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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 SEPTEMBER 30, 2022
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 November 1, 2022 was
48,293,613.
ASSERTIO HOLDINGS, INC.
FORM 10-Q FOR THE PERIOD ENDED SEPTEMBER 30, 2022
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 3. |
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PART I — FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
ASSERTIO HOLDINGS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
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(Unaudited) |
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September 30, 2022 |
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December 31, 2021 |
ASSETS |
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Current assets: |
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Cash and cash equivalents |
$ |
64,826 |
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$ |
36,810 |
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Accounts receivable, net |
44,680 |
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44,361 |
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Inventories, net |
14,268 |
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7,489 |
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Prepaid and other current assets |
2,720 |
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14,838 |
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Total current assets |
126,494 |
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103,498 |
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Property and equipment, net |
935 |
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1,527 |
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Intangible assets, net |
191,617 |
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216,054 |
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Other long-term assets |
4,298 |
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5,468 |
|
Total assets |
$ |
323,344 |
|
|
$ |
326,547 |
|
LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
8,374 |
|
|
$ |
6,685 |
|
Accrued rebates, returns and discounts |
48,608 |
|
|
52,662 |
|
Accrued liabilities |
10,992 |
|
|
14,699 |
|
|
|
|
|
Long-term debt, current portion |
2,175 |
|
|
12,174 |
|
Contingent consideration, current portion |
10,900 |
|
|
14,500 |
|
|
|
|
|
Other current liabilities |
11,247 |
|
|
34,299 |
|
Total current liabilities |
92,296 |
|
|
135,019 |
|
Long-term debt |
65,982 |
|
|
61,319 |
|
Contingent consideration |
25,759 |
|
|
23,159 |
|
Other long-term liabilities |
4,392 |
|
|
4,636 |
|
Total liabilities |
188,429 |
|
|
224,133 |
|
Commitments and contingencies |
|
|
|
Shareholders’ equity: |
|
|
|
Common stock, $0.0001 par value, 200,000,000 shares authorized;
48,196,618
and 44,640,444 shares issued and outstanding as of
September 30, 2022 and December 31, 2021,
respectively.
|
5 |
|
|
4 |
|
Additional paid-in capital |
543,064 |
|
531,636 |
|
Accumulated deficit |
(408,154) |
|
|
(429,226) |
|
|
|
|
|
Total shareholders’ equity |
134,915 |
|
|
102,414 |
|
Total liabilities and shareholders' equity |
$ |
323,344 |
|
|
$ |
326,547 |
|
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 September 30, |
|
Nine Months Ended
September 30, |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Revenues: |
|
|
|
|
|
|
|
Product sales, net |
$ |
34,279 |
|
|
$ |
25,997 |
|
|
$ |
105,258 |
|
|
$ |
77,271 |
|
Royalties and milestones |
473 |
|
|
416 |
|
|
1,916 |
|
|
1,391 |
|
Other revenue |
(540) |
|
|
(941) |
|
|
(1,290) |
|
|
(976) |
|
Total revenues |
34,212 |
|
|
25,472 |
|
|
105,884 |
|
|
77,686 |
|
Costs and expenses: |
|
|
|
|
|
|
|
Cost of sales |
4,009 |
|
|
3,050 |
|
|
12,734 |
|
|
10,936 |
|
|
|
|
|
|
|
|
|
Selling, general and administrative expenses |
11,900 |
|
|
9,013 |
|
|
33,084 |
|
|
41,377 |
|
Fair value of contingent consideration |
3,900 |
|
|
300 |
|
|
6,845 |
|
|
1,902 |
|
Amortization of intangible assets |
7,969 |
|
|
7,175 |
|
|
24,438 |
|
|
20,939 |
|
Restructuring charges |
— |
|
|
— |
|
|
— |
|
|
1,089 |
|
Total costs and expenses |
27,778 |
|
|
19,538 |
|
|
77,101 |
|
|
76,243 |
|
Income from operations |
6,434 |
|
|
5,934 |
|
|
28,783 |
|
|
1,443 |
|
Other (expense) income: |
|
|
|
|
|
|
|
Interest expense |
(2,052) |
|
|
(2,495) |
|
|
(6,648) |
|
|
(7,783) |
|
Other gain |
2 |
|
|
344 |
|
|
453 |
|
|
747 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other expense |
(2,050) |
|
|
(2,151) |
|
|
(6,195) |
|
|
(7,036) |
|
Net income (loss) before income taxes |
4,384 |
|
|
3,783 |
|
|
22,588 |
|
|
(5,593) |
|
Income tax expense |
(210) |
|
|
(46) |
|
|
(1,516) |
|
|
(294) |
|
Net income (loss) and comprehensive income (loss) |
$ |
4,174 |
|
|
$ |
3,737 |
|
|
$ |
21,072 |
|
|
$ |
(5,887) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income (loss) per share |
$ |
0.09 |
|
|
$ |
0.08 |
|
|
$ |
0.45 |
|
|
$ |
(0.14) |
|
Diluted net income (loss) per share |
$ |
0.08 |
|
|
$ |
0.08 |
|
|
$ |
0.42 |
|
|
$ |
(0.14) |
|
Shares used in computing basic net income (loss) per
share |
48,180 |
|
|
44,969 |
|
|
46,566 |
|
|
42,550 |
|
Shares used in computing diluted net income (loss) per
share |
57,386 |
|
|
45,055 |
|
|
50,470 |
|
|
42,550 |
|
|
|
|
|
|
|
|
|
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
Deficit |
|
|
|
Shareholders’
Equity |
|
Shares |
|
Amount |
|
|
|
|
Balances at December 31, 2021 |
44,640 |
|
|
$ |
4 |
|
|
$ |
531,636 |
|
|
$ |
(429,226) |
|
|
|
|
$ |
102,414 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock in conjunction with vesting
of restricted stock units, net of employee's withholding
liability |
307 |
|
|
— |
|
|
(598) |
|
|
— |
|
|
|
|
(598) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock upon exercise of warrant |
388 |
|
|
— |
|
|
— |
|
|
— |
|
|
|
|
— |
|
Stock-based compensation |
— |
|
|
— |
|
|
982 |
|
|
— |
|
|
|
|
982 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income and comprehensive income |
— |
|
|
— |
|
|
— |
|
|
9,064 |
|
|
|
|
9,064 |
|
Balances at March 31, 2022 |
45,335 |
|
|
$ |
4 |
|
|
$ |
532,020 |
|
|
$ |
(420,162) |
|
|
|
|
$ |
111,862 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock in connection with at-the-market
program |
2,464 |
|
|
1 |
|
|
7,019 |
|
|
— |
|
|
|
|
7,020 |
|
Issuance of common stock in conjunction with vesting
of restricted stock units, net of employee's withholding
liability |
373 |
|
|
— |
|
|
(81) |
|
|
— |
|
|
|
|
(81) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation |
— |
|
|
— |
|
|
1,734 |
|
|
— |
|
|
|
|
1,734 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income and comprehensive income |
— |
|
|
— |
|
|
— |
|
|
7,834 |
|
|
|
|
7,834 |
|
Balances at June 30, 2022 |
48,172 |
|
|
$ |
5 |
|
|
$ |
540,692 |
|
|
$ |
(412,328) |
|
|
|
|
$ |
128,369 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock in conjunction with vesting
of restricted stock units, net of employee's withholding
liability |
25 |
|
|
— |
|
|
(28) |
|
|
— |
|
|
|
|
(28) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation |
— |
|
|
— |
|
|
2,400 |
|
|
— |
|
|
|
|
2,400 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income and comprehensive income |
— |
|
|
— |
|
|
— |
|
|
4,174 |
|
|
|
|
4,174 |
|
Balances at September 30, 2022 |
48,197 |
|
|
$ |
5 |
|
|
$ |
543,064 |
|
|
$ |
(408,154) |
|
|
|
|
$ |
134,915 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock |
|
Additional
Paid-In
Capital |
|
Accumulated
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, net of employee's withholding
liability |
211 |
|
|
— |
|
|
(388) |
|
|
— |
|
|
|
|
(388) |
|
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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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, net of employee's withholding
liability |
227 |
|
|
— |
|
|
(19) |
|
|
— |
|
|
|
|
(19) |
|
Issuance of common stock upon exercise of warrant |
845 |
|
|
— |
|
|
— |
|
|
— |
|
|
|
|
— |
|
Stock split fractional shares settlement |
(18) |
|
|
— |
|
|
— |
|
|
— |
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation |
— |
|
|
— |
|
|
957 |
|
|
— |
|
|
|
|
957 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss and comprehensive loss |
— |
|
|
— |
|
|
— |
|
|
(14,169) |
|
|
|
|
(14,169) |
|
Balances at June 30, 2021 |
44,494 |
|
|
$ |
4 |
|
|
$ |
529,831 |
|
|
$ |
(437,570) |
|
|
|
|
$ |
92,265 |
|
Issuance of common stock in conjunction with vesting
of restricted stock units, net of employee's withholding
liability |
128 |
|
|
— |
|
|
(8) |
|
|
— |
|
|
|
|
(8) |
|
Stock-based compensation |
— |
|
|
— |
|
|
866 |
|
|
— |
|
|
|
|
866 |
|
Net income and comprehensive income |
— |
|
|
— |
|
|
— |
|
|
3,737 |
|
|
|
|
3,737 |
|
Balances at September 30, 2021 |
44,622 |
|
|
$ |
4 |
|
|
$ |
530,689 |
|
|
$ |
(433,833) |
|
|
|
|
$ |
96,860 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
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|
|
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|
|
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|
|
|
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|
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|
|
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|
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|
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|
|
|
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|
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|
|
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|
|
|
|
|
|
|
|
|
|
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)
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended
September 30, |
|
2022 |
|
2021 |
Operating Activities |
|
|
|
Net income (loss) |
$ |
21,072 |
|
|
$ |
(5,887) |
|
|
|
|
|
|
|
|
|
Adjustments to reconcile net income to net cash provided by (used
in) operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization |
25,033 |
|
|
21,698 |
|
|
|
|
|
Amortization of debt issuance costs and Royalty Rights |
128 |
|
|
159 |
|
Recurring fair value measurement of assets and
liabilities |
6,845 |
|
|
1,902 |
|
|
|
|
|
|
|
|
|
Stock-based compensation |
5,116 |
|
|
2,596 |
|
Provision for inventory and other assets |
828 |
|
|
(86) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Changes in assets and liabilities, net of acquisition: |
|
|
|
Accounts receivable |
(319) |
|
|
8,205 |
|
Inventories |
(7,607) |
|
|
6,317 |
|
|
|
|
|
Prepaid and other assets |
13,288 |
|
|
5,777 |
|
Accounts payable and other accrued liabilities |
(7,193) |
|
|
(22,405) |
|
Accrued rebates, returns and discounts |
(4,058) |
|
|
(19,284) |
|
Interest payable |
(1,232) |
|
|
2,400 |
|
Net cash provided by operating activities |
51,901 |
|
|
1,392 |
|
Investing Activities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase of Otrexup |
(16,889) |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities |
(16,889) |
|
|
— |
|
Financing Activities |
|
|
|
Proceeds from issuance of 2027 Convertible Notes |
65,916 |
|
|
— |
|
Payments in connection with 2021 Convertible Notes |
— |
|
|
(335) |
|
Payment in connection with 2024 Senior Notes |
(70,750) |
|
|
(4,750) |
|
Payment of contingent consideration |
(7,845) |
|
|
(2,495) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payment of Royalty Rights |
(630) |
|
|
(510) |
|
Proceeds from issuance of common stock |
7,020 |
|
|
44,861 |
|
Proceeds from exercise of stock options |
— |
|
|
193 |
|
|
|
|
|
|
|
|
|
Shares withheld for payment of employee's withholding tax
liability |
(707) |
|
|
(416) |
|
Net cash (used in) provided by financing activities |
(6,996) |
|
|
36,548 |
|
Net increase in cash and cash equivalents |
28,016 |
|
|
37,940 |
|
Cash and cash equivalents at beginning of year |
36,810 |
|
|
20,786 |
|
Cash and cash equivalents at end of period |
$ |
64,826 |
|
|
$ |
58,726 |
|
|
|
|
|
Supplemental Disclosure of Cash Flow Information |
|
|
|
Net cash refunded for income taxes |
$ |
(7,822) |
|
|
$ |
— |
|
Cash paid for interest |
$ |
7,752 |
|
|
$ |
5,216 |
|
|
|
|
|
|
|
|
|
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. The results for the three and nine months ended
September 30, 2022 are not necessarily indicative of results
to be expected for the entire year ending December 31, 2022 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, 2021 included in
Assertio Holdings, Inc.’s Annual Report on Form 10-K filed with the
SEC on March 10, 2022 (the 2021 Form 10-K). The Condensed
Consolidated Balance Sheet as of December 31, 2021 has been derived
from the audited financial statements at that date, as filed in the
Company’s 2021 Form 10-K.
Reclassifications
During the first quarter of 2022, the Company made certain
reclassifications within Selling, general and administrative
expenses related to changes in the fair value
of contingent considerations. These fair value adjustments were
reclassified from Selling, general and administrative expenses to
Fair value of contingent consideration on the Condensed
Consolidated Statements of Comprehensive Income, which impacted
previously reported amounts for the
three and nine months ended September 30, 2021. The
reclassifications were made to separately state
changes in the fair value of contingent considerations from
Selling, general and administrative expenses.
Prior period results were recast to conform with these changes, and
resulted in a decrease to
Selling, general and administrative expenses
and an equal and offsetting increase to
Fair value of contingent consideration
of $0.3 million and $1.9 million for the three and nine months
ended September 30, 2021, respectively. Total cost and
expenses and Income (loss) from operations as previously reported
remains unchanged.
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. Because COVID-19
impacted the Company’s ability to see in person providers who
prescribe our products, the Company transformed its commercial
approach during 2020 and increased virtual visits, ultimately
eliminating its in-person sales force in favor of a digital sales
strategy. 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 actions by government
authorities to contain the outbreak, the emergence of new COVID-19
variants and the related potential for new surges in infections and
the impacts of increases in virtual physician visits on prescriber
behavior. For example, although many public health restrictions
have eased, future surges could result in additional restrictions
or other factors that may contribute to decreases in elective
procedures. The impact of the pandemic on the global financial
markets may reduce the Company’s ability to access capital, which
could negatively impact its liquidity. The Company does not yet
know the full extent of potential delays or impacts on its
business, financing or on healthcare systems or the global economy
as a whole. However, these effects could have a material impact on
the Company’s liquidity, capital resources, operations and business
and those of the third parties on which it relies, including
suppliers and distributors.
NOTE 2. ACQUISITIONS
Otrexup Acquisition
On December 15, 2021, the Company, through a newly-formed
subsidiary, Otter Pharmaceuticals, LLC, entered into an Asset
Purchase Agreement (the “Purchase Agreement”) with Antares Pharma,
Inc. (“Antares”), and concurrently consummated the transaction.
Pursuant to the terms of the Purchase Agreement, the Company
acquired Antares’ rights, title and interest in and to Otrexup,
including certain related assets, intellectual property, contracts,
and product inventory for (i) $18.0 million in cash paid at
closing, (ii) $16.0 million in cash paid on May 31, 2022 and
(iii) and $10.0 million in cash payable on December 15,
2022.
The following table summarizes the aggregate amount paid for the
assets acquired by the Company in connection with the acquisition
of Otrexup (in thousands):
|
|
|
|
|
|
|
|
|
Cash paid to Antares at closing |
|
$ |
18,000 |
|
Cash paid in May 2022 |
|
16,021 |
|
Deferred cash payment due in December 2022 |
|
10,000 |
|
Transaction costs |
|
1,478 |
|
Total purchase price of assets acquired |
|
$ |
45,499 |
|
The acquisition of Otrexup has been accounted for as an asset
acquisition in accordance with FASB ASC 805-50. The Company
accounted for the acquisition of Otrexup as an asset acquisition
because substantially all of the fair value of the assets acquired
is concentrated in a single asset, the Otrexup product rights. The
Otrexup products rights consist of certain patents and trademarks,
at-market contracts and regulatory approvals, customer lists,
marketing assets, and other records, and are considered a single
asset as they are inextricably linked. ASC 805-10-55-5A includes a
screen test, which provides that if substantially all of the fair
value of the assets acquired is concentrated in a single
identifiable asset or group of similar identifiable assets, the
assets acquired are not considered to be a business. As an asset
acquisition, the cost to acquire the group of assets, including
transaction costs, is allocated to the individual assets acquired
or liabilities assumed based on their relative fair values. The
relative fair values of identifiable assets from the acquisition of
Otrexup are based on estimates of fair value using assumptions that
the Company believes is reasonable.
The following table summarizes the fair value of assets acquired in
the acquisition of Otrexup (in thousands):
|
|
|
|
|
|
|
|
|
Inventories |
|
$ |
1,413 |
|
Intangible assets |
|
44,086 |
|
Total assets acquired |
|
$ |
45,499 |
|
The Otrexup product rights will be amortized over an 8 year period.
As of September 30, 2022 and December 31, 2021 deferred cash
payable to Antares were $10.0 million and $26.0 million,
respectively, and were recorded in Other current liabilities in the
Company’s Condensed Consolidated Balance Sheet.
NOTE 3. REVENUE
Disaggregated Revenue
The following table reflects summary revenue, net for the three and
nine months ended September 30, 2022 and 2021 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended
September 30, |
|
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Product sales, net: |
|
|
|
|
|
|
|
|
INDOCIN products |
|
$ |
21,869 |
|
|
$ |
14,541 |
|
|
$ |
66,067 |
|
|
$ |
42,214 |
|
CAMBIA |
|
5,808 |
|
|
5,038 |
|
|
17,464 |
|
|
17,628 |
|
Otrexup |
|
3,004 |
|
|
— |
|
|
8,699 |
|
|
— |
|
Zipsor |
|
259 |
|
|
1,999 |
|
|
2,704 |
|
|
6,802 |
|
SPRIX |
|
2,455 |
|
|
2,272 |
|
|
6,437 |
|
|
6,911 |
|
Other products |
|
884 |
|
|
2,147 |
|
|
3,887 |
|
|
3,716 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product sales, net |
|
34,279 |
|
|
25,997 |
|
|
105,258 |
|
|
77,271 |
|
|
|
|
|
|
|
|
|
|
Royalties and milestone revenue |
|
473 |
|
|
416 |
|
|
1,916 |
|
|
1,391 |
|
Other revenue |
|
(540) |
|
|
(941) |
|
|
(1,290) |
|
|
(976) |
|
Total revenues |
|
$ |
34,212 |
|
|
$ |
25,472 |
|
|
$ |
105,884 |
|
|
$ |
77,686 |
Product Sales, net:
For the three and nine months ended September 30, 2022 and
2021, product sales primarily consisted of sales from INDOCIN
Products, CAMBIA, Otrexup and SPRIX. The Company acquired Otrexup
in December 2021 and began shipping and recognizing product sales
for Otrexup in January 2022.
Other products sales include product sales for non-promoted
products (OXAYDO and SOLUMATRIX). The Company ceased SOLUMATRIX
sales beginning in July 2022.
Royalties and Milestone Revenue
In November 2010, the Company entered into a license agreement with
Tribute Pharmaceuticals Canada Ltd. (now known as Miravo
Pharmaceuticals) granting them the rights to commercially market
CAMBIA in Canada. Miravo 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 $1.5 million for the three and nine
months ended September 30, 2022, respectively and $0.4 million
and $1.4 million for the three and nine months ended
September 30, 2021, respectively.
The Company records contract liabilities in the form of deferred
revenue resulting from prepayments from customers in Other current
liabilities on the Condensed Consolidated Balance Sheets. As of
December 31, 2021, contract liabilities were $0.3 million. For the
nine months ended September 30, 2022, the Company recorded an
additional $0.3 million in contract liabilities and recognized $0.5
million as Milestone revenue associated with completion of service
milestones. As of September 30, 2022, contract liabilities
were $0.2 million.
Other Revenue
Other revenue consists of sales adjustments for previously divested
products, which includes adjustments to reserves for product sales
allowances (gross-to-net sales allowances) and can result in
reductions to total revenue during the period. Sales adjustments
for previously divested products primarily include Gralise, Nucynta
and Lazanda.
NOTE 4. ACCOUNTS RECEIVABLES, NET
The following table reflects accounts receivables, net, as of
September 30, 2022 and December 31, 2021 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2022 |
|
December 31, 2021 |
Receivables related to product sales, net |
|
|
|
|
$ |
42,061 |
|
|
$ |
43,753 |
|
Other |
|
|
|
|
2,619 |
|
|
608 |
|
|
|
|
|
|
|
|
|
Total accounts receivable, net |
|
|
|
|
$ |
44,680 |
|
|
$ |
44,361 |
|
As of September 30, 2022 and December 31, 2021, allowances for
cash discounts for prompt payment were $1.0 million and $0.9
million, respectively.
NOTE 5. INVENTORIES, NET
The following table reflects the components of inventory, net as of
September 30, 2022 and December 31, 2021 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30,
2022 |
|
December 31, 2021 |
Raw materials |
$ |
1,755 |
|
|
$ |
1,242 |
|
Work-in-process |
2,556 |
|
|
823 |
|
Finished goods |
9,957 |
|
|
5,424 |
|
Total Inventories, net |
$ |
14,268 |
|
|
$ |
7,489 |
|
As of September 30, 2022 and December 31, 2021, inventory
reserves were $2.0 million and $3.7 million,
respectively.
NOTE 6. PROPERTY AND EQUIPMENT, NET
The following table reflects property and equipment, net as of
September 30, 2022 and December 31, 2021 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30,
2022 |
|
December 31, 2021 |
Furniture and office equipment |
$ |
2,353 |
|
|
$ |
2,733 |
|
Laboratory equipment |
20 |
|
|
20 |
|
Leasehold improvements |
9,787 |
|
|
10,523 |
|
|
12,160 |
|
|
13,276 |
|
Less: Accumulated depreciation |
(11,225) |
|
|
(11,749) |
|
Property and equipment, net |
$ |
935 |
|
|
$ |
1,527 |
|
Depreciation expense was $0.2 million and $0.6 million for the
three and nine months ended September 30, 2022, respectively
and $0.2 million and $0.8 million for the three and nine months
ended September 30, 2021, respectively. Depreciation expense
is recognized in Selling, general and administrative expense in the
Company’s Condensed Consolidated Statements of Comprehensive
Income.
NOTE 7. INTANGIBLE ASSETS
The following table reflects the gross carrying amounts and net
book values of intangible assets as of September 30, 2022 and
December 31, 2021 (dollar amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2022 |
|
December 31, 2021 |
|
|
Remaining Useful Life
(In years) |
|
Gross Carrying Amount |
|
Accumulated Amortization |
|
|
|
Net Book Value |
|
Gross Carrying Amount |
|
Accumulated Amortization |
|
|
|
Net Book Value |
Products rights: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
INDOCIN |
|
9.6 |
|
$ |
154,100 |
|
|
$ |
(30,285) |
|
|
|
|
$ |
123,815 |
|
|
$ |
154,100 |
|
|
$ |
(20,654) |
|
|
|
|
$ |
133,446 |
|
CAMBIA |
|
0.3 |
|
51,360 |
|
|
(49,372) |
|
|
|
|
1,988 |
|
|
51,360 |
|
|
(43,410) |
|
|
|
|
7,950 |
|
Otrexup |
|
7.2 |
|
44,086 |
|
|
(4,133) |
|
|
|
|
39,953 |
|
|
44,086 |
|
|
— |
|
|
|
|
44,086 |
|
SPRIX |
|
4.6 |
|
39,000 |
|
|
(13,139) |
|
|
|
|
25,861 |
|
|
39,000 |
|
|
(8,960) |
|
|
|
|
30,040 |
|
Zipsor |
|
0.0 |
|
27,250 |
|
|
(27,250) |
|
|
|
|
— |
|
|
27,250 |
|
|
(26,718) |
|
|
|
|
532 |
|
Total Intangible Assets |
|
|
|
$ |
315,796 |
|
|
$ |
(124,179) |
|
|
|
|
$ |
191,617 |
|
|
$ |
315,796 |
|
|
$ |
(99,742) |
|
|
|
|
$ |
216,054 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization expense was $8.0 million and $24.4 million for the
three and nine months ended September 30, 2022, respectively,
and $7.2 million and $20.9 million for the three and nine months
ended September 30, 2021, respectively.
The following table reflects future amortization expense the
Company expects for its intangible assets (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
Year Ending December 31, |
|
Estimated Amortization Expense |
|
2022 (remainder) |
|
$ |
7,969 |
|
|
2023 |
|
23,924 |
|
|
2024 |
|
23,924 |
|
|
2025 |
|
23,924 |
|
|
2026 |
|
23,924 |
|
|
Thereafter |
|
87,952 |
|
|
|
|
|
|
Total |
|
$ |
191,617 |
|
|
We evaluate long-lived assets, including property and equipment and
acquired intangible assets consisting of product rights, for
impairment whenever events or changes in circumstances indicate
that the carrying value of an asset may not be recoverable. As of
September 30, 2022, we determined that there was an indicator of
impairment present based on our market capitalization as of
September 30, 2022 compared to our carrying value. After grouping
the long-lived assets, including purchased developed technology and
trademarks, at the lowest level for which there are identifiable
cash flows that are largely independent of the cash flows of other
assets and liabilities, we estimated the future net undiscounted
cash flows expected to be generated from the use of the long-lived
asset group and its eventual disposition. We then compared the
estimated undiscounted cash flows to the carrying amount of the
long-lived asset group. Based on this test, we determined that the
estimated undiscounted cash flows were in excess of the carrying
amount of the long-lived asset group and, accordingly, the
long-lived asset group is fully recoverable.
NOTE 8. OTHER LONG-TERM ASSETS
The following table reflects other long-term assets as of
September 30, 2022 and December 31, 2021 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2022 |
|
December 31, 2021 |
Investment, net |
$ |
1,579 |
|
|
$ |
1,579 |
|
Operating lease right-of-use assets |
262 |
|
|
735 |
|
Prepaid asset and deposits |
1,760 |
|
|
2,456 |
|
Other |
697 |
|
|
698 |
|
Total other long-term assets |
$ |
4,298 |
|
|
$ |
5,468 |
|
Investment, net consists of the Company’s investment in NES
Therapeutic, Inc. (NES). In August 2018, the Company entered into a
Convertible Secured Note Purchase Agreement (Note Agreement) with
NES. Pursuant the terms of the Note Agreement, the Company
purchased a Convertible Secured Promissory Note (NES Note) for
$3.0 million which accrues interest annually at a rate of 10%
on $3.0 million principal, with both the principal and accrued
interest due at maturity on August 2, 2024. Pursuant to the Note
Agreement, the NES Note is convertible into equity based on (i) FDA
acceptance of the NDA, (ii) initiation of any required clinical
trials by NES, or (iii) a qualified financing event by NES. This
investment is accounted as a long-term loan receivable and is
valued at amortized cost. As of September 30, 2022, the
Company continues to assess an estimated $1.9 million expected
credit loss on its investment based on evaluation of probability of
default that exists.
NOTE 9. ACCRUED LIABILITIES
The following table reflects accrued liabilities as of
September 30, 2022 and December 31, 2021 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2022 |
|
December 31, 2021 |
Accrued compensation |
$ |
2,295 |
|
|
$ |
4,122 |
|
Accrued restructuring costs |
137 |
|
|
828 |
|
Other accrued liabilities |
7,755 |
|
|
8,062 |
|
Interest payable |
455 |
|
|
1,687 |
|
Income tax payable |
350 |
|
|
— |
|
Total accrued liabilities |
$ |
10,992 |
|
|
$ |
14,699 |
|
NOTE 10. DEBT
The following table reflects the Company’s debt as of
September 30, 2022 and December 31, 2021 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2022 |
|
December 31, 2021 |
6.5% Senior Convertible Notes due 2027 |
$ |
70,000 |
|
|
$ |
— |
|
13% Senior Secured Notes due 2024
|
— |
|
|
70,750 |
|
|
|
|
|
Royalty rights obligation |
2,175 |
|
|
2,743 |
|
Total principal amount |
72,175 |
|
|
73,493 |
|
Unamortized debt issuance costs |
(4,018) |
|
|
— |
|
Less: current portion of long-term debt |
(2,175) |
|
|
(12,174) |
|
Net, long-term debt |
$ |
65,982 |
|
|
$ |
61,319 |
|
6.5% Convertible Senior Notes due 2027
On August 22, 2022, Assertio entered into a purchase agreement (the
“Purchase Agreement”), with U.S. Bank Trust Company (the
“Trustee”), as the Trustee of the initial purchasers (the “Initial
Purchasers”) to issue $60.0 million in aggregate principal amount
of 6.5% Convertible Senior Notes due 2027 (the “2027 Convertible
Notes”). Under the Purchase Agreement, the Initial Purchasers were
also granted an overallotment option to purchase up to an
additional $10.0 million of the 2027 Convertible Notes solely to
cover overallotment (the “Overallotment Option”) within a 13-day
period from the date of the initial 2027 Convertible Notes were
issued. On August 24, 2022, the Initial Purchasers exercised the
Overallotment Option in full for the $10.0 million of additional
2027 Convertible Notes. The 2027 Convertible Notes are senior
unsecured obligations of the Company.
The terms of the Notes are governed by the Indenture dated August
25, 2022 (the “Indenture”). The terms of the 2027 Convertible Notes
allow for conversion into Common Stock, cash, or a combination of
cash and Common Stock, at the Company’s election, at an initial
conversion rate of 244.2003 shares of the Company’s Common Stock
per $1,000 principal amount (equal to an initial Conversion Price
of approximately $4.09 per share), subject to adjustments specified
in the Indenture (the “Conversion Rate”). The 2027 Convertible
Notes will mature on September 1, 2027, unless earlier repurchased
or converted.
The 2027 Convertible Notes bears interest from August 25, 2022 at a
rate of 6.5% per annum payable semiannually in arrears on March 1
and September 1 of each year, beginning on March 1,
2023.
Pursuant to the terms of the Indenture, the Company and its
restricted subsidiaries must comply with certain covenants,
including mergers, consolidations, and divestitures; guarantees of
debt by subsidiaries; issuance of preferred and/or disqualified
stock; and liens on the Company’s properties or assets. The Company
was in compliance with its covenants with respect to the 2027
Convertible Notes as of September 30, 2022.
The Company incurred approximately $4.0 million in issuance
costs including legal fees, accounting service fees, printing fees,
and trustee fees associated with the Notes. The issuance costs were
recognized as a discount to the 2027 Convertible Notes and are
amortized over the term of the 2027 Convertible Notes using the
effective interest method. The effective interest rate for the
period is 7.8%.
The following table reflects the carrying balance of the 2027
Convertible Notes as of September 30, 2022 and December 31,
2021 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2022 |
|
December 31, 2021 |
Principal balance |
$ |
70,000 |
|
|
$ |
— |
|
Unamortized debt issuance costs |
(4,018) |
|
|
— |
|
Convertible note payable, net |
$ |
65,982 |
|
|
$ |
— |
|
During the three months ended September 30, 2022, the Company
amortized $0.1 million of the debt discount on the 2027 Convertible
Notes.
All of the embedded features of the 2027 Convertible Notes were
either clearly and closely related to the debt host and did not
require bifurcation as a derivative liability, or the fair value of
the bifurcated features was immaterial to the Company’s financial
statements.
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 2024 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 2024 Secured Notes were issued in two series: $50.0
million of Series A-1 Notes and $45.0 million of Series A-2
Notes.
The Company used the net proceeds from the 2027 Convertible Note
Offering to repurchase $59.0 million aggregate principal amount of
its outstanding 2024 Secured Notes and $3.0 million in associated
interest payment pursuant to privately negotiated exchange
agreements entered into concurrently with the pricing of the 2027
Convertible Note Offering. The 2024 Secured Notes were derecognized
upon extinguishment with no gain or loss recognized, as no
unamortized cost remained at time of extinguishment. Assertio
expects to use the remaining net proceeds of the 2027 Convertible
Note Offering for general corporate purposes. As of
September 30, 2022 there were no outstanding aggregate
principal amounts of the 2024 Secured Notes.
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 2024 Secured Notes pursuant to which the Company will pay the
holders of the 2024 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 2024 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 $2.2 million and $2.7
million as of September 30, 2022 and December 31, 2021,
respectively, which are classified as 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.
Interest Expense
Royalty Rights and debt issuance cost are amortized as interest
expense using the effective interest method. The following table
reflects debt related interest included in Interest expense in the
Company’s Condensed Consolidated Statements of Comprehensive Income
for the three and nine months ended September 30, 2022 and
2021 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended
September 30, |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Interest payable on 2027 Convertible Notes |
$ |
456 |
|
$ |
— |
|
$ |
456 |
|
$ |
— |
Interest paid on 2024 Secured Notes |
1,516 |
|
2,454 |
|
6,064 |
|
7,618 |
Amortization of debt issuance costs and Royalty Rights |
80 |
|
41 |
|
128 |
|
159 |
Other |
— |
|
— |
|
— |
|
6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total interest expense |
$ |
2,052 |
|
$ |
2,495 |
|
$ |
6,648 |
|
$ |
7,783 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NOTE 11. STOCK-BASED COMPENSATION
The Company’s stock-based compensation generally includes
time-based stock options and restricted stock units (RSUs) and
performance-based stock options and RSUs.
For the three and nine months ending September 30, 2022
stock-based compensation of $2.4 million and $5.1 million,
respectively, and for the three and nine months ending
September 30, 2021, $0.9 million and $2.6 million,
respectively, was recognized in Selling, general, and
administrative expenses in the Company’s Condensed Consolidated
Statements of Comprehensive Income.
During the nine months ended September 30, 2022 the Company
granted 1.5 million RSUs at a weighted-average fair market value of
$2.54 per share, 1.0 million options at a weighted-average fair
market value of $2.28 per share, and collectively 2.0 million
performance-based stock options and RSUs at a weighted-average fair
value per unit was $2.02.
NOTE 12. LEASES
As of September 30, 2022, 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, which terminated in
February 2022.
Prior to the Company’s corporate headquarters relocation in 2018,
the Company had leased its previous corporate office in Newark,
California (the Newark lease) which will terminate at the end of
November 2022 and will not be renewed. The Newark lease is
currently partially subleased through the lease term. 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. During the first quarter of
2022, the Company recognized a gain of $0.6 million from the
early termination and settlement of a Newark facility
sublease.
The following table reflects lease expense and income for the three
and nine months ended September 30, 2022 and 2021 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended
September 30, |
|
Financial Statement Classification |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Operating lease cost |
Selling, general and administrative expenses |
|
$ |
39 |
|
|
$ |
54 |
|
|
$ |
118 |
|
|
$ |
256 |
|
Operating lease cost |
Other gain |
|
148 |
|
|
148 |
|
|
444 |
|
|
443 |
|
Total lease cost |
|
|
$ |
187 |
|
|
$ |
202 |
|
|
$ |
562 |
|
|
$ |
699 |
|
|
|
|
|
|
|
|
|
|
|
Sublease Income |
Other gain |
|
$ |
168 |
|
|
$ |
347 |
|
|
$ |
1,111 |
|
|
$ |
1,040 |
|
The following table reflects supplemental cash flow information
related to leases for the three and nine months ended
September 30, 2022 and 2021 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended
September 30, |
|
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Cash paid for amounts included in measurement of
liabilities: |
|
|
|
|
|
|
|
Operating cash flows from operating leases |
$ |
533 |
|
|
$ |
667 |
|
|
$ |
1,593 |
|
|
$ |
2,129 |
|
The following table reflects supplemental balance sheet information
related to leases as of September 30, 2022 and December 31,
2021 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial Statement Classification |
|
September 30, 2022 |
|
December 31, 2021 |
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities |
|
|
|
|
|
Current operating lease liabilities |
Other current liabilities |
|
$ |
673 |
|
|
$ |
1,978 |
|
Noncurrent operating lease liabilities |
Other long-term liabilities |
|
105 |
|
|
397 |
|
Total lease liabilities |
|
|
$ |
778 |
|
|
$ |
2,375 |
|
NOTE 13. 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. The Company has agreed to purchase a minimum
number of batches of SPRIX annually from JHS over the term of the
Agreement. Total commitments to JHS through the period ending July
30, 2022 have been met, and total commitments through the period
ending July 30, 2023 are approximately $1.1 million.
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.
Antares Supply Agreement
In connection with the Otrexup acquisition, the Company entered
into a Supply Agreement with Antares pursuant to which Antares will
manufacture and supply the finished Otrexup products. Under the
Supply Agreement, the Company has agreed to annual minimum purchase
obligations from Antares, which approximate $2.0 million
annually. The Supply Agreement has an initial term through December
2031 with renewal terms beyond.
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. Amounts accrued for
legal contingencies are based on management’s best estimate of a
loss based upon the status of the cases described below,
assessments of the likelihood of damages, and the advice of counsel
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. As of
September 30, 2022 and December 31, 2021 the Company had a
legal contingency accrual of approximately $3.2 million and $3.4
million, respectively. The Company will continue to monitor each
matter and adjust accruals as 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 were
filed in the Northern District of California against the Company
and several other defendants relating to our former drug
Glumetza®.
The plaintiffs sought 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.
(the “Retailer Plaintiffs”), filed substantially similar direct
purchaser antitrust claims.
On July 30, 2020, Humana Inc. also filed a complaint against the
Company and several other defendants in federal court in the
Northern District of California alleging similar claims related to
Glumetza. The claims asserted by Humana in its federal case were
ultimately withdrawn, and analogous claims were instead asserted by
Humana in an action it filed in California state court on February
8, 2021, and subsequently amended in September 2021. Additionally,
on April 5, 2022, Health Care Service Corporation (“HCSC”) filed a
complaint against the Company and the same other defendants in
California state court alleging similar claims related to
Glumetza.
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.
On September 14, 2021, the Retailer Plaintiffs voluntarily
dismissed all claims against the Company pursuant to a settlement
agreement with the Company in return for $3.15 million. On
February 3, 2022, the Court issued its final order approving a
settlement of the direct purchaser class plaintiffs’ claims against
the Company in return for $3.85 million.
With respect to the Humana lawsuit that is continuing in California
state court, on November 24, 2021, the state court granted in part
and denied in part a demurrer by the defendants. That case is now
moving to discovery, and trial is scheduled for August 25,
2023.
The Company intends to defend itself vigorously in the Humana
California state court lawsuit,
and the more recently filed HCSC lawsuit.
A liability for this matter has been recorded in the financial
statements.
Securities Class Action Lawsuit and Related Matters
On August 28, 2022, the U.S. District Court for the Northern
District of California issued a final order approving the
settlement of a purported federal securities law class action that
was pending against the Company, two individuals who formerly
served as its chief executive officer and president, and its former
chief financial officer, thereby concluding this matter. The action
(Huang
v. Depomed et al.,
No. 4:17-cv-4830-JST, N.D. Cal.) alleged violations of Sections
10(b) and 20(a) of the Securities Exchange Act of 1934, as amended,
and Rule 10b-5 related to certain prior disclosures of the Company
about its business, compliance, and operational policies and
practices concerning the sales and marketing of its former opioid
products and contended that the conduct supporting the alleged
violations affected the value of Company common stock and was
seeking damages and other relief.
Additionally, on December 14, 2021, the Superior Court of
California, Alameda County, issued a final order approving the
settlement of the shareholder derivative actions that 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,
thereby concluding these matters. The claims in the shareholder
derivative actions arose out of the same factual allegations as the
purported federal securities class action described
above.
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. Assertio Therapeutics 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.
In July 2022, the Company became aware that the DOJ issued a press
release stating that it had settled claims against a physician whom
the DOJ alleged had received payments for paid speaking and
consulting work from two pharmaceutical companies, including
Depomed, Inc. (now known as Assertio Therapeutics), in exchange for
prescribing certain of the companies’ respective products. As part
of the settlement, the physician did not admit liability for such
claims and the press release stated that there has been no
determination of any liability for such claims. The Company denies
any wrongdoing and disputes DOJ’s characterization of the payments
from Depomed.
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. Assertio Holdings has also been
named in one such case. Plaintiffs may file additional lawsuits in
which Assertio Therapeutics or Assertio Holdings may be named.
Plaintiffs in the pending federal cases involving Assertio
Therapeutics or Assertio
Holdings 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. Assertio Therapeutics
and Assertio Holdings intend to defend themselves 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 Delaware, 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. Assertio
Therapeutics intends to defend itself vigorously in these
matters.
Insurance Litigation
On January 15, 2019,
Assertio Therapeutics
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
Assertio Therapeutics’
primary product liability insurer. Navigators was seeking
declaratory judgment that opioid litigation claims noticed
by
Assertio Therapeutics
(as further described above under “Multidistrict Opioid Litigation”
and “State Opioid Litigation”) are not covered by
Assertio Therapeutics’
life sciences liability policies with Navigators. On February 3,
2021,
Assertio Therapeutics
entered into a Confidential Settlement Agreement and Mutual Release
with Navigators to resolve the declaratory judgment action
and
Assertio Therapeutics’
counterclaims. Pursuant to the Settlement Agreement, the parties
settled and the coverage action was dismissed without
prejudice.
During
the first quarter of 2021, Assertio Therapeutics 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, Assertio Therapeutics 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. Newline removed the case to
the U.S. District Court for the Northern District of California
(Case No. 3:21-cv-06642). Assertio Therapeutics was seeking a
declaratory judgment that Newline has a duty to defend Assertio
Therapeutics or, alternatively, to reimburse Assertio Therapeutics’
attorneys’ fees and other defense costs for opioid litigation
claims noticed by Assertio Therapeutics. On May 18, 2022, Assertio
Therapeutics entered into a Confidential Settlement Agreement and
Mutual Release with Newline to resolve Assertio Therapeutics’
declaratory judgment action. Pursuant to the Settlement Agreement,
the parties settled and the coverage action was dismissed with
prejudice.
During the second quarter of 2022, Assertio Therapeutics received
$2.0 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 April 1, 2022, Assertio Therapeutics filed a complaint for
negligence and breach of fiduciary duty against its former
insurance broker, Woodruff-Sawyer & Co. (“Woodruff”), in the
Superior Court of the State of California for the County of Alameda
(Case No. 22CV009380). Assertio Therapeutics is seeking to recover
its damages caused by Woodruff’s negligence and breaches of its
fiduciary duties in connection with negotiating and procuring
products liability insurance coverage for Assertio Therapeutics.
The litigation is in the early stages. Trial is set for February 2,
2024.
Indemnification Dispute with Collegium Pharmaceutical,
Inc.
On May 24, 2022, Assertio Therapeutics filed an action in the
Superior Court of Delaware against Collegium Pharmaceutical, Inc.
(Collegium) seeking indemnification in excess of $1.8 million
for Collegium’s breach of an asset purchase agreement related to
Assertio Therapeutics’ former product, Nucynta. Assertio
Therapeutics alleges that Collegium agreed to assume certain
liabilities associated with customer returns of Nucynta products
sold by Collegium, but that Collegium has failed to honor that
agreement. On July 14, 2022, Collegium answered the complaint
asserting as a defense that, among other things, the Superior Court
of Delaware does not have jurisdiction over all aspects of the
action because Collegium contends that a portion of the dispute is
subject to the alternative dispute resolution procedures under a
different agreement. On July 18, 2022, Assertio Therapeutics moved
to strike that defense, and on August 8, 2022 in opposition to the
motion to strike, Collegium filed a cross-motion to stay the case.
Assertio Therapeutics filed its opposition to Collegium’s
cross-motion to stay on August 19, 2022. After oral argument on
September 20, 2022, the Court granted in part Assertio
Therapeutics’ motion to strike and denied in full Collegium’s
cross-motion to stay.
NOTE 14. 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.
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 September 30, |
|
Nine Months Ended
September 30, |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Employee compensation costs |
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
876 |
|
|
|
|
|
|
|
|
|
Other exit costs |
— |
|
|
— |
|
|
— |
|
|
213 |
|
Total restructuring costs |
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
1,089 |
|
The following table reflects cash activity relating to the
Company’s accrued restructuring cost as of September 30, 2022
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employee compensation costs |
|
|
|
Total |
Balance as of December 31, 2021 |
$ |
828 |
|
|
|
|
$ |
828 |
|
|
|
|
|
|
|
Cash paid |
(340) |
|
|
|
|
(340) |
|
Balance as of March 31, 2022 |
$ |
488 |
|
|
|
|
$ |
488 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid |
(150) |
|
|
|
|
(150) |
|
Balance as of June 30, 2022 |
$ |
338 |
|
|
|
|
$ |
338 |
|
Cash paid |
(201) |
|
|
|
|
(201) |
|
Balance as of September 30, 2022 |
$ |
137 |
|
|
|
|
$ |
137 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NOTE 15. SHAREHOLDERS EQUITY
At-The-Market Program
On December 17, 2021, the Company entered into a Sales Agreement
with Roth Capital Partners, LLC (Roth) as sales agent to sell
shares of the Company’s common stock, from time to time, through an
at-the-market (ATM) offering program
having an aggregate offering price of up to $25.0 million. As
of September 30, 2022, 2,463,637 shares have been issued and
settled at an average price of $3.02, through which the Company
received gross proceeds of $7.4 million, and net proceeds after
commission and fees of $7.0 million. As a result of the issuance of
the 2027 Convertible Notes (See Note 10. Debt), the Company has
determined to suspend use of its ATM offering program.
Equity Raise
On February 9, 2021, the Company completed a registered direct
offering with certain institutional investors and accredited
investors to sell 5,650,000 shares of our common stock at a
purchase price of $2.48 per share. The gross proceeds from the
offering were approximately $14.0 million. After placement
agent fees and other offering expenses payable by the Company,
Assertio received net proceeds of approximately $13.1 million.
On February 12, 2021, the Company completed a registered direct
offering with certain institutional investors and accredited
investors to sell 8,750,000 shares of our common stock at a
purchase price of $3.92 per share. The gross proceeds from the
offering were approximately $34.3 million. After placement
agent fees and other offering expenses payable by the Company,
Assertio received net proceeds of approximately $32.2 million.
The Company intends to use proceeds from both offerings for general
corporate purposes, including general working capital.
Warrant Agreements
Upon the Zyla Merger, the Company assumed Zyla’s outstanding
Warrant Agreements which provides the holder the right to receive
shares of the Company’s common stock. The warrants are exercisable
at any time at an exercise price of $0.0016 per share, subject to
certain ownership limitations including, with respect to Iroko and
its affiliates, that no such exercise may increase the aggregate
ownership of the Company’s outstanding common stock of such parties
above 49% of the number of shares of its common stock then
outstanding for a period of 18 months . All of the Company’s
outstanding warrants have similar terms whereas under no
circumstance may the warrants be net-cash settled. As such, all
warrants are equity classified.
During the nine months ended September 30, 2022 and 2021, zero
and 392,095 warrants, respectively, were exercised, and zero and
387,802 common shares, respectively, were issued by the Company. As
of September 30, 2022, there were no outstanding warrants
remaining.
NOTE 16. NET INCOME PER SHARE
Basic net income per share is calculated by dividing the net 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 zero and 392,095
unexercised shares of common stock issuable upon the exercise of
warrants as of September 30, 2022 and 2021,
respectively.
Diluted net income per share is calculated by dividing the net
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. For purposes of this calculation, convertible
debt and options to purchase stock are considered to be potential
common shares and are only included in the calculation of diluted
net income per share when their effect is dilutive. 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. Under the
if-converted method, the Company assumes the 2027 Convertible Notes
were converted at the beginning of each period presented. As a
result, interest expense and any adjustments recognized in net
income for the 2027 Convertible Notes is added back to net income
used in the diluted earnings per share calculation. Additionally,
the diluted shares used in the diluted earnings per share
calculation includes the dilution effect of the 2027 Convertible
Notes.
The following table reflects the calculation of basic and diluted
earnings per common share for the three and nine months ended
September 30, 2022 and 2021 (in thousands, except for per
share amounts):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended
September 30, |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Basic net income per share |
|
|
|
|
|
|
|
Net income (loss) |
$ |
4,174 |
|
|
$ |
3,737 |
|
|
$ |
21,072 |
|
|
$ |
(5,887) |
|
Weighted-average common shares and warrants outstanding |
48,180 |
|
|
44,969 |
|
|
46,566 |
|
|
42,550 |
|
Basic net income (loss) per share |
$ |
0.09 |
|
|
$ |
0.08 |
|
|
$ |
0.45 |
|
|
$ |
(0.14) |
|
|
|
|
|
|
|
|
|
Diluted net income per share |
|
|
|
|
|
|
|
Net income (loss) |
$ |
4,174 |
|
|
$ |
3,737 |
|
|
$ |
21,072 |
|
|
$ |
(5,887) |
|
Add: Interest Expense on convertible debt, net of tax |
497 |
|
|
— |
|
|
487 |
|
|
— |
|
Adjusted Net income (loss) |
4,671 |
|
|
3,737 |
|
|
21,559 |
|
|
(5,887) |
|
Weighted-average common shares and share equivalents
outstanding |
48,180 |
|
|
44,969 |
|
|
46,566 |
|
|
42,550 |
|
Add: effect of dilutive stock-based awards and
equivalents |
1,960 |
|
|
86 |
|
|
1,462 |
|
|
— |
|
Add: effect of dilutive convertible debt under if-converted
method |
7,246 |
|
|
— |
|
|
2,442 |
|
|
— |
|
Denominator for diluted income per share |
57,386 |
|
|
45,055 |
|
|
50,470 |
|
|
42,550 |
|
Diluted net income (loss) per share |
$ |
0.08 |
|
|
$ |
0.08 |
|
|
$ |
0.42 |
|
|
$ |
(0.14) |
|
The following table reflects outstanding potentially dilutive
common shares that are not included in the computation of diluted
net income per share, because to do so would be anti-dilutive, for
the three and nine months ended September 30, 2022 and 2021
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
|
|
|
|
|
|
|
|
2021 Convertible Notes |
— |
|
|
3 |
|
|
— |
|
|
4 |
|
Stock-based awards and equivalents |
2,983 |
|
|
2,297 |
|
|
1,329 |
|
|
2,725 |
|
Total potentially dilutive common shares |
2,983 |
|
|
2,300 |
|
|
1,329 |
|
|
2,729 |
|
NOTE 17. 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 September 30, 2022 and December 31, 2021
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2022 |
|
Financial Statement Classification |
|
Level 1 |
|
Level 2 |
|
Level 3 |
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities: |
|
|
|
|
|
|
|
|
|
|
Short-term contingent consideration |
|
Contingent consideration, current portion |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
10,900 |
|
|
$ |
10,900 |
|
Long-term contingent consideration |
|
Contingent consideration |
|
— |
|
|
— |
|
|
25,759 |
|
|
25,759 |
|
Total |
|
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
36,659 |
|
|
$ |
36,659 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2021 |
|
Financial Statement Classification |
|
Level 1 |
|
Level 2 |
|
Level 3 |
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities: |
|
|
|
|
|
|
|
|
|
|
Short-term contingent consideration |
|
Contingent consideration, current portion |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
14,500 |
|
|
$ |
14,500 |
|
Long-term contingent consideration |
|
Contingent consideration |
|
— |
|
|
— |
|
|
23,159 |
|
|
23,159 |
|
Total |
|
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
37,659 |
|
|
$ |
37,659 |
|
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 at a 20% royalty through
January 2029. 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.
During the three and nine months ended September 30, 2022, the
Company recognized an expense of $3.9 million and $6.8 million,
respectively, for the change in fair value of contingent
consideration, which was recognized in Fair value of contingent
consideration on the Company’s Condensed Consolidated Statements of
Comprehensive Income. For the three and nine months ended
September 30, 2021, the Company recognized an expense of $0.3
million and $1.9 million, respectively, for the change in fair
value of contingent consideration. 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
September 30, 2022 included revenue volatility of 30%,
discount rate of 8.5%, credit spread of 4.0% and updated
projections of future INDOCIN Product revenues.
Contingent consideration related to CAMBIA was $0.2 million as of
September 30, 2022 and December 31, 2021.
The following table summarizes changes in fair value that are
measured on a recurring basis using significant unobservable inputs
(Level 3) for the three and nine months ended September 30,
2022 and 2021 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Fair value, beginning of the period |
$ |
36,759 |
|
|
$ |
37,659 |
|
|
$ |
37,659 |
|
|
$ |
38,552 |
|
Change in fair value of contingent consideration recorded within
costs and expenses |
3,900 |
|
|
300 |
|
|
6,845 |
|
|
1,902 |
|
Cash payment related to contingent consideration |
(4,000) |
|
|
— |
|
|
(7,845) |
|
|
(2,495) |
|
Fair value, end of the period |
$ |
36,659 |
|
|
$ |
37,959 |
|
|
$ |
36,659 |
|
|
$ |
37,959 |
|
The Company estimates the fair value of its convertible notes based
on a market approach which represents a Level 2 valuation. The
estimated fair value of the 2027 Convertible Notes, which the
Company issued on August 22, 2022, was approximately $64.3 million
(par value $70.0 million) as of September 30,
2022.
There were no transfers between Level 1, Level 2 or Level 3 of the
fair value hierarchy during the three and nine months ended
September 30, 2022.
NOTE 18. INCOME TAXES
As of September 30, 2022, the Company’s net deferred tax
assets are fully offset by a valuation allowance, with the
exception of a deferred tax liability of $0.3 million for certain
separate filing state jurisdictions. 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
valuation allowance against the majority of its net deferred tax
assets. However, given the current earnings trend, sufficient
positive evidence may become available for the Company to release
all or a portion of the valuation allowance within twelve months.
The exact timing and amount of the valuation allowance releases are
subject to change based on the level of profitability achieved in
future periods. The Company will continue to assess the
realizability of its deferred tax assets on a quarterly
basis.
For the nine months ended September 30, 2022, the Company
recorded an income tax expense of $1.5 million. The difference
between the income tax expense of $1.5 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. Interest and
penalties, if any, related to unrecognized tax benefits, would be
recognized as income tax expense by
the Company. At September 30, 2022, the Company did not have
significant accrued interest and penalties associated with
unrecognized tax benefits.
During the first quarter of 2022, the Company received a refund of
$8.3 million for the carryback of net operating losses under the
Cares Act.
On August 16, 2022, the Inflation Reduction Act of 2022 (“IRA”) was
signed into law. The tax legislation includes a new book-minimum
tax on certain large corporations, an excise tax on stock buybacks,
and tax incentives to address climate change mitigation and clean
energy. The Company considered the income tax accounting
implications of the IRA legislation to the Company’s income tax
provision calculation for the period ended September 30, 2022 and
determined that the impact was not significant.
NOTE 19. SUBSEQUENT EVENTS
On October 27, 2022, Assertio announced the closing of a
transaction to acquire an exclusive license for Sympazan®
(clobazam) oral film from Aquestive Therapeutics, Inc. (Aquestive).
Under the terms of the definitive agreement, the Company acquired
an exclusive license for the Sympazan intellectual property from
Aquestive for an upfront payment of $9.0 million. Assertio
also entered into a long-term supply agreement with Aquestive for
Sympazan. Additionally, Aquestive will continue to prosecute an
existing patent application that could extend patent coverage to as
late as 2039. Upon patent allowance, Assertio will pay a
$6.0 million milestone payment and royalties to
Aquestive.
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
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
|
A suppository form and oral solution of indomethacin used in the
hospital as well as in the out-patient setting. Both products are
nonsteroidal anti-inflammatory drug (NSAID), approved
for:
|
• Moderate to severe rheumatoid arthritis including acute flares of
chronic disease |
• Moderate to severe ankylosing spondylitis |
INDOCIN®
(indomethacin) Oral Suspension
|
• Moderate to severe osteoarthritis |
• Acute painful shoulder (bursitis and/or tendinitis) |
• Acute gouty arthritis |
CAMBIA®
(diclofenac potassium for oral solution)
|
A prescription NSAID indicated for the acute treatment of migraine
attacks with or without aura in adults 18 years of age or older.
CAMBIA can help patients with migraine pain, nausea, photophobia
(sensitivity to light), and phonophobia (sensitivity to sound).
CAMBIA is not a pill, it is a powder, and combining CAMBIA with
water activates the medicine in a unique way.
|
Otrexup®
(methotrexate)
injection for subcutaneous use
|
A once weekly single-dose auto-injector containing a prescription
medicine, methotrexate. Methotrexate is used to:
|
• Treat certain adults with severe, active rheumatoid arthritis,
and children with active polyarticular juvenile idiopathic
arthritis (pJIA), after treatment with other medicines including
non-steroidal anti-inflammatory drugs (NSAIDS) have been used and
did not work well.
|
• Control the symptoms of severe, resistant, disabling psoriasis in
adults when other types of treatment have been used and did not
work well.
|
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. SPRIX is a
non-narcotic nasal spray provides patients with moderate to
moderately severe short-term pain a form of ketorolac that is
absorbed rapidly but does not require an injection administered by
a healthcare provider (HCP).
|
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). Zipsor uses proprietary
ProSorb® delivery technology to deliver a finely dispersed, rapid
and consistently absorbed formulation of diclofenac.
|
Other commercially available products include OXAYDO® (oxycodone
HCI, USP) tablets for oral use only —CII.
On December 15, 2021, we, through a newly-formed subsidiary, Otter
Pharmaceuticals, LLC, entered into an Asset Purchase Agreement (the
“Purchase Agreement”) with Antares Pharma, Inc. (“Antares”), and
concurrently consummated the Otrexup transaction. Pursuant to the
terms of the Purchase Agreement, we acquired Antares’ rights, title
and interest in and to Otrexup, including certain related assets,
intellectual property, contracts, and product inventory for (i)
$18.0 million in cash paid at closing, (ii) $16.0 million in cash
paid on May 31, 2022 and (iii) and $10.0 million in cash payable on
December 15, 2022.
Impact of COVID-19 on our Business
Following the outbreak of COVID-19 in early
2020, our priority was and remains the health and safety of our
employees, their families, and the patients we serve. Because
COVID-19 impacted our ability to see in-person providers who
prescribe our products, we transformed our commercial approach
during 2020 and increased virtual visits, ultimately eliminating
our in-person sales force in favor a digital sales strategy.
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. 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 actions by
government authorities to contain the outbreak, the emergence of
new COVID-19 variants and
the related potential for new surges in infections and the impacts
of increases in virtual physician visits on prescriber behavior.
For example, although many public health restrictions have eased,
future surges could result in additional restrictions or other
factors that may contribute to decreases in elective procedures.
The impact of the pandemic on the global financial markets may
reduce our ability to access capital, which could negatively impact
our liquidity. We do not yet know the full extent of potential
delays or impacts on our business, financing or on healthcare
systems or the global economy as a whole. However, these effects
could have a material impact on our liquidity, capital resources,
operations and business and those of the third parties on which we
rely, including suppliers and distributors.
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.
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
commercial success and market acceptance of our products, including
the coverage of our products by payors and pharmacy benefit
managers;
•our
ability to successfully develop and execute our sales, marketing
and non-personal and digital promotion strategies, including
developing and maintaining relationships with customers,
physicians, payors and other constituencies;
•the
entry and sales of generics or other products competitive with any
of our products;
•our
ability to successfully execute business development, strategic
partnerships, and investment opportunities to build and grow for
the future;
•our
ability to achieve the expected financial performance from products
we acquire, as well as delays, challenges and expenses, and
unexpected costs associated with integrating and operating
newly-acquired products;
•our
ability to attract and retain key executive
leadership;
•the
potential impacts of the ongoing COVID-19 pandemic, including
volatility in prescriptions associated with elective procedures, on
our liquidity, capital resources, operations and business and those
of the third parties on which we rely, including suppliers and
distributors;
•the
ability of our third-party manufacturers to manufacture adequate
quantities of commercially salable inventory and active
pharmaceutical ingredients for each of our products, and our
ability to maintain our supply chain, which relies on single-source
suppliers, in the face of global challenges such as the COVID-19
pandemic;
•the
outcome of opioid-related investigations, opioid-related litigation
and related claims for negligence and breach of fiduciary duty
against our former insurance broker, and other disputes and
litigation, and the costs and expenses associated
therewith;
•our
compliance or non-compliance with legal and regulatory requirements
related to the development or promotion of pharmaceutical products
in the U.S.;
•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
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
ability to raise additional capital or refinance our debt, if
necessary;
•our
estimates regarding contingent consideration obligations and other
expenses, future revenues, capital requirements and needs for
additional financing;
•our
counterparties’ compliance or non-compliance with their obligations
under our agreements;
•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;
•the
timing and results of any future research and development efforts
including potential clinical studies relating to any future product
candidates; and
•our
common stock maintaining compliance with Nasdaq’s minimum closing
bid requirement of at least $1.00 per share.
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, 2021 and in our Quarterly
Report on Form 10-Q for the three months ended March 31, 2022 and
June 30, 2022, respectively. 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.
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, 2021 filed with the SEC on March 10, 2022 (the 2021 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 2021 Form 10-K for further
information.
RESULTS OF OPERATIONS
Revenues
The following table reflects total revenues, net for the three and
nine months ended September 30, 2022 and 2021 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended
September 30, |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Product sales, net: |
|
|
|
|
|
|
|
INDOCIN products |
$ |
21,869 |
|
|
$ |
14,541 |
|
|
$ |
66,067 |
|
|
$ |
42,214 |
|
CAMBIA |
5,808 |
|
|
5,038 |
|
|
17,464 |
|
|
17,628 |
|
Otrexup |
3,004 |
|
|
— |
|
|
8,699 |
|
|
— |
|
Zipsor |
259 |
|
|
1,999 |
|
|
2,704 |
|
|
6,802 |
SPRIX |
2,455 |
|
|
2,272 |
|
|
6,437 |
|
|
6,911 |
|
Other products |
884 |
|
|
2,147 |
|
|
3,887 |
|
|
3,716 |
|
Total product sales, net |
34,279 |
|
|
25,997 |
|
|
105,258 |
|
|
77,271 |
|
|
|
|
|
|
|
|
|
Royalties and milestone revenue |
473 |
|
|
416 |
|
|
1,916 |
|
|
1,391 |
|
Other revenue |
(540) |
|
|
(941) |
|
|
(1,290) |
|
|
(976) |
|
Total revenues |
$ |
34,212 |
|
|
$ |
25,472 |
|
|
$ |
105,884 |
|
|
$ |
77,686 |
|
Product Sales, net
For the three and nine months ended September 30, 2022,
product sales primarily consisted of sales from INDOCIN Products,
CAMBIA, Otrexup and SPRIX. The Company acquired Otrexup in December
2021 and began shipping and recognizing product sales for Otrexup
in January 2022.
INDOCIN net product sales for the three and nine months ended
September 30, 2022 increased $7.3 million from $14.5 million
to $21.9 million and $23.9 million from $42.2 million to $66.1
million, respectively, as compared to the same period in 2021
primarily due to favorable net pricing as result of increase in
gross price and favorable impact of lower returns, partially offset
by lower volume.
CAMBIA
net product sales for the three months ended September 30,
2022 increased $0.8 million from $5.0 million to $5.8 million as
compared to the same period in 2021 primarily due to favorable
payor mix partially offset by lower volume. CAMBIA
net product sales for the nine months ended September 30, 2022
decreased $0.1 million from $17.6 million to $17.5 million as
compared to the same period in 2021 primarily due to lower volume
partially offset by favorable payor mix. Certain parties who have
entered into settlement agreements with us will be able to market
generic versions of Cambia starting in 2023.
Zipsor
net product sales for the three and nine months ended
September 30, 2022 decreased $1.7 million from $2.0 million to
$0.3 million and $4.1 million from $6.8 million to $2.7 million,
respectively, as compared to the same period in 2021 primarily due
to lower volume and unfavorable payor mix as certain parties who
previously entered into settlement agreements with us began to
market generic versions of Zipsor in 2022.
SPRIX net product sales for the three months ended
September 30, 2022 increased $0.2 million from $2.3 million to
$2.5 million as compared to the same period in 2021 primarily due
to higher volume partially offset by unfavorable payor mix. SPRIX
net product sales for the nine months ended September 30, 2022
decreased $0.5 million from $6.9 million to $6.4 million as
compared to the same period in 2021 primarily due to unfavorable
payor mix partially offset by higher volume.
Other net product sales include product sales for non-promoted
products (OXAYDO and SOLUMATRIX) which were acquired from Zyla in
May 2020. In September 2020, we terminated our iCeutica License and
as a result no longer manufacture products using SOLUMATRIX
technology and ceased sales beginning in July 2022.
The increase in total product sales, net, for the three and nine
months ended September 30, 2022 also reflects a decrease year
over year in the amounts charged as a reduction to revenue for
sales & return allowances, discounts, chargebacks, and rebates,
which is attributed to changes in product mix and, specifically, a
higher concentration of INDOCIN Products that typically require
lower levels of product sales allowances relative to our other
products.
Royalties & Milestones
In November 2010, we entered into a license agreement with Tribute
Pharmaceuticals Canada Ltd. (now known as Miravo Pharmaceuticals)
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 nine months
ended September 30, 2022, the Company recognized $0.5 million
and $1.5 million of revenue related to CAMBIA in Canada,
respectively. During the
three and nine months ended September 30, 2021, we recognized
$0.4 million and $1.4 million of revenue related to CAMBIA in
Canada, respectively.
During the nine months ended months ended September 30, 2022,
we recognized $0.5 million Milestone revenue associated with
completion of certain service milestones.
Other Revenue
Other revenue consists of sales adjustments for previously divested
products, which includes adjustments to reserves for product sales
allowances (gross-to-net sales allowances) and can result in
reductions to total revenue during the period. Sales adjustments
for previously divested products primarily include Gralise, Nucynta
and Lazanda resulted in a revenue reduction of $0.5 million and
$1.3 million for the three and nine months ended September 30,
2022, respectively, and revenue reduction of $0.9 million and $1.0
million for the three and nine months ended September 30,
2021, respectively.
Cost of Sales (excluding amortization of intangible
assets)
Cost of sales increased $1.0 million from $3.1 million to
$4.0 million during the three months ended September 30,
2022 and increased $1.8 million from $10.9 million to $12.7 million
during the nine months ended September 30, 2022, respectively,
as compared to the same period in 2021 primarily due to the impact
of higher net sales and product mix.
For the three months ended September 30, 2022 and 2021, there
was no impact to cost of sales related to amortization of inventory
step-up related to acquired inventories sold. For the nine months
ended September 30, 2022 and 2021 cost of sales included $0.7
million and $0.6 million, respectively, of amortization of
inventory step-up related to acquired inventories
sold.
Selling, General and Administrative Expenses
Selling, general, and administrative expenses increased $2.9
million from $9.0 million to $11.9 million for the three months
ended September 30, 2022 compared to the same period in 2021
primarily due to an increase of $1.5 million in stock compensation
expense, $1.0 million in provision benefit recognized in third
quarter of 2021 not repeating in 2022, and remaining increase is
due to general operating expenses.
Selling, general, and administrative expenses decreased $8.3
million from $41.4 million to $33.1 million for the nine months
ended September 30, 2022 compared to the same period in 2021
primarily due to $11.3 million in loss contingency provisions
recognized in second quarter of 2021 that are not repeating in
2022, decrease of approximately $2.5 million in general operating
expenses as a result of prior restructuring events, partially
offset by a net increase of $3.0 million as a result of the $5.0
million gain for insurance reimbursement in the first quarter of
2021 compared to $2.0 million gain for insurance reimbursement in
second quarter of 2022, and an increase of $2.5 million in stock
compensation
expense.
Fair value of contingent consideration
Fair value of contingent consideration increased by $3.6 million
from $0.3 million to $3.9 million and increased by $4.9 million
from $1.9 million to $6.8 million for the three and nine months
ended September 30, 2022, respectively, as compared to the
same period in 2021. The fair value of the contingent consideration
is remeasured each reporting period, with changes in the fair value
resulting from changes in the underlying inputs being recognized in
operating expenses until the contingent consideration arrangement
is settled. 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 September 30, 2022
included revenue volatility of 30%, discount rate of 8.5%, credit
spread of 4.0% and updated projections of future INDOCIN Product
revenues.
Intangible Assets
The following table reflects amortization of intangible assets for
the three and nine months ended September 30, 2022 and 2021
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended
September 30, |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Amortization of intangible assets - INDOCIN |
$ |
3,210 |
|
|
$ |
3,210 |
|
|
$ |
9,631 |
|
|
$ |
9,631 |
|
Amortization of intangible assets - SPRIX |
1,393 |
|
|
1,393 |
|
|
4,179 |
|
|
4,179 |
|
Amortization of intangible assets - CAMBIA |
1,988 |
|
|
1,988 |
|
|
5,963 |
|
|
5,259 |
|
Amortization of intangible assets - Otrexup |
1,378 |
|
|
— |
|
|
4,133 |
|
— |
Amortization of intangible assets - Zipsor |
— |
|
|
584 |
|
|
532 |
|
|
1,752 |
|
Amortization of intangible assets - Oxaydo |
— |
|
|
— |
|
|
— |
|
|
118 |
|
|
|
|
|
|
|
|
|
Total |
$ |
7,969 |
|
|
$ |
7,175 |
|
|
$ |
24,438 |
|
|
$ |
20,939 |
|
Amortization expense increased $0.8 million from $7.2 million to
$8.0 million during the three months ended September 30, 2022
and increased $3.5 million from $20.9 million to $24.4 million
during the nine months ended September 30, 2022, respectively,
as compared to the same period in 2021 primarily due to acquired
Otrexup product rights in December 2021 and full amortization of
Zipsor and Oxaydo.
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.
For the three and nine months ended September 30, 2022 there
were no restructuring charges incurred. For the three and nine
months ended September 30, 2021 restructuring charges incurred
were zero and $1.1 million, respectively.
Other (Expense) Income
The following table reflects other expense for the three and nine
months ended September 30, 2022 and 2021 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended
September 30, |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
$ |
(2,052) |
|
$ |
(2,495) |
|
$ |
(6,648) |
|
|
$ |
(7,783) |
|
|
|
|
|
|
|
|
|
Other gain |
2 |
|
344 |
|
453 |
|
|
747 |
|
|
|
|
|
|
|
|
|
Total other expense |
$ |
(2,050) |
|
$ |
(2,151) |
|
$ |
(6,195) |
|
|
$ |
(7,036) |
|
Other expense decreased by $0.1 million from expense of $2.2
million to expense of $2.1 million for the three months ended
September 30, 2022 and decreased by $0.8 million from expense
of $7.0 million to an expense of $6.2 million for the nine months
ended months ended September 30, 2022, respectively, as
compared to the same period in 2021 primarily due to lower interest
expense.
Sublease income offset by sublease expense is recorded in Other
gain within the above table. For the nine months ended months ended
September 30, 2022, a gain of $0.6 million was recognized from
the early termination and settlement of a Newark facility
sublease.
The following table reflects interest expense for the three and
nine months ended September 30, 2022 and 2021 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended
September 30, |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Interest payable on 2027 Convertible Notes |
$ |
522 |
|
$ |
— |
|
$ |
522 |
|
$ |
— |
Interest paid on 2024 Secured Notes |
1,516 |
|
2,454 |
|
6,064 |
|
7,618 |
Amortization of debt discounts and Royalty Rights |
14 |
|
41 |
|
62 |
|
159 |
Other |
— |
|
— |
|
— |
|
6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total interest expense |
$ |
2,052 |
|
$ |
2,495 |
|
$ |
6,648 |
|
$ |
7,783 |
For the three and nine months ended September 30, 2022, total
interest expense decreased $0.4 million and decreased $1.1 million,
respectively, as compared to the same period in 2021 primarily due
to the impact of the principal payments on the 2024 Secured Notes
during the period. On August 22, 2022, we issued $70.0 million in
aggregate principal amount of 6.5% Convertible Senior Notes due
2027 (the 2027 Convertible Notes). We used the net proceeds from
the 2027 Convertible Note Offering to repurchase $59.0 million
aggregate principal amount of our outstanding 2024 Secured
Notes.
Income Tax Provision
For the three and nine months ended September 30, 2022, we
recorded an income tax expense of approximately $0.2 million and
$1.5 million, respectively, which represents an effective tax rate
of 4.8% and 6.7%, respectively. The difference between income tax
expense of $0.2 million and $1.5 million for the three and nine
months ended September 30, 2022, respectively, and tax at the
statutory rate of 21.0% is principally due to the partial release
of valuation allowance related to the current year movement in the
deferred tax assets.
In the three and nine months ended September 30, 2021, we
recorded an income tax expense of approximately $0.1 million and
$0.3 million, respectively, which represents an effective tax rate
of 1.2% and 5.3%, respectively. The difference between income tax
expense of $0.1 million and $0.3 million for the three and nine
months ended September 30, 2021, respectively, and tax at the
statutory rate of 21.0% was principally due to the partial release
of valuation allowance related to the movement in deferred tax
assets.
LIQUIDITY AND CAPITAL RESOURCES
Historically and through September 30, 2022, 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 August 22, 2022, we issued $70.0 million aggregate principal
amount of 6.5% Convertible Senior Notes Due 2027 which mature on
September 1, 2027 and bear interest at the rate of 6.5% per annum,
payable semi-annually in arrears on March 1 and September 1 of each
year beginning March 1, 2023. We used the net proceeds from the
2027 Convertible Note Offering to repurchase $59.0 million
aggregate principal amount of our outstanding 2024 Secured Notes
and $3.0 million in associated interest payment pursuant to
privately negotiated exchange agreements entered into concurrently
with the pricing of the 2027 Convertible Note Offering. We expect
to use the remaining net proceeds of the 2027 Convertible Note
Offering for general corporate purposes.
On December 17, 2021, we entered into a Sales Agreement with Roth
Capital Partners, LLC (Roth) as sales agent to sell shares of our
common stock, from time to time, through an at-the-market (ATM)
offering program having an aggregate offering price of up to
$25.0 million. As of September 30, 2021, 2,463,637 shares
have been issued and settled at an average price of $3.02, through
which we received gross proceeds of $7.4 million, and net proceeds
after commission and fees of $7.0 million. In connection with the
2027 Convertible Notes (See Note 10. Debt) the company has
determined to suspend use of its ATM offering program.
On February 9, 2021, we completed a registered direct offering with
certain institutional investors and accredited investors to sell
5,650,000 shares of our common stock at a purchase price of $2.48
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 8,750,000 shares of our
common stock at a purchase price of $3.92 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 believe that our existing cash will be sufficient to fund our
operations and make the required payments under our debt agreements
due 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 any 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, payments due under our debt
agreements, 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 nine months ended months ended September 30, 2022 and 2021
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended
September 30, |
|
|
2022 |
|
2021 |
Net cash provided by operating activities |
|
$ |
51,901 |
|
|
$ |
1,392 |
|
Net cash used in investing activities |
|
(16,889) |
|
|
— |
|
Net cash (used in) provided by financing activities |
|
(6,996) |
|
|
36,548 |
|
Net increase in cash and cash equivalents |
|
$ |
28,016 |
|
|
$ |
37,940 |
|
Cash Flows from Operating Activities
Cash provided by operating activities was $51.9 million during the
nine months ended September 30, 2022 compared to $1.4 million
in the same period in 2021. The increase of $50.5 million in cash
provided from operating activities is primarily due to combination
of higher net income excluding non-cash items and favorable working
capital cash flows. For the nine months ended September 30,
2022, net income was $21.1 million compared to a net loss of $5.9
million for the same period in 2021. For the nine months ended
September 30, 2022, non-cash items contributed approximately
$11.7 million more to operating cash flows compared to the same
period in 2021 primarily due to higher amortization expense and
higher expense for recurring fair value measurement of contingent
consideration. For the nine months ended September 30, 2022,
working capital contributed approximately $11.9 million more to
operating cash flows compared to the same period in 2021 primarily
due to less cash used in the settlement of accrued rebates, returns
and discounts due to impact of sales product mix as well as timing
of settlement, receipt of $8.3 million in tax refund in the first
quarter of 2022, and timing of inventory purchases and receipts and
accounts receivable settlement.
Cash Flows from Investing Activities
Cash used in investing activities for the nine months ended months
ended September 30, 2022 was $16.9 million, which was entirely
composed of cash paid in relation to the purchase of Otrexup. There
was no cash flow activity from investing activities for the nine
months ended September 30, 2021.
Cash Flows from Financing Activities
Cash used in financing activities for the nine months ended
September 30, 2022 was $7.0 million, which primarily consisted
of $70.8 million in principal payments on the 2024 Secured Notes
and $7.8 million payment for contingent consideration, partially
offset by $7.0 million in cash proceeds from the ATM program and
$65.9 million in cash proceeds from the issuance of 2027
Convertible Notes. Cash provided by financing activities for the
nine months ended September 30, 2021 was $36.5 million, which
primarily consisted of $44.9 million proceeds from the registered
direct offerings in February 2021, partially offset by $4.8 million
in principal payments on the 2024 Secured Notes and $2.5 million
payment for contingent consideration.
Off-Balance Sheet Arrangement
There were no off-balance sheet arrangements during the quarter
ended September 30, 2022.
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
There were no significant changes in our internal controls over
financial reporting during the three months ended
September 30, 2022 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 13. 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 (i) our Annual
Report on Form 10-K for the year ended December 31, 2021; and (ii)
our Quarterly Report on Form 10-Q for the three months ended June
30, 2022. Except as set forth below, there have been no material
changes to our risk factors since our Quarterly Report on Form 10-Q
for the three months ended June 30, 2022. In addition to other
information in this report, the following risk factors (together
with the risk factors in our Annual Report on Form 10-K for the
year ended December 31, 2021 and our Quarterly Report on Form 10-Q
for the three months ended June 30, 2022) 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
(including those
set forth below) 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.
We have no patent protection for the INDOCIN Products and Zyla
recently began to face competition for INDOCIN suppositories from a
503B outsourcing facility (commonly referred to as a 503B
compounder).
Zipsor began to face generic competition earlier this year, and
Cambia may face generic competition starting in 2023. If we face
competition with generic and/or compounded versions of our marketed
products, our revenues will be adversely affected.
Under the Federal Food, Drug, and Cosmetic Act (FDCA), the FDA can
approve an abbreviated new drug application (“ANDA”) for a generic
version of a branded drug without the ANDA applicant undertaking
the clinical testing necessary to obtain approval to market a new
drug. In place of such clinical studies, an ANDA applicant usually
needs only to submit data demonstrating that its product has the
same active ingredient(s) and is bioequivalent to the branded
product, in addition to any data necessary to establish that any
difference in strength, dosage, form, inactive ingredients or
delivery mechanism does not result in different safety or efficacy
profiles, as compared to the reference drug.
There are no patents covering the INDOCIN Products (which accounted
for 55% of our revenue in 2021), which means that a generic drug
company could introduce a generic for these drugs at any time. In
addition, we are aware of other drug companies that have had
interactions with regulatory agencies including FDA relating to
indomethacin, which could indicate the development of one or more
INDOCIN Product generics or other formulations of indomethacin.
Furthermore, a 503B outsourcing facility (commonly referred to as a
503B compounder) recently began compounding 100 mg indomethacin
suppositories in violation of certain provisions of the FDCA,
including, among others, Section 505 approval requirements for new
drugs and labeling requirements related to adequate directions for
use. For a 503B compounder to qualify for exemptions from these
requirements, the 503B compounder must meet certain conditions set
forth in Section 503B of the FDCA, including (1) using only bulk
drug substances (i.e., indomethacin) that appear on a list
identifying the bulk substances for which FDA has determined that
there is clinical need to use in compounding or that the drug
product compounded from a bulk drug substance appears on FDA’s drug
shortage list; and (2) compounding a drug product that is not
“essentially a copy” of an FDA-approved product. We believe that
the 503B compounder compounding 100 mg indomethacin suppositories
does not meet these conditions as indomethacin is not on FDA’s list
of bulk substances for which there is a clinical need and INDOCIN
suppositories are not on FDA’s drug shortage list; and we believe
that the 100 mg indomethacin suppositories being compounded are
“essentially a copy” of Zyla’s FDA-approved INDOCIN suppositories.
As a result, Zyla currently faces competition for INDOCIN
suppositories from an unlawful compounder and could face generic
competition at any time for the INDOCIN Products. Although Zyla is
vigorously pursuing remedies against the unlawful compounder, we
cannot guarantee that Zyla will be successful in causing it to
discontinue sales of its unapproved indomethacin suppository
product.
With respect to Cambia and Zipsor (which accounted for 23% and 9%
of our revenue in 2021, respectively), we have entered into
settlement agreements with generic drug companies, under which
generic versions of these products can be marketed beginning in
2023 and 2022, respectively. As a result, we began to face generic
competition for Zipsor earlier this year and expect to face generic
competition in the near term for Cambia.
Any introduction of one or more generic versions of our products,
as well as sales of indomethacin suppositories by compounders,
would harm our business, financial condition and results of
operations. The filing of the ANDAs described above, or any other
ANDA or similar application in respect to any of our products, as
well as sales of indomethacin suppositories by compounders, could
have an adverse impact on our stock price. Moreover, if the patents
covering Otrexup (which expire in 2031) are not upheld in
litigation or if a generic competitor is found not to infringe
these patents, the resulting generic competition for Otrexup would
have a further material adverse effect on our business, financial
condition and results of operations.
The market price of our common stock historically has been
volatile. Our results of operations have and may continue to
fluctuate and affect our stock price and the trading price of our
6.50% Convertible Senior Notes due 2027 (the “2027 Convertible
Notes”).
The trading price of our common stock has been, and is likely to
continue to be, volatile and could be subject to wide fluctuations
in response to various factors, some of which are beyond our
control. Factors affecting our operating results and that could
adversely affect our stock price include:
•the
degree of commercial success and market acceptance of our
products;
•the
entry and sales of generics or other products competitive with any
of our products;
•the
outcome of opioid-related investigations, opioid-related litigation
and related claims for negligence and breach of fiduciary duty
against our former insurance broker, and other disputes and
litigation, and the costs and expenses associated
therewith;
•filings
and other regulatory or governmental actions, investigations or
proceedings related to our products and any future product
candidates and those of our commercialization and collaborative
partners;
•developments
concerning proprietary rights, including patents, infringement
allegations, inter parties review proceedings and litigation
matters;
•legal
and regulatory developments in the U.S.;
•actions
taken by industry stakeholders affecting the market for our
products;
•our
ability to generate sufficient cash flow from our business to make
payments on our indebtedness;
•our
and our commercialization and collaborative partners’ compliance or
noncompliance with legal and regulatory requirements and with
obligations under our collaborative agreements;
•our
ability to successfully develop and execute our digital and
non-personal sales and marketing strategies;
•our
plans to acquire, in-license or co-promote other products or
compounds or acquire or combine with other companies, and our
degree of success in realizing the intended advantages of, and
mitigating any risks associated with, any such
transactions;
•adverse
events related to our products, including recalls;
•interruptions
of manufacturing or supply, or other manufacture or supply
difficulties;
•variations
in revenues obtained from commercialization and collaborative
agreements, including contingent milestone payments, royalties,
license fees and other contract revenues, including nonrecurring
revenues, and the accounting treatment with respect
thereto;
•adverse
events or circumstances related to our peer companies or our
industry or the markets for our products;
•adoption
of new technologies by us or our competitors;
•our
compliance with the terms and conditions of the agreements
governing our indebtedness;
•sales
of large blocks of our common stock; and
•variations
in our operating results, earnings per share, cash flows from
operating activities, deferred revenue, and other financial metrics
and non-financial metrics, and how those results are measured,
presented and compare to our financial and operating projections
and analyst expectations.
As a result of these and other such factors, our stock price may
continue to be volatile and investors may be unable to sell their
shares at a price equal to, or above, the price paid. Any
significant drops in our stock price could give rise to shareholder
lawsuits, which are costly and time-consuming to defend against and
which may adversely affect our ability to raise capital while the
suits are pending, even if the suits are ultimately resolved in our
favor.
In addition, if the market for pharmaceutical stocks or the stock
market in general experiences uneven investor confidence, the
market price of our common stock could decline for reasons
unrelated to our business, operating results or financial
condition. For example, if one or more securities or industry
analysts downgrades our stock or publishes an inaccurate research
report about our company, the market price for our common stock
would likely decline. The market price of our common stock might
also decline in reaction to events that affect other companies
within, or outside, our industry even if these events do not
directly affect us.
A decrease in the market price of our common stock would likely
adversely impact the trading price of the 2027 Convertible Notes.
The market price of our common stock could also be affected by
possible sales of our common stock by investors who view the 2027
Convertible Notes as a more attractive means of equity
participation in us and by hedging or arbitrage trading activity
that we expect to develop involving our common stock. This trading
activity could, in turn, affect the trading price of the 2027
Convertible Notes.
Our common stock may be delisted from the Nasdaq Capital Market if
we are unable to maintain compliance with Nasdaq's continued
listing standards.
Our common stock is listed on the Nasdaq Capital Market. There are
a number of continued listing requirements that we must satisfy in
order to maintain our listing on The Nasdaq Capital Market,
including the requirement to maintain a minimum bid price of at
least $1.00 (the “Bid Price Rule”). If a deficiency with respect to
this requirement continues for a period of 30 consecutive business
days, Nasdaq may require us to satisfy a minimum bid price per
share of our common stock of at least $1.00 for a period in excess
of ten consecutive business days, but generally no more than 20
consecutive business days, before determining that we have
demonstrated an ability to maintain long-term compliance with the
Bid Price Rule. Although we are currently in compliance with the
Bid Price Rule, we have been unable to comply with this rule in the
past and for periods in 2021 our continued listing on the Nasdaq
Capital Market required the grant of a grace period from Nasdaq
and
the implementation of a one-for-four reverse stock split. If we
fail to comply with the Bid Price Rule in the future, there can be
no assurance that we will be granted such grace periods or that we
will be able to receive the necessary shareholder approval to
implement an additional reverse stock split. In particular, we may
encounter difficulties obtaining such shareholder approval due to
our heavily retail investor shareholder base, which may also affect
our ability to obtain shareholder approval of other significant
corporate actions.
Any delisting of our common stock would likely adversely affect the
market liquidity and market price of our common stock and our
ability to obtain financing for the continuation of our operations
and/or result in the loss of confidence by investors.
If we were delisted from The Nasdaq Capital Market, it would
constitute a “fundamental change” under the 2027 Convertible Notes,
which would require us to offer to repurchase the 2027 Convertible
Notes and would allow the holders of the 2027 Convertible Notes to
convert their 2027 Convertible Notes into our common stock at an
increased conversion rate, which would make conversion of the 2027
Convertible Notes more dilutive.
Conversions of the 2027 Convertible Notes or future sales of our
common stock or equity-linked securities in the public market could
lower the market price for our common stock and adversely impact
the trading price of the 2027 Convertible Notes.
In 2022, we issued the 2027 Convertible Notes, and in the future,
we may sell additional shares of our common stock or equity-linked
securities to raise capital. A substantial number of shares of our
common stock is reserved for issuance upon the exercise of
restricted stock units and stock options, and upon conversion of
the 2027 Convertible Notes. We cannot predict the effect if any,
that conversions of the 2027 Convertible Notes or of any future
issuances of common stock or equity-linked securities, may have on
the market price for our common stock. The issuance and sale or
conversion of substantial amounts of common stock or equity-linked
securities, or the perception that such issuances and sales may
occur, could adversely affect the trading price of the 2027
Convertible Notes and the market price of our common stock and
impair our ability to raise capital through the sale of additional
equity or equity-linked securities.
Our failure to generate sufficient cash flow from our business to
make payments on our debt would adversely affect our business,
financial condition and results of operations. Our indebtedness
could limit our ability to incur additional debt to fund our
operations.
We have significant indebtedness under the 2027 Convertible Notes.
Holders of the 2027 Convertible Notes will have the right to
require us to repurchase their 2027 Convertible Notes for cash upon
the occurrence a “fundamental change” as defined in the indenture
for the 2027 Convertible Notes and we may elect to settle all or a
portion of the conversion obligation of the 2027 Convertible Notes
in cash. Our ability to make scheduled payments of the principal
of, to pay interest on, to offer to repurchase the 2027 Convertible
Notes upon a fundamental change as defined in the indenture for the
2027 Convertible Notes, or to refinance the 2027 Convertible Notes
and any additional debt obligations we may incur depends on our
future performance, which is subject to economic, financial,
competitive and other factors that may be beyond our control. If we
are unable to generate the necessary cash flow, we may be required
to adopt one or more alternatives, such as selling assets,
restructuring debt or obtaining additional equity capital on terms
that may be onerous or highly dilutive. Any failure to generate
sufficient cash flow to satisfy our obligations under the 2027
Convertible Notes or any future indebtedness could lead to a
default under the 2027 Convertible Notes or such
indebtedness.
The indenture for the 2027 Convertible Notes contains covenants
limiting our ability in the future to secure our or our
subsidiaries’ assets or have our subsidiaries issue guarantees
without equally and ratably securing or guaranteeing the 2027
Convertible Notes. These covenants may make it more difficult for
us to incur indebtedness to fund our operations on attractive terms
or at all.
We may seek to refinance all or a portion of our outstanding
indebtedness in the future. Any such refinancing would depend on
the capital markets and business and financial conditions at the
time, which could affect our ability to obtain attractive terms if
or when desired or at all.
In addition, our significant indebtedness, combined with our other
financial obligations and contractual commitments, could have other
important consequences to our business. For example, it
could:
•make
it more difficult for us to meet our payment and other obligations
under our indebtedness;
•result
in other events of default under our indebtedness, which events of
default could result in all of our debt becoming immediately due
and payable;
•make
us more vulnerable to adverse changes in general economic, industry
and competitive conditions and adverse changes in government
regulation;
•limit
our ability to borrow additional amounts for working capital and
other general corporate purposes, including funding possible
acquisitions of, or investments in, new and complementary
businesses, products and technologies, which is a key element of
our corporate strategy;
•require
the dedication of a substantial portion of our cash flow from
operations to service our indebtedness, thereby reducing the amount
of our cashflow available for other purposes, including working
capital, business development activities, any future clinical
trials and/or research and development, capital expenditures and
other general corporate purposes;
•limit
our flexibility in planning for, or reacting to, changes in our
business and our industry; and
•put
us at a disadvantage compared to our competitors who have less
debt.
Any of these factors can adversely affect our business, financial
condition and results of operations. In addition, if we incur
additional indebtedness, the risks related to our business and our
ability to service or repay our indebtedness would
increase.
The accounting method for the 2027 Convertible Notes or changes in
the accounting method for convertible debt securities that may be
settled in cash, such as the 2027 Convertible Notes, could have a
material effect on our reported financial results.
If holders do not convert their 2027 Convertible Notes, we could be
required under applicable accounting rules to classify all or a
portion of the outstanding principal of the 2027 Convertible Notes
as a current rather than long-term liability, which would result in
a material reduction of our net working capital.
Under Accounting Standards Codification 470-20, Debt with
Conversion and Other Options (“ASC 470-20”), an entity must
separately account for the liability and equity components of
convertible debt instruments (such as the 2027 Convertible Notes)
that may be settled entirely or partially in cash upon conversion
in a manner that reflects the issuer’s economic interest cost. The
effect of ASC 470-20 on the accounting for the 2027 Convertible
Notes is that the equity component would be required to be included
in the additional paid-in capital section of stockholders’ equity
on our consolidated balance sheet at issuance, and the value of the
equity component would be treated as a discount for purposes of
accounting for the debt component of the 2027 Convertible Notes. In
addition, under certain circumstances, convertible debt instruments
(such as the 2027 Convertible Notes) that may be settled entirely
or partly in cash may be accounted for utilizing the treasury stock
method for earnings per share purposes, the effect of which is that
the shares issuable upon conversion of the 2027 Convertible Notes
are not included in the calculation of diluted earnings per share
except to the extent that the conversion value of the 2027
Convertible Notes exceeds their principal amount.
However, in August 2020, the FASB published an accounting standards
update (ASU) 2020-06 (“ASU 2020-06”), which amends these accounting
standards by reducing the number of accounting models for
convertible instruments and limiting instances of separate
accounting for the debt and equity or a derivative component of the
convertible debt instruments. ASU 2020-06 also will no longer allow
for earnings per share purposes the use of the treasury stock
method for convertible instruments and instead require application
of the “if-converted” method. Under that method, diluted earnings
per share will generally be calculated assuming that all the 2027
Convertible Notes were converted solely into shares of common stock
at the beginning of the reporting period, unless the result would
be anti-dilutive, which could adversely affect our diluted earnings
per share. However, if the principal amount of the convertible debt
instrument being converted is required to be paid in cash and only
the excess is permitted to be settled in shares, the if-converted
method will produce a similar result as the treasury stock method
prior to the adoption of ASU 2020-06 for such convertible debt
instrument. These amendments have become effective for public
companies for fiscal years beginning after December 15, 2021. As a
result, we do not expect to bifurcate the equity and debt
components of the 2027 Convertible Notes on our consolidated
balance sheet and expect to apply the if-converted method to
calculate the impact of the 2027 Convertible Notes on our diluted
earnings per share.
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.
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(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 |
July 1, 2022 - July 31, 2022 |
6,190 |
$2.65 |
N/A |
N/A |
August 1,2022 - August 31, 2022 |
6,287 |
$1.90 |
N/A |
N/A |
September 1,2022- September 30,2022 |
— |
— |
N/A |
N/A |
Total |
12,477 |
$2.27 |
|
|
(1) Consists of shares withheld to pay employees’ tax liability in
connection with the vesting of equity awards granted under our
stock-based compensation plans. These shares may be deemed to be
“issuer purchases” of shares.
ITEM 3. EXHIBITS
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4.5 |
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4.6 |
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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
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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 |
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Inline XBRL Taxonomy Extension Schema Document |
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101.CAL |
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Inline XBRL Taxonomy Extension Calculation Linkbase
Document |
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101.DEF |
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Inline XBRL Taxonomy Extension Definition Linkbase
Document |
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101.LAB |
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Inline XBRL Taxonomy Extension Label Linkbase Document |
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101.PRE |
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Inline XBRL Taxonomy Extension Presentation Linkbase
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104 |
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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.
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Date: November 8, 2022 |
ASSERTIO HOLDINGS, INC. |
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/s/ Daniel A. Peisert |
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Daniel A. Peisert |
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President and Chief Executive Officer |
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/s/ Paul Schwichtenberg |
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Paul Schwichtenberg |
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Senior Vice President and Chief Financial Officer |
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/s/ Ajay Patel |
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Ajay Patel |
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Senior Vice President and Chief Accounting Officer |
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