8-K

Amneal Pharmaceuticals, Inc. (AMRX)

8-K 2021-08-09 For: 2021-08-09
View Original
Added on April 06, 2026

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 8-K

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): August 9, 2021

AMNEAL PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

Delaware 001-38485 32-0546926
(State or other jurisdiction<br>of incorporation) (Commission File Number) (IRS Employer<br>Identification No.)

400 Crossing Blvd

Bridgewater, NJ 08807

(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code: (908) 947-3120

N/A

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

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))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class Trading Symbol(s) Name of each exchange on which registered
Class A Common Stock, par value $0.01 per share AMRX New York Stock Exchange

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02 Results of Operations and Financial Condition.

On August 9, 2021, Amneal Pharmaceuticals, Inc. (the “Company”) issued a press release announcing its results for the second quarter ended June 30, 2021. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated by reference herein.

The information in this report furnished pursuant to Item 2.02, including Exhibit 99.1 attached hereto, shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. It may only be incorporated by reference in another filing under the Exchange Act or the Securities Act of 1933, as amended (the "Securities Act"), if such subsequent filing specifically references the information furnished pursuant to Item 2.02 of this report.

Item 7.01 Regulation FD.

To access the Earnings Call through a conference line, dial (844) 746-0741 (in the U.S.) and (412) 317-5273 (international callers). The webcast of the Earnings Call will be accessible through the Investors section of the Company's website at https://investors.amneal.com.

The Company intends to publish an investor presentation which can be accessed at the Investors section of the Company’s website, https://investors.amneal.com, under the “Events & Presentations” heading.

The information in this report furnished pursuant to Item 7.01 shall not be deemed “filed” for the purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that section. It may only be incorporated by reference in another filing under the Exchange Act or the Securities Act if such subsequent filing specifically references the information furnished pursuant to Item 7.01 of this report.

Item 9.01 Financial Statements and Exhibits.

(d)    Exhibits.

The following exhibits are furnished herewith:

Exhibit No. Description
99.1 Press release issuedAugust9, 2021.
104 The cover page from this Current Report on Form 8-K, formatted in Inline XBRL.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: August 9, 2021 AMNEAL PHARMACEUTICALS, INC.
By: /s/ Anastasios Konidaris
Name: Anastasios Konidaris
Title: Executive Vice President and Chief Financial Officer<br>(Principal Financial and Accounting Officer)

Document

Exhibit 99.1

AMNEAL REPORTS SECOND QUARTER 2021 FINANCIAL RESULTS

‒ Q2 2021 Net Revenue of $535 million; GAAP Net Income of $15 million; Diluted Income per Share of $0.10 ‒

‒ Adjusted EBITDA (1) of $151 million; Adjusted Diluted EPS (1) of $0.25 ‒

‒ Maintaining 2021 Full Year Financial Outlook ‒

BRIDGEWATER, NJ, August 9, 2021 - Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (the “Company”) announced its results today for the second quarter ended June 30, 2021.

“Our strong second quarter results reflect the durability and diversity of our business. At a time when drug prices are rising and more people are seeking affordable health care solutions, we are proud to consistently be first or second to market with new and complex generic drugs. Together with our robust pipeline of specialty products, this quarter we achieved Amneal’s highest level of net revenues with adjusted EBITDA reaching its highest level since 2018. Our talented teams are innovating and executing well and we are excited about the opportunities to come,” said Chirag and Chintu Patel, Co-Chief Executive Officers.

Net revenue in the second quarter of 2021 was $535 million, an increase of 15% compared to $465 million in the second quarter of 2020. The increase was driven by Generic product launches, growth in our promoted Specialty products Rytary® and Unithroid®, and overall volume growth within our Generics and AvKARE segments.

Net income attributable to Amneal Pharmaceuticals, Inc. was $15 million in the second quarter of 2021 compared to a net loss of $12 million in the second quarter of 2020. The increase in net income was primarily attributable to growth in net revenue and gross profit, which was driven by strong gross margin improvement in our Generics segment.

Adjusted EBITDA(1) in the second quarter of 2021 was $151 million, an increase of 50% compared to the second quarter of 2020, reflective of net income growth. Adjusted diluted EPS(1) in the second quarter of 2021 was $0.25, an increase of 92% from $0.13 in the second quarter of 2020, reflective mostly of growth in adjusted EBITDA(1).

(1)    See “Non-GAAP Financial Measures” below.

Maintaining Full Year 2021 Financial Outlook

Amneal is maintaining its previously provided guidance.

Full Year 2021 Financial Guidance
Net revenue $2.1 billion - $2.2 billion
Adjusted EBITDA (1) $500 million - $540 million
Adjusted diluted EPS (2) $0.70 - $0.85
Operating cash flow $220 million - $250 million
Capital expenditures $60 million - $70 million
Weighted average diluted shares outstanding (3) Approximately 303 million

(1) Includes 100% of EBITDA from the AvKARE acquisition.

(2) Accounts for 35% non-controlling interest in AvKARE and reflects the current federal tax rate of 21%.

(3) Assumes the weighted average diluted shares outstanding of class A and class B common stock under the if-converted method.

Conference Call Information

Amneal will host a conference call and live webcast at 8:00 am Eastern Time on August 9, 2021 to discuss its results. The live webcast and presentation will be accessible through the Investor Relations section of the Company’s website at https://investors.amneal.com. To access the call through a conference line, dial (844) 746-0741 (in the U.S.) or (412) 317-5273 (international callers). A replay of the conference call will be posted shortly after the call and will be available for seven days. To access the replay, dial (877) 344-7529 (in the U.S.) or (412) 317-0088 (international callers). The access code for the replay is 10158095.

About Amneal

Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully-integrated pharmaceutical company focused on the development, manufacturing and distribution of generic and specialty drug products. The Company has operations in North America, Asia, and Europe, working together to bring high-quality medicines to patients primarily within the United States.

Amneal has an extensive portfolio of approximately 250 product families and is expanding its portfolio to include complex dosage forms, including biosimilars, in a broad range of therapeutic areas. The Company also markets a portfolio of branded pharmaceutical products through its Specialty segment focused principally on central nervous system and endocrine disorders.

The Company also owns 65% of AvKARE. AvKARE provides pharmaceuticals, medical and surgical products, and services, primarily to governmental agencies. AvKARE is a re-packager of bottle and unit dose pharmaceuticals, which services the Department of Defense and the Department of Veterans Affairs as well as institutional customers. AvKARE is also a wholesale distributor of pharmaceuticals, over the counter products and medical supplies to institutional customers which are located throughout the United States focused primarily on offering 340b-qualified entities products to provide consistency in care and pricing.

For more information, visit www.amneal.com.

Cautionary Statement on Forward-Looking Statements

Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future, including among other things: discussions of future operations; expected operating results and financial performance; impact of planned acquisitions and dispositions; the Company’s strategy for growth; product development; regulatory approvals; market position and expenditures. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates” and similar words are intended to identify estimates and forward-looking statements.

The reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events. If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Company.

Such risks and uncertainties include, but are not limited to: the impact of the COVID-19 pandemic; the impact of global economic conditions; our ability to successfully develop, license, acquire and commercialize new products on a timely basis; our ability to obtain exclusive marketing rights for our products; the competition we face in the pharmaceutical industry from brand and generic drug product companies, and the impact of that competition on our ability to set prices; our ability to manage our growth through acquisitions and otherwise; our dependence on the sales of a limited number of products for a substantial portion of our total revenues; the risk of product liability and other claims against us by consumers and other third parties; risks related to changes in the regulatory environment, including U.S. federal and state laws related to healthcare fraud abuse and health information privacy and security and changes in such laws; changes to FDA product approval requirements; risks related to federal regulation of arrangements between manufacturers of branded and generic products; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; the continuing trend of consolidation of certain customer groups; our reliance on certain licenses to proprietary technologies from time to time; our dependence on third-party suppliers and distributors for raw materials for our products and certain finished goods; our dependence on third-party agreements for a portion of our product offerings; our ability to identify and make acquisitions of or investments in complementary businesses and products on advantageous terms; legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; the significant amount of resources we expend on research

and development; our substantial amount of indebtedness and our ability to generate sufficient cash to service our indebtedness in the future, and the impact of interest rate fluctuations on such indebtedness; and the high concentration of ownership of our Class A Common Stock and the fact that we are controlled by the Amneal Group. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Investors are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.

Non-GAAP Financial Measures

This release includes certain non-GAAP financial measures, including EBITDA, adjusted EBITDA, adjusted net income, adjusted net income per diluted share, adjusted gross profit, adjusted gross margin, adjusted operating income, adjusted cost of goods sold, adjusted selling general and administrative expense, and adjusted research and development expense, which are intended as supplemental measures of the Company’s performance that are not required by or presented in accordance with U.S. General Accepted Accounting Principles (“GAAP”). The calculation of non-GAAP adjusted diluted earnings per share assumes the conversion of all outstanding shares of class B Common Stock to shares of class A Common Stock.

Management uses these non-GAAP measures internally to evaluate and manage the Company’s operations and to better understand its business because they facilitate a comparative assessment of the Company's operating performance relative to its performance based on results calculated under GAAP. These non-GAAP measures also isolate the effects of some items that vary from period to period without any correlation to core operating performance and eliminate certain charges that management believes do not reflect the Company's operations and underlying operational performance. The compensation committee of the Company’s board of directors also uses certain of these measures to evaluate management's performance and set its compensation. The Company believes that these non-GAAP measures also provide useful information to investors regarding certain financial and business trends relating to the Company’s financial condition and operating results facilitates an evaluation of the financial performance of the Company and its operations on a consistent basis. Providing this information therefore allows investors to make independent assessments of the Company’s financial performance, results of operation and trends while viewing the information through the eyes of management.

These non-GAAP measures are subject to limitations. The non-GAAP measures presented in this release may not be comparable to similarly titled measures used by other companies because other companies may not calculate one or more in the same manner. Additionally, the non-GAAP performance measures exclude significant expenses and income that are required by GAAP to be recorded in the Company’s financial statements; do not reflect changes in, or cash requirements for, working capital needs; and do not reflect interest expense, or the requirements necessary to service interest or principal payments on debt. Further, our historical adjusted results are not intended to project our adjusted results of operations or financial position for any future period. To compensate for these limitations, management presents and considers these non-GAAP measures in conjunction with the Company’s GAAP results; no non-GAAP measure should be considered in isolation from or as alternatives to net income, diluted earnings per share, gross profit, gross margin, operating income, cost of goods sold, selling general and administrative expense, and research and development expense or any other measure determined in accordance with GAAP. Readers should review the reconciliations included below, and should not rely on any single financial measure to evaluate the Company’s business.

A reconciliation of each historical non-GAAP measure to the most directly comparable GAAP measure is set forth below.

Amneal’s full year 2021 estimates are based on management's current expectations, including with respect to prescription trends, pricing levels, inventory levels, the costs incurred and benefits realized of restructuring activities and the anticipated timing of future product launches and events. The Company cannot provide a reconciliation between non-GAAP projections and the most directly comparable GAAP measures without unreasonable efforts because it is unable to predict with reasonable certainty the ultimate outcome of certain significant items required for the reconciliation. The items include, but are not limited to, acquisition-related expenses, restructuring expenses and benefits, asset impairments and other gains and losses. These items are uncertain, depend on various factors, and could have a material impact on U.S. GAAP reported results for 2021.

Contact

Anthony DiMeo

Senior Director, Investor Relations

anthony.dimeo@amneal.com

Amneal Pharmaceuticals, Inc.

Consolidated Statements of Operations

(Unaudited; In thousands, except per share amounts)

Three Months Ended<br>June 30, Six Months Ended<br>June 30,
2021 2020 2021 2020
Net revenue $ 535,075 $ 464,662 $ 1,028,180 $ 963,195
Cost of goods sold 322,577 319,666 624,120 633,244
Cost of goods sold impairment charges 759 2,215
Gross profit 212,498 144,237 404,060 327,736
Selling, general and administrative 86,157 80,944 176,883 158,920
Research and development 52,864 45,572 101,046 81,951
In-process research and development impairment charges 710 710 960
Intellectual property legal development expenses 1,365 3,550 4,947 4,820
Acquisition, transaction-related and integration expenses 4,283 1,787 7,085 4,362
Charges related to legal matters, net 1,300 5,800
Restructuring and other charges 333 363 2,381
Operating income 67,119 10,751 113,026 68,542
Other (expense) income:
Interest expense, net (34,083) (36,669) (67,968) (76,568)
Foreign exchange (loss) gain, net (2,244) 3,466 (156) (1,715)
Gain on sale of international businesses, net 123 123
Other income, net 4,032 571 4,826 1,204
Total other expense, net (32,295) (32,509) (63,298) (76,956)
Income (loss) before income taxes 34,824 (21,758) 49,728 (8,414)
Provision for (benefit from) income taxes 2,648 2,186 3,007 (105,987)
Net income (loss) 32,176 (23,944) 46,721 97,573
Less: Net (income) loss attributable to non-controlling interests (17,644) 11,948 (25,483) 5,498
Net income (loss) attributable to Amneal Pharmaceuticals, Inc. $ 14,532 $ (11,996) $ 21,238 $ 103,071
Net income (loss) per share attributable to Amneal Pharmaceuticals, Inc.'s class A common stockholders:
Basic $ 0.10 $ (0.08) $ 0.14 $ 0.70
Diluted $ 0.10 $ (0.08) $ 0.14 $ 0.69
Weighted-average common shares outstanding:
Basic 148,996 147,392 148,507 147,286
Diluted 151,986 147,392 151,606 148,309

Amneal Pharmaceuticals, Inc.

Condensed Consolidated Balance Sheets

(Unaudited; In thousands)

June 30, 2021 December 31, 2020
Assets
Current assets:
Cash and cash equivalents $ 278,306 $ 341,378
Restricted cash 4,847 5,743
Trade accounts receivable, net 652,015 638,895
Inventories 523,385 490,649
Prepaid expenses and other current assets 103,798 73,467
Related party receivables 1,124 1,407
Total current assets 1,563,475 1,551,539
Property, plant and equipment, net 468,415 477,754
Goodwill 549,091 522,814
Intangible assets, net 1,293,325 1,304,626
Operating lease right-of-use assets 41,065 33,947
Operating lease right-of-use assets - related party 21,689 24,792
Financing lease right-of-use assets 66,777 9,541
Financing lease right-of-use assets - related party 58,676
Other assets 19,216 22,344
Total assets $ 4,023,053 $ 4,006,033
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable and accrued expenses $ 596,227 $ 611,867
Current portion of long-term debt, net 30,461 44,228
Current portion of operating lease liabilities 8,237 6,474
Current portion of operating and financing lease liabilities - related party 2,201 3,978
Current portion of financing lease liabilities 2,806 1,794
Current portion of note payable - related party 1,000
Related party payable - short term 32,930 7,561
Total current liabilities 672,862 676,902
Long-term debt, net 2,720,117 2,735,264
Note payable - related party 37,224 36,440
Operating lease liabilities 34,723 30,182
Operating lease liabilities - related party 20,131 23,049
Financing lease liabilities 61,643 2,318
Financing lease liabilities - related party 60,193
Related party payable - long term 8,714 1,584
Other long-term liabilities 63,255 83,365
Total long-term liabilities 2,945,807 2,972,395
Redeemable non-controlling interests 14,112 11,804
Total stockholders' equity 390,272 344,932
Total liabilities and stockholders' equity $ 4,023,053 $ 4,006,033

Amneal Pharmaceuticals, Inc.

Consolidated Statements of Cash Flows

(Unaudited; In thousands)

Six Months Ended June 30,
2021 2020
Cash flows from operating activities:
Net income $ 46,721 $ 97,573
Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation and amortization 112,037 116,155
Unrealized foreign currency loss 124 1,251
Amortization of debt issuance costs and discount 4,473 4,214
Gain on sale of international businesses, net (123)
Intangible asset impairment charges 710 3,175
Stock-based compensation 12,962 10,202
Inventory provision 25,805 34,708
Other operating charges and credits, net 2,764 4,156
Changes in assets and liabilities:
Trade accounts receivable, net (13,167) 75,769
Inventories (54,580) (33,182)
Income taxes receivable associated with the CARES Act (110,069)
Prepaid expenses, other current assets and other assets (23,988) 8,772
Related party receivables 7,383 633
Accounts payable, accrued expenses and other liabilities (21,137) 15,172
Related party payables (3,912) (139)
Net cash provided by operating activities 96,195 228,267
Cash flows from investing activities:
Purchases of property, plant and equipment (19,585) (15,919)
Deposits for future acquisition of property, plant, and equipment (1,667)
Acquisition of intangible assets (500) (1,050)
Acquisitions, net of cash acquired (73,828) (254,000)
Net cash used in investing activities (95,580) (270,969)
Cash flows from financing activities:
Proceeds from issuance of debt 180,000
Payments of principal on debt, financing leases and other (33,876) (17,072)
Payments of deferred financing costs (4,102)
Proceeds from exercise of stock options 681 158
Employee payroll tax withholding on restricted stock unit vesting (2,378) (557)
Tax distributions to non-controlling interests (27,551)
Payments of principal on financing lease - related party (93) (530)
Repayment of related party note (1,000)
Net cash (used in) provided by financing activities (64,217) 157,897
Effect of foreign exchange rate on cash (366) 255
Net (decrease) increase in cash, cash equivalents, and restricted cash (63,968) 115,450
Cash, cash equivalents, and restricted cash - beginning of period 347,121 152,822
Cash, cash equivalents, and restricted cash - end of period $ 283,153 $ 268,272
Cash and cash equivalents - end of period $ 278,306 $ 266,143
Restricted cash - end of period 4,847 2,129
Cash, cash equivalents, and restricted cash - end of period $ 283,153 $ 268,272

Amneal Pharmaceuticals, Inc.

Non-GAAP Reconciliations

(Unaudited, In thousands)

Reconciliation of Net Income (Loss) to EBITDA and Adjusted EBITDA

Three Months Ended June 30, Six Months Ended June 30,
2021 2020 2021 2020
Net income (loss) $ 32,176 $ (23,944) $ 46,721 $ 97,573
Adjusted to add (deduct):
Interest expense, net 34,083 36,669 67,968 76,568
Income tax expense (benefit) 2,648 2,186 3,007 (105,987)
Depreciation and amortization 56,487 58,072 112,037 116,155
EBITDA (Non-GAAP) $ 125,394 $ 72,983 $ 229,733 $ 184,309
Adjusted to add (deduct):
Stock-based compensation expense 7,632 5,663 12,962 10,202
Acquisition and site closure expenses (1) 5,964 5,650 11,756 12,628
Restructuring and other charges (2) 333 363 2,381
Inventory related charges (3) 87 5,125 201 5,125
Charges related to legal matters (4) 3,050 5,550
Asset impairment charges (5) 741 2,299 1,064 4,774
Foreign exchange loss (gain) 2,244 (3,466) 156 1,715
Gain on sale of international businesses, net (123) (123)
Research and development milestone payments 7,847 6,841 18,733 8,841
Other 807 2,431 1,806 (238)
Adjusted EBITDA (Non-GAAP) $ 150,716 $ 100,786 $ 276,774 $ 235,164

Amneal Pharmaceuticals, Inc.

Non-GAAP Reconciliations

(Unaudited; In thousands, except per share amounts)

Reconciliation of Net Income (Loss) to Adjusted Net Income and Calculation of Adjusted Diluted EPS

Three Months Ended June 30, Six Months Ended June 30,
2021 2020 2021 2020
Net income (loss) $ 32,176 $ (23,944) $ 46,721 $ 97,573
Adjusted to add (deduct):
Non-cash interest 2,077 1,998 4,049 3,864
GAAP Income tax (benefit) expense 2,648 2,186 3,007 (105,987)
Amortization 41,361 41,181 80,875 81,495
Stock-based compensation expense 7,632 5,663 12,962 10,202
Acquisition and site closure expenses (1) 5,964 5,650 11,756 12,628
Restructuring and other charges (2) 333 363 2,381
Inventory related charges (3) 87 5,125 201 5,125
Charges related to legal matters (4) 3,050 5,550
Asset impairment charges (5) 741 2,299 1,064 4,774
Foreign exchange (gain) loss (6) (3,466) 1,715
Gain on sale of international businesses, net (123) (123)
Research and development milestone payments 7,847 6,841 18,733 8,841
Other 807 2,431 1,806 (238)
Income tax at 21% (21,779) (10,969) (39,118) (27,974)
Net income attributable to non-controlling interests not associated with our Class B common stock (2,054) (305) (3,850) (1,544)
Adjusted net income (Non-GAAP) $ 77,507 $ 37,950 $ 138,569 $ 98,282
Adjusted diluted EPS (Non-GAAP) (7) $ 0.25 $ 0.13 $ 0.46 $ 0.33

Amneal Pharmaceuticals, Inc.

Non-GAAP Reconciliations

(Unaudited; In thousands)

Explanations for Reconciliations of Net Income (Loss) to EBITDA and Adjusted EBITDA and

Net Income (Loss) to Adjusted Net Income and Calculation of Adjusted Diluted EPS

(1) Acquisition and site closure expenses for the three and six months ended June 30, 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; and (iii) site closure costs associated with the planned closure of our Hauppauge, NY facility. Acquisition and site closure expenses for the three and six months ended June 30, 2020 primarily included (i) system integration costs associated with the combination with Impax Laboratories, LLC, (ii) transaction and integration costs associated with the acquisition of AvKARE, and (iii) site closure expenses associated with the planned closure of our Hauppauge, NY facility.
(2) For the six months ended June 30, 2021 and the three and six months June 30, 2020, restructuring and other charges primarily consisted of cash severance charges associated with cost of benefits for former senior executives and management employees.
(3) For the three and six months ended June 30, 2021 and 2020, inventory related charges represented inventory obsolescence and related expenses associated with recalls.
(4) For the three and six months ended June 30, 2020, charges related to legal matters were $3 million and $6 million, respectively, for commercial legal claims in our Generics segment.
(5) Asset impairment charges for the three months ended June 30, 2021 were primarily associated with the write-off of an intangible asset. Asset impairment charges for the six months ended June 30, 2021 and the three and six months ended June 30, 2020 were primarily associated with the write-off of intangible assets and equipment.
(6) Effective January 1, 2021, the Company does not exclude foreign currency gains or losses from the calculations of adjusted net income and adjusted diluted EPS.
(7) For the three and six months ended June 30, 2021, the calculation of adjusted diluted EPS utilized weighted average diluted shares outstanding of 304,103 and 303,722, respectively, which consisted of Class A common stock and Class B common stock under the if-converted method. For the three and six months ended June 30, 2020, the calculation of adjusted diluted EPS utilized weighted average diluted shares outstanding of 300,779 and 300,426, respectively, which consisted of Class A common stock and Class B common stock under the if-converted method.

Amneal Pharmaceuticals, Inc.

Generics Segment

Reconciliation of GAAP to Non-GAAP Operating Results (1)

(Unaudited; In thousands)

Three Months Ended June 30, 2021 Three Months Ended June 30, 2020
As Reported Adjustments Non-GAAP As Reported Adjustments Non-GAAP
Net revenue $ 360,437 $ $ 360,437 $ 306,559 $ $ 306,559
Cost of goods sold (2) 204,154 (13,637) 190,517 218,909 (20,517) 198,392
Cost of goods sold impairment charges (3) 759 (759)
Gross profit 156,283 13,637 169,920 86,891 21,276 108,167
Gross margin % 43.4 % 47.1 % 28.3 % 35.3 %
Selling, general and administrative (4) 11,797 9 11,806 12,802 (1,924) 10,878
Research and development (5) 43,431 (9,043) 34,388 40,316 (8,411) 31,905
In-process research and development impairment charges (3) 710 (710)
Intellectual property legal development expenses 1,340 1,340 3,550 3,550
Acquisition, transaction-related and integration expenses 324 (324)
Charges related to legal matters, net (6) 3,050 (3,050)
Restructuring and other charges 333 (334) (1)
Operating income $ 99,005 $ 23,381 $ 122,386 $ 26,516 $ 35,319 $ 61,835

(1)    Operating results for the sale of Amneal products by AvKARE were included in our Generics segment.

(2)    Adjustments for the three months ended June 30, 2021 and 2020, respectively, were comprised of stock-based compensation expense ($1.4 million and $1.1 million), amortization expense ($9.8 million and $10.5 million), site closure expenses ($2.2 million and $2.5 million), inventory related charges ($0.1 million and $4.6 million), asset impairment charges (none and $1.0 million), and other ($0.1 million and $0.8 million). For the three months ended June 30, 2021 and 2020, site closure expenses were primarily associated with the planned closure of our Hauppauge, NY facility. For the three months ended June 30, 2020, asset impairment charges were associated with the write-off of equipment.

(3)    Adjustments for the three months ended June 30, 2021 and 2020 were associated with intangible asset impairments.

(4)    Adjustments for the three months ended June 30, 2021 and 2020, respectively, were comprised of stock-based compensation expense ($0.4 million, and $0.3 million), site closure costs ($(0.5) million and $1.3 million), and other ($0.1 million and $0.3 million).

(5)    Adjustments for the three months ended June 30, 2021 and 2020, respectively, were comprised of stock-based compensation expense ($1.0 million and $0.8 million), research and development milestones ($7.8 million and $6.8 million), and other ($0.2 million and $0.8 million).

(6)    Adjustments for the three months ended June 30, 2020 were associated with a commercial legal claim.

Amneal Pharmaceuticals, Inc.

Generics Segment

Reconciliation of GAAP to Non-GAAP Operating Results (1)

(Unaudited; In thousands)

Six Months Ended June 30, 2021 Six Months Ended June 30, 2020
As Reported Adjustments Non-GAAP As Reported Adjustments Non-GAAP
Net revenue $ 672,945 $ $ 672,945 $ 659,145 $ $ 659,145
Cost of goods sold (2) 389,452 (25,656) 363,796 437,774 (35,175) 402,599
Cost of goods sold impairment charges (3) 2,215 (2,215)
Gross profit 283,493 25,656 309,149 219,156 37,390 256,546
Gross margin % 42.1 % 45.9 % 33.2 % 38.9 %
Selling, general and administrative (4) 30,559 (815) 29,744 29,425 (2,566) 26,859
Research and development (5) 79,548 (13,493) 66,055 69,350 (8,813) 60,537
In-process research and development impairment charges (3) 710 (710) 960 (960)
Intellectual property legal development expenses 4,922 4,922 4,815 4,815
Acquisition, transaction-related and integration expenses 324 (324)
Charges related to legal matters, net (6) 5,550 (5,550)
Restructuring and other charges 80 (80) 379 (379)
Operating income $ 167,674 $ 40,754 $ 208,428 $ 108,353 $ 55,982 $ 164,335

(1)    Operating results for the sale of Amneal products by AvKARE were included in our Generics segment.

(2)    Adjustments for the six months ended June 30, 2021 and 2020, respectively, were comprised of stock-based compensation expense ($2.0 million and $2.1 million), amortization expense ($17.8 million and $21.2 million), site closure expenses ($4.7 million and $5.5 million), inventory related charges ($0.2 million and $4.6 million), asset impairment charges ($0.4 million and $1.0 million), and other ($0.6 million and $0.8 million). For the six months ended June 30, 2021 and 2020, site closure expenses were primarily associated with the planned closure of our Hauppauge, NY facility. For the six months ended June 30, 2021 and 2020, asset impairment charges were associated with equipment.

(3)    Adjustments for the six months ended June 30, 2021 and 2020 were associated with intangible asset impairments.

(4)    Adjustments for the six months ended June 30, 2021 and 2020, respectively, were comprised of stock-based compensation expense ($0.8 million, and $0.7 million), site closure costs (immaterial and $2.9 million), and other (immaterial and $(1.0) million).

(5)    Adjustments for the six months ended June 30, 2021 and 2020, respectively, were comprised of stock-based compensation expense ($1.8 million and $1.1 million), research and development milestones ($11.3 million and $6.8 million), and other ($0.3 million and $0.9 million).

(6)    Adjustments for the six months ended June 30, 2020 were associated with a commercial legal claim.

Amneal Pharmaceuticals, Inc.

Specialty Segment

Reconciliation of GAAP to Non-GAAP Operating Results

(Unaudited; In thousands)

Three Months Ended June 30, 2021 Three Months Ended June 30, 2020
As Reported Adjustments Non-GAAP As Reported Adjustments Non-GAAP
Net revenue $ 88,635 $ $ 88,635 $ 94,256 $ $ 94,256
Cost of goods sold (1) 48,683 (27,500) 21,183 50,229 (25,445) 24,784
Gross profit 39,952 27,500 67,452 44,027 25,445 69,472
Gross margin % 45.1 % 76.1 % 46.7 % 73.7 %
Selling, general and administrative (2) 20,656 (741) 19,915 16,870 (521) 16,349
Research and development (2) 9,433 (289) 9,144 5,256 (181) 5,075
Intellectual property legal development expenses 25 25
Acquisition, transaction-related and integration expenses 16 (16) 82 (82)
Charges related to legal matters, net (1,750) (1,750)
Operating income $ 9,822 $ 28,546 $ 38,368 $ 23,569 $ 26,229 $ 49,798

(1)    Adjustments for the three months ended June 30, 2021 and 2020 were comprised of amortization expense.

(2)    Adjustments for the three months ended June 30, 2021 and 2020 were primarily comprised of stock-based compensation expense.

Amneal Pharmaceuticals, Inc.

Specialty Segment

Reconciliation of GAAP to Non-GAAP Operating Results

(Unaudited; In thousands)

Six Months Ended June 30, 2021 Six Months Ended June 30, 2020
As Reported Adjustments Non-GAAP As Reported Adjustments Non-GAAP
Net revenue $ 184,566 $ $ 184,566 $ 182,233 $ $ 182,233
Cost of goods sold (1) 96,881 (54,993) 41,888 98,047 (50,891) 47,156
Gross profit 87,685 54,993 142,678 84,186 50,891 135,077
Gross margin % 47.5 % 77.3 % 46.2 % 74.1 %
Selling, general and administrative (2) 40,537 (1,332) 39,205 37,812 (2,374) 35,438
Research and development (3) 21,498 (7,907) 13,591 12,601 (2,322) 10,279
Intellectual property legal development expenses 25 25 5 5
Acquisition, transaction-related and integration expenses 16 (16) 82 (82)
Charges related to legal matters, net 250 250
Operating income $ 25,609 $ 64,248 $ 89,857 $ 33,436 $ 55,669 $ 89,105

(1)    Adjustments for the six months ended June 30, 2021 and 2020 were comprised of amortization expense.

(2)    Adjustments for the six months ended June 30, 2021 and 2020, respectively, were comprised of stock-based compensation expense ($1.3 million and $1 million) and other (none and $1.4 million).

(3)    Adjustments for the six months ended June 30, 2021 and 2020, respectively, were comprised of stock-based compensation expense ($0.5 million and $0.3 million) and research and development milestones ($7.4 million and $2 million).

Amneal Pharmaceuticals, Inc.

AvKARE Segment

Reconciliation of GAAP to Non-GAAP Operating Results (1)

(Unaudited; In thousands)

Three Months Ended June 30, 2021 Three Months Ended June 30, 2020
As Reported Adjustments Non-GAAP As Reported Adjustments Non-GAAP
Net revenue $ 86,003 $ $ 86,003 $ 63,847 $ $ 63,847
Cost of goods sold 69,740 69,740 50,528 50,528
Gross profit 16,263 16,263 13,319 13,319
Gross margin % 18.9 % 18.9 % 20.9 % 20.9 %
Selling, general and administrative (2) 13,599 (6,183) 7,416 15,647 (8,010) 7,637
Acquisition, transaction-related and integration expenses (3) 491 (491)
Operating income (loss) $ 2,173 $ 6,674 $ 8,847 $ (2,328) $ 8,010 $ 5,682

(1)    Operating results for the sale of Amneal products by AvKARE were included in our Generics segment.

(2)    Adjustments for the three months ended June 30, 2021 and 2020 were comprised of amortization expense.

(3)    Adjustments for the three months ended June 30, 2021 were comprised of finance integration expense.

Amneal Pharmaceuticals, Inc.

AvKARE Segment

Reconciliation of GAAP to Non-GAAP Operating Results (1)

(Unaudited; In thousands)

Six Months Ended June 30, 2021 Six Months Ended June 30, 2020 (2)
As Reported Adjustments Non-GAAP As Reported Adjustments Non-GAAP
Net revenue $ 170,669 $ $ 170,669 $ 121,817 $ $ 121,817
Cost of goods sold 137,787 137,787 97,423 97,423
Gross profit 32,882 32,882 24,394 24,394
Gross margin % 19.3 % 19.3 % 20.0 % 20.0 %
Selling, general and administrative (3) 27,303 (12,367) 14,936 26,435 (14,490) 11,945
Acquisition, transaction-related and integration expenses (4) 1,422 (1,422)
Operating income (loss) $ 4,157 $ 13,789 $ 17,946 $ (2,041) $ 14,490 $ 12,449

(1)    Operating results for the sale of Amneal products by AvKARE were included in our Generics segment.

(2)    Our AvKARE segment includes the results of operations of AvKARE from January 31, 2020, the date of the acquisition, to June 30, 2020.

(3)    Adjustments for the six months ended June 30, 2021 and 2020 were comprised of amortization expense.

(4)    Adjustments for the six months ended June 30, 2021 were comprised of finance integration expense.

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