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 ~~September 30,~~December 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 ~~October~~January 31, ~~2020~~2021
Common stock, par value $0.001 per share		~~41,625,636~~41,401,730

Table of Contents

Table of Contents


			Page No.
PART I. FINANCIAL INFORMATION

	ITEM 1.	FINANCIAL STATEMENTS (UNAUDITED)

		Consolidated Balance Sheets as of ~~September 30,~~December 31, 2020 and June 30, 2020	3

		Consolidated Statements of Operations for the three and six months ended ~~September 30,~~December 31, 2020 and 2019	4

		Consolidated Statements of Comprehensive Income/Loss for the three and six months ended ~~September 30,~~December 31, 2020 and 2019	5

		Consolidated Statements of Changes in Stockholders’ Equity for the three and six months ended ~~September 30,~~December 31, 2020 and 2019	6

		Consolidated Statements of Cash Flows for the ~~three~~six months ended ~~September 30,~~December 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	3437

	ITEM 3.	QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK	4654

	ITEM 4.	CONTROLS AND PROCEDURES	4654

PART II. OTHER INFORMATION

	ITEM 1.	LEGAL PROCEEDINGS	4755

	ITEM 1A.	RISK FACTORS	4755

	ITEM 6.	EXHIBITS	4856

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)


	September 30, 2020		June 30, 2020		December 31, 2020		June 30, 2020
ASSETS
Current assets:
Cash and cash equivalents	$	108,774	$	144,329	$	34,224	$	144,329
Accounts receivable, net		138,796		125,688		160,131		125,688
Inventories		156,478		142,867		122,204		142,867
Income taxes receivable		19,703		14,419		64,570		14,419
Assets held for sale		2,678		2,678		2,678		2,678
Other current assets		15,787		13,227		23,993		13,227
Total current assets		442,216		443,208		407,800		443,208
Property, plant and equipment, net		176,984		179,518		173,157		179,518
Intangible assets, net		369,146		374,735		163,488		374,735
Operating lease right-of-use assets		9,085		9,343		8,650		9,343
Deferred tax assets		120,462		117,890		132,409		117,890
Other assets		14,027		11,861		14,767		11,861
TOTAL ASSETS	$	1,131,920	$	1,136,555	$	900,271	$	1,136,555

LIABILITIES
Current liabilities:
Accounts payable	$	47,539	$	32,535	$	42,670	$	32,535
Accrued expenses		15,609		14,962		4,092		14,962
Accrued payroll and payroll-related expenses		9,581		16,304		8,946		16,304
Rebates payable		43,247		38,175		43,791		38,175
Royalties payable		18,366		20,863		20,782		20,863
Restructuring liability		405		27		161		27
Current operating lease liabilities		2,018		1,097		2,115		1,097
Short-term borrowings and current portion of long-term debt		81,314		88,189		39,345		88,189
Other current liabilities		1,125		2,713		1,770		2,713
Total current liabilities		219,204		214,865		163,672		214,865
Long-term debt, net		586,270		592,940		578,483		592,940
Long-term operating lease liabilities		9,546		9,844		9,233		9,844
Other liabilities		17,585		16,010		19,625		16,010
TOTAL LIABILITIES		832,605		833,659		771,013		833,659
Commitments (Note 12)
Commitments and contingencies (Notes 11 and 12)

STOCKHOLDERS’ EQUITY
Common stock ($0.001 par value, 100,000,000 shares authorized; 40,687,784 and 39,963,127 shares issued; 39,393,357 and 38,798,787 shares outstanding at September 30, 2020 and June 30, 2020, respectively)		41		40
Common stock ($0.001 par value, 100,000,000 shares authorized; 40,832,843 and 39,963,127 shares issued; 39,504,777 and 38,798,787 shares outstanding at December 31, 2020 and June 30, 2020, respectively)						41		40
Additional paid-in capital		324,788		321,164		326,939		321,164
Accumulated deficit		(7,790)		(1,291)		(179,738)		(1,291)
Accumulated other comprehensive loss		(548)		(627)		(595)		(627)
Treasury stock (1,294,427 and 1,164,340 shares at September 30, 2020 and June 30, 2020, respectively)		(17,176)		(16,390)
Treasury stock (1,328,066 and 1,164,340 shares at December 31, 2020 and June 30, 2020, respectively)						(17,389)		(16,390)
Total stockholders’ equity		299,315		302,896		129,258		302,896
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY	$	1,131,920	$	1,136,555	$	900,271	$	1,136,555

The accompanying notes are an integral part of the Consolidated Financial Statements.

Table of Contents

LANNETT COMPANY, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(UNAUDITED)

(In thousands, except share and per share data)

Three Months Ended

September 30,

2020

2019

Net sales

$
126,479

$
127,342

Cost of sales

92,187

77,656

Amortization of intangibles

8,589

7,028

Gross profit

25,703

42,658

Operating expenses:

Research and development expenses

6,539

8,940

Selling, general and administrative expenses

15,136

21,308

Restructuring expenses

4,043

1,388

Asset impairment charges

—

1,618

Total operating expenses

25,718

33,254

Operating income (loss)

(15)

9,404

Other income (loss):

Loss on extinguishment of debt

—

(2,145)

Investment income

45

729

Interest expense

(14,486)

(19,292)

Other

(23)

934

Total other loss

(14,464)

(19,774)

Loss before income tax

(14,479)

(10,370)

Income tax expense (benefit)

(7,980)

1,787

Net loss

$
(6,499)

$
(12,157)

Loss per common share:

Basic

$
(0.17)

$
(0.32)

Diluted (1)

$
(0.17)

$
(0.32)

Weighted average common shares outstanding:

Basic

39,070,982

38,309,267

Diluted (1)

39,070,982

38,309,267


	Three Months Ended				Six Months Ended
	December 31,				December 31,
	2020		2019		2020		2019
Net sales	$	133,920	$	136,110	$	260,399	$	263,452
Cost of sales		124,488		86,663		216,675		164,319
Amortization of intangibles		8,657		8,153		17,246		15,181
Gross profit		775		41,294		26,478		83,952
Operating expenses:
Research and development expenses		5,644		6,906		12,183		15,846
Selling, general and administrative expenses		13,730		17,421		28,866		38,729
Restructuring expenses		—		192		4,043		1,580
Asset impairment charges		198,000		—		198,000		1,618
Total operating expenses		217,374		24,519		243,092		57,773
Operating income (loss)		(216,599)		16,775		(216,614)		26,179
Other income (loss):
Loss on extinguishment of debt		—		—		—		(2,145)
Investment income		43		430		88		1,159
Interest expense		(13,496)		(16,694)		(27,982)		(35,986)
Other		28		(735)		5		199
Total other loss		(13,425)		(16,999)		(27,889)		(36,773)
Loss before income tax		(230,024)		(224)		(244,503)		(10,594)
Income tax benefit		(58,076)		(5,308)		(66,056)		(3,521)
Net income (loss)	$	(171,948)	$	5,084	$	(178,447)	$	(7,073)

Earnings (loss) per common share:
Basic	$	(4.36)	$	0.13	$	(4.55)	$	(0.18)
Diluted (1)	$	(4.36)	$	0.13	$	(4.55)	$	(0.18)

Weighted average common shares outstanding:
Basic		39,443,441		38,605,052		39,257,211		38,457,159
Diluted (1)		39,443,441		40,557,503		39,257,211		38,457,159

(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.

Table of Contents

LANNETT COMPANY, INC.

CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

(UNAUDITED)

(In thousands)

Three Months Ended

September 30,

2020

2019

Net loss

$
(6,499)

$
(12,157)

Other comprehensive income (loss):

Foreign currency translation gain (loss)

79

(46)

Total other comprehensive income (loss)

79

(46)

Comprehensive loss

$
(6,420)

$
(12,203)


	Three Months Ended				Six Months Ended
	December 31,				December 31,
	2020		2019		2020		2019
Net income (loss)	$	(171,948)	$	5,084	$	(178,447)	$	(7,073)
Other comprehensive income (loss):
Foreign currency translation gain (loss)		(47)		83		32		37
Total other comprehensive income (loss)		(47)		83		32		37
Comprehensive income (loss)	$	(171,995)	$	5,167	$	(178,415)	$	(7,036)

The accompanying notes are an integral part of the Consolidated Financial Statements.

Table of Contents

LANNETT COMPANY, INC.

CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

(UNAUDITED)

(In thousands)

Three months ended September 30, 2020

Accumulated

Common Stock

Additional

Other

Total

Shares

Paid-In

Accumulated

Comprehensive

Treasury

Stockholders’


Issued

Amount

Capital

Deficit

Income (Loss)

Stock

Equity
Balance, June 30, 2020

39,963

$
40

$
321,164

$
(1,291)

$
(627)

$
(16,390)

$
302,896
Shares issued in connection with share-based compensation plans

724

1

282

—

—

—

283
Share-based compensation

—

—

3,342

—

—

—

3,342
Purchase of treasury stock

—

—

—

—

—

(786)

(786)
Other comprehensive income

—

—

—

—

79

—

79
Net loss

—

—

—

(6,499)

—

—

(6,499)
Balance, September 30, 2020

40,687

$
41

$
324,788

$
(7,790)

$
(548)

$
(17,176)

$
299,315


	Three months ended December 31, 2020
								Accumulated
	Common Stock			Additional				Other				Total
	Shares			Paid-In		Accumulated		Comprehensive		Treasury		Stockholders’
	Issued	Amount		Capital		Deficit		Loss		Stock		Equity
Balance, September 30, 2020	40,687	$	41	$	324,788	$	(7,790)	$	(548)	$	(17,176)	$	299,315
Shares issued in connection with share-based compensation plans	145		—		160		—		—		—		160
Share-based compensation	—		—		1,991		—		—		—		1,991
Purchase of treasury stock	—		—		—		—		—		(213)		(213)
Other comprehensive loss	—		—		—		—		(47)		—		(47)
Net loss	—		—		—		(171,948)		—		—		(171,948)
Balance, December 31, 2020	40,832	$	41	$	326,939	$	(179,738)	$	(595)	$	(17,389)	$	129,258


	Three months ended December 31, 2019
								Accumulated
	Common Stock			Additional				Other				Total
	Shares			Paid-In		Retained		Comprehensive		Treasury		Stockholders’
	Issued	Amount		Capital		Earnings		Loss		Stock		Equity
Balance, September 30, 2019	39,630	$	40	$	314,645	$	19,918	$	(661)	$	(15,838)	$	318,104
Shares issued in connection with share-based compensation plans	222		—		360		—		—		—		360
Share-based compensation	—		—		2,007		—		—		—		2,007
Purchase of treasury stock	—		—		—		—		—		(466)		(466)
Other comprehensive income	—		—		—		—		83		—		83
Net income	—		—		—		5,084		—		—		5,084
Balance, December 31, 2019	39,852	$	40	$	317,012	$	25,002	$	(578)	$	(16,304)	$	325,172


	Six months ended December 31, 2020
								Accumulated
	Common Stock			Additional				Other				Total
	Shares			Paid-In		Accumulated		Comprehensive		Treasury		Stockholders’
	Issued	Amount		Capital		Deficit		Loss		Stock		Equity
Balance, June 30, 2020	39,963	$	40	$	321,164	$	(1,291)	$	(627)	$	(16,390)	$	302,896
Shares issued in connection with share-based compensation plans	869		1		442		—		—		—		443
Share-based compensation	—		—		5,333		—		—		—		5,333
Purchase of treasury stock	—		—		—		—		—		(999)		(999)
Other comprehensive income	—		—		—		—		32		—		32
Net loss	—		—		—		(178,447)		—		—		(178,447)
Balance, December 31, 2020	40,832	$	41	$	326,939	$	(179,738)	$	(595)	$	(17,389)	$	129,258


	Three months ended September 30, 2019													Six months ended December 31, 2019
								Accumulated													Accumulated
	Common Stock			Additional				Other				Total		Common Stock			Additional				Other				Total
	Shares			Paid-In		Retained		Comprehensive		Treasury		Stockholders’		Shares			Paid-In		Retained		Comprehensive		Treasury		Stockholders’
	Issued	Amount		Capital		Earnings		Loss		Stock		Equity		Issued	Amount		Capital		Earnings		Loss		Stock		Equity
Balance, June 30, 2019	38,970	$	39	$	317,023	$	32,075	$	(615)	$	(14,481)	$	334,041	38,970	$	39	$	317,023	$	32,075	$	(615)	$	(14,481)	$	334,041
Shares issued in connection with share-based compensation plans	660		1		235		—		—		—		236	882		1		595		—		—		—		596
Share-based compensation	—		—		4,459		—		—		—		4,459	—		—		6,466		—		—		—		6,466
Purchase of treasury stock	—		—		—		—		—		(1,357)		(1,357)	—		—		—		—		—		(1,823)		(1,823)
Other comprehensive income	—		—		—		—		(46)		—		(46)	—		—		—		—		37		—		37
Purchase of capped call	—		—		(7,072)		—		—		—		(7,072)	—		—		(7,072)		—		—		—		(7,072)
Net loss	—		—		—		(12,157)		—		—		(12,157)	—		—		—		(7,073)		—		—		(7,073)
Balance, September 30, 2019	39,630	$	40	$	314,645	$	19,918	$	(661)	$	(15,838)	$	318,104
Balance, December 31, 2019														39,852	$	40	$	317,012	$	25,002	$	(578)	$	(16,304)	$	325,172

The accompanying notes are an integral part of the Consolidated Financial Statements.

Table of Contents

LANNETT COMPANY, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(UNAUDITED)

(In thousands)


					Six Months Ended
	Three Months Ended September 30,				December 31,
	2020		2019		2020		2019
OPERATING ACTIVITIES:
Net loss	$	(6,499)	$	(12,157)	$	(178,447)	$	(7,073)
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:
Depreciation and amortization		14,342		12,789		28,717		26,878
Deferred income tax benefit		(2,572)		(1,091)		(14,519)		(2,209)
Share-based compensation		3,342		4,459		5,333		6,466
Asset impairment charges		—		1,618		198,000		1,618
Loss (gain) on sale/disposal of assets		(6)		(1,298)
Gain on sale/disposal of assets						(24)		(1,195)
Loss on extinguishment of debt		—		2,145		—		2,145
Amortization of debt discount and other debt issuance costs		3,277		4,008		6,239		7,571
Provision for inventory write-downs						23,214		6,054
Other noncash expenses		242		379		635		829
Changes in assets and liabilities which provided (used) cash:
Accounts receivable, net		(13,108)		(8,357)		(34,443)		6,254
Inventories		(13,611)		(5,191)		(2,551)		(14,173)
Income taxes receivable/payable		(5,106)		(2,193)		(50,065)		(8,982)
Other assets		(4,821)		6,789		(7,248)		5,801
Rebates payable		5,072		(2,817)		5,616		2,272
Royalties payable		(2,497)		382		(81)		4,083
Restructuring liability		378		(1,148)		134		(1,800)
Operating lease liability		623		(364)		407		(716)
Accounts payable		15,004		13,434		10,135		17,390
Accrued expenses		647		471		(10,870)		4,988
Accrued payroll and payroll-related expenses		(6,723)		(7,577)		(7,358)		(7,686)
Other liabilities		(191)		—		2,586		(801)
Net cash provided by (used in) operating activities		(12,207)		4,281		(24,590)		47,714
INVESTING ACTIVITIES:
Purchases of property, plant and equipment		(3,227)		(4,033)		(5,129)		(8,796)
Proceeds from sale of property, plant and equipment		14		6,305		44		6,288
Advance to VIE		—		(250)		—		(250)
Purchases of intangible assets		(3,000)		(23,500)		(4,000)		(27,250)
Net cash used in investing activities		(6,213)		(21,478)		(9,085)		(30,008)
FINANCING ACTIVITIES:
Proceeds from issuance of long-term debt		—		86,250		—		86,250
Purchase of capped call		—		(7,072)		—		(7,072)
Repayments of long-term debt		(16,711)		(96,566)		(68,516)		(113,278)
Proceeds from issuance of stock		283		236		443		596
Payment of debt issuance costs		—		(3,489)		(2,390)		(3,489)
Purchase of treasury stock		(786)		(1,357)		(999)		(1,823)
Net cash used in financing activities		(17,214)		(21,998)		(71,462)		(38,816)
Effect on cash and cash equivalents of changes in foreign exchange rates		79		(46)		32		37
NET DECREASE IN CASH AND CASH EQUIVALENTS		(35,555)		(39,241)
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD		144,329		140,249
CASH AND CASH EQUIVALENTS, END OF PERIOD	$	108,774	$	101,008
NET DECREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH						(105,105)		(21,073)
CASH, CASH EQUIVALENTS AND RESTRICTED CASH, BEGINNING OF PERIOD						144,329		140,249
CASH, CASH EQUIVALENTS AND RESTRICTED CASH, END OF PERIOD					$	39,224	$	119,176

SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:
Interest paid	$	10,241	$	15,316	$	21,844	$	27,762
Income taxes paid (refunded)	$	(303)	$	5,070	$	(1,473)	$	7,670
Accrued purchases of property, plant and equipment	$	1,981	$	1,770	$	994	$	2,304

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 six months ended ~~September 30,~~December 31, 2020 are not necessarily indicative of the results that may be expected for the fiscal year ending June 30, 2021. 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, 2020. The Consolidated Balance Sheet as of June 30, 2020 was derived from audited financial statements.

Note 2. The Business ~~And~~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.

COVID-19 Update

In light of the economic impacts of COVID-19, the Company ~~performed a review of~~reviewed the assets on our Consolidated Balance Sheet as of ~~September 30,~~December 31, 2020, including intangible and other long-lived assets. Based on our review, ~~we believe~~the Company determined 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, 0~~no impairments or other write-downs specifically related to COVID-19 were ~~recorded~~necessary during the first ~~three~~six months of Fiscal Year ~~2021 specifically related to COVID-19.~~2021. Our assessment is based on information currently available and is highly reliant on various assumptions. Changes in market conditions could impact the Company’s future outlook and may lead to impairments in the future.

While COVID-19 has thus far not had a material impact on the Company’s operations, subsequent to an initial stocking up of supplies at the start of the pandemic, the total volume of drug prescriptions being written in the country has decreased causing less demand for our products. We cannot reasonably predict the ultimate impact of COVID-19 on our future results of operations and ~~cashflows~~cash flows due to the continued uncertainty around the duration and severity of the pandemic.

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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.

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 value of inventories and 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 and restricted cash

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 money market funds. The Company maintains its cash deposits and cash equivalents at well-known, stable financial institutions. Such amounts frequently exceed insured limits. In connection with the Amendment No. 4 to the Term Loan B Facility, which is discussed in further detail in Note 10 “Long-Term Debt,” the Company is required to maintain at least $5 million in a deposit account at all times, subject to control by the administrative agent. At December 31, 2020, the Company classified this balance as restricted cash, which is included in other assets.

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Presented in the table below is a reconciliation of the cash, cash equivalents and restricted cash amounts presented on the Consolidated Balance Sheets to the sum of such amounts presented on the Consolidated Statements of Cash Flows for the periods ended December 31, 2020 and 2019.


	December 31, 2020		December 31, 2019
Cash and cash equivalents	$	34,224	$	119,176
Restricted cash, included in other assets		5,000		—
Cash, cash equivalents and restricted cash as presented on the Consolidated Statements of Cash Flows	$	39,224	$	119,176

Allowance for doubtful accounts

On July 1, 2020, the Company adopted guidance issued by the FASB in ASU 2016-13, Measurement of Credit Losses on Financial Instruments, which requires the Company to recognize an allowance that reflects a current estimate of credit losses expected to be incurred over the life of the financial asset, including trade receivables. The adoption of ASU 2016-13 did not have a material impact on the Company’s Consolidated Financial Statements for the three and six months ended ~~September 30,~~December 31, 2020. 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 expected condition of the general economy and the industry as a whole. The Company writes off accounts receivable when they are determined to be uncollectible.

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Inventories

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

Property, Plant and Equipment

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

Intangible Assets

Definite-lived intangible assets are stated at cost less accumulated amortization. Amortization of definite-lived intangible assets is computed on a straight-line basis over the assets’ estimated useful lives which commences upon shipment of the product, generally for periods ranging from 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.

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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 1 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 six months ended ~~September 30,~~December 31, 2020 and 2019.


	Three Months Ended				Three Months Ended				Six Months Ended
(In thousands)	September 30,				December 31,				December 31,
Medical Indication	2020		2019		2020		2019		2020		2019
Analgesic	$	3,120	$	1,884	$	3,572	$	2,111	$	6,692	$	3,995
Anti-Psychosis		13,028		28,034		13,317		22,697		26,345		50,730
Cardiovascular		19,714		21,606		16,336		23,972		36,050		45,579
Central Nervous System		22,525		19,257		24,614		19,331		47,139		38,588
Endocrinology		3,233		—		9,496		—		12,729		—
Gastrointestinal		17,100		16,962		18,575		18,313		35,675		35,275
Infectious Disease		21,932		11,895		23,044		18,078		44,976		29,973
Migraine		9,690		9,143		6,083		10,878		15,773		20,021
Respiratory/Allergy/Cough/Cold		1,426		2,707		2,267		3,075		3,693		5,781
Urinary		1,458		435		1,361		1,233		2,819		1,668
Other		7,634		9,861		8,410		9,934		16,044		19,796
Contract manufacturing revenue		5,619		5,558		6,845		6,488		12,464		12,046
Total net sales	$	126,479	$	127,342	$	133,920	$	136,110	$	260,399	$	263,452

Customer, Supplier and Product Concentration

The following table presents the percentage of total net sales, for the three and six months ended ~~September 30,~~December 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				Three Months Ended				Six Months Ended
	September 30,				December 31,				December 31,
	2020		2019		2020		2019		2020		2019
Product 1	15	%	7	%	15	%	10	%	15	%	9	%
Product 2	9	%	20	%	8	%	15	%	8	%	18	%

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The following table presents the percentage of total net sales, for the three and six months ended ~~September 30,~~December 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				Three Months Ended				Six Months Ended
	September 30,				December 31,				December 31,
	2020		2019		2020		2019		2020		2019
Customer A	26	%	25	%	26	%	21	%	26	%	23	%
Customer B	22	%	27	%	21	%	26	%	22	%	26	%
Customer C	10	%	13	%	12	%	8	%	11	%	10	%

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Revenue Recognition

The Company complies with 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 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.

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 cost-sharing program for certain Medicare Part D beneficiaries designed primarily for the sale of brand drugs and certain generic drugs if their Food and Drug Administration (“FDA”) 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 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. 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.

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

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

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

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

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

Cost of Sales, including Amortization of Intangibles

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

Research and Development

Research and development costs are expensed as incurred, including all production costs until a drug candidate is approved by the FDA. 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 was not material to the consolidated financial position of the Company as of ~~September 30,~~December 31, 2020 and June 30, 2020.

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 Company evaluates the need for a valuation allowance each reporting period weighing all positive and negative evidence. The factors used to assess the likelihood of realization include, but are not limited to, the Company’s forecast of future taxable income, historical results of operations, statutory expirations and available tax planning strategies and actions 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~~realized. The Company continues to ~~achieve~~closely monitor the need for a valuation against its deferred tax assets in light of recent pre-tax losses while also giving consideration to our forecasted taxable income, ~~in applicable tax jurisdictions~~which is inherently uncertain and subject to change based on market conditions. Further near-term losses along with significant changes to our forecasted income could affect the ultimate realization of our 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.

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On March 27, 2020, in response to COVID-19 and its detrimental impact to the global economy, former 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. As a result of the CARES Act, the Company carried back its Fiscal 2020 taxable loss into the Fiscal 2015 tax year. The Company also reviewed its existing deferred tax assets in light of COVID-19 and determined that no additional 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.

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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 Statements 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 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 are required to recognize an allowance that reflects the Company’s current estimate of credit losses expected to be incurred over the life of the financial asset, including trade receivables. The Company adopted this guidance in the first quarter of Fiscal 2021. The adoption of ASU 2016-13 did not have a material impact on the Company’s Consolidated Financial Statements for the three and six months ended ~~September 30,~~December 31, 2020.

In August 2020, the FASB issued ASU 2020-06, Debt - Debt with Conversion and Other Options and Derivatives and Hedging - Contracts in Entity’s Own Equity, with changes to modify and simplify the application of U.S. GAAP for certain financial instruments with characteristics of liabilities and equity. ASU 2020-06 is effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years, with early adoption permitted. The ASU requires adoption using either the retrospective basis or the modified retrospective basis. The Company is currently evaluating the impact of ASU 2020-06 on its Consolidated Financial Statements.

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Note 4. Restructuring Charges

2020 Restructuring ~~Program~~Plan

On July 10, 2020, the Board of Directors authorized a restructuring and cost savings plan (the “2020 Restructuring Plan”)~~. The purpose of the 2020 Restructuring Plan is~~ to enhance manufacturing efficiencies, streamline operations and reduce the Company’s cost ~~structure, and~~structure. The 2020 Restructuring Plan was implemented, in part, as a result of previously anticipated near-term competition and pricing pressure with respect to certain key products. The 2020 Restructuring Plan includes the consolidation of the Company’s R&D function into a single location in Philadelphia, PA, lowering operating costs and reducing the workforce by approximately 80 positions, equal to approximately 8.5% of the Company’s total number of employees. The 2020 Restructuring Plan was initiated on July 13, 2020 and is complete as of December 31, 2020.

The Company incurred $4.0 million in severance-related costs in the first ~~quarter~~six months of Fiscal 2021 in connection with the 2020 Restructuring Plan. The Company expects the 2020 Restructuring Plan to result in annual cost savings in excess of $15.0 million.

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

Employee


(In thousands)

Separation Costs

Total
Balance at June 30, 2020

$
—

$
—
Restructuring Charges

4,043

4,043
Payments

(3,638)

(3,638)
Balance at September 30, 2020

$
405

$
405


	Employee
(In thousands)	Separation Costs
Balance at June 30, 2020	$	—
Restructuring Charges		4,043
Payments		(3,882)
Balance at December 31, 2020	$	161

Note 5. Accounts Receivable, net

Accounts receivable, net consisted of the following components at ~~September 30,~~December 31, 2020 and June 30, 2020:


	September 30,		June 30,		December 31,		June 30,
(In thousands)	2020		2020		2020		2020
Gross accounts receivable	$	284,751	$	271,557	$	320,337	$	271,557
Less: Chargebacks reserve		(70,437)		(61,877)		(81,456)		(61,877)
Less: Rebates reserve		(17,303)		(24,536)		(19,041)		(24,536)
Less: Returns reserve		(40,535)		(40,796)		(39,267)		(40,796)
Less: Other deductions		(16,597)		(17,557)		(19,348)		(17,557)
Less: Allowance for doubtful accounts		(1,083)		(1,103)		(1,094)		(1,103)
Accounts receivable, net	$	138,796	$	125,688	$	160,131	$	125,688

For the three months ended ~~September 30,~~December 31, 2020, the Company recorded a provision for chargebacks, rebates (including rebates presented as rebates payable), returns and other deductions of ~~$188.3~~$191.5 million, ~~$34.3~~$43.4 million, ~~$5.5~~$5.2 million and ~~$15.8~~$20.8 million, respectively. For the three months ended ~~September 30,~~December 31, 2019, the Company recorded a provision for chargebacks, rebates (including rebates presented as rebates payable), returns and other deductions of ~~$207.9~~$199.6 million, ~~$58.5~~$58.3 million, ~~$3.7~~$6.5 million and ~~$12.7~~$28.7 million, respectively.

For the six months ended December 31, 2020, the Company recorded a provision for chargebacks, rebates (including rebates presented as rebates payable), returns and other deductions of $379.8 million, $77.7 million, $10.7 million and $36.6 million, respectively. For the six months ended December 31, 2019, the Company recorded a provision for chargebacks, rebates (including rebates presented as rebates payable), returns and other deductions of $407.5 million, $116.8 million, $10.2 million and $41.4 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 ~~three~~six months ended ~~September 30,~~December 31, 2020 and 2019:


Reserve Category
(In thousands)	Chargebacks		Rebates		Returns		Other		Total		Chargebacks		Rebates		Returns		Other		Total
Balance at June 30, 2020	$	61,877	$	62,711	$	40,796	$	17,557	$	182,941	$	61,877	$	62,711	$	40,796	$	17,557	$	182,941
Current period provision		188,297		34,280		5,526		15,781		243,884		379,821		77,657		10,652		36,624		504,754
Credits issued during the period		(179,737)		(42,269)		(5,787)		(16,741)		(244,534)		(360,242)		(77,536)		(12,181)		(34,833)		(484,792)
Balance at September 30, 2020	$	70,437	$	54,722	$	40,535	$	16,597	$	182,291
Balance at December 31, 2020											$	81,456	$	62,832	$	39,267	$	19,348	$	202,903


Reserve Category
(In thousands)	Chargebacks		Rebates		Returns		Other		Total		Chargebacks		Rebates		Returns		Other		Total
Balance at June 30, 2019	$	89,567	$	78,274	$	55,554	$	18,128	$	241,523	$	89,567	$	78,274	$	55,554	$	18,128	$	241,523
Current period provision		207,933		58,509		3,694		12,705		282,841		407,523		116,803		10,217		41,424		575,967
Credits issued during the period		(214,017)		(61,952)		(5,256)		(11,724)		(292,949)		(427,293)		(119,701)		(11,120)		(33,450)		(591,564)
Balance at September 30, 2019	$	83,483	$	74,831	$	53,992	$	19,109	$	231,415
Balance at December 31, 2019											$	69,797	$	75,376	$	54,651	$	26,102	$	225,926

For the three months ending ~~September 30,~~December 31, 2020 and 2019, as a percentage of gross sales the provision for chargebacks was ~~51.7%~~49.3% and ~~51.4%~~47.2%, the provision for rebates was ~~9.4%~~11.2% and ~~14.5%~~13.8%, the provision for returns was ~~1.5%~~1.3% and ~~0.9%~~1.5% and the provision for other adjustments was ~~4.3%~~5.4% and ~~3.1%~~6.8%, respectively.

For the six months ending December 31, 2020 and 2019, as a percentage of gross sales the provision for chargebacks was 50.5% and 49.3%, the provision for rebates was 10.3% and 14.1%, the provision for returns was 1.4% and 1.2% and the provision for other adjustments was 4.9% and 5.0%, respectively.

The increase in the chargebacks reserve was primarily due to timing of sales and product mix. The ~~increase in~~rebates reserve also increased due to the ~~chargebacks reserve~~timing of sales and product mix but was offset by ~~a decrease in the rebates reserve primarily due to~~ lower sales of Fluphenazine in ~~the first quarter of~~ Fiscal 2021, which had higher than average government-related rebates. 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 ~~September 30,~~December 31, 2020 and June 30, 2020 consisted of the following:


	September 30,		June 30,		December 31,		June 30,
(In thousands)	2020		2020		2020		2020
Raw Materials	$	62,225	$	59,703	$	49,539	$	59,703
Work-in-process		13,815		12,235		18,281		12,235
Finished Goods		80,438		70,929		54,384		70,929
Total	$	156,478	$	142,867	$	122,204	$	142,867

During the three months ended ~~September 30,~~December 31, 2020 and 2019, the Company recorded write-downs to net realizable value for excess and obsolete inventory of ~~$2.6~~$20.6 million and ~~$3.5~~$2.5 million, respectively. During the six months ended December 31, 2020 and 2019, the Company recorded write-downs to net realizable value for excess and obsolete inventory of $23.2 million and $6.1 million, respectively. The increase in write-downs for excess and obsolete inventory was primarily related to the discontinuation of certain product lines during the second quarter of Fiscal 2021, which is discussed further in Note 9 “Intangible Assets.”

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Note 7. Property, Plant and Equipment, net

Property, plant and equipment, net at ~~September 30,~~December 31, 2020 and June 30, 2020 consisted of the following:


		September 30,		June 30,			December 31,		June 30,
(In thousands)	Useful Lives	2020		2020		Useful Lives	2020		2020
Land	—	$	1,783	$	1,783	—	$	1,783	$	1,783
Building and improvements	10 - 39 years		103,265		100,285	10 - 39 years		103,256		100,285
Machinery and equipment	5 - 10 years		165,896		164,704	5 - 10 years		168,036		164,704
Furniture and fixtures	5 - 7 years		3,343		3,116	5 - 7 years		3,402		3,116
Less accumulated depreciation			(108,716)		(102,983)			(114,359)		(102,983)
			165,571		166,905			162,118		166,905
Construction in progress			11,413		12,613			11,039		12,613
Property, plant and equipment, net		$	176,984	$	179,518		$	173,157	$	179,518

Depreciation expense ~~was $5.8 million~~ for the three months ended ~~September 30,~~December 31, 2020 and ~~2019.~~2019 was $5.7 million and $5.9 million, respectively. Depreciation expense for the six months ended December 31, 2020 and 2019 was $11.5 million and $11.7 million, respectively.

Property, plant and equipment, net included amounts held in foreign countries in the amount of $0.6 million at ~~September 30,~~December 31, 2020 and June 30, 2020.

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. The Company’s cash and cash equivalents include bank deposits 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.

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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 ~~$592~~$541 million and $608 million as of ~~September 30,~~December 31, 2020 and June 30, 2020, respectively. The estimated fair value of our 4.50% Convertible Senior Notes was approximately ~~$52~~$54 million and $58 million as of ~~September 30,~~December 31, 2020 and June 30, 2020, respectively. The fair value as of ~~September 30,~~December 31, 2020 was lower than the carrying value primarily due to the Company’s stock price at ~~September 30,~~December 31, 2020 as compared to the $15.29 conversion price.

Non-recurring Fair Value Measurements

The Company has certain assets that are measured at fair value on a non-recurring basis and are adjusted to fair value only when the carrying values are greater than the fair values. These assets are subject to fair value adjustments when there is evidence of impairment. The Company’s estimation of the fair value of intangible assets for impairment represents a Level 3 fair value measurement, due to the use of internal and external projections and unobservable measurement inputs. Based on an impairment analysis performed, the Company adjusted the KUPI product rights assets and the KUPI in-process research and development asset to its fair value, $84.0 million and $4.0 million respectively, as of December 31, 2020. Refer to Note 9 “Intangible Assets” for further information.

Note 9. Intangible Assets

Intangible assets, net as of ~~September 30,~~December 31, 2020 and June 30, 2020 consisted of the following:


	Weighted	Gross Carrying Amount				Accumulated Amortization				Intangible Assets, Net				Weighted	Gross Carrying Amount				Accumulated Amortization				Intangible Assets, Net
	Avg. Life	September 30,		June 30,		September 30,		June 30,		September 30,		June 30,		Avg. Life	December 31,		June 30,		December 31,		June 30,		December 31,		June 30,
(In thousands)	(Yrs.)	2020		2020		2020		2020		2020		2020		(Yrs.)	2020		2020		2020		2020		2020		2020
Definite-lived:
KUPI product rights	15		416,154		416,154		(132,263)		(125,327)		283,891		290,827	15		83,955		416,154		—		(125,327)		83,955		290,827
KUPI trade name	2		2,920		2,920		(2,920)		(2,920)		—		—	2		2,920		2,920		(2,920)		(2,920)		—		—
KUPI other intangible assets	15		19,000		19,000		(6,145)		(5,828)		12,855		13,172	15		19,000		19,000		(6,462)		(5,828)		12,538		13,172
Silarx product rights	15		20,000		20,000		(3,889)		(3,556)		16,111		16,444	15		20,000		20,000		(4,223)		(3,556)		15,777		16,444
Other product rights	10		53,718		50,718		(6,429)		(5,426)		47,289		45,292	10		54,718		50,718		(7,500)		(5,426)		47,218		45,292
Total definite-lived		$	511,792	$	508,792	$	(151,646)	$	(143,057)	$	360,146	$	365,735		$	180,593	$	508,792	$	(21,105)	$	(143,057)	$	159,488	$	365,735

Indefinite-lived:
KUPI in-process research and development	—	$	9,000	$	9,000	$	—	$	—	$	9,000	$	9,000	—	$	4,000	$	9,000	$	—	$	—	$	4,000	$	9,000
Total indefinite-lived			9,000		9,000		—		—		9,000		9,000			4,000		9,000		—		—		4,000		9,000
Total intangible assets, net		$	520,792	$	517,792	$	(151,646)	$	(143,057)	$	369,146	$	374,735		$	184,593	$	517,792	$	(21,105)	$	(143,057)	$	163,488	$	374,735

For the three months ended ~~September 30,~~December 31, 2020 and 2019, the Company recorded amortization expense of ~~$8.6~~$8.7 million and ~~$7.0~~$8.2 million, respectively.

~~Future annual~~ For the six months ended December 31, 2020 and 2019, the Company recorded amortization expense ~~consisted~~ of ~~the following as of September 30, 2020:~~

$17.2 million and $15.2

(In thousands)

Amortization
Fiscal Year Ending June 30,

Expense
2021

$
25,873
2022

36,097
2023

35,795
2024

35,495
2025

35,095
Thereafter

191,791

$
360,146

million, respectively.

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In December 2020, the Company reviewed its product portfolio and decided to discontinue 23 lower gross margin product lines, including product lines that were acquired through various past business and product acquisitions. As a result of the discontinuance and the reduction in net sales and gross margin of certain other product lines, the Company determined that such decision represents a “triggering event” and, therefore, commenced an analysis to determine the potential for impairment of certain long-lived assets, primarily its intangible assets. Based on that analysis, the Company recorded an impairment charge of $193.0 million related to the KUPI product rights intangible assets during the second quarter of Fiscal 2021. The impairment charge is primarily a result of the decline in net sales and gross margin of certain product lines acquired in connection with the KUPI acquisition, including those product lines being discontinued.

In the second quarter of Fiscal 2021, the Company also recorded a $5.0 million impairment charge to its KUPI in-process research and development intangible asset due to delays in the expected launch of a product within the portfolio, which results in reduced projected cash flows.

In November 2020, the Company entered into Amendment No. 2 to License and Supply Agreement (the “2020 Amendment”) with Recro Gainesville LLC (“Recro”), which amended the Company’s agreement with Recro to exclusively distribute Verelan PM ®, Verelan SR ®, and Verapamil PM. In accordance with the Company’s policy to expense costs to renew or extend the term of a recognized intangible asset as incurred, the Company recorded $5.0 million in consideration to renew the Company’s distribution agreement during the second quarter of Fiscal Year 2021, which is included within cost of sales on the Consolidated Statements of Operations.

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


(In thousands)	Amortization
Fiscal Year Ending June 30,	Expense
2021	$	7,675
2022		16,950
2023		16,649
2024		16,349
2025		15,949
Thereafter		85,916
	$	159,488

Note 10. Long-Term Debt

Long-term debt, net consisted of the following:


	September 30,		June 30,		December 31,		June 30,
(In thousands)	2020		2020		2020		2020
Term Loan A due 2020; 6.00% as of September 30, 2020	$	41,969	$	48,844
Term Loan A					$	—	$	48,844
Unamortized discount and other debt issuance costs		(97)		(433)		—		(433)
Term Loan A, net		41,872		48,411		—		48,411
Term Loan B due 2022; 6.38% as of September 30, 2020		563,021		572,857
Term Loan B due 2022; 6.38% as of December 31, 2020						553,185		572,857
Unamortized discount and other debt issuance costs		(20,573)		(23,278)		(18,746)		(23,278)
Term Loan B, net		542,448		549,579		534,439		549,579
4.50% Convertible Senior Notes due 2026		86,250		86,250		86,250		86,250
Unamortized discount and other debt issuance costs		(2,986)		(3,111)		(2,861)		(3,111)
4.50% Convertible Senior Notes, net		83,264		83,139		83,389		83,139
$125 million Revolving Credit Facility due 2020		—		—
$125 million Revolving Credit Facility						—		—
$30 million ABL Credit Facility						—		—
Total debt, net		667,584		681,129		617,828		681,129
Less short-term borrowings and current portion of long-term debt		(81,314)		(88,189)		(39,345)		(88,189)
Total long-term debt, net	$	586,270	$	592,940	$	578,483	$	592,940

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The weighted average interest rate for the three months ended ~~September 30,~~December 31, 2020 and 2019 was ~~8.0%~~7.8% and ~~8.8%~~8.6%, respectively. The weighted average interest rate for the six months ended December 31, 2020 and 2019 was 7.9% and 9.2%, respectively. The Company paid off the outstanding balance of the Term Loan A of $42.0 million ~~is due~~ on November 25, 2020 ~~which the Company anticipates paying down~~ with cash on hand. The Company’s undrawn $125 million Revolving Credit Facility ~~which is undrawn as of September 30, 2020, is~~ also ~~due to expire~~expired on November 25, 2020.

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


	Amounts Payable		Amounts Payable
(In thousands)	to Institutions		to Institutions
2021	$	81,314	$	39,345
2022		39,345		513,840
2023		484,331		—
2024		—		—
2025		—		—
Thereafter		86,250		86,250
Total	$	691,240	$	639,435

On December 7, 2020, the Company entered into a credit and guaranty agreement, which provides for an asset-based revolving credit facility (the “ABL Credit Facility”) of up to $30 million, subject to borrowing base availability, and includes letter of credit and swing line sub-facilities. Borrowing availability under the ABL Credit Facility is determined by a monthly borrowing base collateral calculation that is based on specified percentages of eligible accounts receivable less certain reserves and subject to certain other adjustments as set forth in the ABL Credit Agreement. Availability is reduced by issuance of letters of credit as well as any borrowings. The final maturity of the ABL Credit Facility is December 7, 2023, unless the aggregate outstanding principal amount of any of the Term Loan B Facility (as defined below) or other material indebtedness exceeds $35,000,000 on the date that is 91 days prior to the maturity date with respect to such other indebtedness, in which case the final maturity shall instead be such earlier date. Loans outstanding under the ABL Credit Agreement bear interest at a floating rate measured by reference to an adjusted London Inter-Bank Offered Rate (“LIBOR”), subject to a floor of 0.75%, plus an applicable margin of 2.50% per annum. Unused commitments under the ABL Credit Facility are subject to a per annum fee of 0.50%. The obligations under the ABL Credit Agreement are guaranteed by the Company and all of the Company’s existing and future subsidiaries, subject to certain exceptions (collectively, the “Guarantors”), and such obligations and the obligations of the Guarantors are secured by:

●

a perfected security interest in all present and after-acquired accounts receivable, payment intangibles, inventory, deposit accounts, securities accounts, and any cash, cash equivalents or other assets in such accounts and other related assets owned by each Guarantor and the proceeds of the foregoing, except to the extent such proceeds constitute Cash Flow Priority Collateral (as defined below), and subject to certain exceptions (the “ABL Priority Collateral”), which security interest is senior to the security interest in the ABL Priority Collateral securing the Company’s existing Term Loan B Facility; and

●

a perfected security interest in substantially all present and after-acquired tangible and intangible assets of each Guarantor other than the ABL Priority Collateral (the “Cash Flow Priority Collateral”), which security interest is junior to the security interest in the Cash Flow Priority Collateral securing the Term Loan B Facility.

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The ABL Credit Agreement contains customary representations and warranties and customary affirmative covenants and negative covenants. The negative covenants include restrictions on, among other things: the incurrence of additional indebtedness; the incurrence of additional liens; dividends or other distributions on equity; the purchase, redemption or retirement of capital stock; the payment or redemption of certain indebtedness; the nature of the business activity of the Company and its subsidiaries; loans, guarantees and other investments; entering into other agreements that create restrictions on the ability to pay dividends or make other distributions on equity or create or incur certain liens; asset sales; consolidations or mergers; amendment of certain material documents; changes in fiscal year; and affiliate transactions. The negative covenants are subject to customary exceptions and also permit dividends and other distributions on equity, consolidations, mergers and asset sales, certain acquisitions and other investments, and payments or redemptions of certain indebtedness, in each case upon satisfaction of the “payment conditions”. The payment conditions are deemed satisfied upon Excess Availability (as defined in the ABL Credit Agreement) on the date of the designated action and Excess Availability for the prior 30-day period exceeding agreed-upon thresholds, the absence of the occurrence and continuance of any event of default and, in certain cases, pro forma compliance with a fixed charge coverage ratio of no less than 1.10 to 1.00.

The ABL Credit Agreement includes a minimum fixed charge coverage ratio of no less than 1.10 to 1.00, which is tested only when Excess Availability is less than 15.0% of the lesser of (A) the borrowing base and (B) the then effective commitments under the ABL Credit Facility for 3 consecutive business days, and continuing until the first day immediately succeeding the last day of 30 consecutive days on which Excess Availability is in excess of such threshold.

The ABL Credit Agreement provides for events of default, which, if any of them occurs, would permit or require the principal, premium, if any, and interest on all of the then outstanding obligations under the ABL Credit Facility to be due and payable immediately and the commitments under the ABL Credit Facility to be terminated.

The Company also entered into Amendment No. 4 to the Credit and Guaranty Agreement, which amends the Term Loan B Facility to permit the incurrence of the ABL Credit Facility and requires the Company to maintain at least $5 million in a deposit account at all times, subject to control by the administrative agent, and a minimum cash balance of $15 million as of the last day of each month. At December 31, 2020, the Company classified the $5 million required deposit account balance as restricted cash, which is included in other assets caption in the Consolidated Balance Sheet. The amendment also replaced Morgan Stanley Senior Funding, Inc. with Alter Domus (US) LLC as administrative agent and collateral agent under the Term Loan B Facility.

The outstanding Term Loan ~~A, Term Loan~~ B and ~~Revolving~~ABL 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.

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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. InBeginning in December 2016, the Connecticut Attorney General ~~joined by~~and numerous other State Attorneys General have filed a civil complaint alleging that 6 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, includingcomplaints against the Company and ~~claims~~numerous other companies and individuals 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 1 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 claimsanti-competitive behavior as ~~to it.~~

On May 10, 2019, the State Attorneys General filed a new lawsuit naming the Company, and 1 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.more fully described below.

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~~requested corporate documents of the Company relating to corporate, financial and employee information, communications or correspondence with competitors regarding the sale of generic prescription medications and the marketing, sale, or pricing of certain products, generally for the period of 2005 through the dates of the subpoenas.

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

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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 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. The VA requested additional information for the period of July 1, 2016 through March 2018. The Company is in the process of responding to the information request.

State Attorneys General and Private Plaintiffs Antitrust and Consumer Protection Litigation

In December 2016, the Connecticut Attorney General and various 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 (the “MDL”). On October 31, 2017, the State Attorneys General filed a motion for leave to amend their complaint to add numerous additional defendants, including the Company, and claims relating to 13 additional drugs. The District 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.

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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 companies and individuals. The 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 this complaint against Lannett relate to the Company’s sales of baclofen and levothyroxine. The complaint also names another current employee as a defendant, but the allegations pertain to conduct that occurred prior to their employment by Lannett. In June 2020, the State Attorneys General filed a third overarching conspiracy complaint involving scores of different drugs, including alleged price-fixing by the Company for acetazolamide. Both complaints have been added to the MDL.

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 have conspired to fix prices of generic digoxin, levothyroxine, ursodiol and baclofen. These cases are part of a larger group of more than 100 lawsuits generally alleging that over 30 generic pharmaceutical manufacturers and distributors conspired to fix prices for multiple different generic drugs in violation of the federal Sherman Act, various state antitrust laws, and various state consumer protection statutes. The United States also has been granted leave to intervene in the cases. On April 6, 2017, these cases were added to 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”).MDL. The various plaintiffs are grouped into three categories - Direct Purchaser Plaintiffs, End Payer Plaintiffs, and Indirect Reseller Purchasers - and filed Consolidated Amended Complaints (“CACs”) against the Company and the other defendants in August 2017.

The CACs naming the Company as a defendant involve generic digoxin, levothyroxine, ursodiol and baclofen. Pursuant to a court-ordered schedule grouping the 18 different drug cases into 3 separate tranches, the Company and other generic pharmaceutical manufacturer defendants in October 2017 filed joint and individual motions to dismiss the CACs involving the 6 drugs in the first tranche, including digoxin. In October 2018, the Court (with one exception) denied defendants’ motions to dismiss plaintiffs’ Sherman Act claims with respect to the drugs in the first tranche. In March 2019, the Company and other defendants filed answers to the Sherman Act claims. In addition, in February 2019, the Court dismissed certain of the plaintiffs’ state law claims, but denied the remainder of defendants’ motions to dismiss and set a deadline of April 1, 2019 for certain plaintiffs to amend their existing complaints. Those plaintiffs amended their complaints, but further motions to dismiss the state-law claims remain pending.

In addition to lawsuits brought by private plaintiffs, the Attorneys General of 49 states, the District of Columbia, Puerto Rico and various territories 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 1 drug, doxycycline monohydrate. Defendants’ joint motion to dismiss the overarching conspiracy claims in that suit was denied in August 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 in May 2019 involving dozens of different drugs, including alleged price-fixing by the Company for baclofen and levothyroxine. In June 2020, the Attorneys General filed a third overarching conspiracy complaint involving scores of different drugs, including alleged price-fixing by the Company for acetazolamide.

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Following the lead of the state Attorneys General, the Direct Court Purchaser Plaintiffs, End Payer Plaintiffs and Indirect Reseller Plaintiffs filed their own complaints in June 2018 alleging an overarching conspiracy 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. In August 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~~involves 135 new drugs in addition to those named in previous complaints. As to the Company, the new drugs involved are pilocarpine HCL, ~~triamterence~~triamterene HCTZ capsules, amantadine HCL, and oxycodone HCL. None of the defendants, including the Company, has responded yet to these new complaints.

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Between January 2018 and ~~June~~December 2020, a number of opt-out parties have filed individual complaints or otherwise commenced actions against the Company and dozens of other companies and individuals alleging an overarching conspiracy and individual conspiracies to fix the prices and allocate markets on scores of different drug products, including digoxin, doxycycline, levothyroxine, ursodiol and baclofen. The opt-out parties include various retailers, insurers and county governments, which have filed federal suits in Pennsylvania, New York, California, Minnesota and Texas. All of those complaints have been added to the MDL but none of the defendants, including the Company, has responded to any of the complaints. Other groups of insurers have commenced actions in Pennsylvania state court against the Company and other drug companies by filing writs of summons, which are not complaints but can serve to toll the running of statutes of limitations. Those state-court cases have not been added to the MDL, although the parties have agreed to stay those cases pending further developments in the MDL.

In June 2020, the Company and a number of other generic pharmaceutical manufacturers were named as defendants in a Statement of Claim, along with a number of other generic pharmaceutical manufacturers, in a proposed class proceeding in federal court in Toronto, Ontario, Canada. The case alleges a violation of Canada’s Competition Act. The allegations are similar to those in the MDL alleging an overarching, industry-wide conspiracy to allocate markets and fix the price of generic drugs. That alleged conspiracy reached Canada because these same manufacturers also allegedly sell the majority of generic drugs in Canada. The Statement of Claim alleges that the conspiracy extends to the entire generic pharmaceutical market. The specific drugs identified with respect to the Company are: acetazolamide, baclofen, digoxin, doxycycline monohydrate, levothyroxine, and ursodiol. The Company has not yet responded to the Statement of Claim.

On July 13, 2020, the ~~court~~District Court overseeing the MDL selected as “bellwether” cases the second overarching conspiracy case filed by the state Attorneys General in May 2019 as well as individual-conspiracy cases filed by the Direct Purchaser Plaintiffs, End Payer Plaintiffs, and Indirect Reseller Purchasers involving the drugs clobetasol, clomipramine and pravastatin. The Company is a defendant only in the overarching conspiracy case. To date, none of the “bellwether” cases have been scheduled for trial.

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~~against these claims.

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Shareholder Litigation

In November 2016, a putative class action lawsuit was filed against the Company and 2 of its former officers in the federal district court for the Eastern District of Pennsylvania, alleging that the Company and 2 of its former officers damaged the purported class by making false and misleading statements regarding the Company’s drug pricing methodologies and internal controls. In December 2017, counsel for the putative class filed a second 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 .~~complaint. In September 2018, counsel for the putative class filed a third amended ~~complaint.~~complaint alleging that the Company and two of its former officers made false and misleading statements regarding the impact of competition on prices and sales of certain of the Company’s products and regarding the potential effects on the Company of regulatory investigations and antitrust litigation. 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. On October 1, 2020, the plaintiff filed a motion for class certification. 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.

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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, which was preliminarily approved by the Court on August 7, 2020, requires 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. A Settlement Hearing was held on October 7, 2020. At the settlement hearing, the Magistrate Judge issued an oral ~~Ruling~~Report and Recommendation approving the Settlement and denying the objecting parties’ motion to intervene. The time period to object to the ~~Ruling~~Report and Recommendation has expired. On October 22, 2020, the Court adopted the Report and Recommendation, granted the motion for final approval of the settlement, denied the objecting parties’ motion to intervene, and issued a final judgement dismissing the consolidated cases with prejudice. The Company considers these matters closed.

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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 16, 2020, the Court entered the parties’ 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 February 18, 2020, the Court entered the parties’ 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 March 11, 2020, following notice that Plaintiffs no longer consented to the stay, the Court lifted the stay. 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. On April 29, 2020, the Court entered the parties’ stipulation to stay the action, pending a decision from the Court regarding the settlement in the consolidated derivative actions discussed above. In light of the Final Order and Judgment entered in the two earlier filed consolidated shareholder derivative cases referenced above, the parties filed a stipulation and proposed order dismissing this Action, with prejudice. On October 29, 2020, the District Court Judge entered an Order approving the parties’ Stipulation of Dismissal, with prejudice. The Company considers this matter closed.

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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. The Court granted the stipulation and proposed order that same day. In light of the Final Order and Judgment entered in the two earlier filed consolidated shareholder derivative cases referenced above, the parties agreed to dismiss this action, with prejudice. The Court granted Stipulation of Dismissal ~~has been filed and is awaiting the approval of the Court.~~with Prejudice on November 4, 2020. The Company considers this matter closed.

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.

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Sandoz, Inc.

On July 20, 2020, Sandoz, Inc. (“Sandoz”) filed a complaint in federal court in Philadelphia, alleging claims for tortious interference with contract, unfair competition and conversion of confidential information, arising out of Cediprof, Inc.’s (“Cediprof”) termination of Sandoz’s contract to distribute levothyroxine tablets in the United States and certain territories. Along with the complaint, Sandoz filed a motion for a temporary restraining order and preliminary injunction, seeking to enjoin the Company from commencing the distribution of levothyroxine tablets on August 3, 2020. On the same day, Sandoz filed a separate complaint and application for a temporary restraining order and preliminary injunction against Cediprof in federal court in New York, seeking to prevent Cediprof from selling its levothyroxine tablets in the United States and certain of its territories to anyone other than Sandoz. On July 27, 2020, the New York court held a hearing and denied Sandoz’s application for a temporary restraining order, ruling Sandoz had failed to establish irreparable harm. Sandoz subsequently dismissed the complaint and is proceeding against Cediprof in an Arbitration in New York, where the Company has agreed to indemnify Cediprof. On July 28, 2020, the Philadelphia court held a hearing and denied Sandoz’s application for a temporary restraining order, ruling that Sandoz had failed to establish irreparable harm and failed to establish that it is likely to succeed on the merits of its claim against Lannett. On October 5, 2020, the Company filed a motion to dismiss the complaint. On December 28, 2020, the Court granted in part and denied in part the motion, dismissing certain of the claims. The Company has filed a motion to stay the case pending the Arbitration of the Sandoz/Cediprof dispute. On January 11, 2021, the Company filed an answer and counterclaim to the complaint. The Company denies that it tortiously interfered with Sandoz’s contract or that it converted any of Sandoz’s alleged confidential information. Discovery is ongoing and the Company cannot reasonably predict the outcome of this suit at this time.

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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 or in any of the proceedings described above 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 September 30, 2020 and June 30, 2020, the Company has a ROU lease asset of $9.1 million and $9.3 million, respectively, and a ROU liability of $11.6 million and $10.9 million, respectively. The current balance of the ROU liability at September 30, 2020 and June 30, 2020 was $2.0 million and $1.1 million, respectively.

~~Components of lease cost are as follows:~~

Three Months Ended

Three Months Ended
(In thousands)

September 30, 2020

September 30, 2019
Operating lease cost

$
402

$
481
Variable lease cost

39

28
Short-term lease cost (a)

118

156
Total

$
559

$
665

~~(a)~~

~~Not recorded on the Consolidated Balance Sheet.~~

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Note 12. Commitments

Leases

At December 31, 2020 and June 30, 2020, the Company has a ROU lease asset of $8.7 million and $9.3 million, respectively, and a ROU liability of $11.3 million and $10.9 million, respectively. The current balance of the ROU liability at December 31, 2020 and June 30, 2020 was $2.1 million and $1.1 million, respectively.

Components of lease cost are as follows:


	Three Months Ended				Six Months Ended
	December 31,				December 31,
(In thousands)	2020		2019		2020		2019
Operating lease cost	$	477	$	590	$	879	$	1,071
Variable lease cost		43		32		82		61
Short-term lease cost (a)		108		124		226		279
Total	$	628	$	746	$	1,187	$	1,411

(a)	Not recorded on the Consolidated Balance Sheet.

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


					Six Months Ended
	Three Months Ended		Three Months Ended		December 31,
(In thousands)	September 30, 2020		September 30, 2019		2020		2019
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows from operating leases	$	303	$	481	$	809	$	966
Non-cash activity:
ROU assets obtained in exchange for new operating lease liabilities	$	—	$	—	$	—	$	—

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


					Six Months Ended
	Three Months Ended		Three Months Ended		December 31,
	September 30, 2020		September 30, 2019		2020		2019
Weighted-average remaining lease term	8	years	9	years	8	years	9	years
Weighted-average discount rate	7.98	%	7.50	%	8.0	%	7.5	%

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


(In thousands)	Amounts Due		Amounts Due
2021	$	1,498	$	1,062
2022		2,125		2,125
2023		2,144		2,144
2024		2,164		2,164
2025		2,183		2,183
Thereafter		5,749		5,749
Total lease payments		15,863		15,427
Less: Imputed interest		4,299		4,079
Present value of lease liabilities	$	11,564	$	11,348

Other Commitments

During 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. In Fiscal 2019, the Company sold 50% of the outstanding loan to a third party for $5.6 million, in addition to assigning 50% of all rights, title and interest in the loan and loan documents. As of ~~September 30,~~December 31, 2020, ~~$6.5~~$6.5 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 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~~$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~~.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.

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Note 13. Accumulated Other Comprehensive Loss

The Company’s Accumulated Other Comprehensive Loss was comprised of the following components as of ~~September 30,~~December 31, 2020 and 2019:


	September 30,				December 31,
(In thousands)	2020		2019		2020		2019
Foreign Currency Translation
Beginning Balance	$	(627)	$	(615)
Beginning Balance, June 30					$	(627)	$	(615)
Net income (loss) on foreign currency translation (net of tax of $0 and $0)		79		(46)		32		37
Other comprehensive income (loss), net of tax		79		(46)		32		37
Total Accumulated Other Comprehensive Loss	$	(548)	$	(661)	$	(595)	$	(578)

~~Note 14. Loss Per Common Share~~

~~A reconciliation of the Company’s basic and diluted loss per common share was as follows:~~

Three Months Ended

September 30,
(In thousands, except share and per share data)

2020

2019
Numerator:

Net loss

$
(6,499)

$
(12,157)
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

$
(6,499)

$
(12,157)

Denominator:

Basic weighted average common shares outstanding

39,070,982

38,309,267
Effect of potentially dilutive options and restricted stock awards

—

—
Effect of conversion of the Notes

—

—
Diluted weighted average common shares outstanding

39,070,982

38,309,267

Loss per common share:

Basic

$
(0.17)

$
(0.32)
Diluted

$
(0.17)

$
(0.32)

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 September 30, 2020 and 2019 were 8.2 million and 2.9 million, respectively. The effect of potentially dilutive shares was excluded from the calculation of diluted loss per share in the three months ended September 30, 2020 and 2019 because the effect of including such securities would be anti-dilutive.

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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 was as follows:


	Three Months Ended
	December 31,
(In thousands, except share and per share data)	2020		2019
Numerator:
Net income (loss)	$	(171,948)	$	5,084
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)	$	(171,948)	$	5,084

Denominator:
Basic weighted average common shares outstanding		39,443,441		38,605,052
Effect of potentially dilutive options and restricted stock awards		—		1,952,451
Effect of conversion of the Notes		—		—
Diluted weighted average common shares outstanding		39,443,441		40,557,503

Earnings (loss) per common share:
Basic	$	(4.36)	$	0.13
Diluted	$	(4.36)	$	0.13


	Six Months Ended
	December 31,
(In thousands, except share and per share data)	2020		2019
Numerator:
Net loss	$	(178,447)	$	(7,073)
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	$	(178,447)	$	(7,073)

Denominator:
Basic weighted average common shares outstanding		39,257,211		38,457,159
Effect of potentially dilutive options and restricted stock awards		—		—
Effect of conversion of the Notes		—		—
Diluted weighted average common shares outstanding		39,257,211		38,457,159

Loss per common share:
Basic	$	(4.55)	$	(0.18)
Diluted	$	(4.55)	$	(0.18)

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 December 31, 2020 and 2019 were 8.1 million and 6.0 million, respectively. The number of anti-dilutive shares that have been excluded in the computation of diluted loss and earnings per share for the six months ended December 31, 2020 and 2019 were 8.1 million and 6.7 million, respectively. The effect of potentially dilutive shares was excluded from the calculation of diluted loss per share in the three and six months ended December 31, 2020 and the six months ended December 31, 2019 because the effect of including such securities would be anti-dilutive.

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Note 15. Share-based Compensation

At ~~September 30,~~December 31, 2020, the Company had 2 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 ~~September 30,~~December 31, 2020, the plans have a total of 4570 thousand shares available for future issuances. Additionally, in January 2021, the stockholders of the Company approved a new stock award plan, the 2021 LTIP, which authorized 3.0 million new shares of common stock for future issuances under this plan.

Historically, the Company has issued share-based compensation awards with a vesting period ranging up to 3 years and a maximum contractual term of 10 ~~years~~.years. The Company issues new shares of stock when stock options are exercised. As of ~~September 30,~~December 31, 2020, there was ~~$14.7~~$12.9 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 ~~2.5~~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, the estimated annual forfeiture rates used to recognize the associated compensation expense and the weighted average fair value of the options granted during the ~~three~~six months ended ~~September 30,~~December 31, 2020 and 2019:


							Six Months Ended
	September 30, 2020			September 30, 2019			December 31, 2020			December 31, 2019
Risk-free interest rate		0.2	%		1.9	%		0.2	%		1.9	%
Expected volatility		82.5	%		73.7	%		82.5	%		73.7	%
Expected dividend yield		—	%		—	%		—	%		—	%
Forfeiture rate		—	%		—	%		—	%		—	%
Expected term		5.0	years		5.1	years		5.0	years		5.1	years
Weighted average fair value	$	3.86		$	4.04		$	3.86		$	4.04

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 0, as the Company has not historically issued and has no immediate plans to issue a dividend.

A stock option summary as of ~~September 30,~~December 31, 2020 and changes during the ~~three~~six 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, 2020

991

$
12.11

$
678

5.6
Granted

309

$
5.95

Exercised

(32)

$
4.16

$
48

Forfeited, expired or repurchased

(187)

$
16.56

Outstanding at September 30, 2020

1,081

$
9.81

$
186

7.8

Vested and expected to vest at September 30, 2020

408

$
14.92

$
136

5.3
Exercisable at September 30, 2020

1,079

$
9.81

$
186

7.8


						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, 2020	991	$	12.11	$	678	5.6
Granted	309	$	5.95
Exercised	(37)	$	4.12	$	61
Forfeited, expired or repurchased	(217)	$	17.14
Outstanding at December 31, 2020	1,046	$	9.52	$	313	7.7

Vested and expected to vest at December 31, 2020	1,045	$	9.52	$	313	7.7
Exercisable at December 31, 2020	373	$	14.59	$	137	5.3

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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 ~~three~~six months ended ~~September 30,~~December 31, 2020 and 2019.

A summary of restricted stock awards as of ~~September 30,~~December 31, 2020 and changes during the ~~three~~six months then ended, is presented below:


		Weighted					Weighted
		Average Grant -		Aggregate			Average Grant -		Aggregate
(In thousands, except for weighted average price data)	Awards	date Fair Value		Intrinsic Value		Awards	date Fair Value		Intrinsic Value
Non-vested at June 30, 2020	1,344	$	8.70			1,344	$	8.70
Granted	870		5.72			876		5.73
Vested	(664)		8.75	$	3,798	(778)		8.30	$	4,514
Forfeited	(66)		9.32			(70)		9.46
Non-vested at September 30, 2020	1,484	$	6.90
Non-vested at December 31, 2020						1,372	$	6.99

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 ~~September 30,~~December 31, 2020 and changes during the current fiscal year, is presented below:


		Weighted			Weighted
		Average Grant -			Average Grant -
(In thousands, except for weighted average price and life data)	Awards	date Fair Value		Awards	date Fair Value
Non-vested at June 30, 2020	204	$	12.99	204	$	12.99
Granted	339	$	9.22	339	$	9.22
Performance adjustment (1)	(12)	$	25.58	(12)	$	25.58
Non-vested at September 30, 2020	531	$	10.29
Non-vested at December 31, 2020				531	$	10.29

(1)	Represents the adjustment based on the performance of the September 2017 awards, which was below the Threshold goal level at the end of the three-year performance ~~period~~period.

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 ~~three~~six months ended ~~September 30,~~December 31, 2020 and 2019, 2956 thousand shares and 52 thousand shares were issued under the ~~ESPP.~~ESPP, respectively. As of ~~September 30,~~December 31, 2020, ~~939~~966 thousand total cumulative shares have been issued under the ESPP.

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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				Three Months Ended				Six Months Ended
	September 30,				December 31,				December 31,
(In thousands)	2020		2019		2020		2019		2020		2019
Selling, general and administrative expenses	$	2,714	$	3,635	$	1,507	$	1,205	$	4,221	$	4,840
Research and development expenses		155		224		132		214		287		438
Cost of sales		473		600		352		588		825		1,188
Total	$	3,342	$	4,459	$	1,991	$	2,007	$	5,333	$	6,466

Tax benefit at statutory rate	$	752	$	1,003	$	448	$	452	$	1,200	$	1,455

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 iswas 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. Beginning January 1, 2021, the Company reduced the matching contribution to 50% of each employee’s contribution, not to exceed 2% of the employee’s compensation for the Plan year. Contributions to the Plan were $0.5 million during each of the three months ended ~~September 30,~~December 31, 2020 and ~~2019~~2019. Contributions to the Plan were ~~$0.5~~$1.1 million during each of the six months ended December 31, 2020 and ~~$0.6 million, respectively.~~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 six months ended ~~September 30,~~December 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 are expected to 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 ~~September 30,~~December 31, 2020 was ~~$8.0~~$58.1 million compared to ~~an income tax expense of $1.8~~$5.3 million for the three months ended ~~September 30,~~December 31, 2019. The effective tax rates for the three months ended ~~September 30,~~December 31, 2020 and 2019 were ~~55.1%~~25.2% and ~~(17.2)%~~2369.6%, respectively. The effective tax rate for the three months ended ~~September 30,~~December 31, 2020 was ~~higher~~lower compared to the three months ended ~~September 30,~~December 31, 2019 primarily due to tax credits and deductions relative to a lower pre-tax loss in the three months ended December 31, 2019. The decrease was partially offset by the impact of the CARES Act, which increased the interest expense deductibility limitation in the current year and also allowed the Company to carry back its taxable loss into a prior fiscal year, where the statutory tax rate was 35%.

The federal, state and local income tax benefit for the six months ended December 31, 2020 was $66.1 million compared to $3.5 million for the six months ended December 31, 2019. The effective tax rates for the six months ended December 31, 2020 and 2019 were 27.0% and 33.2%, respectively. The effective tax rate for the six months ended December 31, 2020 was lower compared to the six months ended December 31, 2019 primarily due to tax credits and deductions relative to a lower pre-tax loss in the six months ended December 31, 2019. The decrease was partially offset by the impact of the CARES Act, which increased the interest expense deductibility limitation in the current year and also allowed the Company to carry back its taxable loss into a prior fiscal year, where the statutory tax rate was 35%.

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As of ~~September 30,~~December 31, 2020 and June 30, 2020, the Company has total unrecognized tax benefits of ~~$4.8~~$4.4 million and $4.6 million, respectively, of which ~~$4.7~~$4.4 million and $4.5 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 ~~September 30,~~December 31, 2020 in the statement of operations and 0 cumulative interest and penalties have been recorded either in the Company’s statement of financial position as of ~~September 30,~~December 31, 2020 and June 30, 2020. 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

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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. The Company has received preliminary assessments from the IRS, which are not considered material to Company’s Consolidated Statements of Operations; however, we cannot reasonably predict the final outcome of the examinations at this time. 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~~In December 2020, the Company ~~has received preliminary assessments from~~settled the ~~IRS and~~audit with the Florida Department of Revenue ~~which are not considered material to Company’s Consolidated Statements of Operations; however, we cannot reasonably predict the final outcome of the examinations at this time.~~for an immaterial amount.

Note 18. Related Party Transactions

The Company had sales of ~~$0.7~~$0.8 million and $0.6 million during ~~each of~~ the three months ended ~~September 30,~~December 31, 2020 and 2019, respectively, to a generic distributor, Auburn Pharmaceutical Company (“Auburn”), which is a member of the Premier Buying Group. Sales to Auburn for the six months ended December 31, 2020 and 2019 were $1.5 million and $1.3 million, respectively. Jeffrey Farber, a current board member, is the owner of Auburn. Accounts receivable includes amounts due from Auburn of $0.5 million and $0.7 million at ~~September 30,~~December 31, 2020 and June 30, ~~2020.~~2020, respectively.

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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. The Company was unable to sell the Cody API business as an ongoing operation and sold the equipment utilized by the Cody API business during Fiscal 2020. The Company ceased operations at Cody Labs, leased a portion of the real estate to a third party and intends to sell the remaining real estate. In October 2020, the Company entered into an agreement for the sale of real estate associated with the Cody API business for $3.8 million before fees and selling costs, subject to certain closing conditions. However, prior to closing, the buyer terminated the transaction in December 2020. The Company continues to actively market the real estate and is currently in negotiations with a prospective buyer. As of ~~September 30,~~December 31, 2020, the remaining 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.

The following table summarizes the financial results of the Cody API business for the three and six months ended ~~September 30,~~December 31, 2020 and 2019:


	Three Months Ended				Three Months Ended				Six Months Ended
	September 30,				December 31,				December 31,
(In thousands)	2020		2019		2020		2019		2020		2019
Net sales	$	—	$	1,067	$	—	$	669	$	—	$	1,736
Pretax loss attributable to Cody API business		(502)		(4,417)		(115)		(644)		(617)		(5,061)

The pretax loss attributable to the Cody API business during the ~~three~~six months ended ~~September 30,~~December 31, 2019 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.

~~Note 20. Subsequent Event~~

On October 29, 2020, the Company entered into an agreement for the sale of real estate associated with the Cody API business. The total consideration the Company will receive in connection with the sale is $3.8 million before fees and selling costs. The carrying value of the real estate was included within the Assets Held for Sale line of the Consolidated Balance Sheet as of September 30, 2020.The Company expects to complete the sale by the end of the second quarter of Fiscal Year 2021. The remaining real estate formerly associated with the Cody API business is currently leased to a third party.

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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, 2020. All references to “Fiscal 2021” or “Fiscal Year 2021” shall mean the fiscal year ending June 30, 2021 and all references to “Fiscal 2020” or “Fiscal Year 2020” shall mean the fiscal year ended June 30, 2020.

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.

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, 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.

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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 is 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~~The Company has ~~experienced some increased~~recently seen an increase in absenteeism arising from the recent spike in cases across the country, which has caused an increase in overtime and cost to produce the products, but 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 API and other raw materials of higher demand, which, 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. Additionally, subsequent to an initial stocking up of supplies at the start of the pandemic, the total volume of drug prescriptions written during the pandemic has decreased causing less demand for our products. Specifically, the pandemic has resulted in fewer elective surgeries being performed, causing less demand for our Numbrino cocaine hydrochloride product.

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 various health organizations to combat the virus. Several of those clinical trials were subsequently halted when the product did not show any significant efficacy in treating the virus. Other trials remain ongoing. If those clinical trials show the product to be helpful in combating the virus, which some trials have not, the Company may see an increase in demand. There are other sources of the product including the original brand.

In light of the economic impacts of COVID-19, the Company ~~performed a review of~~reviewed the assets on our Consolidated Balance Sheet as of ~~September 30,~~December 31, 2020, including intangible and other long-lived assets. Based on our review, ~~we continue to believe~~the Company determined 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 specifically related to COVID-19 were ~~recorded~~necessary during the first ~~three~~six months of Fiscal Year ~~2021 specifically related to COVID-19. The Company continues to assess our inventory reserve based on the current level of demand, which may be impacted by the ongoing pandemic.~~2021. Our assessment ~~was~~is 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.~~assumptions. Changes in market conditions ~~or other changes in~~could impact the Company’s future outlook and may lead to impairments in the future.

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As of ~~September 30,~~December 31, 2020, the Company’s outstanding debt balance was ~~$691.2~~$639.5 million, of which ~~$81.3~~$39.3 million represents the current portion. ~~In addition,~~The Company paid off the outstanding balance of the Term Loan A of $42.0 million on November 25, 2020 with cash on hand. The Company’s ~~existing~~undrawn $125 million Revolving Credit Facility also expired on November 25, 2020. On December 7, 2020, the Company entered into a credit and guaranty agreement, which provides for an asset-based revolving credit facility ~~is scheduled~~(the “ABL Credit Facility”) of up to ~~mature on November 25, 2020.~~$30 million, subject to borrowing base availability. 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 cash flows to meet its operating and debt service requirements for at least the next twelve months from the issuance of the ~~September 30,~~December 31, 2020 Consolidated Financial Statements. 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 ~~September 30,~~December 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 cash flows due to the continued uncertainty around the duration and severity of the pandemic.

2020 Restructuring Plan

On July 10, 2020, the Board of Directors authorized a restructuring and cost savings plan (the “2020 Restructuring Plan”)~~. The purpose of the 2020 Restructuring Plan is~~ to enhance manufacturing efficiencies, streamline operations and reduce the Company’s cost ~~structure, and~~structure. The 2020 Restructuring Plan was implemented, in part, as a result of previously anticipated near-term competition and pricing pressure with respect to certain key products. The 2020 Restructuring Plan includes the consolidation of the Company’s research and development (R&D) function into a single location in Philadelphia, PA, lowering operating costs and reducing the workforce by approximately 80 positions, equal to approximately 8.5% of the Company’s total number of employees. The 2020 Restructuring Plan was initiated on July 13, 2020 and is ~~substantially~~ complete as of ~~September 30,~~December 31, 2020.

The Company incurred approximately $4.0 million in severance-related costs in the first ~~quarter~~six months of Fiscal 2021, in connection with the 2020 Restructuring Plan. The Company expects the 2020 Restructuring Plan to result in annual cost savings in excess of $15.0 million.

Financial Summary

For the ~~first~~second quarter of Fiscal Year 2021, net sales decreased to ~~$126.5~~$133.9 million as compared to ~~$127.3~~$136.1 million in the same prior-year period. Gross profit decreased to ~~$25.7~~$0.8 million compared to ~~$42.7~~$41.3 million in the prior-year period and gross profit percentage decreased to ~~20%~~1% compared to ~~33%~~30% in the prior-year period. R&D expenses decreased ~~27%~~18% to ~~$6.5~~$5.6 million compared to ~~$8.9~~$6.9 million in the ~~first~~second quarter of Fiscal Year 2020 while SG&A expenses decreased ~~29%~~21% to ~~$15.1~~$13.7 million from ~~$21.3~~$17.4 million. Operating loss for the second quarter of Fiscal Year 2021, which included intangible asset impairment charges totaling $198.0 million, was $216.6 million compared to operating income of $16.8 million in the second quarter of Fiscal Year 2020. Net loss for the second quarter of Fiscal Year 2021 was $171.9 million, or $(4.36) per diluted share. Comparatively, net income in the prior-year period was $5.1 million, or $0.13 per diluted share.

For the first six months of Fiscal 2021, net sales decreased to $260.4 million compared to $263.5 million in the same prior-year period. Gross profit decreased to $26.5 million compared to $84.0 million in the prior-year period. Gross profit percentage decreased to 10% compared to 32% in the prior-year period. R&D expenses decreased 23% to $12.2 million compared to $15.8 million in the first six months of Fiscal 2020 while SG&A expenses decreased 25% to $28.9 million from $38.7 million in the prior-year period. Restructuring expenses increased to $4.0 million ~~compared to $1.4~~from $1.6 million in the prior-year period. Operating loss for the first ~~quarter~~six months of Fiscal ~~Year~~ 2021, which included intangible asset impairment charges totaling $198.0 million, was ~~$15 thousand~~$216.6 million compared to operating income of ~~$9.4~~$26.2 million in the ~~first quarter of Fiscal Year 2020,~~prior-year period, which included asset impairment charges totaling $1.6 million. Net loss for the first ~~quarter~~six months of Fiscal ~~Year~~ 2021 was ~~$6.5~~$178.4 million, or ~~$(0.17)~~$(4.55) per diluted ~~share. Comparatively,~~share compared to net loss of $7.1 million, or $(0.18) per diluted share in the prior-year ~~period was $12.2 million, or $(0.32) per diluted share.~~period.

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

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Results of Operations - Three months ended ~~September 30,~~December 31, 2020 compared with the three months ended ~~September 30,~~December 31, 2019

Net sales decreased 1%2% to ~~$126.5~~$133.9 million for the three months ended ~~September 30,~~December 31, 2020. The table below identifies the Company’s net product sales by medical indication for the three months ended ~~September 30,~~December 31, 2020 and 2019.


(In thousands)	Three Months Ended September 30,				Three Months Ended December 31,
Medical Indication	2020		2019		2020		2019
Analgesic	$	3,120	$	1,884	$	3,572	$	2,111
Anti-Psychosis		13,028		28,034		13,317		22,697
Cardiovascular		19,714		21,606		16,336		23,972
Central Nervous System		22,525		19,257		24,614		19,331
Endocrinology		3,233		—		9,496		—
Gastrointestinal		17,100		16,962		18,575		18,313
Infectious Disease		21,932		11,895		23,044		18,078
Migraine		9,690		9,143		6,083		10,878
Respiratory/Allergy/Cough/Cold		1,426		2,707		2,267		3,075
Urinary		1,458		435		1,361		1,233
Other		7,634		9,861		8,410		9,934
Contract manufacturing revenue		5,619		5,558		6,845		6,488
Total net sales	$	126,479	$	127,342	$	133,920	$	136,110

The slight decrease in net sales was driven by a decrease in the selling price of products of ~~$21.5~~$28.5 million partially offset by increased volumes of ~~$20.7~~$26.3 million. The decrease in the selling price of products was primarily driven by lower sales prices of Fluphenazine, which is included within the Anti-Psychosis medical indication, due to a new competitor entering the market, as well as lower average selling price across the remaining medical indications. Overall volumes increased primarily due to new product launches, partially offset by lower volumes of Fluphenazine.

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 ~~$4.3~~$4.6 million and $10.4 million during the three months ended ~~September 30,~~December 31, 2020 and 2019, respectively.

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


	Sales volume		Sales price		Sales volume		Sales price
Medical indication	change %		change %		change %		change %
Analgesic	68	%	(2)	%	130	%	(61)	%
Anti-Psychosis	(31)	%	(23)	%	(13)	%	(28)	%
Cardiovascular	3	%	(12)	%	(14)	%	(18)	%
Central Nervous System	60	%	(43)	%	73	%	(46)	%
Endocrinology	100	%	—	%	100	%	—	%
Gastrointestinal	12	%	(11)	%	10	%	(9)	%
Infectious Disease	97	%	(13)	%	31	%	(4)	%
Migraine	19	%	(13)	%	(12)	%	(32)	%
Respiratory/Allergy/Cough/Cold	(40)	%	(7)	%	(25)	%	(1)	%
Urinary	199	%	36	%	5	%	5	%

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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)	September 30,		September 30,		December 31,		December 31,
Customer Distribution Channel	2020		2019		2020		2019
Wholesaler/Distributor	$	100,580	$	102,200	$	108,115	$	103,728
Retail Chain		17,145		17,088		16,217		23,092
Mail-Order Pharmacy		3,135		2,496		2,743		2,802
Contract manufacturing revenue		5,619		5,558		6,845		6,488
Total net sales	$	126,479	$	127,342	$	133,920	$	136,110

The decrease in sales to retail chains was primarily driven by lower sales of Fluphenazine due to a new competitor entering the market.

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Cocaine Hydrochloride Solution

In December 2017, a competitor received approval from the FDA to market and sell a Cocaine Hydrochloride topical product. The approval affected 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 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 was not sold during Fiscal 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 competitor filed a Citizen Petition with the FDA in February 2019, claiming that the grant of the New Chemical Entity (“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 filed responses in opposition and cross motions for summary judgement requesting dismissal of the complaint. The parties submitted further reply briefs and are awaiting a decision by the Court. On September 15, 2020, the Court granted summary judgment in part to the competitor on one of the counts of the complaint. While the Court agreed with the FDA that the competitor’s NCE exclusivity did not block the approval of the Company’s 505(b)(2) application, the Court found that the FDA erred by not requiring the Company to submit a patent certification. The Court requested that the parties file a joint status report indicating the remedy the Court should order to correct the error. The FDA and the Company requested the Court order the case remanded to the FDA without vacating the Company’s 505(b)(2) approval. The competitor requested the Court remand the case to the FDA while also vacating the Company’s 505(b)(2) approval. On October 7, 2020, the Court held a status conference and ordered that the competitor file a motion to vacate on October 16, 2020, and the FDA and the Company to file an opposition and cross motion for reconsideration on October 30, 2020. On October 16, 2020, the competitor filed a motion to vacate the Company’s NDA approval and on October 30, 2020, the Company and FDA filed a response in opposition and a cross motion for reconsideration. On January 11, 2021, the law clerk to the Judge sent an email indicating that Court was inclined to deny the competitor’s motion to vacate, deny the motion for reconsideration and remand the case to the FDA to take appropriate action to cure any procedural defect with the Company’s NDA. On January 21, 2021, the Court held a conference and indicated that it would be issuing an Order remanding the case to FDA for either 45 or 60 days to address the error relating to the missing patent certification in the NDA. By Memorandum and Opinion dated January 27, 2021, the Court denied the FDA and Company’s motion for reconsideration, granted the competitor’s motion to vacate, but stayed the order for 60 days to permit the FDA to take any action necessary to address the Court’s ruling regarding the patent certification in connection with the Company’s 505(b)(2) NDA.

On November 12, 2020, the competitor filed a second lawsuit against the FDA in the United States District Court for the District of Maryland, seeking an order requiring the FDA to initiate proceedings to withdraw the Company’s NDA for alleged false statements in the NDA application. The Company denies that it made any false statements in the NDA application and filed a motion to intervene. Following the Court granting the motion to intervene, on January 15, 2021, both the Company and the FDA filed separate motions to dismiss the second lawsuit.

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On June 6, 2020, the competitor filed a patent infringement complaint in the United States District Court for the District of Delaware, asserting that the Company’s approved cocaine hydrochloride product infringes three patents issued to the competitor. On June 19, 2020, the Company filed an answer and counterclaim, alleging that the Company either does not infringe or the three asserted patents are invalid. In addition, the Company sought a declaration that, as to the competitor’s three additional patents not asserted against the Company, they are either not infringed or invalid. The competitor filed a motion to dismiss a portion of the counterclaim and the Company filed a response in opposition to the motion. The Company continues to market its approved cocaine hydrochloride product.

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 permitted 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 could be delayed until Fiscal Year 2022.

Ranitidine Oral Solution, USP

As part of an industry-wide action, the Company issued a voluntary recall on 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’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.

On June 1, 2020, a class action complaint was served upon the Company and approximately forty-five (45) other companies asserting claims for personal injury arising from the presence of NDMA in Ranitidine products. The complaint is consolidated in a multidistrict litigation (“MDL”) pending in the United States District Court for the Southern District of Florida. ~~A similar complaint was~~Similar complaints were filed in state court in New Mexico and state court in Maryland and served upon the ~~Company by the State~~Company. Subsequently, a number of ~~Mexico in July 2020. The Company has learned that several other~~ similar ~~class action~~ complaints ~~naming the Company and others~~ were ~~filed but, to date, none of those complaints have been~~ served ~~upon~~on the Company. The Company has filed a motion to dismiss the complaint filed in the MDL and has filed a motion to transfer the complaint filed in the New Mexico state court to the MDL. On December 31, 2020, the Court granted the Company’s motion to dismiss Master Personal Injury Complaint, Consolidated Consumer Class Action Complaint and Consolidated third Party Payor Class Complaint, all based on federal preemption. The Court dismissed some of the claims with prejudice and others with leave to amend. Separately, the New Mexico case was conditionally transferred to the MDL and the plaintiff filed a motion to vacate the conditional transfer, which the Company has opposed. The Company filed a notice to remove and transfer the Maryland case to the MDL which the plaintiff has opposed. The Company has placed its insurance carrier on notice of the claim and the carrier has appointed counsel to defend the Company.

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Cost of Sales, including amortization of intangibles. Cost of sales, including amortization of intangibles, for the ~~first~~second quarter of Fiscal Year 2021 increased ~~19%~~40% to ~~$100.8~~$133.1 million from ~~$84.7~~$95.0 million in the same prior-year period. The increase was primarily attributable to additional volumes from new product ~~mix~~launches as well as ~~increased~~an increase of $18.1 million in the write-downs for excess and obsolete inventory, which primarily relates to the Company’s decision to discontinue 23 lower margin product ~~royalties expense related~~lines. The Company also recorded $5.0 million in consideration to ~~various~~renew the Company’s distribution ~~agreements.~~agreement with Recro Gainesville, LLC (“Recro”) during the second quarter of Fiscal Year 2021. Product royalties expense included in cost of sales totaled ~~$18.1~~$18.9 million for the ~~first~~second quarter of Fiscal Year 2021 and ~~$16.3~~$20.0 million for the ~~first~~second quarter of Fiscal Year 2020. Amortization expense included in cost of sales totaled ~~$8.6~~$8.7 million for the ~~first~~second quarter of Fiscal 2021 and ~~$7.0~~$8.2 million for the ~~first~~second quarter of Fiscal 2020.

Gross Profit. Gross profit for the ~~first~~second quarter of Fiscal 2021 decreased ~~40%~~98% to ~~$25.7~~$0.8 million or ~~20%~~1% of net sales. In comparison, gross profit for the ~~first~~second quarter of Fiscal 2020 was ~~$42.7~~$41.3 million or ~~33%~~30% of net sales. The decrease in gross profit percentage was primarily attributable to lower volumes of Fluphenazine, which had higher than average gross profit margins, as well as overall lower average selling prices of our ~~products~~products. The Company also recorded an increase in the write-downs for excess and ~~increased product royalties expense related~~obsolete inventory as well as consideration to ~~various~~renew the distribution ~~agreements.~~agreement with Recro in the second quarter of Fiscal 2021.

Research and Development Expenses. Research and development expenses for the ~~first~~second quarter of Fiscal 2021 decreased ~~27%~~18% to ~~$6.5~~$5.6 million from ~~$8.9~~$6.9 million in Fiscal Year 2020. The decrease was primarily due to lower R&D expenses as a result of timing of certain milestones related to product development projects as well as employee headcount reductions related to the 2020 Restructuring Plan.

Selling, General and Administrative Expenses. Selling, general and administrative expenses decreased ~~29%~~21% to ~~$15.1~~$13.7 million in the ~~first~~second quarter of Fiscal Year 2021 compared with ~~$21.3~~$17.4 million in Fiscal Year 2020. The decrease was primarily driven by lower incentive-based compensation, lower legal expenses, lower expenses at the Company’s Cody Labs subsidiary and other cost reduction initiatives.

Asset impairment charges. In December 2020, the Company reviewed its product portfolio and decided to discontinue 23 lower gross margin product lines, including product lines that were acquired through various past business and product acquisitions. As a result of the discontinuance and the reduction in net sales and gross margin of certain other product lines, the Company recorded an impairment charge of $193.0 million related to the KUPI product rights intangible assets during the second quarter of Fiscal 2021. The impairment charge is primarily a result of the decline in net sales and gross margin of certain product lines acquired in connection with the KUPI acquisition, including those product lines being discontinued.

Other Income (Loss). Interest expense for the three months ended ~~September 30,~~December 31, 2020 totaled ~~$14.5~~$13.5 million compared to ~~$19.3~~$16.7 million for the three months ended ~~September 30,~~December 31, 2019. The decrease was due to a lower weighted-average debt balance in the ~~first~~second quarter of Fiscal 2021 as compared to the prior-year period as well as a lower weighted-average interest rate due to the ~~partial~~full repayment of the outstanding Term Loan A ~~balance with proceeds from the issuance of the Notes.~~balance. The weighted average interest rate for the ~~first~~second quarter of Fiscal 2021 and 2020 was ~~8.0%~~7.8% and ~~9.8%~~8.6%, respectively.

Income Tax. The Company recorded an income tax benefit of ~~$8.0~~$58.1 million in the ~~first~~second quarter of Fiscal Year 2021 as compared to an income tax ~~expense~~benefit of ~~$1.8~~$5.3 million in the ~~first~~second quarter of Fiscal Year 2020. The effective tax rate for the three months ended ~~September 30,~~December 31, 2020 was ~~55.1%~~25.2%, compared to ~~(17.2)%~~2369.6% for the three months ended ~~September 30,~~December 31, 2019. The effective tax rate for the three months ended ~~September 30,~~December 31, 2020 was ~~higher~~lower compared to the three months ended ~~September 30,~~December 31, 2019 primarily due to tax credits and deductions relative to a lower pre-tax loss in the three months ended December 31, 2019. The decrease was partially offset by the impact of the CARES Act, which increased the interest expense deductibility limitation in the current year and also allowed the Company to carry back its taxable loss into a prior fiscal year, where the statutory tax rate was 35%.

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Net Income (Loss). For the three months ended December 31, 2020, the Company reported net loss of $171.9 million, or $(4.36) per diluted share. Comparatively, net income in the corresponding prior-year period was $5.1 million, or $0.13 per diluted share.

Results of Operations - Six months ended December 31, 2020 compared with the six months ended December 31, 2019

Net sales decreased to $260.4 million for the six months ended December 31, 2020. The table below identifies the Company's net product sales by medical indication for the six months ended December 31, 2020 and 2019.


(In thousands)	Six Months Ended December 31,
Medical Indication	2020		2019
Analgesic	$	6,692	$	3,995
Anti-Psychosis		26,345		50,730
Cardiovascular		36,050		45,579
Central Nervous System		47,139		38,588
Endocrinology		12,729		—
Gastrointestinal		35,675		35,275
Infectious Disease		44,976		29,973
Migraine		15,773		20,021
Respiratory/Allergy/Cough/Cold		3,693		5,781
Urinary		2,819		1,668
Other		16,044		19,796
Contract manufacturing revenue		12,464		12,046
Total net sales	$	260,399	$	263,452

The slight decrease in net sales was driven by a decrease in the selling price of products of $56.0 million partially offset by increased volumes of $53.0 million. The decrease in the selling price of products was primarily driven by lower sales prices of Fluphenazine, which is included within the Anti-Psychosis medical indication, due to a new competitor entering the market, as well as lower average selling price across the remaining medical indications. Overall volumes increased primarily due to new product launches, partially offset by lower volumes of Fluphenazine.

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 $8.9 million and $22.6 million during the six months ended December 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	123	%	(55)	%
Anti-Psychosis	(23)	%	(25)	%
Cardiovascular	(7)	%	(14)	%
Central Nervous System	80	%	(58)	%
Endocrinology	100	%	—	%
Gastrointestinal	10	%	(9)	%
Infectious Disease	57	%	(7)	%
Migraine	2	%	(23)	%
Respiratory/Allergy/Cough/Cold	(33)	%	(3)	%
Urinary	54	%	15	%

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


(In thousands)	December 31,		December 31,
Customer Distribution Channel	2020		2019
Wholesaler/Distributor	$	208,695	$	205,928
Retail Chain		33,362		40,181
Mail-Order Pharmacy		5,878		5,297
Contract manufacturing revenue		12,464		12,046
Total net sales	$	260,399	$	263,452

The decrease in sales to retail chains was primarily driven by lower sales of Fluphenazine due to a new competitor entering the market.

Cost of Sales, including amortization of intangibles. Cost of sales, including amortization of intangibles, for the first six months of Fiscal Year 2021 increased 30% to $233.9 million from $179.5 million in the same prior-year period. The increase was primarily attributable to additional volumes from new product launches as well as an increase of $17.2 million in write-downs for excess and obsolete inventory, which primarily relates to the Company’s decision to discontinue 23 lower margin product lines. The Company also recorded $5.0 million in consideration to renew the Company’s distribution agreement with Recro Gainesville, LLC (“Recro”) during the second quarter of Fiscal Year 2021. Product royalties expense included in cost of sales totaled $37.0 million for the first six months of Fiscal Year 2021 and $36.4 million for the first six months of Fiscal Year 2020. Amortization expense included in cost of sales totaled $17.2 million for the first six months of Fiscal 2021 and $15.2 million for the first six months of Fiscal 2020.

Gross Profit. Gross profit for the first six months of Fiscal 2021 decreased 68% to $26.5 million or 10% of net sales. In comparison, gross profit for the first six months of Fiscal 2020 was $84.0 million or 32% of net sales. The decrease in gross profit percentage was primarily attributable to lower volumes of Fluphenazine, which had higher than average gross profit margins, as well as overall lower average selling prices of our products. The Company also recorded an increase in the write-downs for excess and obsolete inventory as well as consideration to renew the distribution agreement with Recro in the second quarter of Fiscal 2021.

Research and Development Expenses. Research and development expenses for the first six months of Fiscal 2021 decreased 23% to $12.2 million from $15.8 million in Fiscal Year 2020. The decrease was primarily due to lower R&D expenses as a result of timing of certain milestones related to product development projects as well as employee headcount reductions related to the 2020 Restructuring Plan.

Selling, General and Administrative Expenses. Selling, general and administrative expenses decreased 25% to $28.9 million in the first six months of Fiscal Year 2021 compared with $38.7 million in Fiscal Year 2020. The decrease was primarily driven by lower incentive-based compensation, lower legal expenses, lower expenses at the Company’s Cody Labs subsidiary and other cost reduction initiatives.

Asset impairment charges. In December 2020, the Company reviewed its product portfolio and decided to discontinue 23 lower gross margin product lines, including product lines that were acquired through various past business and product acquisitions.As a result of the discontinuance and the reduction in net sales and gross margin of certain other product lines, the Company recorded an impairment charge of $193.0 million related to the KUPI product rights intangible assets during the second quarter of Fiscal 2021. The impairment charge is primarily a result of the decline in net sales and gross margin of certain product lines acquired in connection with the KUPI acquisition, including those product lines being discontinued.

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Other Income (Loss). Interest expense for the six months ended December 31, 2020 totaled $28.0 million compared to $36.0 million for the six months ended December 31, 2019. The decrease was due to a lower weighted-average debt balance in the first six months of Fiscal 2021 as compared to the prior-year period as well as a lower weighted-average interest rate due to the full repayment of the outstanding Term Loan A. The weighted average interest rate for the first six months of Fiscal 2021 and 2020 was 7.9% and 9.2%, respectively. Investment income for the six months ended December 31, 2020 was $0.1 million as compared to $1.2 million in the same prior-year period.

Income Tax. The Company recorded an income tax benefit of $66.1 million in the first six months of Fiscal Year 2021 as compared to an income tax expense of $3.5 million in the first six months of Fiscal Year 2020. The effective tax rate for the six months ended December 31, 2020 was 27.0%, compared to 33.2% for the six months ended December 31, 2019. The effective tax rate for the six months ended December 31, 2020 was lower compared to the six months ended December 31, 2019 primarily due to tax credits and deductions relative to a lower pre-tax loss in the six months ended December 31, 2019. The decrease was partially offset by the impact of the CARES Act, which increased the interest expense deductibility limitation in the current year and also allowed the Company to carry back its taxable loss into a prior fiscal year, where the statutory tax rate was 35%.

Net Loss. For the ~~three~~six months ended ~~September 30,~~December 31, 2020, the Company reported net loss of ~~$6.5~~$178.4 million, or ~~$(0.17)~~$(4.55) per diluted share. Comparatively, net loss in the corresponding prior-year period was ~~$12.2~~$7.1 million, or ~~$(0.32)~~$(0.18) per diluted share.

Liquidity and Capital Resources

Cash Flow

The Company has historically financed its operations with cash flow generated from operations supplemented with borrowings from various government agencies and financial institutions. At ~~September 30,~~December 31, 2020, working capital was ~~$223.0~~$244.1 million as compared to $228.3 million at June 30, 2020, ~~a decrease~~an increase of ~~$5.3~~$15.8 million. Current product portfolio sales as well as sales related to future product approvals are anticipated to generate positive cash flow from operations.

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Net cash used in operating activities of ~~$12.2~~$24.6 million for the ~~three~~six months ended ~~September 30,~~December 31, 2020 reflected net loss of ~~$6.5~~$178.4 million, adjustments for non-cash items of ~~$18.6~~$247.6 million, as well as cash used through changes in operating assets and liabilities of ~~$24.3~~$93.8 million. In comparison, net cash provided by operating activities of ~~$4.3~~$47.7 million for the ~~three~~six months ended ~~September 30,~~December 31, 2019 reflected net loss of ~~$12.2~~$7.1 million, adjustments for non-cash items of ~~$23.0~~$42.1 million, as well as cash ~~used~~provided through changes in operating assets and liabilities of ~~$6.6~~$12.7 million.

Significant changes in operating assets and liabilities from June 30, 2020 to ~~September 30,~~December 31, 2020 were comprised of:

●

An increase in accounts receivable of ~~$13.1~~$34.3 million mainly due to the timing of sales and cash receipts. The Company’s days sales outstanding (“DSO”) at ~~September 30,~~December 31, 2020, based on gross sales for the ~~three~~six months ended ~~September 30,~~December 31, 2020 and gross accounts receivable at ~~September 30,~~December 31, 2020, was 7076 days. The level of DSO at ~~September 30,~~December 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 income taxes receivable totaling ~~$5.1~~$50.1 million primarily due to additional estimated tax refunds related to provisions of the CARES ~~Act.~~Act as well as an anticipated Fiscal 2021 taxable loss.

●

A decrease in accrued expenses totaling $10.9 million primarily due to the payment of the branded prescription drug fee in October 2020.

●

An increase in accounts payable totaling $10.1 million primarily due to the timing of vendor invoices and payments.

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●

A decrease in accrued payroll and payroll-related costs of ~~$6.7~~$7.4 million primarily related to payments made in August 2020 in connection with incentive-based compensation accrued in Fiscal Year 2020 as well as the timing of payroll payments.

●

~~An increase in accounts payable totaling $15.0 million primarily due to the timing of vendor invoices and payments.~~

Significant changes in operating assets and liabilities from June 30, 2019 to ~~September 30,~~December 31, 2019 were comprised of:

●

~~An increase~~A decrease in accounts receivable of ~~$8.4~~$6.3 million mainly due to the timing of ~~sales and product launches in the first quarter of Fiscal 2020.~~receipts. The Company’s ~~days sales outstanding (“DSO”)~~DSO at ~~September 30,~~December 31, 2019, based on gross sales for the ~~three~~six months ended ~~September 30,~~December 31, 2019 and gross accounts receivable at ~~September 30,~~December 31, 2019, was 8173 days. The level of DSO at ~~September 30,~~December 31, 2019 was comparable to the Company’s expectation that DSO will be in the 70 to 85-day range based on customer payment terms.

●

An increase in accounts payable totaling ~~$13.4~~$17.4 million primarily due to the timing of payments.

●

A decrease in accrued payroll and payroll-related costs of ~~$7.6~~$7.7 million primarily related to payments made in August 2019 in connection with incentive compensation accrued in Fiscal Year 2019, partially offset by the timing of payroll payments.

●

~~A decrease~~An increase in ~~other assets~~inventories totaling ~~$6.8~~$8.1 million primarily due to ~~receipt~~the timing of ~~an indemnification asset from UCB related~~customer order fulfillment.

●

An increase in prepaid income taxes totaling $9.0 million primarily due to ~~a government pricing contract compliance review.~~estimated tax payments made in the first six months of Fiscal 2020.

Net cash used in investing activities of ~~$6.2~~$9.1 million for the ~~three~~six months ended ~~September 30,~~December 31, 2020 was mainly the result of purchases of property, plant and equipment of ~~$3.2~~$5.1 million and purchases of intangible assets of ~~$3.0~~$4.0 million. Net cash used in investing activities of ~~$21.5~~$30.0 million for the ~~three~~six months ended ~~September 30,~~December 31, 2019 was mainly the result of purchases of intangible assets of ~~$23.5~~$27.3 million and purchases of property, plant and equipment of ~~$4.0~~$8.8 million, partially offset by proceeds from the sale of property, plant and equipment of $6.3 million.

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Net cash used in financing activities of ~~$17.2~~$71.5 million for the ~~three~~six months ended ~~September 30,~~December 31, 2020 was due to debt repayments of ~~$16.7~~$68.5 million, payment of debt issuance costs of $2.4 million, and purchases of treasury stock totaling ~~$0.8~~$1.0 million, partially offset by proceeds from issuance of stock pursuant to stock compensation plans of ~~$0.3~~$0.4 million. Net cash used in financing activities of ~~$22.0~~$38.8 million for the ~~three~~six months ended ~~September 30,~~December 31, 2019 was due to debt repayments of ~~$96.6~~$113.3 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 ~~$1.4~~$1.8 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 ~~$0.2~~$0.6 million.

Credit Facility and Other Indebtedness

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

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

On December 10, 2018, the Company entered into a ~~second~~third 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. ~~As of September 30, 2020, cash and cash equivalents totaled $108.8 million in addition to availability under our undrawn Revolver totaling $125.0 million. As of September 30,~~On November 25, 2020, the Company ~~was in compliance with~~repaid the remaining $42 million outstanding balance of its ~~financial covenants, which will expire upon repayment of the outstanding~~ Term ~~Loan~~ A ~~on November 25, 2020. The Company anticipates paying down the outstanding Term Loan A balance~~Loans with cash on ~~hand.~~hand and, upon repayment, the Company is no longer obligated to comply with the financial leverage ratio and minimum liquidity covenants described above.

On December 7, 2020, the Company entered into Amendment No. 4 to the Credit and Guaranty Agreement, which amends the Term Loan B Facility to permit the incurrence of the ABL Credit Facility, which is discussed further below, and requires the Company to maintain at least $5 million in a deposit account at all times, subject to control by the administrative agent, and a minimum cash balance of $15 million as of the last day of each month. At December 31, 2020, the Company classified the $5 million required deposit account balance as restricted cash, which is included in other assets. The amendment also replaced Morgan Stanley Senior Funding, Inc. with Alter Domus (US) LLC as administrative agent and collateral agent under the Term Loan B Facility.

Refer to the Company’s Form 10-K for the fiscal year ended June 30, 2020 for further details on the Amended Senior Secured Credit Facility.

ABL Credit Facility

The final maturity of the ABL Credit Facility is December 7, 2023, unless the aggregate outstanding principal amount of any of the Term Loan B Facility (as defined above) or other material indebtedness exceeds $35,000,000 on the date that is 91 days prior to the maturity date with respect to such other indebtedness, in which case the final maturity shall instead be such earlier date. Loans outstanding under the ABL Credit Agreement bear interest at a floating rate measured by reference to an adjusted London Inter-Bank Offered Rate (“LIBOR”), subject to a floor of 0.75%, plus an applicable margin of 2.50% per annum. Unused commitments under the ABL Credit Facility are subject to a per annum fee of 0.50%. The obligations under the ABL Credit Agreement are guaranteed by the Company and all of the Company’s existing and future subsidiaries, subject to certain exceptions (collectively, the “Guarantors”), and such obligations and the obligations of the Guarantors are secured by:

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The ABL Credit Agreement includes a minimum fixed charge coverage ratio of no less than 1.10 to 1.00, which is tested only when Excess Availability is less than 15.0% of the lesser of (A) the borrowing base and (B) the then effective commitments under the ABL Credit Facility for three consecutive business days, and continuing until the first day immediately succeeding the last day of 30 consecutive days on which Excess Availability is in excess of such threshold.

4.50% Convertible Senior Notes due 2026

On September 27, 2019, the Company issued $86.3 million 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, 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. The Notes bear interest at an annual rate of 4.50% payable semi-annually in arrears on April 1 and October 1 of each year, beginning on April 1, 2020. The Notes will mature on October 1, 2026, unless earlier repurchased, redeemed or converted in accordance with their terms. The Notes are convertible into shares of the Company’s common stock at an initial conversion rate of 65.4022 shares per $1,000 principal amount of Notes (which is equivalent to an initial conversion price of approximately $15.29 per share), subject to adjustments upon the occurrence of certain events (but will not be adjusted for any accrued and unpaid interest). The Company may redeem all or a part of the Notes on or after October 6, 2023 at a redemption price equal to 100% of the principal amount of the Notes redeemed, plus accrued and unpaid interest, if any, up to, but excluding, the redemption date, subject to certain conditions relating to the Company’s stock price having been met. Following certain corporate events that occur prior to the maturity date or if the Company delivers a notice of redemption, the Company will, in certain circumstances, increase the conversion rate for a holder who elects to convert its Notes in connection with such corporate event or notice of redemption. The indenture covering the Notes contains certain other customary terms and covenants, including that upon certain events of default occurring and continuing, either the trustee or holders of at least 25% in principal amount of the outstanding Notes may declare 100% of the principal of, and accrued and unpaid interest on, all the Notes to be due and payable.

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

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Management plans to attempt, at the appropriate time, 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.

Other Liquidity Matters

Refer to the “Impact of COVID-19 Pandemic” section above for the impact 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.

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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 Intangible Assets, In-Process Research and Development and Share-based Compensation.

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Revenue Recognition

~~On July 1, 2018, the~~The Company ~~adopted ASC~~complies with Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with ~~Customers~~Custom,ers, which superseded ASC Topic 605, Revenue Recognition. Under ASC 606, the Company recognizes revenue when ~~title and risk of loss of~~(or as) we satisfy our performance obligations by transferring a promised ~~goods~~good or ~~services have transferred~~service to ~~the~~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 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.

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Chargebacks

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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

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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, 2020 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 ~~September 30,~~December 31, 2020, each 1/8% increase in interest rates would yield ~~$0.8~~$0.7 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 ~~three~~six months ended ~~September 30,~~December 31, 2020 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

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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, 2020 includes a detailed description of its risk factors.

In Refer to the ~~first quarter~~Form 10-Q for the quarterly period ended September 30, 2020 for a detailed description of ~~Fiscal 2021,~~an additional risk factor identified by the Company ~~updated Item 1A. Risk Factors to include the following:~~

~~We may incur product liability losses or recall expenses relating to the sale of products containing nitrosamines.~~

According to FDA guidance, nitrosamine impurities, including, among others, N-nitrosodimethylamine (“NDMA”) may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time, but a person taking a drug that contains nitrosamines at-or-below the acceptable daily intake limits every day for 70 years is not expected to have an increased risk of cancer. FDA published a guidance entitled “Control of Nitrosamine Impurities in Human Drugs” that recommends steps manufacturers of APIs and drug products should take to detect and prevent unacceptable levels of nitrosamine impurities in pharmaceutical products. Lannett initiated an internal risk assessment and control strategy for nitrosamines prior to issuancesince filing of the guidance. In some cases where its marketed products contain nitrosamines above published FDA acceptable levels (such as ranitidine), Lannett may be required to recall affected product, such as Lannett’s ranitidine product, which was subject to an industry wide recall when NDMA was discovered as a byproduct of the manufacturing process. Subsequent to the recall of its ranitidine product, Lannett was named a defendant in a series of product liability lawsuits. Product liability claims and lawsuits, safety alerts, product recalls or corrective actions, regardless of their ultimate outcome, could have a material adverse effect on our business and reputation and on our ability to attract and retain customers. We are unable to predict at this time if any other Lannett products will be adversely impacted by the global pharmaceutical nitrosamine review.

As part of our risk management policy, we carry third-party product liability insurance coverage; however, the insurance industry recently adopted an exclusion into its comprehensive general liability policies for nitrosamine impurities. To the extent that any of Lannett’s products are subject to recall as a result of nitrosamine impurities and/or is subject to lawsuit arising out of the presence of nitrosamine impurities in its products, such losses may not be covered by insurance and could have a material adverse effect on our profitability and financial~~condition.~~Form 10-K.

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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	Filed Herewith

10.76+*	License and Supply Agreement with Alkermes Pharma Ireland Limited and Kremers Urban Pharmaceuticals Inc.	Filed Herewith

10.77+*	Amendment No. 1 to License and Supply Agreement between Recro Gainesville LLC (as successor to Alkermes Pharma Ireland Limited) and Kremers Urban Pharmaceuticals, Inc.	Filed Herewith

10.78	Amendment No. 2 to License and Supply Agreement between Recro Gainesville LLC (as successor to Alkermes Pharma Ireland Limited) and Kremers Urban Pharmaceuticals, Inc.	Filed Herewith

101.INS	XBRL Instance Document – the instance document does not appear within the Interactive Data File because its XRBL tags are embedded within the Inline XRBL Document	Filed Herewith

101.SCH	XBRL Taxonomy Extension Schema Document	Filed Herewith

101.CAL	XBRL Taxonomy Extension Calculation Linkbase Document	Filed Herewith

101.DEF	XBRL Taxonomy Extension Definition Linkbase Document	Filed Herewith

101.LAB	XBRL Taxonomy Extension Label Linkbase Document	Filed Herewith

101.PRE	XBRL Taxonomy Extension Presentation Linkbase Document	Filed Herewith

104	Cover Page Interactive Data File – The cover page interactive data file does not appear in the Interactive Data File because its XRBL tags are embedded within the Inline XRBL document	Filed Herewith

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

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

** Furnished Herewith

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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: ~~November 5, 2020~~February 4, 2021	By:	/s/ Timothy Crew
		Timothy Crew
		Chief Executive Officer


Dated: ~~November 5, 2020~~February 4, 2021	By:	/s/ John Kozlowski
		John Kozlowski
		Vice President of Finance, Chief Financial Officer and Principal Accounting Officer

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