Amneal Reports First Quarter 2021 Financial Results

Amneal Reports First Quarter 2021 Financial Results




Amneal Reports First Quarter 2021 Financial Results

‒ Q1 2021 Net Revenue of $493 million; GAAP Net Income of $7 million; Diluted Income per Share of $0.04 ‒

‒ Adjusted EBITDA (1) of $126 million; Adjusted Diluted EPS (1) of $0.20 ‒

‒ Maintaining 2021 Full Year Financial Outlook ‒

BRIDGEWATER, N.J.–(BUSINESS WIRE)–Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (the “Company”) announced its results today for the first quarter ended March 31, 2021.

“Amneal delivered solid first quarter results, continuing our positive momentum as we consistently execute against our Amneal 2.0 strategic vision of long-term sustainable growth,” said Chirag and Chintu Patel, Co-Chief Executive Officers. “Our strong profitability reflects the validity of our strategy, our diversified and relevant product portfolio and strength of our research and development pipeline. We are excited about the opportunities in the year ahead and we appreciate the hard work of our employees who make Amneal’s mission of bringing innovative and affordable medicines to patients possible year in and year out.”

Net revenue in the first quarter of 2021 was $493 million, a decrease of 1% compared to $499 million in the first quarter of 2020. This decrease was primarily attributable to decreased influenza activity during the first quarter of 2021 and higher customer purchases at the onset of the COVID-19 pandemic in the prior year quarter. Partially offsetting the decline were strong new Generics product launches and continued growth in our Specialty and AvKARE business segments.

Net income attributable to Amneal Pharmaceuticals, Inc. was $7 million in the first quarter of 2021 compared to net income of $115 million in the first quarter of 2020. The decrease in net income was driven primarily by a discrete tax benefit of $110 million from the Coronavirus Aid, Relief and Economic Security Act in the first quarter of 2020.

Adjusted EBITDA(1) in the first quarter of 2021 was $126 million, a decrease of 6% compared to the prior year, reflective of investments to drive long term sustainable growth, partially offset by gross margin increases across all three of our business segments. Adjusted diluted EPS(1) in the first quarter of 2021 and 2020 were each $0.20 reflective mostly of adjusted EBITDA (1) and lower interest expense.

(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 8:30 am Eastern Time on May 7, 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 10154969.

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, primarily focused on serving the Department of Defense and the Department of Veterans Affairs. AvKARE is also a packager and wholesale distributor of pharmaceuticals and vitamins to its retail and institutional customers who are located throughout the United States focused primarily on offering 340b-qualified entities products to provide consistency in care and pricing. 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 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.

Amneal Pharmaceuticals, Inc.

Consolidated Statements of Operations

(Unaudited; In thousands, except per share amounts)

 

 

Three Months Ended

March 31,

 

2021

 

2020

Net revenue

$

493,105

 

 

$

498,533

 

Cost of goods sold

301,543

 

 

313,578

 

Cost of goods sold impairment charges

 

 

1,456

 

Gross profit

191,562

 

 

183,499

 

Selling, general and administrative

90,726

 

 

77,976

 

Research and development

48,182

 

 

36,379

 

In-process research and development impairment charges

 

 

960

 

Intellectual property legal development expenses

3,582

 

 

1,270

 

Acquisition, transaction-related and integration expenses

2,802

 

 

2,575

 

Charges related to legal matters, net

 

 

4,500

 

Restructuring and other charges

363

 

 

2,048

 

Operating income

45,907

 

 

57,791

 

Other (expense) income:

 

 

 

Interest expense, net

(33,885

)

 

(39,899

)

Foreign exchange gain (loss), net

2,088

 

 

(5,181

)

Other income, net

794

 

 

633

 

Total other expense, net

(31,003

)

 

(44,447

)

Income before income taxes

14,904

 

 

13,344

 

Provision for (benefit from) income taxes

359

 

 

(108,173

)

Net income

14,545

 

 

121,517

 

Less: Net loss attributable to non-controlling interests

(7,839

)

 

(6,450

)

Net income attributable to Amneal Pharmaceuticals, Inc.

$

6,706

 

 

$

115,067

 

Net income per share attributable to Amneal Pharmaceuticals, Inc.’s Class A common stockholders:

 

 

 

Basic

$

0.05

 

 

$

0.78

 

Diluted

$

0.04

 

 

$

0.78

 

Weighted-average common shares outstanding:

 

 

 

Basic

148,013

 

 

147,180

 

Diluted

151,220

 

 

147,956

 

Amneal Pharmaceuticals, Inc.

Condensed Consolidated Balance Sheets

(Unaudited; In thousands)

 

 

March 31, 2021

 

December 31, 2020

Assets

 

 

 

Current assets:

 

 

 

Cash and cash equivalents

$

452,097

 

 

$

341,378

 

Restricted cash

3,717

 

 

5,743

 

Trade accounts receivable, net

530,600

 

 

638,895

 

Inventories

497,008

 

 

490,649

 

Prepaid expenses and other current assets

75,137

 

 

73,467

 

Related party receivables

1,102

 

 

1,407

 

Total current assets

1,559,661

 

 

1,551,539

 

Property, plant and equipment, net

471,165

 

 

477,754

 

Goodwill

522,758

 

 

522,814

 

Intangible assets, net

1,262,954

 

 

1,304,626

 

Operating lease right-of-use assets

32,396

 

 

33,947

 

Operating lease right-of-use assets – related party

24,110

 

 

24,792

 

Financing lease right-of-use assets

67,465

 

 

9,541

 

Financing lease right-of-use assets – related party

 

 

58,676

 

Other assets

19,561

 

 

22,344

 

Total assets

$

3,960,070

 

 

$

4,006,033

 

Liabilities and Stockholders’ Equity

 

 

 

Current liabilities:

 

 

 

Accounts payable and accrued expenses

$

574,322

 

 

$

611,867

 

Current portion of long-term debt, net

29,817

 

 

44,228

 

Current portion of operating lease liabilities

6,637

 

 

6,474

 

Current portion of operating and financing lease liabilities – related party

2,883

 

 

3,978

 

Current portion of financing lease liabilities

3,020

 

 

1,794

 

Current portion of note payable – related party

 

 

1,000

 

Related party payable – short term

20,100

 

 

7,561

 

Total current liabilities

636,779

 

 

676,902

 

Long-term debt, net

2,728,212

 

 

2,735,264

 

Note payable – related party

36,828

 

 

36,440

 

Operating lease liabilities

28,435

 

 

30,182

 

Operating lease liabilities – related party

22,308

 

 

23,049

 

Financing lease liabilities

61,871

 

 

2,318

 

Financing lease liabilities – related party

 

 

60,193

 

Related party payable – long term

2,061

 

 

1,584

 

Other long-term liabilities

63,789

 

 

83,365

 

Total long-term liabilities

2,943,504

 

 

2,972,395

 

Redeemable non-controlling interests

13,079

 

 

11,804

 

Total stockholders’ equity

366,708

 

 

344,932

 

Total liabilities and stockholders’ equity

$

3,960,070

 

 

$

4,006,033

 

Amneal Pharmaceuticals, Inc.

Consolidated Statements of Cash Flows

(Unaudited; In thousands)

 

 

Three Months Ended March 31,

 

2021

 

2020

Cash flows from operating activities:

 

 

 

Net income

$

14,545

 

 

$

121,517

 

Adjustments to reconcile net income to net cash provided by operating activities:

 

 

 

Depreciation and amortization

55,549

 

 

58,083

 

Unrealized foreign currency (gain) loss

(1,970

)

 

5,514

 

Amortization of debt issuance costs and discount

2,183

 

 

2,004

 

Intangible asset impairment charges

 

 

2,416

 

Stock-based compensation

5,330

 

 

4,539

 

Inventory provision

16,021

 

 

15,200

 

Other operating charges and credits, net

1,431

 

 

1,266

 

Changes in assets and liabilities:

 

 

 

Trade accounts receivable, net

108,385

 

 

(60,893

)

Inventories

(20,283

)

 

(2,778

)

Income taxes receivable associated with the CARES Act

 

 

(110,069

)

Prepaid expenses, other current assets and other assets

602

 

 

(26,383

)

Related party receivables

301

 

 

76

 

Accounts payable, accrued expenses and other liabilities

(37,226

)

 

34,839

 

Related party payables

3,260

 

 

3,695

 

Net cash provided by operating activities

148,128

 

 

49,026

 

Cash flows from investing activities:

 

 

 

Purchases of property, plant and equipment

(11,776

)

 

(7,367

)

Deposit for future acquisition of property, plant and equipment

(917

)

 

 

Acquisition of intangible assets

 

 

(1,050

)

Acquisitions, net of cash acquired

 

 

(253,625

)

Net cash used in investing activities

(12,693

)

 

(262,042

)

Cash flows from financing activities:

 

 

 

Proceeds from issuance of debt

 

 

180,000

 

Payments of principal on debt, financing leases and other

(23,630

)

 

(7,158

)

Net borrowings from revolving credit facility

 

 

300,000

 

Payments of deferred financing costs

 

 

(4,102

)

Proceeds from exercise of stock options

676

 

 

5

 

Employee payroll tax withholding on restricted stock unit vesting

(2,102

)

 

(503

)

Payments of principal on financing lease – related party

(93

)

 

(263

)

Repayment of related party note

(1,000

)

 

 

Net cash (used in) provided by financing activities

(26,149

)

 

467,979

 

Effect of foreign exchange rate on cash

(593

)

 

(860

)

Net increase in cash, cash equivalents, and restricted cash

108,693

 

 

254,103

 

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

347,121

 

 

152,822

 

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

$

455,814

 

 

$

406,925

 

Cash and cash equivalents – end of period

$

452,097

 

 

$

405,238

 

Restricted cash – end of period

3,717

 

 

1,687

 

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

$

455,814

 

 

$

406,925

 

Amneal Pharmaceuticals, Inc.

Non-GAAP Reconciliations

(Unaudited, In thousands)

 

Reconciliation of Net Income to EBITDA and Adjusted EBITDA

 

 

Three Months Ended March 31,

 

2021

 

2020

Net income

$

14,545

 

 

$

121,517

 

Adjusted to add (deduct):

 

 

 

Interest expense, net

33,885

 

 

39,899

 

Income tax expense (benefit)

359

 

 

(108,173

)

Depreciation and amortization

55,549

 

 

58,083

 

EBITDA (Non-GAAP)

$

104,338

 

 

$

111,326

 

Adjusted to add (deduct):

 

 

 

Stock-based compensation expense

5,330

 

 

4,539

 

Acquisition and site closure expenses (1)

5,792

 

 

6,978

 

Restructuring and other charges (2)

363

 

 

2,048

 

Inventory related charges (3)

114

 

 

 

Charges related to legal matters (4)

 

 

2,500

 

Asset impairment charges (5)

323

 

 

2,475

 

Foreign exchange (gain) loss

(2,088

)

 

5,181

 

Research and development milestone payments

10,886

 

 

2,000

 

Other

999

 

 

(2,669

)

Adjusted EBITDA (Non-GAAP)

$

126,057

 

 

$

134,378

 

Amneal Pharmaceuticals, Inc.

Non-GAAP Reconciliations

(Unaudited; In thousands, except per share amounts)

 

Reconciliation of Net Income to Adjusted Net Income and Calculation of Adjusted Diluted EPS

 

 

Three Months Ended March 31,

 

2021

 

2020

Net income

$

14,545

 

 

$

121,517

 

Adjusted to add (deduct):

 

 

 

Non-cash interest

1,972

 

 

1,866

 

GAAP Income tax expense (benefit)

359

 

 

(108,173

)

Amortization

39,514

 

 

40,314

 

Stock-based compensation expense

5,330

 

 

4,539

 

Acquisition and site closure expenses (1)

5,792

 

 

6,978

 

Restructuring and other charges (2)

363

 

 

2,048

 

Inventory related charges (3)

114

 

 

 

Charges related to legal matters (4)

 

 

2,500

 

Asset impairment charges (5)

323

 

 

2,475

 

Foreign exchange loss (6)

 

 

5,181

 

Research and development milestone payments

10,886

 

 

2,000

 

Other

999

 

 

(2,669

)

Income tax at 21%

(17,339

)

 

(17,005

)

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

(1,796

)

 

(1,239

)

Adjusted net income (Non-GAAP)

$

61,062

 

 

$

60,332

 

Adjusted diluted EPS (Non-GAAP) (7)

$

0.20

 

 

$

0.20

 

Amneal Pharmaceuticals, Inc.

Non-GAAP Reconciliations

(Unaudited; In thousands)

 

Explanations for Reconciliations of Net Income to EBITDA and Adjusted EBITDA and

Net Income to Adjusted Net Income and Calculation of Adjusted Diluted EPS

 

(1)

Acquisition and site closure 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. Acquisition and site closure expenses for the three months ended March 31, 2020 included transaction costs associated with the acquisition of AvKARE.

 

 

 

 

 

(2)

For the three months March 31, 2021 and 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 months ended March 31, 2021, inventory related charges represented inventory obsolescence and related expenses associated with recalls.

 

 

 

 

 

(4)

For the three months ended March 31, 2020, charges related to legal matters were $2.5 million for a commercial legal claim in our Generics segment.

 

 

(5)

Asset impairment charges for the three months ended March 31, 2021 were associated with equipment. Asset impairment charges for the three months ended March 31, 2020 were primarily associated with the write-off of in process research and development and intangible asset impairment charges.

 

 

 

 

 

(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 months ended March 31, 2021 and 2020, the calculation of adjusted diluted EPS utilized weighted average diluted shares outstanding of 303,337 and 300,073, respectively, which consisted of Class A common stock and Class B common stock under the if-converted method.

Contacts

Anthony DiMeo

Senior Director, Investor Relations

anthony.dimeo@amneal.com

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