a complaint in the District Court of Douglas County, Nebraska asserting claims against Amneal based on the alleged presence of nitrosamines in metformin. On January 10, 2022, Amneal removed the case to the United States District Court for the District of Nebraska. (Conrad et al v. Amneal Pharmaceuticals, Inc., No. 22-cv-00011-BCB-SMB (D. Neb.)). Amneal moved to dismiss the complaint on March 3, 2022, and on March 31, 2022, one plaintiff filed an amended complaint. Amneal moved to dismiss the amended complaint on June 1, 2022. On September 1, 2022, the Court granted Amneal’s motion to dismiss, and ordered the Plaintiff to show cause as to why the case should not be dismissed against the remaining defendant, Amneal Pharmaceuticals Pvt. Ltd. On September 15, 2022, the Plaintiff filed a notice of voluntary dismissal as to Amneal Pharmaceuticals Pvt. Ltd., resulting in the case being completely dismissed.
Xyrem® (Sodium Oxybate) Antitrust Litigation
Amneal has been named as a defendant, along with Jazz Pharmaceuticals, Inc. (“Jazz”) and numerous other manufacturers of generic versions of Jazz’s Xyrem® (sodium oxybate), in several putative class action lawsuits filed in the United States District Court for the Northern District of California and the United States District Court for the Southern District of New York, alleging that the generic manufacturers entered into anticompetitive agreements with Jazz in connection with settling patent litigation related to Xyrem®. Plaintiffs seek unspecified monetary damages and penalties as well as equitable relief, including disgorgement and restitution. On December 16, 2020, the JPML transferred the actions to the United States District Court for the Northern District of California for consolidated pretrial proceedings consolidated as In re Xyrem (Sodium Oxybate) Antitrust Litigation (No. 5:20-md-02966-LHK). Plaintiffs filed a consolidated amended class complaint in March 2021, which Defendants moved to dismiss. On August 13, 2021, the Court granted in part and denied in part Defendants’ motion, dismissing the federal damages claims and several state-law claims, while permitting the remaining claims to proceed. Discovery is currently ongoing.
Value Drug Company v. Takeda Pharmaceuticals U.S.A., Inc.
On August 5, 2021, Value Drug Company filed a purported class action lawsuit in the United States District Court for the Eastern District of Pennsylvania against Takeda Pharmaceuticals U.S.A., Inc. (“Takeda”) and numerous other manufacturers of generic versions of Takeda’s Colcrys® (colchicine), including Amneal, alleging that the generic manufacturers conspired with Takeda to restrict output of generic Colcrys in order to maintain higher prices, in violation of the antitrust laws. The Company, along with the other defendants, moved to dismiss for failure to state a claim, and on December 28, 2021, the Court granted the motion in full, with leave to amend. On January 18, 2022, Plaintiff filed its amended complaint, making substantively the same antitrust allegations, but alleging that the violations were effectuated by either a single overarching conspiracy or a series of bilateral conspiracies. The Company moved to dismiss the amended complaint for failure to state a claim. On March 30, 2022, the Court granted in part and denied in party defendants’ motion, dismissing the newly pled bilateral conspiracy claims but allowing the revised overarching conspiracy claim to proceed against all defendants. Plaintiff filed a motion for class certification on September 6, 2022, and the defendants opposed it on September 21, 2022. That motion remains pending, and discovery is ongoing. Trial is scheduled to begin in February 2023.
Galeas v. Amneal Pharmaceuticals, Inc.
On July 27, 2021, Cesy Galeas filed a purported class action lawsuit in the U.S. District Court for the Eastern District of New York against Amneal Pharmaceuticals, Inc., alleging that the payment schedule for certain workers violated New York Labor Law. Specifically, the purported class, which presently consists of one named plaintiff contends that the Company paid the employees all owed wages, but did so bi-weekly, instead of weekly. In March 2022, the parties reached an agreement to settle the claims for $1.2 million, subject to, among other things, court approval of the contemplated settlement agreement. The parties filed a motion to approve the settlement agreement on July 13, 2022 and the Court granted the same on September 28, 2022. A third-party administrator will now begin the process of notifying class members with instructions on how to submit claims. The Company recorded a $1.2 million charge associated with this matter for the nine months ended September 30, 2022.
Russell Thiele, et al. v. Kashiv Biosciences, LLC, et.al.
On March 22, 2022, two purported Amneal stockholders filed a stockholder derivative lawsuit in the Court of Chancery of the State of Delaware against Kashiv and certain members of the Company’s Board of Directors. The Company is named as a nominal defendant. The suit alleges that the Company’s January 2021 acquisition of a 98% interest in KSP, then a wholly owned subsidiary of Kashiv, was unfair to the Company, that the defendant Directors breached fiduciary duties of loyalty and good faith in connection with the transaction, and that the transaction unjustly enriched Kashiv and certain of the defendants who had a financial interest in Kashiv. The suit, which is allegedly brought on the Company’s behalf, seeks among other remedies rescission of the transaction and unspecified monetary damages. Defendants moved to dismiss the complaint for failure to state a claim and failure to plead demand futility on June 3, 2022, and Plaintiffs filed an amended complaint on July 29, 2022. Defendants moved to dismiss the amended complaint on September 23, 2022, on the same grounds set forth in the original motion to dismiss.
14. Segment Information
The Company has three reportable segments: Generics, Specialty, and AvKARE.
Generics
Generics develops, manufactures and commercializes complex oral solids, injectables, ophthalmics, liquids, topicals, softgels, inhalation products and transdermals across a broad range of therapeutic categories. Generics’ retail and institutional portfolio contains many 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
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. The Company's 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.
AvKARE
AvKARE provides pharmaceuticals, medical and surgical products and services primarily to governmental agencies, primarily focused on serving the Department of Defense and the Department of Veterans Affairs. AvKARE is also a wholesale distributor of bottle and unit dose pharmaceuticals under the registered names of AvKARE and AvPAK, as well as medical and surgical products. AvKARE is also a packager and wholesale distributor of pharmaceuticals and vitamins to its retail and institutional customers who are located throughout the United States focused primarily on offering 340b-qualified entities products to provide consistency in care and pricing.
Chief Operating Decision Markers
The Company’s chief operating decision makers evaluate the financial performance of the Company’s segments based upon segment operating income (loss). Items below operating income (loss) are not reported by segment, since they are excluded from the measure of segment profitability reviewed by the Company’s chief operating decision makers. 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 makers.
The tables below present segment information reconciled to total Company financial results, with segment operating income (loss) including gross profit less direct selling, general and administrative expenses, research and development expenses, and other operating expenses to the extent specifically identified by segment (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Three Months Ended September 30, 2022 | | Generics (1) | | Specialty | | AvKARE (1) | | Corporate and Other | | Total Company |
Net revenue | | $ | 350,266 | | | $ | 89,484 | | | $ | 105,807 | | | $ | — | | | $ | 545,557 | |
Cost of goods sold | | 217,997 | | | 43,719 | | | 88,937 | | | — | | | 350,653 | |
Cost of goods sold impairment charges | | 674 | | | — | | | — | | | — | | | 674 | |
Gross profit | | 131,595 | | | 45,765 | | | 16,870 | | | — | | | 194,230 | |
Selling, general and administrative | | 30,259 | | | 22,201 | | | 13,216 | | | 34,395 | | | 100,071 | |
Research and development | | 41,987 | | | 8,248 | | | — | | | — | | | 50,235 | |
Intellectual property legal development expenses | | 1,369 | | | 42 | | | — | | | — | | | 1,411 | |
Acquisition, transaction-related and integration expenses | | 16 | | | 15 | | | — | | | 8 | | | 39 | |
Charges related to legal matters, net | | 285 | | | — | | | — | | | — | | | 285 | |
Change in fair value of contingent consideration | | — | | | (1,425) | | | — | | | — | | | (1,425) | |
Restructuring and other charges | | 507 | | | — | | | — | | | 74 | | | 581 | |
Other operating income | | (1,320) | | | — | | | — | | | — | | | (1,320) | |
Operating income (loss) | | $ | 58,492 | | | $ | 16,684 | | | $ | 3,654 | | | $ | (34,477) | | | $ | 44,353 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Nine Months Ended September 30, 2022 | | Generics (1) | | Specialty | | AvKARE (1) | | Corporate and Other | | Total Company |
Net revenue | | $ | 1,032,908 | | | $ | 271,571 | | | $ | 298,066 | | | $ | — | | | $ | 1,602,545 | |
Cost of goods sold | | 640,450 | | | 130,363 | | | 256,626 | | | — | | | 1,027,439 | |
Cost of goods sold impairment charges | | 5,786 | | | — | | | — | | | — | | | 5,786 | |
Gross profit | | 386,672 | | | 141,208 | | | 41,440 | | | — | | | 569,320 | |
Selling, general and administrative | | 84,410 | | | 69,772 | | | 39,361 | | | 103,999 | | | 297,542 | |
Research and development | | 129,382 | | | 24,399 | | | — | | | — | | | 153,781 | |
Intellectual property legal development expenses | | 2,919 | | | 77 | | | — | | | — | | | 2,996 | |
Acquisition, transaction-related and integration expenses | | 24 | | | 47 | | | — | | | 643 | | | 714 | |
Charges related to legal matters, net | | 2,442 | | | — | | | — | | | 247,394 | | | 249,836 | |
Charges (insurance recoveries) for property losses and associated expenses | | (1,911) | | | — | | | — | | | — | | | (1,911) | |
Restructuring and other charges | | 713 | | | — | | | — | | | 599 | | | 1,312 | |
Change in fair value of contingent consideration | | — | | | (1,495) | | | — | | | — | | | (1,495) | |
Other operating income | | (2,495) | | | — | | | — | | | — | | | (2,495) | |
Operating income (loss) | | $ | 171,188 | | | $ | 48,408 | | | $ | 2,079 | | | $ | (352,635) | | | $ | (130,960) | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Three Months Ended September 30, 2021 | | Generics (1) | | Specialty | | AvKARE (1) | | Corporate and Other | | Total Company |
Net revenue | | $ | 347,127 | | | $ | 92,745 | | | $ | 88,721 | | | $ | — | | | $ | 528,593 | |
Cost of goods sold | | 208,670 | | | 47,303 | | | 73,421 | | | — | | | 329,394 | |
Cost of goods sold impairment charges | | 688 | | | — | | | — | | | — | | | 688 | |
Gross profit | | 137,769 | | | 45,442 | | | 15,300 | | | — | | | 198,511 | |
Selling, general and administrative | | 15,941 | | | 22,211 | | | 14,683 | | | 38,562 | | | 91,397 | |
Research and development | | 34,999 | | | 13,928 | | | — | | | — | | | 48,927 | |
Intellectual property legal development expenses | | 1,584 | | | 43 | | | — | | | — | | | 1,627 | |
Acquisition, transaction-related and integration expenses | | — | | | — | | | — | | | 134 | | | 134 | |
Charges related to legal matters, net | | — | | | — | | | — | | | 19,000 | | | 19,000 | |
Charges (insurance recoveries) for property losses and associated expenses | | 8,186 | | | — | | | — | | | — | | | 8,186 | |
Restructuring and other charges | | — | | | — | | | — | | | 425 | | | 425 | |
Change in fair value of contingent consideration | | — | | | 300 | | | — | | | — | | | 300 | |
Operating income (loss) | | $ | 77,059 | | | $ | 8,960 | | | $ | 617 | | | $ | (58,121) | | | $ | 28,515 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Nine Months Ended September 30, 2021 | | Generics (1) | | Specialty | | AvKARE (1) | | Corporate and Other | | Total Company |
Net revenue | | $ | 1,020,072 | | | $ | 277,311 | | | $ | 259,390 | | | $ | — | | | $ | 1,556,773 | |
Cost of goods sold | | 598,122 | | | 144,184 | | | 211,208 | | | — | | | 953,514 | |
Cost of goods sold impairment charges | | 688 | | | — | | | — | | | — | | | 688 | |
Gross profit | | 421,262 | | | 133,127 | | | 48,182 | | | — | | | 602,571 | |
Selling, general and administrative | | 46,500 | | | 62,748 | | | 41,986 | | | 117,046 | | | 268,280 | |
Research and development | | 114,547 | | | 35,426 | | | — | | | — | | | 149,973 | |
In-process research and development charges | | 710 | | | — | | | — | | | — | | | 710 | |
Intellectual property legal development expenses | | 6,506 | | | 68 | | | — | | | — | | | 6,574 | |
Acquisition, transaction-related and integration expenses | | — | | | 16 | | | 1,422 | | | 5,781 | | | 7,219 | |
Charges related to legal matters, net | | — | | | — | | | — | | | 19,000 | | | 19,000 | |
Charges (insurance recoveries) for property losses and associated expenses | | 8,186 | | | — | | | — | | | — | | | 8,186 | |
Restructuring and other charges | | 80 | | | — | | | — | | | 708 | | | 788 | |
Change in fair value of contingent consideration | | — | | | 300 | | | — | | | — | | | 300 | |
Operating income (loss) | | $ | 244,733 | | | $ | 34,569 | | | $ | 4,774 | | | $ | (142,535) | | | $ | 141,541 | |
(1)Operating results for the sale of Amneal products by AvKARE are included in Generics.
15. Related Party Transactions
The Company has various business agreements with certain parties in which there is some common ownership. However, the Company does not directly own or manage any of such related parties. Except as disclosed below, as of and for the three and nine months ended September 30, 2022, there were no material changes to our related party agreements or relationships as described in Note 24. Related Party Transactions and Note 22. Stockholders’ Equity in our 2021 Annual Report on Form 10-K.
Amendment to Kashiv Biosciences LLC License and Commercialization Agreement
In 2017 Kashiv and Amneal entered into an exclusive license and commercialization agreement (the “Kashiv Biosimilar Agreement”) to distribute and sell two biosimilar products, Filgrastim and Pegfilgrastim, in the U.S. Kashiv is responsible for development, regulatory filings, obtaining FDA approval, and manufacturing, and Amneal is responsible for marketing, selling, and pricing activities. The term of the agreement is 10 years from the respective product’s launch date.
The Kashiv Biosimilar Agreement provided for potential future milestone payments to Kashiv of up to $183.0 million, as follows: (i.) up to $22.5 million relating to regulatory approval and execution, (ii.) up to $43.0 million for successful delivery of commercial launch inventory, (iii.) up to $50.0 million depending on the number of competitors at launch for one product, and (iv.) between $15.0 million and $67.5 million for the achievement of cumulative net sales for both products.
In July 2022, the Company and Kashiv amended the Kashiv Biosimilar Agreement to, among other things, (i.) eliminate milestones related to the manufacturing and delivery of the Kashiv products, (ii.) revise the net sales milestones to provide for future milestone payments by the Company to Kashiv of up to $37.5 million for the achievement of cumulative combined net sales goals for both products, and (iii.) adjust the supply price of product that Kashiv manufacturers and supplies to the Company, which will lower the cost per unit of both products.
The remaining milestones are subject to reaching certain commercial sales volume objectives. In addition, the agreement provides for Amneal to pay a profit share equal to 50% of net profits, after considering manufacturing and marketing costs.
On May 27, 2022, the FDA approved the Company’s biologic license application, associated with the amended Kashiv Biosimilar Agreement, for Pegfilgrastim-pbbk. In connection with this regulatory approval and associated activity, the Company incurred a milestone of $15.0 million during the nine months ended September 30, 2022, payable to Kashiv. The milestone was capitalized as an intangible asset and will be amortized to cost of sales over an estimated useful life of 8.3 years. The Company paid Kashiv $15.0 million during August 2022 related to this milestone.
The following table summarizes the Company’s related party transactions (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | Three Months Ended September 30, | | Nine Months Ended September 30, |
Related Party and Nature of Transaction | Caption in Balance Sheet and Statement of Operations | | 2022 | | 2021 | | 2022 | | 2021 |
Kashiv Biosciences LLC | | | | | | | | | |
Parking space lease (1) | Cost of goods sold | | $ | 25 | | | $ | 24 | | | $ | 75 | | | $ | 74 | |
Development and commercialization agreements - various products (1) | Research and development | | — | | | — | | | — | | | 32 | |
License and commercialization agreement - Filgrastim and Pegfilgrastim - regulatory approval milestone for Filgrastim(1) | Selling, general and administrative | | — | | | — | | | 5,000 | | | — | |
Development and commercialization agreement - Ganirelix Acetate and Cetrorelix Acetate (1) | Research and development | | 104 | | | 146 | | | 1,827 | | | 790 | |
Development and commercialization agreements - various products (2) | Research and development | | — | | | — | | | — | | | 150 | |
Profit sharing - various products (2) | Cost of goods sold | | — | | | — | | | — | | | 2,680 | |
Commercial product support for EluRyng and other products (2) | Inventory and cost of goods sold | | — | | | — | | | — | | | 1,239 | |
K127 development and commercialization agreement (2) | Research and development | | — | | | — | | | — | | | 3,000 | |
Transition services associated with the KSP Acquisition | Selling, general and administrative | | — | | | — | | | — | | | 300 | |
Development and commercialization - Consulting | Research and development | | — | | | — | | | — | | | 500 | |
License and commercialization agreement - Filgrastim and Pegfilgrastim - regulatory approval milestone for Pegfilgrastim-pbbk(1) | Intangible asset | | — | | | — | | | 15,000 | | | — | |
Total | | | $ | 129 | | | $ | 170 | | | $ | 21,902 | | | $ | 8,765 | |
| | | | | | | | | |
LAX Hotel, LLC (3) | | | | | | | | | |
Financing lease | Inventory and cost of goods sold | | $ | — | | | $ | — | | | $ | — | | | $ | 217 | |
Interest component of financing lease | Interest expense | | — | | | — | | | — | | | 362 | |
Total | | | $ | — | | | $ | — | | | $ | — | | | $ | 579 | |
| | | | | | | | | |
Other Related Parties | | | | | | | | | |
Kanan, LLC - operating lease | Inventory and cost of goods sold | | $ | 526 | | | $ | 526 | | | $ | 1,578 | | | $ | 1,577 | |
Sutaria Family Realty, LLC - operating lease | Inventory and cost of goods sold | | $ | 305 | | | $ | 297 | | | $ | 906 | | | $ | 883 | |
PharmaSophia, LLC - research and development services income | Research and development | | $ | (15) | | | $ | (15) | | | $ | (45) | | | $ | (314) | |
Apace KY, LLC d/b/a Apace Packaging LLC - packaging agreement | Inventory and cost of goods sold | | $ | 800 | | | $ | 3,030 | | | $ | 2,222 | | | $ | 8,547 | |
Tracy Properties LLC - operating lease | Selling, general and administrative | | $ | 155 | | | $ | 136 | | | $ | 426 | | | $ | 398 | |
AzaTech Pharma LLC - supply agreement | Inventory and cost of goods sold | | $ | 1,340 | | | $ | 1,302 | | | $ | 3,992 | | | $ | 3,282 | |
AvPROP, LLC - operating lease | Selling, general and administrative | | $ | 46 | | | $ | 41 | | | $ | 136 | | | $ | 118 | |
Avtar Investments, LLC consulting services | Selling, general and administrative | | $ | 47 | | | $ | 126 | | | $ | 216 | | | $ | 301 | |
TPG Operations, LLC consulting services | Selling, general and administrative | | $ | — | | | $ | — | | | $ | 19 | | | $ | — | |
Alkermes | Inventory and cost of goods sold | | $ | 64 | | | $ | — | | | $ | 171 | | | $ | — | |
R&S Solutions - logistics services | Selling, general and administrative | | $ | 26 | | | $ | — | | | $ | 65 | | | $ | — | |
(1) Agreement between Amneal and Kashiv was not affected by the KSP Acquisition (refer to Note 3. Acquisitions for additional information).
(2) Agreement between Amneal and Kashiv was acquired with KSP and has become a transaction among Amneal’s consolidated subsidiaries subsequent to the transaction closing on April 2, 2021. The disclosure relates to the historical agreement as a related party transaction through April 2, 2021 (refer to Note 3. Acquisitions for additional information).
(3) During January 2021, LAX Hotel LLC sold its interests in the leased buildings to an unrelated third-party. Therefore, this lease was no longer a related party transaction subsequent to that date.
The following table summarizes the amounts due to or from the Company for related party transactions (in thousands):
| | | | | | | | | | | |
| September 30, 2022 | | December 31, 2021 |
Kashiv - deferred consideration associated with the KSP Acquisition (1) | $ | — | | | $ | 30,500 | |
Kashiv - various agreements | 987 | | | 314 | |
Sellers of Puniska - consideration for acquisition (2) | — | | | 14,225 | |
Apace Packaging LLC - packaging agreement | 1,148 | | | 560 | |
AzaTech Pharma LLC - supply agreement | 1,197 | | | 1,783 | |
Avtar Investments LLC - consulting services | 54 | | | 37 | |
Sellers of AvKARE LLC and R&S - accrued interest on Sellers Notes (3) | 442 | | | 442 | |
R&S Solutions - logistics services | 6 | | | — | |
Alkermes | 33 | | | — | |
Related party payables - short term | $ | 3,867 | | | $ | 47,861 | |
| | | |
PharmaSophia, LLC - research and development agreement | $ | 1,127 | | | $ | 1,081 | |
Sellers of AvKARE LLC and R&S - state tax indemnification | 531 | | | 68 | |
Kashiv - various agreements | 11 | | | 14 | |
Apace Packaging, LLC - packaging agreement | 1 | | | 16 | |
Tracy Properties | 26 | | | — | |
Related party receivables - short term | $ | 1,696 | | | $ | 1,179 | |
| | | |
Kashiv - contingent consideration (4) | $ | 4,920 | | | $ | 5,900 | |
Sellers of AvKARE LLC and R&S - accrued interest on Sellers Notes (3) | 5,376 | | | 3,719 | |
Related party payables - long term | $ | 10,296 | | | $ | 9,619 | |
(1) As discussed in Note 3. Acquisitions, the purchase price for the KSP Acquisition included a contractually stated amount of deferred consideration of $30.5 million. The deferred consideration consisted of $30.0 million, which the Company paid during January 2022, and $0.5 million, which the Company paid during the three months ended September 30, 2022.
(2) As discussed in Note 3. Acquisitions, the purchase price for the Puniska Acquisition included $14.2 million due to the sellers for the satisfaction of a preexisting payable upon approval of the transaction by the government of India. The Company satisfied this liability in March 2022.
(3) Represents accrued interest on the Sellers Notes associated with the Rondo Acquisitions, as defined and discussed in Note 3. Acquisitions and Divestitures and Note 17. Debt in the Company’s 2021 Annual Report on Form 10-K.
(4) The contingent consideration liability was associated with the KSP Acquisition. Refer to Note 3. Acquisitions for additional information.
Puniska Acquisition - Redeemable Non-Controlling Interests
The Company paid $1.7 million for the remaining 26% equity interest of Puniska (included in redeemable non-controlling interests in the Company’s consolidated balance sheet as of December 31, 2021) upon approval of the Puniska Acquisition by the government of India in March 2022.
16. Stockholders’ Equity and Redeemable Non-Controlling Interests
Non-Controlling Interests
The Company consolidates the financial statements of Amneal and its subsidiaries and records non-controlling interests for the portion of Amneal’s economic interests that is not held by the Company. Non-controlling interests are adjusted for capital transactions that impact the non-publicly held economic interests in Amneal.
Under the terms of Amneal's limited liability company agreement, as amended, Amneal is obligated to make tax distributions to its members. During the three and nine months ended September 30, 2022, the Company recorded net tax distributions of $2.5
million and $9.8 million, respectively, as a reduction of non-controlling interests. For the three and nine months ended September 30, 2021, the Company recorded tax distributions of $8.6 million and $34.5 million, respectively, as a reduction of non-controlling interests.
As discussed in Note 3. Acquisitions, the Company acquired a 98% interest in KSP on April 2, 2021. The sellers of KSP, a related party, hold the remaining interest. The Company attributes 2% of the net income or loss of KSP to the non-controlling interests.
Redeemable Non-Controlling Interests
As discussed in Note 1. Nature of Operations, the Company acquired a 65.1% controlling interest in both AvKARE, LLC and R&S in 2020. The sellers of AvKARE, LLC and R&S hold the remaining 34.9% interest (“Rondo Class B Units”) in the holding company that directly owns the acquired companies (“Rondo”). Beginning on January 1, 2026, the holders of the Rondo Class B Units have the right (“Put Right”) to require the Company to acquire the Rondo Class B Units for a purchase price that is based on a multiple of Rondo’s earnings before income taxes, depreciation, and amortization (EBITDA) if certain financial targets and other conditions are met. Additionally, beginning on January 31, 2020, the Company has the right to acquire the Rondo Class B Units based on the same value and conditions as the Put Right. The Rondo Class B Units are also redeemable by the holders upon a change in control.
Since the redemption of the Rondo Class B Units is outside of the Company's control, the units have been presented outside of stockholders’ equity as redeemable non-controlling interests. Upon closing of the Rondo Acquisitions, the redeemable non-controlling interests were recorded as a component of the fair value of consideration transferred at an estimated fair value of $11.0 million. The fair value of the redeemable non-controlling interests was estimated using the Monte-Carlo simulation approach under the option pricing framework, which considers the redemption rights of both the Company and the holders of the Rondo Class B Units.
The Company attributes 34.9% of the net income or loss associated with Rondo to redeemable non-controlling interests. The Company will also accrete the redeemable non-controlling interests to redemption value upon an event that makes redemption probable. For the three and nine months ended September 30, 2022, the Company recorded tax distributions of $0.7 million and $3.3 million as a reduction of redeemable non-controlling interests, respectively. For the three and nine months ended September 30, 2021, the Company recorded tax distributions of $0.5 million and $2.2 million as a reduction of redeemable non-controlling interests, respectively.
Redeemable Non-Controlling Interests - Puniska
As discussed in Note 3. Acquisitions, the Company acquired 74% of the equity interests in Puniska on November 2, 2021. Amneal was required pursuant to the purchase agreement to acquire the remaining 26% of Puniska upon approval of the transaction by the government of India. Since approval of the government of India was outside of the Company’s control, upon closing of the Puniska Acquisition, the equity interests of Puniska that the Company did not own were presented outside of stockholders' equity as redeemable non-controlling interests. The Company attributed 26% of the net losses of Puniska to the redeemable non-controlling interests.
Upon approval of the transaction by the government of India in March 2022, the Company paid the $1.7 million redemption value for the remaining 26% of the equity interests of Puniska. For the nine months ended September 30, 2022, the Company recorded accretion of $0.9 million to increase the redeemable non-controlling interests to redemption value.
Changes in Accumulated Other Comprehensive (Loss) Income by Component (in thousands):
| | | | | | | | | | | | | | | | | |
| Foreign currency translation adjustments | | Unrealized (loss) gain on cash flow hedge, net of tax | | Accumulated other comprehensive (loss) income |
Balance December 31, 2020 | $ | (14,497) | | | $ | (26,821) | | | $ | (41,318) | |
Other comprehensive loss before reclassification | (4,255) | | | 20,972 | | | 16,717 | |
Reallocation of ownership interests | (93) | | | (133) | | | (226) | |
Balance December 31, 2021 | (18,845) | | | (5,982) | | | (24,827) | |
Other comprehensive loss before reclassification | (12,426) | | | 49,904 | | | 37,478 | |
Reallocation of ownership interests | (136) | | | 24 | | | (112) | |
Balance September 30, 2022 | $ | (31,407) | | | $ | 43,946 | | | $ | 12,539 | |
17. Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets are comprised of the following (in thousands):
| | | | | | | | | | | |
| September 30, 2022 | | December 31, 2021 |
Deposits and advances | $ | 2,168 | | | $ | 1,174 | |
Prepaid insurance | 10,603 | | | 7,962 | |
Prepaid regulatory fees | — | | | 3,710 | |
Income and other tax receivables | 12,465 | | | 8,850 | |
Prepaid taxes | 16,715 | | | 16,085 | |
Escrow deposits for legal settlements(1) | 73,000 | | | 33,000 | |
Other current receivables | 9,366 | | | 9,770 | |
Other prepaid assets | 17,600 | | | 17,309 | |
Chargebacks receivable (2) | 7,733 | | | 12,358 | |
Total prepaid expenses and other current assets | $ | 149,650 | | | $ | 110,218 | |
(1)Escrow deposits for legal settlements included preliminary settlement escrow deposits by the Company’s insurers of $33.0 million as of December 31, 2021, associated with insured securities class action lawsuits. As of September 30, 2022, escrow deposits for legal settlements included $73.0 million associated with the Opana ER® antitrust litigation settlement agreements and Preliminary Settlement agreements. Refer to Note 13. Commitments and Contingencies for additional details regarding these matters.
(2)When a sale occurs on a contract item, the difference between the cost paid to the manufacturer by the Company and the contract cost that the end customer has with the manufacturer is rebated back to the Company by the manufacturer. The Company establishes a chargeback (rebate) receivable and a reduction to cost of goods sold in the same period as the related sale.
18. Other Assets
Other assets were comprised of the following (in thousands):
| | | | | | | | | | | |
| September 30, 2022 | | December 31, 2021 |
Interest rate swap (1) | $ | 88,860 | | | $ | — | |
Security deposits | 3,743 | | | 3,895 | |
Long-term prepaid expenses | 5,031 | | | 5,896 | |
Deferred revolving credit facility costs | 2,356 | | | 1,603 | |
Other long term assets | 8,272 | | | 9,220 | |
Total | $ | 108,262 | | | $ | 20,614 | |
(1)Refer to Note 10. Fair Value Measurements and Note 11. Financial Instruments for information about the Company’s interest rate swap.
19. Government Grants
In November 2021, Amneal Pharmaceuticals Private Limited, a subsidiary of the Company in India, was selected as one of 55 companies to participate in the PLI Scheme. The government of India established the PLI Scheme to make India’s domestic manufacturing more globally competitive and to create global champions within the pharmaceutical sector by encouraging investment and product diversification with a focus on manufacturing complex and high value goods.
Under the PLI Scheme, the Company is eligible to receive up to 10 billion Indian rupees, or approximately $122.7 million (based on conversion rates as of September 30, 2022), over a maximum six-year period, starting in 2022. To be eligible to receive the cash incentives, Amneal must achieve (i) minimum cumulative expenditures towards developmental and/or capital investments and (ii) a minimum percentage growth in sales of eligible products.
The Company has concluded the PLI Scheme is government assistance in the form of a grant and, in the absence of specific accounting guidance under U.S. GAAP, the Company has analogized to International Accounting Standards 20, Accounting for Government Grants and Disclosure of Government Assistance. The Company has evaluated the PLI Scheme to be a grant related to income and will recognize the cash incentives in the consolidated statements of operations on a systematic basis within other operating income. For the three and nine months ended September 30, 2022, the Company recognized $1.3 million and $2.5 million, respectively, of other operating income associated with the PLI Scheme. Receivables from the government of India of $1.7 million and $0.8 million, respectively, were recorded within prepaid and other current assets and other long-term assets as of September 30, 2022, respectively, based on the terms of the PLI Scheme.
20. Debt
The following is a summary of the Company’s total indebtedness (in thousands):
| | | | | | | | | | | |
| September 30, 2022 | | December 31, 2021 |
Term Loan due May 2025 | $ | 2,570,626 | | | $ | 2,590,876 | |
Rondo Term Loan due January 2025 | 82,000 | | | 139,250 | |
Other | — | | | 624 | |
Total debt | 2,652,626 | | | 2,730,750 | |
Less: debt issuance costs | (15,469) | | | (20,083) | |
Total debt, net of debt issuance costs | 2,637,157 | | | 2,710,667 | |
Less: current portion of long-term debt | (29,940) | | | (30,614) | |
Total long-term debt, net | $ | 2,607,217 | | | $ | 2,680,053 | |
There have been no material changes in the Company’s long-term debt since December 31, 2021, except as disclosed below. Refer to Note 17. Debt in our 2021 Annual Report on Form 10-K for additional information.
On June 2, 2022, the Company entered into a revolving credit agreement (the “New Credit Agreement”), which amended the existing senior secured asset backed revolving credit facility (the “Revolving Credit Facility”). The New Credit Agreement (i) replaced the Revolving Credit Facility with a $350.0 million senior secured revolving credit facility (the “New Revolving Credit Facility”) that matures on June 2, 2027, (ii) provides for up to $25.0 million of the New Revolving Credit Facility to be available for the purpose of issuing letters of credit; (iii) provides for up to $35.0 million of the New Revolving Credit Facility to be available for the purpose of issuing swingline loans; (iv) allows the the Company to request an incremental increase in the revolving facility commitments by up to $150.0 million; and (v) terminated the revolving credit facility commitments of lenders under the Revolving Credit Facility.
Interest is payable on the New Revolving Credit Facility at a rate equal to the alternate base rate (“ABR”) or the secured overnight financing rate (“SOFR”), plus an applicable margin, in each case, subject to a ABR floor of 1.00% or a SOFR floor of 0.00%, as applicable. The applicable margin for the New Revolving Credit Facility is initially 0.25% per annum for ABR loans and 1.25% per annum for SOFR loans. The applicable margin on borrowings under the New Revolving Credit Facility thereafter will adjust ranging from 0.25% to 0.50% per annum for ABR loans and from 1.25% to 1.50% per annum for SOFR loans determined by the average historical excess availability. The proceeds of any loans made under the New Revolving Credit Facility can be used for capital expenditures, acquisitions, working capital needs and other general purposes, subject to covenants as described below. The Company pays a commitment fee based on the average daily unused amount of the New Revolving Credit Facility at a rate of 0.25% per annum.
Subject to the refinancing, there was a decrease in the borrowing capacity of certain lenders between the New Revolving Credit Facility and the Revolving Credit Facility. As a result, the Company recorded $0.3 million charge for the nine months ended September 30, 2022 in loss on refinancing. Additionally, the Company incurred costs of $1.6 million associated with the Credit Agreement, which was capitalized as deferred financing costs with the remaining unamortized costs associated with the New Revolving Credit Facility, and will be amortized over the life of the New Credit Agreement.
The New Credit Agreement contains certain negative covenants that, among other things and subject to certain exceptions, restrict the Company’s and certain subsidiaries’ ability to incur additional debt or guarantees, grant liens, make loans, acquisitions or other investments, dispose of assets, merge, dissolve, liquidate or consolidate, pay dividends or other payments on capital stock, make optional payments or modify certain debt instruments, modify certain organizational documents, enter into arrangements that restrict the ability to pay dividends or grant liens, or enter into or consummate transactions with affiliates. The New Revolving Credit Facility also includes a financial covenant whereby the Company must maintain a minimum fixed-charge coverage ratio if certain borrowing conditions are met. The New Revolving Credit Facility contains customary events of default, subject to certain exceptions. Upon the occurrence of certain events of default, the obligations under the New Revolving Credit Facility may be accelerated and the commitments may be terminated.
As of September 30, 2022, the Company had $60.0 million in borrowings under the New Revolving Credit Facility.
During the nine months ended September 30, 2022, the Company repaid $57.3 million of outstanding principal of the Rondo Term Loan. Additionally, the Company repaid the remaining $0.6 million in principal of other debt obligations in June 2022.
21. Property Losses and Associated Expenses
On September 1, 2021, Tropical Storm Ida brought extreme rainfall and flash flooding to New Jersey that caused damage to two of the Company’s facilities. Operations at these facilities were closed for the majority of September 2021 in order to assess the damage, make repairs and restore operations.
The Company concluded that all inventory on-hand at the time of the flooding was damaged and unsellable and that a majority of the equipment was damaged beyond repair. In addition, the Company incurred significant costs to repair both facilities. Accordingly, the Company recorded $8.2 million of charges for property losses and associated expenses for both of the three and nine months ended September 30, 2021. The Company has insurance policies for property damage, inventory losses and business interruption. Insurance recoveries are recorded in the periods when it is probable they will be realized. During the nine months ended September 30, 2022, insurance recoveries of $1.9 million associated with property damage and inventory losses were received. Charges (insurance recoveries) for property losses and associated expenses was comprised of the following (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2022 | | 2021 | | 2022 | | 2021 |
Impairment of equipment | $ | — | | | $ | 4,202 | | | $ | — | | | $ | 4,202 | |
Impairment of inventory | — | | | 950 | | | — | | | 950 | |
Repairs and maintenance expenses | — | | | 2,025 | | | — | | | 2,025 | |
Salaries and benefits | — | | | 1,009 | | | — | | | 1,009 | |
Total property losses and associated expenses | — | | | 8,186 | | | — | | | 8,186 | |
Less: Insurance recoveries received | — | | | — | | | (1,911) | | | — | |
| $ | — | | | $ | 8,186 | | | $ | (1,911) | | | $ | 8,186 | |