EX-99.1 2 amrxexhibit991pressrelease.htm EXHIBIT 99.1 Exhibit
exhibit991892018image1a01.jpg

CONTACT:
Mark Donohue
(908) 409-6718
                    
AMNEAL REPORTS FOURTH QUARTER AND FULL YEAR 2018 FINANCIAL RESULTS

‒ Q4 2018 Net Revenue of $498 Million; GAAP Loss per share of $0.07; Combined Adjusted Diluted EPS(1) of $0.33 ‒
‒ Full Year 2018 Net Revenue of $1.66 Billion; GAAP Loss per share of $0.16; Combined Net Revenue(1)of $1.86 Billion(3); Combined Adjusted Diluted EPS(1) of $0.98 ‒
‒ Industry Leading Pipeline Execution in 2018; 62 ANDAs Approved and 42 New Products Launched ‒
‒ Targeting up to 50 New Generic Product Launches in 2019 ‒
‒ Provides 2019 Financial Outlook‒

BRIDGEWATER, NJ, February 28, 2019 - Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (the “Company”) announced its results today for the fourth quarter and year ended December 31, 2018.

Summary of GAAP and Non-GAAP Combined and Adjusted Results
(Unaudited; In thousands, except per share amounts)
 
Three Months Ended
 
Variance
 
December 31, 2018
 
September 30, 2018
 
December 31, 2017
 
Sequential
 
Year/ Year
GAAP Results(2)
 
 
 
 
 
 
 
 
 
Net revenue
$
497,528

 
$
476,487

 
$
293,369

 
4.4
 %
 
69.6
 %
Net (loss) income
$
(20,330
)
 
$
17,465

 
$
62,194

 
(216.4
)%
 
(132.7
)%
Diluted (loss) earnings per share (EPS) attributable to Amneal Pharmaceuticals, Inc.
$
(0.07
)
 
$
0.05

 
N/A

 
(240.0
)%
 
N/A

 
 
 
 
 
 
 
 
 
 
Non-GAAP Results(3)
 
 
 
 
 
 
 
 
 
Combined net revenue
$
497,528

 
$
476,487

 
$
487,383

 
4.4
 %
 
2.1
 %
Combined adjusted net income
$
99,976

 
$
82,101

 
$
76,446

 
21.8
 %
 
30.8
 %
Combined adjusted EBITDA
$
186,647

 
$
162,917

 
$
139,625

 
14.6
 %
 
33.7
 %
Combined adjusted diluted EPS
$
0.33

 
$
0.27

 
N/A

 
22.2
 %
 
N/A

 
Years Ended
 
Variance
 
December 31, 2018
 
December 31, 2017
 
Year/Year
GAAP Results(2)
 
 
 
 
 
Net revenue
$
1,662,991

 
$
1,033,654

 
60.9
 %
Net (loss) income
$
(201,303
)
 
$
169,325

 
(218.9
)%
Diluted loss per share attributable to Amneal Pharmaceuticals, Inc.
$
(0.16
)
 
N/A

 
N/A

 
 
 
 
 
 
Non-GAAP Results(3)
 
 
 
 
 
Combined net revenue
$
1,861,473

 
$
1,857,780

 
0.2
 %
Combined adjusted net income
$
293,702

 
$
270,511

 
8.6
 %
Combined adjusted EBITDA
$
584,280

 
$
503,678

 
16.0
 %
Combined adjusted diluted EPS
$
0.98

 
N/A

 
N/A


(1) See “Non-GAAP Financial Measures” below.
(2) Current year financials reflect the results of Amneal Pharmaceuticals LLC consolidating the results of Impax Laboratories, LLC from the transaction closing date on May 4, 2018. Prior year GAAP results represent Amneal Pharmaceuticals LLC only.
(3) Assumes the combination between Amneal Pharmaceuticals LLC and Impax Laboratories, LLC occurred on the first day of the year presented.

Page 1 of 26



Executive Commentary

“We ended a year of significant progress with improved financial results in the fourth quarter,” said Rob Stewart, President and CEO of Amneal. “Our fourth quarter performance is the direct result of our strategic investments, accelerated synergy capture and solid performance from our base business, which helped to offset recent competition on several of our largest products. Both our Generics and Specialty segments grew net revenue sequentially and compared to last year's fourth quarter as we delivered improved consolidated net revenue of $498 million, combined adjusted EBITDA(4) of $187 million and combined adjusted diluted EPS(4) of $0.33.”

“The full year 2018 was marked by several key strategic milestones, most notably the reshaping of our Company through the merger of Impax and Amneal. By the end of 2018, we completed the merger integration and accelerated the capture of synergies, resulting in approximately $60 million of cost savings for the year. We strategically deployed capital with the acquisition of Gemini Laboratories and through several partnerships including agreements with Jerome Stevens Pharmaceuticals, Inc. and Lannett for Levothyroxine. Through our R&D investments, we achieved 62 ANDA approvals, 10 tentative approvals and we submitted 31 ANDAs with the FDA. We launched 42 new generic products, which contributed $171 million in revenue in 2018.”

“Operationally we are doing well as we achieved industry-leading pipeline execution in 2018 with a consistent pace of new approvals and launches. However, the financial benefits of this execution have been slower to materialize than expected as market dynamics are constraining the uptake of certain products. Our 2019 financial outlook reflects the current pricing and competitive challenges within the generic industry, which is impacting our previously expected growth rate. We continue to expect to deliver at least $200 million in merger cost synergies by the end of 2020, as we focus on generating cash to invest in strategic opportunities to diversify the business and accelerate our growth.”

Basis of Presentation

The Company's financial results are presented in accordance with U.S. GAAP, which include the results of operations of Impax Laboratories, LLC ("Impax") and Gemini Laboratories, LLC ("Gemini") subsequent to the transaction closing dates of May 4, 2018 and May 7, 2018, respectively. As used in this press release the term "actual" refers to measures under the accounting principles generally accepted in the United States. The Company has two reportable segments, Generics and Specialty, and does not allocate general corporate services to either segment.

Fourth Quarter 2018 Performance

Net revenue in the fourth quarter of 2018 was $498 million, an increase of 69.6%, compared to the prior year period, primarily due to the combination with Impax and the acquisition of Gemini in May 2018, as well as new generic product launches. Net loss was $20 million in the fourth quarter of 2018, compared to net income of $62 million in the fourth quarter of 2017, primarily due to charges related to the combination with Impax and the acquisition of Gemini, including approximately $23 million of incremental interest expense. Diluted EPS in the fourth quarter of 2018 was a loss of $0.07. Diluted EPS in the fourth quarter of 2017 is not available as Amneal Pharmaceuticals LLC was a privately-held company for the period presented.

Combined net revenue(4) in the fourth quarter of 2018 was $498 million, an increase of 2.1%, compared to the prior year period, due to an increase in net revenue from both Generics and Specialty segments. Combined adjusted net income(4) in the fourth quarter of 2018 was $100 million, an increase of 30.8%, compared to the prior year period. Combined adjusted EBITDA(4) in the fourth quarter of 2018 was $187 million, an increase of 33.7%, compared to the prior year period. The increase in both combined adjusted net income(4) and combined adjusted EBITDA(4) was primarily due to higher revenues and cost synergies from the combination with Impax. Combined adjusted diluted EPS in the fourth quarter of 2018 was $0.33.

Full Year 2018 Performance

Net revenue for the full year 2018 was $1,663 million, an increase of 60.9%, compared to full year 2017, primarily due to the combination with Impax and the acquisition of Gemini in May 2018, as well as the contribution from 42 new generic product launches. Net loss was $201 million for full year 2018, compared to net income of $169 million for full year 2017, primarily due to charges related to the combination with Impax and the acquisition of Gemini, including approximately $73 million of incremental interest expense. Diluted EPS for full year 2018 was a loss of $0.16. Diluted EPS for full year 2017 is not available as Amneal Pharmaceuticals LLC was a privately-held company for the period presented.


Page 2 of 26



Combined net revenue(4) for full year 2018 was $1,861 million, a slight increase compared to full year 2017. Combined adjusted net income(4) for full year 2018 was $294 million, an increase of 8.6%, compared to full year 2017. Combined adjusted EBITDA(4) for full year 2018 was $584 million, an increase of 16.0%, compared to full year 2017. The increase in both combined adjusted net income(4) and combined adjusted EBITDA(4) was primarily due to favorable product sales mix and cost synergies from the combination with Impax. Combined adjusted diluted EPS for the full year 2018 was $0.98.

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

Page 3 of 26



Amneal Pharmaceuticals, Inc.
Reconciliation of Generics Operating Income to Generics Combined Operating Income
(Unaudited; In thousands)
Generics
Three months ended December 31, 2018
 
Three months ended December 31, 2017
 
 
Add:
(Non-GAAP)
 
 
Add:
(Non-GAAP)
 
Actual
Impax/ Gemini
Combined
 
Actual
Impax/ Gemini
Combined
Net revenue - Generics
$
410,897

$

$
410,897

 
$
293,369

$
112,943

$
406,312

Cost of goods sold
263,002


263,002

 
141,953

150,762

292,715

Gross profit
147,895


147,895

 
151,416

(37,819
)
113,597

Selling, general, and administrative
16,572


16,572

 
11,210

8,223

19,433

Research and development
53,650


53,650

 
43,494

12,612

56,106

In-process research and development impairment charges
38,609


38,609

 

186,731

186,731

Restructuring and asset-related charges
12,031


12,031

 



Legal settlement gains
(19,300
)

(19,300
)
 
(7,845
)

(7,845
)
Intellectual property legal development expenses
3,263


3,263

 
2,732


2,732

Change in fair value of contingent consideration



 

(38,123
)
(38,123
)
Fixed asset impairment



 

5,577

5,577

Operating income (loss)
$
43,070

$

$
43,070

 
$
101,825

$
(212,839
)
$
(111,014
)
 
 
 
 
 
 
 
 
Gross margin
36.0
%

36.0
%
 
51.6
%
(33.5
)%
28.0
%
Adjusted gross profit (Non-GAAP)(5)
$
185,268

$

$
185,268

 
$
155,739

$
35,401

$
191,140

Adjusted gross margin (Non-GAAP)(6)
45.1
%

45.1
%
 
53.1
%
31.3
 %
47.0
%
Adjusted operating income (Non-GAAP)
$
150,166

$

$
150,166

 
$
106,148

$
16,431

$
122,579

(5) Adjusted gross profit is calculated as combined net revenue less adjusted cost of goods sold. See Non-GAAP reconciliations below for calculation of adjusted cost of goods sold.
(6) Adjusted gross margin is calculated as adjusted gross profit divided by combined net revenue.

Fourth Quarter 2018 Performance

Generics net revenue of $411 million increased 40.1% for the fourth quarter of 2018, compared to the prior year period. The increase is primarily attributable to the combination with Impax as well as 42 new product launches in 2018, including Methylphenidate Hydrochloride extended release tablets, Phytonadione tablets, Levothyroxine tablets, Potassium Chloride oral solution, Erythromycin instant release tablets and Colesevelam Hydrochloride tablets. Generics combined net revenue(4) in the fourth quarter of 2018 was $411 million, an increase of 1.1%, compared to the prior year period. The increase is primarily due to new product launches as noted above, partially offset by lower sales across a number of existing products due to lower pricing and additional competition.
 
Generics gross margin for the fourth quarter of 2018 was 36.0%, compared to 51.6% for the fourth quarter of 2017. The decrease was primarily as a result of higher cost of sales due to incremental amortization and inventory acquisition accounting adjustments, manufacturing plant closure charges and product sales mix primarily due to additional competition on several key products. Generics combined adjusted gross margin(4) for the fourth quarter of 2018 was 45.1%, compared to 47.0% for the fourth quarter of 2017, primarily due to product sales mix.

Generics operating income for the fourth quarter of 2018 was $43 million, compared to $102 million for the fourth quarter of 2017, primarily due to higher amortization charges, acquisition and site closure expenses, in-process research and development impairment charges and restructuring and asset-related charges, principally a result of the combination with Impax. Generics combined adjusted operating income(4) for the fourth quarter of 2018 was $150 million, an increase of 22.5%, compared to $123 million in the prior year period, primarily due to lower selling, general and administrative expenses, lower research and development expenses and an increase in legal settlement gains.

(4) See “Non-GAAP Financial Measures” below

Page 4 of 26



Amneal Pharmaceuticals, Inc.
Reconciliation of Generics Operating Income to Generics Combined Operating Income
(Unaudited; In thousands)
Generics
Year ended December 31, 2018
 
Year ended December 31, 2017
 
 
Add:
(Non-GAAP)

 
 
Add:
(Non-GAAP)

 
Actual
Impax/ Gemini
Combined
 
Actual
Impax/ Gemini
Combined
Net revenue - Generics
$
1,439,031

$
102,237

$
1,541,268

 
$
1,033,654

$
549,077

$
1,582,731

Cost of goods sold
842,996

122,761

965,757

 
507,476

551,776

1,059,252

Gross profit
596,035

(20,524
)
575,511

 
526,178

(2,699
)
523,479

Selling, general, and administrative
68,426

11,896

80,322

 
56,050

28,294

84,344

Research and development
183,412

13,623

197,035

 
171,420

63,245

234,665

In-process research and development impairment charges
39,259


39,259

 

192,809

192,809

Acquisition, integration and transaction related expenses
114,622


114,622

 



Restructuring and asset-related charges
33,943


33,943

 



Legal settlement gains
(22,300
)

(22,300
)
 
(29,312
)

(29,312
)
Intellectual property legal development expenses
15,772


15,772

 
20,518

715

21,233

Litigation, settlements and related charges

84,597

84,597

 



Change in fair value of contingent consideration



 

(31,048
)
(31,048
)
Fixed asset impairment



 

8,380

8,380

Operating income
$
162,901

$
(130,640
)
$
32,261

 
$
307,502

$
(265,094
)
$
42,408

 
 
 
 
 
 
 
 
Gross margin
41.4
%
(20.1
)%
37.3
%
 
50.9
%
(0.5
)%
33.1
%
Adjusted gross profit (Non-GAAP)(5)
$
712,954

$
3,246

$
716,200

 
$
561,518

$
208,960

$
770,478

Adjusted gross margin (Non-GAAP)(6)
49.5
%
3.2
 %
46.5
%
 
54.3
%
38.1
 %
48.7
%
Adjusted operating income (Non-GAAP)
$
489,520

$
(22,273
)
$
467,247

 
$
342,842

$
123,241

$
466,083

(5) Adjusted gross profit is calculated as combined net revenue less adjusted cost of goods sold. See Non-GAAP reconciliations below for calculation of adjusted cost of goods sold.
(6) Adjusted gross margin is calculated as adjusted gross profit divided by combined net revenue.

Full Year 2018 Performance

Generics net revenue of $1,439 million increased 39.2% for the full year 2018, compared to full year 2017. The increase is primarily attributable to the combination with Impax as well as the contribution from 42 new product launches in 2018, including Methylphenidate Hydrochloride extended release tablets, Phytonadione tablets, Levothyroxine tablets, Potassium Chloride oral solution, Erythromycin instant release tablets and Colesevelam Hydrochloride tablets. Generics combined net revenue(4) for full year 2018 was $1,541 million, a decrease of 2.6%, compared to full year 2017. The decrease was primarily driven by lower sales of Epinephrine Auto-Injector due to an ongoing supply disruption, and lower sales of existing base business products, including Budesonide Inhalation Suspension, Lidocaine, Diclofenac Sodium Gel 3% and Loratadine/PSE as a result of lower pricing and additional competition.

Generics gross margin for full year 2018 was 41.4%, compared to 50.9% for full year 2017. The decrease was primarily as a result of higher cost of sales due to incremental amortization, inventory acquisition accounting adjustments, inventory-related charges, manufacturing plant closure charges, impairment of product intangible assets and lower margin products in the Impax portfolio. Generics combined adjusted gross margin(4) for full year 2018 was 46.5%, compared to 48.7% for full year 2017, primarily due to product sales mix.

Generics operating income for full year 2018 was $163 million, compared to $308 million for full year 2017, primarily due to acquisition, integration and transaction-related expenses, principally a result of the combination with Impax, as noted above. Generics combined adjusted operating income(4) for full year 2018 was $467 million, an increase of 0.2%, compared to $466 million for full year 2017.

(4) See “Non-GAAP Financial Measures” below

Page 5 of 26



Amneal Pharmaceuticals, Inc.
Reconciliation of Specialty Operating Income to Specialty Combined Operating Income
(Unaudited; In thousands)
Specialty
Three months ended December 31, 2018
 
Three months ended December 31, 2017
 
 
Add:
(Non-GAAP)

 
 
Add:
(Non-GAAP)

 
Actual
Impax/ Gemini
Combined
 
Actual
Impax/ Gemini
Combined
Net revenue - Specialty:
 
 
 
 
 
 
 
Rytary®
$
42,680

$

$
42,680

 
$

$
28,290

$
28,290

Zomig®
18,308


18,308

 

15,034

15,034

All other specialty products
25,643


25,643

 

37,747

37,747

Total net revenue - Specialty
86,631


86,631

 

81,071

81,071

Cost of goods sold
41,118


41,118

 

23,405

23,405

Gross profit
45,513


45,513

 

57,666

57,666

Selling, general, and administrative
16,200


16,200

 

22,156

22,156

Research and development
3,647


3,647

 

3,077

3,077

Intellectual property legal development expenses
(26
)

(26
)
 



Restructuring and asset-related charges
1,682


1,682

 



Litigation, settlements and related charges



 

1,111

1,111

Fixed asset impairment



 

74,128

74,128

Operating income (loss)
$
24,010

$

$
24,010

 
$

$
(42,806
)
$
(42,806
)
 
 
 
 
 
 
 
 
Gross margin
52.5
%

52.5
%
 

71.1
%
71.1
%
Adjusted gross profit (Non-GAAP)(5)
$
70,058

$

$
70,058

 
$

$
63,368

$
63,368

Adjusted gross margin (Non-GAAP)(6)
80.9
%

80.9
%
 

78.2
%
78.2
%
Adjusted operating income (Non-GAAP)
$
50,600

$

$
50,600

 
$

$
38,995

$
38,995

(5) Adjusted gross profit is calculated as combined net revenue less adjusted cost of goods sold. See Non-GAAP reconciliations below for calculation of adjusted cost of goods sold.
(6) Adjusted gross margin is calculated as adjusted gross profit divided by combined net revenue.

Fourth Quarter 2018 Performance

The Specialty segment is comprised of the Impax Specialty business acquired on May 4, 2018 and the Gemini Laboratories, LLC business acquired on May 7, 2018. Prior to these two transactions, Amneal did not have a Specialty segment.

Specialty combined net revenue(4) in the fourth quarter of 2018 was $87 million, an increase of 6.9%, compared to the prior year period, driven primarily by higher revenue from Rytary®, Zomig® and Unithroid®, partially offset by significantly lower sales of Albenza® as a result of the loss of exclusivity in September of 2018.

Specialty combined gross margin(4) for the fourth quarter of 2018 was 52.5%, compared to 71.1% for the prior year period, driven primarily by higher amortization expense. Specialty combined adjusted gross margin(4) was 80.9% for the fourth quarter of 2018, compared to 78.2% in the prior year period, primarily due to product sales mix.

Specialty combined operating income(4) for the fourth quarter of 2018 was $24 million, an increase of $67 million, compared to a combined operating loss of $43 million for the fourth quarter of 2017, primarily due to fixed asset impairment charges in the fourth quarter of 2017, for which there were no comparable charges in the current year period, and increased revenue, as noted above. Specialty combined adjusted operating income(4) for the fourth quarter of 2018 was $51 million, an increase of $12 million, compared to $39 million for the prior year period, primarily due to increased revenue and lower selling, general and administrative expenses.

(4) See “Non-GAAP Financial Measures” below


Page 6 of 26



Amneal Pharmaceuticals, Inc.
Reconciliation of Specialty Operating Income to Specialty Combined Operating Income
(Unaudited; In thousands)
Specialty
Year ended December 31, 2018
 
Year ended December 31, 2017
 
 
Add:
(Non-GAAP)

 
 
Add:
(Non-GAAP)

 
Actual
Impax/ Gemini
Combined
 
Actual
Impax/ Gemini
Combined
Net revenue - Specialty:
 
 
 
 
 
 
 
Rytary®
$
95,541

$
35,086

$
130,627

 
$

$
91,637

$
91,637

Zomig®
43,111

14,411

57,522

 

51,115

51,115

All other specialty products sales
85,308

46,748

132,056

 

132,297

132,297

Total net revenue - Specialty
223,960

96,245

320,205

 

275,049

275,049

Cost of goods sold
103,592

26,731

130,323

 

98,650

98,650

Gross profit
120,368

69,514

189,882

 

176,399

176,399

Selling, general, and administrative
49,465

27,942

77,407

 

80,185

80,185

Research and development
10,778

3,664

14,442

 

17,662

17,662

Intellectual property legal development expenses
489

23

512

 

3,167

3,167

Restructuring and asset-related charges
4,076


4,076

 



Litigation, settlements and related charges

940

940

 

1,111

1,111

Fixed asset impairment



 

74,128

74,128

Operating income
$
55,560

$
36,945

$
92,505

 
$

$
146

$
146

 
 
 
 
 
 
 
 
Gross margin
53.7
%
72.2
%
59.3
%
 

64.1
%
64.1
%
Adjusted gross profit (Non-GAAP)(5)
$
178,022

$
75,626

$
253,648

 
$

$
200,937

$
200,937

Adjusted gross margin (Non-GAAP)(6)
79.5
%
78.6
%
79.2
%
 

73.1
%
73.1
%
Adjusted operating income (Non-GAAP)
$
118,127

$
43,997

$
162,124


$

$
101,698

$
101,698

(5) Adjusted gross profit is calculated as combined net revenue less adjusted cost of goods sold. See Non-GAAP reconciliations below for calculation of adjusted cost of goods sold.
(6) Adjusted gross margin is calculated as adjusted gross profit divided by combined net revenue.

Full Year 2018 Performance

The Specialty segment is comprised of the Impax Specialty business acquired on May 4, 2018 and the Gemini Laboratories, LLC business acquired on May 7, 2018. Prior to these two transactions, Amneal did not have a Specialty segment.

Specialty combined net revenue(4) for full year 2018 was $320 million, an increase of 16.4%, compared to full year 2017, driven primarily by higher revenue from Rytary, Zomig and Unithroid.

Specialty combined gross margin(4) for full year 2018 was 59.3%, compared to 64.1% for full year 2017, driven primarily by higher amortization expense. Specialty combined adjusted gross margin(4) was 79.2% for full year of 2018, compared to 73.1% for full year 2017, primarily due to product sales mix.

Specialty combined operating income(4) for full year 2018 was $93 million compared to $146 thousand of operating income for full year 2017, primarily due to fixed asset impairment charges in 2017, for which there were no comparable charges in 2018. Specialty combined adjusted operating income(4) for full year 2018 was $162 million, an increase of $60 million, compared to $102 million for full year 2017, primarily due to increased revenue and lower selling, general and administrative expenses.

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



Page 7 of 26



2019 Financial Outlook

Amneal’s full year 2019 estimates are based on management's current expectations, including with respect to prescription trends, pricing levels, inventory levels, 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, asset impairments and certain 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 2019.

2019 Key Outlook Assumptions

 
Full Year 2019 Financial Outlook
Adjusted gross margin
47% - 50%
Adjusted R&D as a % of net revenue
9% - 10%
Adjusted SG&A as a % of net revenue
11% - 12%
Adjusted EBITDA
$600 million - $650 million
Adjusted diluted EPS
$0.94 - $1.04
Adjusted effective tax rate
19% - 21%
Capital expenditures
Approximately $100 million
Weighted diluted shares outstanding
Approximately 300 million

Conference Call Information

Amneal will hold a conference call on February 28, 2019 at 8:30 a.m. Eastern Time to discuss its results. The call and presentation can also be accessed via a live Webcast through the Investor Relations section of Amneal’s Web site at
https://investors.amneal.com/investor-relations, or directly at https://event.on24.com/wcc/r/1898588/19E7D09970ECDA91F9B21D94F3CEC0AB. The number to call from within the United States is (866) 652-5200 and (412) 317-6060 internationally. A replay of the conference call will be available shortly after the call for a period of seven days. To access the replay, dial (877) 344-7529 (in the U.S.) and (412) 317-0088 (international callers). The access code for the replay is 10128077.

About Amneal

Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is an integrated pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products. The Company has approximately 6,000 employees in its operations in North America, Asia, and Europe, working together to bring high-quality medicines to patients primarily within the United States.

Amneal is one of the largest and fastest growing generic pharmaceutical manufacturers in the United States, with an expanding portfolio of generic products to include complex dosage forms in a broad range of therapeutic areas. The Company also markets a portfolio of branded pharmaceutical products through its Specialty division focused principally on central nervous system disorders and parasitic infections. For more information, visit www.amneal.com.

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 and adjusted operating income, are intended as supplemental measures of the Company’s performance that are not required by or presented in accordance with GAAP. In addition, this release includes these non-GAAP measures and our reported results on a non-GAAP combined basis to include the results of Impax and Gemini as if the transaction closing dates had occurred on the first day of all periods presented herein. Management uses these non-GAAP historical and combined 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 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

Page 8 of 26



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, and doing so on a combined basis 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.

All combined business results presented in this release are not prepared in accordance with Article 11 of Regulation S-X. Adjusted gross profit is calculated as total revenues less adjusted cost of goods sold. Adjusted gross margin is calculated as adjusted gross profit divided by total revenues. 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.

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, the combined results may not represent what our combined results of operations and financial position would have been had the transactions occurred on the dates indicated, nor are they intended to project our combined 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 or any other measure determined in accordance with GAAP. Readers should review the reconciliations of below, and should not rely on any single financial measure to evaluate the Company’s business.

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

Safe Harbor Statement

Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the 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, future operating results and financial performance, product development and launches, integration strategies and resulting cost reduction, market position and business strategy. Words such as “may,” “will,” “could,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “assume,” “continue,” 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 Amneal Pharmaceuticals, Inc. (the “Company”). Such risks and uncertainties include, but are not limited to: the impact of global economic conditions; our ability to integrate the operations of Amneal Pharmaceuticals LLC and Impax Laboratories, LLC pursuant to the business combination completed on May 4, 2018, and our ability to realize the anticipated synergies and other benefits of the combination; our ability to successfully develop and commercialize new products; our ability to obtain exclusive marketing rights for our products and to introduce 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 manage our growth; 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 United States 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 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

Page 9 of 26



rate fluctuations on such indebtedness; the high concentration of ownership of our Class A Common Stock and the fact that we are controlled by a group of stockholders. A further list and descriptions of these risks, uncertainties and other factors can be found in the Company’s most recently filed Quarterly Report on Form 10-Q and in the Company’s subsequent filings with the Securities and Exchange Commission, including its Annual Report on 10-K for the fiscal year ended December 31, 2018 expected to be filed on or about March 1, 2019. Copies of these filings are available online at www.sec.gov, www.amneal.com or on request from the Company.

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.

Trademarks referenced herein are the property of their respective owner.
# # #

Page 10 of 26



Amneal Pharmaceuticals, Inc.
Consolidated Statements of Operations
(In thousands, except per share amounts)

 
(unaudited)
 
 
 
 
 
Three months ended
 
Years ended
 
December 31, 2018
 
December 31, 2017
 
December 31, 2018
 
December 31, 2017
Net revenue
$
497,528

 
$
293,369

 
$
1,662,991

 
$
1,033,654

Cost of goods sold
304,120

 
141,953

 
946,588

 
507,476

Gross profit
193,408

 
151,416

 
716,403

 
526,178

Selling, general and administrative
71,236

 
26,966

 
230,435

 
109,046

Research and development
57,297

 
43,494

 
194,190

 
171,420

In-process research and development impairment charges
38,609

 

 
39,259

 

Acquisition, transaction-related and integration expenses
4,945

 
7,050

 
221,818

 
9,403

Restructuring and asset-related charges
14,104

 

 
56,413

 

Legal settlement gains
(19,300
)
 
(7,845
)
 
(22,300
)
 
(29,312
)
Intellectual property legal development expenses
3,237

 
2,732

 
16,261

 
20,518

Operating income (loss)
23,280

 
79,019

 
(19,673
)
 
245,103

Other (expense) income:
 
 
 
 
 
 
 
   Interest expense, net
(42,880
)
 
(19,956
)
 
(143,571
)
 
(71,061
)
   Foreign exchange gain (loss)
2,817

 
3,341

 
(19,701
)
 
29,092

   Loss on extinguishment of debt

 
(1
)
 
(19,667
)
 
(2,532
)
   Loss on sale of international operations
(146
)
 
(352
)
 
(2,958
)
 
(29,232
)
   Other income (expense)
2,123

 
24

 
2,848

 
(47
)
Total other expense, net
(38,086
)
 
(16,944
)
 
(183,049
)
 
(73,780
)
(Loss) income before income taxes
(14,806
)
 
62,075

 
(202,722
)
 
171,323

Provision for (benefit from) income taxes
5,524

 
(119
)
 
(1,419
)
 
1,998

Net (loss) income
(20,330
)
 
62,194

 
(201,303
)
 
169,325

Less: Net (income) loss attributable to Amneal Pharmaceuticals LLC pre-Combination

 
(61,569
)
 
148,806

 
(167,648
)
Less: Net loss (income) attributable to non-controlling interests
11,562

 
(625
)
 
32,753

 
(1,677
)
Net loss attributable to Amneal Pharmaceuticals, Inc. before accretion of redeemable non-controlling interest
(8,768
)
 

 
(19,744
)
 

Accretion of redeemable non-controlling interest

 

 
(1,176
)
 

Net loss attributable to Amneal Pharmaceuticals, Inc.
$
(8,768
)
 
$

 
$
(20,920
)
 
$

 
 
 
 
 
 
 
 
Net loss per share attributable to Amneal Pharmaceuticals, Inc.'s common stockholders:
 
 
 
 
 
 
 
     Class A and Class B-1 basic and diluted
$
(0.07
)
 
 
 
$
(0.16
)
 
 
 
 
 
 
 
 
 
 
Weighted-average common shares outstanding:
 
 
 
 
 
 
 
     Class A and Class B-1 basic and diluted
127,343

 
 
 
127,252

 
 



Page 11 of 26



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

 
December 31, 2018
 
December 31, 2017
Assets
 
 
 
Current assets:
 
 
 
Cash and cash equivalents
$
213,394

 
$
74,166

Restricted cash
5,385

 
3,756

Trade accounts receivable, net
481,495

 
351,367

Inventories
457,219

 
284,038

Prepaid expenses and other current assets
128,321

 
42,396

Related party receivables
830

 
16,210

Total current assets
1,286,644

 
771,933

Property, plant and equipment, net
544,146

 
486,758

Goodwill
426,226

 
26,444

Intangible assets, net
1,654,969

 
44,599

Deferred tax asset, net
373,159

 
898

Other assets
67,592

 
11,257

Total assets
$
4,352,736

 
$
1,341,889

 
 
 
 
Liabilities and Stockholders' Equity / Members' Deficit
 
 
 
Current liabilities:
 
 
 
Accounts payable and accrued expenses
$
514,440

 
$
194,779

Current portion of long-term debt, net
21,449

 
89,171

Current portion of financing obligations - related party
266

 
311

Related party payables
17,695

 
12,622

Total current liabilities
553,850

 
296,883

Long-term debt, net
2,630,598

 
1,355,274

Financing obligation - related party
39,083

 
39,987

Deferred income taxes
1,178

 
2,491

Liabilities under tax receivable agreement
192,884

 

Other long-term liabilities
38,780

 
7,793

Related party payable- long term

 
15,043

Total long-term liabilities
2,902,523

 
1,420,588

Total stockholders' equity / members' deficit
896,363

 
(375,582)

Total liabilities and stockholders' / members’ deficit
$
4,352,736

 
$
1,341,889



Page 12 of 26



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

 
Years Ended December 31,
 
2018
 
2017
Cash flows from operating activities:
 
 
 
Net (loss) income
$
(201,303
)
 
$
169,325

Adjustments to reconcile net (loss) income to net cash provided by operating activities:
 
 
 
Depreciation and amortization
137,403

 
45,936

Unrealized foreign currency loss (gain)
18,582

 
(30,823
)
Amortization of debt issuance costs
5,859

 
4,585

Loss on extinguishment of debt
19,667

 
2,532

Loss on sale of certain international businesses
2,958

 
29,232

Intangible asset impairment charges
47,928

 

Non-cash restructuring and asset-related charges
11,295

 

Deferred tax (benefit) provision
(9,439)

 
742

Stock-based compensation and PPU expense
167,597

 

Inventory provision
44,539

 
3,771

Other operating charges and credits, net
(1,866)

 
9,935

Changes in assets and liabilities:
 
 
 
Trade accounts receivable, net
89,084

 
35,255

Inventories
(42,875)

 
(31,826
)
Prepaid expenses, other current assets and other assets
19,198

 
(25,305
)
Related party receivables
10,928

 
(5,485
)
Accounts payable, accrued expenses and other liabilities
(55,212)

 
18,105

Related party payables
(14,113)

 
8,208

Net cash provided by operating activities
250,230

 
234,187

Cash flows from investing activities:
 
 
 
Purchases of property, plant and equipment
(83,088)

 
(94,771)

Acquisition of product rights and licenses
(14,000)

 
(19,500
)
Acquisitions, net of cash acquired
(324,634)

 

Proceeds from sale of property, plant and equipment
25,344

 

Proceeds from sale of certain international businesses, net of cash sold

 
15,717

Net cash used in investing activities
(396,378)

 
(98,554)

Cash flows from financing activities:
 
 
 
Payments of deferred financing costs and debt extinguishment costs
(54,955)

 
(5,026)

Proceeds from issuance of debt
1,325,383

 
250,000

Payments of principal on debt and capital leases
(617,051
)
 
(13,625
)
Net (payments) borrowings on revolving credit line
(75,000)

 
50,000

Payments of principal on financing obligation - related party
(243)

 
(274
)
Proceeds from exercise of stock options
3,797

 

Equity contributions
27,742

 
40

Capital contribution from (dividend to) non-controlling interest
360

 
(865
)
Acquisition of redeemable non-controlling interest
(11,775)

 

Tax distribution to non-controlling interest
(35,543)

 

Distributions to members
(182,998)

 
(375,265)

Repayment of related party note
(92,042)

 

Net cash provided by (used in) financing activities
287,675

 
(95,015)

Effect of foreign exchange rate on cash
(670)

 
(242)

Net increase in cash, cash equivalents, and restricted cash
140,857

 
40,376

Cash, cash equivalents, and restricted cash - beginning of period
77,922

 
37,546

Cash, cash equivalents, and restricted cash - end of period
$
218,779

 
$
77,922


Page 13 of 26



Amneal Pharmaceuticals, Inc.
Reconciliation of Non-GAAP Combined Results of Operations
(Unaudited: In thousands)

 
Three months ended December 31, 2018
 
Three months ended December 31, 2017
 
 
Add:
(Non-GAAP)
 
 
Add:
(Non-GAAP)
 
Actual
Impax/ Gemini
Combined
 
Actual
Impax/ Gemini
Combined
Net revenue:
 
 
 
 
 
 
 
Generics
$
410,897

$

$
410,897

 
$
293,369

$
112,943

$
406,312

Specialty
86,631


86,631

 

81,071

81,071

Total net revenue
497,528


497,528

 
293,369

194,014

487,383

Cost of goods sold
304,120


304,120

 
141,953

174,167

316,120

Gross profit
193,408


193,408

 
151,416

19,847

171,263

Selling, general and administrative
71,236


71,236

 
26,966

59,441

86,407

Research and development
57,297


57,297

 
43,494

15,689

59,183

In-process research and development impairment charges
38,609


38,609

 

186,731

186,731

Acquisition, transaction-related and integration expenses
4,945


4,945

 
7,050

8,061

15,111

Restructuring and asset-related charges
14,104


14,104

 



Legal settlement gains
(19,300
)
 
(19,300
)
 
(7,845
)

(7,845
)
Intellectual property legal development expenses
3,237


3,237

 
2,732


2,732

Litigation, settlements and related charges



 

1,223

1,223

Impairment loss on tangible assets



 

79,705

79,705

Gain on sale of assets



 

(656
)
(656
)
Change in fair value of contingent consideration



 

(38,123
)
(38,123
)
Operating income (loss)
23,280


23,280

 
79,019

(292,224
)
(213,205
)
Other (expense) income:
 
 
 
 
 
 
 
Interest expense, net
(42,880)


(42,880
)
 
(19,956)

(13,672)

(33,628
)
Foreign exchange gain
2,817


2,817

 
3,341


3,341

Loss on extinguishment of debt



 
(1
)

(1
)
Loss on sale of international operations
(146
)

(146
)
 
(352
)

(352
)
Other income (expense)
2,123


2,123

 
24

(292)

(268
)
Total other (expense) income, net
(38,086
)

(38,086
)
 
(16,944
)
(13,964
)
(30,908
)
(Loss) income before income taxes
(14,806
)

(14,806
)
 
62,075

(306,188
)
(244,113
)
Provision for (benefit from) income taxes
5,524


5,524

 
(119
)
(9,010
)
(9,129
)
Net (loss) income
$
(20,330
)
$

$
(20,330
)
 
$
62,194

$
(297,178
)
$
(234,984
)
Less: Net income attributable to Amneal Pharmaceuticals LLC pre-Combination

 
 
 
(61,569)

 
 
Less: Net loss (income) attributable to non-controlling interests
11,562

 
 
 
(625)

 
 
Net loss attributable to Amneal Pharmaceuticals, Inc.
$
(8,768
)
 
 
 
$

 
 

Page 14 of 26



Amneal Pharmaceuticals, Inc.
Reconciliation of Non-GAAP Combined Results of Operations
(Unaudited; In thousands)

 
Year ended December 31, 2018
 
Year ended December 31, 2017
 
 
Add:
(Non-GAAP)

 
 
Add:
(Non-GAAP)

 
Actual
Impax/ Gemini

Combined
 
Actual
Impax/ Gemini

Combined
Net revenue:
 
 
 
 
 
 
 
Generics
$
1,439,031

$
102,237

$
1,541,268

 
$
1,033,654

$
549,077

$
1,582,731

Specialty
223,960

96,245

320,205

 

275,049

275,049

Total net revenue
1,662,991

198,482

1,861,473

 
1,033,654

824,126

1,857,780

Cost of goods sold
946,588

149,492

1,096,080

 
507,476

650,426

1,157,902

Gross profit
716,403

48,990

765,393

 
526,178

173,700

699,878

Selling, general and administrative
230,435

80,242

310,677

 
109,046

217,410

326,456

Research and development
194,190

17,287

211,477

 
171,420

80,907

252,327

In-process research and development impairment charges
39,259


39,259

 

192,809

192,809

Acquisition, transaction-related and integration expenses
221,818

4,381

226,199

 
9,403

11,097

20,500

Restructuring and asset-related charges
56,413


56,413

 



Legal settlement gains
(22,300
)

(22,300
)
 
(29,312
)

(29,312
)
Intellectual property legal development expenses
16,261

23

16,284

 
20,518

3,882

24,400

Litigation, settlements and related charges

85,537

85,537

 

1,223

1,223

Impairment loss on tangible assets



 

82,508

82,508

Gain on sale of assets



 

(17,236
)
(17,236
)
Change in fair value of contingent consideration



 

(31,048
)
(31,048
)
Operating (loss) income
(19,673)

(138,480)

(158,153)

 
245,103

(367,852)

(122,749)

Other (expense) income:
 
 
 
 
 
 
 
   Interest expense, net
(143,571)

(18,231
)
(161,802
)
 
(71,061)

(53,412
)
(124,473
)
   Foreign exchange (loss) gain
(19,701)

921

(18,780
)
 
29,092


29,092

   Loss on extinguishment of debt
(19,667)


(19,667
)
 
(2,532)

(1,215
)
(3,747
)
Loss on sale of international operations
(2,958
)

(2,958
)
 
(29,232
)

(29,232
)
   Other income (expense)
2,848

(638
)
2,210

 
(47
)
(10,878
)
(10,925
)
Total other (expense) income, net
(183,049)

(17,948)

(200,997)

 
(73,780)

(65,505)

(139,285)

(Loss) income before income taxes
(202,722)

(156,428)

(359,150)

 
171,323

(433,357)

(262,034)

(Benefit from) provision for income taxes
(1,419
)
(6,273)

(7,692)

 
1,998

18,326

20,324

Net (loss) income
$
(201,303
)
$
(150,155
)
$
(351,458
)
 
$
169,325

$
(451,683
)
$
(282,358
)
Less: Net loss (income) attributable to Amneal Pharmaceuticals LLC pre-Combination
148,806

 
 
 
(167,648
)
 
 
Less: Net loss (income) attributable to non-controlling interests
32,753

 
 
 
(1,677
)
 
 
Accretion of redeemable non-controlling interest
(1,176)

 
 
 

 
 
Net loss attributable to Amneal Pharmaceuticals, Inc.
$
(20,920
)
 
 
 
$

 
 

Page 15 of 26



Amneal Pharmaceuticals, Inc.
Reconciliation of Non-GAAP Combined Results of Operations
(Unaudited; In thousands)


The following reconciliation for the three months ended September 30, 2018 has been provided for sequential comparison.
 
Three months ended September 30, 2018
 
 
Add:
(Non-GAAP)

 
Actual
Impax/ Gemini

Combined
Net revenue:
 
 
 
Generics
$
391,175

$

$
391,175

Specialty
85,312


85,312

Total net revenue
476,487


476,487

Cost of goods sold
276,382


276,382

Gross profit
200,105


200,105

Selling, general and administrative
78,075


78,075

Research and development
42,999


42,999

In-process research and development impairment charges
4,401


4,401

Acquisition, transaction-related and integration expenses
2,231


2,231

Restructuring and asset-related charges
(2,156)


(2,156
)
Operating income
74,555


74,555

Other expense:
 
 
 
   Interest expense, net
(43,018)


(43,018
)
   Foreign exchange loss
(5,137)


(5,137
)
Loss on sale of international operations
(2,812)


(2,812
)
   Other expense
(1,014)


(1,014
)
Total other expense, net
(51,981)


(51,981)

Income before income taxes
22,574


22,574

Provision for income taxes
5,109

 
5,109

Net income
$
17,465

$

$
17,465

Less: Net income attributable to Amneal Pharmaceuticals LLC pre-Combination

 
 
Less: Net income attributable to non-controlling interests
(10,577)

 
 
Accretion of redeemable non-controlling interest
64

 
 
Net income attributable to Amneal Pharmaceuticals, Inc.
$
6,952

 
 




















Page 16 of 26



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

Reconciliation of Generics Cost of Goods Sold to Generics Combined Adjusted Cost of Goods Sold

Generics
Three months ended December 31, 2018
 
Three months ended December 31, 2017
 
 
Add:
(Non-GAAP)

 
 
Add:
(Non-GAAP)

 
Actual
Impax/ Gemini
Combined
 
Actual
Impax/ Gemini
Combined
Cost of goods sold
$
263,002

$

$
263,002

 
$
141,953

$
150,762

$
292,715

Adjusted to deduct:
 
 
 
 
 
 
 
Amortization
10,030


10,030

 
923

13,075

13,998

Inventory related charges(7)
3,620


3,620

 
3,400

6,224

9,624

Acquisition and site closure expenses(8)
12,384


12,384

 



Asset impairment charges(9)
510


510

 

43,961

43,961

Stock-based compensation expense
406


406

 



Restructuring and asset-related charges(10) 



 

9,960

9,960

Amortization of upfront payment(11)
10,423


10,423

 



Adjusted cost of goods sold (Non-GAAP)
$
225,629

$

$
225,629

 
$
137,630

$
77,542

$
215,172




Generics
Year ended December 31, 2018
 
Year ended December 31, 2017
 
 
Add:
(Non-GAAP)

 
 
Add:
(Non-GAAP)

 
Actual
Impax/ Gemini
Combined
 
Actual
Impax/ Gemini
Combined
Cost of goods sold
$
842,996

$
122,761

$
965,757

 
$
507,476

$
551,776

$
1,059,252

Adjusted to deduct:
 
 
 
 
 
 
 
Amortization
23,940

13,823

37,763

 
3,974

53,039

57,013

Inventory related charges(7)
45,615

9,894

55,509

 
22,682

25,740

48,422

Acquisition and site closure expenses(8)
27,619


27,619

 

9,314

9,314

Asset impairment charges(9)
8,401

53

8,454

 

96,864

96,864

Stock-based compensation expense
921


921

 



Restructuring and asset-related charges(10) 



 

26,702

26,702

Amortization of upfront payment(11)
10,423


10,423

 



Royalty expense



 
8,684


8,684

Adjusted cost of goods sold (Non-GAAP)
$
726,077

$
98,991

$
825,068

 
$
472,136

$
340,117

$
812,253














Page 17 of 26



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

Reconciliation of Specialty Cost of Goods Sold to Specialty Combined Adjusted Cost of Goods Sold

Specialty
Three months ended December 31, 2018
 
Three months ended December 31, 2017
 
 
Add:
(Non-GAAP)

 
 
Add:
(Non-GAAP)

 
Actual
Impax/ Gemini
Combined
 
Actual
Impax/ Gemini
Combined
Cost of goods sold
$
41,118

$

$
41,118

 
$

$
23,405

$
23,405

Adjusted to deduct:
 
 
 
 
 
 
 
Amortization
18,848


18,848

 

3,884

3,884

Inventory related charges(7)
5,697


5,697

 



Restructuring and asset-related charges(10) 



 

1,818

1,818

Adjusted cost of goods sold (Non-GAAP)
$
16,573

$

$
16,573

 
$

$
17,703

$
17,703




Specialty
Year ended December 31, 2018
 
Year ended December 31, 2017
 
 
Add:
(Non-GAAP)

 
 
Add:
(Non-GAAP)

 
Actual
Impax/ Gemini
Combined
 
Actual
Impax/ Gemini
Combined
Cost of goods sold
$
103,592

$
26,731

$
130,323

 
$

$
98,650

$
98,650

Adjusted to deduct:
 
 
 
 
 
 
 
Amortization
49,047

6,112

55,159

 

15,457

15,457

Inventory related charges(7)
8,607


8,607

 



Restructuring and asset-related charges(10) 



 

9,081

9,081

Adjusted cost of goods sold (Non-GAAP)
$
45,938

$
20,619

$
66,557

 
$

$
74,112

$
74,112
























Page 18 of 26




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

Reconciliation of Generics Operating (Loss) Income to Generics Combined Adjusted Operating Income

Generics
Three months ended December 31, 2018
 
Three months ended December 31, 2017
 
 
Add:
(Non-GAAP)

 
 
Add:
(Non-GAAP)

 
Actual
Impax/ Gemini
Combined
 
Actual
Impax/ Gemini
Combined
Operating income (loss)
$
43,070

$

$
43,070

 
$
101,825

$
(212,839
)
$
(111,014
)
Adjusted to add (deduct):
 
 
 
 
 
 
 
Acquisition and site closure expenses(8)
20,905


20,905

 



Amortization
10,030


10,030

 
923

13,075

13,998

Inventory related charges(7)
3,620


3,620

 
3,400

6,224

9,624

Stock-based compensation expense
1,926


1,926

 

829

829

Asset impairment charges(9)
39,119

 
39,119

 

236,269

236,269

Restructuring and asset-related charges(10) 
12,031


12,031

 

10,996

10,996

Litigation, settlements and related charges
(97
)

(97
)
 



Amortization of upfront payment (11)
10,423


10,423

 



R&D milestone payment
5,300


5,300

 



Change in fair value of contingent consideration(12)



 

(38,123
)
(38,123
)
Other
3,839


3,839

 



Adjusted operating income (Non-GAAP)
$
150,166

$

$
150,166

 
$
106,148

$
16,431

$
122,579

Generics
Year ended December 31, 2018
 
Year ended December 31, 2017
 
 
Add:
(Non-GAAP)

 
 
Add:
(Non-GAAP)

 
Actual
Impax/ Gemini
Combined
 
Actual
Impax/ Gemini
Combined
Operating income
$
162,901

$
(130,640
)
$
32,261

 
$
307,502

$
(265,094
)
$
42,408

Adjusted to add (deduct):
 
 
 
 
 
 
 
Acquisition and site closure expenses(8)
150,348


150,348

 

9,314

9,314

Amortization
23,940

13,823

37,763

 
3,974

53,039

57,013

Inventory related charges(7)
45,615

9,894

55,509

 
22,682

26,702

49,384

Stock-based compensation expense
3,348


3,348

 

829

829

Asset impairment charges(9)
47,660

53

47,713

 

298,053

298,053

Restructuring and asset-related charges(10) 
33,943


33,943

 

28,911

28,911

Litigation, settlements and related charges
(97
)
84,597

84,500

 



Amortization of upfront payment (11)
10,423


10,423

 



Royalty expense



 
8,684


8,684

R&D milestone payment
8,000


8,000

 



Change in fair value of contingent consideration(12)



 

(31,048
)
(31,048
)
Other
3,439


3,439

 

2,535

2,535

Adjusted operating income (Non-GAAP)
$
489,520

$
(22,273
)
$
467,247


$
342,842

$
123,241

$
466,083


Page 19 of 26



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

Reconciliation of Specialty Operating (Loss) Income to Specialty Combined Adjusted Operating Income

Specialty
Three months ended December 31, 2018
 
Three months ended December 31, 2017
 
 
Add:
(Non-GAAP)

 
 
Add:
(Non-GAAP)

 
Actual
Impax/ Gemini
Combined
 
Actual
Impax/ Gemini
Combined
Operating income (loss)
$
24,010

$

$
24,010

 
$

$
(42,806
)
$
(42,806
)
Adjusted to add:
 
 
 
 
 
 
 
Amortization
18,848


18,848

 

3,884

3,884

Inventory related charges(7)
5,697


5,697

 



Acquisition and site closure expenses(8)
189


189

 



Stock-based compensation expense
11


11

 

1,971

1,971

Asset impairment charges(9)



 

74,128

74,128

Restructuring and asset-related charges(10) 
1,682


1,682

 

1,818

1,818

Litigation, settlements and related charges



 



Other
163


163

 



Adjusted operating income (Non-GAAP)
$
50,600

$

$
50,600

 
$

$
38,995

$
38,995




Specialty
Year ended December 31, 2018
 
Year ended December 31, 2017
 
 
Add:
(Non-GAAP)

 
 
Add:
(Non-GAAP)

 
Actual
Impax/ Gemini
Combined
 
Actual
Impax/ Gemini
Combined
Operating income
$
55,560

$
36,945

$
92,505

 
$

$
146

$
146

Adjusted to add:
 
 
 
 
 
 
 
Amortization
49,047

6,112

55,159

 

15,457

15,457

Inventory related charges(7)
8,607


8,607

 



Acquisition and site closure expenses(8)
189


189

 



Stock-based compensation expense
11


11

 

1,971

1,971

Asset impairment charges(9)



 

74,128

74,128

Restructuring and asset-related charges(10) 
4,076


4,076

 

9,996

9,996

Litigation, settlements and related charges

940

940

 



Other
637


637

 



Adjusted operating income (Non-GAAP)
$
118,127

$
43,997

$
162,124


$

$
101,698

$
101,698










Page 20 of 26



Amneal Pharmaceuticals, Inc.
Non-GAAP Reconciliations
(Unaudited; In thousands, except per share amounts)

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

 
Three months ended December 31, 2018
 
Three months ended December 31, 2017
 
 
Add:
(Non-GAAP)

 
 
Add:
(Non-GAAP)

 
Actual
Impax/ Gemini
Combined
 
Actual
Impax/ Gemini
Combined
Net (loss) income
$
(20,330
)
$

$
(20,330
)
 
$
62,194

$
(297,178
)
$
(234,984
)
Adjusted to add (deduct):
 
 
 
 
 
 
 
Non-cash interest
1,640


1,640

 
690

6,660

7,350

GAAP Income tax expense (benefit)
5,524


5,524

 
(119
)
(9,010
)
(9,129
)
Amortization
28,878


28,878

 
923

16,959

17,882

Stock-based compensation expense
3,606


3,606

 

6,586

6,586

Acquisition and site closure expenses(8)
28,966


28,966

 
7,050

8,061

15,111

Restructuring and asset-related charges(10) 
14,104


14,104

 
245

13,483

13,728

Inventory related charges(7)
9,317


9,317

 
3,400

6,224

9,624

Litigation, settlements and related charges
(497
)

(497
)
 

642

642

Gain on sale of assets



 

(656
)
(656
)
Asset impairment charges(9)
39,119


39,119

 

310,397

310,397

Amortization of upfront payment(11)
10,423


10,423

 



Foreign exchange gain
(2,817
)

(2,817
)
 
(3,341
)

(3,341
)
Loss on sale of international operations
146


146

 
352


352

R&D milestone payments
5,300


5,300

 



Change in fair value of contingent consideration(12)



 

(38,123
)
(38,123
)
Other
3,412


3,412

 

1,328

1,328

Income tax at 21%
(26,626
)

(26,626
)
 
(14,993
)
(5,328
)
(20,321
)
Net income attributable to NCI not associated with our Class B shares


(189
)

(189
)
 



Adjusted net income (Non-GAAP)
$
99,976

$

$
99,976

 
$
56,401

$
20,045

$
76,446

 
 
 
 
 
 
 
 
Adjusted diluted EPS (Non-GAAP(13)
 
 
$
0.33

 
 
 
 

(13) Utilizes weighted diluted average shares outstanding of 299,345, which consists of Class A, Class B & Class B-1 shares.


Page 21 of 26



Amneal Pharmaceuticals, Inc.
Non-GAAP Reconciliations
(Unaudited; In thousands, except per share amounts)

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

 
Year ended December 31, 2018
 
Year ended December 31, 2017
 
 
Add:
(Non-GAAP)

 
 
Add:
(Non-GAAP)

 
Actual
Impax/ Gemini
Combined
 
Actual
Impax/ Gemini
Combined
Net (loss) income
$
(201,303
)
$
(150,155
)
$
(351,458
)
 
$
169,325

$
(451,693
)
$
(282,368
)
Adjusted to add (deduct):
 
 
 
 
 
 
 
Non-cash interest
5,859

9,413

15,272

 
4,585

25,949

30,534

GAAP Income tax (benefit) expense
(1,419
)
(6,273
)
(7,692
)
 
1,998

18,326

20,324

Amortization
72,987

19,935

92,922

 
3,974

68,496

72,470

Stock-based compensation expense
8,840

4,816

13,656

 

26,258

26,258

Acquisition and site closure expenses(8)
264,424

9,829

274,253

 
9,403

20,411

29,814

Restructuring and asset-related charges(10) 
56,413

5,123

61,536

 
245

40,248

40,493

Loss on extinguishment of debt
19,667


19,667

 
2,531

1,215

3,746

Inventory related charges(7)
54,222

9,894

64,116

 
22,682

26,702

49,384

Litigation, settlements and related charges
2,092

90,099

92,191

 

8,351

8,351

Loss (gain) on sale of assets
878


878

 

(17,236
)
(17,236
)
Asset impairment charges(9)
47,660

53

47,713

 

372,181

372,181

Amortization of upfront payment(11)
10,423


10,423

 



Royalty expense



 
8,684


8,684

Foreign exchange loss (gain)
19,701

(921
)
18,780

 
(29,092
)

(29,092
)
Loss on sale of international operations
2,958


2,958

 
29,232


29,232

R&D milestone payments
8,000


8,000

 



Change in fair value of contingent consideration(12)



 

(31,048
)
(31,048
)
Other
7,095

1,953

9,048

 
4,158

6,534

10,692

Income tax at 21%
(79,484
)
1,309

(78,175
)
 
(47,822
)
(24,086
)
(71,908
)
Net income attributable to NCI not associated with our Class B shares


(386
)

(386
)
 



Adjusted net income (Non-GAAP)
$
298,627

$
(4,925
)
$
293,702

 
$
179,903

$
90,608

$
270,511

 
 
 
 
 
 
 
 
Adjusted diluted EPS (Non-GAAP(14)
 
 
$
0.98

 
 
 
 

(14) Utilizes weighted diluted average shares outstanding of 299,328, which consists of Class A, Class B & Class B-1 shares.


Page 22 of 26



Amneal Pharmaceuticals, Inc.
Non-GAAP Reconciliations
(Unaudited; In thousands, except per share amounts)

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

The following reconciliation for the three months ended September 30, 2018 has been provided for sequential comparison.

 
Three months ended September 30, 2018
 
 
Add:
(Non-GAAP)

 
Actual
Impax/ Gemini
Combined
Net income
$
17,465

$

$
17,465

Adjusted to add (deduct):
 
 
 
Non-cash interest
1,452


1,452

GAAP Income tax expense
5,109


5,109

Amortization
25,655


25,655

Stock-based compensation expense
3,590


3,590

Acquisition and site closure expenses(8)
12,430


12,430

Restructuring and asset-related charges(10) 
(2,156
)

(2,156
)
Inventory related charges(7)
17,422


17,422

Litigation, settlements and related charges
2,589


2,589

Asset impairment charges(9)
8,541


8,541

Foreign exchange loss
5,137


5,137

Loss on sale of international operations
2,812


2,812

Other
3,947


3,947

Income tax at 21%
(21,839
)

(21,839
)
Net income attributable to NCI not associated with our Class B shares
(53
)

(53
)
Adjusted net income (Non-GAAP)
$
82,101

$

$
82,101

 
 
 
 
Adjusted diluted EPS (Non-GAAP)(15)
 
 
$
0.27


(15) Utilizes weighted diluted average shares outstanding of 299,483, which consists of Class A, Class B & Class B-1 shares.
























Page 23 of 26






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

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

 
Three months ended December 31, 2018
 
Three months ended December 31, 2017
 
 
Add:
(Non-GAAP)

 
 
Add:
(Non-GAAP)

 
Actual
Impax/ Gemini
Combined
 
Actual
Impax/ Gemini
Combined
Net (loss) income
$
(20,330
)
$

$
(20,330
)
 
$
62,194

$
(297,178
)
$
(234,984
)
Adjusted to add (deduct):
 
 
 
 
 
 
 
Interest expense, net
42,880


42,880

 
19,956

13,672

33,628

Income tax expense (benefit)
5,524


5,524

 
(119
)
(9,010
)
(9,129
)
Depreciation and amortization
47,494


47,494

 
12,842

21,620

34,462

EBITDA (Non-GAAP)
$
75,568

$

$
75,568

 
$
94,873

$
(270,896
)
$
(176,023
)
 
 
 
 
 
 
 
 
Adjusted to add (deduct):
 
 
 
 
 
 
 
Stock-based compensation expense
$
3,606

$

$
3,606

 
$

$
6,586

$
6,586

Acquisition and site closure expenses(8)
28,966


28,966

 
7,050

8,061

15,111

Restructuring and asset-related charges(10) 
14,104


14,104

 
245

13,483

13,728

Inventory related charges(7)
9,317


9,317

 
3,400

6,224

9,624

Litigation, settlements and related charges
(497
)

(497
)
 

642

642

Gain on sale of assets



 

(656
)
(656
)
Asset impairment charges(9)
39,119


39,119

 

310,397

310,397

Amortization of upfront payment(11)
10,423


10,423

 



Foreign exchange gain
(2,817
)

(2,817
)
 
(3,341
)

(3,341
)
Loss on sale of international operations
146


146

 
352


352

R&D milestone payments
5,300


5,300

 



Change in fair value of contingent consideration(12)



 

(38,123
)
(38,123
)
Other
3,412


3,412

 

1,328

1,328

Adjusted EBITDA (Non-GAAP)
$
186,647

$

$
186,647

 
$
102,579

$
37,046

$
139,625



















Page 24 of 26



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

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

 
Year ended December 31, 2018
 
Year ended December 31, 2017
 
 
Add:
(Non-GAAP)

 
 
Add:
(Non-GAAP)

 
Actual
Impax/ Gemini
Combined
 
Actual
Impax/ Gemini
Combined
Net (loss) income
$
(201,303
)
$
(150,155
)
$
(351,458
)
 
$
169,325

$
(451,693
)
$
(282,368
)
Adjusted to add (deduct):
 
 
 
 
 
 
 
Interest expense, net
143,571

18,231

161,802

 
71,061

53,412

124,473

Income tax expense (benefit)
(1,419
)
(6,273
)
(7,692
)
 
1,998

18,326

20,324

Depreciation and amortization
137,403

24,902

162,305

 
45,936

93,854

139,790

EBITDA (Non-GAAP)
$
78,252

$
(113,295
)
$
(35,043
)
 
$
288,320

$
(286,101
)
$
2,219

 
 
 
 
 
 
 
 
Adjusted to add (deduct):
 
 
 
 
 
 
 
Stock-based compensation expense
$
8,840

$
4,816

$
13,656

 
$

$
26,258

$
26,258

Acquisition and site closure expenses(8)
264,424

9,829

274,253

 
9,403

20,411

29,814

Restructuring and asset-related charges(10) 
56,413

5,123

61,536

 
245

40,248

40,493

Loss on extinguishment of debt
19,667


19,667

 
2,531

1,215

3,746

Inventory related charges(7)
54,222

9,894

64,116

 
22,682

26,702

49,384

Litigation, settlements and related charges
2,092

90,099

92,191

 

8,351

8,351

Loss (gain) on sale of assets
878


878

 

(17,236
)
(17,236
)
Asset impairment charges(9)
47,660

53

47,713

 

372,181

372,181

Amortization of upfront payment(11)
10,423


10,423

 



Royalty expense



 
8,684


8,684

Foreign exchange loss (gain)
19,701

(921
)
18,780

 
(29,092
)

(29,092
)
Loss on sale of international operations
2,958


2,958

 
29,232


29,232

R&D milestone payments
8,000


8,000

 



Change in fair value of contingent consideration(12)



 

(31,048
)
(31,048
)
Other
4,285

867

5,152

 
4,158

6,534

10,692

Adjusted EBITDA (Non-GAAP)
$
577,815

$
6,465

$
584,280

 
$
336,163

$
167,515

$
503,678













Page 25 of 26



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

Reconciliation of Net Income to EBITDA and Combined Adjusted EDITBA

The following reconciliation for the three months ended September 30, 2018 has been provided for sequential comparison.

 
Three months ended September 30, 2018
 
 
Add:
(Non-GAAP)

 
Actual
Impax/ Gemini
Combined
Net income
$
17,465

$

$
17,465

Adjusted to add (deduct):
 
 
 
Interest expense, net
43,018


43,018

Income tax expense
5,109


5,109

Depreciation and amortization
43,013


43,013

EBITDA (Non-GAAP)
$
108,605

$

$
108,605

 
 
 
 
Adjusted to add (deduct):
 
 
 
Stock-based compensation expense
$
3,590

$

3,590

Acquisition and site closure expenses(8)
12,430


12,430

Restructuring and asset-related charges(10) 
(2,156
)

(2,156
)
Inventory related charges(7)
17,422


17,422

Litigation, settlements and related charges
2,589


2,589

Asset impairment charges(9)
8,541


8,541

Foreign exchange loss
5,137


5,137

Loss on sale of international operations
2,812


2,812

Other
3,947


3,947

Adjusted EBITDA (Non-GAAP)
$
162,917

$

$
162,917



(7) Inventory related charges primarily represents the amortization of the Impax inventory step-up to fair value in purchase accounting and write-offs of pre-launch inventory quantities.

(8) Acquisition and site closure expenses includes costs related to (i) accelerated vesting of Amneal profit participation units, (ii) special bonuses associated with the combination and integration of Impax, (iii) plant closure and redundant employee costs and (iv) third party costs associated with the combination of Impax and related integration including legal, investment banking, accounting and information technology.

(9) Asset impairment charges for the year ended December 31, 2018 are primarily associated with the write-off of leasehold improvements in connection with the closing of our Hayward, CA facility. Asset impairment charges for the year ended December 31, 2017 are primarily associated with a write-off of in process research and development product rights and impairment charges primarily related to two products acquired in the Teva Transaction as well as fixed asset impairment charges primarily related to the Taiwan and Middlesex, New Jersey facilities.

(10) Restructuring and asset related charges includes employee separation costs associated with the consolidation of sites as well as the write-off of property, plant and equipment at those sites.

(11) Amortization of upfront payment represents the amortization of the upfront payment made to Lannett in connection with our Transition Agreement with Levothyroxine.

(12) Change in fair value of contingent consideration represents the reduction in contingent consideration liability related to a product acquired in the Teva Transaction. Based on timing and probability of product launch, and number of competitors expected in the market, the Company concluded that fair value of the contingent consideration was zero at December 31, 2017.




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