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 MarchDecember 31, 2021
☐ | 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 Road1150 Northbrook Drive, Suite 155
PhiladelphiaTrevose, PA 1913619053
(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 |
Common stock, par value $0.001 per share | |
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Table of Contents
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| | Consolidated Balance Sheets as of | 3 |
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| | Consolidated Statements of Cash Flows for the | 7 |
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| MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
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2
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
LANNETT COMPANY, INC.
CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
(In thousands, except share and per share data)
| | | | | | | | | | | | |
|
| March 31, 2021 |
| June 30, 2020 |
| December 31, 2021 |
| June 30, 2021 | ||||
ASSETS | | | | | | | | | | | | |
Current assets: | | | | | | | | | | | | |
Cash and cash equivalents | | $ | 81,290 | | $ | 144,329 | | $ | 98,635 | | $ | 93,286 |
Accounts receivable, net | |
| 114,691 | |
| 125,688 | |
| 66,275 | |
| 98,834 |
Inventories | |
| 113,074 | |
| 142,867 | |
| 105,779 | |
| 109,545 |
Income taxes receivable | | | 40,043 | | | 14,419 | | | 35,847 | | | 35,050 |
Assets held for sale | |
| 2,678 | |
| 2,678 | |
| 12,733 | |
| 2,678 |
Other current assets | |
| 18,135 | |
| 13,227 | |
| 15,345 | |
| 14,170 |
Total current assets | |
| 369,911 | |
| 443,208 | |
| 334,614 | |
| 353,563 |
Property, plant and equipment, net | |
| 168,844 | |
| 179,518 | |
| 143,104 | |
| 166,674 |
Intangible assets, net | |
| 160,138 | |
| 374,735 | |
| 90,972 | |
| 137,835 |
Operating lease right-of-use assets | | | 10,762 | | | 9,343 | | | 10,227 | | | 10,559 |
Deferred tax assets | |
| 138,019 | |
| 117,890 | ||||||
Other assets | |
| 14,696 | |
| 11,861 | |
| 16,020 | |
| 15,106 |
TOTAL ASSETS | | $ | 862,370 | | $ | 1,136,555 | | $ | 594,937 | | $ | 683,737 |
| | | | | | | | | | | | |
LIABILITIES | | | | | | | | | | | | |
Current liabilities: | | | | | | | | | | | | |
Accounts payable | | $ | 32,605 | | $ | 32,535 | | $ | 25,988 | | $ | 29,585 |
Accrued expenses | |
| 4,025 | |
| 14,962 | |
| 11,206 | |
| 13,077 |
Accrued payroll and payroll-related expenses | |
| 9,758 | |
| 16,304 | |
| 9,606 | |
| 10,680 |
Rebates payable | |
| 31,848 | |
| 38,175 | |
| 25,205 | |
| 19,025 |
Royalties payable | | | 14,541 | | | 20,863 | | | 10,687 | | | 13,779 |
Restructuring liability | | | 42 | | | 27 | | | 620 | | | 8 |
Current operating lease liabilities | | | 2,040 | | | 1,097 | | | 2,054 | | | 2,045 |
Short-term borrowings and current portion of long-term debt | |
| — | |
| 88,189 | ||||||
Other current liabilities | | | 2,270 | | | 2,713 | | | 3,885 | | | 2,270 |
Total current liabilities | |
| 97,129 | |
| 214,865 | |
| 89,251 | |
| 90,469 |
Long-term debt, net | |
| 610,698 | |
| 592,940 | |
| 603,484 | |
| 590,683 |
Long-term operating lease liabilities | | | 11,306 | | | 9,844 | | | 10,554 | | | 11,047 |
Other liabilities | | | 19,187 | | | 16,010 | | | 17,808 | | | 19,009 |
TOTAL LIABILITIES | |
| 738,320 | |
| 833,659 | |
| 721,097 | |
| 711,208 |
Commitments and contingencies (Notes 11 and 12) | | | | | | | | | | | | |
| | | | | | | | | | | | |
STOCKHOLDERS’ EQUITY | | | | | | | ||||||
Common stock ($0.001 par value, 100,000,000 shares authorized; 40,872,485 and 39,963,127 shares issued; 39,539,798 and 38,798,787 shares outstanding at March 31, 2021 and June 30, 2020, respectively) | |
| 41 | |
| 40 | ||||||
STOCKHOLDERS’ DEFICIT | | | | | | | ||||||
Common stock ($0.001 par value, 100,000,000 shares authorized; 42,053,623 and 40,913,148 shares issued; 40,500,320 and 39,576,606 shares outstanding at December 31, 2021 and June 30, 2021, respectively) | |
| 42 | |
| 41 | ||||||
Additional paid-in capital | |
| 328,911 | |
| 321,164 | |
| 360,765 | |
| 355,239 |
Accumulated deficit | |
| (186,880) | |
| (1,291) | |
| (468,193) | |
| (364,766) |
Accumulated other comprehensive loss | |
| (603) | |
| (627) | |
| (519) | |
| (548) |
Treasury stock (1,332,687 and 1,164,340 shares at March 31, 2021 and June 30, 2020, respectively) | |
| (17,419) | |
| (16,390) | ||||||
Total stockholders’ equity | |
| 124,050 | |
| 302,896 | ||||||
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | | $ | 862,370 | | $ | 1,136,555 | ||||||
Treasury stock (1,553,303 and 1,336,542 shares at December 31, 2021 and June 30, 2021, respectively) | |
| (18,255) | |
| (17,437) | ||||||
Total stockholders’ deficit | |
| (126,160) | |
| (27,471) | ||||||
TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT | | $ | 594,937 | | $ | 683,737 |
The accompanying notes are an integral part of the Consolidated Financial Statements.
3
LANNETT COMPANY, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
(In thousands, except share and per share data)
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended | | Nine Months Ended | | | Three Months Ended | | Six Months Ended | | ||||||||||||||||
| | March 31, | | March 31, | | | December 31, | | December 31, | | ||||||||||||||||
|
| 2021 |
| 2020 |
| 2021 |
| 2020 | |
| 2021 |
| 2020 |
| 2021 |
| 2020 | | ||||||||
Net sales | | $ | 112,370 | | $ | 144,372 | | $ | 372,769 | | $ | 407,824 | | | $ | 86,508 | | $ | 133,920 | | $ | 188,033 | | $ | 260,399 | |
Cost of sales | |
| 82,063 | |
| 94,380 | |
| 298,738 | |
| 258,699 | | |
| 76,990 | |
| 124,488 | |
| 157,998 | |
| 216,675 | |
Amortization of intangibles | | | 3,851 | | | 8,316 | | | 21,097 | | | 23,497 | | | | 3,808 | | | 8,657 | | | 7,804 | | | 17,246 | |
Gross profit | |
| 26,456 | |
| 41,676 | |
| 52,934 | |
| 125,628 | | |
| 5,710 | |
| 775 | |
| 22,231 | |
| 26,478 | |
Operating expenses: | | | | | | | | | | | | | | | | | | | | | | | | | | |
Research and development expenses | |
| 5,973 | |
| 7,441 | |
| 18,156 | |
| 23,287 | | |
| 4,747 | |
| 5,644 | |
| 10,511 | |
| 12,183 | |
Selling, general and administrative expenses | |
| 17,636 | |
| 22,147 | |
| 46,502 | |
| 60,876 | | |
| 18,791 | |
| 13,730 | |
| 37,696 | |
| 28,866 | |
Restructuring expenses | | | — | | | 191 | | | 4,043 | | | 1,771 | | | | 891 | | | — | | | 891 | | | 4,043 | |
Asset impairment charges | | | — | | | 13,989 | | | 198,000 | | | 15,607 | | | | 49,361 | | | 198,000 | | | 49,361 | | | 198,000 | |
Total operating expenses | |
| 23,609 | |
| 43,768 | |
| 266,701 | |
| 101,541 | | |
| 73,790 | |
| 217,374 | |
| 98,459 | |
| 243,092 | |
Operating income (loss) | |
| 2,847 | |
| (2,092) | |
| (213,767) | |
| 24,087 | | |||||||||||||
Other income (loss): | | | | | | | | | | | | | | |||||||||||||
Loss on extinguishment of debt | | | — | | | — | | | — | | | (2,145) | | |||||||||||||
Operating loss | |
| (68,080) | |
| (216,599) | |
| (76,228) | |
| (216,614) | | |||||||||||||
Other income (expense): | | | | | | | | | | | | | | |||||||||||||
Investment income | | | 80 | | | 393 | | | 168 | | | 1,552 | | | | 46 | | | 43 | | | 80 | | | 88 | |
Interest expense | |
| (12,631) | |
| (16,177) | |
| (40,613) | |
| (52,163) | | |
| (14,430) | |
| (13,496) | |
| (28,654) | |
| (27,982) | |
Other | | | 18 | | | (380) | | | 23 | | | (181) | | | | 11 | | | 28 | | | (51) | | | 5 | |
Total other loss | |
| (12,533) | |
| (16,164) | |
| (40,422) | |
| (52,937) | | |||||||||||||
Total other expense | |
| (14,373) | |
| (13,425) | |
| (28,625) | |
| (27,889) | | |||||||||||||
Loss before income tax | |
| (9,686) | |
| (18,256) | |
| (254,189) | |
| (28,850) | | |
| (82,453) | |
| (230,024) | |
| (104,853) | |
| (244,503) | |
Income tax benefit | |
| (2,544) | |
| (1,664) | |
| (68,600) | |
| (5,185) | | |
| (1,368) | |
| (58,076) | |
| (1,426) | |
| (66,056) | |
Net loss | | $ | (7,142) | | $ | (16,592) | | $ | (185,589) | | $ | (23,665) | | | $ | (81,085) | | $ | (171,948) | | $ | (103,427) | | $ | (178,447) | |
| | | | | | | | | | | | | | | | | | | | | | | | | | |
Loss per common share: | | | | | | | | | | | | | | |||||||||||||
Loss per common share (1): | | | | | | | | | | | | | | |||||||||||||
Basic | | $ | (0.18) | | $ | (0.43) | | $ | (4.72) | | $ | (0.61) | | | $ | (2.01) | | $ | (4.36) | | $ | (2.58) | | $ | (4.55) | |
Diluted (1) | | $ | (0.18) | | $ | (0.43) | | $ | (4.72) | | $ | (0.61) | | |||||||||||||
Diluted | | $ | (2.01) | | $ | (4.36) | | $ | (2.58) | | $ | (4.55) | | |||||||||||||
| | | | | | | | | | | | | | | | | | | | | | | | | | |
Weighted average common shares outstanding: | | | | | | | | | | | | | | |||||||||||||
Weighted average common shares outstanding (1): | | | | | | | | | | | | | | |||||||||||||
Basic | |
| 39,511,296 | |
| 38,707,049 | |
| 39,340,670 | |
| 38,539,850 | | |
| 40,358,127 | |
| 39,443,441 | |
| 40,142,974 | |
| 39,257,211 | |
Diluted (1) | |
| 39,511,296 | |
| 38,707,049 | |
| 39,340,670 | |
| 38,539,850 | | |||||||||||||
Diluted | |
| 40,358,127 | |
| 39,443,441 | |
| 40,142,974 | |
| 39,257,211 | |
(1) | See Note |
The accompanying notes are an integral part of the Consolidated Financial Statements.
4
LANNETT COMPANY, INC.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(UNAUDITED)
(In thousands)
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended | | Nine Months Ended | | | Three Months Ended | | Six Months Ended | | ||||||||||||||||
| | March 31, | | March 31, | | | December 31, | | December 31, | | ||||||||||||||||
|
| 2021 |
| 2020 | | 2021 |
| 2020 | |
| 2021 |
| 2020 | | 2021 |
| 2020 | | ||||||||
Net loss | | $ | (7,142) | | $ | (16,592) | | $ | (185,589) | | $ | (23,665) | | | $ | (81,085) | | $ | (171,948) | | $ | (103,427) | | $ | (178,447) | |
Other comprehensive income (loss): | | | | | | | | | | | | | | | | | | | | | | | | | | |
Foreign currency translation gain (loss) | |
| (8) | |
| (63) | |
| 24 | |
| (26) | | |
| 5 | |
| (47) | |
| 29 | |
| 32 | |
Total other comprehensive income (loss) | |
| (8) | |
| (63) | |
| 24 | |
| (26) | | |
| 5 | |
| (47) | |
| 29 | |
| 32 | |
Comprehensive loss | | $ | (7,150) | | $ | (16,655) | | $ | (185,565) | | $ | (23,691) | | | $ | (81,080) | | $ | (171,995) | | $ | (103,398) | | $ | (178,415) | |
The accompanying notes are an integral part of the Consolidated Financial Statements.
5
LANNETT COMPANY, INC.
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)
(UNAUDITED)
(In thousands)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|
| Three months ended March 31, 2021 |
| Three Months Ended December 31, 2021 | ||||||||||||||||||||||||||||||||||||
| | | | | | | | | | | | | Accumulated | | | | | | | | | | | | | | | | | | | Accumulated | | | | | | | ||
| | Common Stock | | Additional | | | | | Other | | | | | Total | | Common Stock | | Additional | | | | | Other | | | | | Total | ||||||||||||
| | Shares | | | | | Paid-In | | Accumulated | | Comprehensive | | Treasury | | Stockholders’ | | Shares | | | | | Paid-In | | Accumulated | | Comprehensive | | Treasury | | Stockholders’ | ||||||||||
|
| Issued |
| Amount |
| Capital |
| Deficit |
| Loss |
| Stock |
| Equity |
| Issued |
| Amount |
| Capital |
| Deficit |
| Loss |
| Stock |
| Deficit | ||||||||||||
Balance, December 31, 2020 |
| 40,832 | | $ | 41 | | $ | 326,939 | | $ | (179,738) | | $ | (595) | | $ | (17,389) | | $ | 129,258 | ||||||||||||||||||||
Balance, September 30, 2021 |
| 41,787 | | $ | 42 | | $ | 358,361 | | $ | (387,108) | | $ | (524) | | $ | (18,124) | | $ | (47,353) | ||||||||||||||||||||
Shares issued in connection with share-based compensation plans |
| 40 | |
| — | |
| 109 | |
| — | |
| — | |
| — | |
| 109 |
| 266 | |
| — | |
| 95 | |
| — | |
| — | |
| — | |
| 95 |
Share-based compensation |
| — | |
| — | |
| 1,863 | |
| — | |
| — | |
| — | |
| 1,863 |
| — | |
| — | |
| 2,309 | |
| — | |
| — | |
| — | |
| 2,309 |
Purchase of treasury stock |
| — | |
| — | |
| — | |
| — | |
| — | |
| (30) | |
| (30) |
| — | |
| — | |
| — | |
| — | |
| — | |
| (131) | |
| (131) |
Other comprehensive loss |
| — | |
| — | |
| — | |
| — | |
| (8) | |
| — | |
| (8) | ||||||||||||||||||||
Other comprehensive income |
| — | |
| — | |
| — | |
| — | |
| 5 | |
| — | |
| 5 | ||||||||||||||||||||
Net loss |
| — | |
| — | |
| — | |
| (7,142) | |
| — | |
| — | |
| (7,142) |
| — | |
| — | |
| — | |
| (81,085) | |
| — | |
| — | |
| (81,085) |
Balance, March 31, 2021 |
| 40,872 | | $ | 41 | | $ | 328,911 | | $ | (186,880) | | $ | (603) | | $ | (17,419) | | $ | 124,050 | ||||||||||||||||||||
Balance, December 31, 2021 |
| 42,053 | | $ | 42 | | $ | 360,765 | | $ | (468,193) | | $ | (519) | | $ | (18,255) | | $ | (126,160) |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|
| Three months ended March 31, 2020 |
| Three Months Ended December 31, 2020 | ||||||||||||||||||||||||||||||||||||
| | | | | | | | | | | | | Accumulated | | | | | | | | | | | | | | | | | | | Accumulated | | | | | | | ||
| | Common Stock | | Additional | | | | | Other | | | | | Total | | Common Stock | | Additional | | | | | Other | | | | | Total | ||||||||||||
| | Shares | | | | | Paid-In | | Retained | | Comprehensive | | Treasury | | Stockholders’ | | Shares | | | | | Paid-In | | Accumulated | | Comprehensive | | Treasury | | Stockholders’ | ||||||||||
|
| Issued |
| Amount |
| Capital |
| Earnings |
| Loss |
| Stock |
| Equity |
| Issued |
| Amount |
| Capital |
| Deficit |
| Loss |
| Stock |
| Equity | ||||||||||||
Balance, December 31, 2019 |
| 39,852 | | $ | 40 | | $ | 317,012 | | $ | 25,002 | | $ | (578) | | $ | (16,304) | | $ | 325,172 | ||||||||||||||||||||
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 |
| 47 | |
| — | |
| 182 | |
| — | |
| — | |
| — | |
| 182 |
| 145 | |
| — | |
| 160 | |
| — | |
| — | |
| — | |
| 160 |
Share-based compensation |
| — | |
| — | |
| 1,870 | |
| — | |
| — | |
| — | |
| 1,870 |
| — | |
| — | |
| 1,991 | |
| — | |
| — | |
| — | |
| 1,991 |
Purchase of treasury stock |
| — | |
| — | |
| — | |
| — | |
| — | |
| (31) | |
| (31) |
| — | |
| — | |
| — | |
| — | |
| — | |
| (213) | |
| (213) |
Other comprehensive income |
| — | |
| — | |
| — | |
| — | |
| (63) | |
| — | |
| (63) | ||||||||||||||||||||
Other comprehensive loss |
| — | |
| — | |
| — | |
| — | |
| (47) | |
| — | |
| (47) | ||||||||||||||||||||
Net loss |
| — | |
| — | |
| — | |
| (16,592) | |
| — | |
| — | |
| (16,592) |
| — | |
| — | |
| — | |
| (171,948) | |
| — | |
| — | |
| (171,948) |
Balance, March 31, 2020 |
| 39,899 | | $ | 40 | | $ | 319,064 | | $ | 8,410 | | $ | (641) | | $ | (16,335) | | $ | 310,538 | ||||||||||||||||||||
Balance, December 31, 2020 |
| 40,832 | | $ | 41 | | $ | 326,939 | | $ | (179,738) | | $ | (595) | | $ | (17,389) | | $ | 129,258 |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|
| Nine months ended March 31, 2021 |
| Six Months Ended December 31, 2021 | ||||||||||||||||||||||||||||||||||||
| | | | | | | | | | | | | Accumulated | | | | | | | | | | | | | | | | | | | Accumulated | | | | | | | ||
| | Common Stock | | Additional | | | | | Other | | | | | Total | | Common Stock | | Additional | | | | | Other | | | | | Total | ||||||||||||
| | Shares | | | | | Paid-In | | Accumulated | | Comprehensive | | Treasury | | Stockholders’ | | Shares | | | | | Paid-In | | Accumulated | | Comprehensive | | Treasury | | Stockholders’ | ||||||||||
|
| Issued |
| Amount |
| Capital |
| Deficit |
| Loss |
| Stock |
| Equity |
| Issued |
| Amount |
| Capital |
| Deficit |
| Loss |
| Stock |
| Deficit | ||||||||||||
Balance, June 30, 2020 |
| 39,963 | | $ | 40 | | $ | 321,164 | | $ | (1,291) | | $ | (627) | | $ | (16,390) | | $ | 302,896 | ||||||||||||||||||||
Balance, June 30, 2021 |
| 40,913 | | $ | 41 | | $ | 355,239 | | $ | (364,766) | | $ | (548) | | $ | (17,437) | | $ | (27,471) | ||||||||||||||||||||
Shares issued in connection with share-based compensation plans |
| 909 | |
| 1 | |
| 551 | |
| — | |
| — | |
| — | |
| 552 |
| 1,140 | |
| 1 | |
| 199 | |
| — | |
| — | |
| — | |
| 200 |
Share-based compensation |
| — | |
| — | |
| 7,196 | |
| — | |
| — | |
| — | |
| 7,196 |
| — | |
| — | |
| 5,327 | |
| — | |
| — | |
| — | |
| 5,327 |
Purchase of treasury stock |
| — | |
| — | |
| — | |
| — | |
| — | |
| (1,029) | |
| (1,029) |
| — | |
| — | |
| — | |
| — | |
| — | |
| (818) | |
| (818) |
Other comprehensive income |
| — | |
| — | |
| — | |
| — | |
| 24 | |
| — | |
| 24 |
| — | |
| — | |
| — | |
| — | |
| 29 | |
| — | |
| 29 |
Net loss |
| — | |
| — | |
| — | |
| (185,589) | |
| — | |
| — | |
| (185,589) |
| — | |
| — | |
| — | |
| (103,427) | |
| — | |
| — | |
| (103,427) |
Balance, March 31, 2021 |
| 40,872 | | $ | 41 | | $ | 328,911 | | $ | (186,880) | | $ | (603) | | $ | (17,419) | | $ | 124,050 | ||||||||||||||||||||
Balance, December 31, 2021 |
| 42,053 | | $ | 42 | | $ | 360,765 | | $ | (468,193) | | $ | (519) | | $ | (18,255) | | $ | (126,160) |
| | | | | | | | | | | | | | | | | | | | |
|
| Nine months ended March 31, 2020 | ||||||||||||||||||
| | | | | | | | | | | | | Accumulated | | | | | | | |
| | Common Stock | | Additional | | | | | Other | | | | | Total | ||||||
| | Shares | | | | | Paid-In | | Retained | | Comprehensive | | Treasury | | Stockholders’ | |||||
|
| Issued |
| Amount |
| Capital |
| Earnings |
| Loss |
| Stock |
| Equity | ||||||
Balance, June 30, 2019 |
| 38,970 | | $ | 39 | | $ | 317,023 | | $ | 32,075 | | $ | (615) | | $ | (14,481) | | $ | 334,041 |
Shares issued in connection with share-based compensation plans |
| 929 | |
| 1 | |
| 777 | |
| — | |
| — | |
| — | |
| 778 |
Share-based compensation |
| — | |
| — | |
| 8,336 | |
| — | |
| — | |
| — | |
| 8,336 |
Purchase of treasury stock |
| — | |
| — | |
| — | |
| — | |
| — | |
| (1,854) | |
| (1,854) |
Other comprehensive income |
| — | |
| — | |
| — | |
| — | |
| (26) | |
| — | |
| (26) |
Purchase of capped call | | — | | | — | | | (7,072) | | | — | | | — | | | — | | | (7,072) |
Net loss |
| — | |
| — | |
| — | |
| (23,665) | |
| — | |
| — | |
| (23,665) |
Balance, March 31, 2020 |
| 39,899 | | $ | 40 | | $ | 319,064 | | $ | 8,410 | | $ | (641) | | $ | (16,335) | | $ | 310,538 |
| | | | | | | | | | | | | | | | | | | | |
|
| Six Months Ended December 31, 2020 | ||||||||||||||||||
| | | | | | | | | | | | | Accumulated | | | | | | | |
| | Common Stock | | Additional | | | | | Other | | | | | Total | ||||||
| | Shares | | | | | Paid-In | | Retained | | Comprehensive | | Treasury | | Stockholders’ | |||||
|
| Issued |
| Amount |
| Capital |
| Earnings |
| Loss |
| Stock |
| Equity | ||||||
| | | | | | | | | | | | | | | | | | | | |
Balance, June 30, 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 |
The accompanying notes are an integral part of the Consolidated Financial Statements.
6
LANNETT COMPANY, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
(In thousands)
| | | | | | | | | | | | |
| | Nine Months Ended | | Six Months Ended | ||||||||
| | March 31, | | December 31, | ||||||||
|
| 2021 |
| 2020 |
| 2021 |
| 2020 | ||||
OPERATING ACTIVITIES: | | | | | | | | | | | | |
Net loss | | $ | (185,589) | | $ | (23,665) | | $ | (103,427) | | $ | (178,447) |
Adjustments to reconcile net loss to net cash provided by operating activities: | | | | | | | ||||||
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: | | | | | | | ||||||
Depreciation and amortization | |
| 38,345 | |
| 41,386 | |
| 18,871 | |
| 28,717 |
Deferred income tax benefit | |
| (20,129) | |
| (2,488) | |
| — | |
| (14,519) |
Share-based compensation | |
| 7,196 | |
| 8,336 | |
| 5,327 | |
| 5,333 |
Asset impairment charges | | | 198,000 | | | 15,607 | | | 49,361 | | | 198,000 |
Gain on sale/disposal of assets | |
| (26) | |
| (821) | ||||||
Loss on extinguishment of debt | | | — | | | 2,145 | ||||||
Loss (gain) on sale/disposal of assets | |
| 51 | |
| (24) | ||||||
Accrual of payment-in-kind interest on Second Lien Credit Facility | | | 10,024 | | | — | ||||||
Amortization of debt discount and other debt issuance costs | | | 9,073 | | | 11,001 | | | 2,959 | | | 6,239 |
Provision for inventory write-downs | | | 23,613 | | | 8,486 | | | 4,054 | | | 23,214 |
Other noncash expenses | |
| 853 | |
| 1,387 | |
| 393 | |
| 635 |
Changes in assets and liabilities which provided (used) cash: | | | | | | | | | | | | |
Accounts receivable, net | |
| 10,997 | |
| (15,604) | |
| 32,559 | |
| (34,443) |
Inventories | |
| 6,180 | |
| (470) | |
| (288) | |
| (2,551) |
Income taxes receivable/payable | |
| (25,420) | |
| (10,472) | |
| (833) | |
| (50,065) |
Other assets | |
| (1,423) | |
| 3,006 | |
| (2,255) | |
| (7,248) |
Rebates payable | |
| (6,327) | |
| (2,871) | |
| 6,180 | |
| 5,616 |
Royalties payable | | | (6,322) | | | 5,147 | | | (3,092) | | | (81) |
Restructuring liability | | | 15 | | | (2,254) | | | 612 | | | 134 |
Operating lease liability | | | 52 | | | (1,005) | ||||||
Operating lease assets/liabilities | | | (561) | | | 407 | ||||||
Accounts payable | |
| 70 | |
| 20,341 | |
| (3,597) | |
| 10,135 |
Accrued expenses | |
| (10,937) | |
| 1,366 | |
| (1,871) | |
| (10,870) |
Accrued payroll and payroll-related expenses | | | (6,546) | | | (6,803) | | | (1,074) | | | (7,358) |
Other liabilities | | | 2,530 | | | (1,374) | | | 450 | | | 2,586 |
Net cash provided by operating activities | |
| 34,205 | |
| 50,381 | ||||||
Net cash provided by (used in) operating activities | |
| 13,843 | |
| (24,590) | ||||||
INVESTING ACTIVITIES: | | | | | | | | | | | | |
Purchases of property, plant and equipment | |
| (6,599) | |
| (13,105) | |
| (6,758) | |
| (5,129) |
Proceeds from sale of property, plant and equipment | |
| 51 | |
| 7,332 | |
| 353 | |
| 44 |
Advance to VIE | | | — | | | (250) | ||||||
Purchases of intangible assets | | | (4,500) | | | (27,750) | | | (1,500) | | | (4,000) |
Net cash used in investing activities | |
| (11,048) | |
| (33,773) | |
| (7,905) | |
| (9,085) |
FINANCING ACTIVITIES: | | | | | | | | | | | | |
Proceeds from issuance of long-term debt | | | — | | | 86,250 | ||||||
Purchase of capped call | | | — | | | (7,072) | ||||||
Repayments of long-term debt | |
| (78,353) | |
| (129,989) | |
| — | |
| (68,516) |
Proceeds from issuance of stock | |
| 552 | |
| 778 | |
| 200 | |
| 443 |
Payment of debt issuance costs | | | (2,390) | | | (3,489) | | | — | | | (2,390) |
Purchase of treasury stock | |
| (1,029) | |
| (1,854) | |
| (818) | |
| (999) |
Net cash used in financing activities | |
| (81,220) | |
| (55,376) | |
| (618) | |
| (71,462) |
Effect on cash and cash equivalents of changes in foreign exchange rates | |
| 24 | |
| (26) | |
| 29 | |
| 32 |
NET DECREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH | |
| (58,039) | |
| (38,794) | ||||||
NET INCREASE (DECREASE) IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH | |
| 5,349 | |
| (105,105) | ||||||
CASH, CASH EQUIVALENTS AND RESTRICTED CASH, BEGINNING OF PERIOD | |
| 144,329 | |
| 140,249 | |
| 98,286 | |
| 144,329 |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH, END OF PERIOD | | $ | 86,290 | | $ | 101,455 | | $ | 103,635 | | $ | 39,224 |
| | | | | | | | | | | | |
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION: | | | | | | | | | | | | |
Interest paid | | $ | 30,670 | | $ | 39,554 | | $ | 15,131 | | $ | 21,844 |
Income taxes paid (refunded) | | $ | (23,052) | | $ | 7,775 | ||||||
Accrued purchases of property, plant and equipment | | $ | 803 | | $ | 2,023 | ||||||
Income taxes refunded | | $ | (592) | | $ | (1,473) | ||||||
Purchases of property, plant and equipment included in accounts payable | | $ | 999 | | $ | 994 |
The accompanying notes are an integral part of the Consolidated Financial Statements.
7
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 ninesix months ended MarchDecember 31, 2021 are not necessarily indicative of the results that may be expected for the fiscal year ending June 30, 2021.2022. 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, 2020.2021. The Consolidated Balance Sheet as of June 30, 20202021 was derived from audited financial statements.
Note 2. The Business and Nature of Operations
Lannett Company, Inc. (a Delaware corporation) and its subsidiaries (collectively, the “Company” or “Lannett”) primarily develop, manufacture, package, market and distribute solid oral and extended release (tablets and capsules), topical, nasal and oral solution finished dosage forms of drugs that address a wide range of therapeutic areas. Certain of these products are manufactured by others and distributed by the Company.
The Company operates pharmaceutical manufacturing plants in Carmel, New York and Seymour, Indiana. The Company’s customers include generic pharmaceutical distributors, drug wholesalers, chain drug stores, private label distributors, mail-order pharmacies, other pharmaceutical manufacturers, managed care organizations, hospital buying groups, governmental entities and health maintenance organizations.
COVID-19 Update
In December 2019, theThe COVID-19 virus emerged in Wuhan, China and spreadpandemic continues to other parts of the world. In March 2020, the World Health Organization (“WHO”) designated COVID-19 a global pandemic. Governmentshave an impact on the national, stateglobal economy and local level in the United States, and around the world, implemented lockdown and shelter-in-place orders, requiring many non-essential businesses to shut down operations. The Company’s business, however, is deemed “essential” and it has continued to operate, manufacture, and distribute its medicines to customers.
way companies operate. In light of the economic impacts of COVID-19, the Company reviewed the assets on our Consolidated Balance Sheet as of MarchDecember 31, 2021, including intangible and other long-lived assets. Based on our review, the Company determined that no impairments or other write-downs specifically related to COVID-19 were necessary during the first ninesix months of Fiscal Year2022 and during Fiscal 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 upthe total volume of suppliesdrug prescriptions written in the country decreased 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. WeRecently, prescription volumes have begun to increase back to pre-pandemic levels. However, we 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.
8
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.contingencies.
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 (deficit) 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, 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 TermSecond Lien Secured Loan B Facility which is discussed in further detail in Note 10 “Long-Term Debt,”(“Second Lien Facility”), the Company is required to maintain at least $5 million in a deposit account at all times, subject to control by the administrative agent.Second Lien Collateral Agent. At MarchDecember 31, 2021, the Company classified this balance as restricted cash, which is included in other assets.
9
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 MarchDecember 31, 2021 and 2020.
| | | | | | | | | | |||
|
| March 31, 2021 | | March 31, 2020 |
| December 31, 2021 | | December 31, 2020 | ||||
Cash and cash equivalents | | $ | 81,290 | | $ | 101,455 | | $ | 98,635 | | $ | 34,224 |
Restricted cash, included in other assets | | | 5,000 | | | — | | | 5,000 | | | 5,000 |
Cash, cash equivalents and restricted cash as presented on the Consolidated Statements of Cash Flows | | $ | 86,290 | | $ | 101,455 | | $ | 103,635 | | $ | 39,224 |
Allowance for doubtful accounts
On July 1, 2020, theThe Company adopted guidance issued by the FASB incomplies with 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 nine months ended March 31, 2021. 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.
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.product. 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.
10
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.
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 ninesix months ended MarchDecember 31, 2021 and 2020.
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended | | Nine Months Ended | | | Three Months Ended | | Six Months Ended | | ||||||||||||||||
(In thousands) | | March 31, | | March 31, | | | December 31, | | December 31, | | ||||||||||||||||
Medical Indication |
| 2021 |
| 2020 |
| 2021 |
| 2020 | |
| 2021 |
| 2020 |
| 2021 |
| 2020 | | ||||||||
Analgesic | | $ | 3,836 | | $ | 2,811 | | $ | 10,528 | | $ | 6,806 | | | $ | 3,919 | | $ | 3,572 | | $ | 9,233 | | $ | 6,692 | |
Anti-Psychosis | | | 11,678 | | | 27,858 | | | 38,023 | | | 78,588 | | | | 2,095 | | | 13,317 | | | 5,810 | | | 26,345 | |
Cardiovascular | |
| 16,573 | |
| 21,746 | |
| 52,623 | |
| 67,325 | | |
| 9,753 | |
| 16,336 | |
| 23,853 | |
| 36,050 | |
Central Nervous System | | | 24,509 | | | 18,566 | | | 71,648 | | | 57,154 | | | | 22,340 | | | 24,614 | | | 45,125 | | | 47,139 | |
Endocrinology | | | 6,822 | | | — | | | 19,551 | | | — | | | | 8,297 | | | 9,496 | | | 16,142 | | | 12,729 | |
Gastrointestinal | | | 16,817 | | | 20,745 | | | 52,492 | | | 56,020 | | | | 14,023 | | | 18,575 | | | 29,263 | | | 35,675 | |
Infectious Disease | | | 10,610 | | | 21,749 | | | 55,586 | | | 51,722 | | | | 6,520 | | | 23,044 | | | 19,035 | | | 44,976 | |
Migraine | |
| 5,169 | |
| 12,886 | |
| 20,942 | |
| 32,907 | | |
| 4,446 | |
| 6,083 | |
| 9,131 | |
| 15,773 | |
Respiratory/Allergy/Cough/Cold | | | 2,548 | | | 2,966 | | | 6,241 | | | 8,747 | | | | 1,868 | | | 2,267 | | | 4,982 | | | 3,693 | |
Urinary | | | 1,566 | | | 1,149 | | | 4,385 | | | 2,817 | | | | 1,164 | | | 1,361 | | | 2,340 | | | 2,819 | |
Other | |
| 8,617 | |
| 8,051 | |
| 24,661 | |
| 27,847 | | |
| 9,111 | |
| 8,410 | |
| 18,287 | |
| 16,044 | |
Contract manufacturing revenue | | | 3,625 | | | 5,845 | | | 16,089 | | | 17,891 | | | | 2,972 | | | 6,845 | | | 4,832 | | | 12,464 | |
Total net sales | | $ | 112,370 | | $ | 144,372 | | $ | 372,769 | | $ | 407,824 | | | $ | 86,508 | | $ | 133,920 | | $ | 188,033 | | $ | 260,399 | |
Customer, Supplier and Product Concentration
The following table presents the percentage of total net sales, for the three and ninesix months ended MarchDecember 31, 2021 and 2020, for certain of the Company’s products, defined as products containing the same active ingredient or combination of ingredients, which accounted for at least 10% of net sales in any of those periods:
| | | | | | | | | | | | | | | | | | | | | ||
| | Three Months Ended | | Nine Months Ended | | | | Three Months Ended | | Six Months Ended | | | ||||||||||
| | March 31, | | March 31, | | | | December 31, | | December 31, | | | ||||||||||
|
| 2021 |
| 2020 |
| 2021 |
| 2020 |
| |
| 2021 |
| 2020 |
| 2021 |
| 2020 |
| | ||
Product 1 |
| 8 | % | 11 | % |
| 13 | % | 10 | % |
|
| 5 | % | 15 | % |
| 8 | % | 15 | % |
|
Product 2 |
| 8 | % | 17 | % |
| 8 | % | 18 | % |
|
11
The following table presents the percentage of total net sales, for the three and ninesix months ended MarchDecember 31, 2021 and 2020, for certain of the Company’s customers which accounted for at least 10% of net sales in any of those periods:
| | | | | | | | | | | | | | | | | | | | | ||
| | Three Months Ended | | Nine Months Ended | | | | Three Months Ended | | Six Months Ended | | | ||||||||||
|
| March 31, |
| March 31, |
|
|
| December 31, |
| December 31, |
|
| ||||||||||
|
| 2021 |
| 2020 |
| 2021 |
| 2020 |
| |
| 2021 |
| 2020 |
| 2021 |
| 2020 |
| | ||
Customer A |
| 29 | % | 29 | % |
| 27 | % | 25 | % |
|
| 26 | % | 26 | % |
| 28 | % | 26 | % |
|
Customer B |
| 20 | % | 21 | % |
| 21 | % | 24 | % |
|
| 15 | % | 21 | % |
| 17 | % | 22 | % |
|
Customer C | | 13 | % | 12 | % | | 12 | % | 11 | % | | | 14 | % | 12 | % | | 14 | % | 11 | % | |
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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.
12
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”,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, theThe Company adoptedcomplies with ASC Topic 842, Leases, which superseded ASC Topic 840, Leases. Under ASC 842,states that 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.
13
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.
The Company has elected, as an accounting policy, not to apply the recognition requirements in ASC 842 to short-term leases. Short-term leases are leases that have a term of 12 months or less and do not include an option to purchase the underlying asset that the Company is reasonably certain to exercise. The Company recognizes the lease payments for short-term leases on a straight-line basis over the lease term and the lease cost is not recorded on the Consolidated Balance Sheets.
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.
14
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.
14
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 stock price on the grant date to value restricted stock and performance-based shares with vesting based on the satisfaction of a performance condition. 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.shares with a market condition. 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$1.8 million and $0.8 million as of MarchDecember 31, 2021 and June 30, 2020.2021, respectively, and is recorded in the accrued payroll and payroll-related expenses caption in the Consolidated Balance Sheets.
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. The Company continues to 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, 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.
15
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.
Earnings (Loss) Per Common Share
A dualThe 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. In accordance with ASC 260, Earnings per share, the Company computes earnings (loss) per share using the two-class method, which requires an allocation of earnings between the holders of common stock and the Company’s participating security holders. The warrants issued in connection with the Second Lien Secured Loan Facility (the “Warrants”) are considered participating securities, as discussed further in Note 14 “Warrants.” Basic earnings (loss) per common share excludes the dilutive impact of potentially dilutive securities and is computedcalculated by dividing net income (loss) available to common stockholders, which excludes the income allocated to participating security holders, by the basic weighted average common shares outstanding.
For purposes of determining diluted earnings per share, the Company further adjusts the basic earnings per share to include the effect of potentially dilutive shares outstanding, including options and restricted stock awards, the 4.50% Convertible Senior Notes (the “Convertible Notes”), and the Warrants. In this calculation, the Company reallocates net income based on the rights of each potentially dilutive share and will report the most dilutive earnings (loss) per share. The weighted average number of diluted shares outstanding duringis adjusted for the period. Beginning inpotential dilutive effect of the first quarterexercise of Fiscal 2020,stock options, treats unvested restricted stock as if it were vested, includes performance-based shares that would be issued if the Company's dilutedperformance criteria were met as of the end of the reporting period, and assumes the conversion of the 4.50% Convertible Senior Notes. The Company uses the “if-converted" method to compute earnings (loss) per common share when assuming the conversion of the Convertible Notes, which is computed using the "if-converted" methodcalculated 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 numberNotes. Because the Warrants do not participate in losses, the Company will allocate undistributed earnings when calculating basic and diluted earnings per share in periods 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.net income only. 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) includesreflects all changes in equity during a period except those that resulted from investments by or distributions to the Company’s stockholders. This includes, but is not limited to, foreign currency translation gain (loss). 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 Losseson 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 nine months ended March 31, 2021.
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
20202021 Restructuring Plan
On July 10, 2020,November 1, 2021, the Board of Directors authorized a restructuring and cost savings plan (the “2020“2021 Restructuring Plan”) to enhancefurther optimize its operations, improve efficiencies and reduce costs. Under the 2021 Restructuring Plan, the Company will consolidate its manufacturing efficiencies, streamlinefootprint by transferring certain liquid drug production from its Silarx Pharmaceuticals, Inc. (“Silarx”) facility in Carmel, New York to the Company’s main plant in Seymour, Indiana. Following the transition, which is expected to take 12 to 18 months, the Company intends to shut down operations at Silarx. The Company is also currently pursuing the sale of the facility, which is anticipated within one year and may result in accelerated timing for the shutdown of operations at Silarx. Several products manufactured by Silarx and Kremers Urban Pharmaceuticals, Inc. will be scaled back or discontinued over time. Particularly, the Company will scale back or phase out some small low-margin over-the-counter medicines from Carmel and two low-margin prescription products as part of the restructuring program. During the transition of products from Carmel, New York to the Seymour, Indiana facility, the Company will continue to assess its portfolio and may introduce or discontinue additional products. As part of the 2021 Restructuring Plan, the Company will also scale back its research and development operations and reduceeliminate certain administrative positions that primarily support the Company’s cost structure.Silarx and research and development operations. The 2020total reduction in headcount, and the basis of the estimated severance costs, for the 2021 Restructuring Plan was implemented,is expected to be approximately 165 positions, which includes additional positions identified at the Seymour, Indiana facility in part, as a result of previously anticipated near-term competitionJanuary 2022. The Company initiated the plan on November 3, 2021 and pricing pressure with respect to certain key products. The 2020expects that the actions contemplated under the 2021 Restructuring Plan includes lowering operatingwill be substantially complete by June 30, 2023. The plan is expected to generate cost savings of $20 million, annually.
The Company estimates that it will incur approximately $6.0 million to $7.0 million of total costs to implement the 2021 Restructuring Plan, comprised primarily of approximately $5.0 million of severance and employee-related costs and reducingapproximately $1.0 million to $2.0 million of tech transfer costs. The Company also expects to incur approximately $2.0 million to $3.0 million in capital expenditures to build out the workforce by approximately 80 positions. The 2020 Restructuring Plan was initiated on July 13, 2020 and completed as of December 31, 2020.
liquid manufacturing business at the Kremers Urban Pharmaceuticals, Inc. facility.
The Company incurred $4.0$0.9 million in severance-related costs induring the first nine monthssecond quarter of Fiscal 20212022 in connection with the 20202021 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 changescharges in restructuring liabilities associated with the 20202021 Restructuring Plan from June 30, 20202021 through MarchDecember 31, 2021 is set forth in the following table:
| | | | | | | | | | | | |
|
| Employee |
| Employee |
| Tech Transfer |
| | ||||
(In thousands) |
| Separation Costs |
| Separation Costs |
| Costs |
| Total | ||||
Balance at June 30, 2020 | | $ | — | |||||||||
Balance at June 30, 2021 | | $ | — | | $ | — | | $ | — | |||
Restructuring charges | |
| 4,043 | |
| 864 | |
| 27 | |
| 891 |
Payments | |
| (4,001) | |
| (244) | |
| (27) | |
| (271) |
Balance at March 31, 2021 | | $ | 42 | |||||||||
Balance at December 31, 2021 | | $ | 620 | |
| — | | $ | 620 |
The Company has incurred $48.9 million in non-cash impairment charges in connection with the 2021 Restructuring Plan related to certain long-lived intangible assets as well as certain facility, equipment and other plant-related assets currently utilized by the Company. Refer to Note 7 “Property, Plant and Equipment,” Note 9 “Intangible Assets” and Note 20 “Assets Held for Sale” for further details on the impairment charges incurred as of December 31, 2021 in connection with the 2021 Restructuring Plan.
17
Note 5. Accounts Receivable, net
Accounts receivable, net consisted of the following components at MarchDecember 31, 2021 and June 30, 2020:2021:
| | | | | | | | | | | | |
| | March 31, |
| June 30, | | December 31, |
| June 30, | ||||
(In thousands) |
| 2021 |
| 2020 |
| 2021 |
| 2021 | ||||
Gross accounts receivable | | $ | 258,652 | | $ | 271,557 | | $ | 204,746 | | $ | 239,271 |
Less: Chargebacks reserve | |
| (74,729) | |
| (61,877) | |
| (66,833) | |
| (69,564) |
Less: Rebates reserve | |
| (16,446) | |
| (24,536) | |
| (18,497) | |
| (16,272) |
Less: Returns reserve | |
| (38,708) | |
| (40,796) | |
| (36,770) | |
| (38,395) |
Less: Other deductions | |
| (13,449) | |
| (17,557) | |
| (15,298) | |
| (15,505) |
Less: Allowance for doubtful accounts | |
| (629) | |
| (1,103) | |
| (1,073) | |
| (701) |
Accounts receivable, net | | $ | 114,691 | | $ | 125,688 | | $ | 66,275 | | $ | 98,834 |
For the three months ended MarchDecember 31, 2021, the Company recorded a provision for chargebacks, rebates (including rebates presented as rebates payable), returns and other deductions of $135.4$114.7 million, $27.1$26.5 million, $3.9$7.4 million and $18.6$7.8 million, respectively. For the three months ended MarchDecember 31, 2020, the Company recorded a provision for chargebacks, rebates (including rebates presented as rebates payable), returns and other deductions of $201.0$191.5 million, $63.8$43.4 million, $6.4$5.2 million and $35.7$20.8 million, respectively.
For the ninesix months ended MarchDecember 31, 2021, the Company recorded a provision for chargebacks, rebates (including rebates presented as rebates payable), returns and other deductions of $515.2$245.9 million, $104.8$55.3 million, $14.5$13.3 million and $55.2$26.8 million, respectively. For the ninesix months ended MarchDecember 31, 2020, the Company recorded a provision for chargebacks, rebates (including rebates presented as rebates payable), returns and other deductions of $608.6$379.8 million, $180.6$77.7 million, $16.6$10.7 million and $77.2$36.6 million, respectively.
17
The following table identifies the activity and ending balances of each major category of revenue-related reserve for the ninesix months ended MarchDecember 31, 2021 and 2020:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
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 | |||||||||||||||
Balance at June 30, 2021 | | $ | 69,564 | | $ | 35,297 | | $ | 38,395 | | $ | 15,505 | | $ | 158,761 | |||||||||||||||
Current period provision | |
| 515,196 | |
| 104,795 | |
| 14,545 | |
| 55,213 | |
| 689,749 | |
| 245,900 | | | 55,262 | | | 13,305 | | | 26,761 | |
| 341,228 |
Credits issued during the period | |
| (502,344) | |
| (119,212) | |
| (16,633) | |
| (59,321) | |
| (697,510) | |
| (248,631) | | | (46,857) | | | (14,930) | | | (26,968) | |
| (337,386) |
Balance at March 31, 2021 |
| $ | 74,729 |
| $ | 48,294 |
| $ | 38,708 |
| $ | 13,449 |
| $ | 175,180 | |||||||||||||||
Balance at December 31, 2021 |
| $ | 66,833 |
| $ | 43,702 |
| $ | 36,770 |
| $ | 15,298 |
| $ | 162,603 |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
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 | |||||||||||||||
Balance at June 30, 2020 | | $ | 61,877 | | $ | 62,711 | | $ | 40,796 | | $ | 17,557 | | $ | 182,941 | |||||||||||||||
Current period provision | |
| 608,570 | |
| 180,574 | |
| 16,600 | |
| 77,167 | |
| 882,911 | |
| 379,821 | |
| 77,657 | |
| 10,652 | |
| 36,624 | |
| 504,754 |
Credits issued during the period | |
| (637,664) | |
| (181,465) | |
| (24,466) | |
| (52,508) | |
| (896,103) | |
| (360,242) | |
| (77,536) | |
| (12,181) | |
| (34,833) | |
| (484,792) |
Balance at March 31, 2020 |
| $ | 60,473 |
| $ | 77,383 |
| $ | 47,688 |
| $ | 42,787 |
| $ | 228,331 | |||||||||||||||
Balance at December 31, 2020 |
| $ | 81,456 |
| $ | 62,832 |
| $ | 39,267 |
| $ | 19,348 |
| $ | 202,903 |
For the three months ending Marchended December 31, 2021 and 2020, as a percentage of gross sales the provision for chargebacks was 46.1%47.8% and 45.1%49.3%, the provision for rebates was 9.2%11.1% and 14.3%11.2%, the provision for returns was 1.3%3.1% and 1.4%1.3% and the provision for other adjustments was 6.3%3.2% and 8.0%5.4%, respectively.
For the ninesix months ending Marchended December 31, 2021 and 2020, as a percentage of gross sales the provision for chargebacks was 49.2%46.9% and 47.8%50.5%, the provision for rebates was 10.0%10.5% and 14.2%10.3%, the provision for returns was 1.4%2.5% and 1.3%1.4% and the provision for other adjustments was 5.3%5.1% and 6.1%4.9%, respectively.
18
The increasedecreases in the reserves for chargebacks, reserverebates and returns from June 30, 2021 to December 31, 2021 was primarily dueattributable to timing oflower net sales and product mix partially offset by lower sales.in the three months ended December 31, 2021 as compared to the three months ended June 30, 2021. The rebates reserve decreased primarilywas also impacted by the lower net sales in the three months ended December 31, 2021; however, the reserve increased due to lower salesthe timing of Fluphenazinepayments in Fiscal 2021, which had higher than average government-related rebates. Historically, we2022. We have not recorded any material amounts in the current period related to reversals or additions of prior period reserves.
Note 6. Inventories
Inventories at MarchDecember 31, 2021 and June 30, 20202021 consisted of the following:
| | | | | | | | | | | | |
| | March 31, | | June 30, | | December 31, | | June 30, | ||||
(In thousands) |
| 2021 |
| 2020 |
| 2021 |
| 2021 | ||||
Raw Materials | | $ | 47,307 | | $ | 59,703 | | $ | 49,042 | | $ | 45,370 |
Work-in-process | |
| 16,143 | |
| 12,235 | |
| 4,927 | |
| 12,685 |
Finished Goods | |
| 49,624 | |
| 70,929 | |
| 51,810 | |
| 51,490 |
Total | | $ | 113,074 | | $ | 142,867 | | $ | 105,779 | | $ | 109,545 |
During the three months ended MarchDecember 31, 2021 and 2020, the Company recorded write-downs to net realizable value for excess and obsolete inventory of $0.4$1.2 million and $2.4$20.6 million, respectively. During the ninesix months ended MarchDecember 31, 2021 and 2020, the Company recorded write-downs to net realizable value for excess and obsolete inventory of $23.6$4.1 million and $8.5 million, respectively.$23.2 million. The increasedecrease 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 furtherresulted in Note 9 “Intangible Assets.”a significant write-down in the prior-year period.
18
Note 7. Property, Plant and Equipment, net
Property, plant and equipment, net at MarchDecember 31, 2021 and June 30, 20202021 consisted of the following:
| | | | | | | | | | | | | | | | |
| | | | March 31, |
| June 30, | | | | December 31, |
| June 30, | ||||
(In thousands) |
| Useful Lives |
| 2021 |
| 2020 |
| Useful Lives |
| 2021 |
| 2021 | ||||
Land |
| — | | $ | 1,783 | | $ | 1,783 |
| — | | $ | 533 | | $ | 1,783 |
Building and improvements |
| 10 - 39 years | |
| 103,361 | |
| 100,285 |
| 10 - 39 years | |
| 93,401 | |
| 103,082 |
Machinery and equipment |
| 5 - 10 years | |
| 168,858 | |
| 164,704 |
| 5 - 10 years | |
| 163,352 | |
| 166,617 |
Furniture and fixtures |
| 5 - 7 years | |
| 3,402 | |
| 3,116 |
| 5 - 7 years | |
| 3,367 | |
| 3,399 |
Less accumulated depreciation | | | | | (119,953) | | | (102,983) | | | | | (129,529) | | | (123,294) |
| | | | | 157,451 | | | 166,905 | | | | | 131,124 | | | 151,587 |
Construction in progress |
| | |
| 11,393 | |
| 12,613 |
| | |
| 11,980 | |
| 15,087 |
Property, plant and equipment, net | | | | $ | 168,844 | | $ | 179,518 | | | | $ | 143,104 | | $ | 166,674 |
As a result of the 2021 Restructuring Plan, the Company performed a fair value analysis of the Silarx facility and certain equipment at the facility, which resulted in an $8.4 million impairment charge in the second quarter of Fiscal 2022. The land, facility and equipment identified for sale, totaling $10.5 million, was reclassified to the assets held for sale caption in the Consolidated Balance Sheet as of December 31, 2021.
Depreciation expense for the three months ended MarchDecember 31, 2021 and 2020 was $5.8$5.5 million and $6.2$5.7 million, respectively. Depreciation expense for the ninesix months ended MarchDecember 31, 2021 and 2020 was $17.2$11.1 million and $17.9$11.5 million, respectively.
Property, plant and equipment, net included amounts held in foreign countries in the amount of $0.5$0.6 million at MarchDecember 31, 2021 and June 30, 2020.2021.
19
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, “FairFair 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.
19
Financial Instruments Disclosed, But Not Reported, at Fair Value
We estimate the fair value of our debt utilizing7.750% Senior Secured Notes due 2026 (the “Notes”) and the 4.50% Convertible Senior Notes (“Convertible Senior Notes”) using market quotations for debt that have quoted prices in active markets.markets (Level 1). Since our debtSecond Lien Secured Loan Facility (“Second Lien Facility”) does not trade on a daily basis in an active market, the fair value estimates areestimate is 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 $518 million and $608 millionthe Notes as of MarchDecember 31, 2021 and June 30, 2020,2021 was approximately $266 million and $347 million, respectively. The estimated fair value of our 4.50%the Second Lien Facility as of December 31, 2021 and June 30, 2021 was approximately $144 million and $189 million, respectively. The estimated fair value of the Convertible Senior Notes was approximately $53$27 million and $58$53 million as of MarchDecember 31, 2021 and June 30, 2020,2021, respectively. The fair value of the Convertible Senior Notes as of MarchDecember 31, 2021 was lower than the carrying value primarily due to the Company’s stock price at MarchDecember 31, 2021 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 evidence20
Note 9. Intangible Assets
Intangible assets, net as of MarchDecember 31, 2021 and June 30, 20202021 consisted of the following:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Weighted | | Gross Carrying Amount | | Accumulated Amortization | | Intangible Assets, Net | | Weighted | | Gross Carrying Amount | | Accumulated Amortization | | Intangible Assets, Net | ||||||||||||||||||||||||
|
| Avg. Life |
| March 31, |
| June 30, |
| March 31, |
| June 30, |
| March 31, |
| June 30, |
| Avg. Life |
| December 31, |
| June 30, |
| December 31, |
| June 30, |
| December 31, |
| June 30, | ||||||||||||
(In thousands) |
| (Yrs.) |
| 2021 |
| 2020 |
| 2021 |
| 2020 |
| 2021 |
| 2020 |
| (Yrs.) |
| 2021 |
| 2021 |
| 2021 |
| 2021 |
| 2021 |
| 2021 | ||||||||||||
Definite-lived: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
KUPI product rights | | 15 | | | 83,955 | | | 416,154 | | | (2,099) | | | (125,327) | | | 81,856 | | | 290,827 | | 15 | | $ | 35,000 | | $ | 83,955 | | $ | — | | $ | (4,198) | | $ | 35,000 | | $ | 79,757 |
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 | | | (6,778) | | | (5,828) | | | 12,222 | | | 13,172 | | 15 | | | 19,000 | | | 19,000 | | | (7,728) | | | (7,095) | | | 11,272 | | | 11,905 |
Silarx product rights | | 15 | | | 20,000 | | | 20,000 | | | (4,556) | | | (3,556) | | | 15,444 | | | 16,444 | | 15 | | | 20,000 | | | 20,000 | | | (5,556) | | | (4,889) | | | 14,444 | | | 15,111 |
Other product rights | | 10 | | | 55,218 | | | 50,718 | | | (8,602) | | | (5,426) | | | 46,616 | | | 45,292 | | 10 | | | 37,417 | | | 35,918 | | | (11,161) | | | (8,856) | | | 26,256 | | | 27,062 |
Total definite-lived | | | | $ | 181,093 | | $ | 508,792 | | $ | (24,955) | | $ | (143,057) | | $ | 156,138 | | $ | 365,735 | | | | $ | 114,337 | | $ | 161,793 | | $ | (27,365) | | $ | (27,958) | | $ | 86,972 | | $ | 133,835 |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Indefinite-lived: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
KUPI in-process research and development | | — | | $ | 4,000 | | $ | 9,000 | | $ | — | | $ | — | | $ | 4,000 | | $ | 9,000 | | — | | $ | 4,000 | | $ | 4,000 | | $ | — | | $ | — | | $ | 4,000 | | $ | 4,000 |
Total indefinite-lived | | | | | 4,000 | | | 9,000 | | | — | | | — | | | 4,000 | | | 9,000 | | | | | 4,000 | | | 4,000 | | | — | | | — | | | 4,000 | | | 4,000 |
Total intangible assets, net | | | | $ | 185,093 | | $ | 517,792 | | $ | (24,955) | | $ | (143,057) | | $ | 160,138 | | $ | 374,735 | | | | $ | 118,337 | | $ | 165,793 | | $ | (27,365) | | $ | (27,958) | | $ | 90,972 | | $ | 137,835 |
For the three months ended MarchDecember 31, 2021 and 2020, the Company recorded amortization expense of $3.9$3.8 million and $8.3$8.7 million, respectively. For the ninesix months ended MarchDecember 31, 2021 and 2020, the Company recorded amortization expense of $21.1$7.8 million and $23.5$17.2 million, respectively.
20
In December 2020,November 2021, 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 resultannounced the 2021 Restructuring Plan, which includes the phase out of the discontinuance and the reduction in net sales and gross margin of certain other product lines, thetwo low-margin prescription products at Kremers Urban Pharmaceuticals, Inc. The Company determined that suchthe decision representsto discontinue these products along with continued competitive pressures in the market represent a “triggering event” and, therefore, commencedperformed an analysis to determine the potential for impairment of certain long-lived assets, primarilyincluding its intangible assets. Based on thatthe analysis, the Company recorded an impairment charge of $193.0$40.6 million related to the KUPI product rights intangible assets during the second quarter of Fiscal 2021.assets. 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 resulted 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.acquisition.
Future annual amortization expense consisted of the following as of MarchDecember 31, 2021:
| | | | | | |
(In thousands) |
| Amortization |
| Amortization | ||
Fiscal Year Ending June 30, |
| Expense |
| Expense | ||
2021 | | $ | 3,857 | |||
2022 | |
| 17,026 | | $ | 5,127 |
2023 | |
| 16,726 | |
| 10,295 |
2024 | |
| 16,426 | |
| 10,021 |
2025 | |
| 16,026 | |
| 9,827 |
2026 | |
| 9,173 | |||
Thereafter | |
| 86,077 | |
| 42,529 |
| | $ | 156,138 | | $ | 86,972 |
Note 10. Long-Term Debt
Long-term debt, net consisted of the following:
| | | | | | |
| | March 31, | | June 30, | ||
(In thousands) |
| 2021 |
| 2020 | ||
Term Loan A | | $ | — | | $ | 48,844 |
Unamortized discount and other debt issuance costs | |
| — | |
| (433) |
Term Loan A, net | |
| — | |
| 48,411 |
Term Loan B due 2022; 6.38% as of March 31, 2021 | |
| 543,348 | |
| 572,857 |
Unamortized discount and other debt issuance costs | |
| (16,162) | |
| (23,278) |
Term Loan B, net | |
| 527,186 | |
| 549,579 |
4.50% Convertible Senior Notes due 2026 | | | 86,250 | | | 86,250 |
Unamortized discount and other debt issuance costs | | | (2,738) | | | (3,111) |
4.50% Convertible Senior Notes, net | | | 83,512 | | | 83,139 |
$125 million Revolving Credit Facility | |
| — | |
| — |
$30 million ABL Credit Facility | |
| — | |
| — |
Total debt, net | |
| 610,698 | |
| 681,129 |
Less short-term borrowings and current portion of long-term debt | |
| — | |
| (88,189) |
Total long-term debt, net |
| $ | 610,698 |
| $ | 592,940 |
21
Note 10. Long-Term Debt
Long-term debt, net consisted of the following:
| | | | | | |
| | December 31, | | June 30, | ||
(In thousands) |
| 2021 |
| 2021 | ||
7.75% Senior Secured Notes due 2026 | | $ | 350,000 | | $ | 350,000 |
Unamortized discount and other debt issuance costs | | | (5,106) | | | (5,594) |
7.75% Senior Secured Notes due 2026, net | | | 344,894 | | | 344,406 |
Second Lien Secured Loan Facility due 2026 ($190.0M Principal, $5.7M Exit Fee, and $13.7M and $3.6M accrued PIK interest at December 31, 2021 and June 30, 2021 respectively) | | | 209,366 | | | 199,342 |
Unamortized discount and other debt issuance costs | | | (34,663) | | | (36,701) |
Second Lien Secured Loan Facility due 2026, net | | | 174,703 | | | 162,641 |
4.50% Convertible Senior Notes due 2026 | | | 86,250 | | | 86,250 |
Unamortized discount and other debt issuance costs | | | (2,363) | | | (2,614) |
4.50% Convertible Senior Notes, net | | | 83,887 | | | 83,636 |
$45 million Amended ABL Credit Facility | |
| — | |
| — |
Total debt, net | |
| 603,484 | |
| 590,683 |
Less short-term borrowings and current portion of long-term debt | |
| — | |
| — |
Total long-term debt, net |
| $ | 603,484 |
| $ | 590,683 |
The weighted average interest rate for the three months ended MarchDecember 31, 2021 and 2020 was 7.9%8.9% and 8.6%7.8%, respectively. The weighted average interest rate for the ninesix months ended MarchDecember 31, 2021 and 2020 was 7.9%8.9% and 9.0%7.9%, respectively. 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 undrawn $125 million Revolving Credit Facility also expired on November 25, 2020.
Long-term debt amounts due, for the twelve-month periods ending MarchDecember 31 are as follows:
| | | |
| | Amounts Payable | |
(In thousands) |
| to Institutions | |
2022 (a) | | $ | 39,345 |
2023 | |
| 504,003 |
2024 | |
| — |
2025 | |
| — |
2026 | | | — |
Thereafter | |
| 86,250 |
Total | | $ | 629,598 |
| | | |
| | Amounts Payable | |
(In thousands) |
| to Institutions | |
2022 | | $ | — |
2023 | |
| — |
2024 | |
| — |
2025 | |
| — |
2026 | | | 645,616 |
Total | | $ | 645,616 |
OnThe long-term debt amounts due above include accrued PIK interest on the Second Lien Facility as of December 7, 2020,31, 2021. Following 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. 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 allone-year anniversary 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:
22
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 theclosing date of the designated action and Excess Availability forSecond Lien Facility, the prior 30-day period exceeding agreed-upon thresholds, the absence of the occurrence and continuance ofCompany may elect to pay in cash 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 Facilityrequired 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 March 31, 2021, the Company classified the $5 million required deposit account balance as restricted cash, which is included in other assets captionpaid 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.form of PIK interest.
The outstanding Term Loan BNotes, Second Lien Facility, and Amended 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.
On April 22, 2021, the Company entered into multiple transactions to refinance the existing Term Loan B Facility due 2022. The Company also amended the existing ABL Credit Facility to, among other things, increase the aggregate amount and extend the maturity of the revolving credit. Refer to Note 20 “Subsequent Events” for further discussion of the details of the transactions.
2322
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. Beginning in December 2016, the Connecticut Attorney General and numerous other State Attorneys General have filed civil complaints against the Company and numerous other companies and individuals relating to alleged anti-competitive behavior as 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.
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 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 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 Company 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.
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, following an audit conducted by the Company, 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 (“VA”) as a result of certain commercial customer prices that were not properly disclosed to the VA for the period of January 1, 2012 through June 30, 2016. In August 2019, the Company remitted payment to the VA and received reimbursementwas indemnified from UCB for the indemnified portion of that related to the payment inperiod prior to the amountacquisition of Kremers Urban Pharmaceuticals (January 1, 2012 to November 24, 2015) totaling $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.
2423
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 overarching conspiracy claims as to it.
On May 10, 2019, the State Attorneys General filed a new lawsuit naming the Company and one of its employees as defendants, along with 33 other 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 used primarily to treat dermatological conditions, 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 filed by private plaintiffs 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 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 3three 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.
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.
2524
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 involves 135 new drugs in addition to those named in previous complaints. As to the Company, the new drugs involved are pilocarpine HCL, triamterene HCTZ capsules, amantadine HCL, and oxycodone HCL. None of the defendants, including the Company, has responded yet to these new complaints.
Between January 2018 and December 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 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. On February 9, 2021, the District Court vacated the order selecting the bellwether cases. TheThereafter, the District Court has re-designated the clobetasol and clomipramine cases as individual-conspiracy bellwethers, but has not yet designated aand on May 7, 2021, selected the third complaint filed by the state Attorneys General in June 2020 as the new overarching conspiracy bellwether case. On September 9, 2021, the state Attorneys General amended their bellwether complaint. 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 against these claims.
2625
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. In September 2018, counsel for the putative class filed a third amended 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.litigation, and regarding the defendants’ investigation of purported anticompetitive conduct. 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. OnIn October 1, 2020, counsel for the plaintiffputative class filed a motion for class certification. In March 2021, the Company filed a brief in opposition to the motion to certify the putative class. In August 2021, the court granted the motion to certify the proposed class, to appoint class representatives, and to appoint class counsel. In August 2021, the Company filed a petition for permission to appeal the court’s class certification order. In September 2021, counsel for the class filed a response in opposition to the Company’s position. In November 2021, the United States Court of Appeals for the Third Circuit granted the Company’s petition for permission to appeal the class certification order. In January 2022, the Third Circuit granted the Company’s motion to stay the case pending a decision on the interlocutory appeal. The Company believes it acted in compliance with all applicable laws and planscontinues to vigorously defend itself from these claims. The Company cannot reasonably predict the outcome of the suit at this time.
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 was 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 Report and Recommendation approving the settlement and denying the objecting parties’ motion to intervene. The time period to object to the 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.
27
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.
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 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 deniesdenied that it is falsely advertising its cocaine hydrochloride solution product and continuescontinued 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.application (until August 15, 2019, when it agreed to a request by the FDA to cease marketing its unapproved product as a result of the approval of a competitor’s product). 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 ongoingOn August 16, 2021, the Company and Genus reached an agreement in principle to amicably resolve this case, along with three other cases involving the Company’s approved cocaine hydrochloride product. The parties memorialized the settlement in a series of settlement documents which were signed on October 15, 2021. The terms of the settlement are confidential and include, among other things, a non-exclusive patent license granted by Genus, which allows the Company to continue marketing its approved cocaine hydrochloride product, a payment of $1.5 million by the Company and transfer by the Company of certain ANDAs and an NDA to Genus, and the stipulation that all cases shall be dismissed with prejudice. All cases against the Company cannot reasonably predict the outcome of this suit at this time.
have been dismissed with prejudice.
2826
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. Upon the conclusion of fact discovery, the Court entered an order on July 16, 2021 staying the remaining deadlines in the case pending the outcome of the Arbitration between Sandoz and Cediprof, which began on January 31, 2022. 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 theThe Company cannot reasonably predict the outcome of this suit at this time.
Ranitidine Oral Solution, USP
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. Similar complaints were filed in state court in New Mexico and state court in Maryland and served upon the Company. Subsequently, a number of similar complaints were served on the Company. The Company filed a motion to dismiss the complaint filed in the MDL which was granted with leave to amend on December 31, 2020. The plaintiffs filed a First Amended complaint on February 9, 2021, to which the generic manufacturer defendants, including the Company, filed a renewed motion to dismiss all claims. On July 8, 2021, the Court issued an Order granting the motion and dismissing all claims with prejudice based on federal preemption. The Plaintiffs filed an appeal to the Eleventh Circuit Court of Appeals. Separately, the New Mexico case was conditionally transferred to the MDL, but ultimately remanded back to the state court. The Company, along with other defendants filed a motion to dismiss on preemption ground. The motion was denied on August 17, 2021; however, the Company is currently evaluating options for interlocutory appeal. Since the Company, based upon the information received to date, did not sell Ranitidine in New Mexico, it is pursuing its options for dismissal. It is in the process of negotiating a voluntary dismissal with attorneys for the State and simultaneously moving for dismissal on jurisdiction grounds. Separately, the Company filed a notice to remove and transfer the Maryland case to the MDL which the plaintiff has opposed. On April 1, 2021, the case was remanded back to the state court. Recently, two separate complaints were filed against the Company and others in Philadelphia Court of Common Pleas by parents on behalf of minor children alleging personal injury as a result of using the Company’s Ranitidine products. The Company has filed its preliminary objections to both of the complaints, seeking dismissal on the basis of preemption, legal insufficiency, learned intermediary defense and lack of specificity. The Company has placed its insurance carrier on notice of the claim and the carrier has appointed counsel to defend the Company.
27
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
At MarchDecember 31, 2021 and June 30, 2020,2021, the Company had a ROU lease asset of $10.8$10.2 million and $9.3$10.6 million, respectively, and a ROUan operating lease liability of $13.3$12.6 million and $10.9$13.1 million, respectively. The current balance of the ROUoperating lease liability at MarchDecember 31, 2021 and June 30, 2020 was2021was $2.1 million and $2.0 million, and $1.1 million, respectively.
In February 2021, the Company extended our existing lease for the warehouse in Seymour, Indiana. The lease term is now set to expire in March 2031. Accordingly, the Company recorded a ROU lease asset and liability totaling $2.3 million, respectively, in the third quarter of Fiscal 2021.
Components of lease cost are as follows:
| | | | | | | | | | | | |
| | Three Months Ended | | Nine Months Ended | ||||||||
| | March 31, | | March 31, | ||||||||
(In thousands) | | 2021 |
| 2020 |
| 2021 |
| 2020 | ||||
Operating lease cost | | $ | 463 | | $ | 642 | | $ | 1,342 | | $ | 1,713 |
Variable lease cost | | | 37 | |
| 32 | | | 119 | |
| 93 |
Short-term lease cost (a) | | | 111 | |
| 194 | | | 337 | |
| 473 |
Total | | $ | 611 | | $ | 868 |
| $ | 1,798 | | $ | 2,279 |
| | | | | | | | | | | | |
| | Three Months Ended | | Six Months Ended | ||||||||
| | December 31, | | December 31, | ||||||||
(In thousands) | | 2021 |
| 2020 |
| 2021 |
| 2020 | ||||
Operating lease cost | | $ | 444 | | $ | 477 | | $ | 905 | | $ | 879 |
Variable lease cost | | | 16 | |
| 43 | | | 57 | |
| 82 |
Short-term lease cost | | | 83 | |
| 108 | | | 152 | |
| 226 |
Total | | $ | 543 | | $ | 628 |
| $ | 1,114 | | $ | 1,187 |
Supplemental cash flow information related to our operating leases is as follows:
| | | | | | |
| | Six Months Ended | ||||
| | December 31, | ||||
(In thousands) |
| 2021 |
| 2020 | ||
Cash paid for amounts included in the measurement of lease liabilities: | | | | | | |
Operating cash flows from operating leases |
| $ | 1,084 |
| $ | 809 |
Weighted-average remaining lease term and discount rate for our operating leases are as follows:
| | | | | | |
| | Six Months Ended | ||||
| | December 31, | ||||
|
| 2021 | | 2020 | ||
Weighted-average remaining lease term | | 9 | years | | 8 | years |
Weighted-average discount rate |
| 8.5 | % | | 8.0 | % |
2928
Supplemental cash flow information and non-cash activity related to our operating leases are as follows:
| | | | | | |
| | Nine Months Ended | ||||
| | March 31, | ||||
(In thousands) |
| 2021 |
| 2020 | ||
Cash paid for amounts included in the measurement of lease liabilities: | | | | | | |
Operating cash flows from operating leases |
| $ | 1,405 |
| $ | 1,439 |
Non-cash activity: | | | | | | |
ROU assets obtained in exchange for new operating lease liabilities |
| $ | 2,275 |
| $ | 4,317 |
Weighted-average remaining lease term and discount rate for our operating leases are as follows:
| | | | | | |
| | Nine Months Ended | ||||
| | March 31, | ||||
|
| 2021 | | 2020 | ||
Weighted-average remaining lease term | | 10 | years | | 9 | years |
Weighted-average discount rate |
| 8.5 | % | | 7.9 | % |
Maturities of lease liabilities by fiscal year for our operating leases are as follows:
| | | | | | |
(In thousands) |
| Amounts Due |
| Amounts Due | ||
2021 | | $ | 527 | |||
2022 | | | 2,045 | | $ | 1,045 |
2023 | |
| 2,064 | | | 2,064 |
2024 | |
| 2,083 | |
| 2,083 |
2025 | |
| 2,103 | |
| 2,103 |
2026 | |
| 2,124 | |||
Thereafter | |
| 10,637 | |
| 8,513 |
Total lease payments | |
| 19,459 | |
| 17,932 |
Less: Imputed interest | |
| 6,113 | |
| 5,324 |
Present value of lease liabilities |
| $ | 13,346 |
| $ | 12,608 |
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 March 31, 2021, $6.6 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 million of the development costs and split 50/50/50 any development costs in excess thereof. As of December 31, 2021, the Company has incurred approximately $6.0 million of development costs towards the $32 million commitment made by the Company. Lannett shall receive an exclusive license to distribute and market the product in the United States upon FDA approval under the 50/50/50 profit split for the first ten years following commercialization, followed by a 6060/40/40 split in favor of HEC for the following five years. To date, the COVID-19 pandemic has not had a material impact on the development of the insulin glargine product. The longer that countries aroundAlthough, as a result of stricter procedures required during the world remain on lockdown, the more likely it becomes that thepandemic, there is expected to be a several month delay in completing our upcoming clinical trial. The timing of the product development and approval willcould be delayed. further delayed as the COVID-19 pandemic continues.
30
On February 8, 2021, the Company executed a License and Collaboration Agreement and a Supply Agreement with Sunshine Lake Pharma Co., Ltd. an HEC Group company (“Sunshine”) with respect to the development of a biosimilar insulin aspart product. Under the terms of the deal, among other things, the Company shall fund up to the initial $32 million of the development costs, provided that if total development and other costs paid by Lannett are less than $32 million then the difference will be paid to Sunshine over the first year of commercialization. As of December 31, 2021, the Company has not yet incurred material costs towards the $32 million commitment made by the Company. The parties shall negotiate the sharing of any development costs in excess of $32 million. Lannett shall receive an exclusive license to distribute and market the product in the United States upon FDA approval under the 50/50/50 profit split for the first ten years following commercialization, followed by a 6060/40/40 split in favor of Sunshine for the following five years.years.
Note 13. Accumulated Other Comprehensive Loss
The Company’s Accumulated Other Comprehensive Loss was comprised of the following components as of MarchDecember 31, 2021 and 2020:
| | | | | | |
| | March 31, | ||||
(In thousands) |
| 2021 |
| 2020 | ||
Foreign Currency Translation | | | | | | |
Beginning Balance, June 30 | | $ | (627) | | $ | (615) |
Net income (loss) on foreign currency translation (net of tax of $0 and $0) | |
| 24 | |
| (26) |
Other comprehensive income (loss), net of tax | |
| 24 | |
| (26) |
Total Accumulated Other Comprehensive Loss | | $ | (603) | | $ | (641) |
| | | | | | |
| | December 31, | ||||
(In thousands) |
| 2021 |
| 2020 | ||
Foreign Currency Translation | | | | | | |
Beginning Balance, June 30 | | $ | (548) | | $ | (627) |
Net income on foreign currency translation (net of tax of $0 and $0) | |
| 29 | |
| 32 |
Other comprehensive income, net of tax | |
| 29 | |
| 32 |
Total Accumulated Other Comprehensive Loss | | $ | (519) | | $ | (595) |
3129
Note 14. Warrants
In connection with the Second Lien Facility, the Company issued to the Participating Lenders warrants to purchase up to 8,280,000 shares of common stock of the Company (the “Warrants”) at an exercise price of $6.88 per share. The Warrants were issued on April 22, 2021 with an eight-year term. The Participating Lenders received registration rights with respect to the shares of common stock of the Company to be received upon exercise of the Warrants. The Company concluded that the Warrants were indexed to its own stock and, therefore, are classified as an equity instrument. In accordance with ASC 470, Debt, the Company allocated the proceeds of the Second Lien Facility issuance based on the relative fair value of the debt instrument and the Warrants separately at the time of issuance, which was determined using the Black-Scholes valuation model. The relative fair value allocated to the Warrants was $24.4 million at the issuance date.
The holders of the Warrants are entitled to receive dividends or distributions of any kind made to the common stockholders to the same extent as if the holder had exercised the Warrant into common stock. Although the Company did not issue or declare dividends during the period, the Warrants are considered participating securities under ASC 260, Earnings per share, for purposes of calculating earnings (loss) per share under the two-class method. Refer to Note 15 “Loss Per Common Share” for further details of the two-class method and the Company’s calculation of earnings (loss) per share.
Note 14.15. Loss Per Common Share
A reconciliation of the Company’s basic and diluted loss per common share was as follows:
| | | | | | | | | | | | |
| | Three Months Ended | | Three Months Ended | ||||||||
| | March 31, | | December 31, | ||||||||
(In thousands, except share and per share data) |
| 2021 |
| 2020 |
| 2021 |
| 2020 | ||||
Numerator: | | | | | | | | | | | | |
Net loss |
| $ | (7,142) |
| $ | (16,592) |
| $ | (81,085) |
| $ | (171,948) |
Interest expense applicable to the Convertible Notes, net of tax | |
| — | |
| — | |
| — | |
| — |
Amortization of debt issuance costs applicable to the Convertible Notes, net of tax | |
| — | |
| — | |
| — | |
| — |
Adjusted “if-converted” net loss |
| $ | (7,142) |
| $ | (16,592) |
| $ | (81,085) |
| $ | (171,948) |
| | | | | | | | | | | | |
Denominator: | | | | | | | | | | | | |
Basic weighted average common shares outstanding | |
| 39,511,296 | |
| 38,707,049 | |
| 40,358,127 | |
| 39,443,441 |
Effect of potentially dilutive options and restricted stock awards | |
| — | |
| — | ||||||
Effect of potentially dilutive options, restricted stock awards and performance-based shares | |
| — | |
| — | ||||||
Effect of conversion of the Convertible Notes | |
| — | |
| — | |
| — | |
| — |
Diluted weighted average common shares outstanding | |
| 39,511,296 | |
| 38,707,049 | |
| 40,358,127 | |
| 39,443,441 |
| | | | | | | | | | | | |
Loss per common share: | | | | | | | | | | | | |
Basic |
| $ | (0.18) |
| $ | (0.43) |
| $ | (2.01) |
| $ | (4.36) |
Diluted |
| $ | (0.18) |
| $ | (0.43) |
| $ | (2.01) |
| $ | (4.36) |
30
| | | | | | | | | | | | |
| | Nine Months Ended | | Six Months Ended | ||||||||
| | March 31, | | December 31, | ||||||||
(In thousands, except share and per share data) |
| 2021 |
| 2020 |
| 2021 |
| 2020 | ||||
Numerator: | | | | | | | | | | | | |
Net loss |
| $ | (185,589) |
| $ | (23,665) |
| $ | (103,427) | | $ | (178,447) |
Interest expense applicable to the Convertible Notes, net of tax | |
| — | |
| — | ||||||
Net income allocated to participating securities for the Warrants | | | — | | | — | ||||||
Interest expenses applicable to the Convertible Notes, net of tax | | | — | | | — | ||||||
Amortization of debt issuance costs applicable to the Convertible Notes, net of tax | |
| — | |
| — | | | — | | | — |
Adjusted “if-converted” net loss |
| $ | (185,589) |
| $ | (23,665) | ||||||
Adjusted "if-converted" net loss |
| $ | (103,427) | | $ | (178,447) | ||||||
| | | | | | | | | | | | |
Denominator: | | | | | | | | | | | | |
Basic weighted average common shares outstanding | |
| 39,340,670 | |
| 38,539,850 | |
| 40,142,974 | |
| 39,257,211 |
Effect of potentially dilutive options and restricted stock awards | |
| — | |
| — | ||||||
Effect of potentially dilutive options, restricted stock awards and performance-based shares | |
| — | |
| — | ||||||
Effect of conversion of the Convertible Notes | |
| — | |
| — | |
| — | | | — |
Effect of participating securities for the Warrants | | | — | | | — | ||||||
Diluted weighted average common shares outstanding | |
| 39,340,670 | |
| 38,539,850 | |
| 40,142,974 | |
| 39,257,211 |
| | | | | | | | | | | | |
Loss per common share: | | | | | | | | | | | | |
Basic |
| $ | (4.72) |
| $ | (0.61) |
| $ | (2.58) | | $ | (4.55) |
Diluted |
| $ | (4.72) |
| $ | (0.61) |
| $ | (2.58) | | $ | (4.55) |
In accordance with ASC 260, Earnings per share, the Company computes earnings (loss) per share using the two-class method, which requires an allocation of earnings between the holders of common stock and the Company’s participating security holders. Basic earnings (loss) per share is calculated by dividing net income (loss) available to common stockholders, which excludes the income allocated to participating security holders, by the basic weighted average common shares outstanding. For purposes of determining diluted earnings per share, the Company further adjusts the basic earnings per share to include the effect of potentially dilutive shares outstanding, including options, restricted stock awards, performance-based shares, the Convertible Notes, and the Warrants. In this calculation, the Company reallocates net income based on the rights of each potentially dilutive share and will report the most dilutive earnings (loss) per share. Because the Warrants do not participate in losses, the Company will allocate undistributed earnings when calculating basic and diluted earnings per share in periods of net income only. The effect of the Warrants is excluded from the calculation of basic and diluted loss per share for the three and six months ended December 31, 2021.
The number of anti-dilutive shares that have been excluded in the computation of diluted loss and earnings per share was 8.1 million for each of the three and six months ended MarchDecember 31, 2021 and 2020 were 8.1 million and 7.8 million, respectively. The number of anti-dilutive shares that have been excluded in the computation of diluted loss and earnings per share for the nine months ended March 31, 2021 and 2020 were 8.1 million and 6.0 million, respectively.2020. The effect of potentially dilutive shares was excluded from the calculation of diluted loss per share in the three and ninesix months ended MarchDecember 31, 2021 and 2020 because the effect of including such securities would be anti-dilutive.
3231
Note 15.16. Share-based Compensation
At MarchDecember 31, 2021, the Company had 2 share-based employee compensation plans (the 2014 Long-Term Incentive Plan “LTIP”(“LTIP”) and the 2021 “LTIP”)LTIP). The 2021 LTIP, which authorized 3.0 million new shares of common stock for future issuances, was approved by the stockholders of the Company January 2021. Together these plans authorized an aggregate total of 8.0 million shares to be issued. As of MarchDecember 31, 2021, the plans have a total of 3.01.4 million shares available for future issuances. No awards have been granted from the 2021 LTIP as of March 31, 2021.
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. The Company issues new shares of stock when stock options are exercised. As of MarchDecember 31, 2021, there was $11.2$12.0 million of total unrecognized compensation cost related to non-vested share-based compensation awards. That cost is expected to be recognized over a weighted average period of 2.22.0 years.
Stock Options
The Company measures share-based compensation cost for options using the Black-Scholes option pricing model. There were 0 stock options granted during the six months ended December 31, 2021. 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 ninesix months ended MarchDecember 31, 2021 and 2020:
| | | | | | | | | | | | |
| | Nine Months Ended | | Six Months Ended | ||||||||
| | March 31, 2021 | | March 31, 2020 | | December 31, 2020 | ||||||
Risk-free interest rate | | | 0.2 | % | | | 1.9 | % | | | 0.2 | % |
Expected volatility | | | 82.5 | % | | | 73.7 | % | | | 82.5 | % |
Expected dividend yield | | | — | % | | | — | % | | | 0 | % |
Forfeiture rate | | | — | % | | | — | % | | | — | % |
Expected term | | | 5.0 | years | | | 5.1 | years | | | 5.0 | years |
Weighted average fair value | | $ | 3.86 | | | $ | 4.04 | | | $ | 3.86 | |
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 MarchDecember 31, 2021 and changes during the ninesix months then ended, is presented below:
| | | | | | | | | | | | | | | | | | | | |
|
|
|
| | |
| | |
| Weighted |
|
|
| | |
| | |
| Weighted |
| | | | Weighted- | | | | | Average | | | | Weighted- | | | | | Average | ||
| | | | Average | | Aggregate | | Remaining | | | | Average | | Aggregate | | Remaining | ||||
| | | | Exercise | | Intrinsic | | Contractual | | | | Exercise | | Intrinsic | | Contractual | ||||
(In thousands, except for weighted average price and life data) |
| Awards |
| Price |
| Value |
| Life (yrs.) |
| Awards |
| Price |
| Value |
| Life (yrs.) | ||||
Outstanding at June 30, 2020 |
| 991 | | $ | 12.11 | | $ | 678 | | 5.6 | ||||||||||
Granted |
| 309 | | $ | 5.95 | | | | | | ||||||||||
Outstanding at June 30, 2021 |
| 1,046 | | $ | 9.51 | | $ | 25 | | 7.2 | ||||||||||
Exercised |
| (37) | | $ | 4.12 | | $ | 61 | | |
| (3) | | $ | 3.55 | | $ | 2 | | |
Forfeited, expired or repurchased |
| (217) | | $ | 17.17 | | | | | |
| (11) | | $ | 7.62 | | | | | |
Outstanding at March 31, 2021 |
| 1,046 | | $ | 9.51 | | $ | 62 | | 7.4 | ||||||||||
Outstanding at December 31, 2021 |
| 1,032 | | $ | 9.55 | | $ | — | | 6.8 | ||||||||||
| | | | | | | | | | | | | | | | | | | | |
Vested and expected to vest at March 31, 2021 |
| 1,045 | | $ | 9.51 | | $ | 62 | | 7.4 | ||||||||||
Exercisable at March 31, 2021 |
| 383 | | $ | 14.82 | | $ | 62 | | 5.1 | ||||||||||
Vested and expected to vest at December 31, 2021 |
| 1,032 | | $ | 9.55 | | $ | — | | 6.8 | ||||||||||
Exercisable at December 31, 2021 |
| 626 | | $ | 11.67 | | $ | — | | 5.9 |
32
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 six months ended December 31, 2021 and 2020.
A summary of restricted stock awards as of December 31, 2021 and changes during the six months then ended, is presented below:
| | | | | | | | |
| | | | Weighted | | | | |
| | | | Average Grant - | | Aggregate | ||
(In thousands, except for weighted average price data) |
| Awards |
| date Fair Value |
| Intrinsic Value | ||
Non-vested at June 30, 2021 |
| 1,350 | | $ | 6.75 | | | |
Granted |
| 1,110 | |
| 4.14 | | | |
Vested |
| (973) | |
| 5.98 | | $ | 3,765 |
Forfeited |
| (83) | |
| 5.72 | | | |
Non-vested at December 31, 2021 |
| 1,404 | | $ | 5.28 | | | |
Performance-Based Shares
The Company grants performance-based awards to certain key executives. The stock-settled awards will cliff vest based on a three-year performance measurement period. Awards issued prior to July 2021 are based on relative Total Shareholder Return (“TSR”) over a three-year period. Half of the performance shares granted in July 2021 will be tied to our relative TSR, consistent with awards granted in prior years, with the other half tied to a variety of strategic portfolio goals. The Company measures share-based compensation cost for TSR awards using a Monte-Carlo simulation model. Compensation cost for awards tied to strategic portfolio goals is measured using the stock price at the grant date and is recognized based on performance at target award levels. However, in accordance with ASC 718, Compensation – Stock Compensation, the Company will assess the probability that the strategic portfolio goals will be met and adjust the cumulative compensation cost recognized accordingly at each reporting period.
A summary of performance-based share awards as of December 31, 2021 and changes during the current fiscal year, is presented below:
| | | | | | |
| | | | Weighted | | |
| | | | Average Grant - | | |
(In thousands, except for weighted average price and life data) |
| Awards |
| date Fair Value |
| |
Non-vested at June 30, 2021 |
| 531 | | $ | 10.29 | |
Granted |
| 617 | | $ | 6.04 | |
Performance adjustment (1) | | (40) | | $ | 17.69 | |
Vested |
| (58) | | $ | 7.72 | |
Non-vested at December 31, 2021 |
| 1,050 | | $ | 7.65 | |
(1) | Represents the adjustment based on the performance of the July 2018 awards, which was below the Threshold goal level at the end of the three-year performance period. |
33
Restricted Stock
The Company measures restricted stock compensation costs based on the stock price at the grant date less an estimate for expected forfeitures. The annual forfeiture rate used to calculate compensation expense was 6.5% for the nine months ended March 31, 2021 and 2020.
A summary of restricted stock awards as of March 31, 2021 and changes during the nine months then ended, is presented below:
| | | | | | | | |
| | | | Weighted | | | | |
| | | | Average Grant - | | Aggregate | ||
(In thousands, except for weighted average price data) |
| Awards |
| date Fair Value |
| Intrinsic Value | ||
Non-vested at June 30, 2020 |
| 1,344 | | $ | 8.70 | | | |
Granted |
| 894 | |
| 5.74 | | | |
Vested |
| (792) | |
| 8.49 | | $ | 4,613 |
Forfeited |
| (75) | |
| 9.57 | | | |
Non-vested at March 31, 2021 |
| 1,371 | | $ | 6.85 | | | |
Performance-Based Shares
In September 2017, the Company began granting performance-based awards to certain key executives. The stock-settled awards will cliff vest based on relative Total Shareholder Return (“TSR”) over a three-year period. The Company measures share-based compensation cost for TSR awards using a Monte-Carlo simulation model.
A summary of performance-based share awards as of March 31, 2021 and changes during the current fiscal year, is presented below:
| | | | | | |
| | | | Weighted | | |
| | | | Average Grant - | | |
(In thousands, except for weighted average price and life data) |
| Awards |
| date Fair Value |
| |
Non-vested at June 30, 2020 |
| 204 | | $ | 12.99 | |
Granted |
| 339 | | $ | 9.22 | |
Performance adjustment (1) | | (12) | | $ | 25.58 | |
Non-vested at March 31, 2021 |
| 531 | | $ | 10.29 | |
Employee Stock Purchase Plan
In February 2003, the Company’s stockholders approved an Employee Stock Purchase Plan (“2003 ESPP”). The 2003 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 2003 ESPP. During the six months ended December 31, 2021 and 2020, 107 thousand shares and 56 thousand shares were issued under the 2003 ESPP, respectively. As of December 31, 2021, 1.1 million total cumulative shares have been issued under the 2003 ESPP. In January 2022, the stockholders of the Company approved a new ESPP (“2022 ESPP” and, together with the 2003 ESPP, “ESPPs”). The Company is authorized an additional 1.5 million shares of the Company’s common stock for issuance under the 2022 ESPP, which is qualified under Section 423 of the Internal Revenue Code. Employees eligible to participate in the ESPP may purchase shares of the Company’s stock at 85% of the lower of the fair market value of the common stock on the first day of the calendar quarter, or the last day of the calendar quarter. Under the ESPP, employees can authorize the Company to withhold up to 10% of their compensation during any quarterly offering period, subject to certain limitations. The ESPP was implemented on April 1, 2003 and is qualified under Section 423 of the Internal Revenue Code. The Board of Directors authorized an aggregate total of 1.1 million shares of the Company’s common stock for issuance under the ESPP. During the nine months ended March 31, 2021 and 2020, 81 thousand shares and 83 thousand shares were issued under the ESPP, respectively. As of March 31, 2021, 991 thousand total cumulative shares have been issued under the ESPP.
34
The following table presents the allocation of share-based compensation costs recognized in the Consolidated Statements of Operations by financial statement line item:
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended | | Nine Months Ended | | | Three Months Ended | | Six Months Ended | | ||||||||||||||||
| | March 31, | | March 31, | | | December 31, | | December 31, | | ||||||||||||||||
(In thousands) |
| 2021 |
| 2020 |
| 2021 |
| 2020 | |
| 2021 |
| 2020 |
| 2021 |
| 2020 | | ||||||||
Selling, general and administrative expenses | | $ | 1,411 | | $ | 1,124 | | $ | 5,632 | | $ | 5,965 | | | $ | 2,115 | | $ | 1,507 | | $ | 4,812 | | $ | 4,221 | |
Research and development expenses | |
| 132 | |
| 180 | |
| 419 | |
| 618 | | |
| 27 | |
| 132 | |
| 122 | |
| 287 | |
Cost of sales | |
| 320 | |
| 566 | |
| 1,145 | |
| 1,753 | | |
| 167 | |
| 352 | |
| 393 | |
| 825 | |
Total | | $ | 1,863 | | $ | 1,870 | | $ | 7,196 | | $ | 8,336 | | | $ | 2,309 | | $ | 1,991 | | $ | 5,327 | | $ | 5,333 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | |
Tax benefit at statutory rate | | $ | 419 | | $ | 421 | | $ | 1,619 | | $ | 1,876 | | | $ | 519 | | $ | 448 | | $ | 1,199 | | $ | 1,200 | |
Note 16.17. Employee Benefit Plan
The Company has a 401k defined contribution plan (the “Plan”) covering substantially all employees. Pursuant to the Plan provisions, the Company was 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 $0.3$0.2 million and $0.6$0.5 million during the three months ended MarchDecember 31, 2021 and 2020, respectively. Contributions to the Plan were $1.3$0.5 million and $1.7$1.1 million during the ninesix months ended MarchDecember 31, 2021 and 2020, respectively.
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 ninesix months ended MarchDecember 31, 2021 were not material.
34
Note 17.18. 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 MarchDecember 31, 2021 was $2.5$1.4 million compared to $1.7$58.1 million for the three months ended MarchDecember 31, 2020. The effective tax rates for the three months ended March 31,December 30, 2021 and 2020 were 26.3%1.7% and 9.1%25.2%, respectively. The effective tax rate for the three months ended MarchDecember 31, 2021 was higherlower compared to the three months ended MarchDecember 31, 2020 primarily due to the relative impact of excess tax shortfalls related to stock compensation as well as a non-deductible branded prescription drug feevaluation allowance recorded in the three months ended March 31, 2021 as compared to the three months ended March 31, 2020.Fiscal 2021.
The federal, state and local income tax benefit for the ninesix months ended MarchDecember 31, 2021 was $68.6$1.4 million compared to $5.2$66.1 million for the ninesix months ended MarchDecember 31, 2020. The effective tax rates for the ninesix months ended MarchDecember 31, 2021 and 2020 were 27.0%1.4% and 18.0%27.0%, respectively. The effective tax rate for the ninesix months ended MarchDecember 31, 2021 was higherlower compared to the ninesix months ended MarchDecember 31, 2020 primarily due to the impact of the CARES Act, which increased the interest expense deductibility limitationvaluation allowance recorded 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 impact of excess tax shortfalls related to stock compensation as well as a non-deductible branded prescription drug fee in the nine months ended March 31, 2020 relative to expected pre-tax loss also contributed to a lower effective tax rate as compared to the nine months ended March 31,Fiscal 2021.
35
The Company may recognize the tax benefit from an uncertain tax position claimed on a tax return only if it is more likely than not that the tax position will be sustained on examination by the taxing authorities, based on the technical merits of the position. The tax benefits recognized in the financial statements from such a position should be measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate settlement.
As of MarchDecember 31, 2021 and June 30, 2020,2021, the Company has total unrecognized tax benefits of $4.6$4.5 million, and $4.6 million, respectively, of which $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 MarchDecember 31, 2021 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 MarchDecember 31, 2021 and June 30, 2020.2021. 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 are closed. The Company’s Fiscal Year 2015 through 2017 and 2020 federal returns are currently under examination by the Internal Revenue Service (“IRS”). In March 2021, the Company was notified that its Fiscal Year 2020 federal return was also selected for examination. 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 October 2018, the Company was notified that the Commonwealth of Pennsylvania will conduct a routine field audit of the Company’s Fiscal 2016 and Fiscal 2017 corporate tax returns. In March 2021, the Company received a preliminary assessment from the Commonwealth of Pennsylvania, which is not considered material to the Company’s Consolidated Statement of Operations. In November 2021, the Company was notified that the State of Florida will conduct an audit of the Company’s Fiscal 2019 and 2020 corporate tax returns. The Company cannot currently predict the outcome of the audit.
Note 18.19. Related Party Transactions
The Company had sales of $0.6$0.4 million and $0.9$0.8 million during the three months ended MarchDecember 31, 2021 and 2020, respectively, to a generic distributor, Auburn Pharmaceutical Company (“Auburn”), which is a member of the Premier Buying Group. Sales to Auburn were $2.1 million for each of the ninesix months ended MarchDecember 31, 2021 and 2020.2020 were $0.6 million and $1.5 million, respectively. Jeffrey Farber, a current board member, is the owner of Auburn. Accounts receivable includes amounts due from Auburn of $0.3 million and $0.4 million and $0.7 million at MarchDecember 31, 2021 and June 30, 2020,2021, respectively.
35
Note 19.20. Assets Held for Sale
In the first quarter of Fiscal 2019, the Company approved a plan to sell the Cody API business, which includesReal Estate
In Fiscal 2020, 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,November 2021, 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.business. The Company continuesadjusted the carrying value to actively marketfair value based on the real estate.signed agreement and estimated proceeds of the sale, which resulted in a $0.5 million impairment charge. As of MarchDecember 31, 2021, the remaining real estate associated with the Cody API business, totaling $2.7$2.2 million, was recorded in the assets held for sale caption in the Consolidated Balance Sheets. The financial results of the Cody API business for the three and six months ended December 31, 2021 and 2020 were not material to the Company’s Consolidated Statements of Operations.
Silarx Pharmaceuticals, Inc. Facility in Carmel, New York
In November 2021, the Company announced the 2021 Restructuring Plan, which includes consolidating its manufacturing footprint by transferring certain liquid drug production from its Silarx Pharmaceuticals, Inc. (“Silarx”) facility in Carmel, New York to the Company’s main plant in Seymour, Indiana. Following the transition, which is expected to take 12 to 18 months, the Company intends to shut down operations at the Silarx facility. The Company is also currently pursuing the sale of the facility, which is anticipated to occur within one year and may result in accelerated timing for the shutdown of operations at Silarx. As such, the facility and certain equipment identified for sale are considered held for sale as of December 31, 2021. The Company subsequently performed a fair value analysis which resulted in an $8.4 million impairment charge of the Silarx facility and certain equipment at the facility in the second quarter of Fiscal 2022. As of December 31, 2021, the facility and equipment identified for sale, totaling $10.5 million, was recorded in the assets held for sale caption in the Consolidated Balance Sheet.
36
The following table summarizes the financial results of the Cody API business for the three and nine months ended March 31, 2021 and 2020:
| | | | | | | | | | | | | |
| | Three Months Ended | | Nine Months Ended | | ||||||||
| | March 31, | | March 31, | | ||||||||
(In thousands) |
| 2021 |
| 2020 |
| 2021 |
| 2020 | | ||||
Net sales | | $ | — | | $ | — | | $ | — | | $ | 1,607 | |
Pretax loss attributable to Cody API business | |
| (110) | | | (1,279) | |
| (727) | | | (6,340) | |
The pretax loss attributable to the Cody API business during the nine months ended March 31, 2020 includes a full impairment of a $1.2 million ROU lease asset that was recorded upon adoption of ASU No. 2016-02 on July 1, 2019.
Note 20.21. Subsequent Events
On April 22, 2021,January 31, 2022, the Company issued $350.0completed the sale of certain real estate associated with the former Cody API business for total consideration of $2.2 million, aggregate principal amount of 7.750% senior secured notes due 2026 (the “Notes”) in a private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”)after fees and outside the United States to persons other than U.S. persons in reliance upon Regulation S under the Securities Act.selling costs. The Notes will pay interest semi-annually in arrears on April 15 and October 15 of each year, beginning on October 15, 2021, at a rate of 7.750% per annum in cash. The Notes will mature on April 15, 2026, unless earlier redeemed or repurchased in accordance with their terms. The Notes will be secured by first priority liens on substantially allcarrying value of the real estate was included within the assets ofheld for sale caption in the Company and the guarantors, other than working capital assets pledged to secure the Company’s asset-based credit facility, as to which the Notes will be secured on a second lien basis.
On April 5, 2021, the Company entered into an Exchange Agreement with certain Participating Lenders to exchange a portion of their existing Term B Loans for Second Lien Loans pursuant to a new $190.0 million Second Lien Secured Loan Facility (“Second Lien Facility”). On April 22, 2021, in connection with the issuance of the Notes and the entrance into the Amended ABL Facility, which is discussed further below, the exchange between the Company and the Participating Lenders was consummated. From the Closing Date until the 1-year anniversary of the Closing Date, the Second Lien Loans will pay 10% paid-in-kind interest. Thereafter, the Second Lien notes will pay 5% cash interest and 5% paid-in-kind interest until maturity. The Second Lien Loans will mature on July 15, 2026. In connection with the Second Lien Facility, the Company issued to the Participating Lenders warrants to purchase up to 8,280,000 shares of common stock of the Company (the “Warrants”) at an exercise price of $6.88 per share. The Warrants will have a term of 8 years from issuance and the Participating Lenders will receive registration rights with respect to the shares of common stock of the Company to be received upon exercise of the Warrants.
In addition to the Notes Offering and the Second Lien Facility, the Company entered into an amendment (the “Amended ABL Credit Agreement”) to that certain Credit and Guaranty Agreement, datedConsolidated Balance Sheets as of December 7, 2020, among the Company, certain of its wholly-owned domestic subsidiaries party thereto, as borrowers or as guarantors, Wells Fargo Bank, National Association, as administrative agent and as collateral agent and the other lenders party thereto, for the purpose of, among other things, increasing the aggregate amount of the revolving credit facility to $45.0 million and extending the maturity thereof to the fifth anniversary of the closing date of Notes Offering (subject to a springing maturity as set forth therein.
The Company used the net proceeds of the Notes Offering and Second Lien Facility, in addition to cash on hand, to pay off the existing Term Loan B Facility in full and pay certain fees and expenses related to the transactions.31, 2021.
3736
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, 2020.2021. All references to “Fiscal 2021” or “Fiscal Year 2021”2022” shall mean the fiscal year ending June 30, 20212022 and all references to “Fiscal 2020” or “Fiscal Year 2020”2021” shall mean the fiscal year ended June 30, 2020.2021.
Company Overview
Lannett Company, Inc. (a Delaware corporation) and its subsidiaries (collectively, the “Company”, “Lannett”,“Company,” “Lannett,” “we” or “us”) primarily develop, manufacture, package, market and distribute solid oral and extended release (tablets and capsules), topical, liquids, nasal and oral solution finished dosage forms of drugs, generic forms of both small molecule and biologic medications, that address a wide range of therapeutic areas. Certain of these products are manufactured by others and distributed by the Company. Additionally, the Company is pursuing partnerships, research contracts and internal expansion for the development and production of other dosage forms including: ophthalmic, nasal, patch, foam, buccal, sublingual, suspensions, soft gel, injectable and oral dosages.
The Company operates pharmaceutical manufacturing plants in Carmel, New York and Seymour, Indiana. The Company’s customers include generic pharmaceutical distributors, drug wholesalers, chain drug stores, private label distributors, mail-order pharmacies, other pharmaceutical manufacturers, managed care organizations, hospital buying groups, governmental entities and health maintenance organizations.
Impact of COVID-19 Pandemic
In December 2019,response to the COVID-19 virus emerged in Wuhan, China and spread to other parts ofpandemic, 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,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 and visitors entering its facilities. 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 or completion of published quarantine periods. 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. The Company has experienced an increase in absenteeism arising from intermittent spikes 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 linger due to variants or limited vaccine supplies,other causes, there is an ongoinga continuing 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 ongoing 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, subsequentSubsequent 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. Recently, however, prescription volumes have begun to increase back to pre-pandemic levels.
As a result of the pandemic, certain clinical trials which were underway or scheduled to begin were temporarily placed on hold, although all such clinical trials were resumed and have been completed. Such delays impacted 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.
In light of the economic impacts of COVID-19, the Company reviewed the assets on our Consolidated Balance Sheet as of MarchDecember 31, 2021, including intangible and other long-lived assets. Based on our review, the Company determined that no impairments or other write-downs specifically related to COVID-19 were necessary during the first ninesix months of Fiscal Year2022 and during Fiscal 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.
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.
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2020 Restructuring PlanClimate Change
On July 10, 2020, the Board of Directors authorized a restructuring and cost savings plan (the “2020 Restructuring Plan”) to enhance manufacturing efficiencies, streamline operations and reduce the Company’s cost 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 lowering operating costs and reducing the workforce by approximately 80 positions. The 2020 Restructuring Plan was initiated on July 13, 2020 and completed as of December 31, 2020.
The Company believes in a more sustainable future with a reduced environmental footprint, effective use of natural resources and a multi-pronged approach to reducing our effect on the climate while maintaining our focus on providing affordable medicines to our customers and ultimately the patients who depend on them. Commitment to this belief, however, may come at increased costs to the Company including, but not limited to, capital investments, additional management and compliance costs, and reduced output, all of which may be material. Costs incurred approximately $4.0 millionby our suppliers and vendors to comply with their own sustainability commitments may also be passed through the supply chain resulting in severance-relatedhigher operational costs to the Company. Climate change and the associated risks continues to evolve over time and could materially impact the Company’s results of operations and cash flows in the first nine months of Fiscal 2021, in connection with the 2020 Restructuring Plan.any given year. The Company expects the 2020 Restructuring Planmonitors such changes and strives to resultaddress these risks in annual cost savings in excess of $15.0 million.a timely manner.
Financial Summary
For the third quarter of Fiscal Year 2021, net sales decreased to $112.4 million as compared to $144.4 million in the same prior-year period. Gross profit decreased to $26.5 million compared to $41.7 million in the prior-year period and gross profit percentage decreased to 24% compared to 29% in the prior-year period. R&D expenses decreased 20% to $6.0 million compared to $7.4 million in the third quarter of Fiscal Year 2020 while SG&A expenses decreased 20% to $17.6 million from $22.1 million. Operating income for the third quarter of Fiscal Year 2021 was $2.8 million compared to operating loss of $2.1 million in the third quarter of Fiscal Year 2020, which included an asset impairment charge totaling $14.0 million. Net loss for the third quarter of Fiscal Year 2021 was $7.1 million, or $(0.18) per diluted share. Comparatively, net loss in the prior-year period was $16.6 million, or $(0.43) per diluted share.
For the first nine months of Fiscal 2021, net sales decreased to $372.8 million compared to $407.8 million in the same prior-year period. Gross profit decreased to $52.9 million compared to $125.6 million in the prior-year period. Gross profit percentage decreased to 14% compared to 31% in the prior-year period. R&D expenses decreased 22% to $18.2 million compared to $23.3 million in the first nine months of Fiscal 2020 while SG&A expenses decreased 24% to $46.5 million from $60.9 million in the prior-year period. Restructuring expenses increased to $4.0 million from $1.8 million in the prior-year period. Operating loss for the first nine months of Fiscal 2021, which included intangible asset impairment charges totaling $198.0 million, was $213.8 million compared to operating income of $24.1 million in the prior-year period, which included asset impairment charges totaling $15.6 million. Net loss for the first nine months of Fiscal 2021 was $185.6 million, or $(4.72) per diluted share compared to net loss of $23.7 million, or $(0.61) per diluted share in the prior-year period.
A more detailed discussion of the Company’s financial results can be found below.
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Results of Operations - Three months ended MarchDecember 31, 2021 compared with the three months ended MarchDecember 31, 2020
Net sales decreased 22%35% to $112.4$86.5 million for the three months ended MarchDecember 31, 2021. The table below identifies the Company’s net product sales by medical indication for the three months ended MarchDecember 31, 2021 and 2020.
| | | | | | | | | | | | |
(In thousands) | | Three Months Ended March 31, | | December 31, | ||||||||
Medical Indication |
| 2021 |
| 2020 |
| 2021 |
| 2020 | ||||
Analgesic | | $ | 3,836 | | $ | 2,811 | | $ | 3,919 | | $ | 3,572 |
Anti-Psychosis | |
| 11,678 | |
| 27,858 | |
| 2,095 | |
| 13,317 |
Cardiovascular | |
| 16,573 | |
| 21,746 | |
| 9,753 | |
| 16,336 |
Central Nervous System | |
| 24,509 | |
| 18,566 | |
| 22,340 | |
| 24,614 |
Endocrinology | | | 6,822 | | | — | | | 8,297 | | | 9,496 |
Gastrointestinal | |
| 16,817 | |
| 20,745 | |
| 14,023 | |
| 18,575 |
Infectious Disease | | | 10,610 | | | 21,749 | | | 6,520 | | | 23,044 |
Migraine | |
| 5,169 | |
| 12,886 | |
| 4,446 | |
| 6,083 |
Respiratory/Allergy/Cough/Cold | |
| 2,548 | |
| 2,966 | |
| 1,868 | |
| 2,267 |
Urinary | |
| 1,566 | |
| 1,149 | |
| 1,164 | |
| 1,361 |
Other | |
| 8,617 | |
| 8,051 | |
| 9,111 | |
| 8,410 |
Contract manufacturing revenue | |
| 3,625 | |
| 5,845 | |
| 2,972 | |
| 6,845 |
Total net sales | | $ | 112,370 | | $ | 144,372 | | $ | 86,508 | | $ | 133,920 |
The decrease in net sales was driven by a decrease in the selling price of products of $18.5$24.0 million and a decrease in volumesvolume of $13.5$23.4 million. The decrease in the selling price of products was primarily driven by lower sales prices of Posaconazole, which is included within the Infectious Disease medical indication, Levothyroxine Tablets and Capsules, which are included in the Endocrinology medical indication, Fluphenazine, which is included within the Anti-Psychosis medical indication and Posaconazole,Dexmethylphenidate, which is included within the Infectious DiseaseCentral Nervous System medical indication, due to new competitors enteringindication. The pressure on sales prices across our portfolio is a reflection of the market.competitive environment in the generic drug industry. Overall volumes, decreased primarily due to lowerparticularly volumes of Posaconazole, Fluphenazine and Sumatriptan,Verapamil, which is included within the MigraineCardiovascular medical indication, partially offsetwere also negatively impacted by the launch of Levothyroxine Tablets and Capsules, which are included within the Endocrinology medical indication.competitive environment.
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 $3.7$3.2 million and $9.3$4.6 million during the three months ended MarchDecember 31, 2021 and 2020, respectively.
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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 | | 33 | % | 3 | % | | 32 | % | (22) | % |
Anti-Psychosis |
| (28) | % | (30) | % |
| (50) | % | (34) | % |
Cardiovascular |
| (25) | % | 1 | % |
| (30) | % | (10) | % |
Central Nervous System |
| 29 | % | 3 | % |
| 3 | % | (12) | % |
Endocrinology | | 100 | % | — | % | | 17 | % | (30) | % |
Gastrointestinal |
| (11) | % | (8) | % |
| (11) | % | (14) | % |
Infectious Disease | | (17) | % | (34) | % | | (37) | % | (35) | % |
Migraine |
| (43) | % | (17) | % |
| (21) | % | (6) | % |
Respiratory/Allergy/Cough/Cold |
| (8) | % | (6) | % |
| 26 | % | (44) | % |
Urinary |
| 27 | % | 9 | % |
| (8) | % | (6) | % |
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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) | | March 31, | | March 31, | | December 31, | | December 31, | ||||
Customer Distribution Channel |
| 2021 |
| 2020 |
| 2021 |
| 2020 | ||||
Wholesaler/Distributor | | $ | 94,016 | | $ | 116,025 | | $ | 65,682 | | $ | 108,115 |
Retail Chain | |
| 12,226 | |
| 18,951 | |
| 15,209 | |
| 16,217 |
Mail-Order Pharmacy | |
| 2,503 | |
| 3,551 | |
| 2,645 | |
| 2,743 |
Contract manufacturing revenue | |
| 3,625 | |
| 5,845 | |
| 2,972 | |
| 6,845 |
Total net sales | | $ | 112,370 | | $ | 144,372 | | $ | 86,508 | | $ | 133,920 |
The overall decrease in sales was primarily driven by lower sales of Fluphenazine and Posaconazolecertain key products due to new competitors entering the market. The Company has also seen increased competitive market partiallypressure among the existing competitor base in recent years, which has resulted in overall decrease in sales to the distribution channels above. We will continue to seek opportunities for additional launches to offset by sales from new product launches.these competitive pressures.
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Cocaine Hydrochloride Solution
In December 2017, a competitor received approval from the FDA to market and sell a Cocaine Hydrochloridecocaine hydrochloride topical product. The approval affectedIn March 2018, in accordance with FDA guidance, the Company’s right to marketFDA requested that the Company cease manufacturing and selldistributing its unapproved cocaine hydrochloride solution product. Accordingproduct due 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 ofthere being an approved product on the market, themarket. The Company committed to not manufacturemanufacturing or distributedistributing 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 series of Citizen Petition withPetitions beginning in 2019, seeking to block approval of the FDA in February 2019,Company’s Section 505(b)(2) NDA for its cocaine hydrochloride solution product by claiming that the grant of the New Chemical Entity (“NCE”) exclusivity issued to the competitor blocks the approval of the Company’s application for five yearsyears. Following the FDA’s rejection of the competitor’s argument and requesting that the FDA refuse to accept any further submissions in furtheranceapproval of the Company’s Section 505(b)(2) NDA, application, treat as withdrawn any submissions made by the Company after December 2017competitor filed two lawsuits against the FDA (one in federal court in the District of Columbia and one in federal court in the District of Maryland) seeking a court order in two different federal courts directing the FDA to withdraw approval of 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 March 18, 2021, the FDA filed a status report with the Court re-affirming the Company’s 505(b)(2) approval and on March 26, 2021 the Court vacated the earlier order that had vacated the Company’s approval. On April 5, 2021, the competitor filed an amended complaint seeking to requireTo date, neither court has directed the FDA to withdraw the Company’s 505(b)(2) approvalNDA. The Company has intervened in both lawsuits and on April 12, 2021, the competitor filed a motion for summary judgment. The FDA and Company’s opposition andthere are currently cross motionmotions for summary judgment werepending in the case filed on April 30, 2021.
in federal court for the District of Columbia and a motion to dismiss the complaint filed in the federal court for the District of Maryland.
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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,Separately, on January 15, 2021, both the Company and the FDA filed separate motions to dismiss the second lawsuit.
On June 6, 2020, the competitor filed a patent infringement complaint, since amended, in the United States District Court for the District of Delaware, asserting that the Company’s approved cocaine hydrochloride product infringes threesix patents issued to the competitor. On June 19, 2020, theThe Company filed an answer and counterclaim, alleging that the Company either does not infringe or that the threesix asserted patents are invalid. In addition, the Company sought a declaration that, as to the competitor’sand three additional unasserted patents not asserted against the Company, they are either not infringed or invalid. The competitor filed a motion to partially dismiss a portion of the counterclaim as to the unasserted patents.
On August 16, 2021, the Company and the Company filed a responsecompetitor reached an agreement in oppositionprinciple to amicably resolve all pending cases, including the motion.cases in the federal courts in the District of Columbia, District of Maryland and District of Delaware. The competitor subsequently filed an amended complaint asserting additional patentsparties executed settlement documents on October 15, 2021 and all cases against the Company. The Company is in the process of filing an answer and counterclaim, asserting, among other things, that the patents are invalid.have been dismissed with prejudice. The Company continues to market its approved cocaine hydrochloride solution 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. On March 26, 2021, the Company received a third Major CRL from the FDA relating to continuing issues with the API supplier. The Company is working on addressing the FDA comments and cannot reasonably predict timing of the product launch.
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.
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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. Similar complaints were filed in state court in New Mexico and state court in Maryland and served upon the Company. Subsequently, a number of similar complaints were served 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. The plaintiffs filed an amended complaint on February 9, 2021, and the Company along with the other generic defendants recently filed a joint motion to dismiss these claims. 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. These motions were recently granted and the case has been transferred back to state court in New Mexico. The plaintiffs filed their First Amended Complaint on April 16, 2021 and defendants will have 30 days thereafter to file substantive and jurisdictional motions to dismiss. Since the Company was not licensed to do business in New Mexico and, based upon the information received to date, did not sell Ranitidine in New Mexico, we plan to join both arguments. 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.
Cost of Sales, including amortization of intangibles. Cost of sales, including amortization of intangibles, for the thirdsecond quarter of Fiscal Year 20212022 decreased 16%39% to $85.9$80.8 million from $102.7$133.1 million in the same prior-year period. The Company has experienced increased competitive market pressure in recent years, which has resulted in overall decrease was primarily attributablein sales volumes and, therefore, lower cost of sales in the current period. A decrease in amortization of intangibles as a result of intangible asset impairment charges incurred in Fiscal 2021 also contributed to lower volumes due tocost of sales in the Company’s decision to discontinue lower margin productssecond quarter of Fiscal 2022. In addition, in the second quarter of Fiscal Year 2021, partially offset by additional volumes from newthe Company recorded $17.2 million in write-downs for excess and obsolete inventory as a result of the decision to discontinue 23 lower margin product launches. Product royalties expense includedlines as well as $5.0 million in consideration to renew the Company’s distribution agreement with Recro Gainesville, LLC (“Recro”), which resulted in increased cost of sales totaled $12.6 million forin the third quarter of Fiscal Year 2021 and $21.4 million for the third quarter of Fiscal Year 2020 primarily attributable to lower sales of Posaconazole. Amortization expense included in cost of sales totaled $3.9 million for the third quarter of Fiscal 2021 and $8.3 million for the third quarter of Fiscal 2020.prior-year period.
Gross Profit. Gross profit for the thirdsecond quarter of Fiscal 2021 decreased 37%2022 increased 637% to $26.5$5.7 million or 24%7% of net sales. In comparison, gross profit for the thirdsecond quarter of Fiscal 20202021 was $41.7$0.8 million or 29%1% of net sales. The decreaseincrease in gross profit percentage was primarily attributabledue to lower volumes of Fluphenazine, which had higher than average gross profit margins,a $17.2 million write-down for excess and obsolete inventory as well as overall lower average$5.0 million in consideration to renew the Company’s distribution agreement with Recro Gainesville, LLC (“Recro”) recorded in the second quarter of Fiscal 2021. The increase was partially offset by decreases in the selling prices of our products.products due to increased competitive pressure.
Research and Development Expenses. Research and development expenses for the thirdsecond quarter of Fiscal 20212022 decreased 20%16% to $6.0$4.7 million from $7.4$5.6 million in Fiscal Year 2020.2021. The decrease was primarily due to lower R&D expenses as a result ofthe timing of certain milestonesspend related to product development projects.
Selling, General and Administrative Expenses. Selling, general and administrative expenses decreased 20%increased 37% to $17.6$18.8 million in the thirdsecond quarter of Fiscal Year 20212022 compared with $22.1$13.7 million in Fiscal Year 2020.2021. The decreaseincrease was primarily driven by higher expenses related to the reimbursement of legal costs associated with a lower branded prescription drug fee, lower incentive-based compensation and other cost reduction initiatives, partially offset by higher legal expenses.distribution agreement.
Asset impairment charges.In the third quarter of Fiscal 2020,November 2021, the Company announced the 2021 Restructuring Plan, which includes the phase out of two low-margin prescription products at Kremers Urban Pharmaceuticals, Inc. Based on the impairment analysis performed as a result of this decision and continued competitive pressures in the market, the Company recorded an impairment analysischarge of its AB-rated Methylphenidate Hydrochloride$40.6 million related to the KUPI product whichrights intangible assets. The impairment charge is distributed under a license agreement with Andor Pharmaceuticals, LLC (“Andor”), due to significant declines in the projected profitability of the distribution arrangement. Asprimarily a result of the analysis,decline in net sales and gross margin of certain product lines acquired in connection with the KUPI acquisition.
The 2021 Restructuring Plan also includes consolidating the Company’s manufacturing footprint by transferring certain liquid drug production from its Silarx Pharmaceuticals, Inc. (“Silarx”) facility in Carmel, New York to the Company’s main plant in Seymour, Indiana. Following the transition, which is expected to take 12 to 18 months, the Company recordedintends to shut down operations at the Silarx facility. The Company performed a $14.0fair value analysis to adjust the carrying value of the facility and certain equipment identified for sale to the fair value, which resulted in an $8.4 million impairment charge.
In November 2021, the Company entered into an agreement for the sale of real estate associated with the Cody API business. The Company adjusted the carrying value to fair value based on the signed agreement and estimated proceeds of the sale, which resulted in a $0.5 million impairment charge.
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Other Loss. Interest expense for the three months ended MarchDecember 31, 2021 totaled $12.6$14.4 million compared to $16.2$13.5 million for the three months ended MarchDecember 31, 2020. The decrease was due to a lower average debt balance in the third quarter 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 balance. The weighted average interest rate for the thirdsecond quarter of Fiscal 2022 and 2021 was 8.9% and 2020 was 7.9% and 8.6%7.8%, respectively.
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Table Interest expense was higher for the three months ended December 31, 2021 as a result of Contentsthe higher weighted-average interest rate, which is attributable to higher interest rates on the Notes and the Second Lien Facility discussed further below.
Income Tax. The Company recorded an income tax benefit of $2.5$1.4 million in the thirdsecond quarter of Fiscal Year 20212022 as compared to an income tax benefit of $1.7$58.1 million in the thirdsecond quarter of Fiscal Year 2020.2021. The effective tax rate for the three months ended MarchDecember 31, 2021 was 26.3%1.7%, compared to 9.1%25.2% for the three months ended MarchDecember 31, 2020. The effective tax rate for the three months ended MarchDecember 31, 2021 was higherlower compared to the three months ended MarchDecember 31, 2020 primarily due to the relative impact of excess tax shortfalls related to stock compensation as well as a non-deductible branded prescription drug feevaluation allowance recorded in the three months ended March 31, 2021 as compared to the three months ended March 31, 2020.Fiscal 2021.
Net Loss. For the three months ended MarchDecember 31, 2021, the Company reported net loss of $7.1$81.1 million, or $(0.18)$(2.01) per diluted share. Comparatively, net loss in the corresponding prior-year period was $16.6$171.9 million, or $(0.43)$(4.36) per diluted share.
Results of Operations - NineSix months ended MarchDecember 31, 2021 compared with the ninesix months ended MarchDecember 31, 2020
Net sales decreased to $372.8$188.0 million for the ninesix months ended MarchDecember 31, 2021. The table below identifies the Company's net product sales by medical indication for the ninesix months ended MarchDecember 31, 2021 and 2020.
| | | | | | |
(In thousands) | | Nine Months Ended March 31, | ||||
Medical Indication |
| 2021 |
| 2020 | ||
Analgesic | | $ | 10,528 | | $ | 6,806 |
Anti-Psychosis | |
| 38,023 | |
| 78,588 |
Cardiovascular | |
| 52,623 | |
| 67,325 |
Central Nervous System | |
| 71,648 | |
| 57,154 |
Endocrinology | |
| 19,551 | |
| — |
Gastrointestinal | |
| 52,492 | |
| 56,020 |
Infectious Disease | |
| 55,586 | |
| 51,722 |
Migraine | |
| 20,942 | |
| 32,907 |
Respiratory/Allergy/Cough/Cold | |
| 6,241 | |
| 8,747 |
Urinary | |
| 4,385 | |
| 2,817 |
Other | |
| 24,661 | |
| 27,847 |
Contract manufacturing revenue | |
| 16,089 | |
| 17,891 |
Total net sales | | $ | 372,769 | | $ | 407,824 |
| | | | | | |
(In thousands) | | December 31, | ||||
Medical Indication |
| 2021 |
| 2020 | ||
Analgesic | | $ | 9,233 | | $ | 6,692 |
Anti-Psychosis | |
| 5,810 | |
| 26,345 |
Cardiovascular | |
| 23,853 | |
| 36,050 |
Central Nervous System | |
| 45,125 | |
| 47,139 |
Endocrinology | |
| 16,142 | |
| 12,729 |
Gastrointestinal | |
| 29,263 | |
| 35,675 |
Infectious Disease | |
| 19,035 | |
| 44,976 |
Migraine | |
| 9,131 | |
| 15,773 |
Respiratory/Allergy/Cough/Cold | |
| 4,982 | |
| 3,693 |
Urinary | |
| 2,340 | |
| 2,819 |
Other | |
| 18,287 | |
| 16,044 |
Contract manufacturing revenue | |
| 4,832 | |
| 12,464 |
Total net sales | | $ | 188,033 | | $ | 260,399 |
The decrease in net sales was driven by a decrease in the selling price of products of $64.8$48.6 million partially offset by increased volumesand a decrease in volume of $29.7$23.8 million. The decrease in the selling price of products was primarily driven by lower sales prices of Posaconazole, Levothyroxine Tablets and Capsules, Fluphenazine and Dexmethylphenidate. The pressure on sales prices across our portfolio is a reflection of the competitive environment in the generic drug industry. Overall volumes, particularly volumes of Posaconazole, Fluphenazine, Verapamil and Sumatriptan, which is included within the Anti-PsychosisMigraine medical indication and Posaconazole, which is included in Infectious Disease medical indication, due to new competitors entering, were also negatively impacted by the market, as well as lower average selling price acrosscompetitive environment; however, the remaining medical indications. Overall volumes increased primarily due topressure was partially offset by increased volumes of Posaconazole and fromrelated to certain new product launches includingsuch as Levothyroxine Tablets and Capsules, partially offset by lower volumes of Fluphenazine.Capsules.
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 $12.6$6.8 million and $31.9$8.9 million during the ninesix months ended MarchDecember 31, 2021 and 2020, respectively.
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The following chart details price and volume changes by medical indication:
| | | | | |
| | Sales volume | | Sales price | |
Medical indication |
| change % |
| change % | |
Analgesic |
| 60 | % | (5) | % |
Anti-Psychosis |
| (25) | % | (27) | % |
Cardiovascular |
| (13) | % | (9) | % |
Central Nervous System |
| 49 | % | (24) | % |
Endocrinology | | 100 | % | — | % |
Gastrointestinal |
| 2 | % | (8) | % |
Infectious Disease | | 26 | % | (19) | % |
Migraine | | (13) | % | (23) | % |
Respiratory/Allergy/Cough/Cold | | (25) | % | (4) | % |
Urinary |
| 39 | % | 17 | % |
| | | | | |
| | Sales volume | | Sales price | |
Medical indication |
| change % |
| change % | |
Analgesic |
| 58 | % | (20) | % |
Anti-Psychosis |
| (44) | % | (34) | % |
Cardiovascular |
| (23) | % | (11) | % |
Central Nervous System |
| 2 | % | (6) | % |
Endocrinology | | 99 | % | (72) | % |
Gastrointestinal |
| (7) | % | (11) | % |
Infectious Disease | | (19) | % | (39) | % |
Migraine | | (29) | % | (13) | % |
Respiratory/Allergy/Cough/Cold | | 56 | % | (21) | % |
Urinary |
| (4) | % | (13) | % |
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 ninesix months ended:
| | | | | | |
(In thousands) | | March 31, | | March 31, | ||
Customer Distribution Channel |
| 2021 |
| 2020 | ||
Wholesaler/Distributor | | $ | 302,711 | | $ | 321,953 |
Retail Chain | |
| 45,588 | |
| 59,132 |
Mail-Order Pharmacy | |
| 8,381 | |
| 8,848 |
Contract manufacturing revenue | |
| 16,089 | |
| 17,891 |
Total net sales | | $ | 372,769 | | $ | 407,824 |
| | | | | | |
(In thousands) | | December 31, | | December 31, | ||
Customer Distribution Channel |
| 2021 |
| 2020 | ||
Wholesaler/Distributor | | $ | 150,526 | | $ | 208,695 |
Retail Chain | |
| 27,935 | |
| 33,362 |
Mail-Order Pharmacy | |
| 4,740 | |
| 5,878 |
Contract manufacturing revenue | |
| 4,832 | |
| 12,464 |
Total net sales | | $ | 188,033 | | $ | 260,399 |
The overall decrease in sales was primarily driven by lower sales of Fluphenazine and Posaconazolecertain key products due to new competitors entering the market. The Company has also seen increased competitive market partiallypressure among the existing competitor base in recent years, which has resulted in overall decrease in sales to the distribution channels above. We will continue to seek opportunities for additional launches to offset by sales from new product launches.these competitive pressures.
Cost of Sales, including amortization of intangibles. Cost of sales, including amortization of intangibles, for the first ninesix months of Fiscal Year 2021 increased 13%2022 decreased 29% to $319.8$165.8 million from $282.2$233.9 million in the same prior-year period. Product royalties expense included in cost of sales totaled $22.6 million for the first six months of Fiscal Year 2022 and $37.0 million for the first six months of Fiscal Year 2021. Amortization expense included in cost of sales totaled $7.8 million for the first six months of Fiscal 2022 and $17.2 million for the first six months of Fiscal 2021. The increase was primarily attributableCompany has experienced increased competitive market pressure in recent years, which has resulted in overall decrease in sales volumes and, therefore, lower cost of sales in the current period. A decrease in amortization of intangibles as a result of intangible asset impairment charges incurred in Fiscal 2021 also contributed to additional volumes from new product launches as well as an increaselower cost of $15.1sales in the first six months of Fiscal 2022. In addition, in the second quarter of Fiscal Year 2021, the Company recorded $17.2 million in write-downs for excess and obsolete inventory which primarily relates toas a result of the Company’s decision to discontinue 23 lower margin product lines. The Company also recordedlines as well as $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, which resulted in increased cost of sales totaled $49.6 million forin the first nine months of Fiscal Year 2021 and $57.7 million for the first nine months of Fiscal Year 2020. Amortization expense included in cost of sales totaled $21.1 million for the first nine months of Fiscal 2021 and $23.5 million for the first nine months of Fiscal 2020.prior-year period.
Gross Profit. Gross profit for the first ninesix months of Fiscal 20212022 decreased 58%16% to $52.9$22.2 million or 14%12% of net sales. In comparison, gross profit for the first ninesix months of Fiscal 20202021 was $125.6$26.5 million or 31%10% of net sales. The decreaseincrease in gross profit percentage was primarily attributable to lower volumesa result of Fluphenazine, which had higher than average gross profit margins, as well as overall lower average selling pricescost of our products. The Company also recorded an increasesales in the prior period. In the second quarter of Fiscal Year 2021, the Company recorded $17.2 million in write-downs for excess and obsolete inventory as a result of the decision to discontinue 23 lower margin product lines as well as $5.0 million in consideration to renew the Company’s distribution agreement with Recro Gainesville, LLC (“Recro”), which resulted in a lower gross profit percentage in the second quarterprior-year period. The increase was partially offset by decreases in the selling prices of Fiscal 2021.our products due to increased competitive pressure.
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Research and Development Expenses. Research and development expenses for the first ninesix months of Fiscal 20212022 decreased 22%14% to $18.2$10.5 million from $23.3$12.2 million in Fiscal Year 2020.2021. The decrease was primarily due to lower R&D expenses as a result ofthe timing of certain milestonesspend related to product development projects as well as employee headcount reductions related to the 2020 Restructuring Plan.projects.
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Selling, General and Administrative Expenses. Selling, general and administrative expenses decreased 24%increased 31% to $46.5$37.7 million in the first ninesix months of Fiscal Year 20212022 compared with $60.9$28.9 million in Fiscal Year 2020.2021. The decreaseincrease was primarily driven by higher expenses related to the reimbursement of legal costs associated with a lower branded prescription drug fee, lower incentive-based compensation, lower expenses atdistribution agreement as well as a non-income tax credit received in the Company’s Cody Labs subsidiary and other cost reduction initiatives.first quarter of Fiscal 2021.
Asset impairment charges.In December 2020,November 2021, 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.Asannounced the 2021 Restructuring Plan, which includes the phase out of two low-margin prescription products at Kremers Urban Pharmaceuticals, Inc. Based on the impairment analysis performed as a result of this decision and continued competitive pressures in the discontinuance and the reduction in net sales and gross margin of certain other product lines,market, the Company recorded an impairment charge of $193.0$40.6 million related to the KUPI product rights intangible assets during the second quarter of Fiscal 2021.assets. 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.acquisition.
The 2021 Restructuring Plan also includes consolidating the Company’s manufacturing footprint by transferring certain liquid drug production from its Silarx Pharmaceuticals, Inc. (“Silarx”) facility in Carmel, New York to the Company’s main plant in Seymour, Indiana. Following the transition, which is expected to take 12 to 18 months, the Company intends to shut down operations at the Silarx facility. The Company performed a fair value analysis to adjust the carrying value of the facility and certain equipment identified for sale to the fair value, which resulted in an $8.4 million impairment charge.
In the second quarter of FiscalNovember 2021, the Company also recordedentered into an agreement for the sale of real estate associated with the Cody API business. The Company adjusted the carrying value to fair value based on the signed agreement and estimated proceeds of the sale, which resulted in a $5.0$0.5 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 the first nine months of Fiscal 2020, the Company recorded a ROU lease asset totaling $1.2 million related to an existing lease at Cody Labs upon adoption of ASU No. 2016-02. The Company subsequently recorded a full impairment of the asset as a result of the decision to cease operations at Cody Labs.
In the third quarter of Fiscal 2020, the Company performed an impairment analysis of its AB-rated Methylphenidate Hydrochloride product, which is distributed under a license agreement with Andor, due to significant declines in the projected profitability of the distribution arrangement. As a result of the analysis, the Company recorded a $14.0 million impairment charge.
Other Loss.Income (Loss). Interest expense for the ninesix months ended MarchDecember 31, 2021 totaled $40.6$28.7 million compared to $52.2$28.0 million for the ninesix months ended MarchDecember 31, 2020. The decrease was due to a lower average debt balance was lower in the first ninesix months of Fiscal 20212022 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.A in November 2020. However, the interest expense was consistent between the two periods as a result of the higher weighted-average interest rate, which is attributable to higher interest rates on the Notes and the Second Lien Facility discussed further below. The weighted average interest rate for the first ninesix months of Fiscal 2022 and 2021 was 8.9% and 2020 was 7.9% and 9.0%, respectively.
Income Tax. The Company recorded an income tax benefit of $68.6$1.4 million in the first ninesix months of Fiscal Year 20212022 as compared to an income tax benefit of $5.2$66.1 million in the first ninesix months of Fiscal Year 2020.2021. The effective tax rate for the ninesix months ended MarchDecember 31, 2021 was 27.0%1.4%, compared to 18.0%27.0% for the ninesix months ended MarchDecember 31, 2020. The effective tax rate for the ninesix months ended MarchDecember 31, 2021 was higherlower compared to the ninesix months ended MarchDecember 31, 20202021 primarily due to the impact of the CARES Act, which increased the interest expense deductibility limitationvaluation allowance recorded 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 impact of excess tax shortfalls related to stock compensation as well as a non-deductible branded prescription drug fee in the nine months ended March 31, 2020 relative to expected pre-tax loss also contributed to a lower effective tax rate as compared to the nine months ended March 31,Fiscal 2021.
Net Loss. For the ninesix months ended MarchDecember 31, 2021, the Company reported net loss of $185.6$103.4 million, or $(4.72)$(2.58) per diluted share. Comparatively, net loss in the corresponding prior-year period was $23.7$178.4 million, or $(0.61)$(4.55) per diluted share.
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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.has $45.0 million available to draw upon under the Amended ABL Credit Facility, which is discussed further below. At MarchDecember 31, 2021, working capital was $272.8$245.4 million as compared to $228.3$263.1 million at June 30, 2020, an increase2021, a decrease of $44.5$17.7 million. Current product portfolio sales as well as sales related to future product approvals are anticipated to generate positive cash flow from operations.
Net cash provided by operating activities of $34.2$13.8 million for the ninesix months ended MarchDecember 31, 2021 reflected net loss of $185.6$103.4 million, adjustments for non-cash items of $256.9$91.0 million, as well as cash provided by through changes in operating assets and liabilities of $26.2 million. In comparison, net cash used in operating activities of $24.6 million for the six months ended December 31, 2020 reflected net loss of $178.4 million, adjustments for non-cash items of $247.6 million, as well as cash used through changes in operating assets and liabilities of $37.1 million. In comparison, net cash provided by operating activities of $50.4 million for the nine months ended March 31, 2020 reflected net loss of $23.7 million, adjustments for non-cash items of $76.6 million, as well as cash used through changes in operating assets and liabilities of $2.5$93.8 million.
Significant changes in operating assets and liabilities from June 30, 20202021 to MarchDecember 31, 2021 were comprised of:
● | A decrease in accounts receivable of |
● | An increase in rebates payable of $6.2 million mainly due to the timing of payments in Fiscal 2022. |
Significant changes in operating assets and liabilities from June 30, 2020 to December 31, 2020 were comprised of:
● | An increase in accounts receivable of $34.3 million mainly due to the timing of sales and cash receipts. The Company’s days sales outstanding (“DSO”) at |
● | An increase in income taxes receivable totaling |
● | 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. |
● | A decrease in accrued payroll and payroll-related costs of |
Significant changesNet cash used in operatinginvesting activities of $7.9 million for the six months ended December 31, 2021 was mainly the result of purchases of property, plant and equipment of $6.8 million and purchases of intangible assets and liabilities from June 30, 2019 to Marchof $1.5 million. Net cash used in investing activities of $9.1 million for the six months ended December 31, 2020 were comprised of:was mainly the result of purchases of property, plant and equipment of $5.1 million and purchases of intangible assets of $4.0 million.
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Net cash used in investingfinancing activities of $11.0$0.6 million for the ninesix months ended MarchDecember 31, 2021 was mainly the result ofdue to purchases of property, plant and equipment of $6.6 million and purchases of intangible assets of $4.5 million. Net cash used in investing activities of $33.8 million for the nine months ended March 31, 2020 was mainly the result of purchases of intangible assets of $27.8 million and purchases of property, plant and equipment of $13.1treasury stock totaling $0.8 million, partially offset by proceeds from the saleissuance of property, plant and equipmentstock pursuant to stock compensation plans of $7.3$0.2 million.
Net cash used in financing activities of $81.2$71.5 million for the ninesix months ended MarchDecember 31, 20212020 was due to debt repayments of $78.4$68.5 million, payment of debt issuance costs of $2.4 million, and purchases of treasury stock totaling $1.0 million, partially offset by proceeds from issuance of stock pursuant to stock compensation plans of $0.6 million. Net cash used in financing activities of $55.4 million for the nine months ended March 31, 2020 was due to debt repayments of $130.0 million, purchase of a capped call in connection with the 4.50% Convertible Senior Notes offering totaling $7.1 million, payments of debt issuance costs totaling $3.5 million, and purchases of treasury stock totaling $1.9 million, partially offset by proceeds from the issuance of 4.50% Convertible Senior Notes of $86.3 million and proceeds from issuance of stock pursuant to stock compensation plans of $0.8$0.4 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 MarchDecember 31, 2021 are as follows:
Amended7.750% Senior Secured Credit FacilityNotes due 2026
On November 25, 2015, in connection with its acquisition of KUPI, Lannett entered into a credit and guaranty agreement (the “Credit and Guaranty Agreement”) among certain of its wholly-owned domestic subsidiaries, as guarantors, Morgan Stanley Senior Funding, Inc., as administrative agent and collateral agent and other lenders providing for a senior secured credit facility (the “Senior Secured Credit Facility”). The Senior Secured Credit Facility consisted of Term Loan A in an aggregate principal amount of $275.0 million, Term Loan B in an aggregate principal amount of $635.0 million and a revolving credit facility providing for revolving loans in an aggregate principal amount of up to $125.0 million.
On June 17, 2016, Lannett amendedApril 22, 2021, 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 $250.0issued $350.0 million aggregate principal amount of Lannett’s 12.0%7.750% Senior Secured Notes due 20232026 (the “Senior Notes”“Notes”) issuedin a private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”) and outside the United States to persons other than U.S. persons in reliance upon Regulation S under the Securities Act. The Notes bear interest semi-annually in arrears on April 15 and October 15 of each year, beginning on October 15, 2021, at a rate of 7.750% per annum in cash. The Notes will mature on April 15, 2026, unless earlier redeemed or repurchased in accordance with their terms.
Second Lien Secured Loan Facility
On April 5, 2021, the Company entered into an Exchange Agreement with certain participating lenders to exchange a portion of their existing Term B Loans for Second Lien Loans pursuant to a new $190.0 million Second Lien Secured Loan Facility (“Second Lien Facility”). On April 22, 2021, in connection with the KUPI acquisition.
On December 10, 2018,issuance of the Company entered into a third amendment to the Senior Secured Credit FacilityNotes and the Credit and Guaranty Agreement. Pursuant toentrance into the amendment, the Secured Net Leverage Ratio applicable to the financial leverage ratio covenant was increased from 3.25:1.00 to 4.25:1.00 as of December 31, 2019 and prior to September 30, 2020, and then to 4.00:1.00 as of September 30, 2020. The Amended Senior Secured Credit Facility is also subject to a minimum liquidity covenant, which provides that the Company shall not permit its liquidity as of the last day of any fiscal quarter to be less than $75.0 million. On November 25, 2020, the Company repaid the remaining $42 million outstanding balance of its Term A Loans with cash on 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 requiresthe exchange between the Company and the participating lenders was consummated. From the Closing Date until the one-year anniversary of the Closing Date, the Second Lien Loans bear 10.0% PIK interest. Thereafter, the Second Lien notes will bear 5.0% cash interest and 5.0% PIK interest until maturity, except to the extent the Company elects to pay all or portion of the PIK interest in cash. The Second Lien Loans will mature on July 21, 2026. In connection with the Second Lien Facility, the Company issued to the Participating Lenders warrants to purchase up to 8,280,000 shares of common stock of the Company (the “Warrants”) at an exercise price of $6.88 per share. The Warrants were issued on April 22, 2021 with an eight-year term. The Participating Lenders received registration rights with respect to the shares of common stock of the Company to be received upon exercise of the Warrants. The holders of the Warrants are entitled to receive dividends or distributions of any kind made to the common stockholders to the same extent as if the holder had exercised the Warrant into common stock. The Warrants are considered participating securities under ASC 260, Earnings per share.
In connection with the Second Lien Facility, the Company is required to maintain at least $5$5.0 million in a deposit account at all times subject to control by the administrative agent,Second Lien Collateral Agent, and a minimum cash balance of $15$15.0 million as of the last day of each month. At MarchDecember 31, 2021, the Company classified the $5$5.0 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 underassets caption in the Term Loan B Facility.Consolidated Balance Sheet.
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On April 22, 2021, the Company used the net proceeds of the 7.750% Senior Secured Notes offering and Second Lien Secured Loan Facility, in addition to cash on hand, to pay off the existing Term Loan B Facility in full.
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
On December 7, 2020, the Company entered into a credit and guaranty agreement, which providesprovided for an asset-based revolving credit facility (the “ABL Credit Facility”) of up to $30 million, subject to borrowing base availability, and includesincluded 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.
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:
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 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.
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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.
On April 22, 2021, the Company entered into an amendment (the “Amended ABL Credit Agreement”) to that certain Credit and Guaranty Agreement, dated as of December 7, 2020 (such agreement as so amended, the “Amended ABL Credit Agreement”), among the Company, certain of its wholly-owned domestic subsidiaries party thereto, as borrowers or as guarantors, Wells Fargo Bank, National Association, as administrative agent and as collateral agent, and the other lenders party thereto, for the purpose of, among other things, increasing the aggregate amount of the revolving credit facility from $30.0 million to $45.0 million and extending the maturity thereof to the fifth anniversary of the closing date of the offering of the Notes Offering (subject to a springing maturity as set forth therein).
The Amended ABL Credit Agreement provides for a revolving credit facility (the “Amended ABL Credit Facility”) that includes letter of credit and swing line sub-facilities. Borrowing availability under the Amended ABL Credit Facility was undrawnis 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 of March 31, 2021.
7.750% Senior Secured Notes due 2026
On April 22, 2021, the Company issued $350.0 million aggregate principal amount of 7.750% senior secured notes due 2026 (the “Notes”)set forth in a private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”) and outside the United States to persons other than U.S. persons in reliance upon Regulation S under the Securities Act. The Notes will pay interest semi-annually in arrears on April 15 and October 15 of each year, beginning on October 15, 2021, at a rate of 7.750% per annum in cash. The Notes will mature on April 15, 2026, unless earlier redeemed or repurchased in accordance with their terms. The Notes will be secured by first priority liens on substantially all of the assets of the Company and the guarantors, other than working capital assets pledged to secure the Company’s asset-based credit facility, as to which the Notes will be secured on a second lien basis.
Second Lien Secured Loan Facility
On April 5, 2021, the Company entered into an Exchange Agreement with certain Participating Lenders to exchange a portion of their existing Term B Loans for Second Lien Loans pursuant to a new $190.0 million Second Lien Secured Loan Facility (“Second Lien Facility”). On April 22, 2021, in connection with the issuance of the Notes and the entrance into the Amended ABL Credit Agreement. Availability is reduced by issuance of letters of credit as well as any borrowings. Loans outstanding under the Amended ABL Credit Agreement bear interest at a floating rate measured by reference to, at the Company’s option, either an adjusted London Inter-Bank Offered Rate (“LIBOR”) (subject to a floor of 0.75%) plus an applicable margin of 2.50% per annum, or an alternate base rate plus an applicable margin of 1.50% per annum. Unused commitments under the Amended ABL Credit Facility are subject to a fee of 0.50% per annum, which fee increases to 0.75% per annum for any quarter during which the exchange betweenCompany’s average usage under the Company and the Participating Lenders was consummated. From the Closing Date until the 1-year anniversary of the Closing Date, the Second LienAmended ABL Credit Facility will pay 10% paid-in-kind interest. Thereafter, the Second Lien notes will pay 5% cash interest and 5% paid-in-kind interest until maturity. The Second Lien Loans will mature on July 15, 2026. In connection with the Second Lien Facility, the Company issued to the Participating Lenders warrants to purchase up to 8,280,000 shares of common stock of the Company (the “Warrants”) at an exercise price of $6.88 per share. The Warrants will have a term of 8 years from issuance and the Participating Lenders will receive registration rights with respect to the shares of common stock of the Company to be received upon exercise of the Warrants.is less than $5.0 million.
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4.50% Convertible Senior Notes due 2026
On September 27, 2019, the Company issued $86.3 million aggregate principal amount of the 4.50% Convertible Senior Notes (“the Convertible(the “Convertible 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 portionamended. The Convertible Notes are senior unsecured obligations of the outstanding Term Loan A balance. The Convertible NotesCompany and bear interest at an annual rate of 4.50% payable semi-annually in arrears on April 1 and October 1 of each year, beginning on April 1, 2020. The Convertible Notes will mature on October 1, 2026, unless earlier repurchased, redeemed or converted in accordance with their terms. The Convertible 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 Convertible 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 Convertible Notes on or after October 6, 2023 at a redemption price equal to 100% of the principal amount of the Convertible 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 Convertible Notes in connection with such corporate event or notice of redemption. The indenture covering the Convertible 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 Convertible Notes may declare 100% of the principal of, and accrued and unpaid interest on, all the Convertible Notes to be due and payable.
In connection with the offering of the Convertible 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 Convertible 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 Convertible Notes with such reduction subject to a cap which is initially $19.46 per share.
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Other Liquidity Matters
Refer to the “Impact of COVID-19 Pandemic” section above for the impactAlong with executing on our future liquidity.
Future Acquisitions
Weexisting pipeline products, 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. The continued competive pressures on our current portfolio may impact the ultimate success of existing pipeline projects, which may result in the Company exploring alternative opportunities for capital to support the launch of products in the future.
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.Policies and Estimates.” Critical accounting policies and estimates 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”Policies and Estimates”: Revenue Recognition, Inventories, Income Taxes, and Valuation of Long-Lived Assets, including Intangible Assets, In-Process Research and Development and Share-based Compensation.Assets.
Revenue Recognition
The Company complies with Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with CustomCustomersers,, which superseded ASC Topic 605, Revenue Recognition. Under ASC 606, the Company recognizes revenue when (or as) we satisfy our performance obligations by transferring atitle and risk of loss of promised goodgoods or serviceservices have transferred to athe 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”.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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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:
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Chargebacks
The provision for chargebacks is the most significant and complex estimate used in the recognition of revenue. The Company sells its products directly to wholesale distributors, generic distributors, retail pharmacy chains and mail-order pharmacies. The Company also sells its products indirectly to independent pharmacies, managed care organizations, hospitals, nursing homes and group purchasing organizations, collectively referred to as “indirect customers.” The Company enters into agreements with its indirect customers to establish pricing for certain products. The indirect customers then independently select a wholesaler from which to purchase the products. If the price paid by the indirect customers is lower than the price paid by the wholesaler, the Company will provide a credit, called a chargeback, to the wholesaler for the difference between the contractual price with the indirect customers and the wholesaler purchase price. The provision for chargebacks is based on expected sell-through levels by the Company’s wholesale customers to the indirect customers and estimated wholesaler inventory levels. As sales to the large wholesale customers, such as Cardinal Health, AmerisourceBergen and McKesson increase (decrease), the reserve for chargebacks will also generally increase (decrease). However, the size of the increase (decrease) depends on product mix and the amount of sales made to indirect customers with which the Company has specific chargeback agreements. The Company continually monitors the reserve for chargebacks and makes adjustments when management believes that expected chargebacks may differ from the actual chargeback reserve.
Rebates
Rebates are offered to the Company’s key chain drug store, distributor and wholesaler customers to promote customer loyalty and increase product sales. These rebate programs provide customers with credits upon attainment of pre-established volumes or attainment of net sales milestones for a specified period. Other promotional programs are incentive programs offered to the customers. Additionally, as a result of the Patient Protection and Affordable Care Act (“PPACA”) enacted in the U.S. in March 2010, the Company participates in a new cost-sharing program for certain Medicare Part D beneficiaries designed primarily for the sale of brand drugs and certain generic drugs if their FDA approval was granted under a NDA or 505(b) NDA versus an ANDA. 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.
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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.
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Other Adjustments
Other adjustments consist primarily of “priceprice 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, 20202021 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 withDuring the acquisition of KUPI, the Company entered into a Senior Secured Credit Facility, which was subsequently amended infiscal year ended June 2016. Based on the variable-rate debt outstanding at March 31, 2021, each 1/8% increase in interest rates would yield $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. On April 22,30, 2021, the Company paid off our existing Term Loan Boutstanding, variable-rate Senior Secured Credit Facility with cash and the proceeds from new fixed-rate debt.
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 ninesix months ended MarchDecember 31, 2021 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
There have been no material changes from the risk factors disclosed in 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. Refer to the Form 10-Q for the quarterly period ended September 30, 2020 for a detailed description of an additional risk factor identified by the Company since filing of the Form 10-K.2021.
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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
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31.1 | | Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | | Filed Herewith |
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31.2 | | Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | | Filed Herewith |
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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 |
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101.SCH | | XBRL Taxonomy Extension Schema Document | | Filed Herewith |
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101.CAL | | XBRL Taxonomy Extension Calculation Linkbase Document | | Filed Herewith |
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101.DEF | | XBRL Taxonomy Extension Definition Linkbase Document | | Filed Herewith |
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101.LAB | | XBRL Taxonomy Extension Label Linkbase Document | | Filed Herewith |
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101.PRE | | XBRL Taxonomy Extension Presentation Linkbase Document | | Filed Herewith |
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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.
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| | LANNETT COMPANY, INC. |
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Dated: | By: | /s/ Timothy Crew |
| | Timothy Crew |
| | Chief Executive Officer |
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Dated: | By: | /s/ John Kozlowski |
| | John Kozlowski |
| | Vice President of Finance, Chief Financial Officer and Principal Accounting Officer |
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