Amneal Reports Second Quarter 2022 Financial Results

‒ Q2 2022 Net Revenue of $559 million; GAAP Net Loss of $121 million; Diluted Loss per Share of $(0.80) ‒

‒ Adjusted EBITDA (1) of $135 million; Adjusted Diluted EPS (1) of $0.19 ‒

‒ Updates 2022 Adjusted EBITDA guidance ‒

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) announced its results today for the second quarter ended June 30, 2022.

“Solid second quarter results reflect topline growth across all three segments and meaningful acceleration in performance from the first quarter. Our core business is strong as we expect acceleration in the second half of 2022 and further momentum in the years ahead. On the horizon are a number of key catalyst launches in high growth areas that will build upon our strong, diversified core business performance,” said Chirag and Chintu Patel, Co-Chief Executive Officers.

Net revenue in the second quarter of 2022 was $559 million, an increase of 5% compared to $535 million in the second quarter of 2021. The increase was driven by growth across all three segments with solid broad-based performance in Generics, including Injectables, Specialty growth driven by Rytary® and Unithroid®, and the expansion of AvKARE’s distribution channel.

Net loss attributable to Amneal Pharmaceuticals, Inc. was $121 million in the second quarter of 2022 compared to net income of $15 million in the second quarter of 2021. Net loss in the quarter included a pre-tax charge of $263 million for the previously disclosed preliminary settlement of the Opana ER® antitrust litigation. Adjusted EBITDA(1) in the second quarter of 2022 was $135 million, a decrease of 6% compared to the second quarter of 2021, reflective of lower gross profit due to product mix and a tough comparison to the prior year. Diluted loss per share and adjusted diluted EPS(1) in the second quarter of 2022 were $(0.80) and $0.19, respectively, compared to $0.10 and $0.23, respectively, in the second quarter of 2021.

(1)

See “Non-GAAP Financial Measures” below.

Revised Full Year 2022 Guidance

The Company is updating its full year 2022 guidance.

 

 

Revised Full Year 2022 Guidance

 

Prior Full Year 2022 Guidance

Net revenue

 

$2.15 billion - $2.25 billion

 

$2.15 billion - $2.25 billion

Adjusted EBITDA (1)

 

$500 million - $520 million

 

$540 million - $560 million

Adjusted diluted EPS (2)

 

$0.65 - $0.70

 

$0.80 - $0.85

Operating cash flow (3)

 

$200 million - $225 million

 

$225 million - $250 million

Capital expenditures

 

$65 million - $75 million

 

$75 million - $85 million

Weighted average diluted shares outstanding (4)

 

Approximately 305 million

 

Approximately 307 million

(1)

Includes 100% of EBITDA from the AvKARE acquisition. Beginning in the first quarter of 2022, the Company no longer excludes research and development (“R&D”) milestone expense from its non-GAAP financial measures. In the second quarter of 2022 and 2021, R&D milestone expenses were $1 million and $8 million, respectively. Prior periods presented have been revised to reflect this change. Refer to our Form 8-K filed with the Securities and Exchange Commission on May 4, 2022 for a full reconciliation of previously reported non-GAAP results to revised non-GAAP results for prior periods.

(2)

Accounts for 35% non-controlling interest in AvKARE. Beginning in the first quarter of 2022, the Company no longer excludes R&D milestone expense from its non-GAAP financial measures.

(3)

Represents cash provided by operating activities. Guidance does not contemplate one time and non-recurring items such as legal settlements and other discrete items. These amounts exclude anticipated cash payments this year of approximately $131 million related to the preliminary settlement of the Opana ER® antitrust litigation.

(4)

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

Amneal’s 2022 estimates are based on management's current expectations, including with respect to prescription trends, pricing levels, the timing of future product launches, the costs incurred and benefits realized of restructuring activities, and our long-term strategy. The Company’s financial statements are prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”). The Company cannot provide a reconciliation between non-GAAP projections and the most directly comparable measures in accordance with GAAP 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 GAAP reported results.

Conference Call Information

Amneal will host a conference call and live webcast at 8:30 am Eastern Time on August 5, 2022 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) 200-6205 (in the U.S.) or (929) 526-1599 (international callers). The access code for the call is 236256. 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 (866) 813-9403 (in the U.S.) or +44 (204) 525-0658 (international callers). The access code for the replay is 862075.

About Amneal

Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully-integrated essential medicines company. We make healthy possible through the development, manufacturing, and distribution of generic and specialty pharmaceuticals, primarily within the United States. The Company has a diverse portfolio of over 250 products in its Generics segment and is expanding across a broad range of complex products and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceutical products focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please 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 or estimated operating results and financial performance, the Company’s growth prospects and opportunities as well as its strategy for growth; product development and launches; the successful commercialization and market acceptance of new products, 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: our ability to successfully develop, license, acquire and commercialize new products on a timely basis; the competition we face in the pharmaceutical industry, in general, specifically from brand and generic drug product companies, and the impact of that competition on our ability to set prices; our ability to obtain exclusive marketing rights for our products; 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 continuing trend of consolidation of certain customer groups; our dependence on third-party suppliers and distributors for raw materials for our products and certain finished goods and any associated supply chain disruptions; existing and future legal proceedings, the outcome of which are uncertain and may divert management resources and require us to incur substantial defense or settlement payments and costs; legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; the impact of severe weather; the impact of the ongoing COVID-19 pandemic, and the emergence of variant strains; risks related to federal regulation of arrangements between manufacturers of branded and generic products; our reliance on certain licenses to proprietary technologies from time to time; the significant amount of resources we expend on research and development; 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 Food and Drug Administration (“FDA”) product approval requirements; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; our dependence on third-party agreements for a portion of our product offerings; the impact of global economic conditions, including any economic effects stemming from adverse geopolitical events, an economic downturn and inflation rates; our ability to identify, make and integrate acquisitions or investments in complementary businesses and products on advantageous terms; 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; our obligations under a tax receivable agreement may be significant; 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

As previously disclosed, 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 earnings per share. Prior period adjusted results have been revised to reflect this change.

This release includes certain non-GAAP financial measures, including EBITDA, adjusted EBITDA, adjusted net income, adjusted diluted earnings per 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 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 under the if-converted method.

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 operations 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 Pharmaceuticals, Inc.

Consolidated Statements of Operations

(Unaudited; In thousands, except per share amounts)

 

 

 

Three Months Ended

June 30,

 

Six Months Ended

June 30,

 

 

2022

 

2021

 

2022

 

2021

Net revenue

 

$

559,355

 

 

$

535,075

 

 

$

1,056,988

 

 

$

1,028,180

 

Cost of goods sold

 

 

353,724

 

 

 

322,577

 

 

 

676,786

 

 

 

624,120

 

Cost of goods sold impairment charges

 

 

5,112

 

 

 

 

 

 

5,112

 

 

 

 

Gross profit

 

 

200,519

 

 

 

212,498

 

 

 

375,090

 

 

 

404,060

 

Selling, general and administrative

 

 

98,806

 

 

 

86,157

 

 

 

197,471

 

 

 

176,883

 

Research and development

 

 

50,748

 

 

 

52,864

 

 

 

103,546

 

 

 

101,046

 

In-process research and development impairment charges

 

 

 

 

 

710

 

 

 

 

 

 

710

 

Intellectual property legal development expenses

 

 

821

 

 

 

1,365

 

 

 

1,585

 

 

 

4,947

 

Acquisition, transaction-related and integration expenses

 

 

241

 

 

 

4,283

 

 

 

675

 

 

 

7,085

 

Charges related to legal matters, net

 

 

251,877

 

 

 

 

 

 

249,551

 

 

 

 

Insurance recoveries for property losses and associated expenses

 

 

(1,911

)

 

 

 

 

 

(1,911

)

 

 

 

Restructuring and other charges

 

 

 

 

 

 

 

 

731

 

 

 

363

 

Change in fair value of contingent consideration

 

 

(270

)

 

 

 

 

 

(70

)

 

 

 

Other operating income

 

 

(1,175

)

 

 

 

 

 

(1,175

)

 

 

 

Operating (loss) income

 

 

(198,618

)

 

 

67,119

 

 

 

(175,313

)

 

 

113,026

 

Other (expense) income:

 

 

 

 

 

 

 

 

Interest expense, net

 

 

(35,623

)

 

 

(34,083

)

 

 

(68,958

)

 

 

(67,968

)

Foreign exchange loss, net

 

 

(5,429

)

 

 

(2,244

)

 

 

(7,442

)

 

 

(156

)

Loss on refinancing

 

 

(291

)

 

 

 

 

 

(291

)

 

 

 

Other income, net

 

 

7,230

 

 

 

4,032

 

 

 

9,352

 

 

 

4,826

 

Total other expense, net

 

 

(34,113

)

 

 

(32,295

)

 

 

(67,339

)

 

 

(63,298

)

(Loss) income before income taxes

 

 

(232,731

)

 

 

34,824

 

 

 

(242,652

)

 

 

49,728

 

Provision for income taxes

 

 

7,350

 

 

 

2,648

 

 

 

3,889

 

 

 

3,007

 

Net (loss) income

 

 

(240,081

)

 

 

32,176

 

 

 

(246,541

)

 

 

46,721

 

Less: Net loss (income) attributable to non-controlling interests

 

 

119,273

 

 

 

(17,644

)

 

 

124,015

 

 

 

(25,483

)

Net (loss) income attributable to Amneal Pharmaceuticals, Inc. before accretion of redeemable non-controlling interest

 

 

(120,808

)

 

 

14,532

 

 

 

(122,526

)

 

 

21,238

 

Accretion of redeemable non-controlling interest

 

 

 

 

 

 

 

 

(438

)

 

 

 

Net (loss) income attributable to Amneal Pharmaceuticals, Inc.

 

$

(120,808

)

 

$

14,532

 

 

$

(122,964

)

 

$

21,238

 

 

 

 

 

 

 

 

 

 

Net (loss) income per share attributable to Amneal Pharmaceuticals, Inc.'s class A common stockholders:

 

 

 

 

 

 

 

 

Basic

 

$

(0.80

)

 

$

0.10

 

 

$

(0.82

)

 

$

0.14

 

Diluted

 

$

(0.80

)

 

$

0.10

 

 

$

(0.82

)

 

$

0.14

 

Weighted-average common shares outstanding:

 

 

 

 

 

 

 

 

Basic

 

 

150,993

 

 

 

148,996

 

 

 

150,445

 

 

 

148,507

 

Diluted

 

 

150,993

 

 

 

151,986

 

 

 

150,445

 

 

 

151,606

 

Amneal Pharmaceuticals, Inc.

Condensed Consolidated Balance Sheets

(Unaudited; In thousands)

 

 

 

June 30, 2022

 

December 31, 2021

Assets

 

 

 

 

Current assets:

 

 

 

 

Cash and cash equivalents

 

$

91,979

 

$

247,790

Restricted cash

 

 

6,203

 

 

 

8,949

 

Trade accounts receivable, net

 

 

688,849

 

 

 

662,583

 

Inventories

 

 

533,028

 

 

 

489,389

 

Prepaid expenses and other current assets

 

 

232,204

 

 

 

110,218

 

Related party receivables

 

 

1,338

 

 

 

1,179

 

Total current assets

 

 

1,553,601

 

 

 

1,520,108

 

Property, plant and equipment, net

 

 

483,625

 

 

 

514,158

 

Goodwill

 

 

600,974

 

 

 

593,017

 

Intangible assets, net

 

 

1,204,224

 

 

 

1,166,922

 

Operating lease right-of-use assets

 

 

36,490

 

 

 

39,899

 

Operating lease right-of-use assets - related party

 

 

19,212

 

 

 

20,471

 

Financing lease right-of-use assets

 

 

63,443

 

 

 

64,475

 

Other assets

 

 

79,836

 

 

 

20,614

 

Total assets

 

$

4,041,405

 

 

$

3,939,664

 

Liabilities and Stockholders' Equity

 

 

 

 

Current liabilities:

 

 

 

 

Accounts payable and accrued expenses

 

$

561,692

 

 

$

525,345

 

Current portion of liabilities for legal matters

 

 

275,338

 

 

 

58,000

 

Revolving credit facility

 

 

85,000

 

 

 

 

Current portion of long-term debt, net

 

 

29,920

 

 

 

30,614

 

Current portion of operating lease liabilities

 

 

10,096

 

 

 

9,686

 

Current portion of operating and financing lease liabilities - related party

 

 

2,796

 

 

 

2,636

 

Current portion of financing lease liabilities

 

 

3,318

 

 

 

3,101

 

Related party payables - short term

 

 

24,904

 

 

 

47,861

 

Total current liabilities

 

 

993,064

 

 

 

677,243

 

Long-term debt, net

 

 

2,622,447

 

 

 

2,680,053

 

Note payable - related party

 

 

38,856

 

 

 

38,038

 

Operating lease liabilities

 

 

28,904

 

 

 

32,894

 

Operating lease liabilities - related party

 

 

17,380

 

 

 

18,783

 

Financing lease liabilities

 

 

60,011

 

 

 

60,251

 

Related party payables - long term

 

 

10,654

 

 

 

9,619

 

Other long-term liabilities

 

 

79,213

 

 

 

38,903

 

Total long-term liabilities

 

 

2,857,465

 

 

 

2,878,541

 

Redeemable non-controlling interests

 

 

17,885

 

 

 

16,907

 

Total stockholders' equity

 

 

172,991

 

 

 

366,973

 

Total liabilities and stockholders' equity

 

$

4,041,405

 

 

$

3,939,664

 

Amneal Pharmaceuticals, Inc.

Consolidated Statements of Cash Flows

(Unaudited; In thousands)

 

 

 

Six Months Ended June 30,

 

 

2022

 

2021

Cash flows from operating activities:

 

 

 

 

Net (loss) income

 

$

(246,541

)

 

$

46,721

 

Adjustments to reconcile net (loss) income to net cash (used in) provided by operating activities:

 

 

 

 

Depreciation and amortization

 

 

117,511

 

 

 

112,037

 

Unrealized foreign currency loss

 

 

8,014

 

 

 

124

 

Amortization of debt issuance costs and discount

 

 

4,388

 

 

 

4,473

 

Loss on refinancing

 

 

291

 

 

 

 

Intangible asset impairment charges

 

 

5,112

 

 

 

710

 

Insurance recoveries for property and equipment losses

 

 

(1,000

)

 

 

 

Stock-based compensation

 

 

16,327

 

 

 

12,962

 

Inventory provision

 

 

17,748

 

 

 

25,805

 

Change in fair value of contingent consideration

 

 

(70

)

 

 

 

Other operating charges and credits, net

 

 

3,449

 

 

 

2,764

 

Changes in assets and liabilities:

 

 

 

 

Trade accounts receivable, net

 

 

(26,561

)

 

 

(13,167

)

Inventories

 

 

(65,395

)

 

 

(54,580

)

Prepaid expenses, other current assets and other assets

 

 

(119,747

)

 

 

(23,988

)

Related party receivables

 

 

(159

)

 

 

7,383

 

Accounts payable, accrued expenses and other liabilities

 

 

273,947

 

 

 

(21,137

)

Related party payables

 

 

7,508

 

 

 

(3,912

)

Net cash (used in) provided by operating activities

 

 

(5,178

)

 

 

96,195

 

Cash flows from investing activities:

 

 

 

 

Purchases of property, plant and equipment

 

 

(15,842

)

 

 

(19,585

)

Deposits for future acquisition of property, plant, and equipment

 

 

(3,955

)

 

 

(1,667

)

Acquisition of intangible assets

 

 

(10,000

)

 

 

(500

)

Acquisitions of businesses, net of cash acquired

 

 

(84,714

)

 

 

(73,828

)

Proceeds from insurance recoveries for property and equipment losses

 

 

1,000

 

 

 

 

Net cash used in investing activities

 

 

(113,511

)

 

 

(95,580

)

Cash flows from financing activities:

 

 

 

 

Payments of deferred financing and refinancing costs

 

 

(1,622

)

 

 

 

Payments of principal on debt, financing leases and other

 

 

(63,010

)

 

 

(33,876

)

Borrowings on revolving credit facility

 

 

85,000

 

 

 

 

Proceeds from exercise of stock options

 

 

239

 

 

 

681

 

Employee payroll tax withholding on restricted stock unit vesting

 

 

(3,291

)

 

 

(2,378

)

Tax distributions to non-controlling interests

 

 

(9,917

)

 

 

(27,551

)

Acquisition of redeemable non-controlling interest

 

 

(1,722

)

 

 

 

Payments of deferred consideration for acquisitions - related party

 

 

(43,998

)

 

 

 

Payments of principal on financing lease - related party

 

 

 

 

 

(93

)

Repayment of related party note

 

 

 

 

 

(1,000

)

Net cash used in financing activities

 

 

(38,321

)

 

 

(64,217

)

Effect of foreign exchange rate on cash

 

 

(1,547

)

 

 

(366

)

Net decrease in cash, cash equivalents, and restricted cash

 

 

(158,557

)

 

 

(63,968

)

Cash, cash equivalents, and restricted cash - beginning of period

 

 

256,739

 

 

 

347,121

 

Cash, cash equivalents, and restricted cash - end of period

 

$

98,182

 

 

$

283,153

 

Cash and cash equivalents - end of period

 

$

91,979

 

 

$

278,306

 

Restricted cash - end of period

 

 

6,203

 

 

 

4,847

 

Cash, cash equivalents, and restricted cash - end of period

 

$

98,182

 

 

$

283,153

 

Amneal Pharmaceuticals, Inc.

Non-GAAP Reconciliations

(Unaudited, In thousands)

 

Reconciliation of Net (Loss) Income to EBITDA and Adjusted EBITDA (1)

 

 

 

Three Months Ended June 30,

 

Six Months Ended June 30,

 

 

2022

 

2021

 

2022

 

2021

Net (loss) income

 

$

(240,081

)

 

$

32,176

 

$

(246,541

)

 

$

46,721

Adjusted to add:

 

 

 

 

 

 

 

 

Interest expense, net

 

 

35,623

 

 

 

34,083

 

 

 

68,958

 

 

 

67,968

 

Provision for income taxes

 

 

7,350

 

 

 

2,648

 

 

 

3,889

 

 

 

3,007

 

Depreciation and amortization

 

 

59,696

 

 

 

56,487

 

 

 

117,511

 

 

 

112,037

 

EBITDA (Non-GAAP)

 

$

(137,412

)

 

$

125,394

 

 

$

(56,183

)

 

$

229,733

 

Adjusted to add (deduct):

 

 

 

 

 

 

 

 

Stock-based compensation expense

 

 

8,262

 

 

 

7,632

 

 

 

16,327

 

 

 

12,962

 

Acquisition, site closure, and idle facility expenses (2)

 

 

3,173

 

 

 

5,964

 

 

 

8,762

 

 

 

11,756

 

Restructuring and other charges (3)

 

 

 

 

 

 

 

 

731

 

 

 

363

 

Loss on refinancing

 

 

291

 

 

 

 

 

 

291

 

 

 

 

Inventory related charges

 

 

 

 

 

87

 

 

 

 

 

 

201

 

Charges related to legal matters, net (4)

 

 

251,877

 

 

 

 

 

 

249,551

 

 

 

 

Asset impairment charges

 

 

5,250

 

 

 

741

 

 

 

5,250

 

 

 

1,064

 

Foreign exchange loss

 

 

5,429

 

 

 

2,244

 

 

 

7,442

 

 

 

156

 

Regulatory approval milestone

 

 

 

 

 

 

 

 

5,000

 

 

 

 

Change in fair value of contingent consideration

 

 

(270

)

 

 

 

 

 

(70

)

 

 

 

Insurance recoveries for property losses and associated expenses

 

 

(1,911

)

 

 

 

 

 

(1,911

)

 

 

 

Other

 

 

(104

)

 

 

807

 

 

 

(745

)

 

 

1,806

 

Adjusted EBITDA (Non-GAAP)

 

$

134,585

 

 

$

142,869

 

 

$

234,445

 

 

$

258,041

 

Amneal Pharmaceuticals, Inc.

Non-GAAP Reconciliations

(Unaudited; In thousands, except per share amounts)

 

Reconciliation of Net (Loss) Income to Adjusted Net Income and Calculation of Adjusted Diluted Earnings Per Share (1)

 

 

 

Three Months Ended June 30,

 

Six Months Ended June 30,

 

 

2022

 

2021

 

2022

 

2021

Net (loss) income

 

$

(240,081

)

 

$

32,176

 

 

$

(246,541

)

 

$

46,721

 

Adjusted to add (deduct):

 

 

 

 

 

 

 

 

Non-cash interest

 

 

1,966

 

 

 

2,077

 

 

 

3,948

 

 

 

4,049

 

GAAP provision for income taxes

 

 

7,350

 

 

 

2,648

 

 

 

3,889

 

 

 

3,007

 

Amortization

 

 

40,216

 

 

 

41,361

 

 

 

79,368

 

 

 

80,875

 

Stock-based compensation expense

 

 

8,262

 

 

 

7,632

 

 

 

16,327

 

 

 

12,962

 

Acquisition, site closure expenses, and idle facility expenses (2)

 

 

3,173

 

 

 

5,964

 

 

 

8,762

 

 

 

11,756

 

Restructuring and other charges (3)

 

 

 

 

 

 

 

 

731

 

 

 

363

 

Loss on refinancing

 

 

291

 

 

 

 

 

 

291

 

 

 

 

Inventory related charges

 

 

 

 

 

87

 

 

 

 

 

 

201

 

Charges related to legal matters, including interest, net (4)

 

 

252,230

 

 

 

 

 

 

249,904

 

 

 

 

Asset impairment charges

 

 

5,250

 

 

 

741

 

 

 

5,250

 

 

 

1,064

 

Regulatory approval milestone

 

 

 

 

 

 

 

 

5,000

 

 

 

 

Change in fair value of contingent consideration

 

 

(270

)

 

 

 

 

 

(70

)

 

 

 

Insurance recoveries for property losses and associated expenses

 

 

(1,911

)

 

 

 

 

 

(1,911

)

 

 

 

Other

 

 

(103

)

 

 

807

 

 

 

(603

)

 

 

1,806

 

Provision for income taxes (5)

 

 

(17,451

)

 

 

(20,132

)

 

 

(27,659

)

 

 

(35,185

)

Net income attributable to non-controlling interests not associated with our class B common stock

 

 

(1,889

)

 

 

(2,054

)

 

 

(4,088

)

 

 

(3,850

)

Adjusted net income (Non-GAAP)

 

$

57,033

 

 

$

71,307

 

 

$

92,598

 

 

$

123,769

 

Weighted average diluted shares outstanding (Non-GAAP) (6)

 

 

304,278

 

 

 

304,103

 

 

 

304,456

 

 

 

303,722

 

Adjusted diluted earnings per share (Non-GAAP)

 

$

0.19

 

 

$

0.23

 

 

$

0.30

 

 

$

0.41

 

Amneal Pharmaceuticals, Inc.

Non-GAAP Reconciliations

(Unaudited; In thousands)

 

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

Net (Loss) Income to Adjusted Net Income and Calculation of Adjusted Diluted Earnings per Share

 

(1)

Beginning in the first quarter of 2022, we will 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 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 June 30, 2022 primarily included: (i.) integration costs associated with the acquisition of the baclofen franchise from certain entities affiliated with Saol International Limited which closed on February 9, 2022 (the “Saol Acquisition”) and (ii) site closure costs associated with the planned cessation of manufacturing at our Hauppauge, NY facility. Acquisition, site closure, and idle facility expenses for the six months ended June 30, 2022 primarily included (i) transaction and integration costs associated with the Saol Acquistion; (ii.) integration costs associated with the acquisition of Puniska Healthcare Pvt. Ltd. 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 and six months ended June 30, 2021 primarily included (i) transaction and integration costs associated with the acquisition of Kashiv Specialty Pharmaceuticals, LLC, which closed on April 2, 2021; (ii) integration costs associated with the acquisition of AvKARE; and (iii) site closure expenses associated with the planned cessation of manufacturing at our Hauppauge, NY facility.

 

 

(3)

For the three and six months ended June 30, 2021, restructuring and other charges primarily consisted of cash severance charges associated with the cost of benefits for former management employees.

 

 

(4)

For the three and six months ended June 30, 2022, charges related to legal matters, net, primarily included charges for the preliminary settlement of the Opana ER® antitrust litigation, net of insurance recoveries associated with class action shareholder lawsuits.

 

 

(5)

The non-GAAP effective tax rates for the three and six months ended June 30, 2022 were 23.4% and 23.0%, respectively. The non-GAAP effective tax rates for the three and six months ended June 30, 2021 were 21.0%.

 

 

(6)

Weighted average diluted shares outstanding 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, 2022

 

Three Months Ended June 30, 2021

 

 

As Reported

 

Adjustments

 

Non-GAAP

 

As Reported

 

Adjustments

 

Non-GAAP

Net revenue

 

$

364,895

 

 

$

 

 

$

364,895

 

 

$

360,437

 

 

$

 

 

$

360,437

 

Cost of goods sold (2)

 

 

223,423

 

 

 

(13,961

)

 

 

209,462

 

 

 

204,154

 

 

 

(13,637

)

 

 

190,517

 

Cost of goods sold impairment charges

 

 

5,112

 

 

 

(5,112

)

 

 

 

 

 

 

 

 

 

 

 

 

Gross profit

 

 

136,360

 

 

 

19,073

 

 

 

155,433

 

 

 

156,283

 

 

 

13,637

 

 

 

169,920

 

Gross margin %

 

 

37.4

%

 

 

 

 

42.6

%

 

 

43.4

%

 

 

 

 

47.1

%

 

 

 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative (3)

 

 

26,558

 

 

 

(1,200

)

 

 

25,358

 

 

 

11,797

 

 

 

9

 

 

 

11,806

 

Research and development (4)

 

 

44,174

 

 

 

(1,406

)

 

 

42,768

 

 

 

43,431

 

 

 

(1,196

)

 

 

42,235

 

In-process research and development impairment charges

 

 

 

 

 

 

 

 

 

 

 

710

 

 

 

(710

)

 

 

 

Intellectual property legal development expense

 

 

778

 

 

 

 

 

 

778

 

 

 

1,340

 

 

 

 

 

 

1,340

 

Acquisition, transaction-related and integration expenses

 

 

8

 

 

 

(8

)

 

 

 

 

 

 

 

 

 

 

 

 

Charges related to legal matters

 

 

483

 

 

 

(483

)

 

 

 

 

 

 

 

 

 

 

 

 

Insurance recoveries for property losses and associated expenses

 

 

(1,911

)

 

 

1,911

 

 

 

 

 

 

 

 

 

 

 

 

 

Other operating income

 

 

(1,175

)

 

 

 

 

 

(1,175

)

 

 

 

 

 

 

 

 

 

Operating income

 

$

67,445

 

 

$

20,259

 

 

$

87,704

 

 

$

99,005

 

 

$

15,534

 

 

$

114,539

 

(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, 2022 and 2021, respectively, were comprised of stock-based compensation expense ($1.3 million and $1.4 million), amortization expense ($10.2 million and $9.8 million), site closure and idle facility expenses ($2.4 million and $2.2 million), inventory related charges (none and $0.1 million), asset impairment charges ($0.1 million and none), and other (none and $0.1 million).

 

 

(3)

Adjustments for the three months ended June 30, 2022 and 2021, respectively, were comprised of stock-based compensation expense ($0.6 million and $0.4 million), site closure costs ($0.6 million and $(0.5) million), and other (none and $0.1 million).

 

 

(4)

Adjustments for the three months ended June 30, 2022 and 2021, respectively, were comprised of stock-based compensation expense ($1.4 million and $1.0 million) and other (none and $0.2 million). Non-GAAP adjusted research and development for the three months ended June 30, 2021, as previously reported, has been revised to include $7.8 million of research and development milestone expenses previously excluded.

 

 

Amneal Pharmaceuticals, Inc.

Generics Segment

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

(Unaudited; In thousands)

 

 

 

Six Months Ended June 30, 2022

 

Six Months Ended June 30, 2021

 

 

As Reported

 

Adjustments

 

Non-GAAP

 

As Reported

 

Adjustments

 

Non-GAAP

Net revenue

 

$

682,642

 

 

$

 

 

$

682,642

 

 

$

672,945

 

 

$

 

 

$

672,945

 

Cost of goods sold (2)

 

 

422,453

 

 

 

(29,052

)

 

 

393,401

 

 

 

389,452

 

 

 

(25,656

)

 

 

363,796

 

Cost of goods sold impairment charges

 

 

5,112

 

 

 

(5,112

)

 

 

 

 

 

 

 

 

 

 

 

 

Gross profit

 

 

255,077

 

 

 

34,164

 

 

 

289,241

 

 

 

283,493

 

 

 

25,656

 

 

 

309,149

 

Gross margin %

 

 

37.4

%

 

 

 

 

42.4

%

 

 

42.1

%

 

 

 

 

45.9

%

 

 

 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative (3)

 

 

54,151

 

 

 

(7,450

)

 

 

46,701

 

 

 

30,559

 

 

 

(815

)

 

 

29,744

 

Research and development (4)

 

 

87,395

 

 

 

(2,565

)

 

 

84,830

 

 

 

79,548

 

 

 

(2,198

)

 

 

77,350

 

In-process research and development impairment charges

 

 

 

 

 

 

 

 

 

 

 

710

 

 

 

(710

)

 

 

 

Intellectual property legal development expenses

 

 

1,550

 

 

 

 

 

 

1,550

 

 

 

4,922

 

 

 

 

 

 

4,922

 

Acquisition, transaction-related and integration expenses

 

 

8

 

 

 

(8

)

 

 

 

 

 

 

 

 

 

 

 

 

Charges related to legal matters

 

 

2,157

 

 

 

(2,157

)

 

 

 

 

 

 

 

 

 

 

 

 

Insurance recoveries for property losses and associated expenses

 

 

(1,911

)

 

 

1,911

 

 

 

 

 

 

 

 

 

 

 

 

 

Restructuring and other charges

 

 

206

 

 

 

(206

)

 

 

 

 

 

 

 

 

 

Other operating income

 

 

(1,175

)

 

 

 

 

 

(1,175

)

 

 

80

 

 

 

(80

)

 

 

 

Operating income

 

$

112,696

 

 

$

44,639

 

 

$

157,335

 

 

$

167,674

 

 

$

29,459

 

 

$

197,133

 

(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, 2022 and 2021, respectively, were comprised of stock-based compensation expense ($2.8 million and $2.0 million), amortization expense ($19.5 million and $17.8 million), site closure and idle facility expenses ($7.0 million and $4.7 million), inventory related charges (none and $0.2 million), asset impairment charges ($0.1 and $0.4 million), and other ($(0.3) million and $0.6 million).

 

 

(3)

Adjustments for the six months ended June 30, 2022 and 2021, respectively, were comprised of stock-based compensation expense ($1.3 million and $0.8 million), a regulatory approval milestone ($5.0 million and none), and site closure costs ($1.1 million and immaterial).

 

 

(4)

Adjustments for the six months ended June 30, 2022 and 2021, respectively, were comprised of stock-based compensation expense ($2.6 million and $1.8 million) and other (none and $0.3 million). Non-GAAP adjusted research and development for the six months ended June 30, 2021, as previously reported, has been revised to include $11.3 million of research and development milestone expenses previously excluded.

 

 

Amneal Pharmaceuticals, Inc.

Specialty Segment

Reconciliation of GAAP to Non-GAAP Operating Results

(Unaudited; In thousands)

 

 

 

Three Months Ended June 30, 2022

 

Three Months Ended June 30, 2021

 

 

As Reported

 

Adjustments

 

Non-GAAP

 

As Reported

 

Adjustments

 

Non-GAAP

Net revenue

 

$

97,001

 

 

$

 

 

$

97,001

 

 

$

88,635

 

 

$

 

 

$

88,635

 

Cost of goods sold (1)

 

 

42,791

 

 

 

(26,878

)

 

 

15,913

 

 

 

48,683

 

 

$

(27,500

)

 

 

21,183

 

Gross profit

 

 

54,210

 

 

 

26,878

 

 

 

81,088

 

 

 

39,952

 

 

 

27,500

 

 

 

67,452

 

Gross margin %

 

 

55.9

%

 

 

 

 

83.6

%

 

 

45.1

%

 

 

 

 

76.1

%

 

 

 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative (2)

 

 

23,171

 

 

 

199

 

 

 

23,370

 

 

 

20,656

 

 

 

(741

)

 

 

19,915

 

Research and development (2)

 

 

6,574

 

 

 

(403

)

 

 

6,171

 

 

 

9,433

 

 

 

(289

)

 

 

9,144

 

Intellectual property legal development expenses

 

 

43

 

 

 

 

 

 

43

 

 

 

25

 

 

 

 

 

 

25

 

Acquisition, transaction-related and integration expenses

 

 

32

 

 

 

(32

)

 

 

 

 

 

16

 

 

 

(16

)

 

 

 

Change in fair value of contingent consideration (3)

 

 

(270

)

 

 

270

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating income

 

$

24,660

 

 

$

26,844

 

 

$

51,504

 

 

$

9,822

 

 

$

28,546

 

 

$

38,368

 

(1)

Adjustments for the three months ended June 30, 2022 and 2021 were comprised of amortization expense.

 

 

(2)

Adjustments for the three months ended June 30, 2022 and 2021 were comprised of stock-based compensation expense.

 

 

(3)

Contingent consideration was recorded in connection with the acquisition of Kashiv Specialty Pharmaceuticals, LLC.

Amneal Pharmaceuticals, Inc.

Specialty Segment

Reconciliation of GAAP to Non-GAAP Operating Results

(Unaudited; In thousands)

 

 

 

Six Months Ended June 30, 2022

 

Six Months Ended June 30, 2021

 

 

As Reported

 

Adjustments

 

Non-GAAP

 

As Reported

 

Adjustments

 

Non-GAAP

Net revenue

 

$

182,087

 

 

$

 

 

$

182,087

 

 

$

184,566

 

 

$

 

 

$

184,566

 

Cost of goods sold (1)

 

 

86,644

 

 

 

(53,532

)

 

 

33,112

 

 

 

96,881

 

 

 

(54,993

)

 

 

41,888

 

Gross profit

 

 

95,443

 

 

 

53,532

 

 

 

148,975

 

 

 

87,685

 

 

 

54,993

 

 

 

142,678

 

Gross margin %

 

 

52.4

%

 

 

 

 

81.8

%

 

 

47.5

%

 

 

 

 

77.3

%

 

 

 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative (2)

 

 

47,571

 

 

 

(414

)

 

 

47,157

 

 

 

40,537

 

 

 

(1,332

)

 

 

39,205

 

Research and development (3)

 

 

16,151

 

 

 

(729

)

 

 

15,422

 

 

 

21,498

 

 

 

(469

)

 

 

21,029

 

Intellectual property legal development expenses

 

 

35

 

 

 

 

 

 

35

 

 

 

25

 

 

 

 

 

 

25

 

Acquisition, transaction-related and integration expenses

 

 

32

 

 

 

(32

)

 

 

 

 

 

16

 

 

 

(16

)

 

 

 

Change in fair value of contingent consideration (4)

 

 

(70

)

 

 

70

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating income

 

$

31,724

 

 

$

54,637

 

 

$

86,361

 

 

$

25,609

 

 

$

56,810

 

 

$

82,419

 

(1)

Adjustments for the six months ended June 30, 2022 and 2021 were comprised of amortization expense.

 

 

(2)

Adjustments for the six months ended June 30, 2022 and 2021 were comprised of stock-based compensation expense.

 

 

(3)

Adjustments for the six months ended June 30, 2022 and 2021 were comprised of stock-based compensation expense. Non-GAAP adjusted research and development for the six months ended June 30, 2021, as previously reported, has been revised to include $7.4 million of research and development milestone expenses previously excluded.

 

 

(4)

Contingent consideration was recorded in connection with the acquisition of Kashiv Specialty Pharmaceuticals, LLC.

Amneal Pharmaceuticals, Inc.

AvKARE Segment

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

(Unaudited; In thousands)

 

 

 

Three Months Ended June 30, 2022

 

Three Months Ended June 30, 2021

 

 

As Reported

 

Adjustments

 

Non-GAAP

 

As Reported

 

Adjustments

 

Non-GAAP

Net revenue

 

$

97,459

 

 

$

 

 

$

97,459

 

 

$

86,003

 

 

$

 

 

$

86,003

 

Cost of goods sold

 

 

87,510

 

 

 

 

 

 

87,510

 

 

 

69,740

 

 

 

 

 

 

69,740

 

Gross profit

 

 

9,949

 

 

 

 

 

 

9,949

 

 

 

16,263

 

 

 

 

 

 

16,263

 

Gross margin %

 

 

10.2

%

 

 

 

 

10.2

%

 

 

18.9

%

 

 

 

 

18.9

%

 

 

 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative (2)

 

 

12,735

 

 

 

(4,933

)

 

 

7,802

 

 

 

13,599

 

 

 

(6,183

)

 

 

7,416

 

Acquisition, transaction-related and integration expenses (3)

 

 

 

 

 

 

 

 

 

 

 

491

 

 

 

(491

)

 

 

 

Operating (loss) income

 

$

(2,786

)

 

$

4,933

 

 

$

2,147

 

 

$

2,173

 

 

$

6,674

 

 

$

8,847

 

(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, 2022 and 2021 were comprised of amortization expense.

 

 

(3)

Adjustments for the three months ended June 30, 2021 were comprised of finance integration expenses.

Amneal Pharmaceuticals, Inc.

AvKARE Segment

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

(Unaudited; In thousands)

 

 

 

Six Months Ended June 30, 2022

 

Six Months Ended June 30, 2021

 

 

As Reported

 

Adjustments

 

Non-GAAP

 

As Reported

 

Adjustments

 

Non-GAAP

Net revenue

 

$

192,259

 

 

$

 

 

$

192,259

 

 

$

170,669

 

 

$

 

 

$

170,669

 

Cost of goods sold

 

 

167,689

 

 

 

 

 

 

167,689

 

 

 

137,787

 

 

 

 

 

 

137,787

 

Gross profit

 

 

24,570

 

 

 

 

 

 

24,570

 

 

 

32,882

 

 

 

 

 

 

32,882

 

Gross margin %

 

 

12.8

%

 

 

 

 

12.8

%

 

 

19.3

%

 

 

 

 

19.3

%

 

 

 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative (2)

 

 

26,145

 

 

 

(9,459

)

 

 

16,686

 

 

 

27,303

 

 

 

(12,367

)

 

 

14,936

 

Acquisition, transaction-related and integration expenses (3)

 

 

 

 

 

 

 

 

 

 

 

1,422

 

 

 

(1,422

)

 

 

 

Operating income

 

$

(1,575

)

 

$

9,459

 

 

$

7,884

 

 

$

4,157

 

 

$

13,789

 

 

$

17,946

 

(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, 2022 and 2021, respectively, were comprised of amortization expense ($9.9 million and $12.4 million) and other ($(0.4) million and none).

 

 

(3)

Adjustments for the six months ended June 30, 2021 were comprised of finance integration expenses.

 

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