UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
 
FORM 10-Q
þQUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
  
 FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2018MARCH 31, 2019
  
oTRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934


FOR THE TRANSITION PERIOD FROM ____________   TO ____________                    


COMMISSION FILE NUMBER: 001-32360


AKORN, INC.
(Exact Name of Registrant as Specified in its Charter)
LOUISIANA72-0717400
(State or Other Jurisdiction of(I.R.S. Employer
Incorporation or Organization)Identification No.)
  
1925 W. Field Court, Suite 300 
Lake Forest, Illinois60045
(Address of Principal Executive Offices)(Zip Code)


(847) 279-6100
(Registrant’s telephone number, including area code)


Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yesþ No
o




Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 229.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).
Yes
þ


 Noo


Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filerþ
 
 Accelerated filero
Non-accelerated filero (Do not check if a smaller reporting company)
 
Smaller reporting companyo
 Emerging growth companyo
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.o


Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yeso Noþ



[1]







Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading Symbol(s)Name of each exchange on which registered
Common Stock, No Par ValueAKRXThe NASDAQ Global Select Market

At July 26, 2018,April 30, 2019, there were 125,451,174125,850,278 shares of common stock, no par value, outstanding.


[2]







  
 Page
PART I. FINANCIAL INFORMATION 
ITEM 1. Financial Statements (unaudited). 
Condensed Consolidated Balance Sheets - June 30, 2018March 31, 2019 and December 31, 20172018
Condensed Consolidated Statements of Comprehensive (Loss) Income - Three and six months ended June 30, 2018March 31, 2019 and 2017
Condensed Consolidated Statement of Shareholders’ Equity - Six months ended June 30, 2018
Condensed Consolidated Statements of Cash FlowsShareholders’ Equity - SixThree months ended June 30,March 31, 2019 and 2018 and 2017
of Cash Flows - Three months ended March 31, 2019 and 2018
PART II. OTHER INFORMATION 
  
SIGNATURES 
  
EXHIBIT INDEX 


[3]







PART I. FINANCIAL INFORMATION
Item 1. Financial Statements.
 
Certain prior-period amounts have been reclassified to conform to current-period presentation including cost of sales, selling, generalresearch and administrativedevelopment expenses and other non-operating income (expense),impairment of intangible assets, net on the condensed consolidated statements of comprehensive (loss) income and other non-current assets, prepaid expenses and other current assets, accrued legal fees, FIN 48 reserve and accrued expenses and other liabilities on the condensed consolidated statements of cash flows.



[4]




AKORN, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In Thousands, Except Share Data)
June 30, 2018 (Unaudited)
December 31, 2017March 31, 2019 (Unaudited)
December 31, 2018
ASSETS





CURRENT ASSETS





Cash and cash equivalents$296,782

$368,119
$184,090

$224,868
Trade accounts receivable, net187,318

141,383
174,325

153,126
Inventories, net191,041

183,568
162,752

173,645
Prepaid expenses and other current assets27,613

37,081
29,286

32,180
TOTAL CURRENT ASSETS702,754

730,151
550,453

583,819
PROPERTY, PLANT AND EQUIPMENT, NET328,909

313,418
325,970

334,853
OTHER LONG-TERM ASSETS 

 
 

 
Goodwill284,115

285,310
267,923

283,879
Intangible assets, net459,812

569,484
263,644

284,976
Deferred tax assets6,319

6,521
Right-of-use assets, net - Operating leases21,973
 
Other non-current assets4,647

4,627
7,228

7,730
TOTAL OTHER LONG-TERM ASSETS754,893

865,942
560,768

576,585
TOTAL ASSETS$1,786,556

$1,909,511
$1,437,191

$1,495,257
LIABILITIES AND SHAREHOLDERS’ EQUITY 

 
 

 
CURRENT LIABILITIES 

 
 

 
Trade accounts payable$50,663

$51,976
$38,419

$39,570
Purchase consideration payable201

3,901
Income taxes payable6,792

15,775
13,925


Accrued royalties6,627

5,902
7,079

6,786
Accrued compensation17,239

12,286
16,529

19,745
Accrued administrative fees35,763

38,598
28,165

36,767
Accrued legal fees and contingencies49,710
 52,413
Current portion of lease liability - Operating leases2,238
 
Accrued expenses and other liabilities60,946

42,651
12,721

15,542
TOTAL CURRENT LIABILITIES178,231

171,089
168,786

170,823
LONG-TERM LIABILITIES: 

 
LONG-TERM LIABILITIES 

 
Long-term debt (net of non-current deferred financing costs)817,803

815,195
821,715

820,411
Deferred tax liability19,929

43,404
530

566
Other long-term liabilities48,758

48,578
FIN 48 reserve51,410
 49,990
Long-term lease liability - Operating leases21,480
 
Pension obligations and other liabilities7,521

9,601
TOTAL LONG-TERM LIABILITIES886,490

907,177
902,656

880,568
TOTAL LIABILITIES1,064,721

1,078,266
1,071,442

1,051,391
SHAREHOLDERS’ EQUITY 

 
 

 
Common stock, no par value – 150,000,000 shares authorized; 125,404,158 and 125,090,522 shares issued and outstanding at June 30, 2018 and December 31, 2017, respectively564,988

550,472
Retained earnings178,010

294,741
Accumulated other comprehensive loss(21,163)
(13,968)
Preferred stock, $1 par value - 5,000,000 shares authorized; no shares issued or outstanding at March 31, 2019 and December 31, 2018.
 
Common stock, no par value – 150,000,000 shares authorized; 125,578,913 and 125,492,373 shares issued and outstanding at March 31, 2019 and December 31, 2018, respectively.579,157

574,553
(Accumulated deficit)(189,349)
(107,168)
Accumulated other comprehensive (loss)(24,059)
(23,519)
TOTAL SHAREHOLDERS’ EQUITY721,835

831,245
365,749

443,866
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY$1,786,556

$1,909,511
$1,437,191

$1,495,257
 See notes to condensed consolidated financial statements.


[4]5]







AKORN, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE (LOSS) INCOME
(In Thousands, Except Per Share Data)
(Unaudited)
 Three Months Ended
June 30,

Six Months Ended
June 30,
 2018
2017
2018
2017
Revenues, net$190,944

$199,140

$375,007

$452,560
Cost of sales (exclusive of amortization of intangibles, included within operating expenses below)109,665

96,371

211,500

201,022
GROSS PROFIT81,279

102,769

163,507

251,538
        
Selling, general and administrative expenses83,694

53,981

146,677

101,564
Acquisition-related costs64

76

75

87
Research and development expenses74,271

15,876

105,238

27,167
Amortization of intangibles13,182

15,504

26,372

30,975
Impairment of intangible assets1,634

3,058

2,126

3,058
TOTAL OPERATING EXPENSES172,845

88,495

280,488

162,851












OPERATING (LOSS) INCOME(91,566)
14,274

(116,981)
88,687
Amortization of deferred financing costs(1,304)
(1,304)
(2,608)
(2,608)
Interest expense, net(11,062)
(9,380)
(20,640)
(18,946)
Other non-operating income, net(324)
3,160

(54)
4,943












(LOSS) INCOME BEFORE INCOME TAXES(104,256)
6,750

(140,283)
72,076
Income tax (benefit) provision(16,272)
4,213

(23,552)
28,512












CONSOLIDATED NET (LOSS) INCOME$(87,984)
$2,537

$(116,731)
$43,564
CONSOLIDATED NET (LOSS) INCOME PER SHARE 

 

 

 
CONSOLIDATED NET (LOSS) INCOME PER SHARE, BASIC$(0.70)
$0.02

$(0.93) $0.35
CONSOLIDATED NET (LOSS) INCOME PER SHARE, DILUTED$(0.70)
$0.02

$(0.93) $0.35












SHARES USED IN COMPUTING NET (LOSS) INCOME PER SHARE 

 

 

 
BASIC125,332

124,660

125,286

124,541
DILUTED125,332

125,194

125,286

124,855












COMPREHENSIVE (LOSS) INCOME 

 

 

 
Consolidated net (loss) income$(87,984)
$2,537

$(116,731)
$43,564
Unrealized holding (loss) gain on available-for-sale securities, net of tax of $1 and ($85) for the three months ended June 30, 2018 and 2017, and $1 and ($160) for the six month periods ended June 30, 2018 and 2017 respectively.(4)
144

(5)
272
Foreign currency translation (loss) gain(6,350)
1,239

(7,198)
5,265
Pension liability adjustment gain, net of tax of ($1) and ($6) for the three months ended June 30, 2018 and 2017, and ($2) and ($63) for the six month periods ended June 30, 2018 and 2017 respectively.4

24

8

247
COMPREHENSIVE (LOSS) INCOME$(94,334)
$3,944

$(123,926)
$49,348
 Three Months Ended
March 31,
 2019
2018
Revenues, net$165,871

$184,063
Cost of sales (exclusive of amortization of intangibles, included within operating expenses below)112,358

101,835
GROSS PROFIT53,513

82,228
    
Selling, general and administrative expenses72,498

62,994
Research and development expenses8,714

12,644
Amortization of intangibles11,065

13,190
Impairment of goodwill15,955
 
Impairment of intangible assets10,354

18,815
Litigation rulings and settlements410
 
TOTAL OPERATING EXPENSES118,996

107,643






OPERATING (LOSS)(65,483)
(25,415)
Amortization of deferred financing costs(1,304)
(1,304)
Interest expense, net(14,327)
(9,578)
Other non-operating income, net353

270






(LOSS) BEFORE INCOME TAXES(80,761)
(36,027)
Income tax provision (benefit)1,420

(7,280)






NET (LOSS)$(82,181)
$(28,747)
NET (LOSS) PER SHARE 

 
NET (LOSS) PER SHARE, BASIC$(0.65)
$(0.23)
NET (LOSS) PER SHARE, DILUTED$(0.65)
$(0.23)






SHARES USED IN COMPUTING NET (LOSS) PER SHARE 

 
BASIC125,566

125,240
DILUTED125,566

125,240






COMPREHENSIVE (LOSS) 

 
Net (loss)$(82,181)
$(28,747)
Unrealized holding (loss) on available-for-sale securities, net of tax of $0 for the three month period ended March 31, 2018.

(1)
Foreign currency translation (loss)(424)
(848)
Pension liability adjustment (loss) gain, net of tax of $30 and ($1) for the three months ended March 31, 2019 and 2018, respectively.(116)
4
COMPREHENSIVE (LOSS)$(82,721)
$(29,592)
See notes to condensed consolidated financial statements.


[5]6]







AKORN, INC.
CONDENSED CONSOLIDATED STATEMENTSTATEMENTS OF SHAREHOLDERS’ EQUITY
FOR THE SIXTHREE MONTHS ENDED JUNE 30,MARCH 31, 2019 and 2018
(In Thousands)


 Shares Common Stock 
Retained
Earnings
 
Other
Comprehensive
Loss
 Total Shares Common Stock (Accumulated Deficit) 
Other
Comprehensive
(Loss)
 Total
BALANCES AT DECEMBER 31, 2017 125,091
 $550,472
 $294,741
 $(13,968) $831,245
BALANCES AT DECEMBER 31, 2018 125,492
 $574,553
 $(107,168) $(23,519) $443,866
Consolidated net (loss) 
 
 (116,731) 
 (116,731) 
 
 (82,181) 
 (82,181)
Exercise of stock options 22
 546
 
 
 546
Compensation and share issuances related to restricted stock awards 170
 5,817
 
 
 5,817
 121
 3,110
 
 
 3,110
Stock-based compensation expense - stock options 
 5,636
 
 
 5,636
 
 1,381
 
 
 1,381
Foreign currency translation loss 
 
 
 (7,198) (7,198) 
 
 
 (424) (424)
Stock compensation plan withholdings for employee taxes (25) (292) 
 
 (292) (34) (116) 
 
 (116)
Unrealized holding loss on available-for-sale securities 
 
 
 (5) (5)
Akorn AG pension liability adjustment 
 
 
 8
 8
 
 
 
 (116) (116)
Employee stock purchase plan 146
 2,809
 
 
 2,809
BALANCES AT JUNE 30, 2018 (unaudited) 125,404
 $564,988
 $178,010
 $(21,163) $721,835
Employee stock purchase plan expense 
 229
 
 
 229
BALANCES AT MARCH 31, 2019 (unaudited) 125,579
 $579,157
 $(189,349) $(24,059) $365,749

    Common Stock Retained Earnings 
Other
Comprehensive
(Loss)
 Total
BALANCES AT DECEMBER 31, 2017 125,091
 $550,472
 $294,741

$(13,968) $831,245
Consolidated net (loss) 
 
 (28,747) 
 $(28,747)
Exercise of stock options 22
 546
 
 
 $546
Compensation and share issuances related to restricted stock awards 
 2,349
 
 
 $2,349
Stock-based compensation expense - stock options 
 3,159
 
 
 $3,159
Foreign currency translation loss 
 
 
 (848) $(848)
Unrealized holding loss on available-for-sale securities 
 
 
 (1) $(1)
Akorn AG pension liability adjustment 
 
 
 4
 $4
Employee stock purchase plan payment expense 146
 2,809
 
 
 $2,809
BALANCES AT MARCH 31, 2018 (unaudited) 125,259
 $559,335
 $265,994
 $(14,813) $810,516

See notes to condensed consolidated financial statements.


[6]7]







AKORN, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In Thousands)
(Unaudited)
Six Months Ended
June 30,
Three Months Ended
March 31,
2018
20172019
2018
OPERATING ACTIVITIES: 
  
 
Consolidated net (loss) income$(116,731)
$43,564
Adjustments to reconcile consolidated net income to net cash (used in) provided by operating activities: 

 
Net (loss)$(82,181)
$(28,747)
Depreciation and amortization40,439

42,212
18,750

20,278
Amortization of debt financing costs2,608

2,608
Amortization of debt financing fees1,304

1,304
Impairment of intangible assets83,349

8,079
10,354

18,815
Goodwill impairment15,955
 
Fixed asset impairment and other10,089
 
Non-cash stock compensation expense11,453

9,844
4,720

5,508
Income from available-for-sale securities
 (3,032)
Deferred income taxes, net(24,512)
(2,341)(28)
(7,833)
Loss on sale of available-for-sale securities

196
Other481

(288)(31)
218
Changes in operating assets and liabilities:









Other non-current assets584
 37
Trade accounts receivable(45,893)
105,848
(21,283)
(35,508)
Inventories, net(7,735)
(6,225)10,819

(9,292)
Prepaid expenses and other current assets8,176

2,078
1,079

11,997
Trade accounts payable602

(13,465)722

11,318
Accrued Legal Fees(2,703) (12,853)
FIN 48 Reserve1,420
 512
Accrued expenses and other liabilities16,490

(30,051)(33)
(7,345)
NET CASH (USED IN) PROVIDED BY OPERATING ACTIVITIES$(31,273)
$159,027
NET CASH (USED IN) OPERATING ACTIVITIES$(30,463)
$(31,591)
INVESTING ACTIVITIES: 

 
 

 
Proceeds from disposal of assets20

4,811
Payments for intangible assets(50)
(200)
Purchases of property, plant and equipment(35,862)
(50,072)(10,059)
(22,340)
NET CASH USED IN INVESTING ACTIVITIES$(35,892)
$(45,461)
NET CASH (USED IN) INVESTING ACTIVITIES$(10,059)
$(22,340)
FINANCING ACTIVITIES: 

 
 

 
Proceeds from the exercise of stock options254

6,897


546
Stock compensation plan withholdings for employee taxes(116)

Payment of contingent acquisition liabilities(4,793)



(4,793)
Lease payments(6)

$(335)
$(3)
NET CASH (USED IN) PROVIDED BY FINANCING ACTIVITIES$(4,545)
$6,897
NET CASH (USED IN) FINANCING ACTIVITIES$(451)
$(4,250)
Effect of exchange rate changes on cash and cash equivalents(560)
626
54

41
(DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS$(72,270)
$121,089
Cash and cash equivalents, and restricted at beginning of period369,889

204,034
(DECREASE) IN CASH AND CASH EQUIVALENTS$(40,919)
$(58,140)
Cash and cash equivalents, and restricted cash at beginning of period225,794

369,889
CASH, CASH EQUIVALENTS, AND RESTRICTED CASH AT END OF PERIOD$297,619

$325,123
$184,875

$311,749
SUPPLEMENTAL DISCLOSURES: 

 
 

 
Amount paid for interest$25,462

$22,124
$16,314

$12,262
Amount paid for income taxes, net$9,260

$43,901
Amount (received) paid for income taxes, net$(14,526)
$8,205
Additional capital expenditures included in accounts payable$12,010
 $8,806
$4,641
 $8,227
See notes to condensed consolidated financial statements.


[7]8]







AKORN, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)



Note 1 — Business and Basis of Presentation
 
Business:Akorn, Inc., together with its wholly-owned subsidiaries (collectively “Akorn,” the “Company,” “we,” “our” or “us”) is a specialty generic pharmaceutical company that develops, manufactures and markets generic and branded prescription pharmaceuticals, branded as well as private-label over-the-counter consumer health products and animal health pharmaceuticals. We are an industry leader in the development, manufacturing and marketing of specialized generic pharmaceutical products in alternative dosage forms. We focus on difficult-to-manufacture sterile and non-sterile dosage forms including, but not limited to, ophthalmics, injectables, oral liquids, otics, topicals, inhalants and nasal sprays. In previous years, the Company completed numerous mergers, acquisitions and product acquisitions which resulted in significant growth.
 
Akorn, Inc. is a Louisiana corporation founded in 1971 in Abita Springs, Louisiana. In 1997, we relocated our corporate headquarters to the Chicago, Illinois area and currently maintain our principal corporate offices in Lake Forest, Illinois. We operatehave pharmaceutical manufacturing facilities in Decatur, Illinois; Somerset, New Jersey; Amityville, New York; Hettlingen, Switzerland; and Paonta Sahib, Himachal Pradesh, India. We operate a central distribution warehouse in Gurnee, Illinois and additional distribution facilities in Amityville, New York and Decatur, Illinois. Our research and development (“R&D”) centers are located in Vernon Hills, Illinois and Cranbury, New Jersey. We maintain other corporate offices in Ann Arbor, Michigan and Gurgaon, Haryana, India.


During the three and six month periods ended June 30,March 31, 2019 and 2018, and 2017, the Company reported results for two reportable segments: Prescription Pharmaceuticals and Consumer Health. For further detail concerning our reportable segments please see Part I, Item 1, Note 10 - “Segment Information.”


Our common shares are traded on The NASDAQ Global Select Market under the ticker symbol AKRX. Our principal corporate office is located at 1925 West Field Court Suite 300, Lake Forest, Illinois 60045, with telephone number (847) 279-6100.


Terminated Merger Agreement: On April 24, 2017, the Company entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Fresenius Kabi AG, a German stock corporation (“Parent”), Quercus Acquisition, Inc., a Louisiana corporation and wholly-owned subsidiary of Parent (“Merger Sub”) and, solely for purposes of Article VIII thereof, Fresenius SE & Co. KGaA, a German partnership limited by shares.  The Merger Agreement, which has been adopted by the Board of Directors of the Company, provides for the merger of Merger Sub with and into the Company (the “Merger”), with the Company surviving the Merger as a wholly-owned subsidiary of Parent. On July 19, 2017, the Company's shareholders voted to approve the Merger Agreement.

Subject to the terms and conditions set forth in the Merger Agreement, at the effective time of the Merger (the “Effective Time”), each of the Company’s issued and outstanding shares of common stock, no par value per share (the “Shares”) (other than Shares owned by the Company or by Parent, Merger Sub or any direct or indirect wholly-owned subsidiary of the Company or of Parent (other than Merger Sub) immediately prior to the Effective Time), will be converted into the right to receive $34.00 in cash per Share (the “Merger Consideration”), without interest.

Completion of the Merger is subject to customary closing conditions, including (1) there being no judgment or law enjoining or otherwise prohibiting the consummation of the Merger and (2) the expiration of the waiting period applicable to the Merger under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.  The obligation of each of the Company and Parent to consummate the Merger is also conditioned on the other party’s representations and warranties being true and correct (subject to certain materiality exceptions) and the other party having performed in all material respects its obligations under the Merger Agreement.

The Merger Agreement contains representations and warranties and covenants of the parties customary for a transaction of this nature.  Among other things, Parent has agreed to promptly take all actions necessary to obtain antitrust approval of the Merger, including (i) entering into consent decrees or undertakings with a regulatory authority, (ii) divesting or holding separate any assets or businesses of Parent or the Company, (iii) terminating existing contractual relationships or entering into new contractual relationships, (iv) effecting any other change or restructuring of Parent or the Company and (v) defending through litigation any claim asserted by a regulatory authority that would prevent the closing of the Merger.


On April 22, 2018, Fresenius Kabi AG delivered to Akorn a letter purporting to terminate the Merger Agreement. On April 23, 2018, Akorn filed a verified complaint entitled Akorn, Inc. v. Fresenius Kabi AG, Quercus Acquisition, Inc. and

[8]




Fresenius SE & Co. KGaA, in the Court of Chancery of the State of Delaware for breach of contract and declaratory judgment. The complaint alleges,alleged, among other things, that (i) the defendants anticipatorily breached their obligations under the Merger Agreement by repudiating their obligation to close the Merger, (ii) the defendants knowingly and intentionally breached their obligations under the Merger Agreement by working to slow the antitrust approval process and by engaging in a series of actions designed to hamper and ultimately block the Merger and (iii) Akorn hashad performed its obligations under the Merger Agreement, and iswas ready, willing and able to close the Merger. The complaint seeks,sought, among other things, a declaration that Fresenius Kabi AG's termination iswas invalid, an order enjoining the defendants from terminating the Merger Agreement, and an order compelling the defendants to specifically perform their obligations under the Merger Agreement to use reasonable best efforts to consummate and make effective the Merger. On April 30, 2018, the defendants filed a verified counterclaim alleging that, due primarily to purported data integrity deficiencies, at Akorn, the Company had breached representations, and warranties and covenants in the Merger Agreement, and that it had experienced a material adverse effect. The verified counterclaim seeks,sought, among other things, a declaration that defendants’ purported termination of the Merger Agreement was valid and that defendants arewere not obligated to consummate the transaction.transaction, and damages.


Following expedited discovery, from July 9 to 13, 2018, the Court of Chancery held a trial on the parties’ claims (collectively, the(the “Delaware Action”). At the conclusion of trial, the Court of Chancery ordered post-trial briefing, which is scheduled to bewas completed on August 20, 2018. The Court has scheduled2018, and a post-trial hearing, forwhich was held on August 23, 2018. Akorn expects to receive the Court’s ruling after the post-trial hearing. Any decision by

On October 1, 2018, the Court of Chancery willissued an opinion (the “Opinion”) denying Akorn’s claims for relief and concluding that Fresenius Kabi AG had validly terminated the Merger Agreement. The Court of Chancery concluded that Akorn had experienced a material adverse effect due to its financial performance following the signing of the Merger

[9]




Agreement; that Akorn had breached representations and warranties in the Merger Agreement and that those breaches would reasonably be subjectexpected to give rise to a potentialmaterial adverse effect; that Akorn had materially breached covenants in the Merger Agreement; and that Fresenius was materially in compliance with its own contractual obligations. On October 17, 2018, the Court of Chancery entered partial final judgment against Akorn on its claims and in favor of the Fresenius parties on their claims for declaratory judgment. The Court of Chancery entered an order holding proceedings on the Fresenius parties’ damages claims in abeyance pending the resolution of any appeal tofrom the partial final judgment.

On October 18, 2018, Akorn filed a notice of appeal from the Opinion and the partial final judgment, as well as a motion seeking expedited treatment of its appeal. On October 23, 2018, the Delaware Supreme Court.Court granted Akorn's motion for expedited treatment and set a hearing on Akorn's appeal for December 5, 2018.


On December 7, 2018, the Delaware Supreme Court affirmed the Court of Chancery’s opinion denying Akorn’s claims for declaratory and injunctive relief and granting Defendants’ counterclaim for a declaration that the termination was valid. On December 27, 2018, the Delaware Supreme Court issued a mandate returning the case to the Court of Chancery for consideration of all remaining issues, including the Fresenius parties’ damages claims.

On January 15, 2019, the parties filed a joint letter to the Court of Chancery seeking thirty days to discuss the potential resolution of the Fresenius parties’ damages claims. On February 19, 2019, the parties filed a joint letter advising the Court that they have been unable to resolve the Fresenius parties’ damages claims. The Fresenius parties stated their intention to seek leave to amend their counterclaims to assert a new claim for fraud and that they would seek an expedited trial on such claim purportedly due to Akorn’s financial condition. Akorn stated that it expected to oppose the motions for amendment and expedition, and that it would move to dismiss the Fresenius parties’ damages claims in their entirety.

On February 20, 2019, the Fresenius parties filed a motion for leave to amend and supplement their counterclaim. The Fresenius parties’ proposed amended and supplemented counterclaim alleged that Akorn fraudulently induced Fresenius to enter into the Merger Agreement and thereafter breached contractual representations and warranties and covenants therein. It sought damages of approximately $102 million. On February 25, 2019, Akorn filed an opposition to the Fresenius parties’ motion for leave to amend and supplement their counterclaim, arguing that the motion was untimely and prejudicial. On February 27, 2019, the Fresenius parties filed a reply in further support of their motion to file an amended and supplemented counterclaim. On February 28, 2019, the Court of Chancery denied the Fresenius parties’ motion for leave to file an amended and supplemented counterclaim. On March 15, 2019, the Fresenius parties served interrogatories in furtherance of their claim for damages purportedly resulting from breaches of contractual representations and warranties and covenants in the Merger Agreement.

Basis of Presentation:The Company’s financial statements have been prepared in accordance with accounting principles generally accepted in the United States ("GAAP") for interim financial information and accordingly do not include all the information and footnotes required by GAAP for annual financial statements. In the opinion of management, all adjustments of a normal and recurring nature considered necessary for a fair presentation have been included in these financial statements. Operating results for the three and six month periodsperiod ended June 30, 2018March 31, 2019, are not necessarily indicative of the results that may be expected for the full year. For further information, refer to the consolidated financial statements and footnotes for the year ended December 31, 2017,2018, included in the Company’s Annual Report on Form 10-K filed on February 28, 2018.March 1, 2019.
 
Note 2 — Summary of Significant Accounting Policies
 
Consolidation:  The accompanying condensed consolidated financial statements include the accounts of Akorn, Inc. and its wholly-owned domestic and foreign subsidiaries. All inter-company transactions and balances have been eliminated in consolidation, and the financial statements of Akorn India Private Limited ("AIPL") and Akorn AG have been translated from Indian Rupees to U.S. dollarsDollars and Swiss Francs to U.S. dollars,Dollars, respectively, based on the currency translation rates in effect during the period or as of the date of consolidation, as applicable. The Company has no involvement with variable interest entities.


Use of Estimates: The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America (“GAAP”)GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. Actual results could differ materially from those estimates.


Significant estimates and assumptions for the Company relate to the allowances for chargebacks, rebates, product returns, coupons, promotions and doubtful accounts, as well as the reserve for slow-moving and obsolete inventories, the carrying value and lives of intangible assets, the useful lives of fixed assets, impairments of fixed assets, the carrying value of deferred income

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tax assets and liabilities, the assumptions underlying share-based compensation and accrued but unreported employee benefit costs and assumptions underlying the accounting for business combinations.costs.
 
Going Concern: In connection with the preparation of the financial statements as of and for the sixthree month period ended June 30, 2018,March 31, 2019, the Company conducted an evaluation as to whether there were conditions and events, considered in the aggregate, which raised substantial doubt as to the entity's ability to continue as a going concern within one year after the date of the issuance, or the date of availability, of the financial statements to be issued, noting that there did not appearissued.

As further described in Note 8 - "Financing Arrangements,” on May 6, 2019, the Company and certain Lenders entered into a Standstill Agreement and First Amendment (the “Standstill Agreement”) to be evidence of substantial doubtits Term Loan Agreements. Pursuant to the terms of the entity'sStandstill Agreement, the Company must enter into a “Comprehensive Amendment” to the Term Loan Agreements that is satisfactory in form and substance to the Lenders. If the Company does not enter into a Comprehensive Amendment by December 13, 2019 or refinance or otherwise address the outstanding Term Loans, an event of default will occur under the Term Loan Agreements which, if not waived, could materially affect the Company’s business, financial position and results of operations. If an event of default occurs and the Lenders accelerate the obligations under the Term Loan Agreements, the Company may not be able to repay the obligations that become immediately due and it could have a material negative impact on the Company’s liquidity and business.
The Company evaluated the impact of entering into the Standstill Agreement on its ability to continue as a going concern. As the Company’s ability to enter into a Comprehensive Amendment with the Lenders is not within its control, and failure to do so would result in an event of default under the Term Loan Agreements, these conditions in the aggregate raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the accompanying financial statements are filed. The Company will actively seek to refinance or otherwise address the Term Loans or enter into a “Comprehensive Amendment” to the Term Loan Agreements by December 13, 2019. Based on discussions with the Company’s financial advisor, the Company believes that it will be able to refinance or otherwise address the Term Loans within this timeframe. In the event that the Company is unable to refinance or otherwise address the Term Loans, the Company would seek to enter into a “Comprehensive Amendment” to the Term Loan Agreements. The Standstill Agreement requires the Company and Lenders to negotiate in good faith to enter into such a Comprehensive Amendment.

Revenue Recognition:  Revenue is recognized at a point in time upon the transfer of control of the Company’s products, which occurs upon delivery for substantially all of the Company’s sales. The promises within the contract that are distinct are primarily the Company’s supply of products, which represents a single performance obligation. The consideration the Company receives in exchange for its goods or services is only recognized when it is probable that a significant reversal will not occur.

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The consideration to which the Company expects to be entitled includes a stated list price, less various forms of variable consideration. The Company makes significant estimates for related variable consideration at the point of sale, including chargebacks, rebates, product returns and other discounts and allowances. All sales taxes are excluded from the transaction price. The Company expenses contract fulfillment costs when incurred since the amortization period would have been less than one year. Payment terms are primarily less than 90 days. See Note 16 – Recently Issued and Adopted Accounting Pronouncements for the discussion of the adoption of Accounting Standard Codification ("ASC") Topic 606 Revenue from Contracts with Customers.
 
Provision for estimated chargebacks, rebates, discounts, managed care rebates, product returns and doubtful accounts is made at the time of sale and is analyzed and adjusted, if necessary, at each balance sheet date.


Freight:The Company records shipping and handling expense related to product sales as cost of sales.


Cash and Cash Equivalents: The Company considers all unrestricted, highly liquid investments with maturity of three months or less when acquired, to be cash and cash equivalents. At June 30, 2018March 31, 2019 and December 31, 2017,2018, approximately $0.8 million and $1.8$0.9 million, respectively, of cash held by AIPL was restricted, and was reported within prepaid expenses and other current assets.


The following table sets forth the components of the Company’s cash, cash equivalents, and restricted cash as reported in the consolidated statement of cash flows for the sixthree month periods ended June 30,March 31, 2019 and 2018 and 2017 (in thousands):



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Cash, Cash Equivalents, and Restricted CashSix Months Ended
June 30,
 2018 2017
Cash and cash equivalents$296,782
 $322,742
Restricted cash837
 2,381
Total cash, cash equivalents, and restricted cash$297,619
 $325,123


Cash, Cash Equivalents, and Restricted CashThree Months Ended
March 31,
 2019 2018
Cash and cash equivalents$184,090
 $309,377
Restricted cash785
 2,372
Total cash, cash equivalents, and restricted cash$184,875
 $311,749


Accounts Receivable: Trade accounts receivable are stated at their net realizable value.  The nature of the Company’s business involves, in the ordinary course, significant judgments and estimates relating to chargebacks, coupon redemption, product returns, rebates, discounts given to customers and allowances for doubtful accounts.  Certain rebates, chargebacks and other credits are recorded as deductions to the Company’s trade accounts receivable where applicable, based on product and customer specific terms.


Unless otherwise noted, the provisions and allowances for the following customer deductions are reflected in the accompanying consolidated financial statements as reductions of revenues and trade accounts receivable, respectively.

Chargebacks:The Company enters into contractual agreements with certain third parties such as retailers, hospitals, group-purchasing organizations (“GPOs”) and managed care organizations to sell certain products at predetermined prices. Similarly, we maintain an allowance for rebates and discounts related to billbacks, wholesaler fee for service contracts, GPO administrative fees, government programs, prompt payment and other adjustments with certain customers. Most of the parties have elected to have these contracts administered through wholesalers that buy the product from the Company and subsequently sell it to these third parties. As noted elsewhere, these wholesalers represent a significant percentage of the Company’s gross sales. When a wholesaler sells products to one of these third parties that are subject to a contractual price agreement, the difference between the price paid to the Company by the wholesaler and the price under the specific contract is charged back to the Company by the wholesaler. This process typically takes four to six weeks, but for some products may extend out to twelve weeks. The Company tracks sales and submitted chargebacks by product number and contract for each wholesaler. Utilizing this information, the Company estimates a chargeback percentage for each product and records an allowance as a reduction to gross sales when the Company records its sale of the products. The Company reduces the chargeback allowance when a chargeback request from a wholesaler is processed. Actual chargebacks processed by the Company can vary materially from period to period based upon actual sales volume through the wholesalers. However, the Company’s provision for chargebacks is fully reserved for at the time revenues are recognized.

Management obtains product inventory reports from certain wholesalers to aid in analyzing the reasonableness of the chargeback allowance and to monitor whether wholesaler inventory levels do not significantly exceed customer demand. The Company assesses the reasonableness of its chargeback allowance by applying a product chargeback percentage that is based on a combination of historical activity and future price and mix expectations to the quantities of

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inventory on hand at the wholesalers according to wholesaler inventory reports. In addition, the Company estimates the percent of gross sales generated through direct and indirect sales channels and the percent of contract vs. non-contract revenue in the period, as these each affect the estimated reserve calculation. In accordance with its accounting policy, the Company also estimates the percent of wholesaler inventory that will ultimately be sold to third parties that are subject to contractual price agreements based on a trend of such sales through wholesalers. The Company uses this percentage estimate until historical trends indicate that a revision should be made. On an ongoing basis, the Company evaluates its actual chargeback rate experience and new trends are factored into its estimates each quarter as market conditions change.


For the three month period ended June 30, 2018,March 31, 2019, the Company incurred a chargeback provision of $222.5$205.4 million, or 43.8%44.8% of gross sales of $507.8$458.6 million, compared to $237.3$224.0 million, or 41.8%43.0% of gross sales of $567.1$520.5 million in the prior year period. We note that theThe dollar decrease and percent increase in the comparative period was the result of gross sales decreases and product mix shifts to productsa change in contractual terms with higher chargeback expense percentages.a major customer in the first quarter of 2018. The Company ensures that this rate as a percent of gross sales is reasonable through inspection of contractual obligations, review of historical trends and evaluation of recent activity. Furthermore, other events that could materially alter chargeback rates include: changes in product pricing as a result of competitive market dynamics or negotiations with customers, changes in demand for specific products due to external factors such as competitor supply position or consumer preferences and customer shifts in buying patterns from direct to indirect through wholesalers, which could either individually or in aggregate increase or decrease the chargeback rate depending on the direction and velocity of the change(s).



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To better understand the impact of changes in chargeback reserve based on circumstances that are not fully outside the Company’s control, for instance, the ratio of sales subject to chargeback to indirect sales, the Company performs a sensitivity analysis. Holding all other assumptions constant, for a 480560 basis point (“BP”) change in the ratio of sales subject to chargeback to indirect sales would increase the chargeback reserve by $0.5$0.7 million or decrease the chargeback reserve by $2.6$2.9 million depending on the change in the direction of the ratio. Fundamentally, the BP change calculation is determined based on the six month trend of the average ratio of sales subject to chargeback to indirect sales. Due to the competitive generic pharmaceutical industry and our recent experience with wholesalers’ strategy and shifts in contracted and non-contracted indirect sales, we believe that the six month trend of the proportion of direct to indirect sales provides a representative basis for sensitivity analysis.
 
Rebates, Administrative Fees and Others: The Company maintains an allowance for rebates, administrative fees and others, related to contracts and other rebate programs that it has in place with certain customers. Rebates, administrative fees and other percentages vary by product and by volume purchased by each eligible customer. The Company tracks sales by product number for each eligible customer and then applies the applicable rebate, administrative fees and other percentage, using both historical trends and actual experience to estimate its rebates, administrative fees and others allowances. The Company reduces gross sales and increases the rebates, administrative fees and others allowance by the estimated rebates, administrative fees and others amounts when the Company sells its products to eligible customers. The Company reduces the rebate allowance when it processes a customer request for a rebate. At each balance sheet date, the Company analyzes the allowance for rebates, administrative fees and others against actual rebates processed and makes adjustments as appropriate. The amount of actual rebates processed can vary materially from period to period as discussed below.

The allowances for rebates, administrative fees and others further takes into consideration price adjustments which are credits issued to reflect increases or decreases in the invoice or contract prices of the Company’s products. In the case of a price decrease, a shelf-stock adjustment credit may be given for product remaining in customer’s inventories at the time of the price reduction and is reserved at the point of sale. Contractual price protection results in a similar credit when the invoice or contract prices of the Company’s products increase, effectively allowing customers to purchase products at previous prices for a specified period of time. Amounts recorded for estimated shelf-stock adjustments and price protectionsprotection are based upon specified terms with direct customers, estimated changes in market prices, and estimates of inventory held by customers. The Company regularly monitors these and other factors and evaluates the reserve as additional information becomes available.


Similar to rebates, the reserve for administrative fees and others represents those amounts processed related to contracts and other fee programs which have been in place with certain entities, but they are settled through cash payment to these entities and accordingly are accounted for as a current liability. Otherwise, administrative fees and others operate similarly to rebates.


For the three month period ended June 30, 2018,March 31, 2019, the Company incurred rebates, administrative fees and others fees of $75.1$64.3 million, or 14.8%14.0% of gross sales of $507.8$458.6 million, compared to $109.8$92.3 million, or 19.4%17.7% of gross sales of $567.1

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$520.5 million in the prior year period. We note that theThe dollar and percent decreases from the comparative period were the result of gross sales decreases and product mix shifts to products with lower rebates, administrative fees and others expense percentages. Additionally, a change in contractual terms with a major customer in the first quarter of 2018, resulted in a decrease in rebates, which is also a contributing factor in the variances between the two periods compared. The Company ensures that this rate as a percent of gross sales is reasonable through inspection of contractual obligations, review of historical trends and evaluation of recent activity. Furthermore, other events that could materially alter rebates, administrative fees and others rates include: changes in product pricing as a result of competitive market dynamics or negotiations with customers, changes in demand for specific products due to external factors such as competitor supply position or consumer preferences and customer shifts in buying patterns from direct to indirect through wholesalers, which could either individually or in aggregate increase or decrease the rebate rate depending on the direction and velocity of the change(s).


To better understand the impact of changes in reserves for rebates, administrative fees and others based on circumstances that are not fully outside the Company’s control, for instance, the proportion of direct to indirect sales subject to rebates, administrative fees and others, the Company performs a sensitivity analysis. Holding all other assumptions constant, for a 480560 BP change in the ratio of sales subject to rebates, administrative fees and others to indirect sales would increase the reserve for rebates, administrative fees and others by $0.1$0.0 million or decrease the same reserve by $0.5$0.4 million depending on the direction of the change in the ratio. Fundamentally, the BP change calculation is determined based on the six month trend of the average ratio of sales subject to rebates, administrative fees and others to indirect sales. Due to the competitive generic pharmaceutical industry and our recent experience with wholesalers’

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strategy and shifts in contracted and non-contracted indirect sales, we believe the six month trend of the average ratio of sales subject to rebates, administrative fees and others to indirect sales provides a representative basis for sensitivity analysis.

Sales Returns:Certain of the Company’s products are sold with the customer having the right to return the product within specified periods. Provisions are made at the time of sale based upon historical experience. Historical factors such as one-time recall events as well as pending new developments like comparable product approvals or significant pricing movement that may impact the expected level of returns are taken into account to determine the appropriate reserve estimate at each balance sheet date. As part of the evaluation of the reserve required, the Company considers actual returns to date that are in process, the expected impact of any product recalls and the amount of wholesaler’s inventory to assess the magnitude of unconsumed product that may result in sales returns to the Company in the future. The sales returns level can be impacted by factors such as overall market demand and market competition and availability for substitute products which can increase or decrease the pull through for sales of the Company’s products and ultimately impact the level of sales returns.


For the three month period ended June 30, 2018,March 31, 2019, the Company incurred a return provision of $6.1$11.9 million, or 1.2%2.6% of gross sales of $507.8$458.6 million, compared to $8.1$7.1 million, or 1.4% of gross sales of $567.1$520.5 million in the prior year period. We note that the dollar and percent decreasespercentage increased in the comparative period was primarily due to the resulttiming of gross sales decreases and product mix shifts to products with lower return rates.returns processing. The Company ensures that this rate as a percent of gross sales is reasonable through inspection of historical trends and evaluation of recent activity. Furthermore, other events that could materially alter return rates include: acquisitions and integration activities that consolidate dissimilar contract terms and could increase or decrease the return rate as typicallydepending on the Company purchases smaller entities with less contracting power;power of the acquired business and consumer demand shifts by products, which could either increase or decrease the return rate depending on the product or products specifically demanded and ultimately returned.


To better understand the impact of changes in return reserve based on certain circumstances, the Company performs a sensitivity analysis. Holding all other assumptions constant, for an average one month0.3 months change in the lag from the time of sale to the time the product return is processed, this change would result in an increase of $1.5$0.3 million or decrease of $1.6$0.4 million in return reserve expense if the lag increases or decreases, respectively. The average one month0.3 months change in the lag from the time of sale to the time the product return is processed was determined based on the difference between the high and low lag time for the past twelve month historical activities. This sensitivity analysis is a change from the three month period ended March 31, 2018, which was determined based on the average variances offor the last six-month historical activities.six months of returns activity. The prior method did not give a measurable variance to calculate a sensitivity. Due to the change in the volume and type of products sold by the Company in the recent past, we have determined that the lag calculation provides a reasonable basis for sensitivity analysis.


Allowance for Coupons, Advertising, Promotions and Co-Pay Discount Cards: The Company issues coupons from time to time that are redeemable against certain of our Consumer Health products. In addition to couponing, from time to time the Company authorizes various retailers to run in-store promotional sales and co-pay discount of its products. At the point of sale, the Company records an estimate of the dollar value of coupons expected to be redeemed, the dollar amount owed back to the retailer and co-pay discount as variable consideration since the Company intends to continuously issue coupons, advertising promotion and co-pay discount from time to time. This coupon estimate is based on historical experience and is adjusted as needed based on actual redemptions. Upon receiving confirmation that an advertising promotion was run, the Company adjusts

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the estimate of the dollar amount expected to be owed back to the retailer as needed. This estimate is then adjusted to actual upon receipt of an invoice from the retailer. Additionally, the Company provides consumer co-pay discount cards, administered through outside agents to provide discounted products when redeemed. The Company records an estimate of the dollar value of co-pay discounts expected to be utilized based on historical experience and is adjusted as needed based on actual experience.


Doubtful Accounts: Provisions for doubtful accounts, which reflect trade receivable balances owed to the Company that are believed to be uncollectible, are recorded as a component of selling, general and administrative ("SG&A") expenses. In estimating the allowance for doubtful accounts, the Company considers its historical experience with collections and write-offs, the credit quality of its customers and any recent or anticipated changes thereto, and the outstanding balances and past due amounts from its customers. Note that in the ordinary course of business, and consistent with our peers, we may from time to time offer extended payment terms to our customers as an incentive for new product launches or in other circumstances in accordance with standard industry practices. These extended payment terms do not represent a significant risk to the collectability of accounts receivable as of the period-end. Accounts are considered past due when they remain uncollected beyond the due date specified in the applicable contract or on the applicable invoice, whichever is deemed to take precedence.


Inventories: Inventories are stated at the lower of cost and net realizable value ("NRV") (see Note 5 - Inventories, net). The Company maintains an allowance for slow-moving and obsolete inventory as well as inventory where the cost is in excess

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of its NRV. For finished goods inventory, the Company estimates the amount of inventory that may not be sold prior to its expiration or is slow-moving based upon recent sales activity by unit and wholesaler inventory information. The Company also analyzes its raw material and component inventory for slow-moving items and NRV.


The Company capitalizes inventory costs associated with its products prior to regulatory approval when, based on management judgment, future commercialization is considered probable and future economic benefit is expected to be realized. The Company assesses the regulatory approval process and where the product stands in relation to that approval process including any known constraints or impediments to approval. The Company also considers the shelf life of the product in relation to the product timeline for approval.


Property, Plant and Equipment: Property, plant and equipment is stated at cost, less accumulated depreciation. Depreciation is providedcalculated using the straight-line method in amounts considered sufficient to amortize the cost of the assets to operations over their estimated useful lives.lives or lease terms.


Intangible Assets: Intangible assets consist primarily of goodwill, which is carried at its initial value, subject to impairment testing, In-Process Research and Development ("IPR&D"), which is accounted for as an indefinite-lived intangible asset, subject to impairment testing until completion or abandonment of the project, and product licensing costs, trademarks and other such costs, which are capitalized and amortized on a straight-line basis over their useful lives, normally ranging from one year to thirty years. The Company regularly assesses its amortizable intangible assets for impairment based on several factors, including estimated fair value and anticipated cash flows. If the Company incurs additional costs to renew or extend the life of an intangible asset, such costs are added to the remaining unamortized cost of the asset, if any, and the sum is amortized over the extended remaining life of the asset. Goodwill is tested for impairment annually or more frequently if changes in circumstances or the occurrence of events suggest that impairment may exist. The Company uses widely accepted valuation techniques to determine the fair value of its reporting units used in its annual goodwill impairment analysis. The Company’s valuation is primarily based on qualitative and quantitative assessments regarding the fair value of the reporting unit relative to its carrying value. The Company models the fair value of the reporting unit based on projected earnings and cash flows of the reporting unit.

Impairments of IPR&D are recorded within R&D expenses in the Consolidated Statements of Comprehensive Income, while all other impairments of intangible assets are recorded within the impairment of intangible assets line.line in the Condensed Consolidated Statements of Comprehensive (Loss).


Leases: The Company leases real and personal property in the normal course of business under various operating leases and other insignificant finance leases, including non-cancelable and month-to-month agreements. Our leases have initial lease terms of one to ten years, some of which include options to extend and/or terminate the lease. When deemed reasonably certain of exercise, the renewal options are included in the determination of the lease term and lease payment obligation. The Company’s lease agreements do not contain any material variable lease payments, material residual value guarantees or any material restrictive covenants. Certain leases have free rent periods or escalating rent payment provisions. Leases with an initial term of twelve months or less ("Short-term leases") are not recorded on the Condensed Consolidated Balance Sheet. We recognize rent expense on a straight-line basis over the lease term. Right-of-use ("ROU") assets, net represent the Company's right to use an underlying asset for the lease term and lease liabilities represent the obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at commencement date of the lease based on the present value of lease payments over the lease term. The operating lease ROU asset also include any lease prepayments and is reduced by any lease incentives. When readily determinable, the Company uses the implicit rate in determining the present value of lease payments. When the lease agreement does not provide an implicit rate, the Company uses its incremental borrowing rate based on information available at the lease commencement date, including the lease term. See Note 17 — Leasing Arrangements for more information.

Net (loss)(Loss) Income Per Common Share: Basic net (loss) income (loss) per common share is based upon the weighted average common shares outstanding. Diluted net (loss) income (loss) per common share is based upon the weighted average number of common shares outstanding, including the dilutive effect, if any, of stock options and restricted stock using the treasury stock method. Anti-dilutive shares are excluded from the computation of diluted net (loss) income (loss) per share.


Income Taxes:Income taxes are accounted for under the asset and liability method. Deferred income tax assets and liabilities are determined based on differences between financial reporting and tax bases of assets and liabilities, and net operating loss and other tax credit carry-forwards. These items are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company records a valuation allowance to reduce the deferred income tax assets to the amount that is more likely than not to be realized. On December 22, 2017, the Tax Cuts and Jobs Act (the “Tax Act”) was enacted into law and the new legislation contains several key tax provisions including a one-time mandatory transition tax on accumulated foreign earnings and a reduction of the corporate income tax rate to 21%, among others. We are

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required to recognize the effect of the tax law changes in the period of enactment, such as re-measuring our U.S. deferred tax assets and liabilities and reassessing the net realizability of our deferred tax assets and liabilities. The Company’s foreign subsidiaries do not have accumulated earnings that can be distributed; therefore, the provisions of the Act related to the repatriation of foreign earnings are not applicable to the Company at December 31, 2017 or June 30, 2018. In December 2017, the SEC staff issued Staff Accounting Bulletin No. 118, Income Tax Accounting Implications of the Tax Cuts and Jobs Act (SAB 118), which allows us to record provisional amounts during a measurement period not to extend beyond one year of the enactment date. See Note 14 — Income Taxes for more information.

Fair Value of Financial Instruments:The Company applies ASC 820 - Fair Value Measurement, which establishes a framework for measuring fair value and clarifies the definition of fair value within that framework. ASC 820 - Fair Value Measurement defines fair value as an exit price, which is the price that would be received for an asset or paid to transfer a

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liability in the Company’s principal or most advantageous market in an orderly transaction between market participants on the measurement date. The fair value hierarchy established in ASC 820 - Fair Value Measurement generally requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. Observable inputs reflect the assumptions that market participants would use in pricing the asset or liability and are developed based on market data obtained from sources independent of the reporting entity. Unobservable inputs reflect the entity’s own assumptions based on market data and the entity’s judgments about the assumptions that market participants would use in pricing the asset or liability, and are to be developed based on the best information available in the circumstances.
 
The valuation hierarchy is composed of three levels. The classification within the valuation hierarchy is based on the lowest level of input that is significant to the fair value measurement.  The levels within the valuation hierarchy are described below:


-
Level 1—Assets and liabilities with unadjusted, quoted prices listed on active market exchanges. Inputs to the fair value measurement are observable inputs, such as quoted prices in active markets for identical assets or liabilities. The carrying value of the Company's cash and cash equivalents are considered Level 1 assets.


-
Level 2—Inputs to the fair value measurement are determined using prices for recently traded assets and liabilities with similar underlying terms, as well as directly or indirectly observable inputs, such as interest rates and yield curves that are observable at commonly quoted intervals. The Company has no Level 2 assets or liabilities in any of the periods presented.


-
Level 3—Inputs to the fair value measurement are unobservable inputs, such as estimates, assumptions, and valuation techniques when little or no market data exists for the assets or liabilities. The portion of the fair valuation of the available-for-sale investment held in shares of Nicox stock that is subject to a lock-up provision is considered a Level 3 asset. The additional consideration payable as a result of prior years' acquisitions and other insignificant contingent amounts are considered Level 3 liabilities.


The following table summarizes the basis used to measure the fair values of the Company’s financial instruments (amounts in thousands):
  Fair Value Measurements at Reporting Date, Using:  Fair Value Measurements at Reporting Date, Using:
DescriptionJune 30, 2018 
Quoted Prices
in Active
Markets for
Identical Items
(Level 1)
 
Significant
Other
Observable
Inputs
(Level 2)
 
Significant
Unobservable
Inputs
(Level 3)
March 31, 2019 
Quoted Prices
in Active
Markets for
Identical Items
(Level 1)
 
Significant
Other
Observable
Inputs
(Level 2)
 
Significant
Unobservable
Inputs
(Level 3)
Cash and cash equivalents$296,782
 $296,782
 $
 $
$184,090
 $184,090
 $
 $
Nicox stock with lockup provisions29
 
 
 29
18
 
 
 18
Total assets$296,811
 $296,782
 $
 $29
$184,108
 $184,090
 $
 $18
       
Purchase consideration payable$201
 $
 $
 $201
Total liabilities$201
 $
 $
 $201
 

DescriptionDecember 31, 2018 
Quoted Prices
in Active
Markets for
Identical Items
(Level 1)
 
Significant
Other
Observable
Inputs
(Level 2)
 
Significant
Unobservable
Inputs
(Level 3)
Cash and cash equivalents$224,868
 $224,868
 $
 $
Nicox stock with lockup provisions18
 
 
 18
Total assets$224,886
 $224,868
 $
 $18

In accordance with ASC 820 - Fair Value Measurement, the Company records unrealized holding gains and losses on available-for-sale securities in the “Accumulated other comprehensive (loss)” caption in the Condensed Consolidated Balance Sheet. As of March 31, 2019, the Company maintained rights to receive a small number of shares of Nicox stock held in an expense escrow. The unrealized holding loss on these shares was a negligible dollar amount as of March 31, 2019. The escrow shares are not expected to be released within one year, and accordingly, the original cost basis of less than $0.1 million on these shares is included within other non-current assets on the Company’s Condensed Consolidated Balance Sheet as of March 31,

[14]16]







2019. The fair value of the investment is estimated using observable and unobservable inputs to discount for lack of marketability.
DescriptionDecember 31, 2017 
Quoted Prices
in Active
Markets for
Identical Items
(Level 1)
 
Significant
Other
Observable
Inputs
(Level 2)
 
Significant
Unobservable
Inputs
(Level 3)
Cash and cash equivalents$368,119
 $368,119
 $
 $
Nicox stock with lockup provisions35
 
 
 35
Total assets$368,154
 $368,119
 $
 $35
        
Purchase consideration payable$3,901
 $
 $
 $3,901
Total liabilities$3,901
 $
 $
 $3,901

As of June 30, 2018, the purchase consideration payable balance is attributed to a supply obligation related to one of our divested products.

Stock-Based Compensation: Stock-based compensation cost is estimated at grant date based on the fair value of the award, and the cost is recognized as expense ratably over the vesting period. The Company uses the Black-Scholes model for estimating the grant date fair value of stock options. Determining the assumptions to be used in the model is highly subjective and requires judgment. The Company uses an expected volatility that is based on the historical volatility of its common stock. The expected life assumption is based on historical employee exercise patterns and employee post-vesting termination behavior. The risk-free interest rate for the expected term of the option is based on the average market rate on U.S. Treasury securities of similar term in effect during the quarter in which the options were granted. The dividend yield reflects the Company’s historical experience as well as future expectations over the expected term of the option. The Company estimates forfeitures at the time of grant and revises the estimate in subsequent periods, as necessary, if actual forfeitures differ from initial estimates.


The stock-based compensation expense related to performance share units (“PSUs”) is estimated at grant date based on the fair value of the award. For PSUs granted with vesting subject to market conditions, the fair value of the award is determined at grant date using an advanced option-pricing model, such as a Monte Carlo model, and expense is recognized ratably over the requisite service period regardless of whether or not the market condition is satisfied. For PSUs granted with vesting subject to performance conditions, the fair value of the award is based on the market price of the underlying shares on grant date. Expense from such awards is recognized ratably over the vesting period, but is based upon an ongoing evaluation of the number of shares expected to vest and will be adjusted to reflect those awards that do ultimately vest.

The stock-based compensation expense related to restricted stock unit awards (“RSUs”) is based on the fair value of the underlying shares on date of grant. Expense is recognized ratably over the vesting period, reduced by an estimate of future forfeitures.

Note 3 — Stock Options, Restricted Stock Units and Employee Stock Purchase Plan

The Company maintains equity compensation plans that allow the Company’s Board of Directors to grant stock options and other equity awards to eligible employees, officers, directors and consultants.  On April 27, 2017, the Company’s shareholders voted to approve the Akorn, Inc. 2017 Omnibus Incentive Compensation Plan (the “Omnibus Plan”). Under the Omnibus Plan, 8.0 million shares of the Company’s common stock were made available for issuance pursuant to equity awards. The Omnibus Plan replaced the Akorn, Inc. 2014 Stock Option Plan (the "2014 Plan"), which was approved by shareholders at the Company's 2014 Annual Meeting of Shareholders on May 2, 2014 and subsequently amended by proxy vote of the Company’s shareholders on December 16, 2016. The 2014 Plan had reserved 7.5 million shares for issuance upon the grant of stock options, restricted stock units (“RSUs”), performance share unit awards ("PSUs") or various other instruments to directors, employees and consultants.  Following shareholder approval of the Omnibus Plan, no new awards could be granted under the 2014 Plan, although previously granted awards remain outstanding pursuant to their original terms.
As of June 30, 2018,March 31, 2019, there were approximately 3.73.2 million stock options and 0.20.1 million RSU shares outstanding under the 2014 Plan. The 2014 Plan had replaced the Amended and Restated Akorn, Inc. 2003 Stock Option Plan (the “2003 Plan”), which expired on November 6, 2013. As of June 30, 2018, approximately sixteen thousand stock options wereNo awards remain outstanding under the 2003 Plan.


Under the Omnibus Plan, 2.0there were approximately 3.8 million RSUs have been granted to employeesRSU shares, 1.0 million PSU shares and directors, of which approximately 0.20.5 million have vested and been released, and 0.1 million have been forfeited, leaving 1.7 million RSUsstock option award shares outstanding as of June 30, 2018. No stock options have been granted under the Omnibus Plan.March 31, 2019. As of June 30, 2018,March 31, 2019, approximately 6.12.2 million shares remainremained available for future award grants under the Omnibus Plan.


Also granted in, and outstanding as of the three month period ended March 31, 2019, were inducement awards consisting of 0.5 million RSU shares, 0.2 million PSU shares and 0.4 million stock option award shares.

The Company accounts for stock-based compensation in accordance with ASC Topic 718 - Compensation — Stock Compensation. Accordingly, stock-based compensation cost for stock options and RSUs is estimated at the grant date based on the fair value of the award, and the cost is recognized as expense ratably over the vesting period. The Company uses the Black-Scholes model for estimating the grant date fair value of stock options. Determining the assumptions that enter into the model is highly subjective and requires judgment. The Company uses an expected volatility that is based on the historical volatility of its stock. The expected life assumption is based on historical employee exercise patterns and employee post-vesting termination behavior. The risk-free interest rate for the expected term of the option is based on the average market rate on U.S. Treasury securities in effect during the quarter in which the options were granted. The dividend yield reflects historical

[17]




experience as well as future

[15]




expectations over the expected term of the option. The Company estimates forfeitures at the time of grant and revises in subsequent periods, as necessary, if actual forfeitures differ from those estimates.


PSU awards granted with vesting subject to market conditions are valued at date of grant through a Monte Carlo simulation model. The calculated grant-date fair value is recognized ratably over the vesting period, subject to forfeiture estimates. PSU awards granted with vesting subject to, and determined by, performance conditions are valued at grant based on the closing price of the Company’s stock and anticipated vesting level at grant date. The awards are re-evaluated quarterly to determine the vesting level that is more likely than not to be achieved, and cumulative expense is adjusted accordingly.

The Company uses the single-award method for allocating compensation cost related to stock options to each period. The following table sets forth the components of the Company’s share-based compensation expense for the three month period ended March 31, 2019 and six month periods ended June 30, 2018 and 2017 (in thousands):
 Three Months Ended
March 31,
 2019 2018
Stock options$1,381
 $3,159
Employee stock purchase plan229
 
Restricted stock units and Performance share units3,110
 2,349
Total stock-based compensation expense$4,720
 $5,508
 Three Months Ended
June 30,
 Six Months Ended
June 30,
 2018 2017 2018 2017
Stock options$2,477
 $2,956
 $5,636
 $6,270
Employee stock purchase plan
 275
 
 537
Restricted stock units3,468
 1,904
 5,817
 3,037
Total stock-based compensation expense$5,945
 $5,135
 $11,453
 $9,844

 
Stock Option awards


From time to time, the Company has granted stock option awards to certain employees, executives and directors. No stock options were granted in 2018. Set forth in the following table are the weighted-average assumptions used in estimating the grant date fair value of the stock options granted under the Company's equity compensation plans during the sixthree month period ended June 30, 2017,March 31, 2019, along with the weighted-average grant date fair values:
 Three Months Ended
March 31,
 2019 2018
Expected volatility67% %
Expected life (in years)6.2
 
Risk-free interest rate2.52% %
Dividend yield
 
Fair value per stock option$2.44
 $
Forfeiture rate8% %
 Three Months Ended
June 30,
 Six Months Ended
June 30,
 2018 2017 2018 2017
Expected volatility% % % 50%
Expected life (in years)
 
 
 4.8
Risk-free interest rate% % % 1.75%
Dividend yield
 
 
 
Fair value per stock option$
 $
 $
 $9.25
Forfeiture rate% % % 8%

 
The table below sets forth a summary of stock option activity within the Company’s stock-based compensation plans for the sixthree month period ended June 30, 2018:March 31, 2019: 
 
Number of
Options
(in thousands)
 
Weighted
Average
Exercise Price
 
Weighted
Average
Remaining
Contractual
Term (Years)
 
Aggregate
Intrinsic Value
(in thousands) (1)
Outstanding at December 31, 20183,418
 $28.55
 3.69 $
Granted860
 3.90
    
Exercised
 
    
Forfeited(196) 27.61
    
Outstanding at March 31, 20194,082
 $23.40
 4.38 $
Exercisable at March 31, 20192,599
 $28.64
 2.61 $



[18]



 
Number of
Options
(in thousands)
 
Weighted
Average
Exercise Price
 
Weighted
Average
Remaining
Contractual
Term (Years)
 
Aggregate
Intrinsic Value
(in thousands) (1)
Outstanding at December 31, 20174,053
 $28.95
 4.56 $21,459
Granted
 
    
Exercised(22) 24.99
    
Forfeited(298) 24.76
    
Outstanding at June 30, 20183,733
 $29.30
 4.04 $
Exercisable at June 30, 20182,164
 $30.08
 3.44 $


(1) The Aggregate Intrinsic Value of stock options outstanding and exercisable is defined as the difference between the market value of the Company’s common stock as of the date indicated and the exercise price of the stock options. Stock options for which the exercise price exceeded the market price have been omitted. Fluctuations in the intrinsic value of both outstanding and exercisable options may result from changes in underlying stock price and the timing and volume of option grants, exercises and forfeitures.


[16]




During the three month period ended June 30, 2018, no stock options were exercised, while during the six month period ended June 30, 2018, approximately twenty-two thousand stock options were exercised resulting in cash payments to the Company of $0.5 million. These stock option exercises generated tax deductible expense of $0.2 million. During the three and six month periods ended June 30, 2017, 0.4 million and 0.5 million stock options were exercised resulting in cash payments to the Company of $5.9 million and $7.1 million, respectively. These stock option exercises generated tax deductible expense of $6.1 million and $6.9 million, respectively.


Restricted Stock Unit awards


From time to time, the Company has granted RSUs to certain employees, executives and directors. TheHistorically, the majority of theRSU grants to employees and executives arehave been pursuant to the Company's Long-Term Incentive Plans (the "LTIPs"), which call for annual grants of RSUs to all eligible employees and executives. The RSU awards vest 25% per year on each of the first four anniversaries of the grant date. All RSUs are valued at the closing market price of the Company’s common stock on the day of grant and the total value of the units is recognized as expense ratably over the vesting period of the grant. During the sixthree month period ended June 30, 2018,March 31, 2019, the Company granted 1.33.2 million RSUs to certain employees, executives and directors. Of this total, 2.7 million RSUs were granted to certain employees as a retention incentive. These awards vest in full two years after grant date. The remaining 0.5 million RSUs were granted as an inducement award to the Company’s new CEO.


Set forth below is a summary of unvested RSU activity during the sixthree month period ended June 30, 2018:March 31, 2019:
 
Number of Units
(in thousands)
 
Weighted Average Per Share
Grant Date Fair Value
Unvested at December 31, 20181,643 $19.85
Granted3,197 $4.02
Vested(273) $23.75
Forfeited(153) $16.44
Unvested at March 31, 20194,414 $9.52

During the three month period ended March 31, 2019, approximately 0.3 million RSU shares vested and were released, generating tax-deductible expenses totaling $1.0 million, while no RSU shares vested during the three month period ended March 31, 2018.

Performance Share Unit awards

During the quarter ended March 31, 2019, the Company granted 1.2 million PSU award shares to certain executives. Of this total, 1.0 million vest two years after grant with vesting level contingent upon meeting various performance conditions, while the remaining 0.2 million vest four years after grant with vesting level contingent on various market conditions. No PSU awards were granted by the Company prior to the quarter ended March 31, 2019.

Set forth below is a summary of unvested PSU activity during the three month period ended March 31, 2019:
 
Total Number of Units
(in thousands)
Weighted Average Grant Date Fair Value per Unit Vesting Based on Performance ConditionsWeighted Average Grant Date Fair Value per Unit Vesting Based on Market ConditionsWeighted Average Grant Date Fair Value per Unit
Unvested at December 31, 2018
$
 
$
 
$
Granted1,239
3.99
 985
4.06
 254
3.73
Vested

 

 

Forfeited

 

 

Unvested at March 31, 20191,239
$3.99
 985
$4.06
 254
$3.73


Set forth below is a summary of the valuation inputs for PSUs granted with vesting subject to market conditions during the three month period ended March 31, 2019:

[19]



 
Number of Units
(in thousands)
 
Weighted Average Per Share
Grant Date Fair Value
Unvested at December 31, 2017888 $32.56
Granted1,308 $19.28
Vested(170) $32.40
Forfeited(63) $25.09
Unvested at June 30, 20181,963 $23.96


Valuation Inputs for PSUs with Vesting Subject to Market Conditions: 
PSUs Issued (units in thousands)254
Risk Free Rate2.58%
Volatility55.10%
Dividend%
Valuation Per Share$3.73
Total Fair Value (in thousands)$947
  
Expected Term (years)4
  
Forfeiture Rate Assumed8.00%


Employee Stock Purchase Plan


The 2016 Akorn, Inc. Employee Stock Purchase Plan (the “ESPP”) permits eligible employees to acquire shares of the Company’s common stock through payroll deductions. The ESPP has been structured to qualify under Section 423 of the Internal Revenue Code (“IRC”). Employees who elect to participate in the ESPP may withhold from 1% to 15% of eligible wages toward the purchase of stock. Shares will be purchased at a 15% discount off the lesser of the market price at the beginning or the ending of the applicable offering period. The ESPP is designed with two offering periods each year, one running from January 1st to December 31st and the other running from July 1st to December 31st. In a given year, employees may enroll in only one offering period, not both. Per IRC rules, annual purchases per employee are limited to $25,000 worth of stock, valued as of the beginning of the offering period. Accordingly, with the 15% discount, employees may withhold no more than $21,250 per year toward the purchase of stock under the ESPP. Employees are further limited to purchasing no more than 15,000 shares of stock per year. The ESPP was approved by vote of the Company’s shareholders on December 16, 2016. A total of 2.0 million shares of the Company’s stock have been set aside for issuance under the ESPP, of which 146,247 shares have been issued to date. The ESPP was approved by vote

During the quarter ended March 31, 2019, participants contributed approximately $0.5 million through payroll deductions toward the future purchase of the Company’s shareholders on December 16, 2016.

Pursuant to terms of the Merger Agreement, the Company has not initiated any new offering periods subsequent to entering into the Merger Agreement.  Accordingly, no offering periods are currently activeshares under the ESPP.


Note 4 — Accounts Receivable, Sales and Allowances
 
The nature of the Company’s business inherently involves, in the ordinary course, significant amounts and substantial volumes of transactions and estimates relating to allowances for product returns, chargebacks, rebates, doubtful accounts and discounts given to customers. This is typical of the pharmaceutical industry and is not necessarily specific to the Company. Depending on the product, the end-user customer, the specific terms of national supply contracts and the particular arrangements with the Company’s wholesaler customers, certain rebates, chargebacks and other credits are deducted from the Company’s accounts receivable. The process of claiming these deductions depends on wholesalers reporting to the Company the amount of deductions that were earned under the terms of the respective agreement with the end-user customer (which in turn depends on the specific end-user customer, each having its own pricing arrangement that entitles it to a particular deduction). This process can lead to partial payments to the Company against outstanding invoices as the wholesalers take the claimed deductions at the time of payment.
 

[17]




With the exception of the provision for doubtful accounts, which is reflected as part of selling, general and administrative expense, the provisions for the following customer reserves are reflected as a reduction of revenues in the accompanying condensed consolidated statementsCondensed Consolidated Statements of comprehensive (loss) income.Comprehensive (Loss). Additionally, with the exception of administrative fees and others, which is included as a current liability, the ending reserve balances are included in trade accounts receivable, net in the Company’s condensed consolidated balance sheets.Condensed Consolidated Balance Sheets.
 
Trade accounts receivable, net consists of the following (in thousands):

[20]



 June 30,
2018
 December 31,
2017
Gross accounts receivable$375,051
 $378,759
Less reserves for:   
Chargebacks (1)(68,289) (73,984)
Rebates (1)(67,766) (111,945)
Product returns(40,737) (41,687)
Discounts and allowances(8,215) (7,779)
Advertising and promotions(2,118) (1,301)
Doubtful accounts(608) (680)
Trade accounts receivable, net$187,318
 $141,383


 March 31,
2019
 December 31,
2018
Gross accounts receivable (1)$361,065
 $308,305
Less reserves for:   
Chargebacks (2)(67,474) (55,312)
Rebates (2)(74,723) (55,963)
Product returns(34,411) (35,146)
Discounts and allowances(7,740) (6,561)
Advertising and promotions(1,769) (1,574)
Doubtful accounts(623) (623)
Trade accounts receivable, net$174,325
 $153,126


(1) The reductionsincrease in the Gross accounts receivable balance as of March 31, 2019, when compared to the December 31, 2018 balance is due to higher accounts receivable carryover due to timing of sales during the compared period.

(2) The increase in the Chargebacks and Rebates balances as of June 30, 2018March 31, 2019, when compared to the December 31, 20172018 balance were primarily due to payment timing, product mix, customer mix and lowerhigher wholesaler inventory. Additionally, a change in contractual terms with a major customer in the first quarter of 2018 resulted in an increase in chargebacks and a decrease in rebates, which is also a contributing factor in the variances between the two periods compared.


For the three and six month periods ended June 30,March 31, 2019 and 2018, and 2017, the Company recorded the following adjustments to gross sales (in thousands):
 Three Months Ended
March 31,
 2019 2018
Gross sales$458,641
 $520,533
Less adjustments for:   
Chargebacks (1)(205,394) (223,963)
Rebates, administrative and other fees (1)(64,264) (92,279)
Product returns (2)(11,902) (7,121)
Discounts and allowances(9,050) (10,238)
Advertising, promotions and others(2,160) (2,869)
Revenues, net$165,871
 $184,063

 Three Months Ended
June 30,
 Six Months Ended
June 30,
 2018 2017 2018 2017
Gross sales$507,819
 $567,112
 $1,028,352
 $1,247,647
Less adjustments for:       
Chargebacks (1)(222,482) (237,275) (446,445) (517,437)
Rebates, administrative and other fees (1)(75,094) (109,760) (167,374) (234,138)
Product returns(6,133) (8,116) (13,254) (16,533)
Discounts and allowances(9,946) (10,830) (20,183) (23,752)
Advertising, promotions and others(3,220) (1,991) (6,089) (3,227)
Revenues, net$190,944
 $199,140
 $375,007
 $452,560


(1) The decreases in chargebacks and rebates, administrative and other fees for the three and six month periods ended June 30, 2018March 31, 2019 as compared to the same periods in 2017,2018, were primarily due to volume declines as well as product mix and customer mix.
(2) The increase in product returns for the three month periods ended March 31, 2019, as compared to the same periods in 2018, was primarily due to the timing of returns processing.
Note 5 — Inventories, Net
 
The components of inventories are as follows (in thousands):
 March 31,
2019
 December 31,
2018
Finished goods$68,876
 $76,981
Work in process14,060
 13,870
Raw materials and supplies79,816
 82,794
Inventories, net $162,752
 $173,645
 June 30,
2018
 December 31,
2017
Finished goods$84,594
 $79,226
Work in process15,053
 15,447
Raw materials and supplies91,394
 88,895
Inventories, net $191,041
 $183,568

[18]





 
The Company maintains an allowance for excess and obsolete inventory, as well as inventory for which its cost is in excess of its net realizable value. Inventory at June 30, 2018March 31, 2019 and December 31, 20172018, was reported net of these reserves of $33.5$48.5 million and $34.4$46.5 million, respectively.


[21]





Note 6 — Property, Plant and Equipment, Net
 
Property, plant and equipment, net consist of the following (in thousands):
 March 31,
2019
 December 31,
2018
Land and land improvements$17,516
 $17,608
Buildings and leasehold improvements138,526
 138,126
Furniture and equipment244,178
 240,080
Sub-total400,220
 395,814
Accumulated depreciation(166,300) (158,824)
Property, plant and equipment in service, net$233,920
 $236,990
Construction in progress 92,050
 97,863
Property, plant and equipment, net$325,970
 $334,853

 June 30,
2018
 December 31,
2017
Land and land improvements$17,578
 $17,846
Buildings and leasehold improvements113,632
 106,316
Furniture and equipment225,203
 202,897
Sub-total356,413
 327,059
Accumulated depreciation(143,750) (130,814)
Property, plant and equipment in service, net$212,663
 $196,245
Construction in progress 116,246
 117,173
Property, plant and equipment, net$328,909
 $313,418


At June 30, 2018March 31, 2019 and December 31, 2017,2018, property, plant and equipment, net, with a net carrying value of $86.0$94.0 million and $82.8$91.9 million, respectively, was located outside the United States.

During the six month period ended June 30, 2018, the increase in Property, Plant and Equipment is due primarily to spending on equipment for compliance with the Drug Supply Chain Security Act ("DSCSA") requirements and expansion initiatives at our Decatur and Somerset manufacturing plants.


At June 30, 2018,March 31, 2019, the Company had $116.2$92.1 million of assets under construction which consisted primarily of investment in building expansions, equipment, and compliance with DSCSA.the Drug Supply Chain Security Act ("DSCSA"). Depreciation will begin on these assets once they are placed into service. These projects are expected to be completed in 2018 and 2019. The Company assesses its long-lived assets, consisting primarily of property and equipment, for impairment when material events and changes in circumstances indicate that the carrying value may not be recoverable. There were noDuring the three month period ended March 31, 2019, the Company recorded impairment losses of $8.9 million, as a result of the Company announcing that it was exploring strategic alternatives to exit the India manufacturing facility. No impairment losses were recorded in 2018 or 2017.during three month period ended March 31, 2018.
 
The Company recorded depreciation expense of $7.0$7.6 million and $5.8$7.1 million during the three month periods ended June 30,March 31, 2019 and 2018, and 2017, respectively, and $14.1 million and $11.2 million during the six month periods ended June 30, 2018 and 2017, respectively.


Note 7 — Goodwill and Other Intangible Assets, Net


Intangible assets consist primarily of Goodwill, which is carried at its initial value, subject to evaluation for impairment, In-Process Research and Development (“IPR&D”), which is accounted for as an indefinite-lived intangible asset, subject to impairment testing until completion or abandonment of the project, and product licensing costs, trademarks and other such costs, which are capitalized and amortized on a straight-line basis over their useful lives, ranging from one to thirty years.


During the six month periods ended June 30,As of March 31, 2019 and 2018, and 2017, accumulated amortization of intangible assets was $244.9$224.0 million and $220.6$232.2 million, respectively. The Company recorded amortization expense of $13.2$11.1 million and $15.5$13.2 million during the three month periods ended June 30,March 31, 2019 and 2018, and 2017, respectively, and $26.4 million and $31.0 million during the six month periods ended June 30, 2018 and 2017, respectively.

The Company regularly assesses its amortizable intangible assets for impairment based on several factors, including estimated fair value and anticipated cash flows, and records any impairment expenses in the Consolidated Statements of Comprehensive (Loss) Income. If the Company incurs additional costs to renew or extend the life of an intangible asset, such costs are added to the remaining unamortized cost of the asset, if any, and the sum is amortized over the extended remaining life of the asset.flows.

Goodwill is tested for impairment annually or more frequently if changes in circumstances or the occurrence of events suggest that impairment may exist. The Company uses widely accepted valuation techniques to determine the fair value of its

[19]




reporting units used in its annual goodwill impairment analysis. The Company’s valuation is primarily based on qualitative and quantitative assessments regarding the fair value of the reporting unit relative to its carrying value. The Company also models the fair value of the reporting unit based on projected earnings and cash flows of the reporting unit. The Company performed a qualitative assessment of goodwill and did not identify any indicators of impairment during the quarter.

IPR&D intangible assets represent the value assigned to acquired R&D projects that principally represent rights to develop and sell a product that the Company has acquired which have not yet been completed or approved. These assets are subject to impairment testing until completion or abandonment of each project. Impairment testing requires the development of significant estimates and assumptions involving the determination of estimated net cash flows for each quarteryear for each project or product (including net revenue, cost of sales, R&D costs, selling and marketing costs and other costs which may be allocated), the appropriate discount rate to select in order to measure the risk inherent in each future cash flow stream, the assessment of each asset’s life cycle, the potential regulatory and commercial success risks, and competitive trends impacting the asset and each cash flow stream as well as other factors. The major risks and uncertainties associated with the timely and successful completion of the IPR&D projects include legal risk, market risk and regulatory risk. If applicable, upon abandonment of the IPR&D product, the assets are impaired.


During the three month period ended June 30, 2018, sevenMarch 31, 2019, no IPR&D projects were impaired, primarily due to the anticipated market conditions and competition upon launch, resulting in impairment expenses of $61.6 million, while during the three month period ended June 30, 2017,March 31, 2018, three IPR&D projects were impaired due to the Company recognizedCompany's expectations of market conditions upon launch, resulting in an impairment expense of $3.2 million for one product primarily due to market conditions upon launch.$17.9 million. Additionally, during the three month period ended June 30, 2018, threeMarch 31, 2019, one product licensing rights werewas impaired due to market conditions,competition resulting in impairment expenses of $2.9 $10.4

[22]




million; of which, $1.3 million was recorded to R&D expenses, compared to impairments of $4.7$0.9 million expenses on twoone product licensing rights due to competition during the comparative prior year period.


DuringGoodwill is tested for impairment annually or more frequently if changes in circumstances or the six month period ended June 30,occurrence of events suggest that impairment may exist. The Company uses widely accepted valuation techniques to determine the fair value of its reporting units used in its annual goodwill impairment analysis. The Company’s valuation is primarily based on qualitative and quantitative assessments regarding the fair value of the reporting unit relative to its carrying value. The Company also models the fair value of the reporting unit based on projected earnings and cash flows of the reporting unit. The Company performed an interim impairment test on October 1, 2018 ten IPR&D projects were impaired primarily dueand determined that the fair value of its reporting units are in excess of its carrying value and; therefore, no goodwill impairment charge was necessary. As a result of Akorn announcing that it was exploring strategic alternatives to anticipated market conditions and competition upon launch, resulting in impairment expenses of $79.5 million, while inexit the comparative prior year period,India manufacturing facility, the Company recognizedperformed impairment expensestesting as of $3.4 million for three products primarily due to market conditions upon launch. Additionally, during the six month period ended June 30, 2018, five product licensing rights were impaired due to market conditions resultingMarch 31, 2019, which resulted in a goodwill impairment expenses of $3.9 million; of which, $1.8 million was recorded to R&D expenses, compared to impairments of $4.7 million on two product licensing rights during the comparative prior year period.$16.0 million.

The following table provides a summary of the activity in goodwill by segment for the sixthree month period ended June 30, 2018March 31, 2019 (in thousands):
 
Consumer
Health
 
Prescription
Pharmaceuticals
 Total
Balances at December 31, 2018$16,717
 $267,162
 $283,879
Currency translation adjustments
 (1) (1)
Acquisitions
 
 
Impairments
 (15,955) (15,955)
Dispositions
 
 
Balances at March 31, 2019$16,717
 $251,206
 $267,923


 
Consumer
Health
 
Prescription
Pharmaceuticals
 Total
Balances at December 31, 2017$16,717
 $268,593
 $285,310
Currency translation adjustments
 (1,195) (1,195)
Acquisitions
 
 
Impairments
 
 
Dispositions
 
 
Balances at June 30, 2018$16,717
 $267,398
 $284,115


The following table sets forth the major categories of the Company’s intangible assets as of June 30, 2018March 31, 2019 and December 31, 2017,2018, and the weighted average remaining amortization period as of June 30, 2018March 31, 2019 and December 31, 20172018 (dollar amounts in thousands):


 
Gross
Amount (2)
 
Accumulated
Amortization
 Reclassifications Impairment (1) 
Net
Balance
 
Wtd Avg Remaining
Amortization Period
(years)
March 31, 2019           
Product licensing rights$472,041
 $(209,135) $
 $(15,000) $247,906
 8.9
IPR&D4,400
 
 
 
 4,400
 N/A - Indefinite lived
Trademarks16,000
 (6,535) 
 
 9,465
 17.4
Customer relationships4,225
 (2,383) 
 
 1,842
 7.1
Other intangibles6,000
 (5,969) 
 
 31
 0
 502,666
 $(224,022) $
 $(15,000) $263,644
  
December 31, 2018 
  
      
  
Product licensing rights$597,960
 $(203,323) $5,300
 $(131,306) $268,631
 9.2
IPR&D149,161
 
 (5,300) (139,461) 4,400
 N/A - Indefinite lived
Trademarks16,000
 (6,304) 
 
 9,696
 17.5
Customer relationships4,225
 (2,318) 
 
 1,907
 7.3
Other intangibles11,235
 (5,658) 
 (5,235) 342
 0.3
 $778,581
 $(217,603) $
 $(276,002) $284,976
  

(1) Impairment of product licensing rights is stated at gross carrying cost of $15.0 million less accumulated amortization of $4.6 million as of the impairment date. Accordingly, the total net impairment expense was $10.4 million, for the three month period ended March 31, 2019.

(2) Differences in the Gross Amounts between periods are due to the write down of fully amortized assets and additions during the period.


[20]23]






 
Gross
Amount
 
Accumulated
Amortization
 Reclass-ifications Gross Impairment 
Net
Balance
 
Wtd Avg Remaining
Amortization Period
(years)
June 30, 2018           
Product licensing rights$607,939
 $(229,970) $5,300
 $(4,375) $378,894
 9.0
IPR&D149,161
 
 (5,300) (79,473) 64,388
 N/A - Indefinite lived
Trademarks16,000
 (5,840) 
 
 10,160
 17.6
Customer relationships4,225
 (2,188) 
 
 2,037
 7.8
Other intangibles11,235
 (6,902) 
 
 4,333
 5.7
 $788,560
 $(244,900) $
 $(83,848) $459,812
  
December 31, 2017 
  
      
  
Product licensing rights$747,106
 $(205,549) $
 $(139,217) $402,340
 9.8
IPR&D173,757
 
 
 (24,596) 149,161
 N/A - Indefinite lived
Trademarks16,000
 (5,376) 
 
 10,624
 17.8
Customer relationships4,225
 (2,058) 
 
 2,167
 8.3
Other intangibles11,235
 (6,043) 
 
 5,192
 5.7
 $952,323
 $(219,026) $
 $(163,813) $569,484
  


Note 8 — Financing Arrangements


Term Loans


During 2014, in order to finance its acquisitions of Hi-Tech Pharmacal Co Inc. and VersaPharm Inc., Akorn, Inc., together with certain of its subsidiaries (Akorn, Inc., together with such subsidiaries, the Company“Akorn Loan Parties”), entered into two term loan agreements (the “Term Loan Agreements” and the loans outstanding thereunder, the “Term Loans”) with certain lenders (the “Lenders”) and with JPMorgan Chase Bank, N.A. (“JPMorgan”), as administrative agent.agent (the “Term Loan Administrative Agent”). The aggregate principal amount financedof the Term Loans was $1,045.0 million. As of June 30, 2018,March 31, 2019, outstanding debt under the Term LoansLoan Agreements was $831.9 million and themillion. The Company believes it was in full compliance with all applicable covenants in the Term Loan Agreements, which included customary limitations on indebtedness, distributions, liens, acquisitions, investments, and other activities. Theactivities, as of March 31, 2019. As of March 31, 2019, the Term Loans arewere scheduled to mature inon April 16, 2021.


During the three and six month periods ended June 30,March 31, 2019 and 2018, the Company amortized $1.3 million and $2.5$1.3 million, respectively of the deferred financing cost related to the Term Loans, resulting in $14.0$10.2 million remaining balance of deferred financing costs at June 30, 2018.March 31, 2019. The Company will amortize this balance using the straight-line method over the life of the Term Loan Agreements.


Subsequent to November 13, 2015, interest accrues based at the Company’s election, on an adjusted prime/federal funds rate (“ABR Loan”) or an adjusted LIBOR (“Eurodollar Loan”) rate, plus a margin of 4.00% for ABR Loans, and 5.00% for Eurodollar Loans. As of the date of the filing of this Form 10-Q until the maturity of the Term Loans,March 31, 2019, the Company's spread will bewas based upon the Ratings Level applicable on such date as documented below. As of June 30, 2018,March 31, 2019, the Company was a Ratings Level IIIII for the Existing Term Loan Facility.
Agreements.
Ratings Level
Index Ratings
(Moody’s/S&P)
Eurodollar SpreadABR Spread
Index Ratings
(Moody’s/S&P)
Adjusted LIBOR (Eurodollar) SpreadAdjusted Base Rate (ABR) Spread
Level IB1/B+ or higher4.25%3.25%B1/B+ or higher4.25%3.25%
Level IIB2/B4.75%3.75%B2/B4.75%3.75%
Level IIIB3/B- or lower5.50%4.50%B3/B- or lower5.50%4.50%


For the three month periods ended June 30,March 31, 2019 and 2018, and 2017, the Company recorded interest expense of $13.6$16.7 million and $11.1 million, respectively, in relation to the Term Loans, while for the six month periods ended June 30, 2018 and 2017, the Company recorded interest expense of $25.9 million and $22.0$12.3 million, respectively in relation to the Term Loans. The increase in interest expense is related to higher interest rates during the three month period ended March 31, 2019, compared to the same period in 2018.


On May 6, 2019, the Akorn Loan Parties entered into a Standstill Agreement and First Amendment (the “Standstill Agreement”) in respect of the Term Loan Agreements with an ad hoc group of Lenders (the “Ad Hoc Group”), certain other Lenders (together with the Ad Hoc Group, the “Standstill Lenders”) and the Term Loan Administrative Agent (together with the Akorn Loan Parties and the Standstill Lenders, the “Standstill Parties”). Capitalized terms used but not defined herein have the meanings given to them in the Standstill Agreement or the Term Loan Agreements, as applicable.

The Standstill Agreement provides that, for the duration of the Standstill Period (as defined below), among other matters, neither the Term Loan Administrative Agent nor the Lenders may (i) declare any Event of Default or (ii) otherwise seek to exercise any rights or remedies, in each case of clauses (i) and (ii) above, to the extent directly relating to any alleged Event of Default arising from any alleged breach of any of the covenants contained in Sections 5.01, 5.02, 5.03, 5.06 or 5.07 of the Term Loan Agreements (the “Specified Covenants”), to the extent the facts and circumstances giving rise to any such breach have been (x) publicly disclosed by the Company or (y) disclosed in writing by the Company to private side Lenders or certain advisors to the Ad Hoc Group (collectively, the “Specified Matters”). “Standstill Period” means the period of time from the effective date of the Standstill Agreement (the “Effective Date”) through the earliest of (a) December 13, 2019; (b) the delivery of a notice of termination of the Standstill Period by Lenders holding a majority of the Term Loans (the “Required Lenders”) upon the occurrence of a Default or Event of Default under the Term Loan Agreements, excluding any Default or Event of Default relating to a Specified Matter; or (c) the delivery of a notice of termination of the Standstill Period by the Required Lenders as a result of any breach of, or non-compliance with, any provision of the Standstill Agreement by the Akorn Loan Parties, including without limitation any such breach or noncompliance by the Akorn Loan Parties of or with any Affirmative Covenants and Milestones or Negative Covenants (each as defined below) or other covenants set forth in the Standstill Agreement, subject, in each case, to any applicable cure period expressly set forth therein (each, a “Standstill Event of Default”).
In exchange for the agreement of the Lenders to standstill during the Standstill Period, the Standstill Agreement provides, among other matters, that:

[24]




during the Standstill Period:

the Company must deliver certain financial and other reporting to the Lenders or their advisors, including monthly financial statements, 13-week cash flow forecasts and variance reports and certain regulatory information, and participate in various update calls with the Lenders and their advisors (the “Affirmative Covenants and Milestones”);

the Company and its subsidiaries are restricted, among other matters, from (i) consummating certain asset sales and investments, (ii) making certain restricted payments with respect to the Company’s common stock and any subordinated indebtedness, (iii) engaging in sale and leaseback transactions, (iv) incurring certain liens and indebtedness, (v) reinvesting any proceeds received from certain asset sales, and (vi) without the consent of the Required Lenders at such time, (A) designating any Restricted Subsidiary as an Unrestricted Subsidiary, or otherwise creating or forming any Unrestricted Subsidiary, and/or (B) transferring any assets of the Company or any of its Restricted Subsidiaries to any Unrestricted Subsidiary, except as otherwise permitted under the Term Loan Agreements (after giving effect to the Standstill Agreement) (collectively, the “Negative Covenants”);

the Company must pay a fee in an amount equal to 0.625% of the outstanding principal of any Term Loans prepaid or repaid during the Standstill Period (other than as a result of any asset sale, condemnation event, incurrence of non-permitted indebtedness or excess cash flow);

the Company must notify the Ad Hoc Group and/or such advisors before making certain payments in respect of judgments or settlements of ongoing litigation matters (a “Specified Litigation Payment”); and

the Company must pay the fees and expenses of certain advisors to the Ad Hoc Group;

the Company and the Standstill Lenders must negotiate in good faith to enter into a comprehensive amendment of the Term Loan Agreements (the “Comprehensive Amendment”), which Comprehensive Amendment must be satisfactory in form and substance to the Required Lenders;
on the Effective Date, the Company paid a one-time in-kind fee in an amount equal to 1.75% of the aggregate principal amount of the Term Loans of the Standstill Lenders outstanding on such date; and
the interest margins payable by the Company with respect to outstanding Term Loans (as described above) were increased by 1.50% (i.e., 150 basis points), with 0.75% (i.e., 75 basis points) of such increase payable in cash and 0.75% (i.e., 75 basis points) of such increase payable in kind.

Subject to a five business day cure period (the “Cure Period”), the Company’s failure to comply with the Affirmative Covenants and Milestones during the Standstill Period would permit the Required Lenders to terminate the Standstill Period and exercise any rights and remedies under the Term Loan Agreements with respect to the Specified Matters or a Standstill Event of Default. The Company’s failure to comply with the Negative Covenants during the Standstill Period would permit the Required Lenders to terminate the Standstill Agreement and constitute an immediate Event of Default under the Term Loan Agreements. The Company’s failure to comply with any Affirmative Covenants and Milestones (subject to the Cure Period), Negative Covenants or other covenants in the Standstill Agreement would also result in a further increase of the interest margins payable with respect to outstanding Term Loans by 0.50% (i.e., 50 basis points), which increased interest would be payable in kind.
Any Specified Litigation Payment made over the objection of the Ad Hoc Group would (i) entitle the Required Lenders to terminate the Standstill Period and (ii) constitute an Event of Default under the Term Loan Agreements if such payment has a Material Adverse Effect (as defined in the Term Loan Agreements). The failure of the Company to comply with the
covenant in respect of the Specified Litigation Payment during the Standstill Period would result in an Event of Default
under the Loan Agreement.

The failure to enter into a Comprehensive Amendment on or prior to November 15, 2019, would result in payment by the Company of a one-time in-kind fee in an amount equal to 0.625% of the Term Loans outstanding on such date and require the Akorn Loan Parties to pledge for the benefit of the Lenders all unpledged equity interests in foreign subsidiaries. The failure to enter into a Comprehensive Amendment on or prior to December 13, 2019, constitutes an immediate Event of Default under the Term Loan Agreements.

[25]




The execution of the Standstill Agreement should not be construed as (and does not constitute an admission as to) any right, remedy, claim, defense, liability or wrongdoing or responsibility on the part of any Standstill Party. Entry into the Standstill Agreement also should not be construed as (and does not constitute an admission as to) the occurrence of a Default or Event of Default. In the Standstill Agreement, the Standstill Lenders acknowledged that, as of the Effective Date, to the best of their knowledge, they were not aware of any potential Defaults or Events of Default under the Term Loan Agreements other than with respect to the Specified Covenants relating to the Specified Matters.
The Company will actively seek to refinance or otherwise address the Term Loans or enter into a “Comprehensive Amendment” to the Term Loan Agreements by December 13, 2019. Based on discussions with the Company’s financial advisor, the Company believes that it will be able to refinance or otherwise address the Term Loans within this timeframe. In the event that the Company is unable to refinance or otherwise address the Term Loans by such date, the Company would seek to enter into a “Comprehensive Amendment” to the Term Loan Agreements.
JPMorgan Credit Facility


[21]





On April 17, 2014, the Akorn Loan Parties entered into a Credit Agreement (the “JPM Credit Agreement”) with JPMorgan, as administrative agent, and Bank of America, N.A., as syndication agent, for certain otherand the lenders party thereto (at closing, JPMorgan, Bank of America, N.A. and Wells Fargo Bank, N. A.) for a $150.0 million revolving credit facility (the “JPM Revolving Facility”).


As of June 30, 2018, theThe Company believes it was in full compliance with all covenants applicable to the JPM Revolving Facility.Facility as of March 31, 2019.

The Company may use any proceeds from borrowings under the JPM Revolving Facility for working capital needs and for the general corporate purposes of the Company and its subsidiaries. At June 30, 2018,March 31, 2019, there were no outstanding borrowings under the JPM Revolving Facility, and availability was $135.0 million.

The JPM Credit Agreement places customary limitations on indebtedness, distributions, liens, acquisitions, investments, and other activities of the Akorn Loan Parties and their respective subsidiaries in a manner designed to protect the collateral while providing flexibility for growth and the historic business activities of the Company and its subsidiaries.


On April 16, 2019, the Akorn Loan Parties, entered into an Amended and Restated Credit Agreement (the “A&R Credit Agreement”) governing the JPM Revolving Facility with the lenders party thereto and JPMorgan Chase Bank, N.A., as administrative agent. The A&R Credit Agreement provides for a revolving line of credit of up to $150.0 million on an uncommitted basis, and amends the Existing Credit Agreement in certain other respects, including, among other things:
extending the maturity date by 90 days to July 16, 2019; and
decreasing the undrawn fee from 0.25% to 0.05%.

The JPM Revolving Facility, as amended by the A&R Credit Agreement, is fully uncommitted and discretionary with each lender under the A&R Credit Agreement permitted to make revolving loans or issue letters of credit in its sole discretion.

Debt Maturities Schedule

Aggregate cumulative maturities of long-termdebt obligations (including the Term Loans and the JPM Revolving Facility) as of June 30, 2018March 31, 2019 are:

(In thousands) 2019 2020 2021
Maturities of debt $  $  $831,938 

(In thousands)2018 2019 2020 2021
Maturities of debt$  $  $  $831,938 


Note 9 — (Loss) Earnings Per Share
 
Basic net (loss) income per common share is based upon the weighted average number of common shares outstanding during the period. Diluted net (loss) income per common share is based upon the weighted average number of common shares outstanding, including the dilutive effect, if any, of potentially dilutive securities using the treasury stock method.

The Company’s potentially dilutive shares consist of: (i) vested and unvested stock options that are in-the-money, and (ii) unvested RSUs.RSUs and PSUs.

A reconciliation of the (loss) earnings per share data from a basic to a fully diluted basis is detailed below (amounts in thousands, except per share data):

[26]



 Three Months Ended
June 30,
 Six Months Ended
June 30,
 2018 2017 2018 2017
Net (loss) income$(87,984) $2,537
 $(116,731) $43,564
Net (loss) income per share:       
Basic$(0.70) $0.02
 $(0.93) $0.35
Diluted$(0.70) $0.02
 $(0.93) $0.35
Shares used in computing net (loss) income per share: 
  
  
  
Weighted average basic shares outstanding125,332
 124,660
 125,286
 124,541
Dilutive securities: 
  
    
Stock option and unvested RSUs
 534
 
 314
Total dilutive securities
 534
 
 314
Weighted average diluted shares outstanding125,332
 125,194
 125,286
 124,855
        
Shares subject to stock options omitted from the calculation of (loss) income per share as their effect would have been anti-dilutive3,842
 2,268
 3,815
 3,991


 Three Months Ended
March 31,
 2019 2018
Net (loss)$(82,181) $(28,747)
Net (loss) per share:   
Basic$(0.65) $(0.23)
Diluted$(0.65) $(0.23)
Shares used in computing net (loss) per share: 
  
Weighted average basic shares outstanding125,566
 125,240
Dilutive securities: 
  
Stock option
 
Unvested RSUs and PSUs


 
Total dilutive securities
 
Weighted average diluted shares outstanding125,566
 125,240
    
Shares subject to stock options omitted from the calculation of (loss) per share as their effect would have been anti-dilutive3,917
 3,287
Shares subject to unvested RSUs and PSUs omitted from the calculation of (loss) per share as their effect would have been anti-dilutive

4,423
 70


Note 10 — Segment Information
 

[22]




During the three month period ended March 31, 2019 and six month periods ended June 30, 2018, and 2017, the Company reported results for the following two reportable segments:


-    Prescription Pharmaceuticals
-    Consumer Health


The Company’s Prescription Pharmaceuticals segment principally consists of generic and branded prescription pharmaceuticals products which span a broad range of indications as well as a variety of dosage forms including: sterile ophthalmics, injectables and inhalants, and non-sterile oral liquids, topicals and nasal sprays. The Company’s Consumer Health segment principally consists of animal health and OTC products, both branded and private label. OTC products include, but are not limited to, a suite of products for the treatment of dry eye sold under the TheraTears® brand name.


Financial information about the Company’s reportable segments is based upon internal financial reports that aggregate certain operating information. The Company’s Chief Operating Decision Maker (“CODM”), as defined in ASC 280 - Segment Reporting, who is also the CEO, oversees operational assessments and resource allocations based upon the results of the Company’s reportable segments, which have available and discrete financial information.


Selected financial information by reportable segment is presented below (in thousands):

[27]



 Three Months Ended
June 30,
 Six Months Ended
June 30,
 2018 2017 2018 2017
Revenues, net:       
Prescription Pharmaceuticals$172,163
 $182,645
 $336,464
 $420,024
Consumer Health18,781
 16,495
 38,543
 32,536
Total revenues, net190,944
 199,140
 375,007
 452,560
        
Gross Profit: 
  
  
  
Prescription Pharmaceuticals73,286
 95,906
 146,794
 236,862
Consumer Health7,993
 6,863
 16,713
 14,676
Total gross profit81,279
 102,769
 163,507
 251,538
        
Operating expenses172,845
 88,495
 280,488
 162,851
        
Operating (loss) income(91,566) 14,274
 (116,981) 88,687
Other expenses, net(12,690) (7,524) (23,302) (16,611)
        
(Loss) Income before income taxes$(104,256) $6,750
 $(140,283) $72,076


 Three Months Ended
March 31,
 2019 2018
Revenues, net:   
Prescription Pharmaceuticals$148,015
 $164,302
Consumer Health17,856
 19,761
Total revenues, net165,871
 184,063
    
Gross Profit: 
  
Prescription Pharmaceuticals45,443
 73,508
Consumer Health8,070
 8,720
Total gross profit53,513
 82,228
    
Operating expenses118,996
 107,643
    
Operating (loss)(65,483) (25,415)
    
Other expenses, net(15,278) (10,612)
    
(Loss) before income taxes$(80,761) $(36,027)


The Company manages its business segments to the gross profit level and manages its operating and other costs on a company-wide basis. Inter-segment activity at the gross profit level is minimal. The Company does not have discrete assets by segment, as certain manufacturing and warehouse facilities support more than one segment, and therefore does not report assets by segment. Financial information including revenues and gross profit from external customers by product or product line is not provided as to do so would be impracticable.


[23]





The following table sets forth the Company’s net revenues by geographic region for the three and six month periods ended June 30, 2018March 31, 2019 and 2017.2018. The Domestic region represents sales within the United States of America and its territories while the Foreign region represents sales within all other countries and territories (dollar amounts in thousands):
 
 Three Months Ended
March 31, 2019
 Three Months Ended
March 31, 2018
RegionAmount % of Total Revenues Amount % of Total Revenues
Domestic$164,134
 99.0% $181,015
 98.3%
Foreign1,737
 1.0% 3,048
 1.7%
Total Revenues$165,871
 100.0% $184,063
 100.0%



[28]

 Three Months Ended
June 30, 2018
 Three Months Ended
June 30, 2017
 Six Months Ended
June 30, 2018
 Six Months Ended
June 30, 2017
RegionAmount % of Total Revenues Amount % of Total Revenues Amount % of Total Revenues Amount % of Total Revenues
Domestic$186,726
 97.8% $193,314
 97.1% $367,740
 98.1% $439,018
 97.0%
Foreign4,218
 2.2% 5,826
 2.9% 7,267
 1.9% 13,542
 3.0%
Total Revenues$190,944
 100.0% $199,140
 100.0% $375,007
 100.0% $452,560
 100.0%




Note 11 – Share Repurchases


In July 2016, the Company announced that the Board of Directors authorized a stock repurchase program (the "Stock Repurchase Program") pursuant to which the Company may repurchase up to $200.0 million of the Company’s common stock. The shares may be repurchased from time to time in open market transactions at prevailing market prices, in privately negotiated transactions or others, including accelerated stock repurchase arrangements, pursuant to a Rule 10b5-1 repurchase plan or by other means in accordance with federal securities laws. The timing and the amount of any repurchases will be determined by the Company’s management based on its evaluation of market conditions, capital allocation alternatives, and other factors. There is no guarantee as to the number of shares that will be repurchased, and the repurchase program may be suspended or discontinued at any time without notice and at the Company's discretion, and at this time no estimate to the effect on the results of the Company due to the Stock Repurchase Program can be made.


The Company did not repurchase any shares during the sixthree month period ended June 30, 2018.March 31, 2019. In aggregate, over the life of the Stock Repurchase Program, the Company repurchased 1.8 million shares at an average purchase price of $24.89. As of June 30, 2018,March 31, 2019, the Company had $155.0 million remaining under the repurchase authorization.


Companies incorporated under Louisiana law are subject to the Louisiana Business Corporation Act ("LBCA"). Provisions of the LBCA eliminate the concept of treasury stock and require that shares repurchased by a company are to be treated as authorized but unissued shares instead of treasury stock. As a result, all stock repurchases are presented as a reduction to issued and outstanding shares of common stock.


Note 12 — Commitments and Contingencies


The Company has entered into strategic business agreements for the development and marketing of finished dosage form pharmaceutical products with various pharmaceutical development companies.
 
Each strategic business agreement includes a future payment schedule for contingent milestone payments and in certain strategic business agreements, minimum royalty payments. The Company will be responsible for contingent milestone payments and minimum royalty payments to these strategic business partners based upon the occurrence of future events. Each strategic business agreement defines the triggering event of its future payment schedule, such as meeting product development progress timeline, successful product testing and validation, successful clinical studies, various FDA and other regulatory approvals and other factors as negotiated in each agreement.  None of the contingent milestone payments or minimum royalty payments is individually material to the Company.
 
The Company is engaged in various supply agreements with third parties that obligate the Company to purchase various active pharmaceutical ingredients or finished products at contractual minimum levels. None of these agreements is individually or in aggregate material to the Company. Further, the Company does not believe at this time that any of the purchase obligations represent levels above that of normal business demands.


The table below summarizes contingent, potential milestone payments that would become due to strategic partners in the years 20182019 and beyond, assuming all such contingencies occur (in thousands):

Year ending December 31,Milestone Payments
2019$2,159
20201,890
20212,650
20221,800
Total$8,499


[24]




Year ending December 31,Milestone Payments
2018$6,124
20198,314
20205,070
2021 and Beyond950
Total$20,458


Legal Proceedings


The Company is a party to legal proceedings and potential claims arising in the ordinary course of our business. The amount, if any, of ultimate liability with respect to such matters cannot be determined, but despite the inherent uncertainties of litigation, management of the Company believes that the ultimate disposition of such proceedings and exposure will not have a material adverse impact on the financial condition, results of operations, or cash flows of the Company. Set forth below are material updates to other legal proceedings of the Company.


Shareholder and Derivative Litigation Related to the Terminated Merger


As previously disclosed, on May 2, 2017, a purported shareholder of the Company filed a complaint in a putative class and derivative action in the Circuit Court of Cook County, Illinois, County Department, Chancery Division, captioned Robert J. Shannon, Jr.
[29]





Akorn, Inc. v. Fresenius Kabi AG et al., Case No. 2017-CH-06322. The Shannon Action sought, among other things, to enjoin the transactions contemplated by the merger agreement or, in the alternative, to recover monetary damages. On April 30, 2018, the Circuit Court of Cook County, Illinois, County Department, Chancery Division granted the voluntary dismissal without prejudice of the Shannon Action pursuant to the plaintiff’s motion for dismissal.

On March 8, 2018, a purported shareholder of the Company filed a putative class action complaint entitled Joshi Living Trust v. Akorn, Inc. et al., in the United States District Court for the Northern District of Illinois alleging violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934. The complaint names as defendants the Company, Chief Executive Officer Rajat Rai, Chief Financial Officer Duane Portwood and Chief Accounting Officer Randall Pollard. The complaint alleges that defendants made materially false or misleading statements and/or material omissions by failing to disclose sooner the existence of investigations into data integrity at the Company. The Complaint seeks, among other things, an award of damages, attorneys’ fees and expenses. The Company disputes these claims. On May 24, 2018, the Court ordered that the lead plaintiff file an amended complaint not later than September 5, 2018, that defendants respond to the amended complaint by November 5, 2018. On May 31, 2018, the Court issued an order appointing Gabelli & Co. Investment Advisors, Inc. and Gabelli Funds, LLC as lead plaintiffs pursuant to the Private Securities Litigation Reform Act (“PSLRA”), and approving their selection of lead counsel and liaison counsel. On June 14, 2018, lead plaintiffs filed a motion to lift the PSLRA stay of discovery. On June 22, 2018, the Company filed a memorandum in opposition to the motion to lift the PSLRA stay. On June 26, 2018, the Court denied the motion to lift the PSLRA stay, subject to entry of a preservation order.

Additional Litigation Related to the Merger

On April 22, 2018, Fresenius Kabi AG delivered to Akorn a letter purporting to terminate the Merger Agreement. On April 23, 2018, Akorn filed a verified complaint entitled Akorn, Inc. v. Fresenius Kabi AG, Quercus Acquisition, Inc. and Fresenius SE & Co. KGaA, in the Court of Chancery of the State of Delaware for breach of contract and declaratory judgment. The complaint alleges,alleged, among other things, that (i) the defendants anticipatorily breached their obligations under the Merger Agreement by repudiating their obligation to close the Merger, (ii) the defendants knowingly and intentionally breached their obligations under the Merger Agreement by working to slow the antitrust approval process and by engaging in a series of actions designed to hamper and ultimately block the Merger and (iii) Akorn hashad performed its obligations under the Merger Agreement, and iswas ready, willing and able to close the Merger. The complaint seeks,sought, among other things, a declaration that Fresenius Kabi AG's termination iswas invalid, an order enjoining the defendants from terminating the Merger Agreement, and an order compelling the defendants to specifically perform their obligations under the Merger Agreement to use reasonable best efforts to consummate and make effective the Merger. On April 30, 2018, the defendants filed a verified counterclaim alleging that, due primarily to purported data integrity deficiencies, at Akorn, the Company had breached representations, and warranties and covenants in the Merger Agreement, and that it had experienced a material adverse effect. The verified counterclaim seeks,sought, among other things, a declaration that defendants’ purported termination of the Merger Agreement was valid and that defendants arewere not obligated to consummate the transaction.


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transaction, and damages.
Following expedited discovery, from July 9 to 13, 2018, the Court of Chancery held a trial on the parties’ claims (collectively, the(the “Delaware Action”). At the conclusion of trial, the Court of Chancery ordered post-trial briefing, which is scheduled to bewas completed on August 20, 2018. The Court has scheduled2018, and a post-trial hearing, forwhich was held on August 23, 2018. Akorn expects to receive the Court’s ruling after the post-trial hearing. Any decision by
On October 1, 2018, the Court of Chancery willissued an opinion (the “Opinion”) denying Akorn’s claims for relief and concluding that Fresenius Kabi AG had validly terminated the Merger Agreement. The Court of Chancery concluded that Akorn had experienced a material adverse effect due to its financial performance following the signing of the Merger Agreement; that Akorn had breached representations and warranties in the Merger Agreement and that those breaches would reasonably be subjectexpected to give rise to a potentialmaterial adverse effect; that Akorn had materially breached covenants in the Merger Agreement; and that Fresenius was materially in compliance with its own contractual obligations. On October 17, 2018, the Court of Chancery entered partial final judgment against Akorn on its claims and in favor of the Fresenius parties on their claims for declaratory judgment. The Court of Chancery entered an order holding proceedings on the Fresenius parties’ damages claims in abeyance pending the resolution of any appeal tofrom the partial final judgment.
On October 18, 2018, Akorn filed a notice of appeal from the Opinion and the partial final judgment, as well as a motion seeking expedited treatment of its appeal. On October 23, 2018, the Delaware Supreme Court.Court granted Akorn's motion for expedited treatment and set a hearing on Akorn's appeal for December 5, 2018. On December 7, 2018, the Delaware Supreme Court affirmed the Court of Chancery’s opinion denying Akorn’s claims for declaratory and injunctive relief and granting Defendants’ counterclaim for a declaration that the termination was valid. On December 27, 2018, the Delaware Supreme Court issued a mandate returning the case to the Court of Chancery for consideration of all remaining issues, including the Fresenius parties’ damages claims.

On January 15, 2019, the parties filed a joint letter to the Court of Chancery seeking thirty days to discuss the potential resolution of the Fresenius parties’ damages claims. On February 19, 2019, the parties filed a joint letter advising the Court that they have been unable to resolve the Fresenius parties’ damages claims. The Fresenius parties stated their intention to seek leave to amend their counterclaims to assert a new claim for fraud and that they would seek an expedited trial on such claim purportedly due to Akorn’s financial condition. Akorn stated that it expected to oppose the motions for amendment and expedition, and that it would move to dismiss the Fresenius parties’ damages claims in their entirety.
On February 20, 2019, the Fresenius parties filed a motion for leave to amend and supplement their counterclaim. The Fresenius parties’ proposed amended and supplemented counterclaim alleged that Akorn fraudulently induced Fresenius to enter into the Merger Agreement and thereafter breached contractual representations and warranties and covenants therein. It sought damages of approximately $102 million. On February 25, 2019, Akorn filed an opposition to the Fresenius parties’ motion for leave to amend and supplement their counterclaim, arguing that the motion was untimely and prejudicial. On February 27, 2019, the Fresenius parties filed a reply in further support of their motion to file an amended and supplemented counterclaim. On February 28, 2019, the Court of Chancery denied the Fresenius parties’ motion for leave to file an amended and supplemented counterclaim. On March 15, 2019, the Fresenius parties served interrogatories in furtherance of their claim for damages purportedly resulting from breaches of contractual representations and warranties and covenants in the Merger Agreement.
Other Matters
As previously disclosed in various reports filed with the SEC, on March 4, 2015, a purported class action complaint was filed entitled Yeung
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State of Louisiana v. Akorn, Inc., et al., in the federal district court of Northern District of Illinois, No. 15-cv-1944.  The complaint alleged that the Company and three of its officers violated the federal securities laws in connection with matters related to its accounting and financial reporting in the wake of its acquisitions of Hi-Tech, Pharmaceutical Co., Inc. and VersaPharm, Inc.  A second, related case entitled Sarzynski v. Akorn, Inc., et al., No. 15-cv-3921, was filed on May 4, 2015 making similar allegations.  On August 24, 2015, the two cases were consolidated and a lead plaintiff appointed in In re Akorn, Inc. Securities Litigation.   On July 5, 2016, the lead plaintiff group filed a consolidated amended complaint making similar allegations against the Company and an officer and former officer of the Company. The consolidated amended complaint seeks damages on behalf of the putative class. On August 9, 2016, the defendants filed a motion to dismiss the case. On March 6, 2017, the court denied the motion to dismiss and the defendants subsequently filed an answer to the consolidated amended complaint on March 27, 2017. On October 3, 2017, the parties informed the court that they had reached a settlement in principle of the litigation. In December 2017, following the court's order preliminarily approving the class plaintiffs’ proposed settlement for $24 million, the Company paid $5.0 million and its insurers paid $19.0 million. The court granted final approval of the settlement, reduced plaintiffs’ counsel’s request for attorney fees, and closed the case on June 5, 2018.et. al
The Louisiana Attorney General filed suit, Number 624,522, State of Louisiana v. Abbott Laboratories, Inc., et al., in the Nineteenth Judicial District Court, Parish of East Baton Rouge, Louisiana state court, including Hi-Tech Pharmacal and other defendants. Louisiana’s complaint alleges that the defendants violated Louisiana state laws in connection with Medicaid reimbursement for certain vitamins, dietary supplements, and DESI products that were allegedly ineligible for reimbursement. The defendants filed exceptions of no cause of actionAfter extensive motion and no right of action in response to Louisiana’s amended complaint resulting in a judgment enteredappellate practice, on October 2, 2015, which dismissed all of Louisiana’s claims. Louisiana sought appellate review of the court’s decision. On October 21, 2016, the First Circuit Court of Appeal affirmed the trial court’s judgment in part, reversed it in part, and remanded the case for further proceedings.  On December 22, 2016, the First Circuit denied Louisiana’s application for rehearing with respect to the First Circuit’s affirmance. On January 20, 2017, Louisiana filed an application for certiorari in the Louisiana Supreme Court as to the portion of the First Circuit’s decision affirming the trial court’s judgment.  On January 23, 2017, the defendants filed an application for certiorari in the Louisiana Supreme Court as to the portion of the First Circuit’s decision reversing the trial court’s judgment. On March 13, 2017, the Louisiana Supreme Court denied both writ applications. On May 11, 2017, the defendants filed an exception of no cause of action in response to Louisiana’s amended complaint, which seeks the dismissal of Louisiana’s two remaining statutory claims. In a judgment entered on August 9,3, 2017, the trial court sustained defendants’ exception of no cause of action with respect to Louisiana’s claim under Louisiana’s Medicaid fraud statute.  The trial court issued a further judgment on October 3, 2017, holding that for the one remaining claim, brought under Louisiana’s unfair trade practices claim, Louisiana could not seek civil penalties for conduct pre-dating June 2, 2006. The defendants filed an application for supervisory writs with the Court of Appeal for the First Circuit on October 24, 2017, seeking reversal of the trial court’s denial of their no cause of action exception with respect to the unfair trade practices claim, which would completely dismiss the case.  After the defendants’ refiled the writ to cure a procedural defect, the First Circuit denied the writ on July 24, 2018. On December 21, 2018, the defendants filed their answer to the unfair trade practices claim, the sole remaining claim in the amended petition. On January 31, 2019, Louisiana filed a motion with the trial court raising a procedural argument that the other claims originally pled in the amended petition, including a common law claim for fraud and a statutory claim for fraud against the Louisiana Medicaid agency, had been improperly dismissed. That motion is presently scheduled for hearing in May 2019. There is no overall case schedule in place, and active discovery has not yet commenced.
In re Akorn, Inc. Data Integrity Securities Litigation
On March 8, 2018, a purported shareholder of the Company filed a putative class action complaint entitled Joshi Living Trust v. Akorn, Inc. et al., in the United States District Court for the Northern District of Illinois alleging violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934. The complaint named as defendants the Company, Chief Executive Officer Rajat Rai, Chief Financial Officer Duane Portwood and Chief Accounting Officer Randall Pollard. The complaint alleged that defendants made materially false or misleading statements and/or material omissions by failing to disclose sooner the existence of investigations into data integrity at the Company. The Complaint sought, among other things, an award of damages, attorneys’ fees and expenses. The Company disputes these claims.
On May 31, 2018, the Court issued an order appointing Gabelli & Co. Investment Advisors, Inc. and Gabelli Funds, LLC as lead plaintiffs pursuant to the Private Securities Litigation Reform Act (“PSLRA”), approving their selection of lead counsel and liaison counsel and amending the case caption to In re Akorn, Inc. Data Integrity Securities Litigation (the “Data Integrity Securities Litigation”). On June 14, 2018, lead plaintiffs filed a motion to lift the PSLRA stay of discovery. On June 22, 2018, the Company filed a memorandum in opposition to the motion to lift the PSLRA stay. On June 26, 2018, the Court denied the motion to lift the PSLRA stay, subject to entry of a preservation order.
On September 5, 2018, lead plaintiffs filed an amended complaint against the Company, Rajat Rai, Duane A. Portwood, Mark M. Silverberg, Alan Weinstein, Ronald M. Johnson, Brian Tambi, John Kapoor, Kenneth S. Abramowitz, Adrienne L. Graves, Steven J. Meyer and Terry A. Rappuhn. The amended complaint asserts (i) claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the “Fraud Claims”) against Defendants Akorn, Rai, Portwood, Silverberg, Weinstein, Johnson and Tambi; and (ii) claims under Sections 14(a) and 20(a) of the Securities Exchange Act of 1934 (the “Proxy Claims”) against defendants Akorn, Rai, Kapoor, Weinstein, Abramowitz, Graves, Johnson, Meyer, Rappuhn and Tambi. The amended complaint alleges that, during a class period from November 3, 2016, to April 20, 2018, defendants knew or recklessly disregarded widespread institutional data integrity problems at Akorn’s manufacturing and research and development facilities, while making or causing Akorn to make contrary misleading statements and omissions of material fact concerning the Company’s data integrity at its facilities. The amended complaint alleges that corrective information was provided to the market on two separate dates, causing non-insider shareholders to lose over $1.07 billion and $613 million in value respectively. The amended complaint seeks an award of equitable relief and damages.
On October 29, 2018, the parties filed a stipulation and joint motion providing for the dismissal of certain claims and defendants. On October 30, 2018, the Court granted the parties’ motion, dismissing the Proxy Claims without prejudice; dismissing defendants Kapoor, Abramowitz, Graves, Meyer and Rappuhn without prejudice; and dismissing Defendant Silverberg with prejudice. On December 19, 2018, the remaining defendants filed an answer to the amended complaint, disputing the plaintiffs’ remaining allegations.
On February 21, 2019, Plaintiff Johnny Wickstrom, a purported shareholder of the Company, filed a putative class action complaint in the United States District Court for the Northern District of Illinois alleging violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934. The complaint names as defendants the Company, Rajat Rai and Duane Portwood. The complaint alleged that defendants made materially false or misleading statements and/or material omissions concerning its compliance with U.S. Food and Drug Administration (“FDA”) regulations and that those misstatements were corrected when the Company disclosed its receipt from the FDA of a warning letter at the Company’s facility in Decatur, IL. The complaint seeks, among other things, an award of damages, attorneys’ fees and expenses.

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On March 8, 2019, the parties in the Data Integrity Securities Litigation filed a proposed stipulation which sought, among other things: (i) leave to file a second amended class action complaint, which would extend the end date of the alleged class period from November 3, 2016, through September 28, 2018; (ii) to consolidate the Wickstrom complaint into the Data Integrity Securities Litigation for all purposes; and (iii) to extend the existing discovery schedule in order to permit time to mediate lead plaintiffs’ claims and to conduct additional discovery related to the expanded class period.
On March 12, 2019, counsel for Wickstrom filed a letter with the Court seeking leave to file an opposition to the lead plaintiffs’ request to consolidate the Wickstrom complaint into the Data Integrity Securities Litigation. On March 25, 2019, counsel for Wickstrom filed a memorandum in opposition to the lead plaintiffs’ stipulation. On March 26, 2019, lead plaintiffs filed a reply in further support of their request for consolidation. During a March 27, 2019 conference, the Court found that the Wickstrom action was related to the Data Integrity Securities Litigation and ordered oral argument for April 22, 2019, on lead plaintiffs’ requests to file a second amended complaint and to consolidate the Wickstrom complaint.
Following the March 27, 2019 hearing, the Court entered an order finding the Data Integrity Securities Litigation and Wickstrom action to be related and requesting the reassignment of the Wickstrom action. The Court also extended the discovery and pretrial deadlines.
Kogut v. Akorn, et. al.
On March 8, 2016, a purported shareholder of the Company filed a putative derivative suit entitled Kogut v. Akorn, Inc., et al., in Louisiana state court in the Parish of East Baton Rouge. On June 10, 2016, the plaintiff filed an amended complaint asserting shareholder derivative claims alleging breaches of fiduciary duty in connection with the Company’s accounting for its acquisition and the restatement of its financials. On September 23, 2016, the Company filed a motion to dismiss the case. The case was subsequently stayed. On September 21, 2018, the plaintiff filed a second amended complaint, which added claims for shareholder derivative claims alleging breaches by certain present and former officers and directors of Akorn of fiduciary duties related to, among other matters, Akorn’s compliance with U.S. Food and Drug Administration (“FDA”) regulations and requirements regarding data integrity. On December 3, 2018, the Company and certain individual defendants moved to dismiss the complaint. Briefing on the motion to dismiss was completed on January 31, 2019.
On February 4, 2019, the court held a hearing, at which it instructed the parties to confer concerning the possible retention of a special master to resolve the pending motions to dismiss and to oversee any proceedings thereafter. After conferring, the parties jointly proposed a candidate for special master. On March 6, 2019, the Court entered an order appointing the parties’ proposed candidate as special master. The order directs the special master to provide the Court with a written report and recommendation on the pending motion to dismiss within 60 days of his appointment or 30 days of any oral argument.
In re Akorn, Inc. Shareholder Derivative Litigation
On October 15, 2018, Dale Trsar, a purported shareholder of the Company, filed a putative derivative suit captioned Trsar v. Kapoor, et al., in the Circuit Court of Cook County, IL. The suit alleged breaches by certain present and former officers and directors of Akorn of fiduciary duties related to, among other matters, Akorn’s compliance with FDA regulations and requirements regarding data integrity. On October 26, 2018, Trsar moved to dismiss the complaint voluntarily. On November 5, 2018, the Court granted Plaintiff Trsar’s motion and dismissed the complaint without prejudice.
On November 6, 2018, Trsar filed a putative derivative complaint captioned Trsar v. Kapoor, et al. against defendants John N. Kapoor, Rajat Rai, Duane A. Portwood, Mark M. Silverberg, Alan Weinstein, Kenneth S. Abramowitz, Steven J. Meyer, Terry Allison Rappuhn, Adrienne L. Graves, Ronald M. Johnson and Brian Tambi in the United States District Court for the Northern District of Illinois (the “Trsar Action”). The complaint purports to allege derivatively on behalf of the Company that (i) the defendants breached their fiduciary duties to the Company and its shareholders by failing to address the Company’s alleged non-compliance with FDA regulations; and (ii) the defendants violated Section 14(a) of the Securities Exchange Act of 1934, and SEC Rule 14a-9 promulgated thereunder, by making false or misleading statements in proxy statements issued to Akorn shareholders on November 14, 2016 and March 20, 2017. The complaint seeks an award of equitable relief and damages.
On December 10, 2018, Felix Glaubach, a purported shareholder of the Company, filed a putative derivative complaint captioned Glaubach v. Kapoor, et al. against John N. Kapoor, Rajat Rai, Mark M. Silverberg, Duane A. Portwood, Alan Weinstein, Kenneth S. Abramowitz, Steven J. Meyer, Terry Allison Rappuhn, Adrienne L. Graves, Ronald M. Johnson, and Brian Tambi in the United States District Court for the Northern District of Illinois (the “Glaubach Action”). The complaint purported to allege derivatively on behalf of the Company that (i) the defendants breached their fiduciary duties to the Company and its shareholders by failing to address the Company’s alleged non-compliance with FDA regulations; (ii) John N. Kapoor and Brian Tambi breached their fiduciary duties to the Company and its shareholders by misappropriating inside

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information in connection with sales of the Company’s stock; (iii) Rajat Rai and Duane A. Portwood were unjustly enriched; (iv) the Defendants wasted the Company’s assets; and (v) the Defendants violated Section 14(a) of the Securities Exchange Act of 1934, and SEC Rule 14a-9 promulgated thereunder, by making false or misleading statements in proxy statements issued to the Company’s shareholders. The complaint sought an award of equitable relief and damages. On January 11, the Glaubach Action was consolidated with the Trsar Action, with the complaint filed in the Trsar Action designated as operative, and the case caption was amended to In re Akorn, Inc. Shareholder Derivative Litigation.
On January 14, 2019, defendants filed a motion to dismiss the operative complaint in the consolidated action. Plaintiffs filed an opposition to defendants’ motion to dismiss on February 14, 2019. Defendants filed a reply memorandum of law in further support of their motion to dismiss on February 28, 2019.
The legal matters discussed above and others could result in losses, including damages, fines and civil penalties, and criminal charges, which could be substantial. We record accruals for these contingencies to the extent that we conclude that a loss is both probable and reasonably estimable. Other than amounts previously disclosed that have been recorded for intermediate court decisions and damages claims, the Company has determined that contingent liabilities associated with the other legal matters disclosed above are reasonably possible but they cannot be reasonably estimated. Given the nature of the litigation and investigations and the complexities involved, the Company is unable to reasonably estimate a possible loss for such matters until the Company knows, among other factors, (i) what claims, if any, will survive dispositive motion practice, (ii) the extent of the claims, including the size of any potential class, particularly when damages are not specified or are indeterminate, (iii) how the discovery process will affect the litigation, (iv) the settlement posture of the other parties to the litigation and (v) any other factors that may have a material effect on the litigation or investigation. However, we could incur judgments, enter into settlements or revise our expectations regarding the outcome of certain matters, and such developments could have a material adverse effect on our results of operations in the period in which the amounts are accrued and/or our cash flows in the period in which the amounts are paid.

Data Integrity Investigations


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As previously disclosed in various reports filed with the SEC, the Company and Fresenius Kabi AG, with the assistance of outside consultants, have been investigating alleged breaches of FDA data integrity requirements relating to product development at the Company.  The Company has informed the FDA regarding the investigations and will continue to update the FDA as they proceed. Although Fresenius has sought to rely on purported data integrity deficiencies at Akorn as a basis to terminate the Merger Agreement, to date, the Company’s investigation has not found any facts that would result in a material impact on Akorn’s operations and the Company does not believe such investigations should affect the closing of the transaction with Fresenius.


Note 13 — Customer, Supplier and Product Concentration


Customer Concentration


In the three and six month periods ended June 30,March 31, 2019 and 2018, and 2017, a significant portion of the Company’s gross and net revenues reported were to three large wholesale drug distributors, and a significant portion of the Company’s accounts receivable as of June 30, 2018March 31, 2019 and December 31, 20172018 were due from these wholesale drug distributors as well. AmerisourceBergen Health Corporation (“Amerisource”), Cardinal Health, Inc. (“Cardinal”) and McKesson Drug Company (“McKesson”) collectively referred to herein as the “Big 3 Wholesalers”, are all distributors of the Company’s products, as well as suppliers of a broad range of health care products. Aside from these three wholesale drug distributors, no other individual customer accounted for 10% or more of gross sales, net revenue or gross trade receivables for the indicated dates and periods.

If sales to the Big 3 Wholesalers were to diminish or cease, the Company believes that the end users of its products would find little difficulty obtaining the Company’s products from another distributor. Further, the Company is subject to credit risk from its accounts receivable, more heavily weighted to the Big 3 Wholesalers, but as of and for the three and six month periods ended June 30,March 31, 2019 and December 31, 2018, and 2017, the Company has not experienced significant losses with respect to its collection of these gross accounts receivable balances.


The following table sets forth the percentage of the Company's gross accounts receivable attributable to the Big 3 Wholesalers as of June 30, 2018March 31, 2019 and December 31, 2017:

2018:
Big 3 Wholesalers combined:June 30,
2018
 December 31,
2017
March 31,
2019
 December 31,
2018
Percentage of gross trade accounts receivable87% 86%86% 86%


The following table sets forth the percentage of the Company’s gross sales attributable to the Big 3 Wholesalers for the three and six month periods ended June 30, 2018March 31, 2019 and 2017:

2018:
 Three Months Ended
March 31,
Big 3 Wholesalers combined:2019 2018
Percentage of gross sales84% 83%

 Three Months Ended
June 30,
 Six Months Ended
June 30,
Big 3 Wholesalers combined:2018 2017 2018 2017
Percentage of gross sales83% 81% 83% 80%




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The following table sets forth the Company’s net revenues disaggregated by major customers for the three and six month periods ended June 30,March 31, 2019 and 2018 and 2017 (dollar amounts in thousands):

 Three Months Ended
March 31, 2019
 Three Months Ended
March 31, 2018
Disaggregation of net revenues by major customersNet Revenue Net Revenue % Net Revenue Net Revenue %
Amerisource$30,096
 18.1% $37,955
 20.6%
Cardinal29,761
 17.9% 27,189
 14.8%
McKesson37,752
 22.8% 53,221
 28.9%
Big 3 Wholesalers combined97,609
 58.8% 118,365
 64.3%
All Others68,262
 41.2% 65,698
 35.7%
Total Revenues165,871
 100.0% 184,063
 100.0%


 Three Months Ended
June 30, 2018
 Three Months Ended
June 30, 2017
 Six Months Ended
June 30, 2018
 Six Months Ended
June 30, 2017
Disaggregation of net revenues by major customersAmount % of Total Revenues Amount % of Total Revenues Amount % of Total Revenues Amount % of Total Revenues
Amerisource$39,256
 20.6% $39,654
 19.9% $77,211
 20.6% $83,591
 18.5%
Cardinal29,861
 15.6% 33,260
 16.7% 57,051
 15.2% 82,228
 18.2%
McKesson43,128
 22.6% 50,749
 25.5% 96,349
 25.7% 120,460
 26.6%
Big 3 Wholesalers combined112,245
 58.8% 123,663
 62.1% 230,611
 61.5% 286,279
 63.3%
All Others78,699
 41.2% 75,477
 37.9% 144,396
 38.5% 166,281
 36.7%
Total Revenues190,944
 100.0% 199,140
 100.0% 375,007
 100.0% 452,560
 100.0%

Sales to the Big 3 Wholesalers primarily represent purchases of products in the Prescription Pharmaceuticals segment and generate the majority of the Prescription Pharmaceuticals segment revenue. The Prescription Pharmaceuticals segment revenue represents 90.2%represented 89.2% and 91.7%89.3% of the consolidated net revenue for three month periods ended June 30,March 31, 2019 and 2018, and 2017, respectively, while during six month periods ended June 30, 2018 and 2017, the Prescription Pharmaceuticals segment revenue represents 89.7% and 92.8% of the consolidated net revenue, respectively. Chain pharmacies are the major customers in the Consumer Health segment. For more information, see Note 10 — Segment Information.


Supplier Concentration


The Company requires a supply of quality raw materials and components to manufacture and package pharmaceutical products for its own use and for third parties with which it has contracted. The principal components of the Company’s products are active and inactive pharmaceutical ingredients and certain packaging materials. Certain of these ingredients and components are available from only a single source and, in the case of certain of the Company’s abbreviated new drug applications and new drug applications, only one supplier of raw materials has been identified. Because FDA approval of drugs requires manufacturers to specify their proposed suppliers of active ingredients and certain packaging materials in their applications, FDA approval of any new supplier would be required if active ingredients or such packaging materials were no longer available from the specified supplier. The qualification of a new supplier could delay the Company’s development and marketing efforts. In addition, certain of the pharmaceutical products marketed by the Company are manufactured by a third party manufacturer, which serves as the Company’s sole source of that finished product. If for any reason the Company is unable to obtain sufficient quantities of any of the raw materials or components required to produce and package its products, it may not be able to manufacture its products as planned, which could have a material adverse effect on the Company’s business, financial condition and results of operations. Likewise, if the Company’s manufacturing partners experience any similar difficulties in obtaining raw materials or in manufacturing the finished product, the Company’s results of operations would be negatively impacted.


No individual supplier represented 10% or more of the Company’s purchases in the three and six month periods ended June 30, 2018March 31, 2019 or 2017.2018.


Product Concentration


In the three and six month periodsperiod ended June 30, 2018,March 31, 2019, one of the Company's products, Myorisan™ (isotretinoin capsules, USP), represented approximately 12% of total net revenue while none of the Company's products represented greater than 10% or more of its total net revenue. Insales revenue in the three month period ended June 30, 2017, none of the Company's products represented 10% or more of its total net revenue, while Ephedrine Sulfate Injection represented approximately 13% of the Company's total net revenue in the six month period ended June 30, 2017.March 31, 2018. The Company attempts to minimize the risk associated with product concentrations by continuing to acquire and develop new products to add to its existing product portfolio.


Note 14 — Income Taxes
 
On December 22, 2017, the Tax Cuts and Jobs Act (the “Tax Act”) was enacted and implements comprehensive tax legislation which, among other changes, reduces the federal statutory corporate tax rate from 35% to 21%, requires companies


[28]34]







to pay a one-time transition tax on earnings of certain foreign subsidiaries that were previously deferred, creates new provisions related to foreign sourced earnings, eliminates the domestic manufacturing deduction and moves to a territorial system.  Additionally, in December 2017, the Securities and Exchange Commission staff issued Staff Accounting Bulletin No. 118 (“SAB 118”), which addresses how a company recognizes provisional amounts when a company does not have the necessary information available, prepared or analyzed (including computations) in reasonable detail to complete its accounting for the effect of the changes in the Tax Act. The measurement period, as defined in SAB 118, ends when a company has obtained, prepared and analyzed the information necessary to finalize its accounting, but cannot extend beyond one year. During the measurement period, provisional amounts may also be adjusted for the effects, if any, of interpretative guidance issued after December 31, 2017, by U.S. regulatory and standard-setting bodies.

Based on the provisions of the Tax Act, the Company re-measured its U.S. deferred tax assets and liabilities and adjusted its deferred tax balances to reflect the lower U.S. corporate income tax rate at December 31, 2017. The re-measurement of the Company's U.S. deferred tax assets and liabilities at the lower enacted U.S. corporate tax rate resulted in an income tax benefit of $26.9 million which was included as a discrete item in the 2017 income tax benefit. The Company’s foreign subsidiaries do not have accumulated earnings that can be distributed; therefore, the provisions of the Act related to the repatriation of foreign earnings are not applicable to the Company at December 31, 2017. No additional re-measurement adjustments have been made since December 31, 2017.

The following table sets forth information about the Company’s income tax provision (benefit) provision for the periods indicated (dollar amounts in thousands):
 Three Months Ended
March 31,
 2019 2018
(Loss) before income taxes$(80,761) $(36,027)
Income tax provision (benefit)1,420
 (7,280)
Net (loss)$(82,181) $(28,747)
    
Income tax provision (benefit) as a percentage of (loss) before income taxes(1.8)% 20.2%

 Three Months Ended
June 30,
 Six Months Ended
June 30,
 2018 2017 2018 2017
(Loss) Income before income taxes$(104,256) $6,750
 $(140,283) $72,076
Income tax (benefit) provision(16,272) 4,213
 (23,552) 28,512
Net (loss) income$(87,984) $2,537
 $(116,731) $43,564
        
Income tax (benefit) provision as a percentage of (loss) income before income taxes15.6% 62.4% 16.8% 39.6%


During the three and six month periods ended June 30,March 31, 2019 and 2018, the Company recorded an income tax provision of $1.4 million and an income tax benefit of $16.3 million and $23.6$7.3 million, or 15.6%(1.8)% and 16.8%20.2%, of (loss) before income tax in the applicable periods, respectively, while during the three and six month periods ended June 30, 2017, the Company recorded an income tax provision of $4.2 million and $28.5 million, or 62.4% and 39.6% of income before income tax in the applicable periods, respectively. The decreases in the income tax rate as a percentage of (loss) income before income tax for the three and six month periods ended June 30, 2018 as compared to the same periods in 2017, were principally the result of the enactment of the Tax Act in December 2017, and the incurrence of non-deductible fees in connection with the Delaware Action. The Company useddid not use the discrete method to calculate the quarterly provision.provision due to the company’s overall valuation allowance position. The reason for the overall tax provision rate of (1.8)% during the three month period ended March 31, 2019 is due to the full valuation allowance recorded against our deferred tax assets.


AsThe Company records a valuation allowance to reduce net deferred income tax assets to the amount that is more likely than not to be realized. In performing its analysis of June 30, 2018,whether a valuation allowance to reduce the deferred income tax asset was necessary, the Company could not concludeevaluated the data and believes that it wasis not more likely than not that the deferred tax benefits from certain foreign net operating losses wouldassets in the U.S., India, and Switzerland will be realized. Accordingly, as of the six month period ended June 30, 2018, the Company increased itshas recorded a full valuation allowance to $11.9 million for certain of the losses at its Indian subsidiaryagainst U.S., India, and the entire amount of the loss at its Swiss subsidiary, compared toSwitzerland deferred tax assets. The Company has a valuation allowance of $10.5$84.6 million against its deferred tax assets as of DecemberMarch 31, 2017.2019.


In accordance with ASC 740-10-25, Income Taxes - Recognition, the Company reviews its tax positions to determine whether it is “more likely than not” that its tax positions will be sustained upon examination, and if any tax positions are deemed to fall short of that standard, the Company establishes reserves based on the financial exposure and the likelihood that its tax positions would not be sustained.  Based on its evaluations, the Company determined that it would not recognize tax benefits on $25.5$29.5 million related to uncertain tax positions as of June 30, 2018.March 31, 2019.  If recognized, $2.9$2.4 million of the above positions willwould impact the Company’s effective rate, while the remaining $22.6$27.1 million would result in adjustments to the Company’s deferred taxes. On December 31, 2018, the Company filed a non-automatic accounting method change related to the chargebacks and rebates reserves that accounts for $27.1 million of the unrecognized tax benefits. It is pending approval from the Internal Revenue Service as of March 31, 2019, and as such the Company reasonably expects this balance to reverse during 2019. The Company accounts for interest and penalties as income tax expense. During the sixthree month period ended June 30, 2018,March 31, 2019, the Company recorded no penalties and $0.7$1.3 million interest related to unrecognized tax benefits. As of June 30, 2018,March 31, 2019, the Company had an accrual balanceaccrued a total of $8.9$8.6 million and $6.7$13.4 million of penalties and interest, respectively.


Note 15 – Related Party Transactions


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In 20182019 and 2017,2018, the Company obtained legal services from Polsinelli PC, a law firm for which the spouse of the Company’s Executive Vice President, General Counsel and Secretary is an attorney anda shareholder. During the three month periods ended June 30,March 31, 2019 and 2018, and 2017, the Company obtained legal services totaling $1.1 million and $0.2 million, respectively. During the six months period ending, June 30, 2018 and 2017, the Company obtained legal services totaling $1.7$1.5 million and $0.6 million, respectively, of which $1.1$1.0 million and $0.3$0.5 million was payable as of June 30,March 31, 2019 and 2018, and 2017, respectively.


During the three month periods ended June 30,March 31, 2019 and 2018, and 2017, the Company also obtained and paid legal services totaling $0.2$0.1 million and $0.1$0.2 million, respectively, to Segal McCambridge Singer & Mahoney, a firm for which the brother in lawbrother-in-law of the Company'sCompany’s Executive Vice President, General Counsel and Secretary is a partner, and during the six months period ending, June 30, 2018 and 2017, the Company obtained and paid legal services totaling $0.4 million and $0.3 million to the same firm.shareholder.


Note 16 – Recently Issued and Adopted Accounting Pronouncements


Recently Issued Accounting Pronouncements
 
In August 2018, the Financial Accounting Standards Board ("FASB") issued Accounting Standard Update ("ASU") No.2018-15 — Intangibles — Goodwill and Other—Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract (a consensus of the FASB

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Emerging Issues Task Force). The amendments in this ASU are effective for public business entities for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years. Early adoption of the amendments in this Update is permitted, including adoption in any interim period, for all entities. The amendments in this Update should be applied either retrospectively or prospectively to all implementation costs incurred after the date of adoption. The Company believes that the adoption of this ASU will not have a material impact on its financial position, results of operations or cash flows.

In August 2018, the FASB issued ASU No.2018-13—Fair Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement. The amendments in this ASU are effective for all entities for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. The amendments on changes in unrealized gains and losses, the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements, and the narrative description of measurement uncertainty should be applied prospectively for only the most recent interim or annual period presented in the initial fiscal year of adoption. All other amendments should be applied retrospectively to all periods presented upon their effective date. Early adoption is permitted upon issuance of this Update. An entity is permitted to early adopt any removed or modified disclosures upon issuance of this ASU and delay adoption of the additional disclosures until their effective date. The Company believes that the adoption of this ASU will not have a material impact on its financial position, results of operations or cash flows.

Recently Adopted Accounting Pronouncements

In June 2018, the Financial Accounting Standards Board ("FASB") issued Accounting Standard Update ("ASU") No.2018-07, Compensation—Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting. The amendments in this UpdateASU expand the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. Under this ASU, an entity should apply the requirements of Topic 718 to nonemployee awards except for specific guidance on inputs to an option pricing model and the attribution of cost (that is, the period of time over which share-based payment awards vest and the pattern of cost recognition over that period). The amendments specify that Topic 718 applies to all share-based payment transactions in which a grantor acquires goods or services to be used or consumed in a grantor’s own operations by issuing share-based payment awards. The amendments also clarify that Topic 718 does not apply to share-based payments used to effectively provide (1) financing to the issuer or (2) awards granted in conjunction with selling goods or services to customers as part of a contract accounted for under Topic 606, Revenue from Contracts with Customers. The amendments in this ASU are effective for public entities for fiscal years beginning after December 15, 2018, including interim periods within that fiscal year. For all other entities, the amendments are effective for fiscal years beginning after December 15,standard was adopted on January 1, 2019, and interim periods within fiscal years beginning after December 15, 2020. Early adoption is permitted, but no earlier than an entity’s adoption date of Topic 606. The Company believes that the adoption of this ASU willdid not have a material impact on itsthe Company's financial position, results of operationsstatements or cash flows.financial statement disclosures.


In February 2016, FASB issued ASU No.2016-02 - Leases which(Topic 842), as modified by subsequently issued ASUs 2019-01, 2018-10, 2018-11 and 2018-20 (collectively ASU 2016-02). ASU 2018-02 establishes a comprehensive new lease accounting model. The new standard clarifies the definition of a lease and causes lessees to recognize leases on the balance sheet as a lease liability with a corresponding right-of-use asset for leases with a lease term of more than one year. ASU 2016-02 is effective for financial statements issued for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years. Early adoption is permitted. The new standard requiresinitially required a modified retrospective transition for capital or operating leases existing at or entered into after the beginning of the earliest comparative period presented in the financial statements, but it does not require transition accounting for leases that expire prior to the date of initial application. UponIn July 2018, the FASB decided to provide another transition method in addition to the existing transition method by allowing entities to initially apply the new leases standard at the adoption operatingdate and recognize a cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption. This additional transition method changes only when an entity is required to initially apply the transition requirements of the new leases will be reported onstandard; it does not change how those requirements apply. We elected the statementpractical expedient to not separate non-lease components, to not provide comparative reporting periods and the ‘package of financial position as gross-up assetspractical expedients’, which permits us to forgo reassessment of our prior conclusions about lease identification, lease classification and liabilities. The Company has begun evaluating and planninginitial direct costs for adoption and implementationleases entered into prior to the effective date. We did not elect the use-of-hindsight practical expedient. We have completed our review of this ASU, including reviewing all material leases including the ASUsearch for any embedded leases, elected the package of practical expedient guidelines, currentexpedients and accounting policy, elections, and assessingfinalized our assessment of the overall financial statement impact. We expect this ASU will have a material impactadopted the ASC on January 1, 2019, using the Company’smodified retrospective method and did not restate comparative periods. At adoption, we recorded Total Lease liabilities of $24.7 million and Total Right-of-use assets, net of $23.0 million in its consolidated statement of financial position. The impact on the Company’s results of operations is currently being evaluated.did not materially differ from recorded amounts under ASC 840. The impact of the adoption of this ASU is non-cash in nature and istherefore did not expected tomaterially affect the Company’s cash flows. See Note 17 — Leasing Arrangements for additional disclosures.


Recently Adopted Accounting Pronouncements

In May 2017, the Financial Accounting Standards Board ("FASB")FASB issued Accounting Standard Update ("ASU")ASU No. 2017-09, Compensation — Stock Compensation (Topic 718): Scope of Modification Accounting, which provides guidance about which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting in Topic 718. Per the ASU, an entity should account for the effects of a modification unless all the following are met: (1) The fair value (or calculated value or intrinsic value, if such an alternative measurement method is used) of the modified award is the same as the fair value (or calculated value or intrinsic value, if such

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an alternative measurement method is used) of the original award immediately before the original award is modified. If the modification does not affect any of the inputs to the valuation technique that the entity uses to value the award, the entity is not required to estimate the value immediately before and after the modification, (2) The vesting conditions of the modified award are the same as the vesting conditions of the original award immediately before the original award is modified, and (3) The classification of the modified award as an equity instrument or a liability instrument is the same as the classification of the original award immediately before the original award is modified. The current disclosure requirements in Topic 718 apply regardless of whether an entity is

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required to apply modification accounting under the amendments in this ASU. The ASU is effective for public business entities for annual and interim periods in fiscal years beginning after December 15, 2017. Early adoption is permitted, including adoption in any interim period, for (1) public business entities for reporting periods for which financial statements have not yet been issued and (2) all other entities for reporting periods for which financial statements have not yet been made available for issuance. The amendments in this ASU should be applied prospectively to an award modified on or after the adoption date.TheThe standard was adopted on January 1, 2018, and did not have a material impact on the Company's consolidated financial statements or financial statement disclosures.


In March 2017, the FASB issued ASU No. 2017-07— Compensation — Retirement Benefits (Topic 715): Improving the Presentation of Net Periodic Pension Cost and Net Periodic Postretirement Benefit Cost, which apply to all employers, including not-for-profit entities, that offer to their employees defined benefit pension plans, other postretirement benefit plans, or other types of benefits accounted for under Topic 715. The amendments in this ASU require that an employer report the service cost component in the same line item or items as other compensation costs arising from services rendered by the pertinent employees during the period. The other components of net benefit cost as defined in paragraphs 715-30-35-4 and 715-60- 35-9 are required to be presented in the income statement separately from the service cost component and outside a subtotal of income from operations, if one is presented. If a separate line item or items are used to present the other components of net benefit cost, that line item or items must be appropriately described. If a separate line item or items are not used, the line item or items used in the income statement to present the other components of net benefit cost must be disclosed. The amendments in this ASU also allow only the service cost component to be eligible for capitalization when applicable (for example, as a cost of internally manufactured inventory or a self-constructed asset). The amendments in this ASU are effective for public business entities for annual periods beginning after December 15, 2017, including interim periods within those 3 annual periods. Disclosures of the nature of and reason for the change in accounting principle are required in the first interim and annual periods of adoption. The amendments in this ASU should be applied retrospectively for the presentation of the service cost component and the other components of net periodic pension cost and net periodic postretirement benefit cost in the income statement and prospectively, on and after the effective date, for the capitalization of the service cost component of net periodic pension cost and net periodic postretirement benefit in assets. The amendments allow a practical expedient that permits an employer to use the amounts disclosed in its pension and other postretirement benefit plan note for the prior comparative periods as the estimation basis for applying the retrospective presentation requirements. Disclosure that the practical expedient was used is required. The standard was adopted on January 1, 2018, and did not have a material impact on the Company's consolidated financial statements or financial statement disclosures.

In November 2016, the FASB issued ASU No. 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash (a consensus of the FASB Emerging Issues Task Force), which addresses classification and presentation of changes in restricted cash on the statement of cash flows. The standard requires an entity’s reconciliation of the beginning-of-period and end-of-period total amounts shown on the statement of cash flows to include in cash and cash equivalents amounts generally described as restricted cash and restricted cash equivalents. The ASU does not define restricted cash or restricted cash equivalents, but an entity will need to disclose the nature of the restrictions. The ASU is effective for public business entities for annual and interim periods in fiscal years beginning after December 15, 2017. For all other entities, the ASU is effective for fiscal years beginning after December 15, 2018, and interim periods in fiscal years beginning after December 15, 2019. Early adoption is permitted, including adoption in an interim period. If an entity early adopts the amendments in an interim period, adjustments should be reflected at the beginning of the fiscal year that includes that interim period. Entities should apply this ASU using a retrospective transition method to each period presented. The standard was adopted on January 1, 2018, and did not have a material impact on the Company's consolidated financial statements or financial statement disclosures.



In August 2016, the FASB issued ASU 2016-15,Statement of Cash Flows (Topic 230) Classification of Certain Cash Receipts and Cash Payments. This standard amends and adjusts how cash receipts and cash payments are presented and classified in the statement of cash flows. ASU 2016-15 is effective for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years and will require adoption on a retrospective basis unless impracticable. If impracticable the Company would be required to apply the amendments prospectively as of the earliest date possible. The standard was adopted on January 1, 2018, and did not have a material impact on the Company's consolidated financial statements or financial statement disclosures.


In May 2014, FASB issued ASU 2014-09 - Revenue from Contracts with Customers (Topic 606), as modified by subsequently issued ASUs 2015-14, 2016-08, 2016-10, 2016-12 and 2016-20 (collectively ASU 2014-09). ASU 2014-09 superseded the revenue recognition requirements in ASC (Topic 605) Revenue Recognition, and most industry specific guidance. This ASU also supersedes some cost guidance included in ASC 605-35 Revenue Recognition Construction Type and Production Type Contracts. Similar to the currentprevious guidance, the Company will need to makemakes significant estimates related to variable consideration at the point of sale, including chargebacks, rebates, product returns, and other discounts and allowances. Revenue will beis recognized at a point in time upon the transfer of control of the Company's products, which occurs upon

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delivery for substantially all of the Company's sales. The Company has adopted the practical expedient to exclude all sales taxes and contract fulfillment costs from the transaction price. The Company adopted the standard effective January 1, 2018, using the modified retrospective approach. The adoption of ASU 2014-09 did not have a material impact on the Company’s consolidated financial position, results of operations, equity or cash flows as of the adoption date or for the three months ended March 31, 2018. See Note 13 — Customer, Supplier and Product Concentration for the disaggregation of net revenues by major customers.


Note 17 — Leasing Arrangements

The Company leases real and personal property in the normal course of business under various operating leases and other insignificant finance leases, including non-cancelable and immaterial month-to-month agreements. We recognize rent expense on a straight-line basis over the lease term. During the three month period ended March 31, 2019, total lease cost was $1.2 million. During the three month period ended March 31, 2018, total lease cost under ASC 840 was $0.8 million.


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The following table sets forth the Company’s lease cost components (in thousands):
 Three Months Ended March 31, 2019
Operating lease cost$1,152
Amortization of finance lease assets46
Interest on finance lease liabilities7
Short-term lease cost10
Total lease cost (1)$1,215

(1) Of the total lease cost amount, $0.6 million is being reported in selling, general and administrative, $0.3 million in cost of sales and $0.3 million in research and development expenses within the Condensed Consolidated Statement of Comprehensive (Loss).

The following table sets forth the Company’s Supplemental cash flow information related to leases
(in thousands):
 Three Months Ended March 31, 2019
Cash paid for amounts included in the measurement of lease liabilities:

 
Operating cash flows from operating leases$1,179
Operating cash flows from finance leases

5
Financing cash flows from finance leases

335
  
Right-of-use assets, net obtained in exchange for new lease obligations:

 
Operating lease liabilities

22,523
Finance lease liabilities

$441


The following table sets forth the Company’s Supplemental balance sheet information related to leases (in thousands):
 March 31, 2019
Right-of-use assets, net: 
Operating leases, gross$22,523
Accumulated amortization550
Operating leases, net$21,973
Finance leases (included in "Other non-current assets"), gross75
Accumulated depreciation5
Finance leases (included in "Other non-current assets"), net

$70
Total Right-of-use assets, net$22,043
  
Lease liabilities: 
Current portion of Operating lease liability$2,238
Long-term Operating lease liability21,480
Total Operating lease liability$23,718
Current portion of Finance lease (included in "Accrued expenses and other liabilities") liability$19
Long-term Finance lease (included in "Pension obligations and other liabilities") liability48
Total Finance lease liability$67
Total Lease liabilities$23,785


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The following table sets forth the Company’s Weighted-average lease terms and discount rates (lease term in years):
March 31, 2019
Weighted-average remaining lease terms:
Operating leases8.92
Finance leases

3.33
Weighted-average discount rates:
Operating leases

10.01%
Finance leases

5.50%


The following table sets forth the Company’s scheduled maturities of lease liabilities as of March 31, 2019 (in thousands):
Year ending December 31,Operating leases Finance leases
2019 (last nine months of 2019)$3,332
 $16
20204,531
 22
20214,357
 22
20223,990
 13
20233,323
 
2024 and thereafter17,294
 
Total lease payments (1)$36,827
 $73
Less: Imputed interest$13,109
 $6
Total lease liabilities$23,718
 $67

(1) Under ASC 842, the Company is required to take into consideration contractual lease renewal options that are reasonably assured to be exercised when determining the lease liability at transition.  As of March 31, 2019, the Company has approximately $11 million of reasonably assured renewal option payments included in the total lease payments.


The following table sets forth the Company’s scheduled of future minimum rental payments for operating leases under ASC 840 as of December 31, 2018 (in thousands):

Year ending December 31,Operating leases
2019$4,564
20204,647
20214,283
20223,724
20232,673
2024 and thereafter6,976
Total lease payments$26,867


Note 18 — Pension plan and 401(k) Program

Akorn AG Pension Plan
The Company maintains a pension plan for its employees in Switzerland as required by law. The pension plan is funded by contributions by both employees and employers, with the sum of the contributions made by the employer required to be at least equal to the sum of the contributions made by employees. The Company contributes the necessary amounts required by local laws and regulations. Plan assets for the pension plan are held in a retirement trust fund with investments primarily in publicly traded securities and assets.

The purpose of this pension plan is to provide old age pensions. Some of the pension funds also provide benefits in case

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of disability and to the next of kin in case of premature death. Additionally, the pension funds can be used before retirement to buy a principal residence, to start an independent activity, or when leaving Switzerland permanently. If a participant leaves the company, accumulated pension funds are transferred either into a savings account or into the pension fund of a new employer.
The following table sets forth the components of net periodic cost for our pension plan:
Components of net periodic benefit cost($ in thousands)
 March 31,
 2019 2018
Service cost$632
 $557
Interest cost61
 51
Expected return on plan assets(175) (189)
Amortization of:   
Prior service (benefit)(5) (5)
Net actuarial loss49
 
Participant contributions(194) (168)
Net periodic benefit cost$368
 $246


The Company contributed approximately $0.4 million for the three month period ended March 31, 2019, and expects to contribute a total of approximately $1.7 million to the pension plan in 2019.
Smart Choice! Akorn's 401(k) Program
All U.S. full-time Akorn employees are eligible to participate in the Company’s 401(k) Plan. The Company matches the employee contribution to 50% of the first 6% of an employee's eligible compensation.  Company matching contributions vest 50% after two years of credited service and 100% after three years of credited service. During the three month period ended March 31, 2019 and 2018, plan-related expenses totaled approximately $0.8 million and $0.7 million, respectively. The Company's matching contribution is funded on a current basis.

Item 2.  Management’s Discussion and Analysis of Financial Condition and Results of Operations.


FORWARD-LOOKING STATEMENTS AND FACTORS AFFECTING FUTURE RESULTS
 
Certain statements in this Form 10-Q are forward-looking in nature and are intended to be “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance. In some cases, you can identify forward-looking statements by terminology such as “may,” “should,” "will," “could,” “expects,” “plans,” “intends,” “anticipates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of such terms or other comparable terminology. Any forward-looking statements, including statements regarding our intent, beliefs or expectations are not guarantees of future performance. These statements are subject to risks and uncertainties and actual results, levels of activity, performance or achievements may differ materially from those in the forward-looking statements as a result of various factors. See “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2017,2018, as filed with the SEC on February 28, 2018, in our Form 10-Q filed on May 2, 2018,March 1, 2019, and in this Form 10-Q,part II Item 1A herein, which include, but are not limited to, the following items:


There are material uncertainties and risks associated with damage claims from the pendingFresenius parties' and Akorn's shareholders as a result of the termination of the April 2017 Merger Agreement and MergerAgreement.


The announcementlitigations may involve significant defense costs and pendencyindemnification liabilities and may result in significant monetary judgments against Akorn, which may adversely affect our business, financial condition and results of the Merger may impede Akorn’s ability to retain and hire key personnel, its ability to maintain relationships with its customers, suppliers and others with whom it does business, or its operating results and business generallyoperations;


The attention oflitigations, whether or not resolved favorably, may damage our employees and management may be diverted due to activities related to the Merger, which may affect our business operations
Matters relating to the Merger (including integration planning) may require substantial commitments of time and resources by Akorn management, which could harmlong-term reputation, attract adverse media coverage, interfere with our relationships with key stakeholders and/or interfere with our employees, customers, distributors, suppliers or other business partners,ability to attract and may result in a loss of or a substantial decrease in purchases by our customersretain employees; and


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The Merger Agreement restricts us from engaging in certain actions withoutlitigations may divert the approvalattention of Fresenius Kabi,our employees and management, which could prevent us from pursuing certainmay affect our business opportunities outside the ordinary course of business that arise prior to the closing of the Mergeroperations.

Shareholder litigation in connection with the transactions contemplated by the Merger Agreement may result in significant costs of defense, indemnification and liability; and

The outcome of the Company’s and Fresenius Kabi’s investigations into alleged breaches of FDA data integrity requirements relating to product development at the Company, and any actions taken by the Company, Fresenius Kabi, third parties or the FDA as a result of such investigations may result in significant costs

The Fresenius Kabi AG’s purported termination of the Merger Agreement and the litigation related to the Merger pending in the Court of Chancery of the State of Delaware may result in significant costs and in the Merger not being completed in a timely manner or at all

The risk that the pending merger may not be completed in a timely manner or at all

Our growth depends on our ability to timely and efficiently develop and successfully launch and market new pharmaceutical productsproducts.


We could experience businessBusiness interruptions at our manufacturing facilities which maycan have a material adverse effect on our business, financial position and results of operationsoperations.

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A significant portion of our revenues are generated through the sale of products manufactured by third parties, the loss or failure of any of which may have a material adverse effect on our business, financial position and results of operationsoperations.


We depend on a small number of wholesalers to distribute our products, the loss of any of which could have a material adverse effect on our businessbusiness.


We may be subject to significant disruptions or failures in our information technology systems and network infrastructures that could have a material adverse effect on our businessbusiness.


We depend on our employees and must continue to attract and retain key personnel in order to compete successfully,be successful, and any failure to do so could hinderhinders successful execution of our business and development plans and have a material adverse effect on our financial position and results of operationplans.

Our inability to effectively manage or support our growth may have a material adverse effect on our business, financial position, results of operations and liquidity and could cause the price of our common stock to decline


We have entered into several strategic business alliances that may not result in marketable products and may have a material adverse effect on our business, financial position, results of operations and liquidity

We becomeare involved in legal proceedings and governmental investigations from time to time, any of which may result in substantial losses, government enforcement actions, damage to our business and reputation and place a strain on our internal resourcesresources.


Charges to earnings resulting from acquisitions could have a material adverse effect on our business, financial position and results of operationsoperations.


As a result of a jury finding John N. Kapoor, Ph.D., guilty in a federal criminal case, OIG-HHS’s permissive exclusion rules could lead to the Company’s exclusion from participating in U.S. government healthcare programs, which could have a material adverse effect on our business, financial condition and results of operations.

John N. Kapoor's, Ph.D., involvement with the Company through his stock ownership and his right to nominate up to three directors could have an adverse effect on the price of our common stock and have substantial influence over our business strategies and policies.

Many of the raw materials and components used in our products come from a single source, the loss of any of which could have a material adverse effect on our businessbusiness.


Sales of our products may be adversely affected by the continuingfurther consolidation of our customer base, which may have a material adverse effect on our business, plans, financial position and results of operationsoperations.


Our branded products may become subject to increased generic competitioncompetition.


Changes in technology could render our products obsolete.

We are subject to extensive government regulations. When regulations which if they change and or we are not infall out of compliance, with, could increase ourwe can face increased costs, subject us to variousadditional obligations, and fines, or prevent us from sellinghalts to our products or operatingoperations.

Our inability to timely and adequately address FDA warning letter and OAI facility status may adversely affect our facilitiesbusiness.


Changes in healthcare law and policy changes may adversely affect our business plans and results of operationsoperations.


The FDA may require us to stop marketing certain unapproved drugs, (non-application drugs marketed prior to the 1962 Amendments of the FDC Act), which could have a material adverse effect on our business, financial position and results of operationsoperations.



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Any failure to comply with the complex reporting and payment obligations under Medicare, Medicaid and other government programs may result in litigation or sanctions.

Failure to comply with the U.S. Foreign Corrupt Practices Act could subject us to, among other things, penalties and legal expenses that could harm our reputation and have a material adverse effect on our business, financial condition and operating resultsresults.


Third partiesThe FDA may claim that we infringeauthorize sales of some prescription pharmaceuticals on their proprietary rights anda non-prescription basis, which may prevent or delay us from manufacturing and selling somereduce the profitability of our new productsprescription products.


We may neednot be able to obtain additional capitalextend or replace the JPM Revolving Facility.

Events of default may occur under our debt instruments. If events of default occur and lenders under these debt instruments accelerate the obligations thereunder we may not be able to continuerepay the obligations that become immediately due and the holders of our debt instruments may seek to grow our businessassert their rights under the debt instruments.


Our indebtedness reduces our financial and operating flexibilityflexibility.


We may not generate cash flow sufficient to pay interest and make required principal repayments on our Term LoansLoans.



We may need to obtain additional capital to grow our business, which could restrict our ability to operate in a manner we deem to be in our best interest.
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Third parties may claim that we infringe their proprietary rights and may prevent or delay us from manufacturing and selling some of our new products.


Our patents and proprietary rights may be challenged, circumvented or otherwise compromised by competitors, which may result in our protected products losing their market exclusivity and becoming subject to generic competition before their patents expire.

The issuance of shares related to the Company’s various stock plans may have a substantial dilutive effect on our common stock.

Our announced stock repurchase program could affect the price of our common stock and increase volatility and may be suspended or terminated at any time, which may result in a decrease in the trading price of our common stock.

We may issue preferred stock and the terms of such preferred stock may reduce the market value of our common stock.

The Standstill Agreement with our lenders requires us to observe certain covenants, which creates material uncertainties and risks to our growth and business outlook, and any failure to comply with the Standstill Agreement could result in an event of default under the Term Loan Agreements and render us insolvent.

Pursuant to the terms of the Standstill Agreement, the Company must enter into a comprehensive amendment of the Term Loan Agreements (a “Comprehensive Amendment”) that is satisfactory in form and substance to the lenders. If the Company does not enter into such a Comprehensive Amendment by December 13, 2019, an event of default will occur under the Term Loan Agreements which, if not waived, could materially affect the Company’s business, financial position and results of operations, and could render us insolvent.

The Standstill Agreement requires the Company to pay certain fees and expenses and provides for an increased interest margin, which may negatively impact the Company’s financial condition.

Risks related to the sale of our India manufacturing facility.

If any of these risks or uncertainties materialize, or if our underlying assumptions prove to be incorrect, actual results may vary significantly from what we projected or as compared to prior periods.  As a result, you should not place undue reliance on any forward-looking statements. Any forward-looking statement you read in the following Management’s Discussion and Analysis of Financial Condition and Results of Operations reflects our current views with respect to future events and is subject to these and other risks, uncertainties, and assumptions relating to our operations, results of operations, growth strategy, and

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liquidity.  Unless required by law, we undertake no obligation to publicly update any forward-looking statements for any reason, whether as a result of new information, future events, or otherwise.




[34]43]







RESULTS OF OPERATIONS


The following table sets forth the amounts and percentages of total revenue for certain items from our Condensed Consolidated Statements of Comprehensive (Loss) Income and our segment reporting information for the three month periods ended March 31, 2019 and six months ended June 30, 2018 and 2017 (dollar amounts in thousands):  
Three Months Ended
June 30,
 Six Months Ended
June 30,
Three Months Ended
March 31,
2018 2017 2018 20172019 2018
Amount % of
Revenue
 Amount % of
Revenue
 Amount 
% of
Revenue
 Amount 
% of
Revenue
Amount % of
Revenue
 Amount % of
Revenue
Revenues, net: 
  
  
  
  
  
  
  
 
  
  
  
Prescription Pharmaceuticals$172,163
 90.2 % $182,645
 91.7 % $336,464
 89.7 % $420,024
 92.8 %$148,015
 89.2 % $164,302
 89.3 %
Consumer Health18,781
 9.8 % 16,495
 8.3 % 38,543
 10.3 % 32,536
 7.2 %17,856
 10.8 % 19,761
 10.7 %
Total revenues, net190,944
 100.0 % 199,140
 100.0 % 375,007
 100.0 % 452,560
 100.0 %165,871
 100.0 % 184,063
 100.0 %
Gross profit: 
  
  
  
  
  
  
  
 
  
  
  
Prescription Pharmaceuticals73,286
 42.6 % 95,906
 52.5 % 146,794
 43.6 % 236,862
 56.4 %45,443
 30.7 % 73,508
 44.7 %
Consumer Health7,993
 42.6 % 6,863
 41.6 % 16,713
 43.4 % 14,676
 45.1 %8,070
 45.2 % 8,720
 44.1 %
Total gross profit81,279
 42.6 % 102,769
 51.6 % 163,507
 43.6 % 251,538
 55.6 %53,513
 32.3 % 82,228
 44.7 %
Operating expenses: 
  
  
  
  
  
  
  
 
  
  
  
SG&A expenses83,694
 43.8 % 53,981
 27.1 % 146,677
 39.1 % 101,564
 22.4 %
Acquisition-related costs64
  % 76
  % 75
  % 87
  %
R&D expenses74,271
 38.9 % 15,876
 8.0 % 105,238
 28.1 % 27,167
 6.0 %
Amortization of intangible assets13,182
 6.9 % 15,504
 7.8 % 26,372
 7.0 % 30,975
 6.8 %
Selling, general and administrative expenses72,498
 43.7 % 62,994
 34.2 %
Research and development expenses8,714
 5.3 % 12,644
 6.9 %
Amortization of intangibles11,065
 6.7 % 13,190
 7.2 %
Impairment of goodwill15,955
 9.6 % 
  %
Impairment of intangible assets1,634
 0.9 % 3,058
 1.5 % 2,126
 0.6 % 3,058
 0.7 %10,354
 6.2 % 18,815
 10.2 %
Operating (loss) income$(91,566) (48.0)% $14,274
 7.2 % $(116,981) (31.2)% $88,687
 19.6 %
Litigation rulings and settlements410
 0.2 % 
  %
Operating (loss)$(65,483) (39.5)% $(25,415) (13.8)%
Other expense, net(12,690) (6.6)% (7,524) (3.8)% (23,302) (6.2)% (16,611) (3.7)%(15,278) (9.2)% (10,612) (5.8)%
(Loss) Income before income taxes(104,256) (54.6)% 6,750
 3.4 % (140,283) (37.4)% 72,076
 15.9 %
Income tax provision(16,272) (8.5)% 4,213
 2.1 % (23,552) (6.3)% 28,512
 6.3 %
Net (loss) income$(87,984) (46.1)% $2,537
 1.3 % $(116,731) (31.1)% $43,564
 9.6 %
(Loss) before income taxes(80,761) (48.7)% (36,027) (19.6)%
Income tax provision (benefit)1,420
 0.9 % (7,280) (4.0)%
Net (loss)$(82,181) (49.5)% $(28,747) (15.6)%


THREE MONTHS ENDED JUNE 30, 2018MARCH 31, 2019 COMPARED TO THREE MONTHS ENDED JUNE 30, 2017MARCH 31, 2018
 
Net revenue was $190.9$165.9 million for the three month period ended June 30, 2018,March 31, 2019, representing a decrease of $8.2$18.2 million, or 4.1%9.9%, as compared to net revenue of $199.1$184.1 million for the three month period ended June 30, 2017.March 31, 2018. The decrease in net revenue in the period was primarily due to $12.2$18.1 million decline in organic revenue that was partially offset by $5.9$0.7 million net revenue increase in new products and product relaunches. The $12.2$18.1 million decline in organic revenue was due to approximately $7.0$30.5 million, or 3.5%, and $5.216.6% in volume declines partially offset by $12.3 million, or 2.6%, in6.7% of positive price andvariance. The volume declines, respectively. The organic revenue decline was principally due to the effect of competition on Nembutal and Ephedrine Sulfate Injection, that were partially offset by revenue increase in Myorisan.Nembutal® and Cosopt® PF and supply shortfalls from the continued production ramp-up at our Somerset and Decatur manufacturing facilities.


The Prescription Pharmaceuticals segment revenue of $172.2$148.0 million for the three month period ended June 30, 2018March 31, 2019, represented a decrease of $10.5$16.3 million, or 5.7%9.9%, as compared to revenue of $182.6$164.3 million for the three month period ended June 30, 2017.March 31, 2018.


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The Consumer Health segment revenue of $18.8$17.9 million for the three month period ended June 30, 2018March 31, 2019, represented an increasea decrease of $2.3$1.9 million, or 13.9%9.6%, as compared to revenue of $16.5$19.8 million for three month period ended June 30, 2017. The $2.3 million increase in revenue is primarily attributed to the TheraTears® direct-to-consumer ("DTC") advertising campaign.March 31, 2018.


The net revenue for the three month period ended June 30, 2018March 31, 2019, of $190.9$165.9 million was net of adjustments totaling $316.9$292.8 million for chargebacks, rebates, administrative fees and others, product returns, discounts and allowances and advertising, promotions and other.  Chargeback expenses for the three month period ended June 30, 2018March 31, 2019, were $222.5$205.4 million, or 43.8%44.8% of gross sales, compared to $237.3$224.0 million, or 41.8%43.0% of gross sales for the three month period ended June 30, 2017.March

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31, 2018.  The $14.8$18.6 million decrease in chargeback expense was primarily due to lower gross sales in the current periodvolume declines as well as product mix and customer mix compared to prior year same period. Rebates, administrative fees and other expenses for the three month period ended June 30, 2018March 31, 2019, were $75.1$64.3 million, or 14.8%14.0% of gross sales, compared to $109.8$92.3 million, or 19.4%17.7% for three month period ended June 30, 2017.March 31, 2018. The $34.7$28.0 million decrease in rebates, administrative fees and other expenses was primarily due to volume declines as well as product mix and customer mix.  Our product returns provision for the three month period ended June 30, 2018March 31, 2019, was $6.1$11.9 million, or 1.2%2.6% of gross sales, compared to $8.1$7.1 million, or 1.4% of gross sales for the three month period ended June 30, 2017.March 31, 2018. The increase in product returns for the three month periods ended March 31, 2019, as compared to the same periods in 2018, was primarily due to the timing of returns processing. Discounts and allowances were $9.9$9.0 million or 2.0% of gross sales for the three month period ended June 30, 2018,March 31, 2019, compared to $10.8$10.2 million, or 1.9%2.0% of gross sales for the three month period ended June 30, 2017.March 31, 2018. Advertisement and promotion expenses were $3.2$2.2 million or 0.5% of gross sales for the three month period ended March 31, 2019, compared to $2.9 million, or 0.6% of gross sales for the three month period ended June 30, 2018, compared to $2.0 million, or 0.4% of gross sales for the three month period ended June 30, 2017.March 31, 2018.
 
Consolidated gross profit for the quarter ended June 30, 2018March 31, 2019, was $81.3$53.5 million, or 42.6%32.3% of net revenue, compared to $102.8$82.2 million, or 51.6%44.7% of net revenue, in the corresponding prior year quarter. The decline in the gross profit percentage was principally due to unfavorable product mix shifts primarily driven by the effect of competition on Ephedrine Sulfate Injection, Nembutal® and Nembutal,Cosopt® PF, unfavorable variances due to decreased production at our Somerset manufacturing facility, as well as increased operating costs at our manufacturing facilities.associated with FDA compliance related improvement activities.
  
Total operating expenses were $172.8$119.0 million in the three month period ended June 30, 2018,March 31, 2019, an increase of $84.3$11.4 million, or 95.3%10.5%, from the prior year quarter amount of $88.5$107.6 million. The $84.3$11.4 million increase was primarily driven by approximately $58.4respective increases of $16.0 million and $29.7$9.5 million increasesof goodwill impairments and selling, general and administrative (“SG&A”), that were partially offset by decreases of $8.4 million, $3.9 million and $2.1 million in Researchimpairment of intangibles, research and development (“R&D”) expenses and Selling, general and administrative (“SG&A”), respectively that were partially offset by a decreaseamortization of $2.3 million in Amortization of intangibles.intangibles, respectively. The following is a discussion of the main drivers of the increase:
 
R&D expensesGoodwill Impairments were $74.3$16.0 million in the three month period ended June 30, 2018, an increaseMarch 31, 2019, as a result of $58.4 million or 367.8% over the prior year quarter amount of $15.9 million.  The $58.4 million increaseCompany announcing that it was primarily dueexploring strategic alternatives to IPR&D impairments of $61.6exit the India manufacturing facility.

SG&A expenses were $72.5 million in the three month period ended June 30, 2018 compared to IPR&D impairments of $3.2 million in the three month period ended June 30, 2017.

SG&A expenses were $83.7 million in the three month period ended June 30, 2018,March 31, 2019, an increase of $29.7$9.5 million, or 55.0%15.1%, from the prior year quarter amount of $54.0$63.0 million. The primary drivers of the $29.7$9.5 million increase were $23.7$10.1 million legal expenses attributedrelated to the Delaware ActionIndia plant assets impairments, $5.7 million in financial advisor fees and $12.4$3.1 million expenses related to the data integrity assessment projects.projects, which were partially offset by a decrease of $9.0 million in marketing and advertising expenses in 2018, related to the TheraTears® direct-to-consumer ("DTC") advertising campaign.


Non-operating expensesImpairments of intangible assets were $12.7$10.4 million in the three month period ended June 30, 2018,March 31, 2019, a decrease of $8.4 million or 44.7% over the prior year amount of $18.8 million. During three month period ended March 31, 2019, the Company recorded Intangible assets impairment expense of $10.4 million on one Product licensing rights compared to $17.9 million on three IPR&D projects and $0.9 million on one Product licensing rights during the comparative prior year period.

Non-operating expenses were $15.3 million in the three month period ended March 31, 2019, an increase of $5.2$4.7 million, or 68.7%44.3%, from the comparative prior year period amount of $7.5$10.6 million. The $5.2$4.7 million increase was primarily driven by $2.6 million income attributed to receipt and subsequent sale of the Nicox securities that the Company received as a milestone payment in the second quarter of 2017, and $1.7$4.4 million increase in interest expense related to higher interest rates during the three month period ended June 30, 2018March 31, 2019, compared to the same period in 2017.2018.

For the three month period ended June 30, 2018,March 31, 2019, we recorded an income tax benefitprovision of approximately $16.3$1.4 million on our net loss before income taxes of $104.3$80.8 million, which represented an effective tax benefit rate of 15.6%1.8%. In the prior year quarter ended June 30, 2017,March 31, 2018, our income tax provisionbenefit was $4.2$7.3 million based on an effective tax benefit rate of 20.2%. The reason for the overall tax provision rate of 62.4%. The decrease in(1.8)% during the income tax rate as a percentage of (loss) income before income tax for the quarterthree month period ended June 30, 2018 as comparedMarch 31, 2019 is due to the same period in 2017, was principally the result of the enactment of the Tax Act in December 2017, and the incurrence of non-deductible fees in connection with the Delaware Action.full valuation allowance recorded against our deferred tax assets.
 
The Company reported a net loss of $88.0$82.2 million for the three month period ended June 30, 2018,March 31, 2019, or 46.1%49.5% of net revenue, compared to net incomeloss of $2.5$28.7 million for the three month period ended June 30, 2017,March 31, 2018, or 1.3%15.6% of net revenue.

SIX MONTHS ENDED JUNE 30, 2018 COMPARED TO SIX MONTHS ENDED JUNE 30, 2017

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Net revenue was $375.0 million for the six month period ended June 30, 2018, representing a decrease of $77.6 million, or 17.1%, as compared to net revenue of $452.6 million for the six month period ended June 30, 2017. The decrease in net revenue in the period was primarily due to $84.1 million decline in organic revenue. The $84.1 million decline in organic revenue was due to approximately $46.9 million, or 10.4%, and $37.2 million, or 8.2%, in volume and price declines, respectively. The organic revenue decline was principally due to the effect of competition on Ephedrine Sulfate Injection, Nembutal and Lidocaine Ointment.

The Prescription Pharmaceuticals segment revenue of $336.5 million for the six month period ended June 30, 2018 represented a decrease of $83.6 million, or 19.9%, as compared to revenue of $420.0 million for the six month period ended June 30, 2017.

The Consumer Health segment revenue of $38.5 million for the six month period ended June 30, 2018 represented an increase of $6.0 million, or 18.5%, as compared to revenue of $32.5 million for the six month period ended June 30, 2017. The $6.0 million increase in revenue is primarily attributed to the TheraTears® direct-to-consumer ("DTC") advertising campaign.

The net revenue for the six month period ended June 30, 2018 of $375.0 million was net of adjustments totaling $653.3 million for chargebacks, rebates, administrative fees and others, product returns, discounts and allowances and advertising, promotions and other.  Chargeback expenses for the six month period ended June 30, 2018 were $446.4 million, or 43.4% of gross sales, compared to $517.4 million, or 41.5% of gross sales for the six month period ended June 30, 2017.  The $71.0 million decrease in chargeback expense was due to lower gross sales in the current period as compared to prior year same period. Rebates, administrative fees and other expenses for the six month period ended June 30, 2018 were $167.4 million, or 16.3% of gross sales, compared to $234.1 million, or 18.8% for six month period ended June 30, 2017. The $66.8 million decrease in rebates, administrative fees and other expenses was primarily due to volume declines as well as product mix and customer mix. Our product returns provision for the six month period ended June 30, 2018 was $13.3 million, or 1.3% of gross sales, compared to $16.5 million, or 1.3% of gross sales for the six month period ended June 30, 2017.  Discounts and allowances were $20.2 million or 2.0% of gross sales for the six month period ended June 30, 2018, compared to $23.8 million, or 1.9% of gross sales for the six month period ended June 30, 2017. Advertisement and promotion expenses were $6.1 million or 0.6% of gross sales for the six month period ended June 30, 2018, compared to $3.2 million, or 0.3% of gross sales for the six month period ended June 30, 2017.
Consolidated gross profit for the six month period ended June 30, 2018 was $163.5 million, or 43.6% of net revenue, compared to $251.5 million, or 55.6% of net revenue, in the corresponding prior year period. The decline in the gross profit percentage was principally due to unfavorable product mix shifts primarily driven by the effect of competition on Ephedrine Sulfate Injection and Nembutal, as well as increased operating costs at our manufacturing facilities.
Total operating expenses were $280.5 million in the six month period ended June 30, 2018, an increase of $117.6 million, or 72.2%, from the comparative prior year period amount of $162.9 million. The $117.6 million increase was primarily driven by approximately $78.1 million and $45.1 million increases in Research and development (“R&D”) expenses and Selling, general and administrative (“SG&A”), respectively that were partially offset by a decrease of and $4.6 million in Amortization of intangibles. The following is a discussion of the main drivers of the increase:
R&D expenses were $105.2 million in the six month period ended June 30, 2018, an increase of $78.1 million or 287.4% over the comparative prior year period amount of $27.2 million.  The $78.1 million increase was primarily due to IPR&D impairments of $79.5 million in the six month period ended June 30, 2018 compared to IPR&D impairments of $3.4 million in the six month period ended June 30, 2017.

SG&A expenses were $146.7 million in the six month period ended June 30, 2018, an increase of $45.1 million, or 44.4%, from the comparative prior year period amount of $101.6 million. The primary drivers of the $45.1 million increase were $25.0 million legal expenses attributed to the Delaware Action, $10.3 million increase in advertising and promotional expenses of which $9.5 million is related to the TheraTears® direct-to-consumer ("DTC") advertising campaign and $16.7 million expenses related to the data integrity assessment projects.

Non-operating expenses were $23.3 million in the six month period ended June 30, 2018, an increase of $6.7 million, or 40.3%, from the comparative prior year period amount of $16.6 million. The $6.7 million increase was primarily driven by $2.6 million income attributed to receipt and subsequent sale of the Nicox securities that the Company received as a milestone payment in the second quarter of 2017, and $1.7 million increase in interest expense during the six month period ended June 30, 2018 compared to the same period in 2017.

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For the six month period ended June 30, 2018, we recorded an income tax benefit of approximately $23.6 million on our net loss before income taxes of $140.3 million, which represented an effective tax benefit rate of 16.8%.  In the prior year six month period ended June 30, 2017, our income tax provision was $28.5 million based on an effective tax provision rate of 39.6%. The decrease in the income tax rate as a percentage of (loss) income before income tax for the six month period ended June 30, 2018 as compared to the same period in 2017, was principally the result of the enactment of the Tax Act in December 2017, and the incurrence of non-deductible fees in connection with the Delaware Action.
The Company reported a net loss of $116.7 million for the six month period ended June 30, 2018, or 31.1% of net revenue, compared to net income of $43.6 million for the six month period ended June 30, 2017, or 9.6% of net revenue.


FINANCIAL CONDITION AND LIQUIDITY


As of June 30, 2018,March 31, 2019, we had cash and cash equivalents of $296.8$184.1 million, which was $71.3$40.8 million less than our cash and cash equivalents balance of $368.1$224.9 million as of December 31, 2017.2018. This decrease in cash and cash equivalents was driven by

[45]




net operating cash outflows of $30.5 million, net investing cash outflows of $35.9 million, net operating cash outflows of $31.3$10.1 million, and net financing cash outflows of $4.5$0.5 million. Our net working capital was $524.5$381.7 million at June 30, 2018,March 31, 2019, compared to $559.1$413.0 million at December 31, 2017,2018, a decrease of $34.5$31.3 million.

Operating Cash Flows

 (amounts in thousands)
Six Months Ended
June 30,
 2018 2017
OPERATING ACTIVITIES:   
Consolidated net (loss) income$(116,731) $43,564
Adjustments to reconcile consolidated net income to net cash (used in) provided by operating activities: 
  
Depreciation and amortization40,439
 42,212
Amortization of debt financing costs2,608
 2,608
Impairment of intangible assets83,349
 8,079
Non-cash stock compensation expense11,453
 9,844
Income from available-for-sale securities
 (3,032)
Deferred income taxes, net(24,512) (2,341)
Loss on sale of available-for-sale securities
 196
Other481
 (288)
Changes in operating assets and liabilities:

 

Trade accounts receivable(45,893) 105,848
Inventories, net(7,735) (6,225)
Prepaid expenses and other current assets8,176
 2,078
Trade accounts payable602
 (13,465)
Accrued expenses and other liabilities16,490
 (30,051)
NET CASH (USED IN) PROVIDED BY OPERATING ACTIVITIES$(31,273) $159,027


During the year to datethree month period ended June 30, 2018,March 31, 2019, net cash used in operating activities generated $31.3 million in negative cash flows.was $30.5 million. This negative cash flow was principally the result of our consolidated net loss of $116.7$82.2 million, an increase of $45.9$21.3 million in trade accounts receivable, an increase of $7.7 million in inventories, net, partially offset by a net inflow from non-cash expenses of $113.3$61.1 million, a decrease of $10.8 million in inventories, net, and $1.4 million related to FIN 48 reserve, which mainly represents uncertain tax position regarding the reserve for chargebacks & rebates, penalties and interest for the change from accrual basis to cash basis.

During the three month period ended March 31, 2018, net cash used in operating activities was $31.6 million. This negative cash flow was principally the result of an increase of $35.5 million in trade accounts receivable, our consolidated net loss of $28.7 million, a decrease in accrued legal fees of $12.9 million, an increase of $16.5$9.3 million in inventories, net, a decrease in accrued expenses and other liabilities of $7.3 million, offset by a $38.1 million net inflow of non-cash expenses, a decrease in prepaid expenses and other current assets of $8.2$12.0 million, and a $0.6$11.3 million increase in trade accounts payable.

During the six month period ended June 30, 2017, operating activities generated $159.0 million in cash flows. This positive cash flow was principally the result of a decrease of $105.8 million in accounts receivable, consolidated net income of $43.6 million, a $57.4 million net inflow of non-cash expenses, partially offset by a decrease of $30.1 million in accrued expenses and other liabilities and a $13.5 million trade payable.


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Investing Cash Flows

 (amounts in thousands)
Six Months Ended
June 30,
 2018 2017
INVESTING ACTIVITIES: 
  
Proceeds from disposal of assets$20
 $4,811
Payments for intangible assets(50) (200)
Purchases of property, plant and equipment(35,862) (50,072)
NET CASH USED IN INVESTING ACTIVITIES$(35,892) $(45,461)


We used $35.9$10.1 million in investing activities during the sixthree month period ended June 30, 2018.March 31, 2019. Of this total, $35.9$10.1 million was used to acquire property, plant and equipment. 


We used $45.5$22.3 million in investing activities during the sixthree month period ended June 30, 2017.March 31, 2018. Of this total $50.1$22.3 million was used to acquire property, plant and equipment, partially offset by $4.8 million received in proceeds related to the disposition of assets.equipment.


Financing Cash Flows

 (amounts in thousands)
Six Months Ended
June 30,
 2018 2017
FINANCING ACTIVITIES: 
  
Proceeds from the exercise of stock options$254
 $6,897
Payment of contingent acquisition liabilities(4,793) 
Lease payments(6) 
NET CASH (USED IN) PROVIDED BY FINANCING ACTIVITIES$(4,545) $6,897


Financing activities used $4.5$0.5 million in the sixthree month period ended June 30,March 31, 2019, consisting of $0.3 million for lease payments and $0.1 million for stock compensation plan withholdings for employee taxes related to vested RSUs. 

Financing activities used $4.3 million in the three month period ended March 31, 2018, consisting of $4.8 million used for consideration payable payments, partially offset by $0.3$0.5 million of proceeds from employee stock option exercises. 

Financing activities provided $6.9 million in the six month period ended June 30, 2017, in proceeds from employee stock option exercises. 

Liquidity and Capital Needs


We require certain capital resources in order to maintain and expand our business. The company has incurred and expects in 2019 to continue to incur significant costs related to consultants assisting with cGMP improvements. Our future capital expenditures may include substantial projects undertaken to upgrade, expand and improve our manufacturing facilities, in the United States India and Switzerland. Most notably, we continueOur ability to expend significant amountsinvest in order to gain compliance with FDA requirements at AIPL. Furthermore,our foreign facilities may be limited by the Company expects to continue to expend significant amounts in order to comply withterms of the DSCSA. We also expect to continue to incur a significant amount of expenses for the ongoing Delaware Action and data integrity related FDA compliance matters.Standstill Agreement. Our cash obligations include the principal and interest payments due on our Term Loans and any amount we may borrow under the JPMorgan Revolving Facility (as both described throughout this report). These principal and interest payments will increase under the amountStandstill Agreement. Also, ongoing legal and financial advisory fees may be significant, including those of the advisors to the Ad Hoc Group, which are required to effectbe paid pursuant to the repurchaseterms of shares of our common stock in accordance with the Stock Repurchase Program discussed in Item 1, Note 11 - "Share Repurchases." As of June 30, 2018, the Company had $155.0 million remaining under the repurchase authorization.Standstill Agreement. We believe that our cash reserves and operating cash flows and availability under our credit facilities will be sufficient to finance any future expansions and meet our cash needs for the foreseeable future.


Refer to Item 1, Note 8 - "Financing Arrangements" for further detail of debt obligations as of and for the quarter ended June 30, 2018.March 31, 2019, and for a description of the terms of the Standstill Agreement. In addition, refer to Item 1, Note 2 - “Summary of Significant Accounting Policies,” for management’s going concern assessment.


CRITICAL ACCOUNTING POLICIES
 
The preparation of financial statements in accordance with generally accepted accounting principles requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses. A summary of

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our significant accounting policies is included in Part II - Item 8, Note 2 - "Summary of Significant Accounting Policies", in our Annual Report on Form 10-K for the year ended December 31, 20172018, and in Item 1, Note 2 - "Summary of Significant Accounting Policies" of this Form 10-Q. Certain of our accounting policies are considered critical, as these policies require

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significant, difficult or complex judgments by management, often requiring the use of estimates about the effects of matters that are inherently uncertain.


The Company consolidates the financial statements of its foreign subsidiaries in accordance with ASC 830 - Foreign Currency Matters, under which the statement of operations amounts are translated from Indian rupeesRupees (“INR”) and Swiss Francs (“CHF”), respectively, to U.S. Dollars at the average exchange rate during the applicable period, while balance sheet amounts are generally translated at the exchange rate in effect as of the applicable balance sheet date.  Cash flows are translated at the average exchange rate in place during the applicable period.  Differences arising from foreign currency translation are included in accumulated other comprehensive loss and are carried as a separate component of equity on our condensed consolidated balance sheets.


OFF-BALANCE SHEET ARRANGEMENTS
 
We do not have any off-balance sheet arrangements that have had, or are reasonably likely to have, a current or future material effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures, or capital resources.


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Item 3. Quantitative and Qualitative Disclosures About Market Risk.


There has been no material change in the information reported under Part II, Item 7A - “Quantitative and Qualitative Disclosures About Market Risk” in our Form 10-K for the fiscal year ended December 31, 2017.2018.


Item 4. Controls and Procedures.
 
Evaluation of Disclosure Controls and Procedures


Our disclosure controls and procedures are designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in reports we file or submit under the Exchange Act is accumulated and communicated to our management including the Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.

As of June 30, 2018, an evaluation was conducted under the supervision andevaluated, with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of our disclosure controls and procedures, (as defined in Rule 13a-15(e) and Rule 15d-15(e) of the Exchange Act). Based on this evaluation, such officers have concluded that our disclosure controls and procedures are effective as of June 30, 2018.

Changes in Internal Control Over Financial Reporting

There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, for the three month period ended June 30,March 31, 2019.

Based on this evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that, because of the material weakness in internal control over financial reporting described in our 2018 Form 10-K as filed on March 1, 2019, our disclosure controls and procedures were not effective as of March 31, 2019.
A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
In prior filings, we identified and reported a material weakness in the Company’s internal controls over financial reporting, over the accounting for interpretation and calculation of Stock Award Modifications, (non-routine in nature), which still exists as of March 31, 2019. In response to the identified material weakness, our management, with oversight from our audit committee, has dedicated resources to improve our control environment and to remedy the identified material weakness. We are executing our remediation plan and testing procedures.
We believe that we have designed and implemented the appropriate controls to fully remediate the material weakness. These controls include additional procedures related to the interpretation and calculation of stock award modifications with respect to accelerated vesting in conjunction with separation packages and other non-routine performance awards granted. The Company is required to demonstrate the effectiveness of the new processes for a sufficient period of time; therefore, until all remedial actions as described fully in our 2018 Form 10-K, as filed on March 1, 2019, including the efforts to test the necessary control activities we identified, are fully completed, the material weakness identified will continue to exist.
During the three month period ended March 31, 2019, the Company commenced testing of the redesigned controls directly related to the identified material weakness. We are committed to achieving and maintaining a strong control environment, high ethical standards and financial reporting integrity and transparency.
Changes in Internal Control Over Financial Reporting

As described above, we have designed and implemented additional controls in connection with our remediation plan. Other than these additional controls, there were no changes in our internal control over financial reporting, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, for the three month period ended March 31, 2019, that has materially affected, or areis reasonably likely to materially affect the Company’s internal control over financial reporting.



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PART II. OTHER INFORMATION


Item 1. Legal Proceedings.


The Company’s disclosure of legal proceedings within Part I - Item 1, Note 12 - "Commitments and Contingencies" of this Report, is incorporated into this Part II - Item 1 by reference.


Item 1A. Risk Factors.
 
Other than the risk factors described in our Form 10-Q filed on May 2, 2018, and set forth below, thereThere have been no material changes to the risk factors disclosed in Part 1 - Item 1A, of our Form 10-K for the year ended December 31, 2017:2018, as filed with the SEC on March 1, 2019, except as set forth below:


Risks related to the sale of our India manufacturing facility.
We have filedmay not be able to recover all or any of the net asset value and may incur additional costs as we exit our India manufacturing facility.

Risks related to John N. Kapoor’s, Ph.D., stock ownership the Company.

As a lawsuit against Fresenius Kabi AG, Quercus Acquisition, Inc. and Fresenius SE & Co. KGaAresult of a jury verdict finding John N. Kapoor, Ph.D., guilty in relationa federal criminal case, OIG-HHS’s permissive exclusion rules could lead to the Merger,Company’s exclusion from participating in U.S. government healthcare programs, which could have a material adverse effect on our business, financial condition and defendants filedresults of operations.

The Office of the Inspector General of the U.S. Department of Health and Human Services (“OIG-HHS”) has permissive authority to exclude individuals and entities convicted of certain crimes from participation in U.S. government healthcare programs, including Medicare and Medicaid. Under OIG-HHS’s permissive exclusion rules, OIG-HHS may exclude an entity from participation in U.S. government healthcare programs if an individual with a counterclaim. If wedirect or indirect ownership or control interest of 5% or more in such entity is convicted of certain criminal offenses.

John N. Kapoor, Ph.D., is a principal shareholder of the Company. As of March 31, 2019, Dr. Kapoor beneficially owned approximately 23% of our common stock. On May 2, 2019, a federal jury found Dr. Kapoor guilty of racketeering conspiracy. Due to the jury verdict finding Dr. Kapoor guilty, OIG-HHS’s permissive exclusion rules could lead to the exclusion of the Company from participation in U.S. government healthcare programs, which could have a material adverse effect on our business, financial condition and results of operations.

John N. Kapoor’s, Ph.D., involvement with the Company through his stock ownership and his right to nominate up to three directors could have an adverse effect on the price of our common stock and have substantial influence over our business strategies and policies.

John N. Kapoor, Ph.D., is a principal shareholder of the Company. As of March 31, 2019, Dr. Kapoor beneficially owned approximately 23%. On May 2, 2019, a federal jury found Dr. Kapoor guilty of racketeering conspiracy. As a result of the verdict and the permissive exclusion rules of the OIG-HHS with respect to participation in U.S. government healthcare programs, it is possible Dr. Kapoor will divest all or a part of his ownership in the Company. Further, NASDAQ has the discretionary authority to deny continued listing to a company when an individual with a history of regulatory misconduct is associated with a company. As a result of the jury verdict finding Dr. Kapoor guilty, it is possible Dr. Kapoor would be required to divest all or a part of his ownership in the Company in order for the Company to continue to be listed on NASDAQ.

In addition, through the Kapoor Trust and EJ Financial, Dr. Kapoor is entitled to nominate up to three persons to serve on our Board. Mr. Brian Tambi was nominated for these purposes. The other seats for nomination are unsuccessfulvacant. Nomination of any directors to our Board or any trading of our common stock or divestments by Dr. Kapoor and his related parties could have an adverse effect on the price of our common stock and an adverse effect on our business.

Risks related to the Standstill Agreement.

The Standstill Agreement with our lenders requires us to observe certain covenants, which creates material uncertainties and risks to our growth and business outlook, and any failure to comply with the Standstill Agreement could result in our lawsuit, our current shareholdersan event of default under the Term Loan Agreements and render us insolvent.


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On May 7, 2019, the Company announced that it entered into a Standstill Agreement and First Amendment (the “Standstill Agreement”) in respect of the Term Loan Agreements with an ad hoc group of lenders (the “Ad Hoc Group”), certain other lenders (together with the Ad Hoc Group, the “Standstill Lenders”) and JPMorgan Chase Bank, N.A., as administrative agent (the “Term Loan Administrative Agent”).

The Standstill Agreement provides that, for the duration of the Standstill Period (as defined below), among other matters, neither the Term Loan Administrative Agent nor the lenders may not realize(i) declare any event of default under the anticipated benefits contemplatedTerm Loan Agreements or (ii) otherwise seek to exercise any rights or remedies, in each case of clauses (i) and (ii) above, to the extent directly relating to any alleged event of default arising from any alleged breach of any of the covenants contained in Sections 5.01, 5.02, 5.03, 5.06 or 5.07 of the Term Loan Agreements, to the extent the facts and circumstances giving rise to any such breach have been (x) publicly disclosed by the Merger Agreement.

On April 22, 2018, Fresenius Kabi AG deliveredCompany or (y) disclosed in writing by the Company to private side lenders or certain advisors to the Ad Hoc Group (collectively, the “Specified Matters”). “Standstill Period” means the period of time from the effective date of the Standstill Agreement (the “Effective Date”) through the earliest of (a) December 13, 2019; (b) the delivery of a notice of termination of the Standstill Period by lenders holding a majority of the Term Loans (the “Required Lenders”) upon the occurrence of a default or event of default under the Term Loan Agreements, excluding any default or event of Default relating to a Specified Matter; or (c) the delivery of a notice of termination of the Standstill Period by the Required Lenders as a result of any breach of, or non-compliance with, any provision of the Standstill Agreement by the Akorn a letter purporting to terminateLoan Parties, including without limitation any such breach or noncompliance by the Merger Agreement.  On April 23, 2018, Akorn filed a verified complaint entitled Akorn, Inc. v. Fresenius Kabi AG, Quercus Acquisition, Inc. and Fresenius SE & Co. KGaA,Loan Parties of or with any affirmative covenants, milestones, negative covenants or other covenants set forth in the CourtStandstill Agreement, subject, in each case, to any applicable cure period expressly set forth therein.

In exchange for the lenders’ agreement to standstill during the Standstill Period, the Standstill Agreement requires the Company to comply with certain affirmative covenants, including delivery of Chancerycertain financial and other reporting to the lenders or their advisors. The Company is also required to participate in various update calls with the lenders and their advisors. Preparation of such deliverables and participation in such update calls could distract the Company’s management from their focus on the Company’s business operations, which could materially affect the Company’s business, financial position and results of operations. The failure by the Company to comply with any of these covenants could result in the termination of the StateStandstill Agreement by the lenders. Any termination of Delaware for breachthe Standstill Agreement would allow the lenders to assert any events of contractdefault with respect to the Specified Matters that are otherwise precluded by the Standstill Agreement and, declaratory judgment.  The complaint alleges, among other things, that (i) the defendants anticipatorily breached theiras a result thereof, all obligations under the MergerTerm Loan Agreements could be declared to be immediately due and payable.

The Standstill Agreement also imposes a number of restrictions on the Company, including restrictions on:

consummating certain asset sales and investments;

making certain restricted payments with respect to the Company’s common stock and any subordinated indebtedness;

engaging in sale and leaseback transactions;

incurring certain liens and indebtedness;

reinvesting any proceeds received from certain asset sales; and

designating any restricted subsidiary as an unrestricted subsidiary, or otherwise creating or forming any unrestricted subsidiary, and/or transferring any assets of the Company or any of its restricted subsidiaries to any unrestricted subsidiary, except as otherwise permitted under the Term Loan Agreements (after giving effect to the Standstill Agreement).

These restrictions are in addition to those otherwise contained in the Term Loan Agreements.

The Standstill Agreement also restricts the Company’s ability to make payments in excess of $20 million in respect of settlements or judgments of certain ongoing litigation matters of the Company (a “Specified Litigation Payment”) over the objection of the Ad Hoc Group. If any such payment is made over the objection of the Ad Hoc Group, the Required Lenders could (i) terminate the Standstill Period and assert any events of default under the Term Loan Agreements with respect to the Specified Matters that are otherwise precluded by repudiating their obligationthe Standstill Agreement, and (ii) assert a separate event of default under the Term Loan Agreements if such payment has a material adverse effect on the Company. The failure of the Company to close
comply with the Merger, (ii)covenant in respect of the defendants knowinglySpecified Litigation Payment during the Standstill Period would result in an

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event of default under the Term Loan Agreements. Additionally, the failure by the Company to discharge an unstayed judgment in excess of $20 million for a period of thirty days would constitute a separate event of default under the Term Loan Agreements. If a judgment were to be rendered against the Company in excess of $20 million, an event of default could occur if the Company were to make such payment and an event of default could occur if the Company were to fail to make such payment which, in either case, if not waived, could materially affect the Company’s business, financial position and intentionally breached theirresults of operations.

The Company’s ability to comply with these covenants and restrictions may be affected by events beyond its control and its failure to comply, or obtain a waiver in the event it cannot comply, could result in an event of default under the Term Loan Agreements that, if not waived, could materially affect the Company’s business, financial position and results of operations.

As a result of these covenants and restrictions, the Company may be limited in its ability to conduct its business, and respond to changing business, market and economic conditions. These provisions may also limit the Company’s ability to pursue new business opportunities and strategies. The Standstill Agreement may also result in business uncertainties during the Standstill Period and require substantial attention of management of the Company. These uncertainties may impair the Company’s ability to attract, retain and motivate key personnel, and could cause partners and others that deal with the Company to seek to change existing business relationships, cease doing business with the Company or cause potential new partners to delay doing business with the Company. The failure to retain key personnel or attract new personnel could materially affect the Company’s business, financial position and results of operations.

Pursuant to the terms of the Standstill Agreement, the Company must enter into a comprehensive amendment of the Term Loan Agreements (a “Comprehensive Amendment”) that is satisfactory in form and substance to the lenders. If the Company does not enter into such a Comprehensive Amendment by December 13, 2019, an event of default will occur under the Term Loan Agreements which, if not waived, could materially affect the Company’s business, financial position and results of operations, and could render us insolvent.

The Company has agreed to negotiate in good faith with the lenders under the Term Loan Agreements to enter into a Comprehensive Amendment. If the Company is not able to reach agreement with such lenders on or before November 15, 2019, the Company must pay an in-kind fee in an amount equal to 0.625% of the loans outstanding on such date and at that time pledge all equity interests in its foreign subsidiaries that are not then subject to a lien in favor of the lenders. If the Company is not able to reach agreement with such lenders on or before December 13, 2019 and the loans under the Term Loan Agreements remain outstanding on such date, such failure would constitute an immediate event of default under the Term Loan Agreements. If an event of default occurs and the lenders accelerate the obligations under the Merger Agreement by working to slow the antitrust approval process and by engaging in a series of actions designed to hamper and ultimately block the Merger and (iii) Akorn has performed its obligations under the Merger Agreement, and is ready, willing and able to close the Merger.  The complaint seeks, among other things, a declaration that Fresenius Kabi AG's termination is invalid, an order enjoining the defendants from terminating the Merger Agreement, and an order compelling the defendants to specifically perform their obligations under the Merger Agreement to use reasonable best efforts to consummate and make effective the Merger. On April 30, 2018, the defendants filed a verified counterclaim alleging that, due primarily to purported data integrity deficiencies at Akorn, the Company had breached representations and warranties and covenants in the Merger Agreement, and that it had experienced a material adverse effect. The verified counterclaim seeks, among other things, a declaration that defendants’ purported termination of the Merger Agreement was valid and that defendants are not obligated to consummate the transaction.

Following expedited discovery, from July 9 to 13, 2018, the Court of Chancery held a trial on the parties’ claims (collectively, the “Delaware Action”). At the conclusion of trial, the Court of Chancery ordered post-trial briefing, which is scheduled to be completed on August 20, 2018. The Court has scheduled a post-trial hearing for August 23, 2018. Akorn expects to receive the Court’s ruling after the post-trial hearing. Any decision by the Court of Chancery will be subject to a potential appeal to the Delaware Supreme Court.

We believe that this lawsuit is necessary to enforce our rights under the Merger Agreement and to deliver to our shareholders the benefits of the Merger Agreement. At this stage, there is no way to predict the outcome of this lawsuit. IfTerm Loan Agreements, we are unsuccessful in our lawsuit, the Merger may not be consummatedable to repay the obligations that become immediately due and it could have a material negative impact on our current shareholdersliquidity and on our business. If we do not have sufficient funds on hand to pay our debt when due, we may not receivebe required to refinance our indebtedness, incur additional indebtedness, sell assets or sell additional securities. There is no guarantee that the consideration which they are entitled, pursuantCompany may be able to reach any such Comprehensive Amendment, or that any Comprehensive Amendment would be satisfactory in form and substance to the Merger Agreement, to receive upon consummationlenders which is in the sole discretion of the Merger.lenders.


The Standstill Agreement requires the Company to pay certain fees and expenses and provides for an increased interest margin, which may negatively impact the Company’s financial condition.

The Standstill Agreement requires the Company to pay certain fees, including: (i) a one-time in-kind fee in an amount equal to 1.75% of the aggregate principal amount of the loans of the Standstill Lenders on the Effective Date, which fee was paid in kind on such date; (ii) fees and expenses of certain advisors to the Ad Hoc Group; and (iii) a one-time in-kind fee in an amount equal to 0.625% of the loans outstanding under the Term Loan Agreements on November 15, 2019 if a Comprehensive Amendment is not entered into on or before such date, which fee will be payable in kind on such date.

The Standstill Agreement also increases the interest margins the Company is required to pay under the Term Loan Agreements by 1.50% (i.e., 150 basis points), with 0.75% (i.e., 75 basis points) of such increase payable in cash and 0.75% (i.e., 75 basis points) of such increase payable in kind. If the Company does not comply with the terms and conditions of the Standstill Agreement, the failure to comply would result in an additional 0.50% (i.e., 50 basis points) increase to the interest margins, which increased interest would be payable in kind.

Additionally, if the Company prepays or repays outstanding loans under the Term Loan Agreements during the Standstill Period (other than as a result of any asset sale, condemnation event, incurrence of non-permitted indebtedness or excess cash flow), the Company is required to pay a fee in an amount equal to 0.625% of the outstanding principal of loans so prepaid or repaid.


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Any amounts paid in cash will reduce the Company’s cash on hand, which could materially affect the Company’s business, financial position and results of operations. Any payments in kind or premium to be paid in connection with any repayment or prepayment of the loans may need to be paid by the Company in cash in order to successfully refinance the outstanding loans.


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Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
 
None.


Item 3. Defaults Upon Senior Securities.
 
None.


Item 4. Mine Safety Disclosures.


Not applicable.


Item 5. Other Information.
 
None.
 
Item 6. Exhibits.
 
The list of exhibits in the Exhibit Index to this Report is incorporated herein by reference.


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EXHIBIT INDEX

Those exhibits marked with a (*) refer to exhibits filed herewith. The other exhibits are incorporated herein by reference, as indicated in the following list. Those exhibits marked with a (†) refer to management contracts or compensatory plans or arrangements. Portions of the exhibits marked with a (Ω) are the subject of a Confidential Treatment Request under 17 C.F.R. §§ 200.80(b)(4), 200.83 and 240.24b-2.  Omitted material for which confidential treatment has been requested has been filed separately with the SEC.
Exhibit
No.
Description

101.INSXBRL Instance Document - The instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.

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101.SCH XBRL Taxonomy Extension Schema Document.
101.CALXBRL Taxonomy Extension Calculation Linkbase Document.
101.LABXBRL Taxonomy Extension Label Linkbase Document.
101.PREXBRL Taxonomy Extension Presentation Linkbase Document.
101.DEFXBRL Taxonomy Extension Definition Linkbase Document.

SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
AKORN, INC.
 AKORN, INC.
/s/ DUANE A. PORTWOOD
   Duane A. Portwood
   Chief Financial Officer
      (on behalf of the registrant and as its
      Principal Financial Officer)
 
 
Date: August 1, 2018May 8, 2019




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EXHIBIT INDEX

Those exhibits marked with a (*) refer to exhibits filed herewith.
Exhibit
No.
Description
101 *The financial statements and footnotes from the Akorn, Inc. Quarterly Report on Form 10-Q for the three and six month periods ended June 30, 2018, filed on August 1, 2018, formatted in XBRL: (i) Condensed Consolidated Balance Sheets, (ii) Condensed Consolidated Statements of Comprehensive (Loss) Income, (iii) Condensed Consolidated Statement of Shareholders’ Equity, (iv) Condensed Consolidated Statements of Cash Flows, and (v) Notes to Condensed Consolidated Financial Statements.



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