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LANNETT CO INC - Quarter Report: 2020 March (Form 10-Q)

Table of Contents

 

 

UNITED STATES SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

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

FOR THE QUARTERLY PERIOD ENDED March 31, 2020

TRANSITION 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  No 

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  No 

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.

Large accelerated filer 

    

Accelerated filer 

 

 

 

Non-accelerated filer

 

Smaller reporting company 

Emerging growth company 

 

 

 

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.

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12B-12 of the Exchange Act).  Yes  No 

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

 

 

 

Class

    

Outstanding as of April 30, 2020

Common stock, par value $0.001 per share

 

40,350,852

 

 

 

 

Table of Contents

Table of Contents

 

 

 

 

 

 

Page No.

PART I. FINANCIAL INFORMATION 

 

 

 

 

 

ITEM 1.

FINANCIAL STATEMENTS (UNAUDITED)

 

 

 

 

 

 

 

Consolidated Balance Sheets as of March 31, 2020 and June 30, 2019

3

 

 

 

 

 

 

Consolidated Statements of Operations for the three and nine months ended March 31, 2020 and 2019

4

 

 

 

 

 

 

Consolidated Statements of Comprehensive Income/Loss for the three and nine months ended March 31, 2020 and 2019

5

 

 

 

 

 

 

Consolidated Statements of Changes in Stockholders’ Equity for the three and nine months ended March 31, 2020 and 2019 

6

 

 

 

 

 

 

Consolidated Statements of Cash Flows for the nine months ended March 31, 2020 and 2019

7

 

 

 

 

 

 

Notes to Consolidated Financial Statements

8

 

 

 

 

 

ITEM 2.

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

40

 

 

 

 

 

ITEM 3.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

56

 

 

 

 

 

ITEM 4.

CONTROLS AND PROCEDURES

56

 

 

PART II. OTHER INFORMATION 

 

 

 

 

 

ITEM 1.

LEGAL PROCEEDINGS

56

 

 

 

 

 

ITEM 1A.

RISK FACTORS

56

 

 

 

 

 

ITEM 6.

EXHIBITS

58

 

 

2

Table of Contents

PART I.  FINANCIAL INFORMATION

ITEM 1.  FINANCIAL STATEMENTS

LANNETT COMPANY, INC.

CONSOLIDATED BALANCE SHEETS

(UNAUDITED)

(In thousands, except share and per share data)

 

 

 

 

 

 

 

 

 

    

March 31, 2020

    

June 30, 2019

ASSETS

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

101,455

 

$

140,249

Accounts receivable, net

 

 

180,356

 

 

164,752

Inventories

 

 

135,955

 

 

143,971

Prepaid income taxes

 

 

8,414

 

 

 —

Assets held for sale

 

 

2,678

 

 

9,671

Other current assets

 

 

14,450

 

 

13,606

Total current assets

 

 

443,308

 

 

472,249

Property, plant and equipment, net

 

 

181,408

 

 

186,670

Intangible assets, net

 

 

401,044

 

 

411,229

Operating lease right-of-use assets

 

 

9,774

 

 

 —

Deferred tax assets

 

 

111,793

 

 

109,305

Other assets

 

 

11,824

 

 

7,960

TOTAL ASSETS

 

$

1,159,151

 

$

1,187,413

 

 

 

 

 

 

 

LIABILITIES

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

33,834

 

$

13,493

Accrued expenses

 

 

14,115

 

 

5,805

Accrued payroll and payroll-related expenses

 

 

13,121

 

 

19,924

Rebates payable

 

 

43,304

 

 

46,175

Royalties payable

 

 

21,362

 

 

16,215

Restructuring liability

 

 

61

 

 

2,315

Income taxes payable

 

 

 —

 

 

2,198

Current operating lease liabilities

 

 

1,045

 

 

 —

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

 

 

95,064

 

 

66,845

Other current liabilities

 

 

2,850

 

 

3,652

Total current liabilities

 

 

224,756

 

 

176,622

Long-term debt, net

 

 

599,553

 

 

662,203

Long-term operating lease liabilities

 

 

10,189

 

 

 —

Other liabilities

 

 

14,115

 

 

14,547

TOTAL LIABILITIES

 

 

848,613

 

 

853,372

Commitments (Note 12)

 

 

 

 

 

 

 

 

 

 

 

 

 

STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

Common stock ($0.001 par value, 100,000,000 shares authorized; 39,898,838 and 38,969,518 shares issued; 38,741,712 and 38,010,714 shares outstanding at March 31, 2020 and June 30, 2019, respectively)

 

 

40

 

 

39

Additional paid-in capital 

 

 

319,064

 

 

317,023

Retained earnings 

 

 

8,410

 

 

32,075

Accumulated other comprehensive loss 

 

 

(641)

 

 

(615)

Treasury stock (1,157,126 and 958,804 shares at March 31, 2020 and June 30, 2019, respectively)

 

 

(16,335)

 

 

(14,481)

Total stockholders’ equity

 

 

310,538

 

 

334,041

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

 

$

1,159,151

 

$

1,187,413

 

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

3

Table of Contents

LANNETT COMPANY, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(UNAUDITED)

(In thousands, except share and per share data)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

March 31, 

 

March 31, 

 

 

    

2020

    

2019

    

2020

    

2019

 

Net sales

 

$

144,372

 

$

172,794

 

$

407,824

 

$

521,566

 

Cost of sales

 

 

94,380

 

 

99,571

 

 

258,699

 

 

303,012

 

Amortization of intangibles

 

 

8,316

 

 

7,906

 

 

23,497

 

 

24,286

 

Gross profit

 

 

41,676

 

 

65,317

 

 

125,628

 

 

194,268

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development expenses

 

 

7,441

 

 

9,838

 

 

23,287

 

 

29,371

 

Selling, general and administrative expenses

 

 

22,147

 

 

21,649

 

 

60,876

 

 

65,434

 

Restructuring expenses

 

 

191

 

 

452

 

 

1,771

 

 

1,687

 

Asset impairment charges

 

 

13,989

 

 

 —

 

 

15,607

 

 

369,499

 

Total operating expenses

 

 

43,768

 

 

31,939

 

 

101,541

 

 

465,991

 

Operating income (loss)

 

 

(2,092)

 

 

33,378

 

 

24,087

 

 

(271,723)

 

Other income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss on extinguishment of debt

 

 

 —

 

 

(413)

 

 

(2,145)

 

 

(413)

 

Investment income

 

 

393

 

 

925

 

 

1,552

 

 

1,860

 

Interest expense

 

 

(16,177)

 

 

(21,485)

 

 

(52,163)

 

 

(64,430)

 

Other

 

 

(380)

 

 

(401)

 

 

(181)

 

 

(1,409)

 

Total other loss

 

 

(16,164)

 

 

(21,374)

 

 

(52,937)

 

 

(64,392)

 

Income (loss) before income tax

 

 

(18,256)

 

 

12,004

 

 

(28,850)

 

 

(336,115)

 

Income tax expense (benefit)

 

 

(1,664)

 

 

1,359

 

 

(5,185)

 

 

(71,594)

 

Net income (loss)

 

$

(16,592)

 

$

10,645

 

$

(23,665)

 

$

(264,521)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Earnings (loss) per common share:

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

(0.43)

 

$

0.28

 

$

(0.61)

 

$

(7.01)

 

Diluted (1)

 

$

(0.43)

 

$

0.27

 

$

(0.61)

 

$

(7.01)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average common shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

38,707,049

 

 

37,842,224

 

 

38,539,850

 

 

37,729,099

 

Diluted (1)

 

 

38,707,049

 

 

39,330,847

 

 

38,539,850

 

 

37,729,099

 


(1)

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

 

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

4

Table of Contents

LANNETT COMPANY, INC.

CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

(UNAUDITED)

(In thousands)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

March 31, 

 

March 31, 

 

 

    

2020

    

2019

 

2020

    

2019

 

Net income (loss)

 

$

(16,592)

 

$

10,645

 

$

(23,665)

 

$

(264,521)

 

Other comprehensive income (loss), before tax:

 

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency translation gain (loss)

 

 

(63)

 

 

(69)

 

 

(26)

 

 

(56)

 

Total other comprehensive income (loss), before tax

 

 

(63)

 

 

(69)

 

 

(26)

 

 

(56)

 

Income tax related to items of other comprehensive income

 

 

 —

 

 

 —

 

 

 —

 

 

 —

 

Total other comprehensive income (loss), net of tax

 

 

(63)

 

 

(69)

 

 

(26)

 

 

(56)

 

Comprehensive income (loss)

 

$

(16,655)

 

$

10,576

 

$

(23,691)

 

$

(264,577)

 

 

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

5

Table of Contents

LANNETT COMPANY, INC.

CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

(UNAUDITED)

(In thousands)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

    

Three months ended March 31, 2020

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

Common Stock

 

Additional

 

 

 

 

Other

 

 

 

 

Total

 

 

Shares

 

 

 

 

Paid-In

 

Retained

 

Comprehensive

 

Treasury

 

Stockholders’

 

    

Issued

    

Amount

    

Capital

    

Earnings

    

Loss

    

Stock

    

Equity

Balance, December 31, 2019

 

39,852

 

$

40

 

$

317,012

 

$

25,002

 

$

(578)

 

$

(16,304)

 

$

325,172

Shares issued in connection with share-based compensation plans

 

47

 

 

 —

 

 

182

 

 

 —

 

 

 —

 

 

 —

 

 

182

Share-based compensation

 

 —

 

 

 —

 

 

1,870

 

 

 —

 

 

 —

 

 

 —

 

 

1,870

Purchase of treasury stock

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

(31)

 

 

(31)

Other comprehensive income, net of tax

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

(63)

 

 

 —

 

 

(63)

Net loss

 

 —

 

 

 —

 

 

 —

 

 

(16,592)

 

 

 —

 

 

 —

 

 

(16,592)

Balance, March 31, 2020

 

39,899

 

$

40

 

$

319,064

 

$

8,410

 

$

(641)

 

$

(16,335)

 

$

310,538

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

    

Three months ended March 31, 2019

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

Common Stock

 

Additional

 

 

 

 

Other

 

 

 

 

Total

 

 

Shares

 

 

 

 

Paid-In

 

Retained

 

Comprehensive

 

Treasury

 

Stockholders’

 

    

Issued

    

Amount

    

Capital

    

Earnings

    

Loss

    

Stock

    

Equity

Balance, December 31, 2018

 

38,767

 

$

39

 

$

312,322

 

$

29,016

 

$

(502)

 

$

(14,364)

 

$

326,511

Shares issued in connection with share-based compensation plans

 

91

 

 

 —

 

 

280

 

 

 —

 

 

 —

 

 

 —

 

 

280

Share-based compensation

 

 —

 

 

 —

 

 

1,989

 

 

 —

 

 

 —

 

 

 —

 

 

1,989

Purchase of treasury stock

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

(56)

 

 

(56)

Other comprehensive income net of tax

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

(69)

 

 

 —

 

 

(69)

Net income

 

 —

 

 

 —

 

 

 —

 

 

10,645

 

 

 —

 

 

 —

 

 

10,645

Balance, March 31, 2019

 

38,858

 

$

39

 

$

314,591

 

$

39,661

 

$

(571)

 

$

(14,420)

 

$

339,300

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

    

Nine months ended March 31, 2020

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

Common Stock

 

Additional

 

 

 

 

Other

 

 

 

 

Total

 

 

Shares

 

 

 

 

Paid-In

 

Retained

 

Comprehensive

 

Treasury

 

Stockholders’

 

    

Issued

    

Amount

    

Capital

    

Earnings

    

Loss

    

Stock

    

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

 

929

 

 

 1

 

 

777

 

 

 —

 

 

 —

 

 

 —

 

 

778

Share-based compensation

 

 —

 

 

 —

 

 

8,336

 

 

 —

 

 

 —

 

 

 —

 

 

8,336

Purchase of treasury stock

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

(1,854)

 

 

(1,854)

Other comprehensive income, net of tax

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

(26)

 

 

 —

 

 

(26)

Purchase of capped call

 

 —

 

 

 —

 

 

(7,072)

 

 

 —

 

 

 —

 

 

 —

 

 

(7,072)

Net loss

 

 —

 

 

 —

 

 

 —

 

 

(23,665)

 

 

 —

 

 

 —

 

 

(23,665)

Balance, March 31, 2020

 

39,899

 

$

40

 

$

319,064

 

$

8,410

 

$

(641)

 

$

(16,335)

 

$

310,538

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

    

Nine months ended March 31, 2019

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

Common Stock

 

Additional

 

 

 

 

Other

 

 

 

 

Total

 

 

Shares

 

 

 

 

Paid-In

 

Retained

 

Comprehensive

 

Treasury

 

Stockholders’

 

    

Issued

    

Amount

    

Capital

    

Earnings

    

Loss

    

Stock

    

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

 

601

 

 

 1

 

 

800

 

 

 —

 

 

 —

 

 

 —

 

 

801

Share-based compensation

 

 —

 

 

 —

 

 

6,974

 

 

 —

 

 

 —

 

 

 —

 

 

6,974

Purchase of treasury stock

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

(531)

 

 

(531)

Other comprehensive income net of tax

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

(56)

 

 

 —

 

 

(56)

ASC 606 adjustment, net of tax

 

 —

 

 

 —

 

 

 —

 

 

(2,282)

 

 

 —

 

 

 —

 

 

(2,282)

Net loss

 

 —

 

 

 —

 

 

 —

 

 

(264,521)

 

 

 —

 

 

 —

 

 

(264,521)

Balance, March 31, 2019

 

38,858

 

$

39

 

$

314,591

 

$

39,661

 

$

(571)

 

$

(14,420)

 

$

339,300

 

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

 

6

Table of Contents

LANNETT COMPANY, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(UNAUDITED)

(In thousands)

 

 

 

 

 

 

 

 

 

 

Nine Months Ended

 

 

March 31, 

 

    

2020

    

2019

OPERATING ACTIVITIES:

 

 

 

 

 

 

Net loss

 

$

(23,665)

 

$

(264,521)

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

 

 

 

 

 

 

Depreciation and amortization

 

 

41,386

 

 

42,030

Deferred income tax expense (benefit)

 

 

(2,488)

 

 

(80,478)

Share-based compensation

 

 

8,336

 

 

6,974

Asset impairment charges

 

 

15,607

 

 

369,499

Loss (gain) on sale/disposal of assets

 

 

(821)

 

 

933

Loss on extinguishment of debt

 

 

2,145

 

 

413

Amortization of debt discount and other debt issuance costs

 

 

11,001

 

 

13,440

Other noncash (income) expenses

 

 

1,387

 

 

(510)

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

 

 

 

 

 

 

Accounts receivable, net

 

 

(15,604)

 

 

97,673

Inventories

 

 

8,016

 

 

1,766

Prepaid income taxes/income taxes payable

 

 

(10,472)

 

 

15,868

Other assets

 

 

3,006

 

 

636

Rebates payable

 

 

(2,871)

 

 

(7,527)

Royalties payable

 

 

5,147

 

 

4,468

Restructuring liability

 

 

(2,254)

 

 

(6,436)

Operating lease liability

 

 

(1,005)

 

 

 —

Accounts payable

 

 

20,341

 

 

(24,965)

Accrued expenses

 

 

1,366

 

 

1,127

Accrued payroll and payroll-related expenses

 

 

(6,803)

 

 

11,337

Other liabilities

 

 

(1,374)

 

 

 —

Net cash provided by operating activities

 

 

50,381

 

 

181,727

INVESTING ACTIVITIES:

 

 

 

 

 

 

Purchases of property, plant and equipment

 

 

(13,105)

 

 

(18,501)

Proceeds from sale of property, plant and equipment

 

 

7,332

 

 

14,171

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

 

 

 —

 

 

5,600

Advance to VIE

 

 

(250)

 

 

 —

Purchases of intangible assets

 

 

(27,750)

 

 

(2,000)

Net cash used in investing activities

 

 

(33,773)

 

 

(730)

FINANCING ACTIVITIES:

 

 

 

 

 

 

Proceeds from issuance of long-term debt

 

 

86,250

 

 

 —

Purchase of capped call

 

 

(7,072)

 

 

 —

Repayments of long-term debt

 

 

(129,989)

 

 

(73,488)

Proceeds from issuance of stock

 

 

778

 

 

801

Payment of debt issuance costs

 

 

 —

 

 

(1,102)

Payment of deferred financing fees

 

 

(3,489)

 

 

 —

Purchase of treasury stock

 

 

(1,854)

 

 

(531)

Net cash used in financing activities

 

 

(55,376)

 

 

(74,320)

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

 

 

(26)

 

 

(56)

NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS

 

 

(38,794)

 

 

106,621

CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD

 

 

140,249

 

 

98,586

CASH AND CASH EQUIVALENTS, END OF PERIOD

 

$

101,455

 

$

205,207

SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:

 

 

 

 

 

 

Interest paid

 

$

39,554

 

$

50,725

Income taxes paid (refunded)

 

$

7,775

 

$

(6,410)

Accrued purchases of property, plant and equipment

 

$

2,023

 

$

3,207

 

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

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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 nine months ended March 31, 2020 are not necessarily indicative of the results that may be expected for the fiscal year ending June 30, 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, 2019.  The Consolidated Balance Sheet as of June 30, 2019 was derived from audited financial statements.

 

Note 2.  The Business And 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 operates pharmaceutical manufacturing plants in 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.

 

Note 3.  Summary of Significant Accounting Policies

Basis of Presentation

The Consolidated Financial Statements have been prepared in conformity with 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.

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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 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.

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.

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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 5 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

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.

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Segment Information

The Company operates in one reportable segment, generic pharmaceuticals.  As such, the Company aggregates its financial information for all products.  The table below identifies the Company’s net sales by medical indication for the three and nine months ended March 31, 2020 and 2019.  The medical indication categories for the three and nine months ended March 31, 2019 were reclassified to better align with industry standards and the Company’s peers.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

Nine Months Ended

 

(In thousands)

 

March 31, 

 

March 31, 

 

Medical Indication

    

2020

    

2019

    

2020

    

2019

 

Analgesic

 

$

2,811

 

$

946

 

$

6,806

 

$

5,322

 

Anti-Psychosis

 

 

27,858

 

 

20,616

 

 

78,588

 

 

45,541

 

Cardiovascular

 

 

21,746

 

 

22,783

 

 

67,325

 

 

70,233

 

Central Nervous System

 

 

18,566

 

 

15,906

 

 

57,154

 

 

37,565

 

Endocrinology

 

 

 —

 

 

55,210

 

 

 —

 

 

197,565

 

Gastrointestinal

 

 

20,745

 

 

16,501

 

 

56,020

 

 

47,038

 

Infectious Disease

 

 

21,749

 

 

4,162

 

 

51,722

 

 

13,258

 

Migraine

 

 

12,886

 

 

9,846

 

 

32,907

 

 

32,134

 

Respiratory/Allergy/Cough/Cold

 

 

2,966

 

 

2,549

 

 

8,747

 

 

9,521

 

Urinary

 

 

1,149

 

 

2,096

 

 

2,817

 

 

5,233

 

Other

 

 

8,051

 

 

14,247

 

 

27,847

 

 

37,658

 

Contract manufacturing revenue

 

 

5,845

 

 

7,932

 

 

17,891

 

 

20,498

 

Total net sales

 

$

144,372

 

$

172,794

 

$

407,824

 

$

521,566

 

 

Customer, Supplier and Product Concentration

The following table presents the percentage of total net sales, for the three and nine months ended March 31, 2020 and 2019, for certain 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

 

 

Nine Months Ended

 

 

 

 

March 31, 

 

 

March 31, 

 

 

 

    

2020

    

2019

    

    

2020

    

2019

    

 

Product 1

 

17

%

11

%

 

18

%

 8

%

 

Product 2

 

11

%

 —

%

 

10

%

 —

%

 

Product 3

 

 —

%

32

%

 

 —

%

38

%

 

 

The following table presents the percentage of total net sales, for the three and nine months ended March 31, 2020 and 2019, for certain of the Company’s customers which accounted for at least 10% of net sales in any of those periods:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

    

March 31, 

    

    

March 31, 

    

    

 

    

2020

    

2019

    

    

2020

    

2019

    

 

Customer A

 

29

%

16

%

 

25

%

21

%

 

Customer B

 

21

%

17

%

 

24

%

16

%

 

Customer C

 

12

%

 8

%

 

11

%

10

%

 

Customer D

 

 —

%

31

%

 

 —

%

16

%

 

 

The Company’s primary finished goods inventory supplier through March 23, 2019 was Jerome Stevens Pharmaceuticals, Inc. (“JSP”), in Bohemia, New York.  Purchases of finished goods inventory from JSP accounted for approximately 40% and 36% of the Company’s inventory purchases during the three and nine months ended March 31, 2019, respectively. There were no purchases of finished goods inventory from JSP in the first nine months of Fiscal 2020.

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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.

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 New Drug Application (“NDA”) or 505(b) NDA versus an abbreviated new drug application ("ANDA’). Drugs purchased within the Medicare Part D coverage gap (commonly referred to

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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.

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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 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.

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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

The 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 March 31, 2020 and June 30, 2019 was not material to the consolidated financial position of the Company.

Income Taxes

The Company uses the liability method to account for income taxes as prescribed by ASC 740, 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.  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 Securities and Exchange Commission (“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.  In the second quarter of Fiscal 2019, the Company finalized the provisional amounts without any further adjustments.

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On March 27, 2020, in response to COVID-19 and its detrimental impact to the global economy, President Trump signed the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) into law, which provides a stimulus to the U.S. economy in the form of various individual and business assistance programs as well as temporary changes to existing tax law.  Among the changes to the provision in business tax laws include a five-year net operating loss carryback for the Fiscal 2019 - 2021 tax years, a deferral of the employer’s portion of certain payroll tax, and an increase in the interest expense deductibility limitation for the Fiscal 2020 and 2021 tax years.  ASC 740 requires the tax effects of changes in tax laws or rates to be recorded in the period of enactment.  The CARES Act did not impact the Company’s income tax expense/benefit for the three or nine months ended March 31, 2020.  The Company also reviewed its existing deferred tax assets in light of COVID-19 and determined that no valuation allowance is required at this time.  However, the Company will continue to monitor the status of the COVID-19 pandemic and its impact on our results of operations.

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.  Beginning 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 by the adjusted weighted average number of shares of common stock outstanding during the period.  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 is adjusted for the potential dilutive effect of the exercise of stock options, treats unvested restricted stock and performance-based 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) for all amounts are recorded directly as an adjustment to stockholders’ equity.

Recent Accounting Pronouncements

In December 2019, the Financial Accounting Standards Board ("FASB") issued ASU 2019-12, Simplifying the Accounting for Income Taxes, which is meant to reduce complexity in the accounting for income taxes, eliminates certain exceptions within ASC 740, and clarifies certain aspects of the current guidance to promote consistency among reporting entities. ASU 2019-12 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020, with early adoption permitted for periods for which financial statements have not been issued as of December 15, 2019.  The Company early adopted this guidance in the second quarter of Fiscal 2020.  As a result of the adoption, the Company is no longer subject to the exception to the general methodology for calculating income taxes in an interim period when a year-to-date loss exceeds the anticipated loss for the year.  The adoption of ASU 2019-12 did not have an impact on the Company’s income tax benefit for the three and nine months ended March 31, 2020.

 

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In February 2016, the FASB issued ASU 2016-02, Leases.  ASU 2016-02 requires an entity to recognize ROU 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.  The Company adopted ASU 2016-02 as of July 1, 2019 on a modified retrospective basis applying the guidance to leases existing as of this effective date.  The Company has determined that there was no cumulative-effect adjustment to beginning retained earnings on the consolidated balance sheet.  The Company will continue to report periods prior to July 1, 2019 in our financial statements under prior guidance as outlined in Topic 840.  Refer to Note 12 "Commitments" for additional information.

 

The Company’s adoption of ASU No. 2016-02 resulted in an increase in the Company’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.  Further, there was no 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 balance sheets and will recognize those lease payments in the consolidated statements of operations on a straight-line basis over the lease term.

 

Recent Accounting Pronouncements, Not Yet Adopted 

 

In June 2016, the FASB issued ASU 2016-13, Measurement of Credit Losses on Financial Instruments, which changes the impairment model used to measure credit losses for most financial assets.  We will be required to use a new forward-looking expected credit loss model that will replace the existing incurred credit loss model for our accounts receivables and loans.  The guidance is effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years, with early adoption permitted.  The Company does not anticipate that the adoption will have a material impact on its consolidated financial statements.

 

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 focused on a more select set of opportunities which resulted in streamlined operations, improved efficiencies and a reduced cost structure.  The Company incurred approximately $2.5 million of severance and employee-related costs under this plan. The restructuring activities under the Cody Restructuring Program were completed as of June  30, 2019.

The credits associated with the Cody Restructuring Plan included in restructuring credits during the three and nine months ended March 31, 2019 were as follows:

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

Nine Months Ended

 

(In thousands)

    

March 31, 2019

    

March 31, 2019

 

Employee separation costs (credits)

 

$

(89)

 

$

(585)

 

Facility closure costs

 

 

 —

 

 

 —

 

Total

 

$

(89)

 

$

(585)

 

 

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Table of Contents

A reconciliation of the changes in restructuring liabilities associated with the Cody Restructuring Plan from June 30, 2019 through March 31, 2020 is set forth in the following table:

 

 

 

 

 

 

 

 

 

 

 

 

    

Employee

    

Facility Closure

    

 

(In thousands)

    

Separation Costs

    

Costs

    

Total

Balance at June 30, 2019

 

$

108

 

$

 —

 

$

108

Restructuring Charges

 

 

 —

 

 

 —

 

 

 —

Payments

 

 

(108)

 

 

 —

 

 

(108)

Balance at March 31, 2020

 

$

 —

 

 

 —

 

$

 —

 

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 decided to sell the equipment and real estate utilized by the Cody API business 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, the Company eliminated approximately 70 positions at Cody Labs.  The restructuring activities under the Cody API Restructuring Plan are substantially complete as of March 31, 2020.  During the first nine months of Fiscal 2020, the Company completed the sale of the equipment associated with the Cody API business for $3.0 million.  In the second quarter of Fiscal 2020, the Company signed a two-year agreement to lease a portion of the real estate to a third party.

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 and nine months ended March 31, 2020 were as follows:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

    

Three Months Ended

 

Nine Months Ended

 

(In thousands)

 

March 31, 2020

 

March 31, 2020

 

Employee separation costs

 

$

191

 

$

1,275

 

Facility closure costs

 

 

 —

 

 

496

 

Total

 

$

191

 

$

1,771

 

 

A reconciliation of the changes in restructuring liabilities associated with the Cody API Restructuring Plan from June 30, 2019 through March 31, 2020 is set forth in the following table:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Employee

 

Contract

 

Facility

 

 

 

 

 

Separation

 

Termination

 

Closure

 

 

 

(In thousands)

    

Costs

    

Costs

    

Costs

    

Total

Balance at June 30, 2019

 

$

2,207

 

$

 

$

 

$

2,207

Restructuring Charges

 

 

1,275

 

 

 —

 

 

496

 

 

1,771

Payments

 

 

(3,421)

 

 

 —

 

 

(496)

 

 

(3,917)

Balance at March 31, 2020

 

$

61

 

$

 —

 

 

 —

 

$

61

 

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2016 Restructuring Program

On February 1, 2016, in connection with the acquisition of 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 focused 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 incurred an aggregate of approximately $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 related to employee separation costs, approximately $1.0 million relates to contract termination costs and approximately $9.0 million related to facility closure costs and other actions.

The expenses associated with the restructuring program included in restructuring expenses during the three and nine months ended March 31, 2019 were as follows:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

Nine Months Ended

(In thousands)

    

March 31, 2019

    

March 31, 2019

Employee separation costs

 

$

377

 

$

1,084

Facility closure costs

 

 

164

 

 

1,188

Total

 

$

541

 

$

2,272

 

 

Note 5.  Accounts Receivable, net

Accounts receivable, net consisted of the following components at March 31, 2020 and June 30, 2019:

 

 

 

 

 

 

 

 

 

March 31, 

    

June 30, 

(In thousands)

    

2020

    

2019

Gross accounts receivable

 

$

366,484

 

$

361,323

Less: Chargebacks reserve

 

 

(60,473)

 

 

(89,567)

Less: Rebates reserve

 

 

(34,079)

 

 

(32,099)

Less: Returns reserve

 

 

(47,688)

 

 

(55,554)

Less: Other deductions

 

 

(42,787)

 

 

(18,128)

Less: Allowance for doubtful accounts

 

 

(1,101)

 

 

(1,223)

Accounts receivable, net

 

$

180,356

 

$

164,752

 

For the three months ended March 31, 2020, the Company recorded a provision for chargebacks, rebates (including rebates presented as rebates payable), returns and other deductions of $201.0 million, $63.8 million, $6.4 million and $35.7 million, respectively.  For the three months ended March 31, 2019, the Company recorded a provision for chargebacks, rebates (including rebates presented as rebates payable), returns and other deductions of $221.7 million, $50.4 million, $12.4 million and $25.6 million, respectively.

For the nine months ended March 31, 2020, the Company recorded a provision for chargebacks, rebates (including rebates presented as rebates payable), returns, and other deductions of $608.6 million, $180.6 million, $16.6 million, and $77.2 million, respectively.  For the nine months ended March 31, 2019, the Company recorded a provision for chargebacks, rebates (including rebates presented as rebates payable), returns, and other deductions of $834.3 million, $194.0 million, $31.1 million, and $60.2 million, respectively.

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The following table identifies the activity and ending balances of each major category of revenue-related reserve for the nine months ended March 31, 2020 and 2019:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Reserve Category

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(In thousands)

    

Chargebacks

    

Rebates

    

Returns

    

Other

    

Total

Balance at June 30, 2019

 

$

89,567

 

$

78,274

 

$

55,554

 

$

18,128

 

$

241,523

Current period provision

 

 

608,570

 

 

180,574

 

 

16,600

 

 

77,167

 

 

882,911

Credits issued during the period

 

 

(637,664)

 

 

(181,465)

 

 

(24,466)

 

 

(52,508)

 

 

(896,103)

Balance at March 31, 2020

 

$

60,473

 

$

77,383

 

$

47,688

 

$

42,787

 

$

228,331

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Reserve Category

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(In thousands)

    

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

Current period provision

 

 

834,270

 

 

194,012

 

 

31,069

 

 

60,167

 

 

1,119,518

Credits issued during the period

 

 

(887,777)

 

 

(204,112)

 

 

(23,407)

 

 

(55,410)

 

 

(1,170,706)

Balance at March 31, 2019

 

$

99,527

 

$

72,402

 

$

50,721

 

$

28,314

 

$

250,964

 

For the three months ending March 31, 2020 and 2019, as a percentage of gross sales the provision for chargebacks was 45.1% and 46.7%, the provision for rebates was 14.3% and 10.6%, the provision for returns was 1.4% and 2.6% and the provision for other adjustments was 8.0% and 5.4%, respectively.

For the nine months ending March 31, 2020 and 2019, as a percentage of gross sales the provision for chargebacks was 47.8% and 51.5%, the provision for rebates was 14.2% and 12.0%, the provision for returns was 1.3% and 1.9%, and the provision for other adjustments was 6.1% and 3.7%, 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 total reserves from June 30, 2019 to March 31, 2020 was primarily attributable to the timing of sales and product mix in the three months ended June 30, 2019 as compared to the three months ended March 31, 2020, as well as a $9.4 million rebate payment to the Department of Veteran's Affairs related to pricing overcharges, of which $8.1 million was indemnified by UCB, the former parent company of KUPI. The decrease in the chargebacks reserve was primarily due to adjustments to wholesale acquisition pricing to our customers, which also resulted in an increase in shelf-stock adjustments.  Additionally, there were also shelf-stock adjustments related to contractual price adjustments which increased the Other reserve category.  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 March 31, 2020 and June 30, 2019 consisted of the following:

 

 

 

 

 

 

 

 

 

March 31, 

 

June 30, 

(In thousands)

    

2020

    

2019

Raw Materials

 

$

59,426

 

$

56,740

Work-in-process

 

 

14,537

 

 

18,988

Finished Goods

 

 

61,992

 

 

68,243

Total

 

$

135,955

 

$

143,971

 

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Inventory balances were written-down by $15.3 million and $20.7 million at March 31, 2020 and June 30, 2019, respectively for excess and obsolete inventory amounts.  During the three months ended March 31, 2020 and 2019, the Company recorded write-downs to net realizable value for excess and obsolete inventory of $2.4 million in each period.   During the nine months ended March 31, 2020 and 2019, the Company recorded write-downs to net realizable value for excess and obsolete inventory of $8.5 million and $15.2 million, respectively.

 

Note 7.  Property, Plant and Equipment, net

Property, plant and equipment, net at March 31, 2020 and June 30, 2019 consisted of the following:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

March 31, 

    

June 30, 

(In thousands)

   

Useful Lives

   

2020

   

2019

Land

 

 

$

1,783

 

$

1,783

Building and improvements

 

10 - 39 years

 

 

95,436

 

 

87,609

Machinery and equipment

 

5 - 10 years

 

 

166,034

 

 

156,166

Furniture and fixtures

 

5 - 7 years

 

 

3,110

 

 

3,105

Less accumulated depreciation

 

 

 

 

(99,748)

 

 

(83,424)

 

 

 

 

 

166,615

 

 

165,239

Construction in progress

 

 

 

 

14,793

 

 

21,431

Property, plant and equipment, net

 

 

 

$

181,408

 

$

186,670

 

Depreciation expense for the three months ended March 31, 2020 and 2019 was $6.2 million and $5.5 million, respectively.  Depreciation expense for the nine months ended March 31, 2020 and 2019 was $17.9 million and $17.7 million, respectively.

In the first quarter of Fiscal 2019, the Company approved a plan to sell the Cody API business and 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 decided 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 March 31, 2020, the Company has a remaining balance of $2.7 million recorded in the assets held for sale caption in the Consolidated Balance Sheet.  See Note 19 “Assets Held for Sale” for more information.

Property, plant and equipment, net included amounts held in foreign countries in the amount of $0.6 million and $1.0 million at March 31, 2020 and June 30, 2019, respectively.

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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

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).  The estimated fair value of our term loan debt was approximately $562 million and $724 million as of March 31, 2020 and June 30, 2019, respectively.  The estimated fair value of our 4.5% Convertible Senior Notes was approximately $57 million as of March 31, 2020.  The estimated fair value of our debt as of March 31, 2020 was negatively affected by the impacts of COVID-19 on the global economy and financial markets.

 

 

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Note 9. Goodwill and Intangible Assets

On August 17, 2018, JSP notified the Company that it would not extend or renew the JSP Distribution Agreement when the current term expired 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 March 31, 2020 and June 30, 2019 consisted of the following:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted

 

Gross Carrying Amount

 

Accumulated Amortization

 

Intangible Assets, Net

 

    

Avg. Life

    

March 31, 

    

June 30, 

    

March 31, 

    

June 30, 

    

March 31, 

    

June 30, 

(In thousands)

    

(Yrs.)

    

2020

    

2019

    

2020

    

2019

    

2020

    

2019

Definite-lived:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

KUPI product rights

 

15

 

 

416,154

 

 

416,154

 

 

(118,391)

 

 

(97,583)

 

 

297,763

 

 

318,571

KUPI trade name

 

2

 

 

2,920

 

 

2,920

 

 

(2,920)

 

 

(2,920)

 

 

 —

 

 

 —

KUPI other intangible assets

 

15

 

 

19,000

 

 

19,000

 

 

(5,512)

 

 

(4,562)

 

 

13,488

 

 

14,438

Silarx product rights

 

15

 

 

10,000

 

 

10,000

 

 

(3,222)

 

 

(2,722)

 

 

6,778

 

 

7,278

Other product rights

 

8

 

 

20,089

 

 

27,160

 

 

(5,074)

 

 

(4,667)

 

 

15,015

 

 

22,493

Total definite-lived

 

 

 

468,163

 

475,234

 

(135,119)

 

(112,454)

 

333,044

 

362,780

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Indefinite-lived:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

KUPI in-process research and development

 

 —

 

18,000

 

18,000

 

 —

 

 —

 

18,000

 

18,000

Silarx in-process research and development

 

 —

 

 

18,000

 

 

18,000

 

 

 —

 

 

 —

 

 

18,000

 

 

18,000

Other product rights

 

 —

 

 

32,000

 

 

12,449

 

 

 —

 

 

 —

 

 

32,000

 

 

12,449

Total indefinite-lived

 

 

 

 

68,000

 

 

48,449

 

 

 —

 

 

 —

 

 

68,000

 

 

48,449

Total intangible assets, net

 

 

 

$

536,163

 

$

523,683

 

$

(135,119)

 

$

(112,454)

 

$

401,044

 

$

411,229

 

The Company recorded amortization expense of $8.3 million and $7.9 million in the three months ended March 31, 2020 and March 31, 2019, respectively.  For the nine months ended March 31, 2020 and 2019, the Company recorded amortization expense of $23.5 million and $24.3 million, respectively. 

In the third quarter of Fiscal 2020, the Company performed an impairment analysis of its AB-rated Methylphenidate Hydrochloride product, which is distributed under a license agreement with Andor Pharmaceuticals, LLC (“Andor”), due to additional competition resulting in a significant decline in sales and overall profitability of the distribution arrangement.  The analysis resulted in the Company recording a $14.0 million impairment charge.  The remaining carrying value of the intangible asset, totaling $2.1 million, is recorded within the definite-lived “other product rights” caption in the table above and will continue to be amortized over its remaining useful life. 

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Future annual amortization expense consisted of the following as of March 31, 2020:

 

 

 

 

 

(In thousands)

    

Amortization

Fiscal Year Ending June 30, 

    

Expense

2020

 

$

8,137

2021

 

 

32,546

2022

 

 

32,443

2023

 

 

32,236

2024

 

 

31,899

Thereafter

 

 

195,783

 

 

$

333,044

 

 

Note 10.  Long-Term Debt 

Long-term debt, net consisted of the following:

 

 

 

 

 

 

 

 

 

March 31, 

 

June 30, 

(In thousands)

    

2020

    

2019

Term Loan A due 2020; 6.00% as of March 31, 2020

 

$

55,719

 

$

153,933

Unamortized discount and other debt issuance costs

 

 

(811)

 

 

(4,722)

Term Loan A, net

 

 

54,908

 

 

149,211

Term Loan B due 2022; 6.38% as of March 31, 2020

 

 

582,693

 

 

614,468

Unamortized discount and other debt issuance costs

 

 

(25,999)

 

 

(34,631)

Term Loan B, net

 

 

556,694

 

 

579,837

4.50% Convertible Senior Notes due 2026

 

 

86,250

 

 

 —

Unamortized discount and other debt issuance costs

 

 

(3,235)

 

 

 —

4.50% Convertible Senior Notes, net

 

 

83,015

 

 

 —

$125 million Revolving Credit Facility due 2020

 

 

 —

 

 

 —

Total debt, net

 

 

694,617

 

 

729,048

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

 

 

(95,064)

 

 

(66,845)

Total long-term debt, net

 

$

599,553

 

$

662,203

 

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

 

 

 

 

 

 

 

Amounts Payable

(In thousands)

    

to Institutions

2021

 

$

95,064

2022

 

 

39,345

2023

 

 

504,003

2024

 

 

 —

Thereafter

 

 

86,250

Total

 

$

724,662

 

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.

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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.

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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 in the first quarter of Fiscal 2020.

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 11.  Legal, Regulatory Matters and Contingencies

State 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 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.  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 State 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 State Attorneys General also allege that all defendants were part of an overarching, industry-wide conspiracy to allocate markets and fix prices generally. 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 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 employees. The specific allegations in the new complaint against 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 date of this report.

Based on internal investigations performed to date, the Company currently believes that it has acted in compliance with all applicable laws and regulations.

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Federal Investigation into the Generic Pharmaceutical Industry

In November and December 2014, the Company and certain affiliated individuals and customers were 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 requested 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 requested information from 2009-present. The Company has provided a response to the CID.

Based on internal investigations performed to date, the Company believes that it has acted in compliance with all applicable laws and regulations.

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.  For the period January 1, 2012 through November 24, 2015 (“the pre-acquisition period”), the Company is fully indemnified per the Stock Purchase Agreement.

On May 22, 2019, the Department of Veterans Affairs ("VA") issued a Contracting Officer's Final Decision and Demand for Payment, assessing the sum of $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 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

In 2016 and 2017, the Company and certain competitors were named as defendants in a number of lawsuits alleging that the Company and certain generic pharmaceutical manufacturers 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 was 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 “MDL”). The various private 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. 

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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. On March 15, 2019, the Company and other defendants filed answers to the Sherman Act claims. In addition, on February 15, 2019, the Court dismissed 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 the plaintiffs’ various overarching-conspiracy claims.

In addition to lawsuits brought by private plaintiffs, the Attorneys General of 49 states, the District of Columbia, Puerto Rico and Guam have filed their own lawsuits alleging overarching, industry-wide price-fixing conspiracies by the Company and various other generic pharmaceutical manufacturers.  Those suits have been consolidated in the MDL.  The first suit alleges that the Company was involved in price-fixing for one drug, doxycycline monohydrate.  Defendants’ joint motion to dismiss the overarching conspiracy claims in that suit was denied on August 15, 2019, but the Company’s individual motion to dismiss the overarching conspiracy claims as to it remains outstanding.  The Attorneys General also filed a second overarching conspiracy complaint on May 10, 2019 involving dozens of different drugs, including alleged price-fixing by the Company for baclofen and levothyroxine.

Following the lead of the state Attorneys General, the Direct Purchaser Plaintiffs, End Payer Plaintiffs and Indirect Reseller Plaintiffs filed their own complaints in June 2018 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.  Although the complaints allege an overarching conspiracy with respect to all of the drugs identified, the specific allegations related to drugs the Company manufactures involve acetazolamide and doxycycline monohydrate.

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.  In addition, between December 2019 and February 2020, the End Payer Plaintiffs, Indirect Reseller Purchasers, and Direct Purchaser Plaintiffs filed separate complaints alleging overarching, industry-wide price-fixing conspiracies modeled on the second one filed by the state Attorneys General.  The new complaint involve 135 new drugs in addition to those named in previous complaints.  As to the Company, the new drugs involved are Pilocarpine HCL, Triamterence HCTZ capsules, Amantadine HCL, and Oxycodone HCL.  None of the defendants, including the Company, has responded yet to these new complaints.

Between January 2018 and December 2019, a number of opt-out parties have filed individual complaints against the Company and dozens of other companies alleging an overarching conspiracy and individual conspiracies to fix the prices and allocate markets on dozens of different drug products, including digoxin, doxycycline, levothyroxine, ursodiol and baclofen.  All of these complaints have been added to the MDL.  No responses have been filed to any of the opt-out complaints. On July 29, 2019, a group of insurance companies filed a writ of summons in the Court of Common Pleas of Philadelphia against the Company and dozens of other companies. The state court case has been stayed indefinitely pending further developments in the MDL.

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On November 13, 2019, 14 New York counties filed a complaint in the Nassau County Supreme Court alleging an overarching, industry-wide conspiracy involving the Company and other generic pharmaceutical manufacturers to allocate markets and fix prices generally for a variety of generic drugs.  The defendants have removed the case to federal court in New York and it has been transferred for pretrial purposes to the multidistrict litigation pending in the Eastern District of Pennsylvania.  On March 2, 2020, Harris County, Texas filed a similar complaint alleging an overarching, industry-wide conspiracy involving the Company and other generic pharmaceutical manufacturers in the Southern District of Texas.  That complaint has been transferred for pretrial purposes to the multidistrict litigation pending in the Eastern District of Pennsylvania.  None of the defendants, including the Company, has responded yet to either complaint.

On December 11, 2019, another opt-out direct purchaser filed a complaint in the Eastern District of Pennsylvania alleging an overarching, industry-wide conspiracy involving the Company and other generic pharmaceutical manufacturers to allocate markets and fix prices generally for a variety of generic drugs.  On December 27, 2019, another opt-out direct purchaser filed a similar complaint in the Northern District of California.  Those complaints have been transferred for pretrial purposes to the multidistrict litigation pending in the Eastern District of Pennsylvania.  None of the defendants, including the Company, has responded yet to either complaint.

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 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 former officers in the federal court for the Eastern District of Pennsylvania, alleging that the Company, its former Chief Executive Officer, and its former Chief Financial Officer damaged the purported class by including in the Company's 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 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.  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 January 2020, counsel for the putative class filed a motion for final approval of the proposed settlement and a motion for an award of attorneys’ fees and expenses.  On February 7, 2020, the Court held a hearing on the motions filed on behalf of the putative class.  The same day, the Court issued an order granting both motions, entering judgment in favor of the plaintiffs and the settlement class consistent with the settlement agreement, and dismissing all claims with prejudice.

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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. On December 4, 2019 the court entered a stipulation consolidating the suit with a separate shareholder derivative suit filed in July 2019, as described below.   On December 6, 2019, the Company filed a motion to dismiss the consolidated cases. On January 14, 2020, the parties reached an agreement in principle to resolve the consolidated cases, subject to the execution of a mutually acceptable settlement document and Court approval. 

In July 2019, a shareholder derivative lawsuit was filed against certain of the Company’s current and former officers and directors in the federal court for the Eastern District of Pennsylvania. 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 and that certain of the defendants caused the Company to violate Sections 10(b), 14(a), and 29(b) of the Securities Exchange Act of 1934. In October 2019, this suit was transferred to the federal court for the District of Delaware and is pending before the same judge presiding over the shareholder derivative suit that was filed in May 2019. On December 4, 2019, the Court entered a stipulation consolidating the suit with a separate shareholder derivative suit filed in May 2019, as described above.   On December 6, 2019, the Company filed a motion to dismiss the consolidated cases.  On January 14, 2020, the parties reached an agreement in principle to resolve the consolidated cases, subject to the execution of a mutually agreeable settlement document and Court approval. 

The settlement of the two consolidated cases, if approved by the Court, will require the Company to implement certain new corporate policies and pay the plaintiffs’ counsel in the consolidated cases, collectively, the sum of $600,000 in exchange for a release of all liability with respect to both of the consolidated cases.  On March 23, 2020, the parties executed a Memorandum of Understanding setting forth the terms of their agreement.  On March 27, 2020, the parties jointly submitted a letter to the Court enclosing the executed Memorandum of Understanding and stating that the parties intend to execute and file a formal settlement stipulation for approval by the Court.  As a result of the pending settlement, on April 8, 2020 the parties entered into a stipulation to extend time for Plaintiffs to respond to Defendants’ motion to dismiss and joinder until April 24, 2020.  The Court granted the stipulation on April 16, 2020.  

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 gross mismanagement, and alleges that certain of the defendants caused the Company to violate Section 14(a) of the Securities and Exchange Act of 1934. On November 22, 2019, the Company filed a motion to dismiss the complaint. On January 9, 2020, the parties filed a stipulation to stay the case pending the resolution of the defendants’ motion to dismiss the two earlier filed consolidated shareholder derivative cases referenced above.  On January 16, 2020, the Court entered the parties’ stipulation.  On February 14, 2020, the parties filed a stipulation to withdraw the Company’s motion to dismiss without prejudice to the Company’s ability to refile a renewed motion to dismiss after the stay is lifted.  On February 18, 2020, the Court entered the parties’ stipulation.  On March 11, 2020, following notice that Plaintiffs no longer consented to the stay, the Court lifted the stay. On March 16, 2020, the parties filed a stipulation setting a briefing schedule for a renewed motion to dismiss.  On March 17, 2020, the Court entered the parties’ stipulation.  The Company cannot reasonably predict the outcome of the suit at this time.    On April 6, 2020, certain of the Defendants, including the Company, filed a renewed motion to dismiss or, in the alternative, to stay the account, and an opening brief in support thereof.  On April 24, 2020, the parties stipulated to stay the action, pending a decision from the Court regarding the settlement in the derivative actions discussed above.  The Court granted the Stipulation on April 29, 2020.

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In February 2020, a shareholder derivative lawsuit was filed against certain of the Company’s current and former officers, directors and employees in the Court of Chancery of the State 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, and were unjustly enriched.  On March 16, 2020, the Company filed a motion to dismiss the complaint, and a motion to stay the proceedings.  On March 27, 2020, the Company filed its opening brief in support of its motion to stay the proceedings.  On April 6, 2020, the parties entered into a stipulation and proposed order to stay the action, which was subsequently granted by the Court that same day.  Under the terms of the stipulated stay, the action shall be stayed pending a decision from the Court in the shareholder derivative lawsuit filed in May 2019 on the approval of the settlement.

 

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 solution product.  The Company denies that it is falsely advertising its cocaine 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. On November 20, 2019, Genus filed a second amended complaint. On December 17, 2019, the Company filed an answer to the second amended complaint. 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.

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 12.  Commitments

Leases

The Company’s adoption of ASU No. 2016-02 resulted in an increase in the Company’s assets and liabilities of $7.9 million at July 1, 2019.    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.  At March 31, 2020, the Company has a ROU lease asset of $9.8 million and a ROU liability of $11.2 million, of which $1.0 million and $10.2 million represent the current and non-current balance, respectively.

In November 2019, the Company signed an eight year lease for its new headquarters in Trevose, Pennsylvania.  The Company is currently providing lease improvements and has met the lease commencement date criteria under ASC Topic 842 Leases as of March 31, 2020.   Accordingly, the Company recorded a ROU lease asset and liability totaling $4.3 million, respectively, in the third quarter of Fiscal 2020.

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Components of lease cost are as follows:

 

 

 

 

 

 

 

 

 

Three Months Ended

 

Nine Months Ended

(In thousands)

    

March 31, 2020

    

March 31, 2020

Operating lease cost

 

$

642

 

$

1,713

Variable lease cost

 

 

32

 

 

93

Short-term lease cost (a)

 

 

194

 

 

473

Total

 

$

868

 

$

2,279


(a)

Not recorded on the Consolidated Balance Sheet.

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

 

 

 

 

 

 

Nine Months Ended

(In thousands)

    

March 31, 2020

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

 

 

 

Operating cash flows from operating leases

 

$

1,439

Non-cash activity:

 

 

 

ROU assets obtained in exchange for new operating lease liabilities

 

$

4,317

 

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

 

 

 

 

 

 

Nine Months Ended

 

 

    

March 31, 2020

 

Weighted-average remaining lease term

 

 9

years

Weighted-average discount rate

 

7.90

%

 

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

 

 

 

 

(In thousands)

    

Amounts Due

2020

 

$

502

2021

 

 

1,101

2022

 

 

2,125

2023

 

 

2,144

2024

 

 

2,164

Thereafter

 

 

7,932

Total lease payments

 

 

15,968

Less: Imputed interest

 

 

4,734

Present value of lease liabilities

 

$

11,234

 

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 twelve-month periods ending June 30 thereafter are as follows:

 

 

 

 

(In thousands)

    

Amounts Due

2020

 

$

1,898

2021

 

 

1,450

2022

 

 

1,123

2023

 

 

1,123

2024

 

 

1,123

Thereafter

 

 

3,839

Total

 

$

10,556

 

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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 March 31, 2020, $6.4 million was outstanding under the revolving loan and is included in other assets.  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.

In the second quarter of Fiscal 2020, the Company executed a License and Collaboration Agreement 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.  Under the terms of the deal, among other things, the Company shall fund up to the initial $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.    To date, the COVID-19 pandemic has not had a material impact on the development of the insulin glargine product.  The longer that countries around the world remain on lockdown, the more likely it becomes that the timing of the product development and approval will be delayed. 

Note 13.  Accumulated Other Comprehensive Loss

The Company’s Accumulated Other Comprehensive Loss was comprised of the following components as of March 31, 2020 and 2019:

 

 

 

 

 

 

 

 

 

 

March 31, 

(In thousands)

    

2020

    

2019

Foreign Currency Translation

 

 

 

 

 

 

Beginning Balance, June 30

 

$

(615)

 

$

(515)

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

 

 

(26)

 

 

(56)

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

 

 

 —

 

 

 —

Other comprehensive income (loss), net of tax

 

 

(26)

 

 

(56)

Ending Balance, March 31

 

 

(641)

 

 

(571)

Total Accumulated Other Comprehensive Loss

 

$

(641)

 

$

(571)

 

 

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Note 14. Earnings (Loss) Per Common Share

A reconciliation of the Company’s basic and diluted earnings (loss) per common share is as follows:

 

 

 

 

 

 

 

 

 

Three Months Ended

 

 

March 31, 

(In thousands, except share and per share data)

    

2020

    

2019

Numerator:

 

 

 

 

 

 

Net income (loss)

 

$

(16,592)

 

$

10,645

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 income (loss)

 

$

(16,592)

 

$

10,645

 

 

 

 

 

 

 

Denominator:

 

 

 

 

 

 

Basic weighted average common shares outstanding

 

 

38,707,049

 

 

37,842,224

Effect of potentially dilutive options and restricted stock awards

 

 

 —

 

 

1,488,623

Effect of conversion of the Notes

 

 

 

 

Diluted weighted average common shares outstanding

 

 

38,707,049

 

 

39,330,847

 

 

 

 

 

 

 

Earnings (loss) per common share:

 

 

 

 

 

 

Basic

 

$

(0.43)

 

$

0.28

Diluted

 

$

(0.43)

 

$

0.27

 

 

 

 

 

 

 

 

 

 

Nine Months Ended

 

 

March 31, 

(In thousands, except share and per share data)

    

2020

    

2019

Numerator:

 

 

 

 

 

 

Net loss

 

$

(23,665)

 

$

(264,521)

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

 

$

(23,665)

 

$

(264,521)

 

 

 

 

 

 

 

Denominator:

 

 

 

 

 

 

Basic weighted average common shares outstanding

 

 

38,539,850

 

 

37,729,099

Effect of potentially dilutive options and restricted stock awards

 

 

 

 

Effect of conversion of the Notes

 

 

 

 

Diluted weighted average common shares outstanding

 

 

38,539,850

 

 

37,729,099

 

 

 

 

 

 

 

Loss per common share:

 

 

 

 

 

 

Basic

 

$

(0.61)

 

$

(7.01)

Diluted

 

$

(0.61)

 

$

(7.01)

 

The number of anti-dilutive shares that have been excluded in the computation of diluted loss and earnings per share for the three months ended March 31, 2020 and 2019 were 7.8 million and 481 thousand, respectively.  The number of anti-dilutive shares that have been excluded in the computation of diluted loss per share for the nine months ended March 31, 2020 and 2019 were 6.0 million and 2.0 million, respectively.  The effect of potentially dilutive shares was excluded from the calculation of diluted loss per share in the three and nine months ended March 31, 2020 and the nine months ended March 31, 2019 because the effect of including such securities would be anti-dilutive.

 

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Note 15.  Share-based Compensation

At March 31, 2020, 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 6.5 million shares to be issued.  As of March 31, 2020, the plans have a total of 1.2 million shares available for future issuances.  

Historically, the Company issued 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 March 31, 2020, there was $11.4 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 2.3 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 nine months ended March 31, 2020 and 2019, the estimated annual forfeiture rates used to recognize the associated compensation expense and the weighted average fair value of the options granted:

 

 

 

 

 

 

 

 

 

 

Nine Months Ended

    

 

 

March 31, 2020

 

March 31, 2019

 

Risk-free interest rate

 

 

1.9

%

 

2.9

%

Expected volatility

 

 

73.7

%

 

58.4

%

Expected dividend yield

 

 

 —

%

 

 —

%

Forfeiture rate

 

 

 —

%

 

6.5

%

Expected term

 

 

5.1

years

 

5.3

years

Weighted average fair value

 

$

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 summary as of March 31, 2020 and changes during the nine months then ended, is presented below:

 

 

 

 

 

 

 

 

 

 

 

 

    

    

    

 

 

    

 

 

    

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

 

(50)

 

5.60

 

$

210

 

 

Forfeited, expired or repurchased

 

(34)

 

24.89

 

 

 

 

 

Outstanding at March 31, 2020

 

1,010

 

12.22

 

$

503

 

5.8

 

 

 

 

 

 

 

 

 

 

 

Vested and expected to vest at March 31, 2020

 

1,008

 

12.21

 

$

503

 

5.8

Exercisable at March 31, 2020

 

513

 

16.85

 

$

334

 

2.6

 

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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 nine months ended March 31, 2020 and 2019.

A summary of restricted stock awards as of March 31, 2020 and changes during the nine months then ended, is presented below:

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted

 

 

 

 

 

 

 

Average Grant -

 

Aggregate

(In thousands, except for weighted average price data)

    

Awards

    

date Fair Value

    

Intrinsic Value

Non-vested at June 30, 2019

 

1,288

 

$

11.63

 

 

 

Granted

 

941

 

 

6.45

 

 

 

Vested

 

(751)

 

 

10.47

 

$

6,231

Forfeited

 

(70)

 

 

12.50

 

 

 

Non-vested at March 31, 2020

 

1,408

 

$

8.75

 

 

 

 

Performance-Based Shares

In September 2017, the Company began 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 March 31, 2020 and changes during the current fiscal year, is presented below:

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted

 

 

 

 

 

 

 

Average Grant -

 

Aggregate

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

    

Awards

    

date Fair Value

    

Intrinsic Value

Non-vested at June 30, 2019

 

72

 

$

19.92

 

 

  

Granted

 

178

 

$

10.71

 

 

  

Vested

 

(46)

 

$

15.08

 

$

477

Forfeited

 

 —

 

$

 —

 

 

  

Non-vested at March 31, 2020

 

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 nine months ended March 31, 2020 and 2019, 83 thousand shares and 143 thousand shares were issued under the ESPP, respectively.  As of March 31, 2020, 874 thousand total cumulative shares have been issued under the ESPP.

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Table of Contents

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

 

Nine Months Ended

 

 

 

March 31, 

 

March 31, 

 

(In thousands)

    

2020

    

2019

    

2020

    

2019

 

Selling, general and administrative expenses

 

$

1,124

 

$

1,125

 

$

5,965

 

$

4,434

 

Research and development expenses

 

 

180

 

 

208

 

 

618

 

 

608

 

Cost of sales

 

 

566

 

 

656

 

 

1,753

 

 

1,932

 

Total

 

$

1,870

 

$

1,989

 

$

8,336

 

$

6,974

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Tax benefit at statutory rate

 

$

421

 

$

447

 

$

1,876

 

$

1,569

 

 

 

Note 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.  Contributions to the Plan totaled $0.6 million during each of the three months  ended March 31, 2020 and 2019.  Contributions to the Plan totaled $1.7 million during each of the nine months ended March 31, 2020 and 2019.

 

In Fiscal 2020, the Company implemented a non-qualified deferred compensation plan for certain senior-level management and executives.  The non-qualified deferred compensation plan allows certain eligible employees to defer additional pre-tax earnings for retirement, beyond the IRS limits in place under the Plan.  Contributions to the non-qualified deferred compensation plan during the three and nine months ended March 31, 2020 were not material. 

 

Note 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 benefit for the three months ended March 31, 2020 was $1.7 million compared to an income tax expense of $1.4 million for the three months ended March 31, 2019.  The effective tax rates for the three months ended March 31, 2020 and 2019 were 9.1% and 11.3%, respectively.  The effective tax rate for the three months ended March 31, 2020 was lower compared to the three months ended March 31, 2019 primarily due to a non-deductible branded prescription drug fee as well as tax credits and deductions relative to a higher pre-tax loss in the three months ended March 31, 2020.

The federal, state and local income tax benefit for the nine months ended March 31, 2020 was $5.2 million compared to $71.6 million for the nine months ended March 31, 2019.  The effective tax rates for the nine months ended March 31, 2020 and 2019 were 18.0% and 21.3%, respectively.  The effective tax rate for the nine months ended March 31, 2020 was lower compared to the nine months ended March 31, 2019 primarily due to the impact of excess tax shortfalls related to stock compensation as well as a non-deductible branded prescription drug fee, partially offset by research and development credits relative to expected pre-tax loss.

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.

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As of March 31, 2020 and June 30, 2019, the Company has total unrecognized tax benefits of $2.3 million and $2.2 million, respectively, of which $2.1 million would impact the Company’s effective tax rate for each period, if recognized.  As a result of the positions taken during the period, the Company has not recorded any material interest and penalties for the period ended March 31, 2020 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 March 31, 2020 and June 30, 2019.  The Company will recognize interest accrued on unrecognized tax benefits in interest expense and any related penalties in operating expenses.    

The Company files income tax returns in the United States federal jurisdiction and various states.  The Company’s federal 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 2015 through 2017 federal returns are currently under examination by the Internal Revenue Service (“IRS”).  In October 2018, the Company was notified that the Commonwealth of Pennsylvania will conduct a routine field audit of the Company’s Fiscal 2016 and Fiscal 2017 corporate tax returns.  In December 2019, the Company was notified that the Florida Department of Revenue will conduct a routine field audit of the Company’s Fiscal 2016, 2017 and 2018 corporate tax returns.    The Company cannot reasonably predict the outcome of the examinations at this time. 

 

Note 18.  Related Party Transactions

The Company had sales of $0.9 million during each of the three months ended March 31, 2020 and 2019, to a generic distributor, Auburn Pharmaceutical Company (“Auburn”), which is a member of the Premier Buying Group.  Sales to Auburn for the nine months ended March 31, 2020 and 2019 were $2.1 million and $2.4 million, respectively.  Jeffrey Farber, a current board member, is the owner of Auburn.  Accounts receivable includes amounts due from Auburn of $0.8 million and $1.2 million at March 31, 2020 and June 30, 2019, respectively.

The Company also had sales of $0.7 million and $0.5 million during the three months ended March 31, 2020 and 2019, respectively, to a generic distributor, KeySource, which is a member of the OptiSource Buying Group.  Sales to KeySource for the nine months ended March 31, 2020 and 2019 were $1.9 million and $2.0 million, respectively.  Albert Paonessa,  a board member until the date of the Company’s 2020 Annual Meeting of Stockholders, was appointed the CEO of KeySource in May 2017.  Accounts receivable includes amounts due from KeySource of $0.8 million and $0.7 million as of March 31, 2020 and June 30, 2019, respectively.

 

Note 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 a result of the 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 in the first quarter of Fiscal 2019. 

The Company 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 the Company’s cocaine hydrochloride solution Section 505(b)(2) NDA application and to have Cody Labs cease all operations.  During the first nine months of Fiscal 2020, the Company completed the sale of the equipment associated with the Cody API business for $3.0 million.  In the second quarter of Fiscal 2020, the Company signed a two-year agreement to lease a portion of the real estate to a third party.  As of March 31, 2020, the real estate associated with the Cody API business, totaling $2.7 million, was recorded in the assets held for sale caption in the Consolidated Balance Sheet.

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Table of Contents

The following table summarizes the financial results of the Cody API business for the three and nine months ended March 31, 2020 and 2019:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

March 31, 

 

March 31, 

 

(In thousands)

   

2020

   

2019

   

2020

   

2019

 

Net sales

 

$

 —

 

$

 —

 

$

1,067

 

$

2,142

 

Pretax loss attributable to Cody API business

 

 

(1,279)

 

 

(2,502)

 

 

(6,340)

 

 

(41,837)

 

 

The pretax loss attributable to the Cody API business during the nine months ended March  31, 2020 includes a full impairment of a  $1.2 million ROU lease asset 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 nine months ended March  31, 2019 includes impairment charges totaling $29.9 million to adjust the long-lived assets to its fair value less costs to sell.

 

Note 20.  Subsequent Event

 

In December 2019, the COVID-19 virus emerged in Wuhan, China and spread to other parts of the world.  In March 2020, the World Health Organization (“WHO”) designated COVID-19 a global pandemic.  Governments on the national, state and local level in the United States, and around the world, have implemented lockdown and shelter-in-place orders, requiring many non-essential businesses to shut down operations for the time being.  The Company’s business, however, is deemed “essential” and it has continued to operate and has continued to manufacture and distribute its medicines to customers. 

 

In light of the economic impacts of COVID-19, the Company performed a review of the assets on our consolidated balance sheet as of March 31, 2020, including intangible and other long-lived assets.  Based on our review, we continue to believe that we will be able to realize the full value of our assets and that a triggering event does not exist at this time.  As such, no impairments or other write-downs were recorded during the three and nine months ended March 31, 2020 specifically related to COVID-19.  Our assessment was based on information currently available and is highly reliant on various assumptions which include estimates of future cash flows and the probability of achieving the estimated cash flows.  Changes in market conditions or other changes in the future outlook may lead to impairments in the future.

 

While COVID-19 has thus far not had a material impact on the Company’s operations, we cannot reasonably predict the ultimate impact of COVID-19 on our future results of operations and cashflows due to the continued uncertainty around the duration and severity of the pandemic.

 

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Table of Contents

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 (“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 and other events or factors, many of which are beyond our control, including those resulting from such events, or the prospect of such events, such as public health issues including health epidemics or pandemics, such as the recent outbreak of the novel coronavirus (“COVID-19”), whether occurring in the United States or elsewhere, which could disrupt our operations, disrupt the operations of our suppliers and business development and other strategic partners, disrupt the global financial markets or result in political or economic instability.

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, 2019.  All references to “Fiscal 2020” or “Fiscal Year 2020” shall mean the fiscal year ending June 30, 2020 and all references to “Fiscal 2019” or “Fiscal Year 2019” shall mean the fiscal year ended June 30, 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.

The Company operates pharmaceutical manufacturing plants in 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.

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Impact of COVID-19 Pandemic

In December 2019, the COVID-19 virus emerged in Wuhan, China and spread to other parts of the world.  In March 2020, the World Health Organization (“WHO”) designated COVID-19 a global pandemic.  Governments on the national, state and local level in the United States, and around the world, have implemented lockdown and shelter-in-place orders, requiring many non-essential businesses to shut down operations for the time being.  The Company’s business, however, is deemed “essential” and it has continued to operate and has continued to manufacture and distribute its medicines to customers.  The Company has developed a comprehensive plan that enables it to maintain operational continuity with an emphasis on manufacturing, distribution and R&D facilities during this crisis, and to date, has not encountered any significant obstacles implementing its business continuity plans.  However, the Company continually assesses COVID-19 related developments and adjusts its risk mitigation planning and business continuity activities as needed. 

In mid-March, 2020, the Company instituted a work from home process for all employees,  other than employees in our manufacturing plants, distribution center, and R&D facilities which support manufacturing.  For employees who cannot perform their job remotely, the Company has implemented enhanced cleaning and sanitizing procedures, weekly fogging and provided additional personal hygiene supplies and personal protective equipment such as rubber gloves, N95 respirators and powered air-purifying respirator that are in line with Centers for Disease Control and Preventions (“CDC”) recommendations.  The Company has also implemented thermal screening for all employees entering its plants.  Employees are required to adhere to the CDC guidelines, social distancing and any employee experiencing any symptoms of COVID-19 are required to stay home and seek medical attention.  Any employee who tests positive for COVID-19 is required to quarantine and is not allowed to return to the facilities without a physician’s release.  The Company has closed its facilities to outside persons that are not critical to continuing our operations. In cases where they are essential, visitors undergo a pre-admittance check to include a thermal screening and risk evaluation. While the Company has experienced some increased absenteeism, to date the rate of employee absenteeism has not had any material effect on the Company’s business or its ability to manufacture and distribute products and plants continue to operate at normal capacity.  As the pandemic continues to spread over time, there is an increased risk of employee absenteeism which could materially impact the Company’s operations.  To date, the Company’s work from home process has not materially impacted the Company’s financial reporting systems or controls over financial reporting and disclosures nor do we expect that the remote work arrangement will have a material impact in the future.

Currently and as anticipated for the near future, the supply chain supporting the Company’s products remains intact, enabling the Company to receive sufficient inventory of the key materials needed across the Company’s network.  The Company is experiencing some delays and allocations for certain raw materials of higher demand, which delays, to date, have not had a material impact on its results of operations.  However, the Company is regularly communicating with its suppliers, third-party partners, customers, healthcare providers and government officials in order to respond rapidly to any issues as they arise.  The longer the current situation continues, it is more likely that the Company may experience some sort of interruption to its supply chain, and such an interruption could materially affect its business, including but not limited to, our ability to timely manufacture and distribute its products as well as unfavorably impact our results of operations.

As a result of the pandemic, certain clinical trials which were underway or scheduled to begin have been temporarily placed on hold.  Such delays will impact the Company’s timing for filing applications for product approvals with the FDA as well as related timing of FDA approval of such filings.  Additionally, the pandemic has slowed down the Company’s efforts to expand its product portfolio through acquisitions and distribution opportunities, impacting the speed with which the Company is able to bring additional products to market.  While there have been some efforts by some of our customers to increase their inventory levels for the Company’s products in the near term, the Company has not seen significant increases in demand.  The Company does not anticipate any significant changes in demand for its products in the future, however, depending on the duration and severity of the outbreak, levels of demand may change.  The Company currently markets an HIV product, Lopinavir-Ritonavir, which is the subject of clinical trials by the WHO to combat the virus.  If those clinical trials show the product to be effective in combating the virus, the Company may see an increase in demand.  There are other sources of the product including the original brand.

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In light of the economic impacts of COVID-19, the Company performed a review of the assets on our consolidated balance sheet as of March 31, 2020, including intangible and other long-lived assets.  Based on our review, we continue to believe that we will be able to realize the full value of our assets and that a triggering event does not exist at this time.  As such, no impairments or other write-downs were recorded during the three and nine months ended March 31, 2020 specifically related to COVID-19.  Our assessment was based on information currently available and is highly reliant on various assumptions which include estimates of future cash flows and the probability of achieving the estimated cash flows.  Changes in market conditions or other changes in the future outlook may lead to impairments in the future.

As of March 31, 2020, the Company’s outstanding debt balance was $724.7 million, of which $95.1 million represents the current portion.  In addition, the Company’s existing revolving credit facility is scheduled to mature on November 25, 2020.  The impacts of COVID-19 have adversely affected the capital markets and the ability for many companies to access capital and liquidity on favorable terms or at all.  The Company believes it has sufficient liquidity and cashflows to meet its operating and debt service requirements for at least the next twelve months from the issuance of the March 31, 2020 consolidated financial statements.  The Company also expects to be in compliance with its financial covenants during the same period.  However, the Company is currently unable to predict the precise impact that COVID-19 will have on its ability to access capital in the future.  If the Company is unable to access additional capital and liquidity on acceptable terms, it could adversely impact the Company’s ability to meet its future obligations beyond the next twelve months subsequent to the issuance of the March 31, 2020 consolidated financial statements as well as unfavorably impact our results of operations.

Based on the foregoing, the Company cannot reasonably predict the ultimate impact of COVID-19 on our future results of operations and cashflows due to the continued uncertainty around the duration and severity of the pandemic.

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 August 2018, JSP notified the Company that it would not extend or renew the JSP Distribution Agreement.  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.  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 in Fiscal 2019.  On March 23, 2019, the JSP Distribution Agreement expired and was not renewed or extended.

Net sales of JSP products totaled $202.5 million in Fiscal Year 2019.  Of that amount, Levothyroxine Sodium Tablets USP net sales totaled $197.5 million in Fiscal Year 2019, with gross margins of approximately 60%.

Because products covered by the JSP Distribution Agreement generated 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.  When announced on August 20, 2018, this resulted in a significant decline in the Company’s market capitalization.

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As noted above, JSP’s decision not to renew or extend its distribution agreement with us has 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.  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.  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 March 31, 2020, the Company was in compliance with its financial covenants.  As of March 31, 2020, cash and cash equivalents totaled $101.5 million in addition to availability under our undrawn Revolver totaling $125.0 million.

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 execute 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 40 new products since January 2018, which are expected to generate annualized net sales of over $160 million and plans to maintain this pace of new product launches going forward.  The Company has also recently signed several distribution and in-licensing agreements that will provide both immediate and longer-term contribution margins.  Additionally, the Company has 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 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.

Cody API Restructuring Plan

On June 11, 2019, the Company approved a restructuring plan (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 distribution business of Cody Labs (the “Cody API business”) but the Company was unable to sell the Cody API business as an ongoing operation.  Therefore, the Company decided to sell the equipment and real estate utilized by the Cody API business and to have Cody Labs cease all operations.  In connection with the Cody API Restructuring Plan, the Company eliminated approximately 70 positions at Cody Labs.  The restructuring activities under the Cody API Restructuring Plan are substantially complete as of March 31, 2020.  During the first nine months of Fiscal 2020, the Company completed the sale of the equipment associated with the Cody API business for $3.0 million.  In the second quarter of Fiscal 2020, the Company signed a two-year agreement to lease a portion of the Cody Labs real estate to a third party.

The costs to implement the Cody API Restructuring Plan totaled 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 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.

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Financial Summary

For the third quarter of Fiscal Year 2020, net sales decreased to $144.4 million as compared to $172.8 million in the same prior-year period.  Gross profit decreased to $41.7 million compared to $65.3 million in the prior-year period and gross profit percentage decreased to 29% compared to 38% in the prior-year period.  R&D expenses decreased 24% to $7.4 million compared to $9.8 million in the third quarter of Fiscal Year 2019 while SG&A expenses increased 2% to $22.1 million from $21.6 million. Operating loss for the third quarter of Fiscal Year 2020, which included an asset impairment charge totaling $14.0 million, was $2.1 million compared to operating income of $33.4 million in the same prior-year period.  Net loss for the third quarter of Fiscal Year 2020 was $16.6 million, or $(0.43) per diluted share compared to net income of $10.6 million, or $0.27 per diluted share in the third quarter of Fiscal Year 2019.

For the first nine months of Fiscal 2020, net sales decreased to $407.8 million compared to $521.6 million in the same prior-year period.  Gross profit decreased to $125.6 million compared to $194.3 million in the prior-year period.  Gross profit percentage decreased to 31% compared to 37% in the prior-year period.  R&D expenses decreased 21% to $23.3 million compared to $29.4 million in the first nine months of Fiscal 2019 while SG&A expenses decreased 7% to $60.9 million from $65.4 million in the prior-year period.  Operating income for the first nine months of Fiscal 2020, which included asset impairment charges totaling $15.6 million, was $24.1 million compared to an operating loss of $271.7 million in the prior-year period, which included asset impairment charges totaling $369.5 million.  Net loss for the first nine months of Fiscal 2020 was $23.7 million, or $(0.61) per diluted share compared to net loss of $264.5 million, or $(7.01) per diluted share in the prior-year period.

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

Results of Operations - Three months ended March 31, 2020 compared with the three months ended March 31, 2019

Net sales decreased to $144.4 million for the three months ended March 31, 2020 as compared to the prior-year period.  The table below identifies the Company’s net product sales by medical indication for the three months ended March 31, 2020 and 2019.  The medical indication categories for the three months ended March 31, 2019 was reclassified to better align with industry standards and the Company’s peers.

 

 

 

 

 

 

 

(In thousands)

 

Three Months Ended March 31, 

Medical Indication

    

2020

    

2019

Analgesic

 

$

2,811

 

$

946

Anti-Psychosis

 

 

27,858

 

 

20,616

Cardiovascular

 

 

21,746

 

 

22,783

Central Nervous System

 

 

18,566

 

 

15,906

Endocrinology

 

 

 —

 

 

55,210

Gastrointestinal

 

 

20,745

 

 

16,501

Infectious Disease

 

 

21,749

 

 

4,162

Migraine

 

 

12,886

 

 

9,846

Respiratory/Allergy/Cough/Cold

 

 

2,966

 

 

2,549

Urinary

 

 

1,149

 

 

2,096

Other

 

 

8,051

 

 

14,247

Contract manufacturing revenue

 

 

5,845

 

 

7,932

Total net sales

 

$

144,372

 

$

172,794

 

The decrease in net sales was driven by decreased volumes of $17.1 million as well as a decrease in the average selling price of products of $11.3 million.  Overall volumes decreased primarily due to the loss of 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.  Net sales within the infectious disease category increased significantly as a result of the distribution and supply agreement with Sinotherapeutics Inc., which was signed in August 2019, to distribute Posaconazole tablets.

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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 $9.3 million and $8.0 million during the three months ended March 31, 2020 and 2019, respectively.

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

 

 

 

 

 

 

 

 

Sales volume

 

Sales price

 

Medical indication

    

change %

  

change %

 

Analgesic

 

72

%  

125

%

Anti-Psychosis

 

29

%  

 6

%

Cardiovascular

 

 1

%  

(6)

%

Central Nervous System

 

44

%  

(27)

%  

Endocrinology

 

(100)

%  

 —

%  

Gastrointestinal

 

35

%  

(9)

%  

Infectious Disease

 

429

%  

(6)

%  

Migraine

 

52

%  

(21)

%  

Respiratory/Allergy/Cough/Cold

 

12

%  

 4

%  

Urinary

 

(144)

%  

99

%  

 

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. 

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.  On January 10, 2020, the FDA denied the second Citizen Petition and the FDA approved the Company’s Section 505(b)(2) NDA application.  On January 27, 2020, the competitor filed a complaint against the FDA seeking an order invalidating the approval of the Company’s 505(b)(2) NDA, claiming the approval violates the competitor’s five-year exclusivity.  On February 14, 2020, the Company filed a motion to intervene in the competitor’s lawsuit in order to argue that the request for relief be denied.  On April 15, 2020, the competitor filed a motion for summary judgment.  The Company and FDA are required a response in opposition and cross motions for summary judgment on or before May 6, 2020.  Further reply briefing is scheduled through May 27, 2020.

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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 (“CRL”) related to issues at its API supplier.  The Company filed a response to the CRL.  The Company received a second Major CRL in the first quarter of Fiscal 2020 related to continued issues at the API supplier, as well as issues with the Risk Evaluation and Mitigation Strategy (“REMS”) program hosted by Celgene.  The Company is working on addressing the FDA comments and expects its product launch to be delayed until Fiscal Year 2021.

Ranitidine Oral Solution, USP

As part of an industry-wide action, the Company is voluntarily recalling all lots within expiry of Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL to the consumer level due to levels 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 the Company immediately commenced testing and analysis of the active pharmaceutical ingredient (“API”) and drug product and confirmed the presence of NDMA.  The Company is in the process of switching its API supplier for its Ranitidine Oral Solution, USP product.  The Company’s net sales of Ranitidine Oral Solution in the fourth quarter of fiscal year 2019 totaled $1.9 million.  On April 1, 2020, the FDA ordered all Ranitidine products (including the Company’s product) withdrawn from the US market and provided guidance on the requirements for submitting additional information to the FDA in order to re-introduce the product to the market.  Since initiating the voluntary recall, the Company has not been marketing its Ranitidine Oral Solution product and has no future plans to attempt to re-introduce the product at this time.  The Company does not believe the recall will have a significant impact on our future expected financial position, results of operations and cash flows.

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:

 

 

 

 

 

 

 

(In thousands)

 

March 31, 

 

March 31, 

Customer Distribution Channel

    

2020

    

2019

Wholesaler/Distributor

 

$

116,025

 

$

150,726

Retail Chain

 

 

18,951

 

 

11,841

Mail-Order Pharmacy

 

 

3,551

 

 

2,295

Contract manufacturing revenue

 

 

5,845

 

 

7,932

Total net sales

 

$

144,372

 

$

172,794

 

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 decrease in sales to wholesalers and mail-order pharmacies was consistent with the decrease in overall net sales.  Retail chain sales benefited from increased orders on certain key products in the three months ended March 31, 2020 as compared to the same prior-year period.

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Cost of Sales, including amortization of intangibles. Cost of sales, including amortization of intangibles for the third quarter of Fiscal Year 2020 decreased 4% to $102.7 million from $107.5 million in the same prior-year period.  The decrease was primarily attributable to the loss of Levothyroxine sales associated with the expiration of the JSP Distribution Agreement, partially offset by additional volumes of products sold as well as increased product royalties expense related to various distribution agreements.  Product royalties expense included in cost of sales totaled $21.4 million for the third quarter of Fiscal Year 2020 and $10.7 million for the third quarter of Fiscal Year 2019.  Amortization expense included in cost of sales totaled $8.3 million for the third quarter of Fiscal 2020 compared to $7.9 million in the same prior-year period.

Gross Profit. Gross profit for the third quarter of Fiscal 2020 decreased 36% to $41.7 million or 29% of net sales.  In comparison, gross profit for the third quarter of Fiscal 2019 was $65.3 million or 38% of net sales.  The decrease in gross profit percentage was primarily attributable to the loss of Levothyroxine sales associated with the expiration of the JSP Distribution Agreement, which had higher than average gross profit margins, as well as increased product royalties expense related to various distribution agreements.

Research and Development Expenses. Research and development expenses for the third quarter decreased 24% to $7.4 million in Fiscal Year 2020 from $9.8 million in Fiscal Year 2019.  The decrease was primarily due to lower R&D expenses as a result of the Company's decision to cease operations at Cody Labs as well as timing of certain milestones related to product development projects.

Selling, General and Administrative Expenses. Selling, general and administrative expenses increased 2% to $22.1 million in the third quarter of Fiscal Year 2020 compared with $21.6 million in Fiscal Year 2019.  The increase was primarily driven by a branded prescription drug fee as well as increased legal costs, partially offset by lower regulatory costs and other cost reduction initiatives.

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

Asset Impairment Charges.  In the third quarter of Fiscal 2020, the Company performed an impairment analysis of its AB-rated Methylphenidate Hydrochloride product, which is distributed under a license agreement with Andor, due to significant declines in the projected profitability of the distribution arrangement.  As a result of the analysis, the Company recorded a $14.0 million impairment charge.  See Note 9 “Goodwill and Intangible Assets” for more information.

Other Income (Loss). Interest expense for the three months ended March 31, 2020 totaled $16.2 million compared to $21.5 million for the three months ended March 31, 2019.  The decrease was due to a lower weighted-average debt balance in the third quarter of Fiscal 2020 as compared to the prior-year period as well as a lower weighted-average interest rate due to the partial repayment of the outstanding Term Loan A balance with proceeds from the issuance of the Notes.  The weighted average interest rate for the third quarter of Fiscal 2020 and 2019 was 8.6% and 10.0%, respectively.  Investment income totaled $0.4 million in the third quarter of Fiscal 2020 compared to $0.9 million in the third quarter of Fiscal 2019.

Income Tax. The Company recorded an income tax benefit of $1.7 million in the third quarter of Fiscal Year 2020 as compared to an income tax expense of $1.4 million in the third quarter of Fiscal Year 2019.  The effective tax rate for the three months ended March 31, 2020 was 9.1%, compared to 11.3% for the three months ended March 31, 2019.  The effective tax rate for the three months ended March 31, 2020 was lower compared to the three months ended March 31, 2019 primarily due to a non-deductible branded prescription drug fee as well as tax credits and deductions relative to a higher pre-tax loss in the three months ended March 31, 2020.

Net Loss. For the three months ended March 31, 2020, the Company reported net loss of $16.6 million, or $(0.43) per diluted share.  Comparatively, net income in the corresponding prior-year period was $10.6 million, or $0.27 per diluted share.

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Results of Operations - Nine months ended March 31, 2020 compared with the nine months ended March 31, 2019

Net sales decreased to $407.8 million for the nine months ended March 31, 2020.  The table below identifies the Company's net product sales by medical indication for the nine months ended March 31, 2020 and 2019.   The medical indication categories for the nine months ended March 31, 2019 was reclassified to better align with industry standards and the Company's peers.

 

 

 

 

 

 

 

(In thousands)

 

Nine Months Ended March 31, 

Medical Indication

    

2020

    

2019

Analgesic

 

$

6,806

 

$

5,322

Anti-Psychosis

 

 

78,588

 

 

45,541

Cardiovascular

 

 

67,325

 

 

70,233

Central Nervous System

 

 

57,154

 

 

37,565

Endocrinology

 

 

 —

 

 

197,565

Gastrointestinal

 

 

56,020

 

 

47,038

Infectious Disease

 

 

51,722

 

 

13,258

Migraine

 

 

32,907

 

 

32,134

Respiratory/Allergy/Cough/Cold

 

 

8,747

 

 

9,521

Urinary

 

 

2,817

 

 

5,233

Other

 

 

27,847

 

 

37,658

Contract manufacturing revenue

 

 

17,891

 

 

20,498

Total net sales

 

$

407,824

 

$

521,566

 

The decrease in net sales was driven by decreased volumes of $82.3 million and, to a lesser extent, decreased average selling price of products of $31.4 million.  Overall volumes decreased primarily due to the loss of 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.  Average selling prices were impacted by product mix and 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.  Net sales within the infectious disease category increased significantly as a result of the distribution and supply agreement with Sinotherapeutics Inc., which was signed in August 2019, to distribute Posaconazole tablets.

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 $31.9 million and $23.0 million during the nine months ended March 31, 2020 and 2019, respectively, which contributed to the overall decreased average selling price.

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

 

 

 

 

 

 

 

 

Sales volume

    

Sales price

 

Medical indication

    

change %

  

change %

 

Analgesic

 

48

%  

(20)

%  

Anti-Psychosis

 

62

%  

11

%

Cardiovascular

 

(9)

%  

 5

%

Central Nervous System

 

79

%  

(27)

%

Endocrinology

 

(100)

%  

 —

%  

Gastrointestinal

 

21

%  

(2)

%

Infectious Disease

 

310

%  

(20)

%  

Migraine

 

23

%  

(21)

%

Respiratory/Allergy/Cough/Cold

 

(8)

%  

 —

%

Urinary

 

(42)

%  

(4)

%

 

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Table of Contents

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 nine months ended:

 

 

 

 

 

 

 

(In thousands)

 

March 31, 

 

March 31, 

Customer Distribution Channel

    

2020

    

2019

Wholesaler/Distributor

 

$

321,953

 

$

420,720

Retail Chain

 

 

59,132

 

 

61,509

Mail-Order Pharmacy

 

 

8,848

 

 

18,839

Contract manufacturing revenue

 

 

17,891

 

 

20,498

Total net sales

 

$

407,824

 

$

521,566

 

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 decrease in sales to wholesalers and mail-order pharmacies was consistent with the decrease in overall net sales.  Retail chain sales benefited from increased orders on certain key products in the nine months ended March 31, 2020 as compared to the same prior-year period.

Cost of Sales, including amortization of intangibles. Cost of sales, including amortization of intangibles for the first nine months of Fiscal 2020 decreased 14% to $282.2 million from $327.3 million in the same prior-year period.  The decrease was primarily attributable to the loss of Levothyroxine sales associated with the expiration of the JSP Distribution Agreement as well as lower cost of sales as a result of the Company’s decision to cease operations at Cody Labs, partially offset by additional volumes of products sold as well as increased product royalties expense related to various distribution agreements.  Product royalties expense included in cost of sales totaled $57.7 million for the first nine months of Fiscal Year 2020 and $27.4 million for the first nine months of Fiscal Year 2019.  Amortization expense included in cost of sales totaled $23.5 million for the first nine months of Fiscal Year 2020 and $24.3 million for the first nine months of Fiscal Year 2019.

Gross Profit. Gross profit for the first nine months of Fiscal 2020 decreased 35% to $125.6 million or 31% of net sales.  In comparison, gross profit for the first nine months of Fiscal 2019 was $194.3 million or 37% of net sales.  The decrease in gross profit percentage was primarily attributable to the loss of Levothyroxine sales associated with the expiration of the JSP Distribution Agreement, which had higher than average gross profit margins, as well as increased product royalties related to various distribution agreements, partially offset by manufacturing efficiencies as a result of cost reduction initiatives.

Research and Development Expenses. Research and development expenses for the first nine months decreased 21% to $23.3 million in Fiscal 2020 from $29.4 million in the same prior-year period.  The decrease was primarily due to lower R&D expenses as a result of the Company’s decision to cease operations at Cody Labs as well as timing of certain milestones related to product development projects.

Selling, General and Administrative Expenses.    Selling, general and administrative expenses decreased 7% to $60.9 million in the first nine months of Fiscal 2020 compared with $65.4 million in the same prior-year period.  The decrease was primarily driven by lower financial advisory costs, a decrease in regulatory-related costs, lower expenses at the Company’s Cody Labs subsidiary and other cost reduction initiatives, partially offset by a branded prescription drug fee as well as increased legal costs.

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

Asset Impairment Charges. In the first nine months 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. 

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In the third quarter of Fiscal 2020, the Company performed an impairment analysis of its AB-rated Methylphenidate Hydrochloride product, which is distributed under a license agreement with Andor, due to significant declines in the projected profitability of the distribution arrangement.  As a result of the analysis, the Company recorded a $14.0 million impairment charge.  See Note 9 “Goodwill and Intangible Assets” for more information.

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 were recorded in the assets and liabilities held for sale captions in the Consolidated Balance Sheet as of 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.

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 9 “Goodwill and Intangible Assets” for more information.

Other Income (Loss). Interest expense in the first nine months of Fiscal 2020 totaled $52.2 million compared to $64.4 million in Fiscal 2019.  The weighted average interest rate for the first nine months of Fiscal 2020 and 2019 was 9.0% and 9.6%, respectively.  Investment income in the first nine months of Fiscal 2020 totaled $1.6 million compared to $1.9 million in the same prior-year period.

Income Tax. The Company recorded an income tax benefit in the first nine months of Fiscal 2020 of $5.2 million compared to an income tax benefit of $71.6 million in the first nine months of Fiscal 2019.  The effective tax rate for the nine months ended March 31, 2020 was 18.0% compared to 21.3% for the nine months ended March 31, 2019.  The effective tax rate for the nine months ended March 31, 2020 was lower compared to the nine months ended March 31, 2019 primarily due to the impact of excess tax shortfalls related to stock compensation as well as a non-deductible branded prescription drug fee, partially offset by research and development credits relative to expected pre-tax loss.

Net Loss. For the nine months ended March 31, 2020, the Company reported net loss of $23.7 million, or $(0.61) per diluted share.  Comparatively, net loss in the corresponding prior-year period was $264.5 million, or $(7.01) per diluted share.

Liquidity and Capital Resources

Cash Flow

The Company had historically financed its operations with cash flow generated from operations supplemented with borrowings from financial institutions.  At March 31, 2020, working capital was $218.6 million as compared to $295.6 million at June 30, 2019, a decrease of $77.0 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 $50.4 million for the nine months ended March 31, 2020 reflected net loss of $23.7 million, adjustments for non-cash items of $76.6 million, as well as cash used through changes in operating assets and liabilities of $2.5 million.  In comparison, net cash provided by operating activities of $181.7 million for the nine months ended March 31, 2019 reflected net loss of $264.5 million, adjustments for non-cash items of $352.3 million, as well as cash provided by changes in operating assets and liabilities of $93.9 million.

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Significant changes in operating assets and liabilities from June 30, 2019 to March 31, 2020 were comprised of:

·

An increase in accounts receivable of $15.6 million mainly due to the timing of sales and cash receipts.  The Company’s days sales outstanding (“DSO”) at March 31, 2020, based on gross sales for the nine months ended March 31, 2020 and gross accounts receivable at March 31, 2020, was 78 days.  The level of DSO at March 31, 2020 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 prepaid income taxes totaling $10.5 million primarily due to estimated tax payments made in the first nine months of Fiscal 2020. 

·

A decrease in accrued payroll and payroll-related costs of $6.8 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.

·

An increase in accounts payable totaling $20.3 million primarily due to the timing of vendor invoices and payments.

Significant changes in operating assets and liabilities from June 30, 2018 to March 31, 2019 were comprised of:

·

A decrease in accounts receivable of $97.7 million primarily as a result of the collection of receivables related to Levothyroxine sales as well as of the timing of receipts.  The Company’s days sales outstanding (“DSO”) at March 31, 2019, based on gross sales for the nine months ended March 31, 2019 and gross accounts receivable at March 31, 2019 was 60 days.  The level of DSO at March 31, 2019 was significantly lower than the Company’s expectations that DSO will be in the 70 to 85 day range based on customer payment terms, due to the receipt of an upfront payment of Levothyroxine sales under the Amneal Agreement.

·

A decrease in prepaid income taxes totaling $15.9 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 $11.3 million primarily due to higher accrued incentive compensation-related costs and, to a lesser extent, the timing of payroll payments.

·

A decrease in accounts payable totaling $25.0 million primarily due to a lower balance as of March 31, 2019 related to the expiration of the JSP Distribution Agreement.  The timing of payments also contributed to the decrease in accounts payable.

Net cash used in investing activities of $33.8 million for the nine months ended March 31, 2020 was mainly the result of purchases of intangible assets of $27.8 million and purchases of property, plant and equipment of $13.1 million, partially offset by proceeds from the sale of property, plant and equipment of $7.3 million.  Net cash used in investing activities of $0.7 million for the nine months ended March 31, 2019 was mainly the result of purchases of property, plant and equipment of $18.5 million and purchases of an intangible asset of $2.0 million, partially offset by proceeds from the sale of property, plant and equipment of $14.2 million and proceeds from the sale of an outstanding VIE loan to a third party of $5.6 million.

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Net cash used in financing activities of $55.4 million for the nine months ended March 31, 2020 was primarily due to debt repayments of $130.0 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 treasury stock totaling $1.9 million, partially offset by proceeds from the issuance of 4.50% Convertible Senior Notes of $86.3 million and proceeds from issuance of stock pursuant to stock compensation plans of $0.8 million.  Net cash used in financing activities of $74.3 million for the nine months ended March 31, 2019 was primarily due to debt repayments of $73.5 million, of which $23.4 million were open market repurchases, payments of debt issuance costs totaling $1.1 million and purchases of treasury stock totaling $0.5 million, partially offset by proceeds from issuance of stock pursuant to stock compensation plans of $0.8 million.

Credit Facility and Other Indebtedness

The Company has previously entered into and may enter future agreements with 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 March 31, 2020 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.

Refer to the Company’s Form 10‑K for the fiscal year ended June 30, 2019 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.

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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” and “Impact of COVID-19 Pandemic” sections above for the impact of each 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.

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 has 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.

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Revenue Recognition

On July 1, 2018, the Company adopted 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.

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.

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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. 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, 2019 for a description of our remaining Critical Accounting Policies.

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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.  Based on the variable-rate debt outstanding at March 31, 2020, each 1/8% increase in interest rates would yield $0.8 million of incremental annual interest expense.  The Company’s variable-rate debt is subject to a 1.0% London Inter-bank Offered Rate (“LIBOR”) floor.

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 nine months ended March 31, 2020 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 11 “Legal, Regulatory Matters and Contingencies” of the Consolidated Financial Statements included in Part I, Item 1 of this Quarterly Report on Form 10‑Q and is incorporated by reference herein.

 

ITEM 1A.  RISK FACTORS

Lannett Company, Inc’s Annual Report on Form 10‑K for the fiscal year ended June 30, 2019 includes a detailed description of its risk factors.

In addition to the information set forth in this Form 10-Q, you should carefully consider the risk factors discussed in Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended June 30, 2019.

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Public health threats, including a pandemic, epidemic or outbreak of an infectious disease in the United States or elsewhere may adversely affect our business and financial results

Our business may be adversely affected by public health threats, including any pandemic, epidemic or outbreak of an infectious disease occurring in the United States or worldwide. In December 2019, a novel strain of coronavirus (“COVID-19”) was identified in Wuhan, China. This virus continues to spread globally and, as of April 2020, has spread to over 175 countries, including the United States, and has been declared a pandemic by the World Health Organization (“WHO”). The spread of COVID-19 has impacted the global economy and may impact our business, operations and financial results.

For example, COVID-19 has resulted in significant governmental “social-distancing” measures being implemented to control the spread of the virus, including quarantines, travel restrictions and business shutdowns.  Any business shutdowns or other business interruptions affecting our suppliers or interruptions in global shipping affecting our suppliers could result in our inability to continue receiving sufficient amount of API and other raw materials.  Any business shutdowns or other business interruptions affecting our business development and other strategic partners could also cause delays in the regulatory approval process for and launching of some or all of our pipeline drug candidates. We cannot presently predict the duration and severity of any potential business shutdowns or disruptions, but if we or any of the third parties with whom we engage, including the partners and other third parties with whom we conduct business, were to experience shutdowns or other business disruptions, our ability to conduct our business in the manner and on the timelines presently planned could be materially and adversely impacted.

Additionally, while the potential economic impact brought by, and the duration of, COVID-19 may be difficult to assess or predict, a widespread pandemic could result in significant disruption of global economies and financial markets, reducing our ability to access funding sources and capital, and our ability to refinance our existing indebtedness on reasonable terms or at all, which could in the future negatively affect our liquidity and our results of operations.

Infections and deaths related to COVID-19 may disrupt the United States’ healthcare and healthcare regulatory systems. Such disruptions could divert healthcare resources away from, or materially delay the FDA approval with respect to, our pending and future drug product applications. It is unknown how long these disruptions could continue, were they to occur. 

In line with the WHO recommendation to practice social distancing, individuals may be more reluctant to go to hospitals or see doctors, and hospitals and doctors may temporarily cease performing elective procedures, all of which could impact the number of overall prescriptions prescribed.  Furthermore, we have taken temporary precautionary measures intended to help minimize the risk of the virus to our employees, including temporarily requiring all employees, other than employees in our manufacturing plants, distribution centers, and R&D facilities, who are able to work from home to work remotely. We have already suspended non-essential travel worldwide for our employees and are discouraging employee attendance at other gatherings. These measures could negatively affect our business. For instance, temporarily requiring many of our employees to work remotely may disrupt our operations or increase the risk of a cybersecurity incident.

The full extent to which COVID-19 may impact our business will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the duration of the outbreak, the severity of COVID-19 or the effectiveness of actions to contain and treat COVID-19, particularly in the geographies where we or our third party suppliers or business development and other strategic partners operate. Given the speed and frequency of continuously evolving developments with respect to this pandemic, we cannot reasonably estimate the magnitude of any impact on our operations and the full extent to which COVID-19 may impact our business, results of operations, liquidity or financial position is uncertain. 

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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

 

 

 

 

 

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

 

 

 

 

 

 

 

 

 

 

 

 

101.INS

 

XBRL Instance Document

 

Filed Herewith

 

 

 

 

 

101.SCH

 

XBRL Extension Schema Document

 

Filed Herewith

 

 

 

 

 

101.CAL

 

XBRL Calculation Linkbase Document

 

Filed Herewith

 

 

 

 

 

101.DEF

 

XBRL Definition Linkbase Document

 

Filed Herewith

 

 

 

 

 

101.LAB

 

XBRL Label Linkbase Document

 

Filed Herewith

 

 

 

 

 

101.PRE

 

XBRL Presentation Linkbase Document

 

Filed Herewith


*   Furnished Herewith

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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: May 7, 2020

By:

/s/ Timothy Crew

 

 

Timothy Crew

 

 

Chief Executive Officer

 

 

 

 

 

 

Dated: May 7, 2020

By:

/s/ John Kozlowski

 

 

John Kozlowski

 

 

Vice President of Finance and Chief Financial Officer

 

 

 

 

 

 

Dated: May 7, 2020

By:

/s/ G. Michael Landis

 

 

G. Michael Landis

 

 

Senior Director of Finance, Principal Accounting Officer and Treasurer

 

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