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Amneal Reports First Quarter 2022 Financial Results

‒ Q1 2022 Net Revenue of $498 million; GAAP Net Loss of $2 million; Diluted Loss per Share of $(0.01) ‒

‒ Adjusted EBITDA (1) of $100 million includes $5 million of R&D milestone expense; Adjusted Diluted EPS (1) of $0.12 ‒

‒ Maintaining 2022 Full Year Outlook ‒

BRIDGEWATER, N.J., May 04, 2022--(BUSINESS WIRE)--Amneal Pharmaceuticals, Inc. (NYSE: AMRX) ("Amneal" or the "Company") announced its results today for the first quarter ended March 31, 2022.

"We are very pleased with our first quarter results and the progress we have made to advance our growth strategy. With recent U.S. FDA approvals for our first two biosimilars, as well as the closing of our Saol Baclofen acquisition, Amneal is expanding in high growth areas, including biosimilars and injectables, which we expect to drive meaningful growth going forward. These important milestones, as well as our continued focus on advancing R&D initiatives, are diversifying our business as we work to fulfill our mission of bringing innovative and affordable medicines to patients and creating value for shareholders," said Chirag and Chintu Patel, Co-Chief Executive Officers.

Net revenue in the first quarter of 2022 was $498 million, an increase of 1% compared to $493 million in the first quarter of 2021. The increase was driven by solid broad-based performance in Generics, including new product launches, and the expansion of AvKARE’s distribution channel, partially offset by the loss of exclusivity of Zomig® Nasal Spray.

Net loss attributable to Amneal Pharmaceuticals, Inc. was $2 million in the first quarter of 2022 compared to a net income of $7 million in the first quarter of 2021. Beginning in the first quarter of 2022, we will no longer exclude research and development milestone expenses from non-GAAP financial measures. In the first quarter of 2022 and 2021, R&D milestone expenses were $5 million and $11 million, respectively. Prior periods presented have been revised to reflect this change. Adjusted EBITDA(1) in the first quarter of 2022 was $100 million, a decrease of 13% compared to the first quarter of 2021, reflective of lower gross profit due to product mix and a tough comparison to the prior year. Adjusted diluted EPS(1) in the first quarter of 2022 was $0.12, compared to $0.17 in the first quarter of 2021.

(1) See "Non-GAAP Financial Measures" below.

Maintaining Full Year 2022 Financial Outlook

Amneal is maintaining its previously provided guidance.

Full Year 2022 Financial Guidance

Net revenue

$2.15 billion - $2.25 billion

Adjusted EBITDA (1)

$540 million - $560 million

Adjusted diluted EPS (2)

$0.80 - $0.85

Operating cash flow (3)

$225 million - $250 million

Capital expenditures

$75 million - $85 million

Weighted average diluted shares outstanding (4)

Approximately 307 million

(1)

Includes 100% of EBITDA from the AvKARE acquisition. Beginning in the first quarter of 2022, we will no longer exclude research and development milestone expense from non-GAAP financial measures.

(2)

Accounts for 35% non-controlling interest in AvKARE. Beginning in the first quarter of 2022, we will no longer exclude research and development milestone expense from 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.

(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 May 4, 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 874223. 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 097886.

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 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: our ability to successfully develop, license, acquire and commercialize new products on a timely basis; 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 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; 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; 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 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

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.

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
March 31,

2022

2021

Net revenue

$

497,633

$

493,105

Cost of goods sold

323,062

301,543

Gross profit

174,571

191,562

Selling, general and administrative

98,665

90,726

Research and development

52,798

48,182

Intellectual property legal development expenses

764

3,582

Acquisition, transaction-related and integration expenses

434

2,802

Credit related to legal matters, net

(2,326

)

Restructuring and other charges

731

363

Change in fair value of contingent consideration

200

Operating income

23,305

45,907

Other (expense) income:

Interest expense, net

(33,335

)

(33,885

)

Foreign exchange (loss) gain, net

(2,013

)

2,088

Other income, net

2,122

794

Total other expense, net

(33,226

)

(31,003

)

(Loss) income before income taxes

(9,921

)

14,904

(Benefit from) provision for income taxes

(3,461

)

359

Net (loss) income

(6,460

)

14,545

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

4,742

(7,839

)

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

$

(1,718

)

$

6,706

Accretion of redeemable non-controlling interest

(438

)

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

$

(2,156

)

$

6,706

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

Basic

$

(0.01

)

$

0.05

Diluted

$

(0.01

)

$

0.04

Weighted-average common shares outstanding:

Basic

149,892

148,013

Diluted

149,892

151,220

Amneal Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
(Unaudited; In thousands)

March 31, 2022

December 31, 2021

Assets

Current assets:

Cash and cash equivalents

$

210,477

$

247,790

Restricted cash

6,068

8,949

Trade accounts receivable, net

538,309

662,583

Inventories

512,241

489,389

Prepaid expenses and other current assets

121,408

110,218

Related party receivables

1,175

1,179

Total current assets

1,389,678

1,520,108

Property, plant and equipment, net

500,911

514,158

Goodwill

602,893

593,017

Intangible assets, net

1,209,818

1,166,922

Operating lease right-of-use assets

37,675

39,899

Operating lease right-of-use assets - related party

19,846

20,471

Financing lease right-of-use assets

64,204

64,475

Other assets

63,943

20,614

Total assets

$

3,888,968

$

3,939,664

Liabilities and Stockholders' Equity

Current liabilities:

Accounts payable and accrued expenses

$

539,734

$

583,345

Current portion of long-term debt, net

30,523

30,614

Current portion of operating lease liabilities

9,901

9,686

Current portion of operating and financing lease liabilities - related party

2,692

2,636

Current portion of financing lease liabilities

3,233

3,101

Related party payables - short term

15,960

47,861

Total current liabilities

602,043

677,243

Long-term debt, net

2,672,661

2,680,053

Note payable - related party

38,443

38,038

Operating lease liabilities

30,378

32,894

Operating lease liabilities - related party

18,093

18,783

Financing lease liabilities

60,286

60,251

Related party payables - long term

10,371

9,619

Other long-term liabilities

32,866

38,903

Total long-term liabilities

2,863,098

2,878,541

Redeemable non-controlling interests

16,420

16,907

Total stockholders' equity

407,407

366,973

Total liabilities and stockholders' equity

$

3,888,968

$

3,939,664

Amneal Pharmaceuticals, Inc.
Consolidated Statements of Cash Flows
(Unaudited; In thousands)

Three Months Ended
March 31,

2022

2021

Cash flows from operating activities:

Net (loss) income

$

(6,460

)

$

14,545

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

Depreciation and amortization

57,815

55,549

Unrealized foreign currency loss (gain)

3,140

(1,970

)

Amortization of debt issuance costs and discount

2,195

2,183

Stock-based compensation

8,065

5,330

Inventory provision

3,578

16,021

Change in fair value of contingent consideration

200

Other operating charges and credits, net

1,155

1,431

Changes in assets and liabilities:

Trade accounts receivable, net

124,268

108,385

Inventories

(25,549

)

(20,283

)

Prepaid expenses, other current assets and other assets

(4,423

)

602

Related party receivables

4

301

Accounts payable, accrued expenses and other liabilities

(48,777

)

(37,226

)

Related party payables

5,132

3,260

Net cash provided by operating activities

120,343

148,128

Cash flows from investing activities:

Purchases of property, plant and equipment

(10,793

)

(11,776

)

Deposits for future acquisition of property, plant, and equipment

(1,888

)

(917

)

Acquisition of business

(84,714

)

Net cash used in investing activities

(97,395

)

(12,693

)

Cash flows from financing activities:

Payments of principal on debt, financing leases and other

(9,796

)

(23,630

)

Proceeds from exercise of stock options

111

676

Employee payroll tax withholding on restricted stock unit vesting

(3,001

)

(2,102

)

Tax distributions to non-controlling interests

(3,164

)

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

(61,570

)

(26,149

)

Effect of foreign exchange rate on cash

(1,572

)

(593

)

Net (decrease) increase in cash, cash equivalents, and restricted cash

(40,194

)

108,693

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

256,739

347,121

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

$

216,545

$

455,814

Cash and cash equivalents - end of period

$

210,477

$

452,097

Restricted cash - end of period

6,068

3,717

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

$

216,545

$

455,814

Amneal Pharmaceuticals, Inc.
Non-GAAP Reconciliations
(Unaudited, In thousands)

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

Three Months Ended
March 31,

2022

2021

Net (loss) income

$

(6,460

)

$

14,545

Adjusted to add (deduct):

Interest expense, net

33,335

33,885

Income tax expense (benefit)

(3,461

)

359

Depreciation and amortization

57,815

55,549

EBITDA (Non-GAAP)

$

81,229

$

104,338

Adjusted to add (deduct):

Stock-based compensation expense

8,065

5,330

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

5,589

5,792

Restructuring and other charges (3)

731

363

Inventory related charges

114

Credit related to legal matters, net (4)

(2,326

)

Asset impairment charges

323

Foreign exchange loss (gain)

2,013

(2,088

)

Regulatory approval milestone

5,000

Change in fair value of contingent consideration

200

Other

(641

)

999

Adjusted EBITDA (Non-GAAP)

$

99,860

$

115,171

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
March 31,

2022

2021

Net (loss) income

$

(6,460

)

$

14,545

Adjusted to add (deduct):

Non-cash interest

1,982

1,972

GAAP Income tax (benefit) expense

(3,461

)

359

Amortization

39,152

39,514

Stock-based compensation expense

8,065

5,330

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

5,589

5,792

Restructuring and other charges (3)

731

363

Inventory related charges

114

Credit related to legal matters, net (4)

(2,326

)

Asset impairment charges

323

Regulatory approval milestone

5,000

Change in fair value of contingent consideration

200

Other

(500

)

999

Income tax (5)

(10,185

)

(15,053

)

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

B common stock

(2,199

)

(1,796

)

Adjusted net income (Non-GAAP)

$

35,588

$

52,462

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

304,630

303,337

Adjusted diluted earnings per share (Non-GAAP)

$

0.12

$

0.17

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.

(2)

Acquisition, site closure, and idle facility expenses for the three months ended March 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; (ii.) integration costs associated with the acquisition of Puniska Healthcare Pvt. Ltd.; 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 ended March 31, 2021 primarily included (i) transaction 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 months ended March 31, 2022 and 2021, restructuring and other charges primarily consisted of cash severance charges associated with the cost of benefits for former senior executives and management employees.

(4)

For the three months ended March 31, 2022, we recorded a net credit of $2.3 million consisting of an insurance recovery of $4 million, partially offset by charges for legal proceedings (none for the three months ended March 31, 2021).

(5)

The non-GAAP effective tax rates for the three months ended March 31, 2022 and 2021 were 22.3% and 21.0%, respectively.

(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
March 31, 2022

Three Months Ended
March 31, 2021

As Reported

Adjustments

Non-GAAP

As Reported

Adjustments

Non-GAAP

Net revenue

$

317,747

$

$

317,747

$

312,508

$

$

312,508

Cost of goods sold (2)

199,030

(15,091

)

183,939

185,298

(12,019

)

173,279

Gross profit

118,717

15,091

133,808

127,210

12,019

139,229

Gross margin %

37.4

%

42.1

%

40.7

%

44.6

%

Selling, general and administrative (3)

27,593

(6,250

)

21,343

18,762

(824

)

17,938

Research and development (4)

43,221

(1,159

)

42,062

36,117

(1,002

)

35,115

Charges related to legal matters, net (5)

1,674

(1,674

)

Intellectual property legal development expenses

772

772

3,582

3,582

Restructuring and other charges

206

...