Table of Contents

 

 

UNITED STATES SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

xQUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934

 

FOR THE QUARTERLY PERIOD ENDED DECEMBER 31, 2018SEPTEMBER 30, 2019

 

oTRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934

 

FOR THE TRANSITION PERIOD FROM                  TO

 

Commission File No. 001-31298

 

LANNETT COMPANY, INC.

(Exact Name of Registrant as Specified in its Charter)

 

State of Delaware

 

23-0787699

(State of Incorporation)

 

(I.R.S. Employer I.D. No.)

 

9000 State Road

Philadelphia, PA 19136

(215) 333-9000

(Address of principal executive offices and telephone number)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, $0.001 par value

LCI

New York Stock Exchange

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the past 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.  Yes x No o

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes x No o

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company.  See the definitions of “large accelerated filer,” “accelerated filer”, and “smaller reporting company”, and “emerging growth company” in Rule 12b-2 of the Exchange Act.  (Check one):

 

Large accelerated filer xo

 

Accelerated filer ox

 

 

 

Non-accelerated filer o

 

Smaller reporting company o

Emerging growth company o

 

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-12 of the Exchange Act).  Yes o No x

 

Indicate the number of shares outstanding of each class of the registrant’s common stock, as of the latest practical datedate.

 

Class

Outstanding as of JanuaryOctober 31, 2019

Common stock, par value $0.001 per share

 

39,286,74440,335,406

 

 

 


Table of Contents

 

Table of Contents

 

 

Page No.

PART I. FINANCIAL INFORMATION

 

 

 

 

ITEM 1.

FINANCIAL STATEMENTS (UNAUDITED)

 

 

 

 

 

Consolidated Balance Sheets as of December 31, 2018 (unaudited)September 30, 2019 and June 30, 20182019

3

 

 

 

 

Consolidated Statements of Operations (unaudited) for the three and six months ended December 31,September 30, 2019 and 2018 and 2017

4

 

 

 

 

Consolidated Statements of Comprehensive Income (Loss) (unaudited)Income/Loss for the three and six months ended December 31,September 30, 2019 and 2018 and 2017

5

 

 

 

 

Consolidated Statements of Changes in Stockholders’ Equity (unaudited) for the three and six months ended December 31,September 30, 2019 and 2018 and 2017

6

 

 

 

 

Consolidated Statements of Cash Flows (unaudited) for the sixthree months ended December 31,September 30, 2019 and 2018 and 2017

87

 

 

 

 

Notes to Consolidated Financial Statements (unaudited)

98

 

 

 

ITEM 2.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

3331

 

 

 

ITEM 3.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

4641

 

 

 

ITEM 4.

CONTROLS AND PROCEDURES

4641

 

 

 

PART II. OTHER INFORMATION

 

 

 

 

ITEM 1.

LEGAL PROCEEDINGS

4741

 

 

 

ITEM 1A.

RISK FACTORS

4741

 

 

 

ITEM 6.

EXHIBITS

4744

PART I.  FINANCIAL INFORMATION

ITEM 1.  FINANCIAL STATEMENTS

 

LANNETT COMPANY, INC.

CONSOLIDATED BALANCE SHEETS

(In thousands, except share and per share data)

 

 

(Unaudited)

 

 

 

 

(Unaudited)

 

 

 

 

December 31, 2018

 

June 30, 2018

 

 

September 30, 2019

 

June 30, 2019

 

ASSETS

 

 

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

163,774

 

$

98,586

 

 

$

101,008

 

$

140,249

 

Accounts receivable, net

 

275,364

 

252,651

 

 

173,109

 

164,752

 

Inventories

 

136,128

 

141,635

 

 

149,162

 

143,971

 

Prepaid income taxes

 

 

15,159

 

 

159

 

 

Assets held for sale

 

11,422

 

13,976

 

 

4,637

 

9,671

 

Other current assets

 

7,958

 

4,863

 

 

6,994

 

13,606

 

Total current assets

 

594,646

 

526,870

 

 

435,069

 

472,249

 

Property, plant and equipment, net

 

195,607

 

233,247

 

 

184,889

 

186,670

 

Intangible assets, net

 

409,870

 

424,425

 

 

427,253

 

411,229

 

Goodwill

 

 

339,566

 

Operating lease right-of-use assets

 

6,410

 

 

Deferred tax assets

 

100,013

 

22,063

 

 

110,396

 

109,305

 

Other assets

 

19,320

 

29,133

 

 

7,914

 

7,960

 

TOTAL ASSETS

 

$

1,319,456

 

$

1,575,304

 

 

$

1,171,931

 

$

1,187,413

 

 

 

 

 

 

 

 

 

 

 

LIABILITIES

 

 

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

 

 

Accounts payable

 

$

60,178

 

$

56,767

 

 

$

26,927

 

$

13,493

 

Accrued expenses

 

7,283

 

7,425

 

 

6,233

 

5,805

 

Accrued payroll and payroll-related expenses

 

15,545

 

7,819

 

 

12,347

 

19,924

 

Deferred revenue

 

23,998

 

 

Rebates payable

 

44,384

 

49,400

 

 

43,358

 

46,175

 

Royalties payable

 

9,615

 

5,955

 

 

16,597

 

16,215

 

Restructuring liability

 

5,693

 

6,706

 

 

1,167

 

2,315

 

Liabilities held for sale

 

1,204

 

 

Settlement liability

 

8,000

 

 

Income taxes payable

 

1,346

 

 

 

 

2,198

 

Current operating lease liabilities

 

1,932

 

 

Short-term borrowings and current portion of long-term debt

 

66,845

��

66,845

 

 

66,845

 

66,845

 

Other current liabilities

 

3,652

 

3,652

 

Total current liabilities

 

244,091

 

200,917

 

 

179,058

 

176,622

 

Long-term debt, net

 

746,607

 

772,425

 

 

654,432

 

662,203

 

Long-term operating lease liabilities

 

5,626

 

 

Other liabilities

 

2,247

 

3,047

 

 

14,711

 

14,547

 

TOTAL LIABILITIES

 

992,945

 

976,389

 

 

853,827

 

853,372

 

Commitments and Contingencies (Note 12 and 13)

 

 

 

 

 

Commitments and contingencies (Note 12)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

 

 

Common stock ($0.001 par value, 100,000,000 shares authorized; 38,766,807 and 38,256,839 shares issued; 37,822,927, and 37,380,517 shares outstanding at December 31, 2018 and June 30, 2018, respectively)

 

39

 

38

 

Common stock ($0.001 par value, 100,000,000 shares authorized; 39,629,271 and 38,969,518 shares issued; 38,526,558 and 38,010,714 shares outstanding at September 30, 2019 and June 30, 2019, respectively)

 

40

 

39

 

Additional paid-in capital

 

312,322

 

306,817

 

 

314,645

 

317,023

 

Retained earnings

 

29,016

 

306,464

 

 

19,918

 

32,075

 

Accumulated other comprehensive loss

 

(502

)

(515

)

 

(661

)

(615

)

Treasury stock (943,880 and 876,322 shares at December 31, 2018 and June 30, 2018, respectively)

 

(14,364

)

(13,889

)

Treasury stock (1,102,713 and 958,804 shares at September 30, 2019 and June 30, 2019, respectively)

 

(15,838

)

(14,481

)

Total stockholders’ equity

 

326,511

 

598,915

 

 

318,104

 

334,041

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

 

$

1,319,456

 

$

1,575,304

 

 

$

1,171,931

 

$

1,187,413

 

 

The accompanying notes are an integral part of the consolidated financial statements.

LANNETT COMPANY, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(UNAUDITED)

(In thousands, except share and per share data)

 

 

Three months ended

 

Six months ended

 

 

December 31,

 

December 31,

 

 

2018

 

2017

 

2018

 

2017

 

 

Three Months Ended
September 30,

 

 

 

 

 

 

 

 

 

 

 

2019

 

2018

 

Net sales

 

$

193,718

 

$

184,305

 

$

348,772

 

$

339,266

 

 

$

127,342

 

$

155,054

 

Cost of sales

 

115,751

 

88,914

 

203,441

 

168,467

 

 

77,656

 

87,690

 

Amortization of intangibles

 

8,157

 

7,941

 

16,380

 

15,678

 

 

7,028

 

8,223

 

Gross profit

 

69,810

 

87,450

 

128,951

 

155,121

 

 

42,658

 

59,141

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development expenses

 

9,723

 

10,722

 

19,533

 

18,131

 

 

8,940

 

9,810

 

Selling, general and administrative expenses

 

23,197

 

28,493

 

43,785

 

47,531

 

 

21,308

 

20,588

 

Acquisition and integration-related expenses

 

 

65

 

 

83

 

Restructuring expenses

 

213

 

1,035

 

1,235

 

1,562

 

 

1,388

 

1,022

 

Asset impairment charges

 

 

 

369,499

 

 

 

1,618

 

369,499

 

Total operating expenses

 

33,133

 

40,315

 

434,052

 

67,307

 

 

33,254

 

400,919

 

Operating income (loss)

 

36,677

 

47,135

 

(305,101

)

87,814

 

 

9,404

 

(341,778

)

Other income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss on extinguishment of debt

 

(2,145

)

 

Investment income

 

556

 

2,325

 

935

 

3,489

 

 

729

 

379

 

Interest expense

 

(21,512

)

(20,686

)

(42,945

)

(41,598

)

 

(19,292

)

(21,433

)

Other

 

(712

)

3,386

 

(1,008

)

3,135

 

 

934

 

(296

)

Total other loss

 

(21,668

)

(14,975

)

(43,018

)

(34,974

)

 

(19,774

)

(21,350

)

Income (loss) before income tax

 

15,009

 

32,160

 

(348,119

)

52,840

 

Loss before income tax

 

(10,370

)

(363,128

)

Income tax expense (benefit)

 

2,647

 

18,138

 

(72,953

)

25,561

 

 

1,787

 

(75,600

)

Net income (loss)

 

$

12,362

 

$

14,022

 

$

(275,166

)

$

27,279

 

Net loss

 

$

(12,157

)

$

(287,528

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Earnings (loss) per common share:

 

 

 

 

 

 

 

 

 

Loss per common share:

 

 

 

 

 

Basic

 

$

0.33

 

$

0.38

 

$

(7.30

)

$

0.74

 

 

$

(0.32

)

$

(7.65

)

Diluted

 

$

0.32

 

$

0.37

 

$

(7.30

)

$

0.72

 

Diluted (1)

 

$

(0.32

)

$

(7.65

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average common shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

37,761,176

 

37,066,902

 

37,674,200

 

37,029,483

 

 

38,309,267

 

37,586,327

 

Diluted

 

39,112,547

 

38,290,358

 

37,674,200

 

38,087,826

 

Diluted (1)

 

38,309,267

 

37,586,327

 


(1) See Note 14 “Loss Per Common Share” for details on calculation.

 

The accompanying notes are an integral part of the consolidated financial statements.

LANNETT COMPANY, INC.

CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

(UNAUDITED)

(In thousands)

 

 

 

Three months ended

 

Six months ended

 

 

 

December 31,

 

December 31,

 

 

 

2018

 

2017

 

2018

 

2017

 

 

 

 

 

 

 

 

 

 

 

Net income (loss)

 

$

12,362

 

$

14,022

 

$

(275,166

)

$

27,279

 

Other comprehensive income (loss), before tax:

 

 

 

 

 

 

 

 

 

Foreign currency translation gain (loss)

 

7

 

(126

)

13

 

(125

)

Total other comprehensive income (loss), before tax

 

7

 

(126

)

13

 

(125

)

Income tax related to items of other comprehensive income

 

 

 

 

 

Total other comprehensive income (loss), net of tax

 

7

 

(126

)

13

 

(125

)

Comprehensive income (loss)

 

$

12,369

 

$

13,896

 

$

(275,153

)

$

27,154

 

 

 

Three Months Ended
September 30,

 

 

 

2019

 

2018

 

Net loss

 

$

(12,157

)

$

(287,528

)

Other comprehensive loss, before tax:

 

 

 

 

 

Foreign currency translation gain (loss)

 

(46

)

6

 

Total other comprehensive (loss) income, before tax

 

(46

)

6

 

Income tax related to items of other comprehensive (loss) income

 

 

 

Total other comprehensive (loss) income, net of tax

 

(46

)

6

 

Comprehensive loss

 

$

(12,203

)

$

(287,522

)

 

The accompanying notes are an integral part of the consolidated financial statements.

LANNETT COMPANY, INC.

CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

(UNAUDITED)

(In thousands)

 

 

 

Three months ended December 31, 2018

 

 

 

Common Stock

 

Additional

 

 

 

Accumulated
Other

 

 

 

 

 

 

 

Shares
Issued

 

Amount

 

Paid-In
Capital

 

Retained
Earnings

 

Comprehensive
Loss

 

Treasury
Stock

 

Stockholders’
Equity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, September 30, 2018

 

38,665

 

$

39

 

$

310,135

 

$

16,654

 

$

(509

)

$

(14,295

)

$

312,024

 

Shares issued in connection with share-based compensation plans

 

102

 

 

237

 

 

 

 

237

 

Share-based compensation

 

 

 

1,950

 

 

 

 

1,950

 

Purchase of treasury stock

 

 

 

 

 

 

(69

)

(69

)

Other comprehensive income net of tax

 

 

 

 

 

7

 

 

7

 

Net income

 

 

 

 

12,362

 

 

 

12,362

 

Balance, December 31, 2018

 

38,767

 

$

39

 

$

312,322

 

$

29,016

 

$

(502

)

$

(14,364

)

$

326,511

 

 

 

Common Stock

 

Additional

 

 

 

Accumulated
Other

 

 

 

Total

 

 

 

Shares
Issued

 

Amount

 

Paid-In
Capital

 

Retained
Earnings

 

Comprehensive
Loss

 

Treasury
Stock

 

Stockholders’
Equity

 

Balance, June 30, 2019

 

38,970

 

$

39

 

$

317,023

 

$

32,075

 

$

(615

)

$

(14,481

)

$

334,041

 

Shares issued in connection with share-based compensation plans

 

660

 

1

 

235

 

 

 

 

236

 

Share-based compensation

 

 

 

4,459

 

 

 

 

4,459

 

Purchase of treasury stock

 

 

 

 

 

 

(1,357

)

(1,357

)

Other comprehensive income, net of tax

 

 

 

 

 

(46

)

 

(46

)

Purchase of capped call

 

 

 

(7,072

)

 

 

 

(7,072

)

Net loss

 

 

 

 

(12,157

)

 

 

(12,157

)

Balance, September 30, 2019

 

39,630

 

$

40

 

$

314,645

 

$

19,918

 

$

(661

)

$

(15,838

)

$

318,104

 

 

 

 

Three months ended December 31, 2017

 

 

 

Common Stock

 

Additional

 

 

 

Accumulated
Other

 

 

 

 

 

 

 

Shares
Issued

 

Amount

 

Paid-In
Capital

 

Retained
Earnings

 

Comprehensive
Loss

 

Treasury
Stock

 

Stockholders’
Equity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, September 30, 2017

 

37,672

 

$

38

 

$

295,282

 

$

291,031

 

$

(221

)

$

(9,859

)

$

576,271

 

Shares issued in connection with share-based compensation plans

 

89

 

 

492

 

 

 

 

492

 

Share-based compensation

 

 

 

2,563

 

 

 

 

2,563

 

Purchase of treasury stock

 

 

 

 

 

 

(426

)

(426

)

Other comprehensive loss, net of tax

 

 

 

 

 

(126

)

 

(126

)

Net income

 

 

 

 

14,022

 

 

 

14,022

 

Balance, December 31, 2017

 

37,761

 

$

38

 

$

298,337

 

$

305,053

 

$

(347

)

$

(10,285

)

$

592,796

 

 

 

Common Stock

 

Additional

 

 

 

Accumulated
Other

 

 

 

Total

 

 

 

Shares
Issued

 

Amount

 

Paid-In
Capital

 

Retained
Earnings

 

Comprehensive
Loss

 

Treasury
Stock

 

Stockholders’
Equity

 

Balance, June 30, 2018

 

38,257

 

$

38

 

$

306,817

 

$

306,464

 

$

(515

)

$

(13,889

)

$

598,915

 

Shares issued in connection with share-based compensation plans

 

408

 

1

 

283

 

 

 

 

284

 

Share-based compensation

 

 

 

3,035

 

 

 

 

3,035

 

Purchase of treasury stock

 

 

 

 

 

 

(406

)

(406

)

Other comprehensive income, net of tax

 

 

 

 

 

6

 

 

6

 

ASC 606 adjustment, net of tax

 

 

 

 

(2,283

)

 

 

(2,283

)

Net loss

 

 

 

 

(287,528

)

 

 

(287,528

)

Balance, September 30, 2018

 

38,665

 

$

39

 

$

310,135

 

$

16,653

 

$

(509

)

$

(14,295

)

$

312,023

 

 

The accompanying notes are an integral part of the consolidated financial statements.

LANNETT COMPANY, INC.

CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITYCASH FLOWS

(UNAUDITED)

(In thousands)

 

 

 

Six months ended December 31, 2018

 

 

 

Common Stock

 

Additional

 

 

 

Accumulated
Other

 

 

 

 

 

 

 

Shares
Issued

 

Amount

 

Paid-In
Capital

 

Retained
Earnings

 

Comprehensive
Loss

 

Treasury
Stock

 

Stockholders’
Equity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, June 30, 2018

 

38,257

 

$

38

 

$

306,817

 

$

306,464

 

$

(515

)

$

(13,889

)

$

598,915

 

Shares issued in connection with share-based compensation plans

 

510

 

1

 

520

 

 

 

 

521

 

Share-based compensation

 

 

 

4,985

 

 

 

 

4,985

 

Purchase of treasury stock

 

 

 

 

 

 

(475

)

(475

)

Other comprehensive income net of tax

 

 

 

 

 

13

 

 

13

 

ASC 606 adjustment

 

 

 

 

(2,282

)

 

 

(2,282

)

Net loss

 

 

 

 

(275,166

)

 

 

(275,166

)

Balance, December 31, 2018

 

38,767

 

$

39

 

$

312,322

 

$

29,016

 

$

(502

)

$

(14,364

)

$

326,511

 

 

 

Six months ended December 31, 2017

 

 

 

Common Stock

 

Additional

 

 

 

Accumulated
Other

 

 

 

 

 

 

 

Shares
Issued

 

Amount

 

Paid-In
Capital

 

Retained
Earnings

 

Comprehensive
Loss

 

Treasury
Stock

 

Stockholders’
Equity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, June 30, 2017

 

37,528

 

$

37

 

$

292,780

 

$

277,774

 

$

(222

)

$

(9,247

)

$

561,122

 

Shares issued in connection with share-based compensation plans

 

233

 

1

 

805

 

 

 

 

806

 

Share-based compensation

 

 

 

4,752

 

 

 

 

4,752

 

Purchase of treasury stock

 

 

 

 

 

 

(1,038

)

(1,038

)

Other comprehensive loss, net of tax

 

 

 

 

 

(125

)

 

(125

)

Net income

 

 

 

 

27,279

 

 

 

27,279

 

Balance, December 31, 2017

 

37,761

 

$

38

 

$

298,337

 

$

305,053

 

$

(347

)

$

(10,285

)

$

592,796

 

 

 

Three Months Ended
September 30,

 

 

 

2019

 

2018

 

OPERATING ACTIVITIES:

 

 

 

 

 

Net loss

 

$

(12,157

)

$

(287,528

)

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

 

 

 

 

 

Depreciation and amortization

 

12,789

 

14,802

 

Deferred income tax benefit

 

(1,091

)

(77,698

)

Share-based compensation

 

4,459

 

3,035

 

Asset impairment charges

 

1,618

 

369,499

 

Loss (gain) on sale/disposal of assets

 

(1,298

)

37

 

Loss on extinguishment of debt

 

2,145

 

 

Amortization of debt discount and other debt issuance costs

 

4,008

 

4,539

 

Other noncash expenses

 

379

 

 

Changes in assets and liabilities which provided (used) cash:

 

 

 

 

 

Accounts receivable, net

 

(8,357

)

44,127

 

Inventories

 

(5,191

)

(9,842

)

Prepaid income taxes/income taxes payable

 

(2,193

)

14,386

 

Other assets

 

6,789

 

(2,149

)

Rebates payable

 

(2,817

)

(12,911

)

Royalties payable

 

382

 

(77

)

Restructuring liability

 

(1,148

)

205

 

Operating lease liability

 

(364

)

 

Accounts payable

 

13,434

 

(7,320

)

Accrued expenses

 

471

 

(1,253

)

Accrued payroll and payroll-related expenses

 

(7,577

)

2,872

 

Net cash provided by operating activities

 

4,281

 

54,724

 

INVESTING ACTIVITIES:

 

 

 

 

 

Purchases of property, plant and equipment

 

(4,033

)

(5,802

)

Proceeds from sale of property, plant and equipment

 

6,305

 

14,046

 

Proceeds from sale of outstanding loan to Variable Interest Entity (“VIE”)

 

 

5,600

 

Advance to VIE

 

(250

)

 

Purchases of intangible assets

 

(23,500

)

 

Net cash provided by (used in) provided by investing activities

 

(21,478

)

13,844

 

FINANCING ACTIVITIES:

 

 

 

 

 

Proceeds from issuance of long-term debt

 

86,250

 

 

Purchase of capped call

 

(7,072

)

 

Repayments of long-term debt

 

(96,566

)

(16,711

)

Proceeds from issuance of stock

 

236

 

284

 

Payment of deferred financing fees

 

(3,489

)

 

Purchase of treasury stock

 

(1,357

)

(406

)

Net cash used in financing activities

 

(21,998

)

(16,833

)

Effect on cash and cash equivalents of changes in foreign exchange rates

 

(46

)

6

 

NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS

 

(39,241

)

51,741

 

CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD

 

140,249

 

98,586

 

CASH AND CASH EQUIVALENTS, END OF PERIOD

 

$

101,008

 

$

150,327

 

SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:

 

 

 

 

 

Interest paid

 

$

15,316

 

$

16,716

 

Income taxes paid (refunded)

 

$

5,070

 

$

(12,282

)

Accrued purchases of property, plant and equipment

 

$

1,770

 

$

3,620

 

 

The accompanying notes are an integral part of the consolidated financial statements.

LANNETT COMPANY, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(UNAUDITED)

(In thousands)

 

 

Six Months Ended
December 31,

 

 

 

2018

 

2017

 

OPERATING ACTIVITIES:

 

 

 

 

 

Net income (loss)

 

$

(275,166

)

$

27,279

 

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

 

 

 

 

 

Depreciation and amortization

 

28,622

 

27,354

 

Deferred income tax expense (benefit)

 

(77,950

)

22,169

 

Share-based compensation

 

4,985

 

4,752

 

Asset impairment charges

 

369,499

 

 

Loss on sale of assets

 

644

 

233

 

Loss (gain) on investment securities

 

 

(2,834

)

Amortization of debt discount and other debt issuance costs

 

8,934

 

9,987

 

Other noncash (income) expenses

 

(510

)

87

 

Changes in assets and liabilities which provided (used) cash:

 

 

 

 

Accounts receivable, net

 

(25,887

)

(52,662

)

Inventories

 

2,156

 

(12,987

)

Prepaid income taxes/Income taxes payable

 

17,516

 

15,040

 

Other assets

 

(678

)

(8,160

)

Accounts payable

 

3,701

 

28,913

 

Accrued expenses

 

(4

)

231

 

Accrued payroll and payroll-related expenses

 

8,501

 

11,203

 

Deferred revenue

 

23,998

 

 

Rebates payable

 

(5,016

)

3,786

 

Royalties payable

 

3,660

 

2,564

 

Restructuring liability

 

(1,013

)

(850

)

Settlement liability

 

8,000

 

 

Net cash provided by operating activities

 

93,992

 

76,105

 

INVESTING ACTIVITIES:

 

 

 

 

 

Purchases of property, plant and equipment

 

(12,030

)

(26,402

)

Proceeds from sale of property, plant and equipment

 

14,091

 

17

 

Proceeds from sale of outstanding loan to Variable Interest Entity (“VIE”)

 

5,600

 

 

Purchase of intangible asset

 

(2,000

)

(2,038

)

Proceeds from sale of investment securities

 

 

44,924

 

Purchase of investment securities

 

 

(42,841

)

Net cash provided by (used in) investing activities

 

5,661

 

(26,340

)

FINANCING ACTIVITIES:

 

 

 

 

 

Repayments of long-term debt

 

(33,422

)

(27,283

)

Proceeds from issuance of stock

 

521

 

806

 

Payment of debt issuance costs

 

(1,102

)

 

Purchase of treasury stock

 

(475

)

(1,038

)

Net cash used in financing activities

 

(34,478

)

(27,515

)

Effect on cash and cash equivalents of changes in foreign exchange rates

 

13

 

(125

)

NET INCREASE IN CASH AND CASH EQUIVALENTS

 

65,188

 

22,125

 

CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD

 

98,586

 

117,737

 

CASH AND CASH EQUIVALENTS, END OF PERIOD

 

$

163,774

 

$

139,862

 

SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:

 

 

 

 

 

Interest paid (net of capitalized interest of $0 and $974 thousand for the six months ended December 31, 2018 and 2017, respectively)

 

$

34,190

 

$

31,250

 

Income taxes paid (refunded)

 

$

(11,993

)

$

(7,567

)

Credits issued pursuant to a Settlement Agreement

 

$

 

$

5,000

 

The accompanying notes are an integral part of the consolidated financial statements.

LANNETT COMPANY, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

 

Note 1.  Interim Financial Information

 

The accompanying unaudited financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) for the presentation of interim financial statements and with the instructions to Form 10-Q and Article 10 of Regulation S-X.  Accordingly, the unaudited financial statements do not include all the information and footnotes necessary for a comprehensive presentation of the financial position, results of operations and cash flows for the periods presented.  In the opinion of management, the unaudited financial statements include all the normal recurring adjustments that are necessary for a fair presentation of the financial position, results of operations and cash flows for the periods presented.  Operating results for the three and six months ended December 31, 2018September 30, 2019 are not necessarily indicative of the results that may be expected for the fiscal year ending June 30, 2019.2020.  These unaudited financial statements should be read in combination with the other Notes in this section; “Management’s Discussion and Analysis of Financial Condition and Results of Operations” appearing in Item 2; and the Consolidated Financial Statements, including the Notes to the Consolidated Financial Statements, included in our Annual Report on Form 10-K for the fiscal year ended June 30, 2018.2019.  The Consolidated Balance Sheet as of June 30, 20182019 was derived from audited financial statements.

 

Note 2.  The Business andAnd Nature of Operations

 

Lannett Company, Inc. (a Delaware corporation) and its subsidiaries (collectively, the “Company” or “Lannett”) primarily develop, manufacture, package, market and distribute solid oral and extended release (tablets and capsules), topical, nasal and oral solution finished dosage forms of drugs that address a wide range of therapeutic areas.  Certain of these products are manufactured by others and distributed by the Company. The Company also manufactures active pharmaceutical ingredients through its Cody Laboratories, Inc. (“Cody Labs”) subsidiary primarily for use in its finished dosage forms.  In the first quarter of Fiscal 2019, the Company approved a plan to sell the Cody API business.  See Note 22 “Assets Held for Sale” for more information.

 

On November 25, 2015, the Company completed the acquisition of Kremers Urban Pharmaceuticals, Inc. (“KUPI”), the former U.S. specialty generic pharmaceuticals subsidiary of global biopharmaceuticals company UCB S.A. (“UCB”).  KUPI is a specialty pharmaceuticals manufacturer focused on the development of products that are difficult to formulate or utilize specialized delivery technologies.

The Company operates pharmaceutical manufacturing plants in Philadelphia, Pennsylvania; Cody, Wyoming; Carmel, New York and Seymour, Indiana.  The Company’s customers include generic pharmaceutical distributors, drug wholesalers, chain drug stores, private label distributors, mail-order pharmacies, other pharmaceutical manufacturers, managed care organizations, hospital buying groups, governmental entities and health maintenance organizations.In the second quarter of Fiscal 2019, the Company ceased manufacturing functions at its State Road facility in Philadelphia, Pennsylvania.  The Company discontinued distribution from its Townsend Road facility in Philadelphia, Pennsylvania as of January 31, 2019.  The Company intends to sell its Townsend Road facility by the end of Fiscal 2019.

 

Note 3.  Summary of Significant Accounting Policies

 

Basis of Presentation

 

The Consolidated Financial Statements have been prepared in conformity with generally accepted accounting principles in the United States (“U.S. GAAP”).

 

Principles of consolidation

 

The Consolidated Financial Statements include the accounts of Lannett Company, Inc. and its wholly-owned subsidiaries.  All intercompany accounts and transactions have been eliminated.

 

Business Combinations

 

Acquired businesses are accounted for using the acquisition method of accounting, which requires that the assets acquired and liabilities assumed be recorded at the date of acquisition at their respective estimated fair values.  The fair values and useful lives assigned to each class of assets acquired and liabilities assumed are based on, among other factors, the expected future period of benefit of the asset, the various characteristics of the asset and projected future cash flows.  Significant judgment is employed in

determining the assumptions utilized as of the acquisition date and for each subsequent measurement period.  Accordingly, changes in assumptions described above could have a material impact on our consolidated results of operations.

 

Reclassifications

Certain prior year amounts have been reclassified to conform to the current year financial statement presentation.

Use of estimates

 

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period.  Significant estimates and assumptions are required in the determination of revenue recognition and sales deductions for estimated chargebacks, rebates, returns and other adjustments including a provision for the Company’s liability under the Medicare Part D program.  Additionally, significant estimates and assumptions are required when determining the fair value of long-lived assets, including goodwill and intangible assets, income taxes, contingencies and share-based compensation.

 

Because of the inherent subjectivity and complexity involved in these estimates and assumptions, actual results could differ from those estimates.

 

Foreign currency translation

 

The Consolidated Financial Statements are presented in U.S. Dollars, the reporting currency of the Company.  The financial statements of the Company’s foreign subsidiary are maintained in local currency and translated into U.S. dollars at the end of each reporting period.  Assets and liabilities are translated at period-end exchange rates, while revenues and expenses are translated at average exchange rates during the period.  The adjustments resulting from the use of differing exchange rates are recorded as part of stockholders’ equity in accumulated other comprehensive income (loss).  Gains and losses resulting from transactions denominated in foreign currencies are recognized in the Consolidated Statements of Operations under Other income (loss).  Amounts recorded due to foreign currency fluctuations are immaterial to the Consolidated Financial Statements.

 

Cash and cash equivalents

 

The Company considers all highly liquid investments with original maturities less than or equal to three months at the date of purchase to be cash and cash equivalents.  Cash and cash equivalents are stated at cost, which approximates fair value, and consist of bank deposits and certificates of deposit that are readily convertible into cash.  The Company maintains its cash deposits and cash equivalents at well-known, stable financial institutions.  Such amounts frequently exceed insured limits.

 

Investment securities

The Company’s investment securities consisted of publicly-traded equity securities which were classified as trading investments.  Investment securities were recorded at fair value based on quoted market prices from broker or dealer quotations or transparent pricing sources at each reporting date.  Realized and unrealized gains and losses are included in the Consolidated Statements of Operations under Other income (loss).  In May 2018, the Company liquidated the remainder of the investment securities portfolio.  As of December 31, 2018 and June 30, 2018, the Company does not own investment securities.

Allowance for doubtful accounts

 

The Company continuously monitors collections and payments from its customers and maintains a provision for estimated credit losses.  The Company determines its allowance for doubtful accounts by considering a number of factors, including the length of time balances are past due, the Company’s previous loss history, the customer’s current ability to pay its obligations to the Company and the condition of the general economy and the industry as a whole.  The Company writes off accounts receivable when they are determined to be uncollectible.

 

Inventories

 

Inventories are stated at the lower of cost or net realizable value by the first-in, first-out method.  Inventories are regularly reviewed and write-downs for excess and obsolete inventory are recorded based primarily on current inventory levels, expiration date and estimated sales forecasts.

 

Property, Plant and Equipment

 

Property, plant and equipment are stated at cost less accumulated depreciation.  Depreciation is computed on a straight-line basis over the assets’ estimated useful lives. Repairs and maintenance costs that do not extend the useful life of the asset are expensed as incurred.

Intangible Assets

 

Definite-lived intangible assets are stated at cost less accumulated amortization.  Amortization of definite-lived intangible assets is computed on a straight-line basis over the assets’ estimated useful lives which commences upon shipment of the product, generally for periods ranging from 10 to 15 years.  The Company continually evaluates the reasonableness of the useful lives of these assets.  Indefinite-lived intangible assets are not amortized, but instead are tested at least annually for impairment.  Costs to renew or extend the term of a recognized intangible asset are expensed as incurred.

 

Valuation of Long-Lived Assets, including Intangible Assets other than Goodwill

 

The Company’s long-lived assets primarily consist of property, plant and equipment and definite and indefinite-lived intangible assets. Property, plant and equipment and definite-lived intangible assets are reviewed for impairment whenever events or changes in circumstances (“triggering events”) indicate that the carrying amount of the asset may not be recoverable.  If a triggering event is determined to have occurred, the asset’s carrying value is compared to the future undiscounted cash flows expected to be generated by the asset.  If the carrying value exceeds the undiscounted cash flows of the asset, then impairment exists.  Indefinite-lived intangible

assets are tested for impairment at least annually during the fourth quarter of each fiscal year or more frequently if events or triggering events indicate that the asset might be impaired.

 

An impairment loss is measured as the excess of the asset’s carrying value over its fair value, which in most cases is calculated using a discounted cash flow model.  Discounted cash flow models are highly reliant on various assumptions which are considered Level 3 inputs, including estimates of future cash flows (including long-term growth rates), discount rates and the probability of achieving the estimated cash flows.

 

In-Process Research and Development

 

Amounts allocated to in-process research and development in connection with a business combination are recorded at fair value and are considered indefinite-lived intangible assets subject to impairment testing in accordance with the Company’s impairment testing policy for indefinite-lived intangible assets.  As products in development are approved for sale, amounts will be allocated to product rights and will be amortized over their estimated useful lives.  Definite-lived intangible assets are amortized over the expected lives of the related assets. The judgments made in determining the estimated fair value of in-process research and development, as well as asset lives, can materially impact our results of operations.  The Company’s fair value assessments are highly reliant on various assumptions which are considered Level 3 inputs, including estimates of future cash flows (including long-term growth rates), discount rates and the probability of achieving the estimated cash flows.

 

Goodwill

Goodwill, which represented the excess of purchase price over the fair value of net assets acquired, was carried at cost.  Goodwill was tested for impairment on an annual basis on the first day of the fourth quarter of each fiscal year or more frequently if events or triggering events indicate that the asset might be impaired.  The Company utilized a quantitative assessment to determine the fair value of our reporting unit (generic pharmaceuticals) based on market data as well as projected cash flows. If the carrying value of our reporting unit exceeded its fair value, the difference would be recorded as a goodwill impairment, not to exceed the carrying amount of goodwill.  The Company’s fair value assessments are highly reliant on various assumptions which are considered Level 3 inputs, including estimates of future cash flows (including long-term growth rates), discount rates and the probability of achieving the estimated cash flows.  The judgments made in determining the estimated fair value of goodwill can materially impact our results of operations.

Segment Information

 

The Company operates in one reportable segment, generic pharmaceuticals.  As such, the Company aggregates its financial information for all products.  The following table below identifies the Company’s net sales by medical indication for the three and six months ended December 31,September 30, 2019 and 2018.  The medical indication categories for the three months ended September 30, 2018 was reclassified to better align with industry standards and 2017:the Company’s peers.

 

(In thousands)

 

Three Months Ended
December 31,

 

Six Months Ended
December 31,

 

 

Three Months Ended
September 30,

 

Medical Indication

 

2018

 

2017

 

2018

 

2017

 

 

2019

 

2018

 

Antibiotic

 

$

4,187

 

$

3,552

 

$

8,276

 

$

6,900

 

Analgesic

 

$

1,884

 

$

1,829

 

Anti-Psychosis

 

14,036

 

22,799

 

24,924

 

37,791

 

 

28,034

 

10,889

 

Cardiovascular

 

25,680

 

10,135

 

47,450

 

21,441

 

 

21,606

 

21,770

 

Central Nervous System

 

6,187

 

6,925

 

13,384

 

15,742

 

 

19,257

 

14,286

 

Gallstone

 

2,489

 

5,282

 

4,703

 

11,846

 

Endocrinology

 

 

53,878

 

Gastrointestinal

 

10,009

 

15,055

 

25,048

 

29,608

 

 

16,962

 

17,594

 

Glaucoma

 

512

 

2,164

 

1,060

 

4,832

 

Infectious Disease

 

11,895

 

4,480

 

Migraine

 

12,551

 

15,484

 

22,288

 

30,499

 

 

9,143

 

9,737

 

Muscle Relaxant

 

3,121

 

3,219

 

6,300

 

7,010

 

Pain Management

 

8,968

 

6,128

 

13,915

 

11,889

 

Respiratory

 

1,163

 

2,230

 

2,178

 

3,876

 

Thyroid Deficiency

 

88,477

 

68,794

 

142,354

 

116,008

 

Respiratory/Allergy/Cough/Cold

 

2,707

 

3,584

 

Urinary

 

1,606

 

2,840

 

3,158

 

5,837

 

 

435

 

1,541

 

Other

 

6,827

 

13,105

 

21,168

 

25,802

 

 

9,861

 

10,805

 

Contract manufacturing revenue

 

7,905

 

6,593

 

12,566

 

10,185

 

 

5,558

 

4,661

 

Net sales

 

$

193,718

 

$

184,305

 

$

348,772

 

$

339,266

 

Total

 

$

127,342

 

$

155,054

 

 

Customer, Supplier and Product Concentration

 

The following table presents the percentage of total net sales, for the three and six months ended December 31,September 30, 2019 and 2018, and 2017, for certainone of the Company’s products, defined as products containing the same active ingredient or combination of ingredients, which accounted for at least 10% of net sales in any of those periods:

 

 

Three Months Ended
December 31,

 

Six Months Ended
December 31,

 

 

2018

 

2017

 

2018

 

2017

 

 

 

 

 

 

 

 

 

 

 

2019

 

2018

 

Product 1

 

46

%

37

%

41

%

34

%

 

20

%

6

%

Product 2

 

7

%

12

%

7

%

10

%

 

%

35

%

 

The following table presents the percentage of total net sales, for the three and six months ended December 31,September 30, 2019 and 2018, and 2017, for certain of the Company’s customers which accounted for at least 10% of net sales in any of those periods:

 

 

 

Three Months Ended
December 31,

 

Six Months Ended
December 31,

 

 

 

2018

 

2017

 

2018

 

2017

 

 

 

 

 

 

 

 

 

 

 

Customer A

 

18

%

22

%

23

%

25

%

Customer B

 

14

%

 

8

%

 

Customer C

 

14

%

19

%

16

%

20

%

Customer D

 

13

%

5

%

11

%

5

%

Customer E

 

3

%

13

%

3

%

8

%

 

 

2019

 

2018

 

Customer A

 

27

%

18

%

Customer B

 

25

%

29

%

Customer C

 

13

%

7

%

The Company’s primary finished goods inventory supplier isthrough March 23, 2019 was Jerome Stevens Pharmaceuticals, Inc. (“JSP”), in Bohemia, New York.  Purchases of finished goods inventory from JSP accounted for approximately 34% and 39%32% of the Company’s inventory purchases during the three months ended December 31, 2018 and 2017, respectively.  PurchasesSeptember 30, 2018.  There were no purchases of finished goods inventory from JSP accounted for approximately 33% and 36%in the first quarter of the Company’s inventory purchases during the six months ended December 31, 2018 and 2017, respectively.  See Note 21 “Material Contracts with Suppliers” for more information.Fiscal 2020.

Revenue Recognition

 

On July 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606,Revenue from Contracts with Customers, which superseded ASC Topic 605, Revenue Recognition.  Under ASC 606, the Company recognizes revenue when (or as) we satisfy our performance obligations by transferring a promised good or service to a customer at an amount that reflects the consideration the Company is expected to be entitled.  Our revenue consists almost entirely of sales of our pharmaceutical products to customers, whereby we ship product to a customer pursuant to a purchase order.  Revenue contracts such as these do not generally give rise to contract assets or contract liabilities because: (i) the underlying contracts generally have only a single performance obligation and (ii) we do not generally receive consideration until the performance obligation is fully satisfied.  The new revenue standard impacts the timing of the Company’s revenue recognition by requiring recognition of certain contract manufacturing arrangements to change from “upon shipment or delivery” to “over time”.  However, the recognition of these arrangements over time does not currently have a material impact on the Company’s consolidated results of operations or financial position. The Company adopted ASC 606 using the modified retrospective method.  Refer to the “Recent Accounting Pronouncements” section of this footnote for further discussion of the impact of the adoption.

 

When revenue is recognized, a simultaneous adjustment to gross sales is made for estimated chargebacks, rebates, returns, promotional adjustments and other potential adjustments.  These provisions are primarily estimated based on historical experience, future expectations, contractual arrangements with wholesalers and indirect customers and other factors known to management at the time of accrual.  Accruals for provisions are presented in the Consolidated Financial Statements as a reduction to gross sales with the corresponding reserve presented as a reduction of accounts receivable or included as rebates payable, depending on the nature of the reserve.

 

Provisions for chargebacks, rebates, returns and other adjustments require varying degrees of subjectivity.  While rebates generally are based on contractual terms and require minimal estimation, chargebacks and returns require management to make more subjective assumptions.  Each major category is discussed in detail below:

 

Chargebacks

 

The provision for chargebacks is the most significant and complex estimate used in the recognition of revenue. The Company sells its products directly to wholesale distributors, generic distributors, retail pharmacy chains and mail-order pharmacies. The Company also sells its products indirectly to independent pharmacies, managed care organizations, hospitals, nursing homes and group purchasing organizations, collectively referred to as “indirect customers.” The Company enters into agreements with its indirect customers to establish pricing for certain products. The indirect customers then independently select a wholesaler from which to purchase the products. If the price paid by the indirect customers is lower than the price paid by the wholesaler, the Company will provide a credit, called a chargeback, to the wholesaler for the difference between the contractual price with the indirect customers and the wholesaler purchase price. The provision for chargebacks is based on expected sell-through levels by the Company’s wholesale customers to the indirect customers and estimated wholesaler inventory levels. As sales to the large wholesale customers, such as Cardinal Health, AmerisourceBergen and McKesson increase (decrease), the reserve for chargebacks will also generally increase (decrease). However, the size of the increase (decrease) depends on product mix and the amount of sales made to indirect customers with which the Company has specific chargeback agreements. The Company continually monitors the reserve for chargebacks and makes adjustments when management believes that expected chargebacks may differ from the actual chargeback reserve.

 

Rebates

 

Rebates are offered to the Company’s key chain drug store, distributor and wholesaler customers to promote customer loyalty and increase product sales. These rebate programs provide customers with credits upon attainment of pre-established volumes or attainment of net sales milestones for a specified period. Other promotional programs are incentive programs offered to the customers. Additionally, as a result of the Patient Protection and Affordable Care Act (“PPACA”) enacted in the U.S. in March 2010, the Company participates in a new cost-sharing program for certain Medicare Part D beneficiaries designed primarily for the sale of brand drugs and certain generic drugs if their Food and Drug Administration (“FDA”)FDA approval was granted under a New Drug Application (“NDA”) or 505(b) NDA versus an Abbreviated New Drugabbreviated new drug application (“ANDA’).  Because our drugs used for the treatment of thyroid deficiency and our Morphine Sulfate Oral Solution product were both approved by the FDA as 505(b)(2) NDAs, they are considered “brand” drugs for purposes of the PPACA.  Drugs purchased within the Medicare Part D coverage gap (commonly referred to as the “donut hole”) result in additional rebates. The Company estimates the reserve for rebates and other promotional credit programs based on the specific terms in each agreement when revenue is recognized. The reserve for rebates increases (decreases) as sales to certain wholesale and retail customers increase (decrease). However, since these rebate programs are not identical for all customers, the size of the reserve will depend on the mix of sales to customers that are eligible to receive rebates.

Returns

 

Consistent with industry practice, the Company has a product returns policy that allows customers to return product within a specified time period prior to and subsequent to the product’s expiration date in exchange for a credit to be applied to future purchases. The Company’s policy requires that the customer obtain pre-approval from the Company for any qualifying return. The Company estimates its provision for returns based on historical experience, changes to business practices, credit terms and any extenuating circumstances known to management. While historical experience has allowed for reasonable estimations in the past, future returns may or may not follow historical trends. The Company continually monitors the reserve for returns and makes adjustments when management believes that actual product returns may differ from the established reserve. Generally, the reserve for returns increases as net sales increase.

 

Other Adjustments

 

Other adjustments consist primarily of “price adjustments, also known as “shelf-stock adjustments” and “price protections,” which are both 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 credit is given for product remaining in customer’s inventories at the time of the price reduction.  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 protections 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.  Other adjustments also include prompt payment discounts and “failure-to-supply” adjustments.  If the Company is unable to fulfill certain customer orders, the customer can purchase products from our competitors at their prices and charge the Company for any difference in our contractually agreed upon prices.

 

Leases

On July 1, 2019, the Company adopted ASC Topic 842, Leases, which superseded ASC Topic 840, Leases.  Refer to the “Recent Accounting Pronouncements” section of this footnote for further discussion on the impact of the adoption.  Under ASC 842, when the Company enters into a new arrangement, it must determine, at the inception date, whether the arrangement is or contains a lease.  This determination generally depends on whether the arrangement conveys to the Company the right to control the use of an explicitly or implicitly identified asset for a period of time in exchange for consideration.  Control of an underlying asset is conveyed to the Company if the Company obtains the rights to direct the use of and to obtain substantially all of the economic benefits from using the underlying asset.  Once a lease has been identified, the Company must determine the lease term, the present value of lease payments and the classification of the lease as either operating or financing.

The lease term is determined to be the non-cancelable period including any lessee renewal options which are considered to be reasonably certain of exercise.  Our lease agreements do not contain any material residual value guarantees or material restrictive covenants

The present value of lease payments includes fixed and certain variable payments, less lease incentives, together with amounts probable of being owed by the Company under residual value guarantees and, if reasonably certain of being paid, the cost of certain renewal options and early termination penalties set forth in the lease arrangement.  To calculate the present value of lease payments, we use our incremental borrowing rate based on the information available at commencement date, as the rate implicit in the lease is generally not readily available.

In making the determination of whether a lease is an operating lease or a finance lease, the Company considers the lease term in relation to the economic life of the leased asset, the present value of lease payments in relation to the fair value of the leased asset and certain other factors.

Upon the commencement of the lease, the Company will record a lease liability and right-of-use (“ROU”) asset based on the present value of the future minimum lease payments over the lease term at commencement date.  The ROU asset also includes any lease payments made and excludes lease incentives and initial direct costs incurred.

For operating leases, a single lease cost is generally recognized in the Consolidated Statements of Operations on a straight-line basis over the lease term unless an impairment has been recorded with respect to a leased asset.  For finance leases, amortization expense and interest expense are recognized separately in the Consolidated Statements of Operations, with amortization expense generally recorded on a straight-line basis and interest expense recorded using the effective interest method.  Variable lease costs not initially included in the lease liability and ROU asset impairment charges are expensed as incurred.

Cost of Sales, including Amortization of Intangibles

 

Cost of sales includes all costs related to bringing products to their final selling destination, which includes direct and indirect costs, such as direct material, labor and overhead expenses.  Additionally, cost of sales includes product royalties, depreciation, amortization and costs to renew or extend recognized intangible assets, freight charges and other shipping and handling expenses.

 

Research and Development

 

Research and development costs are expensed as incurred, including all production costs until a drug candidate is approved by the FDA.Food and Drug Administration (“FDA”).  Research and development expenses include costs associated with internal projects as well as costs associated with third-party research and development contracts.

 

Contingencies

 

Loss contingencies, including litigation-related contingencies, are included in the Consolidated Statements of Operations when the Company concludes that a loss is both probable and reasonably estimable.  Legal fees for litigation-related matters are expensed as incurred and included in the Consolidated Statements of Operations under the Selling, general and administrative expenses line item.

 

Restructuring Costs

 

The Company records charges associated with approved restructuring plans to remove duplicative headcount and infrastructure associated with business acquisitions or to simplify business processes.  Restructuring charges can include severance costs to eliminate a specified number of employees, infrastructure charges to vacate facilities and consolidate operations and contract cancellation costs. The Company records restructuring charges based on estimated employee terminations, site closure and consolidation plans. The Company accrues severance and other employee separation costs under these actions when it is probable that a liability exists and the amount is reasonably estimable.

 

Share-based Compensation

 

Share-based compensation costs are recognized over the vesting period, using a straight-line method, based on the fair value of the instrument on the date of grant less an estimate for expected forfeitures.  The Company uses the Black-Scholes valuation model to determine the fair value of stock options, the stock price on the grant date to value restricted stock and the Monte-Carlo simulation model to determine the fair value of performance-based shares.  The Black-Scholes valuation and Monte-Carlo simulation models include various assumptions, including the expected volatility, the expected life of the award, dividend yield and the risk-free interest rate as well as performance assumptions of peer companies.  These assumptions involve inherent uncertainties based on market

conditions which are generally outside the Company’s control.  Changes in these assumptions could have a material impact on share-based compensation costs recognized in the consolidated financial statements.

 

Self-Insurance

 

Effective January 1, 2017, theThe Company self-insures for certain employee medical and prescription benefits.  The Company also maintains stop loss coverage with third party insurers to limit its total liability exposure.  The liability for self-insured risks is primarily calculated using independent third-party actuarial valuations which take into account actual claims, claims growth and claims incurred but not yet reported.  Actual experience, including claim frequency and severity as well as health-care inflation, could result in different liabilities than the amounts currently recorded.  The liability for self-insured risks under this plan as of December 31, 2018September 30, 2019 totaled $2.9$1.5 million and was not material to the financial position of the Company as of June 30, 2018.2019.

 

Income Taxes

 

The Company uses the liability method to account for income taxes as prescribed by Accounting Standards Codification (“ASC”)ASC 740, Income Taxes.Taxes.  Deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities as measured by the enacted tax rates which will be in effect when these differences reverse.  Deferred tax expense (benefit) is the result of changes in deferred tax assets and liabilities.  Deferred income tax assets and liabilities are adjusted to recognize the effects of changes in tax laws or enacted tax rates in the period during which they are signed into law.  The factors used to assess the likelihood of realization are the Company’s forecast of future taxable income and available tax planning strategies that could be implemented to realize the net deferred tax assets.  Under ASC 740, Income Taxes, a valuation allowance is required when it is more likely than not that all or some portion of the deferred tax assets will not be realized through generating sufficient future taxable income.  Failure to achieve forecasted taxable income in applicable tax jurisdictions could affect the ultimate realization of deferred tax assets and could result in an increase in the Company’s effective tax rate on future earnings.

The Company may recognize the tax benefit from an uncertain tax position claimed on a tax return only if it is more likely than not that the tax position will be sustained on examination by the taxing authorities, based on the technical merits of the position.  The tax benefits recognized in the financial statements from such a position should be measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate settlement.  The authoritative accounting standards also provide guidance on de-recognition, classification, interest and penalties on income taxes, accounting in interim periods and requires increased disclosures.

 

On December 22, 2017, President Trump signed the Tax Cut and Jobs Act legislation (“2017 Tax Reform”) into law, which included a broad range of tax reform provisions affecting businesses, including corporate tax rates, business deductions and international tax provisions.  Many of these provisions significantly differ from the then-current U.S. tax law, resulting in pervasive financial reporting implications.  As a result of the new law, the SEC issued Staff Accounting Bulletin No. 118 (“SAB 118”) to address the application of U.S. GAAP in situations when a registrant does not have the necessary information available, prepared, or analyzed in reasonable detail to complete the accounting for certain income tax effects of 2017 Tax Reform.  SAB 118 requires registrants to report the tax effects of 2017 Tax Reform, inclusive of provisional amounts for which the accounting is incomplete but a reasonable estimate can be determined.  SAB 118 also allows for a measurement period of up to one year in cases where a registrant reports a provisional amount or is unable to reasonably estimate the impact of 2017 Tax Reform.   In the second quarter of Fiscal 2019, the Company finalized the provisional amounts without any further adjustments, in accordance with the expiration of the SAB 118 measurement period.adjustments.

 

Earnings (Loss) Per Common Share

 

A dual presentation of basic and diluted earnings (loss) per common share is required on the face of the Company’s Consolidated Statement of Operations as well as a reconciliation of the computation of basic earnings (loss) per common share to diluted earnings (loss) per common share.  Basic earnings (loss) per common share excludes the dilutive impact of potentially dilutive securities and is computed by dividing net income (loss) by the weighted average number of shares outstanding during the period.  DilutedBeginning in the first quarter of Fiscal 2020, the Company’s diluted earnings (loss) per common share is computed using the “if-converted” method by dividing the adjusted “if-converted” net income (loss) by the adjusted weighted average number of shares of common stock outstanding during the period including additionalperiod.  The adjusted “if-converted” net income is adjusted for interest expense and amortization of debt issuance costs, both net of tax, associated with the Company’s 4.50% Convertible Senior Notes due 2026.  The weighted average number of diluted shares that would have been outstanding related to potentiallyis adjusted for the potential dilutive securities.  These potentially dilutive securities consisteffect of the exercise of stock options, treats unvested restricted stock and performance-based shares.shares as if it were vested, and assumes the conversion of the 4.50% Convertible Senior Notes.  Anti-dilutive securities are excluded from the calculation.  Dilutive shares are also excluded in the calculation in periods of net loss because the effect of including such securities would be anti-dilutive.

 

Comprehensive Income (Loss)

 

Comprehensive income (loss) includes all changes in equity during a period except those that resulted from investments by or distributions to the Company’s stockholders.  Other comprehensive income (loss) refers to gains and losses that are included in comprehensive income (loss), but excluded from income (loss) as thesefor all amounts are recorded directly as an adjustment to stockholders’ equity.

Recent Accounting Pronouncements

In May 2014, the Financial Accounting Standards Board (“FASB”) issued ASU 2014-09, which created ASC Topic 606 Revenue from Contracts with Customers.  The core principle of the guidance is that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services.  The authoritative guidance is effective for annual reporting periods beginning after December 15, 2017.  Based on a review of the contracts representing a substantial portion of our revenues, which is primarily generated from product sales, the Company determined that the updated guidance does not have a material impact on our disclosures or the timing and recognition of our revenues.  Under the new standard, the Company estimates certain amounts as variable consideration, specifically any “failure-to-supply” adjustments at the point of product sale in future periods.

The new revenue standard also impacts the timing of the Company’s revenue recognition by requiring recognition of certain contract manufacturing arrangements to change from “upon shipment or delivery” to “over time”.  However, the recognition of these arrangements over time does not currently have a material impact on the Company’s consolidated results of operations or financial position.

The cumulative impact of the adoption of ASC 606 resulted in a $2.3 million adjustment, net of tax, to opening retained earnings on July 1, 2018.

 

In February 2016, the FASB issued ASU 2016-02, Leases.  ASU 2016-02 requires an entity to recognize right-of-useROU assets and liabilities on its balance sheet for all leases with terms longer than 12 months.  Lessees and lessors are required to disclose quantitative and qualitative information about leasing arrangements to enable a user of the financial statements to assess the amount, timing and uncertainty of cash flows arising from leases.  ASU 2016-02 is effective for annual reporting periods beginning after December 15, 2018, including interim periods within that reporting period and requires a modified retrospective application, with early adoption permitted.  In December 2018,The Company adopted ASU 2016-02 as of July 1, 2019 on a modified retrospective basis applying the FASB issued ASU 2018-20, Leases — Narrow Scope Improvements for lessors, which allows entitiesguidance to choose an additional transition methodleases existing as of adoption, under which an entity initially applies the new standard at the adoption date and recognize athis effective date.  The Company has determined that there was no cumulative-effect adjustment to the opening balance ofbeginning retained earinings in the period of adoption.  The Company is currently in the process of assessing the impact this guidance will haveearnings on the consolidated balance sheet.  The Company will continue to report periods prior to July 1, 2019 in our financial statements.statements under prior guidance as outlined in Topic 840.  Refer to Note 12 “Commitments” for additional information.

 

In August 2016, the FASB issuedThe Company’s adoption of ASU 2016-15, Statement of Cash Flows — Classification of Certain Cash Receipts and Cash Payments.  ASU 2016-15 addresses how certain cash receipts and cash payments are presented and classifiedNo. 2016-02 resulted in an increase in the statementCompany’s assets and liabilities of $7.9 million at July 1, 2019.  The Company’s adoption of ASU No. 2016-02 did not have any impact to the Company’s consolidated statements of operations, or its consolidated statements of cash flows.  The standardFurther, there was adopted on July 1, 2018 and did not have anno impact on the Company’s covenant compliance under its current debt agreements as a result of the adoption of ASU No. 2016-02.  The Company elected the package of practical expedients included in this guidance, which allowed it to not reassess: (i) whether any expired or existing contracts contain leases; (ii) the lease classification for any expired or existing leases; and, (iii) the initial direct costs for existing leases.  The Company does not recognize short-term leases of 12 months or less on its consolidated financial statements.balance sheets and will recognize those lease payments in the consolidated statements of operations on a straight-line basis over the lease term.

Note 4.  Restructuring Charges

 

Cody Restructuring Program

 

On June 29, 2018, the Company announced a restructuring plan with respect to Cody Labs (the “Cody Restructuring Plan”).  The plan focusesfocused on a more select set of opportunities which will resultresulted in streamlined operations, improved efficiencies and a reduced cost structure.  The Company currently estimates that it will incurincurred approximately $4.5 million of total costs to implement the Cody Restructuring Plan, comprised primarily of approximately $3.0$2.5 million of severance and employee-related costs.costs under this plan.  The restructuring activities under the Cody Restructuring Program are complete as of September 30, 2019.

 

The expenses associated with the Cody Restructuring Plan included in restructuring expenses (credits) during the three and six months ended December 31,September 30, 2019 and September 30, 2018 were as follows:

 

 

Three Months Ended

 

Six Months Ended

 

 

Three Months Ended

 

Three Months Ended

 

(In thousands)

 

December 31, 2018

 

December 31, 2018

 

 

September 30, 2019

 

September 30, 2018

 

Employee separation costs (credits)

 

$

(640

)

$

(496

)

Employee separation costs

 

$

 

$

144

 

Facility closure costs

 

 

 

 

 

 

Total

 

$

(640

)

$

(496

)

 

$

 

$

144

 

 

In the second quarter of Fiscal 2019, the Company adjusted separation costs related to changes in stock price for unvested equity awards, which will be paid upon termination to certain employees.

A reconciliation of the changes in restructuring liabilities associated with the Cody Restructuring Plan from June 30, 20182019 through December 31, 2018September 30, 2019 is set forth in the following table:

 

(In thousands)

 

Employee
Separation Costs

 

Facility Closure
Costs

 

Total

 

 

Employee
Separation Costs

 

Facility Closure
Costs

 

Total

 

Balance at June 30, 2018

 

$

3,092

 

$

 

$

3,092

 

Balance at June 30, 2019

 

$

108

 

$

 

$

108

 

Restructuring Charges

 

(496

)

 

(496

)

 

 

 

 

Payments

 

(1,074

)

 

(1,074

)

 

(108

)

 

(108

)

Balance at December 31, 2018

 

$

1,522

 

 

$

1,522

 

Balance at September 30, 2019

 

$

 

 

$

 

Cody API Restructuring Plan

In September 2018, the Company approved a plan to sell the active pharmaceutical ingredient manufacturing distribution business of Cody Labs (the “Cody API business”).  The Company was unable to sell the Cody API business as an ongoing operation and intended to sell the equipment and real estate utilized by the Cody API business upon receiving approval of the Company’s cocaine hydrochloride solution Section 505(b)(2) NDA application and to have Cody Labs cease all operations.  In June 2019, the Company approved the Cody API Restructuring Plan.  In connection with the Cody API Restructuring Plan, there has been a reduction of almost 70 positions at Cody Labs.  The restructuring activities under the Cody API Restructuring Plan are substantially complete as of September 30, 2019.  In the first quarter of Fiscal 2020, the Company completed the sale of a portion of the equipment associated with the Cody API business for $2.0 million.

The costs to implement the Cody API Restructuring Plan total approximately $6.0 million, including approximately $3.5 million of severance and employee-related costs and approximately $2.0 million of contract termination costs, as well as approximately $0.5 million of costs to be incurred in connection with moving equipment and other property to other Company-owned facilities that were originally anticipated to be incurred in connection with the Cody Restructuring Plan announced in June 2018.

The expenses associated with the Cody API Restructuring Plan included in restructuring expenses during the three months ended September 30, 2019 were as follows:

(In thousands)

 

Three Months Ended
September 30, 2019

 

Employee separation costs

 

$

892

 

Facility closure costs

 

496

 

Total

 

$

1,388

 

A reconciliation of the changes in restructuring liabilities associated with the Cody API Restructuring Plan from June 30, 2019 through September 30, 2019 is set forth in the following table:

(In thousands)

 

Employee
Separation Costs

 

Contract
Termination
Costs

 

Facility Closure
Costs

 

Total

 

Balance at June 30, 2019

 

$

2,207

 

$

 

$

 

$

2,207

 

Restructuring Charges

 

892

 

 

496

 

1,388

 

Payments

 

(1,932

)

 

(496

)

(2,428

)

Balance at September 30, 2019

 

$

1,167

 

$

 

 

$

1,167

 

 

2016 Restructuring Program

 

On February 1, 2016, in connection with the acquisition of KUPI,Kremers Urban Pharmaceuticals Inc.( “KUPI”), the Company announced a plan related to the future integration of KUPI and the Company’s operations (the “2016 Restructuring Program”).  The plan focusesfocused on the closure of KUPI’s corporate functions and the consolidation of manufacturing, sales, research and development and distribution functions.  The restructuring activities under the 2016 Restructuring Program were completed as of March 31, 2019.  The Company estimates that it will incurincurred an aggregate of up to approximately $20.0$21.0 million in restructuring charges for actions that have been announced or communicated since the 2016 Restructuring Program began.  Of this amount, approximately $11.0 million relatesrelated to employee separation costs, approximately $1.0 million relates to contract termination costs and approximately $8.0$9.0 million relatesrelated to facility closure costs and other actions. The 2016 Restructuring Program is expected to be completed by the end of Fiscal 2019.

 

The expenses associated with the restructuring program included in restructuring expenses during the three and six months ended December 31,September 30, 2018 and 2017 were as follows:

 

 

 

Three Months Ended
December 31,

 

Six Months Ended
December 31,

 

(In thousands)

 

2018

 

2017

 

2018

 

2017

 

Employee separation costs (credits)

 

$

293

 

$

210

 

$

707

 

$

(380

)

Facility closure costs

 

560

 

825

 

1,024

 

1,942

 

Total

 

$

853

 

$

1,035

 

$

1,731

 

$

1,562

 

A reconciliation of the changes in restructuring liabilities associated with the 2016 Restructuring Program from June 30, 2018 through December 31, 2018 is set forth in the following table:

(In thousands)

 

Employee
Separation Costs

 

Facility Closure
Costs

 

Total

 

Balance at June 30, 2018

 

$

3,614

 

$

 

$

3,614

 

Restructuring Charges

 

707

 

1,024

 

1,731

 

Payments

 

(150

)

(1,024

)

(1,174

)

Balance at December 31, 2018

 

$

4,171

 

$

 

$

4,171

 

 

 

Three

 

 

 

Months Ended

 

(In thousands)

 

September 30, 2018

 

Employee separation costs

 

$

414

 

Facility closure costs

 

464

 

Total

 

$

878

 

 

Note 5.  Accounts Receivable

 

Accounts receivable consisted of the following components at December 31, 2018September 30, 2019 and June 30, 2018:2019:

 

(In thousands)

 

December 31,
2018

 

June 30,
2018

 

Gross accounts receivable

 

$

515,266

 

$

503,175

 

Less Chargebacks reserve

 

(128,102

)

(153,034

)

Less Rebates reserve

 

(34,673

)

(33,102

)

Less Returns reserve

 

(49,508

)

(43,059

)

Less Other deductions

 

(26,263

)

(20,021

)

Less Allowance for doubtful accounts

 

(1,356

)

(1,308

)

Accounts receivable, net

 

$

275,364

 

$

252,651

 

(In thousands)

 

September 30,
2019

 

June 30,
2019

 

Gross accounts receivable

 

$

362,309

 

$

361,323

 

Less: Chargebacks reserve

 

(83,483

)

(89,567

)

Less: Rebates reserve

 

(31,473

)

(32,099

)

Less: Returns reserve

 

(53,992

)

(55,554

)

Less: Other deductions

 

(19,109

)

(18,128

)

Less: Allowance for doubtful accounts

 

(1,143

)

(1,223

)

Accounts receivable, net

 

$

173,109

 

$

164,752

 

 

For the three months ended December 31,September 30, 2019, the Company recorded a provision for chargebacks, rebates (including rebates presented as rebates payable), returns and other deductions of $207.9 million, $58.5 million, $3.7 million and $12.7 million, respectively.  For the three months ended September 30, 2018, the Company recorded a provision for chargebacks, rebates (including rebates presented as rebates payable), returns and other deductions of $334.6$277.9 million, $78.8$64.7 million, $11.3$7.3 million and $20.7 million, respectively.  For the three months ended December 31, 2017, the Company recorded a provision for chargebacks, rebates (including rebates presented as rebates payable), returns and other deductions of $220.2 million, $77.6 million, $4.1 million, and $16.3$13.9 million, respectively.

For the six months ended December 31, 2018, the Company recorded a provision for chargebacks, rebates (including rebates presented as rebates payable), returns, and other deductions of $612.6 million, $143.6 million, $18.7 million, and $34.6 million, respectively.  For the six months ended December 31, 2017, the Company recorded a provision for chargebacks, rebates (including rebates presented as rebates payable), returns, and other deductions of $474.9 million, $156.1 million, $14.5 million, and $28.6 million, respectively.

The following table identifies the activity and ending balances of each major category of revenue-related reserve for the sixthree months ended December 31, 2018September 30, 2019 and 2017:2018:

 

Reserve Category
(In thousands)

 

Chargebacks

 

Rebates

 

Returns

 

Other

 

Total

 

 

Chargebacks

 

Rebates

 

Returns

 

Other

 

Total

 

Balance at June 30, 2018

 

$

153,034

 

$

82,502

 

$

43,059

 

$

20,021

 

$

298,616

 

Adjustment related to adoption of ASC 606

 

 

 

 

3,536

 

3,536

 

Balance at June 30, 2019

 

$

89,567

 

$

78,274

 

$

55,554

 

$

18,128

 

$

241,523

 

Current period provision

 

612,560

 

143,578

 

18,662

 

34,574

 

809,374

 

 

207,933

 

58,509

 

3,694

 

12,705

 

282,841

 

Credits issued during the period

 

(637,492

)

(147,023

)

(12,213

)

(31,868

)

(828,596

)

 

(214,017

)

(61,952

)

(5,256

)

(11,724

)

(292,949

)

Balance at December 31, 2018

 

$

128,102

 

$

79,057

 

$

49,508

 

$

26,263

 

$

282,930

 

Balance at September 30, 2019

 

$

83,483

 

$

74,831

 

$

53,992

 

$

19,109

 

$

231,415

 

 

Reserve Category
(In thousands)

 

Chargebacks

 

Rebates

 

Returns

 

Other

 

Total

 

 

Chargebacks

 

Rebates

 

Returns

 

Other

 

Total

 

Balance at June 30, 2017

 

$

79,537

 

$

87,616

 

$

42,135

 

$

11,096

 

$

220,384

 

Balance at June 30, 2018

 

$

153,034

 

$

82,502

 

$

43,059

 

$

20,021

 

$

298,616

 

Adjustment related to adoption of ASC 606

 

 

 

 

3,536

 

3,536

 

Current period provision

 

474,882

 

156,073

 

14,541

 

28,623

 

674,119

 

 

277,949

 

64,749

 

7,347

 

13,889

 

363,934

 

Credits issued during the period

 

(499,959

)

(157,071

)

(11,881

)

(21,713

)

(690,624

)

 

(305,407

)

(76,626

)

(6,045

)

(13,146

)

(401,224

)

Balance at December 31, 2017

 

$

54,460

 

$

86,618

 

$

44,795

 

$

18,006

 

$

203,879

 

Balance at September 30, 2018

 

$

125,576

 

$

70,625

 

$

44,361

 

$

24,300

 

$

264,862

 

 

For the three months ending December 31,September 30, 2019 and 2018, and 2017, as a percentage of gross sales the provision for chargebacks was 53.0%51.4% and 44.4%54.0%, the provision for rebates was 12.5%14.5% and 15.7%12.6%, the provision for returns was 1.8%0.9% and 0.8%1.4% and the provision for other adjustments was 3.3%3.1% and 3.3%, respectively.

For the six months ending December 31, 2018 and 2017, as a percentage of gross sales the provision for chargebacks was 53.5% and 47.3%, the provision for rebates was 12.5% and 15.6%, the provision for returns was 1.6% and 1.4%, and the provision for other adjustments was 3.0% and 2.9%2.7%, respectively.

 

On July 1, 2018, the Company adopted ASC 606 which resulted in a $3.2 million pre-tax adjustment to opening retained earnings and accounts receivable, of which $3.5 million related to “failure-to-supply” reserves offset by $0.3 million related to the timing of recognition of certain contract manufacturing arrangements.

 

The decrease in the chargebacks reservetotal reserves from June 30, 20182019 to December 31, 2018September 30, 2019 was primarily the result of increased customer orders in June 2018 in advance ofmainly attributable to a mid-week holiday as well as a related maintenance shutdown of the Company’s Seymour, Indiana manufacturing facility in the first week of July 2018.  The Amneal Distribution and Transition Support Agreement (the “Amneal Agreement”), which shifted the Company’s sales of Levothyroxine Sodium Tablets directly to Amneal, also contributed$9.4 million rebate payment to the decrease inDepartment of Veteran’s Affairs related to pricing overcharges, of which $8.1 million was indemnified by UCB, the chargebacks reserve.  The activity in the “Other” categoryformer parent company of KUPI.  See Note 11 “Legal, Regulatory Matters and Contingencies” for the six months ended December 31, 2018 and 2017 includes, shelf-stock, shipping and other sales adjustments including prompt payment discounts and “failure-to-supply” adjustments.more information.  Historically, we have not recorded any material amounts in the current period related to reversals or additions of prior period reserves.  If the Company were to record a material reversal or addition of any prior period reserve amount, it would be separately disclosed.

 

Note 6.  Inventories

 

Inventories at December 31, 2018September 30, 2019 and June 30, 20182019 consisted of the following:

 

(In thousands)

 

December 31,
2018

 

June 30,
2018

 

Raw materials

 

$

57,780

 

$

64,647

 

Work-in-process

 

30,726

 

19,983

 

Finished goods

 

47,622

 

57,005

 

Total

 

$

136,128

 

$

141,635

 

(In thousands)

 

September 30,
2019

 

June 30,
2019

 

Raw Materials

 

$

59,115

 

$

56,740

 

Work-in-process

 

14,359

 

18,988

 

Finished Goods

 

75,688

 

68,243

 

Total

 

$

149,162

 

$

143,971

 

Inventory balances were written-down by $20.7 million and $11.9 million at December 31, 2018 and June 30, 2018, respectively for excess and obsolete inventory amounts. 

During the three months ended December 31,September 30, 2019 and 2018, and 2017, the Company recorded write-downs to net realizable value for excess and obsolete inventory of $8.9$3.5 million and $2.2$3.4 million, respectively.  During the six months ended December 31, 2018 and 2017, the Company recorded write-downs to net realizable value for excess and obsolete inventory of $12.8 million and $4.4 million, respectively.

In the first quarter of Fiscal 2019, the Company approved a plan to sell the Cody API business.  As such, all assets, including inventory totaling $3.4 million, and liabilities associated with the Cody API business are recorded in the assets and liabilities held for sale captions in the Consolidated Balance Sheet as of December 31, 2018.  See Note 22 “Assets Held for Sale” for more information.

 

Note 7.  Property, Plant and Equipment

 

Property, plant and equipment net at December 31, 2018September 30, 2019 and June 30, 20182019 consisted of the following:

 

(In thousands)

 

Useful Lives

 

December 31,
2018

 

June 30,
2018

 

Land

 

 

$

2,283

 

$

2,900

 

Building and improvements

 

10 - 39 years

 

85,958

 

105,041

 

Machinery and equipment

 

5 - 10 years

 

156,903

 

173,988

 

Furniture and fixtures

 

5 - 7 years

 

3,224

 

4,099

 

Less: accumulated depreciation

 

 

 

(79,991

)

(89,996

)

 

 

 

 

168,377

 

196,032

 

Construction in progress

 

 

 

27,230

 

37,215

 

Property, plant and equipment, net

 

 

 

$

195,607

 

$

233,247

 

(In thousands)

 

Useful Lives

 

September 30,
2019

 

June 30,
2019

 

Land

 

 

$

1,783

 

$

1,783

 

Building and improvements

 

10 – 39 years

 

89,901

 

87,609

 

Machinery and equipment

 

5 – 10 years

 

158,555

 

156,166

 

Furniture and fixtures

 

5 – 7 years

 

3,110

 

3,105

 

Less accumulated depreciation

 

 

 

(89,182

)

(83,424

)

 

 

 

 

164,167

 

165,239

 

Construction in progress

 

 

 

20,722

 

21,431

 

Property, plant and equipment, net

 

 

 

$

184,889

 

$

186,670

 

Depreciation expense for the three months ended December 31,September 30, 2019 and 2018 and 2017 was $5.7$5.8 million and $5.4 million, respectively.  Depreciation expense for the six months ended December 31, 2018 and 2017 was $12.2 million and $11.1$6.6 million, respectively.

 

In the first quarter of Fiscal 2019, the Company approved a plan to sell the Cody API business.  As such, all assets, including property, plantbusiness and equipment totaling $36.6 million, and liabilities associated with the Cody API business are recorded in the assets and liabilities held for sale captions in the Consolidated Balance Sheet as of December 31, 2018.  In addition, as part of the held for sale classification, the Company is required to record the assets of the Cody API business at fair value less costs to sell.  The Company performed a fair value analysis which resulted in a $29.9 million impairment of the Cody API property, plant and equipment assets.  The Company was unable to sell the Cody API business as an ongoing operation and intended to sell the equipment and real estate utilized by the Cody API business and to have Cody Labs cease all operations.  As such, Cody Labs’ property, plant and equipment totaling $6.7 million, were recorded in the assets held for sale caption in the Consolidated Balance Sheet as of June 30, 2019.  As of September 30, 2019, the Company has a remaining balance of $4.6 million recorded in the assets held for sale caption in the Consolidated Balance Sheet.  See Note 2219 “Assets Held for Sale” for more information.  During

In the three months ended December 31, 2018,second quarter of Fiscal 2019, the Company had no impairment charges relatedceased manufacturing functions at the Townsend Road facility and decided to property, plant and equipment.sell the property.  The sale was finalized in the first quarter of Fiscal 2020 for total proceeds of $4.3 million.

 

Property, plant and equipment, net included amounts held in foreign countries in the amount of $1.7 million and $1.1$1.0 million at December 31, 2018September 30, 2019 and June 30, 2018, respectively.2019.

 

Note 8.  Fair Value Measurements

 

The Company’s financial instruments recorded in the Consolidated Balance Sheets include cash and cash equivalents, accounts receivable, accounts payable, accrued expenses and debt obligations.  Included in cash and cash equivalents are certificates of deposit with maturities less than or equal to three months at the date of purchase and money market funds.  The carrying value of certain financial instruments, primarily cash and cash equivalents, accounts receivable, accounts payable and accrued expenses, approximate their estimated fair values based upon the short-term nature of their maturity dates.

 

The Company follows the authoritative guidance of ASC Topic 820 “Fair Value Measurements and Disclosures.”  Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date.  The authoritative guidance also establishes a fair value hierarchy which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value.  The Company’s financial assets and liabilities measured at fair value are entirely within Level 1 of the hierarchy as defined below:

 

Level 1 — Quoted prices (unadjusted) in active markets for identical assets or liabilities that the reporting entity can access at the measurement date.

Level 2 — Directly or indirectly observable inputs, other than quoted prices, such as quoted prices for similar assets or liabilities; quoted prices for identical or similar instruments in markets that are not active; or model-derived valuations whose inputs are observable or whose significant value drivers are observable.

 

Level 3 — Unobservable inputs that are supported by little or no market activity and that are material to the fair value of the asset or liability.  Financial instruments whose values are determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation are examples of Level 3 assets and liabilities.

 

If the inputs used to measure the financial assets and liabilities fall within more than one level described above, the categorization is based on the lowest level input that is significant to the fair value measurement of the instrument.

 

Financial Instruments Disclosed, But Not Reported, at Fair Value

 

The fair value of our long-term debt was approximately $727 million and $893 million as of December 31, 2018 and June 30, 2018, respectively.  We estimate the fair value of our debt utilizing market quotations for debt that have quoted prices in active markets. Since our debt does not trade on a daily basis in an active market, the fair value estimates are based on market observable inputs based on borrowing rates currently available for debt with similar terms and average maturities (Level 2).

Note 9.  Investment Securities

The Company uses the specific identification method to determine the costestimated fair value of securities sold, which consisted entirelyour term loan debt was approximately $656 million and $724 million as of equity securities classified as trading.

In May 2018, the Company liquidated the remainder of the investment securities portfolio.  As of December 31, 2018September 30, 2019 and June 30, 2018,2019, respectively.  The estimated fair value of our 4.5% Convertible Senior Notes was approximately $87 million as of September 30, 2019.  The difference between the Company does not own investment securities.

The Company had a net gain on investment securitiesprincipal amount of $2.0 million during the three months ended December 31, 2017, which included an unrealized gain related to securities still held at December 31, 2017 of $1.2 million.

The Company had a net gain on investment securities of $2.8 million during4.5% Convertible Senior Notes and its’ estimated fair value represents the six months ended December 31, 2017, which included an unrealized gain related to securities still held at December 31, 2017 of $1.1 million.equity conversion value premium.

Note 10.9.  Goodwill and Intangible Assets

The changes in the carrying amount of goodwill for the six months ended December 31, 2018 are as follows:

(In thousands)

 

Generic
Pharmaceuticals

 

Balance at June 30, 2018

 

$

339,566

 

Goodwill acquired

 

 

Impairment

 

(339,566

)

Balance at December 31, 2018

 

$

 

 

On August 17, 2018, JSP notified the Company that it willwould not extend or renew the JSP Distribution Agreement when the current term expiresexpired on March 23, 2019.  The Company determined that JSP’s decision represented a triggering event under U.S. GAAP to perform an analysis to determine the potential for impairment of goodwill. On October 4, 2018, the Company completed the analysis based on market data and concluded a full impairment of goodwill, totaling $339.6 million, was required.

Intangible assets, net as of December 31, 2018September 30, 2019 and June 30, 2018,2019, consisted of the following:

 

 

Weighted

 

Gross Carrying Amount

 

Accumulated Amortization

 

Intangible Assets, Net

 

 

Weighted

 

Gross Carrying Amount

 

Accumulated Amortization

 

Intangible Assets, Net

 

(In thousands)

 

Avg. Life
(Yrs.)

 

December 31,
2018

 

June 30,
2018

 

December 31,
2018

 

June 30,
2018

 

December 31,
2018

 

June 30,
2018

 

 

Avg. Life
(Yrs.)

 

September 30,
2019

 

June 30,
2019

 

September 30,
2019

 

June 30,
2019

 

September 30,
2019

 

June 30,
2019

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Definite-lived:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cody Labs import license

 

15

 

$

 

$

581

 

$

 

$

(386

)

$

 

$

195

 

 

15

 

$

581

 

$

581

 

$

(434

)

$

(424

)

$

147

 

$

157

 

KUPI product rights

 

15

 

416,154

 

416,154

 

(83,712

)

(69,840

)

332,442

 

346,314

 

 

15

 

416,154

 

416,154

 

(104,519

)

(97,583

)

311,635

 

318,571

 

KUPI trade name

 

2

 

2,920

 

2,920

 

(2,920

)

(2,920

)

 

 

 

2

 

2,920

 

2,920

 

(2,920

)

(2,920

)

 

 

KUPI other intangible assets

 

15

 

19,000

 

19,000

 

(3,928

)

(3,295

)

15,072

 

15,705

 

 

15

 

19,000

 

19,000

 

(4,878

)

(4,562

)

14,122

 

14,438

 

Silarx product rights

 

15

 

10,000

 

10,000

 

(2,389

)

(2,056

)

7,611

 

7,944

 

 

15

 

10,000

 

10,000

 

(2,889

)

(2,722

)

7,111

 

7,278

 

Other product rights

 

13

 

21,692

 

19,693

 

(3,396

)

(1,875

)

18,296

 

17,818

 

 

13

 

30,192

 

26,579

 

(3,954

)

(4,243

)

26,238

 

22,336

 

Total definite-lived

 

 

 

$

469,766

 

$

468,348

 

$

(96,345

)

$

(80,372

)

$

373,421

 

$

387,976

 

 

 

 

$

478,847

 

$

475,234

 

$

(119,594

)

$

(112,454

)

$

359,253

 

$

362,780

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Indefinite-lived:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

KUPI in-process research and development

 

 

$

18,000

 

$

18,000

 

$

 

$

 

$

18,000

 

$

18,000

 

 

 

$

18,000

 

$

18,000

 

$

 

$

 

$

18,000

 

$

18,000

 

Silarx in-process research and development

 

 

18,000

 

18,000

 

 

 

18,000

 

18,000

 

 

 

18,000

 

18,000

 

 

 

18,000

 

18,000

 

Other product rights

 

 

449

 

449

 

 

 

449

 

449

 

 

 

32,000

 

12,449

 

 

 

32,000

 

12,449

 

Total indefinite-lived

 

 

 

36,449

 

36,449

 

 

 

36,449

 

36,449

 

 

 

 

68,000

 

48,449

 

 

 

68,000

 

48,449

 

Total intangible assets, net

 

 

 

$

506,215

 

$

504,797

 

$

(96,345

)

$

(80,372

)

$

409,870

 

$

424,425

 

 

 

 

$

546,847

 

$

523,683

 

$

(119,594

)

$

(112,454

)

$

427,253

 

$

411,229

 

 

For the three months ended December 31,September 30, 2019 and 2018, and 2017, the Company recorded amortization expense of $7.0 million and $8.2 million.  For the six months ended December 31, 2018 and 2017,million, respectively.

In July 2019, the Company recorded amortization expenseentered into a distribution and supply agreement with Cediprof, Inc.  The Company made an upfront payment of $16.4$20.0 million to distribute Levothyroxine Sodium Tablets USP, commencing no later than August 1, 2022, which is included within the “Other product rights” category of indefinite-lived intangible assets.  In August 2019, the Company entered into a distribution and $16.3supply agreement with Sinotherapeutics Inc. to distribute Posaconazole Delayed-Release Tablets 100mg.  The Company paid $2.0 million respectively.upon FDA approval of the product and $1.5 million upon the first commercial sale of the product, which is included within the “Other product rights” category of definite-lived intangible assets.

 

Future annual amortization expense consisted of the following as of December 31, 2018:September 30, 2019:

 

(In thousands)
Fiscal Year Ending June 30,

 

Annual Amortization Expense

 

2019

 

$

15,224

 

2020

 

30,443

 

2021

 

30,443

 

2022

 

30,443

 

2023

 

30,443

 

Thereafter

 

236,425

 

 

 

$

373,421

 

(In thousands)
Fiscal Year Ending June 30,

 

Amortization Expense

 

2020

 

$

24,228

 

2021

 

32,304

 

2022

 

32,304

 

2023

 

32,304

 

2024

 

31,967

 

Thereafter

 

206,146

 

 

 

$

359,253

 

Note 11.10. Long-Term Debt

 

Long-term debt, net consisted of the following:

 

 

December 31,

 

June 30,

 

 

September 30,

 

June 30,

 

(In thousands)

 

2018

 

2018

 

 

2019

 

2019

 

Term Loan A due 2020; 7.52% as of December 31, 2018

 

$

213,526

 

$

227,276

 

Term Loan A due 2020; 7.04% as of September 30, 2019

 

$

69,469

 

$

153,933

 

Unamortized discount and other debt issuance costs

 

(8,843

)

(10,178

)

 

(1,713

)

(4,722

)

Term Loan A, net

 

204,683

 

217,098

 

 

67,756

 

149,211

 

Term Loan B due 2022; 7.90% as of December 31, 2018

 

650,338

 

670,011

 

Term Loan B due 2022; 7.42% as of September 30, 2019

 

602,366

 

614,468

 

Unamortized discount and other debt issuance costs

 

(41,569

)

(47,839

)

 

(31,611

)

(34,631

)

Term Loan B, net

 

608,769

 

622,172

 

 

570,755

 

579,837

 

4.50% Convertible Senior Notes due 2026

 

86,250

 

 

Unamortized discount and other debt issuance costs

 

(3,484

)

 

4.50% Convertible Senior Notes, net

 

82,766

 

 

Revolving Credit Facility due 2020

 

 

 

 

 

 

Total debt, net

 

813,452

 

839,270

 

 

721,277

 

729,048

 

Less short-term borrowings and current portion of long-term debt

 

(66,845

)

(66,845

)

 

(66,845

)

(66,845

)

Total long-term debt, net

 

$

746,607

 

$

772,425

 

 

$

654,432

 

$

662,203

 

 

On December 10, 2018, the Company entered into an amendment to the Senior Secured Credit Facility and the Credit and Guaranty Agreement.  Pursuant to the amendment, the Secured Net Leverage Ratio applicable to the financial leverage ratio covenant was increased from 3:25:1.00 to 4.25:1.00 as of December 31, 2019 and prior to September 30, 2020, and then to 4:00:1:00 as of September 30, 2020.  In exchange, the Company agreed to include a minimum liquidity covenant of $75 million, a 25-basis point

increase to the interest rate margin paid on the Term A Loans and pay a consent fee equal to 50 basis points, paid only to consenting lenders.

Long-term debt amounts due, for the twelve-month periods ending December 31September 30 are as follows:

 

 

Amounts Payable

 

 

Amounts Payable

 

(In thousands)

 

to Institutions

 

 

to Institutions

 

2019

 

$

66,845

 

2020

 

225,371

 

 

$

66,845

 

2021

 

39,345

 

 

81,314

 

2022

 

532,303

 

 

39,345

 

2023

 

484,331

 

Thereafter

 

86,250

 

Total

 

$

863,864

 

 

$

758,085

 

On September 27, 2019, the Company issued $86,250,000 aggregate principal amount of its 4.50% convertible senior notes due 2026 (the “Notes”) in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended.  The Notes are senior unsecured obligations of the Company and bear interest at an annual rate of 4.50% payable semi-annually in arrears on April 1 and October 1 of each year, beginning on April 1, 2020.  The Notes will mature on October 1, 2026, unless earlier repurchased, redeemed or converted in accordance with their terms.  The Notes are convertible into shares of the Company’s common stock at an initial conversion rate of 65.4022 shares per $1,000 principal amount of Notes (which is equivalent to an initial conversion price of approximately $15.29 per share), subject to adjustments upon the occurrence of certain events (but will not be adjusted for any accrued and unpaid interest).  The Company may redeem all or a part of the Notes on or after October 6, 2023 at a redemption price equal to 100% of the principal amount of the Notes redeemed, plus accrued and unpaid interest, if any, up to, but excluding, the redemption date, subject to certain conditions relating to the Company’s stock price having been met.  Following certain corporate events that occur prior to the maturity date or if the Company delivers a notice of redemption, the Company will, in certain circumstances, increase the conversion rate for a holder who elects to convert its Notes in connection with such corporate event or notice of redemption.  The indenture covering the Notes contains certain other customary terms and covenants, including that upon certain events of default occurring and continuing, either the trustee or holders of at least 25% in principal amount of the outstanding Notes may declare 100% of the principal of, and accrued and unpaid interest on, all the Notes to be due and payable.

In connection with the offering of the Notes, the Company also entered into privately negotiated “capped call” transactions with several counterparties.  The capped call transaction will initially cover, subject to customary anti-dilution adjustments, the number of shares of common stock that initially underlie the Notes.  The capped call transactions are expected to generally reduce the potential dilutive effect on the Company’s common stock upon any conversion of the Notes with such reduction subject to a cap which is initially $19.46 per share.  The capped call transactions are recorded in stockholders’ equity and are not accounted for as derivatives.  The fees associated with the capped call transactions totaled $7.1 million, which was recorded as a reduction to additional paid-in capital on the Consolidated Balance Sheet.  The form of capped call confirmations was filed as Exhibit 10.57 to the Form 8-K filed with the SEC on September 27, 2019.

A portion of the net proceeds received from the offering of the Notes was used to pay the cost of the capped call transactions.  The remaining net proceeds, totaling $77.0 million, was used to repay a portion of the outstanding Term Loan A balance on September 27, 2019.  As a result of the repayment, the Company recorded a loss on extinguishment of debt of $2.1 million in the Consolidated Statement of Operations.

The outstanding Term Loan A, Term Loan B and Revolving Credit Facility amounts above are guaranteed by all of Lannett’s significant wholly-owned domestic subsidiaries and are collateralized by substantially all present and future assets of the Company.

 

Note 12.11.  Legal, Regulatory Matters and Contingencies

 

Connecticut AttorneyState Attorneys General Inquiry into the Generic Pharmaceutical Industry

 

In July 2014, the Company received interrogatories and a subpoena from the State of Connecticut Office of the Attorney General concerning its investigation into the pricing of digoxin.  According to the subpoena, the Connecticut Attorney General is investigating whether anyone engaged in any activities that resulted in (a) fixing, maintaining or controlling prices of digoxin or (b) allocating and dividing customers or territories relating to the sale of digoxin in violation of Connecticut antitrust law.  In June 2016, the Connecticut Attorney General issued interrogatories and a subpoena to an employee of the Company in order to gain access to documents and responses previously supplied to the Department of Justice.Justice pursuant to the federal investigation described below.  In December 2016, the Connecticut Attorney General, joined by numerous other State Attorneys General, filed a civil complaint alleging that six pharmaceutical companies engaged in anti-competitive behavior related to doxycycline hyclate and gliburide.behavior.  The Company was not named in the action and does not compete on the products that formed the basis of the complaint.  The complaint was later transferred for pretrial purposes to the United States District Court for the Eastern District of Pennsylvania as part of a multidistrict litigation captioned In re: Generic Pharmaceuticals Pricing Antitrust Litigation.  On October 31, 2017, the stateState Attorneys General filed a motion in the District Court for leave to amend their complaint to add numerous additional defendants, including the Company, and claims relating to 13 additional drugs.  The Court granted that motion on June 5, 2018.  The State Attorneys General filed their amended complaint on June 18, 2018. The claim relating to Lannett involves alleged price-fixing for one drug, doxycycline monohydrate, but does not involve the pricing for digoxin.  The stateState Attorneys General also allege that all defendants were part of an overarching, industry-wide conspiracy to allocate markets and fix prices generally.  TheOn August 15, 2019, the Court granted thatdenied the defendants’ joint motion on June 5, 2018.  The stateto dismiss the overarching conspiracy claims, but has yet to decide an individual motion filed by the Company to dismiss the overreaching conspiracy claims as to it.

On May 10, 2019, the State Attorneys General filed a new lawsuit naming the Company and one of its employees as defendants, along with 33 other corporations and individuals. The new complaint again alleges an overarching conspiracy and contains claims for price fixing and market allocation under the Sherman Act and related state laws. The complaint focuses on the conduct of another generic pharmaceutical company, and the relationships that company had with other generic companies and their amendedemployees. The specific allegations in the new complaint on June 15, 2018.  Noneagainst Lannett relate to the Company’s sales of baclofen and levothyroxine. The new complaint also names another current employee as a defendant, however the allegations pertain to conduct that occurred prior to their employment by Lannett. The Company has not responded to the new complaint as of the defendants, includingdate of this report.

Based on internal investigations performed to date, the Company has responded yet to the amended complaint.

The Company maintainscurrently believes that it has acted in compliance with all applicable laws and regulations and continues to cooperate with the Connecticut Attorney General investigation.regulations.

 

Federal Investigation into the Generic Pharmaceutical Industry

 

TheIn November and December 2014, the Company and certain affiliated individuals and customers have beenwere served with grand jury subpoenas relating to a federal investigation of the generic pharmaceutical industry into possible violations of the Sherman Act.  The subpoenas request corporate documents of the Company relating to corporate, financial and employee information, communications or correspondence with competitors regarding the sale of generic prescription medications and the marketing, sale, or pricing of certain products, generally, for the period of 2005 through the dates of the subpoenas.

 

The Company received a Civil Investigative Demand (“CID”) from the Department of Justice on May 14, 2018.  The CID requests information regarding allegations that the generic pharmaceutical industry engaged in market allocation, price fixing, payment of illegal remuneration and submission of false claims.  The CID requests information from 2009-present. The Company is in the process of responding to the CID.

 

Based on reviewsinternal investigations performed to date, by outside counsel, the Company currently believes that it has acted in compliance with all applicable laws and regulations and continues to cooperate with the federal investigation.

Texas Medicaid Investigation

In August 2015, KUPI received a letter from the Texas Office of the Attorney General alleging that it had inaccurately reported certain price information in violation of the Texas Medicaid Fraud Prevention Act. UCB, KUPI’s previous parent company is handling the defense and is evaluating the allegations and cooperating with the Texas Attorney General’s Office.  Per the terms of the Stock Purchase Agreement between the Company and UCB (“Stock Purchase Agreement”) dated September 2, 2015, the Company is fullyregulations.

indemnified for any pre-acquisition amounts.  In December 2018, KUPI and the State of Texas settled the allegations for the sum of $8.0 million, which is fully indemnified by UCB.  UCB forwarded the $8.0 million to KUPI in December 2018 and, following its receipt of the fully executed settlement agreement, KUPI forwarded the settlement funds to the State of Texas in January 2019.

Government Pricing

 

During the quarter ended December 31, 2016, the Company completed a contract compliance review, for the period January 1, 2012 through June 30, 2016, for one of KUPI’s government-entity customers.  As a result of the review, the Company identified certain commercial customer prices and other terms that were not properly disclosed to the government-entity resulting in potential overcharges.  As of December 31, 2018 and June 30, 2018, the Company’s best estimate of the liability for potential overcharges was approximately $9.3 million.  For the period January 1, 2012 through November 24, 2015 (“the pre-acquisition period”), the Company is fully indemnified per the Stock Purchase Agreement.  Accordingly,On May 22, 2019, the Company has recorded an indemnification asset and related liability of $8.3 million related to the pre-acquisition period.  The Company does not believe that the ultimate resolution of this matter will have a significant impact on our financial position, results of operations or cash flows.

EPA Violation Notice

On July 13, 2017, the United States Department of Environmental Protection AgencyVeterans Affairs (“EPA”VA”) sentissued a Finding of Violation to KUPI alleging several violations of national emissions standardsContracting Officer’s Final Decision and Demand for hazardous air pollutants at KUPI’s Seymour, Indiana facility.  The EPA and KUPI have entered into an agreed Administrative Consent Order and Consent Assessment and Final Order to resolve the alleged violations, whereby KUPI made a payment of $60,000 to the EPA and escrowedPayment, assessing the sum of $225,000$9.4 million for overpayments by the Veteran’s Administration for the period of January 1, 2012 through June 30, 2016.  In August 2019, the Company remitted payment to be used to fund an environmental project. The Orders were fully executed on December 31, 2018.the VA and received reimbursement from UCB for the indemnified portion of the payment in the amount of $8.1 million.

 

Private Antitrust and Consumer Protection Litigation

 

The Company and certain competitors have been named as defendants in a number of lawsuits filed in 2016 and 2017 alleging that the Company and certain generic pharmaceutical manufacturers have conspired to fix prices of generic digoxin, levothyroxine, ursodiol and baclofen.  These cases are part of a larger group of more than 100 lawsuits generally alleging that over 30 generic pharmaceutical manufacturers and distributors conspired to fix prices for at least 18 different generic drugs in violation of the federal Sherman Act, various state antitrust laws, and various state consumer protection statutes.  The United States also has been granted leave to intervene in the cases.  On April 6, 2017, the Judicial Panel on Multidistrict Litigation (the “JPML”) ordered that all of the cases alleging price-fixing for generic drugs be consolidated for pretrial proceedings in the United States District Court for the Eastern District of Pennsylvania under the caption In re: Generic Pharmaceuticals Pricing Antitrust Litigation.  The various plaintiffs are grouped into three categories — Direct Purchaser Plaintiffs, End Payer Plaintiffs, and Indirect Reseller Purchasers — and filed Consolidated Amended Complaints (“CACs”) against the Company and the other defendants on August 15, 2017.

 

The CACs naming the Company as a defendant involve generic digoxin, levothyroxine, ursodiol and baclofen.  Pursuant to a court-ordered schedule grouping the 18 different drug cases into three separate tranches, the Company and other generic pharmaceutical manufacturer defendants on October 6, 2017 filed joint and individual motions to dismiss the CACs involving the six drugs in the first tranche, including digoxin.  On October 16, 2018, the Court (with one exception) denied defendants’ motions to dismiss plaintiffs’ Sherman Act claims with respect to the drugs in the first tranche. Defendants’On March 15, 2019, the Company and other defendants filed answers to the Sherman Act claims. In addition, on February 15, 2019, the Court granted defendants’ motions to dismiss certain of the plaintiffs’ state law claims brought under the laws of Illinois, Rhode Island, Georgia, South Carolina, Montana, West Virginia, Alabama, New Jersey, Michigan and Nevada, but denied the remainder of defendants’ motions to dismiss. The Court set a deadline of April 1, 2019 for certain plaintiffs to amend their existing complaints to reflect the rulings set forth in the Court’s February 15, 2019 ruling on the state law motions to dismiss. Those plaintiffs amended their complaints, but further motions to dismiss the state-law claims have been deferred until the Court decides pending motions to dismiss with respect to those drugs remain pending.the plaintiffs’ various overarching-conspiracy claims.

 

On January 22, 2018, three opt-out direct purchasers filed a complaint alleging an overarching conspiracy and individual conspiracies on behalf ofagainst the Company and numerous other defendants to fix the prices of and allocate markets for at least 30 different drugs, including digoxin, doxycycline, levothyroxine, ursodiol and baclofen. On August 3, 2018, another opt-out direct purchaser filed a complaint alleging an overarching conspiracy and individual conspiracies on behalf ofagainst the Company and numerous other defendants to fix the prices of and allocate markets for 16 different drugs, including digoxin, doxycycline, levothyroxine, ursodiol and baclofen.  On February 21, 2019, the Company and the other defendants filed motions to dismiss the overarching conspiracy claims.  On August 15, 2019, the Court denied the defendants’ joint motion to dismiss the overarching conspiracy claims, but has yet to decide an individual motion filed by the Company to dismiss the overarching conspiracy claims as to it.  On January 16, 2019, another opt-out direct purchaser filed a complaint alleging an overarching conspiracy and individual conspiracies on behalf of the Company and numerous other defendants to fix the prices of and allocate markets for the 30 different drugs, including digoxin, doxycycline, levothyroxine, ursodiol, baclofen and acetazolamide. None of the defendants, including the Company, has responded yet to this particular complaint. On July 29, 2019, a group of insurance company opt-out plaintiffs commenced an action against the Company and numerous other defendants by filing a writ of summons in the Court of Common Pleas of Philadelphia County, Pennsylvania, but have yet to file a complaint. The parties have since entered into a stipulation to defer any action in the state court case indefinitely pending further developments in the federal multidistrict litigation. On October 11, 2019, one of the opt-out direct purchasers filed another complaint in federal court in Minnesota alleging an overarching conspiracy and individual conspiracies on behalf of the Company to fix the prices of and allocate markets for dozens of different drugs, including baclofen. That complaint has since been added to the multidistrict litigation in Pennsylvania. On October 18, 2019, another of the opt-out direct purchasers filed another complaint alleging an overarching conspiracy and individual conspiracies on behalf of the Company to fix the prices of and allocate markets for over 100 drugs, including glyburide. None of the defendants, including the Company, has responded yet to these opt-out complaints.

 

In addition to the lawsuits brought by private plaintiffs, the Attorneys General of 48 states, the District of Columbia and Puerto Rico have filed parens patriae lawsuits alleging price-fixing conspiracies by various generic pharmaceutical manufacturers.  The JPML has consolidated the suits by the state Attorneys General in the Eastern District of Pennsylvania as part of the multidistrict litigation. The original lawsuits did not name the Company, but the state Attorneys General filed an amended complaint on June 5,18, 2018 to add numerous additional defendants, including the Company, and claims relating to 13 additional drugs.  The claim relating to Lannettthe Company involves alleged price-fixing for one drug, doxycycline monohydrate, although the state Attorneys General allege that all defendants were part of an overarching, industry-wide conspiracy to allocate markets and fix prices generally.  On February 21, 2019,

the Company and the other defendants filed motions to dismiss the overarching conspiracy claims.  On August 15, 2019, the Court denied the defendants’ joint motion to dismiss the overarching conspiracy claims, but has yet to decide an individual motion filed by the Company to dismiss the overarching conspiracy claims as to it.  Additionally, on May 5, 2019, the state Attorneys General filed a new complaint in Connecticut alleging price-fixing conspiracies by the Company and various generic pharmaceutical manufacturers and individuals relating to more than 40 additional drugs. The complaint has since been added to the multidistrict litigation in the Eastern District of Pennsylvania.  The additional claims relating to the Company involve baclofen and levothyroxine, although the state Attorneys General allege that all defendants were part of an overarching, industry-wide conspiracy to allocate markets and fix prices generally.  None of the defendants, including the Company, has responded yet to the amendedthis particular complaint.

 

Following the lead of the state Attorneys General, the Direct Purchaser Plaintiffs, End Payer Plaintiffs and Indirect Reseller Plaintiffs have filed their own complaints also alleging an overarching conspiracy, making similar allegations to those contained in the state Attorneys General complaint, relating to 14 generic drugs in the End Payer complaint and 15 generic drugs in the Indirect Reseller complaint.  The End Payer Plaintiffs filed their complaint on June 7, 2018, the Indirect Reseller Plaintiffs filed their complaint on June 18, 2018, and the Direct Purchaser Plaintiffs filed their complaint on June 22, 2018.  Although the complaints allege an overarching conspiracy with respect to all of the drugs identified, the specific allegations related to drugs Lannett makesmanufactures involve acetazolamide and doxycycline monohydrate. None of the defendants, includingOn February 21, 2019, the Company and the other defendants filed motions to dismiss the overarching conspiracy claims. On August 15, 2019, the Court denied the defendants’ joint motion to dismiss the overarching conspiracy claims, but has responded yet to these complaints.decide an individual motion filed by the Company to dismiss the overarching conspiracy claims as to it.

 

On September 25, 2018, two other alleged direct purchasers filed a purported class action complaint alleging an overreaching, industry-wide horizontal and vertical conspiracy involving the company, numerous other generic pharmaceutical manufacturers, and various pharmaceutical distributors to allocate markets and fix prices generally for a variety of generic drugs. The case has been added to the multidistrict litigation. On December 21, 2018, the plaintiffs filed an amended complaint. None of the defendants, includingOn February 21, 2019, the Company and the other defendants filed motions to dismiss the overarching conspiracy claims. On August 15, 2019, the Court denied the defendants’ joint motion to dismiss the overarching conspiracy claims, but has responded yet to decide an individual motion filed by the amended complaint.Company to dismiss the overarching conspiracy claims as to it.

 

The Company believes that it acted in compliance with all applicable laws and regulations.  Accordingly, the Company disputes the allegations set forth in these class actions.actions and plans to vigorously defend itself from these claims.

 

Shareholder Litigation

 

In November 2016, a putative class action lawsuit was filed against the Company and two of its officers claimingin the federal court for the Eastern District of Pennsylvania, alleging that the Company damaged the purported class by including in its securities filings false and misleading statements regarding the Company’s drug pricing methodologies and internal controls.  An amended complaint was filed in May 2017, and the Company filed a motion to dismiss the amended complaint in September 2017.  In December 2017, counsel for the putative class filed a second amended complaint, and the Court denied as moot the Company’s motion to dismiss the first amended complaint.  The Company filed a motion to dismiss the second amended complaint in February 2018.  In July 2018, the court granted the Company’s motion to dismiss the second amended complaint.  In September 2018, counsel for the putative class filed a third amended complaint.  The Company filed a motion to dismiss the third amended complaint in November 2018.  In May 2019, the court denied the Company’s motion to dismiss the third amended complaint.  In July 2019, the Company filed an answer to the third amended complaint.  The Company believes it acted in compliance with all applicable laws and plans to vigorously defend itself from these claims.  The Company cannot reasonably predict the outcome of the suit at this time.

In July 2018, a shareholder derivative complaint was filed against the Company and certain of its current and former directors and executives in the United States District Court for the Eastern District of Pennsylvania.  The derivative complaint alleges that the Company engaged in an illegal conspiracy to fix generic drug prices and that the Company’s directors and executives violated their fiduciary duties by allowing the Company to violate the applicable laws and regulations and failing to take any action to curtail management’s deliberate price-fixing scheme.  The derivative complaint includes causes of action for violation of Section 10(b) of the Exchange Act, violation of Section 14(a) of the Exchange Act, violation of Section 29(a) of the Exchange Act, and for breach of fiduciary duty. In October 2018, the Court issued an order stating the derivative suit for all purposes for a period of 180 days or until the Court issues an order on the motion to dismiss the third amended complaint filed in the matter of Utesch v. Lannett Co., Inc., et al., No. 2:16cv-05932, whichever is later. The Company cannot reasonably predict the outcome of the suit at this time.

 

In October 2018, a putative class action lawsuit was filed against the Company and two of its officers in the federal court for the Eastern District of Pennsylvania, alleging that the Company, its Chief Executive Officer and its former Chief Financial Officer damaged the purported class by making false and misleading statements in connection with the possible renewal of the JSP Distribution Agreement.  The Company and the corporate executives named in the complaint deny that they made any false or misleading statements.  In December 2018, counsel for the putative class filed an amended complaint. The Company moved to dismiss the amended complaint in January 2019.  In March 2019, the Court granted in part and denied in part the Company’s motion to dismiss.  In May 2019, the Company filed an answer to the amended complaint.  During May and June 2019, the parties negotiated a proposed settlement and agreed to settle the litigation, by which the Company agreed to pay the sum of $300,000 without an admission of liability and subject to the negotiation of the terms of a stipulation of settlement and approval by the Court.  In July 2019, counsel for the putative class filed a motion for preliminary approval of the proposed settlement and on July 31, 2019, the Court issued an Order granting the motion and scheduling a hearing for final approval of the settlement for February 7, 2020.

In May 2019, a shareholder derivative lawsuit was filed against certain of the Company’s current and former officers and certain of the current and former members of the Company’s Board of Directors in the federal court for the District of Delaware. The Company was also named as a nominal defendant in the suit. The suit alleges that the defendants breached their fiduciary duties as directors and/or officers of the Company, that certain of the defendants caused the Company to issue false and misleading proxy statements in violation of Section 14(a) of the Securities Exchange Act of 1934, that the defendants were unjustly enriched at the expense of the Company, and that the defendants wasted corporate assets belonging to the Company. The Company cannot reasonably predict the outcome of thisthe suit at this time.

 

In December 2018, the ChairmanJuly 2019, a shareholder derivative lawsuit was filed against certain of the Company’s Boardcurrent and former officers and directors in the federal court for the Eastern District of Directors receivedPennsylvania.  The Company was also named as a letter sent on behalf of two purported shareholders demandingnominal defendant in the suit.  The suit alleges that the Company’s Board of Directors investigate and commence legal proceedings against certain formerdefendants breached their fiduciary duties as directors and/or current directors, officers and agents of the Company relatingand that certain of the defendants caused the Company to alleged breachesviolate Sections 10(b), 14(a), and 29(b) of fiduciary duties, corporate waste, and unjust enrichment. The Company and the Company’s BoardSecurities Exchange Act of Directors responded1934.  In October 2019, this suit was transferred to the demand letter by requestingfederal court for the District of Delaware and is pending before the same judge presiding over the shareholder derivative suit that the purported shareholders provide proof of their status and shareholders of the Company.was filed in May 2019.  The Company and the Company’s Board of Directors recently received a reply to the letter sent in response to the demand letter and are reviewing the information provided. At this time the Company cannot reasonably predict whatthe outcome if any, will follow fromof the suit at this time.

In September 2019, a shareholder derivative lawsuit was filed against certain of the Company’s current and former officers, directors and employees in the federal court for the District of Delaware.  The Company was also named as a nominal defendant in the suit.  The suit alleges that the defendants breached their fiduciary duties as directors and/or officers of the Company, alleges waste of corporate assets and the Company’s Board of Director’s receiptgross mismanagement, and alleges that certain of the demand letter.defendants caused the Company to violate Section 14(a) of the Securities and Exchange Act of 1934.  The Company cannot reasonably predict the outcome of the suit at this time.

Genus Life Sciences

 

In December 2018, Genus Lifesciences, Inc. (“Genus”) sued the Company, Cody Labs, and others in California federal court, alleging violations of the Lanham Act, Sherman Act, and California false advertising law.  Genus received FDA approval for a cocaine hydrochloride product in December 2018, and its claims are premised in part on allegations that the Company falsely advertises its unapproved cocaine hydrochloride product, C-Topical.solution product.  The Company denies that it is falsely advertising its C-Topicalcocaine hydrochloride solution product and continues to market its unapproved product relying on the Guidance for FDA Staff and Industry, Marketed Unapproved Drugs — Compliance Policy Guide, pending approval of its Section 505(b)(2) application.  In January 2019, the Company filed a motion to dismiss the complaint.  On May 3, 2019, the Court issued a written decision granting in part and denying in part the motion to dismiss.  On June 6, 2019, Genus filed an Amended Complaint.  On June 27, 2019, the Company filed a motion to dismiss the amended complaint.  By Order dated September 3, 2019, the Court granted in part and denied in part the Company’s motion to dismiss.  The Company believes it acted in compliance with all applicable laws and regulations and plans to vigorously defend itself from these claims.  Discovery is ongoing and the Company cannot reasonably predict the outcome of this suit at this time.

Patent Infringement (Paragraph IV Certification)

There is substantial litigation in the pharmaceutical industry with respect to the manufacture, use and sale of new products which are the subject of conflicting patent and intellectual property claims.  Certain of these claims relate to paragraph IV certifications, which allege that an innovator patent is invalid or would not be infringed upon by the manufacture, use, or sale of the new drug.

Zomig®

The Company filed with the FDA an ANDA No. 206350, along with a paragraph IV certification, alleging that the two patents associated with the Zomig® nasal spray product (U.S. Patent No. 6,750,237 and U.S. Patent No. 67,220,767) are invalid.

In July 2014, AstraZeneca AB, AstraZeneca UK Limited and Impax Laboratories, Inc. filed two patent infringement lawsuits in the United States District Court for the District of Delaware, alleging that the Company’s filing of ANDA No. 206350 constitutes an act of patent infringement and seeking a declaration that the two patents at issue are valid and infringed.

In September 2014, the Company filed a motion to dismiss one patent infringement lawsuit for lack of standing and responded to the second lawsuit by denying that any valid patent claim would be infringed.  In the second lawsuit, the Company also counterclaimed for a declaratory judgment that the patent claims are invalid and not infringed.  The Court has consolidated the two actions and denied the motion to dismiss the first action without prejudice.

In July 2015, the Company filed with the United States Patent and Trademark Office (“USPTO”) a Petition for Inter Partes Review of each of the patents in suit seeking to reject as invalid all claims of the patents in suit.  The USPTO has issued a decision denying initiation of the Inter Partes Review.

A trial was conducted in September 2016.  The Court issued its decision on March 29, 2017, finding that Lannett did not prove that the patents at issue are invalid.  The Company has appealed the decision. All briefing to the appellate court has been submitted, and oral argument before the appellate court was conducted on April 5, 2018.  The appellate court issued an opinion on June 28, 2018, upholding the decision of the District Court.  The Company requested a rehearing by the appellate court on August 13, 2018.  The appellate court denied the request on September 14, 2018, and issued its mandate terminating the appeal on September 21, 2018.

 

Other Litigation Matters

 

The Company is also subject to various legal proceedings arising out of the normal course of its business including, but not limited to, product liability, intellectual property, patent infringement claims and antitrust matters.  It is not possible to predict the outcome of these various proceedings.  An adverse determination in any of these proceedings in the future could have a significant impact on the financial position, results of operations and cash flows of the Company.

Note 13.12.  Commitments

 

Leases

 

In the first quarter of Fiscal 2020, the Company recorded a ROU lease asset totaling $1.2 million related to an existing lease at Cody Labs upon adoption of ASU No. 2016-02.  The Company leases certain manufacturingsubsequently recorded a full impairment of the asset as a result of the decision to cease operations at Cody Labs.  At September 30, 2019, the Company has a ROU lease asset of $6.4 million and office equipment, ina ROU liability of $7.5 million, of which $1.9 million and $5.6 million represent the ordinary course of business.  These leases are typically renewed annually.  Rentalcurrent and lease expense was not material for all periods presented.non-current balance, respectively.

 

FutureComponents of lease cost are as follows:

 

 

Three Months Ended

 

(In thousands)

 

September 30, 2019

 

Operating lease cost

 

$

481

 

Variable lease cost

 

28

 

Short-term lease cost (a)

 

156

 

Total

 

$

665

 


(a) Not recorded on the Consolidated Balance Sheet.

Supplemental cash flow information and non-cash activity related to our operating leases are as follows:

 

 

Three Months Ended

 

(In thousands)

 

September 30, 2019

 

Cash paid for amounts included in the measurement of lease liabilities:

 

 

 

Operating cash flows from operating leases

 

$

481

 

Non-cash activity:

 

 

 

ROU assets obtained in exchange for new operating lease liabilities

 

$

 

Weighted-average remaining lease term and discount rate for our operating leases are as follows:

Three Months Ended

September 30, 2019

Weighted-average remaining lease term

9 years

Weighted-average discount rate

7.50%

Maturities of lease liabilities by fiscal year for our operating leases are as follows:

(In thousands)

 

Amounts Due

 

Remainder of 2020

 

$

1,460

 

2021

 

1,487

 

2022

 

1,169

 

2023

 

1,169

 

2024

 

1,169

 

Thereafter

 

3,929

 

Total lease payments

 

10,383

 

Less: Imputed interest

 

2,825

 

Present value of lease liabilities

 

$

7,558

 

As of June 30, 2019, future minimum lease payments under noncancelable operating leases (with initial or remaining lease terms in excess of one year) for the remainder of Fiscal 2019 and the twelve-month periods ending June 30 thereafter are as follows:

 

(In thousands)

 

Amounts Due

 

 

Amounts Due

 

Remainder of 2019

 

$

922

 

2020

 

1,855

 

 

$

1,898

 

2021

 

1,406

 

 

1,450

 

2022

 

1,080

 

 

1,123

 

2023

 

1,080

 

 

1,123

 

2024

 

1,123

 

Thereafter

 

4,158

 

 

3,839

 

Total

 

$

10,501

 

 

$

10,556

 

 

Other Commitment

 

During the third quarter of Fiscal 2017, the Company signed an agreement with a company operating in the pharmaceutical business, under which the Company agreed to provide up to $15.0 million in revolving loans, which expires in seven years and bears interest at 2.0%, for the purpose of expansion and other business needs.  The decision to provide any portion of the revolving loan is at the Company’s sole discretion.  Prior to the first quarter of Fiscal 2019, the Company had the option to convert the first $7.5 million into a 50% ownership interest in the entity.  The board of the entity is comprised of five members, one of which is an employee of the Company.

 

In the first quarter of Fiscal 2019, the Company sold 50% of the outstanding loan to a third party for $5.6 million and, in addition to assigning 50% of all right, title and interest in the loan and loan documents, the Company relinquished its right to convert a portion of the outstanding loan balance to an equity interest in the entity.  As of December 31, 2018, $5.8September 30, 2019, $6.1 million was outstanding under the revolving loan and is included in other assets.  In addition to the loan repayment, the agreement was amended to eliminate the Company’s ability to convert the outstanding loan balance into an ownership interest.  Based on the guidance set forth in ASC 810-10 Consolidation,, the Company has concluded that it has a variable interest in the entity.  However, the Company is not the primary beneficiary to the entity and as such, is not required to consolidate the entity’s results of operations.

Note 14.13.  Accumulated Other Comprehensive Loss

 

The Company’s Accumulated Other Comprehensive Loss was comprised of the following components as of December 31, 2018September 30, 2019 and 2017:2018:

 

(In thousands)

 

December 31,
2018

 

December 31,
2017

 

Foreign Currency Translation

 

 

 

 

 

Beginning Balance, June 30

 

$

(515

)

$

(222

)

Net gain (loss) on foreign currency translation (net of tax of $0 and $0)

 

13

 

(125

)

Reclassifications to net income (net of tax of $0 and $0)

 

 

 

Other comprehensive income (loss), net of tax

 

13

 

(125

)

Ending Balance, December 31

 

(502

)

(347

)

Total Accumulated Other Comprehensive Loss

 

$

(502

)

$

(347

)

 

 

September 30,

 

(In thousands)

 

2019

 

2018

 

Foreign Currency Translation

 

 

 

 

 

Beginning Balance, June 30

 

$

(615

)

$

(515

)

Net gain (loss) gain on foreign currency translation (net of tax of $0 and $0)

 

(46

)

6

 

Reclassifications to net income (net of tax of $0 and $0)

 

 

 

Other comprehensive income (loss), net of tax

 

(46

)

6

 

Ending Balance, September 30

 

(661

)

(509

)

Total Accumulated Other Comprehensive Loss

 

$

(661

)

$

(509

)

Note 15.  Earnings (Loss)14.  Loss Per Common Share

 

A dual presentation of basic and diluted earnings (loss) per common share is required on the face of the Company’s Consolidated Statement of Operations as well as a reconciliation of the computation of basic earnings per common share to diluted earnings per common share.  Basic earnings (loss) per common share excludes the dilutive impact of potentially dilutive securities and is computed by dividing net income (loss) by the weighted average number of common shares outstanding for the period.  Diluted earnings (loss) per common share is computed using the treasury stock method and includes the effect of potential dilution from the exercise of outstanding stock options and treats unvested restricted stock and performance-based shares as if they were vested.  Potentially dilutive securities have been excluded in the weighted average number of common shares used for the calculation of earnings per share in periods of net loss because the effect of including such securities would be anti-dilutive.  A reconciliation of the Company’s basic and diluted earnings (loss)loss per common share was as follows:

 

 

 

Three Months Ended
December 31,

 

(In thousands, except share and per share data)

 

2018

 

2017

 

 

 

 

 

 

 

Net income

 

$

12,362

 

$

14,022

 

 

 

 

 

 

 

Basic weighted average common shares outstanding

 

37,761,176

 

37,066,902

 

Effect of potentially dilutive stock options and restricted stock awards

 

1,351,371

 

1,223,456

 

Diluted weighted average common shares outstanding

 

39,112,547

 

38,290,358

 

 

 

 

 

 

 

Earnings per common share:

 

 

 

 

 

Basic

 

$

0.33

 

$

0.38

 

Diluted

 

$

0.32

 

$

0.37

 

 

Six Months Ended
December 31,

 

 

Three Months Ended
September 30,

 

(In thousands, except share and per share data)

 

2018

 

2017

 

 

2019

 

2018

 

Numerator:

 

 

 

 

 

Net loss

 

$

(12,157

)

$

(287,528

)

Interest expense applicable to the Notes, net of tax

 

 

 

Amortization of debt issuance costs applicable to the Notes, net of tax

 

 

 

Adjusted “if-converted” net loss

 

$

(12,157

)

$

(287,528

)

 

 

 

 

 

 

 

 

 

 

Net income (loss)

 

$

(275,166

)

$

27,279

 

 

 

 

 

 

Denominator:

 

 

 

 

 

Basic weighted average common shares outstanding

 

37,674,200

 

37,029,483

 

 

38,309,267

 

37,586,327

 

Effect of potentially dilutive stock options and restricted stock awards

 

 

1,058,343

 

Effect of potentially dilutive options and restricted stock awards

 

 

 

Effect of conversion of the Notes

 

 

 

Diluted weighted average common shares outstanding

 

37,674,200

 

38,087,826

 

 

38,309,267

 

37,586,327

 

 

 

 

 

 

 

 

 

 

 

Earnings (loss) per common share:

 

 

 

 

 

Loss per common share:

 

 

 

 

 

Basic

 

$

(7.30

)

$

0.74

 

 

$

(0.32

)

$

(7.65

)

Diluted

 

$

(7.30

)

$

0.72

 

 

$

(0.32

)

$

(7.65

)

 

The number of anti-dilutive shares that have been excluded in the computation of diluted earningsloss per share for the three months ended December 31,September 30, 2019 and 2018 was 2.9 million and 2017 were 540 thousand and 3.04.6 million, respectively.  The numbereffect of anti-dilutivepotentially dilutive shares that have beenwas excluded from the calculation of diluted loss per share in the computation of diluted earnings per share for the sixthree months ended December 31,September 30, 2019 and 2018 and 2017 were 2.2 million and 3.0 million, respectively.

Note 16.  Warrant

In connection withbecause the KUPI acquisition on November 25, 2015, Lannett issued to UCB Manufacturing a warrant to purchase up to a totaleffect of 2.5 million shares of Lannett’s common stock (the “Warrant”).

The Warrant had a term of three years (expiring November 25, 2018) and an exercise price of $48.90 per share, subject to customary adjustments, including for stock splits, dividends and combinations.  The Warrant also contained a “weighted average” anti-dilution adjustment provision.  The fair value included as part of the total consideration transferred to UCB at the acquisition date was $29.9 million.  The fair value assigned to the Warrant was determined using the Black-Scholes valuation model.  The Company concluded that the warrant was indexed to its own stock and therefore the Warrant was classified as an equity instrument.  On November 25, 2018, the Warrant expired and was not exercised.such securities would be anti-dilutive.

Note 17.  Share-Based15.  Share-based Compensation

 

At December 31, 2018,September 30, 2019, the Company had two share-based employee compensation plans (the 2011 Long-Term Incentive Plan “LTIP” and the 2014 “LTIP”).  Together these plans authorized an aggregate total of 4.56.5 million shares to be issued.  TheAs of September 30, 2019, the plans have a total of 615 thousand1.2 million shares available for future issuances.  On January 23, 2019, the shareholders of

Historically, the Company approved an Amendment to and Restatement of the 2014 LTIP to increase the amount of shares authorized to be issued by 2.0 million shares.

The Company issues share-based compensation awards with a vesting period ranging up to 3 years and a maximum contractual term of 10 years.  Beginning in Fiscal 2020, the Company extended the vesting period of new share-based compensation awards to 4 years.  The Company issues new shares of stock when stock options are exercised.  As of December 31, 2018,September 30, 2019, there was $14.4$15.1 million of total unrecognized compensation cost related to non-vested share-based compensation awards.  That cost is expected to be recognized over a weighted average period of 2.22.6 years.

Stock Options

 

The Company measures share-based compensation cost for options using the Black-Scholes option pricing model.  The following table presents the weighted average assumptions used to estimate fair values of the stock options granted during the sixthree months ended December 31,September 30, 2019 and 2018, the estimated annual forfeiture rates used to recognize the associated compensation expense and 2017:the weighted average fair value of the options granted:

 

 

Six Months Ended

 

 

December 31, 2018

 

December 31, 2017

 

 

September 30,
2019

 

September 30,
2018

 

Risk-free interest rate

 

2.9

%

1.9

%

 

1.9

%

2.9

%

Expected volatility

 

58.4

%

57.4

%

 

73.7

%

58.4

%

Expected dividend yield

 

%

%

 

 

 

Forfeiture rate

 

6.5

%

6.5

%

 

6.5

%

6.5

%

Expected term (in years)

 

5.3 years

 

5.4 years

 

 

5.1 years

 

5.3 years

 

Weighted average fair value

 

$

6.52

 

$

9.06

 

 

$4.04

 

$6.52

 

 

Expected volatility is based on the historical volatility of the price of our common shares during the historical period equal to the expected term of the option.  The Company uses historical information to estimate the expected term, which represents the period of time that options granted are expected to be outstanding.  The risk-free rate for the period equal to the expected life of the option is based on the U.S. Treasury yield curve in effect at the time of grant. The forfeiture rate assumption is the estimated annual rate at which unvested awards are expected to be forfeited during the vesting period.  This assumption is based on our actual forfeiture rate on historical awards.  Periodically, management will assess whether it is necessary to adjust the estimated rate to reflect changes in actual forfeitures or changes in expectations.  Additionally, the expected dividend yield is equal to zero, as the Company has not historically issued and has no immediate plans to issue, a dividend.

 

A stock option roll-forwardsummary as of December 31, 2018September 30, 2019 and changes during the sixthree months then ended, is presented below:

 

(In thousands, except for weighted average price and life data)

 

Awards

 

Weighted-
Average
Exercise
Price

 

Aggregate
Intrinsic
Value

 

Weighted
Average
Remaining
Contractual
Life (yrs.)

 

 

 

 

 

 

 

 

 

 

 

Outstanding at June 30, 2018

 

1,057

 

$

22.46

 

$

2,584

 

5.4

 

Granted

 

73

 

$

12.20

 

 

 

 

 

Exercised

 

(32

)

$

4.39

 

$

141

 

 

 

Forfeited, expired or repurchased

 

(336

)

$

34.95

 

 

 

 

 

Outstanding at December 31, 2018

 

762

 

$

16.71

 

$

170

 

5.2

 

 

 

 

 

 

 

 

 

 

 

Vested and expected to vest at December 31, 2018

 

752

 

$

16.74

 

$

170

 

5.1

 

Exercisable at December 31, 2018

 

648

 

$

16.84

 

$

170

 

4.4

 

 

 

 

 

 

 

 

 

Weighted

 

 

 

 

 

Weighted-

 

 

 

Average

 

 

 

 

 

Average

 

Aggregate

 

Remaining

 

 

 

 

 

Exercise

 

Intrinsic

 

Contractual

 

(In thousands, except for weighted average price and life data)

 

Awards

 

Price

 

Value

 

Life (yrs.)

 

Outstanding at June 30, 2019

 

572

 

$

17.56

 

$

273

 

5.0

 

Granted

 

522

 

$

6.57

 

 

 

 

 

Exercised

 

(9

)

$

9.76

 

$

35

 

 

 

Forfeited, expired or repurchased

 

(9

)

$

27.63

 

 

 

 

 

Outstanding at September 30, 2019

 

1,076

 

$

12.21

 

$

3,488

 

7.2

 

 

 

 

 

 

 

 

 

 

 

Vested and expected to vest at September 30, 2019

 

1,073

 

$

12.20

 

$

3,488

 

7.2

 

Exercisable at September 30, 2019

 

569

 

$

16.18

 

$

1,425

 

5.1

 

Restricted Stock

 

The Company measures restricted stock compensation costs based on the stock price at the grant date less an estimate for expected forfeitures.  The annual forfeiture rate used to calculate compensation expense was 6.5% for the sixthree months ended December 31, 2018September 30, 2019 and 2017.2018.

 

A summary of restricted stock awards as of December 31, 2018September 30, 2019 and changes during the sixthree months then ended, is presented below:

 

(In thousands, except for weighted average price and life data)

 

Awards

 

Weighted
Average Grant -
date Fair Value

 

Aggregate
Intrinsic Value

 

 

 

 

 

 

 

 

 

Non-vested at June 30, 2018

 

704

 

$

20.06

 

 

 

Granted

 

1,170

 

$

9.91

 

 

 

Vested

 

(383

)

$

20.12

 

$

3,732

 

Forfeited

 

(94

)

$

14.33

 

 

 

Non-vested at December 31, 2018

 

1,397

 

$

11.93

 

 

 

(In thousands, except for weighted average price data)

 

Awards

 

Weighted
Average Grant -
date Fair Value

 

Aggregate
Intrinsic Value

 

Non-vested at June 30, 2019

 

1,288

 

$

11.63

 

 

 

Granted

 

936

 

6.44

 

 

 

Vested

 

(575

)

10.82

 

$

4,634

 

Forfeited

 

(29

)

14.09

 

 

 

Non-vested at September 30, 2019

 

1,620

 

$

8.88

 

 

 

Performance-Based Shares

 

OnIn September 22, 2017, and July 30, 2018, the Company approved and grantedbegan granting performance-based awards to certain key executives.  The stock-settled awards will cliff vest based on relative Total Shareholder Return (“TSR”) over a three-year period.  The Company measures share-based compensation cost for TSR awards using a Monte-Carlo simulation model.

 

A summary of performance-based share awards as of December 31, 2018September 30, 2019 and changes during the current fiscal year, is presented below:

 

(In thousands, except for weighted average price and life data)

 

Awards

 

Weighted
Average Grant -
date Fair Value

 

Aggregate
Intrinsic Value

 

 

Awards

 

Weighted
Average Grant -
date Fair Value

 

Aggregate
Intrinsic Value

 

 

 

 

 

 

 

 

Non-vested at June 30, 2018

 

20

 

$

25.58

 

 

 

Non-vested at June 30, 2019

 

72

 

$

19.92

 

 

 

Granted

 

52

 

$

17.69

 

 

 

 

178

 

$

10.71

 

 

 

Vested

 

 

$

 

$

 

 

(46

)

$

15.08

 

$

477

 

Forfeited

 

 

$

 

 

 

 

 

$

 

 

 

Non-vested at December 31, 2018

 

72

 

$

19.92

 

 

 

Non-vested at September 30, 2019

 

204

 

$

12.99

 

 

 

 

Employee Stock Purchase Plan

 

In February 2003, the Company’s stockholders approved an Employee Stock Purchase Plan (“ESPP”).  Employees eligible to participate in the ESPP may purchase shares of the Company’s stock at 85% of the lower of the fair market value of the common stock on the first day of the calendar quarter, or the last day of the calendar quarter.  Under the ESPP, employees can authorize the Company to withhold up to 10% of their compensation during any quarterly offering period, subject to certain limitations.  The ESPP was implemented on April 1, 2003 and is qualified under Section 423 of the Internal Revenue Code.  The Board of Directors authorized an aggregate total of 1.1 million shares of the Company’s common stock for issuance under the ESPP.  During the sixthree months ended December 31,September 30, 2019 and 2018, and 2017, 9529 thousand shares and 2850 thousand shares were issued under the ESPP, respectively.  As of December 31, 2018, 702September 30, 2019, 821 thousand total cumulative shares have been issued under the ESPP.

 

The following table presents the allocation of share-based compensation costs recognized in the Consolidated Statements of Operations by financial statement line item:

 

 

 

Three Months Ended

 

Six Months Ended

 

 

 

December 31,

 

December 31,

 

(In thousands)

 

2018

 

2017

 

2018

 

2017

 

Selling, general and administrative expenses

 

$

1,095

 

$

1,926

 

$

3,309

 

$

3,713

 

Research and development expenses

 

199

 

176

 

400

 

327

 

Cost of sales

 

655

 

461

 

1,276

 

712

 

Total

 

$

1,949

 

$

2,563

 

$

4,985

 

$

4,752

 

 

 

 

 

 

 

 

 

 

 

Tax benefit at statutory rate

 

$

439

 

$

756

 

$

1,122

 

$

1,402

 

 

 

Three Months Ended
September 30,

 

(In thousands)

 

2019

 

2018

 

Selling, general and administrative

 

$

3,635

 

$

2,213

 

Research and development

 

224

 

201

 

Cost of sales

 

600

 

621

 

Total

 

$

4,459

 

$

3,035

 

 

 

 

 

 

 

Tax benefit at statutory rate

 

$

1,003

 

$

683

 

Note 18.16.  Employee Benefit Plan

 

The Company has a 401k defined contribution plan (the “Plan”) covering substantially all employees.  Pursuant to the Plan provisions, the Company is required to make matching contributions equal to 50% of each employee’s contribution, not to exceed 4% of the employee’s compensation for the Plan year.year.  Contributions to the Plan during the three months ended December 31,September 30, 2019 and 2018 and 2017 were $445 thousand and $458 thousand, respectively.  Contributions to the Plan during the six months ended December 31, 2018 and 2017 were $1.1 million and $1.0 million, respectively.was $0.6 million.

Note 19.17.  Income Taxes

 

The Company uses the liability method to account for income taxes.  Deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities as measured by the enacted tax rates which will be in effect when these differences reverse.  Deferred tax expense (benefit) is the result of changes in deferred tax assets and liabilities.

 

The federal, state and local income tax expense for the three months ended December 31, 2018September 30, 2019 was $2.6$1.8 million compared to $18.1an income tax benefit of $75.6 million for the three months ended December 31, 2017.September 30, 2018.  The effective tax rates for the three months ended December 31,September 30, 2019 and 2018 were (17.2)% and 2017 were 17.6% and 56.4%20.8%, respectively.  The effective tax rate for the three months ended December 31, 2018September 30, 2019 was lower compared to the three months ended December 31, 2017September 30, 2018 primarily due to research and development credits relative to expected pre-tax income, partially offset by the applicationimpact of 2017 Tax Reform in the prior-year period, which resulted in a revaluation of the Company’s net long term deferredexcess tax assets.  In addition, the federal statutory tax rate for the three months ended December 31, 2018 was 21% comparedshortfalls related to a blended federal statutory tax rate of 28% in the prior-year period.

The federal, state and local income tax benefit for the six months ended December 31, 2018 was $73.0 million compared to income tax expense of $25.6 million for the six months ended December 31, 2017.  The effective tax rates for the six months ended December 31, 2018 and 2017 were 21.0% and 48.4%, respectively.  The effective tax rate for the six months ended December 31, 2018 was lower compared to the six months ended December 31, 2017 primarily due to the application of 2017 Tax Reform in the prior-year period, which resulted in a revaluation of the Company’s net long term deferred tax assets.  In addition, the federal statutory tax rate for the six months ended December 31, 2018 was 21% compared to a blended federal statutory tax rate of 28% in the prior-year period.stock compensation.

 

The Company may recognize the tax benefit from an uncertain tax position claimed on a tax return only if it is more likely than not that the tax position will be sustained on examination by the taxing authorities, based on the technical merits of the position.  The tax benefits recognized in the financial statements from such a position should be measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate settlement.

 

As of December 31, 2018September 30, 2019 and June 30, 2018, 2019, the Company has total unrecognized tax benefits of $2.4 million and $2.2 million, respectively, of which $2.2 million and 2.5$2.1 million respectively, which would impact the Company’s effective tax rate, respectively, if recognized.  As a result of the positions taken during the period, the Company has not recorded any interest and penalties for the period ended December 31, 2018September 30, 2019 in the statement of operations and no cumulative interest and penalties have been recorded either in the Company’s statement of financial position as of December 31, 2018September 30, 2019 and June 30, 2018.2019.  The Company will recognize interest accrued on unrecognized tax benefits in interest expense and any related penalties in operating expenses.

As of December 31, 2018 and June 30, 2018, the Company had net long term deferred tax assets of $100.0 million and $22.1 million, respectively.  The significant increase was primarily a result of the goodwill impairment charge recorded in the first quarter of Fiscal 2019, which negatively impacted book income, but is excluded from the calculation of taxable income.

 

The Company files income tax returns in the United States federal jurisdiction and various states.  The Company’s tax returns for Fiscal Year 2014 and prior generally are no longer subject to review as such years generally are closed.  The Company’s Fiscal Year 2016 federal return is currently under examination by the Internal Revenue Service (“IRS”).  The Company cannot reasonably predict the outcome of the examination at this time.  In July 2018, the Company was notified that the IRS will also expand their examination to include the Company’s Fiscal 2015 and Fiscal 2017 federal returns.  In October 2018, the Company was notified that the StateCommonwealth of Pennsylvania will conduct a routine field audit of the Company’s Fiscal 2016 and Fiscal 2017 corporate tax returns.

 

Note 20.18.  Related Party Transactions

 

The Company had sales of $1.0$0.7 million and $1.2$0.5 million during the three months ended December 31,September 30, 2019 and 2018, and 2017, respectively, to a generic distributor, Auburn Pharmaceutical Company (“Auburn”), which is a member of the Premier Buying Group.  Sales to Auburn for the six months ended December 31, 2018 and 2017 were $1.5 million and $2.0 million, respectively.  Jeffrey Farber, a current board member, is the owner of Auburn.  Accounts receivable includes amounts due from Auburn of $849 thousand$0.6 million and $585 thousand$1.2 million at December 31, 2018September 30, 2019 and June 30, 2018,2019, respectively.

The Company also had sales of $920 thousand$0.7 million and $516 thousand$0.5 million during the three months ended December 31,September 30, 2019 and 2018, and 2017, respectively, to a generic distributor, KeySource, which is a member of the OptiSource Buying Group.Sales to KeySource for the six months ended December 31, 2018 and 2017 were $1.5 million and $983 thousand, respectively.  Albert Paonessa, a current board member, was appointed the CEO of KeySource in May 2017.  Accounts receivable includes amounts due from KeySource of $605 thousand$0.6 million and $514 thousand$0.7 million as of December 31, 2018September 30, 2019 and June 30, 2018,2019, respectively.

The Company incurred expenses totaling $188 thousand and $369 thousand during the three and six months ended December 31, 2018, respectively, for online medical benefit services provided by a subsidiary of a variable interest entity.  See Note 13 “Commitments” for more information.  Accounts payable includes amounts due to the variable interest entity of $58 thousand as of June 30, 2018.  There were no amounts due to the variable interest entity as of December 31, 2018.

Note 21.  Material Contracts with Suppliers

Jerome Stevens Pharmaceuticals Distribution Agreement:

The Company’s primary finished goods inventory supplier is JSP, in Bohemia, New York.  Purchases of finished goods inventory from JSP accounted for approximately 34% and 39% of the Company’s inventory purchases in the three months ended December 31, 2018 and 2017, respectively.  Purchases of finished goods inventory from JSP accounted for approximately 33% and 36% of the Company’s inventory purchases in the six months ended December 31, 2018 and 2017, respectively.

On August 19, 2013, the Company entered into an agreement with JSP to extend its initial contract to continue as the exclusive distributor in the United States of three JSP products: Butalbital, Aspirin, Caffeine with Codeine Phosphate Capsules USP; Digoxin Tablets USP; and Levothyroxine Sodium Tablets USP.  The amendment to the original agreement extends the initial contract, which was due to expire on March 22, 2014, for five years through March 2019.  In connection with the amendment, the Company issued a total of 1.5 million shares of the Company’s common stock to JSP and JSP’s designees.  In accordance with its policy related to renewal and extension costs for recognized intangible assets, the Company recorded a $20.1 million expense in cost of sales, which represents the fair value of the shares on August 19, 2013.  On August 20, 2018, the Company announced that the JSP Distribution Agreement, which expires on March 23, 2019, will not be renewed or extended.

 

Note 22.19.  Assets Held for Sale

 

In the first quarter of Fiscal 2019, the Company approved a plan to sell the Cody API business, which includes the manufacturing and distribution of active pharmaceutical ingredients for use in finished goods production.  As such, all assets and liabilities associated with the Cody API business are recorded in the assets and liabilities held for sale captions in the Consolidated Balance Sheet as of December 31, 2018.  As parta result of the held for sale classification,plan, the Company recorded the assets of the Cody API business at fair value less costs to sell.  The Company performed a fair value analysis which resulted in a $29.9 million impairment of the Cody Labs’ long-lived assets.assets in the first quarter of Fiscal 2019.

 

The following table summarizes the assets and liabilities ofCompany was unable to sell the Cody API business as an ongoing operation and intended to sell the equipment utilized by the Cody API business as well as the real estate upon receiving approval of December 31, 2018:the Company’s cocaine hydrochloride solution Section 505(b)(2) NDA application and to have Cody Labs cease all operations.  In the first quarter of Fiscal 2020, the Company completed the sale of a portion of the equipment associated with the Cody API business for $2.0 million.  As of September 30, 2019, the real estate and remaining equipment associated with the Cody API business, totaling $4.6 million, was recorded in the assets held for sale caption in the Consolidated Balance Sheet.

(In thousands)

 

December 31,
2018

 

Assets

 

 

 

Inventories

 

$

3,351

 

Other current assets

 

355

 

Property, plant and equipment

 

6,736

 

Intangible assets, net

 

176

 

Other assets

 

804

 

Total assets held for sale

 

$

11,422

 

Liabilities

 

 

 

Accounts payable

 

$

291

 

Accrued expenses

 

138

 

Accrued payroll and payroll-related expenses

 

775

 

Total liabilities held for sale

 

$

1,204

 

The following table summarizes the financial results of the Cody API business for the three and six months ended December 31, 2018September 30, 2019 and 2017:2018:

 

 

Three Months Ended

 

Six Months Ended

 

 

December 31,

 

December 31,

 

 

For the Three Months Ended

 

For the Three Months Ended

 

(In thousands)

 

2018

 

2017

 

2018

 

2017

 

 

September 30, 2019

 

September 30, 2018

 

Net sales

 

$

654

 

$

387

 

$

2,142

 

$

1,086

 

 

$

1,067

 

$

1,488

 

Pretax loss attributable to Cody API business

 

(4,314

)

(4,468

)

(39,335

)

(9,957

)

 

$

(4,417

)

$

(35,021

)

 

The pretax loss attributable to the Cody API business during the sixthree months ended December 31,September 30, 2019 includes a full impairment of the ROU lease asset, totaling $1.2 million, that was recorded upon adoption of ASU No. 2016-02 on July 1, 2019.

The pretax loss attributable to the Cody API business during the three months ended September 30, 2018 includes theimpairment charges totaling $29.9 million impairment charge to adjust the long-lived assets to its fair value less costs to sell.

Note 23. Amneal Distribution and Transition Support Agreement

On November 9, 2018, the Company entered into the Amneal Agreement, pursuant to which Amneal will be the Company’s sole customer for Levothyroxine Sodium Tablets USP (the “Product”) from December 1, 2018 through March 23, 2019 and Amneal will re-sell the Product to its customers.  Pursuant to the terms of the Agreement, the Company will receive an upfront payment of $50 million, which will guarantee the Company at least $50 million of gross profit on approximately $80 million of net sales of the Product during the term of the Agreement, subject to certain adjustments.  The Company will continue to distribute Butalbital, Aspirin, Caffeine with Codeine Phosphate Capsules USP and Digoxin Tablets USP pursuant to its distribution agreement with JSP through March 23, 2019.  Upon the effective date of the agreement on December 1, 2018, the Company received an upfront payment of $43.0 million, which was recorded as deferred revenue in the Consolidated Balance Sheet, with the remaining $7.0 million to be received on February 1, 2019.  As of December 31, 2018, based on Product sold to Amneal under the agreement, the remaining deferred revenue balance is $24.0 million.

ITEM 2.                                                MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

Cautionary Statement About Forward-Looking Statements

 

This Report on Form 10-Q and certain information incorporated herein by reference contains forward-looking statements which are not historical facts made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995.  Forward-looking statements are not promises or guarantees and investors are cautioned that all forward-looking statements involve risks and uncertainties, including but not limited to the impact of competitive products and pricing, product demand and market acceptance, new product development, acquisition-related challenges, the regulatory environment, interest rate fluctuations, reliance on key strategic alliances, availability of raw materials, fluctuations in operating results and other risks detailed from time to time in our filings with the Securities and Exchange Commission (the “SEC”). These statements are based on management’s current expectations and are naturally subject to uncertainty and changes in circumstances.  We caution you not to place undue reliance upon any such forward-looking statements which speak only as of the date made.  Lannett is under no obligation to, and expressly disclaims any such obligation to, update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.

 

The following information should be read in conjunction with the consolidated financial statements and notes in Part I, Item 1 of this Quarterly Report and with Management’s Discussion and Analysis of Financial Condition and Results of Operations contained in the Company’s Annual Report on Form 10-K for the fiscal year ended June 30, 2018.2019.  All references to “Fiscal 2020” or “Fiscal Year 2020” shall mean the fiscal year ended June 30, 2020 and all references to “Fiscal 2019” or “Fiscal Year 2019” shall mean the fiscal year ending June 30, 2019 and all references to “Fiscal 2018” or “Fiscal Year 2018” shall mean the fiscal year ended June 30, 2018.2019.

 

Company Overview

 

Lannett Company, Inc. (a Delaware corporation) and its subsidiaries (collectively, the “Company”, “Lannett”, “we” or “us”) primarily develop, manufacture, package, market and distribute solid oral and extended release (tablets and capsules), topical, liquids, nasal and oral solution finished dosage forms of drugs, generic forms of both small molecule and biologic medications, that address a wide range of therapeutic areas.  Certain of these products are manufactured by others and distributed by the Company.  Additionally, the Company is pursuing partnerships, research contracts and internal expansion for the development and production of other dosage forms including: ophthalmic, nasal, patch, foam, buccal, sublingual, suspensions, soft gel, injectable and oral dosages.

 

On November 25, 2015, the Company completed the acquisition of Kremers Urban Pharmaceutical, Inc. (“KUPI”), the former subsidiary of global biopharmaceuticals company UCB S.A.  KUPI is a specialty pharmaceuticals manufacturer focused on the development of products that are difficult to formulate or utilize specialized delivery technologies.  Strategic benefits of the acquisition include expanded manufacturing capacity, a diversified product portfolio and pipeline and complementary research and development expertise.

The Company operates pharmaceutical manufacturing plants in Philadelphia, Pennsylvania; Cody, Wyoming; Carmel, New York and Seymour, Indiana.  The Company’s customers include generic pharmaceutical distributors, drug wholesalers, chain drug stores, private label distributors, mail-order pharmacies, other pharmaceutical manufacturers, managed care organizations, hospital buying groups, governmental entities and health maintenance organizations.  In the second quarter of Fiscal 2019, the Company ceased manufacturing functions at its State Road facility in Philadelphia, Pennsylvania.  The Company discontinued distribution from its Townsend Road facility in Philadelphia, Pennsylvania as of January 31, 2019.  The Company intends to sell its Townsend Road facility by the end of Fiscal 2019.

 

JSP Distribution Agreement

 

On March 23, 2004, the Company entered into an agreement with JSP (the “JSP Distribution Agreement”) for the exclusive distribution rights in the United States to four different JSP products, in exchange for 4.0 million shares of the Company’s common stock.  On August 19, 2013, the Company entered into an agreement with JSP to extend the JSP Distribution Agreement to continue as the exclusive distributor in the United States of three JSP products: Butalbital, Aspirin, Caffeine with Codeine Phosphate Capsules USP; Digoxin Tablets USP; and Levothyroxine Sodium Tablets USP.  The amendment to the JSP Distribution Agreement extended the term of the initial contract, which was due to expire on March 22, 2014, for five years through March 23, 2019.

In connection with the amendment,August 2018, JSP notified the Company issuedthat it would not extend or renew the JSP Distribution Agreement. The Company determined that JSP’s decision represented a totaltriggering event under U.S. GAAP to perform an analysis to determine the potential for impairment of 1.5goodwill.  In October 2018, the Company completed the analysis based on market data and concluded that it would record a full impairment of goodwill totaling $339.6 million shares ofin Fiscal 2019.  On March 23, 2019, the Company’s common stock to JSP Distribution Agreement expired and JSP’s designees.was not renewed or extended.

 

Net sales of JSP products totaled $253.1 million and $144.9$202.5 million in Fiscal Year 2018 and the first six months of Fiscal Year 2019, respectively.2019.  Of that amount, Levothyroxine Sodium Tablets USP net sales totaled $245.9 million and $142.4$197.5 million in Fiscal Year 2018 and the first six months2019, with gross margins of Fiscal Year 2019, respectively.  Gross margins were approximately 60% in both periods.

After the close of business on August 17, 2018, JSP notified the Company that it will not extend or renew the JSP Distribution Agreement when the current term expires on March 23, 2019..

 

Because products covered by the JSP Distribution Agreement generategenerated a significant portion of our revenues and gross profits, JSP’s decision not to renew or extend its distribution agreement with us have and will materially adversely affect our future operating results and cash flows beginning in the fourth quarter of Fiscal 2019.flows.  When announced on August 20, 2018, this resulted in a significant decline in the Company’s market capitalization.

As noted above, JSP’s decision not to renew or extend its distribution agreement with us have and will materially adversely affect our future operating results, liquidity and cash flows, which could impact our ability to comply with the financial and other covenants in our Amended Senior Secured Credit Facility.  As of December 31, 2018, the Company was in compliance with its financial covenants.  As of December 31, 2018, cash and cash equivalents totaled $163.8 million in addition to availability under our undrawn Revolver totaling $125.0 million.

On December 10, 2018, the Company entered into an amendment to the Senior Secured Credit Facility and the Credit and Guaranty Agreement.  Pursuant to the amendment, the Secured Net Leverage Ratio applicable to the financial leverage ratio covenant was increased from 3:25:3.25:1.00 to 4.25:1.00 as of December 31, 2019 and prior to September 30, 2020, and then to 4:00:4.00:1:00 as of September 30, 2020.  The Amended Senior Secured Credit Facility is also subject to a minimum liquidity covenant, which provides that the Company shall not permit its liquidity as of the last day of any fiscal quarter to be less than $75.0 million.  On September 27, 2019, the Company issued $86,250,000 aggregate principal amount of its 4.50% convertible senior notes due 2026 (the “Notes”) and used the net proceeds to repay a portion of the outstanding Term Loan A balance.  The Notes are senior unsecured obligations of the Company and therefore are not included within the calculation of the Secured Net Leverage Ratio under the existing Amended Senior Secured Credit Facility.  As of September 30, 2019, the Company was in compliance with its financial covenants.  As of September 30, 2019, cash and cash equivalents totaled $101.0 million in addition to availability under our undrawn Revolver totaling $125.0 million.

 

Based on its projections over the next twelve months, the Company expects to have sufficient liquidity and cashflows to meet its operating and debt service requirements for at least the next twelve months from the issuance of the December 31, 2018September 30, 2019 consolidated financial statements.  The Company also expects to be in compliance with its financial covenants during the same period.

 

Although management cannot predict with certainty the precise impact its plans will have on offsetting the loss of the JSP Distribution Agreement, management is continuing to finalizeexecute on plans to offset the impact of the loss on a short- and long-term basis.  These plans currently include, among other things, an emphasis on reducing cost of sales, research and development (“R&D”) and selling, general and administrative (“SG&A”) expenses; continuing to accelerate new product launches; increasing the level of strategic partnerships; and reducing capital expenditures.  To that end, the Company has already launched more than 1528 new products since January 2018, which are expected to generate annualized net sales of over $80$100 million, and expectsplans to maintain this pace with approximately 10 additional launches in the first half of calendar year 2019, two of which have already launched in January 2019.going forward.  The Company has also recently signed several distribution and in-licensing agreements during this fiscal year that will provide both immediate and longer-term contribution margins in the near future.margins.  Additionally, the Company continues to supplementhas supplemented existing in-process cost reduction plans with additional cost savings initiatives, which is expected to generate annualized cost savings of approximately $66.0 million by the end of Fiscal 2020 when compared to the Fiscal 2018 expenses, of which approximately half will be reinvested into other business growth opportunities.  Management will also continue its emphasis on accelerating ANDA filings, as evidenced by the five ANDAs filed with the FDA in the first half of Fiscal 2019.  Management also plans to attempt, at the appropriate time, to continue to refinance a significant portion of its outstanding long-term debt to reduce principal repayment requirements and eliminate existing financial covenants, which we expect will increase related interest expense, but will positively impact short-term cash flows.

 

Amneal Distribution and Transition Support AgreementCody API Restructuring Plan

 

On November 9, 2018, the Company entered into a Distribution and Transition Support Agreement (the “Amneal Agreement”) with Amneal Pharmaceuticals, Inc. (“Amneal”) and JSP, pursuant to which Amneal will be the Company’s sole customer for Levothyroxine Sodium Tablets USP (the “Product”) from December 1, 2018 through March 23,June 11, 2019, and Amneal will re-sell the Product to its customers.  Pursuant to the terms of the Agreement, the Company will receive an upfront payment of $50 million, which will guarantee the Company at least $50 million of gross profit on approximately $80 million of net sales of the Product during the term of the Agreement, subject to certain adjustments.  The Company will continue to distribute Butalbital, Aspirin, Caffeine with Codeine Phosphate Capsules USP and Digoxin Tablets USP pursuant to its distribution agreement with JSP through March 23, 2019.

Sale of Cody API Business

The Company is analyzing and exploring various financing and operational courses to improve the Company’s base business, including a focus on nearer term opportunities and an overall strategic shift toward the Company’s core competencies and optimization of its cost structure.  In connection therewith, the Company approved a restructuring plan in(the “Cody API Restructuring Plan”) with respect to Cody Labs.  In September 2018, the Company approved a plan to sell the active pharmaceutical ingredient manufacturing and distribution business of its Cody Laboratories subsidiaryLabs (the “Cody API business”).  As part of its decision, but the Company considered (i) the Cody API business’s timeline to profitability, (ii) continuing investment needed to be competitive and (iii) the reduction to the Company’s operating expenses, estimated to be approximately $18 million on an annualized basis, that would result from a sale of the Cody API business.  Excluded from the sale will be the manufacturing of the finished dosage form of the Company’s Cocaine Hydrochloride product line.

As a result of the decisionwas unable to sell the Cody API business allas an ongoing operation.  Therefore, the Company intends to sell the real estate utilized by the Cody API business upon receiving approval of the assets, excludingCompany’s cocaine hydrochloride solution Section 505(b)(2) NDA application and to have Cody Labs cease all operations.  In connection with the Cocaine Hydrochloride product line mentioned above, and allCody API Restructuring Plan, there has been a reduction of almost 70 positions at Cody Labs.  The restructuring activities under the Cody API Restructuring Plan are substantially complete as of September 30, 2019.  In the first quarter of Fiscal 2020, the Company completed the sale of a portion of the liabilitiesequipment associated with the Cody API business are classified as assets and liabilities held for sale on the Company’s Consolidated Balance Sheet as of December 31, 2018, with such assets and liabilities recorded at fair value less costs to sell.  As a result of a fair value analysis of the Cody API business, the Company recorded an impairment charge of $29.9 million in the first quarter of Fiscal 2019.$2.0 million.

 

Cody Restructuring Plan

On June 29, 2018, the Company announced a restructuring plan related to the future of Cody Laboratories, Inc. and the Company’s operations (the “Cody Restructuring Plan”).  The plan focuses on a more select set of opportunities which will result in streamlined operations, improved efficiencies and a reduced cost structure.  The Company currently estimates that it will incur approximately $4.5 million of total costs to implement the Cody API Restructuring Plan comprised primarily oftotal approximately $3.0$6.0 million, including approximately $3.5 million of severance and employee-related costs.  These amounts are preliminary estimates based on the information currently availablecosts and approximately $2.0 million of contract termination costs, as well as approximately $0.5 million of costs to management. It is possiblebe incurred in connection with moving equipment and other property to other Company-owned facilities that additional charges and future cash payments could occur in relationwere originally anticipated to the restructuring actions.

2016 Restructuring Plan

On February 1, 2016,be incurred in connection with the acquisition of KUPI, the CompanyCody Restructuring Plan announced a plan related to the future integration of KUPI and the Company’s operations (the “2016 Restructuring Program”). The plan focuses on the closure of KUPI’s corporate functions and the consolidation of manufacturing, sales, research and development and distribution functions. The Company estimates that it will incur an aggregate of up to approximately $20.0 million in restructuring charges for actions that have been announced or communicated since the 2016 Restructuring Program began.  Of this amount, approximately $11.0 million relates to employee separation costs, approximately $1.0 million relates to contract termination costs and approximately $8.0 million relates to facility closures costs and other actions.  In the second quarter of Fiscal 2019, the Company ceased manufacturing functions at its State Road facility in Philadelphia, Pennsylvania.  The Company discontinued distribution from its Townsend Road facility in Philadelphia, Pennsylvania as of January 31, 2019.  The Company intends to sell its Townsend Road facility by the end of Fiscal 2019.June 2018.

 

Financial Summary

 

For the secondfirst quarter of Fiscal Year 2019,2020, net sales increaseddecreased to $193.7$127.3 million as compared to $184.3$155.1 million in the same prior-year period.  Gross profit decreased to $69.8$42.7 million compared to $87.5$59.1 million in the prior-year period and gross profit percentage decreased to 36%33% compared to 47%38% in the prior-year period.  R&D expenses decreased 9% to $9.7$8.9 million compared to $10.7$9.8 million in the second quarter of Fiscal Year 2018 while SG&A expenses decreased 19% to $23.2 million from $28.5 million in the prior-year period.  Restructuring expenses decreased to $213 thousand from $1.0 million in the prior-year period.  Operating income for the secondfirst quarter of Fiscal Year 2019 was $36.7while SG&A expenses increased 3% to $21.3 million comparedfrom $20.6 million.  Restructuring expenses increased to $47.1$1.4 million infrom $1.0 million.  Operating income for the secondfirst quarter of Fiscal Year 2018.  Net income for2020, which included asset impairment charges totaling $1.6 million, was $9.4 million compared to operating loss of $341.8 million in the secondfirst quarter of Fiscal Year 2019, which included asset impairment charges totaling $369.5 million.  Net loss for the first quarter of Fiscal Year 2020 was $12.4$12.2 million, or $0.32 per diluted share compared to $14.0net loss of $287.5 million or $0.37$7.65 per diluted share in the secondfirst quarter of Fiscal Year 2018.

For the first six months of Fiscal 2019, net sales increased to $348.8 million compared to $339.3 million in the same prior-year period.  Gross profit decreased to $129.0 million compared to $155.1 million in the prior-year period.  Gross profit percentage decreased to 37% compared to 46% in the prior-year period.  R&D expenses increased 8% to $19.5 million compared to $18.1 million in the first six months of Fiscal 2018 while SG&A expenses decreased 8% to $43.8 million from $47.5 million in the prior-year period.  Restructuring expenses decreased to $1.2 million from $1.6 million in the prior-year period.  Operating loss for the first six months of Fiscal 2019, which included asset impairment charges totaling $369.5 million was $305.1 million compared to operating income of $87.8 million in the prior-year period.  Net loss for the first six months of Fiscal 2019 was $275.2 million, or $7.30 per diluted share compared to net income of $27.3 million, or $0.72 per diluted share in the prior-year period.2019.

A more detailed discussion of the Company’s financial results can be found below.

 

Results of Operations - Three months ended December 31, 2018September 30, 2019 compared with the three months ended December 31, 2017September 30, 2018

 

Net sales increased 5%decreased to $193.7$127.3 million for the three months ended December 31, 2018.September 30, 2019.  The following table below identifies the Company’s net product sales by medical indication for the three months ended December 31,September 30, 2019 and 2018.  The medical indication categories for the three months ended September 30, 2018 was reclassified to better align with industry standards and 2017:the Company’s peers.

 

(In thousands)

 

Three Months Ended December 31,

 

 

Three Months Ended September 30,

 

Medical Indication

 

2018

 

2017

 

 

2019

 

2018

 

Antibiotic

 

$

4,187

 

$

3,552

 

Analgesic

 

$

1,884

 

$

1,829

 

Anti-Psychosis

 

14,036

 

22,799

 

 

28,034

 

10,889

 

Cardiovascular

 

25,680

 

10,135

 

 

21,606

 

21,770

 

Central Nervous System

 

6,187

 

6,925

 

 

19,257

 

14,286

 

Gallstone

 

2,489

 

5,282

 

Endocrinology

 

 

53,878

 

Gastrointestinal

 

10,009

 

15,055

 

 

16,962

 

17,594

 

Glaucoma

 

512

 

2,164

 

Infectious Disease

 

11,895

 

4,480

 

Migraine

 

12,551

 

15,484

 

 

9,143

 

9,737

 

Muscle Relaxant

 

3,121

 

3,219

 

Pain Management

 

8,968

 

6,128

 

Respiratory

 

1,163

 

2,230

 

Thyroid Deficiency

 

88,477

 

68,794

 

Respiratory/Allergy/Cough/Cold

 

2,707

 

3,584

 

Urinary

 

1,606

 

2,840

 

 

435

 

1,541

 

Other

 

6,827

 

13,105

 

 

9,861

 

10,805

 

Contract manufacturing revenue

 

7,905

 

6,593

 

 

5,558

 

4,661

 

Net sales

 

$

193,718

 

$

184,305

 

Total

 

$

127,342

 

$

155,054

 

 

The increasedecrease in net sales was driven by increaseddecreased volumes of $39.8$19.9 million partially offset byand, to a lesser extent, decreased average selling price of products of $30.4$7.8 million.  Volumes were favorably impactedOverall volumes decreased primarily due to increased salesthe loss of Levothyroxine as customer demand increased in anticipationsales associated with the expiration of the transition of the Product.  Additional salesJSP Distribution Agreement, partially offset by additional volumes from product launches and increased market share in the Cardiovascular medical indication related to a distribution agreement entered into with Aralez in November 2017 also contributed to increased volumes.  On August 10, 2018, Aralez filed a Chapter 11 petition in the United States Bankruptcy Court for the Southern District of New York and continues to operate its business in the normal course.  The Company does not believe this will materially affect our distribution agreement with Aralez.  Average selling prices were negatively impacted by price protection and stock-shelf adjustments in the second quarter of Fiscal 2019 as a result of anticipated price increases and decreases, respectively, on certain key products.  Average selling prices were also impacted by product mix changes within distribution channelsand price decreases in certain key products and, to a lesser extent, competitive pricing pressures.  Although the Company has benefited in the past from favorable pricing trends, these trends have reversed.

 

In January 2017, a provision in the Bipartisan Budget Act of 2015 required drug manufacturers to pay additional rebates to state Medicaid programs if the prices of their generic drugs rise at a rate faster than inflation.  The provision negatively impacted the Company’s net sales by $7.1$10.4 million during the three months ended December 31,September 30, 2019 and $7.9 million during the three months ended September 30, 2018, and 2017, respectively.which contributed to the overall decreased average selling price.

 

The following chart details price and volume changes by medical indication:

 

Medical indication

 

Sales volume
change %

 

Sales price
change %

 

 

Sales volume
change %

 

Sales price
change %

 

Antibiotic

 

30

%

(12

)%

Analgesic

 

143

%

(140

)%

Anti-Psychosis

 

(15

)%

(23

)%

 

130

%

28

%

Cardiovascular

 

133

%

20

%

 

(28

)%

27

%

Central Nervous System

 

(3

)%

(8

)%

 

63

%

(28

)%

Gallstone

 

8

%

(61

)%

Endocrinology

 

(100

)%

%

Gastrointestinal

 

(3

)%

(31

)%

 

(2

)%

(1

)%

Glaucoma

 

(58

)%

(18

)%

Infectious Disease

 

197

%

(31

)%

Migraine

 

(7

)%

(12

)%

 

17

%

(23

)%

Muscle Relaxant

 

13

%

(16

)%

Pain Management

 

62

%

(16

)%

Respiratory

 

(47

)%

(1

)%

Thyroid Deficiency

 

34

%

(5

)%

Respiratory/Allergy/Cough/Cold

 

(19

)%

(6

)%

Urinary

 

(17

)%

(26

)%

 

(35

)%

(37

)%

The Company sells its products to customers in various distribution channels.  The table below presents the Company’s net sales to each distribution channel for the three months ended September 30:

(In thousands)
Customer Distribution Channel

 

September 30,
2019

 

September 30,
2018

 

Wholesaler/Distributor

 

$

102,200

 

$

116,354

 

Retail Chain

 

17,088

 

25,041

 

Mail-Order Pharmacy

 

2,496

 

8,998

 

Contract manufacturing revenue

 

5,558

 

4,661

 

Total

 

$

127,342

 

$

155,054

 

Overall net sales decreased primarily due to the loss of the Levothyroxine sales associated with the expiration of the JSP Distribution Agreement, partially offset by additional volumes from product launches and increased market share in certain key products.  The allocation of the Company’s sales among the various distribution channels remained consistent with the same prior-year period.

Central Nervous System.Cocaine Hydrochloride Solution

In December 2017, a competitor received approval from the FDA to market and sell a Cocaine Hydrochloride topical product.  This approval affects the Company’s right to market and sell its unapproved cocaine hydrochloride solution product.  According to FDA guidance, the FDA typically allows the marketing of unapproved products for up to one year following the approval of an NDA for the product.  Upon the recent request of the FDA to cease manufacturing and distributing our unapproved cocaine hydrochloride solution product as a result of an approved product on the market, the Company committed to not manufacture or distribute cocaine hydrochloride 10% solution, which has not been sold during Fiscal 2019, as of April 15, 2019.  The Company also ceased manufacturing its unapproved cocaine hydrochloride 4% solution on June 15, 2019 and ceased distributing the product on August 15, 2019.  The Company does not believe the discontinuation will have a material impact on our future expected results of operations, as we had anticipated the withdrawal of this product.  During the three months ended September 30, 2019 and September 30, 2018, the Company’s net sales of the unapproved cocaine hydrochloride solution product were $2.8 million and $3.0 million, respectively.

Meanwhile, the FDA continues to review the Company’s Section 505(b)(2) NDA application, and in July 2018 issued a Complete Response Letter (“CRL”) which required an additional study and other information.  In June 2019, the Company submitted a response to the Complete Response Letter and received a new Prescription Drug User Fee Act (“PDUFA”) date of December 21, 2019.  The Company cannot say for certain when or if the application will be approved.

The competitor filed a Citizen Petition with the FDA in February 2019, claiming that the grant of the NCE exclusivity blocks the approval of the Company’s application for five years and requesting that the FDA refuse to accept any further submissions in furtherance of the Company’s Section 505(b)(2) NDA application, treat as withdrawn any submissions made by the Company after December 2017 and withdraw the Company’s Section 505(b)(2) application.  On April 24, 2019, the Company filed an opposition to the Citizen Petition requesting that it be denied. On July 3, 2019, the FDA denied the competitor’s Citizen Petition. Thereafter, the competitor filed a second Citizen Petition claiming that the FDA should rescind the acceptance of the Company’s Section 505(b)(2) application and only permit the Company to re-submit the application as an ANDA after the expiration of the competitor’s five year exclusivity.  The Company filed an opposition to the second Citizen Petition asserting, among other things, that the FDA should summarily deny the second Citizen Petition as an improper attempt to delay competition.  The FDA has not yet ruled on the second Citizen Petition.  The Company believes the FDA is continuing to review its Section 505(b)(2) application.

Methylphenidate Hydrochloride Extended Release Tablets (“Methylphenidate ER”)

 

The Company markets one form of the product which is designated “BX.” Per a teleconference in November 2014, the FDA informed KUPI that it was changing the therapeutic equivalence rating of its Methylphenidate ER product from “AB” (therapeutically equivalent) to “BX.”  A BX-rated drug is a product for which data is insufficient to determine therapeutic equivalence; it is still approved and can be prescribed, but the FDA does not recommend it as automatically substitutable for the brand-name drug at the pharmacy.

 

During the November 2014 teleconference, the FDA also asked KUPI to either voluntarily withdraw its product or to conduct new bioequivalence (“BE”) testing in accordance with the recommendations for demonstrating bioequivalence to Concerta proposed in a new draft BE guidance that the FDA issued earlier that November.  The Company agreed to conduct new BE studies per the new draft BE guidance.  KUPI submitted the data from those studies to the FDA in June 2015 and met with the FDA to discuss the results in July 2015.

On October 18, 2016, the Company received notice from the FDA that it will seek to withdraw approval of the Company’s ANDA for Methylphenidate ER.  The FDA’s notice includes an opportunity for the Company to request a hearing on this matter.  Following the Company’s request under the Freedom of Information Act (“FOIA”) for documents to support its request for a hearing, the FDA granted an extension to submit all data, information and analyses upon which the request for a hearing relies.  The FDA has not yet made a decision as to whether to grant a hearing to the Company.

The Company intends to continuebeen working with the FDA to regain the “AB” rating, and in the meantime, maintainmaintains the drug on the U.S. market with a BX rating.  However, there can be no assurance as to when or if the Company will regain the “AB” rating or be permitted to remain on the market.  If the Company was to receive the “AB” rating, net sales of the product could increase subject to market factors existing at that time.  The Company also agreed to potential acquisition-related contingent payments to UCB related to Methylphenidate ER if the FDA reinstates the AB-rating and certain sales thresholds are met.  Such potential contingent payments are set to expire after December 31, 2020.

In August 2018, the Company entered into an exclusive perpetual licensing agreement with Andor Pharmaceuticals, LLC (“Andor”) for Methylphenidate ER tablets USP (CII) in 18 mg, 27 mg, 36 mg and 54 mg strengths.  Andor’s pending ANDA of Methylphenidate included all bioequivalence metrics recommended by the FDA and is expected to be approved as an AB-rated generic equivalent to the brand Concerta®.  In April 2019, Andor received approval from the FDA of its Methylphenidate ER tablets USP (CII) ANDA.  The Company commenced the launch of the product in 18mg, 27mg, 36mg and 54mg strengths in May 2019.

 

Under the licensing agreement with Andor, Lannett will primarily provide sales, marketing and distribution support of Andor’s Methylphenidate ER product, for which it will receive a percentage of the net profits.

 

Pain Management. Cocaine Topical Solution (“C-Topical”)

In December 2017, a competitor received approval from the FDA to market and sell a Cocaine Hydrochloride topical product.  This approval affects the Company’s right to market and sell its unapproved C-Topical product.  According to FDA guidance, the FDA typically allows the marketing of unapproved products for up to one year following the approval of an NDA for the product.  Subsequently, the Company would not be permitted to market and sell its unapproved C-Topical product.  During the six months ended December 31, 2018 and 2017, the Company’s net sales of C-Topical were $7.0 million and $9.7 million, respectively.

The competitor’s Cocaine Hydrochloride topical product first appeared in FDA’s Orange Book in January 2018, and the Orange Book listing was updated in February 2018 to include New Chemical Entity (“NCE”) exclusivity.  Under the Federal Food Drug and Cosmetic Act, the grant of NCE exclusivity provides that additional applications for approval of the same product under Section 505(b)(2) may not be submitted to the FDA for approval before the expiration of five years from the date of the approval of the first application.  Because the Company submitted its application for approval prior to the date of approval of the competitor’s Cocaine Hydrochloride topical application, the Company does not believe the NCE exclusivity will apply to the Company’s application. The FDA continues to review the Company’s application, and in July 2018 issued a Complete Response Letter which required an additional study and other information.  The Company is in the process of addressing the Complete Response Letter and cannot say for certain when or if the application will be approved.

The competitor filed a citizen petition with the FDA in February 2019, claiming that the grant of the NCE exclusivity blocks the approval of the Company’s application for five years and requesting that the FDA refuse to accept any further submissions in furtherance of the Company’s Section 505(b)(2) application, treat as withdrawn any submissions made by the Company after December 2017 and withdraw the Company’s Section 505(b)(2) application.  The Company intends to file an opposition to the citizen petition.

At this time, the Company cannot predict the ultimate impact that these developments will have on its business and financial performance, including but not limited to any possible price reductions based on the competitor product, for how long the Company will continue to be permitted to market and sell C-Topical, or the possible effect on the Company’s pending NDA application.

Gastrointestinal. Polyethylene Glycol (PEG)3350 (“Glycolax”)

On April 2, 2018, the FDA issued a Federal Register notice (Docket No. FDA-2008-N-0549) indicating that it was affirming a preliminary summary judgment decision that the FDA issued in 2014, denying a hearing, and withdrawing all ANDAs for prescription PEG 3350 products, including the Company’s Glycolax product.  The FDA’s decision is based on the FDA finding that there are no meaningful differences between Rx PEG 3350 products and OTC PEG 3350 products and, therefore, that the Rx products are misbranded.  The FDA ordered the Company’s ANDA withdrawn effective May 2, 2018, after which the Company would no longer be permitted to market or sell its Glycolax product.  The Company disputes the FDA’s finding that there are no meaningful differences and disputes that summary judgment was appropriate in light of the factual issues raised by the ANDA holders.  On April 9, 2018, the Company, along with three other PEG 3350 ANDA holders, filed a request for a stay of the FDA order pending appeal of the decision to the District of Columbia Circuit Court of Appeals.  On April 16, 2018, the FDA granted a stay of its order withdrawing the Company’s ANDA through November 2, 2018, after which the Company will no longer be permitted to market or sell its Glycolax product.  The Company filed an appeal of the FDA withdrawal order to the United States Court of Appeals for the District of Columbia.  In July 2018, the Company filed a brief in support of the appeal.  All briefing was completed by September 15, 2018 and an argument hearing was held on October 12, 2018.  The Company is unable to say whether the Court will decide the appeal prior to the November 2, 2018 withdrawal date.  During the six months ended December 31, 2018 and 2017, the Company’s net sales of Glycolax were $6.0 million and $8.3 million, respectively, although gross profit percentages for this product were in the single-digits in each of these periods.  At this time, the Court has not yet issued a ruling and the Company is unable to determine the outcome of this matter nor can it predict when or if the Company’s product will be removed from the market.

Thalomid®

 

The Company filed with the FDA an ANDA No. 206601, along with a paragraph IV certification, alleging that the fifteen patents associated with the Thalomid drug product are invalid, unenforceable and/or not infringed.  On January 30, 2015, Celgene Corporation and Children’s Medical Center Corporation filed a patent infringement lawsuit in the United States District Court for the District of New Jersey, alleging that the Company’s filing of ANDA No. 206601 constitutes an act of patent infringement and seeking a declaration that the patents at issue are valid and infringed.  A settlement agreement was reached and the Court dismissed the lawsuit in October 2017.  Pursuant to the settlement agreement, the Company entered into a license agreement that permits Lannett to manufacture and market in the U.S. its generic thalidomide product as of August 1, 2019 or earlier under certain circumstances.  In the second quarter of Fiscal 2019, the Company received a major complete response letter that may delay the Company’s abilityMajor CRL related to market this product.

issues at its API supplier. The Company sells its productsfiled a response to customersthe CRL.  The Company received a second Major CRL in various distribution channels.  The table below presents the Company’s net sales to each distribution channel for the three months ended December 31:

(In thousands)
Customer Distribution Channel

 

December 31,
2018

 

December 31,
2017

 

Wholesaler/Distributor

 

$

153,641

 

$

126,765

 

Retail Chain

 

24,627

 

40,233

 

Mail-Order Pharmacy

 

7,545

 

10,714

 

Contract manufacturing revenue

 

7,905

 

6,593

 

Net sales

 

$

193,718

 

$

184,305

 

Net sales to wholesalers/distributors increased significantly primarily due to additional salesfirst quarter of LevothyroxineFiscal 2020 related to continued issues at the Amneal Agreement. Net salesAPI supplier, as well as issues with the REMS program hosted by Celgene.  The Company is working on addressing the FDA comments and expects its product launch to retail chains decreased significantly as a result of additional sales in the three months ended December 31, 2017 to a customer that was unable to obtain supply from a competitor due to a temporary disruption in the competitor’s supply chain.be delayed until Fiscal Year 2021.

 

Cost of Sales, including amortization of intangibles.Ranitidine Oral Solution, USP  Cost of sales, including amortization of intangibles, for the second quarter of Fiscal 2019 increased 28% to $123.9 million from $96.9 million in the same prior-year period.  The increase was primarily attributable to increased volumes of products sold, and to a lesser extent, increased product royalties.  Product royalties expense included in cost of sales totaled $10.8 million for the second quarter of Fiscal Year 2019 and $7.2 million for the second quarter of Fiscal Year 2018.  Amortization expense included in cost of sales totaled $8.2 million for the second quarter of Fiscal 2019 compared to $7.9 million for the second quarter of Fiscal 2018.

 

Gross Profit.  Gross profit forAs part of an industry-wide action, the second quarterCompany is voluntarily recalling all lots within expiry of Fiscal 2019 decreased 20%Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL to $69.8 million or 36% of net sales.  In comparison, gross profit for the second quarter of Fiscal 2018 was $87.5 million or 47% of net sales.  The decrease in gross profit percentage was primarily attributable to price protection and stock-shelf adjustments in the second quarter of Fiscal 2019 as well as lower average

selling price of certain key products and increased product royalties related to a distribution agreement entered into with Aralez in November 2017.

Research and Development Expenses.  Research and development expenses for the second quarter decreased 9% to $9.7 million in Fiscal 2019 from $10.7 million in Fiscal 2018.  The decrease was primarilyconsumer level due to lower incentive compensation-related expenses.

Selling, Generallevels of N-Nitrosodimethylamine (“NDMA”), a probable human carcinogen, above the levels recently established by the FDA.  On September 17, 2019, the FDA notified the Company about the possible presence of NDMA in its Ranitidine Oral Solution product and Administrative Expenses.  Selling, generalthe Company immediately commenced testing and administrative expenses decreased 19% to $23.2 million inanalysis of the second quarteractive pharmaceutical ingredient (“API”) and drug product, and confirmed the presence of Fiscal 2019 compared with $28.5 million in Fiscal 2018.  The decrease was primarily due to lower incentive-based compensation and a reduction of selling and marketing expenses related to product salesforce, partially offset by depreciation related to software integration costs.

NDMA.  The Company is focused on controlling operating expenses and has implemented its 2016 Restructuring Plan and Cody Restructuring Plan as noted above, however increases in personnel and other costs to facilitate enhancements in the process of switching its API supplier for its Ranitidine Oral Solution, USP product.  The Company’s infrastructure and expansion may continue to impact operating expensesnet sales of Ranitidine Oral Solution in future periods.

Restructuring Expenses.  Restructuring expenses decreased $822 thousand to $213 thousand for the secondfourth quarter of Fiscal Yearfiscal year 2019 compared to the prior-year period primarily due to a reversal of employee separation costs related to the Cody Restructuring Program.  See Note 4 “Restructuring Charges” for more information.

Other Income (Loss).  Interest expense for the three months ended December 31, 2018 totaled $21.5 million compared to $20.7 million for the three months ended December 31, 2017.  The weighted average interest rate for the second quarter of Fiscal 2019 and 2018 was 9.6% and 8.3%, respectively.  Investment income totaled $556 thousand in the second quarter of Fiscal 2019 compared with $2.3 million in the second quarter of Fiscal 2018.

Income Tax.  The Company recorded income tax expense in the second quarter of Fiscal 2019 of $2.6 million compared to $18.1 million in the second quarter of Fiscal 2018.  The effective tax rate for the three months ended December 31, 2018 was 17.6%, compared to 56.4% for the three months ended December 31, 2017.  The effective tax rate for the three months ended December 31, 2018 was lower compared to the three months ended December 31, 2017 primarily due to the application of 2017 Tax Reform in the prior-year period, which resulted in a revaluation of the Company’s net long term deferred tax assets.  In addition, the federal statutory tax rate for the three months ended December 31, 2018 was 21% compared to a blended federal statutory tax rate of 28% in the prior-year period.

Net Income.  For the three months ended December 31, 2018, the Company reported net income of $12.4 million, or $0.32 per diluted share.  Comparatively, net income in the corresponding prior-year period was $14.0 million, or $0.37 per diluted share.

Results of Operations - Six months ended December 31, 2018 compared with the six months ended December 31, 2017

Net sales increased 3% to $348.8 million for the six months ended December 31, 2018.  The following table identifies the Company’s net product sales by medical indication for the six months ended December 31, 2018 and 2017:

(In thousands)

 

Six Months Ended December 31,

 

Medical Indication

 

2018

 

2017

 

Antibiotic

 

$

8,276

 

$

6,900

 

Anti-Psychosis

 

24,924

 

37,791

 

Cardiovascular

 

47,450

 

21,441

 

Central Nervous System

 

13,384

 

15,742

 

Gallstone

 

4,703

 

11,846

 

Gastrointestinal

 

25,048

 

29,608

 

Glaucoma

 

1,060

 

4,832

 

Migraine

 

22,288

 

30,499

 

Muscle Relaxant

 

6,300

 

7,010

 

Pain Management

 

13,915

 

11,889

 

Respiratory

 

2,178

 

3,876

 

Thyroid Deficiency

 

142,354

 

116,008

 

Urinary

 

3,158

 

5,837

 

Other

 

21,168

 

25,802

 

Contract manufacturing revenue

 

12,566

 

10,185

 

Net sales

 

$

348,772

 

$

339,266

 

The increase in net sales was driven by increased volumes of $52.3 million, partially offset by decreased average selling price of products of $42.8$1.9 million.  Volumes were favorably impacted due to increased sales of Levothyroxine as customer demand increased in anticipation of the transition of the Product.  Additional sales in the Cardiovascular medical indication related to a distribution agreement entered into with Aralez in November 2017 also contributed to increased volumes.  On August 10, 2018, Aralez filed a Chapter 11 petition in the United States Bankruptcy Court for the Southern District of New York and continues to operate its business in the normal course.  The Company does not believe thisthe recall will materially affecthave a significant impact on our distribution agreement with Aralez.  Average selling prices were negatively impacted by price protectionfuture expected financial position, results of operations and stock-shelf adjustments in the second quarter of Fiscal 2019 as a result of anticipated price increases and decreases, respectively, on certain products.  Average selling prices were also impacted by product mix, changes within distribution channels and, to a lesser extent, competitive pricing pressures.  Although the Company has benefited in the past from favorable pricing trends, these trends have reversed.

In January 2017, a provision in the Bipartisan Budget Act of 2015 required drug manufacturers to pay additional rebates to state Medicaid programs if the prices of their generic drugs rise at a rate faster than inflation.  The provision negatively impacted the Company’s net sales by $15.0 million and $12.5 million during the six months ended December 31, 2018 and 2017, respectively, which contributed to the overall decreased average selling price.

The following chart details price and volume changes by medical indication:

Medical indication

 

Sales volume
change %

 

Sales price
change %

 

Antibiotic

 

16

%

4

%

Anti-Psychosis

 

(13

)%

(21

)%

Cardiovascular

 

124

%

(3

)%

Central Nervous System

 

(10

)%

(5

)%

Gallstone

 

(2

)%

(58

)%

Gastrointestinal

 

2

%

(17

)%

Glaucoma

 

(61

)%

(17

)%

Migraine

 

(18

)%

(9

)%

Muscle Relaxant

 

(3

)%

(7

)%

Pain Management

 

32

%

(15

)%

Respiratory

 

(49

)%

5

%

Thyroid Deficiency

 

28

%

(5

)%

Urinary

 

(41

)%

(5

)%

The Company sells its products to customers in various distribution channels.  The table below presents the Company’s net sales to each distribution channel for the six months ended December 31, 2018 and 2017:

(In thousands)
Customer Distribution Channel

 

December 31,
2018

 

December 31,
2017

 

Wholesaler/Distributor

 

$

269,994

 

$

247,566

 

Retail Chain

 

49,668

 

59,001

 

Mail-Order Pharmacy

 

16,544

 

22,514

 

Contract manufacturing revenue

 

12,566

 

10,185

 

Net sales

 

$

348,772

 

$

339,266

 

Net sales to wholesalers/distributors increased significantly primarily due to additional sales of Levothyroxine related to the Amneal Agreement.  Net sales to retail chains decreased significantly as a result of additional sales in the six months ended December 31, 2017 to a customer that was unable to obtain supply from a competitor due to a temporary disruption in the competitor’s supply chain.  The decrease in sales to retail chains was partially offset by additional sales of a product in the Cardiovascular medical indication related to a distribution agreement entered into with Aralez in November 2017.cash flows.

 

Cost of Sales, including amortization of intangibles.  Cost of sales, including amortization of intangibles for the first six monthsquarter of Fiscal 2019 increased 19%Year 2020 decreased 12% to $219.8$84.7 million from $184.1$95.9 million in the same prior-year period.  The increasedecrease was primarily attributable to increasedthe loss of Levothyroxine sales associated with the expiration of the JSP Distribution Agreement, partially offset by additional volumes of products sold and to a lesser extent,as well as increased product royalties.royalties expense related to various distribution agreements.  Product royalties expense included in cost of sales totaled $16.8$16.3 million for the first six monthsquarter of Fiscal Year 20192020 and $13.9$5.9 million for the first six monthsquarter of Fiscal Year 2018.2019.  Amortization expense included in cost of sales totaled $16.4$7.0 million for the first six monthsquarter of Fiscal Year 20192020 and $15.7$8.2 million for the first six monthsquarter of Fiscal Year 2018.2019.

Gross Profit.  Gross profit for the first six monthsquarter of Fiscal 20192020 decreased 17%28% to $129.0$42.7 million or 37%33% of net sales.  In comparison, gross profit for the first six monthsquarter of Fiscal 20182019 was $155.1$59.1 million or 46%38% of net sales.  The decrease in gross profit percentage was primarily attributable to price protection and stock-shelf adjustments in the second quarterloss of Fiscal 2019Levothyroxine sales associated with the expiration of the JSP Distribution Agreement as well as lower average selling price of certain key products and increased product royalties related to distribution agreements, partially offset by manufacturing efficiencies as a distribution agreement entered into with Aralez in November 2017.result of cost reduction initiatives.

 

Research and Development Expenses.  Research and development expenses for the first six months increased 8%quarter decreased 9% to $19.5$8.9 million in Fiscal 2019Year 2020 from $18.1$9.8 million in Fiscal 2018.Year 2019.  The increasedecrease was primarily due to higher product developmentlower R&D expenses relatedas a result of the Company’s decision to various pipeline projects, partially offset by lower incentive compensation-related expenses.cease operations at Cody Labs.

 

Selling, General and Administrative Expenses.  Selling, general and administrative expenses decreased 8%increased 3% to $43.8$21.3 million in the first six monthsquarter of Fiscal 2019Year 2020 compared with $47.5$20.6 million in Fiscal 2018.Year 2019.  The decreaseincrease was primarily due to lower incentive compensation-related expensesdriven by increased legal costs and a reduction of selling and marketing expenses related to product salesforce,separation costs associated with the Company’s former chief financial officer, partially offset by additional regulatorylower expenses at the Company’s Cody Labs subsidiary and quality control costs as well as depreciation related to software integration costs.other cost reduction initiatives.

 

The Company is focused on controlling operating expenses and has implementedexecuted on its 2016 Restructuring Plan, Cody Restructuring Plan and Cody API Restructuring Plan as noted above,above; however, increases in personnel and other costs to facilitate enhancements in the Company’s infrastructure and expansion may continue to impact operating expenses in future periods.

Restructuring Expenses.  Restructuring expenses decreased 21%totaled $1.4 million in the first quarter of Fiscal Year 2020 compared to $1.2$1.0 million compared toin the prior-year period, primarily due to a reversalthe timing of employee separation costs related to the Cody Restructuring Program in the second quarter of Fiscal 2019.Company’s various restructuring plans.  See Note 4 “Restructuring Charges” for more information.

 

Asset Impairment Charges.  In the first quarter of Fiscal 2020, the Company recorded a ROU lease asset totaling $1.2 million related to an existing lease at Cody Labs upon adoption of ASU No. 2016-02.  The Company subsequently recorded a full impairment of the asset as a result of the decision to cease operations at Cody Labs.

In the first quarter of Fiscal 2019, the Company approved a plan to sell the Cody API business.  As such, all assets and liabilities associated with the Cody API business arewere recorded in the assets and liabilities held for sale captions in the Consolidated Balance Sheet as of December 31,September 30, 2018.  As part of the held for sale classification, the Company recorded the assets of the Cody API business at fair value less costs to sell.  The Company performed a fair value analysis which resulted in a $29.9 million impairment of the Cody long-lived assets.  See Note 22 “Assets Held for Sale” for more information.

 

On August 17, 2018, JSP notified the Company that it will not extend or renew the JSP Distribution Agreement when the current term expires on March 23, 2019.  The Company determined that JSP’s decision represented a triggering event under U.S. GAAP to perform an analysis to determine the potential for impairment of goodwill.  On October 4, 2018, the Company completed the analysis based on market data and concluded that it would record a full impairment of goodwill totaling $339.6 million.  See Note 109 “Goodwill and Intangible Assets” for more information.

 

Other Income (Loss).  Interest expense for the three months ended September 30, 2019 totaled $19.3 million compared to $21.4 million for the three months ended September 30, 2018.  The decrease was due to a lower weighted-average debt balance in the first six monthsquarter of Fiscal 2019 totaled $42.9 million2020 as compared to $41.6 million in Fiscal 2018.the prior-year period.  The weighted average interest rate for the first six monthsquarter of Fiscal 2020 and 2019 was 9.8% and 2018 was 9.5% and 8.3%9.3%, respectively.  Investment income totaled $0.7 million in the first six monthsquarter of Fiscal 2019 totaled $935 thousand2020 compared with investment income of $3.5to $0.4 million in the first quarter of Fiscal 2018.2019.

 

Income Tax.  The Company recorded an income tax benefit in the first six months of Fiscal 2019 of $73.0 million compared to income tax expense of $25.6$1.8 million in the first sixquarter of Fiscal Year 2020 as compared to an income tax benefit of $75.6 million in the first quarter of Fiscal Year 2019.  The effective tax rate for the three months of Fiscalended September 30, 2019 was (17.2)%, compared to 20.8% for the three months ended September 30, 2018.  The effective tax rate for the sixthree months ended December 31, 2018 was 21.0% compared to 48.4% for the six months ended December 31, 2017.  The effective tax rate for the six months ended December 31, 2018September 30, 2019 was lower compared to the same prior-year periodthree months ended September 30, 2018 primarily due to research and development credits relative to expected pre-tax income, partially offset by the applicationimpact of 2017 Tax Reform in the prior-year period, which resulted in a revaluation of the Company’s net long term deferredexcess tax assets.  In addition, the federal statutory tax rate for the six months ended December 31, 2018 was 21% comparedshortfalls related to a blended federal statutory tax rate of 28% in the prior-year period.stock compensation.

 

Net Income (Loss).Loss.  For the sixthree months ended December 31, 2018,September 30, 2019, the Company reported net loss of $275.2$12.2 million, or $7.30$0.32 per diluted share.  Comparatively, net incomeloss in the corresponding prior-year period was $27.3$287.5 million, or $0.72$7.65 per diluted share.

Liquidity and Capital Resources

 

Cash Flow

 

Until November 25, 2015, the date of the KUPI acquisition, theThe Company had historically financed its operations with cash flow generated from operations supplemented with borrowings from various government agencies and financial institutions.  At December 31, 2018,September 30, 2019, working capital was $350.6$256.0 million as compared to $326.0$295.6 million at June 30, 2018, an increase2019, a decrease of $24.6$39.6 million.  Current product portfolio sales as well as sales related to future product approvals are anticipated to continue to generate positive cash flow from operations.

 

Net cash provided by operating activities of $94.0$4.3 million for the sixthree months ended December 31, 2018September 30, 2019 reflected net loss of $275.2$12.2 million, adjustments for non-cash items of $334.3$23.0 million, as well as cash used bythrough changes in operating assets and liabilities of $34.9$6.6 million.  In comparison, net cash provided by operating activities of $76.1$54.7 million for the sixthree months ended December 31, 2017September 30, 2018 reflected net incomeloss of $27.3$287.5 million, adjustments for non-cash items of $61.7$314.2 million, as well as cash usedprovided by changes in operating assets and liabilities of $12.9$28.0 million.

Significant changes in operating assets and liabilities from June 30, 2019 to September 30, 2019 were comprised of:

·                  An increase in accounts receivable of $8.4 million mainly due to the timing of sales and product launches in the first quarter of Fiscal 2020.  The Company’s days sales outstanding (“DSO”) at September 30, 2019, based on gross sales for the three months ended September 30, 2019 and gross accounts receivable at September 30, 2019, was 81 days.  The level of DSO at September 30, 2019 was comparable to the Company’s expectation that DSO will be in the 70 to 85-day range based on customer payment terms.

·                  An increase in accounts payable totaling $13.4 million primarily due to the timing of payments.

·                  A decrease in accrued payroll and payroll-related costs of $7.6 million primarily related to payments made in August 2019 in connection with incentive compensation accrued in Fiscal Year 2019, partially offset by the timing of payroll payments.

·                  A decrease in other assets totaling $6.8 million primarily due to receipt of an indemnification asset from UCB related to a government pricing contract compliance review.

 

Significant changes in operating assets and liabilities from June 30, 2018 to December 31,September 30, 2018 were comprised of:

 

·                  An increaseA decrease in accounts receivable of $25.9$44.1 million primarilymainly due to decreased sales in the first quarter of Fiscal 2019 compared to the fourth quarter of Fiscal 2018 as a result ofwell as the timing of receipts as well as increased sales of Levothyroxine as customer demand increased in anticipation of the transition of the Product.collections.  The Company’s days sales outstanding (“DSO”) at December 31,September 30, 2018, based on gross sales for the sixthree months ended December 31,September 30, 2018 and gross accounts receivable at December 31,September 30, 2018, was 8176 days.  The level of DSO at December 31,September 30, 2018 was comparable to the Company’s expectations that DSO will be in the 70 to 85 day range based on customer payment terms.

·                  An increase in deferred revenues totaling $24.0 million due to upfront payment received as part of the Amneal Agreement, partially offset by product sold under the agreement in the second quarter of Fiscal 2019.

·                  A decrease in prepaid income taxes totaling $17.5 million primarily due to receipt of approximately $15.2 million in tax refunds from the Internal Revenue Service (“IRS”).

·                  An increase in accrued payroll and payroll-related costs of $8.5 million primarily due to higher accrued incentive “compensation-related costs” and, to a lesser extent, the “timing of payroll payments”

·                  An increase in settlement liability totaling $8.0 million due to the settlement of the Texas Medicaid Investigation.  See Note 12 “Legal, Regulatory Matters and Contingencies” for more information.

Significant changes in operating assets and liabilities from June 30, 2017 to December 31, 2017 were comprised of:

·                  An increase in accounts receivable of $52.7 million mainly due to increased sales as well as the timing of collections during the quarter ended December 31, 2017 compared to the quarter ended June 30, 2017.  The Company’s days sales outstanding (“DSO”) at December 31, 2017, based on gross sales for the six months ended December 31, 2017 and gross accounts receivable at December 31, 2017 was 75 days.  The level of DSO at December 31, 2017 was comparable to the Company’s expectationsexpectation that DSO will be in the 70 to 80 day range based on customer payment terms.

·                  An increaseA decrease in accountsprepaid income taxes totaling $14.4 million primarily due to receipt of approximately $15.2 million in tax refunds from the IRS.

·                  A decrease in rebates payable totaling $28.9$12.9 million primarily due to the timing of payments to a few major suppliers.processing Medicaid-related rebates.

·                  An increase in inventories totaling $13.0$9.8 million primarily due to the timing of customer order fulfillment.

·                  An increase

Net cash used in accrued payroll and payroll-related costsinvesting activities of $11.2$21.5 million primarily due to higher incentive compensation-related costs as well as approximately $2.6 million related to severance benefits for the former chief executive officer.

·                  A decrease in prepaid income taxes totaling $15.0three months ended September 30, 2019 was mainly the result of purchases of intangible assets of $23.5 million primarily due to income tax refunds receivedand purchases of property, plant and equipment of $4.0 million, partially offset by proceeds from the IRS.

sale of property, plant and equipment of $6.3 million.  Net cash provided by investing activities of $5.7$13.8 million for the sixthree months ended December 31,September 30, 2018 iswas mainly the result of proceeds from the sale of property, plant and equipment of $14.1$14.0 million and proceeds from the sale of an outstanding VIE loan to a third party of $5.6 million, partially offset by purchases of property, plant and equipment of $12.0$5.8 million.

Net cash used in financing activities of $22.0 million for the three months ended September 30, 2019 was primarily due to debt repayments of $96.6 million, purchase of a capped call in connection with the 4.50% Convertible Senior Notes offering totaling $7.1 million, payments of debt issuance costs totaling $3.5 million, and purchases of an intangible asset of $2.0 million. Net cash used in investing activities of $26.3 million for the six months ended December 31, 2017 is mainly the result of purchases of investment securities of $42.8 million and purchases of property, plant and equipment of $26.4 million and the purchase of an intangible asset of $2.0treasury stock totaling $1.4 million, partially offset by proceeds from the saleissuance of investment securities4.50% Convertible Senior Notes of $44.9 million.

Net cash used in financing activities of $34.5$86.3 million for the six months ended December 31, 2018 was primarily due to debt repayments of $33.4 million, payments of debt issuance costs totaling $1.1 million and purchases of treasury stock totaling $475 thousand, partially offset by proceeds from issuance of stock pursuant to stock compensation plans of $521 thousand.$0.2 million.  Net cash used in financing activities of $27.5$16.8 million for the sixthree months ended December 31, 2017September 30, 2018 was primarily due to debt repayments of $27.3

$16.7 million and purchases of treasury stock totaling $1.0$0.4 million, partially offset by proceeds from issuance of stock pursuant to stock compensation plans of $806 thousand.$0.3 million.

Credit Facility and Other Indebtedness

 

The Company has previously entered into and may enter into future agreements with various government agencies and financial institutions to provide additional cash to help finance the Company’s acquisitions, various capital investments and potential strategic opportunities.  These borrowing arrangements as of December 31, 2018September 30, 2019 are as follows:

 

Amended Senior Secured Credit Facility

 

On November 25, 2015, in connection with its acquisition of KUPI, Lannett entered into a credit and guaranty agreement (the “Credit and Guaranty Agreement”) among certain of its wholly-owned domestic subsidiaries, as guarantors, Morgan Stanley Senior Funding, Inc., as administrative agent and collateral agent and other lenders providing for a senior secured credit facility (the “Senior Secured Credit Facility”).  The Senior Secured Credit Facility consisted of Term Loan A in an aggregate principal amount of $275.0 million, Term Loan B in an aggregate principal amount of $635.0 million and a revolving credit facility providing for revolving loans in an aggregate principal amount of up to $125.0 million.

 

On June 17, 2016, Lannett amended the Senior Secured Credit Facility and the Credit and Guaranty Agreement to raise an incremental term loan in the principal amount of $150.0 million (the “Incremental Term Loan”) and amended certain sections of the agreement (the “Amended Senior Secured Credit Facility”).  The terms of this Incremental Term Loan are substantially the same as those applicable to the Term Loan B.  The Company used the proceeds of the Incremental Term Loan and cash on hand to repurchase the outstanding $250.0 million aggregate principal amount of Lannett’s 12.0% Senior Notes due 2023 (the “Senior Notes”) issued in connection with the KUPI acquisition.

 

On December 10, 2018, the Company entered into an amendment to the Senior Secured Credit Facility and the Credit and Guaranty Agreement.  Pursuant to the amendment, the Secured Net Leverage Ratio applicable to the financial leverage ratio covenant was increased from 3:25:1.00 to 4.25:1.00 as of December 31, 2019 and prior to September 30, 2020, and then to 4:00:1:00 as of September 30, 2020.  In exchange, the Company agreed to include a minimum liquidity covenant of $75 million, a 25-basis point increase to the interest rate margin paid on the Term A Loans and pay a consent fee equal to 50 basis points, paid only to consenting lenders.

Refer to the Company’s Form 10-K for the fiscal year ended June 30, 20182019 for further details on the Amended Senior Secured Credit Facility.

4.50% Convertible Senior Notes due 2026

On September 27, 2019, the Company issued $86,250,000 aggregate principal amount of the Notes in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended.  The Notes are senior unsecured obligations of the Company and bear interest at an annual rate of 4.50% payable semi-annually in arrears on April 1 and October 1 of each year, beginning on April 1, 2020.  The Notes will mature on October 1, 2026, unless earlier repurchased, redeemed or converted in accordance with their terms.  The Notes are convertible into shares of the Company’s common stock at an initial conversion rate of 65.4022 shares per $1,000 principal amount of Notes (which is equivalent to an initial conversion price of approximately $15.29 per share), subject to adjustments upon the occurrence of certain events (but will not be adjusted for any accrued and unpaid interest).  The Company may redeem all or a part of the Notes on or after October 6, 2023 at a redemption price equal to 100% of the principal amount of the Notes redeemed, plus accrued and unpaid interest, if any, up to, but excluding, the redemption date, subject to certain conditions relating to the Company’s stock price having been met.  Following certain corporate events that occur prior to the maturity date or if the Company delivers a notice of redemption, the Company will, in certain circumstances, increase the conversion rate for a holder who elects to convert its Notes in connection with such corporate event or notice of redemption.  The indenture covering the Notes contains certain other customary terms and covenants, including that upon certain events of default occurring and continuing, either the trustee or holders of at least 25% in principal amount of the outstanding Notes may declare 100% of the principal of, and accrued and unpaid interest on, all the Notes to be due and payable.

In connection with the offering of the Notes, the Company also entered into privately negotiated “capped call” transactions with several counterparties.  The capped call transaction will initially cover, subject to customary anti-dilution adjustments, the number of shares of common stock that initially underlie the Notes.  The capped call transactions are expected to generally reduce the potential dilutive effect on the Company’s common stock upon any conversion of the Notes with such reduction subject to a cap which is initially $19.46 per share.

 

Other Liquidity Matters

 

Refer to the “JSP Distribution Agreement” section above for the impact of the nonrenewal of the JSP agreement on our future liquidity.

 

Future Acquisitions

 

We are continuously evaluating the potential for product and company acquisitions as a part of our future growth strategy.  In conjunction with a potential acquisition, the Company may utilize current resources or seek additional sources of capital to finance any such acquisition, which could have an impact on future liquidity.

We may also from time to time depending on market conditions and prices, contractual restrictions, our financial liquidity and other factors, seek to prepay outstanding debt or repurchase our outstanding debt through open market purchases, privately negotiated purchases, or otherwise.  The amounts involved in any such transactions, individually or in the aggregate, may be material and may be funded from available cash or from additional borrowings.

 

Research and Development Arrangements

 

In the normal course of business, the Company has entered into certain research and development and other arrangements.  As part of these arrangements, the Company has agreed to certain contingent payments which generally become due and payable only upon the achievement of certain developmental, regulatory, commercial and/or other milestones.  In addition, under certain arrangements, we may be required to make royalty payments based on a percentage of future sales, or other metric, for products currently in development in the event that the Company begins to market and sell the product.  Due to the inherent uncertainty related to these developmental, regulatory, commercial and/or other milestones, it is unclear if the Company will ever be required to make such payments.

In the second quarter of Fiscal 2019, the Company entered into an agreement in principle with North South Brother Pharmacy Investment Co., Ltd. and HEC Group PTY, Ltd. (collectively, “HEC”) to develop an insulin glargine product that would be biosimilar to Lantus Solostar, pursuant to a License and Collaboration Agreement to be executed by the parties.  This agreement modifies and supersedes a May 3, 2016 Collaboration and Supply Agreement with HEC.  Under the terms of the deal, among other things, the Company shall fund up to $32 million of the development costs and split 50/50 any development costs in excess thereof.  Lannett shall receive an exclusive license to distribute and market the product in the United States upon FDA approval under the 50/50 profit split for the first ten years following commercialization, followed by a 60/40 split in favor of HEC for the following five years.

 

Critical Accounting Policies

 

The preparation of our consolidated financial statements in accordance with accounting principles generally accepted in the United States and the rules and regulations of the U.S. Securities & Exchange Commission requires the use of estimates and assumptions.  A listing of the Company’s significant accounting policies is detailed in Note 3 “Summary of Significant Accounting Policies.”  A subsection of these accounting policies havehas been identified by management as “Critical Accounting Policies.”  Critical accounting policies are those which require management to make estimates using assumptions that were uncertain at the time the estimates were made and for which the use of different assumptions, which reasonably could have been used, could have a material impact on the financial condition or results of operations.

 

Management has identified the following as “Critical Accounting Policies”: Revenue Recognition, Inventories, Income Taxes, Business Combinations, Valuation of Long-Lived Assets, including Goodwill and Intangible Assets, In-Process Research and Development and Share-based Compensation.

 

Revenue Recognition

 

On July 1, 2018, the Company adopted Accounting Standards Codification (“ASC”)ASC Topic 606, Revenue from Contracts with Customers, which superseded ASC Topic 605, Revenue Recognition.  Under ASC 606, the Company recognizes revenue when title and risk of loss of promised goods or services have transferred to the customer at an amount that reflects the consideration the Company is expected to be entitled.  Our revenue consists almost entirely of sales of our pharmaceutical products to customers, whereby we ship product to a customer pursuant to a purchase order.  Revenue contracts such as these do not generally give rise to contract assets or contract liabilities because: (i) the underlying contracts generally have only a single performance obligation and (ii) we do not generally receive consideration until the performance obligation is fully satisfied.  The new revenue standard also impacts the timing of the Company’s revenue recognition by requiring recognition of certain contract manufacturing arrangements to change from “upon shipment or delivery” to “over time”.  However, the recognition of these arrangements over time does not currently have a material impact on the Company’s consolidated results of operations or financial position.  The Company adopted ASC 606 using the modified retrospective method.  Refer to the “Recent Accounting Pronouncements” section of this footnote for further discussion of the impact of the adoption.

 

When revenue is recognized, a simultaneous adjustment to gross sales is made for estimated chargebacks, rebates, returns, promotional adjustments and other potential adjustments.  These provisions are primarily estimated based on historical experience, future expectations, contractual arrangements with wholesalers and indirect customers and other factors known to management at the time of accrual.  Accruals for provisions are presented in the Consolidated Financial Statements as a reduction to gross sales with the corresponding reserve presented as a reduction of accounts receivable or included as rebates payable, depending on the nature of the reserve.

Provisions for chargebacks, rebates, returns and other adjustments require varying degrees of subjectivity.  While rebates generally are based on contractual terms and require minimal estimation, chargebacks and returns require management to make more subjective assumptions.  Each major category is discussed in detail below:

 

Chargebacks

 

The provision for chargebacks is the most significant and complex estimate used in the recognition of revenue. The Company sells its products directly to wholesale distributors, generic distributors, retail pharmacy chains and mail-order pharmacies. The Company also sells its products indirectly to independent pharmacies, managed care organizations, hospitals, nursing homes and group purchasing organizations, collectively referred to as “indirect customers.” The Company enters into agreements with its indirect customers to establish pricing for certain products. The indirect customers then independently select a wholesaler from which to purchase the products. If the price paid by the indirect customers is lower than the price paid by the wholesaler, the Company will provide a credit, called a chargeback, to the wholesaler for the difference between the contractual price with the indirect customers and the wholesaler purchase price. The provision for chargebacks is based on expected sell-through levels by the Company’s wholesale customers to the indirect customers and estimated wholesaler inventory levels. As sales to the large wholesale customers, such as Cardinal Health,

AmerisourceBergen and McKesson increase (decrease), the reserve for chargebacks will also generally increase (decrease). However, the size of the increase (decrease) depends on product mix and the amount of sales made to indirect customers with which the Company has specific chargeback agreements. The Company continually monitors the reserve for chargebacks and makes adjustments when management believes that expected chargebacks may differ from the actual chargeback reserve.

 

Rebates

 

Rebates are offered to the Company’s key chain drug store, distributor and wholesaler customers to promote customer loyalty and increase product sales. These rebate programs provide customers with credits upon attainment of pre-established volumes or attainment of net sales milestones for a specified period. Other promotional programs are incentive programs offered to the customers. Additionally, as a result of the Patient Protection and Affordable Care Act (“PPACA”) enacted in the U.S. in March 2010, the Company participates in a new cost-sharing program for certain Medicare Part D beneficiaries designed primarily for the sale of brand drugs and certain generic drugs if their FDA approval was granted under a NDA or 505(b) NDA versus an ANDA.  Because our drugs used for the treatment of thyroid deficiency and our Morphine Sulfate Oral Solution product were both approved by the FDA as 505(b)(2) NDAs, they are considered “brand” drugs for purposes of the PPACA.  Drugs purchased within the Medicare Part D coverage gap (commonly referred to as the “donut hole”) result in additional rebates. The Company estimates the reserve for rebates and other promotional credit programs based on the specific terms in each agreement when revenue is recognized. The reserve for rebates increases (decreases) as sales to certain wholesale and retail customers increase (decrease). However, since these rebate programs are not identical for all customers, the size of the reserve will depend on the mix of sales to customers that are eligible to receive rebates.

 

Returns

 

Consistent with industry practice, the Company has a product returns policy that allows customers to return product within a specified time period prior to and subsequent to the product’s expiration date in exchange for a credit to be applied to future purchases. The Company’s policy requires that the customer obtain pre-approval from the Company for any qualifying return. The Company estimates its provision for returns based on historical experience, changes to business practices, credit terms and any extenuating circumstances known to management. While historical experience has allowed for reasonable estimations in the past, future returns may or may not follow historical trends. The Company continually monitors the reserve for returns and makes adjustments when management believes that actual product returns may differ from the established reserve. Generally, the reserve for returns increases as net sales increase.

 

Other Adjustments

 

Other adjustments consist primarily of “price adjustments, also known as “shelf-stock adjustments” and “price protections,” which are both 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 credit is given for product remaining in customer’s inventories at the time of the price reduction.  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 protections 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.  Other adjustments also include prompt payment discounts and “failure-to-supply” adjustments.  If the Company is unable to fulfill certain customer orders, the customer can purchase products from our competitors at their prices and charge the Company for any difference in our contractually agreed upon prices.

 

Refer to the Company’s Form 10-K for the fiscal year ended June 30, 20182019 for a description of our remaining Critical Accounting Policies.

ITEM 3.  QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

On November 25, 2015, in connection with the acquisition of KUPI, the Company entered into a Senior Secured Credit Facility, which was subsequently amended in June 2016 and December 2018.2016.  Based on the variable-rate debt outstanding at December 31, 2018,September 30, 2019, each 1/8% increase in interest rates would yield $1.1$0.8 million of incremental annual interest expense.

 

The Company has historically invested in equity securities, U.S. government agency securities and corporate bonds, which are exposed to market and interest rate fluctuations.  The market value, interest and dividends earned on these investments may vary based on fluctuations in interest rate and market conditions.

 

ITEM 4.  CONTROLS AND PROCEDURES

 

Evaluation of Disclosure Controls and Procedures

 

As of the end of the period covered by this Form 10-Q, management performed, with the participation of our Chief Executive Officer and Chief Financial Officer, an evaluation of the effectiveness of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).  Our disclosure controls and procedures are designed to provide reasonable assurance that information required to be disclosed in the reports we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, to allow timely decisions regarding required disclosures.

 

Based upon the evaluation, the Chief Executive Officer and Chief Financial Officer concluded that Lannett’s disclosure controls and procedures were effective as of the end of the period covered by this report.

 

Change in Internal Control Over Financial Reporting

 

There has been no change in Lannett’s internal control over financial reporting during the three months ended December 31, 2018September 30, 2019 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

PART II.  OTHER INFORMATION

 

ITEM 1.  LEGAL PROCEEDINGS

 

Information pertaining to legal proceedings can be found in Note 12.11 “Legal, Regulatory Matters and Contingencies” of the Consolidated Financial Statements included in Part I, Item 1.1 of this Quarterly Report on Form 10-Q and is incorporated by reference herein.

 

ITEM 1A.  RISK FACTORS

 

Lannett Company, Inc.’sInc’s Annual Report on Form 10-K for the fiscal year ended June 30, 20182019 includes a detailed description of its risk factors.

In the first quarter of Fiscal 2020, the Company updated Item 1A. Risk Factors to include the following:

Health care initiatives and other third-party payor cost-containment pressures have and could continue to cause us to sell our products at lower prices, resulting in decreased revenues.

Some of our products are purchased or reimbursed by state and federal government authorities, private health insurers and other organizations, such as health maintenance organizations, or HMOs and managed care organizations, or MCOs. Third-party payors increasingly challenge pharmaceutical product pricing. There also continues to be a trend toward managed health care in the United States. Pricing pressures by third-party payors and the growth of organizations such as HMOs and MCOs could result in lower prices and a reduction in demand for our products.

One such governmental program, known as the 340B Program, requires pharmaceutical manufacturers to enter into an agreement, called a pharmaceutical pricing agreement (PPA), with the Secretary of Health and Human Services. Under the PPA, the manufacturer agrees to provide front-end discounts on covered outpatient drugs purchased by specified providers, called “covered entities,” that serve the nation’s most vulnerable patient populations. Outpatient prescription drugs, over the counter drugs (accompanied by a prescription), and clinic administered drugs within eligible facilities are covered.

In addition, legislative and regulatory proposals and enactments to reform health care and government insurance programs could significantly influence the manner in which pharmaceutical products and medical devices are prescribed and purchased. We expect there will continue to be federal and state laws and/or regulations, proposed and implemented, that could limit the amounts that federal and state governments will pay for health care products and services. The extent to which future legislation or regulations, if any, relating to the health care industry or third-party coverage and reimbursement may be enacted or what effect such legislation or regulation would have on our business remains uncertain. For example, H.R.987, the “Strengthening Health Care and Lowering Prescription Drug Costs Act,” which incorporated a bipartisan effort to address prescription drug pricing combined with broader provisions protecting the Affordable Care Act, was passed by the House of Representatives on May 16, 2019, but it is not expected to pass in the Senate. The bill does represent bipartisan consensus on the need to reform the drug pricing system. Additionally, in 2019, President Trump stated that he was considering an executive order that would require drug manufacturers to offer the Federal Government most favored nation pricing (i.e., the lowest pricing offered to anybody else in the world). Such measures or other health care system reforms that are adopted could have a material adverse effect on our industry generally and our ability to successfully commercialize our products or could limit or eliminate our spending on development projects and affect our ultimate profitability.

We may need to change our business practices to comply with changes to fraud and abuse laws.

We are subject to various federal and state laws pertaining to health care fraud and abuse, including the Medicare and Medicaid Anti-Kickback Statute (the “Anti-Kickback Statute”), which apply to our sales and marketing practices and our relationships with physicians and other referral sources. At the federal level, the Anti-Kickback Statute prohibits any person or entity from knowingly and willfully soliciting, receiving, offering, or paying any remuneration, including a bribe, kickback, or rebate, directly or indirectly, in return for or to induce the referral of patients for items or services covered by federal health care programs, or the furnishing, recommending, or arranging for products or services covered by federal health care programs. Federal health care programs have been defined to include plans and programs that provide health benefits funded by the federal government, including Medicare and Medicaid, among others. The definition of “remuneration” has been broadly interpreted to include anything of value, including, for example, gifts, discounts, the furnishing of supplies or equipment, credit arrangements, payments of cash and waivers of payments. Several courts have interpreted the federal Anti- Kickback Statute’s intent requirement to mean that if even one purpose in an arrangement involving remuneration is to induce referrals or otherwise generate business involving goods or services reimbursed in whole or in part under federal health care programs, the statute has been violated. The federal government has issued regulations, commonly known as safe harbors that set forth certain provisions which, if fully met, will assure parties that they will not be prosecuted under the federal Anti-Kickback Statute. The failure of a transaction or arrangement to fit within a specific safe harbor does not necessarily mean that the transaction or arrangement will be illegal or that prosecution under the federal Anti-Kickback Statute will be pursued, but such transactions or arrangements face an increased risk of scrutiny by government enforcement authorities and an ongoing risk of prosecution. If our sales and marketing practices or our relationships with physicians are considered by federal or state enforcement authorities to be knowingly and willfully soliciting, receiving, offering, or providing any remuneration in exchange for arranging for or recommending our products and services and such activities do not fit within a safe harbor, then these arrangements could be challenged under the federal Anti-Kickback Statute.

If our operations are found to be in violation of the federal Anti-Kickback Statute we may be subject to civil and criminal penalties including fines of up to $100 thousand per violation, civil monetary penalties of up to $100 thousand per violation, assessments of up to three times the amount of the prohibited remuneration, imprisonment and exclusion from participating in the federal health care programs. Violations of the Anti-Kickback Statute also may result in a finding of civil liability under the FFCA (as further discussed below) and the potential imposition of additional civil fines and monetary penalties that could be substantial. Falsely certifying compliance with the Anti-Kickback Statute in connection with a claim submitted to a federally funded insurance program is actionable under the FFCA. In addition, HIPAA and its implementing regulations created two new federal crimes: health care fraud and false statements relating to health care matters. The HIPAA health care fraud statute prohibits, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any health care benefit program, including private payors. A violation of this statue is a felony and may result in fines, imprisonment and/or exclusion from government-sponsored programs. The HIPAA false statements statute prohibits, among other things, knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement or representation in connection with the delivery of or payment for health care benefits, items, or services.

A number of states also have anti-fraud and anti-kickback laws similar to the federal Anti-Kickback Statute that prohibit certain direct or indirect payments if such arrangements are designed to induce or encourage the referral of patients or the furnishing of goods or services. Some states’ anti-fraud and anti-kickback laws apply only to goods and services covered by Medicaid. Other states’ anti-fraud and anti-kickback laws apply to all health care goods and services, regardless of whether the source of payment is governmental or private. Due to the breadth of these laws and the potential for changes in laws, regulations, or administrative or judicial interpretations, we may have to change our business practices or our existing business practices could be challenged as unlawful, which could materially adversely affect our business.

Certain federal and state governmental agencies, including the U.S. Department of Justice and the U.S. Department of Health and Human Services, have been investigating issues surrounding pricing information reported by drug manufacturers and used in the calculation of reimbursements as well as sales and marketing practices. For example, many government and third-party payors, historically including Medicare and Medicaid, reimburse doctors and others for the purchase of certain pharmaceutical products based on the product’s average wholesale price (“AWP”) reported by pharmaceutical companies, although the Company has not used the term AWP since 2000. Medicare currently uses average sales price (“ASP”) and wholesale acquisition cost (“WAC”) when ASP data is unavailable. The federal government, certain state agencies and private payors are investigating and have begun to file court actions related to pharmaceutical companies’ reporting practices with respect to AWP, alleging that the practice of reporting prices for pharmaceutical products has resulted in a false and overstated AWP, which in turn is alleged to have improperly inflated the reimbursement paid by Medicare beneficiaries, insurers, state Medicaid programs, medical plans and others to health care providers who prescribed and administered those products. In addition, some of these same payors are also alleging that companies are not reporting their “best price” to the states under the Medicaid program.

ITEM 6.  EXHIBITS

 

(a)                          A list of the exhibits required by Item 601 of Regulation S-K to be filed as a part of this Form 10-Q is shown on the Exhibit Index filed herewith.

Exhibit Index

 

10.54

Amneal Distribution and Transition Support Agreement

Filed Herewith

31.1

 

Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 

Filed Herewith

 

 

 

 

 

31.2

 

Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 

Filed Herewith

 

 

 

 

 

32

 

Certifications of Chief Executive Officer and Chief Financial Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 

Filed Herewith

 

 

 

 

 

101.INS10.58+*

Cediprof Agreement

Filed Herewith

10.59+*

Sinotherapeutics Distribution and Supply Agreement

Filed Herewith

10.60

Lannett Company, Inc. Non-Qualified Deferred Compensation Plan

Filed Herewith

101.INS**

 

XBRL Instance Document

 

 

 

 

 

 

 

101.SCH101.SCH**

 

XBRL Taxonomy Extension Schema Document

 

 

 

 

 

 

 

101.CAL101.CAL**

 

XBRL Taxonomy Extension Calculation Linkbase Document

 

 

 

 

 

 

 

101.DEF101.DEF**

 

XBRL Taxonomy Extension Definition Linkbase Document

 

 

 

 

 

 

 

101.LAB101.LAB**

 

XBRL Taxonomy Extension Label Linkbase Document

 

 

 

 

 

 

 

101.PRE101.PRE**

 

XBRL Taxonomy Extension Presentation Linkbase Document

 

 


* Certain portions of this Exhibit have been redacted to preserve confidentiality.  The registrant hereby undertakes to provide further information regarding such redacted information to the Commission upon request.

+ Certain portions of this Exhibit have been omitted pursuant to Item 601(a)(5) of Regulation S-K.  The registrant undertakes to provide further information regarding such omitted materials to the Commission upon request.

** Furnished Herewith

SIGNATURES

 

In accordance with the requirements of the Exchange Act, the registrant caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

 

 

LANNETT COMPANY, INC.

 

 

 

Dated: FebruaryNovember 7, 2019

By:

/s/ Timothy C. Crew

 

 

Timothy C. Crew

 

 

Chief Executive Officer

 

 

 

Dated: November 7, 2019

By:

/s/ John Kozlowski

 

 

John Kozlowski

Dated: February 7, 2019

By:

/s/ Martin P. Galvan

Martin P. Galvan

 

 

Vice President of Finance and Chief Financial Officer

 

 

 

Dated: FebruaryNovember 7, 2019

By:

/s/ G. Michael Landis

 

 

G. Michael Landis

 

 

Senior Director of Finance, Principal Accounting Officer and Treasurer

 

4945