(State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |||||
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||||||||
Item 2.02 | Results of Operations and Financial Condition. |
Item 7.01 | Regulation FD Disclosure. |
Item 9.01 | Financial Statements and Exhibits. |
Exhibit No. | Description | |||||||
104 | The cover page from this Current Report on Form 8-K, formatted in Inline XBRL. |
Date: | AMNEAL PHARMACEUTICALS, INC. | ||||||||||
By: | /s/ Anastasios Konidaris | ||||||||||
Name: | Anastasios Konidaris | ||||||||||
Title: | Executive Vice President and Chief Financial Officer (Principal Financial and Accounting Officer) |
Full Year 2023 Guidance | |||||
Net revenue | $2.25 billion - $2.35 billion | ||||
Adjusted EBITDA (1) | $500 million - $530 million | ||||
Adjusted diluted EPS (2) | $0.40 - $0.50 | ||||
Operating cash flow (3) | $200 million - $230 million | ||||
Capital expenditures | $50 million - $60 million | ||||
Weighted average diluted shares outstanding (4) | Approximately 307 million |
Three Months Ended December 31, | Year Ended December 31, | ||||||||||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
Net revenue | $ | 609,759 | $ | 536,896 | $ | 2,212,304 | $ | 2,093,669 | |||||||||||||||
Cost of goods sold | 389,046 | 348,490 | 1,416,485 | 1,302,004 | |||||||||||||||||||
Cost of goods sold impairment charges | 5,325 | 22,004 | 11,111 | 22,692 | |||||||||||||||||||
Gross profit | 215,388 | 166,402 | 784,708 | 768,973 | |||||||||||||||||||
Selling, general and administrative | 102,158 | 97,224 | 399,700 | 365,504 | |||||||||||||||||||
Research and development | 41,907 | 51,874 | 195,688 | 201,847 | |||||||||||||||||||
In-process research and development impairment charges | 12,970 | — | 12,970 | 710 | |||||||||||||||||||
Intellectual property legal development expenses | 1,362 | 1,142 | 4,358 | 7,716 | |||||||||||||||||||
Acquisition, transaction-related and integration expenses | (5) | 836 | 709 | 8,055 | |||||||||||||||||||
Restructuring and other charges | 109 | 1,069 | 1,421 | 1,857 | |||||||||||||||||||
Change in fair value of contingent consideration | 2,226 | (100) | 731 | 200 | |||||||||||||||||||
(Insurance recoveries) charges for property losses and associated expenses, net | — | (2,818) | (1,911) | 5,368 | |||||||||||||||||||
Charges related to legal matters, net | 20,094 | 6,000 | 269,930 | 25,000 | |||||||||||||||||||
Other operating income | (1,465) | — | (3,960) | — | |||||||||||||||||||
Operating (loss) income | 36,032 | 11,175 | (94,928) | 152,716 | |||||||||||||||||||
Other (expense) income: | |||||||||||||||||||||||
Interest expense, net | (47,028) | (33,957) | (158,377) | (136,325) | |||||||||||||||||||
Foreign currency exchange gain (loss), net | 569 | (170) | (12,364) | (355) | |||||||||||||||||||
Loss on refinancing - revolving credit facility | — | — | (291) | — | |||||||||||||||||||
Other income, net | 2,772 | 6,633 | 17,833 | 15,330 | |||||||||||||||||||
Total other expense, net | (43,687) | (27,494) | (153,199) | (121,350) | |||||||||||||||||||
(Loss) income before income taxes | (7,655) | (16,319) | (248,127) | 31,366 | |||||||||||||||||||
(Benefit from) provision for income taxes | (1,797) | 4,140 | 6,662 | 11,196 | |||||||||||||||||||
Net (loss) income | (5,858) | (20,459) | (254,789) | 20,170 | |||||||||||||||||||
Less: Net loss (income) attributable to non-controlling interests | 1,525 | 14,082 | 125,241 | (9,546) | |||||||||||||||||||
Net (loss) income attributable to Amneal Pharmaceuticals, Inc. before accretion of redeemable non-controlling interest | (4,333) | (6,377) | (129,548) | 10,624 | |||||||||||||||||||
Accretion of redeemable non-controlling interest | — | — | (438) | — | |||||||||||||||||||
Net (loss) income attributable to Amneal Pharmaceuticals, Inc. | $ | (4,333) | $ | (6,377) | $ | (129,986) | $ | 10,624 | |||||||||||||||
Net (loss) income per share attributable to Amneal Pharmaceuticals, Inc.'s Class A common stockholders: | |||||||||||||||||||||||
Basic | $ | (0.03) | $ | (0.04) | $ | (0.86) | $ | 0.07 | |||||||||||||||
Diluted | $ | (0.03) | $ | (0.04) | $ | (0.86) | $ | 0.07 | |||||||||||||||
Weighted-average common shares outstanding: | |||||||||||||||||||||||
Basic | 151,476 | 149,369 | 150,944 | 148,922 | |||||||||||||||||||
Diluted | 151,476 | 149,369 | 150,944 | 151,821 |
December 31, 2022 | December 31, 2021 | ||||||||||
Assets | |||||||||||
Current assets: | |||||||||||
Cash and cash equivalents | $ | 25,976 | $ | 247,790 | |||||||
Restricted cash | 9,251 | 8,949 | |||||||||
Trade accounts receivable, net | 741,791 | 662,583 | |||||||||
Inventories | 530,735 | 489,389 | |||||||||
Prepaid expenses and other current assets | 103,565 | 110,218 | |||||||||
Related party receivables | 500 | 1,179 | |||||||||
Total current assets | 1,411,818 | 1,520,108 | |||||||||
Property, plant and equipment, net | 469,815 | 514,158 | |||||||||
Goodwill | 598,853 | 593,017 | |||||||||
Intangible assets, net | 1,096,093 | 1,166,922 | |||||||||
Operating lease right-of-use assets | 38,211 | 39,899 | |||||||||
Operating lease right-of-use assets - related party | 17,910 | 20,471 | |||||||||
Financing lease right-of-use assets | 63,424 | 64,475 | |||||||||
Other assets | 103,217 | 20,614 | |||||||||
Total assets | $ | 3,799,341 | $ | 3,939,664 | |||||||
Liabilities and Stockholders’ Equity | |||||||||||
Current liabilities: | |||||||||||
Accounts payable and accrued expenses | $ | 538,199 | $ | 525,345 | |||||||
Current portion of liabilities for legal matters | 107,483 | 58,000 | |||||||||
Revolving credit facility | 60,000 | — | |||||||||
Current portion of long-term debt, net | 29,961 | 30,614 | |||||||||
Current portion of operating lease liabilities | 8,321 | 9,686 | |||||||||
Current portion of operating and financing lease liabilities - related party | 2,869 | 2,636 | |||||||||
Current portion of financing lease liabilities | 3,488 | 3,101 | |||||||||
Related party payables - short term | 2,479 | 47,861 | |||||||||
Total current liabilities | 752,800 | 677,243 | |||||||||
Long-term debt, net | 2,591,981 | 2,680,053 | |||||||||
Note payable - related party | 39,706 | 38,038 | |||||||||
Operating lease liabilities | 32,126 | 32,894 | |||||||||
Operating lease liabilities - related party | 15,914 | 18,783 | |||||||||
Financing lease liabilities | 60,769 | 60,251 | |||||||||
Related party payable - long term | 9,649 | 9,619 | |||||||||
Other long-term liabilities | 87,468 | 38,903 | |||||||||
Total long-term liabilities | 2,837,613 | 2,878,541 | |||||||||
Redeemable non-controlling interests | 24,949 | 16,907 | |||||||||
Total stockholders' equity | 183,979 | 366,973 | |||||||||
Total liabilities and stockholders' equity | $ | 3,799,341 | $ | 3,939,664 |
Years Ended December 31, | |||||||||||
2022 | 2021 | ||||||||||
Cash flows from operating activities: | |||||||||||
Net (loss) income | $ | (254,789) | $ | 20,170 | |||||||
Adjustments to reconcile net (loss) income to net cash provided by operating activities: | |||||||||||
Depreciation and amortization | 240,175 | 233,406 | |||||||||
Unrealized foreign currency loss (gain) | 15,190 | 175 | |||||||||
Amortization of debt issuance costs and discount | 8,595 | 9,203 | |||||||||
Loss on refinancing - revolving credit facility | 291 | — | |||||||||
Intangible asset impairment charges | 24,081 | 23,402 | |||||||||
Change in fair value of contingent consideration | 731 | 200 | |||||||||
Stock-based compensation | 31,847 | 28,412 | |||||||||
Inventory provision | 51,096 | 54,660 | |||||||||
Insurance recoveries for property and equipment losses | (1,000) | (5,000) | |||||||||
Non-cash property losses | — | 5,152 | |||||||||
Other operating charges and credits, net | 8,828 | 5,633 | |||||||||
Changes in assets and liabilities: | |||||||||||
Trade accounts receivable, net | (79,717) | (23,621) | |||||||||
Inventories | (102,396) | (49,015) | |||||||||
Prepaid expenses, other current assets and other assets | 9,882 | (21,981) | |||||||||
Related party receivables | 646 | 7,311 | |||||||||
Accounts payable, accrued expenses and other liabilities | 109,568 | (43,932) | |||||||||
Related party payables | 2,072 | (2,355) | |||||||||
Net cash provided by operating activities | 65,100 | 241,820 | |||||||||
Cash flows from investing activities: | |||||||||||
Purchases of property, plant and equipment | (46,407) | (47,728) | |||||||||
Acquisition of intangible assets | (41,800) | (1,700) | |||||||||
Deposits for future acquisition of property, plant, and equipment | (2,388) | (3,211) | |||||||||
Acquisitions of businesses, net of cash acquired | (84,714) | (146,543) | |||||||||
Proceeds from insurance recoveries for property and equipment losses | 1,000 | 5,000 | |||||||||
Net cash used in investing activities | (174,309) | (194,182) | |||||||||
Cash flows from financing activities: | |||||||||||
Payments of deferred financing and refinancing costs | (1,663) | — | |||||||||
Payments of principal on debt, revolving credit facility, financing leases and other | (123,272) | (78,086) | |||||||||
Borrowings on revolving credit facility | 85,000 | — | |||||||||
Proceeds from exercise of stock options | 662 | 853 | |||||||||
Employee payroll tax withholding on restricted stock unit vesting | (3,571) | (2,664) | |||||||||
Payments of deferred consideration for acquisitions - related party | (44,498) | — | |||||||||
Acquisition of redeemable non-controlling interests | (1,722) | — | |||||||||
Tax distributions to non-controlling interest | (17,556) | (57,132) | |||||||||
Payments of principal on financing lease - related party | — | (93) | |||||||||
Repayment of related party note | — | (1,000) | |||||||||
Net cash used in financing activities | (106,620) | (138,122) | |||||||||
Effect of foreign exchange rate on cash | (5,683) | 102 | |||||||||
Net decrease in cash, cash equivalents, and restricted cash | (221,512) | (90,382) | |||||||||
Cash, cash equivalents, and restricted cash - beginning of period | 256,739 | 347,121 | |||||||||
Cash, cash equivalents, and restricted cash - end of period | $ | 35,227 | $ | 256,739 | |||||||
Cash and cash equivalents - end of period | $ | 25,976 | $ | 247,790 | |||||||
Restricted cash - end of period | $ | 9,251 | $ | 8,949 | |||||||
Cash, cash equivalents, and restricted cash - end of period | $ | 35,227 | $ | 256,739 |
Three Months Ended December 31, | Year Ended December 31, | ||||||||||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
Net (loss) income | $ | (5,858) | $ | (20,459) | $ | (254,789) | $ | 20,170 | |||||||||||||||
Adjusted to add (deduct): | |||||||||||||||||||||||
Interest expense, net | 47,028 | 33,957 | 158,377 | 136,325 | |||||||||||||||||||
(Benefit from) provision for income taxes | (1,797) | 4,140 | 6,662 | 11,196 | |||||||||||||||||||
Depreciation and amortization | 61,056 | 61,183 | 240,175 | 233,406 | |||||||||||||||||||
EBITDA (Non-GAAP) | $ | 100,429 | $ | 78,821 | $ | 150,425 | $ | 401,097 | |||||||||||||||
Adjusted to add (deduct): | |||||||||||||||||||||||
Stock-based compensation expense | 7,831 | 7,742 | 31,847 | 28,412 | |||||||||||||||||||
Acquisition, site closure, and idle facility expenses (2) | 3,452 | 6,027 | 15,682 | 20,003 | |||||||||||||||||||
Restructuring and other charges | 109 | — | 1,378 | 788 | |||||||||||||||||||
Loss on refinancing | — | — | 291 | — | |||||||||||||||||||
Inventory related charges | — | 16 | — | 261 | |||||||||||||||||||
Charges related to legal matters, net (3) | 20,094 | 6,000 | 269,930 | 25,000 | |||||||||||||||||||
Asset impairment charges (4) | 18,551 | 22,353 | 26,909 | 24,105 | |||||||||||||||||||
Foreign exchange (gain) loss | (569) | 170 | 12,364 | 355 | |||||||||||||||||||
Change in fair value of contingent consideration | 2,226 | (100) | 731 | 200 | |||||||||||||||||||
(Insurance recoveries) charges for property losses and associated expenses, net (5) | — | (2,818) | (1,911) | 5,368 | |||||||||||||||||||
Regulatory approval milestone | — | — | 5,000 | — | |||||||||||||||||||
Other | 1,909 | 3,592 | 1,464 | 6,680 | |||||||||||||||||||
Adjusted EBITDA (Non-GAAP) | $ | 154,032 | $ | 121,803 | $ | 514,110 | $ | 512,269 |
Three Months Ended December 31, | Year Ended December 31, | ||||||||||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
Net (loss) income | $ | (5,858) | $ | (20,459) | $ | (254,789) | $ | 20,170 | |||||||||||||||
Adjusted to add (deduct): | |||||||||||||||||||||||
Non-cash interest | 1,885 | 2,123 | 7,715 | 8,355 | |||||||||||||||||||
GAAP (benefit from) provision for income taxes | (1,797) | 4,140 | 6,662 | 11,196 | |||||||||||||||||||
Amortization | 42,851 | 41,543 | 164,997 | 164,069 | |||||||||||||||||||
Stock-based compensation expense | 7,831 | 7,742 | 31,847 | 28,412 | |||||||||||||||||||
Acquisition, site closure expenses, and idle facility expenses (2) | 3,452 | 6,027 | 15,682 | 20,003 | |||||||||||||||||||
Restructuring and other charges | 109 | — | 1,378 | 788 | |||||||||||||||||||
Loss on refinancing | — | — | 291 | — | |||||||||||||||||||
Inventory related charges | — | 16 | — | 261 | |||||||||||||||||||
Charges related to legal matters, including interest, net (3) | 21,564 | 6,000 | 273,226 | 25,000 | |||||||||||||||||||
Asset impairment charges (4) | 18,485 | 22,353 | 26,843 | 24,105 | |||||||||||||||||||
Regulatory approval milestone | — | — | 5,000 | — | |||||||||||||||||||
Change in fair value of contingent consideration | 2,226 | (100) | 731 | 200 | |||||||||||||||||||
(Insurance recoveries) charges for property losses and associated expenses (5) | — | (2,818) | (1,911) | 5,368 | |||||||||||||||||||
Other | 1,910 | 3,592 | 1,607 | 6,680 | |||||||||||||||||||
Provision for income taxes (6) | (15,297) | (18,193) | (56,450) | (70,199) | |||||||||||||||||||
Net income attributable to non-controlling interests not associated with our class B common stock | (5,958) | (1,191) | (15,121) | (6,582) | |||||||||||||||||||
Adjusted net income (Non-GAAP) | $ | 71,403 | $ | 50,775 | $ | 207,708 | $ | 237,826 | |||||||||||||||
Weighted average diluted shares outstanding (Non-GAAP)(7) | 305,145 | 304,429 | 304,598 | 303,937 | |||||||||||||||||||
Adjusted diluted earnings per share (Non-GAAP) | $ | 0.23 | $ | 0.17 | $ | 0.68 | $ | 0.78 |
(1) | Beginning in the first quarter of 2022, we no longer exclude research and development milestone expenses related to license and collaboration agreements from our non-GAAP financial measures and our line item components, including adjusted research and development, adjusted EBITDA, adjusted operating income, adjusted net income and adjusted diluted earnings per share. Prior period adjusted results have been revised to reflect this change. Refer to our Form 8-K filed on May 4, 2022 for additional information. | |||||||||||||
(2) | Acquisition, site closure, and idle facility expenses for the three months ended December 31, 2022 primarily included site closure costs associated with the planned cessation of manufacturing at our Hauppauge, NY facility. Acquisition, site closure, and idle facility expenses for the year ended December 31, 2022 primarily included (i) transaction and integration costs associated with the acquisition of the baclofen franchise from certain entities affiliated with Saol International Limited, which closed on February 9, 2022; (ii) integration costs associated with the acquisition of Puniska Healthcare Pvt. Ltd. (“Puniska”), which closed on November 2, 2021; and (iii) site closure costs associated with the planned cessation of manufacturing at our Hauppauge, NY facility. Acquisition, site closure, and idle facility expenses for the three months and year ended December 31, 2021 primarily included (i) transaction and integration costs associated with the acquisition of Kashiv Specialty Pharmaceuticals, LLC; (ii) integration costs associated with the acquisition of AvKARE; (iii) site closure costs associated with the planned cessation of manufacturing at our Hauppauge, NY facility; (iv) transaction and integration costs associated with the acquisition of Puniska; and (v) site closure expenses associated with damage from Tropical Storm Ida to two of our facilities in New Jersey. | |||||||||||||
(3) | For the three months ended December 31, 2022 charges related to legal matters, net primarily related to prescription opioid litigation. For the year ended December 31, 2022, charges related to legal matters, net, primarily included charges for (i) the settlements of the Opana ER® antitrust litigation and (ii) prescription opioid litigation, offset by insurance recoveries associated with class action shareholder lawsuits. For the three months and year ended December 31, 2021, charges related to legal matters, net were for legal claims in our Corporate segment. | |||||||||||||
(4) | Asset impairment charges for the three months and years ended December 31, 2022 and 2021 were associated with the write-offs of intangible assets and equipment, except for equipment discussed in (5) below. | |||||||||||||
(5) | (Insurance recoveries) charges for property losses and associated expenses, net for the year ended December 31, 2022 included $1.9 million of insurance recoveries for damage to two of our facilities in NJ from Tropical Storm Ida. Property losses and associated expenses, net for the three months and year ended December 31, 2021 were associated with damage from Tropical Storm Ida to two of our facilities in New Jersey, net of insurance recoveries. Expenses consisted of impairment of equipment and inventory, and repairs and maintenance and salaries and benefits. | |||||||||||||
(6) | The Non-GAAP effective tax rates for the three months ended December 31, 2022 and 2021 were 17.6% and 26.3%, respectively. The Non-GAAP tax rates for the years ended December 31, 2022 and 2021 were 21.4% and 22.7%, respectively. | |||||||||||||
(7) | Weighted average diluted shares outstanding consisted of class A common stock and class B common stock under the if-converted method. |
Three Months Ended December 31, 2022 | Three Months Ended December 31, 2021 | |||||||||||||||||||||||||||||||||||||
As Reported | Adjustments | Non-GAAP | As Reported | Adjustments | Non-GAAP | |||||||||||||||||||||||||||||||||
Net revenue | $ | 399,165 | $ | — | $ | 399,165 | $ | 346,266 | $ | — | $ | 346,266 | ||||||||||||||||||||||||||
Cost of goods sold (2) | 249,795 | (16,875) | 232,920 | 227,446 | (16,558) | 210,888 | ||||||||||||||||||||||||||||||||
Cost of goods sold impairment charges | — | — | — | 22,004 | (22,004) | — | ||||||||||||||||||||||||||||||||
Gross profit | 149,370 | 16,875 | 166,245 | 96,816 | 38,562 | 135,378 | ||||||||||||||||||||||||||||||||
Gross margin % | 37.4 | % | 41.6 | % | 28.0 | % | 39.1 | % | ||||||||||||||||||||||||||||||
Selling, general and administrative (3) | 25,371 | (1,319) | 24,052 | 18,000 | (861) | 17,139 | ||||||||||||||||||||||||||||||||
Research and development (4) | 38,127 | (1,112) | 37,015 | 43,818 | (1,030) | 42,788 | ||||||||||||||||||||||||||||||||
In-process research and development impairment charges | 12,970 | (12,970) | — | — | — | — | ||||||||||||||||||||||||||||||||
Intellectual property legal development expenses | 1,332 | — | 1,332 | 1,056 | — | 1,056 | ||||||||||||||||||||||||||||||||
Acquisition, transaction-related and integration expenses | 1 | (1) | — | — | — | — | ||||||||||||||||||||||||||||||||
Restructuring and other charges | 108 | (108) | — | — | — | — | ||||||||||||||||||||||||||||||||
Insurance recoveries for property losses and associated expenses, net (5) | — | — | — | (2,818) | 2,818 | — | ||||||||||||||||||||||||||||||||
Charges related to legal matters, net (6) | 19,958 | (19,958) | — | — | — | — | ||||||||||||||||||||||||||||||||
Other operating income | (1,465) | — | (1,465) | — | — | — | ||||||||||||||||||||||||||||||||
Operating income | $ | 52,968 | $ | 52,343 | $ | 105,311 | $ | 36,760 | $ | 37,635 | $ | 74,395 |
(1) | Operating results for the sale of Amneal products by AvKARE were included in our Generics segment. | |||||||||||||
(2) | Adjustments for the three months ended December 31, 2022 and 2021, respectively, were comprised of stock-based compensation expense ($1.2 million and $1.4 million), amortization expense ($12.4 million and $10.0 million), site closure and idle facility expenses ($2.7 million and $4.8 million), asset impairment charges ($0.3 million and $0.4 million), and other ($0.3 million and none). | |||||||||||||
(3) | Adjustments for the three months ended December 31, 2022 and 2021, respectively, were comprised of stock-based compensation expense (each $0.5 million) and site closure costs ($0.8 million and $0.4 million). | |||||||||||||
(4) | Adjustments for the three months ended December 31, 2022 and 2021 were comprised of stock-based compensation expense. Non-GAAP adjusted research and development for the three months ended December 31, 2021, as previously reported, has been revised to include $3.6 million of research and development milestone expenses previously excluded. | |||||||||||||
(5) | Adjustments for the three months December 31, 2021 were comprised of expenses associated with damage from Tropical Storm Ida to two of our facilities in New Jersey of $2.2 million, net of insurance recoveries of $5.0 million. Expenses consisted of impairment of equipment and inventory, and repairs and maintenance and salaries and benefits. | |||||||||||||
(6) | Adjustments for the three months ended December 31, 2022 were primarily comprised of charges related to civil prescription opioid litigation. | |||||||||||||
Year Ended December 31, 2022 | Year Ended December 31, 2021 | |||||||||||||||||||||||||||||||||||||
As Reported | Adjustments | Non-GAAP | As Reported | Adjustments | Non-GAAP | |||||||||||||||||||||||||||||||||
Net revenue | $ | 1,432,073 | $ | — | $ | 1,432,073 | $ | 1,366,338 | $ | — | $ | 1,366,338 | ||||||||||||||||||||||||||
Cost of goods sold (2) | 890,245 | (64,294) | 825,951 | 825,568 | (55,263) | 770,305 | ||||||||||||||||||||||||||||||||
Cost of goods sold impairment charges | 5,786 | (5,786) | — | 22,692 | (22,692) | — | ||||||||||||||||||||||||||||||||
Gross profit | 536,042 | 70,080 | 606,122 | 518,078 | 77,955 | 596,033 | ||||||||||||||||||||||||||||||||
Gross margin % | 37.4 | % | 42.3 | % | 37.9 | % | 43.6 | % | ||||||||||||||||||||||||||||||
Selling, general and administrative (3) | 109,781 | (9,960) | 99,821 | 64,500 | (2,664) | 61,836 | ||||||||||||||||||||||||||||||||
Research and development (4) | 167,509 | (4,819) | 162,690 | 158,365 | (4,269) | 154,096 | ||||||||||||||||||||||||||||||||
In-process research and development impairment charges | 12,970 | (12,970) | — | 710 | (710) | — | ||||||||||||||||||||||||||||||||
Intellectual property legal development expenses | 4,251 | — | 4,251 | 7,562 | — | 7,562 | ||||||||||||||||||||||||||||||||
Acquisition, transaction-related and integration expenses | 25 | (25) | — | — | — | — | ||||||||||||||||||||||||||||||||
Restructuring and other charges | 821 | (821) | — | 80 | (80) | — | ||||||||||||||||||||||||||||||||
(Insurance recoveries) charges for property losses and associated expenses, net (5) | (1,911) | 1,911 | — | 5,368 | (5,368) | — | ||||||||||||||||||||||||||||||||
Charges related to legal matters, net (6) | 22,400 | (22,400) | — | — | — | — | ||||||||||||||||||||||||||||||||
Other operating income | (3,960) | — | (3,960) | — | — | — | ||||||||||||||||||||||||||||||||
Operating income | $ | 224,156 | $ | 119,164 | $ | 343,320 | $ | 281,493 | $ | 91,046 | $ | 372,539 |
(1) | Operating results for the sale of Amneal products by AvKARE were included in our Generics segment. | |||||||||||||
(2) | Adjustments for the years ended December 31, 2022 and 2021, respectively, were comprised of stock-based compensation expense ($4.8 million and $4.7 million), amortization expense ($44.2 million and $38.0 million), site closure and idle facility expenses ($12.5 million and $11.0 million), inventory related charges (none and $0.2 million), asset impairment charges ($2.8 million and $0.7 million), and other (none and $0.7 million). | |||||||||||||
(3) | Adjustments for the years ended December 31, 2022 and 2021, respectively, were comprised of stock-based compensation expense ($2.5 million, and $1.7 million), site closure expenses ($2.5 million and $0.9 million), a regulatory approval milestone ($5.0 million and none) and other (none and $0.1 million). | |||||||||||||
(4) | Adjustments for the years ended December 31, 2022 and 2021, respectively, were comprised of stock-based compensation expense ($4.8 million and $3.9 million) and other (none and $0.3 million). Non-GAAP adjusted research and development for the year ended December 31, 2021, as previously reported, has been revised to include $15.4 million of research and development milestone expenses previously excluded. | |||||||||||||
(5) | Adjustments for the year ended December 31, 2021 were comprised of expenses associated with damage from Tropical Storm Ida to two of our facilities in New Jersey of $10.4 million, net of insurance recoveries of $5.0 million. Expenses consisted of impairment of equipment and inventory, and repairs and maintenance and salaries and benefits. Adjustments for the year ended December 31, 2022 included $1.9 million of insurance recoveries. | |||||||||||||
(6) | Adjustments for the year ended December 31, 2022 were primarily comprised of charges related to civil prescription opioid litigation. | |||||||||||||
Three Months Ended December 31, 2022 | Three Months Ended December 31, 2021 | ||||||||||||||||||||||||||||||||||
As Reported | Adjustments | Non-GAAP | As Reported | Adjustments | Non-GAAP | ||||||||||||||||||||||||||||||
Net revenue | $ | 102,550 | $ | — | $ | 102,550 | $ | 101,008 | $ | — | $ | 101,008 | |||||||||||||||||||||||
Cost of goods sold (1) | 46,744 | (27,327) | 19,417 | 49,378 | (27,483) | 21,895 | |||||||||||||||||||||||||||||
Cost of goods sold impairment charges | 5,325 | (5,325) | — | — | — | — | |||||||||||||||||||||||||||||
Gross profit | 50,481 | 32,652 | 83,133 | 51,630 | 27,483 | 79,113 | |||||||||||||||||||||||||||||
Gross margin % | 49.2 | % | 81.1 | % | 51.1 | % | 78.3 | % | |||||||||||||||||||||||||||
Selling, general and administrative (2) | 20,259 | (119) | 20,140 | 21,733 | (749) | 20,984 | |||||||||||||||||||||||||||||
Research and development (3) | 3,780 | (372) | 3,408 | 8,056 | (300) | 7,756 | |||||||||||||||||||||||||||||
Intellectual property legal development expenses | 30 | — | 30 | 86 | — | 86 | |||||||||||||||||||||||||||||
Acquisition, transaction-related and integration expenses | 2 | (2) | — | — | — | — | |||||||||||||||||||||||||||||
Change in fair value of contingent consideration (4) | 2,226 | (2,226) | — | (100) | 100 | — | |||||||||||||||||||||||||||||
Operating income | $ | 24,184 | $ | 35,371 | $ | 59,555 | $ | 21,855 | $ | 28,432 | $ | 50,287 |
(1) | Adjustments for the three months ended December 31, 2022 and 2021 were comprised of amortization expense. | |||||||||||||
(2) | Adjustments for the three months ended December 31, 2022 and 2021 were comprised of stock-based compensation expense. | |||||||||||||
(3) | Adjustments for the three months ended December 31, 2022 and 2021 were comprised of stock-based compensation expense. Non-GAAP adjusted research and development for the three months ended December 31, 2021, as previously reported, has been revised to include $1.0 million of research and development milestone expenses previously excluded. | |||||||||||||
(4) | Contingent consideration was recorded in connection with the acquisitions of (i) the baclofen franchise from certain entities affiliated with Saol International Limited and (ii) Kashiv Specialty Pharmaceuticals, LLC. |
Year Ended December 31, 2022 | Year Ended December 31, 2021 | ||||||||||||||||||||||||||||||||||
As Reported | Adjustments | Non-GAAP | As Reported | Adjustments | Non-GAAP | ||||||||||||||||||||||||||||||
Net revenue | $ | 374,121 | $ | — | $ | 374,121 | $ | 378,319 | $ | — | $ | 378,319 | |||||||||||||||||||||||
Cost of goods sold (1) | 177,107 | (108,187) | 68,920 | 193,562 | (109,979) | 83,583 | |||||||||||||||||||||||||||||
Cost of goods sold impairment charges | 5,325 | (5,325) | — | — | — | — | |||||||||||||||||||||||||||||
Gross profit | 191,689 | 113,512 | 305,201 | 184,757 | 109,979 | 294,736 | |||||||||||||||||||||||||||||
Gross margin % | 51.2 | % | 81.6 | % | 48.8 | % | 77.9 | % | |||||||||||||||||||||||||||
Selling, general and administrative (2) | 90,031 | (913) | 89,118 | 84,481 | (2,830) | 81,651 | |||||||||||||||||||||||||||||
Research and development (3) | 28,179 | (1,471) | 26,708 | 43,482 | (1,083) | 42,399 | |||||||||||||||||||||||||||||
Intellectual property legal development expenses | 107 | — | 107 | 154 | — | 154 | |||||||||||||||||||||||||||||
Acquisition, transaction-related and integration expenses | 49 | (49) | — | 16 | (16) | — | |||||||||||||||||||||||||||||
Change in fair value of contingent consideration (4) | 731 | (731) | — | 200 | (200) | — | |||||||||||||||||||||||||||||
Operating income | $ | 72,592 | $ | 116,676 | $ | 189,268 | $ | 56,424 | $ | 114,108 | $ | 170,532 |
(1) | Adjustments for the years ended December 31, 2022 and 2021 were comprised of amortization expense. | |||||||||||||
(2) | Adjustments for the years ended December 31, 2022 and 2021 were comprised of stock-based compensation expense. | |||||||||||||
(3) | Adjustments for the years ended December 31, 2022 and 2021 were comprised of stock-based compensation expense. Non-GAAP adjusted research and development for the year ended December 31, 2021, as previously reported, has been revised to include $10.4 million of research and development milestone expenses previously excluded. | |||||||||||||
(4) | Contingent consideration was recorded in connection with the acquisitions of (i) the baclofen franchise from certain entities affiliated with Saol International Limited and (ii) Kashiv Specialty Pharmaceuticals, LLC. |
Three Months Ended December 31, 2022 | Three Months Ended December 31, 2021 | ||||||||||||||||||||||||||||||||||
As Reported | Adjustments | Non-GAAP | As Reported | Adjustments | Non-GAAP | ||||||||||||||||||||||||||||||
Net revenue | $ | 108,044 | $ | — | $ | 108,044 | $ | 89,622 | $ | — | $ | 89,622 | |||||||||||||||||||||||
Cost of goods sold | 92,507 | — | 92,507 | 71,666 | — | 71,666 | |||||||||||||||||||||||||||||
Gross profit | 15,537 | — | 15,537 | 17,956 | — | 17,956 | |||||||||||||||||||||||||||||
Gross margin % | 14.4 | % | 14.4 | % | 20.0 | % | 20.0 | % | |||||||||||||||||||||||||||
Selling, general and administrative (2) | 14,298 | (4,932) | 9,366 | 15,932 | (8,093) | 7,839 | |||||||||||||||||||||||||||||
Operating income | $ | 1,239 | $ | 4,932 | $ | 6,171 | $ | 2,024 | $ | 8,093 | $ | 10,117 |
(1) | Operating results for the sale of Amneal products by AvKARE were included in our Generics segment. | |||||||||||||
(2) | Adjustments for the three months ended December 31, 2022 and 2021, respectively, were comprised of amortization ($4.9 million and $6.2 million) and other (none and $1.9 million). | |||||||||||||
Year Ended December 31, 2022 | Year Ended December 31, 2021 | ||||||||||||||||||||||||||||||||||
As Reported | Adjustments | Non-GAAP | As Reported | Adjustments | Non-GAAP | ||||||||||||||||||||||||||||||
Net revenue | $ | 406,110 | $ | — | $ | 406,110 | $ | 349,012 | $ | — | $ | 349,012 | |||||||||||||||||||||||
Cost of goods sold | 349,133 | — | 349,133 | 282,874 | — | 282,874 | |||||||||||||||||||||||||||||
Gross profit | 56,977 | — | 56,977 | 66,138 | — | 66,138 | |||||||||||||||||||||||||||||
Gross margin % | 14.0 | % | 14.0 | % | 19.0 | % | 19.0 | % | |||||||||||||||||||||||||||
Selling, general and administrative (2) | 53,659 | (19,324) | 34,335 | 57,918 | (26,764) | 31,154 | |||||||||||||||||||||||||||||
Acquisition, transaction-related and integration expenses (3) | — | — | — | 1,422 | (1,422) | — | |||||||||||||||||||||||||||||
Operating income | $ | 3,318 | $ | 19,324 | $ | 22,642 | $ | 6,798 | $ | 28,186 | $ | 34,984 |
(1) | Operating results for the sale of Amneal products by AvKARE were included in our Generics segment. | |||||||||||||
(2) | Adjustments for the years ended December 31, 2022 and 2021, respectively, were comprised of amortization ($19.7 million and $24.7 million) and other ($(0.4) million and $2.1 million). | |||||||||||||
(3) | Adjustments for the year ended December 31, 2021 were comprised of finance integration expenses. |
Cover |
Mar. 02, 2022 |
---|---|
Cover [Abstract] | |
Document Type | 8-K |
Document Period End Date | Mar. 02, 2023 |
Entity Registrant Name | AMNEAL PHARMACEUTICALS, INC. |
Entity Incorporation, State or Country Code | DE |
Entity File Number | 001-38485 |
Entity Tax Identification Number | 32-0546926 |
Entity Address, Address Line One | 400 Crossing Blvd |
Entity Address, State or Province | NJ |
Entity Address, Postal Zip Code | 08807 |
Entity Address, City or Town | Bridgewater |
City Area Code | 908 |
Local Phone Number | 947-3120 |
Written Communications | false |
Soliciting Material | false |
Pre-commencement Tender Offer | false |
Pre-commencement Issuer Tender Offer | false |
Title of 12(b) Security | Class A Common Stock, par value $0.01 per share |
Trading Symbol | AMRX |
Security Exchange Name | NYSE |
Entity Emerging Growth Company | false |
Amendment Flag | false |
Entity Central Index Key | 0001723128 |
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