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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, 2023
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)
| | | | | |
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: | | Trading Symbol(s): | | Name of each exchange on which registered: |
Common Stock, $0.0001 par value | | ASRT | | The Nasdaq Stock Market LLC |
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.
| | | | | | | | | | | | | | | | | | | | |
| Large accelerated filer | ☐ | | Accelerated filer | ☒ | |
| Non-accelerated filer | ☐ | | Smaller reporting company | ☒ | |
| Emerging growth company | ☐ | | | | |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-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 6, 2023 was 94,668,523.
ASSERTIO HOLDINGS, INC.
FORM 10-Q FOR THE PERIOD ENDED SEPTEMBER 30, 2023
TABLE OF CONTENTS
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Item 1. | | |
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Item 2. | | |
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Item 3. | | |
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Item 4. | | |
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Item 1. | | |
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Item 1A. | | |
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Item 2. | | |
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Item 6. | | |
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PART I — FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
ASSERTIO HOLDINGS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share data)
| | | | | | | | | | | |
| (Unaudited) | | |
| September 30, 2023 | | December 31, 2022 |
ASSETS | | | |
Current assets: | | | |
Cash and cash equivalents | $ | 76,888 | | | $ | 64,941 | |
Accounts receivable, net | 62,467 | | | 45,357 | |
Inventories, net | 42,710 | | | 13,696 | |
Prepaid and other current assets | 2,895 | | | 8,268 | |
Total current assets | 184,960 | | | 132,262 | |
Property and equipment, net | 804 | | | 744 | |
Intangible assets, net | 170,413 | | | 197,996 | |
Goodwill | 19,856 | | | — | |
Deferred tax asset | — | | | 80,202 | |
Other long-term assets | 3,995 | | | 2,709 | |
Total assets | $ | 380,028 | | | $ | 413,913 | |
LIABILITIES AND SHAREHOLDERS’ EQUITY | | | |
Current liabilities: | | | |
Accounts payable | $ | 19,004 | | | $ | 5,991 | |
Accrued rebates, returns and discounts | 59,424 | | | 49,426 | |
Accrued liabilities | 22,065 | | | 12,181 | |
Long-term debt, current portion | — | | | 470 | |
Contingent consideration, current portion | 12,800 | | | 26,300 | |
Other current liabilities | 996 | | | 948 | |
Total current liabilities | 114,289 | | | 95,316 | |
Long-term debt | 38,866 | | | 66,403 | |
Contingent consideration | 16,100 | | | 22,200 | |
Other long-term liabilities | 17,900 | | | 4,269 | |
Total liabilities | 187,155 | | | 188,188 | |
Commitments and contingencies (Note 14) | | | |
Shareholders’ equity: | | | |
Common stock, $0.0001 par value, 200,000,000 shares authorized; 94,553,009 and 48,319,838 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively. | 9 | | | 5 | |
Additional paid-in capital | 787,023 | | | 545,321 | |
Accumulated deficit | (594,159) | | | (319,601) | |
Total shareholders’ equity | 192,873 | | | 225,725 | |
Total liabilities and shareholders' equity | $ | 380,028 | | | $ | 413,913 | |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
ASSERTIO HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE (LOSS) INCOME
(in thousands, except per share data)
(Unaudited)
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2023 | | 2022 | | 2023 | | 2022 |
Revenues: | | | | | | | |
Product sales, net | $ | 35,137 | | | $ | 34,279 | | | $ | 116,989 | | | $ | 105,258 | |
Royalties and milestones | 490 | | | 473 | | | 1,910 | | | 1,916 | |
Other revenue | — | | | (540) | | | 185 | | | (1,290) | |
Total revenues | 35,627 | | | 34,212 | | | 119,084 | | | 105,884 | |
Costs and expenses: | | | | | | | |
Cost of sales | 7,060 | | | 4,009 | | | 17,299 | | | 12,734 | |
Research and development expenses | 1,316 | | | — | | | 1,819 | | | — | |
Selling, general and administrative expenses | 21,005 | | | 11,900 | | | 54,680 | | | 33,084 | |
Change in fair value of contingent consideration | (17,532) | | | 3,900 | | | (8,124) | | | 6,845 | |
Amortization of intangible assets | 10,184 | | | 7,969 | | | 22,752 | | | 24,438 | |
Loss on impairment of intangible assets | 238,831 | | | — | | | 238,831 | | | — | |
Restructuring charges | 3,034 | | | — | | | 3,034 | | | — | |
Total costs and expenses | 263,898 | | | 27,778 | | | 330,291 | | | 77,101 | |
(Loss) income from operations | (228,271) | | | 6,434 | | | (211,207) | | | 28,783 | |
Other (expense) income: | | | | | | | |
Debt-related expenses | — | | | — | | | (9,918) | | | — | |
Interest expense | (752) | | | (2,052) | | | (2,625) | | | (6,648) | |
Other gain | 138 | | | 2 | | | 1,601 | | | 453 | |
Total other expense | (614) | | | (2,050) | | | (10,942) | | | (6,195) | |
Net (loss) income before income taxes | (228,885) | | | 4,384 | | | (222,149) | | | 22,588 | |
Income tax expense | (50,659) | | | (210) | | | (52,409) | | | (1,516) | |
Net (loss) income and comprehensive income | $ | (279,544) | | | $ | 4,174 | | | $ | (274,558) | | | $ | 21,072 | |
| | | | | | | |
Basic net (loss) income per share | $ | (3.42) | | | $ | 0.09 | | | $ | (4.35) | | | $ | 0.45 | |
Diluted net (loss) income per share | $ | (3.42) | | | $ | 0.08 | | | $ | (4.35) | | | $ | 0.42 | |
Shares used in computing basic net (loss) income per share | 81,713 | | | 48,180 | | | 63,066 | | | 46,566 | |
Shares used in computing diluted net (loss) income per share | 81,713 | | | 57,386 | | | 63,066 | | | 50,470 | |
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 | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
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| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
Balances at June 30, 2023 | 56,513 | | | $ | 5 | | | $ | 568,881 | | | $ | (314,615) | | | | | $ | 254,271 | |
Issuance of common stock upon exercise of options | 23 | | | — | | | 54 | | | — | | | | | 54 | |
Common stock issuance and other impacts of the vesting and settlement of equity awards | 9 | | | — | | | (33) | | | — | | | | | (33) | |
Issuance of common stock in connection with the Spectrum Merger, net of fractional share settlement | 38,008 | | | 4 | | | 216,257 | | | — | | | | | 216,261 | |
| | | | | | | | | | | |
Stock-based compensation | — | | | — | | | 1,864 | | | — | | | | | 1,864 | |
Net loss and comprehensive loss | — | | | — | | | — | | | (279,544) | | | | | (279,544) | |
Balances at September 30, 2023 | 94,553 | | | $ | 9 | | | $ | 787,023 | | | $ | (594,159) | | | | | $ | 192,873 | |
| | | | | | | | | | | |
| | | | | | | | | | | |
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| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Common Stock | | Additional Paid-In Capital | | Accumulated Deficit | | | | Shareholders’ Equity |
| Shares | | Amount | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
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| | | | | | | | | | | |
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| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
Balances at June 30, 2022 | 48,172 | | $ | 5 | | | $ | 540,692 | | | $ | (412,328) | | | | | $ | 128,369 | |
| | | | | | | | | | | |
| | | | | | | | | | | |
Common stock issuance and other impacts of the vesting and settlement of equity awards | 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 | |
| | | | | | | | | | | |
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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 SHAREHOLDERS’ EQUITY
(in thousands)
(Unaudited)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Common Stock | | Additional Paid-In Capital | | Accumulated Deficit | | | | Shareholders’ Equity |
| Shares | | Amount | | | | |
Balances at December 31, 2022 | 48,320 | | | $ | 5 | | | $ | 545,321 | | | $ | (319,601) | | | | | $ | 225,725 | |
Issuance of common stock upon exercise of options | 133 | | | — | | | 210 | | | — | | | | | 210 | |
Common stock issuance and other impacts of the vesting and settlement of equity awards | 1,102 | | | — | | | (7,980) | | | — | | | | | (7,980) | |
Induced exchange of convertible notes - (See Note 15) | 6,990 | | | — | | | 26,699 | | | — | | | | | 26,699 | |
Issuance of common stock in connection with the Spectrum Merger, net of fractional share settlement | 38,008 | | | 4 | | | 216,257 | | | — | | | | | 216,261 | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
Stock-based compensation | — | | | — | | | 6,516 | | | — | | | | | 6,516 | |
| | | | | | | | | | | |
| | | | | | | | | | | |
Net loss and comprehensive loss | — | | | — | | | — | | | (274,558) | | | | | (274,558) | |
Balances at September 30, 2023 | 94,553 | | | $ | 9 | | | $ | 787,023 | | | $ | (594,159) | | | | | $ | 192,873 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 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 | |
Common stock issuance and other impacts of the vesting and settlement of equity awards | 705 | | | — | | | (707) | | | — | | | | | (707) | |
Issuance of common stock in connection with at-the-market program | 2,464 | | | 1 | | | 7,019 | | | — | | | | | 7,020 | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
Issuance of common stock upon exercise of warrant | 388 | | | — | | | — | | | — | | | | | — | |
Stock-based compensation | — | | | — | | | 5,116 | | | — | | | | | 5,116 | |
| | | | | | | | | | | |
| | | | | | | | | | | |
Net income and comprehensive income | — | | | — | | | — | | | 21,072 | | | | | 21,072 | |
Balances at September 30, 2022 | 48,197 | | | $ | 5 | | | $ | 543,064 | | | $ | (408,154) | | | | | $ | 134,915 | |
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, |
| 2023 | | 2022 |
Operating Activities | | | |
Net (loss) income | $ | (274,558) | | | $ | 21,072 | |
Adjustments to reconcile net (loss) income to net cash from operating activities: | | | |
Depreciation and amortization | 23,321 | | | 25,033 | |
Amortization of debt issuance costs and Royalty Rights | 350 | | | 128 | |
Loss on impairment of intangible assets | 238,831 | | | — | |
Recurring fair value measurements of assets and liabilities | (7,612) | | | 6,845 | |
Debt-related expenses | 9,918 | | | — | |
Provisions for inventory and other assets | 2,129 | | | 828 | |
Stock-based compensation | 6,516 | | | 5,116 | |
Deferred income taxes | 47,192 | | | — | |
Changes in assets and liabilities, net of acquisition: | | | |
Accounts receivable | 33,865 | | | (319) | |
Inventories | (8,898) | | | (7,607) | |
Prepaid and other assets | 6,769 | | | 13,288 | |
Accounts payable and other accrued liabilities | (21,523) | | | (7,193) | |
Accrued rebates, returns and discounts | (11,027) | | | (4,058) | |
Interest payable | (1,376) | | | (1,232) | |
Net cash provided by operating activities | 43,897 | | | 51,901 | |
Investing Activities | | | |
Purchases of property and equipment | (528) | | | — | |
Purchase of Sympazan | (280) | | | — | |
Net cash acquired in Spectrum Merger | 1,950 | | | — | |
Purchase of Otrexup | — | | | (16,889) | |
Proceeds from sale of investments | 2,194 | | | — | |
Net cash provided by (used in) investing activities | 3,336 | | | (16,889) | |
Financing Activities | | | |
Proceeds from issuance of 2027 Convertible Notes | — | | | 65,916 | |
Payments in connection with 2027 Convertible Notes | (10,500) | | | — | |
| | | |
Payment of direct transaction costs related to convertible debt inducement | (1,119) | | | — | |
Payment in connection with 2024 Senior Notes | — | | | (70,750) | |
Payment of contingent consideration | (15,408) | | | (7,845) | |
| | | |
Proceeds from the issuance of common stock | — | | | 7,020 | |
| | | |
Payments related to the vesting and settlement of equity awards, net | (7,770) | | | (707) | |
| | | |
Other financing activities | (489) | | | (630) | |
Net cash used in financing activities | (35,286) | | | (6,996) | |
Net increase in cash and cash equivalents | 11,947 | | | 28,016 | |
Cash and cash equivalents at beginning of year | 64,941 | | | 36,810 | |
Cash and cash equivalents at end of period | $ | 76,888 | | | $ | 64,826 | |
| | | |
Supplemental Disclosure of Cash Flow Information | | | |
Net cash paid (refunded) for income taxes | $ | 3,424 | | | $ | (7,822) | |
Cash paid for interest | $ | 3,651 | | | $ | 7,752 | |
| | | |
| | | |
| | | |
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. ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Organization
Assertio Holdings, Inc., or the Company, is a commercial pharmaceutical company offering differentiated products to patients. The Company has built its commercial portfolio through a combination of increased opportunities with existing products, as well as through the acquisition or licensing of additional approved products. The Company’s primary marketed products include INDOCIN® (indomethacin) Suppositories, INDOCIN® (indomethacin) Oral Suspension, ROLVEDONTM (elflapegrastim-xnst) injection for subcutaneous use, Otrexup® (methotrexate) injection for subcutaneous use, Sympazan® (clobazam) oral film, SPRIX® (ketorolac tromethamine) Nasal Spray, CAMBIA® (diclofenac potassium for oral solution), and Zipsor® (diclofenac potassium) Liquid filled capsules. Other commercially available products include OXAYDO® (oxycodone HCI, USP) tablets for oral use only —CII.
Unless otherwise noted or required by context, use of “Assertio,” “Company,” “we,” “our” and “us” refer to Assertio Holdings and/or its applicable subsidiary or subsidiaries.
On July 31, 2023 (the “Effective Date”), the Company completed the acquisition of Spectrum Pharmaceuticals, Inc. (“Spectrum”), a commercial stage biopharmaceutical company focused on novel and targeted oncology products, (the “Spectrum Merger”). Refer to Note 2, Acquisitions, for additional information.
Basis of Presentation
The unaudited condensed consolidated financial statements of the Company 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 United States (“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, 2023 are not necessarily indicative of results to be expected for the entire year ending December 31, 2023 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, 2022 included in Assertio Holdings, Inc.’s Annual Report on Form 10-K filed with the SEC on March 8, 2023 (the “2022 Form 10-K”). The Condensed Consolidated Balance Sheet as of December 31, 2022 has been derived from the audited financial statements at that date, as filed in the Company’s 2022 Form 10-K.
NOTE 2. ACQUISITIONS
Spectrum Pharmaceuticals
On the Effective Date, the Company completed the Spectrum Merger pursuant to an Agreement and Plan of Merger (“the Merger Agreement”), dated as of April 24, 2023, with Spectrum surviving the Merger as a wholly-owned subsidiary of the Company. The Company accounted for the Spectrum Merger using the acquisition method of accounting under Accounting Standards Codification (“ASC”) 805 and is considered the accounting acquirer.
Pursuant to the Merger Agreement, each issued and outstanding share of Spectrum common stock as of the Effective Date was converted into the right to receive (i) 0.1783 shares of the Company’s common stock and (ii) one contingent value right (“CVR”) representing a contractual right to receive future conditional payments worth up to an aggregate maximum amount of $0.20, settleable in cash, additional shares of Assertio common stock or a combination of cash and additional shares of Assertio common stock at the Company’s sole discretion, upon the achievement of certain sales milestones related to Spectrum’s product ROLVEDON. Subject to adjustments, each CVR represents the right to receive up to $0.10 payable upon ROLVEDON net sales (less certain deductions) achieving $175 million during the calendar year ending December 31, 2024, and up to $0.10 payable upon ROLVEDON net sales (less certain deductions) achieving $225 million during the calendar year
ending December 31, 2025. In addition, upon consummation of the Spectrum Merger, Spectrum’s outstanding employee stock awards and other warrants that were outstanding immediately as of the Effective Date automatically vested (if unvested) and/or cancelled, as applicable, which generally resulted in the issuance of shares of the Company’s common stock and/or CVRs to the holders of such stock awards or other warrants, in each case as dictated by the terms of the Merger Agreement. These shares and CVRs issued are considered part of the consideration transferred, and no compensation expense was recognized because the settlement was a condition of the Merger Agreement and other existing individual agreements, no future performance is required by the holders, and the fair value of the shares and CVRs is equivalent to the fair value of the existing employee stock awards and other warrants.
The following table reflects the components of the consideration transferred in the Spectrum Merger (in thousands, except exchange ratio and per share data):
| | | | | | | | |
| | |
| | |
| | |
| | |
| | |
Assertio shares issued | | 38,013 | |
Assertio closing price per share as of the Effective Date | | $ | 5.69 | |
Fair value of Assertio shares issued | | $ | 216,294 | |
Repayment of Spectrum's long-term debt (1) | | 32,647 | |
CVRs(2) | | 3,932 | |
Total fair value of consideration transferred | | $ | 252,873 | |
(1)Represents settlement of Spectrum’s existing long-term debt in connection with the close of the transaction. The Company concluded it did not assume the debt, therefore the amount paid to settle the debt has been accounted for and disclosed as part of the consideration transferred.
(2)Represents the fair value of 223,397 CVRs at $0.0176 per CVR issued to holders of Spectrum common stock, employee stock awards and warrants as of the Effective Date.
The CVRs represent a contingent consideration obligation measured at fair value and classified as liabilities on the Company’s Condensed Consolidated Balance Sheets. The fair value of the CVR contingent consideration is determined using a Monte Carlo simulation model under the income approach and is based on Level 3 inputs. Refer to Note 17, Fair Value, for additional information. Fair value is based on the probability of achievement of 2024 and 2025 annual ROLVEDON net sales milestones. Significant assumptions include the discount rate and the probability assigned to the achievement of the net sales milestones. Achievement of both the 2024 and 2025 annual ROLVEDON net sales milestones would obligate the Company to transfer a maximum of approximately $44.7 million of additional consideration. No additional consideration would be paid by the Company if neither the 2024 nor 2025 annual ROLVEDON net sales milestones are achieved.
The following table reflects the preliminary fair value of the assets acquired and liabilities assumed at the Effective Date (in thousands). Goodwill is primarily attributable to expected synergies between the Company and Spectrum and is not expected to be deductible for tax purposes. The Company continues to assess the fair value of the assets acquired and liabilities assumed at the Effective Date, including any which may be impacted by Spectrum’s pending legal proceedings. Accordingly, the provisional fair value estimates of net assets acquired could potentially change, and the Company expects to finalize these values as soon as practical and no later than one year from the Effective Date.
| | | | | | | | | | | | | | |
Consideration transferred | | | | $ | 252,873 | |
| | | | |
Assets: | | | | |
Cash and cash equivalents | | $ | 34,600 | | | |
Marketable securities | | 2,194 | | | |
Accounts receivable | | 50,975 | | | |
Inventories | | 22,244 | | | |
Prepaid and other current assets | | 1,287 | | | |
Property and equipment | | 100 | | | |
Intangible assets | | 234,000 | | | |
Other long-term assets | | 1,396 | | | |
Total | | $ | 346,796 | | | |
| | | | |
Liabilities: | | | | |
Accounts payable | | $ | 10,108 | | | |
Accrued rebates, returns and discounts | | 21,025 | | | |
Accrued liabilities | | 36,509 | | | |
Other current liabilities | | 784 | | | |
Deferred taxes | | 34,250 | | | |
Other long-term liabilities | | 11,103 | | | |
Total | | $ | 113,779 | | | |
| | | | |
Total Spectrum net assets acquired (1) | | | | $ | 233,017 | |
Goodwill | | | | $ | 19,856 | |
(1)Application of the acquisition method required the Company to adjust Spectrum assets and liabilities as of the Effective Date, including certain liabilities for variable consideration associated with ROLVEDON, to reflect conformity of Spectrum’s accounting policies to those of Assertio. Liabilities assumed include certain bonuses owed to former Spectrum executives under the terms of existing employment agreements triggered by the consummation of the Spectrum Merger.
The income approach was primarily used to value the acquired intangible assets, representing rights to Spectrum’s product ROLVEDON. Significant assumptions include the amount and timing of projected future cash flows; the discount rate selected to measure the inherent risk of future cash flows; and the assessment of the product’s life cycle and the competitive trends impacting the product. The ROLVEDON product rights will be amortized on a straight-line basis over its estimated useful life of 10 years.
Acquisition costs related to the Spectrum Merger were approximately $2.7 million and $8.5 million for the three and nine months ended September 30, 2023, respectively. These costs are included within Selling, general and administrative expenses in the Condensed Consolidated Statement of Comprehensive (Loss) Income.
The following unaudited pro forma information represents the Company’s results of operations as if the Spectrum Merger had been completed as of January 1, 2022 (in thousands) and includes nonrecurring adjustments for additional costs of sales from the fair value step-up of inventories and transaction costs. The disclosure of pro forma net sales and net loss does not purport to indicate the results that would actually have been obtained had the Spectrum Merger been completed on the assumed date for the periods presented, or which may be realized in the future. The unaudited pro forma information does not reflect any operating efficiencies or cost savings that may be realized from the integration of the acquisition.
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2023 | | 2022 | | 2023 | | 2022 |
Net sales | $ | 35,629 | | $ | 34,212 | | | $ | 159,528 | | $ | 42,466 | |
Net loss | (285,658) | | (22,073) | | | (326,769) | | (98,616) | |
See Note 3, Revenue, for net sales of ROLVEDON from the Effective Date to September 30, 2023.
NOTE 3. REVENUE
Disaggregated Revenue
The following table reflects total revenue, net for the three and nine months ended September 30, 2023 and 2022 (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended September 30, | | Nine Months Ended September 30, |
| | 2023 | | 2022 | | 2023 | | 2022 |
Product sales, net: | | | | | | | | |
INDOCIN products | | $ | 17,948 | | $ | 21,869 | | | $ | 76,369 | | $ | 66,067 | |
ROLVEDON | | 7,132 | | — | | | 7,132 | | — | |
Otrexup | | 2,807 | | | 3,004 | | | 9,222 | | | 8,699 | |
Sympazan | | 2,103 | | | — | | | 7,232 | | | — | |
SPRIX | | 2,545 | | | 2,455 | | | 6,807 | | | 6,437 | |
CAMBIA | | 1,993 | | | 5,808 | | | 6,062 | | | 17,464 | |
Zipsor | | 597 | | | 259 | | | 2,751 | | | 2,704 | |
Other products | | 12 | | | 884 | | | 1,414 | | | 3,887 | |
Total product sales, net | | 35,137 | | | 34,279 | | | 116,989 | | | 105,258 | |
Royalties and milestone revenue | | 490 | | | 473 | | | 1,910 | | | 1,916 | |
Other revenue | | — | | | (540) | | | 185 | | | (1,290) | |
Total revenues | | $ | 35,627 | | | $ | 34,212 | | | $ | 119,084 | | | $ | 105,884 | |
Product Sales, net
Product sales consists of sales of the Company’s products as listed above. As a result of the Spectrum Merger, the Company began recognizing ROLVEDON sales in August 2023. The Company acquired Sympazan and began shipping and recognizing its product sales in October 2022.
Other product sales include product sales for OXAYDO and SOLUMATRIX product.. The Company ceased OXAYDO product sales beginning in September 2023, and ceased SOLUMATRIX sales beginning in July 2022.
Royalties and Milestone Revenue
In November 2010, the Company entered into a license agreement granting the counterparty the rights to commercially market CAMBIA in Canada. The counterparty to the license agreement 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, 2023, respectively, and $0.5 million and $1.5 million for the three and nine months ended September 30, 2022, respectively.
The Company records contract liabilities in the form of deferred revenue resulting from prepayments from customers in Other current liabilities in the Company’s Condensed Consolidated Balance Sheets. As of September 30, 2023 and December 31, 2022, contract liabilities were zero and $0.2 million, respectively. The Company recognized Milestone revenue associated with the completion of certain service milestones of $0.5 million for both the nine months ended September 30, 2023 and 2022.
The Company recognized no Milestone revenue associated with the completion of certain service milestones for both the three months ended September 30, 2023 and 2022.
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 a reduction to or an increase to total revenue during the period.
NOTE 4. ACCOUNTS RECEIVABLES, NET
As of September 30, 2023 and December 31, 2022, accounts receivable, net, of $62.5 million and $45.4 million, respectively, consisted entirely of receivables related to product sales, net of allowances for cash discounts for prompt payment of $1.5 million and $0.9 million, respectively.
NOTE 5. INVENTORIES, NET
The following table reflects the components of inventory, net as of September 30, 2023 and December 31, 2022 (in thousands):
| | | | | | | | | | | |
| September 30, 2023 | | December 31, 2022 |
Raw materials | $ | 15,355 | | | $ | 1,367 | |
Work-in-process | 1,330 | | | 2,735 | |
Finished goods | 26,025 | | | 9,594 | |
Total inventories, net | $ | 42,710 | | | $ | 13,696 | |
The Company writes down the value of inventory for potentially excess or obsolete inventories based on an analysis of inventory on hand and projected demand. As of September 30, 2023 and December 31, 2022, the Company recorded inventory write-downs of $5.7 million and $2.8 million, respectively.
NOTE 6. PREPAID AND OTHER CURRENT ASSETS
The following table reflects prepaid and other current as of September 30, 2023 and December 31, 2022 (in thousands):
| | | | | | | | | | | |
| September 30, 2023 | | December 31, 2022 |
Prepaid assets and deposits | $ | 2,614 | | | $ | 8,268 | |
Other current assets | 281 | | | — | |
| | | |
Total prepaid and other current assets | $ | 2,895 | | | $ | 8,268 | |
Other current assets includes the Company’s investment in NES Therapeutic, Inc. (“NES”). In August 2018, the Company entered into a Convertible Secured Note Purchase Agreement (the “Note Agreement”) with NES. Pursuant the terms of the Note Agreement, the Company purchased a $3.0 million aggregate principal Convertible Secured Promissory Note (the “NES Note”) which accrues interest annually at a rate of 10% for total consideration of $3.0 million, with both the aggregate 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) U.S. Food and Drug Administration (“FDA”) acceptance of the New Drug Application (“NDA”), (ii) initiation of any required clinical trials by NES, or (iii) a qualified financing event by NES, as defined in the Note Agreement. The Company’s investment in the NES Note is accounted as a loan receivable and is valued at amortized cost. As of both September 30, 2023 and December 31, 2022, the Company has assessed an estimated $3.5 million expected credit loss reserve on its investment based on its evaluation of probability of default that exists. The expected credit loss reserve recognized in each period represents the entire aggregate principal amount and outstanding interest incurred on the NES Note as of both September 30, 2023 and December 31, 2022. The Company’s investment in NES has been reclassified to Other current assets as of September 30, 2023 as it will mature within one year of the balance sheet date.
NOTE 7. PROPERTY AND EQUIPMENT, NET
The following table reflects property and equipment, net as of September 30, 2023 and December 31, 2022 (in thousands):
| | | | | | | | | | | |
| September 30, 2023 | | December 31, 2022 |
Furniture and office equipment | $ | 1,808 | | | $ | 1,712 | |
Laboratory equipment | 20 | | | 20 | |
Leasehold improvements | 2,945 | | | 2,945 | |
Construction in progress | 528 | | | — | |
| 5,301 | | | 4,677 | |
Less: Accumulated depreciation | (4,497) | | | (3,933) | |
Property and equipment, net | $ | 804 | | | $ | 744 | |
Depreciation expense was $0.2 million and $0.6 million for the three and nine months ended September 30, 2023 and 2022, respectively. Depreciation expense is recognized in Selling, general and administrative expense in the Company’s Condensed Consolidated Statements of Comprehensive (Loss) Income.
NOTE 8. INTANGIBLE ASSETS AND GOODWILL
Intangible Assets
The following table reflects the gross carrying amounts and net book values of intangible assets as of September 30, 2023 and December 31, 2022 (dollar amounts in thousands):
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | September 30, 2023 | | December 31, 2022 |
| | Remaining Useful Life (In years) | | Gross Carrying Amount | | Accumulated Amortization | | Impairment | | | | Net Book Value | | Gross Carrying Amount | | Accumulated Amortization | | | | Net Book Value |
Products rights: | | | | | | | | | | | | | | | | | | | | |
INDOCIN | | 8.6 | | $ | 154,100 | | | $ | (43,126) | | | $ | (52,463) | | | | | $ | 58,511 | | | $ | 154,100 | | | $ | (33,495) | | | | | $ | 120,605 | |
ROLVEDON | | 9.8 | | 234,000 | | | (3,900) | | | (157,095) | | | | | 73,005 | | | — | | | — | | | | | — | |
Otrexup | | 6.2 | | 44,086 | | | (9,644) | | | (22,946) | | | | | 11,496 | | | 44,086 | | | (5,511) | | | | | 38,575 | |
Sympazan | | 11.1 | | 14,550 | | | (1,111) | | | — | | | | | 13,439 | | | 14,550 | | | (202) | | | | | 14,348 | |
SPRIX | | 3.6 | | 39,000 | | | (18,711) | | | (6,327) | | | | | 13,962 | | | 39,000 | | | (14,532) | | | | | 24,468 | |
Total intangible assets | | | | $ | 485,736 | | | $ | (76,492) | | | $ | (238,831) | | | | | $ | 170,413 | | | $ | 251,736 | | | $ | (53,740) | | | | | $ | 197,996 | |
| | | | | | | | | | | | | | | | | | | | |
During the three months ended September 30, 2023, the Company’s market capitalization declined to below the book value of the Company’s equity. Management determined that the Company’s book value of equity exceeding its market capitalization represented an indicator of impairment with respect to its long-lived assets.
Applying the relevant accounting guidance, the Company first assessed the recoverability of its long-lived assets. In performing this assessment, management concluded it was appropriate to group its assets at the entity level, most notably attributed to the significant shared operating cost structure which characterizes Assertio. The Company determined the carrying value of this asset group was not recoverable. Management then assessed and concluded that the fair value of the asset group was less than its carrying value and so recognized an impairment loss of approximately $238.8 million, which was allocated to the individual intangible assets of the group and is classified within Loss on impairment of intangible assets in the Condensed Consolidated Statement of Comprehensive (Loss) Income. The fair value of the asset group was determined using both an income and a market approach and used Level 3 inputs. These inputs included estimates of forecasted cash flows and the selection of comparable revenue and earnings multiples utilizing guideline companies.
Amortization expense was $10.2 million and $22.8 million for the three and nine months ended September 30, 2023, respectively, and $8.0 million and $24.4 million for three and nine months ended September 30, 2022, respectively.
The following table reflects future amortization expense the Company expects for its intangible assets (in thousands):
| | | | | | | | |
Year Ending December 31, | | Estimated Amortization Expense |
2023 (remainder) | | 5,259 | |
2024 | | 21,035 | |
2025 | | 21,035 | |
2026 | | 21,035 | |
2027 | | 18,814 | |
Thereafter | | 83,235 | |
Total | | $ | 170,413 | |
Goodwill
During the three months ended September 30, 2023, the Company recorded $19.9 million of goodwill from the Spectrum Merger. Refer to Note 2, Acquisitions, for additional details. Following the Company’s long-lived asset impairment discussed above, which was determined to be an indicator of impairment with respect to the Company’s goodwill, management tested goodwill for impairment by determining and comparing the fair value of its reporting unit to its carrying value, with the carrying value reflecting the allocated long-lived asset impairment loss. The fair value of the reporting unit was determined using both an income and a market approach and used Level 3 inputs. These inputs included estimates of forecasted cash flows, a discount rate to reflect the risk inherent in the forecasted cash flows, and the selection of comparable revenue and earnings multiples utilizing guideline companies. Management concluded that the fair value of the reporting unit exceeded its carrying value and, accordingly, goodwill was not impaired as of September 30, 2023. NOTE 9. OTHER LONG-TERM ASSETS
The following table reflects other long-term assets as of September 30, 2023 and December 31, 2022 (in thousands):
| | | | | | | | | | | |
| September 30, 2023 | | December 31, 2022 |
Operating lease right-of-use assets | $ | 1,806 | | | $ | 137 | |
Prepaid asset and deposits | 1,493 | | | 1,607 | |
Other | 696 | | | 965 | |
Total other long-term assets | $ | 3,995 | | | $ | 2,709 | |
NOTE 10. ACCRUED LIABILITIES
The following table reflects accrued liabilities as of September 30, 2023 and December 31, 2022 (in thousands):
| | | | | | | | | | | |
| September 30, 2023 | | December 31, 2022 |
Accrued compensation | $ | 2,468 | | | $ | 3,117 | |
Accrued restructuring costs (See Note 19) | 4,420 | | | — | |
Other accrued liabilities | 12,778 | | | 6,561 | |
Taxes payable | 1,353 | | | — | |
Interest payable | 217 | | | 1,593 | |
Accrued royalties | 829 | | | 910 | |
Total accrued liabilities | $ | 22,065 | | | $ | 12,181 | |
NOTE 11. DEBT
The following table reflects the Company’s debt as of September 30, 2023 and December 31, 2022 (in thousands):
| | | | | | | | | | | |
| September 30, 2023 | | December 31, 2022 |
6.5% Convertible Senior Secured Notes due 2027 | $ | 40,000 | | $ | 70,000 |
Royalty Rights obligation | — | | 470 |
Total principal amount | 40,000 | | 70,470 |
Plus: derivative liability for embedded conversion feature | 764 | | 252 |
Less: unamortized debt issuance costs | (1,898) | | (3,849) |
Carrying value | 38,866 | | 66,873 |
Less: current portion of long-term debt | — | | (470) |
Long-term debt, net | $ | 38,866 | | | $ | 66,403 |
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 as the trustee (the “2027 Convertible Note 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 aggregate principal amount of the 2027 Convertible Notes solely to cover overallotment (the “Overallotment Option”) within a 13-day period from the date 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 aggregate principal of additional 2027 Convertible Notes. The 2027 Convertible Notes are senior unsecured obligations of the Company.
The Company used the net proceeds from the issuance of the 2027 Convertible Notes to repurchase $59.0 million aggregate principal amount of its then outstanding 13% senior secured notes due 2024 (the “2024 Secured Notes”) assumed in accordance with the Company’s merger with Zyla Life Sciences (“Zyla”) in May 2020 (the “Zyla Merger”) and $3.0 million in associated interest payments pursuant to privately negotiated exchange agreements entered into concurrently with the pricing of the offering of the 2027 Convertible Notes.
On February 27, 2023, the Company completed a privately negotiated exchange of $30.0 million principal amount of the 2027 Convertible Notes (the “Convertible Note Exchange”). Pursuant to the Convertible Note Exchange, 6,990,000 shares of the Company’s common stock, plus an additional $10.5 million in cash, were issued in a partial settlement of the 2027 Convertible Notes (the “Exchanged Notes”). As a result of the Convertible Note Exchange in the first quarter of 2023, the Company recorded an induced conversion expense of approximately $8.8 million and direct transaction costs of approximately $1.1 million, the total of which is reported in Debt-related expenses in the Company’s Condensed Consolidated Statements of Comprehensive (Loss) Income for the nine months ended September 30, 2023. The induced conversion expense represents the fair value of the consideration transferred in the Convertible Note Exchange in excess of the fair value of common stock issuable under the original terms of the 2027 Convertible Notes. Additionally, approximately $1.6 million of unamortized issuance costs related to the Exchanged Notes were recognized as Additional paid-in capital in the Company’s Condensed Consolidated Balance Sheets for the nine months ended September 30, 2023.
The terms of the 2027 Convertible Notes are governed by an indenture dated August 25, 2022 (the “2027 Convertible Note Indenture”). The terms of the 2027 Convertible Notes allow for conversion into the Company’s common stock, cash, or a combination of cash and common stock, at the Company’s election only, 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 2027 Convertible Note Indenture (the “Conversion Rate”). The 2027 Convertible Notes will mature on September 1, 2027, unless earlier repurchased or converted.
The 2027 Convertible Notes bear 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, 2023.
The following table reflects the carrying balance of the 2027 Convertible Notes as of September 30, 2023 and December 31, 2022 (in thousands):
| | | | | | | | | | | |
| September 30, 2023 | | December 31, 2022 |
Principal balance | $ | 40,000 | | | $ | 70,000 | |
Derivative liability for embedded conversion feature | 764 | | | 252 | |
Unamortized debt issuance costs | (1,898) | | | (3,849) | |
Carrying balance | $ | 38,866 | | | $ | 66,403 | |
The debt issuance costs incurred related to the 2027 Convertible Notes are recognized as a debt discount and are being amortized as interest expense over the term of the 2027 Convertible Notes using the effective interest method, with an effective interest rate determined to be 7.8%. During the three and nine months ended September 30, 2023, the Company amortized $0.1 million and $0.4 million, respectively, of the debt discount on the 2027 Convertible Notes. During the nine months ended September 30, 2023, $1.6 million of unamortized issuance costs related to the Exchanged Notes were recognized as Additional paid-in capital.
The Company determined that an embedded conversion feature included in the 2027 Convertible Notes required bifurcation from the host contract and to be recognized as a separate derivative liability carried at fair value. See Note 17, Fair Value, for further details around the estimated fair value of the derivative liability. The estimated fair value of the derivative liability, which represents a Level 3 valuation, was $0.8 million and $0.3 million as of September 30, 2023 and December 31, 2022, respectively, and was determined using a binomial lattice model using certain assumptions and consideration of an increased conversion ratio on the underlying convertible notes that could result from the occurrence of certain events. Accordingly, the Company has recognized a loss on the fair value adjustment of the derivative liability in the amount of $0.5 million in Other (loss) gain in the Consolidated Statements of Comprehensive Loss (Income) for both the three and nine months ended September 30, 2023. There was no gain or loss on the fair value adjustment of the derivative liability for the three and nine months ended September 30, 2022. All of the other embedded features of the 2027 Convertible Notes were 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.
Royalty Rights Obligation
In accordance with the Zyla Merger, the Company assumed a royalty rights agreement (the “Royalty Rights”) with each of the holders of its 2024 Secured Notes pursuant to which the Company agreed to pay an aggregate 1.5% royalty on Net Sales (as defined in the indenture governing the 2027 Secured Notes) through December 31, 2022. The Royalty Rights terminated on December 31, 2022, and the Company paid in cash its remaining Royalty Rights obligations during the second quarter of 2023.
Interest Expense
Royalty Rights and debt issuance costs 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 (Loss) Income for the three and nine months ended September 30, 2023 and 2022 (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2023 | | 2022 | | 2023 | | 2022 |
Interest on 2027 Convertible Notes | $ | 650 | | $ | 456 | | $ | 2,275 | | $ | 456 |
Interest on 2024 Secured Notes | — | | 1,516 | | — | | 6,064 |
Amortization of Royalty Rights(1) | — | | 80 | | — | | 128 |
Amortization of debt issuance costs | 102 | | — | | 350 | | — |
Total interest expense | $ | 752 | | $ | 2,052 | | $ | 2,625 | | $ | 6,648 |
| | | | | | | |
| | | | | | | |
(1)As a result of the extinguishment of the Royalty Rights obligation in the fourth quarter of 2022, there will be no additional amortization expense recognized in future periods.
NOTE 12. STOCK-BASED COMPENSATION
The Company’s stock-based compensation generally includes time-based restricted stock units (“RSU”) and options, as well as performance-based RSUs and options.
Stock-based compensation of $1.9 million and $6.5 million, respectively, for the three and nine months ending September 30, 2023, and $2.4 million and $5.1 million, respectively, for the three and nine months ended September 30, 2022, was recognized in Selling, general, and administrative expenses in the Company’s Condensed Consolidated Statements of Comprehensive (Loss) Income.
During the nine months ended September 30, 2023 the Company granted 0.8 million RSUs at a weighted-average fair market value of $5.61 per share, and 0.7 million options at a weighted-average fair market value of $4.51 per share.
As previously disclosed, during the three months ended June 30, 2022, the Company granted a total of 1.0 million market-based performance RSUs (“performance RSUs”) to executive officers under the Company’s Amended and Restated 2014 Omnibus Incentive Plan. At the grant date, the weighted-average fair value of the performance RSUs was determined using a Monte Carlo simulation model to be $2.24 per performance RSU. The market-based conditions of the performance RSUs were achieved in the first quarter of 2023. Then, upon vesting of the performance RSUs in the second quarter of 2023, the compensation committee of the Company’s board of directors elected, under the terms of the performance RSU grants, to settle approximately 0.3 million of the performance RSUs in cash based on their fair market value on the vesting date, and settle 0.2 million of the performance RSUs in shares of the Company’s common stock. Approximately 0.5 million of the performance RSUs were withheld to settle the employees’ tax liability.
During the second quarter of 2023, approximately $2.6 million was paid by the Company to cash settle the performance RSUs and $3.4 million was paid by the Company to settle the employee’s tax liability, which are included in both Common stock issuance and other impacts of the vesting and settlement of equity awards in the Company’s Condensed Consolidated Statements of Shareholders’ Equity, and Payments related to the vesting and settlement of equity awards in the Company’s Condensed Consolidated Statements of Cash Flows.
NOTE 13. LEASES
As of September 30, 2023, the Company has a non-cancelable operating lease for its corporate office, which is located in Lake Forest, Illinois (the “Lake Forest Lease”). On May 1, 2023, the Company amended the Lake Forest Lease to reduce the size of leased premises and extend the term of the lease through December 31, 2030. In conjunction with the amendment of the Lake Forest Lease on May 1, 2023, the Company recognized an increase to both operating right-of-use asset and noncurrent operating lease liability of approximately $1.3 million, calculated using a discount rate of 7.41%.
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 terminated at the end of November 2022. The Newark lease was partially subleased through the lease term of November 2022. Operating lease costs and sublease income related to the Newark facility are accounted for in Other gain in the Company’s Condensed Consolidated Statements of Comprehensive (Loss) Income. Sublease income for the nine months ended September 30, 2022 includes a gain of $0.6 million from the early termination and settlement of a Newark facility sublease during the first quarter of 2022.
In connection with the Spectrum Merger, the Company assumed leases for two facilities and certain office equipment which Spectrum had previously been the lessee. As of September 30, 2023, the Company has recognized an operating right-of-use asset associated with these leases of $0.4 million, and a current and noncurrent lease liability associated with these leases of $0.7 million and $0.3 million, respectively. Refer to Note 19, Restructuring Charges, for further detail on the accounting for the leases assumed in the Spectrum Merger.
The following table reflects lease expense and income for the three and nine months ended September 30, 2023 and 2022 (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | Three Months Ended September 30, | | Nine Months Ended September 30, |
| Financial Statement Classification | | 2023 | | 2022 | | 2023 | | 2022 |
Operating lease cost | Selling, general and administrative expenses | | $ | 65 | | | $ | 39 | | | $ | 161 | | | $ | 118 | |
Operating lease cost | Other gain | | — | | | 148 | | | — | | | 444 | |
Total lease cost | | | $ | 65 | | | $ | 187 | | | $ | 161 | | | $ | 562 | |
| | | | | | | | | |
Sublease Income | Other gain | | $ | — | | | $ | 168 | | | $ | — | | | $ | 1,111 | |
The following table reflects supplemental cash flow information related to leases for the three and nine months ended September 30, 2023 and 2022 (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended September 30, | | Nine Months Ended September 30, |
| | 2023 | | 2022 | | 2023 | | 2022 |
Cash paid for amounts included in measurement of liabilities: | | | | | | | |
Operating cash flows from operating leases | $ | 225 | | | $ | 533 | | | $ | 433 | | | $ | 1,593 | |
The following table reflects supplemental balance sheet information related to leases as of September 30, 2023 and December 31, 2022 (in thousands):
| | | | | | | | | | | | | | | | | |
| Financial Statement Classification | | September 30, 2023 | | December 31, 2022 |
Assets | | | | | |
Operating lease right-of-use assets | Other long-term assets | | $ | 1,806 | | | $ | 137 | |
Liabilities | | | | | |
Current operating lease liabilities | Other current liabilities | | $ | 970 | | | $ | 401 | |
Noncurrent operating lease liabilities | Other long-term liabilities | | 1,679 | | | — | |
Total lease liabilities | | | $ | 2,649 | | | $ | 401 | |
NOTE 14. COMMITMENTS AND CONTINGENCIES
Jubilant HollisterStier Manufacturing and Supply Agreement
Pursuant to the Zyla Merger, the Company assumed a Manufacturing and Supply Agreement (the “Jubilant HollisterStier 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 Jubilant HollisterStier Agreement, JHS is responsible for supplying a minimum of 75% of the Company’s annual requirements of SPRIX. The Company agreed to purchase a minimum number of batches of SPRIX per calendar year from JHS over the term of the Jubilant HollisterStier Agreement. Total commitments to JHS through the remainder of 2023 are approximately $1.0 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 “Cosette 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 Cosette Supply Agreement, to among other things, extend the expiration date of the Cosette 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 Cosette Supply Agreement. Total
commitments to Cosette under the Cosette Supply Agreement 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 (the “Antares Supply Agreement”). Under the Antares Supply Agreement, the Company has agreed to annual minimum purchase obligations from Antares, which approximate $2.0 million annually. The Antares 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 the Company’s 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 both September 30, 2023 and December 31, 2022, the Company had a legal contingency accrual of approximately $3.2 million. The Company continues 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. Provisions for loss contingencies are recorded in Selling, general and administrative expense in the Company’s Condensed Consolidated Statements of Comprehensive (Loss) Income and the related accruals are recorded in Accrued liabilities in the Company’s Condensed Consolidated Balance Sheets.
Other than matters 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, cash flows 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 U.S. District Court for the Northern District of California against the Company and several other defendants relating to its 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 in the same District Court.
On July 30, 2020, Humana Inc. (“Humana”) also filed a complaint against the Company and several other defendants in the U.S. District Court for 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 the California Superior Court of Alameda 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 the California Superior Court of Alameda 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 District 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 California state court lawsuits, on November 24, 2021, the state court granted in part and denied in part a demurrer by the defendants in the Humana action. That case was consolidated in November 2022 with the HCSC action for pre-trial and trial purposes. On July 5, 2023, the state court denied a motion for judgment on the pleadings filed by the defendants in the Humana action. These California state cases are now in the midst of discovery, and trial is scheduled for 2024.
The Company intends to defend itself vigorously in the consolidated California state court lawsuits. A liability for this matter has been recorded in the financial statements.
Opioid-Related Request and Subpoenas
As a result of the greater public awareness of the public health issue of opioid abuse, there has been increased scrutiny of, and investigation into, the commercial practices of opioid manufacturers generally by federal, state, and local regulatory and governmental agencies. In March 2017, Assertio Therapeutics received a letter from then-Sen. Claire McCaskill (D-MO), the then-Ranking Member on the U.S. Senate Committee on Homeland Security and Governmental Affairs, requesting certain information regarding Assertio Therapeutics’ historical commercialization of opioid products. Assertio Therapeutics voluntarily furnished information responsive to Sen. McCaskill’s request. Since 2017, Assertio Therapeutics has received and responded to subpoenas from the U.S. Department of Justice (“DOJ”) seeking documents and information regarding its historical sales and marketing of opioid products. Assertio Therapeutics has also received and responded to subpoenas or civil investigative demands focused on its historical promotion and sales of Lazanda, NUCYNTA, and NUCYNTA ER from various state attorneys general seeking documents and information regarding Assertio Therapeutics’ historical sales and marketing of opioid products. In addition, Assertio Therapeutics received and responded to a subpoena from the State of California Department of Insurance (“CDI”) seeking information relating to its historical sales and marketing of Lazanda. The CDI subpoena also seeks information on Gralise, a non-opioid product formerly in Assertio Therapeutics’ portfolio. In addition, Assertio Therapeutics received and responded to a subpoena from the New York Department of Financial Services seeking information relating to its historical sales and marketing of opioid products. The Company has also received a subpoena from the New York Attorney General, pursuant to which the New York Attorney General is seeking information concerning the sales and marketing of opioid products (Lazanda, NUCYNTA, NUCYNTA ER, and OXAYDO) by Assertio Therapeutics and Zyla. The Company also from time to time receives and responds to subpoenas from governmental authorities related to investigations primarily focused on third parties, including healthcare practitioners. The Company 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. (“Depomed,” 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 the DOJ’s characterization of the payments from Depomed.
Multidistrict and Other Federal 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 six such cases. In April 2022, the Judicial Panel on Multi-District Litigation issued an
order stating that it would no longer transfer new opioid cases to the MDL Court. Since that time, Assertio Therapeutics has been named in lawsuits pending in federal courts outside of the MDL Court (in Georgia and New York). Plaintiffs may file additional lawsuits in which the Company 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 federal cases 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, Pennsylvania, Texas and Utah. Assertio Holdings is named as a defendant in one of these cases in Pennsylvania. Plaintiffs may file additional lawsuits in which the Company may be named. In the pending cases involving Assertio Therapeutics or Assertio Holdings, 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 or Assertio Holdings has been served are generally each at an early stage of proceedings. Assertio Therapeutics and Assertio Holdings intend to defend themselves 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 was 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 and Other Federal 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 Company’s Condensed Consolidated Statements of Comprehensive Income (Loss) for the year ended December 31, 2021.
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 Company’s Condensed Consolidated Statements of Comprehensive (Loss) Income for the year ended December 31, 2022.
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 parties are in discovery. Trial is scheduled for February 2024.
Stockholder Actions
Luo v. Spectrum Pharmaceuticals, Inc., et al., U.S. District Court, District of Nevada, Case No. 2:21-cv-01612. On August 31, 2021, this putative securities class action lawsuit was filed by a purported shareholder, alleging that Spectrum and certain of its former executive officers and directors made false or misleading statements and failed to disclose material facts about Spectrum’s business and the prospects of approval for its BLA to the FDA for eflapegrastim (ROLVEDON) in violation of Section 10(b) (and Rule 10b-5 promulgated thereunder) and 20(a) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). On November 1, 2021, four individuals and one entity filed competing motions to be appointed lead plaintiff and for approval of counsel. On July 28, 2022, the Court appointed a lead plaintiff and counsel for the putative class. On September 26, 2022, an amended complaint was filed alleging, inter alia, false and misleading statements with respect to ROLVEDON manufacturing operations and controls and adding allegations that defendants misled investors about the efficacy of, clinical trial data and market need for Poziotinib during a Class Period of March 7, 2018 to August 5, 2021. The amended complaint seeks damages, interest, costs, attorneys’ fees, and such other relief as may be determined by the Court. On November 30, 2022, the defendants filed a motion to dismiss the amended complaint, which was fully briefed as of February 27, 2023 and remains pending. Discovery is stayed pending resolution of the motion to dismiss. There is no hearing date presently scheduled. The Company intends to vigorously defend itself in this matter.
Christiansen v. Spectrum Pharmaceuticals, Inc. et al., Case No. 1:22-cv-10292 (filed December 5, 2022 in the U.S. District Court for the Southern District of New York) (the “New York Action”). Three additional related putative securities class action lawsuits were subsequently filed by Spectrum shareholders against Spectrum and certain of its former executive officers in the U.S. District Court for the Southern District of New York: Osorio-Franco v. Spectrum Pharmaceuticals, Inc., et al., Case No. 1:22-cv-10292 (filed December 5, 2022); Cummings v. Spectrum Pharmaceuticals, Inc., et al., Case No. 1:22-cv-10677 (filed December 19, 2022); and Carneiro v. Spectrum Pharmaceuticals, Inc., et al., Case No. 1:23-cv-00767 (filed January 30, 2023). These three New York lawsuits allege that Spectrum and certain of its former executive officers made false or misleading statements about, inter alia, the safety and efficacy of and clinical trial data for Poziotinib in violation of Section 10(b) (and Rule 10b-5 promulgated thereunder) and 20(a) of the Exchange Act, and seek remedies including damages, interest, costs, attorneys’ fees, and such other relief as may be determined by the Court. On February 15, 2023, the Court consolidated the three New York lawsuits. On March 21, 2023, the Court entered an order designating Steven Christiansen as the lead plaintiff. Lead plaintiff Christiansen filed an amended consolidated complaint in the New York Action under the caption Christiansen v. Spectrum Pharmaceuticals, Inc, et al., on May 30, 2023, alleging a Class Period between March 17, 2022 and September 2022. The defendants filed a motion to dismiss the consolidated New York Action on July 25, 2023, which was fully briefed as of October 19, 2023 and remains pending. Discovery is stayed pending resolution of the motion to dismiss. There is no hearing date presently scheduled. The Company intends to vigorously defend itself in this matter.
Csaba v. Turgeon, et. al, (filed December 15, 2021 in the U.S. District Court District of Nevada); Shumacher v. Turgeon, et. al, (filed March 15, 2022 in the U.S. District Court District of Nevada); Johnson v. Turgeon, et. al, (filed March 29, 2022 in the U.S. District Court District of Nevada); Raul v. Turgeon, et. al, (filed April 28, 2022 in the U.S. District Court District of Delaware); and Albayrak v. Turgeon, et. al, (filed June 9, 2022 in the U.S. District Court District of Nevada). These putative stockholder derivative actions were filed against Spectrum (as a nominal defendant), certain of Spectrum’s former executive officers and directors. The stockholder derivative complaints allege, inter alia, that certain of Spectrum’s former executive officers are liable to Spectrum, pursuant to Section 10(b) and 21(d) of the Exchange Act for contribution and indemnification, if they are deemed (in the Luo class action), to have made false or misleading statements and failed to disclose material facts about Spectrum’s business and the prospects of approval for its BLA to the FDA for eflapegrastim. The complaints generally but not uniformly further allege that certain of Spectrum’s former officers and directors breached their fiduciary duties, and certain of Spectrum’s former directors negligently violated Section 14(a) of the Exchange Act, by allegedly causing such false or misleading statements to be issued and/or failing to disclose material facts about Spectrum’s business and the prospects of approval for its BLA to the FDA for eflapegrastim. The allegations state that as a result of the violations, certain of Spectrum’s former executive officers and directors committed acts of gross mismanagement, abuse of control, or were unjustly enriched. The plaintiffs generally seek corporate reforms, damages, interest, costs, attorneys’ fees, and other unspecified equitable relief.
The parties have agreed to stay all derivative actions until there is a decision on a motion to dismiss in the Luo Nevada securities class action.
NOTE 15. SHAREHOLDERS EQUITY
Issuance of Common Stock in the Spectrum Merger
Pursuant to the Merger Agreement, shares of Spectrum common stock issued and outstanding immediately prior to the Effective Date, as well as Spectrum restricted stock units, certain stock appreciation rights, certain options to purchase Spectrum common stock, and warrants to purchase Spectrum common stock, which, in each case, were outstanding immediately prior to the Effective Date and were either vested or became vested as a result of the Spectrum Merger on the Effective Date, were converted into the right to receive fully paid and non-assessable shares of the Company’s common stock based on the exchange ratio as set forth in the Merger Agreement (see Note 2, Acquisitions). Accordingly, on the Effective Date the Company issued approximately 38.0 million shares of its common stock to the previous holders of Spectrum common stock, net of a fractional share settlement.
Exchanged Convertible Notes
Related to the Convertible Note Exchange (See Note 11, Debt) in the first quarter of 2023, the Company paid an aggregate of $10.5 million in cash and issued an aggregate of approximately 7.0 million shares of its common stock in the transactions. The Company did not receive any cash proceeds from the issuance of the shares of its common stock but recognized additional paid-in capital of $28.3 million during the nine months ended September 30, 2023 related to the common stock share issuance, net of approximately $1.6 million of unamortized issuance costs related to the Exchanged Notes.
At-The-Market Program
The Company is party to 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 a result of the issuance of the 2027 Convertible Notes (See Note 11, Debt), the Company has determined to suspend use of its ATM offering program. Prior to suspending the ATM offering program, 2,463,637 shares had 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.
Warrant Agreements
Upon the Zyla Merger, the Company assumed Zyla’s outstanding warrants which provided the holder the right to receive shares of the Company’s common stock. The warrants were exercisable at any time at an exercise price of $0.0016 per share, subject to certain ownership limitations including, with respect to Iroko Pharmaceuticals, Inc. 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.
During the nine months ended September 30, 2022, 0.4 million warrants were exercised, and 0.4 million of the Company’s common shares, were issued by the Company. Subsequent to these warrant exercises in the nine months ended September 30, 2022, there were no outstanding warrants remaining.
NOTE 16. NET (LOSS) INCOME PER SHARE
Basic net (loss) income per share is calculated by dividing the net (loss) income by the weighted-average number of shares of common stock outstanding during the period.
Diluted net (loss) income per share is calculated by dividing the net (loss) income by the weighted-average number of shares of common stock outstanding during the period, plus potentially dilutive common shares, consisting of stock-based awards and equivalents, and convertible debt. For purposes of this calculation, stock-based awards and convertible debt 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-based awards 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 any convertible debt outstanding was converted at the beginning of each period presented when the effect is dilutive. As a result, interest expense, net of tax, and any other income statement impact associated with the 2027 Convertible Notes, net of tax, is added back to net (loss) income used in the diluted earnings per share calculation. Additionally, the diluted shares used in the diluted earnings per share calculation includes the potential dilution effect of the convertible debt if converted into the Company’s common stock. For the three and nine months
ended September 30, 2022, the Company’s potentially dilutive stock-based awards and convertible debt were included in the computation of diluted net income per share. However, as the Company was in a net loss position for the three and nine months ended September 30, 2023, the Company’s potentially dilutive stock-based awards and convertible debt were not included in the computation of diluted net loss per share, because to do so would be anti-dilutive.
The following table reflects the calculation of basic and diluted (loss) earnings per common share for the three and nine months ended September 30, 2023 and 2022 (in thousands, except for per share amounts):
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2023 | | 2022 | | 2023 | | 2022 |
Basic net (loss) income per share | | | | | | | |
Net (loss) income | $ | (279,544) | | | $ | 4,174 | | | $ | (274,558) | | | $ | 21,072 | |
Weighted-average common shares outstanding | 81,713 | | | 48,180 | | | 63,066 | | | 46,566 | |
Basic net (loss) income per share | $ | (3.42) | | | $ | 0.09 | | | $ | (4.35) | | | $ | 0.45 | |
| | | | | | | |
Diluted net (loss) income per share | | | | | | | |
Net (loss) income | $ | (279,544) | | | $ | 4,174 | | | $ | (274,558) | | | $ | 21,072 | |
| | | | | | | |
Add: Convertible debt interest expense, net of tax | — | | | 497 | | | — | | | 487 | |
Adjusted net (loss) income | (279,544) | | | 4,671 | | | (274,558) | | | 21,559 | |
Weighted-average common shares and share equivalents outstanding | 81,713 | | | 48,180 | | | 63,066 | | | 46,566 | |
Add: effect of dilutive stock-based awards and equivalents | — | | | 1,960 | | | — | | | 1,462 | |
Add: effect of dilutive convertible debt under if-converted method | — | | | 7,246 | | | — | | | 2,442 | |
Denominator for diluted net (loss) income per share | 81,713 | | | 57,386 | | | 63,066 | | | 50,470 | |
Diluted net (loss) income per share | $ | (3.42) | | | $ | 0.08 | | | $ | (4.35) | | | $ | 0.42 | |
The following table reflects outstanding potentially dilutive common shares that are not included in the computation of diluted net (loss) income per share, because to do so would be anti-dilutive, for the three and nine months ended September 30, 2023 and 2022 (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2023 | | 2022 | | 2023 | | 2022 |
Convertible notes | 9,768 | | | — | | | 11,324 | | | — | |
Stock-based awards and equivalents | 7,016 | | | 2,983 | | | 7,641 | | | 1,329 | |
Total potentially dilutive common shares | 16,784 | | | 2,983 | | | 18,965 | | | 1,329 |
NOTE 17. FAIR VALUE
Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs.
•Level 1: Quoted prices in active markets for identical assets or liabilities.
•Level 2: Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
•Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
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, 2023 and December 31, 2022 (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
September 30, 2023 | | Financial Statement Classification | | Level 1 | | Level 2 | | Level 3 | | Total |
Assets: | | | | | | | | | | |
| | | | | | | | | | |
U.S. Treasuries | | Cash and cash equivalents | | $ | — | | | $ | 38,204 | | | $ | — | | | $ | 38,204 | |
| | | | | | | | | | |
Money market funds | | Cash and cash equivalents | | 22,797 | | | — | | | — | | | 22,797 | |
Total | | | | $ | 22,797 | | | $ | 38,204 | | | $ | — | | | $ | 61,001 | |
Liabilities: | | | | | | | | | | |
Short-term contingent consideration | | Contingent consideration, current portion | | $ | — | | | $ | — | | | $ | 12,800 | | | $ | 12,800 | |
Long-term contingent consideration | | Contingent consideration | | — | | | — | | | 16,100 | | | 16,100 | |
Derivative liability | | Long-term debt | | — | | | — | | | 764 | | | 764 | |
Total | | | | $ | — | | | $ | — | | | $ | 29,664 | | | $ | 29,664 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
December 31, 2022 | | Financial Statement Classification | | Level 1 | | Level 2 | | Level 3 | | Total |
Assets: | | | | | | | | | | |
Commercial paper | | Cash and cash equivalents | | $ | — | | | $ | 4,983 | | | $ | — | | | $ | 4,983 | |
U.S. Treasuries | | Cash and cash equivalents | | — | | | 3,981 | | | — | | | 3,981 | |
U.S. Government agencies | | Cash and cash equivalents | | — | | | 10,937 | | | — | | | 10,937 | |
Money market funds | | Cash and cash equivalents | | 38,478 | | | — | | | — | | | 38,478 | |
Total | | | | $ | 38,478 | | | $ | 19,901 | | | $ | — | | | $ | 58,379 | |
Liabilities: | | | | | | | | | | |
Short-term contingent consideration | | Contingent consideration, current portion | | $ | — | | | $ | — | | | $ | 26,300 | | | $ | 26,300 | |
Long-term contingent consideration | | Contingent consideration | | — | | | — | | | 22,200 | | | 22,200 | |
Derivative liability | | Long-term debt | | — | | | — | | | 252 | | | 252 | |
Total | | | | $ | — | | | $ | — | | | $ | 48,752 | | | $ | 48,752 | |
Cash and Cash Equivalents
The Company considers all highly liquid investments with a maturity date of purchase of three months or less to be cash equivalents. The Company invests its cash in money market funds and marketable securities including U.S. Treasury and government agency securities, commercial paper, and higher quality debt securities of financial and commercial institutions. The Company classified money market funds as Level 1, due to their short-term maturity, and measured the fair value based on quoted prices in active markets for identical assets. The Company classified commercial paper, U.S. Treasury and government agency securities as Level 2, as the inputs used to value these instruments are directly observable or can be corroborated by observable market data for substantially the full term of the assets.
Contingent Consideration Obligations
Spectrum Merger Contingent Variable Right
Pursuant to the Spectrum Merger, the Company issued CVRs (See Note 2, Acquisitions) that represent a contingent consideration obligation which is measured at fair value. The Company has a contingent obligation to make payments to the holders of the CVRs representing a contractual right to receive consideration worth up to an aggregate maximum amount of $0.20 per CVR, contingent on the achievement of annual sales milestones in 2024 and 2025 of Spectrum’s product ROLVEDON. The Company classified the acquisition-related contingent consideration liabilities as a Level 3 measurement, due to the lack of relevant observable inputs and market activity.
The initial fair value of the CVR determined as of the Effective Date of the Spectrum Merger was $3.9 million. As of September 30, 2023, the fair value of the Company’s CVR liability related to the Spectrum Merger was determined by the
Company to be zero. During both the three and nine months ended September 30, 2023, the Company recognized a benefit of $3.9 million for the change in fair value of the CVR contingent consideration, which was recognized in Change in fair value of contingent consideration in the Company’s Condensed Consolidated Statements of Comprehensive (Loss) Income. The fair value of the CVR contingent consideration is determined using a Monte Carlo simulation model under the income approach based on the probability of achievement of ROLVEDON net sales milestones using projections of 2024 and 2025 net sales and discounted to present value. The significant assumptions used in the calculation of the fair value as of September 30, 2023 included the discount rate of 18.0% and updated projections of future ROLVEDON product net sales, which resulted in no probability of achievement under the Monte Carlo simulation.
Zyla Merger Contingent Consideration Obligation
Pursuant to the 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 an affiliate of CR Group L.P. 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 a Level 3 measurement, due to the lack of relevant observable inputs and market activity. As of September 30, 2023 and December 31, 2022, INDOCIN product contingent consideration was $28.9 million and $48.5 million, respectively, with $12.8 million and $26.3 million classified as current and $16.1 million and $22.2 million classified as long-term contingent consideration, respectively, in the Company’s Condensed Consolidated Balance Sheets.
During the three and nine months ended September 30, 2023, the Company recognized a benefit of $17.5 million and $8.1 million, respectively, for the change in fair value of contingent consideration, which was recognized in Change in fair value of contingent consideration in the Company’s Condensed Consolidated Statements of Comprehensive (Loss) Income. 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. 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, 2023 included revenue volatility of 30%, discount rate of 8.5%, credit spread of 3.8% and updated projections of future INDOCIN product revenues.
The following table summarizes changes in fair value of the Company’s contingent consideration obligations that are measured on a recurring basis using significant unobservable inputs (Level 3) for the three and nine months ended September 30, 2023 and 2022 (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2023 | | 2022 | | 2023 | | 2022 |
Fair value, beginning of the period | $ | 42,500 | | | $ | 36,759 | | | $ | 48,500 | | | $ | 37,659 | |
Fair value of contingent consideration incurred in Spectrum Merger | 3,932 | | | — | | | 3,932 | | | — | |
Change in fair value of contingent consideration recorded within costs and expenses | (17,532) | | | 3,900 | | | (8,124) | | | 6,845 | |
Cash payment related to contingent consideration | — | | | (4,000) | | | (15,408) | | | (7,845) | |
Fair value, end of the period | $ | 28,900 | | | $ | 36,659 | | | $ | 28,900 | | | $ | 36,659 | |
Derivative Liability
The Company determined that an embedded conversion feature included in the 2027 Convertible Notes required bifurcation from the host contract and to be recognized as a separate derivative liability carried at fair value. The estimated fair value of the derivative liability, which represents a Level 3 valuation, was $0.8 million and $0.3 million as of September 30, 2023 and December 31, 2022, respectively, and was determined using a binomial lattice model using certain assumptions and consideration of an increased conversion ratio on the underlying convertible notes that could result from the occurrence of certain events. Accordingly, the Company has recognized a loss on the fair value adjustment of the derivative liability in the amount of $0.5 million in Other (loss) gain in the Consolidated Statements of Comprehensive Loss for the three and nine months ended September 30, 2023. There was no gain or loss on the fair value adjustment of the derivative liability for the three and nine months ended September 30, 2022.
The following table summarizes changes in fair value of the derivative liability that is measured on a recurring basis using significant unobservable inputs (Level 3) for the three and nine months ended September 30, 2023 (in thousands):
| | | | | | | | | | | | | | |
| | Three Months Ended September 30, 2023 | | Nine Months Ended September 30, 2023 |
Fair value, beginning of the period | | $ | 252 | | | $ | 252 | |
Change in fair value of derivative liability recorded within Other (loss) gain | | 512 | | | 512 | |
Fair value, end of the period | | $ | 764 | | | $ | 764 | |
There was no change in the fair value of the derivative liability for the three and nine months ended September 30, 2022.
Financial Instruments Not Required to be Remeasured at Fair Value
The Company’s other financial assets and liabilities, including trade accounts receivable and accounts payable, are not remeasured to fair value, as the carrying cost of each approximates its fair value. As of September 30, 2023, the estimated fair value of the 2027 Convertible Notes, excluding the bifurcated embedded conversion option, was approximately $41.8 million, compared to a par value of $40.0 million. As of December 31, 2022, the estimated fair value of the 2027 Convertible Notes, excluding the bifurcated embedded conversion option, was approximately $92.5 million, compared to a par value of $70.0 million. The Company estimated the fair value of its 2027 Convertible Notes as of September 30, 2023 and December 31, 2022 based on a market approach which represents a Level 2 valuation.
NOTE 18. INCOME TAXES
As of September 30, 2023, the Company’s net deferred tax assets are expected to be fully offset by a valuation allowance for the year ending December 31, 2023. 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. 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 continues to assess the realizability of its deferred tax assets on a quarterly basis. As part of its valuation allowance assessment as of September 30, 2023, the Company was no longer able to rely on its projected availability of future taxable income from pre-tax income forecasts. As such, the Company primarily relied on its reversing taxable temporary differences to assess its valuation allowance, which resulted in the recording of the full valuation allowance during the three months ended September 30, 2023. If it is determined that a portion or all of the valuation allowance is not required, it will generally be a benefit to the income tax provision in the period such determination is made.
For the three and nine months ended September 30, 2023, the Company recorded an income tax expense of $50.7 million and $52.4 million, respectively. The difference between the income tax expense in each period and the tax at the federal statutory rate of 21.0% on current year operations is principally due to the impact of the valuation allowance, offset by state taxes, disallowed officer’s compensation, and capital expenses.
The Company files income tax returns in the United States federal jurisdiction and in various states. The statutes of limitations for the Company's tax returns filed for the years 2007 through 2021 have not expired. Because of net operating losses and unutilized research and development 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. As of September 30, 2023, the Company did not have significant accrued interest and penalties associated with unrecognized tax benefits.
NOTE 19. RESTRUCTURING CHARGES
In August 2023, the Company implemented a reorganization plan of its workforce and other resources primarily designed to realize the synergies of the Spectrum Merger (the “Spectrum Reorganization Plan”). The Spectrum Reorganization Plan was primarily focused on the reduction of staff at the Company’s headquarters office and the exit of certain leased facilities and office equipment. The Company will continue to implement additional measures under the Spectrum Reorganization Plan as needed and expects the recognition of any costs and cash payments under the Spectrum Reorganization Plan to be completed by the end of the third quarter of 2024.
The staff reductions under the Spectrum Reorganization Plan are the result of a distinct severance plan approved by the Company’s board of directors and are not being executed as part of established Company policies or plans. Accordingly, the related employee compensation costs were primarily recognized in the third quarter of 2023, which is when the plan and
underlying terms were finalized, approved by the Company’s board of directors, and communicated to the impacted staff, and since the reductions were effective immediately. Total employee compensation costs recognized under the Spectrum Reorganization Plan through September 30, 2023 were approximately $2.3 million. In addition, the leased facilities and office equipment referenced above are not expected to be in use for any business purpose by the end of 2023, and the Company will not sublease the facilities and office equipment due to the short remaining lease terms. Accordingly, the criteria for abandonment accounting to be applied to the leased facilities and office equipment were met in the third quarter of 2023. The facility exit costs represent the acceleration of the underlying right-of-use asset amortization to align with the cease use date for the abandoned facilities and office equipment. Total facility exit costs under the Spectrum Reorganization Plan are expected to be $1.3 million.
The following table reflects total expenses related to the Spectrum Reorganization Plan recognized within the Condensed Consolidated Statement of Comprehensive (Loss) Income as Restructuring charges for three and nine months ended September 30, 2023 (in thousands):
| | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2023 | | | | 2023 | | |
Employee compensation costs | $ | 2,257 | | | | | $ | 2,257 | | | |
Facility exit costs | 777 | | | | | 777 | | | |
Total restructuring charges | $ | 3,034 | | | | | $ | 3,034 | | | |
The following table summarizes the changes in the Company’s accrued restructuring liability under the Spectrum Reorganization Plan, which is classified within Accrued liabilities in the Condensed Consolidated Balance Sheet as of September 30, 2023 (in thousands):
| | | | | | | | | |
| Employee compensation costs | | | | |
Balance as of December 31, 2022 | $ | — | | | | | |
Restructuring accrual assumed in Spectrum Merger (See Note 2) | 7,508 | | | | | |
Net accrual additions | 2,257 | | | | | |
| | | | | |
Cash paid | (5,345) | | | | | |
Balance as of September 30, 2023 | $ | 4,420 | | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
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. 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 and oral solution of indomethacin used both in hospitals and out-patient settings. Both products are nonsteroidal anti-inflammatory drug (NSAID), indicated 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 |
ROLVEDONTM (eflapegrastim-xnst) injection for subcutaneous use | A novel long-acting granulocyte colony-stimulating factor for the treatment of chemotherapy-induced neutropenia. |
Otrexup® (methotrexate) injection for subcutaneous use | A once weekly single-dose auto-injector containing a prescription medicine, methotrexate. Otrexup is a folate analog metabolic inhibitor indicated for the: |
| • Management of patients with severe, active rheumatoid arthritis (RA) and polyarticular juvenile idiopathic arthritis (pJIA), who are intolerant of or had an inadequate response to first-line therapy.
|
| • Symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy. |
Sympazan® (clobazam) oral film | A benzodiazepine indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients aged two years of age or older . Sympazan is the only product to offer clobazam in a convenient film with PharmFilm® technology. Sympazan is taken without water or liquid, adheres to the tongue, and dissolves to deliver clobazam. |
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 an opioid level. SPRIX is a non-narcotic nasal spray that 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. |
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. |
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 July 31, 2023 (the “Effective Date”), pursuant to an Agreement and Plan of Merger (the “Merger Agreement”), dated as of April 24, 2023, we completed the acquisition of Spectrum Pharmaceutical, Inc. (“Spectrum”), a commercial stage biopharmaceutical company focused on novel and targeted oncology products (the “Spectrum Merger”). We accounted for the Spectrum Merger using the acquisition method of accounting under Accounting Standards Codification (“ASC”) 805 and are considered the accounting acquirer. The results of operations of Spectrum are included in our condensed consolidated financial statements as of the Effective Date.
Pursuant to the Merger Agreement, each issued and outstanding share of Spectrum common stock as of the Effective Date was converted into the right to receive (i) 0.1783 shares of our common stock and (ii) one contingent value right (“CVR”)
representing a contractual right to receive future conditional payments worth up to an aggregate maximum amount of $0.20, settleable in cash, additional shares of Assertio common stock or a combination of cash and additional shares of Assertio common stock at our sole discretion, upon the achievement of certain sales milestones related to Spectrum’s product ROLVEDON. Subject to adjustments, each CVR represents the right to receive up to $0.10 payable upon ROLVEDON net sales (less certain deductions) achieving $175 million during the calendar year ending December 31, 2024, and up to $0.10 payable upon ROLVEDON net sales (less certain deductions) achieving $225 million during the calendar year ending December 31, 2025. In addition, upon consummation of the Spectrum Merger, Spectrum’s outstanding employee stock awards and other warrants that were outstanding immediately as of the Effective Date automatically vested (if unvested) and/or cancelled, as applicable, which generally resulted in the issuance of shares of Assertio common stock and/or CVRs to the holders of such stock awards or other warrants, in each case as dictated by the terms of the Merger Agreement. These shares and CVRs issued are considered part of the consideration transferred, and no compensation expense was recognized because the settlement was a condition of the Merger Agreement and other existing individual agreements, no future performance is required by the holders, and the fair value of the shares and CVRs is equivalent to the fair value of the existing employee stock awards and other warrants.
On August 22, 2022, we issued $70.0 million aggregate principal amount of Convertible Senior Notes 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 (the “2027 Convertible Notes”). We used the net proceeds from the issuance of the 2027 Convertible Notes to repurchase the remaining $59.0 million aggregate principal amount of our then outstanding 13.0% Senior Secured Notes due 2024 (the “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 Notes. We expect to use the remaining net proceeds from the 2027 Convertible Notes for general corporate purposes.
On February 27, 2023, we completed a privately negotiated exchange of $30.0 million principal amount of the 2027 Convertible Notes (the “Convertible Note Exchange”). Pursuant to the Convertible Note Exchange, 6,990,000 shares of the Company’s common stock, plus an additional $10.5 million in cash, were issued in a partial settlement of the 2027 Convertible Notes (the “Exchanged Notes”). Refer to Note 11, Debt, of the accompanying Condensed Consolidated Financial Statements for additional information on the 2027 Convertible Notes.
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 our 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, 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,” “seek,” “estimate,” “could,” “might,” “should,” “goal,” “target,” “project,” “approximate”, “potential,” “opportunity,” “pursue,” “strategy,” “prospective” 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 of our products (including the INDOCIN products which are not patent protected and now face generic competition as a result of the August 2023 approval and launch of generic indomethacin suppositories and potential additional generic competition at any time after the 180-day Competitive Generic Therapy (“CGT”) exclusivity expires) and/or other products competitive with any of our products (including indomethacin suppositories compounded by hospitals and other institutions including a 503B compounder that commenced sales of
its competitive product in the second half of 2022, in what we believe to be violation of certain provisions of the Food, Drug and Cosmetic Act);
•the uncertainty around the potential impacts of the August 2023 approval and launch of generic indomethacin suppositories, as well as potential additional generic indomethacin suppositories after the 180-day CGT exclusivity expires, on our future results of operations, financial condition, and cash flows;
•our ability to successfully execute our business strategy, business development, strategic partnerships, and investment opportunities to build and grow for the future, including through product acquisitions, commercialization agreements, licensing or technology agreements, equity investments, and business combinations;
•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, including our expectations around the sales and growth prospect of ROLVEDON;
•our expectations regarding industry trends, including pricing pressures and managed healthcare practices;
•our ability to execute on and realize anticipated benefits from our reorganization plan in connection with the Spectrum Merger;
•our ability to attract and retain key executive leadership;
•the potential impacts of future outbreaks of epidemics, pandemics or other diseases, 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 on commercially reasonable terms and in compliance with their contractual obligations to us, and our ability to maintain our supply chain, which relies on single-source suppliers;
•the outcome of, and our intentions with respect to, any litigation or investigations, including antitrust litigation, opioid-related investigations, opioid-related litigation and related claims for negligence and breach of fiduciary duty against our former insurance broker, as well as Spectrum’s legacy shareholder litigation, and other disputes and litigation, and the costs and expenses associated therewith;
•our compliance or non-compliance with, or being subject to, legal and regulatory requirements related to the development or promotion of pharmaceutical products in the United States (“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 fund operations and 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 intentions or expectations regarding the use of available funds and any future earnings or the use of net proceeds from securities offerings;
•our commitments and estimates regarding future obligations, 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, cost and results of any future research and development efforts including potential clinical studies relating to any future product candidates;
•the estimation, projection or availability of net operating losses or credit carryforwards;
•the potential impacts of adverse business and economic conditions including inflationary pressures, general economic slowdown or a recession, increasing interest rates, changes in monetary policy and financial institution instability; and
•our common stock maintaining compliance with The Nasdaq Capital Market’s minimum closing bid requirement of at least $1.00 per share.
This document also contains statements about the Spectrum Merger. Many factors could cause actual results to differ materially from these forward-looking statements with respect to the Spectrum Merger, including (1) the tax treatment, unforeseen liabilities, future capital expenditures, revenues, expenses, earnings, synergies, economic performance, indebtedness, financial condition, losses, future prospects, business and management strategies for the management, expansion and growth of the new combined company’s operations resulting from the Spectrum Merger; (2) the impact of pending Spectrum litigation and potential litigation relating to the Spectrum Merger; (3) the impact of disruption of management time from ongoing business operations due to the Spectrum Merger; (4) unexpected costs, charges or expenses resulting from the Spectrum Merger; (5) our and Spectrum’s ability to retain and hire key personnel; (6) competitive responses to the Spectrum Merger and the impact of competitive services; (7) potential adverse changes to business relationships resulting from the announcement or completion of the Spectrum Merger; (8) the combined company’s ability to achieve the growth prospects and synergies expected from the Spectrum Merger, as well as delays, challenges and expenses associated with integrating the combined company’s existing businesses; (9) negative effects of the announcement or the consummation of the Spectrum Merger on the market price of our common stock, credit ratings and operating results; and (10) legislative, regulatory and economic developments, including changing business conditions in the industries in which the new combined company operates. These risks, as well as other risks associated with the Spectrum Merger, are more fully discussed in the Amended Registration Statement on Form S-4 that we filed with the U.S. Securities and Exchange Commission in connection with the Spectrum Merger on June 14, 2023. While the list of factors presented here and in the Amended Registration Statement on Form S-4 are considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements.
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, and in our Annual Report on Form 10-K for the year ended December 31, 2022 filed with the Securities and Exchange Commission on March 8, 2023 (the “2022 Form 10-K”). 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, acquisitions, contingent consideration obligations, impairment of long-lived assets, goodwill, and income taxes to be critical policies. These estimates form the basis for making judgments about the carrying value of assets and liabilities. Except for critical accounting policies related to the accounting for goodwill discussed below, we believe there have been no significant changes in our critical accounting policies and significant judgements and estimates since we filed our 2022 Form 10-K. See ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS — Critical Accounting Policies and Significant Estimates in our 2022 Form 10-K for further information.
Goodwill
Under the purchase method of accounting pursuant to Accounting Standards Codification (“ASC”) 805, goodwill is calculated as the excess of the purchase price over the fair value of the assets acquired and liabilities assumed. Goodwill is recognized within other long-term assets, and is not amortized but subject to an annual review for impairment. Goodwill is tested for impairment at the reporting unit level at least annually or when a triggering event occurs that could indicate a potential impairment by assessing qualitative factors or performing a quantitative analysis in determining whether it is more
likely than not that the fair value of net assets are below their carrying amounts. A reporting unit is the same as, or one level below, an operating segment. Our operations are currently comprised of a single reporting unit.
During the three months ended September 30, 2023, we recorded $19.9 million of goodwill from the Spectrum Merger. Also, during the three months ended September 30, 2023, we recognized a long-lived asset impairment, which was determined to be an indicator of impairment with respect to our goodwill, and as a result management tested goodwill for impairment by determining and comparing the fair value of its reporting unit to its carrying value, with the carrying value reflecting the allocated long-lived asset impairment loss. The fair value of the reporting unit was determined using both an income and a market approach and used Level 3 inputs. These inputs included estimates of forecasted cash flows, a discount rate to reflect the risk inherent in the forecasted cash flows, and the selection of comparable revenue and earnings multiples utilizing guideline companies. Management concluded that the fair value of the reporting unit exceeded its carrying value and, accordingly, goodwill was not impaired as of September 30, 2023.
RESULTS OF OPERATIONS
Revenues
The following table reflects total revenues, net for the three and nine months ended September 30, 2023 and 2022 (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2023 | | 2022 | | 2023 | | 2022 |
Product sales, net: | | | | | | | |
INDOCIN products | $ | 17,948 | | | $ | 21,869 | | | $ | 76,369 | | | $ | 66,067 | |
ROLVEDON | 7,132 | | | — | | | 7,132 | | | — | |
Otrexup | 2,807 | | | 3,004 | | | 9,222 | | | 8,699 | |
Sympazan | 2,103 | | | — | | | 7,232 | | | — | |
SPRIX | 2,545 | | | 2,455 | | | 6,807 | | | 6,437 | |
CAMBIA | 1,993 | | | 5,808 | | | 6,062 | | | 17,464 | |
Zipsor | 597 | | | 259 | | | 2,751 | | | 2,704 | |
Other products | 12 | | | 884 | | | 1,414 | | | 3,887 | |
Total product sales, net | 35,137 | | | 34,279 | | | 116,989 | | | 105,258 | |
Royalties and milestone revenue | 490 | | | 473 | | | 1,910 | | | 1,916 | |
Other revenue | — | | | (540) | | | 185 | | | (1,290) | |
Total revenues | $ | 35,627 | | | $ | 34,212 | | | $ | 119,084 | | | $ | 105,884 | |
Product sales, net
INDOCIN net product sales for the three months ended September 30, 2023 decreased $3.9 million from $21.9 million to $17.9 million, as compared to the same period in 2022 due to lower volume as a result of the August 2023 approval and launch of generic indomethacin suppositories and the sales by a 503B compounder of its competitive products. INDOCIN net product sales for the nine months ended September 30, 2023 increased $10.3 million from $66.1 million to $76.4 million, as compared to the same period in 2022 due to favorable net pricing as a result of a shift to more profitable channels, partially offset by a decrease in volume as a result of the August 2023 approval and launch of generic indomethacin suppositories and the sales by a 503B compounder of its competitive products. We expect INDOCIN volumes to continue to be impacted unfavorably by increasing competition as a result of the August 2023 approval and launch of generic indomethacin suppositories and the sales by a 503B compounder of its competitive products.
We acquired ROLVEDON on July 31, 2023 and began shipping and recognizing product sales for ROLVEDON immediately. ROLVEDON net product sales were $7.1 million during both the three and nine months ended September 30, 2023. Our initial assessment indicates there were several dynamics that impacted net product sales of ROLVEDON during the third quarter. While the early phase of the launch benefited from favorable reimbursement; expectations for an incremental demand increase from a permanent J-code issued by Centers for Medicare & Medicaid Services, effective April 1, 2023, have not been achieved, and there were high levels of inventory in the channel at the end of the second quarter of 2023.
ROLVEDON net product sales are impacted by the dynamic reimbursement environment and competitive market, changes in which will have an impact on sales recognized by us in future periods.
Otrexup net product sales for the three months ended September 30, 2023 decreased $0.2 million from $3.0 million to $2.8 million, as compared to the same period in 2022, primarily due to unfavorable payor mix, partially offset by higher volume. Otrexup net product sales for the nine months ended September 30, 2023 increased $0.5 million from $8.7 million to $9.2 million, as compared to the same period in 2022, primarily due to higher volume, partially offset by unfavorable payor mix.
We acquired Sympazan and began shipping and recognizing its product sales in October 2022. Sympazan net product sales totaled $2.1 million and $7.2 million for the three and nine months ended September 30, 2023.
SPRIX net product sales totaled $2.5 million for both the three months ended September 30, 2023 and 2022. SPRIX net product sales for the nine months ended September 30, 2023 increased $0.4 million from $6.4 million to $6.8 million, as compared to the same period in 2022, primarily due to favorable payor mix, partially offset by lower volume.
CAMBIA net product sales for the three and nine months ended September 30, 2023 decreased $3.8 million from $5.8 million to $2.0 million, and decreased $11.4 million from $17.5 million to $6.1 million, respectively, as compared to the same periods in 2022, primarily due to lower volume caused by generic entrants in 2023.
Zipsor net product sales for the three and nine months ended September 30, 2023 increased $0.3 million from $0.3 million to $0.6 million, and increased $0.1 million from $2.7 million to $2.8 million, respectively, as compared to the same periods in 2022, primarily due to favorable payor mix.
Other net product sales include sales for OXAYDO and SOLUMATRIX products. We ceased OXAYDO product sales beginning in September 2023, and ceased SOLUMATRIX product sales beginning in July 2022.
The increase in total product sales, net, for the three and nine months ended September 30, 2023, also reflects a decrease year over year in the amounts charged as a reduction to revenue for sales and return allowances, discounts, chargebacks, and rebates, which is attributed to changes in product mix and, specifically, a higher concentration of products that require lower levels of product sales allowances relative to our other products.
Royalties & Milestone revenue
In November 2010, we entered into a license agreement granting the counterparty the rights to commercially market CAMBIA in Canada. We receive royalties on net sales as well as certain one-time contingent milestone payments. We recognized revenue related to CAMBIA in Canada of $0.5 million and $1.5 million for the three and nine months ended September 30, 2023, respectively, and $0.5 million and $1.5 million for the three and nine months ended September 30, 2022, respectively.
We recognized Milestone revenue associated with the completion of certain service milestones of $0.5 million for both the nine months ended September 30, 2023 and 2022. We recognized no Milestone revenue for both the three months ended September 30, 2023 and 2022.
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 or an increase to total revenue during the period.
Cost of Sales (excluding amortization of intangible assets)
Cost of sales for the three months ended September 30, 2023 increased $3.1 million from $4.0 million to $7.1 million as compared to the same period in 2022, primarily due to (i) $2.6 million of cost of sales, including inventory step-up amortization, attributable to ROLVEDON, which began shipping in August 2023, and (ii) a $1.0 million increase in cost of sales attributable to Otrexup and SPRIX for the three months ended September 30, 2023 compared to the same period last year, partially offset by the impact of product mix.
Cost of sales for the nine months ended September 30, 2023 increased $4.6 million from $12.7 million to $17.3 million as compared to the same period in 2022, primarily due to: (i) $2.6 million of cost of sales, including inventory step-up amortization, attributable to ROLVEDON, (ii) a $3.4 million increase in cost of sales attributable to Otrexup and
SPRIX, and (iii) $1.8 million of cost of sales attributable to Sympazan, which began shipping in October 2022, partially offset by the impact of product mix.
Cost of sales are impacted by both product volume and mix, changes in which will have an impact on Cost of sales recognized by us in future periods.
Research and Development Expenses
Research and development expenses include salaries, costs for planned clinical trials, consultant fees, supplies, and allocations of corporate costs. It is difficult to predict the scope and magnitude of future research and development expenses for our product candidates in research and development, as it is difficult to determine the nature, timing and extent of planned clinical trials and studies and the FDA’s requirements for a particular drug. As potential products proceed through the development process, each step is typically more extensive, and therefore more expensive, than the previous step. Therefore, success in development generally results in increasing expenditures until actual product approval.
Research and development expenses were $1.3 million and $1.8 million for the three and nine months ended September 30, 2023, respectively, representing primarily costs directly associated with ongoing clinical trial activity for ROLVEDON. We did not have research and development expenses during the three and nine months ended September 30, 2022.
Selling, General and Administrative Expenses
Selling, general, and administrative expenses increased $9.1 million from $11.9 million for the three months ended September 30, 2022 to $21.0 million for the three months ended September 30, 2023, primarily due to: (i) $2.7 million of transaction-related expenses, primarily legal and professional fees, associated with the Spectrum Merger, (ii) $4.9 million of higher operating expenses as a result of the Spectrum Merger, (iii) $1.0 million of higher selling and marketing expenses related to Sympazan, and (iv) a net increase of $0.5 million in other general operating expenses.
Selling, general, and administrative expenses increased $21.6 million from $33.1 million for the nine months ended September 30, 2022 to $54.7 million for the nine months ended September 30, 2023, primarily due to: (i) $8.5 million of transaction-related expenses, primarily legal and professional fees, associated with the Spectrum Merger, (ii) $5.6 million of higher operating expenses as a result of the Spectrum Merger, (iii) $4.3 million of higher selling and marketing expenses for Sympazan and Otrexup, (iv) a gain of $2.0 million in the second quarter of 2022 for insurance reimbursement for previous opioid-related spend not repeating in 2023, and (v) an increase of $1.4 million in stock-based compensation expense.
Change in fair value of contingent consideration
Pursuant to the Spectrum Merger, we issued contingent value rights (“CVRs”) that represent a contingent consideration obligation which is measured at fair value. Pursuant to our merger with Zyla Life Sciences (“Zyla”) in May 2020 (the “Zyla Merger”), we assumed a contingent consideration obligation for future royalties on annual INDOCIN product net sales which is measured at fair value. The fair value of both contingent considerations are remeasured each reporting period, with changes in the fair values resulting from changes in the respective underlying inputs being recognized in operating expenses until both the contingent considerations arrangements are settled. Changes in the fair values of the contingent considerations are recognized in Change in fair value of contingent consideration in the Company’s Condensed Consolidated Statements of Comprehensive Loss (Income).
During the three and nine months ended September 30, 2023, we recognized a benefit of $17.5 million and $8.1 million, respectively, for the change in fair value of contingent consideration, compared to an expense of $3.9 million and $6.8 million recognized for the three and nine months ended September 30, 2022, respectively.
The fair value of the CVR contingent consideration is determined using a Monte Carlo simulation model under the income approach based on the probability of achievement of ROLVEDON net sales milestones using projections of 2024 and 2025 net sales and discounted to present value. The initial fair value of the CVR determined as of the Effective Date of the Spectrum Merger was $3.9 million. As of September 30, 2023, the fair value of the CVR liability was determined to be zero. Accordingly, during both the three and nine months ended September 30, 2023, the Company recognized a benefit of $3.9 million for the change in fair value of the CVR contingent consideration. The significant assumptions used in the calculation of the fair value as of September 30, 2023 included the discount rate of 18.0% and updated projections of future ROLVEDON product net sales, which resulted in no probability of achievement under the Monte Carlo simulation.
The fair value of the contingent consideration obligation incurred in the Zyla Merger 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, 2023 included revenue volatility of 30%, discount rate of 8.5%, credit spread of 3.8% and updated projections of future INDOCIN product revenues. Accordingly, during the three and nine months ended September 30, 2023, we recognized a benefit in costs and expenses of $13.6 million and $4.2 million, respectively, attributable to a decrease in the fair value of the contingent consideration incurred in the Zyla Merger in each of the periods, compared to an expense of $3.9 million and $6.8 million recognized for the three and nine months ended September 30, 2022, respectively
Intangible Assets
The following table reflects amortization of intangible assets for the three and nine months ended September 30, 2023 and 2022 (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2023 | | 2022 | | 2023 | | 2022 |
Amortization of intangible assets—INDOCIN | $ | 3,210 | | | $ | 3,210 | | | $ | 9,631 | | | $ | 9,631 | |
Amortization of intangible assets—ROLVEDON | 3,900 | | | — | | | 3,900 | | | — | |
Amortization of intangible assets—Otrexup | 1,378 | | | 1,378 | | | 4,133 | | | 4,133 | |
Amortization of intangible assets—Sympazan | 303 | | | — | | | 909 | | | — | |
Amortization of intangible assets—SPRIX | 1,393 | | | 1,393 | | | 4,179 | | | 4,179 | |
Amortization of intangible assets—CAMBIA | — | | | 1,988 | | | — | | | 5,963 | |
Amortization of intangible assets—Zipsor | — | | | — | | | — | | | 532 | |
Total | $ | 10,184 | | | $ | 7,969 | | | $ | 22,752 | | | $ | 24,438 | |
Amortization expense for the three months ended September 30, 2023 increased $2.2 million from $8.0 million to $10.2 million, as compared to the same period in 2022, primarily due to the additional amortization of the ROLVEDON and Sympazan product rights acquired in July 2023 and October 2022, respectively, offset by the full amortization of CAMBIA intangible assets in the fourth quarter of 2022.
Amortization expense for the nine months ended September 30, 2023 decreased $1.7 million from $24.4 million to $22.8 million, respectively, as compared to the same period in 2022, primarily due to the full amortization of CAMBIA intangible assets in the fourth quarter of 2022 and the full amortization of Zipsor intangible assets in the first quarter of 2022, partially offset by additional amortization of the ROLVEDON and Sympazan product rights acquired in July 2023 and October 2022, respectively.
Loss on Impairment of Long-Lived Assets
During the three months ended September 30, 2023, our market capitalization declined to below the book value of our equity. Management determined that the Company’s book value of equity exceeding its market capitalization represented an indicator of impairment with respect to its long-lived assets.
Applying the relevant accounting literature, we first assessed the recoverability of our long-lived assets. In performing this assessment, management concluded it was appropriate to group its assets at the entity level, most notably attributed to the significant shared operating cost structure which characterizes Assertio. We determined the carrying value of this asset group was not recoverable. Management then assessed and concluded that the fair value of the asset group was less than its carrying value and so recognized an impairment loss of approximately $238.8 million, which was allocated to the intangible assets of the group and is classified within Loss on impairment of intangible assets in the Condensed Consolidated Statement of Comprehensive (Loss) Income. The fair value of the asset group was determined using both an income and a market approach and used Level 3 inputs. These inputs included estimates of forecasted cash flows and the selection of comparable revenue and earnings multiples utilizing guideline companies.
Restructuring Charges
Restructuring charges were $3.0 million during both the three and nine months ended September 30, 2023. In August 2023, we implemented a reorganization plan of our workforce and other resources primarily designed to realize the synergies of the Spectrum Merger (the “Spectrum Reorganization Plan”). The Spectrum Reorganization Plan was primarily focused on the reduction of staff at our headquarters office and the exit of certain leased facilities. We will continue to implement additional measures under the Spectrum Reorganization Plan as needed and expect the recognition of any costs and cash payments under the Spectrum Reorganization Plan to be completed by the end of the third quarter of 2024.
The staff reductions under the Spectrum Reorganization Plan are the result of a distinct severance plan approved by our board of directors and are not being executed as part of established Company policies or plans. Accordingly, the related employee compensation costs were primarily recognized in the third quarter of 2023, which is when the plan and underlying terms were finalized, approved by our board of directors, and communicated to the impacted staff, and since the reductions were effective immediately. Total employee compensation costs recognized under the Spectrum Reorganization Plan through September 30, 2023 were approximately $2.3 million. In addition, the leased facilities referenced above are not expected to be in use for any business purpose by the end of 2023, and we will not sublease the facilities due to the short remaining lease terms. Accordingly, the criteria for abandonment accounting to be applied to the leased facilities were met in the third quarter of 2023. We recognized facility exit costs of $0.7 million for the three months ended September 30, 2023, representing the acceleration of the underlying right-of-use asset amortization to align with the cease use date for the abandoned facilities. Total facility exit costs under the Spectrum Reorganization Plan are expected to be $1.3 million.
For the three and nine months ended September 30, 2022, there were no restructuring charges.
We regularly evaluate our operations to identify opportunities to streamline operations and optimize operating efficiencies as an anticipation to changes in the business environment.
Other (Expense) Income
The following table reflects other expense (income) for the three and nine months ended September 30, 2023 and 2022 (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2023 | | 2022 | | 2023 | | 2022 |
Debt-related expenses | $ | — | | | $ | — | | | $ | (9,918) | | | $ | — | |
Interest expense | (752) | | | (2,052) | | | (2,625) | | | (6,648) | |
Other gain | 138 | | | 2 | | | 1,601 | | | 453 | |
Total other expense | $ | (614) | | | $ | (2,050) | | | $ | (10,942) | | | $ | (6,195) | |
Other expense decreased from $2.1 million to $0.6 million for the three months ended September 30, 2023, as compared to the same period in 2022, primarily due to lower interest expense and an increase in other gain, as further described below. Other expense increased from $6.2 million to $10.9 million for the nine months ended September 30, 2023, as compared to the same period in 2022, primarily due to debt-related expenses incurred in the current year, partially offset by lower interest expense and increase in other gain, as further described below.
Debt-related expenses for the nine months ended September 30, 2023 consist of an induced conversion expense of approximately $8.8 million and direct transaction costs of approximately $1.1 million incurred as a result of the $30.0 million Convertible Note Exchange in the first quarter of 2023, as described in Note 11, Debt, of the accompanying Condensed Consolidated Financial Statements.
The following table reflects interest expense for the three and nine months ended September 30, 2023 and 2022 (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2023 | | 2022 | | 2023 | | 2022 |
Interest payable on 2027 Convertible Notes | $ | 650 | | | $ | 522 | | | $ | 2,275 | | | $ | 522 | |
Interest paid on 2024 Secured Notes | — | | | 1,516 | | | — | | | 6,064 | |
Amortization of Royalty Rights(1) | — | | | 14 | | | — | | | 62 | |
Amortization of debt issuance costs | 102 | | | — | | | 350 | | | — | |
Total interest expense | $ | 752 | | | $ | 2,052 | | | $ | 2,625 | | | $ | 6,648 | |
(1)As a result of the extinguishment of the Royalty Rights obligation during the fourth quarter of 2022, there will be no additional amortization expense recognized in future periods. Refer to Note 11 of the accompanying Condensed Consolidated Financial Statements for additional information on the Royalty Rights obligation.
For the three and nine months ended September 30, 2023, total interest expense decreased $1.3 million and $4.0 million, respectively, as compared to the same periods in 2022, primarily due to lower amounts of interest incurred on debt outstanding. On August 22, 2022, we issued $70.0 million in aggregate principal amount of 2027 Convertible Notes. We used the net proceeds from the 2027 Convertible Notes issuance to repurchase the remaining $59.0 million aggregate principal amount of our 2024 Secured Notes, which were outstanding during the three months ended September 30, 2022, and carried a higher interest rate.
For the three and nine months ended September 30, 2023, other gain increased $0.1 million and $1.1 million, respectively, as compared to the same periods in 2022, primarily due to higher interest income, partially offset by a loss of $0.5 million recognized in both the three and nine months ended September 30, 2023 for the change in the fair value of a derivative liability associated with an embedded derivative feature of our 2027 Convertible Notes, and a gain of $0.6 million from the early termination and settlement of a Newark facility sublease in 2022 that did not repeat in subsequent periods.
Income Tax Provision
For the three and nine months ended September 30, 2023, we recorded an income tax expense of $50.7 million and $52.4 million, respectively. The difference between the income tax expense in each period and the tax at the federal statutory rate of 21.0% on current year operations is principally due to the impact of the valuation allowance, offset by state taxes, disallowed officer’s compensation, and capital expenses. As part of our valuation allowance assessment as of September 30, 2023, we were no longer able to rely on our projected availability of future taxable income from pre-tax income forecasts. As such, we primarily relied on our reversing taxable temporary differences to assess our valuation allowance, which resulted in recording of the full valuation allowance during the three months ended September 30, 2023.
For the three and nine months ended September 30, 2022, we recorded an income tax expense of $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, and tax at the federal statutory rate of 21.0% was principally due to the partial release of the valuation allowance related to the movement in deferred tax assets.
LIQUIDITY AND CAPITAL RESOURCES
Historically and through September 30, 2023, 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.
As previously disclosed, in the three months ended June 30, 2022, we granted a total of 1.0 million market-based performance RSUs (“performance RSUs”) to executive officers under our Amended and Restated 2014 Omnibus Incentive Plan. The market-based conditions of the performance RSUs were achieved in the first quarter of 2023. Then, upon vesting of the performance RSUs in the second quarter of 2023, the compensation committee of our board of directors elected, under the terms of the performance RSU grants, to settle approximately 0.3 million of the outstanding performance RSUs in cash based on their fair market value on the vesting date, resulting in a cash payment of approximately $2.6 million, with the remaining
performance RSUs and the employee’s tax withholding liabilities settled in shares of our common stock. The total cash payment of taxes related to net share settlement of the performance RSUs was approximately $3.4 million.
On August 22, 2022, we issued $70.0 million aggregate principal amount of 2027 Convertible Notes which mature on September 1, 2027 and bear interest at a 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 Notes to repurchase the remaining $59.0 million aggregate principal amount of our then 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 Notes. We expect to use the remaining net proceeds from the 2027 Convertible Notes for general corporate purposes.
On February 27, 2023, we completed the Convertible Note Exchange pursuant to which we exchanged $30.0 million principal amount of our 2027 Convertible Notes for 6,990,000 shares of our common stock, plus an additional $10.5 million in cash. As a result of the Convertible Note Exchange in the first quarter of 2023, we recorded a non-cash induced conversion expense of approximately $8.8 million and direct transaction costs of approximately $1.1 million. As a result of the Convertible Note Exchange, we expect our cash interest expense in future periods to decrease in accordance with the decrease in the aggregate principal amount of the 2027 Convertible Notes outstanding.
The terms of the 2027 Convertible Notes are governed by an indenture dated August 25, 2022 (the “2027 Convertible Note Indenture”). Pursuant to the terms of the 2027 Convertible Note Indenture, we and our 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 our properties or assets. We were in compliance with our covenants with respect to the 2027 Convertible Notes as of September 30, 2023.
We are party to 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 a result of the issuance of the 2027 Convertible Notes, we suspended use of the ATM offering program. Prior to our suspension of the ATM offering program, 2,463,637 shares of our common stock had 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.
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;
•declines in sales of our marketed products, including those resulting from the entry and sales of generics and/or other products competitive with any of our products;
•expenditures related to our commercialization of our products, including our efforts to enhance the long-term prospects of ROLVEDON product sales;
•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;
•potential additional expenses relating to the Spectrum Reorganization Plan; and
•expenditures related to future clinical trial costs.
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 the Company.
The following table reflects summarized cash flow activities for the nine months ended September 30, 2023 and 2022 (in thousands):
| | | | | | | | | | | | | | |
| | Nine Months Ended September 30, |
| | 2023 | | 2022 |
Net cash provided by operating activities | | $ | 43,897 | | | $ | 51,901 | |
Net cash provided by (used in) investing activities | | 3,336 | | | (16,889) | |
Net cash used in financing activities | | (35,286) | | | (6,996) | |
Net increase in cash and cash equivalents | | $ | 11,947 | | | $ | 28,016 | |
Cash Flows from Operating Activities
Cash provided by operating activities was $43.9 million for the nine months ended September 30, 2023 compared to $51.9 million in the same period in 2022, primarily due to lower net income excluding non-cash items, partially offset by lower net working capital cash used in operations compared to last year.
For the nine months ended September 30, 2023, net loss was $274.6 million compared to net income of $21.1 million for the same period in 2022. For the nine months ended September 30, 2023, adjustments for non-cash items contributed approximately $282.7 million more to operating cash flows compared to the same period in 2022, primarily due to a $238.8 million loss on impairment of intangible assets, deferred income taxes, and debt-related expenses, of which there were none in the prior year period. For the nine months ended September 30, 2023, net working capital cash used in operations of approximately $2.2 million was $4.9 million lower than net working capital cash used in operations of approximately $7.1 million in the same period in 2022, primarily due to increased cash from accounts receivable payments, partially offset by (i) increased cash used in the payment of accounts payable and accrued liabilities due to timing, (ii) increased cash used in the settlement of accrued rebates, returns and discounts due to impact of sales product mix as well as timing of settlement, and (iii) the receipt of an $8.3 million one-time tax refund in the first quarter of 2022 not repeating.
Cash flows from operating activities are impacted by, among other things, product revenue, operating profit and changes in working capital. Fluctuations in any of these will impact our cash flows from operating activities recognized in future periods.
Cash Flows from Investing Activities
Cash provided by investing activities for the nine months ended September 30, 2023 was $3.3 million, which consisted of $2.2 million of proceeds from the sale of investments, and $2.0 million of net cash acquired in the Spectrum Merger, partially offset by cash paid for the transaction costs incurred with the acquisition of Sympazan and cash paid for purchases of property and equipment. Cash used in investing activities for the nine months ended September 30, 2022 was $16.9 million, which consisted entirely of cash paid for the transaction costs incurred with the acquisition of Otrexup.
Cash Flows from Financing Activities
Cash used in financing activities for the nine months ended September 30, 2023 was $35.3 million, which primarily consisted of (i) a $15.4 million payment for contingent consideration, (ii) $10.5 million in cash payments related to the Company’s 2027 Convertible Notes, (iii) $1.1 million of direct transaction cost payments made in connection with the Convertible Note Exchange, and (iv) cash payments related to the vesting and settlement of equity awards, of which $2.6 million related to the cash settlement of the vested performance RSUs, $3.4 million related to the total cash payment of taxes for the net share settlement of the vested performance RSUs, and $1.8 million related to cash used for employees’ withholding tax liability on stock award releases, net of cash received from stock option exercises. 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 $65.9 million in cash proceeds from the issuance of the 2027 Convertible Notes and $7.0 million in cash proceeds from the Company’s ATM offering program.
Contractual Obligations
Our principal material cash requirements consist of obligations related to our debt, our contingent consideration obligations, payments for rebates, returns and discounts, non-cancelable contractual obligations for our purchase commitments, remaining compensation and other potential cash payments under the Spectrum Reorganization Plan, and a non-cancelable lease for our office space. There were no material changes to our material cash requirements from contractual or other obligations outside the ordinary course of business or due to other factors since our Annual Report on Form 10-K for the year ended December 31, 2022. For a description of our material contractual or other obligations, see “Note 14. Commitments and Contingencies” of the Notes to the Condensed Consolidated Financial Statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We are a smaller reporting company, as defined by Rule 12b-2 of the Exchange Act, and therefore are not required to provide the information called for by this Item 3.
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 as of September 30, 2023.
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
We are finalizing the process of integrating our acquisition of Spectrum, including evaluating our internal controls, and designing and implementing an internal control structure over Spectrum’s operations, which we expect to complete in the first quarter of 2024.
There were no other changes in our internal controls over financial reporting during the three months ended September 30, 2023 that have materially affected, or are reasonably likely to materially affect, our internal controls over financial reporting.
PART II — OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
For a description of our material pending legal proceedings, see “Note 14. Commitments and Contingencies” of the Notes to the Condensed Consolidated Financial Statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q, which is incorporated herein by reference.
ITEM 1A. RISK FACTORS
We are subject to various risks and uncertainties that could have a material impact on our business, results of operations and financial condition, including those hereby incorporated by reference from Part I, Item 1A, “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2022, and our Quarterly Report on Form 10-Q for the three months ended June 30, 2023. Except as set forth below and in our Quarterly Report on Form 10-Q for the three months ended June 30, 2023, there have been no material changes since our Annual Report on Form 10-K for the year ended December 31, 2022. In addition to other information in this report, the following information and risk factors, and the risks and uncertainties referenced above, should be considered carefully in evaluating an investment in our securities. If any of these risks or uncertainties actually occurs, our business, results of operations or financial condition would be materially and adversely affected. The risks and uncertainties referenced above, including that 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.
On July 31, 2023, we announced the completion of our acquisition of Spectrum. Additional material risks related to Spectrum could have a material impact on our business. For more information on the risks associated with the Spectrum business, see the “Risk Factors” section in the Annual Report on Form 10-K filed by Spectrum on March 31, 2023, as amended on May 1, 2023, and for more information on the risks associated with the combined company, see the “Risks Relating to the Combined Company” section in the Amended Registration Statement on Form S-4 that we filed on June 14, 2023.
Cambia, Zipsor and INDOCIN suppositories recently began facing competition from generics, which adversely affects our business. Approval of additional generic versions of our products would have an adverse effect on our business.
Under the Food, Drug and Cosmetic Act (the “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 64% of our revenue in 2022 and the first nine months of 2023), which means that a generic drug company could introduce a generic for these drugs at any time. In August 2023, a generic pharmaceutical company received approval from the FDA, and has started to manufacture and market 50mg indomethacin suppositories, the generic version of INDOCIN Suppositories. As a result, INDOCIN Suppositories now face competition from generic indomethacin suppositories. In addition, we are aware of other drug companies that have had interactions with regulatory agencies including the FDA relating to indomethacin, which could indicate the development of one or more additional INDOCIN product generics or other formulations of indomethacin. Accordingly, we could face competition from other generic versions of the INDOCIN products at any time after the 180-day Competitive Generic Therapy (“CGT”) exclusivity expires. In addition, we also face competition for INDOCIN Suppositories from hospitals and other institutions, including a 503B outsourcing facility (commonly referred to as a 503B compounder), which began compounding 100 mg indomethacin suppositories in the second half of 2022 in what we believe to be violation of state and federal requirements for new drugs and labeling requirements related to adequate directions for use. For a 503B compounder to qualify for exemptions from these state and federal 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 the 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 the 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, while it is included on the FDA’s Category 1 list of bulk substances it is evaluating, is not on the FDA’s list of bulk substances for which there is a clinical need and INDOCIN Suppositories are not on the FDA’s drug shortage list; and we believe that the 100 mg indomethacin suppositories being compounded are “essentially a copy” of our FDA-approved INDOCIN Suppositories. Although we are vigorously pursuing remedies against this compounder, we cannot guarantee that we will be successful in causing it to discontinue sales of its unapproved indomethacin suppository product. We filed an unfair competition lawsuit in the United States District Court (S.D. Tex.) against this 503B compounder, which was dismissed on September 27, 2023; we have filed a notice of appeal.
With respect to Cambia and Zipsor (which accounted for 16% and 2% of our revenue in 2022, respectively), we have entered into settlement agreements with generic drug companies, under which generic versions of these products can be marketed beginning in January 2023 and March 2022, respectively. As a result, we face generic competition for Cambia and Zipsor.
The introduction of known and potential additional generic versions of our products, as well as sales of indomethacin suppositories by compounders, or disclosure of ANDA filings and/or similar applications in respect to any of our products, have and in the future could adversely impact our business, financial condition, results of operations and stock price. Moreover, if the orange book patents covering Otrexup (which expire in 2031) and/or Sympazan (which expire in 2040) are not upheld in litigation or if a generic competitor is found not to infringe these patents, the resulting generic competition for Otrexup and/or Sympazan would have a further adverse effect on our business, financial condition and results of operations.
We depend on one qualified supplier for the active pharmaceutical ingredient in each of our products, and we depend on third parties that are single source suppliers to manufacture our products. Insufficient availability of our products or the active pharmaceutical ingredients and other raw materials necessary to manufacture our products, or the inability of our suppliers to manufacture and supply our products on commercially reasonable terms, will adversely impact our sales and/or margins upon depletion of the active ingredient and product inventories.
We have one qualified supplier for the active pharmaceutical ingredient in each of our products. We do not have, and we do not intend to establish in the foreseeable future, internal commercial-scale manufacturing capabilities. Rather, we intend to use the facilities of third parties to manufacture products for commercialization and clinical trials. Our dependence on third parties for the manufacture of our products and any future product candidates may adversely affect our ability to obtain such products on a timely or competitive basis, if at all. Any stock out, quality concern or failure to obtain sufficient supplies of our products, or the necessary active pharmaceutical ingredients, excipients or components, from our suppliers, including as a result of disruptions to supplier operations resulting from factors such as supply chain delays, public health emergencies, climate events or political unrest, or failures by us to satisfy minimum order requirements due to declines in product demand or otherwise, would adversely affect our business, results of operations and financial condition. In particular, our suppliers may be impacted by ongoing supply chain disruptions and inflationary pressures related to the COVID-19 pandemic and general macroeconomic conditions, which may result in supply delays and cost increases.
The manufacturing process for pharmaceutical products is highly regulated, and regulators may from time to time shut down manufacturing facilities that they believe do not comply with regulations. We, our third-party manufacturers and our suppliers are subject to numerous regulations, including current FDA regulations governing manufacturing processes, stability testing, record keeping, product serialization and quality standards. Similar regulations are in effect in other countries. Our third-party manufacturers and suppliers are independent entities who are subject to their own operational and financial risks which are out of our control. If we or any third-party manufacturer or supplier fails to perform as required or fails to comply with the regulations of the FDA and other applicable governmental authorities, our ability to deliver adequate supplies of our products to our customers on a timely basis and on commercially reasonable terms, or to conduct clinical trials, could be adversely affected. For example, in October 2023, Spectrum’s drug product manufacturer for ROLVEDON demanded a significant price increase despite fixed pricing provisions in Spectrum’s supply agreement through the latter half of 2025. Additionally, although we have fixed pricing with our contract manufacturer for INDOCIN Suppositories through July 2028, we understand the active pharmaceutical ingredient (API) provider to our INDOCIN contract manufacturer has demanded a significant price increase to continue supplying API to our contract manufacturer on a purchase order basis. We are assessing the legal and business implications of these circumstances and cannot predict how they may ultimately be resolved. The manufacturing processes of our third-party manufacturers and suppliers may also be found to violate the proprietary rights of others. To the extent these risks materialize and adversely affect such third-party manufacturers’ and/or suppliers’ performance obligations to us, and we are unable to contract for a sufficient supply of required products on acceptable terms, or if we encounter delays and difficulties in our relationships with manufacturers or suppliers, our business, results of operations and financial condition could be adversely affected.
We have significant amounts of long-lived assets and goodwill which depend upon future positive cash flows to support the values recorded in our balance sheet. We are subject to increased risk of future impairment charges should actual financial results differ materially from our projections.
Our consolidated balance sheet contains significant amounts of long-lived assets, including intangible assets representing the product rights which we have acquired, and goodwill recorded from the Spectrum Merger. We review the carrying value of our long-lived assets and goodwill when indicators of impairment are present, as was the case in the three months ended September 30, 2023. Conditions that could indicate impairment of long-lived assets and/or goodwill include, but are not limited to, our market capitalization declining below the book value of our equity, a significant adverse change in market conditions, significant competing product launches by our competitors, significant adverse change in the manner in which the long-lived asset is being used, and adverse legal or regulatory outcomes.
During the three months ended September 30, 2023, we determined that our book value of equity exceeding its market capitalization represented an indicator of impairment with respect to our long-lived assets. Applying the relevant accounting literature, management first assessed the recoverability of our long-lived assets. In performing this assessment, management concluded it was appropriate to group its assets at the entity level, most notably attributed to the significant shared operating cost structure which characterizes Assertio. We determined the carrying value of this asset group was not recoverable.
Management then assessed and concluded that the fair value of the asset group was less than its carrying value and so recognized an impairment loss of approximately $238.8 million, which was allocated to the intangible assets of the group and is classified within Loss on impairment of intangible assets in the Condensed Consolidated Statement of Comprehensive (Loss) Income. The fair value of the asset group was determined using both an income and a market approach and used Level 3 inputs. These inputs included estimates of forecasted cash flows and the selection of comparable revenue and earnings multiples utilizing guideline companies.
Following our long-lived asset impairment, which was determined to be an indicator of impairment with respect to our goodwill, management tested goodwill for impairment in the three months ended September 30, 2023 by determining and comparing the fair value of its reporting unit to its carrying value, with the carrying value reflecting the allocated long-lived asset impairment loss. The fair value of the reporting unit was determined using both an income and a market approach and used Level 3 inputs. These inputs included estimates of forecasted cash flows, a discount rate to reflect the risk inherent in the forecasted cash flows, and the selection of comparable revenue and earnings multiples utilizing guideline companies. Management concluded that the fair value of the reporting unit exceeded its carrying value and, accordingly, goodwill was not impaired as of September 30, 2023.
In performing our impairment tests, which assess the recoverability of our assets, we utilize our future projections of cash flows. Projections of future cash flows are inherently subjective and reflect assumptions that may or may not ultimately be realized. Significant assumptions utilized in our projections include, but are not limited to, our evaluation of the market opportunity for our products, the current and future competitive landscape and resulting impacts to product pricing, future regulatory actions, planned strategic initiatives and the realization of benefits associated with our existing patents. Given the inherent subjectivity and uncertainty in projections, we could experience significant unfavorable variances in future periods or revise our projections downward. This would result in an increased risk that our goodwill and long-lived assets may be impaired. Any future impairments could have a material adverse effect on our financial condition and results of operations.
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, 2023 - July 31, 2023 | 2,226 | $5.42 | N/A | N/A |
August 1, 2023 - August 30, 2023 | 3,787 | $2.91 | N/A | N/A |
September 1, 2023- September 30, 2023 | — | $— | N/A | N/A |
Total | 6,013 | $3.84 | | |
(1) Consists of shares withheld to pay employees’ tax liability in connection with the vesting of restricted stock units granted under our stock-based compensation plans. These shares may be deemed to be “issuer purchases” of shares.
ITEM 6. EXHIBITS
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31.1 | | |
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101.INS | | Inline XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document |
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101.SCH | | Inline XBRL Taxonomy Extension Schema Document |
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101.CAL | | Inline XBRL Taxonomy Extension Calculation Linkbase Document |
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101.DEF | | Inline XBRL Taxonomy Extension Definition Linkbase Document |
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101.LAB | | Inline XBRL Taxonomy Extension Label Linkbase Document |
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101.PRE | | Inline XBRL Taxonomy Extension Presentation Linkbase Document |
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104 | | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
_______________________________________________________
** Furnished Herewith
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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Date: November 8, 2023 | ASSERTIO HOLDINGS, INC. |
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| /s/ Daniel A. Peisert |
| Daniel A. Peisert |
| President and Chief Executive Officer |
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| /s/ Paul Schwichtenberg |
| Paul Schwichtenberg |
| Senior Vice President and Chief Financial Officer |
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| /s/ Ajay Patel |
| Ajay Patel |
| Senior Vice President and Chief Accounting Officer |
CONTINGENT VALUE RIGHTS AGREEMENT
THIS CONTINGENT VALUE RIGHTS AGREEMENT, dated as of July 31, 2023, (this
“Agreement”), is entered into by and between Assertio Holdings, Inc., a Delaware corporation (“Parent”), and Computershare Inc., a Delaware corporation (“Computershare”), and its affiliate, Computershare Trust Company, N.A., a federally chartered trust company, collectively as Rights Agent (the “Rights Agent”).
RECITALS
WHEREAS, Parent, Spectrum Pharmaceuticals, Inc., a Delaware corporation (the “Company”) and Spade Merger Sub 1, a Delaware corporation and wholly owned subsidiary of the Parent (“Merger Sub”) have entered into an Agreement and Plan of Merger dated as of April 24, 2023 (as amended, restated, supplemented or otherwise modified from time to time pursuant to its terms, the “Merger Agreement”), pursuant to which Merger Sub will merge with and into the Company, with the Company being the surviving corporation (the “Surviving Corporation”).
WHEREAS, pursuant to the Merger Agreement, Parent has agreed to provide to (i) the holders of shares of Company Common Stock, and the holders of the Company Warrants immediately prior to the Effective Time that are, in each case, validly converted into Merger Consideration (or a portion thereof) and (ii) the holders of Company Stock Options, Company RSUs and Company SARs (the awards in clause (ii) collectively, “Company Equity Awards”) who are entitled to CVRs pursuant to Section 2.3 of the Merger Agreement, in each case, pursuant to terms set forth in the Merger Agreement, the right to receive contingent cash payments and/or Parent Common Stock (as determined in the sole discretion of Parent) (each, a “CVR”) as hereinafter described; and
WHEREAS, pursuant to this Agreement, the maximum potential amount payable per CVR is $0.20, without interest.
NOW, THEREFORE, in consideration of the foregoing and the consummation of the transactions referred to above, Parent and Rights Agent agree, for the equal and proportionate benefit of all holders of CVRs, as follows:
ARTICLE I
DEFINITIONS; CERTAIN RULES OF CONSTRUCTION
Section 1.1 Definitions. Capitalized terms used but not otherwise defined herein shall have the meanings ascribed to them in the Merger Agreement. As used in this Agreement, the following terms will have the following meanings:
“2024 Annual Net Sales Milestone” means the achievement of Net Sales exceeding
$175,000,000 during the 2024 Annual Net Sales Milestone Period.
“2024 Annual Net Sales Milestone Payment” means a dollar amount per CVR equal to the lesser of (i) $0.10 and (ii) (A) 0.249 multiplied by (B) (I) the Applicable Parent Stock Price,
multiplied by (II) the Exchange Ratio (rounded down to the closest hundredth of a penny) (provided that such amount shall not be less than $0).
“2024 Annual Net Sales Milestone Period” means the period commencing on January 1, 2024 and ending December 31, 2024.
“2025 Annual Net Sales Milestone” means the achievement of Net Sales exceeding
$225,000,000 for the 2025 Annual Net Sales Milestone Period.
“2025 Annual Net Sales Milestone Payment” means a dollar amount per CVR equal to the lesser of (i) $0.10 and (ii) (A) 0.249 multiplied by (B) (I) the Applicable Parent Stock Price, multiplied by (II) the Exchange Ratio, less (III) the 2024 Annual Net Sales Milestone Payment (rounded down to the closest hundredth of a penny) (provided that such amount shall not be less than $0).
“2025 Annual Net Sales Milestone Period” means the period commencing on January 1, 2025 and ending December 31, 2025.
“Acting Holders” means, at the time of determination, Holders of not less than 35% of the outstanding CVRs, as set forth in the CVR Register.
“Applicable Parent Stock Price” means the lower of the closing price for Parent Common Stock as reported by Nasdaq (or any national securities exchange or over the counter trading market on which the Parent Common Stock primarily trades if the Parent Common Stock is no longer listed on Nasdaq) (A) on the Closing Date, and (B) on the applicable Milestone Payment Date.
“Agreement” has the meaning set forth in the first paragraph hereof.
“Annual Net Sales Milestone” means any of the 2024 Annual Net Sales Milestone and the 2025 Annual Net Sales Milestone.
“Authorized Officer” means an employee of Parent with the title of President, Vice President, Senior Vice President, Executive Vice President, Secretary, Treasurer or Assistant Treasurer.
“Board of Directors” means the board of directors of Parent.
“Board Resolution” means a copy of a resolution certified by an Authorized Officer to have been duly adopted by the Board of Directors and to be in full force and effect on the date of such certification, and delivered to the Rights Agent.
“Business Day” means any day other than a Saturday, Sunday or a day on which banking institutions in New York, New York are authorized or obligated by law or executive order to remain closed.
“Calendar Year” means each respective period of twelve (12) consecutive months beginning on January 1 and ending on December 31.
“Change of Control” means (a) a sale or other disposition of all or substantially all of the assets of either Parent or the Surviving Corporation on a consolidated basis (other than to any Subsidiary (direct or indirect) of Parent), (b) a merger or consolidation involving either Parent or the Surviving Corporation in which Parent or the Surviving Corporation, as applicable, is not the surviving entity, or (c) any other transaction involving either Parent or the Surviving Corporation in which the stockholders of Parent or the Surviving Corporation, as applicable, immediately prior to such transaction own less than 50% of the surviving entity’s voting power immediately after the transaction.
“Code” shall mean the Internal Revenue Code of 1986, as amended.
“Combination Product” means any product comprising the Product and at least one other therapeutically active product, compound or pharmaceutical ingredient that is not the Product.
“Combined Milestone Cash and Stock Payment” has the meaning set forth in Section 2.4(a).
“Company” has the meaning set forth in the recitals to this Agreement.
“Company Common Stock” means shares of common stock, par value $0.001, of the Company.
“Company Equity Awards” has the meaning set forth in the recitals to this Agreement. “CVR” has the meaning set forth in the recitals to this Agreement.
“Diligent Efforts” means, with respect to a particular task related to the Product, the efforts required to carry out such task in a good faith, diligent and sustained manner without undue interruption, pause or delay, which level is at least commensurate with the level of commercially reasonable efforts that a pharmaceutical company of comparable size and resources as those of Parent and its Affiliates would devote to a product of similar commercial potential and stage in development or product life as the Product, taking into account its safety, tolerability, and efficacy, its proprietary position (including patent coverage) and profitability (including pricing, supply costs and reimbursement status), the competitiveness of alternative third party products, the regulatory structure involved, the regulatory environment, and technical, commercial, legal, scientific and/or medical factors. Notwithstanding anything to the contrary herein, Diligent Efforts shall be determined without regard to any payments hereunder. For the avoidance of doubt, Parent shall not be required to pursue a Combination Product in order to satisfy its obligation to use Diligent Efforts.
“DTC” means The Depository Trust Company or any successor thereto.
“Equity Award Holders” means the Holders of CVRs granted with respect to Company Equity Awards.
“Fiscal Quarter” means each of the following three (3)-month periods: January 1 through March 31; April 1 through June 30; July 1 through September 30; and October 1 through December
31.
“GAAP” means the generally accepted accounting principles in the United States as established by the Financial Accounting Standards Board or any successor entity or other entity generally recognized as having the right to establish such principles in the United States, in each case, (i) which principals are currently used at the applicable time by Parent in the preparation of the consolidated financial statements of Parent and (ii) as consistently applied throughout the periods involved.
“Holder” means a Person in whose name a CVR is registered in the CVR Register at the applicable time.
“Independent Accountant” means an independent certified public accounting firm of nationally recognized standing designated either (a) jointly by the Acting Holders and Parent, or
(b) if such parties fail to make a designation, jointly by an independent public accounting firm selected by Parent and an independent public accounting firm selected by the Acting Holders.
“Merger” has the meaning set forth in the recitals to this Agreement.
“Merger Agreement” has the meaning set forth in the recitals to this Agreement. “Merger Sub” has the meaning set forth in the recitals to this Agreement. “Milestone Cash Payment” has the meaning set forth in Section 2.4(a). “Milestone Determination Date” means, with respect to any Annual Net Revenue Milestone, the date that is sixty (60) days following the last day of the applicable Annual Net Sales Milestone Period.
“Milestone Parent Stock Price” means an amount equal to the closing price for Parent Common Stock as reported by Nasdaq (or any national securities exchange or over the counter trading market on which the Parent Common Stock primarily trades if the Parent Common Stock is no longer listed on Nasdaq) on the applicable Milestone Payment Date.
“Milestone Payment” means any of the 2024 Annual Net Sales Milestone Payment or the 2025 Annual Net Sales Milestone Payment.
“Milestone Payment Amount” means, in respect of an Annual Net Sales Milestone, for a given Holder, the product of (a) the Milestone Payment in respect of such Annual Net Sales
Milestone and (b) the number of CVRs held by such Holder as reflected on the CVR Register as of the close of business on the date of the applicable Milestone Notice.
“Net Sales” means without duplication, the aggregate gross worldwide revenues received
(i) by or on behalf of Parent and its Affiliates for the Product sold to third parties, including to distributors and end-users (other than to Parent or any of its Affiliates), (ii) by or on behalf of Parent and its Affiliates in the form of any upfront fees, royalty, milestone payments or other consideration received from any third party to whom rights to the Product have been licensed (such royalty and sales milestone payments described in this clause (ii) collectively, “Sublicensing Revenue”) and (iii) by or on behalf of Sublicensees in respect of sales by such Sublicensees of the Product; provided, that aggregate gross worldwide revenues received pursuant to clause (i) and clause (ii) of this definition shall be reduced by the Permitted Deductions incurred by the applicable entity with respect to such sales or licenses, all as determined in accordance with the applicable entity’s usual and customary accounting methods consistent with the treatment of other branded prescription products sold or licensed by the applicable entity, which shall be in accordance with GAAP, including the accounting methods for translating gross revenues denominated in foreign currencies into United States dollar amounts. Notwithstanding the foregoing, if the Product is sold as part of a Combination Product, then Net Sales for such Product shall be determined by multiplying the Net Sales of the Combination Product (as calculated in accordance with analogous criteria as set forth above for the “Net Sales” definition) by the fraction, A / (A+B) where A is the weighted average sale price of such Product when sold separately in finished form, and B is the weighted average sale price of the other active product(s), compound(s) or ingredient(s) in such Combination Product sold separately in finished form (the “Other Product(s)”); provided that (i) if the weighted average sale price of the Product when sold separately in finished form can be determined but the weighted average sale price of the Other Product(s) cannot be determined, then Net Sales for such Product shall be calculated by multiplying the Net Sales of such Combination Product (as calculated in accordance with analogous criteria as set forth above for the “Net Sales” definition) by the fraction A / C where A is the weighted average sale price of such Product when sold separately in finished form and C is the weighted average sale price of the Combination Product; (ii) if the weighted average sale price of the Other Product(s) can be determined but the weighted average sale price of the Product when sold separately in finished form cannot be determined, Net Sales for such Product shall be calculated by multiplying the Net Sales of such Combination Product (as calculated in accordance with analogous criteria as set forth above for the “Net Sales” definition) by the following formula: one (1) minus B / C where B is the weighted average sale price of the Other Product(s) and C is the weighted average sale price of the Combination Product; and (iii) if the weighted average sale price of both the Product and the Other Product(s) cannot be determined, then Net Sales for such Product shall be calculated by multiplying the Net Sales of such Combination Product (as calculated in accordance with analogous criteria as set forth above for the “Net Sales” definition) by the fraction 1 / D where D is the number of active products, compounds or ingredients in the Combination Product including the Product.
“Net Sales Statement” means, for a given Annual Net Sales Milestone Period, a written statement of Parent, setting forth with reasonable detail (a) an itemized delineation and calculation of Net Sales during such Annual Net Sales Milestone Period, (b) an itemized delineation and calculation of the Permitted Deductions during such Annual Net Sales Milestone Period, (c) an itemized delineation and calculation of the Sublicensing Revenue, and (d) to the extent that revenues for the Product is recorded in currencies other than United States dollars during such Annual Net Sales Milestone Period, the exchange rates used for conversion of such foreign currency into United States dollars.
“Officer’s Certificate” means a certificate signed by an Authorized Officer of Parent, in his or her capacity as such an officer, and delivered to the Rights Agent.
“Parent” has the meaning set forth in the first paragraph of this Agreement.
“Parent Common Stock” means shares of common stock, par value $0.0001, of Parent. “Permitted Deductions” means, to the extent not already excluded from Net Sales, the
following deductions that are either included in the billing as part of the amount charged or invoiced, or otherwise documented as a deduction and accrued in accordance with GAAP specifically attributable to Net Sales:
(1)normal and customary trade and quantity discounts;
(2)accrued credits, price reductions or discounts by reasons of defects, recalls, returns, rebates or allowances of goods or because of retroactive price reductions specifically attributable to the Product;
(3)chargebacks, rebates (or the equivalent thereof) and other amounts accrued on sale of the Product, including such amounts mandated by programs of Governmental Entities;
(4)accruals for rebates (or the equivalent thereof) and administrative fees payable to medical healthcare organizations, commercial payors, group purchasing organizations or trade customers in line with approved contract terms or other normal and customary understandings and arrangements;
(5)accruals for tariffs, duties, excise, sales, value-added and other Taxes (other than Taxes based on net income) and charges of Governmental Entities;
(6)bad debts, provided that (i) any recovery of bad debts shall be included in Net Sales in the Fiscal Quarter in which recovered and (ii) such bad debts shall not exceed five percent (5%) of Net Sales;
(7)transportation, freight, postage, importation, insurance and other handling expenses to the extent included in gross amounts invoiced;
(8)discounts pursuant to patient discount programs and any voucher, co-pay assistance and coupon discounts;
(9)any costs associated with effecting a technology transfer with respect to the Product;
(10)accruals for amounts payable to wholesalers for services related to sales or distribution of the Product; and
(11)accruals for distribution and specialty pharmacy provider commissions and fees (including administrative fees and fees related to services provided pursuant to agreements with specialty pharmacy providers or distribution service agreements with wholesalers, fee-for-service wholesaler fees and inventory management fees) payable to any third party providing specialty pharmacy or distribution services to Parent, any Assignee and each of their respective Affiliates, licensees and sublicensees.
For the avoidance of doubt, if a single item falls into more than one of the categories set forth in clauses (1) through (10) above, such item may not be deducted more than once.
True-ups, changes in estimate, and other adjustments to Permitted Deduction amounts (whether positive or negative) shall be included in Permitted Deductions in the Fiscal Quarter as such items are recorded in accordance with GAAP.
“Permitted Transfer” means: a Transfer of CVRs (a) upon death of a Holder by will or intestacy; (b) made by instrument to an inter vivos or testamentary trust in which the CVRs are to be passed to beneficiaries upon the death of the trustee; (c) made pursuant to a court order; (d) made by operation of law (including by consolidation or merger) or without consideration in connection with the dissolution, liquidation or termination of any corporation, limited liability company, partnership or other Person; (e) in the case of CVRs held in book-entry or other similar nominee form, from a nominee to a beneficial owner and, if applicable, through an intermediary, or from such nominee to another nominee for the same beneficial owner, to the extent allowable by DTC; or (f) to Parent as provided in Section 2.7, provided, that with respect to the foregoing clauses (a) – (e), the transferee in such Transfer of CVRs shall have provided to Parent a W-8 or W-9, as applicable as soon as practicable following such Transfer.
“Product” means the approved product sold as of the Effective Date under the proprietary name ROLVEDON.
“Product Transfer” has the meaning set forth in Section 4.7.
“Qualified Transferee” means (i) any Affiliate of Parent, (ii) any third party acquirer or successor of all or substantially all of the assets Parent in connection with a Change of Control as specified in clause (a) of the definition of “Change of Control”, or (iii) any third party that has net assets of at least $200,000,000 (as shown on its most recently prepared financial statements) at the time of the applicable Product Transfer or (iv) other person with the prior written consent of the Acting Holders.
“Rights Agent” means the Rights Agent named in the first paragraph of this Agreement, until a successor Rights Agent will have become such pursuant to the applicable provisions of this Agreement, and thereafter “Rights Agent” will mean such successor Rights Agent.
“Share Payment Information” has the meaning set forth in Section 2.3(b). “Share Payment Instructions” has the meaning set forth in Section 2.3(b).
“Sublicensee” shall mean an authorized or permitted licensee, sublicensee (including at any tier of sublicense) or transferee of Parent or any of its Affiliates, in each case with respect to rights to the Product.
“Surviving Corporation” has the meaning set forth in the recitals to this Agreement.
“Trading Day” means a day on which Nasdaq (or any national securities exchange or over the counter trading market on which Company primarily trades if Parent Common Stock is no longer listed on Nasdaq) is open for trading.
“Transfer” means any transfer, pledge, hypothecation, encumbrance, assignment or other disposition (whether by sale, merger, consolidation, liquidation, dissolution, dividend, distribution or otherwise), the offer to make such a transfer or other disposition, and each contract, arrangement or understanding, whether or not in writing, to effect any of the foregoing.
“Transfer Agent” means Continental Stock Transfer & Trust Company, the current transfer agent for the Parent Common Stock and any successor transfer agent thereof.
Section 1.2 Rules of Construction. When a reference is made in this Agreement to a Section, Article, Exhibit or Schedule such reference shall be to a Section, Article, Exhibit or Schedule of this Agreement unless otherwise indicated. The table of contents and headings contained in this Agreement or in any Exhibit or Schedule are for convenience of reference purposes only and shall not affect in any way the meaning or interpretation of this Agreement. All words used in this Agreement will be construed to be of such gender or number as the circumstances require. Any capitalized terms used in any Exhibit or Schedule but not otherwise defined therein shall have the meaning as defined in this Agreement. All Exhibits and Schedules annexed hereto or referred to herein are hereby incorporated in and made a part of this Agreement as if set forth herein. The word “including” and words of similar import when used in this Agreement will mean “including, without limitation,” unless otherwise specified. The words “hereof,” “herein” and “hereunder” and words of similar import when used in this Agreement shall refer to the Agreement as a whole and not to any particular provision in this Agreement. The term “or” is not exclusive. The word “will” shall be construed to have the same meaning and effect as the word “shall.” References to days mean calendar days unless otherwise specified. If the last day of a period by which an act is to be done under this Agreement is a non-Business Day, the period in question shall end on the next succeeding Business Day. Except as otherwise explicitly specified to the contrary, (a) references to a particular statute or regulation include all rules and regulations thereunder and any successor statute, rules or regulation, in each case as amended or otherwise modified from time to time, (b) words in the singular or plural form include the plural and singular form, respectively, (c) references to a particular Person include such Person’s
successors and assigns to the extent not prohibited by this Agreement and (d) all references to dollars or “$” refer to United States dollars.
ARTICLE II CONTINGENT VALUE RIGHTS
Section 2.1 CVRs. The CVRs represent the rights of Holders to receive the Milestone
Payments in accordance with this Agreement. The initial Holders will be the holders of Company Shares that are cancelled as of the Effective Time pursuant to the Merger Agreement and the holders of the Company Warrants immediately prior to the Effective Time that are validly converted into Merger Consideration pursuant to terms set forth in the Merger Agreement and the holders of Company Equity Awards who are entitled to CVRs pursuant to Section 2.3 of the Merger Agreement.
Section 2.2 Nontransferable. The CVRs may not be sold, assigned, Transferred, pledged, encumbered or in any other manner transferred or disposed of, in whole or in part, other than through a Permitted Transfer. Any attempted Transfer, pledge, encumbrance or disposition of CVRs, in whole or in part, in violation of this Section 2.2 shall be void ab initio and of no effect. The CVRs will not be listed on any quotation system or traded on any securities exchange.
Section 2.3 No Certificate; Registration; Registration of Transfer; Change of Address.
(a)The CVRs will be issued in book-entry form only and will not be evidenced by a certificate or other instrument.
(b)The Rights Agent will keep a register (the “CVR Register”) for the purpose of registering CVRs and Permitted Transfers thereof. The CVR Register will initially show one position for Cede & Co. representing all of the Company Shares held by DTC on behalf of the street holders of the Company Shares held by such holders as of immediately prior to the Effective Time. The Rights Agent will have no responsibility whatsoever directly to the street name holders with respect to Transfers of CVRs unless and until such CVRs are Transferred into the name of such street name holders in accordance with Section 2.2 of this Agreement. With respect to any cash payments to be made under Section 2.4 below, the Rights Agent will accomplish the payment to any former street name holders of Company Shares by sending one lump-sum payment to DTC. With respect to any payments to be made under Section 2.4 below that include shares of Parent Common Stock, Parent shall calculate and transmit to the Rights Agent the number of Parent Common Stock to be issued in respect of each CVR in connection with such payment (the “Share Payment Information”) together with directions and any other letter of instruction or other information reasonably required and requested in writing by the Rights Agent to deliver such Share Payment Information to the Transfer Agent for the issuance of Parent Common Stock to Holders in accordance with such Share Payment Information (the “Share Payment Instructions”), and the Rights Agent shall so deliver such Share Payment Information and Share Payment Instruction to the Transfer Agent. The Rights Agent shall be fully protected in relying on the Share Payment Information and Share Payment Instruction and shall have no duty or obligation to investigate or confirm the accuracy of the calculations and statements contained therein, including, without limitation, the number of Parent Common Stock to be issued in connection with such payment.
The Rights Agent shall have no responsibilities whatsoever with regard to the distribution of Parent Common Stock by the Transfer Agent or the payments by DTC to such street name holders. Parent may receive and inspect a copy of the CVR Register, from time to time, upon written request made to the Rights Agent. The Rights Agent shall, as promptly as practicable after receipt of such request, deliver a copy of the CVR Register, as then in effect, to Parent at the address set forth in Section 7.1.
(c)Subject to the restrictions on transferability set forth in Section 2.2, every request made to Transfer a CVR must be in writing and accompanied by a written instrument of Transfer and other customary documentation as the Rights Agent may reasonably request, in a form reasonably satisfactory to the Rights Agent pursuant to its guidelines, duly executed by the Holder thereof, the Holder’s attorney or other personal representative duly authorized in writing or the Holder’s survivor (with written documentation evidencing such person’s status as the Holder’s survivor), and setting forth in reasonable detail the circumstances relating to the Transfer. Upon receipt of such written notice, the Rights Agent will, subject to its reasonable determination that the Transfer instrument is in proper form and the Transfer otherwise complies with the other terms and conditions of this Agreement (including the provisions of Section 2.2), register the Transfer of the CVRs in the CVR Register. The Rights Agent shall not be obligated to undertake any action with respect to the Transfer of the CVRs until it shall have been provided with such additional information or material as it may reasonably require to determine that the Transfer complies with the terms and conditions of this Agreement. As a condition of such transfer, Parent and/or Rights Agent may require payment of a sum sufficient to cover any stamp or other Tax or governmental charge that is imposed in connection with any such registration of Transfer, unless such Holder has demonstrated to the reasonable satisfaction of Parent and Rights Agent that any such Tax or charge has been paid or is not applicable. The Rights Agent shall have no duty or obligation to take any action under any section of this Agreement that requires the payment by a Holder of applicable Taxes or charges unless and until the Rights Agent is satisfied that all such Taxes or charges have been paid or that such Taxes or charges are not applicable. All duly Transferred CVRs registered in the CVR Register will be the valid obligations of Parent and will entitle the transferee to the same benefits and rights under this Agreement as those held immediately prior to the Transfer by the transferor. No Transfer of a CVR will be valid until registered in the CVR Register in accordance with this Agreement, and any transfer not duly registered in the CVR Register will be void and invalid.
(d)A Holder may make a written request to the Rights Agent to change such Holder’s address of record in the CVR Register. The written request must be duly executed by the Holder. Upon receipt of such written notice, the Rights Agent will promptly record the change of address in the CVR Register.
Section 2.4 Payment Procedures; Notices.
(a)If an Annual Net Sales Milestone is attained, then, on or prior to the applicable Milestone Determination Date, Parent shall: (i) deliver to the Rights Agent a written notice indicating that the applicable Annual Net Sales Milestone has been achieved and specifying such Annual Net Sales Milestone (a “Milestone Notice”), and, if the Milestone Payment is a Milestone Stock Payment or a Combined Milestone Cash and Stock Payment, such Milestone Notice shall include the applicable Share Payment Information and Share Payment Instruction; and (ii) duly
deposit with or transfer to, or cause to be deposited with or transferred to, the Rights Agent, upon or prior to the delivery of the Milestone Notice, the cash portion (if any) of the applicable Milestone Payment Amount to be made to the Holders, other than any Milestone Payment Amounts to be paid in cash to Equity Award Holders (with respect to which any such amounts payable shall be retained by Parent for payment pursuant to this Section 2.4). Parent may make the Milestone Payments in the form of any of (x) subject to the valuation methodology set forth below, solely shares of Parent Common Stock (a “Milestone Stock Payment”), (y) solely cash (a “Milestone Cash Payment”), or (z) a combination of, subject to the valuation methodology set forth below, shares of Parent Common Stock and cash (a “Combined Milestone Cash and Stock Payment”). Without limiting Parent’s obligations to pay the Milestone Payments hereunder, Parent shall have the right, in its sole discretion, to elect one of the payments described in foregoing clause (x), (y), or (z) of this Section 2.4(a) in paying any Milestone Payment payable hereunder. Such amounts shall be considered paid if on such date the Rights Agent has received in accordance with this Agreement money or shares of Parent Common Stock sufficient to pay all such amounts required by Section 4.2.
(b)The Rights Agent will, within twenty (20) calendar days of receipt of any Milestone Notice (each such date, a “Milestone Payment Date”), send each Holder at its registered address a copy of the applicable Milestone Notice. At the time the Rights Agent sends a copy of such Milestone Notice to each Holder, the Rights Agent will also pay (or cause to be paid as described in Section 2.3(b) and this Section 2.4(b)) the applicable Milestone Payment Amount to each of the Holders, with each Holder receiving, subject to Section 2.4(c):
(i)if Parent elects the Milestone Stock Payment, the number of shares of Parent Common Stock determined by dividing the applicable Milestone Payment Amount by the Milestone Parent Stock Price;
(ii)if Parent elects the Milestone Cash Payment, the Milestone Payment Amount; and
(iii)if Parent elects the Combined Milestone Cash and Stock Payment: (A) (1) the applicable Milestone Payment divided by the Milestone Parent Stock Price, multiplied by (2) the percentage of the Milestone Payment that Parent has elected to pay in shares of Parent Common Stock (in accordance with the foregoing Section 2.4(a)), multiplied by (3) the number of CVRs held by such Holder as reflected on the CVR Register, plus (B)(1) the applicable Milestone Payment Amount multiplied by (2) the percentage of the Milestone Payment that Parent has elected to pay in cash (in accordance with the foregoing Section 2.4(a)).
The Parent hereby instructs the Rights Agent to make payments of the Milestone Cash Payment and the cash portion of the Combined Milestone Cash and Stock Payment to the Holders in accordance with this Agreement. The Rights Agent’s sole responsibility with respect to payments of Milestone Stock Payment and the portion of the Combined Milestone Cash and Stock Payment consisting of Parent Common Stock shall be to deliver the Stock Payment Information and Stock Payment Instructions to the Transfer Agent and the Transfer Agent shall be responsible for making payments of Milestone Stock Payment
and the portion of the Combined Milestone Cash and Stock Payment consisting of Parent Common Stock to the Holders.
Notwithstanding the foregoing, with respect to any Milestone Payment that is payable in respect of Company Equity Awards, Parent shall, as soon as reasonably practicable following the Milestone Payment Date (but in any event no later than the second regular payroll date following the Milestone Payment Date, and, except as described in Section 4.4(b), in all events no later than March 15th of the calendar year immediately following the last day of the applicable Annual Net Sales Milestone Period), or shall cause an Affiliate thereof (including the Surviving Corporation) to, pay the amount, through Parent’s or such Affiliate’s payroll system, or, if applicable, issue the number of shares of Parent Common Stock for distribution by the Transfer Agent, in either case, as described in clause (i), (ii) or (iii) of the first sentence of this Section 2.4(b), to the applicable Equity Award Holder.
(c)Notwithstanding anything to the contrary herein, with respect to any CVR issued in respect of a Contingent In-the-Money Stock Option, in the event a Milestone Payment is payable hereunder, the Holder of such CVR shall be entitled to receive an amount equal to (i) such Milestone Payment less (ii) the amount by which the exercise price of such Contingent In-the- Money Stock Option per share exceeded the value of the Upfront Consideration. For clarity, the Milestone Payment Amount (or any portion thereof) shall not be paid or payable to any Holder of CVRs issued in respect of Contingent In-the-Money Stock Options unless the aggregate amount of such Milestone Payment Amounts payable hereunder exceed the exercise price applicable to such Contingent In-the-Money Stock Options.
(d)In the event that any Milestone Payment payable to the Holders under this Agreement includes shares of Parent Common Stock, Parent and the Transfer Agent shall take such actions as are necessary to issue or transfer to each Holder such Holder’s shares of Parent Common Stock, in accordance with applicable Law. Notwithstanding anything to the contrary herein, no fractional shares of Parent Common Stock shall be issued under this Agreement. In lieu of any fractional share of Parent Common Stock otherwise issuable under this Agreement, if any, the Holder shall receive a cash payment, rounded to the nearest whole cent and without interest, in an amount equal to the product of the Milestone Parent Stock Price for the applicable payment and the fraction of a share the Holder would otherwise be entitled to receive. The shares of Parent Common Stock to be issued to Holders pursuant to the foregoing shall be evidenced by properly authorized share certificates registered with the Transfer Agent, or, at Parent’s discretion, by book- entry registration with the Transfer Agent.
(e)The Milestone Cash Payment or the cash portion of any Combined Milestone Cash and Stock Payment payable under this Agreement (including any cash payment in lieu of fractional shares of Parent Common Stock) shall be paid in United States dollars by wire transfer or check mailed to the address of each Holder as reflected in the CVR Register as of the close of business on the last Business Day prior to such Milestone Payment Date. The portion of any Milestone Payment Amount payable in cash shall be rounded to the nearest cent. Notwithstanding the foregoing, with respect to any Milestone Payment that is payable in cash in respect of Company Equity Awards, Parent shall, as soon as reasonably practicable following the Milestone Payment Date (but in any event no later than the second regular payroll date following the Milestone Payment Date, and in all events no later than March 15th of the year following the year in which
the Annual Net Revenue Milestone is attained), or shall cause the Company or an Affiliate thereof to, pay, through Parent’s or any of its Affiliate’s (including the Surviving Corporation’s) payroll system, the applicable cash Milestone Payment to the applicable Equity Award Holder in accordance with the Merger Agreement.
(f)Any portion of any Milestone Payment Amount delivered to the Rights Agent that remains undistributed to a Holder one year after the date of the delivery of the Milestone Notice will be delivered by the Rights Agent to Parent, upon demand, and any Holder will thereafter look only to Parent for payment of such Milestone Payment Amount, without interest, but such Holder will have no greater rights against Parent than those accorded to general unsecured creditors of Parent under applicable Law.
(g)Commencing with, (i) in the case of the 2024 Annual Net Sales Milestone, the first Fiscal Quarter of the Calendar Year beginning on January 1, 2025, and (ii) in the case of the 2025 Annual Net Revenue Milestone, the first Fiscal Quarter of the Calendar Year beginning on January 1, 2026, if Parent has not delivered to the Rights Agent a Milestone Notice pursuant to Section 2.4(a) with respect to the achievement of any of such Annual Net Sales Milestones, no later than the forty-fifth (45th) day following the completion of such Fiscal Quarter, without limiting any of Parent’s obligations hereunder (including with respect to payment of any of the Annual Net Sales Milestones), Parent shall deliver to the Rights Agent (i) written notice indicating that the applicable Annual Net Sales Milestone was not achieved during the applicable Annual Net Sales Milestone Period (a “Milestone Failure Notice”) and an Officer’s Certificate certifying the same and (ii) the Net Sales Statement for such Calendar Year. The Rights Agent will promptly, and in any event within ten (10) Business Days of receipt of a Milestone Failure Notice, send each Holder at its registered address a copy of such Milestone Failure Notice and Net Sales Statement (which statement may be modified or redacted, at the reasonable request of Parent, so as to provide only the total amount of gross amounts invoiced by Parent, any Assignee and each of their respective Affiliates, the total amount of Permitted Deductions).
(h)Neither Parent nor the Rights Agent will be liable to any person in respect of any Milestone Payment Amount delivered to a public official pursuant to any applicable abandoned property, escheat or similar law.
(i)Unless otherwise required by applicable Law, Parent and each Holder agree that for all U.S. federal (and applicable state, local and non-U.S.) income Tax purposes, (i) amounts payable pursuant to this Agreement may be treated as deferred contingent purchase price for Company Common Stock; and (ii) if and to the extent such amounts are paid to any Person under this Agreement, a portion of such amounts may be treated as interest pursuant to Section 483 or Section 1274 of the Code.
(j)Notwithstanding the foregoing or anything herein to the contrary, Milestone Payments payable to Equity Award Holders will be paid, as, if and when (i.e., at the same time) such Milestone Payments are made to the Holders generally, but in no event later than five (5) years following the Effective Date, in compliance with all requirements of Section 409A of the Code, to the extent applicable.
Section 2.5 No Voting, Dividends or Interest; No Equity or Ownership Interest in Parent
(a)The CVRs will not have any voting or dividend rights, and interest will not accrue on any amounts payable on the CVR to any Holder.
(b)The CVRs will not represent any interest in the capital of, or any equity or ownership interest in, Parent, any constituent company to the Merger or any of their respective Affiliates. The sole right of each Holder to receive property hereunder is the right to receive the Milestone Payment Amount, in accordance with the terms hereof.
Section 2.6 Changes in Parent Common Stock.
(a)If Parent Common Stock is changed into, or exchanged for, a different number of shares or a different class, by reason of any subdivision, reclassification, reorganization, recapitalization, split, combination, contribution or exchange of shares, or a stock dividend or dividend payable in any other securities shall be declared with a record date within such period, or any similar event shall have occurred, any Milestone Stock Payment or the stock portion of any Combined Milestone Cash and Stock Payment shall be correspondingly adjusted to provide the Holders the same economic effect as contemplated by this Agreement prior to such event; provided, however, that this sentence shall not be construed to permit Parent to take any action with respect to its securities that is prohibited by the terms of this Agreement.
(b)If, as a result of any reorganization, recapitalization, reclassification, or other similar change in Parent Common Stock, the outstanding Parent Common Stock is exchanged for a different kind, class or series of shares or other securities of Parent, an appropriate adjustment to the kind, class or series of shares or other securities subject to the CVRs and this Agreement shall be made.
Section 2.7 Ability to Abandon CVR. A Holder may at any time, at such Holder’s option, abandon all of such Holder’s remaining rights in a CVR by transferring such CVR to Parent or a Person nominated in writing by Parent (with written notice thereof from Parent to the Rights Agent) without consideration therefor, and such rights will be cancelled, with the Rights Agent being promptly notified in writing by Parent of such Transfer and cancellation. Nothing in this Agreement shall prohibit Parent or any of its Affiliates from offering to acquire or acquiring any CVRs for consideration from the Holders, in private transactions or otherwise, in its sole discretion. Any CVRs acquired by Parent or any of its Affiliates shall be automatically deemed extinguished and no longer outstanding for purposes of this Agreement.
ARTICLE III
THE RIGHTS AGENT
Section 3.1 Certain Duties and Responsibilities. The Rights Agent will not have any
liability for or in respect of any actions taken, suffered or not taken in connection with this Agreement and the exercise and performance of its duties hereunder, except to the extent of its own willful misconduct, bad faith or gross negligence (each as determined by a final non- appealable judgment of a court of competent jurisdiction). Notwithstanding anything in this
Agreement to the contrary, in no event will the Rights Agent be liable for special, punitive, indirect, incidental or consequential loss or damages of any kind whatsoever (including, without limitation, lost profits), even if the Rights Agent has been advised of the likelihood of such loss or damages and regardless of the form of action.
Section 3.2 Certain Rights of Rights Agent. Parent hereby appoints the Rights Agent to act as rights agent for Parent in accordance with the express terms and conditions hereof and the Rights Agent undertakes to perform such duties and only such duties as are specifically set forth in this Agreement, and no implied duties, covenants or obligations will be read into this Agreement against the Rights Agent. In addition:
(a)the Rights Agent may rely and will be protected and held harmless by Parent in acting or refraining from acting upon any resolution, certificate, statement, instrument, opinion, report, notice, request, direction, consent, order or other paper or document believed by it to be genuine and to have been signed or presented by the proper party or parties;
(b)whenever the Rights Agent will deem it desirable that a matter be proved or established prior to taking, suffering or omitting any action hereunder, the Rights Agent may, in the absence of bad faith, gross negligence or willful misconduct (each as determined by a final non-appealable judgment of a court of competent jurisdiction) on the part of the Rights Agent, rely upon an Officer’s Certificate with respect to such matter delivered to the Rights Agent and the Rights Agent shall incur no liability and be held harmless by Parent for or in respect of any action taken, suffered or omitted to be taken by it under the provisions of this Agreement in reliance upon such Officer’s Certificate;
(c)the Rights Agent may engage and consult with counsel of its selection and the written advice of such counsel or any written opinion of counsel will be full and complete authorization and protection to the Rights Agent and the Rights Agent shall be held harmless by Parent in respect of any action taken, suffered or omitted by it hereunder in the absence of bad faith, gross negligence or willful misconduct (each as determined by a final non-appealable judgment of a court of competent jurisdiction) and in reliance thereon;
(d)the permissive rights of the Rights Agent to do things enumerated in this Agreement will not be construed as a duty;
(e)the Rights Agent will not be required to give any note or surety in respect of the execution of such powers or otherwise in respect of the premises;
(f)Parent agrees to indemnify the Rights Agent for, and hold the Rights Agent harmless against, any loss, liability, damage, judgment, fine, penalty, claim, demands, suits or expense arising out of or in connection with the Rights Agent’s duties under this Agreement, including the reasonable costs and expenses of defending the Rights Agent against any liability, damage, judgment, fine, penalty, claims, charges, demands, suits or loss, unless such loss has been determined by a final non-appealable judgment of court of competent jurisdiction to be a result of the Rights Agent’s gross negligence, bad faith or willful misconduct;
(g)Parent agrees (i) to pay the fees and expenses of the Rights Agent in connection with this Agreement in accordance with the fee schedule agreed upon by the Rights Agent and
Parent and incorporated herein by reference and (ii) to reimburse the Rights Agent for all Taxes and governmental charges (other than Taxes imposed on or measured by the Rights Agent’s net income and franchise or similar Taxes imposed on it (in lieu of net income Taxes)). The Rights Agent will also be entitled to reimbursement from Parent for all reasonable and necessary out-of- pocket expenses paid or incurred by it in connection with the administration by the Rights Agent of its duties hereunder
(h)no provision of this Agreement shall require the Rights Agent to expend or risk its own funds or otherwise incur any financial liability in the performance of any of its duties hereunder or in the exercise of its rights if there shall be reasonable grounds for believing that repayment of such funds or adequate indemnification against such risk or liability is not reasonably assured to it;
(i)anything to the contrary notwithstanding, except with respect to the Rights Agent’s own fraud, bad faith or willful misconduct (each as determined by a final non-appealable judgment of a court of competent jurisdiction), any liability of the Rights Agent under this Agreement will be limited to the aggregate amount of the annual fees (but not reimbursed expenses) paid by Parent to the Rights Agent under this Agreement during the twelve months immediately preceding the event for which recovery is sought;
(j)the Rights Agent shall not be deemed to have knowledge of any event of which it was supposed to receive notice thereof hereunder, and the Rights Agent shall be fully protected and shall incur no liability for failing to take action in connection therewith, in each case, unless and until such notice has been given in accordance with Section 7.1;
(k)the Rights Agent shall neither be responsible for, nor chargeable with, knowledge of, nor have any requirements to comply with, the terms and conditions of the Merger Agreement, nor shall the Rights Agent be required to determine if any Person has complied with the Merger Agreement, nor shall any additional obligations of the Rights Agent be inferred from the terms of the Merger Agreement even though reference thereto may be made in this Agreement;
(l)the recitals or statements of fact contained herein shall be taken as statements of Parent, and the Rights Agent assumes no responsibility for their correctness nor shall it be required to verify the same. The Rights Agent shall be under no responsibility for the validity or sufficiency of this Agreement with respect to any other party hereto or the execution and delivery hereof (except the due execution hereof by the Rights Agent) or in respect of the validity or execution of the CVRs, nor shall it be responsible for any breach by Parent or any other Person of any covenant or condition contained in this Agreement or any CVR. The Rights Agent shall not have any duty or responsibility to initiate or attempt to initiate any proceedings at law or otherwise or to make any demand upon the Parent, Holder or any other Person;
(m)all funds received by the Rights Agent under this Agreement that are to be distributed or applied by Computershare in the performance of services hereunder (the “Funds”) shall be held by Computershare as agent for Parent and deposited in one or more bank accounts to be maintained by Computershare in its name as agent for Parent. Until paid pursuant to the terms of this Agreement, Computershare will hold the Funds through such accounts in: deposit accounts of commercial banks with Tier 1 capital exceeding $1 billion or with an average rating above
investment grade by S&P (LT Local Issuer Credit Rating), Moody’s (Long Term Rating) and Fitch Ratings, Inc. (LT Issuer Default Rating) (each as reported by Bloomberg Finance L.P.). The Rights Agent shall have no responsibility or liability for any diminution of the Funds that may result from any deposit made by the Rights Agent in accordance with this paragraph, including any losses resulting from a default by any bank, financial institution or other Person. The Rights Agent may from time to time receive interest, dividends or other earnings in connection with such deposits. The Rights Agent shall not be obligated to pay such interest, dividends or earnings to Parent, any Holder or any other Person; and
(n)the provisions of Section 3.1 and this Section 3.2 shall survive the resignation, replacement or removal of the Rights Agent and the termination of this Agreement.
Section 3.3 Resignation and Removal; Appointment of Successor.
(a)The Rights Agent may resign at any time by giving written notice thereof to Parent specifying a date when such resignation will take effect, which notice will be sent at least sixty
(60) days prior to the date so specified but in no event will such resignation become effective until a successor Rights Agent has been appointed. Parent has the right to remove Rights Agent at any time by a Board Resolution specifying a date when such removal will take effect but no such removal will become effective until a successor Rights Agent has been appointed. Notice of such removal will be given by Parent to Rights Agent, which notice will be sent at least sixty (60) days prior to the date so specified.
(b)If the Rights Agent provides notice of its intent to resign, is removed pursuant to Section 3.3(a) or becomes incapable of acting, Parent, by a Board Resolution, will promptly appoint a qualified successor Rights Agent who, unless otherwise consented to in writing by the Acting Holders, shall be a stock transfer agent of national reputation or the corporate trust department of a commercial bank. The successor Rights Agent so appointed will, forthwith upon its acceptance of such appointment in accordance with Section 3.4, become the successor Rights Agent.
(c)Parent will give notice of each resignation and each removal of a Rights Agent and each appointment of a successor Rights Agent by mailing written notice of such event by first- class mail to the Holders as their names and addresses appear in the CVR Register. Each notice will include the name and address of the successor Rights Agent. If Parent fails to send such notice within ten (10) days after acceptance of appointment by a successor Rights Agent in accordance with Section 3.4, the successor Rights Agent will cause the notice to be mailed at the expense of Parent.
(d)The Rights Agent will reasonably cooperate with Parent and any successor Rights Agent in connection with the transition of the duties and responsibilities of the Rights Agent to the successor Rights Agent, including the transfer of all relevant data, including the CVR Register, to the successor Rights Agent.
Section 3.4 Acceptance of Appointment by Successor. Every successor Rights Agent appointed pursuant to Section 3.3(b) hereunder will execute, acknowledge and deliver to Parent and to the predecessor Rights Agent an instrument accepting such appointment and a counterpart
of this Agreement, and thereupon such successor Rights Agent, without any further act, deed or conveyance, will become vested with all the rights, powers, trusts and duties of the predecessor Rights Agent. On request of Parent or the successor Rights Agent, the predecessor Rights Agent will execute and deliver an instrument transferring to the successor Rights Agent all the rights, powers and trusts of the predecessor Rights Agent, but such predecessor Rights Agent shall not be required to make any additional expenditure or assume any additional liability in connection with the foregoing, unless, if requested by Rights Agent, it has been furnished with assurances of repayment or indemnity satisfactory to it.
ARTICLE IV COVENANTS
Section 4.1 List of Holders. Parent will furnish or cause to be furnished to the Rights
Agent in such form as Parent receives from the Company’s transfer agent (or other agent performing similar services for the Company), the names and addresses of the Holders within twenty (20) Business Days of the Effective Time. Until such list of Holders are furnished to the Rights Agent, the Rights Agent shall have no duties, responsibilities or obligations with respect to such Holders
Section 4.2 Payment of Milestone Payment Amounts. If an Annual Net Sales Milestone has been achieved in accordance with this Agreement, Parent will, promptly (but in any event no later than ten (10) Business Days) following the delivery of the applicable Milestone Notice to the Rights Agent, deposit with or transfer to the Rights Agent (or the Transfer Agent, as applicable), for payment or issuance to the Holders in accordance with Section 2.4, the aggregate amount of cash and or shares of Parent Common Stock necessary to pay the Milestone Payment Amount to each Holder (other than cash payments to the Equity Award Holders, in respect of which any Milestone Payment Amounts shall be paid in accordance with Section 2.4(b)). For the avoidance of doubt, the Milestone Payment Amount shall only be paid in respect of each given Annual Net Sales Milestone, if at all, one time under this Agreement, and the maximum aggregate potential amount payable per CVR under this Agreement shall be $0.20.
Section 4.3 Books and Records. Parent shall, and shall cause its Affiliates to, keep true, complete and accurate records in sufficient detail to enable the Holders and the Independent Accountant to determine the amounts payable hereunder.
Section 4.4 Audits.
(a)Upon the reasonable written request of the Acting Holders provided to Parent within forty-five (45) days of the delivery of any Net Sales Statement pursuant to Section 2.4(g) of this Agreement (the “Review Request Period”), but no more than once following each respective Annual Net Sales Milestone Period, Parent shall as promptly as reasonably practicable provide the Acting Holders with reasonable documentation to support its calculation of Net Sales, and shall make its financial personnel reasonably available to a designated representative of the Acting Holders to discuss and answer the Acting Holders’ questions regarding such calculations; provided that (x) the Acting Holders enter into customary confidentiality agreements reasonably satisfactory to Parent with respect to the confidential information of Parent or its Affiliates to be furnished
pursuant to this Section 4.4, (y) such access does not unreasonably interfere with the conduct of the business of Parent or any of its Affiliates and (z) such information or access would not reasonably be expected to result in the waiver of any attorney-client privilege or violate any applicable Law (provided that the Parent shall use commercially reasonable efforts to make alternative arrangements with respect to providing such information or access). If the Acting Holders do not agree with Parent’s calculations, the Acting Holders may, no later than twenty (20) Business Days after the Acting Holders request documentation supporting Parent’s calculation, submit a written dispute notice to Parent setting forth the specific disputed items in the Net Sales Statement and a reasonably detailed explanation thereof (such notice, a “Dispute Notice”). If the Acting Holders and Parent fail to agree on the matter under dispute within twenty (20) Business Days after the Acting Holders deliver the Dispute Notice to Parent, Parent shall permit, and shall use commercially reasonable efforts to cause its Affiliates to permit, the Independent Accountant (subject to the Independent Accountant’s entry into a customary confidentiality agreement reasonably satisfactory to Parent with respect to the confidential information of Parent or its Affiliates to be furnished pursuant to this Section 4.4) to have access at reasonable times during normal business hours to such of the books and records of Parent and any of its Affiliates as may be reasonably necessary to verify the accuracy of such Net Sales Statement and the figures underlying the calculations set forth therein, provided that such information or access (i) does not unreasonably interfere with the conduct of the business of Parent or any of its Affiliates or (ii) would not reasonably be expected to result in the waiver of any attorney-client privilege or violate any applicable Law (provided that the Parent shall use commercially reasonable efforts to make alternative arrangements with respect to providing such information or access). The Independent Accountant, acting as an expert and not as an arbitrator, shall be charged to come to a final determination solely with respect to those specific items in the Net Sales Statement that the parties disagree on and submit to it for resolution. All other items in the Net Sales Statement that the parties do not submit, prior to the end of the Review Request Period, to the Independent Accountant for resolution shall be deemed to be agreed by the parties and the Independent Accountant shall not be charged with calculating or validating those agreed upon items. If issues are submitted to the Independent Accountant for resolution, Parent shall, and shall use commercially reasonable efforts to cause its Affiliates, to furnish to the Independent Accountant such access, work papers and other documents and information related to those disputed issues as the Independent Accountant may reasonably request and as are available to Parent. The Independent Accountant shall deliver a written report to Parent setting forth its determinations with respect to the disputed matters, and shall disclose to the Acting Holders whether an Annual Net Sales Milestone was achieved and such additional information directly related to its findings. The Independent Accountant shall provide Parent with a copy of all disclosures made to the Acting Holders. The fees charged by such accounting firm shall be paid by Parent.
(b)If the Independent Accountant concludes that a Milestone Payment that was properly due was not paid to the Holders, Parent shall pay or transfer, or cause to be paid or transferred, to the Rights Agent and/or to the Transfer Agent (in each case, for further distribution to the Holders) or to each Holder the applicable Milestone Payment Amount, plus interest on such Milestone Payment Amount at the “prime rate” as published in the Wall Street Journal or similar reputable data source from time to time calculated from when the Milestone Payment should have been paid (if Parent had given notice of achievement of the Annual Net Sales Milestone pursuant to the terms of this Agreement), as applicable, to the date of actual payment (such amount, including interest, being the “CVR Shortfall”). The CVR Shortfall shall be paid by Parent within
thirty (30) calendar days of the date the Independent Accountant’s written report is provided to Parent. Absent manifest error, the decision of the Independent Accountant shall be final, conclusive and binding on Parent and the Holders, shall be non-appealable and shall not be subject to further review. In the event Holders are entitled to Milestone Payment Amounts pursuant to this Section 4.4(b) and such Milestone Payments are made after March 15 of the calendar year immediately following the last day of the applicable Annual Net Sales Milestone Period, the parties hereto intend that such Milestone Payments remain exempt from Section 409A of the Code as “short-term deferrals” pursuant to Treasury Regulation Section 1.409A-1(b)(4) because payment before such March 15 was administratively impracticable and such administrative impracticability was unforeseeable as of the date hereof, as contemplated by Treasury Regulation Section 1.409A- 1(b)(4)(ii).
(c)If, upon the expiration of the applicable Review Request Period, the Acting Holders has not requested a review of the Net Sales Statement, or if the Acting Holders have not delivered a timely Dispute Notice, in each case in accordance with this Section 4.4, the calculations set forth in the Net Sales Statement shall be binding and conclusive upon the Holders.
(d)Each Person seeking to receive information from Parent in connection with a review pursuant to this Section 4.4 shall enter into, and shall cause its accounting firm to enter into, a reasonable and mutually satisfactory confidentiality agreement with Parent or any Affiliate obligating such party to retain all such information disclosed to such party in confidence pursuant to such confidentiality agreement.
Section 4.5 Parent Stock Issuance. If Parent elects to pay the applicable Milestone Payment as either a Milestone Stock Payment or a Combined Milestone Cash and Stock Payment, Parent shall use commercially reasonable efforts to cause the shares of Parent Common Stock to be issued in connection with such payment to be listed on Nasdaq, subject to official notice of issuance, prior to the Milestone Payment Date. Parent shall use commercially reasonable efforts to take all actions reasonably required to be taken under state securities Laws in connection with the Milestone Stock Payment or stock portion of the Combined Milestone Cash and Stock Payment.
Section 4.6 Diligent Efforts. Commencing upon the Closing, subject to Section 6.2, and ending at the termination of the 2025 Annual Net Sales Milestone Period, Parent shall, and shall cause its Affiliates to, (i) use Diligent Efforts to achieve the 2024 Annual Net Sales Milestone and the 2025 Annual Net Sales Milestone, and (ii) not intentionally take any actions for the primary purpose of frustrating the payment of the Milestone Payments.
Section 4.7 Product Transfer. If, at any time on or prior to the termination of the 2025 Net Sales Milestone Period, Parent or its Affiliates, directly or indirectly, by a sale or swap of assets, merger, reorganization, joint venture, lease, license or any other transaction or arrangement (other than in connection with a Change of Control as defined in clauses (b)-(c) of the definition of “Change of Control”), sells, transfers, conveys or otherwise disposes of (each, a “Product Transfer”) all or substantially all of its respective right, title and interest (including all or substantially all Intellectual Property with respect thereto) in and to the Product to any Qualified Transferee, then Parent shall no longer be liable for any obligations under this Agreement; provided, that (a) such Qualified Transferee assumes and succeeds to the obligations of Parent set
forth in this Agreement (by operation of law or otherwise), and (b) prior to or simultaneously with the consummation of such Product Transfer any outstanding payments owed to the Holders hereunder shall have been paid by Parent. Following any Product Transfer to a Person other than a Qualified Transferee, Parent shall remain secondarily liable for any obligations of Parent set forth in this Agreement.
Section 4.8 Net Sales Statements. Within forty-five (45) days after the end of each Fiscal Quarter during the 2024 Annual Net Sales Milestone Period and the 2025 Annual Net Sales Milestone Period, Parent shall compile a Net Sales Statement for each such Fiscal Quarter. Parent shall keep each such Net Sales Statement in its books and records.
ARTICLE V AMENDMENTS
Section 5.1 Amendments without Consent of Holders.
(a)Without the consent of any Holders, Parent, when authorized by a Board Resolution, at any time and from time to time, may and the Rights Agent shall, if directed by the Parent, enter into one or more amendments hereto, for any of the following purposes:
(i)To evidence the succession of another Person to Parent and the assumption by any such successor of the covenants of Parent herein as provided in Section 7.3.
(ii)to add to the covenants of Parent such further covenants, restrictions, conditions or provisions as Parent and the Rights Agent will consider to be for the protection of the Holders; provided that, in each case, such provisions do not adversely affect any interests of the Holders;
(iii)to cure any ambiguity, to correct or supplement any provision herein that may be defective or inconsistent with any other provision herein, or to make any other provisions with respect to matters or questions arising under this Agreement; provided that, in each case, such provisions do not adversely affect any interests of the Holders;
(iv)as may be necessary or appropriate to ensure that the CVRs are not subject to registration under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder; provided that, in each case, such provisions do not adversely affect any interests of the Holders;
(v)to evidence the succession of another Person as a successor Rights Agent and the assumption by any such successor of the covenants and obligations of the Rights Agent herein in accordance with Sections 3.3 and 3.4;
(vi)as may be necessary to comply with or be exempt from the requirements of Section 409A of the Code;
(vii)to cancel CVRs in the event that any Holder has abandoned its rights to such CVRs in accordance with Section 2.7;
(viii)as may be necessary to ensure that Parent complies with applicable Law; provided that in each case, such amendments shall not adversely affect the interests of the Holders; or
(ix)any other amendments hereto for the purpose of adding, eliminating or changing any provisions of this Agreement, unless such addition, elimination or change is adverse to the interests of the Holders.
(b)Promptly after the execution by Parent and the Rights Agent of any amendment pursuant to the provisions of this Section 5.1, Parent will deliver (or cause the Rights Agent to deliver, at Parent’s expense) in accordance with Section 7.1 a notice thereof to the Holders at their addresses as they appear on the CVR Register, setting forth such amendment.
Section 5.2 Amendments with Consent of Holders.
(a)Subject to Section 5.1 (which amendments pursuant to Section 5.1 may be made without the consent of the Holders), with the consent of the Acting Holders whether evidenced in writing or taken at a meeting of the Holders, Parent, when authorized by a Board Resolution, and the Rights Agent may enter into one or more amendments hereto for the purpose of adding, eliminating or changing any provisions of this Agreement, even if such addition, elimination or change is materially adverse to the interest of the Holders; provided, however, that no such amendment shall, without the consent of the Acting Holders:
(i)modify in a manner adverse to the Holders (A) any provision contained herein with respect to the termination of this Agreement or the CVRs, (B) the time for, and amount of, any payment to be made to the Holders pursuant to this Agreement, or (C) the definition of any Annual Net Sales Milestone;
or
(iii)modify any provisions of this Section 5.2, except to increase the percentage
of Holders from whom consent is required or to provide that certain provisions of this Agreement cannot be modified or waived without the consent of the Holder of each outstanding CVR affected thereby.
(b)Promptly after the execution by Parent and the Rights Agent of any amendment pursuant to the provisions of this Section 5.2, Parent will deliver (or cause the Rights Agent to deliver, at Parent’s expense) in accordance with Section 7.2 a notice thereof to the Holders at their addresses as they appear on the CVR Register, setting forth such amendment.
Section 5.3 Execution of Amendments. In executing any amendment permitted by this Article V, the Rights Agent will be entitled to receive, and will be fully protected in relying upon, an opinion of counsel selected by Parent stating that the execution of such amendment is authorized or permitted by this Agreement. The Rights Agent may, but is not obligated to, enter into any such amendment that affects the Rights Agent’s own rights, immunities, protections, privileges, covenants or duties under this Agreement or otherwise, including any amendments pursuant to Section 5.1(a)(viii).
Section 5.4 Effect of Amendments. Upon the execution of any amendment under this Article V, this Agreement will be modified in accordance therewith, such amendment will form a part of this Agreement for all purposes and every Holder will be bound thereby.
ARTICLE VI
MANAGEMENT DISCRETION; NO FIDUCIARY DUTIES; REMEDIES OF THE HOLDERS
Section 6.1 Management of Consumer Business Unit. For the avoidance of doubt, subject to and consistent with its obligations set forth in this Agreement, management of the Company shall have full discretion in management of its business and the Product in all respects, including without limitation decisions relating to Taxes, application of US GAAP, selection of auditor, questions of accounting policy decisions/elections, working capital management, risk management, business opportunities, hiring and terminations of employees and consultants, etc.
Section 6.2 No Fiduciary Duties. Neither the Company’s officers nor its directors owe fiduciary duties of any kind to the Holders of the CVRs. Notwithstanding anything to the contrary in this Agreement, the Holders acknowledge that Parent has a fiduciary obligation to operate its business in the best interests of its stockholders, and any potential obligation to pay the Milestone Payments hereunder will not create any express or implied obligation to operate Parent’s business in any particular manner in order to maximize such Milestone Payments.
Section 6.3 Event of Default. An “Event of Default” with respect to the CVRs, means any of the following events which shall have occurred and be continuing (whatever the reason for such Event of Default and whether it shall be voluntary or involuntary or be effected by operation of Law or pursuant to any judgment, decree or order of any court or any order, rule or regulation of any Governmental Entity):
(a)default in the payment by Parent pursuant to the terms of this Agreement of all or any part of a Milestone Payment Amount after a period of ten (10) Business Days after such Milestone Payment Amount shall become due and payable; or
(b)material default in the performance, or breach in any material respect, of any covenant or warranty of Parent hereunder (other than a payment default subject to Section 6.3(a)), and continuance of such default or breach for a period of thirty (30) days after a written notice specifying such default or breach and requiring it to be remedied is given, which written notice states that it is a “notice of default” hereunder and is sent by registered or certified mail to Parent and the Rights Agent by the Acting Holders.
If an Event of Default described above occurs and is continuing (and has not been cured or waived), then, and in each and every such case, the Acting Holders by notice in writing to Parent and to the Rights Agent, may, in their discretion and at their own expense, commence a legal proceeding to protect the rights of the Holders, including to obtain payment for any amounts then due and payable. Notwithstanding anything herein to the contrary, damages directly resulting from and in the event of an Event of Default shall be the sole and exclusive remedy of any and all Holders for any claims or causes of action (whether in contract, tort or statute) that may be based upon, arise
out of or relate to this Agreement or the CVRs, or the negotiation, execution or performance hereof or thereof or the transactions contemplated hereby, and Parent and its Affiliates shall not be liable for special, punitive, indirect, incidental or consequential loss or damages of any kind whatsoever (including, without limitation, lost profits).
Section 6.4 Limitations on Suits by Holders. Except for the rights of the Rights Agent set forth herein, the Acting Holders, will have the sole right, on behalf of all Holders, by virtue of or under any provision of this Agreement, to institute any action or proceeding with respect to this Agreement, and no individual Holder or other group of Holders, will be entitled to exercise such rights. Notwithstanding any other provision in this Agreement, (a) the right of any Holder of any CVR to receive payment of the amounts that a Milestone Notice indicates are payable in respect of such CVR on or after the applicable due date, or to commence proceedings for the enforcement of any such payment on or after such due date shall not be impaired or affected without the consent of such Holder and (b) in the event of an insolvency proceeding of the Parent, individual Holders shall be entitled to assert claims in such insolvency proceeding and take related actions in pursuit of such claims with respect to any payment that may be claimed by or on behalf of the Parent or by any creditor of the Parent.
Section 6.5 Control by Acting Holders. The Acting Holders shall have the right to direct the conduct of any proceeding for any remedy available to the Holders under this Agreement, or exercising any power conferred on the Holders by this Agreement; provided that such direction shall not be otherwise than in accordance with applicable Law and the provisions of this Agreement.
ARTICLE VII
OTHER PROVISIONS OF GENERAL APPLICATION
Section 7.1 Notices to Rights Agent and Parent. All notices and other communications hereunder shall be in writing and shall be deemed duly given on (a) the date of delivery if delivered personally, or if by e-mail, on the date of transmittal (provided that the transmission of the email is promptly confirmed by telephone or response email), (b) the second Business Day following the date of dispatch if delivered utilizing a next-day service by a recognized next-day courier or
(c) upon confirmed receipt if delivered by registered or certified mail, return receipt requested, postage prepaid. All notices hereunder shall be delivered to the addresses set forth below, or pursuant to such other instructions as may be designated in writing by the party to receive such notice:
If to the Rights Agent, to it at:
Computershare Inc.
Computershare Trust Company, N.A. 150 Royall Street
Canton, MA 02021
Attention: Relationship Manager
with a copy to:
Gibson, Dunn & Crutcher LLP 200 Park Avenue
New York, NY 10166 Attention: Saee Muzumdar
Branden C. Berns
Email: SMuzumdar@gibsondunn.com
BBerns@gibsondunn.com
If to Parent, to it at:
Assertio Holdings, Inc.
100 S. Saunders Rd., Suite 300 Lake Forest, IL 60045
Attention: Legal Department Email: Legal@assertiotx.com
with a copy to:
Latham & Watkins LLP
330 N Wabash Ave, Suite 2800
Chicago, IL 60613
Attention: Zachary Judd
Owen Alexander
Email: Zachary.Judd@lw.com Owen.Alexander@lw.com
The Rights Agent or Parent may specify a different address or facsimile number by giving notice in accordance with this Section 7.1.
Section 7.2 Notice to Holders. Where this Agreement provides for notice to Holders, such notice will be sufficiently given (unless otherwise herein expressly provided) if in writing and transmitted through the facilities of DTC or mailed, first-class postage prepaid, to each Holder affected by such event, at the Holder’s address as it appears in the CVR Register, not later than the latest date, and not earlier than the earliest date, if any, prescribed for the giving of such notice. In any case where notice to Holders is given by mail, neither the failure to mail such notice, nor any defect in any notice so mailed, to any particular Holder will affect the sufficiency of such notice with respect to other Holders.
Section 7.3 Parent Successors and Assigns. Parent may assign any or all of its rights, interests and obligations hereunder (a) in its sole discretion and without the consent of any other party (i) to, any controlled Affiliate of Parent, but only for so long as it remains a controlled Affiliate of Parent, (ii) in connection with a Change of Control, provided that in the case of a Change of Control as defined in clauses (a) and (b) of the definition of “Change of Control”, unless otherwise consented to by the Acting Holders, any applicable Milestone Payment Amount due and payable pursuant to the terms of this Agreement shall be paid solely in cash, or (iii) in accordance
with Section 4.7 to a Qualified Transferee in connection with a Product Transfer, or (b) with the prior written consent of the Acting Holders, any other Person (any permitted assignee under clause (a) or (b), an “Assignee”), in each case provided that the Assignee agrees to assume and be bound by all of the terms of this Agreement; provided, however, that Parent may assign, in its sole discretion, any or all of its rights, interests and obligations under this Agreement after the Effective Time to any Person, provided that no such assignment shall relieve Parent of its obligations hereunder except as otherwise provided for in this Agreement. Subject to the preceding sentence, this Agreement will be binding upon, inure to the benefit of, and be enforceable by, the parties and their respective successors and assigns. Any attempted assignment of this Agreement or any such rights in violation of this Section 7.3 shall be void and of no effect. Each of Parent’s successors and each Assignee shall, by an instrument supplemental hereto, executed and delivered to the Rights Agent, expressly assume the due and punctual payment of the CVRs and the due and punctual performance of every duty, obligation, agreement and covenant of this Agreement on the part of Parent to be performed or observed by Parent.
Section 7.4 Benefits of Agreement. Nothing in this Agreement, express or implied, will give to any Person (other than the Rights Agent and its successors and assigns, Parent, Parent’s successors and Assignees, the Holders and the Holders’ successors and assigns pursuant to a Permitted Transfer) any benefit or any legal or equitable right, remedy or claim under this Agreement or under any covenant or provision herein contained, all such covenants and provisions being for the sole benefit of the foregoing. The rights of Holders and their successors and assigns pursuant to Permitted Transfers are limited to those expressly provided in this Agreement and the Merger Agreement. Notwithstanding anything to the contrary contained herein, any Holder or Holder’s successor or assign pursuant to a Permitted Transfer may agree to renounce, in whole or in part, its rights under this Agreement by written notice to the Rights Agent and Parent, which notice, if given, shall be irrevocable.
Section 7.5 Governing Law; Jurisdiction; Waiver of Jury Trial.
(a)This Agreement, the CVRs and all disputes or controversies arising out of or relating to this Agreement, the CVRs or the transactions contemplated hereby shall be governed by, and construed in accordance with, the internal laws of the State of Delaware, without regard to the laws of any other jurisdiction that might be applied because of the conflicts of laws principles of the State of Delaware.
(b)Each of the parties irrevocably agrees that any legal action or proceeding arising out of or relating to this Agreement brought by any party or its Affiliates against any other party or its Affiliates shall be brought and determined in the Court of Chancery of the State of Delaware; provided, that if jurisdiction is not then available in the Court of Chancery of the State of Delaware, then any such legal action or proceeding may be brought in any federal court located in the State of Delaware or any other Delaware state court. Each of the parties hereby irrevocably submits to the jurisdiction of the aforesaid courts for itself and with respect to its property, generally and unconditionally, with regard to any such action or proceeding arising out of or relating to this Agreement and the transactions contemplated hereby, including the Merger. Each of the parties agrees not to commence any action, suit or proceeding relating thereto except in the courts described above in Delaware, other than actions in any court of competent jurisdiction to enforce any judgment, decree or award rendered by any such court in Delaware as described herein. Each
of the parties (other than the Rights Agent) further agrees that notice as provided herein shall constitute sufficient service of process and each of the parties (other than the Rights Agent) further waives any argument that such service is insufficient. Each of the parties hereby irrevocably and unconditionally waives, and agrees not to assert, by way of motion or as a defense, counterclaim or otherwise, in any action or proceeding arising out of or relating to this Agreement or the transactions contemplated hereby, including the Merger, (i) any claim that it is not personally subject to the jurisdiction of the courts in Delaware as described herein for any reason, (ii) that it or its property is exempt or immune from jurisdiction of any such court or from any legal process commenced in such courts (whether through service of notice, attachment prior to judgment, attachment in aid of execution of judgment, execution of judgment or otherwise) and (iii) that
(A) the suit, action or proceeding in any such court is brought in an inconvenient forum, (B) the venue of such suit, action or proceeding is improper or (C) this Agreement, or the subject matter hereof, may not be enforced in or by such courts.
(c)EACH OF THE PARTIES TO THIS AGREEMENT HEREBY IRREVOCABLY WAIVES ALL RIGHT TO A TRIAL BY JURY IN ANY ACTION, PROCEEDING OR COUNTERCLAIM ARISING OUT OF OR RELATING TO THIS AGREEMENT, THE CVRS OR THE TRANSACTIONS CONTEMPLATED HEREBY. EACH PARTY TO THIS AGREEMENT CERTIFIES AND ACKNOWLEDGES THAT: (i) NO REPRESENTATIVE OF ANY OTHER PARTY HAS REPRESENTED, EXPRESSLY OR OTHERWISE, THAT SUCH OTHER PARTY WOULD NOT SEEK TO ENFORCE THE FOREGOING WAIVER IN THE EVENT OF A LEGAL ACTION; (ii) SUCH PARTY HAS CONSIDERED THE IMPLICATIONS OF THIS WAIVER; (iii) SUCH PARTY MAKES THIS WAIVER VOLUNTARILY; AND (iv) SUCH PARTY HAS BEEN INDUCED TO ENTER INTO THIS AGREEMENT BY, AMONG OTHER THINGS, THE MUTUAL WAIVERS AND CERTIFICATIONS IN THIS SECTION 7.5(C).
Section 7.6 Section 409A. For the avoidance of doubt, it is intended that the benefits payable under this Agreement satisfy, to the greatest extent possible, the exemption from the application of Section 409A of the Code provided under Treasury Regulation Section 1.409A- 1(b)(4) and, to the extent not so exempt, that the benefits payable under this Agreement constitute “transaction-based compensation” that complies with Treasury Regulation Section 1.409A- 3(i)(5)(iv)(A), and this Agreement shall be interpreted and construed to the greatest extent possible to be consistent with such intent. Notwithstanding the foregoing, the Parent does not guarantee any particular Tax effect for income provided to the Holders pursuant to this Agreement and is not responsible for any Taxes owed by Holders.
Section 7.7 Severability. Whenever possible, each provision or portion of any provision of this Agreement shall be interpreted in such manner as to be effective and valid under applicable Law, but if any provision or portion of any provision of this Agreement is held to be invalid, illegal or unenforceable in any respect under any applicable Law or rule in any jurisdiction, such invalidity, illegality or unenforceability shall not affect any other provision or portion of any provision in such jurisdiction, and this Agreement shall be reformed, construed and enforced in such jurisdiction as if such invalid, illegal or unenforceable provision or portion of any provision had never been contained herein; provided, however, that if any excluded provision shall materially and adversely affect the rights, immunities, liabilities, duties or obligations of the Rights Agent, the Rights Agent shall be entitled to resign immediately upon written notice to Parent.
Section 7.8 Counterparts and Signature. This Agreement may be executed in two or more counterparts, all of which shall be considered one and the same instrument and shall become effective when one or more counterparts have been signed by each of the parties and delivered to the other parties. This Agreement may be executed by facsimile, electronic mail (including any electronic signature covered by the U.S. federal ESIGN Act of 2000, Uniform Electronic Transactions Act, the Electronic Signatures and Records Act or other applicable law, e.g., www.docusign.com) or .pdf signature, and any signature so delivered shall be deemed to have been duly and validly delivered and be valid and effective, and constitute an original, for all purposes.
Section 7.9 Termination. This Agreement will be terminated and of no force or effect, the parties hereto will have no liability hereunder (other than with respect to monies due and owing by Parent to Rights Agent) and no payments will be required to be made, upon the earliest to occur of (a) the delivery by the Rights Agent to the address of each Holder as reflected in the CVR Register of the full amount of all potential Milestone Payment Amounts required to be paid under the terms of this Agreement, (b) the delivery of a written notice of termination duly executed by Parent and the Acting Holders, (c) expiration of the Review Request Period following the expiration of an Annual Net Sales Milestone Period (provided no written request is received during such Review Request Period pursuant to Section 4.4(a)), (d) if a written request is received during the Review Request Period immediately following the expiration of an Annual Net Sales Milestone Period, the decision of the Independent Accountant (and, if applicable, payment of any CVR Shortfall as determined to be owing by the Independent Accountant) pursuant to Section 4.4(a).
Section 7.10 Entire Agreement. As between Parent and the Holders, this Agreement (including the fee schedule referred to in Section 3.2(g)) and the Merger Agreement constitute the entire agreement, and supersede all prior written agreements, arrangements, communications and understandings and all prior and contemporaneous oral agreements, arrangements, communications and understandings among the parties hereto with respect to the subject matter hereof and thereof. As between Parent and the Rights Agent, this Agreement (including the fee schedule referred to in Section 3.2(g)) constitutes the entire agreement, and supersedes all prior written agreements, arrangements, communications and understandings and all prior and contemporaneous oral agreements, arrangements, communications and understandings among the parties hereto with respect to the subject matter hereof and thereof.
Section 7.11 Legal Holiday. In the event that a Milestone Payment Date shall not be a Business Day, then, notwithstanding any provision of this Agreement to the contrary, any payment required to be made in respect of the CVRs on such date need not be made on such date, but may be made on the next succeeding Business Day with the same force and effect as if made on the applicable Milestone Payment Date.
Section 7.12 Force Majeure. Notwithstanding anything to the contrary contained herein, the Rights Agent shall not be liable for any delays or failures in performance resulting from acts beyond its reasonable control including, without limitation, acts of God, terrorist acts, pandemics, epidemics, shortage of supply, breakdowns or malfunctions, interruptions or malfunctions of any utilities, communications, or computer facilities, or loss of data due to power failures or mechanical difficulties with information storage or retrieval systems, labor difficulties, war or civil unrest.
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IN WITNESS WHEREOF, each of the parties has caused this Agreement to be executed on its behalf by its duly authorized officers as of the day and year first above written.
ASSERTIO HOLDINGS, INC.
By: /s/ Daniel Peisert Name: Daniel Peisert
Title: President and Chief Executive Officer
COMPUTERSHARE INC. and COMPUTERSHARE TRUST COMPANY,
N.A., collectively as Rights Agent
By: Name:
Title:
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[Signature Page to Contingent Value Rights Agreement] |
IN WITNESS WHEREOF, each of the parties has caused this Agreement to be executed on its behalf by its duly authorized officers as of the day and year first above written.
ASSERTIO HOLDINGS, INC.
By: Name:
Title:
COMPUTERSHARE INC. and COMPUTERSHARE TRUST COMPANY,
N.A., collectively as Rights Agent
By: /s/ Collin Ekeogu
Name: Collin Ekeogu
Title: Manager, Corporate Actions
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[Signature Page to Contingent Value Rights Agreement] |
Exhibit 31.1
CERTIFICATION OF THE CHIEF EXECUTIVE OFFICER
I, Daniel A. Peisert, certify that:
1.I have reviewed this Quarterly Report on Form 10-Q of Assertio Holdings, Inc.;
2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a)designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b)designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c)evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d)disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.The registrant’s other certifying officers and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
(a)all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
(b)any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
| | | | | | | | |
Date: November 8, 2023 | By: | /s/ Daniel A. Peisert |
| | Daniel A. Peisert |
| | President and Chief Executive Officer (Principal Executive Officer) |
Exhibit 31.2
CERTIFICATION OF THE CHIEF FINANCIAL OFFICER
I, Paul Schwichtenberg, certify that:
1.I have reviewed this Quarterly Report on Form 10-Q of Assertio Holdings, Inc.;
2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a)designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b)designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c)evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d)disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.The registrant’s other certifying officers and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
(a)all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
(b)any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
| | | | | | | | |
Date: November 8, 2023 | By: | /s/ Paul Schwichtenberg |
| | Paul Schwichtenberg |
| | Senior Vice President and Chief Financial Officer (Principal Financial Officer) |
Exhibit 32.1
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report on Form 10-Q of Assertio Holdings, Inc. (the “Company”) for the quarterly period ended September 30, 2023 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Daniel A Peisert, President and Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. §1350, as adopted pursuant to §906 of the Sarbanes-Oxley Act of 2002, that:
(1) The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
| | | | | | | | |
Date: November 8, 2023 | | /s/ Daniel A. Peisert |
| | Daniel A. Peisert |
| | President and Chief Executive Officer (Principal Executive Officer) |
Exhibit 32.2
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report on Form 10-Q of Assertio Holdings, Inc. (the “Company”) for the quarterly period ended September 30, 2023 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Paul Schwichtenberg, Senior Vice President and Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. §1350, as adopted pursuant to §906 of the Sarbanes-Oxley Act of 2002, that:
(1) The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
| | | | | | | | |
Date: November 8, 2023 | | /s/ Paul Schwichtenberg |
| | Paul Schwichtenberg |
| | Senior Vice President and Chief Financial Officer (Principal Financial Officer) |
v3.23.3
Cover Page - shares
|
9 Months Ended |
|
Sep. 30, 2023 |
Nov. 06, 2023 |
Cover [Abstract] |
|
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Document Type |
10-Q
|
|
Document Quarterly Report |
true
|
|
Document Period End Date |
Sep. 30, 2023
|
|
Document Transition Report |
false
|
|
Entity File Number |
001-39294
|
|
Entity Registrant Name |
ASSERTIO HOLDINGS, INC.
|
|
Entity Incorporation, State or Country Code |
DE
|
|
Entity Tax Identification Number |
85-0598378
|
|
Entity Address, Address Line One |
100 South Saunders Road
|
|
Entity Address, Address Line Two |
Suite 300
|
|
Entity Address, City or Town |
Lake Forest
|
|
Entity Address, State or Province |
IL
|
|
Entity Address, Postal Zip Code |
60045
|
|
City Area Code |
224
|
|
Local Phone Number |
419-7106
|
|
Title of 12(b) Security |
Common Stock, $0.0001 par value
|
|
Trading Symbol |
ASRT
|
|
Security Exchange Name |
NASDAQ
|
|
Entity Current Reporting Status |
Yes
|
|
Entity Interactive Data Current |
Yes
|
|
Entity Filer Category |
Accelerated Filer
|
|
Entity Smaller Reporting Company |
true
|
|
Entity Emerging Growth Company |
false
|
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Entity Shell Company |
false
|
|
Entity Common Stock, Shares Outstanding |
|
94,668,523
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Entity Central Index Key |
0001808665
|
|
Amendment Flag |
false
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Current Fiscal Year End Date |
--12-31
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2023
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v3.23.3
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
Current assets: |
|
|
Cash and cash equivalents |
$ 76,888
|
$ 64,941
|
Accounts receivable, net |
62,467
|
45,357
|
Inventories, net |
42,710
|
13,696
|
Prepaid and other current assets |
2,895
|
8,268
|
Total current assets |
184,960
|
132,262
|
Property and equipment, net |
804
|
744
|
Intangible assets, net |
170,413
|
197,996
|
Goodwill |
19,856
|
0
|
Deferred tax asset |
0
|
80,202
|
Other long-term assets |
3,995
|
2,709
|
Total assets |
380,028
|
413,913
|
Current liabilities: |
|
|
Accounts payable |
19,004
|
5,991
|
Accrued rebates, returns and discounts |
59,424
|
49,426
|
Accrued liabilities |
22,065
|
12,181
|
Long-term debt, current portion |
0
|
470
|
Contingent consideration, current portion |
12,800
|
26,300
|
Other current liabilities |
996
|
948
|
Total current liabilities |
114,289
|
95,316
|
Long-term debt |
38,866
|
66,403
|
Contingent consideration |
16,100
|
22,200
|
Other long-term liabilities |
17,900
|
4,269
|
Total liabilities |
187,155
|
188,188
|
Commitments and contingencies (Note 14) |
|
|
Shareholders’ equity: |
|
|
Common stock, $0.0001 par value, 200,000,000 shares authorized; 94,553,009 and 48,319,838 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively. |
9
|
5
|
Additional paid-in capital |
787,023
|
545,321
|
Accumulated deficit |
(594,159)
|
(319,601)
|
Total shareholders’ equity |
192,873
|
225,725
|
Total liabilities and shareholders' equity |
$ 380,028
|
$ 413,913
|
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v3.23.3
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares
|
Sep. 30, 2023 |
Dec. 31, 2022 |
Statement of Financial Position [Abstract] |
|
|
Common stock, par value (in dollars per share) |
$ 0.0001
|
$ 0.0001
|
Common stock, authorized (in shares) |
200,000,000
|
200,000,000
|
Common stock, issued (in shares) |
94,553,009
|
48,319,838
|
Spectrum common shares outstanding |
94,553,009
|
48,319,838
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.23.3
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE (LOSS) INCOME - USD ($) shares in Thousands, $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Revenues: |
|
|
|
|
Total revenues |
$ 35,627
|
$ 34,212
|
$ 119,084
|
$ 105,884
|
Costs and expenses: |
|
|
|
|
Cost of sales |
7,060
|
4,009
|
17,299
|
12,734
|
Research and development expenses |
1,316
|
0
|
1,819
|
0
|
Selling, general and administrative expenses |
21,005
|
11,900
|
54,680
|
33,084
|
Change in fair value of contingent consideration |
(17,532)
|
3,900
|
(8,124)
|
6,845
|
Amortization of intangible assets |
10,184
|
7,969
|
22,752
|
24,438
|
Loss on impairment of intangible assets |
238,831
|
0
|
238,831
|
0
|
Restructuring charges |
3,034
|
0
|
3,034
|
0
|
Total costs and expenses |
263,898
|
27,778
|
330,291
|
77,101
|
(Loss) income from operations |
(228,271)
|
6,434
|
(211,207)
|
28,783
|
Other (expense) income: |
|
|
|
|
Debt-related expenses |
0
|
0
|
(9,918)
|
0
|
Interest expense |
(752)
|
(2,052)
|
(2,625)
|
(6,648)
|
Other gain |
138
|
2
|
1,601
|
453
|
Total other expense |
(614)
|
(2,050)
|
(10,942)
|
(6,195)
|
Net (loss) income before income taxes |
(228,885)
|
4,384
|
(222,149)
|
22,588
|
Income tax expense |
(50,659)
|
(210)
|
(52,409)
|
(1,516)
|
Net (loss) income and comprehensive income |
(279,544)
|
4,174
|
(274,558)
|
21,072
|
Net (loss) income and comprehensive income |
$ (279,544)
|
$ 4,174
|
$ (274,558)
|
$ 21,072
|
Basic net (loss) income per share (in dollars per share) |
$ (3.42)
|
$ 0.09
|
$ (4.35)
|
$ 0.45
|
Diluted net (loss) income per share (in dollars per share) |
$ (3.42)
|
$ 0.08
|
$ (4.35)
|
$ 0.42
|
Shares used in computing diluted net (loss) income per share (in shares) |
81,713
|
48,180
|
63,066
|
46,566
|
Shares used in computing diluted net (loss) income per share (in shares) |
81,713
|
57,386
|
63,066
|
50,470
|
Product sales, net |
|
|
|
|
Revenues: |
|
|
|
|
Total revenues |
$ 35,137
|
$ 34,279
|
$ 116,989
|
$ 105,258
|
Royalties and milestones |
|
|
|
|
Revenues: |
|
|
|
|
Total revenues |
490
|
473
|
1,910
|
1,916
|
Other revenue |
|
|
|
|
Revenues: |
|
|
|
|
Total revenues |
$ 0
|
$ (540)
|
$ 185
|
$ (1,290)
|
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v3.23.3
CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY - USD ($) $ in Thousands |
Total |
Common Stock |
Additional Paid-In Capital |
Accumulated Deficit |
Balances (in shares) at Dec. 31, 2021 |
|
44,640,000
|
|
|
Balances at Dec. 31, 2021 |
$ 102,414
|
$ 4
|
$ 531,636
|
$ (429,226)
|
Increase (Decrease) in Stockholders' Equity |
|
|
|
|
Common stock issuance and other impacts of the vesting and settlement of equity awards (in shares) |
|
705,000
|
|
|
Common stock issuance and other impacts of the vesting and settlement of equity awards |
(707)
|
|
(707)
|
|
Issuance of common stock in connection with at-the-market program (in shares) |
|
2,464,000
|
|
|
Issuance of common stock in connection with at-the-market program |
7,020
|
$ 1
|
7,019
|
|
Issuance of common stock upon exercise of warrant (in shares) |
|
388,000
|
|
|
Stock-based compensation |
5,116
|
|
5,116
|
|
Net loss and comprehensive loss |
21,072
|
|
|
21,072
|
Net income and comprehensive income |
21,072
|
|
|
21,072
|
Balances (in shares) at Sep. 30, 2022 |
|
48,197,000
|
|
|
Balances at Sep. 30, 2022 |
134,915
|
$ 5
|
543,064
|
(408,154)
|
Balances (in shares) at Jun. 30, 2022 |
|
48,172,000
|
|
|
Balances at Jun. 30, 2022 |
128,369
|
$ 5
|
540,692
|
(412,328)
|
Increase (Decrease) in Stockholders' Equity |
|
|
|
|
Common stock issuance and other impacts of the vesting and settlement of equity awards (in shares) |
|
25,000
|
|
|
Common stock issuance and other impacts of the vesting and settlement of equity awards |
(28)
|
|
(28)
|
|
Stock-based compensation |
2,400
|
|
2,400
|
|
Net loss and comprehensive loss |
4,174
|
|
|
4,174
|
Net income and comprehensive income |
4,174
|
|
|
|
Balances (in shares) at Sep. 30, 2022 |
|
48,197,000
|
|
|
Balances at Sep. 30, 2022 |
$ 134,915
|
$ 5
|
543,064
|
(408,154)
|
Balances (in shares) at Dec. 31, 2022 |
48,319,838
|
48,320,000
|
|
|
Balances at Dec. 31, 2022 |
$ 225,725
|
$ 5
|
545,321
|
(319,601)
|
Increase (Decrease) in Stockholders' Equity |
|
|
|
|
Issuance of common stock upon exercise of options (in shares) |
|
133,000
|
|
|
Issuance of common stock upon exercise of options |
210
|
|
210
|
|
Common stock issuance and other impacts of the vesting and settlement of equity awards (in shares) |
|
1,102,000
|
|
|
Common stock issuance and other impacts of the vesting and settlement of equity awards |
(7,980)
|
|
(7,980)
|
|
Induced exchange of convertible notes (in shares) |
|
6,990,000
|
|
|
Induced exchange of convertible notes |
26,699
|
|
26,699
|
|
Issuance of common stock in connection with the Spectrum Merger, net of fractional share settlement (in shares) |
|
38,008,000
|
|
|
Issuance of common stock in connection with the Spectrum Merger, net of fractional share settlement |
216,261
|
$ 4
|
216,257
|
|
Stock-based compensation |
6,516
|
|
6,516
|
|
Net loss and comprehensive loss |
(274,558)
|
|
|
(274,558)
|
Net income and comprehensive income |
$ (274,558)
|
|
|
(274,558)
|
Balances (in shares) at Sep. 30, 2023 |
94,553,009
|
94,553,000
|
|
|
Balances at Sep. 30, 2023 |
$ 192,873
|
$ 9
|
787,023
|
(594,159)
|
Balances (in shares) at Jun. 30, 2023 |
|
56,513,000
|
|
|
Balances at Jun. 30, 2023 |
254,271
|
$ 5
|
568,881
|
(314,615)
|
Increase (Decrease) in Stockholders' Equity |
|
|
|
|
Issuance of common stock upon exercise of options (in shares) |
|
23,000
|
|
|
Issuance of common stock upon exercise of options |
54
|
|
54
|
|
Common stock issuance and other impacts of the vesting and settlement of equity awards (in shares) |
|
9,000
|
|
|
Common stock issuance and other impacts of the vesting and settlement of equity awards |
(33)
|
|
(33)
|
|
Issuance of common stock in connection with the Spectrum Merger, net of fractional share settlement (in shares) |
|
38,008,000
|
|
|
Issuance of common stock in connection with the Spectrum Merger, net of fractional share settlement |
216,261
|
$ 4
|
216,257
|
|
Stock-based compensation |
1,864
|
|
1,864
|
|
Net loss and comprehensive loss |
(279,544)
|
|
|
(279,544)
|
Net income and comprehensive income |
$ (279,544)
|
|
|
(279,544)
|
Balances (in shares) at Sep. 30, 2023 |
94,553,009
|
94,553,000
|
|
|
Balances at Sep. 30, 2023 |
$ 192,873
|
$ 9
|
$ 787,023
|
$ (594,159)
|
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v3.23.3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Operating Activities |
|
|
Net (loss) income |
$ (274,558)
|
$ 21,072
|
Adjustments to reconcile net (loss) income to net cash from operating activities: |
|
|
Depreciation and amortization |
23,321
|
25,033
|
Amortization of debt issuance costs and Royalty Rights |
350
|
128
|
Loss on impairment of intangible assets |
238,831
|
0
|
Recurring fair value measurements of assets and liabilities |
(7,612)
|
6,845
|
Debt-related expenses |
9,918
|
0
|
Provisions for inventory and other assets |
2,129
|
828
|
Stock-based compensation |
6,516
|
5,116
|
Deferred income taxes |
47,192
|
0
|
Changes in assets and liabilities, net of acquisition: |
|
|
Accounts receivable |
33,865
|
(319)
|
Inventories |
(8,898)
|
(7,607)
|
Prepaid and other assets |
6,769
|
13,288
|
Accounts payable and other accrued liabilities |
(21,523)
|
(7,193)
|
Accrued rebates, returns and discounts |
(11,027)
|
(4,058)
|
Interest payable |
(1,376)
|
(1,232)
|
Net cash provided by operating activities |
43,897
|
51,901
|
Investing Activities |
|
|
Purchases of property and equipment |
(528)
|
0
|
Purchase of Sympazan |
(280)
|
0
|
Net cash acquired in Spectrum Merger |
1,950
|
0
|
Purchase of Otrexup |
0
|
(16,889)
|
Proceeds from sale of investments |
2,194
|
0
|
Net cash provided by (used in) investing activities |
3,336
|
(16,889)
|
Financing Activities |
|
|
Proceeds from issuance of 2027 Convertible Notes |
0
|
65,916
|
Payments in connection with 2027 Convertible Notes |
(10,500)
|
0
|
Payment of direct transaction costs related to convertible debt inducement |
(1,119)
|
0
|
Payment in connection with 2024 Senior Notes |
0
|
(70,750)
|
Payment of contingent consideration |
(15,408)
|
(7,845)
|
Proceeds from the issuance of common stock |
0
|
7,020
|
Payments related to the vesting and settlement of equity awards, net |
(7,770)
|
(707)
|
Other financing activities |
(489)
|
(630)
|
Net cash used in financing activities |
(35,286)
|
(6,996)
|
Net increase in cash and cash equivalents |
11,947
|
28,016
|
Cash and cash equivalents at beginning of year |
64,941
|
36,810
|
Cash and cash equivalents at end of period |
76,888
|
64,826
|
Supplemental Disclosure of Cash Flow Information |
|
|
Net cash paid (refunded) for income taxes |
3,424
|
(7,822)
|
Cash paid for interest |
$ 3,651
|
$ 7,752
|
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v3.23.3
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
|
9 Months Ended |
Sep. 30, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES |
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Organization
Assertio Holdings, Inc., or the Company, is a commercial pharmaceutical company offering differentiated products to patients. The Company has built its commercial portfolio through a combination of increased opportunities with existing products, as well as through the acquisition or licensing of additional approved products. The Company’s primary marketed products include INDOCIN® (indomethacin) Suppositories, INDOCIN® (indomethacin) Oral Suspension, ROLVEDONTM (elflapegrastim-xnst) injection for subcutaneous use, Otrexup® (methotrexate) injection for subcutaneous use, Sympazan® (clobazam) oral film, SPRIX® (ketorolac tromethamine) Nasal Spray, CAMBIA® (diclofenac potassium for oral solution), and Zipsor® (diclofenac potassium) Liquid filled capsules. Other commercially available products include OXAYDO® (oxycodone HCI, USP) tablets for oral use only —CII.
Unless otherwise noted or required by context, use of “Assertio,” “Company,” “we,” “our” and “us” refer to Assertio Holdings and/or its applicable subsidiary or subsidiaries.
On July 31, 2023 (the “Effective Date”), the Company completed the acquisition of Spectrum Pharmaceuticals, Inc. (“Spectrum”), a commercial stage biopharmaceutical company focused on novel and targeted oncology products, (the “Spectrum Merger”). Refer to Note 2, Acquisitions, for additional information.
Basis of Presentation
The unaudited condensed consolidated financial statements of the Company 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 United States (“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, 2023 are not necessarily indicative of results to be expected for the entire year ending December 31, 2023 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, 2022 included in Assertio Holdings, Inc.’s Annual Report on Form 10-K filed with the SEC on March 8, 2023 (the “2022 Form 10-K”). The Condensed Consolidated Balance Sheet as of December 31, 2022 has been derived from the audited financial statements at that date, as filed in the Company’s 2022 Form 10-K.
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v3.23.3
ACQUISITIONS
|
9 Months Ended |
Sep. 30, 2023 |
Business Combination and Asset Acquisition [Abstract] |
|
ACQUISITIONS |
ACQUISITIONS Spectrum Pharmaceuticals
On the Effective Date, the Company completed the Spectrum Merger pursuant to an Agreement and Plan of Merger (“the Merger Agreement”), dated as of April 24, 2023, with Spectrum surviving the Merger as a wholly-owned subsidiary of the Company. The Company accounted for the Spectrum Merger using the acquisition method of accounting under Accounting Standards Codification (“ASC”) 805 and is considered the accounting acquirer.
Pursuant to the Merger Agreement, each issued and outstanding share of Spectrum common stock as of the Effective Date was converted into the right to receive (i) 0.1783 shares of the Company’s common stock and (ii) one contingent value right (“CVR”) representing a contractual right to receive future conditional payments worth up to an aggregate maximum amount of $0.20, settleable in cash, additional shares of Assertio common stock or a combination of cash and additional shares of Assertio common stock at the Company’s sole discretion, upon the achievement of certain sales milestones related to Spectrum’s product ROLVEDON. Subject to adjustments, each CVR represents the right to receive up to $0.10 payable upon ROLVEDON net sales (less certain deductions) achieving $175 million during the calendar year ending December 31, 2024, and up to $0.10 payable upon ROLVEDON net sales (less certain deductions) achieving $225 million during the calendar year ending December 31, 2025. In addition, upon consummation of the Spectrum Merger, Spectrum’s outstanding employee stock awards and other warrants that were outstanding immediately as of the Effective Date automatically vested (if unvested) and/or cancelled, as applicable, which generally resulted in the issuance of shares of the Company’s common stock and/or CVRs to the holders of such stock awards or other warrants, in each case as dictated by the terms of the Merger Agreement. These shares and CVRs issued are considered part of the consideration transferred, and no compensation expense was recognized because the settlement was a condition of the Merger Agreement and other existing individual agreements, no future performance is required by the holders, and the fair value of the shares and CVRs is equivalent to the fair value of the existing employee stock awards and other warrants.
The following table reflects the components of the consideration transferred in the Spectrum Merger (in thousands, except exchange ratio and per share data):
| | | | | | | | | | | | | | | | | | | | | | | | Assertio shares issued | | 38,013 | | Assertio closing price per share as of the Effective Date | | $ | 5.69 | | Fair value of Assertio shares issued | | $ | 216,294 | | Repayment of Spectrum's long-term debt (1) | | 32,647 | | CVRs(2) | | 3,932 | | Total fair value of consideration transferred | | $ | 252,873 | |
(1)Represents settlement of Spectrum’s existing long-term debt in connection with the close of the transaction. The Company concluded it did not assume the debt, therefore the amount paid to settle the debt has been accounted for and disclosed as part of the consideration transferred. (2)Represents the fair value of 223,397 CVRs at $0.0176 per CVR issued to holders of Spectrum common stock, employee stock awards and warrants as of the Effective Date.
The CVRs represent a contingent consideration obligation measured at fair value and classified as liabilities on the Company’s Condensed Consolidated Balance Sheets. The fair value of the CVR contingent consideration is determined using a Monte Carlo simulation model under the income approach and is based on Level 3 inputs. Refer to Note 17, Fair Value, for additional information. Fair value is based on the probability of achievement of 2024 and 2025 annual ROLVEDON net sales milestones. Significant assumptions include the discount rate and the probability assigned to the achievement of the net sales milestones. Achievement of both the 2024 and 2025 annual ROLVEDON net sales milestones would obligate the Company to transfer a maximum of approximately $44.7 million of additional consideration. No additional consideration would be paid by the Company if neither the 2024 nor 2025 annual ROLVEDON net sales milestones are achieved. The following table reflects the preliminary fair value of the assets acquired and liabilities assumed at the Effective Date (in thousands). Goodwill is primarily attributable to expected synergies between the Company and Spectrum and is not expected to be deductible for tax purposes. The Company continues to assess the fair value of the assets acquired and liabilities assumed at the Effective Date, including any which may be impacted by Spectrum’s pending legal proceedings. Accordingly, the provisional fair value estimates of net assets acquired could potentially change, and the Company expects to finalize these values as soon as practical and no later than one year from the Effective Date.
| | | | | | | | | | | | | | | Consideration transferred | | | | $ | 252,873 | | | | | | | Assets: | | | | | Cash and cash equivalents | | $ | 34,600 | | | | Marketable securities | | 2,194 | | | | Accounts receivable | | 50,975 | | | | Inventories | | 22,244 | | | | Prepaid and other current assets | | 1,287 | | | | Property and equipment | | 100 | | | | Intangible assets | | 234,000 | | | | Other long-term assets | | 1,396 | | | | Total | | $ | 346,796 | | | | | | | | | Liabilities: | | | | | Accounts payable | | $ | 10,108 | | | | Accrued rebates, returns and discounts | | 21,025 | | | | Accrued liabilities | | 36,509 | | | | Other current liabilities | | 784 | | | | Deferred taxes | | 34,250 | | | | Other long-term liabilities | | 11,103 | | | | Total | | $ | 113,779 | | | | | | | | | Total Spectrum net assets acquired (1) | | | | $ | 233,017 | | Goodwill | | | | $ | 19,856 | |
(1)Application of the acquisition method required the Company to adjust Spectrum assets and liabilities as of the Effective Date, including certain liabilities for variable consideration associated with ROLVEDON, to reflect conformity of Spectrum’s accounting policies to those of Assertio. Liabilities assumed include certain bonuses owed to former Spectrum executives under the terms of existing employment agreements triggered by the consummation of the Spectrum Merger.
The income approach was primarily used to value the acquired intangible assets, representing rights to Spectrum’s product ROLVEDON. Significant assumptions include the amount and timing of projected future cash flows; the discount rate selected to measure the inherent risk of future cash flows; and the assessment of the product’s life cycle and the competitive trends impacting the product. The ROLVEDON product rights will be amortized on a straight-line basis over its estimated useful life of 10 years.
Acquisition costs related to the Spectrum Merger were approximately $2.7 million and $8.5 million for the three and nine months ended September 30, 2023, respectively. These costs are included within Selling, general and administrative expenses in the Condensed Consolidated Statement of Comprehensive (Loss) Income.
The following unaudited pro forma information represents the Company’s results of operations as if the Spectrum Merger had been completed as of January 1, 2022 (in thousands) and includes nonrecurring adjustments for additional costs of sales from the fair value step-up of inventories and transaction costs. The disclosure of pro forma net sales and net loss does not purport to indicate the results that would actually have been obtained had the Spectrum Merger been completed on the assumed date for the periods presented, or which may be realized in the future. The unaudited pro forma information does not reflect any operating efficiencies or cost savings that may be realized from the integration of the acquisition. | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | 2023 | | 2022 | | 2023 | | 2022 | Net sales | $ | 35,629 | | $ | 34,212 | | | $ | 159,528 | | $ | 42,466 | | Net loss | (285,658) | | (22,073) | | | (326,769) | | (98,616) | | See Note 3, Revenue, for net sales of ROLVEDON from the Effective Date to September 30, 2023.
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v3.23.3
REVENUE
|
9 Months Ended |
Sep. 30, 2023 |
Revenue from Contract with Customer [Abstract] |
|
REVENUE |
REVENUE Disaggregated Revenue The following table reflects total revenue, net for the three and nine months ended September 30, 2023 and 2022 (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | | 2023 | | 2022 | | 2023 | | 2022 | Product sales, net: | | | | | | | | | INDOCIN products | | $ | 17,948 | | $ | 21,869 | | | $ | 76,369 | | $ | 66,067 | | ROLVEDON | | 7,132 | | — | | | 7,132 | | — | | Otrexup | | 2,807 | | | 3,004 | | | 9,222 | | | 8,699 | | Sympazan | | 2,103 | | | — | | | 7,232 | | | — | | SPRIX | | 2,545 | | | 2,455 | | | 6,807 | | | 6,437 | | CAMBIA | | 1,993 | | | 5,808 | | | 6,062 | | | 17,464 | | Zipsor | | 597 | | | 259 | | | 2,751 | | | 2,704 | | Other products | | 12 | | | 884 | | | 1,414 | | | 3,887 | | Total product sales, net | | 35,137 | | | 34,279 | | | 116,989 | | | 105,258 | | Royalties and milestone revenue | | 490 | | | 473 | | | 1,910 | | | 1,916 | | Other revenue | | — | | | (540) | | | 185 | | | (1,290) | | Total revenues | | $ | 35,627 | | | $ | 34,212 | | | $ | 119,084 | | | $ | 105,884 | |
Product Sales, net
Product sales consists of sales of the Company’s products as listed above. As a result of the Spectrum Merger, the Company began recognizing ROLVEDON sales in August 2023. The Company acquired Sympazan and began shipping and recognizing its product sales in October 2022.
Other product sales include product sales for OXAYDO and SOLUMATRIX product.. The Company ceased OXAYDO product sales beginning in September 2023, and ceased SOLUMATRIX sales beginning in July 2022.
Royalties and Milestone Revenue
In November 2010, the Company entered into a license agreement granting the counterparty the rights to commercially market CAMBIA in Canada. The counterparty to the license agreement 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, 2023, respectively, and $0.5 million and $1.5 million for the three and nine months ended September 30, 2022, respectively. The Company records contract liabilities in the form of deferred revenue resulting from prepayments from customers in Other current liabilities in the Company’s Condensed Consolidated Balance Sheets. As of September 30, 2023 and December 31, 2022, contract liabilities were zero and $0.2 million, respectively. The Company recognized Milestone revenue associated with the completion of certain service milestones of $0.5 million for both the nine months ended September 30, 2023 and 2022. The Company recognized no Milestone revenue associated with the completion of certain service milestones for both the three months ended September 30, 2023 and 2022. 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 a reduction to or an increase to total revenue during the period.
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v3.23.3
ACCOUNTS RECEIVABLES, NET
|
9 Months Ended |
Sep. 30, 2023 |
Receivables [Abstract] |
|
ACCOUNTS RECEIVABLES, NET |
ACCOUNTS RECEIVABLES, NET As of September 30, 2023 and December 31, 2022, accounts receivable, net, of $62.5 million and $45.4 million, respectively, consisted entirely of receivables related to product sales, net of allowances for cash discounts for prompt payment of $1.5 million and $0.9 million, respectively.
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- DefinitionThe entire disclosure for claims held for amounts due a entity, excluding financing receivables. Examples include, but are not limited to, trade accounts receivables, notes receivables, loans receivables. Includes disclosure for allowance for credit losses.
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v3.23.3
INVENTORIES, NET
|
9 Months Ended |
Sep. 30, 2023 |
Inventory Disclosure [Abstract] |
|
INVENTORIES, NET |
INVENTORIES, NET The following table reflects the components of inventory, net as of September 30, 2023 and December 31, 2022 (in thousands): | | | | | | | | | | | | | September 30, 2023 | | December 31, 2022 | Raw materials | $ | 15,355 | | | $ | 1,367 | | Work-in-process | 1,330 | | | 2,735 | | Finished goods | 26,025 | | | 9,594 | | Total inventories, net | $ | 42,710 | | | $ | 13,696 | |
The Company writes down the value of inventory for potentially excess or obsolete inventories based on an analysis of inventory on hand and projected demand. As of September 30, 2023 and December 31, 2022, the Company recorded inventory write-downs of $5.7 million and $2.8 million, respectively.
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v3.23.3
PREPAID AND OTHER CURRENT ASSETS
|
9 Months Ended |
Sep. 30, 2023 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] |
|
PREPAID AND OTHER CURRENT ASSETS |
PREPAID AND OTHER CURRENT ASSETS The following table reflects prepaid and other current as of September 30, 2023 and December 31, 2022 (in thousands):
| | | | | | | | | | | | | September 30, 2023 | | December 31, 2022 | Prepaid assets and deposits | $ | 2,614 | | | $ | 8,268 | | Other current assets | 281 | | | — | | | | | | Total prepaid and other current assets | $ | 2,895 | | | $ | 8,268 | |
Other current assets includes the Company’s investment in NES Therapeutic, Inc. (“NES”). In August 2018, the Company entered into a Convertible Secured Note Purchase Agreement (the “Note Agreement”) with NES. Pursuant the terms of the Note Agreement, the Company purchased a $3.0 million aggregate principal Convertible Secured Promissory Note (the “NES Note”) which accrues interest annually at a rate of 10% for total consideration of $3.0 million, with both the aggregate 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) U.S. Food and Drug Administration (“FDA”) acceptance of the New Drug Application (“NDA”), (ii) initiation of any required clinical trials by NES, or (iii) a qualified financing event by NES, as defined in the Note Agreement. The Company’s investment in the NES Note is accounted as a loan receivable and is valued at amortized cost. As of both September 30, 2023 and December 31, 2022, the Company has assessed an estimated $3.5 million expected credit loss reserve on its investment based on its evaluation of probability of default that exists. The expected credit loss reserve recognized in each period represents the entire aggregate principal amount and outstanding interest incurred on the NES Note as of both September 30, 2023 and December 31, 2022. The Company’s investment in NES has been reclassified to Other current assets as of September 30, 2023 as it will mature within one year of the balance sheet date.
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v3.23.3
PROPERTY AND EQUIPMENT, NET
|
9 Months Ended |
Sep. 30, 2023 |
Property, Plant and Equipment [Abstract] |
|
PROPERTY AND EQUIPMENT, NET |
PROPERTY AND EQUIPMENT, NET The following table reflects property and equipment, net as of September 30, 2023 and December 31, 2022 (in thousands):
| | | | | | | | | | | | | September 30, 2023 | | December 31, 2022 | Furniture and office equipment | $ | 1,808 | | | $ | 1,712 | | Laboratory equipment | 20 | | | 20 | | Leasehold improvements | 2,945 | | | 2,945 | | Construction in progress | 528 | | | — | | | 5,301 | | | 4,677 | | Less: Accumulated depreciation | (4,497) | | | (3,933) | | Property and equipment, net | $ | 804 | | | $ | 744 | |
Depreciation expense was $0.2 million and $0.6 million for the three and nine months ended September 30, 2023 and 2022, respectively. Depreciation expense is recognized in Selling, general and administrative expense in the Company’s Condensed Consolidated Statements of Comprehensive (Loss) Income.
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- DefinitionThe entire disclosure for long-lived, physical asset used in normal conduct of business and not intended for resale. Includes, but is not limited to, work of art, historical treasure, and similar asset classified as collections.
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v3.23.3
INTANGIBLE ASSETS AND GOODWILL
|
9 Months Ended |
Sep. 30, 2023 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
INTANGIBLE ASSETS AND GOODWILL |
INTANGIBLE ASSETS AND GOODWILL Intangible Assets
The following table reflects the gross carrying amounts and net book values of intangible assets as of September 30, 2023 and December 31, 2022 (dollar amounts in thousands):
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | September 30, 2023 | | December 31, 2022 | | | Remaining Useful Life (In years) | | Gross Carrying Amount | | Accumulated Amortization | | Impairment | | | | Net Book Value | | Gross Carrying Amount | | Accumulated Amortization | | | | Net Book Value | Products rights: | | | | | | | | | | | | | | | | | | | | | INDOCIN | | 8.6 | | $ | 154,100 | | | $ | (43,126) | | | $ | (52,463) | | | | | $ | 58,511 | | | $ | 154,100 | | | $ | (33,495) | | | | | $ | 120,605 | | ROLVEDON | | 9.8 | | 234,000 | | | (3,900) | | | (157,095) | | | | | 73,005 | | | — | | | — | | | | | — | | Otrexup | | 6.2 | | 44,086 | | | (9,644) | | | (22,946) | | | | | 11,496 | | | 44,086 | | | (5,511) | | | | | 38,575 | | Sympazan | | 11.1 | | 14,550 | | | (1,111) | | | — | | | | | 13,439 | | | 14,550 | | | (202) | | | | | 14,348 | | SPRIX | | 3.6 | | 39,000 | | | (18,711) | | | (6,327) | | | | | 13,962 | | | 39,000 | | | (14,532) | | | | | 24,468 | | Total intangible assets | | | | $ | 485,736 | | | $ | (76,492) | | | $ | (238,831) | | | | | $ | 170,413 | | | $ | 251,736 | | | $ | (53,740) | | | | | $ | 197,996 | | | | | | | | | | | | | | | | | | | | | | |
During the three months ended September 30, 2023, the Company’s market capitalization declined to below the book value of the Company’s equity. Management determined that the Company’s book value of equity exceeding its market capitalization represented an indicator of impairment with respect to its long-lived assets.
Applying the relevant accounting guidance, the Company first assessed the recoverability of its long-lived assets. In performing this assessment, management concluded it was appropriate to group its assets at the entity level, most notably attributed to the significant shared operating cost structure which characterizes Assertio. The Company determined the carrying value of this asset group was not recoverable. Management then assessed and concluded that the fair value of the asset group was less than its carrying value and so recognized an impairment loss of approximately $238.8 million, which was allocated to the individual intangible assets of the group and is classified within Loss on impairment of intangible assets in the Condensed Consolidated Statement of Comprehensive (Loss) Income. The fair value of the asset group was determined using both an income and a market approach and used Level 3 inputs. These inputs included estimates of forecasted cash flows and the selection of comparable revenue and earnings multiples utilizing guideline companies.
Amortization expense was $10.2 million and $22.8 million for the three and nine months ended September 30, 2023, respectively, and $8.0 million and $24.4 million for three and nine months ended September 30, 2022, respectively. The following table reflects future amortization expense the Company expects for its intangible assets (in thousands):
| | | | | | | | | Year Ending December 31, | | Estimated Amortization Expense | 2023 (remainder) | | 5,259 | | 2024 | | 21,035 | | 2025 | | 21,035 | | 2026 | | 21,035 | | 2027 | | 18,814 | | Thereafter | | 83,235 | | Total | | $ | 170,413 | |
Goodwill During the three months ended September 30, 2023, the Company recorded $19.9 million of goodwill from the Spectrum Merger. Refer to Note 2, Acquisitions, for additional details. Following the Company’s long-lived asset impairment discussed above, which was determined to be an indicator of impairment with respect to the Company’s goodwill, management tested goodwill for impairment by determining and comparing the fair value of its reporting unit to its carrying value, with the carrying value reflecting the allocated long-lived asset impairment loss. The fair value of the reporting unit was determined using both an income and a market approach and used Level 3 inputs. These inputs included estimates of forecasted cash flows, a discount rate to reflect the risk inherent in the forecasted cash flows, and the selection of comparable revenue and earnings multiples utilizing guideline companies. Management concluded that the fair value of the reporting unit exceeded its carrying value and, accordingly, goodwill was not impaired as of September 30, 2023.
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v3.23.3
OTHER LONG-TERM ASSETS
|
9 Months Ended |
Sep. 30, 2023 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] |
|
OTHER LONG-TERM ASSETS |
OTHER LONG-TERM ASSETS The following table reflects other long-term assets as of September 30, 2023 and December 31, 2022 (in thousands):
| | | | | | | | | | | | | September 30, 2023 | | December 31, 2022 | Operating lease right-of-use assets | $ | 1,806 | | | $ | 137 | | Prepaid asset and deposits | 1,493 | | | 1,607 | | Other | 696 | | | 965 | | Total other long-term assets | $ | 3,995 | | | $ | 2,709 | |
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v3.23.3
ACCRUED LIABILITIES
|
9 Months Ended |
Sep. 30, 2023 |
Accounts Payable and Accrued Liabilities, Current [Abstract] |
|
ACCRUED LIABILITIES |
ACCRUED LIABILITIES The following table reflects accrued liabilities as of September 30, 2023 and December 31, 2022 (in thousands):
| | | | | | | | | | | | | September 30, 2023 | | December 31, 2022 | Accrued compensation | $ | 2,468 | | | $ | 3,117 | | Accrued restructuring costs (See Note 19) | 4,420 | | | — | | Other accrued liabilities | 12,778 | | | 6,561 | | Taxes payable | 1,353 | | | — | | Interest payable | 217 | | | 1,593 | | Accrued royalties | 829 | | | 910 | | Total accrued liabilities | $ | 22,065 | | | $ | 12,181 | |
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v3.23.3
DEBT
|
9 Months Ended |
Sep. 30, 2023 |
Debt Disclosure [Abstract] |
|
DEBT |
DEBT The following table reflects the Company’s debt as of September 30, 2023 and December 31, 2022 (in thousands):
| | | | | | | | | | | | | September 30, 2023 | | December 31, 2022 | 6.5% Convertible Senior Secured Notes due 2027 | $ | 40,000 | | $ | 70,000 | Royalty Rights obligation | — | | 470 | Total principal amount | 40,000 | | 70,470 | Plus: derivative liability for embedded conversion feature | 764 | | 252 | Less: unamortized debt issuance costs | (1,898) | | (3,849) | Carrying value | 38,866 | | 66,873 | Less: current portion of long-term debt | — | | (470) | Long-term debt, net | $ | 38,866 | | | $ | 66,403 |
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 as the trustee (the “2027 Convertible Note 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 aggregate principal amount of the 2027 Convertible Notes solely to cover overallotment (the “Overallotment Option”) within a 13-day period from the date 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 aggregate principal of additional 2027 Convertible Notes. The 2027 Convertible Notes are senior unsecured obligations of the Company.
The Company used the net proceeds from the issuance of the 2027 Convertible Notes to repurchase $59.0 million aggregate principal amount of its then outstanding 13% senior secured notes due 2024 (the “2024 Secured Notes”) assumed in accordance with the Company’s merger with Zyla Life Sciences (“Zyla”) in May 2020 (the “Zyla Merger”) and $3.0 million in associated interest payments pursuant to privately negotiated exchange agreements entered into concurrently with the pricing of the offering of the 2027 Convertible Notes.
On February 27, 2023, the Company completed a privately negotiated exchange of $30.0 million principal amount of the 2027 Convertible Notes (the “Convertible Note Exchange”). Pursuant to the Convertible Note Exchange, 6,990,000 shares of the Company’s common stock, plus an additional $10.5 million in cash, were issued in a partial settlement of the 2027 Convertible Notes (the “Exchanged Notes”). As a result of the Convertible Note Exchange in the first quarter of 2023, the Company recorded an induced conversion expense of approximately $8.8 million and direct transaction costs of approximately $1.1 million, the total of which is reported in Debt-related expenses in the Company’s Condensed Consolidated Statements of Comprehensive (Loss) Income for the nine months ended September 30, 2023. The induced conversion expense represents the fair value of the consideration transferred in the Convertible Note Exchange in excess of the fair value of common stock issuable under the original terms of the 2027 Convertible Notes. Additionally, approximately $1.6 million of unamortized issuance costs related to the Exchanged Notes were recognized as Additional paid-in capital in the Company’s Condensed Consolidated Balance Sheets for the nine months ended September 30, 2023.
The terms of the 2027 Convertible Notes are governed by an indenture dated August 25, 2022 (the “2027 Convertible Note Indenture”). The terms of the 2027 Convertible Notes allow for conversion into the Company’s common stock, cash, or a combination of cash and common stock, at the Company’s election only, 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 2027 Convertible Note Indenture (the “Conversion Rate”). The 2027 Convertible Notes will mature on September 1, 2027, unless earlier repurchased or converted.
The 2027 Convertible Notes bear 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, 2023.
The following table reflects the carrying balance of the 2027 Convertible Notes as of September 30, 2023 and December 31, 2022 (in thousands):
| | | | | | | | | | | | | September 30, 2023 | | December 31, 2022 | Principal balance | $ | 40,000 | | | $ | 70,000 | | Derivative liability for embedded conversion feature | 764 | | | 252 | | Unamortized debt issuance costs | (1,898) | | | (3,849) | | Carrying balance | $ | 38,866 | | | $ | 66,403 | |
The debt issuance costs incurred related to the 2027 Convertible Notes are recognized as a debt discount and are being amortized as interest expense over the term of the 2027 Convertible Notes using the effective interest method, with an effective interest rate determined to be 7.8%. During the three and nine months ended September 30, 2023, the Company amortized $0.1 million and $0.4 million, respectively, of the debt discount on the 2027 Convertible Notes. During the nine months ended September 30, 2023, $1.6 million of unamortized issuance costs related to the Exchanged Notes were recognized as Additional paid-in capital.
The Company determined that an embedded conversion feature included in the 2027 Convertible Notes required bifurcation from the host contract and to be recognized as a separate derivative liability carried at fair value. See Note 17, Fair Value, for further details around the estimated fair value of the derivative liability. The estimated fair value of the derivative liability, which represents a Level 3 valuation, was $0.8 million and $0.3 million as of September 30, 2023 and December 31, 2022, respectively, and was determined using a binomial lattice model using certain assumptions and consideration of an increased conversion ratio on the underlying convertible notes that could result from the occurrence of certain events. Accordingly, the Company has recognized a loss on the fair value adjustment of the derivative liability in the amount of $0.5 million in Other (loss) gain in the Consolidated Statements of Comprehensive Loss (Income) for both the three and nine months ended September 30, 2023. There was no gain or loss on the fair value adjustment of the derivative liability for the three and nine months ended September 30, 2022. All of the other embedded features of the 2027 Convertible Notes were 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.
Royalty Rights Obligation
In accordance with the Zyla Merger, the Company assumed a royalty rights agreement (the “Royalty Rights”) with each of the holders of its 2024 Secured Notes pursuant to which the Company agreed to pay an aggregate 1.5% royalty on Net Sales (as defined in the indenture governing the 2027 Secured Notes) through December 31, 2022. The Royalty Rights terminated on December 31, 2022, and the Company paid in cash its remaining Royalty Rights obligations during the second quarter of 2023. Interest Expense
Royalty Rights and debt issuance costs 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 (Loss) Income for the three and nine months ended September 30, 2023 and 2022 (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | 2023 | | 2022 | | 2023 | | 2022 | Interest on 2027 Convertible Notes | $ | 650 | | $ | 456 | | $ | 2,275 | | $ | 456 | Interest on 2024 Secured Notes | — | | 1,516 | | — | | 6,064 | Amortization of Royalty Rights(1) | — | | 80 | | — | | 128 | Amortization of debt issuance costs | 102 | | — | | 350 | | — | Total interest expense | $ | 752 | | $ | 2,052 | | $ | 2,625 | | $ | 6,648 | | | | | | | | | | | | | | | | |
(1)As a result of the extinguishment of the Royalty Rights obligation in the fourth quarter of 2022, there will be no additional amortization expense recognized in future periods.
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v3.23.3
STOCK-BASED COMPENSATION
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9 Months Ended |
Sep. 30, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
STOCK-BASED COMPENSATION |
STOCK-BASED COMPENSATION The Company’s stock-based compensation generally includes time-based restricted stock units (“RSU”) and options, as well as performance-based RSUs and options.
Stock-based compensation of $1.9 million and $6.5 million, respectively, for the three and nine months ending September 30, 2023, and $2.4 million and $5.1 million, respectively, for the three and nine months ended September 30, 2022, was recognized in Selling, general, and administrative expenses in the Company’s Condensed Consolidated Statements of Comprehensive (Loss) Income.
During the nine months ended September 30, 2023 the Company granted 0.8 million RSUs at a weighted-average fair market value of $5.61 per share, and 0.7 million options at a weighted-average fair market value of $4.51 per share.
As previously disclosed, during the three months ended June 30, 2022, the Company granted a total of 1.0 million market-based performance RSUs (“performance RSUs”) to executive officers under the Company’s Amended and Restated 2014 Omnibus Incentive Plan. At the grant date, the weighted-average fair value of the performance RSUs was determined using a Monte Carlo simulation model to be $2.24 per performance RSU. The market-based conditions of the performance RSUs were achieved in the first quarter of 2023. Then, upon vesting of the performance RSUs in the second quarter of 2023, the compensation committee of the Company’s board of directors elected, under the terms of the performance RSU grants, to settle approximately 0.3 million of the performance RSUs in cash based on their fair market value on the vesting date, and settle 0.2 million of the performance RSUs in shares of the Company’s common stock. Approximately 0.5 million of the performance RSUs were withheld to settle the employees’ tax liability. During the second quarter of 2023, approximately $2.6 million was paid by the Company to cash settle the performance RSUs and $3.4 million was paid by the Company to settle the employee’s tax liability, which are included in both Common stock issuance and other impacts of the vesting and settlement of equity awards in the Company’s Condensed Consolidated Statements of Shareholders’ Equity, and Payments related to the vesting and settlement of equity awards in the Company’s Condensed Consolidated Statements of Cash Flows.
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- DefinitionThe entire disclosure for share-based payment arrangement.
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v3.23.3
LEASES
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9 Months Ended |
Sep. 30, 2023 |
Leases [Abstract] |
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LEASES |
LEASES As of September 30, 2023, the Company has a non-cancelable operating lease for its corporate office, which is located in Lake Forest, Illinois (the “Lake Forest Lease”). On May 1, 2023, the Company amended the Lake Forest Lease to reduce the size of leased premises and extend the term of the lease through December 31, 2030. In conjunction with the amendment of the Lake Forest Lease on May 1, 2023, the Company recognized an increase to both operating right-of-use asset and noncurrent operating lease liability of approximately $1.3 million, calculated using a discount rate of 7.41%.
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 terminated at the end of November 2022. The Newark lease was partially subleased through the lease term of November 2022. Operating lease costs and sublease income related to the Newark facility are accounted for in Other gain in the Company’s Condensed Consolidated Statements of Comprehensive (Loss) Income. Sublease income for the nine months ended September 30, 2022 includes a gain of $0.6 million from the early termination and settlement of a Newark facility sublease during the first quarter of 2022.
In connection with the Spectrum Merger, the Company assumed leases for two facilities and certain office equipment which Spectrum had previously been the lessee. As of September 30, 2023, the Company has recognized an operating right-of-use asset associated with these leases of $0.4 million, and a current and noncurrent lease liability associated with these leases of $0.7 million and $0.3 million, respectively. Refer to Note 19, Restructuring Charges, for further detail on the accounting for the leases assumed in the Spectrum Merger. The following table reflects lease expense and income for the three and nine months ended September 30, 2023 and 2022 (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | Financial Statement Classification | | 2023 | | 2022 | | 2023 | | 2022 | Operating lease cost | Selling, general and administrative expenses | | $ | 65 | | | $ | 39 | | | $ | 161 | | | $ | 118 | | Operating lease cost | Other gain | | — | | | 148 | | | — | | | 444 | | Total lease cost | | | $ | 65 | | | $ | 187 | | | $ | 161 | | | $ | 562 | | | | | | | | | | | | Sublease Income | Other gain | | $ | — | | | $ | 168 | | | $ | — | | | $ | 1,111 | |
The following table reflects supplemental cash flow information related to leases for the three and nine months ended September 30, 2023 and 2022 (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | | 2023 | | 2022 | | 2023 | | 2022 | Cash paid for amounts included in measurement of liabilities: | | | | | | | | Operating cash flows from operating leases | $ | 225 | | | $ | 533 | | | $ | 433 | | | $ | 1,593 | |
The following table reflects supplemental balance sheet information related to leases as of September 30, 2023 and December 31, 2022 (in thousands): | | | | | | | | | | | | | | | | | | | Financial Statement Classification | | September 30, 2023 | | December 31, 2022 | Assets | | | | | | Operating lease right-of-use assets | Other long-term assets | | $ | 1,806 | | | $ | 137 | | Liabilities | | | | | | Current operating lease liabilities | Other current liabilities | | $ | 970 | | | $ | 401 | | Noncurrent operating lease liabilities | Other long-term liabilities | | 1,679 | | | — | | Total lease liabilities | | | $ | 2,649 | | | $ | 401 | |
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LEASES |
LEASES As of September 30, 2023, the Company has a non-cancelable operating lease for its corporate office, which is located in Lake Forest, Illinois (the “Lake Forest Lease”). On May 1, 2023, the Company amended the Lake Forest Lease to reduce the size of leased premises and extend the term of the lease through December 31, 2030. In conjunction with the amendment of the Lake Forest Lease on May 1, 2023, the Company recognized an increase to both operating right-of-use asset and noncurrent operating lease liability of approximately $1.3 million, calculated using a discount rate of 7.41%.
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 terminated at the end of November 2022. The Newark lease was partially subleased through the lease term of November 2022. Operating lease costs and sublease income related to the Newark facility are accounted for in Other gain in the Company’s Condensed Consolidated Statements of Comprehensive (Loss) Income. Sublease income for the nine months ended September 30, 2022 includes a gain of $0.6 million from the early termination and settlement of a Newark facility sublease during the first quarter of 2022.
In connection with the Spectrum Merger, the Company assumed leases for two facilities and certain office equipment which Spectrum had previously been the lessee. As of September 30, 2023, the Company has recognized an operating right-of-use asset associated with these leases of $0.4 million, and a current and noncurrent lease liability associated with these leases of $0.7 million and $0.3 million, respectively. Refer to Note 19, Restructuring Charges, for further detail on the accounting for the leases assumed in the Spectrum Merger. The following table reflects lease expense and income for the three and nine months ended September 30, 2023 and 2022 (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | Financial Statement Classification | | 2023 | | 2022 | | 2023 | | 2022 | Operating lease cost | Selling, general and administrative expenses | | $ | 65 | | | $ | 39 | | | $ | 161 | | | $ | 118 | | Operating lease cost | Other gain | | — | | | 148 | | | — | | | 444 | | Total lease cost | | | $ | 65 | | | $ | 187 | | | $ | 161 | | | $ | 562 | | | | | | | | | | | | Sublease Income | Other gain | | $ | — | | | $ | 168 | | | $ | — | | | $ | 1,111 | |
The following table reflects supplemental cash flow information related to leases for the three and nine months ended September 30, 2023 and 2022 (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | | 2023 | | 2022 | | 2023 | | 2022 | Cash paid for amounts included in measurement of liabilities: | | | | | | | | Operating cash flows from operating leases | $ | 225 | | | $ | 533 | | | $ | 433 | | | $ | 1,593 | |
The following table reflects supplemental balance sheet information related to leases as of September 30, 2023 and December 31, 2022 (in thousands): | | | | | | | | | | | | | | | | | | | Financial Statement Classification | | September 30, 2023 | | December 31, 2022 | Assets | | | | | | Operating lease right-of-use assets | Other long-term assets | | $ | 1,806 | | | $ | 137 | | Liabilities | | | | | | Current operating lease liabilities | Other current liabilities | | $ | 970 | | | $ | 401 | | Noncurrent operating lease liabilities | Other long-term liabilities | | 1,679 | | | — | | Total lease liabilities | | | $ | 2,649 | | | $ | 401 | |
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v3.23.3
COMMITMENTS AND CONTINGENCIES
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9 Months Ended |
Sep. 30, 2023 |
Commitments and Contingencies Disclosure [Abstract] |
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COMMITMENTS AND CONTINGENCIES |
COMMITMENTS AND CONTINGENCIES Jubilant HollisterStier Manufacturing and Supply Agreement
Pursuant to the Zyla Merger, the Company assumed a Manufacturing and Supply Agreement (the “Jubilant HollisterStier 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 Jubilant HollisterStier Agreement, JHS is responsible for supplying a minimum of 75% of the Company’s annual requirements of SPRIX. The Company agreed to purchase a minimum number of batches of SPRIX per calendar year from JHS over the term of the Jubilant HollisterStier Agreement. Total commitments to JHS through the remainder of 2023 are approximately $1.0 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 “Cosette 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 Cosette Supply Agreement, to among other things, extend the expiration date of the Cosette 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 Cosette Supply Agreement. Total commitments to Cosette under the Cosette Supply Agreement 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 (the “Antares Supply Agreement”). Under the Antares Supply Agreement, the Company has agreed to annual minimum purchase obligations from Antares, which approximate $2.0 million annually. The Antares 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 the Company’s 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 both September 30, 2023 and December 31, 2022, the Company had a legal contingency accrual of approximately $3.2 million. The Company continues 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. Provisions for loss contingencies are recorded in Selling, general and administrative expense in the Company’s Condensed Consolidated Statements of Comprehensive (Loss) Income and the related accruals are recorded in Accrued liabilities in the Company’s Condensed Consolidated Balance Sheets.
Other than matters 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, cash flows 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 U.S. District Court for the Northern District of California against the Company and several other defendants relating to its 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 in the same District Court.
On July 30, 2020, Humana Inc. (“Humana”) also filed a complaint against the Company and several other defendants in the U.S. District Court for 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 the California Superior Court of Alameda 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 the California Superior Court of Alameda 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 District 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 California state court lawsuits, on November 24, 2021, the state court granted in part and denied in part a demurrer by the defendants in the Humana action. That case was consolidated in November 2022 with the HCSC action for pre-trial and trial purposes. On July 5, 2023, the state court denied a motion for judgment on the pleadings filed by the defendants in the Humana action. These California state cases are now in the midst of discovery, and trial is scheduled for 2024.
The Company intends to defend itself vigorously in the consolidated California state court lawsuits. A liability for this matter has been recorded in the financial statements.
Opioid-Related Request and Subpoenas
As a result of the greater public awareness of the public health issue of opioid abuse, there has been increased scrutiny of, and investigation into, the commercial practices of opioid manufacturers generally by federal, state, and local regulatory and governmental agencies. In March 2017, Assertio Therapeutics received a letter from then-Sen. Claire McCaskill (D-MO), the then-Ranking Member on the U.S. Senate Committee on Homeland Security and Governmental Affairs, requesting certain information regarding Assertio Therapeutics’ historical commercialization of opioid products. Assertio Therapeutics voluntarily furnished information responsive to Sen. McCaskill’s request. Since 2017, Assertio Therapeutics has received and responded to subpoenas from the U.S. Department of Justice (“DOJ”) seeking documents and information regarding its historical sales and marketing of opioid products. Assertio Therapeutics has also received and responded to subpoenas or civil investigative demands focused on its historical promotion and sales of Lazanda, NUCYNTA, and NUCYNTA ER from various state attorneys general seeking documents and information regarding Assertio Therapeutics’ historical sales and marketing of opioid products. In addition, Assertio Therapeutics received and responded to a subpoena from the State of California Department of Insurance (“CDI”) seeking information relating to its historical sales and marketing of Lazanda. The CDI subpoena also seeks information on Gralise, a non-opioid product formerly in Assertio Therapeutics’ portfolio. In addition, Assertio Therapeutics received and responded to a subpoena from the New York Department of Financial Services seeking information relating to its historical sales and marketing of opioid products. The Company has also received a subpoena from the New York Attorney General, pursuant to which the New York Attorney General is seeking information concerning the sales and marketing of opioid products (Lazanda, NUCYNTA, NUCYNTA ER, and OXAYDO) by Assertio Therapeutics and Zyla. The Company also from time to time receives and responds to subpoenas from governmental authorities related to investigations primarily focused on third parties, including healthcare practitioners. The Company 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. (“Depomed,” 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 the DOJ’s characterization of the payments from Depomed.
Multidistrict and Other Federal 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 six such cases. In April 2022, the Judicial Panel on Multi-District Litigation issued an order stating that it would no longer transfer new opioid cases to the MDL Court. Since that time, Assertio Therapeutics has been named in lawsuits pending in federal courts outside of the MDL Court (in Georgia and New York). Plaintiffs may file additional lawsuits in which the Company 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 federal cases 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, Pennsylvania, Texas and Utah. Assertio Holdings is named as a defendant in one of these cases in Pennsylvania. Plaintiffs may file additional lawsuits in which the Company may be named. In the pending cases involving Assertio Therapeutics or Assertio Holdings, 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 or Assertio Holdings has been served are generally each at an early stage of proceedings. Assertio Therapeutics and Assertio Holdings intend to defend themselves 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 was 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 and Other Federal 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 Company’s Condensed Consolidated Statements of Comprehensive Income (Loss) for the year ended December 31, 2021.
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 Company’s Condensed Consolidated Statements of Comprehensive (Loss) Income for the year ended December 31, 2022.
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 parties are in discovery. Trial is scheduled for February 2024.
Stockholder Actions
Luo v. Spectrum Pharmaceuticals, Inc., et al., U.S. District Court, District of Nevada, Case No. 2:21-cv-01612. On August 31, 2021, this putative securities class action lawsuit was filed by a purported shareholder, alleging that Spectrum and certain of its former executive officers and directors made false or misleading statements and failed to disclose material facts about Spectrum’s business and the prospects of approval for its BLA to the FDA for eflapegrastim (ROLVEDON) in violation of Section 10(b) (and Rule 10b-5 promulgated thereunder) and 20(a) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). On November 1, 2021, four individuals and one entity filed competing motions to be appointed lead plaintiff and for approval of counsel. On July 28, 2022, the Court appointed a lead plaintiff and counsel for the putative class. On September 26, 2022, an amended complaint was filed alleging, inter alia, false and misleading statements with respect to ROLVEDON manufacturing operations and controls and adding allegations that defendants misled investors about the efficacy of, clinical trial data and market need for Poziotinib during a Class Period of March 7, 2018 to August 5, 2021. The amended complaint seeks damages, interest, costs, attorneys’ fees, and such other relief as may be determined by the Court. On November 30, 2022, the defendants filed a motion to dismiss the amended complaint, which was fully briefed as of February 27, 2023 and remains pending. Discovery is stayed pending resolution of the motion to dismiss. There is no hearing date presently scheduled. The Company intends to vigorously defend itself in this matter.
Christiansen v. Spectrum Pharmaceuticals, Inc. et al., Case No. 1:22-cv-10292 (filed December 5, 2022 in the U.S. District Court for the Southern District of New York) (the “New York Action”). Three additional related putative securities class action lawsuits were subsequently filed by Spectrum shareholders against Spectrum and certain of its former executive officers in the U.S. District Court for the Southern District of New York: Osorio-Franco v. Spectrum Pharmaceuticals, Inc., et al., Case No. 1:22-cv-10292 (filed December 5, 2022); Cummings v. Spectrum Pharmaceuticals, Inc., et al., Case No. 1:22-cv-10677 (filed December 19, 2022); and Carneiro v. Spectrum Pharmaceuticals, Inc., et al., Case No. 1:23-cv-00767 (filed January 30, 2023). These three New York lawsuits allege that Spectrum and certain of its former executive officers made false or misleading statements about, inter alia, the safety and efficacy of and clinical trial data for Poziotinib in violation of Section 10(b) (and Rule 10b-5 promulgated thereunder) and 20(a) of the Exchange Act, and seek remedies including damages, interest, costs, attorneys’ fees, and such other relief as may be determined by the Court. On February 15, 2023, the Court consolidated the three New York lawsuits. On March 21, 2023, the Court entered an order designating Steven Christiansen as the lead plaintiff. Lead plaintiff Christiansen filed an amended consolidated complaint in the New York Action under the caption Christiansen v. Spectrum Pharmaceuticals, Inc, et al., on May 30, 2023, alleging a Class Period between March 17, 2022 and September 2022. The defendants filed a motion to dismiss the consolidated New York Action on July 25, 2023, which was fully briefed as of October 19, 2023 and remains pending. Discovery is stayed pending resolution of the motion to dismiss. There is no hearing date presently scheduled. The Company intends to vigorously defend itself in this matter.
Csaba v. Turgeon, et. al, (filed December 15, 2021 in the U.S. District Court District of Nevada); Shumacher v. Turgeon, et. al, (filed March 15, 2022 in the U.S. District Court District of Nevada); Johnson v. Turgeon, et. al, (filed March 29, 2022 in the U.S. District Court District of Nevada); Raul v. Turgeon, et. al, (filed April 28, 2022 in the U.S. District Court District of Delaware); and Albayrak v. Turgeon, et. al, (filed June 9, 2022 in the U.S. District Court District of Nevada). These putative stockholder derivative actions were filed against Spectrum (as a nominal defendant), certain of Spectrum’s former executive officers and directors. The stockholder derivative complaints allege, inter alia, that certain of Spectrum’s former executive officers are liable to Spectrum, pursuant to Section 10(b) and 21(d) of the Exchange Act for contribution and indemnification, if they are deemed (in the Luo class action), to have made false or misleading statements and failed to disclose material facts about Spectrum’s business and the prospects of approval for its BLA to the FDA for eflapegrastim. The complaints generally but not uniformly further allege that certain of Spectrum’s former officers and directors breached their fiduciary duties, and certain of Spectrum’s former directors negligently violated Section 14(a) of the Exchange Act, by allegedly causing such false or misleading statements to be issued and/or failing to disclose material facts about Spectrum’s business and the prospects of approval for its BLA to the FDA for eflapegrastim. The allegations state that as a result of the violations, certain of Spectrum’s former executive officers and directors committed acts of gross mismanagement, abuse of control, or were unjustly enriched. The plaintiffs generally seek corporate reforms, damages, interest, costs, attorneys’ fees, and other unspecified equitable relief.
The parties have agreed to stay all derivative actions until there is a decision on a motion to dismiss in the Luo Nevada securities class action.
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v3.23.3
SHAREHOLDERS' EQUITY
|
9 Months Ended |
Sep. 30, 2023 |
Stockholders' Equity Note [Abstract] |
|
SHAREHOLDERS' EQUITY |
SHAREHOLDERS EQUITY Issuance of Common Stock in the Spectrum Merger
Pursuant to the Merger Agreement, shares of Spectrum common stock issued and outstanding immediately prior to the Effective Date, as well as Spectrum restricted stock units, certain stock appreciation rights, certain options to purchase Spectrum common stock, and warrants to purchase Spectrum common stock, which, in each case, were outstanding immediately prior to the Effective Date and were either vested or became vested as a result of the Spectrum Merger on the Effective Date, were converted into the right to receive fully paid and non-assessable shares of the Company’s common stock based on the exchange ratio as set forth in the Merger Agreement (see Note 2, Acquisitions). Accordingly, on the Effective Date the Company issued approximately 38.0 million shares of its common stock to the previous holders of Spectrum common stock, net of a fractional share settlement.
Exchanged Convertible Notes
Related to the Convertible Note Exchange (See Note 11, Debt) in the first quarter of 2023, the Company paid an aggregate of $10.5 million in cash and issued an aggregate of approximately 7.0 million shares of its common stock in the transactions. The Company did not receive any cash proceeds from the issuance of the shares of its common stock but recognized additional paid-in capital of $28.3 million during the nine months ended September 30, 2023 related to the common stock share issuance, net of approximately $1.6 million of unamortized issuance costs related to the Exchanged Notes.
At-The-Market Program
The Company is party to 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 a result of the issuance of the 2027 Convertible Notes (See Note 11, Debt), the Company has determined to suspend use of its ATM offering program. Prior to suspending the ATM offering program, 2,463,637 shares had 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.
Warrant Agreements
Upon the Zyla Merger, the Company assumed Zyla’s outstanding warrants which provided the holder the right to receive shares of the Company’s common stock. The warrants were exercisable at any time at an exercise price of $0.0016 per share, subject to certain ownership limitations including, with respect to Iroko Pharmaceuticals, Inc. 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.
During the nine months ended September 30, 2022, 0.4 million warrants were exercised, and 0.4 million of the Company’s common shares, were issued by the Company. Subsequent to these warrant exercises in the nine months ended September 30, 2022, there were no outstanding warrants remaining.
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v3.23.3
NET (LOSS) INCOME PER SHARE
|
9 Months Ended |
Sep. 30, 2023 |
Earnings Per Share [Abstract] |
|
NET (LOSS) INCOME PER SHARE |
NET (LOSS) INCOME PER SHARE Basic net (loss) income per share is calculated by dividing the net (loss) income by the weighted-average number of shares of common stock outstanding during the period.
Diluted net (loss) income per share is calculated by dividing the net (loss) income by the weighted-average number of shares of common stock outstanding during the period, plus potentially dilutive common shares, consisting of stock-based awards and equivalents, and convertible debt. For purposes of this calculation, stock-based awards and convertible debt 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-based awards 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 any convertible debt outstanding was converted at the beginning of each period presented when the effect is dilutive. As a result, interest expense, net of tax, and any other income statement impact associated with the 2027 Convertible Notes, net of tax, is added back to net (loss) income used in the diluted earnings per share calculation. Additionally, the diluted shares used in the diluted earnings per share calculation includes the potential dilution effect of the convertible debt if converted into the Company’s common stock. For the three and nine months ended September 30, 2022, the Company’s potentially dilutive stock-based awards and convertible debt were included in the computation of diluted net income per share. However, as the Company was in a net loss position for the three and nine months ended September 30, 2023, the Company’s potentially dilutive stock-based awards and convertible debt were not included in the computation of diluted net loss per share, because to do so would be anti-dilutive.
The following table reflects the calculation of basic and diluted (loss) earnings per common share for the three and nine months ended September 30, 2023 and 2022 (in thousands, except for per share amounts):
| | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | 2023 | | 2022 | | 2023 | | 2022 | Basic net (loss) income per share | | | | | | | | Net (loss) income | $ | (279,544) | | | $ | 4,174 | | | $ | (274,558) | | | $ | 21,072 | | Weighted-average common shares outstanding | 81,713 | | | 48,180 | | | 63,066 | | | 46,566 | | Basic net (loss) income per share | $ | (3.42) | | | $ | 0.09 | | | $ | (4.35) | | | $ | 0.45 | | | | | | | | | | Diluted net (loss) income per share | | | | | | | | Net (loss) income | $ | (279,544) | | | $ | 4,174 | | | $ | (274,558) | | | $ | 21,072 | | | | | | | | | | Add: Convertible debt interest expense, net of tax | — | | | 497 | | | — | | | 487 | | Adjusted net (loss) income | (279,544) | | | 4,671 | | | (274,558) | | | 21,559 | | Weighted-average common shares and share equivalents outstanding | 81,713 | | | 48,180 | | | 63,066 | | | 46,566 | | Add: effect of dilutive stock-based awards and equivalents | — | | | 1,960 | | | — | | | 1,462 | | Add: effect of dilutive convertible debt under if-converted method | — | | | 7,246 | | | — | | | 2,442 | | Denominator for diluted net (loss) income per share | 81,713 | | | 57,386 | | | 63,066 | | | 50,470 | | Diluted net (loss) income per share | $ | (3.42) | | | $ | 0.08 | | | $ | (4.35) | | | $ | 0.42 | |
The following table reflects outstanding potentially dilutive common shares that are not included in the computation of diluted net (loss) income per share, because to do so would be anti-dilutive, for the three and nine months ended September 30, 2023 and 2022 (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | 2023 | | 2022 | | 2023 | | 2022 | Convertible notes | 9,768 | | | — | | | 11,324 | | | — | | Stock-based awards and equivalents | 7,016 | | | 2,983 | | | 7,641 | | | 1,329 | | Total potentially dilutive common shares | 16,784 | | | 2,983 | | | 18,965 | | | 1,329 |
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v3.23.3
FAIR VALUE
|
9 Months Ended |
Sep. 30, 2023 |
Fair Value Disclosures [Abstract] |
|
FAIR VALUE |
FAIR VALUE Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. •Level 1: Quoted prices in active markets for identical assets or liabilities. •Level 2: Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. •Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. 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, 2023 and December 31, 2022 (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | September 30, 2023 | | Financial Statement Classification | | Level 1 | | Level 2 | | Level 3 | | Total | Assets: | | | | | | | | | | | | | | | | | | | | | | U.S. Treasuries | | Cash and cash equivalents | | $ | — | | | $ | 38,204 | | | $ | — | | | $ | 38,204 | | | | | | | | | | | | | Money market funds | | Cash and cash equivalents | | 22,797 | | | — | | | — | | | 22,797 | | Total | | | | $ | 22,797 | | | $ | 38,204 | | | $ | — | | | $ | 61,001 | | Liabilities: | | | | | | | | | | | Short-term contingent consideration | | Contingent consideration, current portion | | $ | — | | | $ | — | | | $ | 12,800 | | | $ | 12,800 | | Long-term contingent consideration | | Contingent consideration | | — | | | — | | | 16,100 | | | 16,100 | | Derivative liability | | Long-term debt | | — | | | — | | | 764 | | | 764 | | Total | | | | $ | — | | | $ | — | | | $ | 29,664 | | | $ | 29,664 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | December 31, 2022 | | Financial Statement Classification | | Level 1 | | Level 2 | | Level 3 | | Total | Assets: | | | | | | | | | | | Commercial paper | | Cash and cash equivalents | | $ | — | | | $ | 4,983 | | | $ | — | | | $ | 4,983 | | U.S. Treasuries | | Cash and cash equivalents | | — | | | 3,981 | | | — | | | 3,981 | | U.S. Government agencies | | Cash and cash equivalents | | — | | | 10,937 | | | — | | | 10,937 | | Money market funds | | Cash and cash equivalents | | 38,478 | | | — | | | — | | | 38,478 | | Total | | | | $ | 38,478 | | | $ | 19,901 | | | $ | — | | | $ | 58,379 | | Liabilities: | | | | | | | | | | | Short-term contingent consideration | | Contingent consideration, current portion | | $ | — | | | $ | — | | | $ | 26,300 | | | $ | 26,300 | | Long-term contingent consideration | | Contingent consideration | | — | | | — | | | 22,200 | | | 22,200 | | Derivative liability | | Long-term debt | | — | | | — | | | 252 | | | 252 | | Total | | | | $ | — | | | $ | — | | | $ | 48,752 | | | $ | 48,752 | |
Cash and Cash Equivalents
The Company considers all highly liquid investments with a maturity date of purchase of three months or less to be cash equivalents. The Company invests its cash in money market funds and marketable securities including U.S. Treasury and government agency securities, commercial paper, and higher quality debt securities of financial and commercial institutions. The Company classified money market funds as Level 1, due to their short-term maturity, and measured the fair value based on quoted prices in active markets for identical assets. The Company classified commercial paper, U.S. Treasury and government agency securities as Level 2, as the inputs used to value these instruments are directly observable or can be corroborated by observable market data for substantially the full term of the assets.
Contingent Consideration Obligations
Spectrum Merger Contingent Variable Right
Pursuant to the Spectrum Merger, the Company issued CVRs (See Note 2, Acquisitions) that represent a contingent consideration obligation which is measured at fair value. The Company has a contingent obligation to make payments to the holders of the CVRs representing a contractual right to receive consideration worth up to an aggregate maximum amount of $0.20 per CVR, contingent on the achievement of annual sales milestones in 2024 and 2025 of Spectrum’s product ROLVEDON. The Company classified the acquisition-related contingent consideration liabilities as a Level 3 measurement, due to the lack of relevant observable inputs and market activity.
The initial fair value of the CVR determined as of the Effective Date of the Spectrum Merger was $3.9 million. As of September 30, 2023, the fair value of the Company’s CVR liability related to the Spectrum Merger was determined by the Company to be zero. During both the three and nine months ended September 30, 2023, the Company recognized a benefit of $3.9 million for the change in fair value of the CVR contingent consideration, which was recognized in Change in fair value of contingent consideration in the Company’s Condensed Consolidated Statements of Comprehensive (Loss) Income. The fair value of the CVR contingent consideration is determined using a Monte Carlo simulation model under the income approach based on the probability of achievement of ROLVEDON net sales milestones using projections of 2024 and 2025 net sales and discounted to present value. The significant assumptions used in the calculation of the fair value as of September 30, 2023 included the discount rate of 18.0% and updated projections of future ROLVEDON product net sales, which resulted in no probability of achievement under the Monte Carlo simulation.
Zyla Merger Contingent Consideration Obligation Pursuant to the 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 an affiliate of CR Group L.P. 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 a Level 3 measurement, due to the lack of relevant observable inputs and market activity. As of September 30, 2023 and December 31, 2022, INDOCIN product contingent consideration was $28.9 million and $48.5 million, respectively, with $12.8 million and $26.3 million classified as current and $16.1 million and $22.2 million classified as long-term contingent consideration, respectively, in the Company’s Condensed Consolidated Balance Sheets.
During the three and nine months ended September 30, 2023, the Company recognized a benefit of $17.5 million and $8.1 million, respectively, for the change in fair value of contingent consideration, which was recognized in Change in fair value of contingent consideration in the Company’s Condensed Consolidated Statements of Comprehensive (Loss) Income. 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. 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, 2023 included revenue volatility of 30%, discount rate of 8.5%, credit spread of 3.8% and updated projections of future INDOCIN product revenues.
The following table summarizes changes in fair value of the Company’s contingent consideration obligations that are measured on a recurring basis using significant unobservable inputs (Level 3) for the three and nine months ended September 30, 2023 and 2022 (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | 2023 | | 2022 | | 2023 | | 2022 | Fair value, beginning of the period | $ | 42,500 | | | $ | 36,759 | | | $ | 48,500 | | | $ | 37,659 | | Fair value of contingent consideration incurred in Spectrum Merger | 3,932 | | | — | | | 3,932 | | | — | | Change in fair value of contingent consideration recorded within costs and expenses | (17,532) | | | 3,900 | | | (8,124) | | | 6,845 | | Cash payment related to contingent consideration | — | | | (4,000) | | | (15,408) | | | (7,845) | | Fair value, end of the period | $ | 28,900 | | | $ | 36,659 | | | $ | 28,900 | | | $ | 36,659 | |
Derivative Liability The Company determined that an embedded conversion feature included in the 2027 Convertible Notes required bifurcation from the host contract and to be recognized as a separate derivative liability carried at fair value. The estimated fair value of the derivative liability, which represents a Level 3 valuation, was $0.8 million and $0.3 million as of September 30, 2023 and December 31, 2022, respectively, and was determined using a binomial lattice model using certain assumptions and consideration of an increased conversion ratio on the underlying convertible notes that could result from the occurrence of certain events. Accordingly, the Company has recognized a loss on the fair value adjustment of the derivative liability in the amount of $0.5 million in Other (loss) gain in the Consolidated Statements of Comprehensive Loss for the three and nine months ended September 30, 2023. There was no gain or loss on the fair value adjustment of the derivative liability for the three and nine months ended September 30, 2022. The following table summarizes changes in fair value of the derivative liability that is measured on a recurring basis using significant unobservable inputs (Level 3) for the three and nine months ended September 30, 2023 (in thousands):
| | | | | | | | | | | | | | | | | Three Months Ended September 30, 2023 | | Nine Months Ended September 30, 2023 | Fair value, beginning of the period | | $ | 252 | | | $ | 252 | | Change in fair value of derivative liability recorded within Other (loss) gain | | 512 | | | 512 | | Fair value, end of the period | | $ | 764 | | | $ | 764 | |
There was no change in the fair value of the derivative liability for the three and nine months ended September 30, 2022.
Financial Instruments Not Required to be Remeasured at Fair Value
The Company’s other financial assets and liabilities, including trade accounts receivable and accounts payable, are not remeasured to fair value, as the carrying cost of each approximates its fair value. As of September 30, 2023, the estimated fair value of the 2027 Convertible Notes, excluding the bifurcated embedded conversion option, was approximately $41.8 million, compared to a par value of $40.0 million. As of December 31, 2022, the estimated fair value of the 2027 Convertible Notes, excluding the bifurcated embedded conversion option, was approximately $92.5 million, compared to a par value of $70.0 million. The Company estimated the fair value of its 2027 Convertible Notes as of September 30, 2023 and December 31, 2022 based on a market approach which represents a Level 2 valuation.
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- DefinitionThe entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.
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v3.23.3
INCOME TAXES
|
9 Months Ended |
Sep. 30, 2023 |
Income Tax Disclosure [Abstract] |
|
INCOME TAXES |
INCOME TAXES As of September 30, 2023, the Company’s net deferred tax assets are expected to be fully offset by a valuation allowance for the year ending December 31, 2023. 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. 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 continues to assess the realizability of its deferred tax assets on a quarterly basis. As part of its valuation allowance assessment as of September 30, 2023, the Company was no longer able to rely on its projected availability of future taxable income from pre-tax income forecasts. As such, the Company primarily relied on its reversing taxable temporary differences to assess its valuation allowance, which resulted in the recording of the full valuation allowance during the three months ended September 30, 2023. If it is determined that a portion or all of the valuation allowance is not required, it will generally be a benefit to the income tax provision in the period such determination is made.
For the three and nine months ended September 30, 2023, the Company recorded an income tax expense of $50.7 million and $52.4 million, respectively. The difference between the income tax expense in each period and the tax at the federal statutory rate of 21.0% on current year operations is principally due to the impact of the valuation allowance, offset by state taxes, disallowed officer’s compensation, and capital expenses.
The Company files income tax returns in the United States federal jurisdiction and in various states. The statutes of limitations for the Company's tax returns filed for the years 2007 through 2021 have not expired. Because of net operating losses and unutilized research and development 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. As of September 30, 2023, the Company did not have significant accrued interest and penalties associated with unrecognized tax benefits.
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- DefinitionThe entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.
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v3.23.3
RESTRUCTURING CHARGES
|
9 Months Ended |
Sep. 30, 2023 |
Restructuring and Related Activities [Abstract] |
|
RESTRUCTURING CHARGES |
RESTRUCTURING CHARGES In August 2023, the Company implemented a reorganization plan of its workforce and other resources primarily designed to realize the synergies of the Spectrum Merger (the “Spectrum Reorganization Plan”). The Spectrum Reorganization Plan was primarily focused on the reduction of staff at the Company’s headquarters office and the exit of certain leased facilities and office equipment. The Company will continue to implement additional measures under the Spectrum Reorganization Plan as needed and expects the recognition of any costs and cash payments under the Spectrum Reorganization Plan to be completed by the end of the third quarter of 2024.
The staff reductions under the Spectrum Reorganization Plan are the result of a distinct severance plan approved by the Company’s board of directors and are not being executed as part of established Company policies or plans. Accordingly, the related employee compensation costs were primarily recognized in the third quarter of 2023, which is when the plan and underlying terms were finalized, approved by the Company’s board of directors, and communicated to the impacted staff, and since the reductions were effective immediately. Total employee compensation costs recognized under the Spectrum Reorganization Plan through September 30, 2023 were approximately $2.3 million. In addition, the leased facilities and office equipment referenced above are not expected to be in use for any business purpose by the end of 2023, and the Company will not sublease the facilities and office equipment due to the short remaining lease terms. Accordingly, the criteria for abandonment accounting to be applied to the leased facilities and office equipment were met in the third quarter of 2023. The facility exit costs represent the acceleration of the underlying right-of-use asset amortization to align with the cease use date for the abandoned facilities and office equipment. Total facility exit costs under the Spectrum Reorganization Plan are expected to be $1.3 million.
The following table reflects total expenses related to the Spectrum Reorganization Plan recognized within the Condensed Consolidated Statement of Comprehensive (Loss) Income as Restructuring charges for three and nine months ended September 30, 2023 (in thousands):
| | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | 2023 | | | | 2023 | | | Employee compensation costs | $ | 2,257 | | | | | $ | 2,257 | | | | Facility exit costs | 777 | | | | | 777 | | | | Total restructuring charges | $ | 3,034 | | | | | $ | 3,034 | | | |
The following table summarizes the changes in the Company’s accrued restructuring liability under the Spectrum Reorganization Plan, which is classified within Accrued liabilities in the Condensed Consolidated Balance Sheet as of September 30, 2023 (in thousands): | | | | | | | | | | | Employee compensation costs | | | | | Balance as of December 31, 2022 | $ | — | | | | | | Restructuring accrual assumed in Spectrum Merger (See Note 2) | 7,508 | | | | | | Net accrual additions | 2,257 | | | | | | | | | | | | Cash paid | (5,345) | | | | | | Balance as of September 30, 2023 | $ | 4,420 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
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v3.23.3
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)
|
9 Months Ended |
Sep. 30, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Basis of Presentation |
Basis of Presentation
The unaudited condensed consolidated financial statements of the Company 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 United States (“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, 2023 are not necessarily indicative of results to be expected for the entire year ending December 31, 2023 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, 2022 included in Assertio Holdings, Inc.’s Annual Report on Form 10-K filed with the SEC on March 8, 2023 (the “2022 Form 10-K”). The Condensed Consolidated Balance Sheet as of December 31, 2022 has been derived from the audited financial statements at that date, as filed in the Company’s 2022 Form 10-K.
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- DefinitionDisclosure of accounting policy for basis of accounting, or basis of presentation, used to prepare the financial statements (for example, US Generally Accepted Accounting Principles, Other Comprehensive Basis of Accounting, IFRS).
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v3.23.3
ACQUISITIONS (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Business Combination and Asset Acquisition [Abstract] |
|
Schedule of Consideration Transferred |
The following table reflects the components of the consideration transferred in the Spectrum Merger (in thousands, except exchange ratio and per share data):
| | | | | | | | | | | | | | | | | | | | | | | | Assertio shares issued | | 38,013 | | Assertio closing price per share as of the Effective Date | | $ | 5.69 | | Fair value of Assertio shares issued | | $ | 216,294 | | Repayment of Spectrum's long-term debt (1) | | 32,647 | | CVRs(2) | | 3,932 | | Total fair value of consideration transferred | | $ | 252,873 | |
(1)Represents settlement of Spectrum’s existing long-term debt in connection with the close of the transaction. The Company concluded it did not assume the debt, therefore the amount paid to settle the debt has been accounted for and disclosed as part of the consideration transferred. (2)Represents the fair value of 223,397 CVRs at $0.0176 per CVR issued to holders of Spectrum common stock, employee stock awards and warrants as of the Effective Date.
|
Schedule of Assets Acquired and Liabilities Assumed |
The following table reflects the preliminary fair value of the assets acquired and liabilities assumed at the Effective Date (in thousands). Goodwill is primarily attributable to expected synergies between the Company and Spectrum and is not expected to be deductible for tax purposes. The Company continues to assess the fair value of the assets acquired and liabilities assumed at the Effective Date, including any which may be impacted by Spectrum’s pending legal proceedings. Accordingly, the provisional fair value estimates of net assets acquired could potentially change, and the Company expects to finalize these values as soon as practical and no later than one year from the Effective Date.
| | | | | | | | | | | | | | | Consideration transferred | | | | $ | 252,873 | | | | | | | Assets: | | | | | Cash and cash equivalents | | $ | 34,600 | | | | Marketable securities | | 2,194 | | | | Accounts receivable | | 50,975 | | | | Inventories | | 22,244 | | | | Prepaid and other current assets | | 1,287 | | | | Property and equipment | | 100 | | | | Intangible assets | | 234,000 | | | | Other long-term assets | | 1,396 | | | | Total | | $ | 346,796 | | | | | | | | | Liabilities: | | | | | Accounts payable | | $ | 10,108 | | | | Accrued rebates, returns and discounts | | 21,025 | | | | Accrued liabilities | | 36,509 | | | | Other current liabilities | | 784 | | | | Deferred taxes | | 34,250 | | | | Other long-term liabilities | | 11,103 | | | | Total | | $ | 113,779 | | | | | | | | | Total Spectrum net assets acquired (1) | | | | $ | 233,017 | | Goodwill | | | | $ | 19,856 | |
(1)Application of the acquisition method required the Company to adjust Spectrum assets and liabilities as of the Effective Date, including certain liabilities for variable consideration associated with ROLVEDON, to reflect conformity of Spectrum’s accounting policies to those of Assertio. Liabilities assumed include certain bonuses owed to former Spectrum executives under the terms of existing employment agreements triggered by the consummation of the Spectrum Merger.
|
Schedule of Pro Forma Financial Information |
The following unaudited pro forma information represents the Company’s results of operations as if the Spectrum Merger had been completed as of January 1, 2022 (in thousands) and includes nonrecurring adjustments for additional costs of sales from the fair value step-up of inventories and transaction costs. The disclosure of pro forma net sales and net loss does not purport to indicate the results that would actually have been obtained had the Spectrum Merger been completed on the assumed date for the periods presented, or which may be realized in the future. The unaudited pro forma information does not reflect any operating efficiencies or cost savings that may be realized from the integration of the acquisition. | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | 2023 | | 2022 | | 2023 | | 2022 | Net sales | $ | 35,629 | | $ | 34,212 | | | $ | 159,528 | | $ | 42,466 | | Net loss | (285,658) | | (22,073) | | | (326,769) | | (98,616) | |
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- DefinitionTabular disclosure of pro forma results of operations for a material business acquisition or series of individually immaterial business acquisitions that are material in the aggregate.
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v3.23.3
REVENUE (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Revenue from Contract with Customer [Abstract] |
|
Schedule of Net Revenue |
The following table reflects total revenue, net for the three and nine months ended September 30, 2023 and 2022 (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | | 2023 | | 2022 | | 2023 | | 2022 | Product sales, net: | | | | | | | | | INDOCIN products | | $ | 17,948 | | $ | 21,869 | | | $ | 76,369 | | $ | 66,067 | | ROLVEDON | | 7,132 | | — | | | 7,132 | | — | | Otrexup | | 2,807 | | | 3,004 | | | 9,222 | | | 8,699 | | Sympazan | | 2,103 | | | — | | | 7,232 | | | — | | SPRIX | | 2,545 | | | 2,455 | | | 6,807 | | | 6,437 | | CAMBIA | | 1,993 | | | 5,808 | | | 6,062 | | | 17,464 | | Zipsor | | 597 | | | 259 | | | 2,751 | | | 2,704 | | Other products | | 12 | | | 884 | | | 1,414 | | | 3,887 | | Total product sales, net | | 35,137 | | | 34,279 | | | 116,989 | | | 105,258 | | Royalties and milestone revenue | | 490 | | | 473 | | | 1,910 | | | 1,916 | | Other revenue | | — | | | (540) | | | 185 | | | (1,290) | | Total revenues | | $ | 35,627 | | | $ | 34,212 | | | $ | 119,084 | | | $ | 105,884 | |
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v3.23.3
INVENTORIES, NET (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Inventory Disclosure [Abstract] |
|
Schedule of Inventory, Net |
The following table reflects the components of inventory, net as of September 30, 2023 and December 31, 2022 (in thousands): | | | | | | | | | | | | | September 30, 2023 | | December 31, 2022 | Raw materials | $ | 15,355 | | | $ | 1,367 | | Work-in-process | 1,330 | | | 2,735 | | Finished goods | 26,025 | | | 9,594 | | Total inventories, net | $ | 42,710 | | | $ | 13,696 | |
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v3.23.3
PREPAID AND OTHER CURRENT ASSETS (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] |
|
Schedule of Prepaid and Other Current Assets |
The following table reflects prepaid and other current as of September 30, 2023 and December 31, 2022 (in thousands):
| | | | | | | | | | | | | September 30, 2023 | | December 31, 2022 | Prepaid assets and deposits | $ | 2,614 | | | $ | 8,268 | | Other current assets | 281 | | | — | | | | | | Total prepaid and other current assets | $ | 2,895 | | | $ | 8,268 | |
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v3.23.3
PROPERTY AND EQUIPMENT, NET (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Property, Plant and Equipment [Abstract] |
|
Schedule of Property and Equipment |
The following table reflects property and equipment, net as of September 30, 2023 and December 31, 2022 (in thousands):
| | | | | | | | | | | | | September 30, 2023 | | December 31, 2022 | Furniture and office equipment | $ | 1,808 | | | $ | 1,712 | | Laboratory equipment | 20 | | | 20 | | Leasehold improvements | 2,945 | | | 2,945 | | Construction in progress | 528 | | | — | | | 5,301 | | | 4,677 | | Less: Accumulated depreciation | (4,497) | | | (3,933) | | Property and equipment, net | $ | 804 | | | $ | 744 | |
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v3.23.3
INTANGIBLE ASSETS AND GOODWILL (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
Schedule of Gross Carrying Amounts and Net Book Values of Intangible Assets and Goodwill |
The following table reflects the gross carrying amounts and net book values of intangible assets as of September 30, 2023 and December 31, 2022 (dollar amounts in thousands):
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | September 30, 2023 | | December 31, 2022 | | | Remaining Useful Life (In years) | | Gross Carrying Amount | | Accumulated Amortization | | Impairment | | | | Net Book Value | | Gross Carrying Amount | | Accumulated Amortization | | | | Net Book Value | Products rights: | | | | | | | | | | | | | | | | | | | | | INDOCIN | | 8.6 | | $ | 154,100 | | | $ | (43,126) | | | $ | (52,463) | | | | | $ | 58,511 | | | $ | 154,100 | | | $ | (33,495) | | | | | $ | 120,605 | | ROLVEDON | | 9.8 | | 234,000 | | | (3,900) | | | (157,095) | | | | | 73,005 | | | — | | | — | | | | | — | | Otrexup | | 6.2 | | 44,086 | | | (9,644) | | | (22,946) | | | | | 11,496 | | | 44,086 | | | (5,511) | | | | | 38,575 | | Sympazan | | 11.1 | | 14,550 | | | (1,111) | | | — | | | | | 13,439 | | | 14,550 | | | (202) | | | | | 14,348 | | SPRIX | | 3.6 | | 39,000 | | | (18,711) | | | (6,327) | | | | | 13,962 | | | 39,000 | | | (14,532) | | | | | 24,468 | | Total intangible assets | | | | $ | 485,736 | | | $ | (76,492) | | | $ | (238,831) | | | | | $ | 170,413 | | | $ | 251,736 | | | $ | (53,740) | | | | | $ | 197,996 | | | | | | | | | | | | | | | | | | | | | | |
|
Schedule of the Future Amortization Expenses of Intangible Assets |
The following table reflects future amortization expense the Company expects for its intangible assets (in thousands):
| | | | | | | | | Year Ending December 31, | | Estimated Amortization Expense | 2023 (remainder) | | 5,259 | | 2024 | | 21,035 | | 2025 | | 21,035 | | 2026 | | 21,035 | | 2027 | | 18,814 | | Thereafter | | 83,235 | | Total | | $ | 170,413 | |
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v3.23.3
OTHER LONG-TERM ASSETS (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] |
|
Schedule of Other Long-Term Assets |
The following table reflects other long-term assets as of September 30, 2023 and December 31, 2022 (in thousands):
| | | | | | | | | | | | | September 30, 2023 | | December 31, 2022 | Operating lease right-of-use assets | $ | 1,806 | | | $ | 137 | | Prepaid asset and deposits | 1,493 | | | 1,607 | | Other | 696 | | | 965 | | Total other long-term assets | $ | 3,995 | | | $ | 2,709 | |
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v3.23.3
ACCRUED LIABILITIES (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Accounts Payable and Accrued Liabilities, Current [Abstract] |
|
Schedule of Accrued Liabilities |
The following table reflects accrued liabilities as of September 30, 2023 and December 31, 2022 (in thousands):
| | | | | | | | | | | | | September 30, 2023 | | December 31, 2022 | Accrued compensation | $ | 2,468 | | | $ | 3,117 | | Accrued restructuring costs (See Note 19) | 4,420 | | | — | | Other accrued liabilities | 12,778 | | | 6,561 | | Taxes payable | 1,353 | | | — | | Interest payable | 217 | | | 1,593 | | Accrued royalties | 829 | | | 910 | | Total accrued liabilities | $ | 22,065 | | | $ | 12,181 | |
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v3.23.3
DEBT (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Debt Disclosure [Abstract] |
|
Schedule of Long-Term Debt |
The following table reflects the Company’s debt as of September 30, 2023 and December 31, 2022 (in thousands):
| | | | | | | | | | | | | September 30, 2023 | | December 31, 2022 | 6.5% Convertible Senior Secured Notes due 2027 | $ | 40,000 | | $ | 70,000 | Royalty Rights obligation | — | | 470 | Total principal amount | 40,000 | | 70,470 | Plus: derivative liability for embedded conversion feature | 764 | | 252 | Less: unamortized debt issuance costs | (1,898) | | (3,849) | Carrying value | 38,866 | | 66,873 | Less: current portion of long-term debt | — | | (470) | Long-term debt, net | $ | 38,866 | | | $ | 66,403 |
|
Schedule of Carrying Values Convertible Notes |
The following table reflects the carrying balance of the 2027 Convertible Notes as of September 30, 2023 and December 31, 2022 (in thousands):
| | | | | | | | | | | | | September 30, 2023 | | December 31, 2022 | Principal balance | $ | 40,000 | | | $ | 70,000 | | Derivative liability for embedded conversion feature | 764 | | | 252 | | Unamortized debt issuance costs | (1,898) | | | (3,849) | | Carrying balance | $ | 38,866 | | | $ | 66,403 | |
|
Schedule of Debt Related Interest |
The following table reflects debt-related interest included in Interest expense in the Company’s Condensed Consolidated Statements of Comprehensive (Loss) Income for the three and nine months ended September 30, 2023 and 2022 (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | 2023 | | 2022 | | 2023 | | 2022 | Interest on 2027 Convertible Notes | $ | 650 | | $ | 456 | | $ | 2,275 | | $ | 456 | Interest on 2024 Secured Notes | — | | 1,516 | | — | | 6,064 | Amortization of Royalty Rights(1) | — | | 80 | | — | | 128 | Amortization of debt issuance costs | 102 | | — | | 350 | | — | Total interest expense | $ | 752 | | $ | 2,052 | | $ | 2,625 | | $ | 6,648 | | | | | | | | | | | | | | | | |
(1)As a result of the extinguishment of the Royalty Rights obligation in the fourth quarter of 2022, there will be no additional amortization expense recognized in future periods.
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v3.23.3
LEASES (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Leases [Abstract] |
|
Schedule of Lease Expense |
The following table reflects lease expense and income for the three and nine months ended September 30, 2023 and 2022 (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | Financial Statement Classification | | 2023 | | 2022 | | 2023 | | 2022 | Operating lease cost | Selling, general and administrative expenses | | $ | 65 | | | $ | 39 | | | $ | 161 | | | $ | 118 | | Operating lease cost | Other gain | | — | | | 148 | | | — | | | 444 | | Total lease cost | | | $ | 65 | | | $ | 187 | | | $ | 161 | | | $ | 562 | | | | | | | | | | | | Sublease Income | Other gain | | $ | — | | | $ | 168 | | | $ | — | | | $ | 1,111 | |
The following table reflects supplemental cash flow information related to leases for the three and nine months ended September 30, 2023 and 2022 (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | | 2023 | | 2022 | | 2023 | | 2022 | Cash paid for amounts included in measurement of liabilities: | | | | | | | | Operating cash flows from operating leases | $ | 225 | | | $ | 533 | | | $ | 433 | | | $ | 1,593 | |
|
Schedule of Supplemental Balance Sheet Information |
The following table reflects supplemental balance sheet information related to leases as of September 30, 2023 and December 31, 2022 (in thousands): | | | | | | | | | | | | | | | | | | | Financial Statement Classification | | September 30, 2023 | | December 31, 2022 | Assets | | | | | | Operating lease right-of-use assets | Other long-term assets | | $ | 1,806 | | | $ | 137 | | Liabilities | | | | | | Current operating lease liabilities | Other current liabilities | | $ | 970 | | | $ | 401 | | Noncurrent operating lease liabilities | Other long-term liabilities | | 1,679 | | | — | | Total lease liabilities | | | $ | 2,649 | | | $ | 401 | |
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v3.23.3
NET (LOSS) INCOME PER SHARE (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Earnings Per Share [Abstract] |
|
Schedule of Calculation of Basic and Diluted Earnings Per Common Share |
The following table reflects the calculation of basic and diluted (loss) earnings per common share for the three and nine months ended September 30, 2023 and 2022 (in thousands, except for per share amounts):
| | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | 2023 | | 2022 | | 2023 | | 2022 | Basic net (loss) income per share | | | | | | | | Net (loss) income | $ | (279,544) | | | $ | 4,174 | | | $ | (274,558) | | | $ | 21,072 | | Weighted-average common shares outstanding | 81,713 | | | 48,180 | | | 63,066 | | | 46,566 | | Basic net (loss) income per share | $ | (3.42) | | | $ | 0.09 | | | $ | (4.35) | | | $ | 0.45 | | | | | | | | | | Diluted net (loss) income per share | | | | | | | | Net (loss) income | $ | (279,544) | | | $ | 4,174 | | | $ | (274,558) | | | $ | 21,072 | | | | | | | | | | Add: Convertible debt interest expense, net of tax | — | | | 497 | | | — | | | 487 | | Adjusted net (loss) income | (279,544) | | | 4,671 | | | (274,558) | | | 21,559 | | Weighted-average common shares and share equivalents outstanding | 81,713 | | | 48,180 | | | 63,066 | | | 46,566 | | Add: effect of dilutive stock-based awards and equivalents | — | | | 1,960 | | | — | | | 1,462 | | Add: effect of dilutive convertible debt under if-converted method | — | | | 7,246 | | | — | | | 2,442 | | Denominator for diluted net (loss) income per share | 81,713 | | | 57,386 | | | 63,066 | | | 50,470 | | Diluted net (loss) income per share | $ | (3.42) | | | $ | 0.08 | | | $ | (4.35) | | | $ | 0.42 | |
|
Schedule of Anti-Dilutive Securities Excluded from Computation of Diluted Net (Loss) Income Per Share |
The following table reflects outstanding potentially dilutive common shares that are not included in the computation of diluted net (loss) income per share, because to do so would be anti-dilutive, for the three and nine months ended September 30, 2023 and 2022 (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | 2023 | | 2022 | | 2023 | | 2022 | Convertible notes | 9,768 | | | — | | | 11,324 | | | — | | Stock-based awards and equivalents | 7,016 | | | 2,983 | | | 7,641 | | | 1,329 | | Total potentially dilutive common shares | 16,784 | | | 2,983 | | | 18,965 | | | 1,329 |
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v3.23.3
FAIR VALUE (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Fair Value Disclosures [Abstract] |
|
Schedule of Fair Value Hierarchy for Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis |
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, 2023 and December 31, 2022 (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | September 30, 2023 | | Financial Statement Classification | | Level 1 | | Level 2 | | Level 3 | | Total | Assets: | | | | | | | | | | | | | | | | | | | | | | U.S. Treasuries | | Cash and cash equivalents | | $ | — | | | $ | 38,204 | | | $ | — | | | $ | 38,204 | | | | | | | | | | | | | Money market funds | | Cash and cash equivalents | | 22,797 | | | — | | | — | | | 22,797 | | Total | | | | $ | 22,797 | | | $ | 38,204 | | | $ | — | | | $ | 61,001 | | Liabilities: | | | | | | | | | | | Short-term contingent consideration | | Contingent consideration, current portion | | $ | — | | | $ | — | | | $ | 12,800 | | | $ | 12,800 | | Long-term contingent consideration | | Contingent consideration | | — | | | — | | | 16,100 | | | 16,100 | | Derivative liability | | Long-term debt | | — | | | — | | | 764 | | | 764 | | Total | | | | $ | — | | | $ | — | | | $ | 29,664 | | | $ | 29,664 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | December 31, 2022 | | Financial Statement Classification | | Level 1 | | Level 2 | | Level 3 | | Total | Assets: | | | | | | | | | | | Commercial paper | | Cash and cash equivalents | | $ | — | | | $ | 4,983 | | | $ | — | | | $ | 4,983 | | U.S. Treasuries | | Cash and cash equivalents | | — | | | 3,981 | | | — | | | 3,981 | | U.S. Government agencies | | Cash and cash equivalents | | — | | | 10,937 | | | — | | | 10,937 | | Money market funds | | Cash and cash equivalents | | 38,478 | | | — | | | — | | | 38,478 | | Total | | | | $ | 38,478 | | | $ | 19,901 | | | $ | — | | | $ | 58,379 | | Liabilities: | | | | | | | | | | | Short-term contingent consideration | | Contingent consideration, current portion | | $ | — | | | $ | — | | | $ | 26,300 | | | $ | 26,300 | | Long-term contingent consideration | | Contingent consideration | | — | | | — | | | 22,200 | | | 22,200 | | Derivative liability | | Long-term debt | | — | | | — | | | 252 | | | 252 | | Total | | | | $ | — | | | $ | — | | | $ | 48,752 | | | $ | 48,752 | |
|
Schedule of Changes in Fair Value |
The following table summarizes changes in fair value of the Company’s contingent consideration obligations that are measured on a recurring basis using significant unobservable inputs (Level 3) for the three and nine months ended September 30, 2023 and 2022 (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | 2023 | | 2022 | | 2023 | | 2022 | Fair value, beginning of the period | $ | 42,500 | | | $ | 36,759 | | | $ | 48,500 | | | $ | 37,659 | | Fair value of contingent consideration incurred in Spectrum Merger | 3,932 | | | — | | | 3,932 | | | — | | Change in fair value of contingent consideration recorded within costs and expenses | (17,532) | | | 3,900 | | | (8,124) | | | 6,845 | | Cash payment related to contingent consideration | — | | | (4,000) | | | (15,408) | | | (7,845) | | Fair value, end of the period | $ | 28,900 | | | $ | 36,659 | | | $ | 28,900 | | | $ | 36,659 | |
|
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation |
The following table summarizes changes in fair value of the derivative liability that is measured on a recurring basis using significant unobservable inputs (Level 3) for the three and nine months ended September 30, 2023 (in thousands):
| | | | | | | | | | | | | | | | | Three Months Ended September 30, 2023 | | Nine Months Ended September 30, 2023 | Fair value, beginning of the period | | $ | 252 | | | $ | 252 | | Change in fair value of derivative liability recorded within Other (loss) gain | | 512 | | | 512 | | Fair value, end of the period | | $ | 764 | | | $ | 764 | |
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v3.23.3
RESTRUCTURING CHARGES (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Restructuring and Related Activities [Abstract] |
|
Schedule of Restructuring Charges |
The following table reflects total expenses related to the Spectrum Reorganization Plan recognized within the Condensed Consolidated Statement of Comprehensive (Loss) Income as Restructuring charges for three and nine months ended September 30, 2023 (in thousands):
| | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | 2023 | | | | 2023 | | | Employee compensation costs | $ | 2,257 | | | | | $ | 2,257 | | | | Facility exit costs | 777 | | | | | 777 | | | | Total restructuring charges | $ | 3,034 | | | | | $ | 3,034 | | | |
|
Schedule of Accrued Restructuring and Severance Costs |
The following table summarizes the changes in the Company’s accrued restructuring liability under the Spectrum Reorganization Plan, which is classified within Accrued liabilities in the Condensed Consolidated Balance Sheet as of September 30, 2023 (in thousands): | | | | | | | | | | | Employee compensation costs | | | | | Balance as of December 31, 2022 | $ | — | | | | | | Restructuring accrual assumed in Spectrum Merger (See Note 2) | 7,508 | | | | | | Net accrual additions | 2,257 | | | | | | | | | | | | Cash paid | (5,345) | | | | | | Balance as of September 30, 2023 | $ | 4,420 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|
X |
- DefinitionTabular disclosure of costs incurred for restructuring including, but not limited to, exit and disposal activities, remediation, implementation, integration, asset impairment, and charges against earnings from the write-down of assets.
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v3.23.3
ACQUISITIONS - Narrative (Details) - Spectrum Pharmaceuticals, Inc. - USD ($) $ / shares in Units, $ in Millions |
|
3 Months Ended |
9 Months Ended |
|
|
Jul. 31, 2023 |
Sep. 30, 2023 |
Sep. 30, 2023 |
Dec. 31, 2025 |
Dec. 31, 2024 |
Business Acquisition [Line Items] |
|
|
|
|
|
Business acquisition, fixed exchange ratio |
$ 0.1783
|
|
|
|
|
Business acquisition, contingent consideration, per share, maximum (in dollars per share) |
$ 0.20
|
|
|
|
|
Business combination, contingent consideration liability, number of shares (in shares) |
223,397
|
|
|
|
|
Business acquisition, contingent consideration, per share (in dollars per share) |
$ 0.0176
|
|
|
|
|
Acquired finite-lived intangible assets, useful life |
10 years
|
|
|
|
|
Acquisition costs related to the transaction |
|
$ 2.7
|
$ 8.5
|
|
|
ROLVEDON |
|
|
|
|
|
Business Acquisition [Line Items] |
|
|
|
|
|
Business combination, contingent consideration arrangements, range of outcomes, value, high |
$ 44.7
|
|
|
|
|
ROLVEDON | Forecast |
|
|
|
|
|
Business Acquisition [Line Items] |
|
|
|
|
|
Business acquisition, contingent consideration, per share, maximum (in dollars per share) |
|
|
|
$ 0.10
|
$ 0.10
|
Business combination, contingent consideration arrangements, range of outcomes, value, high |
|
|
|
$ 225.0
|
$ 175.0
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v3.23.3
ACQUISITIONS - Acquisition Date Fair Value of Consideration Transferred (Details) - Spectrum Pharmaceuticals, Inc. - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands |
Jul. 31, 2023 |
Sep. 30, 2023 |
Business Acquisition [Line Items] |
|
|
Assertio shares issued (in shares) |
38,013
|
|
Assertio closing price per share as of the Effective Date (in dollars per share) |
$ 5.69
|
|
Fair value of Assertio shares issued |
$ 216,294
|
|
Repayment of Spectrum's long-term debt |
32,647
|
|
CVRs |
3,932
|
$ 0
|
Consideration transferred |
$ 252,873
|
|
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v3.23.3
ACQUISITIONS - Fair Values of Assets Acquired and Liabilities Assumed (Details) - USD ($) $ in Thousands |
Jul. 31, 2023 |
Sep. 30, 2023 |
Dec. 31, 2022 |
Liabilities: |
|
|
|
Goodwill |
|
$ 19,856
|
$ 0
|
Spectrum Pharmaceuticals, Inc. |
|
|
|
Business Acquisition [Line Items] |
|
|
|
Consideration transferred |
$ 252,873
|
|
|
Assets: |
|
|
|
Cash and cash equivalents |
34,600
|
|
|
Marketable securities |
2,194
|
|
|
Accounts receivable |
50,975
|
|
|
Inventories |
22,244
|
|
|
Prepaid and other current assets |
1,287
|
|
|
Property and equipment |
100
|
|
|
Intangible assets |
234,000
|
|
|
Other long-term assets |
1,396
|
|
|
Total |
346,796
|
|
|
Liabilities: |
|
|
|
Accounts payable |
10,108
|
|
|
Accrued rebates, returns and discounts |
21,025
|
|
|
Accrued liabilities |
36,509
|
|
|
Other current liabilities |
784
|
|
|
Deferred taxes |
34,250
|
|
|
Other long-term liabilities |
11,103
|
|
|
Total |
113,779
|
|
|
Total Spectrum net assets acquired |
233,017
|
|
|
Goodwill |
$ 19,856
|
|
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v3.23.3
ACQUISITIONS - Unaudited Pro Forma Financial Information (Details) - Spectrum Pharmaceuticals, Inc. - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Business Acquisition [Line Items] |
|
|
|
|
Net sales |
$ 35,629
|
$ 34,212
|
$ 159,528
|
$ 42,466
|
Net loss |
$ (285,658)
|
$ (22,073)
|
$ (326,769)
|
$ (98,616)
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v3.23.3
REVENUE - Schedule of Disaggregated Revenue from Contracts with Customers (Details) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Disaggregation of Revenue [Line Items] |
|
|
|
|
Total revenues |
$ 35,627
|
$ 34,212
|
$ 119,084
|
$ 105,884
|
Total product sales, net |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Total revenues |
35,137
|
34,279
|
116,989
|
105,258
|
INDOCIN products |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Total revenues |
17,948
|
21,869
|
76,369
|
66,067
|
ROLVEDON |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Total revenues |
7,132
|
0
|
7,132
|
0
|
Otrexup |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Total revenues |
2,807
|
3,004
|
9,222
|
8,699
|
Sympazan |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Total revenues |
2,103
|
0
|
7,232
|
0
|
SPRIX |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Total revenues |
2,545
|
2,455
|
6,807
|
6,437
|
CAMBIA |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Total revenues |
1,993
|
5,808
|
6,062
|
17,464
|
Zipsor |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Total revenues |
597
|
259
|
2,751
|
2,704
|
Other products |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Total revenues |
12
|
884
|
1,414
|
3,887
|
Royalties and milestone revenue |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Total revenues |
490
|
473
|
1,910
|
1,916
|
Other revenue |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Total revenues |
$ 0
|
$ (540)
|
$ 185
|
$ (1,290)
|
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ACCOUNTS RECEIVABLES, NET (Details) - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
ACCOUNTS RECEIVABLES, NET |
|
|
Accounts receivable, net |
$ 62,467
|
$ 45,357
|
Allowance for cash discounts for prompt payment |
1,500
|
900
|
Product Sales Receivable |
|
|
ACCOUNTS RECEIVABLES, NET |
|
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Accounts receivable, net |
$ 62,500
|
$ 45,400
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INVENTORIES, NET - Schedule of Inventories, Net (Details) - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
Inventory |
|
|
Raw materials |
$ 15,355
|
$ 1,367
|
Work-in-process |
1,330
|
2,735
|
Finished goods |
26,025
|
9,594
|
Total inventories, net |
$ 42,710
|
$ 13,696
|
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v3.23.3
PROPERTY AND EQUIPMENT, NET - Schedule of Property and Equipment (Details) - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment, gross |
$ 5,301
|
$ 4,677
|
Less: Accumulated depreciation |
(4,497)
|
(3,933)
|
Property and equipment, net |
804
|
744
|
Furniture and office equipment |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment, gross |
1,808
|
1,712
|
Laboratory equipment |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment, gross |
20
|
20
|
Leasehold improvements |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment, gross |
2,945
|
2,945
|
Construction in progress |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment, gross |
$ 528
|
$ 0
|
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v3.23.3
INTANGIBLE ASSETS AND GOODWILL - Summary of Gross Carrying Amounts and Net Book Values of Intangible Assets and Goodwill (Details) - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
Intangible assets |
|
|
Gross Carrying Amount |
$ 485,736
|
$ 251,736
|
Accumulated Amortization |
(76,492)
|
(53,740)
|
Impairment |
(238,831)
|
|
Total |
$ 170,413
|
197,996
|
INDOCIN | Product Rights |
|
|
Intangible assets |
|
|
Remaining Useful Life (In years) |
8 years 7 months 6 days
|
|
Gross Carrying Amount |
$ 154,100
|
154,100
|
Accumulated Amortization |
(43,126)
|
(33,495)
|
Impairment |
(52,463)
|
|
Total |
$ 58,511
|
120,605
|
ROLVEDON | Product Rights |
|
|
Intangible assets |
|
|
Remaining Useful Life (In years) |
9 years 9 months 18 days
|
|
Gross Carrying Amount |
$ 234,000
|
0
|
Accumulated Amortization |
(3,900)
|
0
|
Impairment |
(157,095)
|
|
Total |
$ 73,005
|
0
|
Otrexup | Product Rights |
|
|
Intangible assets |
|
|
Remaining Useful Life (In years) |
6 years 2 months 12 days
|
|
Gross Carrying Amount |
$ 44,086
|
44,086
|
Accumulated Amortization |
(9,644)
|
(5,511)
|
Impairment |
(22,946)
|
|
Total |
$ 11,496
|
38,575
|
Sympazan | Product Rights |
|
|
Intangible assets |
|
|
Remaining Useful Life (In years) |
11 years 1 month 6 days
|
|
Gross Carrying Amount |
$ 14,550
|
14,550
|
Accumulated Amortization |
(1,111)
|
(202)
|
Impairment |
0
|
|
Total |
$ 13,439
|
14,348
|
SPRIX | Product Rights |
|
|
Intangible assets |
|
|
Remaining Useful Life (In years) |
3 years 7 months 6 days
|
|
Gross Carrying Amount |
$ 39,000
|
39,000
|
Accumulated Amortization |
(18,711)
|
(14,532)
|
Impairment |
(6,327)
|
|
Total |
$ 13,962
|
$ 24,468
|
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v3.23.3
INTANGIBLE ASSETS AND GOODWILL - Narrative (Details) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Intangible assets |
|
|
|
|
Loss on impairment of intangible assets |
$ 238,831
|
$ 0
|
$ 238,831
|
$ 0
|
Amortization expense |
10,184
|
$ 7,969
|
$ 22,752
|
$ 24,438
|
Spectrum Pharmaceuticals, Inc. |
|
|
|
|
Intangible assets |
|
|
|
|
Goodwill acquired during period |
$ 19,900
|
|
|
|
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v3.23.3
INTANGIBLE ASSETS AND GOODWILL - Summary of Future Amortization Expense of Intangible Assets (Details) - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
|
2023 (remainder) |
$ 5,259
|
|
2024 |
21,035
|
|
2025 |
21,035
|
|
2026 |
21,035
|
|
2027 |
18,814
|
|
Thereafter |
83,235
|
|
Total |
$ 170,413
|
$ 197,996
|
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v3.23.3
OTHER LONG-TERM ASSETS (Details) - USD ($) $ in Thousands |
Sep. 30, 2023 |
May 01, 2023 |
Dec. 31, 2022 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] |
|
|
|
Operating lease right-of-use assets |
$ 1,806
|
$ 1,300
|
$ 137
|
Prepaid asset and deposits |
1,493
|
|
1,607
|
Other |
696
|
|
965
|
Total other long-term assets |
$ 3,995
|
|
$ 2,709
|
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v3.23.3
ACCRUED LIABILITIES (Details) - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
Accounts Payable and Accrued Liabilities, Current [Abstract] |
|
|
Accrued compensation |
$ 2,468
|
$ 3,117
|
Accrued restructuring costs (See Note 19) |
4,420
|
0
|
Other accrued liabilities |
12,778
|
6,561
|
Taxes payable |
1,353
|
0
|
Interest payable |
217
|
1,593
|
Accrued royalties |
829
|
910
|
Total accrued liabilities |
$ 22,065
|
$ 12,181
|
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v3.23.3
DEBT - Schedule of Long-term Debt (Details) - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
Aug. 22, 2022 |
Debt Instrument [Line Items] |
|
|
|
Gross, long-term debt |
$ 40,000
|
$ 70,470
|
|
Plus: derivative liability for embedded conversion feature |
764
|
252
|
|
Less: unamortized debt issuance costs |
(1,898)
|
(3,849)
|
|
Carrying value |
38,866
|
66,873
|
|
Less: current portion of long-term debt |
0
|
(470)
|
|
Long-term debt, net |
38,866
|
66,403
|
|
Convertible notes |
|
|
|
Debt Instrument [Line Items] |
|
|
|
Less: unamortized debt issuance costs |
$ (1,600)
|
|
|
Convertible notes | 6.5% Convertible Senior Secured Notes due 2027 |
|
|
|
Debt Instrument [Line Items] |
|
|
|
Interest rate |
6.50%
|
|
6.50%
|
Gross, long-term debt |
$ 40,000
|
70,000
|
|
Plus: derivative liability for embedded conversion feature |
764
|
252
|
|
Less: unamortized debt issuance costs |
(1,600)
|
|
|
Senior Notes | Royalty Rights obligation |
|
|
|
Debt Instrument [Line Items] |
|
|
|
Gross, long-term debt |
$ 0
|
$ 470
|
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v3.23.3
DEBT - Narrative (Details)
|
|
|
3 Months Ended |
9 Months Ended |
12 Months Ended |
Feb. 27, 2023
USD ($)
shares
|
Aug. 22, 2022
USD ($)
$ / shares
Rate
|
Sep. 30, 2023
USD ($)
shares
|
Sep. 30, 2022
USD ($)
|
Sep. 30, 2023
USD ($)
shares
|
Sep. 30, 2022
USD ($)
|
Dec. 31, 2022
USD ($)
shares
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
Common stock, issued (in shares) | shares |
|
|
94,553,009
|
|
94,553,009
|
|
48,319,838
|
Direct transaction costs |
|
|
$ 0
|
$ 0
|
$ 9,918,000
|
$ 0
|
|
Unamortized issuance costs |
|
|
1,898,000
|
|
1,898,000
|
|
$ 3,849,000
|
Derivative liability |
|
|
764,000
|
|
764,000
|
|
252,000
|
Recurring |
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
Derivative liability |
|
|
764,000
|
|
764,000
|
|
252,000
|
Level 3 | Recurring |
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
Derivative liability |
|
|
764,000
|
|
764,000
|
|
252,000
|
Convertible notes |
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
Unamortized issuance costs |
|
|
1,600,000
|
|
1,600,000
|
|
|
Senior Notes |
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
Amortization of debt issuance costs |
|
|
$ 102,000
|
$ 0
|
$ 350,000
|
$ 0
|
|
6.5% Convertible Senior Secured Notes due 2027 | Convertible notes |
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
Interest rate |
|
6.50%
|
6.50%
|
|
6.50%
|
|
|
Aggregate principal amount |
$ 30,000,000
|
$ 60,000,000
|
|
|
|
|
|
Additional purchase capacity |
|
$ 10,000,000
|
|
|
|
|
|
Number of days to cover over allotment (in days) |
|
13 days
|
|
|
|
|
|
Common stock, issued (in shares) | shares |
6,990,000
|
|
|
|
|
|
|
Repayments of debt |
$ 10,500,000
|
|
|
|
|
|
|
Induced conversion of convertible debt expense |
8,800,000
|
|
|
|
|
|
|
Direct transaction costs |
$ 1,100,000
|
|
|
|
|
|
|
Unamortized issuance costs |
|
|
$ 1,600,000
|
|
$ 1,600,000
|
|
|
Conversion ratio |
|
0.2442003
|
|
|
|
|
|
Conversion price (in dollars per share) | $ / shares |
|
$ 4.09
|
|
|
|
|
|
Effective interest rate (as a percent) | Rate |
|
7.80%
|
|
|
|
|
|
Amortization of debt issuance costs |
|
|
100,000
|
|
400,000
|
|
|
Derivative liability |
|
|
764,000
|
|
764,000
|
|
$ 252,000
|
Derivative, fair value |
|
|
$ 500,000
|
|
$ 500,000
|
|
|
Senior Secured Notes Due 2024 | Senior Notes |
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
Interest rate |
|
13.00%
|
|
|
|
|
|
Repayment of debt, principal |
|
$ 59,000,000
|
|
|
|
|
|
Repayment of debt, interest |
|
$ 3,000,000
|
|
|
|
|
|
Royalty Rights obligation | Senior Notes |
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
Royalty payments, percentage of revenue |
|
|
|
|
|
|
1.50%
|
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v3.23.3
DEBT - Schedule of Interest Expense (Details) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Debt Instrument [Line Items] |
|
|
|
|
Amortization of Royalty Rights |
$ 0
|
$ 80
|
$ 0
|
$ 128
|
Total interest expense |
752
|
2,052
|
2,625
|
6,648
|
Senior Notes |
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
Amortization of debt issuance costs |
102
|
0
|
350
|
0
|
Senior Notes | Interest on 2027 Convertible Notes |
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
Interest payable on notes |
650
|
456
|
2,275
|
456
|
Interest on 2024 Secured Notes |
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
Interest payable on notes |
0
|
$ 1,516
|
0
|
$ 6,064
|
Interest on 2024 Secured Notes | Interest on 2027 Convertible Notes |
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
Amortization of debt issuance costs |
$ 100
|
|
$ 400
|
|
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v3.23.3
STOCK-BASED COMPENSATION (Details) - USD ($) $ / shares in Units, $ in Thousands, shares in Millions |
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Jun. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
Settlement of employee equity awards |
|
|
|
$ 7,770
|
$ 707
|
Restricted stock units |
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
Awards granted (in shares) |
|
1.0
|
|
0.8
|
|
Average fair market value (in dollars per share) |
|
$ 2.24
|
|
$ 5.61
|
|
Shares outstanding value (in shares) |
|
0.3
|
|
|
|
Employee’s tax withholding liability (in shares) |
|
0.2
|
|
|
|
Vesting and settlement value |
|
$ 2,600
|
|
|
|
Options |
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
Options granted (in shares) |
|
|
|
0.7
|
|
Average market fair value (in dollars per share) |
|
|
|
$ 4.51
|
|
Performance stock units |
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
Settlement of employee equity awards (in shares) |
|
0.5
|
|
|
|
ESPP |
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
Settlement of employee equity awards |
|
$ 3,400
|
|
|
|
Selling, General and Administrative Expenses |
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
Share-based compensation expense |
$ 1,900
|
|
$ 2,400
|
$ 6,500
|
$ 5,100
|
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v3.23.3
LEASES - Narrative (Details) - USD ($) $ in Thousands |
3 Months Ended |
|
|
|
Mar. 31, 2022 |
Sep. 30, 2023 |
May 01, 2023 |
Dec. 31, 2022 |
Lessee, Lease, Description [Line Items] |
|
|
|
|
Operating lease right-of-use assets |
|
$ 1,806
|
$ 1,300
|
$ 137
|
Noncurrent operating lease liabilities |
|
1,679
|
$ 1,300
|
0
|
Lessee, operating lease, discount rate |
|
|
7.41%
|
|
Gain on early termination of sublease |
$ 600
|
|
|
|
Current operating lease liabilities |
|
970
|
|
$ 401
|
Spectrum Pharmaceuticals, Inc. |
|
|
|
|
Lessee, Lease, Description [Line Items] |
|
|
|
|
Operating lease right-of-use assets |
|
400
|
|
|
Noncurrent operating lease liabilities |
|
300
|
|
|
Current operating lease liabilities |
|
$ 700
|
|
|
X |
- DefinitionAmount of gain (loss) on termination of lease before expiration of lease term.
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v3.23.3
LEASES - Lease Cost Components (Details) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Lessee, Lease, Description [Line Items] |
|
|
|
|
Total lease cost |
$ 65
|
$ 187
|
$ 161
|
$ 562
|
Selling, general and administrative expenses |
|
|
|
|
Lessee, Lease, Description [Line Items] |
|
|
|
|
Operating lease cost |
65
|
39
|
161
|
118
|
Other gain |
|
|
|
|
Lessee, Lease, Description [Line Items] |
|
|
|
|
Operating lease cost |
0
|
148
|
0
|
444
|
Sublease Income |
$ 0
|
$ 168
|
$ 0
|
$ 1,111
|
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v3.23.3
LEASES - Supplemental Balance Sheet Information (Details) - USD ($) $ in Thousands |
Sep. 30, 2023 |
May 01, 2023 |
Dec. 31, 2022 |
Assets |
|
|
|
Operating lease right-of-use assets |
$ 1,806
|
$ 1,300
|
$ 137
|
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible Enumeration] |
Other long-term assets
|
|
Other long-term assets
|
Liabilities |
|
|
|
Current operating lease liabilities |
$ 970
|
|
$ 401
|
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] |
Other current liabilities
|
|
Other current liabilities
|
Noncurrent operating lease liabilities |
$ 1,679
|
$ 1,300
|
$ 0
|
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] |
Other long-term liabilities
|
|
Other long-term liabilities
|
Total lease liabilities |
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|
|
$ 401
|
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v3.23.3
SHAREHOLDERS' EQUITY (Details) - USD ($) $ / shares in Units, $ in Thousands |
|
3 Months Ended |
9 Months Ended |
|
|
|
Jul. 31, 2023 |
Mar. 31, 2023 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Dec. 31, 2022 |
Dec. 17, 2021 |
May 20, 2020 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Proceeds from the issuance of common stock |
|
|
$ 0
|
$ 7,020
|
|
|
|
Unamortized issuance costs |
|
|
$ 1,898
|
|
$ 3,849
|
|
|
Warrants term |
|
|
|
|
|
|
18 months
|
Warrants exercised (in shares) |
|
|
|
400,000
|
|
|
|
Common shares issued (in shares) |
|
|
|
400,000
|
|
|
|
Warrants outstanding |
|
|
|
$ 0
|
|
|
|
Zyla Life Sciences | Iroko | Warrant Agreements |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Exercise aggregate ownership percentage maximum threshold |
|
|
|
|
|
|
49.00%
|
Zyla Life Sciences | Money market funds | Zyla Life Sciences |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Purchase price, number of shares outstanding, per share (in dollars per share) |
|
|
|
|
|
|
$ 0.0016
|
Spectrum Pharmaceuticals, Inc. |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Issuance of common stock (in shares) |
38,000,000
|
|
|
|
|
|
|
At The Market Program |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Aggregate offering price |
|
|
|
|
|
$ 25,000
|
|
Stock offering, shares sold (in shares) |
|
|
2,463,637
|
|
|
|
|
Stock offering, purchase price (in dollars per share) |
|
|
$ 3.02
|
|
|
|
|
Stock offering, gross proceeds |
|
|
$ 7,400
|
|
|
|
|
Stock offering, net proceeds |
|
|
7,000
|
|
|
|
|
Additional Paid-In Capital |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Induced exchange of convertible notes, gross |
|
|
28,300
|
|
|
|
|
Convertible notes |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Unamortized issuance costs |
|
|
1,600
|
|
|
|
|
6.5% Convertible Senior Secured Notes due 2027 | Convertible notes |
|
|
|
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
|
|
|
|
|
Proceeds from the issuance of common stock |
|
$ 10,500
|
|
|
|
|
|
Induced exchange of convertible notes (in shares) |
|
7,000,000
|
|
|
|
|
|
Unamortized issuance costs |
|
|
$ 1,600
|
|
|
|
|
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v3.23.3
NET (LOSS) INCOME PER SHARE - Schedule of Earnings Per Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Basic net (loss) income per share |
|
|
|
|
Net (loss) income |
$ (279,544)
|
$ 4,174
|
$ (274,558)
|
$ 21,072
|
Weighted-average common shares outstanding/share equivalents outstanding (in shares) |
81,713
|
48,180
|
63,066
|
46,566
|
Basic net (loss) income per share (in dollars per share) |
$ (3.42)
|
$ 0.09
|
$ (4.35)
|
$ 0.45
|
Diluted net (loss) income per share |
|
|
|
|
Net (loss) income |
$ (279,544)
|
$ 4,174
|
$ (274,558)
|
$ 21,072
|
Add: Convertible debt interest expense, net of tax |
0
|
497
|
0
|
487
|
Adjusted net (loss) income |
$ (279,544)
|
$ 4,671
|
$ (274,558)
|
$ 21,559
|
Weighted-average common shares outstanding/share equivalents outstanding (in shares) |
81,713
|
48,180
|
63,066
|
46,566
|
Add: effect of dilutive stock-based awards and equivalents (in shares) |
0
|
1,960
|
0
|
1,462
|
Add: effect of dilutive convertible debt under if-converted method (in shares) |
0
|
7,246
|
0
|
2,442
|
Denominator for diluted net (loss) income per share (in shares) |
81,713
|
57,386
|
63,066
|
50,470
|
Diluted net (loss) income per share (in dollars per share) |
$ (3.42)
|
$ 0.08
|
$ (4.35)
|
$ 0.42
|
X |
- DefinitionThe amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period.
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v3.23.3
NET (LOSS) INCOME PER SHARE - Schedule Dilutive Shares Information (Details) - shares shares in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Total potentially dilutive common shares (in shares) |
16,784
|
2,983
|
18,965
|
1,329
|
Convertible notes |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Total potentially dilutive common shares (in shares) |
9,768
|
0
|
11,324
|
0
|
Stock-based awards and equivalents |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Total potentially dilutive common shares (in shares) |
7,016
|
2,983
|
7,641
|
1,329
|
X |
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v3.23.3
FAIR VALUE - Schedule of Fair Value Hierarchy for Financial Assets and Liabilities (Details) - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
Liabilities: |
|
|
Short-term contingent consideration |
$ 12,800
|
$ 26,300
|
Long-term contingent consideration |
16,100
|
22,200
|
Derivative liability |
764
|
252
|
Recurring |
|
|
ASSETS |
|
|
Total |
61,001
|
58,379
|
Liabilities: |
|
|
Short-term contingent consideration |
12,800
|
26,300
|
Long-term contingent consideration |
16,100
|
22,200
|
Derivative liability |
764
|
252
|
Total |
29,664
|
48,752
|
Recurring | Commercial paper |
|
|
ASSETS |
|
|
Cash and cash equivalents |
|
4,983
|
Recurring | U.S. Treasuries |
|
|
ASSETS |
|
|
Cash and cash equivalents |
38,204
|
3,981
|
Recurring | U.S. Government agencies |
|
|
ASSETS |
|
|
Cash and cash equivalents |
|
10,937
|
Recurring | Money market funds |
|
|
ASSETS |
|
|
Cash and cash equivalents |
22,797
|
38,478
|
Recurring | Level 1 |
|
|
ASSETS |
|
|
Total |
22,797
|
38,478
|
Liabilities: |
|
|
Short-term contingent consideration |
0
|
0
|
Long-term contingent consideration |
0
|
0
|
Derivative liability |
0
|
0
|
Total |
0
|
0
|
Recurring | Level 1 | Commercial paper |
|
|
ASSETS |
|
|
Cash and cash equivalents |
|
0
|
Recurring | Level 1 | U.S. Treasuries |
|
|
ASSETS |
|
|
Cash and cash equivalents |
0
|
0
|
Recurring | Level 1 | U.S. Government agencies |
|
|
ASSETS |
|
|
Cash and cash equivalents |
|
0
|
Recurring | Level 1 | Money market funds |
|
|
ASSETS |
|
|
Cash and cash equivalents |
22,797
|
38,478
|
Recurring | Level 2 |
|
|
ASSETS |
|
|
Total |
38,204
|
19,901
|
Liabilities: |
|
|
Short-term contingent consideration |
0
|
0
|
Long-term contingent consideration |
0
|
0
|
Derivative liability |
0
|
0
|
Total |
0
|
0
|
Recurring | Level 2 | Commercial paper |
|
|
ASSETS |
|
|
Cash and cash equivalents |
|
4,983
|
Recurring | Level 2 | U.S. Treasuries |
|
|
ASSETS |
|
|
Cash and cash equivalents |
38,204
|
3,981
|
Recurring | Level 2 | U.S. Government agencies |
|
|
ASSETS |
|
|
Cash and cash equivalents |
|
10,937
|
Recurring | Level 2 | Money market funds |
|
|
ASSETS |
|
|
Cash and cash equivalents |
0
|
0
|
Recurring | Level 3 |
|
|
ASSETS |
|
|
Total |
0
|
0
|
Liabilities: |
|
|
Short-term contingent consideration |
12,800
|
26,300
|
Long-term contingent consideration |
16,100
|
22,200
|
Derivative liability |
764
|
252
|
Total |
29,664
|
48,752
|
Recurring | Level 3 | Commercial paper |
|
|
ASSETS |
|
|
Cash and cash equivalents |
|
0
|
Recurring | Level 3 | U.S. Treasuries |
|
|
ASSETS |
|
|
Cash and cash equivalents |
0
|
0
|
Recurring | Level 3 | U.S. Government agencies |
|
|
ASSETS |
|
|
Cash and cash equivalents |
|
0
|
Recurring | Level 3 | Money market funds |
|
|
ASSETS |
|
|
Cash and cash equivalents |
$ 0
|
$ 0
|
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v3.23.3
FAIR VALUE - Narrative (Details) $ / shares in Units, $ in Thousands |
3 Months Ended |
9 Months Ended |
|
|
Sep. 30, 2023
USD ($)
|
Sep. 30, 2022
USD ($)
|
Sep. 30, 2023
USD ($)
Rate
|
Sep. 30, 2022
USD ($)
|
Jul. 31, 2023
USD ($)
$ / shares
|
Dec. 31, 2022
USD ($)
|
Schedule of Cash and Cash Equivalents and Marketable Securities [Line Items] |
|
|
|
|
|
|
Change in fair value of contingent consideration |
$ (17,532)
|
$ 3,900
|
$ (8,124)
|
$ 6,845
|
|
|
Short-term contingent consideration |
12,800
|
|
12,800
|
|
|
$ 26,300
|
Long-term contingent consideration |
16,100
|
|
16,100
|
|
|
22,200
|
Derivative liability |
764
|
|
764
|
|
|
252
|
Recurring |
|
|
|
|
|
|
Schedule of Cash and Cash Equivalents and Marketable Securities [Line Items] |
|
|
|
|
|
|
Short-term contingent consideration |
12,800
|
|
12,800
|
|
|
26,300
|
Long-term contingent consideration |
16,100
|
|
16,100
|
|
|
22,200
|
Derivative liability |
764
|
|
764
|
|
|
252
|
Level 3 |
|
|
|
|
|
|
Schedule of Cash and Cash Equivalents and Marketable Securities [Line Items] |
|
|
|
|
|
|
Change in fair value of contingent consideration recorded within costs and expenses |
512
|
|
512
|
|
|
|
Level 3 | Recurring |
|
|
|
|
|
|
Schedule of Cash and Cash Equivalents and Marketable Securities [Line Items] |
|
|
|
|
|
|
Short-term contingent consideration |
12,800
|
|
12,800
|
|
|
26,300
|
Long-term contingent consideration |
16,100
|
|
16,100
|
|
|
22,200
|
Derivative liability |
764
|
|
764
|
|
|
252
|
Level 2 |
|
|
|
|
|
|
Schedule of Cash and Cash Equivalents and Marketable Securities [Line Items] |
|
|
|
|
|
|
Debt conversion option value |
41,800
|
|
41,800
|
|
|
92,500
|
Convertible notes, par value |
40,000
|
|
40,000
|
|
|
70,000
|
Level 2 | Recurring |
|
|
|
|
|
|
Schedule of Cash and Cash Equivalents and Marketable Securities [Line Items] |
|
|
|
|
|
|
Short-term contingent consideration |
0
|
|
0
|
|
|
0
|
Long-term contingent consideration |
0
|
|
0
|
|
|
0
|
Derivative liability |
$ 0
|
|
$ 0
|
|
|
0
|
Revenue Volatility |
|
|
|
|
|
|
Schedule of Cash and Cash Equivalents and Marketable Securities [Line Items] |
|
|
|
|
|
|
Contingent consideration, measurement input |
0.30
|
|
0.30
|
|
|
|
Discount Rate |
|
|
|
|
|
|
Schedule of Cash and Cash Equivalents and Marketable Securities [Line Items] |
|
|
|
|
|
|
Contingent consideration, measurement input |
0.180
|
|
0.180
|
|
|
|
Discounted Cash Flow | Discount Rate |
|
|
|
|
|
|
Schedule of Cash and Cash Equivalents and Marketable Securities [Line Items] |
|
|
|
|
|
|
Contingent consideration, measurement input |
0.085
|
|
0.085
|
|
|
|
Discounted Cash Flow | Credit Spread |
|
|
|
|
|
|
Schedule of Cash and Cash Equivalents and Marketable Securities [Line Items] |
|
|
|
|
|
|
Contingent consideration, measurement input |
0.038
|
|
0.038
|
|
|
|
Spectrum Pharmaceuticals, Inc. |
|
|
|
|
|
|
Schedule of Cash and Cash Equivalents and Marketable Securities [Line Items] |
|
|
|
|
|
|
Business acquisition, contingent consideration, per share, maximum (in dollars per share) | $ / shares |
|
|
|
|
$ 0.20
|
|
Contingent consideration |
$ 0
|
|
$ 0
|
|
$ 3,932
|
|
Change in fair value of contingent consideration |
3,900
|
|
3,900
|
|
|
|
INDOCIN |
|
|
|
|
|
|
Schedule of Cash and Cash Equivalents and Marketable Securities [Line Items] |
|
|
|
|
|
|
Contingent consideration |
28,900
|
|
28,900
|
|
|
48,500
|
Contingent payment consideration, future royalties covenant, product net sales (over) |
|
|
$ 20,000
|
|
|
|
Contingent consideration, royalty percentage | Rate |
|
|
20.00%
|
|
|
|
Short-term contingent consideration |
12,800
|
|
$ 12,800
|
|
|
26,300
|
Long-term contingent consideration |
$ 16,100
|
|
$ 16,100
|
|
|
$ 22,200
|
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v3.23.3
FAIR VALUE - Schedule of Changes in Fair Value (Details) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] |
|
|
|
|
Change in fair value of contingent consideration recorded within costs and expenses [Extensible Enumeration] |
Costs and Expenses
|
Costs and Expenses
|
Costs and Expenses
|
Costs and Expenses
|
Level 3 |
|
|
|
|
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] |
|
|
|
|
Change in fair value of contingent consideration recorded within costs and expenses |
$ 512
|
|
$ 512
|
|
Level 3 | Contingent consideration |
|
|
|
|
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] |
|
|
|
|
Fair value, beginning of the period |
42,500
|
$ 36,759
|
48,500
|
$ 37,659
|
Fair value of contingent consideration incurred in Spectrum Merger |
3,932
|
0
|
3,932
|
0
|
Change in fair value of contingent consideration recorded within costs and expenses |
(17,532)
|
3,900
|
(8,124)
|
6,845
|
Cash payment related to contingent consideration |
0
|
(4,000)
|
(15,408)
|
(7,845)
|
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$ 28,900
|
$ 36,659
|
$ 28,900
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$ 36,659
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v3.23.3
v3.23.3
v3.23.3
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