Amneal Reports Third Quarter 2021 Financial Results

November 03, 2021

‒ Q3 2021 Net Revenue of $529 million; GAAP Net Loss of $(4) million; Diluted Loss per Share of $(0.03) ‒

‒ Adjusted EBITDA (1) of $135 million; Adjusted Diluted EPS (1) of $0.21 ‒

‒ Updating 2021 Full Year Financial Outlook, Including Raising Adjusted EBITDA and Adjusted EPS Guidance ‒

‒ Announces Acquisition of Puniska Healthcare to Significantly Expand Injectable Business ‒

BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) announced its results today for the third quarter ended September 30, 2021.

“Our solid third quarter results further validate our strategy for growth and value creation, focused on operational excellence and a robust innovation engine to strengthen and diversify Amneal,” said Chirag and Chintu Patel, Co-Chief Executive Officers. “We are pleased to be raising our adjusted EBITDA guidance for full year 2021, underscoring our continued strong business performance. We are also excited to announce the acquisition of Puniska, and we welcome the Puniska team to the Amneal family. This acquisition is a pivotal step that meaningfully enhances our injectables capabilities for the U.S. market and enables international expansion as we look to become a leading player in the global injectables market,” said Chirag and Chintu Patel, Co-Chief Executive Officers.

Net revenue in the third quarter of 2021 was $529 million, an increase of 2% compared to $519 million in the third quarter of 2020. The increase was driven by Generic product launches and growth in our promoted Specialty products Rytary® and Unithroid®, partially offset by price erosion in our base business and slow demand at the start of the flu season.

Net loss attributable to Amneal Pharmaceuticals, Inc. was $4 million in the third quarter of 2021 compared to a net loss of $9 million in the third quarter of 2020. The decrease in net loss was primarily attributable to growth in net revenue and gross profit, which was driven by strong gross margin improvement in our Generics segment and a reduction in impairment charges.

Adjusted EBITDA(1) in the third quarter of 2021 was $135 million, an increase of 19% compared to the third quarter of 2020, reflective of an increase in gross profit. Adjusted diluted EPS(1) in the third quarter of 2021 was $0.21, an increase of 31% from $0.16 in the third quarter of 2020, reflective mostly of growth in adjusted EBITDA(1).

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

Updating Full Year 2021 Financial Outlook

Amneal is updating its previously provided guidance.

 

Existing Full Year 2021 Guidance

Revised Full Year 2021 Financial Guidance

Net revenue

$2.1 billion - $2.2 billion

~ $2.1 billion

Adjusted EBITDA (1)

$500 million - $540 million

$530 million - $550 million

Adjusted diluted EPS (2)

$0.70 - $0.85

$0.78 - $0.88

Operating cash flow

$220 million - $250 million

$220 million - $250 million

Capital expenditures

$60 million - $70 million

$50 million - $60 million

Weighted average diluted shares outstanding (3)

Approximately 303 million

Approximately 304 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.

Acquisition of Puniska Healthcare to Significantly Expand Injectable Business

Today, Amneal announced it signed a definitive agreement to acquire Puniska Healthcare Pvt. Ltd. (“Puniska”). The acquisition will significantly enhance Amneal’s injectables manufacturing infrastructure, capabilities, and capacity to support the U.S. market and serve as a foundation for international markets. Puniska includes a 293,000 square foot, state-of-the-art manufacturing facility in Ahmedabad, India, with a number of sterile injectable production lines. Production capabilities include robotic, aseptic and lyophilize vial lines, emulsion line, and large-volume parenteral bag line. The acquisition also brings to Amneal approximately 550 Puniska employees with key capabilities in injectables manufacturing, research and development, and commercialization. The acquisition has a total value of $93 million and closed on November 2, 2021.

Conference Call Information

Amneal will host a conference call and live webcast at 8:30 am Eastern Time on November 3, 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) 200-6205 (in the U.S.) or (929) 526-1599 (international callers). The access code for the call is 086998. 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 781882.

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 wholesale distributor of bottle and unit dose pharmaceuticals under the registered names of AvKARE and AvPAK, as well as medical and surgical products. 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, make and integrate acquisitions 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; the impact of severe weather, and the high concentration of ownership of our Class A Common Stock and the fact that we are controlled by the Amneal Group. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Investors are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.

Non-GAAP Financial Measures

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

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

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

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

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

Amneal Pharmaceuticals, Inc.

Consolidated Statements of Operations

(Unaudited; In thousands, except per share amounts)

 

 

Three Months Ended

September 30,

 

Nine Months Ended

September 30,

 

2021

 

2020

 

2021

 

2020

Net revenue

$

528,593

 

 

$

519,294

 

 

$

1,556,773

 

 

$

1,482,489

 

Cost of goods sold

329,394

 

 

353,345

 

 

953,514

 

 

986,589

 

Cost of goods sold impairment charges

688

 

 

32,364

 

 

688

 

 

34,579

 

Gross profit

198,511

 

 

133,585

 

 

602,571

 

 

461,321

 

Selling, general and administrative

91,397

 

 

83,120

 

 

268,280

 

 

242,040

 

Research and development

48,927

 

 

44,519

 

 

149,973

 

 

126,470

 

In-process research and development impairment charges

 

 

 

 

710

 

 

960

 

Intellectual property legal development expenses

1,627

 

 

2,134

 

 

6,574

 

 

6,954

 

Acquisition, transaction-related and integration expenses

134

 

 

1,041

 

 

7,219

 

 

5,403

 

Charges related to legal matters, net

19,000

 

 

60

 

 

19,000

 

 

5,860

 

Restructuring and other charges

425

 

 

276

 

 

788

 

 

2,657

 

Change in fair value of contingent consideration

300

 

 

 

 

300

 

 

 

Property losses and associated expenses

8,186

 

 

 

 

8,186

 

 

 

Operating income

28,515

 

 

2,435

 

 

141,541

 

 

70,977

 

Other (expense) income:

 

 

 

 

 

 

 

Interest expense, net

(34,400)

 

 

(34,895)

 

 

(102,368)

 

 

(111,463)

 

Foreign exchange (loss) gain, net

(29)

 

 

9,673

 

 

(185)

 

 

7,958

 

Gain on sale of international businesses, net

 

 

 

 

 

 

123

 

Other income, net

3,871

 

 

898

 

 

8,697

 

 

2,102

 

Total other expense, net

(30,558)

 

 

(24,324)

 

 

(93,856)

 

 

(101,280)

 

(Loss) income before income taxes

(2,043)

 

 

(21,889)

 

 

47,685

 

 

(30,303)

 

Provision for (benefit from) income taxes

4,049

 

 

144

 

 

7,056

 

 

(105,843)

 

Net (loss) income

(6,092)

 

 

(22,033)

 

 

40,629

 

 

75,540

 

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

1,855

 

 

13,058

 

 

(23,628)

 

 

18,556

 

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

$

(4,237)

 

 

$

(8,975)

 

 

$

17,001

 

 

$

94,096

 

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

 

 

 

 

 

 

 

Basic

$

(0.03)

 

 

$

(0.06)

 

 

$

0.11

 

 

$

0.64

 

Diluted

$

(0.03)

 

 

$

(0.06)

 

 

$

0.11

 

 

$

0.63

 

Weighted-average common shares outstanding:

 

 

 

 

 

 

 

Basic

149,290

 

 

147,558

 

 

148,771

 

 

147,377

 

Diluted

149,290

 

 

147,558

 

 

151,655

 

 

148,622

 

Amneal Pharmaceuticals, Inc.

Condensed Consolidated Balance Sheets

(Unaudited; In thousands)

 

 

September 30, 2021

 

December 31, 2020

Assets

 

 

 

Current assets:

 

 

 

Cash and cash equivalents

$

302,655

 

 

$

341,378

 

Restricted cash

7,964

 

 

5,743

 

Trade accounts receivable, net

627,954

 

 

638,895

 

Inventories

520,245

 

 

490,649

 

Prepaid expenses and other current assets

110,212

 

 

73,467

 

Related party receivables

1,307

 

 

1,407

 

Total current assets

1,570,337

 

 

1,551,539

 

Property, plant and equipment, net

459,651

 

 

477,754

 

Goodwill and intangible assets, net

1,799,133

 

 

1,827,440

 

Other assets

145,288

 

 

149,300

 

Total assets

$

3,974,409

 

 

$

4,006,033

 

Liabilities and Stockholders' Equity

 

 

 

Current liabilities:

 

 

 

Accounts payable and accrued expenses

$

589,412

 

 

$

611,867

 

Current portion of long-term debt, net

30,471

 

 

44,228

 

Current portion of operating lease liabilities

9,180

 

 

6,474

 

Current portion of operating and financing lease liabilities - related party

2,580

 

 

3,978

 

Current portion of financing lease liabilities

3,218

 

 

1,794

 

Current portion of note payable - related party

 

 

1,000

 

Related party payable - short term

32,474

 

 

7,561

 

Total current liabilities

667,335

 

 

676,902

 

Long-term debt, net

2,687,668

 

 

2,735,264

 

Other long-term liabilities

220,980

 

 

237,131

 

Total long-term liabilities

2,908,648

 

 

2,972,395

 

Redeemable non-controlling interests

15,260

 

 

11,804

 

Total stockholders' equity

383,166

 

 

344,932

 

Total liabilities and stockholders' equity

$

3,974,409

 

 

$

4,006,033

 

Amneal Pharmaceuticals, Inc.

Consolidated Statements of Cash Flows

(Unaudited; In thousands)

 

 

Nine Months Ended
September 30,

 

2021

 

2020

Cash flows from operating activities:

 

 

 

Net income

$

40,629

 

 

$

75,540

 

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

 

 

 

Depreciation and amortization

172,223

 

 

175,514

 

Unrealized foreign currency loss

(94)

 

 

(7,779)

 

Amortization of debt issuance costs and discount

6,873

 

 

6,449

 

Gain on sale of international businesses, net

 

 

(123)

 

Intangible asset impairment charges

1,398

 

 

35,539

 

Asset-related credit

 

 

(536)

 

Change in fair value of contingent consideration

300

 

 

 

Stock-based compensation

20,670

 

 

15,617

 

Inventory provision

39,290

 

 

56,198

 

Non-cash property losses

5,152

 

 

 

Other operating charges and credits, net

3,965

 

 

6,248

 

Changes in assets and liabilities:

 

 

 

Trade accounts receivable, net

10,894

 

 

(50,748)

 

Inventories

(65,643)

 

 

(80,722)

 

Prepaid expenses, other current assets and other assets

(27,493)

 

 

17,638

 

Related party receivables

7,201

 

 

870

 

Accounts payable, accrued expenses and other liabilities

(32,819)

 

 

21,737

 

Related party payables

(3,987)

 

 

1,601

 

Net cash provided by operating activities

178,559

 

 

273,043

 

Cash flows from investing activities:

 

 

 

Purchases of property, plant and equipment

(30,230)

 

 

(26,912)

 

Deposits for future acquisition of property, plant, and equipment

(2,655)

 

 

(4,229)

 

Acquisition of intangible assets

(500)

 

 

(3,250)

 

Acquisitions, net of cash acquired

(73,828)

 

 

(251,360)

 

Net cash used in investing activities

(107,213)

 

 

(285,751)

 

Cash flows from financing activities:

 

 

 

Proceeds from issuance of debt

 

 

180,000

 

Payments of principal on debt, financing leases and other

(68,240)

 

 

(26,500)

 

Payments of deferred financing costs

 

 

(4,102)

 

Proceeds from exercise of stock options

834

 

 

216

 

Employee payroll tax withholding on restricted stock unit vesting

(2,595)

 

 

(795)

 

Tax distributions to non-controlling interests

(36,678)

 

 

(1,628)

 

Distribution of earnings to and acquisition of non-controlling interests

 

 

(3,300)

 

Payments of principal on financing lease - related party

(93)

 

 

(802)

 

Repayment of related party note

(1,000)

 

 

 

Net cash (used in) provided by financing activities

(107,772)

 

 

143,089

 

Effect of foreign exchange rate on cash

(76)

 

 

447

 

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

(36,502)

 

 

130,828

 

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

347,121

 

 

152,822

 

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

$

310,619

 

 

$

283,650

 

Cash and cash equivalents - end of period

$

302,655

 

 

$

281,278

 

Restricted cash - end of period

7,964

 

 

2,372

 

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

$

310,619

 

 

$

283,650

 

 

Amneal Pharmaceuticals, Inc.

Non-GAAP Reconciliations

(Unaudited, In thousands)

 

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

 

 

Three Months Ended

September 30,

 

Nine Months Ended
September 30,

 

2021

 

2020

 

2021

 

2020

Net (loss) income

$

(6,092)

 

 

$

(22,033)

 

 

$

40,629

 

 

$

75,540

 

Adjusted to add (deduct):

 

 

 

 

 

 

 

Interest expense, net

34,400

 

 

34,895

 

 

102,368

 

 

111,463

 

Income tax expense (benefit)

4,049

 

 

144

 

 

7,056

 

 

(105,843)

 

Depreciation and amortization

60,186

 

 

59,359

 

 

172,223

 

 

175,514

 

EBITDA (Non-GAAP)

$

92,543

 

 

$

72,365

 

 

$

322,276

 

 

$

256,674

 

Adjusted to add (deduct):

 

 

 

 

 

 

 

Stock-based compensation expense

7,708

 

 

5,415

 

 

20,670

 

 

15,617

 

Acquisition and site closure expenses (1)

2,220

 

 

3,979

 

 

13,976

 

 

16,607

 

Restructuring and other charges (2)

425

 

 

276

 

 

788

 

 

2,657

 

Inventory related charges (3)

44

 

 

1,054

 

 

245

 

 

6,179

 

Charges related to legal matters (4)

19,000

 

 

60

 

 

19,000

 

 

5,610

 

Asset impairment charges (5)

688

 

 

33,350

 

 

1,752

 

 

38,124

 

Foreign exchange (gain) loss

29

 

 

(9,673)

 

 

185

 

 

(7,958)

 

Gain on sale of international businesses, net

 

 

 

 

 

 

(123)

 

Research and development milestone payments

2,496

 

 

6,304

 

 

21,229

 

 

15,145

 

Change in fair value of contingent consideration (6)

300

 

 

 

 

300

 

 

 

Property losses and associated expenses (7)

8,186

 

 

 

 

8,186

 

 

 

Other

1,282

 

 

468

 

 

3,088

 

 

230

 

Adjusted EBITDA (Non-GAAP)

$

134,921

 

 

$

113,598

 

 

$

411,695

 

 

$

348,762

 

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 EPS

 

 

Three Months Ended

September 30,

 

Nine Months Ended

September 30,

 

2021

 

2020

 

2021

 

2020

Net (loss) income

$

(6,092)

 

 

$

(22,033)

 

 

$

40,629

 

 

$

75,540

 

Adjusted to add (deduct):

 

 

 

 

 

 

 

Non-cash interest

2,183

 

 

2,021

 

 

6,232

 

 

5,885

 

GAAP Income tax (benefit) expense

4,049

 

 

144

 

 

7,056

 

 

(105,843)

 

Amortization

41,651

 

 

41,514

 

 

122,526

 

 

123,009

 

Stock-based compensation expense

7,708

 

 

5,415

 

 

20,670

 

 

15,617

 

Acquisition and site closure expenses (1)

2,220

 

 

3,979

 

 

13,976

 

 

16,607

 

Restructuring and other charges (2)

425

 

 

276

 

 

788

 

 

2,657

 

Inventory related charges (3)

44

 

 

1,054

 

 

245

 

 

6,179

 

Charges related to legal matters (4)

19,000

 

 

60

 

 

19,000

 

 

5,610

 

Asset impairment charges (5)

688

 

 

33,350

 

 

1,752

 

 

38,124

 

Foreign exchange gain (8)

 

 

(9,673)

 

 

 

 

(7,958)

 

Gain on sale of international businesses, net

 

 

 

 

 

 

(123)

 

Research and development milestone payments

2,496

 

 

6,304

 

 

21,229

 

 

15,145

 

Change in fair value of contingent consideration(6)

300

 

 

 

 

300

 

 

 

Property losses and associated expenses (7)

8,186

 

 

 

 

8,186

 

 

 

Other

1,282

 

 

468

 

 

3,088

 

 

230

 

Income tax at 21%

(17,346)

 

 

(13,886)

 

 

(56,464)

 

 

(41,860)

 

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

(1,541)

 

 

393

 

 

(5,391)

 

 

(1,151)

 

Adjusted net income (Non-GAAP)

$

65,253

 

 

$

49,386

 

 

$

203,822

 

 

$

147,668

 

Adjusted diluted EPS (Non-GAAP) (9)

$

0.21

 

 

$

0.16

 

 

$

0.67

 

 

$

0.49

 

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 EPS

(1)

 

Acquisition and site closure expenses for the three and nine months ended September 30, 2021 primarily included (i) transaction and integration costs associated with the acquisition of Kashiv Specialty Pharmaceuticals, LLC; (ii) integration costs associated with the acquisition of AvKARE; and (iii) site closure costs associated with the planned cessation of manufacturing at our Hauppauge, NY facility. Acquisition and site closure expenses for the three and nine months ended September 30, 2020 primarily included (i) system integration costs associated with the combination with Impax Laboratories, LLC, (ii) transaction and integration costs associated with the acquisition of AvKARE, and (iii) site closure expenses associated with the planned cessation of manufacturing at our Hauppauge, NY facility.

 

 

 

 

 

 

(2)

 

For the three and nine months ended September 30, 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 and nine months ended September 30, 2021 and 2020, inventory related charges represented inventory obsolescence and related expenses associated with recalls.

 

 

 

 

 

 

(4)

 

For both the three and nine months ended September 30, 2021, charges related to legal matters were $19 million for commercial legal claims in our Corporate segment. For the nine months ended September 30, 2020, charges related to legal matters were $6 million for commercial legal claims in our Generics segment (immaterial charges for the three months ended September 30, 2020).

 

 

 

(5)

 

Asset impairment charges for the three and nine months ended September 30, 2021 and 2020 were primarily associated with the write-off of intangible assets and equipment, except for equipment discussed in (7) below.

 

 

 

 

 

 

(6)

 

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

 

 

 

 

 

 

(7)

 

Property losses and associated expenses for both the three and nine months ended September 30, 2021 were a result of damage to two of our Branchburg, NJ facilities from Tropical Storm Ida, which consisted of impairment of equipment and inventory, repairs and maintenance expenses and salaries and benefits.

 

 

 

 

 

 

(8)

 

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.

 

 

 

 

 

 

(9)

 

For the three and nine months ended September 30, 2021, the calculation of adjusted diluted EPS utilized weighted average diluted shares outstanding of 303,861 and 303,772, respectively, which consisted of Class A common stock and Class B common stock under the if-converted method. For the three and nine months ended September 30, 2020, the calculation of adjusted diluted EPS utilized weighted average diluted shares outstanding of 301,364 and 300,739, respectively, which consisted of Class A common stock and Class B common stock under the if-converted method.

Amneal Pharmaceuticals, Inc.

Generics Segment

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

(Unaudited; In thousands)

 

 

 

Three Months Ended September 30, 2021

 

Three Months Ended September 30, 2020

 

 

As Reported

 

Adjustments

 

Non-GAAP

 

As Reported

 

Adjustments

 

Non-GAAP

Net revenue

 

$

347,127

 

 

$

 

 

$

347,127

 

 

$

341,920

 

 

$

 

 

$

341,920

 

Cost of goods sold (2)

 

208,670

 

 

(13,049)

 

 

195,621

 

 

229,067

 

 

(15,194)

 

 

213,873

 

Cost of goods sold impairment charges (3)

 

688

 

 

(688)

 

 

 

 

32,364

 

 

(32,364)

 

 

 

Gross profit

 

137,769

 

 

13,737

 

 

151,506

 

 

80,489

 

 

47,558

 

 

128,047

 

Gross margin %

 

39.7

%

 

 

 

43.6

%

 

23.5

%

 

 

 

37.4

%

 

 

 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative (4)

 

15,941

 

 

(988)

 

 

14,953

 

 

13,153

 

 

(1,654)

 

 

11,499

 

Research and development (5)

 

34,999

 

 

(1,538)

 

 

33,461

 

 

39,232

 

 

(7,252)

 

 

31,980

 

Intellectual property legal development expenses

 

1,584

 

 

 

 

1,584

 

 

2,132

 

 

 

 

2,132

 

Property losses and associated expenses (6)

 

8,186

 

 

(8,186)

 

 

 

 

 

 

 

 

 

Charges related to legal matters, net

 

 

 

 

 

 

 

60

 

 

(60)

 

 

 

Restructuring and other charges

 

 

 

 

 

 

 

(536)

 

 

536

 

 

 

Operating income

 

$

77,059

 

 

$

24,449

 

 

$

101,508

 

 

$

26,448

 

 

$

55,988

 

 

$

82,436

 

(1)

 

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

 

 

 

 

 

 

(2)

 

Adjustments for the three months ended September 30, 2021 and 2020, respectively, were comprised of stock-based compensation expense ($1.3 million and $1.2 million), amortization expense ($10.2 million and $10.7 million), site closure expenses ($1.5 million and $2.3 million), inventory related charges (immaterial and $0.4 million), asset impairment charges (none and $0.3 million) and other (none and $0.3 million). For the three months ended September 30, 2021 and 2020, site closure expenses were primarily associated with the planned cessation of manufacturing at our Hauppauge, NY facility. For the three months ended September 30, 2020, asset impairment charges were associated with the write-off of equipment.

 

 

 

 

 

 

(3)

 

Adjustments for the three months ended September 30, 2021 and 2020 were associated with intangible asset impairments.

 

 

 

 

 

 

(4)

 

Adjustments for the three months ended September 30, 2021 and 2020, respectively, were comprised of stock-based compensation expense ($0.5 million and $0.3 million), site closure costs ($0.5 million and $0.6 million), inventory related charges (none and $0.6 million), and other (none and $0.2 million).

 

 

 

(5)

 

Adjustments for the three months ended September 30, 2021 and 2020, respectively, were comprised of stock-based compensation expense ($1.0 million and $0.7 million), research and development milestones ($0.5 million and $6.3 million), and other (none and $0.3 million).

 

 

 

 

 

 

(6)

 

Adjustments for the three months ended September 30, 2021 were a result of damage to two of our Branchburg, NJ facilities from Tropical Storm Ida, which consisted of impairment of equipment and inventory, repairs and maintenance expenses and salaries and benefits.

 

 

 

 

 

 

Amneal Pharmaceuticals, Inc.

Generics Segment

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

(Unaudited; In thousands)

 

 

 

Nine Months Ended September 30, 2021

 

Nine Months Ended September 30, 2020

 

 

As Reported

 

Adjustments

 

Non-GAAP

 

As Reported

 

Adjustments

 

Non-GAAP

Net revenue

 

$

1,020,072

 

 

$

 

 

$

1,020,072

 

 

$

1,001,065

 

 

$

 

 

$

1,001,065

 

Cost of goods sold (2)

 

598,122

 

 

(38,705)

 

 

559,417

 

 

666,841

 

 

(50,369)

 

 

616,472

 

Cost of goods sold impairment charges (3)

 

688

 

 

(688)

 

 

 

 

34,579

 

 

(34,579)

 

 

 

Gross profit

 

421,262

 

 

39,393

 

 

460,655

 

 

299,645

 

 

84,948

 

 

384,593

 

Gross margin %

 

41.3

%

 

 

 

45.2

%

 

29.9

%

 

 

 

38.4

%

 

 

 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative (4)

 

46,500

 

 

(1,803)

 

 

44,697

 

 

42,578

 

 

(4,220)

 

 

38,358

 

Research and development (5)

 

114,547

 

 

(15,031)

 

 

99,516

 

 

108,582

 

 

(16,065)

 

 

92,517

 

In-process research and development impairment charges (3)

 

710

 

 

(710)

 

 

 

 

960

 

 

(960)

 

 

 

Intellectual property legal development expenses

 

6,506

 

 

 

 

6,506

 

 

6,947

 

 

 

 

6,947

 

Property losses and associated expenses (6)

 

8,186

 

 

(8,186)

 

 

 

 

 

 

 

 

 

Acquisition, transaction-related and integration expenses

 

 

 

 

 

 

 

325

 

 

(325)

 

 

 

Charges related to legal matters, net (7)

 

 

 

 

 

 

 

5,610

 

 

(5,610)

 

 

 

Restructuring and other charges

 

80

 

 

(80)

 

 

 

 

(158)

 

 

158

 

 

 

Operating income

 

$

244,733

 

 

$

65,203

 

 

$

309,936

 

 

$

134,801

 

 

$

111,970

 

 

$

246,771

 

(1)

 

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

 

 

 

 

 

 

(2)

 

Adjustments for the nine months ended September 30, 2021 and 2020, respectively, were comprised of stock-based compensation expense ($3.3 million and $3.3 million), amortization expense ($28.0 million and $31.9 million), site closure expenses ($6.2 million and $7.8 million), inventory related charges ($0.2 million and $5.0 million), asset impairment charges ($0.4 million and $1.3 million), and other ($0.6 million and $1.1 million). For the nine months ended September 30, 2021 and 2020, site closure expenses were primarily associated with the planned cessation of manufacturing at our Hauppauge, NY facility. For the nine months ended September 30, 2021 and 2020, asset impairment charges were associated with the write-off of equipment.

 

 

 

 

 

 

(3)

 

Adjustments for the nine months ended September 30, 2021 and 2020 were associated with intangible asset impairments.

 

 

 

 

 

 

(4)

 

Adjustments for the nine months ended September 30, 2021 and 2020, respectively, were comprised of stock-based compensation expense ($1.3 million, and $1.0 million), site closure costs ($0.5 million and $3.5 million), inventory related charges (none and $0.6 million), and other (immaterial and $(0.9) million).

 

 

 

(5)

 

Adjustments for the nine months ended September 30, 2021 and 2020, respectively, were comprised of stock-based compensation expense ($2.9 million and $1.8 million), research and development milestones ($11.8 million and $13.1 million), and other ($0.3 million and $1.2 million).

 

 

 

 

 

 

(6)

 

Adjustments for the nine months ended September 30, 2021 were a result of damage to two of our Branchburg facilities due to Tropical Storm Ida, which consisted of impairment of equipment and inventory, repairs and maintenance expenses and salaries and benefits.

 

 

 

 

 

 

(7)

 

Adjustments for the nine months ended September 30, 2020 were associated with a commercial legal claim.

Amneal Pharmaceuticals, Inc.

Specialty Segment

Reconciliation of GAAP to Non-GAAP Operating Results

(Unaudited; In thousands)

 

 

Three Months Ended September 30, 2021

 

Three Months Ended September 30, 2020

 

As Reported

 

Adjustments

 

Non-GAAP

 

As Reported

 

Adjustments

 

Non-GAAP

Net revenue

$

92,745

 

 

$

 

 

$

92,745

 

 

$

87,868

 

 

$

 

 

$

87,868

 

Cost of goods sold (1)

47,303

 

 

(27,503)

 

 

19,800

 

 

47,735

 

 

(25,126)

 

 

22,609

 

Gross profit

45,442

 

 

27,503

 

 

72,945

 

 

40,133

 

 

25,126

 

 

65,259

 

Gross margin %

49.0

%

 

 

 

78.7

%

 

45.7

%

 

 

 

74.3

%

 

 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative (2)

22,211

 

 

(749)

 

 

21,462

 

 

19,181

 

 

(587)

 

 

18,594

 

Research and development (3)

13,928

 

 

(2,314)

 

 

11,614

 

 

5,287

 

 

(170)

 

 

5,117

 

Intellectual property legal development expenses

43

 

 

 

 

43

 

 

2

 

 

 

 

2

 

Change in fair value of contingent consideration(4)

300

 

 

(300)

 

 

 

 

 

 

 

 

 

Acquisition, transaction-related and integration expenses

 

 

 

 

 

 

1

 

 

(1)

 

 

 

Operating income

$

8,960

 

 

$

30,866

 

 

$

39,826

 

 

$

15,662

 

 

$

25,884

 

 

$

41,546

 

(1)

 

Adjustments for the three months ended September 30, 2021 and 2020 were comprised of amortization expense.

 

 

 

 

 

 

(2)

 

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

 

 

 

 

 

 

(3)

 

Adjustments for the three months ended September 30, 2021 and 2020, respectively, were comprised of stock-based compensation expense ($0.3 million and $0.2 million) and research and development milestones ($2 million and none).

 

 

 

 

 

 

(4)

 

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)

 

 

Nine Months Ended September 30, 2021

 

Nine Months Ended September 30, 2020

 

As Reported

 

Adjustments

 

Non-GAAP

 

As Reported

 

Adjustments

 

Non-GAAP

Net revenue

$

277,311

 

 

$

 

 

$

277,311

 

 

$

270,101

 

 

$

 

 

$

270,101

 

Cost of goods sold (1)

144,184

 

 

(82,496)

 

 

61,688

 

 

145,782

 

 

(76,017)

 

 

69,765

 

Gross profit

133,127

 

 

82,496

 

 

215,623

 

 

124,319

 

 

76,017

 

 

200,336

 

Gross margin %

48.0

%

 

 

 

77.8

%

 

46.0

%

 

 

 

74.2

%

 

 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative (2)

62,748

 

 

(2,081)

 

 

60,667

 

 

56,993

 

 

(2,961)

 

 

54,032

 

Research and development (3)

35,426

 

 

(10,221)

 

 

25,205

 

 

17,888

 

 

(2,492)

 

 

15,396

 

Intellectual property legal development expenses

68

 

 

 

 

68

 

 

7

 

 

 

 

7

 

Change in fair value of contingent consideration(4)

300

 

 

(300)

 

 

 

 

 

 

 

 

 

Acquisition, transaction-related and integration expenses

16

 

 

(16)

 

 

 

 

83

 

 

(83)

 

 

 

Charges related to legal matters, net

 

 

 

 

 

 

250

 

 

 

 

250

 

Operating income

$

34,569

 

 

$

95,114

 

 

$

129,683

 

 

$

49,098

 

 

$

81,553

 

 

$

130,651

 

(1)

 

Adjustments for the nine months ended September 30, 2021 and 2020 were comprised of amortization expense.

 

 

 

 

 

 

(2)

 

Adjustments for the nine months ended September 30, 2021 and 2020, respectively, were comprised of stock-based compensation expense ($2.1 million and $1.6 million) and other (none and $1.4 million).

 

 

 

 

 

 

(3)

 

Adjustments for the nine months ended September 30, 2021 and 2020, respectively, were comprised of stock-based compensation expense ($0.8 million and $0.5 million) and research and development milestones ($9.4 million and $2.0 million).

 

 

 

 

 

 

(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 September 30, 2021

 

Three Months Ended September 30, 2020

 

As Reported

 

Adjustments

 

Non-GAAP

 

As Reported

 

Adjustments

 

Non-GAAP

Net revenue

$

88,721

 

 

$

 

 

$

88,721

 

 

$

89,506

 

 

$

 

 

$

89,506

 

Cost of goods sold

73,421

 

 

 

 

73,421

 

 

76,543

 

 

 

 

76,543

 

Gross profit

15,300

 

 

 

 

15,300

 

 

12,963

 

 

 

 

12,963

 

Gross margin %

17.2

%

 

 

 

17.2

%

 

14.5

%

 

 

 

14.5

%

 

 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative (2)

14,683

 

 

(6,303)

 

 

8,380

 

 

15,374

 

 

(8,694)

 

 

6,680

 

Operating income (loss)

$

617

 

 

$

6,303

 

 

$

6,920

 

 

$

(2,411)

 

 

$

8,694

 

 

$

6,283

 

(1)

 

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

 

 

 

 

 

 

(2)

 

Adjustments for the three months ended September 30, 2021 and 2020 were comprised of amortization expense.

Amneal Pharmaceuticals, Inc.

AvKARE Segment

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

(Unaudited; In thousands)

 

 

Nine Months Ended September 30, 2021

 

Nine Months Ended September 30, 2020 (2)

 

As Reported

 

Adjustments

 

Non-GAAP

 

As Reported

 

Adjustments

 

Non-GAAP

Net revenue

$

259,390

 

 

$

 

 

$

259,390

 

 

$

211,323

 

 

$

 

 

$

211,323

 

Cost of goods sold

211,208

 

 

 

 

211,208

 

 

173,966

 

 

 

 

173,966

 

Gross profit

48,182

 

 

 

 

48,182

 

 

37,357

 

 

 

 

37,357

 

Gross margin %

18.6

%

 

 

 

18.6

%

 

17.7

%

 

 

 

17.7

%

 

 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative (3)

41,986

 

 

(18,670)

 

 

23,316

 

 

41,809

 

 

(23,184)

 

 

18,625

 

Acquisition, transaction-related and integration expenses (4)

1,422

 

 

(1,422)

 

 

 

 

 

 

 

 

 

Operating income (loss)

$

4,774

 

 

$

20,092

 

 

$

24,866

 

 

$

(4,452)

 

 

$

23,184

 

 

$

18,732

 

(1)

 

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

 

 

 

 

 

 

(2)

 

Our AvKARE segment includes the results of operations of AvKARE from January 31, 2020, the date of the acquisition, to September 30, 2020.

 

 

 

 

 

 

(3)

 

Adjustments for the nine months ended September 30, 2021 and 2020 were comprised of amortization expense.

 

 

 

 

 

 

(4)

 

Adjustments for the nine months ended September 30, 2021 were comprised of finance integration expense.

 

Anthony DiMeo
Senior Director, Investor Relations
anthony.dimeo@amneal.com

Source: Amneal Pharmaceuticals, Inc.