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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
EXCHANGE ACT OF 1934
FOR
THE QUARTERLY PERIOD ENDED JUNE 30, 2021
OR
☐ TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
FOR
THE TRANSITION PERIOD FROM
TO
COMMISSION
FILE NUMBER 001-39294
ASSERTIO
HOLDINGS, INC.
(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
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Delaware |
85-0598378 |
(STATE OR OTHER JURISDICTION OF
INCORPORATION OR ORGANIZATION) |
(I.R.S. EMPLOYER IDENTIFICATION NUMBER) |
100
South Saunders Road, Suite 300
Lake Forest, Illinois 60045
(ADDRESS OF PRINCIPAL EXECUTIVE OFFICES; ZIP CODE)
(224)
419-7106
(REGISTRANT’S TELEPHONE NUMBER, INCLUDING AREA
CODE)
Securities registered pursuant to Section 12(b) of the
Act:
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Title of each class: |
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Trading Symbol(s): |
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Name of each exchange on which registered: |
Common Stock, $0.0001 par value
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ASRT |
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Nasdaq Stock Market |
Indicate by check mark whether the registrant (1) has filed
all reports required to be filed by Section 13 or
15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant
was required to file such reports), and (2) has been subject
to such filing requirements for the past 90
days. 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,” “smaller reporting company,” and
“emerging growth company” in Rule 12b-2 of the Exchange
Act.
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Large accelerated filer |
☐
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Accelerated filer |
☒ |
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Non-accelerated filer |
☐
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Smaller reporting company |
☒ |
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Emerging growth company |
☐
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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-2 of the Exchange
Act). Yes ☐
No ☒
The number of issued and outstanding shares of the registrant’s
Common Stock, $0.0001 par value, as of July 30, 2021 was
44,494,051.
ASSERTIO HOLDINGS, INC.
FORM 10-Q FOR THE PERIOD ENDED JUNE 30, 2021
TABLE OF CONTENTS
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Item 1. |
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Item 2. |
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Item 3. |
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Item 4. |
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Item 1. |
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Item 1A. |
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Item 2. |
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Item 6. |
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PART I — FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
ASSERTIO HOLDINGS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(Unaudited)
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June 30, 2021 |
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December 31, 2020 |
ASSETS |
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Current assets: |
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Cash and cash equivalents |
$ |
54,428 |
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$ |
20,786 |
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Accounts receivable, net |
45,468 |
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44,350 |
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Inventories, net |
6,617 |
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11,712 |
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Prepaid and other current assets |
12,835 |
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17,406 |
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Total current assets |
119,348 |
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94,254 |
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Property and equipment, net |
1,915 |
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2,437 |
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Intangible assets, net |
186,318 |
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200,082 |
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Other long-term assets |
4,435 |
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6,501 |
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Total assets |
$ |
312,016 |
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$ |
303,274 |
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LIABILITIES AND SHAREHOLDERS’ EQUITY |
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Current liabilities: |
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Accounts payable |
$ |
16,483 |
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$ |
14,808 |
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Accrued rebates, returns and discounts |
45,108 |
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63,114 |
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Accrued liabilities |
22,867 |
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27,071 |
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Current portion of long-term debt |
12,222 |
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11,942 |
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Contingent consideration, current portion |
6,850 |
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6,776 |
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Interest payable |
1,743 |
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1,793 |
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Other current liabilities |
11,641 |
|
|
7,182 |
|
Total current liabilities |
116,914 |
|
|
132,686 |
|
Long-term debt |
66,751 |
|
|
72,160 |
|
Contingent consideration |
30,809 |
|
|
31,776 |
|
Other long-term liabilities |
5,277 |
|
|
11,138 |
|
Total liabilities |
219,751 |
|
|
247,760 |
|
Commitments and contingencies |
|
|
|
Shareholders’ equity: |
|
|
|
Common stock, $0.0001 par value, 200,000,000 shares authorized;
44,494,051
and 28,392,149 shares issued and outstanding as of
June 30, 2021 and December 31, 2020, respectively
|
4 |
|
|
3 |
|
Additional paid-in capital |
529,831 |
|
|
483,456 |
|
Accumulated deficit |
(437,570) |
|
|
(427,945) |
|
|
|
|
|
Total shareholders’ equity |
92,265 |
|
|
55,514 |
|
Total liabilities and shareholders' equity |
$ |
312,016 |
|
|
$ |
303,274 |
|
The accompanying notes are an integral part of these unaudited
condensed consolidated financial statements.
ASSERTIO HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE
INCOME
(in thousands, except per share data)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Revenues: |
|
|
|
|
|
|
|
Product sales, net |
$ |
24,831 |
|
|
$ |
20,165 |
|
|
$ |
51,238 |
|
|
$ |
29,417 |
|
Commercialization agreement, net |
— |
|
|
— |
|
|
— |
|
|
11,258 |
|
Royalties and milestones |
542 |
|
|
452 |
|
|
975 |
|
|
859 |
|
Total revenues |
25,373 |
|
|
20,617 |
|
|
52,213 |
|
|
41,534 |
|
Costs and expenses: |
|
|
|
|
|
|
|
Cost of sales |
3,921 |
|
|
5,238 |
|
|
7,886 |
|
|
6,637 |
|
Research and development expenses |
— |
|
|
1,626 |
|
|
— |
|
|
2,667 |
|
Selling, general and administrative expenses |
26,235 |
|
|
28,131 |
|
|
33,966 |
|
|
55,445 |
|
Amortization of intangible assets |
7,218 |
|
|
4,855 |
|
|
13,764 |
|
|
12,650 |
|
Restructuring charges |
— |
|
|
6,519 |
|
|
1,089 |
|
|
6,519 |
|
Total costs and expenses |
37,374 |
|
|
46,369 |
|
|
56,705 |
|
|
83,918 |
|
Loss from operations |
(12,001) |
|
|
(25,752) |
|
|
(4,492) |
|
|
(42,384) |
|
Other (expense) income : |
|
|
|
|
|
|
|
Interest expense |
(2,605) |
|
|
(1,604) |
|
|
(5,288) |
|
|
(10,278) |
|
Other gain (loss), net |
137 |
|
|
(499) |
|
|
403 |
|
|
(3,824) |
|
(Loss) Gain on sale of Gralise |
— |
|
|
(850) |
|
|
— |
|
|
126,655 |
|
Loss on extinguishment of convertible notes |
— |
|
|
(16,272) |
|
|
— |
|
|
(47,880) |
|
Gain (Loss) on sale of NUCYNTA |
— |
|
|
1,006 |
|
|
— |
|
|
(14,749) |
|
Loss on debt extinguishment |
— |
|
|
— |
|
|
— |
|
|
(8,233) |
|
|
|
|
|
|
|
|
|
Total other (expense) income |
(2,468) |
|
|
(18,219) |
|
|
(4,885) |
|
|
41,691 |
|
Net loss before income taxes |
(14,469) |
|
|
(43,971) |
|
|
(9,377) |
|
|
(693) |
|
Income tax benefit (expense) |
300 |
|
|
9,472 |
|
|
(248) |
|
|
7,424 |
|
Net (loss) income and Comprehensive (loss) income |
$ |
(14,169) |
|
|
$ |
(34,499) |
|
|
$ |
(9,625) |
|
|
$ |
6,731 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net (loss) income per share |
$ |
(0.32) |
|
|
$ |
(1.40) |
|
|
$ |
(0.23) |
|
|
$ |
0.30 |
|
Diluted net (loss) income per share |
$ |
(0.32) |
|
|
$ |
(1.40) |
|
|
$ |
(0.23) |
|
|
$ |
0.30 |
|
Shares used in computing basic net (loss) income per
share |
44,706 |
|
|
24,640 |
|
|
41,321 |
|
|
22,459 |
|
Shares used in computing diluted net (loss) income per
share |
44,706 |
|
|
24,640 |
|
|
41,321 |
|
|
22,559 |
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these unaudited
condensed consolidated financial statements.
ASSERTIO HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS’
EQUITY
(in thousands)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock |
|
Additional
Paid-In
Capital* |
|
Accumulated
Earnings
(Deficit) |
|
|
|
Shareholders’
Equity |
|
Shares* |
|
Amount* |
|
|
|
|
Balances at December 31, 2020 |
28,392 |
|
|
$ |
3 |
|
|
$ |
483,456 |
|
|
$ |
(427,945) |
|
|
|
|
$ |
55,514 |
|
Issuance of common stock upon exercise of options |
73 |
|
|
— |
|
|
— |
|
|
— |
|
|
|
|
— |
|
Issuance of common stock in connection with stock
offerings |
14,400 |
|
|
1 |
|
|
44,860 |
|
|
— |
|
|
|
|
44,861 |
|
Issuance of common stock in conjunction with vesting
of restricted stock units |
211 |
|
|
— |
|
|
— |
|
|
— |
|
|
|
|
— |
|
Issuance of common stock in conjunction with vesting
of performance stock units |
13 |
|
|
— |
|
|
— |
|
|
— |
|
|
|
|
— |
|
Issuance of common stock upon exercise of warrant |
347 |
|
|
— |
|
|
— |
|
|
— |
|
|
|
|
— |
|
Stock-based compensation |
— |
|
|
— |
|
|
772 |
|
|
— |
|
|
|
|
772 |
|
Shares withheld for payment of employee's withholding tax
liability |
— |
|
|
— |
|
|
(388) |
|
|
— |
|
|
|
|
(388) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income and comprehensive income |
— |
|
|
— |
|
|
— |
|
|
4,544 |
|
|
|
|
4,544 |
|
Balances at March 31, 2021 |
43,436 |
|
$ |
4 |
|
|
$ |
528,700 |
|
|
$ |
(423,401) |
|
|
|
|
$ |
105,303 |
|
Issuance of common stock upon exercise of options |
— |
|
|
— |
|
|
193 |
|
|
— |
|
|
|
|
193 |
|
Issuance of common stock under employee stock
purchase plan |
4 |
|
|
— |
|
|
— |
|
|
— |
|
|
|
|
— |
|
Issuance of common stock in conjunction with vesting
of restricted stock units |
227 |
|
|
— |
|
|
— |
|
|
— |
|
|
|
|
— |
|
Issuance of common stock upon exercise of warrant |
845 |
|
|
— |
|
|
— |
|
|
— |
|
|
|
|
— |
|
Stock split fractional shares settlement |
(18) |
|
|
— |
|
|
|
|
— |
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation |
— |
|
|
— |
|
|
957 |
|
|
— |
|
|
|
|
957 |
|
Shares withheld for payment of employee's withholding tax
liability |
— |
|
|
— |
|
|
(19) |
|
|
— |
|
|
|
|
(19) |
|
Net loss and comprehensive loss |
— |
|
|
— |
|
|
— |
|
|
(14,169) |
|
|
|
|
(14,169) |
|
Balances at June 30, 2021 |
44,494 |
|
$ |
4 |
|
|
$ |
529,831 |
|
|
$ |
(437,570) |
|
|
|
|
$ |
92,265 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances at December 31, 2019 |
20,222 |
|
|
$ |
2 |
|
|
$ |
457,757 |
|
|
$ |
(399,801) |
|
|
|
|
$ |
57,958 |
|
Issuance of common stock in conjunction with vesting
of restricted stock units |
109 |
|
|
— |
|
|
— |
|
|
— |
|
|
|
|
— |
|
Reacquisition of equity component of 2021 Notes and 2024
Notes |
— |
|
|
— |
|
|
(16,814) |
|
|
— |
|
|
|
|
(16,814) |
|
Stock-based compensation |
— |
|
|
— |
|
|
1,934 |
|
|
— |
|
|
|
|
1,934 |
|
Shares withheld for payment of employee's withholding tax
liability |
— |
|
|
— |
|
|
(271) |
|
|
— |
|
|
|
|
(271) |
|
Net income and comprehensive income |
— |
|
|
— |
|
|
— |
|
|
41,230 |
|
|
|
|
41,230 |
|
Balances at March 31, 2020 |
20,331 |
|
|
$ |
2 |
|
|
$ |
442,606 |
|
|
$ |
(358,571) |
|
|
|
|
$ |
84,037 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock under employee stock
purchase plan |
19 |
|
|
— |
|
|
49 |
|
|
— |
|
|
|
|
49 |
|
Issuance of common stock in conjunction with vesting
of restricted stock units |
54 |
|
|
— |
|
|
— |
|
|
— |
|
|
|
|
— |
|
Issuance of common stock in connection with the Zyla
Merger |
6,370 |
|
|
1 |
|
22,930 |
|
|
— |
|
|
|
|
22,931 |
|
Issuance of warrants and stock options in conjunction with the Zyla
Merger |
— |
|
|
— |
|
|
11,626 |
|
|
— |
|
|
|
|
11,626 |
|
Reacquisition of equity component of 2021 Notes and 2024
Notes |
— |
|
|
— |
|
|
(2,718) |
|
|
— |
|
|
|
|
(2,718) |
|
Stock-based compensation |
— |
|
|
— |
|
|
3,593 |
|
|
— |
|
|
|
|
3,593 |
|
Shares withheld for payment of employee's withholding tax
liability |
— |
|
|
— |
|
|
(41) |
|
|
— |
|
|
|
|
(41) |
|
Net loss and comprehensive loss |
— |
|
|
— |
|
|
— |
|
|
(34,499) |
|
|
|
|
(34,499) |
|
Balances at June 30, 2020 |
26,774 |
|
|
$ |
3 |
|
|
$ |
478,045 |
|
|
$ |
(393,070) |
|
|
|
|
$ |
84,978 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(*) Adjusted to reflect the
1-for-4 reverse stock split effected on May 18, 2021.
The accompanying notes are an integral part of these unaudited
condensed consolidated financial statements.
ASSERTIO HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, |
|
2021 |
|
2020 |
Operating Activities |
|
|
|
Net (loss) income |
$ |
(9,625) |
|
|
$ |
6,731 |
|
Adjustments to reconcile net (loss) income to net cash used in
operating activities: |
|
|
|
Gain on sale of Gralise |
— |
|
|
(126,655) |
|
|
|
|
|
Loss on sale of NUCYNTA |
— |
|
|
14,749 |
|
Loss on extinguishment of Convertible Notes |
— |
|
|
47,880 |
|
Loss on prepayment of Senior Notes |
— |
|
|
8,233 |
|
Depreciation and amortization |
14,286 |
|
|
13,319 |
|
|
|
|
|
Amortization of debt discount, debt
issuance costs and royalty rights |
118 |
|
|
5,511 |
|
Recurring fair value measurement of assets and
liabilities |
1,602 |
|
|
3,629 |
|
|
|
|
|
Stock-based compensation |
1,729 |
|
|
5,527 |
|
Provision for inventory and other assets |
140 |
|
|
1,808 |
|
|
|
|
|
|
|
|
|
Other |
— |
|
|
(9) |
|
Changes in assets and liabilities, net of acquisition: |
|
|
|
Accounts receivable |
(1,118) |
|
|
29,414 |
|
Inventories |
4,955 |
|
|
512 |
|
|
|
|
|
Prepaid and other assets |
6,640 |
|
|
4,810 |
|
Accounts payable and other accrued liabilities |
(3,933) |
|
|
(13,337) |
|
Accrued rebates, returns and discounts |
(18,006) |
|
|
(39,757) |
|
Interest payable |
(50) |
|
|
(7,524) |
|
Net cash used in operating activities |
(3,262) |
|
|
(45,159) |
|
Investing Activities |
|
|
|
Purchases of property and equipment |
— |
|
|
(9) |
|
Cash acquired in Zyla Merger |
— |
|
|
7,585 |
|
Proceeds from sale of NUCYNTA |
— |
|
|
368,965 |
|
Proceeds from sale of Gralise |
— |
|
|
130,261 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from sale of investments |
— |
|
|
6,000 |
|
Net cash provided by investing activities |
— |
|
|
512,802 |
|
Financing Activities |
|
|
|
|
|
|
|
Payments in connection with convertible notes
extinguishment |
— |
|
|
(264,731) |
|
Payment in connection with Series A-1 and A-2 debt |
(4,750) |
|
|
— |
|
Payment of contingent consideration |
(2,495) |
|
|
— |
|
Payments in connection with Senior Notes settlement |
— |
|
|
(171,775) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments on Revolver |
— |
|
|
(10,000) |
|
Payments on Promissory Note |
— |
|
|
(3,000) |
|
Payment of Royalty Rights |
(498) |
|
|
— |
|
Proceeds from issuance of common stock |
44,861 |
|
|
— |
|
Proceeds from exercise of stock options |
193 |
|
|
— |
|
|
|
|
|
Shares withheld for payment of employee's withholding tax
liability |
(407) |
|
|
(841) |
|
Net cash provided by (used in) financing activities |
36,904 |
|
|
(450,347) |
|
Net increase in cash and cash equivalents |
33,642 |
|
|
17,296 |
|
Cash and cash equivalents at beginning of year |
20,786 |
|
|
42,107 |
|
Cash and cash equivalents at end of period |
$ |
54,428 |
|
|
$ |
59,403 |
|
|
|
|
|
Supplemental Disclosure of Cash Flow Information |
|
|
|
Net cash paid for income taxes |
$ |
— |
|
|
$ |
396 |
|
Cash paid for interest |
$ |
5,216 |
|
|
$ |
11,213 |
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these unaudited
condensed consolidated financial statements.
ASSERTIO HOLDINGS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
NOTE 1. SUMMARY OF SIGNIFICANT ACCOUNTING
POLICIES
Basis of Presentation
The unaudited condensed consolidated financial statements of
Assertio Holdings, Inc. (the Company or Assertio) and its
subsidiaries and the related footnote information of the Company
have been prepared pursuant to the requirements of the Securities
and Exchange Commission (SEC) for interim reporting. As permitted
under those rules and regulations, certain footnotes or other
financial information that are normally required by U.S. generally
accepted accounting principles (U.S. GAAP) have been condensed or
omitted pursuant to such rules and regulations. In the opinion of
the Company’s management, the accompanying interim unaudited
condensed consolidated financial statements include all adjustments
necessary for a fair presentation of the information for the
periods presented. Certain amounts in prior periods have been
reclassified to conform with current period presentation. The
results for the three and six months ended June 30, 2021 are
not necessarily indicative of results to be expected for the entire
year ending December 31, 2021 or future operating
periods.
The accompanying unaudited condensed consolidated financial
statements and related financial information should be read in
conjunction with the audited financial statements and the related
notes thereto for the year ended December 31, 2020 included in
Assertio Holdings, Inc.’s Annual Report on Form 10-K filed with the
SEC on March 12, 2021 (the 2020 Form 10-K). The Condensed
Consolidated Balance Sheet as of December 31, 2020 has been derived
from the audited financial statements at that date, as filed in the
Company’s 2020 Form 10-K. The Company’s significant one-time 2020
transactions such as the sale of the NUCYNTA franchise, sale of
Gralise, repayment of its debt obligations, and merger with Zyla
Life Sciences are discussed in the 2020 Form 10-K and have not been
duplicated in the accompanying unaudited condensed consolidated
financial statements and related financial
information.
Stock Split
On May 18, 2021, the Company effected a 1-for-4 reverse stock split
of its issued and outstanding common stock. The par value of the
common stock was not adjusted as a result of the reverse stock
split. All common stock share and per-share data included in these
financial statements have been retrospectively adjusted to reflect
the effect of the reverse stock split for all periods
presented.
Impact of COVID-19 on our Business
Following
the outbreak of COVID-19 during early 2020, the Company’s priority
was and remains the health and safety of its employees, their
families, and the patients it serves. As a result, in March 2020,
the Company initiated remote working arrangements and maintained
flexible work arrangements for individuals, which continued through
the remainder of 2020 and into 2021. In addition to the health and
safety of its employees, the Company is focused on ensuring that it
continues making its products accessible to the patients who need
them. Because COVID-19 impacted the Company’s ability to see
in-person providers who prescribe its products, the Company adapted
its approach during 2020 and increased its virtual visits.
Additionally, due to the limitations on elective surgeries and
changes in patient behavior since the outbreak of COVID-19, the
Company has experienced a decline and subsequent volatility in
prescriptions associated with those elective procedures. The extent
to which the Company’s operations may continue to be impacted by
the COVID-19 pandemic will depend largely on future developments,
which are highly uncertain and cannot be accurately predicted,
including new information which may emerge concerning the severity
of the outbreak, actions by government authorities to contain the
outbreak or treat its impact, the emergence of new COVID-19
variants and the related potential for new surges in infections,
and the distribution, public acceptance and efficacy of COVID-19
vaccines including for emerging variants.
NOTE 2. REVENUE
Disaggregated Revenue
The following table reflects summary revenue, net for the three and
six months ended June 30, 2021 and 2020 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Product sales, net: |
|
|
|
|
|
|
|
|
INDOCIN products
(1)
|
|
$ |
13,075 |
|
|
$ |
5,434 |
|
|
$ |
27,673 |
|
|
$ |
5,434 |
CAMBIA |
|
6,128 |
|
|
7,780 |
|
|
12,590 |
|
|
14,054 |
Zipsor |
|
2,581 |
|
|
3,535 |
|
|
4,803 |
|
|
5,866 |
SPRIX
(1)
|
|
2,942 |
|
|
1,602 |
|
|
4,639 |
|
|
1,602 |
Other |
|
105 |
|
|
1,814 |
|
|
1,533 |
|
|
2,461 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product sales, net |
|
24,831 |
|
|
20,165 |
|
|
51,238 |
|
|
29,417 |
Commercialization agreement revenue, net |
|
— |
|
|
— |
|
|
— |
|
|
11,258 |
Royalties and milestone revenue |
|
542 |
|
|
452 |
|
|
975 |
|
|
859 |
Total revenues |
|
$ |
25,373 |
|
|
$ |
20,617 |
|
|
$ |
52,213 |
|
|
$ |
41,534 |
(1)Products
acquired in connection with the May 20, 2020 Zyla
Merger.
Product Sales, net:
For the three and six months ended June 30, 2021, product
sales primarily consisted of sales from INDOCIN Products, CAMBIA,
Zipsor and SPRIX. The Company began shipping and recognizing
product sales for INDOCIN Products and SPRIX upon the Zyla Merger
on May 20, 2020.
Other product sales includes
product sales adjustments for previously divested products,
including Gralise, which was divested in January 2020; and product
sales for non-promoted products (OXAYDO and SOLUMATRIX) which were
acquired from Zyla in May 2020.
The Company records contract liabilities in the form of deferred
revenue resulting from prepayments from customers. The Company
recorded contract liabilities of $0.3 million in the three months
ended June 30, 2021 which are included in Other Current
Liabilities on the Condensed Consolidated Balance
Sheet.
Pro Forma Information
Supplemental unaudited proforma information is based upon
accounting estimates and judgments that the Company believes are
reasonable. This supplemental unaudited pro forma financial
information has been prepared for comparative purposes only, and is
not necessarily indicative of what actual results would have
occurred, or of results that may occur in the future. The pro forma
consolidated product sales, net for the three and six months ended
June 30, 2020, as if the acquisition of Zyla had occurred on
January 1, 2020, was $28.2 million and $56.5 million,
respectively.
Commercialization Agreement Revenue, net
The Company ceased recognizing commercialization revenue and
related costs for NUCYNTA effective with the closing of the
transaction to sell its rights, title and interest in and to the
NUCYNTA franchise to Collegium on February 13, 2020. In
connection with the sale, the Commercialization Agreement
terminated at closing with certain specified provisions of the
Commercialization Agreement surviving in accordance with the terms
of the purchase agreement. During the six months ended
June 30, 2020, the Company recognized net revenue from the
Commercialization Agreement of $11.3 million. This included
variable royalty revenue of $13.1 million offset by the
amortization of the $1.8 million net contract asset in
connection with the termination of the Commercialization
Agreement.
Royalties and Milestone Revenue
In November 2010, the Company entered into a license agreement with
Tribute Pharmaceuticals Canada Ltd. (now known as Nuvo
Pharmaceuticals, Inc.) granting them the rights to commercially
market CAMBIA in Canada. Nuvo independently contracts with
manufacturers to produce a specific CAMBIA formulation in Canada.
The Company receives royalties on net sales on a quarterly basis as
well as certain one-time contingent milestone payments upon the
occurrence of certain events. The Company recognized revenue
related to CAMBIA in Canada of $0.5 million and $1.0 million for
the three and six months ended June 30, 2021, respectively,
and $0.5 million and $0.9 million for the three and six months
ended June 30, 2020, respectively.
NOTE 3. ACCOUNTS RECEIVABLES, NET
The following table reflects accounts receivables, net, as of
June 30, 2021 and December 31, 2020 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
2021 |
|
December 31, 2020 |
Receivables related to product sales, net |
|
|
|
|
$ |
45,368 |
|
|
$ |
40,784 |
|
Receivables from Collegium |
|
|
|
|
— |
|
|
3,566 |
|
Other |
|
|
|
|
100 |
|
|
— |
|
Total accounts receivable, net |
|
|
|
|
$ |
45,468 |
|
|
$ |
44,350 |
|
As of June 30, 2021 and December 31, 2020, allowances for cash
discounts for prompt payment were $0.9 million and $1.3 million,
respectively.
NOTE 4. INVENTORIES, NET
The following table reflects the components of inventory, net as of
June 30, 2021 and December 31, 2020 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
2021 |
|
December 31, 2020 |
Raw materials |
$ |
884 |
|
|
$ |
1,136 |
|
Work-in-process |
252 |
|
|
1,340 |
|
Finished goods |
5,481 |
|
|
9,236 |
|
Total |
$ |
6,617 |
|
|
$ |
11,712 |
|
As of June 30, 2021 and December 31, 2020, inventory reserves
were $2.5 million and $2.3 million, respectively.
NOTE 5. PROPERTY AND EQUIPMENT, NET
The following table reflects property and equipment, net as of
June 30, 2021 and December 31, 2020 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
2021 |
|
December 31, 2020 |
Furniture and office equipment |
$ |
2,680 |
|
|
$ |
2,680 |
|
Laboratory equipment |
20 |
|
|
20 |
|
Leasehold improvements |
10,523 |
|
|
10,523 |
|
|
13,223 |
|
|
13,223 |
|
Less: Accumulated depreciation and amortization |
(11,308) |
|
|
(10,786) |
|
Property and equipment, net |
$ |
1,915 |
|
|
$ |
2,437 |
|
Depreciation expense was $0.3 million and $0.5 million for the
three and six months ended June 30, 2021, respectively, and
$0.4 million and $0.7 million for the three and six months ended
June 30, 2020, respectively. Depreciation expense is
recognized in Selling, general and administrative expense in the
Company’s Condensed Consolidated Statements of Comprehensive
Income.
NOTE 6. INTANGIBLE ASSETS
The following table reflects the gross carrying amounts and net
book values of intangible assets as of June 30, 2021 and
December 31, 2020 (dollar amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2021 |
|
December 31, 2020 |
|
|
Remaining Useful Life
(In years) |
|
Gross Carrying Amount |
|
Accumulated Amortization |
|
|
|
Net Book Value |
|
Gross Carrying Amount |
|
Accumulated Amortization |
|
|
|
Net Book Value |
Products rights: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
INDOCIN |
|
10.9 |
|
$ |
154,100 |
|
|
$ |
(14,233) |
|
|
|
|
$ |
139,867 |
|
|
$ |
154,100 |
|
|
$ |
(7,812) |
|
|
|
|
$ |
146,288 |
|
SPRIX |
|
5.9 |
|
39,000 |
|
|
(6,175) |
|
|
|
|
32,825 |
|
|
39,000 |
|
|
(3,389) |
|
|
|
|
35,611 |
|
CAMBIA |
|
1.5 |
|
51,360 |
|
|
(39,435) |
|
|
|
|
11,925 |
|
|
51,360 |
|
|
(36,163) |
|
|
|
|
15,197 |
|
Zipsor |
|
Less than 1 year
|
|
27,250 |
|
|
(25,550) |
|
|
|
|
1,700 |
|
|
27,250 |
|
|
(24,381) |
|
|
|
|
2,869 |
|
Oxaydo |
|
— |
|
300 |
|
|
(300) |
|
|
|
|
— |
|
|
300 |
|
|
(183) |
|
|
|
|
117 |
|
Total Intangible Assets |
|
|
|
$ |
272,010 |
|
|
$ |
(85,692) |
|
|
|
|
$ |
186,318 |
|
|
$ |
272,010 |
|
|
$ |
(71,928) |
|
|
|
|
$ |
200,082 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization expense was $7.2 million and $13.8 million for
the three and six months ended June 30, 2021, respectively,
and $4.9 million and $12.7 million for the three and six
months ended June 30, 2020, respectively.
The following table reflects future amortization expense the
Company expects for its intangible assets (in
thousands):
|
|
|
|
|
|
|
|
|
Year Ending December 31, |
|
Estimated Amortization Expense |
2021 (remainder) |
|
$ |
14,351 |
|
2022 |
|
26,895 |
|
2023 |
|
18,412 |
|
2024 |
|
18,413 |
|
2025 |
|
18,413 |
|
Thereafter |
|
89,834 |
|
|
|
|
Total |
|
$ |
186,318 |
|
NOTE 7. OTHER LONG-TERM ASSETS
The following table reflects other long-term assets as of
June 30, 2021 and December 31, 2020 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
2021 |
|
December 31, 2020 |
Investment, net |
$ |
1,579 |
|
|
$ |
1,579 |
|
Operating lease right-of-use assets |
1,054 |
|
|
1,955 |
|
Deposits |
952 |
|
|
1,936 |
|
Other |
850 |
|
|
1,031 |
|
Total other long-term assets |
$ |
4,435 |
|
|
$ |
6,501 |
|
Investment consists of the Company’s $3.5 million investment
in a company engaged in medical research. This investment is
structured as a long-term loan receivable with a convertible
feature and is valued at amortized cost. As a result of the
Company’s adoption of ASU 2016-13
Financial Instruments-Credit Losses
(ASU 2016-13 or Topic 326):
Measurement of Credit Losses on Financial Instruments
on January 1, 2020, the Company estimated an expected credit loss
of approximately $1.9 million on its investment, which was
recognized in Other (expense) income in the Company’s Condensed
Consolidated Statement of Comprehensive Income in the first quarter
of 2020. To calculate the expected credit loss allowance, the
Company utilized a probability-of-default method (PDM). This
process estimates the probability of the loan being successfully
paid back
or converted into equity based on the ability of the investee to
obtain FDA acceptance of its research. The Company’s expected
credit losses can vary from period to period based on several
factors, such as progress of the medical research and FDA
submission, and overall economic environment and the ability of the
investee to fund its operations. As of June 30, 2021, the
Company continues to assess an estimated $1.9 million expected
credit loss on its investment based on evaluation of probability of
default that exist.
NOTE 8. ACCRUED LIABILITIES
The following table reflects accrued liabilities as of
June 30, 2021 and December 31, 2020 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
2021 |
|
December 31, 2020 |
Accrued compensation |
$ |
2,122 |
|
|
$ |
5,498 |
|
|
|
|
|
Accrued restructuring costs |
2,197 |
|
|
8,744 |
|
Other accrued liabilities |
18,548 |
|
|
12,829 |
|
Total accrued liabilities |
$ |
22,867 |
|
|
$ |
27,071 |
|
NOTE 9. DEBT
The following table reflects the Company’s debt as of June 30,
2021 and December 31, 2020 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2021 |
|
December 31, 2020 |
13% Senior Secured Notes due 2024
|
$ |
75,500 |
|
|
$ |
80,250 |
|
|
|
|
|
Royalty rights obligation |
3,138 |
|
|
3,533 |
|
2.50% Convertible Notes due 2021
|
335 |
|
|
335 |
|
Total principal amount |
78,973 |
|
|
84,118 |
|
|
|
|
|
Unamortized debt discounts |
— |
|
|
(16) |
|
Carrying value |
78,973 |
|
|
84,102 |
|
Less: current portion of long-term debt |
(12,222) |
|
|
(11,942) |
|
Net, long-term debt |
$ |
66,751 |
|
|
$ |
72,160 |
|
13% Senior Secured Notes due 2024
In accordance with the Zyla Merger, Assertio assumed $95.0 million
aggregate principal amount of 13% senior secured notes due 2024
(the Secured Notes) issued pursuant to an indenture (the Existing
Indenture) entered into on January 31, 2019, by and among Zyla Life
Sciences, the guarantors party thereto (the Guarantors) and
Wilmington Savings Fund Society, FSB (as successor to U.S. Bank
National Association), as trustee and collateral agent (the
Trustee). The Secured Notes were issued in two series: $50.0
million of Series A-1 Notes and $45.0 million of Series A-2
Notes.
As of May 20, 2020, the Existing Indenture was modified by a
Supplemental Indenture (the Supplemental
Indenture and the Existing Indenture, as
so modified, the Indenture), pursuant to which Assertio (the
Issuer) assumed the obligations as issuer of the Secured Notes and
the subsidiaries of Assertio became guarantors of the Secured
Notes. The Supplemental Indenture, among other things, provides for
certain amendments to the restrictive covenants in the
Indenture.
Interest on the Secured Notes accrues at a rate of 13% per annum
and is payable semi-annually in arrears on May 1 and November 1 of
each year (each, a Payment Date).
The Existing Indenture also requires payments of outstanding
principal on the Secured Notes equal to
10%
per
annum of the issued principal amount, payable semi-annually on each
Payment Date.
The Secured Notes are senior secured obligations of the Issuer and
are secured by a lien on substantially all assets of the Issuer and
the guarantors. The stated maturity date of the Secured Notes is
January 31, 2024. Upon the occurrence of a Change
of Control, subject to certain conditions (as defined in the
Existing Indenture), holders of the Secured Notes may require the
Issuer to repurchase for cash all or part of their Secured Notes at
a repurchase price equal to 100% of the principal amount of the
Secured Notes to be repurchased, plus accrued and unpaid interest
to the date of repurchase.
The Company may redeem the Secured Notes at its option, in whole or
in part from time to time, at a redemption price equal to 100% of
the principal amount of the Secured Notes being redeemed, plus
accrued and unpaid interest, if any, through the redemption date.
No sinking fund is provided for the Secured Notes.
Pursuant to the Supplemental Indenture, Assertio and its restricted
subsidiaries must also comply with certain covenants, including
limitations on the issuance of debt; the issuance of preferred
and/or disqualified stock; the payment of dividends and other
restricted payments; the prepayment, redemption or repurchase of
subordinated debt; mergers, amalgamations or consolidations;
engaging in certain transactions with affiliates; and the making of
investments. In addition, the Issuer must maintain a minimum level
of consolidated liquidity, based on unrestricted cash on hand and
availability under any revolving credit facility, equal to the
greater of (1) the quotient of the outstanding principal amount of
the Secured Notes divided by 9.5 and (2) $7.5 million. The Company
was in compliance with its covenants with respect to the Secured
Notes as of June 30, 2021.
The Company had Senior Secured Notes obligations of $75.5 million
as of June 30, 2021, with $9.5 million
classified
as current and $66.0 million classified as non-current debt in the
Company’s Condensed Consolidated Balance Sheets.
Royalty Rights Obligation
In accordance with the Zyla Merger, the Company assumed a royalty
rights agreements (the Royalty Rights) with each of the holders of
its Secured Notes pursuant to which the Company will pay the
holders of the Secured Notes an aggregate 1.5% royalty on Net Sales
(as defined in the Existing Indenture) through December 31, 2022.
The Royalty Rights were determined to be a freestanding element
with respect to the Secured Notes and the Company is accounting for
the Royalty Rights obligation relating to future royalties as a
debt instrument.
The Company has Royalty Rights obligations of $3.1 million as of
June 30, 2021, with $2.4 million
classified
as current and $0.7 million classified as non-current debt in the
Company’s Condensed Consolidated Balance Sheets.
The accounting for the Royalty Rights requires the Company to make
certain estimates and assumptions about the future net sales. The
estimates of the magnitude and timing of net sales are subject to
significant variability due to the extended time period associated
with the financing transaction and are thus subject to significant
uncertainty.
Convertible Notes
2.50% Convertible Senior Notes Due 2021
On September 9, 2014, the Company issued $345.0 million
aggregate principal amount of 2.50% Convertible Senior Notes Due
2021 (the 2021 Notes). The 2021 Notes were issued pursuant to an
indenture, as supplemented by a supplemental indenture dated
September 9, 2014, between the Company and The Bank of New York
Mellon Trust Company, N.A., as trustee (the Trustee), and mature on
September 1, 2021, unless earlier converted, redeemed, or
repurchased. The 2021 Notes bear interest at the rate of 2.50% per
annum, payable semi-annually in arrears on March 1 and
September 1 of each year, beginning March 1,
2015.
On February 19, 2020, the Company entered into purchase agreements
with a limited number of holders of the Company’s outstanding 2021
Notes to repurchase $102.5 million aggregate principal amount of
2021 Notes. On April 8, 2020, the Company completed its public
tender offers to purchase the $42.1 million in aggregate principal
amount outstanding 2021 Notes. As of December 31, 2020 and
June 30, 2021, only $0.3 million in aggregate principal amount
of the 2021 Notes were outstanding and were classified as part of
current portion of long-term debt on the Company’s Condensed
Consolidated Balance Sheets.
On or after March 1, 2021 to the close of business on the second
scheduled trading day immediately preceding the maturity date, the
holders of the 2021 Convertible Notes may convert all or any
portion of their notes, in multiples of 1,000 principal amount, at
the option of the holder. The initial conversion rate of 12.9963
shares of common stock per 1,000 principal amount of Convertible
Notes is equivalent to a conversion price of approximately $76.96
per share of common stock. Upon conversion, the Company will pay or
deliver, as appropriate, cash, shares of the Company’s common stock
or a combination of cash and shares of the Company’s common stock,
at the Company’s election. If the conversion obligation is
satisfied solely in
cash or through payment and delivery of a combination of cash and
shares, the amount of cash and shares, if any, due upon conversion
will be based on a daily conversion value calculated on a
proportionate basis for each trading day in a 40 trading day
observation period. As of June 30, 2021, none of the remaining
2021 Notes had been converted.
5.00% Convertible Senior Notes Due 2024
On August 13, 2019, the Company issued $120.0 million aggregate
principal of Convertible Senior Notes Due
2024 (the 2024 Notes). On February 19, 2020, the Company entered
into purchase agreements with a limited number of holders of the
Company’s outstanding 2024 Notes to repurchase $85.5 million
aggregate principal amount of 2024 Notes. On April 8, 2020, the
Company completed its public tender offers to purchase the
remaining $34.5 million in aggregate principal amount outstanding
2024 Notes. As of December 31, 2020 there were no outstanding
aggregate principal amount of the 2024 Notes.
Senior Secured Notes
On April 2, 2015, the Company issued $575 million aggregate
principal amount of senior secured notes pursuant to a Note
Purchase Agreement dated March 12, 2015 (Note Purchase Agreement).
On February 13, 2020, the Company repaid in full all outstanding
indebtedness, and terminated all commitments and obligations, under
its Note Purchase Agreement.
Interest Expense
Debt discount and royalty rights are amortized as interest expense
using the effective interest method. The following table reflects
debt related interest included in the Interest expense in the
Company’s Condensed Consolidated Statements of Comprehensive Income
for the three and six months ended June 30, 2021 and 2020 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Stated coupon interest |
$ |
2,557 |
|
|
$ |
1,476 |
|
|
$ |
5,170 |
|
|
$ |
4,778 |
|
Amortization of debt discount, and royalty rights |
48 |
|
|
125 |
|
|
118 |
|
5,511 |
|
|
|
|
|
|
|
|
Total interest expense |
$ |
2,605 |
|
$ |
1,601 |
|
$ |
5,288 |
|
$ |
10,289 |
NOTE 10. STOCK-BASED COMPENSATION
The Company’s stock-based compensation generally includes stock
options, restricted stock units (RSUs), performance share units
(PSUs), and purchases under the Company’s employee stock purchase
program (ESPP).
The following table reflects stock-based compensation expense
recognized in the Company’s Condensed Consolidated Statements of
Comprehensive Income for the three and six months June 30,
2021 and 2020 (in thousands).
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Cost of sales |
$ |
— |
|
$ |
18 |
|
|
$ |
— |
|
|
$ |
41 |
|
Research and development expense |
— |
|
80 |
|
|
— |
|
|
243 |
|
Selling, general and administrative expense |
957 |
|
2,496 |
|
|
1,729 |
|
|
4,244 |
|
Restructuring charges |
— |
|
999 |
|
|
— |
|
|
999 |
|
Total |
$ |
957 |
|
$ |
3,593 |
|
|
$ |
1,729 |
|
|
5,527 |
|
During the six months ended June 30, 2021 the Company granted
1.7 million RSUs at an average fair market value of $3.54 per
share.
NOTE 11. LEASES
As of June 30, 2021, the Company has non-cancelable operating
leases for its offices and certain office equipment. The Company
has the right to renew the term of the Lake Forest lease for one
period of five years, provided that written notice
is made to the Landlord no later than twelve months prior to the
expiration of the initial term of the lease which is on December
31, 2023. In connection with the Zyla Merger, the Company assumed
an operating lease for offices in Wayne, Pennsylvania. The Wayne,
Pennsylvania office lease terminates in 2022 and will not be
renewed. The Company relocated its corporate headquarters from
Newark, California to Lake Forest, Illinois in 2018 and
subsequently entered into two subleases which,
together, account for the entirety of the Newark facility.
Operating lease costs and sublease income related to the Newark
facility are accounted for in Other gain (loss) in the Condensed
Consolidated Statements of Comprehensive Income.
The following table reflects lease expense for the three and six
months ended June 30, 2021 and 2020 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
Financial Statement Classification |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Operating lease cost |
Selling, general and administrative expenses |
|
$ |
91 |
|
|
$ |
216 |
|
|
$ |
202 |
|
|
$ |
373 |
|
Operating lease cost |
Other gain (loss), net |
|
148 |
|
|
147 |
|
|
295 |
|
|
295 |
|
Total lease cost |
|
|
$ |
239 |
|
|
$ |
363 |
|
|
$ |
497 |
|
|
$ |
668 |
|
|
|
|
|
|
|
|
|
|
|
Sublease Income |
Other gain (loss), net |
|
$ |
347 |
|
|
$ |
346 |
|
|
$ |
693 |
|
|
$ |
693 |
|
The following table reflects supplemental cash flow information
related to leases for the three and six ended June 30, 2021
and 2020 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Cash paid for amounts included in measurement of
liabilities: |
|
|
|
|
|
|
|
Operating cash flows from operating leases |
697 |
|
|
606 |
|
|
1,462 |
|
|
1,224 |
|
The following table reflects supplemental balance sheet information
related to leases as of June 30, 2021 and December 31, 2020
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial Statement Classification |
|
June 30,
2021 |
|
December 31,
2020 |
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities |
|
|
|
|
|
Current operating lease liabilities |
Other current liabilities |
|
$ |
2,340 |
|
|
$ |
2,683 |
|
Noncurrent operating lease liabilities |
Other long-term liabilities |
|
1,290 |
|
|
2,815 |
|
Total lease liabilities |
|
|
$ |
3,630 |
|
|
$ |
5,498 |
|
NOTE 12. COMMITMENTS AND CONTINGENCIES
Jubilant HollisterStier Manufacturing and Supply
Agreement
Pursuant to the Zyla Merger, the Company assumed a Manufacturing
and Supply Agreement (the “Agreement”) with Jubilant HollisterStier
LLC (“JHS”) pursuant to which the Company engaged JHS to provide
certain services related to the manufacture and supply of SPRIX for
the Company’s commercial use. Under the Agreement, JHS will be
responsible for supplying a minimum of 75% of the Company’s annual
requirements of SPRIX through July 30, 2022. The Company has agreed
to purchase a minimum number of batches of SPRIX per calendar year
from JHS over the term of the Agreement. Total commitments to JHS
are approximately $1.8 million through the period ending July 30,
2022 and are expected to be met.
Cosette Pharmaceuticals Supply Agreement
Pursuant to the Zyla Merger, the Company assumed a Collaborative
License, Exclusive Manufacture and Global Supply Agreement with
Cosette Pharmaceuticals, Inc. (formerly G&W Laboratories, Inc.)
(the “Supply Agreement”) for the manufacture and supply of INDOCIN
Suppositories to Zyla for commercial distribution in the United
States. On July 9, 2021, the Company and Cosette entered into
Amendment No. 3 to the Supply Agreement, to among other things,
extend the expiration date of the Supply Agreement from July 31,
2023
to July 9, 2028. The Company is obligated to purchase all of its
requirements for INDOCIN Suppositories from Cosette
Pharmaceuticals, Inc., and is required to meet minimum
purchase
requirements each calendar year during the extended term of the
agreement. Total commitments to Cosette are approximately $6.3
million annually through the end of the contract term.
Legal Matters
General
The Company is currently involved in various lawsuits, claims,
investigations and other legal proceedings that arise in the
ordinary course of business. The Company recognizes a loss
contingency provision in its financial statements when it concludes
that a contingent liability is probable, and the amount thereof is
estimable. Costs associated with our involvement in legal
proceedings are expensed as incurred. Based upon the status of the
cases described below, management’s assessments of the likelihood
of damages, and the advice of counsel, the Company recognized a
loss contingency provision of $11.3 million in the three and six
months ended June 30, 2021. Amounts accrued for legal
contingencies are based on management’s best estimate of a loss and
often result from a complex series of judgments about future events
and uncertainties that rely heavily on estimates and assumptions
including timing of related payments. The Company will continue to
monitor each matter and adjust accruals as might be warranted based
on new information and further developments in accordance with ASC
450-20- 25. For matters discussed below for which a loss is not
probable, or a probable loss cannot be reasonably estimated, no
liability has been recorded. Legal expenses are recorded in
Selling, general and administrative expense in the Company’s
Condensed Consolidated Statements of Comprehensive Income and the
related accruals are recorded in Accrued Liabilities in the
Company’s Condensed Consolidated Balance Sheets.
Other than matters that we have disclosed below, the Company may
from time to time become party to actions, claims, suits,
investigations or proceedings arising from the ordinary course of
its business, including actions with respect to intellectual
property claims, breach of contract claims, labor and employment
claims and other matters. The Company may also become party to
further litigation in federal and state courts relating to opioid
drugs. Although actions, claims, suits, investigations and
proceedings are inherently uncertain and their results cannot be
predicted with certainty, other than the matters set forth below,
the Company is not currently involved in any matters that the
Company believes may have a material adverse effect on its
business, results of operations or financial condition. However,
regardless of the outcome, litigation can have an adverse impact on
the Company because of associated cost and diversion of management
time.
Glumetza Antitrust Litigation
Antitrust class actions and related direct antitrust actions have
been filed in the Northern District of California against the
Company and several other defendants relating to our former drug
Glumetza®.
The named class representatives in the currently pending actions
include Meijer, Inc., Bi-Lo, LLC, Winn-Dixie Logistics, Inc., City
of Providence, and KPH Healthcare Services, Inc. These class
representatives seek to represent a putative class of direct
purchasers of Glumetza. In addition, several retailers, including
CVS Pharmacy, Inc., Rite Aid Corporation, Walgreen Co., the Kroger
Co., the Albertsons Companies, Inc., H-E-B, L.P., and Hy-Vee, Inc.,
have filed substantially similar direct antitrust claims based on
alleged assignments of claims from direct purchaser wholesalers. On
December 23, 2019, the Company filed a motion to dismiss all claims
in the actions. That motion was heard by the District Court on
February 20, 2020. On March 5, 2020 the District Court issued an
order denying the motion to dismiss. However, based on the order on
the motion, claims previously filed by a putative class of end
payor plaintiffs were voluntarily dismissed.
On July 30, 2020, Humana Inc. also filed a complaint against the
Company in the Northern District of California alleging similar
claims related to Glumetza®.
On February 2, 2021, the District Court dismissed Humana’s
state-law antitrust claims, but permitted Humana to proceed on its
federal claims. On February 8, 2021, Humana refiled those state-law
claims against the Company and several other defendants in the
Superior Court for the State of California in the County of
Alameda.
These antitrust cases arise out of a Settlement and License
Agreement (the Settlement) that the Company, Santarus, Inc.
(Santarus) and Lupin Limited (Lupin) entered into in February 2012
that resolved patent infringement litigation filed by the Company
against Lupin regarding Lupin’s Abbreviated New Drug Application
for generic 500 mg and 1000 mg tablets of Glumetza. The antitrust
plaintiffs allege, among other things, that the Settlement violated
the antitrust laws because it allegedly included a “reverse
payment” that caused Lupin to delay its entry in the market with a
generic version of Glumetza. The alleged “reverse payment” is an
alleged commitment on the part of the settling parties not to
launch an authorized generic version of Glumetza for a certain
period. The antitrust plaintiffs allege that the Company and its
co-defendants, which include Lupin as well as Bausch Health (the
alleged successor in interest to Santarus) are liable for damages
under the antitrust laws for overcharges that the antitrust
plaintiffs allege they paid when they purchased the branded version
of Glumetza®
due to delayed generic entry. Plaintiffs seek treble damages for
alleged past harm, attorneys’ fees and costs.
In the federal litigation, fact and expert discovery have now
closed, and the court heard summary judgment arguments on April 22,
2021. On May 6, 2021, the court denied all motions for summary
judgment. The federal court granted class certification in the
direct purchaser action on August 15, 2020. In the event that the
federal case proceeds to trial, that trial is expected to occur on
or about October 2021. With respect to the newly-filed Humana case
in California state court, the Company and other defendants filed a
motion to dismiss all claims in the action on April 16, 2021. The
Company intends to defend itself vigorously in these matters. A
liability for this matter has been recorded in the financial
statements.
Securities Class Action Lawsuit and Related Matters
On August 23, 2017, the Company, two individuals who formerly
served as its chief executive officer and president, and its former
chief financial officer were named as defendants in a purported
federal securities law class action filed in the U.S. District
Court for the Northern District of California (the District Court).
The action (Huang
v. Depomed et al.,
No. 4:17-cv-4830-JST, N.D. Cal.) alleges violations of Sections
10(b) and 20(a) of the Securities Exchange Act of 1934, as amended,
and Rule 10b-5 relating to certain prior disclosures of the Company
about its business, compliance, and operational policies and
practices concerning the sales and marketing of its opioid products
and contends that the conduct supporting the alleged violations
affected the value of Company common stock and is seeking damages
and other relief. In an amended complaint filed on February 6,
2018, the lead plaintiff (referred to in its pleadings as the
Depomed Investor Group), which seeks to represent a class
consisting of all purchasers of Company common stock between July
29, 2015 and August 7, 2017, asserted the same claims arising out
of the same and similar disclosures against the Company and the
same individuals as were involved in the original complaint. The
Company and the individuals filed a motion to dismiss the amended
complaint on April 9, 2018. On March 18, 2019, the District Court
granted the motion to dismiss without prejudice, and the plaintiffs
filed a second amended complaint on May 2, 2019. The second amended
complaint asserted the same claims arising out of the same and
similar disclosures against the Company and the same individuals as
were involved in the original complaint. The Company and the
individuals filed a motion to dismiss the second amended complaint
on June 17, 2019, and the District Court granted that motion with
prejudice on March 11, 2020. On April 9, 2020, the plaintiffs filed
a notice of appeal with the United States Court of Appeals for the
Ninth Circuit. The parties completed their briefing of the appeal
on December 14, 2020. On March 1, 2021, the court granted the
parties’ joint motion to stay the appeal pending settlement
discussions. On July 30, 2021, the Company
reached an agreement to settle the matter subject to District Court
approval. The parties are in the process of seeking preliminary
District Court approval.
In addition, five shareholder derivative actions were filed on
behalf of the Company against its officers and directors for breach
of fiduciary duty, unjust enrichment, abuse of control, gross
mismanagement, waste of corporate assets, and violations of the
federal securities laws. The claims arise out of the same factual
allegations as the purported federal securities class action
described above. The first derivative action was filed in the
Superior Court of California, Alameda County on September 29, 2017
(Singh
v. Higgins et al.,
RG17877280). The second and third actions were filed in the
Northern District of California on November 10, 2017
(Solak
v. Higgins et al.,
No. 3:17-cv-6546-JST) and November 15, 2017 (Ross
v. Fogarty et al.,
No. 3:17-cv-6592- JST). The fourth action was filed in the District
of Delaware on December 21, 2018 (Lutz
v. Higgins et al,
No. 18-2044-CFC). The fifth derivative action was filed in the
Superior Court of California, Alameda County on January 28, 2019
(Youse
v. Higgins et al,
No. HG19004409). On December 7, 2017, the plaintiffs in
Solak v. Higgins, et al.
voluntarily dismissed the action. On July 12, 2019, the
Singh
and
Youse
actions were consolidated. All of the derivative actions were
stayed pending the resolution of the class action, and the stays
have been extended pending the resolution of the appeal. On July
30, 2021, the Company reached an agreement to settle these matters
subject to court approval.
The parties
are in the process of seeking preliminary court
approval.
A liability for these matters and the securities law class action
described in the preceding paragraph has been recorded in the
financial statements.
Opioid-Related Request and Subpoenas
As a result of the greater public awareness of the public health
issue of opioid abuse, there has been increased scrutiny of, and
investigation into, the commercial practices of opioid
manufacturers generally by federal, state, and local regulatory and
governmental agencies. In March 2017, the Company’s subsidiary
Assertio Therapeutics, Inc. (Assertio Therapeutics) received a
letter from then-Sen. Claire McCaskill (D-MO), the then-Ranking
Member on the U.S. Senate Committee on Homeland Security and
Governmental Affairs, requesting certain information regarding
Assertio Therapeutics’ historical commercialization of opioid
products. Assertio Therapeutics voluntarily furnished information
responsive to Sen. McCaskill’s request. Since 2017, Assertio
Therapeutics has received and responded to subpoenas from the U.S.
Department of Justice (DOJ) seeking documents and information
regarding its historical sales and marketing of opioid products.
Assertio Therapeutics has also received and responded to subpoenas
or civil investigative demands focused on its historical promotion
and sales of Lazanda, NUCYNTA, and NUCYNTA ER from various state
attorneys general seeking documents and information
regarding
Assertio Therapeutics’ historical sales and marketing of opioid
products. In addition, Assertio Therapeutics received and responded
to a subpoena from the State of California Department of Insurance
(CDI) seeking information relating to its historical sales and
marketing of Lazanda. The CDI subpoena also seeks information on
Gralise, a non-opioid product formerly in Assertio Therapeutics’
portfolio. In addition, Assertio Therapeutics received and
responded to a subpoena from the New York Department of Financial
Services seeking information relating to its historical sales and
marketing of opioid products. The Company also from time to time
receives and complies with subpoenas from governmental authorities
related to investigations primarily focused on third parties,
including healthcare practitioners. Assertio Therapeutics is
cooperating with the foregoing governmental investigations and
inquiries.
Multidistrict Opioid Litigation
A number of pharmaceutical manufacturers, distributors and other
industry participants have been named in numerous lawsuits around
the country brought by various groups of plaintiffs, including city
and county governments, hospitals, individuals and others. In
general, the lawsuits assert claims arising from defendants’
manufacturing, distributing, marketing and promoting of
FDA-approved opioid drugs. The specific legal theories asserted
vary from case to case, but the lawsuits generally include federal
and/or state statutory claims, as well as claims arising under
state common law. Plaintiffs seek various forms of damages,
injunctive and other relief and attorneys’ fees and
costs.
For such cases filed in or removed to federal court, the Judicial
Panel on Multi-District Litigation issued an order in December
2017, establishing a Multi-District Litigation court (MDL Court) in
the Northern District of Ohio (In re National Prescription Opiate
Litigation, Case No. 1:17-MD-2804). Since that time, more than
2,000 such cases that were originally filed in U.S. District
Courts, or removed to federal court from state court, have been
filed in or transferred to the MDL Court. Assertio Therapeutics is
currently involved in a subset of the lawsuits that have been filed
in or transferred to the MDL Court,
as well as one additional federal lawsuit in the Eastern District
of Kentucky.
Plaintiffs may file additional lawsuits in which the Company may be
named. Plaintiffs in the pending federal cases involving the
Company include individuals; county, municipal and other
governmental entities; employee benefit plans, health insurance
providers and other payors; hospitals, health clinics and other
health care providers; Native American tribes; and non-profit
organizations who assert, for themselves and in some cases for a
putative class, federal and state statutory claims and state common
law claims, such as conspiracy, nuisance, fraud, negligence, gross
negligence, negligent and intentional infliction of emotional
distress, deceptive trade practices, and products liability claims
(defective design/failure to warn). In these cases, plaintiffs seek
a variety of forms of relief, including actual damages to
compensate for alleged personal injuries and for alleged past and
future costs such as to provide care and services to persons with
opioid-related addiction or related conditions, injunctive relief,
including to prohibit alleged deceptive marketing practices and
abate an alleged nuisance, establishment of a compensation fund,
establishment of medical monitoring programs, disgorgement of
profits, punitive and statutory treble damages, and attorneys’ fees
and costs. No trial date has been set in any of these lawsuits,
which are at an early stage of proceedings. The Company intends to
defend itself vigorously in these matters.
State Opioid Litigation
Related to the cases in the MDL Court noted above, there have been
hundreds of similar lawsuits filed in state courts around the
country, in which various groups of plaintiffs assert opioid-drug
related claims against similar groups of defendants. Assertio
Therapeutics is currently named in a subset of those cases,
including cases in Missouri, Nevada, Pennsylvania, Texas and Utah.
Plaintiffs may file additional lawsuits in which Assertio
Therapeutics may be named. In the pending cases involving Assertio
Therapeutics, plaintiffs are asserting state common law and
statutory claims against the defendants similar in nature to the
claims asserted in the MDL cases. Plaintiffs are seeking actual
damages, disgorgement of profits, injunctive relief, punitive and
statutory treble damages, and attorneys’ fees and costs. The state
lawsuits in which Assertio Therapeutics has been served are
generally each at an early stage of proceedings. The Company
intends to defend itself vigorously in these matters.
Insurance Litigation
On January 15, 2019, the Company was named as a defendant in a
declaratory judgment action filed by Navigators Specialty Insurance
Company (Navigators) in the U.S. District Court for the Northern
District of California (Case No. 3:19-cv-255). Navigators is the
Company’s primary product liability insurer. Navigators was seeking
declaratory judgment that opioid litigation claims noticed by the
Company (as further described above under “Multidistrict Opioid
Litigation” and “State Opioid Litigation”) are not covered by the
Company’s life sciences liability policies with Navigators. On
February 3, 2021, the Company entered into a Confidential
Settlement Agreement and Mutual Release with Navigators to resolve
the declaratory judgment action and the Company’s counterclaims.
Pursuant to the Settlement Agreement, the parties settled and the
coverage action was dismissed without prejudice.
During
the first quarter of 2021, the Company received $5.0 million
in insurance reimbursement for previous opioid-related spend, which
was recognized within Selling, general and administrative expenses
in the Condensed Consolidated Statements of Comprehensive
Income.
On July 16, 2021, the Company filed a complaint for declaratory
relief against one of its excess products liability insurers,
Lloyd’s of London Newline Syndicate 1218 and related entities
(Newline), in the Superior Court of the State of California for the
County of Alameda. The Company is seeking a declaratory judgment
that Newline has a duty to defend the Company or, alternatively, to
reimburse the Company’s attorneys’ fees and other defense costs for
opioid litigation claims noticed by the Company.
CAMBIA®
ANDA Litigation
On July 16, 2020, the Company and APR Applied Pharma Research SA
(APR), received notice from Patrin Pharma Inc. (Patrin) advising
that Patrin had filed an Abbreviated New Drug Application (ANDA)
seeking to market a generic version of CAMBIA®
50 mg prior to the expiration of U.S. patents in June 2026 as
listed in the FDA “Orange Book” for CAMBIA (Orange Book Patents).
The Orange Book Patents are licensed to the Company by APR. On
August 27, 2020, the Company and APR filed a lawsuit against Patrin
in the U.S. District Court for the Northern District of Illinois,
Eastern Division, seeking an injunction to prevent approval of the
Patrin ANDA. The lawsuit alleges that Patrin has infringed the
Orange Book Patents by filing an ANDA with a Paragraph IV
Certification seeking approval from the FDA to market a generic
version of CAMBIA prior to the expiration of the patents. The
commencement of the patent infringement suit stays or bars the FDA
from approving Patrin’s ANDA for 30 months or until an earlier
district court decision that each of the patents is invalid or not
infringed. On September 18, 2020, Patrin filed its answer including
affirmative defenses and counterclaims. On October 9, 2020, the
Company and APR filed an answer to Patrin’s counterclaims. On
January 21, 2021, the court stayed all case deadlines pending
settlement discussions between the parties. On March 8, 2021, the
Company entered into a confidential settlement agreement with
Patrin. On March 10, 2021, the Court granted the parties’ agreed
motion for entry of Judgment and Order of Permanent Injunction.
This settlement concludes all ongoing ANDA litigation.
NOTE 13. RESTRUCTURING CHARGES
The Company continually evaluates its operations to identify
opportunities to streamline operations and optimize operating
efficiencies as an anticipation to changes in the business
environment.
On December 15, 2020, the Company announced
the December 2020 Plan which was designed to substantially reduce
the Company’s operating footprint through the reduction of its
staff at our headquarters office and remote sales force. The
Company substantially completed the workforce reduction in the
first quarter of 2021.
In May 2020, the Company began implementing reorganization plans of
its workforce and other restructuring activities to realize the
synergies of the Zyla Merger and to re-align resources to strategic
areas and drive growth (Zyla Merger Reorganization). The Company
completed the restructuring activities in 2020 and does not expect
to incur significant costs related to the Zyla Merger
Reorganization in 2021.
The following table reflects total expenses
related to restructuring activities recognized within the
Condensed
Consolidated Statement of Comprehensive Income as restructuring
costs (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
Six Months Ended June 30, |
|
2021 |
2020 |
2021 |
2020 |
Employee compensation costs |
$ |
— |
|
$ |
5,435 |
|
$ |
876 |
|
$ |
5,435 |
|
Equity compensation costs |
— |
|
999 |
|
— |
|
999 |
|
Other exit costs |
— |
|
85 |
|
213 |
|
85 |
|
Total restructuring costs |
$ |
— |
|
$ |
6,519 |
|
$ |
1,089 |
|
$ |
6,519 |
|
The following table reflects cash activity relating to the
Company’s accrued restructuring cost as of June 30, 2021 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employee compensation costs |
|
Other exit costs |
|
Total |
Balance as of December 31, 2020 |
$ |
8,744 |
|
|
$ |
— |
|
|
$ |
8,744 |
|
Restructuring charges |
876 |
|
|
213 |
|
|
1,089 |
|
Cash paid |
(5,879) |
|
|
(213) |
|
|
(6,092) |
|
|
|
|
|
|
|
Balance as of March 31, 2021 |
$ |
3,741 |
|
|
$ |
— |
|
|
$ |
3,741 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid |
(1,544) |
|
|
— |
|
|
(1,544) |
|
Balance as of June 30, 2021 |
$ |
2,197 |
|
|
$ |
— |
|
|
$ |
2,197 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NOTE 14. NET INCOME (LOSS) PER SHARE
Basic net (loss) income per share is calculated by dividing the net
(loss) income by the weighted-average number of shares of common
stock outstanding during the period. Upon consummation of the Zyla
Merger in May 2020, the Company inherited outstanding Zyla warrants
to purchase Zyla common stock, which were converted into the right
to purchase shares of Assertio’s common stock. As these warrants
are exercisable at any time at an exercise price of $0.0016 per
share, they represent contingently issuable shares and therefore
are included in the number of outstanding shares used for the
computation of basic income per share. There were 392,095
unexercised shares of common stock issuable upon the exercise of
warrants as of June 30, 2021.
Diluted net (loss) income per share is calculated by dividing the
net (loss) income by the weighted-average number of shares of
common stock outstanding during the period, plus potentially
dilutive common shares, consisting of stock options, awards, and
equivalents and convertible debt. The Company uses the
treasury-stock method to compute diluted earnings per share with
respect to its stock options and equivalents. The Company uses the
if-converted method to compute diluted earnings per share with
respect to its convertible debt. For purposes of this calculation,
options to purchase stock are considered to be potential common
shares and are only included in the calculation of diluted net
(loss) income per share when their effect is dilutive.
The following table reflects the calculation of basic and diluted
earnings per common share for the three and six months ended
June 30, 2021 and 2020 (in thousands, except for per share
amounts):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2021 |
|
2020 |
|
2021 |
|
2020 |
|
Basic net income (loss) per share |
|
|
|
|
|
|
|
|
Net (loss) income |
$ |
(14,169) |
|
|
$ |
(34,499) |
|
|
$ |
(9,625) |
|
|
$ |
6,731 |
|
|
Weighted average common shares and warrants outstanding |
44,706 |
|
|
24,640 |
|
|
41,321 |
|
|
22,459 |
|
|
Basic net (loss) income per share |
$ |
(0.32) |
|
|
$ |
(1.40) |
|
|
$ |
(0.23) |
|
|
$ |
0.30 |
|
|
|
|
|
|
|
|
|
|
|
Diluted net income (loss) per share |
|
|
|
|
|
|
|
|
Net (loss) income |
$ |
(14,169) |
|
|
$ |
(34,499) |
|
|
$ |
(9,625) |
|
|
$ |
6,731 |
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares and share equivalents
outstanding |
44,706 |
|
|
24,640 |
|
|
41,321 |
|
|
22,459 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Add: effect of dilutive stock options, awards, and
equivalents |
— |
|
|
— |
|
|
— |
|
|
100 |
|
|
Diluted net (loss) income per share |
$ |
(0.32) |
|
|
$ |
(1.40) |
|
|
$ |
(0.23) |
|
|
$ |
0.30 |
|
|
The following table reflects outstanding potentially dilutive
common shares that are not included in the computation of diluted
net income (loss) per share, because to do so would be
anti-dilutive, for the three and six months ended June 30,
2021 and 2020 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
2.5% Convertible Notes debt 2021
|
4 |
|
|
59 |
|
|
4 |
|
|
671 |
|
5.0% Convertible Notes debt 2024
|
— |
|
|
276 |
|
|
— |
|
|
3,435 |
|
|
|
|
|
|
|
|
|
Stock options, awards and equivalents |
2,924 |
|
|
2,625 |
|
|
2,899 |
|
|
1,957 |
|
Total potentially dilutive common shares |
2,928 |
|
|
2,960 |
|
|
2,903 |
|
|
6,063 |
|
NOTE 15. FAIR VALUE
The following table reflects the Company’s fair value hierarchy for
its financial assets and liabilities measured at fair value on a
recurring basis as of June 30, 2021 and December 31, 2020 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2021 |
|
Financial Statement Classification |
|
Level 1 |
|
Level 2 |
|
Level 3 |
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities: |
|
|
|
|
|
|
|
|
|
|
Short-term contingent consideration |
|
Contingent consideration, current portion |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
6,850 |
|
|
$ |
6,850 |
|
Long-term contingent consideration |
|
Contingent consideration |
|
— |
|
|
— |
|
|
30,809 |
|
|
30,809 |
|
Total |
|
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
37,659 |
|
|
$ |
37,659 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2020 |
|
Financial Statement Classification |
|
Level 1 |
|
Level 2 |
|
Level 3 |
|
Total |
Assets: |
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
Cash and cash equivalents |
|
$ |
77 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
77 |
|
Total |
|
|
|
$ |
77 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
77 |
|
Liabilities: |
|
|
|
|
|
|
|
|
|
|
Short-term contingent consideration |
|
Contingent consideration, current portion |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
6,776 |
|
|
$ |
6,776 |
|
Long-term contingent consideration |
|
Contingent consideration |
|
— |
|
|
— |
|
|
31,776 |
|
|
31,776 |
|
Total |
|
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
38,552 |
|
|
$ |
38,552 |
|
Cash equivalents consisted of money market funds with overnight
liquidity and no stated maturities. The Company classified cash
equivalents as Level 1, due to their short-term maturity, and
measured the fair value based on quoted prices in active markets
for identical assets.
Pursuant to the May 2020 Zyla Merger, the Company assumed a
contingent consideration obligation which is measured at fair
value. The Company has obligations to make contingent consideration
payments for future royalties to Iroko based upon annual INDOCIN
Product net sales over $20.0 million. The Company classified the
acquisition-related contingent consideration liabilities to be
settled in cash as Level 3, due to the lack of relevant observable
inputs and market activity. As of June 30, 2021, INDOCIN
Product contingent consideration was $37.5 million with $6.9
million classified as short-term and $30.6 million classified as
long-term contingent consideration, respectively, in the Condensed
Consolidated Balance Sheet. During the three and six months ended
June 30, 2021 the Company recognized a charge of $2.2 million
and $1.6 million, respectively, for the change in fair value of
contingent consideration, which was recognized in Selling, general
and administrative expense in the Company’s Condensed Consolidated
Statements of Comprehensive Income. The fair value of the
contingent consideration is determined using an option pricing
model under the income approach based on estimated INDOCIN product
revenues through January 2029 and discounted to present value. The
significant assumptions used in the calculation of the fair value
as of June 30, 2021 included revenue volatility of 40.0%,
discount rate of 7.0%, credit spread of 5.2% and updated
projections of future INDOCIN Product revenues.
Contingent consideration related to CAMBIA was $0.2 million as
of June 30, 2021 and 2020.
The carrying value of the Company’s debt for the period ended
June 30, 2021 approximates its fair value. When determining
the estimated fair value of the Company’s debt, the Company uses a
commonly accepted valuation methodology and market-based risk
measurements that are indirectly observable, such as credit
risk.
There were no transfers between Level 1, Level 2 or Level 3 of the
fair value hierarchy during the three and six months ended
June 30, 2021.
NOTE 16. INCOME TAXES
As of June 30, 2021, the Company’s net deferred tax assets are
fully offset by a valuation allowance. The valuation allowance is
determined in accordance with the provisions of ASC 740, Income
Taxes, which require an assessment of both negative and positive
evidence when measuring the need for a valuation allowance. Based
on the weight of available evidence, the Company recorded a full
valuation allowance against its net deferred tax assets beginning
in the fourth quarter of 2016 and continues to provide a full
valuation allowance against the its net deferred tax assets in
subsequent quarters. The Company reassesses the need for a
valuation allowance on a quarterly basis. If it is determined that
a portion or all of the valuation allowance is not required, it
will generally be a benefit to the income tax provision in the
period such determination is made.
For the six months ended June 30, 2021, the Company recorded
an income taxes expense of approximately $0.2 million. The
difference between the income tax expense of $0.2 million and the
tax at the statutory rate of 21.0% to date on current year
operations is principally due to the partial release of valuation
allowance related to the current year movement in deferred tax
assets.
The Company files income tax returns in the
United States federal jurisdiction and in various states, and the
tax returns filed for the years 2007 through 2020 and the
applicable statutes of limitation have not expired with respect to
those returns. Because of NOLs and unutilized R&D credits,
substantially all of the Company’s tax years remain open to
examination. The Company previously exhausted all the federal
research and development credit in the 2018 tax return, but the NOL
carryback from CARES Act will result in making R&D credits
utilized in 2018 available for future use, the percentage of
unrecognized tax benefit against the R&D credit remains
reserved, and the rest will be offset by valuation allowance.
Interest and penalties, if any, related to unrecognized tax
benefits, would be recognized as income tax expense by the Company.
At June 30, 2021 the Company did not have significant accrued
interest and penalties associated with unrecognized tax
benefits.
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
FORWARD-LOOKING INFORMATION
Statements made in this “Management’s Discussion and Analysis of
Financial Condition and Results of Operations” and elsewhere in
this Quarterly Report on Form 10-Q that are not statements of
historical fact are forward-looking statements within the meaning
of Section 27A of the Securities Act of 1933, as amended (the
Securities Act), and Section 21E of the Securities Exchange Act of
1934, as amended (the Exchange Act). We have based these
forward-looking statements on our current expectations and
projections about future events. Our actual results could differ
materially from those discussed in, or implied by, these
forward-looking statements. Forward-looking statements are
identified by words such as “believe,” “anticipate,” “expect,”
“intend,” “plan,” “will,” “may” and other similar expressions. In
addition, any statements that refer to expectations, projections or
other characterizations of future events or circumstances are
forward-looking statements. Forward-looking statements include, but
are not necessarily limited to, those relating to:
•the
potential impacts of disasters, acts of terrorism or global
pandemics, including the ongoing COVID-19 pandemic, on our
liquidity, capital resources, operations and business and those of
the third parties on which we rely, including suppliers and
distributors;
•our
ability to execute and achieve the expense savings expected from
our restructuring plan announced in December 2020, which is
designed to further reduce our cost base and right size the
organization, as well as delays, challenges and expenses, and
unexpected costs associated with executing the restructuring
plan;
•our
ability to achieve the growth prospects and synergies expected from
our merger with Zyla Life Sciences, as well as delays, challenges
and expenses, and unexpected costs associated with integrating and
operating the combined company’s businesses;
•our
ability to successfully pursue business development, strategic
partnerships, and investment opportunities to build and grow for
the future;
•the
commercial success and market acceptance of our
products;
•the
coverage of our products by payors and pharmacy benefit
managers;
•the
entry of generics for any of our products;
•the
outcome of opioid-related investigations, opioid-related litigation
and related claims for insurance coverage, and other disputes and
litigation, and the costs and expenses associated
therewith;
•the
outcome of our antitrust litigation relating to our former drug
Glumetza®;
•our
ability to obtain and maintain intellectual property protection for
our products and operate our business without infringing the
intellectual property rights of others;
•our
estimates regarding expenses, future revenues, capital requirements
and needs for additional financing;
•our
ability to generate sufficient cash flow from our business to make
payments on our indebtedness, our ability to restructure or
refinance our indebtedness, if necessary, and our compliance with
the terms and conditions of the agreements governing our
indebtedness;
•our
common stock maintaining compliance with Nasdaq’s minimum closing
bid requirement of at least $1.00 per share;
•our
compliance or non-compliance with legal and regulatory requirements
related to the development or promotion of pharmaceutical products
in the U.S.;
•our
plans to acquire, in-license or co-promote other products, and/or
acquire companies;
•the
timing and results of our research and development efforts
including clinical studies relating to any future product
candidates;
•our
ability to raise additional capital, if necessary;
•our
ability to successfully develop and execute our sales, marketing
and non-personal and digital promotion strategies, including
developing relationships with customers, physicians, payors and
other constituencies;
•variations
in revenues obtained from commercialization agreements, including
contingent milestone payments, royalties, license fees and other
contract revenues, including non-recurring revenues, and the
accounting treatment with respect thereto;
•our
counterparties’ compliance or non-compliance with their obligations
under our agreements; and
•our
ability to attract and retain key executive
leadership.
Factors that could cause actual results or conditions to differ
from those anticipated by these and other forward-looking
statements include those more fully described and incorporated by
reference in the “RISK
FACTORS”
section and elsewhere in this Quarterly Report on Form 10-Q, in our
Annual Report on Form 10-K for the fiscal year ended December
31, 2020 and in our Quarterly Report on Form 10-Q for the three
months ended March 31, 2021. Except as required by law, we assume
no obligation to update any forward-looking statement publicly, or
to revise any forward-looking statement to reflect events or
developments occurring after the date of this Quarterly Report on
Form 10-Q, even if new information becomes available in the
future.
COMPANY OVERVIEW
We are a commercial pharmaceutical company offering differentiated
products to patients. Our commercial portfolio of branded products
focuses on three areas: neurology, hospital, and pain and
inflammation. We have built our commercial portfolio through a
combination of increased opportunities with existing products, as
well as through the acquisition or licensing of additional approved
products. Our primary marketed products are:
|
|
|
|
|
|
INDOCIN®
(indomethacin) Suppositories
INDOCIN®
(indomethacin) Oral Suspension
|
A suppository form and oral solution of indomethacin, a
nonsteroidal anti-inflammatory drug (NSAID), approved
for:
•Moderate
to severe rheumatoid arthritis including acute flares of chronic
disease
•Moderate
to severe ankylosing spondylitis
•Moderate
to severe osteoarthritis
•Acute
painful shoulder (bursitis and/or tendinitis)
•Acute
gouty arthritis
|
CAMBIA® (diclofenac potassium for oral solution) |
A prescription medicine used to treat migraine attacks in adults.
CAMBIA does not prevent or lessen the number of migraines one has,
and it is not for other types of headaches. It contains diclofenac
potassium, a non-steroidal anti-inflammatory drug
(NSAID). |
SPRIX®
(ketorolac tromethamine) Nasal Spray
|
A prescription NSAID indicated in adult patients for the short term
(up to five days) management of moderate to moderately severe pain
that requires analgesia at the opioid level. |
Zipsor®
(diclofenac potassium) Liquid filled capsules
|
A prescription NSAID used for relief of mild-to-moderate pain in
adults (18 years of age and older) |
Other commercially available products include OXAYDO® (oxycodone
HCI, USP) tablets for oral use only —CII.
Impact of COVID-19 on our Business
Following the outbreak of COVID-19 during
early 2020, our priority was and remains the health and safety of
our employees, their families, and the patients we serve. As a
result, in March 2020, we initiated remote working arrangements and
maintained flexible work arrangements for individuals, which
continued through the remainder of 2020 and into 2021. In addition
to the health and safety of our employees, we are focused on
ensuring that we continue making our products accessible to the
patients who need them. Because COVID-19 impacted our ability to
see in-person providers who prescribe our products, we adapted our
approach during 2020 and increased our virtual visits.
Additionally, due to the limitations on elective surgeries and
changes in patient behavior since the outbreak of COVID-19, we have
experienced a decline and subsequent volatility in prescriptions
associated with those elective procedures.
We implemented a restructuring plan in December 2020 which, we
believe, allows our business to continue to provide our
differentiated products to patients and better positions ourselves
for future success. We believe that we are prepared with sufficient
product inventory, technology to facilitate virtual and/or digital
communications, and operations prepared to adapt our work
environment as needed. The extent to which our operations may
continue to be impacted by the COVID-19 pandemic will depend
largely on future developments, which are highly uncertain and
cannot be accurately predicted, including new information which may
emerge concerning the severity of the outbreak, actions by
government authorities to contain the outbreak or treat its impact,
the emergence of new COVID-19 variants and the related potential
for new surges in infections, and the distribution, public
acceptance and efficacy of COVID-19 vaccines including for emerging
variations.
Segment Information
We manage our business within one reportable segment. Segment
information is consistent with how management reviews the business,
makes investing and resource allocation decisions and assesses
operating performance. To date, substantially all of revenues from
product sales are related to sales in the U.S.
CRITICAL ACCOUNTING POLICIES
Critical accounting policies are those that require significant
judgment and/or estimates by management at the time that the
financial statements are prepared such that materially different
results might have been reported if other assumptions
had been made. We consider certain accounting policies related to
revenue recognition, accrued liabilities and use of estimates to be
critical policies. These estimates form the basis for making
judgments about the carrying value of assets and liabilities. We
believe there have been no significant changes in our critical
accounting policies and significant judgements and estimates since
we filed our Annual Report on Form 10-K for the year ended December
31, 2020 filed with the SEC on March 12, 2021 (the 2020 Form 10-K),
see ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS — Critical Accounting Policies
and Estimates in our 2020 Form 10-K for further
information.
RESULTS OF OPERATIONS
Revenues
The following table reflects total revenues, net for the three and
six months ended June 30, 2021 and 2020 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Product sales, net: |
|
|
|
|
|
|
|
INDOCIN products
(1)
|
$ |
13,075 |
|
|
$ |
5,434 |
|
|
$ |
27,673 |
|
|
$ |
5,434 |
|
CAMBIA |
6,128 |
|
|
7,780 |
|
|
12,590 |
|
|
14,054 |
|
Zipsor |
2,581 |
|
|
3,535 |
|
|
4,803 |
|
|
5,866 |
|
SPRIX
(1)
|
2,942 |
|
|
1,602 |
|
|
4,639 |
|
|
1,602 |
|
Other |
105 |
|
|
1,814 |
|
|
1,533 |
|
|
2,461 |
|
Total product sales, net |
24,831 |
|
|
20,165 |
|
|
51,238 |
|
|
29,417 |
|
Commercialization agreement revenue, net |
— |
|
|
— |
|
|
— |
|
|
11,258 |
|
Royalties and milestone revenue |
542 |
|
|
452 |
|
|
975 |
|
|
859 |
|
Total revenues |
$ |
25,373 |
|
|
$ |
20,617 |
|
|
$ |
52,213 |
|
|
$ |
41,534 |
|
(1)Products
acquired in connection with May 20, 2020 Zyla Merger.
Product Sales, net
For the three and six months ended June 30, 2021, product
sales primarily consisted of sales from INDOCIN Products, CAMBIA,
Zipsor and SPRIX. We began shipping and recognizing product sales
for INDOCIN Products and SPRIX upon the Zyla Merger on May 20,
2020.
CAMBIA
net product sales for the three and six months ended June 30,
2021 decreased $1.7 million from $7.8 million to $6.1 million and
$1.5 million from $14.1 million to $12.6 million, respectively,
primarily due to lower volume partially offset by favorable payor
mix.
Zipsor
net product sales for the three and six months ended June 30,
2021 decreased $1.0 million from $3.5 million to $2.6 million
and $1.1 million from $5.9 million to $4.8 million, respectively,
primarily due to lower volume partially offset by favorable payor
mix.
Other product sales includes product sales adjustments for
previously divested products, including Gralise, which was divested
in January 2020; and product sales for non-promoted products
(OXAYDO and SOLUMATRIX) which were acquired from Zyla in May 2020.
Product sales for our non-promoted products were $0.5 million
and $1.6 million, respectively, for the three and six months
ended June 30, 2021. In September 2020, we terminated our
iCeutica License and as a result will no longer manufacture
products using SOLUMATRIX technology. Product sales adjustments for
previously divested products include adjustments to recorded sales
reserve estimates.
Commercialization Agreement Revenue, net
We ceased recognizing commercialization revenue and related costs
for NUCYNTA effective the closing of the transaction to divest its
rights, title and interest in and to the NUCYNTA franchise to
Collegium on February 13, 2020. During the six months ended
June 30, 2020, we recognized net revenue from the
Commercialization Agreement of $11.3 million.
This
included variable royalty revenue of $13.1 million partially
offset by the amortization of the $1.8 million net contract
asset in connection with the termination of the Commercialization
Agreement.
Royalties & Milestones
In November 2010, we entered into a license agreement with Tribute
Pharmaceuticals Canada Ltd. (now known as Nuvo Pharmaceuticals,
Inc.) granting them the rights to commercially market CAMBIA in
Canada. We receive royalties on net sales as well as certain
one-time contingent milestone payments. During the three and six
months ended June 30, 2021, the Company recognized $0.5
million and $1.0 million of revenue related to CAMBIA in Canada,
respectively. During the three and six ended June 30, 2020,
the Company recognized $0.5 million and $0.9 million of revenue
related to CAMBIA in Canada, respectively.
Cost of Sales (excluding amortization of intangible
assets)
Cost of sales decreased $1.3 million from $5.2 million to
$3.9 million during the three months ended June 30, 2021
as compared to the same period in 2020 primarily due to higher Zyla
Merger related inventory step-up expense in the second quarter of
2020 not repeating in the current period partially offset by lower
cost of sales for Zyla products in the second quarter 2020 based on
timing of Zyla Merger on May 20, 2020.
Cost of sales increased $1.2 million from $6.6 million to $7.9
million during the six months ended June 30, 2021 as compared
to the same period in 2020 primarily due to higher cost of sales
for Zyla products in the current period based on timing of Zyla
Merger on May 20, 2020, partially offset by lower cost of sales as
a result of the Gralise divestiture in the first quarter of 2020
and lower Zyla Merger related inventory step-up expense in current
period.
The three and six months ended June 30, 2021 cost of sales
included $0.3 million and $0.6 million, respectively, of
amortization of inventory step-up related to Zyla acquired
inventories sold. The three and six months ended June 30, 2020
cost of sales included $2.4 million and $2.4 million,
respectively, of amortization of inventory step-up related to Zyla
acquired inventories sold.
Research and Development Expenses
Research and development expense decreased $1.6 million from $1.6
million to zero for the three months ended June 30, 2021 and
decreased $2.7 million from $2.7 million to zero for the six months
ended June 30, 2021 as compared to the same period in 2020
primarily due to the completion of all material research and
development activities in 2020. As a result of the December 2020
restructuring plan, we do not expect to incur significant research
and development costs in 2021.
Selling, General and Administrative Expenses
Selling, general, and administrative expenses decreased $1.9
million from $28.1 million to $26.2 million for the three months
ended June 30, 2021 primarily due to lower employee costs in
2021 as a result of prior restructuring plans partially offset by
additional expense for loss contingency provision recognized in the
current period.
Selling, general, and administrative expenses decreased $21.5
million from $55.4 million to $34.0 million for the six months
ended June 30, 2021, as compared to the same period in 2020
primarily due to one-time transaction costs in 2020 not repeating,
lower employee costs in 2021 as a result of prior restructuring
plans, receipt of insurance reimbursement in the first quarter of
2021 for previous opioid-related expenses, partially offset by
additional expense for loss contingency provision recognized in the
second quarter of 2021.
Intangible Assets
The following table reflects amortization of intangible assets for
the three and six months ended June 30, 2021 and 2020 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Amortization of intangible assets - INDOCIN |
$ |
3,210 |
|
|
$ |
1,941 |
|
|
$ |
6,420 |
|
|
$ |
1,941 |
|
Amortization of intangible assets - SPRIX |
1,393 |
|
|
948 |
|
|
2,786 |
|
|
948 |
|
Amortization of intangible assets - CAMBIA |
1,988 |
|
|
1,284 |
|
|
3,272 |
|
|
2,568 |
|
Amortization of intangible assets - Zipsor |
584 |
|
|
585 |
|
|
1,168 |
|
|
1,169 |
|
Amortization of intangible assets - Oxaydo |
43 |
|
|
97 |
|
|
118 |
|
|
97 |
|
Amortization of intangible assets - NUCYNTA |
— |
|
|
— |
|
|
— |
|
|
5,927 |
|
Total |
$ |
7,218 |
|
|
$ |
4,855 |
|
|
$ |
13,764 |
|
|
$ |
12,650 |
|
Amortization expense during the three months ended June 30,
2021 increased $2.4 million from $4.9 million to $7.2 million as
compared to the same period in 2020 primarily due to the timing of
Zyla Merger in May 2020, where we acquired product rights for
INDOCIN Products, SPRIX, and OXAYDO which are being amortized on a
straight-line basis over their respective estimated useful
lives.
Amortization expense during the six months ended June 30, 2021
increased $1.1 million from $12.7 million to $13.8 million as
compared to the same period in 2020 primarily due to the timing of
Zyla Merger in May 2020 partially offset by the February 2020
divestiture of our rights, title and interest to the NUCYNTA
franchise of products to Collegium. As a result, we derecognized
the remaining carrying value of the NUCYNTA product rights and
ceased recognizing related amortization.
Restructuring Charges
We continually evaluate our operations to identify opportunities to
streamline operations and optimize operating efficiencies as an
anticipation to changes in the business environment.
On December 15, 2020, we announced the December 2020 Plan which was
designed to substantially reduce the Company’s operating footprint
through the reduction of its staff at our headquarters office and
remote sales force. We substantially completed the workforce
reduction in the first quarter of 2021.
In May 2020, we began implementing reorganization plans of our
workforce and other restructuring activities to realize the
synergies of the Zyla Merger and to re-align resources to strategic
areas and drive growth (Zyla Merger Reorganization). We completed
the restructuring activities in 2020 and do not expect to incur
significant costs related to the Zyla Merger Reorganization in
2021.
For the three and six months ended June 30, 2021 restructuring
charges and one-time termination costs incurred were zero and $1.1
million, respectively. The restructuring charges cost and one-time
termination costs incurred for the three and six months ended
June 30, 2020 were $6.5 million and $6.5 million,
respectively.
Other (Expense) Income
The following table reflects other (expense) income for the three
and six months ended June 30, 2021 and 2020 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
(Loss) Gain on sale of Gralise |
$ |
— |
|
|
$ |
(850) |
|
|
$ |
— |
|
|
$ |
126,655 |
|
Loss on extinguishment of convertible notes |
— |
|
|
(16,272) |
|
|
— |
|
|
(47,880) |
|
Gain (Loss) on sale of NUCYNTA |
— |
|
|
1,006 |
|
|
— |
|
|
(14,749) |
|
Change in fair value of Collegium warrants |
— |
|
|
(484) |
|
|
— |
|
|
(3,629) |
|
Interest expense |
(2,605) |
|
|
(1,604) |
|
|
(5,288) |
|
|
(10,278) |
|
Loss on prepayment of Senior Notes |
— |
|
|
— |
|
|
— |
|
|
(8,233) |
|
Other gain (loss) |
137 |
|
|
(15) |
|
|
403 |
|
|
(195) |
|
|
|
|
|
|
|
|
|
Total other (expense) income |
$ |
(2,468) |
|
$ |
(18,219) |
|
$ |
(4,885) |
|
|
$ |
41,691 |
Other (expense) income changed by $15.8 million from other expense
of $18.2 million to $2.5 million for the three months ended
June 30, 2021 and changed $46.6 million from other income of
$41.7 million to other expense of $4.9 million for the six months
ended June 30, 2021, respectively, as compared to the same
period in 2020 primarily due to the prior year (loss) gain on the
sale of Gralise, gain (loss) on sale of NUCYNTA, loss on debt
extinguishment and change in fair value of Collegium warrants not
repeating. Sublease income offset by sublease expense is recorded
in Other gain (loss) within the above table.
The following table reflects interest expense for the three and six
months ended June 30, 2021 and 2020 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Interest payable on 13% Senior Secured Notes due 2024 |
$ |
2,557 |
|
$ |
1,407 |
|
$ |
— |
|
$ |
1,407 |
Interest payable on Senior Notes |
— |
|
— |
|
5,164 |
|
1,648 |
Interest payable on Convertible Notes |
— |
|
69 |
|
6 |
|
1,723 |
Amortization of debt discounts, and royalty rights |
48 |
|
125 |
|
118 |
|
5,511 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other |
— |
|
3 |
|
— |
|
(11) |
Total interest expense |
$ |
2,605 |
|
$ |
1,604 |
|
$ |
5,288 |
|
$ |
10,278 |
For the three and six months ended June 30, 2021, total
interest expense increased $1.0 million, and decreased $5.0
million, respectively, primarily due the settlement of the
remaining principal of our Senior Notes and the repurchase of a
portion of our 2021 and 2014 Notes in the second quarter of 2020
partially offset by interest expense associated with 13% Senior
Secured Notes assumed from the Zyla Merger in May
2020.
Income Tax Provision
For the three and six months ended June 30, 2021, we recorded
an income tax benefit of approximately $0.3 million and income tax
expense of approximately $0.2 million, respectively, which
represents an effective tax rate of 2.1% and (2.6)%, respectively.
The difference between the income tax benefit of $0.3 million and
income tax expenses of $0.2 million for the three and six months
ended June 30, 2021, respectively, and the tax at the
statutory rate of 21.0% to date on current period operations is
principally due to the partial release of valuation allowance
related to the current year movement in deferred tax
assets.
In the three and six months ended June 30, 2020, we recorded
an income tax benefit of approximately $9.5 million and $7.4
million, respectively, that represents an effective tax rate of
21.5% and 1071.3%, respectively. The difference between income tax
benefit of $9.5 million and income tax benefit of $7.4 million for
the three and six months ended June 30, 2020, respectively,
and the tax at the statutory rate of 21.0% was principally due to
the valuation allowance recorded against the beginning of year
deferred tax asset related the NOL carryback to the 2018 and 2019
tax years permitted by the CARES Act.
LIQUIDITY AND CAPITAL RESOURCES
Historically and through June 30, 2021, we have financed our
operations and business development efforts primarily from product
sales, private and public sales of equity securities, including
convertible debt securities, the proceeds of secured borrowings,
the sale of rights to future royalties and milestones, upfront
license, milestone and fees from collaborative and license
partners.
On February 9, 2021, we completed a registered direct offering with
certain institutional investors and accredited investors to sell
22,600,000 shares of our common stock at a purchase price of $0.62
per share. The gross proceeds from the offering were approximately
$14.0 million. After placement agent fees, we received net
proceeds of approximately $13.1 million. On February 12, 2021,
we completed a registered direct offering with certain
institutional investors and accredited investors to sell 35,000,000
shares of our common stock at a purchase price of $0.98 per share.
The gross proceeds from the offering were approximately
$34.3 million. After placement agent fees, we received net
proceeds of approximately $32.2 million. We also incurred $0.5
million direct incremental cost to complete both registered direct
offerings. We intend to use proceeds from both offerings for
general corporate purposes, including general working
capital.
We may incur operating losses in future years. We believe that our
existing cash will be sufficient to fund our operations for the
next twelve months from the date of this filing. We base this
expectation on our current operating plan, which may change as a
result of many factors.
Our cash needs may vary materially from our current expectations
because of numerous factors, including:
•acquisitions
or licenses of complementary businesses, products, technologies or
companies;
•sales
of our marketed products;
•expenditures
related to our commercialization of our products;
•milestone
and royalty revenue we receive under our collaborative development
arrangements;
•interest
and principal payments on our current and future
indebtedness;
•financial
terms of definitive license agreements or other commercial
agreements we may enter into;
•changes
in the focus and direction of our business strategy and/or research
and development programs;
•potential
expenses relating to ongoing litigation matters, including relating
to Assertio Therapeutics’ prior opioid product franchise for which
we have not accrued any reserves due to an inability to estimate
the magnitude and/or probability of such expenses, and former drug
Glumetza; and
•effects
of the COVID-19 pandemic on our operations.
The inability to raise any additional capital that may be required
to fund our future operations or product acquisitions and strategic
transactions which we may pursue could have a material adverse
effect on our company.
The following table reflects summarized cash flow activities for
the six months ended June 30, 2021 and 2020 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, |
|
|
2021 |
|
2020 |
Net cash used in operating activities |
|
$ |
(3,262) |
|
|
$ |
(45,159) |
|
Net cash provided by investing activities |
|
— |
|
|
512,802 |
|
Net cash provided by (used in) financing activities |
|
36,904 |
|
|
(450,347) |
|
Net increase in cash and cash equivalents |
|
$ |
33,642 |
|
|
$ |
17,296 |
|
Cash Flows from Operating Activities
Cash used in operating activities was $3.3 million during the six
months ended June 30, 2021 compared to $45.2 million in the
same period in 2020. The decrease in cash used from operating
activities is primarily due to combination of lower net income
offset by lower non-cash adjustments and favorable working capital
cash flows.
Cash Flows from Investing Activities
There was no cash flow activity from investing activities for the
six months ended June 30, 2021. Cash provided from investing
activities for the six months ended June 30, 2020 was $512.8
million, which included cash received for the sales of NUCYNTA,
Gralise and Collegium warrants as well as cash acquired in Zyla
Merger.
Cash Flows from Financing Activities
Cash provided by financing activities for the six months ended
June 30, 2021 was $36.9 million, which primarily consisted of
proceeds from the registered direct offerings in February 2021
partially offset by payments of our debt as well as contingent
consideration. Cash used in financing activities for the six months
ended June 30, 2020 was $450.3 million, which was primarily due to
the settlement of our Senior Notes and the repurchase of our
outstanding 2021 Notes and 2024 Notes.
Off-Balance Sheet Arrangement
There were no off-balance sheet arrangements during the quarter
ended June 30, 2021.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET
RISK
Not applicable
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
An evaluation was performed under the supervision and with the
participation of our management, including our Chief Executive
Officer and Chief Financial Officer, of the effectiveness of the
design and operation of our disclosure controls and procedures as
of the end of the period covered by this quarterly report. Based on
that evaluation, our management, including our Chief Executive
Officer and Chief Financial Officer, concluded that our disclosure
controls and procedures were effective.
We review and evaluate the design and effectiveness of our
disclosure controls and procedures on an ongoing basis to improve
our controls and procedures over time and to correct any
deficiencies that we may discover in the future. Our goal is to
ensure that our senior management has timely access to all material
financial and non-financial information concerning our business.
While we believe the present design of our disclosure controls and
procedures is effective to achieve our goal, future events
affecting our business may cause us to significantly modify our
disclosure controls and procedures
Changes in Internal Controls over Financial Reporting
During the first quarter of 2021, we finalized the process of
integrating our acquisition of Zyla’s operations in our internal
control environment. There were no other significant changes in our
internal controls over financial reporting during the six months
ended June 30, 2021 that have materially affected, or are
reasonably likely to materially affect, our internal controls over
financial reporting.
PART II — OTHER INFORMATION
ITEM 1. LEGAL PROCEEDING
For a description of our material pending legal proceedings, see
“Note 12. Commitments and Contingencies - Legal Matters” of the
Notes to the Condensed Consolidated Financial Statements included
in Part I, Item 1 of this Quarterly Report on Form 10-Q, which is
incorporated herein by reference.
ITEM 1A. RISK FACTORS
We are subject to various risks and uncertainties that could have a
material impact on our business, results of operations and
financial condition, including those hereby incorporated by
reference from Part I, Item 1A, “Risk Factors” in our Annual Report
on Form 10-K for the year ended December 31, 2020. There have been
no material changes to our risk factors since our Annual Report on
Form 10-K for the year ended December 31, 2020. In addition to
other information in this report, the risk factors referenced above
should be considered carefully in evaluating an investment in our
securities. If any of these risks or uncertainties actually occurs,
our business, results of operations or financial condition would be
materially and adversely affected. The risks and uncertainties
referenced above are not the only ones facing us. Additional risks
and uncertainties of which we are unaware or that we currently deem
immaterial may also become important factors that may harm our
business, results of operations and financial
condition.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF
PROCEEDS
We did not repurchase any shares of the Company’s common stock
during the period covered by this
Quarterly Report,
except for shares surrendered to us, as reflected in the following
table, to satisfy tax withholding obligations in connection with
the vesting of equity awards.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a)
Total Number of Shares (or Units) Purchased
(1)
|
(b)
Average Price Paid per Share |
(c)
Total Number of Shares (or Units) Purchased as Part of Publicly
Announced Plans or Programs |
(d)
Maximum Number (or Approximate Dollar Value) of Shares (or Units)
that May Yet Be Purchased Under the Plans or Programs |
April 1, 2021 -
April 30, 2021 |
4,645 |
$2.53 |
N/A |
N/A |
May 1, 2021 -
May 31, 2021 |
7,762 |
$1.65 |
N/A |
N/A |
June 1, 2021 -
June 30, 2021 |
— |
— |
N/A |
N/A |
Total |
12,407 |
$1.98 |
|
|
(1) Consists of shares withheld to pay employees’ tax liability in
connection with the vesting of equity awards granted under the our
stock-based compensation plans. These shares may be deemed to be
“issuer purchases” of shares.
ITEM 6. EXHIBITS
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|
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|
|
31.1 |
|
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|
|
31.2 |
|
|
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|
|
32.1* |
|
|
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|
|
32.2* |
|
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|
|
|
101.INS
|
|
Inline XBRL Instance Document - the instance document does not
appear in the Interactive Data File because its XBRL tags are
embedded within the Inline XBRL document |
|
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|
101.SCH |
|
Inline XBRL Taxonomy Extension Schema Document |
|
|
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101.CAL |
|
Inline XBRL Taxonomy Extension Calculation Linkbase
Document |
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101.DEF |
|
Inline XBRL Taxonomy Extension Definition Linkbase
Document |
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101.LAB |
|
Inline XBRL Taxonomy Extension Label Linkbase Document |
|
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101.PRE |
|
Inline XBRL Taxonomy Extension Presentation Linkbase
Document |
|
|
|
104 |
|
Cover Page Interactive Data File (formatted as Inline XBRL and
contained in Exhibit 101) |
_______________________________________________________
(*) Furnished herewith
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of
1934, the registrant has duly caused this report to be signed on
its behalf by the undersigned thereunto duly
authorized.
|
|
|
|
|
|
Date: August 5, 2021 |
ASSERTIO HOLDINGS, INC. |
|
|
|
/s/ Daniel A. Peisert |
|
Daniel A. Peisert |
|
President and Chief Executive Officer |
|
|
|
/s/ Paul Schwichtenberg |
|
Paul Schwichtenberg |
|
Senior Vice President and Chief Financial Officer |
|
|
|
/s/ Ajay Patel |
|
Ajay Patel |
|
Senior Vice President and Chief Accounting Officer |
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