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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2024
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:
| | | | | | | | | | | | | | |
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 August 1, 2024, was 95,335,629.
ASSERTIO HOLDINGS, INC.
FORM 10-Q FOR THE PERIOD ENDED JUNE 30, 2024
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) | | |
| June 30, 2024 | | December 31, 2023 |
ASSETS | | | |
Current assets: | | | |
Cash and cash equivalents | $ | 44,735 | | | $ | 73,441 | |
Short-term investments | 43,644 | | | — | |
Accounts receivable, net | 39,913 | | | 47,663 | |
Inventories, net | 39,080 | | | 37,686 | |
Prepaid and other current assets | 10,480 | | | 12,272 | |
Total current assets | 177,852 | | | 171,062 | |
Property and equipment, net | 664 | | | 770 | |
Intangible assets, net | 99,030 | | | 111,332 | |
| | | |
| | | |
Other long-term assets | 1,897 | | | 3,255 | |
Total assets | $ | 279,443 | | | $ | 286,419 | |
LIABILITIES AND SHAREHOLDERS’ EQUITY | | | |
Current liabilities: | | | |
Accounts payable | $ | 15,271 | | | $ | 13,439 | |
Accrued rebates, returns and discounts | 58,424 | | | 58,137 | |
Accrued liabilities | 15,124 | | | 18,213 | |
| | | |
Contingent consideration, current portion | 2,700 | | | 2,700 | |
Other current liabilities | 665 | | | 954 | |
Total current liabilities | 92,184 | | | 93,443 | |
Long-term debt | 38,729 | | | 38,514 | |
| | | |
Other long-term liabilities | 16,377 | | | 16,459 | |
Total liabilities | 147,290 | | | 148,416 | |
Commitments and contingencies (Note 15) | | | |
Shareholders’ equity: | | | |
Common stock, $0.0001 par value, 200,000,000 shares authorized; 95,333,214 and 94,668,523 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively. | 9 | | | 9 | |
Additional paid-in capital | 791,871 | | | 789,537 | |
Accumulated deficit | (659,727) | | | (651,543) | |
| | | |
Total shareholders’ equity | 132,153 | | | 138,003 | |
Total liabilities and shareholders' equity | $ | 279,443 | | | $ | 286,419 | |
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 June 30, | | Six Months Ended June 30, |
| 2024 | | 2023 | | 2024 | | 2023 |
Revenues: | | | | | | | |
Product sales, net | $ | 30,695 | | | $ | 40,083 | | | $ | 62,557 | | | $ | 81,852 | |
Royalties and milestones | 431 | | | 723 | | | 1,017 | | | 1,420 | |
Other revenue | — | | | 185 | | | — | | | 185 | |
Total revenues | 31,126 | | | 40,991 | | | 63,574 | | | 83,457 | |
Costs and expenses: | | | | | | | |
Cost of sales | 8,889 | | | 4,772 | | | 20,066 | | | 10,239 | |
Research and development expenses | 798 | | | 503 | | | 1,531 | | | 503 | |
Selling, general and administrative expenses | 18,385 | | | 16,771 | | | 36,909 | | | 33,675 | |
Change in fair value of contingent consideration | — | | | 241 | | | — | | | 9,408 | |
Amortization of intangible assets | 6,671 | | | 6,284 | | | 12,302 | | | 12,568 | |
| | | | | | | |
Restructuring charges | — | | | — | | | 720 | | | — | |
Total costs and expenses | 34,743 | | | 28,571 | | | 71,528 | | | 66,393 | |
(Loss) income from operations | (3,617) | | | 12,420 | | | (7,954) | | | 17,064 | |
Other income (expense): | | | | | | | |
Debt-related expenses | — | | | — | | | — | | | (9,918) | |
Interest expense | (758) | | | (751) | | | (1,515) | | | (1,873) | |
Interest income | 842 | | | 650 | | | 1,554 | | | 1,109 | |
Other gain | 8 | | | 11 | | | 12 | | | 354 | |
Total other income (expense) | 92 | | | (90) | | | 51 | | | (10,328) | |
Net (loss) income before income taxes | (3,525) | | | 12,330 | | | (7,903) | | | 6,736 | |
Income tax expense | (149) | | | (3,860) | | | (281) | | | (1,750) | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
Comprehensive (loss) income | $ | (3,674) | | | $ | 8,470 | | | $ | (8,184) | | | $ | 4,986 | |
| | | | | | | |
Basic net (loss) income per share | $ | (0.04) | | | $ | 0.15 | | | $ | (0.09) | | | $ | 0.09 | |
Diluted net (loss) income per share | $ | (0.04) | | | $ | 0.13 | | | $ | (0.09) | | | $ | 0.09 | |
Shares used in computing basic net (loss) income per share | 95,240 | | | 56,142 | | | 95,110 | | | 53,588 | |
Shares used in computing diluted net (loss) income per share | 95,240 | | | 70,144 | | | 95,110 | | | 58,010 | |
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 March 31, 2024 | 95,115 | | | $ | 9 | | | 790,538 | | | (656,053) | | | | | $ | 134,494 | |
Common stock issuance and other impacts of the vesting and settlement of equity awards | 218 | | | — | | | (75) | | | — | | | | | (75) | |
Stock-based compensation | — | | | — | | | 1,408 | | | — | | | | | 1,408 | |
| | | | | | | | | | | |
Net loss | — | | | — | | | — | | | (3,674) | | | | | (3,674) | |
Balances at June 30, 2024 | 95,333 | | | $ | 9 | | | $ | 791,871 | | | $ | (659,727) | | | | | $ | 132,153 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Common Stock | | Additional Paid-In Capital | | Accumulated Deficit | | | | | Shareholders’ Equity |
| Shares | | Amount | | | | | |
Balances at March 31, 2023 | 55,662 | | | $ | 5 | | | $ | 573,744 | | | $ | (323,085) | | | | | | $ | 250,664 | |
Issuance of common stock upon exercise of options | 110 | | | — | | | 157 | | | — | | | | | | 157 | |
Common stock issuances and other impacts of the vesting and settlement of equity awards | 741 | | | — | | | (7,225) | | | — | | | | | | (7,225) | |
Stock-based compensation | — | | | — | | | 2,205 | | | — | | | | | | 2,205 | |
Net income | — | | | — | | | — | | | 8,470 | | | | | | 8,470 | |
Balances at June 30, 2023 | 56,513 | | | $ | 5 | | | $ | 568,881 | | | $ | (314,615) | | | | | | $ | 254,271 | |
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, 2023 | 94,669 | | | $ | 9 | | | $ | 789,537 | | | $ | (651,543) | | | | | | | $ | 138,003 | |
Common stock issuance and other impacts of the vesting and settlement of equity awards | 664 | | | — | | | (281) | | | — | | | | | | | (281) | |
Stock-based compensation | — | | | — | | | 2,615 | | | — | | | | | | | 2,615 | |
| | | | | | | | | | | | | |
Net loss | — | | | — | | | — | | | (8,184) | | | | | | | (8,184) | |
Balances at June 30, 2024 | 95,333 | | | $ | 9 | | | $ | 791,871 | | | $ | (659,727) | | | | | | | $ | 132,153 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 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 | |
Induced exchange of convertible notes (See Note 16) | 6,990 | | | — | | | 26,699 | | | — | | | | | | | 26,699 | |
Common stock issuance and other impacts of the vesting and settlement of equity awards | 1,093 | | | — | | | (7,947) | | | — | | | | | | | (7,947) | |
Issuance of common stock upon exercise of options | 110 | | | — | | | 157 | | | — | | | | | | | 157 | |
Stock-based compensation | — | | | — | | | 4,651 | | | — | | | | | | | 4,651 | |
Net income | — | | | — | | | — | | | 4,986 | | | | | | | 4,986 | |
Balances at June 30, 2023 | 56,513 | | | $ | 5 | | | $ | 568,881 | | | $ | (314,615) | | | | | | | $ | 254,271 | |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
ASSERTIO HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(Unaudited) | | | | | | | | | | | |
| Six Months Ended June 30, |
| 2024 | | 2023 |
Operating Activities | | | |
Net (loss) income | $ | (8,184) | | | $ | 4,986 | |
Adjustments to reconcile net (loss) income to net cash from operating activities: | | | |
Depreciation and amortization | 12,407 | | | 12,964 | |
Amortization of debt issuance costs and Royalty Rights | 215 | | | 248 | |
Accretion of interest income from short-term investments | (338) | | | — | |
| | | |
Recurring fair value measurements of assets and liabilities | 15 | | | 9,408 | |
Debt-related expenses | — | | | 9,918 | |
Provisions for inventory and other assets | 3,877 | | | 1,390 | |
Stock-based compensation | 2,615 | | | 4,651 | |
Deferred income taxes | — | | | (1,385) | |
| | | |
Changes in assets and liabilities: | | | |
Accounts receivable | 7,750 | | | 3,749 | |
Inventories | (5,271) | | | (6,511) | |
Prepaid and other assets | 3,150 | | | 4,289 | |
Accounts payable and other accrued liabilities | (1,627) | | | 4,906 | |
Accrued rebates, returns and discounts | 286 | | | (6,569) | |
Interest payable | — | | | (726) | |
Net cash provided by operating activities | 14,895 | | | 41,318 | |
Investing Activities | | | |
Purchases of property and equipment | — | | | (528) | |
Purchase of Sympazan | — | | | (280) | |
| | | |
| | | |
Purchases of short-term investments | (43,320) | | | — | |
Net cash used in investing activities | (43,320) | | | (808) | |
Financing Activities | | | |
| | | |
Payments in connection with 2027 Convertible Notes | — | | | (10,500) | |
| | | |
Payment of direct transaction costs related to convertible debt inducement | — | | | (1,119) | |
| | | |
Payment of contingent consideration | — | | | (15,408) | |
Payment of Royalty Rights | — | | | (459) | |
Proceeds from exercise of stock options | — | | | 157 | |
| | | |
Payments related to the vesting and settlement of equity awards, net | (281) | | | (7,947) | |
| | | |
| | | |
Net cash used in financing activities | (281) | | | (35,276) | |
Net (decrease) increase in cash and cash equivalents | (28,706) | | | 5,234 | |
Cash and cash equivalents at beginning of year | 73,441 | | | 64,941 | |
Cash and cash equivalents at end of period | $ | 44,735 | | | $ | 70,175 | |
| | | |
Supplemental Disclosure of Cash Flow Information | | | |
Net cash paid for income taxes | $ | 1,384 | | | $ | 2,295 | |
Cash paid for interest | $ | 1,300 | | | $ | 2,351 | |
| | | |
| | | |
| | | |
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 pharmaceutical company with comprehensive commercial capabilities offering differentiated products to patients. The Company has built its product portfolio through the acquisition or licensing of approved products. The Company’s commercial capabilities include marketing through both a sales force and a non-personal promotion model, market access through payor contracting, and trade and distribution. The Company’s primary marketed products include ROLVEDONTM (elflapegrastim-xnst) injection for subcutaneous use, INDOCIN® (indomethacin) Suppositories, INDOCIN® (indomethacin) Oral Suspension, Sympazan® (clobazam) oral film, Otrexup® (methotrexate) injection for subcutaneous use, SPRIX® (ketorolac tromethamine) Nasal Spray, CAMBIA® (diclofenac potassium for oral solution), and Zipsor® (diclofenac potassium) liquid filled capsules. To date, substantially all of the Company’s revenues are related to product sales in the United States (“U.S.”).
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.
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 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, consisting only of normal and recurring adjustments, necessary for a fair presentation of the information for the periods presented. The results for the three and six months ended June 30, 2024, are not necessarily indicative of results to be expected for the entire year ending December 31, 2024.
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, 2023, included in Assertio Holdings, Inc.’s Annual Report on Form 10-K filed with the SEC on March 11, 2024 (the “2023 Form 10-K”). The Condensed Consolidated Balance Sheet as of December 31, 2023, has been derived from the audited financial statements at that date, as filed in the Company’s 2023 Form 10-K.
Reclassifications
During the second quarter of 2024, the Company reclassified interest income from Other gain to Interest income on the Company’s Condensed Consolidated Statements of Comprehensive (Loss) Income. Prior period amounts were also reclassified to conform with the current period presentation.
NOTE 2. ACQUISITIONS
Spectrum Pharmaceuticals
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”). The Spectrum Merger was completed pursuant to an Agreement and Plan of Merger (the “Merger Agreement”), dated as of April 24, 2023, through a merger of a wholly-owned subsidiary of the Company with and into Spectrum, 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) or were 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 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 included as part of the consideration transferred.
(2)Represents the Effective Date fair value of 223,397 CVRs at $0.0176 per CVR issued to holders of Spectrum common stock, employee stock awards and warrants.
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 18, 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 fair values of the assets acquired and liabilities assumed at the Effective Date (in thousands). The fair values were based on management’s estimates and assumptions. Management’s determination of the fair values of the assets acquired and liabilities assumed was completed as of March 31, 2024.
| | | | | | | | | | | | | | | | | | | | |
| | Initial Preliminary Purchase Price Allocation to Fair Value | | Adjustments to Purchase Price Allocation to Fair Value (2) | | Final Purchase Price Allocation to Fair Value |
Assets: | | | | | | |
Cash and cash equivalents | | $ | 34,600 | | | $ | — | | | $ | 34,600 | |
Marketable securities | | 2,194 | | | — | | | 2,194 | |
Accounts receivable | | 50,975 | | | — | | | 50,975 | |
Inventories | | 22,244 | | | 61 | | | 22,305 | |
Prepaid and other current assets | | 1,287 | | | 698 | | | 1,985 | |
Property and equipment | | 100 | | | — | | | 100 | |
Intangible assets | | 234,000 | | | (13,500) | | | 220,500 | |
Other long-term assets | | 1,396 | | | — | | | 1,396 | |
Total | | $ | 346,796 | | | $ | (12,741) | | | $ | 334,055 | |
| | | | | | |
Liabilities: | | | | | | |
Accounts payable | | $ | 10,108 | | | $ | — | | | $ | 10,108 | |
Accrued rebates, returns and discounts | | 21,025 | | | — | | | 21,025 | |
Accrued liabilities | | 36,509 | | | (2,343) | | | 34,166 | |
Other current liabilities | | 784 | | | — | | | 784 | |
Deferred taxes | | 34,250 | | | (30,254) | | | 3,996 | |
Other long-term liabilities | | 11,103 | | | — | | | 11,103 | |
Total | | $ | 113,779 | | | $ | (32,597) | | | $ | 81,182 | |
| | | | | | |
Total Spectrum net assets acquired (1) | | $ | 233,017 | | | $ | 19,856 | | | $ | 252,873 | |
Goodwill | | $ | 19,856 | | | $ | (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.
(2)Adjustments made to the preliminary purchase price allocation to fair value primarily reflect completion of studies and other analyses necessary to determine the income tax effects of the net identifiable assets acquired and further refinement of the assumptions used in the valuation supporting the ROLVEDON product rights. These adjustments did not materially impact the Consolidated Statement of Comprehensive (Loss) Income.
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 recognized for the three and six months ended June 30, 2023, were $3.4 million and $5.8 million, respectively. There were no acquisition costs related to the Spectrum Merger recognized for the three and six months ended June 30, 2024.
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, 2023, (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 total revenues and net income (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 | | Six Months Ended |
| | June 30, 2023 | | June 30, 2023 |
Total revenues | | $ | 64,729 | | | $ | 122,810 | |
Net income (loss) | | 4,938 | | | (9,006) | |
NOTE 3. REVENUE
Disaggregated Revenue
The following table reflects total revenues for the three and six months ended June 30, 2024 and 2023 (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended June 30, | | Six Months Ended June 30, |
| | 2024 | | 2023 | | 2024 | | 2023 |
Product sales, net: | | | | | | | | |
ROLVEDON | | $ | 15,144 | | | $ | — | | | $ | 29,622 | | $ | — | |
INDOCIN products | | 6,913 | | | 28,075 | | | 15,596 | | | 58,421 | |
Sympazan | | 2,668 | | | 2,627 | | | 5,285 | | | 5,129 | |
Otrexup | | 2,014 | | | 3,594 | | | 4,896 | | | 6,416 | |
SPRIX | | 2,147 | | | 2,373 | | | 3,584 | | | 4,262 | |
CAMBIA | | 1,403 | | | 1,805 | | | 2,660 | | | 4,069 | |
| | | | | | | | |
Other products | | 406 | | | 1,609 | | | 914 | | | 3,555 | |
Total product sales, net | | 30,695 | | | 40,083 | | | 62,557 | | | 81,852 | |
Royalties and milestone revenue | | 431 | | | 723 | | | 1,017 | | | 1,420 | |
Other revenue | | — | | | 185 | | | — | | | 185 | |
Total revenues | | $ | 31,126 | | | $ | 40,991 | | | $ | 63,574 | | | $ | 83,457 | |
Product Sales, net
As a result of the Spectrum Merger, the Company began recognizing ROLVEDON sales in August 2023.
Other product sales, net, for the three and six months ended June 30, 2023 include product sales for OXAYDO and Zipsor. As the Company ceased OXAYDO product sales beginning in September 2023, other net product sales for the three and six months ended June 30, 2024 represent only net product sales of Zipsor.
Royalties and Milestone Revenue
In November 2010, the Company entered into a license agreement granting Tribune Pharmaceuticals Canada Ltd. (now known as Miravo Pharmaceuticals, or “Miravo”) the rights to commercially market CAMBIA in Canada. Miravo independently contracts with manufacturers to produce a specific CAMBIA formulation in Canada. The Company recognized royalties revenue related to the CAMBIA licensing agreement of $0.4 million and $1.0 million for the three and six months ended June 30, 2024, respectively, and $0.4 million and $1.0 million for the three and six months ended June 30, 2023, respectively.
The Company recognized no milestone revenue associated with the completion of certain service milestones for the three and six months ended June 30, 2024, and $0.3 million and $0.5 million and for the three and six months ended June 30, 2023, respectively.
NOTE 4. ACCOUNTS RECEIVABLES, NET
As of June 30, 2024 and December 31, 2023, accounts receivable, net, consisted entirely of receivables related to product sales, net of allowances for cash discounts for prompt payment of $0.5 million and $0.9 million, respectively.
NOTE 5. INVENTORIES, NET
The following table reflects the components of inventories, net as of June 30, 2024 and December 31, 2023 (in thousands):
| | | | | | | | | | | |
| June 30, 2024 | | December 31, 2023 |
Raw materials | $ | 19,159 | | | $ | 10,537 | |
Work-in-process | 870 | | | 2,239 | |
Finished goods | 19,051 | | | 24,910 | |
Total inventories, net | $ | 39,080 | | | $ | 37,686 | |
The Company writes down the value of inventory for potential excess or obsolete inventories based on an analysis of inventory on hand and projected demand. As of June 30, 2024 and December 31, 2023, inventory reserves were $6.1 million and $6.8 million, respectively.
NOTE 6. PREPAID AND OTHER CURRENT ASSETS
The following table reflects prepaid and other current as of June 30, 2024 and December 31, 2023 (in thousands):
| | | | | | | | | | | |
| June 30, 2024 | | December 31, 2023 |
Prepaid assets and deposits | $ | 10,179 | | | $ | 11,973 | |
Other current assets | 301 | | | 299 | |
| | | |
Total prepaid and other current assets | $ | 10,480 | | | $ | 12,272 | |
In August 2018, the Company entered into a Convertible Secured Note Purchase Agreement (the “Note Agreement”) with NES Therapeutic, Inc. (“NES”), pursuant to which it purchased a Convertible Secured Promissory Note (the “NES Note”). The Company’s investment in the NES Note, which is included in other current assets, is accounted for as a loan receivable and is valued at amortized cost. As of both June 30, 2024 and December 31, 2023, the Company recorded a $3.5 million credit loss reserve on its investment based on its evaluation of the probability of default that exists at NES. The credit loss reserve recorded in each period represents the entire aggregate principal amount and outstanding interest incurred on the NES Note as of both June 30, 2024 and December 31, 2023.
On August 2, 2024, the NES Note was amended to extend the maturity date to August 16, 2024. All other terms of the existing Note Agreement were unchanged by the extension.
NOTE 7. PROPERTY AND EQUIPMENT, NET
The following table reflects property and equipment, net as of June 30, 2024 and December 31, 2023 (in thousands):
| | | | | | | | | | | |
| June 30, 2024 | | December 31, 2023 |
Furniture and office equipment | $ | 1,412 | | | $ | 1,908 | |
Laboratory equipment | 20 | | | 20 | |
Leasehold improvements | 2,551 | | | 2,945 | |
Construction in progress | — | | | 528 | |
| 3,983 | | | 5,401 | |
Less: Accumulated depreciation | (3,319) | | | (4,631) | |
Property and equipment, net | $ | 664 | | | $ | 770 | |
Depreciation expense was less than $0.1 million and $0.1 million for the three and six months ended June 30, 2024, respectively, and $0.2 million and $0.4 million for three and six months ended June 30, 2023, 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
The following table reflects the gross carrying amounts and net book values of intangible assets as of June 30, 2024 and December 31, 2023 (dollar amounts in thousands):
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | June 30, 2024 | | December 31, 2023 |
Products rights: | | Remaining Useful Life (In years) | | Gross Carrying Amount | | Accumulated Amortization | | | | | | Net Book Value | | Gross Carrying Amount | | Accumulated Amortization | | Impairment | | Net Book Value |
ROLVEDON | | 9.1 | | $ | 63,405 | | | $ | (8,303) | | | | | | | $ | 55,102 | | | $ | 220,500 | | | $ | (5,270) | | | $ | (157,095) | | | $ | 58,135 | |
INDOCIN | | 1.0 | | 65,605 | | | (51,052) | | | | | | | 14,553 | | | 154,100 | | | (44,814) | | | (88,494) | | | 20,792 | |
Sympazan | | 10.3 | | 14,550 | | | (2,020) | | | | | | | 12,530 | | | 14,550 | | | (1,415) | | | — | | | 13,135 | |
Otrexup | | 5.5 | | 16,364 | | | (10,625) | | | | | | | 5,739 | | | 44,086 | | | (10,103) | | | (27,723) | | | 6,260 | |
SPRIX | | 2.9 | | 32,673 | | | (21,567) | | | | | | | 11,106 | | | 39,000 | | | (19,663) | | | (6,327) | | | 13,010 | |
Total intangible assets | | | | $ | 192,597 | | | $ | (93,567) | | | | | | | $ | 99,030 | | | $ | 472,236 | | | $ | (81,265) | | | $ | (279,639) | | | $ | 111,332 | |
| | | | | | | | | | | | | | | | | | | | |
Amortization expense was $6.7 million and $12.3 million for the three and six months ended June 30, 2024, respectively, and $6.3 million and $12.6 million for three and six months ended June 30, 2023, respectively.
Effective April 1, 2024, the Company revised the remaining estimated useful life of the INDOCIN product rights intangible asset to 1.3 years, which better reflects the realization of the economic benefit of the intangible asset. The impact of this change in estimate is reflected in expected future amortization expense disclosed below.
The following table reflects future amortization expense the Company expects for its intangible assets (in thousands):
| | | | | | | | |
Year Ending December 31, | | Estimated Amortization Expense |
2024 (remainder) | | 13,342 | |
2025 | | 19,407 | |
2026 | | 12,130 | |
2027 | | 9,909 | |
2028 | | 8,322 | |
Thereafter | | 35,920 | |
Total | | $ | 99,030 | |
During each of the three months ended June 30, 2024 and March 31, 2024, the Company’s market capitalization was below the book value of the Company’s equity, which management determined 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 at each date. Similar to its previous assessment in the fourth quarter of 2023, as described in the Company’s 2023 Form 10-K, the Company concluded that it was appropriate to group its assets at the product level. After grouping the long-lived assets at the lowest level for which there are identifiable cash flows that are largely independent of the cash flows of other assets and liabilities, the Company estimated the future net undiscounted cash flows expected to be generated from the use of the long-lived asset groups and their eventual disposition at each of the three months ended June 30, 2024 and March 31, 2024. The Company then compared the estimated undiscounted cash flows to the carrying amounts of the long-lived asset groups at each date. Based on these tests, the Company determined that the estimated undiscounted cash flows were in excess of the carrying amounts for all of the long-lived asset groups as of both June 30, 2024 and March 31, 2024 and, accordingly, the Company concluded that the long-lived asset groups are fully recoverable and no adjustment to their carrying values was required.
NOTE 9. OTHER LONG-TERM ASSETS
The following table reflects other long-term assets as of June 30, 2024 and December 31, 2023 (in thousands):
| | | | | | | | | | | |
| June 30, 2024 | | December 31, 2023 |
Operating lease right-of-use assets | $ | 1,198 | | | $ | 1,269 | |
| | | |
Other | 699 | | | 1,986 | |
Total other long-term assets | $ | 1,897 | | | $ | 3,255 | |
NOTE 10. ACCRUED LIABILITIES
The following table reflects accrued liabilities as of June 30, 2024 and December 31, 2023 (in thousands):
| | | | | | | | | | | |
| June 30, 2024 | | December 31, 2023 |
Accrued compensation | $ | 1,772 | | | $ | 2,438 | |
Accrued restructuring costs (See Note 20) | 2,330 | | | 4,378 | |
Other accrued liabilities | 8,936 | | | 9,492 | |
| | | |
Interest payable | 867 | | | 867 | |
Accrued royalties | 1,219 | | | 1,038 | |
Total accrued liabilities | $ | 15,124 | | | $ | 18,213 | |
NOTE 11. DEBT
As of June 30, 2024 and December 31, 2023, long-term debt, net, consisted entirely of the carrying value of the Company’s 6.5% Convertible Senior Notes due 2027 (the “2027 Convertible Notes”) of $38.7 million and $38.5 million, respectively.
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. 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.
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”). 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 six months ended June 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.
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 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 June 30, 2024.
The following table reflects the carrying value of the 2027 Convertible Notes as of June 30, 2024 and December 31, 2023 (in thousands):
| | | | | | | | | | | |
| June 30, 2024 | | December 31, 2023 |
Principal balance | $ | 40,000 | | | $ | 40,000 | |
Derivative liability for embedded conversion feature | 308 | | | 308 | |
Unamortized debt issuance costs | (1,579) | | | (1,794) | |
Carrying value | $ | 38,729 | | | $ | 38,514 | |
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%. The Company amortized $0.1 million and $0.2 million of the debt discount on the 2027 Convertible Notes during the three and six months ended June 30, 2024, respectively, and $0.1 million and $0.2 million during the three and six months ended June 30, 2023, respectively. During the six months ended June 30, 2023, $1.6 million of unamortized issuance costs related to the Convertible Note Exchange 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 18, Fair Value, for further details around the estimated fair value of the derivative liability. 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.
Interest Expense
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 six months ended June 30, 2024 and 2023 (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended June 30, | | Six Months Ended June 30, |
| 2024 | | 2023 | | 2024 | | 2023 |
Interest on 2027 Convertible Notes | $ | 650 | | $ | 650 | | $ | 1,300 | | $ | 1,625 |
Amortization of debt issuance costs | 108 | | 101 | | 215 | | 248 |
Total interest expense | $ | 758 | | $ | 751 | | $ | 1,515 | | $ | 1,873 |
| | | | | | | |
| | | | | | | |
NOTE 12. OTHER LONG-TERM LIABILITIES
The following table reflects other long-term liabilities as of June 30, 2024 and December 31, 2023 (in thousands):
| | | | | | | | | | | |
| June 30, 2024 | | December 31, 2023 |
ROLVEDON product royalties | $ | 9,224 | | | $ | 9,224 | |
Noncurrent operating lease liabilities | 1,254 | | | 1,470 | |
Liability for uncertain tax provisions | 4,687 | | | 4,553 | |
Deferred employee retention credits | 1,212 | | | 1,212 | |
| | | |
Total other long-term liabilities | $ | 16,377 | | | $ | 16,459 | |
NOTE 13. STOCK-BASED COMPENSATION
The Company’s stock-based compensation generally includes time-based restricted stock units (“RSU”) and stock options, as well as performance-based RSUs and stock options.
Stock-based compensation of $1.4 million and $2.6 million for the three and six months ended June 30, 2024, respectively, and $2.2 million and $4.7 million for three and six months ended June 30, 2023, respectively, was recognized in Selling, general, and administrative expenses in the Company’s Condensed Consolidated Statements of Comprehensive (Loss) Income.
During the six months ended June 30, 2024, the Company granted 1.7 million RSUs at a weighted-average fair market value of $0.89 per share, and 5.3 million stock options at a weighted-average fair market value of $0.82 per share. During the six months ended June 30, 2023, the Company granted 0.7 million RSUs at a weighted-average fair market value of $5.64 per share, and 0.6 million stock options at a weighted-average fair market value of $4.49 per share.
NOTE 14. LEASES
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. Additionally, in connection with the Spectrum Merger, the Company assumed leases for two facilities and certain office equipment which Spectrum had previously been the lessee (See Note 20, Restructuring Charges).
The following table reflects lease expense for the three and six months ended June 30, 2024 and 2023 (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | Three Months Ended June 30, | | Six Months Ended June 30, |
| Financial Statement Classification | | 2024 | | 2023 | | 2024 | | 2023 |
Operating lease cost | Selling, general and administrative expenses | | $ | 65 | | | $ | 57 | | | $ | 131 | | | $ | 96 | |
The following table reflects supplemental cash flow information related to leases for the three and six months ended June 30, 2024 and 2023 (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended June 30, | | Six Months Ended June 30, |
| | 2024 | | 2023 | | 2024 | | 2023 |
Cash paid for amounts included in measurement of liabilities: | | | | | | | |
Operating cash flows from operating leases | $ | 258 | | | $ | 104 | | | $ | 540 | | | $ | 208 | |
The following table reflects supplemental balance sheet information related to leases as of June 30, 2024 and December 31, 2023 (in thousands):
| | | | | | | | | | | | | | | | | |
| Financial Statement Classification | | June 30, 2024 | | December 31, 2023 |
Assets | | | | | |
Operating lease right-of-use assets | Other long-term assets | | $ | 1,198 | | | $ | 1,269 | |
Liabilities | | | | | |
Current operating lease liabilities | Other current liabilities | | $ | 665 | | | $ | 928 | |
Noncurrent operating lease liabilities | Other long-term liabilities | | 1,254 | | | 1,470 | |
Total lease liabilities | | | $ | 1,919 | | | $ | 2,398 | |
NOTE 15. COMMITMENTS AND CONTINGENCIES
COMMITMENTS
Jubilant HollisterStier Manufacturing and Supply Agreement
In connection with the Company’s merger with Zyla Life Sciences (“Zyla”) in May 2020 (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 annual commitments to JHS are approximately $1.5 million.
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.
Hanmi Supply Agreement
In connection with the Spectrum Merger, the Company assumed a Manufacturing and Supply Agreement (the “Hanmi Agreement”) with Hanmi Pharmaceutical Co. Ltd. (“Hanmi”) pursuant to which the Company engaged Hanmi to provide certain services related to the manufacture and supply of ROLVEDON for the Company’s commercial use. The Company has agreed to purchase a minimum number of batches totaling approximately $19.1 million in 2024 and $3.8 million in 2025. The Company purchased $12.6 million of inventory from Hanmi during the six months ended months ended June 30, 2024.
CONTINGENCIES
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. 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 Superior Court of the State of California for the County of Alameda (“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 alleged, 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. Discovery has now been completed in these California state cases, and on June 18, 2024, the Company moved for summary judgment. Trial is scheduled for December 2024.
The Company intends to defend itself vigorously in the consolidated California state court lawsuits. A liability for this matter has been recorded, which is not material to the Condensed Consolidated 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 sought 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 in May 2023, 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 (one of which remains pending in Georgia). Plaintiffs may file additional lawsuits in which the Company may be named, and plaintiffs may also seek leave to add the Company to lawsuits already on file in the MDL Court. 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 for 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, New York, Pennsylvania, Texas and Utah. Plaintiffs may file additional lawsuits in which the Company may be named. In the pending cases involving Assertio Therapeutics, plaintiffs are asserting state common law and statutory claims against the defendants, and the majority of those cases are 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. Discovery has begun in one of the state court cases (Tarnopol, et al. v. Janssen Pharmaceuticals, Inc, et al., Case No. 002584, in the Court of Common Pleas of Philadelphia County, First Judicial District of Pennsylvania, Civil Trial Division), and the court in that case has entered an order providing that the case shall be ready for trial by April 7, 2025. The other state lawsuits in which Assertio Therapeutics has been served are generally each at an early stage of proceedings. Assertio Therapeutics intends to defend itself vigorously in these matters.
Qui Tam Litigation
The Company has learned that on October 30, 2017, a qui tam lawsuit was filed against Depomed in the United States District Court for the District of Columbia (United States of America ex rel. Webb, et al. v. Depomed, Inc., Case No. 1:17-cv-02309-JDB). The case was filed under seal and remained under seal until after an order was entered by the district court on July 12, 2024, which followed a notice from the DOJ electing to intervene, in part, and declining to intervene, in part, and which granted the DOJ’s request to unseal the complaint, the DOJ’s notice concerning intervention, and DOJ’s proposed order concerning its intervention. The district court order gives DOJ and the relator until October 10, 2024, to serve their respective complaints on Depomed.
The relator’s complaint alleges that Depomed violated the federal False Claims Act, 31 U.S.C. § 3729, as well as similar laws in California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Montana, Nevada, New Jersey, New Mexico, New York, North Carolina, Oklahoma, Rhode Island, Tennessee, Texas, Vermont, Virginia, Washington, and the District of Columbia; the federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7(b)(2)(B); the United States Food, Drug and Cosmetic Act, 21 U.S.C. §§ 331(d), 355(a); and laws in California and Illinois concerning fraudulent insurance claims. The relator’s complaint generally alleges that Depomed marketed off-label uses for its drugs Gralise and Lazanda, which were divested in 2020 and 2017, respectively, and that Depomed paid illegal kickbacks to physicians to induce them to write Gralise and Lazanda prescriptions. The relator also alleges that Depomed retaliated against her for complaining about Depomed’s alleged unlawful conduct. On behalf of herself, the United States, the several states whose laws the Complaint alleges to have been violated, and certain unnamed insurance companies, the relator seeks, among other things, actual damages, treble damages, back pay, two times back pay, special damages, civil penalties, pre- and post-judgment interest, attorneys’ fees, costs, and expenses.
The DOJ filed its notice of intervention on July 3, 3024, stating that the United States was intervening on the allegations that Depomed knowingly marketed Lazanda in a manner that caused the submission of false claims for Lazanda to Medicare and TRICARE. The DOJ noted that the United States declined to intervene on all other allegations not related to Lazanda. Therefore, the DOJ has declined to intervene with respect to the relator’s allegations concerning Gralise. The DOJ stated that it would file its complaint in intervention within 90 days of its notice. The Company is not currently aware of any involvement in the lawsuit of any of the governments of the states (or the District of Columbia) on whose behalf the relator purports to act.
The Company has not yet been served with process in the lawsuit. If served, the Company intends to vigorously defend itself in this matter.
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 California Superior Court 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 against its former insurance broker, Woodruff-Sawyer & Co. (“Woodruff”), in the California Superior Court of Alameda (Case No. 22CV009380). Assertio Therapeutics alleged claims for negligence and breach of fiduciary duty in connection with Woodruff’s negotiation and procurement of products liability insurance coverage for Assertio Therapeutics.
During the second quarter of 2024, Assertio Therapeutics settled with Woodruff and received $1.9 million in connection with its claims for insurance reimbursement for previous opioid-related legal expenses, which was recognized within Selling, general and administrative expenses in the Company’s Condensed Consolidated Statements of Comprehensive (Loss) Income for the three and six months ended June 30, 2024.
Stockholder Actions
Shapiro v. Assertio Holdings, Inc., et al., U.S. District Court, Northern District of Illinois, Case No. 1:24-cv-00169. On January 5, 2024, this putative securities class action lawsuit was filed by a purported shareholder, alleging that Assertio and certain of its current and former executive officers made false or misleading statements and failed to disclose material facts regarding the likely impact of INDOCIN sales and the Spectrum Merger on Assertio’s profitability in violation of Sections 10(b) (and Rule 10b-5 promulgated thereunder) and 20(a) of the Exchange Act of 1934, as amended (the “Exchange Act”). On April 11, 2024, the court appointed Continental General Insurance Company as the lead plaintiff. The plaintiffs filed an amended complaint on June 10, 2024, that names as defendants Assertio and certain of its current and former officers and directors, and Spectrum and certain of its former officers and directors. It alleges violations of Sections 10(b) and 20(a) of the Exchange Act between March 9, 2023 and January 3, 2024, and violations of Sections 14(a) and 20(a) of the Exchange Act in connection with the proxy statement issued in connection with the Spectrum Merger. The defendants are scheduled to file their motion to dismiss on August 9, 2024. The Company intends to vigorously defend itself in this matter.
Edwards v. Assertio Holdings, Inc., et al., Court of Chancery of the State of Delaware, Case No. 2024-0151. On February 19, 2024, this putative securities class action lawsuit was filed by a purported shareholder, alleging that certain former officers and directors of Spectrum breached their fiduciary duties in connection the Spectrum Merger and that Guggenheim Securities LLC and Assertio aided and abetted such fiduciary duty breaches. The defendants moved to dismiss the Edwards complaint on June 29, 2024. The plaintiff’s answering brief is due on August 28, 2024, and the defendants’ reply brief is due on September 27, 2024. The Company intends to vigorously defend itself in this matter.
Jung v. Peisert, et al., U.S. District Court, Delaware, Case No. 1:24-cv-00383-UNA. On March 26, 2024, this putative stockholder derivative action was filed against the Company (as a nominal defendant) and certain of its current and former executive officers and directors. The stockholder derivative complaint alleges, inter alia, that certain of the Company’s current and former executive officers and directors are liable to the Company, pursuant to Section 10(b) and 21(d) of the Exchange Act
for contribution and indemnification, relating to allegedly false or misleading statements and alleged failure to disclose material facts regarding the likely impact of INDOCIN sales and the Spectrum Merger on the Company’s profitability. The complaint further alleges that certain of the Company’s current and former officers and directors breached their fiduciary duties, and that certain of the Company’s 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 such matters. The allegations state that as a result of the violations, certain of the Company’s current and former executive officers and directors committed acts of gross mismanagement, abuse of control, or were unjustly enriched. The plaintiff generally seeks corporate reforms, damages, interest, costs, attorneys’ fees, and other unspecified equitable relief. The defendants’ deadline to respond to the complaint is September 6, 2024.
Hollin v. Mason, et al., U.S. District Court, Delaware, Case No. 1:24-cv-00785-UNA. On July 3, 2024, this putative stockholder derivative action was filed against the Company (as a nominal defendant) and certain of its current and former executive officers and directors. The stockholder derivative complaint is largely duplicative of the Jung stockholder derivative complaint described above.
Jung v. Lebel, et al., Court of Chancery of the State of Delaware, Case No. 2024-0821. On August 5, 2024, alleged former Spectrum stockholder and current Assertio stockholder Jung (the same plaintiff who previously filed Jung v. Peisert, et. al., in Delaware federal court, as discussed above) filed a stockholder derivative complaint in the Delaware Chancery Court against certain former Spectrum officers and directors and naming both Assertio and Spectrum as nominal defendants. The complaint is largely duplicative of the allegations in the ongoing Christiansen shareholder class action in the Southern District of New York (discussed below), alleging that Spectrum officers made various alleged misstatements regarding Spectrum’s application for FDA approval of poziotinib. Jung previously raised these allegations in a demand letter to Assertio’s Board of Directors (“the Board”), demanding that the Board take legal action against the individuals now named in this complaint. In response to Jung’s demand letter, the Board retained independent counsel, considered Jung’s demand, and provided a substantive response explaining the Board’s reasons for denying Jung’s demand. The complaint now alleges that the Board wrongfully refused his demand. Neither the Company nor the individual defendants have been served with the complaint and there is no schedule in place for responding to the complaint.
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 Biologic License Application (“BLA”) to the FDA for eflapegrastim (ROLVEDON) in violation of Section 10(b) (and Rule 10b-5 promulgated thereunder) and 20(a) of 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. On February 6, 2024, the Court held a hearing on the motion to dismiss and issued an order dismissing the lawsuit without prejudice to the lead plaintiff’s ability to replead their claims. The lead plaintiff filed a further amended complaint on March 29, 2024. On May 13, 2024, the defendants filed a motion to dismiss that further amended complaint, which was fully briefed as of July 22, 2024. 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. On January 23, 2024, the Court granted the motion to dismiss in part as to five of the challenged statements but denied the motion to dismiss as to two specific statements. The Company filed its answer to the complaint on March 8, 2024. Discovery is currently ongoing. 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) and 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 these derivative actions until there is a decision in the Luo Nevada securities class action either denying a motion to dismiss in whole or in part, or dismissing that securities class action with prejudice.
NOTE 16. 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) and the CVRs. 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
In connection with 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 partial settlement of the 2027 Convertible Notes (the “Exchanged Notes”). 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 six months ended June 30, 2023, related to the common stock share issuance, net of approximately $1.6 million of unamortized issuance costs related to the Exchanged Notes.
NOTE 17. 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 equivalents and convertible debt are considered to be potential common shares and are only included in the calculation of diluted net (loss) income per share when their effect is dilutive. The 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. The Company’s potentially dilutive stock-based awards and convertible debt were not included in the computation of diluted net loss per share for the three and six months ended June 30, 2024, because to do so would be anti-dilutive. For the three months ended June 30, 2023, the Company’s potentially dilutive convertible debt was included in the computation of diluted net income per share. However, for the six months ended June 30, 2023, the Company’s potentially dilutive convertible debt was not included in the computation of diluted net income per share, because to do so would be anti-dilutive.
The following table reflects the calculation of basic and diluted (loss) income per common share for the three and six months ended June 30, 2024 and 2023 (in thousands, except for per share amounts):
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended June 30, | | Six Months Ended June 30, |
| 2024 | | 2023 | | 2024 | | 2023 |
Basic net (loss) income per share | | | | | | | |
Net (loss) income | $ | (3,674) | | | $ | 8,470 | | | $ | (8,184) | | | $ | 4,986 | |
Weighted-average common shares outstanding | 95,240 | | | 56,142 | | | 95,110 | | | 53,588 | |
Basic net (loss) income per share | $ | (0.04) | | | $ | 0.15 | | | $ | (0.09) | | | $ | 0.09 | |
| | | | | | | |
Diluted net (loss) income per share | | | | | | | |
Net (loss) income | $ | (3,674) | | | $ | 8,470 | | | $ | (8,184) | | | $ | 4,986 | |
| | | | | | | |
Add: Convertible debt interest expense, net of tax | — | | | 563 | | | — | | | — | |
Adjusted net (loss) income | (3,674) | | | 9,033 | | | (8,184) | | | 4,986 | |
Weighted-average common shares and share equivalents outstanding | 95,240 | | | 56,142 | | | 95,110 | | | 53,588 | |
Add: effect of dilutive stock-based awards and equivalents | — | | | 4,234 | | | — | | | 4,422 | |
Add: effect of dilutive convertible debt under if-converted method | — | | | 9,768 | | | — | | | — | |
Denominator for diluted net (loss) income per share | 95,240 | | | 70,144 | | | 95,110 | | | 58,010 | |
Diluted net (loss) income per share | $ | (0.04) | | | $ | 0.13 | | | $ | (0.09) | | | $ | 0.09 | |
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 six months ended June 30, 2024 and 2023 (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended June 30, | | Six Months Ended June 30, |
| 2024 | | 2023 | | 2024 | | 2023 |
Convertible notes | 9,768 | | | — | | | 9,768 | | | 12,116 | |
Stock-based awards and equivalents | 9,624 | | | 721 | | | 9,023 | | | 548 | |
Total potentially dilutive common shares | 19,392 | | | 721 | | | 18,791 | | | 12,664 |
NOTE 18. 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 June 30, 2024 and December 31, 2023 (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
June 30, 2024 | | Financial Statement Classification | | Level 1 | | Level 2 | | Level 3 | | Total |
Assets | | | | | | | | | | |
| | | | | | | | | | |
Cash equivalents: | | | | | | | | | | |
U.S. Treasuries | | Cash and cash equivalents | | $ | — | | | $ | 7,761 | | | $ | — | | | $ | 7,761 | |
| | | | | | | | | | |
Money market funds | | Cash and cash equivalents | | 35,896 | | | — | | | — | | | 35,896 | |
Short-term investments: | | | | | | | | | | |
Commercial paper | | Short-term investments | | — | | | 3,964 | | | — | | | 3,964 | |
U.S. Treasuries | | Short-term investments | | — | | | 39,680 | | | — | | | 39,680 | |
Total | | | | $ | 35,896 | | | $ | 51,405 | | | $ | — | | | $ | 87,301 | |
Liabilities | | | | | | | | | | |
Short-term contingent consideration | | Contingent consideration, current portion | | $ | — | | | $ | — | | | $ | 2,700 | | | $ | 2,700 | |
| | | | | | | | | | |
Derivative liability | | Long-term debt | | — | | | — | | | 308 | | | 308 | |
Total | | | | $ | — | | | $ | — | | | $ | 3,008 | | | $ | 3,008 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
December 31, 2023 | | Financial Statement Classification | | Level 1 | | Level 2 | | Level 3 | | Total |
Assets | | | | | | | | | | |
| | | | | | | | | | |
Cash equivalents: | | | | | | | | | | |
U.S. Treasuries | | Cash and cash equivalents | | $ | — | | | $ | 35,458 | | | $ | — | | | $ | 35,458 | |
U.S. Government agencies | | Cash and cash equivalents | | — | | | 3,294 | | | — | | | 3,294 | |
Money market funds | | Cash and cash equivalents | | 32,534 | | | — | | | — | | | 32,534 | |
Total | | | | $ | 32,534 | | | $ | 38,752 | | | $ | — | | | $ | 71,286 | |
Liabilities | | | | | | | | | | |
Short-term contingent consideration | | Contingent consideration, current portion | | $ | — | | | $ | — | | | $ | 2,700 | | | $ | 2,700 | |
| | | | | | | | | | |
Derivative liability | | Long-term debt | | — | | | — | | | 308 | | | 308 | |
Total | | | | $ | — | | | $ | — | | | $ | 3,008 | | | $ | 3,008 | |
Cash and Cash Equivalents
The Company considers all highly liquid investments with a maturity date at 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, 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 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.
Short-Term Investments
The Company considers all highly liquid investments with a maturity date at purchase of more than three months and less than one year to be short-term investments. The Company’s short-term investments consist of marketable securities, including commercial paper and U.S. Treasury securities. The Company has classified its short-term investments as trading securities. The short-term investments are recorded at fair value using Level 2 inputs, 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. Gains and losses on short-term investments are included in Interest income in the Condensed Consolidated Statements of Comprehensive (Loss) Income.
The Company recognized no unrealized gains from its short-term investments classified as trading securities for the three and six months ended June 30, 2024, and unrealized losses from short-term investments classified as trading securities recognized for the three and six months ended June 30, 2024 were immaterial. The Company had no short-term investments classified as trading securities during the three and six months ended June 30, 2023.
Contingent Consideration Obligations
Spectrum Merger Contingent Variable Rights
In connection with the Spectrum Merger, the Company issued CVRs (See Note 2, Acquisitions) that represent a contingent consideration obligation which is measured at fair value.
As of both June 30, 2024 and December 31, 2023, the fair value of the Company’s CVR liability related to the Spectrum Merger was determined by the Company to be zero. Accordingly, the Company recognized no expense or benefit for the change in fair value of the CVR contingent consideration during the three and six months ended June 30, 2024. 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 June 30, 2024 included 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
In connection with 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 Level 3, due to the lack of relevant observable inputs and market activity. As of both June 30, 2024 and December 31, 2023, the fair value of the INDOCIN product contingent consideration was determined to be $2.7 million and has been classified as Contingent consideration, current in the Company’s Condensed Consolidated Balance Sheets.
During each of the three and six months ended June 30, 2024, the Company recognized an expense of zero for the change in fair value of contingent consideration. During the three and six months ended June 30, 2023, the Company recognized an expense of $0.2 million and $9.4 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. The fair value of the contingent consideration incurred in the Zyla Merger is determined using an option pricing model under the income approach based on estimated INDOCIN product net sales through January 2029 and discounted to present value. The significant assumptions used in the calculation of the fair value as of June 30, 2024 included updated projections of future INDOCIN product net sales.
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 six months ended June 30, 2024 and 2023 (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended June 30, | | Six Months Ended June 30, |
| 2024 | | 2023 | | 2024 | | 2023 |
Fair value, beginning of the period | $ | 2,700 | | | $ | 51,058 | | | $ | 2,700 | | | $ | 48,500 | |
| | | | | | | |
Change in fair value of contingent consideration recorded within costs and expenses | — | | | 241 | | | — | | | 9,408 | |
Cash payment related to contingent consideration | — | | | (8,799) | | | — | | | (15,408) | |
Fair value, end of the period | $ | 2,700 | | | $ | 42,500 | | | $ | 2,700 | | | $ | 42,500 | |
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 $0.3 million as of both June 30, 2024 and December 31, 2023, 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. The significant assumption used in the binomial lattice model is a credit spread of 8.8%.
There was no change in the fair value of the derivative liability for the three and six months ended June 30, 2024 or 2023.
Financial Instruments Not Required to be Remeasured at Fair Value
The Company’s other financial assets and liabilities are not remeasured to fair value, as the carrying cost of each approximates its fair value. As of June 30, 2024, the estimated fair value of the 2027 Convertible Notes, excluding the bifurcated embedded conversion option, was approximately $34.7 million, compared to a par value of $40.0 million. As of December 31, 2023, the estimated fair value of the 2027 Convertible Notes, excluding the bifurcated embedded conversion option, was approximately $35.7 million, compared to a par value of $40.0 million. The Company estimated the fair value of its 2027 Convertible Notes as of June 30, 2024 and December 31, 2023 based on a market approach, which represents a Level 2 valuation.
NOTE 19. INCOME TAXES
As of June 30, 2024, the Company has concluded that it is not more likely than not that it will realize the net deferred tax asset recorded as of June 30, 2024. As a result, the Company has recorded a full valuation allowance against the net deferred tax asset recorded as of June 30, 2024. 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 Company primarily relied on its reversing taxable temporary differences to assess its valuation allowance, which resulted in recording a full valuation allowance against its net deferred tax assets during the quarter. 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 six months ended June 30, 2024, the Company recorded an income tax expense of $0.1 million and $0.3 million, respectively, which represents an effective tax rate of (4.2)% and (3.6)%, respectively. The difference between the income tax expense 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 and state income taxes.
For the three and six months ended June 30, 2023, the Company recorded an income tax expense of $3.9 million and $1.8 million, respectively, which represents an effective tax rate of 31.3% and 26.0%, 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 state taxes, disallowed officer’s compensation, and capital expenses, offset by a partial reversal of previously recorded valuation allowance in those periods.
NOTE 20. 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 does not expect to recognize any additional restructuring charges related to the Spectrum Reorganization Plan. The Company expects all cash payments under the Spectrum Reorganization Plan to be completed by the end of 2025.
The staff reductions under the Spectrum Reorganization Plan were the result of a distinct severance plan approved by the Board and were not executed as part of established Company policies or plans. Total employee compensation costs recognized under the Spectrum Reorganization Plan through June 30, 2024, were approximately $3.3 million. In addition, the leased facilities and office equipment referenced above are not expected to be used for any business purpose, and the Company will not sublease the facilities and office equipment due to the short remaining lease terms. 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 recognized under the Spectrum Reorganization Plan through June 30, 2024, were
approximately $1.3 million. There are no remaining facility exit costs expected to be recognized by the Company under the Spectrum Reorganization Plan as of June 30, 2024.
Effective January 2, 2024, the Company separated from the service of its former President and Chief Executive Officer. Pursuant to his then existing Management Continuity Agreement with the Company, the former President and Chief Executive Officer was entitled to severance compensation and benefits of approximately $1.5 million, which was recognized as Restructuring charges within the Condensed Consolidated Statement of Comprehensive (Loss) Income for year ended December 31, 2023, the period in which the separation and related severance benefit was determined to be probable. The Company does not expect to recognize any additional restructuring charges related to the separation from the former President and Chief Executive Officer.
The Company recognized restructuring charges of zero and $0.7 million for the three and six months ended June 30, 2024, respectively, all of which related to employee compensation costs. The Company recognized no restructuring charges for the three and six months ended June 30, 2023.
The following table summarizes the changes in the Company’s accrued restructuring liability for employee compensation costs, which is classified within Accrued liabilities in the Condensed Consolidated Balance Sheets (in thousands):
| | | | | | | | | |
| Employee compensation costs | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
Balance as of December 31, 2023 | $ | 4,378 | | | | | |
| | | | | |
Restructuring charges | 720 | | | | | |
Cash paid | (2,768) | | | | | |
Balance as of June 30, 2024 | $ | 2,330 | | | | | |
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
FORWARD-LOOKING INFORMATION
Statements made in this “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this Quarterly Report on Form 10-Q that are not statements of historical fact are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, 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 “anticipate,” “approximate”, “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “may,” “might,” “opportunity,” “plan,” “potential,” “project,” “prospective,” “pursue,” “seek,” “should,” “strategy,” “target,” “will” 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. Examples of forward-looking statements include, but are not necessarily limited to, those relating to:
•our ability to grow sales of ROLVEDON and the commercial success and market acceptance of ROLVEDON and our other products, including the coverage of our products by payors and pharmacy benefit managers;
•our ability to successfully develop and execute our sales, marketing and promotion strategies using our sales force and non-personal promotion model capabilities, including developing and maintaining relationships with customers, physicians, payors and other constituencies;
•the entry and sales of generics of our products and/or other products competitive with any of our products (including indomethacin suppositories compounded by hospitals and other institutions including a 503B compounder which we believe is violating certain provisions of the Food, Drug and Cosmetic Act);
•the timing and impact of additional generic approvals and uncertainty around the recent approvals and launches of generic 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 January 2024 approval and subsequent launch of a generic indomethacin oral suspension product) 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 liabilities and costs associated with integrating and operating newly-acquired products, including our expectations around the sales and growth prospects 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 executive leadership and key employees;
•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 government investigations, including pending and potential future shareholder litigation relating to the Spectrum Merger and/or the approval and launch of generic indomethacin suppositories in the second half of 2023, antitrust litigation, opioid-related government investigations and opioid-related litigation, the recently unsealed qui tam litigation, as well as Spectrum’s legacy shareholder and other litigation, and other disputes and litigation, and the costs and expenses associated therewith;
•the timing, cost and results of our clinical studies and other research and development efforts, including the extent to which data from the ROLVEDON same-day dosing trial may support our ongoing commercialization efforts;
•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.”);
•the potential impacts of future outbreaks of epidemics, pandemics or other diseases on our liquidity, capital resources, operations and business and those of the third parties on which we rely, including suppliers and distributors;
•our ability to 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 estimation, projection or availability of net operating losses or credit carryforwards;
•the potential impacts of adverse business and economic conditions including inflationary pressures, economic slowdown or recession, relatively high interest rates, changes in monetary policy, potential U.S. federal government shutdowns, geopolitical conflicts 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, particularly in light of our stock trading below or only slightly above $1.00 per share recently.
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, 2023, filed with the Securities and Exchange Commission on March 11, 2024 (the “2023 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.
COMPANY OVERVIEW
We are a pharmaceutical company with comprehensive commercial capabilities offering differentiated products to patients. We have built our product portfolio through the acquisition or licensing of approved products. Our commercial capabilities include marketing through both a sales force and a non-personal promotion model, market access through payor contracting, and trade and distribution. Our primary marketed products are:
| | | | | |
ROLVEDONTM (eflapegrastim-xnst) injection for subcutaneous use | A long-acting granulocyte colony-stimulating factor (G-CSF) with a novel formulation that is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. |
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 |
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. |
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. |
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 relief in 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. |
| |
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 Pharmaceuticals, Inc. (“Spectrum”), a commercial stage biopharmaceutical company focused on novel and targeted oncology products (the “Spectrum Merger”), through a merger of a wholly-owned subsidiary of the Company with and into Spectrum, with Spectrum surviving the merger as a wholly-owned subsidiary of the Company. 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) or were 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.
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 are related to product sales in the U.S.
RESULTS OF OPERATIONS
Comparison of the three months ended June 30, 2024 to the three months ended March 31, 2024 and June 30, 2023
The following table reflects (loss) income from operations for the three months ended June 30, 2024, March 31, 2024, and June 30, 2023 (in thousands):
| | | | | | | | | | | | | | | | | |
| Three Months Ended |
| June 30, 2024 | | March 31, 2024 | | June 30, 2023 |
Product sales, net: | | | | | |
ROLVEDON | $ | 15,144 | | $ | 14,478 | | | $ | — | |
INDOCIN products | 6,913 | | 8,682 | | | 28,075 | |
Sympazan | 2,668 | | 2,617 | | | 2,627 | |
Otrexup | 2,014 | | 2,882 | | | 3,594 | |
SPRIX | 2,147 | | 1,437 | | | 2,373 | |
CAMBIA | 1,403 | | 1,256 | | | 1,805 | |
| | | | | |
Other products | 406 | | 510 | | | 1,609 | |
Total product sales, net | 30,695 | | 31,862 | | | 40,083 | |
Royalties and milestone revenue | 431 | | 586 | | | 723 | |
Other revenue | — | | | — | | | 185 | |
Total revenues | 31,126 | | 32,448 | | | 40,991 | |
Costs and expenses: | | | | | |
Cost of sales | 8,889 | | 11,177 | | | 4,772 | |
Research and development expenses | 798 | | 733 | | | 503 | |
Selling, general and administrative expenses | 18,385 | | 18,524 | | | 16,771 | |
Change in fair value of contingent consideration | — | | — | | | 241 | |
Amortization of intangible assets | 6,671 | | 5,631 | | | 6,284 | |
| | | | | |
Restructuring charges | — | | 720 | | | — | |
Total costs and expenses | 34,743 | | | 36,785 | | | 28,571 | |
(Loss) income from operations | $ | (3,617) | | | $ | (4,337) | | | $ | 12,420 | |
Product Sales, net
As a result of the Spectrum Merger, we began recognizing ROLVEDON sales in August 2023. ROLVEDON net product sales were $15.1 million for the three months ended June 30, 2024, compared to $14.5 million for the three months ended March 31, 2024. The quarter-over-quarter increase of $0.7 million was primarily due to volume growth, partially offset by lower net pricing.
INDOCIN net product sales for the three months ended June 30, 2024 were $6.9 million, a decrease of $1.8 million from net product sales of $8.7 million for the three months ended March 31, 2024, and a decrease of $21.2 million from net product sales of $28.1 million for the three months ended June 30, 2023. The decrease for the three months ended June 30, 2024 compared to both prior periods is primarily due to lower volume and pricing as a result of the August 2023 approval and launch of generic indomethacin suppositories. In the remainder of 2024, we expect INDOCIN net product sales to continue to be impacted unfavorably by increasing competition as a result of existing generic entrants, expected future generic entrants and other competitive products.
Sympazan net product sales for the three months ended June 30, 2024 were $2.7 million, an increase of $0.1 million from net product sales of $2.6 million for each of three months ended March 31, 2024 and June 30, 2023. The increase for the three months ended June 30, 2024 compared to March 31, 2024 is primarily due to favorable payor mix, partially offset by lower volume. The increase for the three months ended June 30, 2024 compared to June 30, 2023 is primarily due to higher volume and favorable payor mix.
Otrexup net product sales for the three months ended June 30, 2024 were $2.0 million, a decrease of $0.9 million from net product sales of $2.9 million for the three months ended March 31, 2024, and a decrease of $1.6 million from net product
sales of $3.6 million for the three months ended June 30, 2023. The decrease for the three months ended June 30, 2024 compared to the three months ended March 31, 2024 is primarily due to unfavorable payor mix, while the decrease for the three months ended June 30, 2024 compared to the three months ended June 30, 2023 was due to lower volume and unfavorable payor mix.
SPRIX net product sales for the three months ended June 30, 2024 were $2.1 million, an increase of $0.7 million from net product sales of $1.4 million for the three months ended March 31, 2024, primarily driven by higher volume, and a decrease of $0.2 million from net product sales of $2.4 million for the three months ended June 30, 2023, primarily driven by lower volume.
CAMBIA net product sales for the three months ended June 30, 2024 were $1.4 million, an increase of $0.1 million from net product sales of $1.3 million for the three months ended March 31, 2024, primarily driven by higher volume and partially offset by unfavorable payor mix, and a decrease of $0.4 million from net product sales of $1.8 million for the three months ended June 30, 2023, primarily due to lower volume caused by generic entrants in 2023.
Other net product sales for the three months ended June 30, 2023 includes sales of OXAYDO of $0.6 million and net product sales of Zipsor of $1.0 million. As we ceased OXAYDO product sales beginning in September 2023, other net product sales for the three months ended June 30, 2024 and March 31, 2024 of $0.4 million and $0.5 million, respectively, represent only net product sales of Zipsor.
The decrease in total product sales, net, for the three months ended June 30, 2024 as compared to the three months ended March 31, 2024 and three months ended June 30, 2023, also reflects a year-over-year increase in the amounts charged as a reduction to revenue for sales and return allowances, discounts, chargebacks, and rebates, which is primarily attributed to a shift in product mix with the addition of ROLVEDON and the decrease in product sales of INDOCIN.
Royalties & Milestone Revenue
In November 2010, we entered into a license agreement granting Tribune Pharmaceuticals Canada Ltd. (now known as Miravo Pharmaceuticals, or “Miravo”) the rights to commercially market CAMBIA in Canada. Miravo independently contracts with manufacturers to produce a specific CAMBIA formulation in Canada. We recognized royalties revenue related to the CAMBIA license agreement of $0.4 million for each of the three months ended June 30, 2024 and 2023, respectively, and $0.6 million for the three months ended March 31, 2024.
We recognized no milestone revenue associated with the completion of certain service milestones for each of the three months ended June 30, 2024 and March 31, 2024, and milestone revenue associated with the completion of certain service milestones of $0.3 million for the three months ended June 30, 2023.
Cost of Sales
Cost of sales consists of costs of the active pharmaceutical ingredient, contract manufacturing and packaging costs, royalties payable to third parties, inventory write downs, product quality testing, internal employee costs related to the manufacturing process, distribution costs, and shipping costs related to our product sales. Cost of sales excludes the amortization of intangible assets. Fair value of inventories acquired through business combinations or asset acquisitions include an inventory step-up within the value of inventories. The inventory step-up value is amortized as the related inventory is sold and is included in cost of sales.
Cost of sales for the three months ended June 30, 2024 decreased $2.3 million from $11.2 million for the three months ended March 31, 2024 to $8.9 million for the three months ended June 30, 2024, primarily due a decrease in cost of sales related to ROLVEDON, including a quarter-over-quarter decrease in inventory step-up amortization of $3.6 million, and $1.1 million of ROLVEDON inventory write downs included in the three months ended March 31, 2024 that did not recur. The decrease in cost of sales was partially offset by a net increase of $2.0 million of non-ROLVEDON inventory write downs and a $0.4 million increase due to product mix for the three months ended June 30, 2024.
Cost of sales for the three months ended June 30, 2024 increased $4.1 million from $4.8 million for the three months ended June 30, 2023 to $8.9 million for the three months ended June 30, 2024, primarily due a $3.5 million increase in cost of sales related to ROLVEDON, and $1.9 million of non-ROLVEDON inventory write downs. The increase was partially offset by the impact of product mix, which decreased cost of sales by $1.3 million for the three months ended June 30, 2024 compared to the three months ended June 30, 2023.
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. For the remainder of 2024, we expect Cost of sales, as a percentage of sales, to be higher due to changes in product volume and mix when compared to 2023.
Research and Development Expenses
Research and development expenses include salaries, costs for ongoing 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 or ongoing clinical trials and studies and the U.S. Food and Drug Administration’s (“FDA”) 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 increased $0.1 million from $0.7 million for the three months ended March 31, 2024, to $0.8 million for the three months ended June 30, 2024, primarily due to higher costs associated with ongoing clinical activity for ROLVEDON.
Research and development expenses increased $0.3 million from $0.5 million for the three months ended June 30, 2023, to $0.8 million for the three months ended June 30, 2024, primarily due to $0.6 million of costs associated with ongoing clinical activity for ROLVEDON included in the three months ended June 30, 2024, partially offset by a decrease of $0.2 million in costs associated with the planned clinical trial for INDOCIN® (indomethacin) suppositories.
Selling, General and Administrative Expenses
Selling, general and administrative expenses primarily consist of personnel, contract personnel, marketing and promotion expenses associated with our commercial products, personnel expenses to support our administrative and operating activities, facility costs, and professional expenses, such as legal and accounting fees.
Selling, general and administrative expenses decreased $0.1 million from $18.5 million for the three months ended March 31, 2024 to $18.4 million for the three months ended June 30, 2024, primarily due to (i) the recognition of a $1.9 million insurance reimbursement in the three months ended June 30, 2024 for previous opioid-related legal expenses, and (ii) a decrease of $0.9 million in personnel expenses in the three months ended June 30, 2024 compared to the three months ended March 31, 2024. This was partially offset by (i) $1.8 million of higher legal expenses, and (ii) a net increase of $0.9 million in other general operating expenses.
Selling, general and administrative expenses increased $1.6 million from $16.8 million for the three months ended June 30, 2023 to $18.4 million for the three months ended June 30, 2024, primarily due to (i) $2.2 million of expenses related to ROLVEDON, of which there were none in the prior year period, (ii) $2.8 million of higher legal expenses, (iii) $2.5 million of higher personnel expenses, and (iv) a net increase of $0.3 million in other general operating expenses. These increases were partially offset by (i) a $3.5 million decrease in transaction-related expenses associated with the Spectrum Merger, (ii) the recognition of a $1.9 million insurance reimbursement in the three months ended June 30, 2024 for previous opioid-related legal expenses, and (iii) a decrease of $0.8 million in stock-based compensation expense.
Change in Fair Value of Contingent Consideration
In connection with the Spectrum Merger, we issued CVRs that represent a contingent consideration obligation which is measured at fair value. See Company Overview for further information. 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 values of both contingent consideration obligations are remeasured each reporting period, with changes in the fair value of each of the contingent consideration obligations resulting from changes in the respective underlying inputs being recognized in operating expenses until both the contingent consideration obligation arrangements are settled.
For each of the three months ended June 30, 2024 and March 31, 2024 we recognized an expense of zero for the change in fair value of contingent consideration. For the three months ended June 30, 2023, we recognized an expense of $0.2 million for the change in fair value of contingent consideration.
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. As of June 30, 2024 and December 31, 2023, the fair value of the CVR liability was determined to be zero. The significant assumptions used in the calculation of the fair value as of June 30, 2024, included updated projections of future ROLVEDON 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 net sales through January 2029, and discounted to present value. As of both June 30, 2024 and December 31, 2023, the fair value of the INDOCIN product contingent consideration was determined to be $2.7 million. The significant assumption used in the calculation of the fair value as of June 30, 2024 included updated projections of future INDOCIN product net sales.
Amortization of Intangible Assets
The following table reflects amortization of intangible assets for the three months ended June 30, 2024, March 31, 2024, and June 30, 2023 (in thousands):
| | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended | | |
| June 30, 2024 | | March 31, 2024 | | June 30, 2023 | | | | |
Amortization of intangible assets—ROLVEDON | $ | 1,516 | | | $ | 1,517 | | $ | — | | | | | |
Amortization of intangible assets—INDOCIN | 3,640 | | | 2,598 | | 3,211 | | | | | |
Amortization of intangible assets—Sympazan | 302 | | | 303 | | 303 | | | | | |
Amortization of intangible assets—Otrexup | 261 | | | 261 | | 1,378 | | | | | |
Amortization of intangible assets—SPRIX | 952 | | | 952 | | 1,392 | | | | | |
| | | | | | | | | |
| | | | | | | | | |
Total | $ | 6,671 | | | $ | 5,631 | | $ | 6,284 | | | | | |
Amortization expense for the three months ended June 30, 2024 was $6.7 million, an increase of $1.0 million from amortization expense of $5.6 million for the three months ended March 31, 2024, and an increase of $0.4 million from amortization expense of $6.3 million for the three months ended June 30, 2023. The increase for the three months ended June 30, 2024 compared to March 31, 2024 is primarily due to a revision to the remaining estimated useful life of the INDOCIN product rights intangible assets to 1.3 years as of April 1, 2024, which increased amortization expense by $1.0 million. We believe the revised remaining estimated useful life better reflects the realization of the economic benefit of the intangible asset. The increase for the three months ended June 30, 2024 compared to June 30, 2023 is primarily due to the additional amortization of the ROLVEDON product rights, acquired in July 2023, offset by a lower amortization due to impairment charges recognized in the third and fourth quarters of 2023.
As of June 30, 2024, the estimated undiscounted cash flows of the INDOCIN and SPRIX assets groups exceeded their respective carrying values by approximately 10% and 20%, respectively. The sum of the undiscounted cash flows could continue to decrease in the event of significant unfavorable changes in their estimated undiscounted future cash flows due to increased competition and, in the case of INDOCIN, due to potential future generic entrants. Any significant unfavorable changes in the estimated undiscounted future cash flows would also impact the related assets, such as inventory, leading to potential charges in addition to a potential impairment. Any future impairment of our long-lived assets, including INDOCIN and SPRIX, may result in material charges that could have a material adverse effect on the Company’s business and financial results.
Restructuring Charges
Restructuring charges were zero for each of the three months ended June 30, 2024 and June 30, 2023, and $0.7 million for the three months ended March 31, 2024. 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 do not expect to recognize any additional restructuring charges related to the Spectrum Reorganization Plan. We expect all cash payments under the Spectrum Reorganization Plan to be completed by the end of 2025.
We regularly evaluate our operations to identify opportunities to streamline operations and optimize operating efficiencies as an anticipation to changes in the business environment.
Comparison of the six months ended June 30, 2024 to the six months ended June 30, 2023
The following table reflects (loss) income from operations for the six months ended June 30, 2024 and 2023 (in thousands):
| | | | | | | | | | | | | | |
| | Six Months Ended June 30, |
| | 2024 | | 2023 |
Product sales, net: | | | | |
ROLVEDON | | $ | 29,622 | | $ | — | |
INDOCIN products | | 15,596 | | 58,421 | |
Sympazan | | 5,285 | | 5,129 | |
Otrexup | | 4,896 | | 6,416 | |
SPRIX | | 3,584 | | 4,262 | |
CAMBIA | | 2,660 | | 4,069 | |
| | | | |
Other products | | 914 | | 3,555 | |
Total product sales, net | | 62,557 | | 81,852 | |
Royalties and milestone revenue | | 1,017 | | 1,420 | |
Other revenue | | — | | | 185 | |
Total revenues | | 63,574 | | 83,457 | |
Costs and expenses: | | | | |
Cost of sales | | 20,066 | | | 10,239 | |
Research and development expenses | | 1,531 | | | 503 | |
Selling, general and administrative expenses | | 36,909 | | | 33,675 | |
Change in fair value of contingent consideration | | — | | | 9,408 | |
Amortization of intangible assets | | 12,302 | | | 12,568 | |
| | | | |
Restructuring charges | | 720 | | | — | |
Total costs and expenses | | 71,528 | | | 66,393 | |
(Loss) income from operations | | $ | (7,954) | | | $ | 17,064 | |
Product Sales, net
ROLVEDON net product sales were $29.6 million for the six months ended June 30, 2024.
INDOCIN net product sales for the six months ended June 30, 2024 were $15.6 million, a decrease of $42.8 million from net product sales of $58.4 million for the six months ended June 30, 2023, primarily due to lower volume and pricing as a result of the August 2023 approval and launch of generic indomethacin suppositories. In the remainder of 2024, we expect INDOCIN net product sales to continue to be impacted unfavorably by increasing competition as a result of existing generic entrants, expected future generic entrants and other competitive products.
Sympazan net product sales for the six months ended June 30, 2024 were $5.3 million, an increase of $0.2 million from net product sales of $5.1 million for the six months ended June 30, 2023, primarily due to favorable payor mix.
Otrexup net product sales for the six months ended June 30, 2024 were $4.9 million, a decrease of $1.5 million from net product sales of $6.4 million for the six months ended June 30, 2023, primarily due to lower volume and unfavorable payor mix.
SPRIX net product sales for the six months ended June 30, 2024 were $3.6 million, a decrease of $0.7 million from net product sales of $4.3 million for the six months ended June 30, 2023, primarily due to lower volume.
CAMBIA net product sales for the six months ended June 30, 2024 were $2.7 million, a decrease of $1.4 million from net product sales of $4.1 million for the six months ended June 30, 2023, primarily due to lower volume caused by generic entrants in 2023.
Other net product sales for the six months ended June 30, 2023 include net product sales for Zipsor of $2.2 million and net product sales for OXAYDO of $1.4 million. As we ceased OXAYDO product sales beginning in September 2023, other net product sales for the six months ended June 30, 2024 of $0.9 million represent only net product sales of Zipsor.
The decrease in total product sales, net, for the six months ended June 30, 2024 as compared to the six months ended June 30, 2023, also reflects a year-over-year increase in the amounts charged as a reduction to revenue for sales and return allowances, discounts, chargebacks, and rebates, which is primarily attributed to a shift in product mix with the addition of ROLVEDON and the decrease in product sales of INDOCIN and CAMBIA.
Royalties & Milestone Revenue
We recognized royalties revenue related to the CAMBIA license agreement of $1.0 million for each of the six months ended June 30, 2024 and 2023.
We recognized no milestone revenue associated with the completion of certain service milestones for the six months ended June 30, 2024, and $0.5 million and for the six months ended months ended June 30, 2023.
Cost of Sales
Cost of sales for the six months ended June 30, 2024 increased $9.8 million from $10.2 million for the six months ended June 30, 2023 to $20.1 million for the six months ended June 30, 2024, primarily due an $11.5 million increase in cost of sales related to ROLVEDON, and a $0.5 million increase in other cost of sales. The increase was partially offset by a decline of $2.2 million in INDOCIN cost of sales due to lower INDOCIN product sales.
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. For the remainder of 2024, we expect Cost of sales, as a percentage of sales, to be higher due to changes in product volume and mix when compared to 2023.
Research and Development Expenses
Research and development expenses increased $1.0 million from $0.5 million for the six months ended June 30, 2023 to $1.5 million for the three months ended June 30, 2024, primarily due to $1.0 million of costs associated with ongoing clinical activity for ROLVEDON included in the six months ended June 30, 2024.
Selling, General and Administrative Expenses
Selling, general and administrative expenses increased $3.2 million from $33.7 million for the six months ended June 30, 2023 to $36.9 million for the six months ended June 30, 2024, primarily due to (i) $5.7 million of higher personnel expenses following the Spectrum Merger (ii) $4.4 million related to ROLVEDON, of which there were none in the prior year period, and (iii) $2.8 million of higher legal expenses. These increases were partially offset by (i) $5.8 million of lower transaction-related expenses associated with the Spectrum Merger, (ii) a $2.0 million decrease in stock-based compensation expense, and (iii) the recognition of a $1.9 million insurance reimbursement in the six months ended June 30, 2024 for previous opioid-related legal expenses.
Change in Fair Value of Contingent Consideration
For the six months ended June 30, 2024 and 2023, we recognized an expense of zero and $9.4 million, respectively, for the change in fair value of contingent consideration. For information regarding the period-on-period decrease for the six months ended June 30, 2024 and 2023, see “RESULTS OF OPERATIONS--Comparison of the three months ended June 30, 2024 to the three months ended March 31, 2024 and June 30, 2023—Change in Fair Value of Contingent Consideration” above.
Amortization of Intangible Assets
The following table reflects amortization of intangible assets for the six months ended June 30, 2024 and 2023 (in thousands):
| | | | | | | | | | | | | | | |
| | | Six Months Ended June 30, |
| | | | | 2024 | | 2023 |
Amortization of intangible assets—ROLVEDON | | | | | $ | 3,033 | | | $ | — |
Amortization of intangible assets—INDOCIN | | | | | 6,238 | | | 6,421 | |
Amortization of intangible assets—Sympazan | | | | | 605 | | | 606 |
Amortization of intangible assets—Otrexup | | | | | 522 | | | 2,755 | |
Amortization of intangible assets—SPRIX | | | | | 1,904 | | | 2,786 | |
| | | | | | | |
| | | | | | | |
Total | | | | | $ | 12,302 | | | $ | 12,568 | |
Amortization expense decreased $0.3 million from $12.6 million for the six months ended June 30, 2023 to $12.3 million for the six months ended June 30, 2024, primarily due to lower amortization as a result of impairment charges recognized in the third and fourth quarters of 2023, partially offset by the amortization of the ROLVEDON product rights, acquired in July 2023.
For information regarding our impairment assessment of the INDOCIN and SPRIX asset groups as of June 30, 2024 and 2023, see “RESULTS OF OPERATIONS—Comparison of the three months ended June 30, 2024 to the three months ended March 31, 2024 and June 30, 2023—Amortization of Intangible Assets” above.
Restructuring Charges
Restructuring charges were $0.7 million and zero for the six months ended June 30, 2024 and 2023, respectively. For information regarding our reorganization plan associated with the Spectrum Merger, see “RESULTS OF OPERATIONS—Comparison of the three months ended June 30, 2024 to the three months ended March 31, 2024 and June 30, 2023—Restructuring Charges” above.
The following is a discussion of Other Income (Expense) and Income Tax Provision for the three and six months ended June 30, 2024 and 2023:
Other Income (Expense)
The following table reflects other income (expense) for the three and six months ended June 30, 2024 and 2023 (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended June 30, | | Six Months Ended June 30, |
| 2024 | | 2023 | | 2024 | | 2023 |
Debt-related expenses | $ | — | | | $ | — | | | $ | — | | | $ | (9,918) | |
Interest expense | (758) | | | (751) | | | (1,515) | | | (1,873) | |
Interest income | 842 | | | 650 | | | 1,554 | | | 1,109 | |
Other income | 8 | | | 11 | | | 12 | | | 354 | |
Total other income (expense) | $ | 92 | | | $ | (90) | | | $ | 51 | | | $ | (10,328) | |
Total other income (expense) changed by $0.2 million from expense of $0.1 million for the three months ended June 30, 2023 to income of $0.1 million for the three months ended June 30, 2024.
Total other income (expense) changed by $10.4 million from expense of $10.3 million for the six months ended June 30, 2023, to income of $0.1 million for the six months ended June 30, 2024, primarily due to debt-related expenses incurred in the prior year, lower interest expense, and higher interest income due to investment in short-term investments in the three and six months ended June 30, 2024. Debt related expenses for the six months ended June 30, 2023 consisted 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 further described under the heading “Liquidity and Capital Resources” below. There were no similar debt-related expenses in the six months ended June 30, 2024.
The following table reflects interest expense for the three and six months ended June 30, 2024 and 2023 (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended June 30, | | Six Months Ended June 30, |
| 2024 | | 2023 | | 2024 | | 2023 |
Interest payable on 2027 Convertible Notes | $ | 650 | | | $ | 650 | | | $ | 1,300 | | | $ | 1,625 | |
| | | | | | | |
| | | | | | | |
Amortization of debt issuance costs | 108 | | | 101 | | | 215 | | | 248 | |
Total interest expense | $ | 758 | | | $ | 751 | | | $ | 1,515 | | | $ | 1,873 | |
Total interest expense for each of the three months ended June 30, 2024 and 2023 was $0.8 million. Total interest expense decreased $0.4 million from $1.9 million for the six months ended June 30, 2023 to $1.5 million for the six months ended June 30, 2024, primarily due to a lower principal balance of our outstanding 6.5% Convertible Senior Notes due 2027.
Income Tax Provision
For the three and six months ended June 30, 2024, we recorded an income tax expense of $0.1 million and $0.3 million, respectively, which represents an effective tax rate of (4.2)% and (3.6)%, respectively. The difference between the income tax expense and the tax at the federal statutory rate of 21.0% on current year operations is primarily due to the impact of the valuation allowance and state income taxes. As of June 30, 2024, we concluded that it is not more likely than not that we will realize the net deferred tax asset recorded as of June 30, 2024. As a result, we have recorded a full valuation allowance against the net deferred tax asset as of June 30, 2024.
For the three and six months ended June 30, 2023, we recorded an income tax expense of $3.9 million and $1.8 million, respectively, which represents an effective tax rate of 31.3% and 26.0%, respectively. The difference between the income tax expense and the tax at the federal statutory rate of 21.0% was principally due to state taxes, disallowed officer’s compensation, and capital expenses, offset by a partial reversal of previously recorded valuation allowance in those periods.
LIQUIDITY AND CAPITAL RESOURCES
We have and continue to finance our operations and business development efforts primarily from product sales, private and public sales of equity securities, including convertible debt securities, the proceeds of secured borrowings, the sale of rights to future royalties and milestones, upfront license, milestone and fees from collaborative and license partners.
On August 22, 2022, we issued $70.0 million aggregate principal amount of 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”). 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 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 June 30, 2024.
We believe that our existing cash and cash equivalents and short-term investments 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 differences between the actual cash impacts and our expected impacts related to 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 manage supply costs and 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, our former drug Glumetza, and the recently unsealed qui tam litigation;
•potential expenses and/or termination expenses if a decision is made to cease development of Spectrum’s de-prioritized development asset poziotinib; 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 agreement, or product acquisitions and strategic transactions that we may pursue could have a material adverse effect on the Company.
The following table reflects summarized cash flow activities for the six months ended June 30, 2024 and 2023 (in thousands):
| | | | | | | | | | | | | | |
| | Six Months Ended June 30, |
| | 2024 | | 2023 |
Net cash provided by operating activities | | $ | 14,895 | | | $ | 41,318 | |
Net cash used in investing activities | | (43,320) | | | (808) | |
Net cash used in financing activities | | (281) | | | (35,276) | |
Net (decrease) increase in cash and cash equivalents | | $ | (28,706) | | | $ | 5,234 | |
Cash Flows from Operating Activities
Cash provided by operating activities was $14.9 million for the six months ended June 30, 2024 compared to $41.3 million for the six months ended June 30, 2023, primarily due to lower net income, partially offset by favorable working capital cash flows compared to last year.
For the six months ended June 30, 2024, net loss was $8.2 million compared to net income of $5.0 million for the six months ended June 30, 2023. For the six months ended June 30, 2024, adjustments for non-cash items contributed approximately $18.4 million less to operating cash flows compared to the same period in 2023, primarily due to debt-related expenses of $9.9 million and an expense of $9.4 million for the change in fair value of contingent consideration, both of which did not recur in the current year period. For the six months ended June 30, 2024, net working capital cash generated by operations of approximately $4.3 million was $5.2 million higher than net working capital cash used in operations of approximately $0.9 million in the same period in 2023, primarily due to less cash used in the settlement of accrued rebates, returns and discounts due to impact of sales product mix as well as timing of settlement, and increased cash from accounts receivable payments, partially offset by increased cash used in the settlement of accounts payable and other accrued liabilities due to payments under the Spectrum Reorganization Plan.
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, and cash flows from operating activities in future periods may vary significantly from those in prior periods as a result of these factors.
Cash Flows from Investing Activities
Cash used in investing activities for the six months ended June 30, 2024, was $43.3 million, which consisted entirely of purchases of short-term investments in highly liquid marketable securities with a maturity date at purchase of more than three months and less than one year. Cash used in investing activities for the six months ended June 30, 2023, was $0.8 million, which consisted of cash paid for purchases of property and equipment of $0.5 million and cash paid for transaction costs incurred with the acquisition of Sympazan of $0.3 million.
Cash Flows from Financing Activities
Cash used in financing activities for the six months ended June 30, 2024, was $0.3 million, which consisted entirely of cash used for employees’ withholding tax liability upon the vesting of employee stock awards. Cash used in financing activities for the six months ended June 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 and $1.1 million of direct transaction cost payments made in connection with the Convertible Note Exchange, and (iii) cash payments of $7.9 million related to the vesting and settlement of equity awards of which $2.6 million related to the cash settlement of the vested performance restricted stock units (“RSUs”), $3.4 million related to the total cash payment of taxes for the net share settlement of the vested performance RSUs, and $1.9 million related to cash used for employees’ withholding tax liability upon the vesting of employee stock awards.
Contractual Obligations
Our principal material cash requirements consist of obligations related to our debt, our contingent consideration obligation, payments for rebates, returns and discounts, non-cancelable contractual obligations for our purchase commitments, and non-cancelable leases 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 we filed our 2023 Form 10-K. For a description of our material contractual or other obligations, see “Note 15. 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.
CRITICAL ACCOUNTING POLICIES AND SIGNIFICANT ESTIMATES
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, impairment of long-lived assets, contingent consideration obligations, and income taxes to be critical policies. These estimates form the basis for making judgments about the carrying value of assets and liabilities. We believe there have been no significant changes in our critical accounting policies and significant judgements and estimates since we filed our 2023 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 2023 Form 10-K for further information.
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 on Form 10-Q. 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 June 30, 2024.
We review and evaluate the design and effectiveness of our disclosure controls and procedures on an ongoing basis to improve our controls and procedures over time and to correct any deficiencies that we may discover in the future. Our goal is to ensure that our senior management has timely access to all material financial and non-financial information concerning our business. While we believe the present design of our disclosure controls and procedures is effective to achieve our goal, future events affecting our business may cause us to significantly modify our disclosure controls and procedures.
Changes in Internal Controls over Financial Reporting
There were no changes in our internal controls over financial reporting during the three months ended June 30, 2024, 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 15. 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 2023 Form 10-K. Except as set forth below, there have been no material changes to our risk factors since our 2023 Form 10-K. In addition to other information in this report, the following risk factor, together with 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 are not the only ones facing us. Additional risks and uncertainties of which we are unaware or that we currently deem immaterial may also become important factors that may harm our business, results of operations and financial condition.
We face risks relating to product liability losses and other litigation liability for which we may be unable to maintain or obtain adequate protection.
We are or may be involved in various legal proceedings, lawsuits and certain government inquiries and investigations, including with respect to, but not limited to, patent infringement, product liability, personal injury, antitrust matters, securities class action lawsuits, breach of contract, Medicare and Medicaid reimbursement claims, opioid-related matters, promotional practices and compliance with laws relating to the manufacture and sale of controlled substances. For example, we, along with other opioid manufacturers and, often, distributors, have been named in lawsuits related to the manufacturing, distribution, marketing and promotion of opioids. In addition, we have also received various subpoenas and requests for information related to the distribution, marketing and sale of our former opioid products. Moreover, we have settled coverage litigation with our primary product liability insurer and first excess carrier regarding whether opioid litigation claims noticed by us are covered by our policies with such insurers. We have also settled with our former insurance broker to resolve Assertio Therapeutics’ claims against the broker for negligence and breach of fiduciary duty in connection with the broker’s negotiation and procurement of products liability insurance coverage for Assertio Therapeutics. Further, we are subject to pending antitrust litigation and pending and potential future shareholder litigation relating to the Spectrum Merger and/or the approval and launch of generic indomethacin suppositories in the second half of 2023, and Spectrum is named in several securities class action and shareholder derivative lawsuits filed by former Spectrum stockholders. We have also learned of a qui tam complaint filed against Depomed, Inc. (now known as Assertio Therapeutics) for which we may be served. Such litigation and related matters are described in “Item 8. Financial Statements and Supplementary Data – Note 15. Commitments and Contingencies.” The defense of these legal proceedings, inquiries, and investigations have resulted in, and are expected to continue to result in, us incurring significant expenses and may adversely impact our ability to execute product acquisitions and strategic transactions using our common stock, obtain financing or refinance existing debt, or could make us less attractive to potential acquirers. In addition, other than with respect to shareholder litigation, we do not presently anticipate receiving any insurance coverage for any of our pending litigation (or for potential future claims relating to our historical commercialization of opioids), and there is no guarantee that our shareholder litigation insurance coverage will adequately protect us from our pending or future shareholder litigation claims. If any of these legal proceedings, inquiries or investigations were to result in an adverse outcome, the impact could have an adverse effect on our competitive position, business, financial condition, results of operations and cash flows.
We have obtained product liability insurance for sales of our products and any future clinical trials currently underway, but:
•we may be unable to maintain product liability insurance on acceptable terms;
•we may be unable to obtain product liability insurance for future trials;
•we may be unable to obtain product liability insurance for future products; or
•our insurance may not provide adequate protection against potential liabilities or may provide no protection at all.
Our inability to obtain or maintain adequate insurance coverage at an acceptable cost could prevent or inhibit the commercialization of our products. Defending a lawsuit could be costly and significantly divert management’s attention from conducting our business. If third parties were to bring a successful product liability or other claims, or series of claims, against us for uninsured liabilities, or in excess of our insured liability limits, our business, results of operations and financial condition could be adversely affected.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
We did not repurchase any shares of the Company’s common stock during the period covered by this Quarterly Report, except for shares surrendered to us, as reflected in the following table, to satisfy tax withholding obligations in connection with the vesting of equity awards.
| | | | | | | | | | | | | | |
| (a) Total Number of Shares (or Units) Purchased (1) | (b) Average Price Paid per Share | (c) Total Number of Shares (or Units) Purchased as Part of Publicly Announced Plans or Programs | (d) Maximum Number (or Approximate Dollar Value) of Shares (or Units) that May Yet Be Purchased Under the Plans or Programs |
April 1, 2024 - April 30, 2024 | 4,097 | $0.91 | N/A | N/A |
May 1, 2024 - May 31, 2024 | 74,305 | $0.96 | N/A | N/A |
June 1, 2024- June 30, 2024 | — | $— | N/A | N/A |
Total | 78,402 | $0.96 | | |
(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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3.1 | | |
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10.1 | | |
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10.2 | | |
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31.1 | | |
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32.1** | | |
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32.2** | | |
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101.INS | | Inline XBRL Instance Document |
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101.SCH | | Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents |
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104 | | Cover Page Interactive Data File (formatted as Inline XBRL with applicable taxonomy extension information contained in Exhibit 101) |
_______________________________________________________
** Furnished Herewith
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| | | | | |
Date: August 7, 2024 | ASSERTIO HOLDINGS, INC. |
| |
| /s/ Brendan P. O’Grady |
| Brendan P. O’Grady |
| Chief Executive Officer |
| |
| /s/ Ajay Patel |
| Ajay Patel |
| Senior Vice President and Chief Financial Officer |
| |
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| |
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Exhibit 10.2 May 19, 2024
Brendan O’Grady
Dear Brendan:
I am pleased to provide this letter agreement setting forth the key terms and conditions for you to serve as the Chief Executive Officer (“CEO”) of Assertio Holdings, Inc. (the “Company”) reporting to the Board of Directors of the Company (the “Board”) with an agreed upon start date of May 29, 2024.
1. Duties; Responsibilities. You will have such duties and responsibilities as are customary for a Chief Executive Officer. You will devote substantially all of your business time and attention to the performance of your obligations, duties and responsibilities as CEO of the Company. It is our mutual understanding that you will devote a substantial period of time in performing your role at the Company’s headquarters and in business-related travel, per your phone conversation with Heather Mason on May 10, 2024.
This is a full-time position. While you render services to the Company, you will not engage in any other employment, consulting or other business activity (whether full-time or part-time, “Other Commitments”) that would interfere with your full-time obligation to the Company or otherwise create a conflict of interest with the Company, provided, however, that you are permitted to maintain the one external board seat that you currently hold (or one similar replacement external board seat to be reviewed with the Board in advance), in each case as long as it also does not create a conflict of interest. By signing this letter agreement, you confirm to the Company that you have disclosed in writing to the Company all current or expected future Other Commitments, and you have no contractual commitments or other legal obligations that would prohibit you from performing your duties for the Company, or otherwise conflict with such duties.
2. Base Salary. For your service as CEO, you will be paid a base salary at the annual rate of $850,000 (the “Base Salary”), prorated for partial years and payable in accordance with the Company’s standard payroll procedures. This salary will be subject to adjustment pursuant to the Company’s employee compensation policies in effect from time to time.
3. Annual Cash Incentive Opportunity. For your service as CEO, you will be eligible to earn a cash bonus with a target opportunity equal to 85% of your Base Salary (the “Bonus”), with the actual amount of the Bonus determined by the Board in its sole discretion based upon the achievement of performance goals agreed upon between the CEO and the Board. The Bonus in year one, if earned, will be prorated and payable in accordance with the Company’s standard payroll procedures at the same time annual bonuses are paid to employees of the Company generally, or at such earlier time as may be determined by the Board. You shall be subject to, and comply with, all Company policies applicable to you, including, without limitation, the Company’s claw back policy as in effect from time to time.
4. Equity Awards. In connection with your commencement of employment, you will be granted an initial stock option award to acquire 1,800,000 shares of Company common stock (the “Option”) at an exercise price equal to the closing price of the common stock on the date of grant, and an award of 500,000 restricted stock units (the “RSUs”), in each case, as part of the Inducement Award Program. It is anticipated that the grant date of such Option and RSU’s will be May 31, 2024. Subject to your continued employment, the Option and RSUs will vest one third each year over a three-year period commencing with your start date. You will continue to be eligible for annual grants pursuant to the Company’s Amended and Restated 2014 Omnibus Incentive Plan.
5. Employee Non-Competition, Confidential Information, Inventions and Non-Solicitation Agreement: Like all Company employees, you will be required, as a condition of your employment with the Company, to sign the Company’s standard Confidential Information, Secrecy and Invention Agreement, a copy of which will be included your offer packet as Appendix A.
6. Employment Relationship. Employment with the Company is for no specific period of time. Your employment with the Company will be “at will,” meaning that either you or the Company may terminate your employment at any time and for any reason, with or without cause. Any contrary representations that may have been made to you are superseded by this letter agreement. This is the full and complete agreement between you and the Company on this term. Although your job duties, title, reporting relationship, compensation and benefits, as well as the Company’s personnel policies and procedures, may change from time to time, the “at will” nature of your employment may only be changed in an express written agreement signed by you and the Chairman of the Board of Directors.
7. Employee Benefits; Indemnification Agreement. You will be eligible to participate in the employee benefit plans made available to similarly situated employees of the Company from time to time, subject to applicable plan terms. You will also enter into the Company’s updated form of Management Continuity Agreement for senior executives which include severance protections under Change in Control and Non-Change in Control situations (details outlined in Appendix B) and the Company’s standard Indemnification Agreement for Directors and Officers.
8. Reimbursement of Certain Expenses. The Company shall promptly reimburse you for all reasonable business expenses incurred by you in connection with the business of the Company and in accordance with and subject to the terms of the Company’s business reimbursement expense policy as in effect from time to time. Further, and for the avoidance of doubt, the Company will, in accordance with its business expense reimbursement policy, reimburse you for reasonable hotel or temporary living expenses incurred while you are in Illinois and related travel costs between your residence and the Company’s headquarters for a period of three years from your start date (at which time the arrangement will be reviewed).
9. Withholding. All payments hereunder shall be subject to all applicable tax withholdings. As we discussed, you will consult your tax professional about your individual tax implications arising from compensation from Assertio.
10. Entire Agreement. This letter agreement constitutes the entire understanding of the parties hereto with regard to the subject matter contained herein.
11. Governing Law. This letter agreement shall be deemed to be made in, and in all respects shall be interpreted, construed and governed by and in accordance with, the laws of the State of Delaware, without regard to conflicts of law principles thereof.
12. Counterparts. This letter agreement may be signed in counterparts, each of which shall be an original, with the same effect as if the signatures thereto and hereto were upon the same instrument.
Your employment with the Company is contingent upon completion of the Company’s background screening process and as required by law, and on your providing legal proof of your identity and authorization to work in the United States.
We are very excited to have you serve the Company as CEO. Please confirm your agreement to the terms specified in this letter agreement by signing below.
Sincerely,
/s/ Peter D. Staple______________________________
Peter Staple
Charmain of the Board of Directors, Assertio Holdings, Inc.
AGREED AND ACKNOWLEDGED:
/s/ Brendan P. O’Grady____________________________
Brendan O’Grady
APPENDIX A
EMPLOYEE NON-COMPETITION, CONFIDENTIAL INFORMATION, INVENTIONS, AND NON-SOLICITATION AGREEMENT
In partial consideration and as a condition of my employment, or my continued employment, with ASSERTIO HOLDINGS, INC., a Delaware corporation (which together with any parent, subsidiary, affiliate, or successor is hereinafter referred to as the "Company"), and effective as of the date that my employment with the Company first commenced, I hereby agree as follows:
1.NON-COMPETITION
During my employment with the Company, I will perform for the Company such duties as it may designate from time to time and will devote my full time and best efforts to the business of the Company and will not, without the prior written approval of (i) an officer of the Company if I am not an executive officer of the Company or (ii) the Board of Directors of the Company if I am an executive officer of the Company, (a) engage in any other professional employment or consulting, or (b) directly or indirectly participate in or assist any business which is a current or potential supplier, customer, or competitor of the Company.
During my employment with the Company and for 12 months after termination of my employment, I will not directly or indirectly, on behalf of myself or in conjunction with any other person or entity; (c) own any business (other than less than 3% ownership in a publicly traded company) that sells Competing Products in the Restricted Territory; or (d) work in the Restricted Territory for any person or entity that sells Competing Products, in any role: (i) that is similar to any position I held with the Company during the 24 months preceding the termination of my employment, or (ii) that may cause me to inevitably rely upon or disclose the Company’s Confidential Information.
“Competing Products” means products or services sold by the Company, or any prospective product or service the Company took steps to develop, and for which I had any responsibility during the 24 months preceding the termination of my employment.
“Restricted Territory” means the geographic territory over which I had responsibility during the 24 months preceding the termination of my employment.
2.CONFIDENTIALITY OBLIGATION
I will hold all Company Confidential Information in confidence and will not disclose, use, copy, publish, summarize, or remove from the Company's premises any Confidential Information, except (a) as necessary to carry out my assigned responsibilities as a Company employee, and (b) after termination of my employment, only as specifically authorized in writing by an officer of the Company. "Confidential Information" is all information related to any aspect of the Company's business which is either information not
known by actual or potential competitors of the Company or is proprietary information of the Company, whether of a technical nature or otherwise.
Confidential Information includes but is not limited to products, inventions, ideas, discoveries, designs, methods, formulas, assays, cell lines, software, databases, algorithms, trade secrets, works of authorship, mask works, developmental or experimental work, processes, techniques, improvements, know-how, licenses, data, financial information and forecasts, business plans, product plans, pricing information, new and existing customer or supplier programs and services, customer terms, customer service and integration processes, requirements and costs of providing service, marketing plans and strategies, and customer lists. “Confidential Information” does not include information that (a) is in the public domain or information that is generally known in the trade; (b) has become publicly known through no violation of an obligation of non-disclosure by any person or entity; (c) was obtained by me from a third party who, to my knowledge, obtained such information through no violation of an obligation of non-disclosure by any person or entity; (d) has been approved for disclosure in writing by the Company; or (e) has been disclosed pursuant to a requirement of law, but only to the extent such disclosure is required.
The obligations under this Section 2 are in addition to and not in lieu of any other rights or obligations, at law or in equity, to maintain the confidentiality of the Confidential Information, including under any applicable state’s Uniform Trade Secrets Act and any other applicable “trade secret” laws. As to Confidential Information that constitutes a trade secret, the obligations under this Section 2 shall last for as long as the item qualifies as a trade secret under federal or state law. As to Confidential Information that does not constitute a trade secret, the obligations under this Section 2 shall last during my employment and for three (3) years following the termination of my employment with the Company.
I understand that nothing contained in this Agreement limits my ability to file a charge or complaint with the Equal Employment Opportunity Commission, the National Labor Relations Board, the Occupational Safety and Health Administration, the Securities and Exchange Commission or any other federal, state or local governmental agency or commission (the “Government Agencies”). I also understand that this Agreement does not limit my ability to communicate with any of the Government Agencies or otherwise participate in any investigation or proceeding that may be conducted by any of the Government Agencies, including providing documents or other information, without notice to the Company.
Pursuant to 18 USC Section 1833(b), I understand that I will not be held criminally or civilly liable under any federal or state trade secret law for any disclosure of a trade secret that is made (i) in confidence to a federal, state, or local government official, either directly or indirectly, or to an attorney; and (ii) solely for the purpose of reporting or investigating a suspected violation of law; or is made in a complaint or other document that is filed under seal in a lawsuit or other proceeding. If I file a lawsuit for retaliation by the Company for reporting a suspected violation of law, I may disclose the Company’s trade secrets to the employee’s attorney and use the trade secret information in the court proceeding if I: (i) file any document containing the trade secret under seal, and (ii) do not disclose the trade secret, except pursuant to court order.
3.INFORMATION OF OTHERS
I will safeguard and keep confidential the proprietary information of customers, vendors, consultants, and other parties with which the Company does business to the same extent as if it were Company Confidential Information. I will not, during my employment with the Company or otherwise, use or disclose to the Company any confidential, trade secret, or other proprietary information or material of any previous employer or other person, and I will not bring onto the Company's premises any unpublished document or any other property belonging to any former employer without the written consent of that former employer.
4.COMPANY PROPERTY
All papers, records, data, notes, drawings, files, documents, samples, devices, products, equipment, and other materials, including copies, relating to the Company's business that I possess or create as a result of my employment with the Company, whether or not confidential, are the sole and exclusive property of the Company. In the event of the termination of my employment, I will promptly deliver all such materials to the Company and will sign and deliver to the Company a "Termination Certificate" provided by the Company.
5.OWNERSHIP OF INVENTIONS
All products, inventions, ideas, discoveries, designs, methods, formulas, assays, cell lines, software, databases, algorithms, trade secrets, works of authorship, mask works, developments, processes, techniques, improvements, and related know-how which result from work performed by me, alone or with others, on behalf of the Company or from access to the Company Confidential Information or property whether or not patentable, copyrightable, or qualified for mask work protection (collectively "Inventions") shall be the
property of the Company, and, to the extent permitted by law, shall be "works made for hire." I hereby assign and agree to assign to the Company or its designee, without further consideration, my entire right, title, and interest in and to all Inventions, other than those described in Section 6 of this Agreement, including all rights to obtain, register, perfect, and enforce patents, copyrights, mask work rights, and other intellectual property protection for Inventions. I will disclose promptly and in writing to the individual designated by the Company or to my immediate supervisor all Inventions which I have made or reduced to practice. During my employment and for four years after, I will assist the Company (at its expense) to obtain and enforce patents, copyrights, mask work rights, and other forms of intellectual property protection on Inventions.
6.EXCLUDED INVENTIONS
Attached hereto as Schedule 6 is a list of all inventions, improvements, and original works of authorship which I desire to exclude from this Agreement, each of which has been made or reduced to practice by me prior to my employment by the Company. If no list is attached to this Agreement, or if I have completed Schedule 6 by writing "None," there are no inventions to be excluded at the time of my signing of this Agreement. I understand that this Agreement does not apply to an invention for which no equipment, supplies, facility, or trade secret information of the Company was used and which was developed entirely on my own time, unless (a) the invention relates (i) to the business of the Company, or (ii) to the Company’s actual or demonstrably anticipated research or development, or (b) the invention results from any work performed by me for the Company.
7.PRIOR CONTRACTS
I represent that there are no other contracts to assign inventions that are now in existence between any other person or entity and me. I further represent that I have no other employments, consultancies, or undertakings which would restrict or impair my performance of this Agreement.
8.AGREEMENTS WITH THIRD PARTIES
I acknowledge that the Company from time to time may have agreements with other persons or with the United States Government or agencies thereof which impose obligations or restrictions on the Company regarding Inventions made during the course of work under such agreements or regarding the confidential nature of such work. I agree to be bound by all such obligations or restrictions and to take all action necessary to discharge the obligations of the Company thereunder.
9.NONSOLICITATION
To the fullest extent permitted under applicable law, from the date of this Agreement until twelve (12) months after the termination of this Agreement for any reason (the “Restricted Period”), I will not, without the Company’s prior written consent, directly or indirectly, Solicit, or attempt to solicit, any current or former Company employee or consultant who was employed/engaged with the Company within six (6) months of the date of Employee’s termination, and about whom Employee has had material personal contact with, supervised or managed, or otherwise possesses Confidential Information or the Company’s goodwill that would assist the recruitment or solicitation of the person, to leave his or her employment with the Company, either for myself or for any other person or entity. I agree that nothing in this Section 9 shall affect my continuing obligations under this Agreement during and after this twelve (12) month period.
During my employment and for 12 months after termination of my employment, I will not directly or indirectly, on behalf of myself or in conjunction with any other person or entity solicit or accept business from any customer or prospective customer of the Company with whom, during the last 24 months of my employment, I (i) personally performed services for or provided products to, (ii) dealt on behalf of the Company, (iii) bore responsibility for the Company, or (iv) otherwise possess Confidential Information, Company trade secrets, or Company goodwill that would assist me in the solicitation of the Customer, if the products or services that customer intends to purchase are similar to products or services offered by the Company.
“Solicit” means: (a) any comments, conduct or activity that would influence a customer’s decision to continue doing business with the Company, regardless of who initiates contact; (b) any comments, conduct or activity that would influence an employee’s or consultant’s decision to resign his/her employment with the Company or accept employment with my new company, regardless of who initiates contact; and (c) any comments that would interfere with the relationship of the Company and the employee, consultant, or customer.
10.NO EMPLOYMENT AGREEMENT
I agree that unless specifically provided in another writing signed by me and an officer of the Company, my employment by the Company is not for a definite period of time. Rather, my employment relationship with the Company is one of employment at will and my continued employment is not obligatory by either myself or the Company.
11.MISCELLANEOUS
11.1Governing Law
This Agreement shall be governed by, and construed in accordance with, the laws of the State of Illinois, excluding those laws that direct the application of the laws of another jurisdiction.
11.2Reasonability; Severability
I acknowledge and agree that the restrictions contained in this Agreement with respect to time, geographical area, and scope of activity are reasonable and do not impose a greater restraint than is necessary to protect the goodwill and other legitimate business interests of the Company and that I have had the opportunity to review the provisions of this Agreement with my legal counsel. In particular, I agree and acknowledge that the Company is currently engaging in business and actively marketing its services and products throughout the Restricted Territory, the Company expends significant time and effort developing and protecting the confidentiality of its methods of doing business, technology, customer lists, long term customer relationships and trade secrets and such methods, technology, customer lists, customer relationships and trade secrets have significant value and that the Company would suffer irreparable harm if I breach this Agreement. However, if, at the time of enforcement of this Agreement, a court holds that the duration, geographical area or scope of activity restrictions stated herein are unreasonable under circumstances then existing or impose a greater restraint than is necessary to protect the goodwill and other business interests of the Company, the Parties agree that the maximum duration, scope or area reasonable under such circumstances will be substituted for the stated duration, scope or area and that the court will be allowed to revise the restrictions contained herein to cover the maximum duration, scope and area permitted by law, in all cases giving effect to the intent of the parties that the restrictions contained herein be given effect to the broadest extent possible.
11.3Injunctive Relief; Consent to Jurisdiction; Attorneys’ Fees
I acknowledge and agree that damages will not be an adequate remedy in the event of a breach of any of my obligations under this Agreement. I therefore agree that the Company shall be entitled (without limitation of any other rights or remedies otherwise available to the Company) to obtain, without posting bond, specific performance and preliminary and permanent injunction from any court of competent jurisdiction prohibiting the continuance or recurrence of any breach of this Agreement. Further, I will be responsible for all attorneys’ fees, costs and expenses incurred by the Company to enforce this Agreement. I hereby submit myself to the jurisdiction and venue of the courts of the State of Illinois for purposes of any such action. I further agree that service upon me in any such action or proceeding may be made by first class mail, certified or registered, to my address as last appearing on the records of the Company.
11.4Binding Effect; Waiver
This Agreement shall be binding upon and shall inure to the benefit of the successors, executors, administrators, heirs, representatives, and assigns of the parties. The waiver by the Company of a breach of any provision of this Agreement shall not operate or be construed as a waiver of any subsequent breach of the same or any other provision hereof.
11.5Headings
The Section headings herein are intended for reference and shall not by themselves determine the construction or interpretation of this Agreement.
11.6Entire Agreement; Modifications
This Employee Confidential Information and Inventions Agreement contains the entire agreement between the Company and the undersigned employee concerning the subject matter hereof and supersedes any and all prior and contemporaneous negotiations, correspondence, understandings, and agreements, whether oral or written, respecting that subject matter. All modifications to this Agreement must be in writing and signed by the party against whom enforcement of such modification is sought.
IN WITNESS WHEREOF, I have executed this Employee Confidential Information and Inventions Agreement as of the
day of
Signature
Name of Employee Street Address City, State, Zip
RECEIPT ACKNOWLEDGED: ASSERTIO HOLDINGS, INC.
By
SCHEDULE 6
(Excluded Inventions, Improvements, and Original Works of Authorship)
Identifying Number
Title Date or Brief Description
APPENDIX B
Severance Terms
Your Management Continuity Agreement (“MCA”) will provide that, in the event of the termination of your employment other than for Cause, death or Disability, or due to a voluntary termination for Good Reason (each as defined in the MCA), outside of the Change in Control Period (as defined below), you would be entitled to receive severance benefits as follows:
a)payment of base salary for eighteen (18) months after the effective date of the termination;
b)payment of the full cost of the health insurance benefits provided to you and your spouse and dependents through the earlier of the end of the eighteen (18) month period following the date of termination or the date upon which you are no longer eligible for such COBRA or other benefits under applicable law;
c)payment of any earned but unpaid annual bonus for the year immediately preceding the year of termination, to be paid at the time the Company pays bonuses with respect to such year to its executives generally; and
d)outplacement services not to exceed $5,000 per month for up to three consecutive months.
Your MCA will also provide that, in lieu of the foregoing benefits, upon the termination of your employment other than for Cause, death or Disability, or upon your termination for Good Reason (each as defined in the MCA), within the period beginning ninety (90) days prior to a Change in Control (as defined in the MCA) and ending twenty-four (24) months following a Change in Control (the “Change in Control Period”), you would be entitled to receive severance benefits as follows:
a)a lump sum cash payment in an amount equal to the sum of:
i.two (2) times the higher of the base salary which you were receiving immediately prior to the Change in Control, or the base salary you were receiving immediately prior to your termination of employment, plus
ii.two (2) times your annual target bonus;
M
b)payment of the full cost of the health insurance benefits provided to you and your spouse and dependents through the earlier of the end of the twenty-four (24) month period following the date of termination or the date upon which you are no longer eligible for such COBRA or other benefits under applicable law;
c)payment of any earned but unpaid annual bonus for the year immediately preceding the year of termination, to be paid at the time the Company pays bonuses with respect to such year to its executives generally;
d)outplacement services not to exceed $5,000 per month for up to three consecutive months; and
e)100% of your unvested option shares, restricted stock, restricted stock units, other equity-based awards and other long-term incentive awards shall become immediately vested, and payment with respect to any open periods of performance-based awards will be calculated as set forth in the applicable award agreement or, if not specified therein, based on achieving the target level of performance.
This summary of the terms of the MCA does not purport to be complete and is qualified in its entirety by reference to the full text of the MCA, a copy of which will be provided to you before your offer letter agreement is signed by you and the Company. In the event of any conflict between this Appendix and the MCA, the terms and conditions of the MCA shall prevail.
ASSERTIO HOLDINGS, INC
MANAGEMENT CONTINUITY AGREEMENT
This Management Continuity Agreement (the “Agreement”) is effective as of May 29, 2024 (the “Effective Date”) by and between Brendan O’Grady (“Employee”) and Assertio Holdings, Inc., a Delaware corporation (the “Company”). This Agreement is intended to provide Employee with certain benefits described herein upon the occurrence of specific events.
RECITALS
A.It is expected that the Company may from time to time consider the possibility of realigning its organization.
B.It is further expected that another company may from time to time consider the possibility of acquiring the Company or that a Change in Control may otherwise occur, with or without the approval of the Board of Directors (the “Board of Directors”) of the Company.
C.The Board of Directors recognizes that such considerations can be a distraction to Employee and can cause Employee to consider alternative employment opportunities.
D.The Board of Directors has determined that it is in the best interests of the Company and its shareholders to assure that the Company will have the continued dedication and objectivity of the Employee, notwithstanding the foregoing factors.
E.The Board of Directors believes it is in the best interests of the Company and its shareholders to retain Employee and provide incentives to Employee to continue in the service of the Company.
F.The Board of Directors further believes that it is imperative to provide Employee with certain benefits upon certain termination of Employee’s employment, including in connection with a Change in Control, which benefits are intended to provide Employee with financial security and provide sufficient income and encouragement to Employee to remain with the Company, including and notwithstanding the possibility of a Change in Control.
G.To accomplish the foregoing objectives, the Board of Directors has directed the Company, upon execution of this Agreement by Employee, to agree to the terms provided in this Agreement.
Now therefore, in consideration of the mutual promises, covenants and agreements contained herein, and in consideration of the employment of Employee by the Company, the parties hereto agree as follows:
1.At-Will Employment; Term.
(a)The Company and Employee acknowledge that Employee’s employment is and shall continue to be at-will, as defined under applicable law, and that Employee’s employment with the Company may be terminated by either party at any time for any or no reason. If Employee’s employment terminates for any reason, Employee shall not be entitled to any payments, benefits, damages, award or compensation other than as provided in this Agreement or otherwise agreed to by the Company. Employee’s right to receive the payments and benefits set forth in Sections 2(a) and 2(b) of this Agreement are contingent upon the Employee’s continued compliance with the Restrictive Covenants (as defined in Section 4) and execution of a release of claims against the Company, in substantially the form attached hereto as Appendix A, within the time period following Employee’s termination of employment and the expiration of any statutory revocation period and may not be modified in any way except by a
written agreement executed by the Employee and an officer of the Company upon direction from the Board of Directors.
(b)The term of this Agreement shall commence on the Effective Date and shall end on the date on which Employee’s employment with the Company terminates for any reason (the period of Employee’s employment under this Agreement is referred to as the “Term”); provided, however, that Sections 2 through and including 10 of this Agreement shall survive the termination of the Term and Employee’s employment with the Company, in each case, in accordance with the terms of such sections.
2.Termination Benefits.
(a)Benefits Upon a Change in Control Involuntary Termination.
(i)Treatment of Equity Awards. In the event that Employee is subject to a Change in Control Involuntary Termination, 100% of Employee’s unvested Company option shares, restricted stock, restricted stock units, other equity-based awards and other long-term incentive awards, including cash settled components, shall become immediately vested on such termination date and the risk of forfeiture of 100% of Employee’s restricted stock shall lapse on such termination date. Each such award shall be exercisable in accordance with the provisions of the award agreement and plan pursuant to which such equity award was granted, including, in the case of stock options, the plan or award agreement provisions regarding any post-termination period of exercisability. Notwithstanding the provisions of such award agreement and plan, any restricted stock units, performance stock units, long-term incentive cash awards and other similar awards shall be settled within ten (10) days after the date of such termination of employment and any payment in respect of open periods of performance-based awards shall be calculated as set forth in the applicable award agreement, or, if not specified in the award agreement, based on the target level of performance. In the event of a Change in Control Involuntary Termination that occurs prior to the date of the applicable Change in Control, then if any of Employee’s unvested Company option shares, restricted stock, restricted stock units, other equity-based awards and other long-term incentive awards, including cash settled components, are forfeited as the result of such termination of employment, Employee shall be entitled to receive a lump sum cash payment equal to the value of all such awards that were forfeited as the result of such termination of employment (as determined in good faith by the Board based on the per share value of the Company implied by such Change in Control and for any option or similar award, based on the spread of such option or similar award (not a Black Scholes or similar value), with the value of performance-based awards that had an open performance period as of such termination of employment being calculated as set forth in the applicable award agreement, or, if not specified in the award agreement, based on the target level of performance) (the “Unvested Equity Value Payment”).
(ii)Severance. In the event that Employee is subject to a Change in Control Involuntary Termination, Employee shall be entitled to receive severance benefits as follows: (A) a lump sum cash payment in an amount equal to two (2) times the higher of (1) the base salary which Employee was receiving immediately prior to the Change in Control or (2) the base salary which Employee was receiving immediately prior to the Change in Control Involuntary Termination (the “Salary Payment”); (B) a lump sum cash payment in an amount equal to two (2) times Employee’s Target Annual Bonus (the “Bonus Payment”); (C) payment by the Company of the full cost of the health insurance benefits provided to Employee and Employee’s spouse and dependents, as applicable, immediately prior to the Change in Control pursuant to the terms of the Consolidated Omnibus Budget Reconciliation Act of 1985, as amended (“COBRA”) or other applicable law through the earlier of the end of the twenty four (24) month period following the Change in Control Involuntary Termination date or the date upon which Employee is no longer eligible for such COBRA or other benefits under applicable law; and (D) payment of any earned but unpaid annual bonus for the year immediately preceding the year of termination, to be paid at the time the Company pays bonuses with respect to such year to its executives generally (and in all events between January 1st and March 15th of the calendar year immediately following the calendar year in which such termination of employment occurs). The benefits to be provided under clauses (a)(i) and (a)(ii)(A) and (B) of this section shall be paid on the sixtieth (60th) day following Employee’s termination of employment; except that if a Change in Control occurs after the applicable
Change in Control Involuntary Termination, then the Unvested Equity Value Payment, Salary Payment and Bonus Payment shall be payable in a lump sum on the date of such Change in Control. The benefits to be provided under clause (a)(ii)(C) of this section shall be paid on a monthly basis commencing on the sixtieth (60th) day following Employee’s termination of employment, or, if earlier, the next payroll cycle following Employee’s execution of a release of claims against the Company and the expiration of any statutory waiting period (with a catch-up payment covering any payments that would have been made prior to such first payment had such payments commenced on the date of Employee’s termination of employment). In addition, all payments and benefits under Section 2(a)(i) and (ii) (other than the Accrued Benefits) are subject to Employee’s continued compliance with the Restrictive Covenants and release of claims against the Company as set forth in Section 1(a). Notwithstanding the foregoing, in the event the Board of Directors concludes in its reasonable judgment that the provision of subsidized COBRA benefits to Employee is likely to cause the Company to become subject to excise tax as a result of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (the “Healthcare Reform Act”), the Company shall pay Employee a monthly amount in cash equal to the amount of the COBRA subsidy during the period the Company is obligated to provide subsidized COBRA benefits to Employee. In addition, Employee shall receive payment(s) for all salary, bonuses and unpaid vacation accrued as of the date of Employee’s termination of employment (the “Accrued Benefits”) and up to three (3) consecutive months of outplacement services not to exceed $5,000 per month (with a provider and in a program selected by the Employee, provided Employee commences such services within ninety (90) days of Employee’s Change in Control Involuntary Termination date).
(a)Benefits Upon an Other Involuntary Termination.
(i)Severance. In the event that Employee is subject to an Other Involuntary Termination, Employee shall be entitled to receive severance benefits as follows: (A) severance payments for eighteen (18) months after the effective date of the termination (the “Non-CIC Severance Period”) equal to the base salary which Employee was receiving immediately prior to the Other Involuntary Termination, which payments shall be paid during the Non-CIC Severance Period in accordance with the Company’s standard payroll practices; and (B) payment by the Company of the full cost of the health insurance benefits provided to Employee and Employee’s spouse and dependents, as applicable, immediately prior to the Other Involuntary Termination pursuant to the terms of COBRA or other applicable law through the earlier of the end of the Non-CIC Severance Period or the date upon which Employee is no longer eligible for such COBRA or other benefits under applicable law. (C) payment of any earned but unpaid annual bonus for the year immediately preceding the year of termination, to be paid at the time the Company pays bonuses with respect to such year to its executives generally (and in all events between January 1st and March 15th of the calendar year immediately following the calendar year in which such termination of employment occurs). The benefits to be provided under Section 2(b)(i)(A) and (B) shall commence to be paid on the sixtieth (60th) day following Employee’s termination of employment (subject to Employee’s continued compliance with the Restrictive Covenants and release of claims against the Company as set forth in Section 1(a)), or, if earlier, the next payroll cycle following Employee’s execution of a release of claims against the Company and the expiration of any statutory waiting period, with a catch-up payment covering any payments that would have been made prior to such first payment had such payments commenced on the date of Employee’s termination of employment. Notwithstanding the foregoing, in the event the Board of Directors concludes in its reasonable judgment that the provision of subsidized COBRA benefits to Employee could cause the Company to become subject to excise tax as a result of the Patient Protection and Affordable Care Act, as amended by the Healthcare Reform Act, the Company shall pay Employee a monthly amount in cash equal to the amount of the COBRA subsidy during the period the Company is obligated to provide subsidized COBRA benefits to Employee. In addition, Employee shall receive payment of the Accrued Benefits and up to three (3) consecutive months of outplacement services not to exceed $5,000 per month (with a provider and in a program selected by the Company, provided Employee commences such services within ninety (90) days of Employee’s Other Involuntary Termination date).
(a)Termination for Cause. If Employee’s employment is terminated for Cause at any time, then Employee shall not be entitled to receive payment of any severance benefits or equity award acceleration. Employee shall receive payment(s) for all Accrued Benefits
(b)Voluntary Resignation. If Employee voluntarily resigns from the Company under circumstances which do not constitute a Change in Control Involuntary Termination or an Other Involuntary Termination, then Employee shall not be entitled to receive payment of any severance benefits or equity award acceleration. Employee shall receive payment(s) for all Accrued Benefits.
(c)Death or Disability. If Employee’s employment terminates on account of Employee’s death or Disability at any time, whether or not in connection with a Change in Control, then Employee shall not be entitled to receive payment of any severance benefits or equity award acceleration. Employee shall receive payment(s) for (x) all Accrued Benefits and (y) any earned but unpaid annual bonus for the year immediately preceding the year of termination, to be paid at the time the Company pays bonuses with respect to such year to its executives generally (and in all events between January 1st and March 15th of the calendar year immediately following the calendar year in which such termination of employment occurs).
1.Definition of Terms. The following terms referred to in this Agreement shall have the following meanings:
(a)Cause. “Cause” shall mean (i) gross negligence or willful misconduct in the performance of Employee’s duties to any member of the Company Group where such gross negligence or willful misconduct has resulted or is likely to result in substantial and material damage to any member of the Company Group, (ii) repeated and documented unexplained or unjustified absence from the performance of services for any member of the Company Group, (iii) a material and willful violation of any federal or state law resulting or likely to result in substantial and material damage to any member of the Company Group; (iv) commission of any act of fraud with respect to any member of the Company Group resulting or likely to result in substantial and material damage to any member of the Company Group, or (v) conviction of a felony or a crime involving moral turpitude causing material harm to the standing and reputation of any member of the Company Group, in each case as determined in good faith by the Board of Directors, subject to the Company’s compliance with the “Cause Cure Process”. For purposes of this Agreement, “Company Group” shall mean the Company and each of its subsidiaries.
(b)Cause Cure Process. “Cause Cure Process” shall mean that (i) Company reasonably determines that Employee has engaged in behavior constituting “Cause”; (ii) Company notifies the Employee in writing of the first occurrence of the behavior constituting “Cause” within ninety (90) days of the first occurrence of such condition; (iii) the Employee shall have thirty (30) business days following such notice (the “Cause Cure Period”), to substantially remedy the condition, if curable; (iv) notwithstanding such efforts, the condition constituting “Cause” continues to exist; and (v) Company terminates Employee’s employment due to “Cause” within ninety (90) days after the end of the Cause Cure Period. For avoidance of doubt, if the behavior constituting “Cause” is not substantially curable, then the Cause Cure Period shall end on the date the Employee receives the Company’s written notice set forth in clause (ii) above. If the Employee substantially cures the condition constituting “Cause” during the Cause Cure Period, such behavior constituting “Cause” shall be deemed not to have occurred.
(c)Change in Control. “Change in Control” means after the Effective Date, any of the following events: (A) a “person” (as such term in used in Sections 13(d) and 14(d) of the Securities Exchange Act of 1934, as amended (the “1934 Act”)), other than a trustee or other fiduciary holding securities under an employee benefit plan of the Company or a corporation owned, directly or indirectly, by the stockholders of the Company in substantially the same proportions as their ownership of stock of the Company, is or becomes the “beneficial owner” (as defined in Rule 13D-3 under the 1934 Act), directly or indirectly, of securities of the Company representing more than fifty percent (50%) of the combined voting power of the Company’s then outstanding securities; (B) the Company merges or consolidates with any other corporation, other than in a merger or consolidation that would result in the voting securities of the Company outstanding immediately prior thereto continuing to represent (either by remaining outstanding or by being converted into voting securities of the surviving entity) at least fifty percent (50%) of the combined voting power of the voting securities of the Company or such surviving entity outstanding immediately after such merger or consolidation; or (C) the complete liquidation of the Company or the sale or other disposition of
all or substantially all of the Company’s assets (other than a transfer of the Company’s assets to a majority-owned subsidiary of the Company or any other entity the majority of whose voting power is held by the shareholders of the Company in approximately the same proportion as before such transaction); provided that in no event shall any such event constitute a Change in Control unless such event is also a “change in control event” as defined in Section 409A of the Internal Revenue Code of 1986, as amended (the “Code”).
(d)Change in Control Involuntary Termination. “Change in Control Involuntary Termination” shall mean: (i) any termination by the Company other than for Cause, death or Disability, or (ii) Employee’s voluntary termination for Good Reason (as defined in this Section 3(d)), in each case within the period beginning (A) ninety (90) days prior to the effective date of a Change in Control and ending (B) twenty-four (24) months following the effective date of a Change in Control. For purposes of this Section 3(d), “Good Reason” shall mean that Employee has complied with the “Good Reason Process” following the occurrence of any of the following events: (i) a material diminution in Employee’s responsibilities, authority or duties; (ii) a material diminution in the authority, duties, or responsibilities of the supervisor to whom Employee is required to report; (iii) a material diminution (which shall be a decrease in excess of five percent (5%)) in Employee’s base salary or target annual bonus amount, in each case other than in connection with a general decrease in base salaries or target annual bonuses, as applicable, for officers of the successor corporation; provided, however, that any decrease in base salary and/or target annual bonus greater than five percent (5%) shall provide grounds for “Good Reason” regardless of whether a general decrease in base salaries and/or target bonuses occurs for officers of the successor corporation; (iv)a change in the geographic location at which Employee provides services to the Company that increases Employee’s one way commute by twenty-five (25) miles or more; or (v) failure of the successor corporation to assume the obligations under this Agreement.
(e)Disability. “Disability” shall mean that in the opinion of a qualified physician, mutually acceptable to the Company and the Employee, by reason of any medically determinable physical or mental impairment that can be expected to result in death or can be expected to last for a continuous period of not less than twelve (12) months, the Employee (x) is unable to engage in any substantial gainful activity or (y) has been receiving income replacement benefits for a period of not less than three (3) months under an accident and health plan covering employees of the Company.
(f)Good Reason Process. “Good Reason Process” shall mean that (i) Employee reasonably determines in good faith that a “Good Reason” condition has occurred, as may be applicable; (ii) Employee notifies the Company in writing of the first occurrence of the Good Reason condition within ninety (90) days of the first occurrence of such condition; (iii) Employee cooperates in good faith with the Company’s efforts, for a period of thirty (30) business days following such notice (the “Good Reason Cure Period”), to remedy the condition; (iv) notwithstanding such efforts, the Good Reason condition continues to exist; and (v) Employee terminates his employment within ninety (90) days after the end of the Good Reason Cure Period. If the Company substantially cures the Good Reason condition during the Good Reason Cure Period, Good Reason shall be deemed not to have occurred.
(g)Other Involuntary Termination. “Other Involuntary Termination” shall mean (i) any termination by the Company other than for Cause, death or Disability, or (ii) Employee’s voluntary termination for Good Reason (as defined in this Section 3(g)), in each case during the Term and excluding a Change in Control Involuntary Termination. For purposes of this Section 3(g), “Good Reason” shall mean that Employee has complied with the “Good Reason Process” following the occurrence of any of the following events: (i) a material diminution of Employee’s authorities, duties or responsibilities, (ii) a five percent (5%) or greater decrease in Employee’s annual base salary or annual bonus target other than in connection with a general decrease in annual base salary or annual bonus target (as applicable) for officers of the Company and the successor corporation, if applicable; or (iii) a change in the geographic location at which Employee provides services to the Company that increases the Employee’s one-way commute by twenty-five (25) miles or more.
(h)Target Annual Bonus. “Target Annual Bonus” shall mean Employee’s target annual bonus that may be earned for performance during the Company’s fiscal year in which a termination occurs; provided, however, that sign-on or other special bonuses shall not be taken into account. If Employee’s Target Annual Bonus has not been set or determined as of the termination date, the “Target Annual Bonus” shall mean Employee’s target annual bonus for the Company’s most recently completed fiscal year.
4. Restrictive Covenants. The restrictive covenants and other rights and obligations of Employee and the Company (collectively, the “Restrictive Covenants”) set forth in that certain Employee Confidential Information and Inventions Agreement between Employee and the Company (the “Employee Restrictive Agreement”) are hereby incorporated by reference into this Section 4, mutandis mutatis. Employee shall comply with each of the Restrictive Covenants.
5. Limitation and Conditions on Payments.
In the event that the severance and other benefits provided to Employee under this Agreement and any other agreement (i) constitute “parachute payments” within the meaning of Section 280G of the Code and (ii) but for this Section, would be subject to the excise tax imposed by Section 4999 of the Code, then Employee’s severance benefits under Sections 2(a) and 2(b) shall be payable either:
(a) in full; or
(b) as to such lesser amount which would result in no portion of such severance benefits being subject to excise tax under Section 4999 of the Code;
whichever of the foregoing amounts, taking into account the applicable federal, state and local income taxes and the excise tax imposed by Section 4999 of the Code, results in the receipt by Employee on an after-tax basis, of the greatest amount of severance benefits under Section 2(a) or Section 2(b) (as applicable), notwithstanding that all or some portion of such severance benefits may be taxable under Section 4999 of the Code. The reduction of payments and benefits hereunder, if applicable, shall be made by reducing, first, cash severance pay that is exempt from Section 409A of the Code (beginning with such payment that would be made last in time and continuing, to the extent necessary, through to such payment that would be made first in time); second, any other cash severance pay (reduced in the same order as the previous item); third, any other payments or benefits to be paid in cash hereunder (reduced in the same order as the previous item); fourth, reducing any benefit to be provided in kind hereunder (reduced in the same order as the previous item), except for equity-based awards; fifth, any equity-based awards valued at full value under Section 280G of the Code, to be reduced in the order of highest value to lowest value under Section 280G of the Code; and lastly, sixth, any equity-based awards valued at a discounted value under Section 280G of the Code, to be reduced in the order of highest value to lowest value under Section 280G of the Code. Unless the Company and Employee otherwise agree in writing, any determination required under this Section 5 shall be made in writing by a qualified independent certified public accounting or law firm selected by the Company and approved by the Employee, which such approval shall not be unreasonably withheld (the “Independent Tax Professional”). The Employee shall not be deemed to have unreasonably withheld approval if the Employee does not consent to an Independent Tax Professional selected by the Company that has provided any services to the Company or any successor corporation within the preceding five (5) year period. The Independent Tax Professional shall provide its determinations and any supporting calculations both to the Company and the Employee in writing setting forth in reasonable detail the basis of the Independent Tax Professional’s determinations, which shall be subject to approval by the Employee, which such approval shall not be unreasonably withheld. Such determination shall be conclusive and binding upon Employee and the Company for all purposes. For purposes of making the calculations required by this Section 5, the Independent Tax Professional may make reasonable assumptions and approximations concerning applicable taxes and may rely on reasonable, good faith interpretations concerning the application of Sections 280G and 4999 of the Code. The Company and Employee shall furnish to the Independent Tax Professional such information and documents as the Independent Tax
Professional may reasonably request in order to make a determination under this Section. The Company shall bear all costs the Independent Tax Professional may reasonably incur in connection with any calculations contemplated by this Section 5. If, after the payment of severance benefits has been made to the Employee, it is established that the payments made to, or provided for the benefit of Employee, exceed the limitations provided in Section 5(b) (an “Excess Payment”) or are less than such limitations (an “Underpayment”), as the case may be, then the following shall apply: (x) if it is determined that an Excess Payment has been made, the Employee shall repay the Excess Payment within 20 days following the determination of such Excess Payment; and (y) if it is determined that an Underpayment has occurred, the Company shall pay an amount equal to the Underpayment to the Employee on the later of (A) 20 days after such determination or resolution and (B) the time period such payment would otherwise have been paid or provided to the Employee absent the application of Section 5(b) (and in all events, within the time period permitted by Section 409A of the Code).
6. Section 409A. If Employee’s termination of employment hereunder does not constitute a “separation from service” within the meaning of Section 409A of the Code, then any amounts payable hereunder on account of a termination of Employee’s employment and which are subject to Section 409A of the Code shall not be paid until Employee has experienced a “separation from service” within the meaning of Section 409A of the Code. If, and only if, Employee is a “specified employee” (as defined in Section 409A of the Code) and a payment or benefit provided for in this Agreement would be subject to additional tax under Section 409A of the Code if such payment or benefit is paid within six (6) months after Employee’s separation from service, then such payment or benefit shall not be paid (or commence) during the six (6)-month period immediately following Employee’s separation from service except as provided in the immediately following sentence. In such an event, any payment or benefits that otherwise would have been made or provided during such six(6)-month period and that would have incurred such additional tax under Section 409A of the Code shall instead be paid to Employee in a lump-sum payment on the first day following the termination of such six (6)-month period or, if earlier, within ten (10) days following the date of Employee’s death (but not earlier than such payment would have been made absent such death). For these purposes, each severance payment or benefit is designated as a separate payment or benefit for purposes of Treas. Reg. § 1.409A-2(b) and will not collectively be treated as a single payment or benefit. This paragraph is intended to comply with the requirements of Section 409A of the Code so that none of the severance payments and benefits to be provided hereunder will be subject to the additional tax imposed under Section 409A of the Code and any ambiguities herein will be interpreted to so comply. Employee and the Company agree to work together in good faith to consider amendments to this Agreement and to take such reasonable actions which are necessary, appropriate or desirable to avoid imposition of any additional tax or income recognition prior to actual payment to Employee under Section 409A of the Code. Notwithstanding anything to the contrary contained herein, to the extent that any amendment to this Agreement with respect to the payment of any severance payments or benefits would constitute under Code Section 409A a delay in a payment or a change in the form of payment, then such amendment must be done in a manner that complies with Code Section 409A(a)(4)(C).
7. Conflicts. Employee represents that Employee’s performance of all the terms of this Agreement will not breach any other agreement to which Employee is a party. Employee has not, and will not during the term of this Agreement, enter into any oral or written agreement in conflict with any of the provisions of this Agreement. Employee further represents that Employee is entering into or has entered into an employment relationship with the Company of Employee’s own free will.
8. Successors. Any successor to the Company (whether direct or indirect and whether by purchase, lease, merger, consolidation, liquidation or otherwise) to all or substantially all of the Company’s business and/or assets shall assume the obligations under this Agreement and agree expressly to perform the obligations under this Agreement in the same manner and to the same extent as the Company would be required to perform such obligations in the absence of a succession. The terms of this Agreement and all of Employee’s rights hereunder shall inure to the benefit of, and be enforceable by, Employee’s personal or legal representatives, executors, administrators, successors, heirs, distributees, devisees and legatees.
9. Notice. Notices and all other communications contemplated by this Agreement shall be in writing and shall be deemed to have been duly given when personally delivered or when mailed by U.S. registered or
certified mail, return receipt requested and postage prepaid. Mailed notices to Employee shall be addressed to Employee at the home address which Employee most recently communicated to the Company in writing. In the case of the Company, mailed notices shall be addressed to its corporate headquarters, and all notices shall be directed to the attention of the Company’s Legal Department.
10. Miscellaneous Provisions.
(a) No Duty to Mitigate. Employee shall not be required to mitigate the amount of any payment contemplated by this Agreement (whether by seeking new employment or in any other manner), nor shall any such payment be reduced by any earnings that Employee may receive from any other source.
(b) Waiver. No provision of this Agreement shall be modified, waived or discharged unless the modification, waiver or discharge is agreed to in writing and signed by Employee and by an authorized officer of the Company (other than Employee). No waiver by either party of any breach of, or of compliance with, any condition or provision of this Agreement by the other party shall be considered a waiver of any other condition or provision or of the same condition or provision at another time.
(c) Entire Agreement. No agreements, representations or understandings (whether oral or written and whether express or implied) which are not expressly set forth in this Agreement have been made or entered into by either party with respect to the subject matter hereof. This Agreement (along with the Employee Restrictive Agreement) supersedes any agreement of the same title and concerning similar subject matter dated prior to the date hereof, and by execution of this Agreement both parties agree that any such predecessor agreement shall be deemed null and void. For avoidance of doubt, in no event shall Employee receive duplicate benefits under any other plan (including the Company’s Change in Control Benefits Plan) and/or any other change in control or severance arrangement with the Company.
(d) Choice of Law. The validity, interpretation, construction and performance of this Agreement shall be governed by the laws of the State of Delaware without reference to conflict of laws provisions.
(e) Severability. If any term or provision of this Agreement or the application thereof to any circumstance shall, in any jurisdiction and to any extent, be invalid or unenforceable, such term or provision shall be ineffective as to such jurisdiction to the extent of such invalidity or unenforceability without invalidating or rendering unenforceable the remaining terms and provisions of this Agreement or the application of such terms and provisions to circumstances other than those as to which it is held invalid or unenforceable, and a suitable and equitable term or provision shall be substituted therefor to carry out, insofar as may be valid and enforceable, the intent and purpose of the invalid or unenforceable term or provision.
(f) Arbitration. All claims, demands, causes of action, disputes, controversies or other matters in question (“Claims”) arising out of this Agreement or the Employee’s service (or termination from service) with the Company, whether arising in contract, tort or otherwise and whether provided by statute, equity or common law, that the Company may have against the Employee or that the Employee may have against the Company, or its parents or subsidiaries, or against each of the foregoing entities’ respective officers, directors, employees or agents in their capacity as such or otherwise, shall be settled in accordance with the procedures described in Section 10(f)(i) and (ii). Claims covered by this Section 10(f) include, without limitation, claims by the Employee for breach of this Agreement, wrongful termination, discrimination (based on age, race, sex, disability, national origin, sexual orientation, or any other factor), harassment and retaliation.
(i)Agreement to Negotiate. First, the parties shall attempt in good faith to resolve any Claims promptly by negotiations between the Employee and executives or directors of the Company or its affiliates (or, following the occurrence of a Change in Control, any person or committee selected by the Compensation Committee of the Board of Directors prior to the Change in Control (referred to as the “Independent Decision Maker”), who shall act on behalf of the Company or its affiliates), who shall have authority to settle the Claims. Either party may give the other disputing party written notice of any Claim not resolved in the normal course of business. Within five
(5) days after the effective date of that notice, the Employee and such executives or directors of the Company, or, following the occurrence of a Change in Control, the Independent Decision Maker, shall agree upon a mutually acceptable time and place to meet and shall meet at that time and place, and thereafter as often as they reasonably deem necessary, to exchange relevant information and to attempt to resolve the Claim. The first of those meetings shall take place within thirty (30) days of the date of the disputing party’s notice. If the Claim has not been resolved within sixty (60) days of the date of the disputing party’s notice, or if the parties fail to agree on a time and place for an initial meeting within five (5) days of that notice, either party may elect to undertake arbitration in accordance with Section 10(f)(ii).
(ii)Agreement to Arbitrate. If a Claim is not resolved by negotiation pursuant to Section 10(f)(i), such Claim must be resolved through arbitration regardless of whether the Claim involves claims that the Agreement is unlawful, unenforceable, void, or voidable or involves claims under statutory, civil or common law. Any arbitration shall be conducted in accordance with the then-current International Arbitration Rules of the American Arbitration Association (“AAA”). If a party refuses to honor its obligations under this Section 10(f)(ii), the other party may compel arbitration in any federal or state court of competent jurisdiction. The arbitrator shall apply the substantive law of Delaware (excluding choice-of-law principles that might call for the application of some other jurisdiction’s law) or federal law as applied by the United States Court of Appeals for the Third Circuit, or both as applicable to the Claims asserted. The arbitration shall be conducted by a single arbitrator selected by the parties according to the rules of AAA. In the event that the parties fail to agree on the selection of the arbitrator within 30 days after either party’s request for arbitration, the arbitrator will be chosen by AAA. The arbitration proceeding shall commence on a mutually agreeable date within 90 days after the request for arbitration, unless otherwise agreed by the parties. The arbitrator shall have exclusive authority to resolve any dispute relating to the interpretation, applicability or enforceability or formation of this Agreement (including this Section 10(f)), including any claim that all or part of the Agreement is void or voidable and any Claim that an issue is not subject to arbitration. The results of arbitration will be binding and conclusive on the parties hereto. Any arbitrator’s award or finding or any judgment or verdict thereon will be final and unappealable. The seat of arbitration shall be in the State of Delaware, and unless agreed otherwise by the parties, all hearings shall take place at the seat. Any and all of the arbitrator’s orders, decisions and awards may be enforceable in, and judgment upon any award rendered by the arbitrator may be confirmed and entered by any federal or state court having jurisdiction. All evidentiary privileges under applicable state and federal law, including attorney-client, work product and party communication privileges, shall be preserved and protected. The decision of the arbitrator will be binding on all parties. Arbitrations will be conducted in such a manner that the final decision of the arbitrator will be made and provided to the Employee and the Company no later than 120 days after a matter is submitted to arbitration. All proceedings conducted pursuant to this agreement to arbitrate, including any order, decision or award of the arbitrators, shall be kept confidential by all parties. Each party shall pay its own attorneys’ fees and disbursements and other costs of arbitration and the parties to the arbitration shall split all of the arbitrator’s fees equally; provided, however, that following the occurrence of a Change in Control, the Company will bear the forum fees required by AAA and any other administrative fees associated with the arbitration and shall advance to the Employee the fees and expenses (including legal fees) in connection with any arbitration proceeding provided that Employee shall be obligated to repay all such amounts in the event the Employee does not prevail in such proceeding. EMPLOYEE ACKNOWLEDGES THAT, BY SIGNING THIS AGREEMENT, EMPLOYEE IS WAIVING ANY RIGHT THAT EMPLOYEE MAY HAVE TO A JURY TRIAL OR A COURT TRIAL OF ANY SERVICE RELATED CLAIM ALLEGED BY EMPLOYEE.
(g) Legal Fees and Expenses. The parties shall each bear their own expenses, legal fees and other fees incurred in connection with entering into this Agreement. If any action is brought to enforce the terms of this Agreement, including the release attached hereto as Appendix A, the prevailing party will be entitled to recover its reasonable attorneys’ fees, costs and expenses from the other party, in addition to any other relief to which the prevailing party may be entitled.
(h) No Assignment of Benefits. The rights of any person to payments or benefits under this Agreement shall not be made subject to option or assignment, either by voluntary or involuntary assignment or by operation of law, including (without limitation) bankruptcy, garnishment, attachment or other creditor’s process, and any action in violation of this Section 10(h) shall be void.
(i) Employment Taxes. All payments made pursuant to this Agreement will be subject to withholding of applicable income and employment taxes.
(j) Assignment by Company. The Company may assign its rights under this Agreement to an affiliate, and an affiliate may assign its rights under this Agreement to another affiliate of the Company or to the Company. In the case of any such assignment, the term “Company” when used in a section of this Agreement shall mean the company that actually employs the Employee. Notwithstanding the foregoing, neither the Company (or any successor thereto) nor the Employee may assign its obligations under this Agreement without the prior written consent of the other party hereto, unless such assignment by the Company is in connection with the assignment of this Agreement to the entity that actually employs the Employee.
(k) Counterparts. This Agreement may be executed in counterparts, each of which shall be deemed an original, but all of which together will constitute one and the same instrument.
[SIGNATURE PAGE FOLLOWS]
The parties have executed this Management Continuity Agreement on the date first written above.
ASSERTIO HOLDINGS, INC.
By: /s/ Heather Mason
Name: Heather Mason
Title: Interim Chief Executive Officer
EMPLOYEE
/s/ Brendan O’Grady
Name: Brendan O’Grady
Address:
APPENDIX A
ASSERTIO HOLDINGS, INC.
WAIVER AND RELEASE AGREEMENT
Assertio Holdings, Inc. has offered to pay me certain benefits (the “Benefits”) pursuant to Section 2 of my Management Continuity Agreement with Assertio Holdings, Inc., effective as of Date (the “Management Continuity Agreement”), which were offered to me in exchange for my agreement, among other things, to waive all of my claims against and release Assertio Holdings, Inc. and its predecessors, successors and assigns (collectively referred to as the “Company”), all of the affiliates (including parents and subsidiaries) of the Company (collectively referred to as the “Affiliates”) and the Company’s and Affiliates’ directors and officers, employees and agents, insurers, employee benefit plans and the fiduciaries and agents of said plans (collectively, with the Company and Affiliates, referred to as the “Corporate Group”) from any and all claims, demands, actions, liabilities and damages; provided, however, that this Waiver and Release shall not apply to (1) any existing right I have to indemnification, contribution and a defense, (2) any directors and officers and general liability insurance coverage, (3) any rights I may have as a shareholder of the Company, (4) any rights I have to the Benefits, (5) rights to vested benefits under the Company’s benefit plans and (6) any rights which cannot be waived or released as a matter of law.
I understand that signing this Waiver and Release is an important legal act. The Company hereby advises me to consult an attorney before signing this Waiver and Release and has given me at least forty-five (45) calendar days from the day I received a copy of this Waiver and Release to sign it and if I sign it before the expiration of such forty-five (45) day period, I have knowingly and voluntarily waived any longer consideration period than the one provided to me. I understand that no changes (whether material or immaterial) to this Waiver and Release shall restart the running of this forty-five (45) day period. I understand my termination is an [“Other Involuntary Termination”][“Change in Control Involuntary Termination”] pursuant to the Management Continuity Agreement.
In exchange for the payment to me of Benefits, I, on behalf of myself and my heirs, executors, personal representatives, administrators, and assigns: (1) knowingly and voluntarily waive all claims and release the Corporate Group from any and all claims, demands, actions, liabilities, and damages, whether known or unknown, arising at any time prior to or on the date that I sign this Waiver and Release, including but not limited to all claims arising out of or relating in any way to my employment with or separation from the Company or the Affiliates (including any claim for a bonus in respect of actual performance for the year of termination in the event that such bonus has not yet been paid), (2) agree not to assert in any local, state and/or federal court any claim released by this Waiver and Release, and (3) waive any rights that I may have under any of the Company’s involuntary severance benefit plans (other than the Management Continuity Agreement), except to the extent that my rights are vested under the terms of an employee benefit plan sponsored by the Company or an Affiliate and except with respect to such rights or claims as may arise after the date this Waiver and Release is executed. This Waiver and Release includes, but is not limited to, claims and causes of action under: Title VII of the Civil Rights Act of 1964, as amended (“Title VII”); the Age Discrimination in Employment Act of 1967, as amended, including the Older Workers Benefit Protection Act of 1990 (“ADEA”); the Civil Rights Act of 1866, as amended; the Civil Rights Act of 1991; the Americans with Disabilities Act of 1990 (“ADA”); the Energy Reorganization Act, as amended, 42 U.S.C. §§ 5851; the Workers Adjustment and Retraining Notification Act of 1988; the Sarbanes-Oxley Act of 2002; the Employee Retirement Income Security Act of 1974, as amended; the Family and Medical Leave Act of 1993; the Fair Labor Standards Act; the Occupational Safety and Health Act; the Illinois Human Rights Act, the Florida Civil Rights Act and the Kansas Act Against Discrimination; retaliation claims; claims arising under any “whistle blower” statutes (except to the extent prohibited by law); and/or contract, tort, defamation, slander, wrongful termination or any other state or federal regulatory, statutory or common law. Further, I expressly represent that no promise or agreement which is not expressed in the Management Continuity Agreement has been made to me in executing this
Waiver and Release, and that I am relying on my own judgment in executing this Waiver and Release, and that I am not relying on any statement or representation of the Company, any of the Affiliates or any other member of the Corporate Group or any of their agents. I agree that this Waiver and Release is valid, fair, adequate and reasonable, is entered into with my full knowledge and consent, was not procured through fraud, duress or mistake and has not had the effect of misleading, misinforming or failing to inform me.
I agree that I am not entitled to any severance or benefits, bonus, commissions, equity, paid time off, vehicle allowance, other wages, or any other payments of any kind. In particular, I agree that I have been paid all compensation, bonuses, commissions, and equity, received all benefits due to me as a result of my employment with or separation from the Company, and am not aware of any facts or circumstances constituting a violation of the Fair Labor Standards Act (“FLSA”) or any other federal, state or local constitution, statute, rule, regulation, or common law. I understand that I will not be entitled to receive any amounts under any other plan, program, or agreement with the Company, including, without limitation, incentive bonuses, stock options, equity, profit interest units, and any grant agreements, which bonuses, options, agreements, and unvested awards shall automatically terminate, cancel, forfeit, and expire on the [Separation Date], and all other benefits and perquisites that I am currently receiving cease on my [Separation Date].
The Company takes its obligations to comply with applicable laws and regulations very seriously and, therefore, needs to be made aware of any violations of applicable rules as well as applicable laws and regulations so that the Company may continuously improve their compliance efforts. Therefore, I certify that during my employment with the Company, I had an opportunity to read the Company’s policies, employment manuals, and code of conduct, and as the former {Title}, I was responsible for enforcing and adhering to these policies and programs. I certify that I have not become aware of any violations of law or of such policies by the Company or any of its employees, including, but not limited to, law and policies concerning: corporate securities; compliance with requirements of Medicare, Medicaid, and other federal health care programs; discrimination, harassment and equal employment opportunity; workplace safety; and gifts and gratuities.
In further exchange for the payment to me of Benefits, I agree not to make any disparaging or derogatory statements concerning the Company. The Company hereby agrees to instruct its officers and directors not to make any disparaging statements concerning you. These non-disparagement obligations shall not in any way affect my or the Company’s obligation or rights in connection with any legal proceeding and nothing herein shall prevent me or the Company from discussing or disclosing information about unlawful acts in the workplace, such as harassment or discrimination or any other conduct that either party, acting in good faith, has reason to believe is unlawful. I further acknowledge and agree that I am bound by and will comply with the Employee Confidential Information and Inventions Agreement and any similar agreements that I have entered into with the Company and that I will, within seven (7) calendar days of the date of this Waiver and Release, return all Company property and any confidential Company information (including any such information that may reside on personal devices) to the Company and certify the return of same in accordance with Section 4 (Company Property) of the Employee Confidential Information and Inventions Agreement. I further acknowledge and agree that payment of the Benefits is contingent upon my continued cooperation with the Company and its affiliates (including their attorneys) to provide information and reasonable assistance as requested by the Company or its affiliates in connection with any claim, dispute, investigation (including without limitation inquiries by Federal and State regulators), action, suit, or proceeding, whether civil, criminal, administrative, regulatory, arbitral, investigative or otherwise, whether now pending or hereinafter threatened or instituted, directly or indirectly, by or against the Company or any of its affiliates (each an “Action” and, collectively, the “Actions”). Such information and assistance may include testifying (and preparing to testify) as a witness in any proceeding or otherwise providing information or reasonable assistance to the Company or its affiliates in connection with any Action, and cooperating with the Company or its affiliates regarding any Action directly or indirectly involving the Company or any of its affiliates. Specifically, I agree (i) to meet with the Company’s or its affiliates’ representatives, their counsel or other designees at reasonable times and places with respect to any Action; (ii) to provide truthful testimony regarding any such matter to any applicable court, agency or other adjudicatory body; (iii) to provide the Company or any of its affiliates with immediate notice of contact or subpoena by any adverse party (known to me to be adverse to the Company or any of its affiliates or their interests), and (iv) to not voluntarily assist any such non-governmental adverse party or such non-governmental
adverse party’s representatives. Except for its de minimis requests for information, the Company agrees to reimburse you for your reasonable, documented and out of pocket travel expenses.
I agree in connection with the termination of my employment that I hereby resign from all positions as an officer, director and all other positions I may hold with the Company and all of its subsidiaries and affiliates effective [Separation Date].
Notwithstanding the foregoing, nothing contained in this Waiver and Release is intended to prohibit or restrict me in any way from (1) bringing arbitration against the Company to enforce the Company’s obligations under the Management Continuity Agreement; (2) making any disclosure of information permitted or required by law; (3) providing information to, or testifying or otherwise assisting in any investigation or proceeding brought by, any federal regulatory or law enforcement agency or legislative body, any self-regulatory organization, or the Company’s legal, compliance or human resources officers; (4) testifying or participating in or otherwise assisting in a proceeding relating to an alleged violation of any federal, state or municipal law relating to fraud or any rule or regulation of the Securities and Exchange Commission or any self-regulatory organization; or (5) reporting violations of U.S. federal or state laws or regulations to a relevant government agency, from making disclosures that are protected under U.S. federal and state whistleblower laws and regulations or from accepting any monetary reward in connection therewith; or (6) filing any claims that are not permitted to be waived or released under applicable law (although my ability to recover damages or other relief is still waived and released to the extent permitted by law). Nothing contained in this Waiver and Release is intended to waive any rights I may have related to unemployment compensation and workers’ compensation and indemnification claims.
I acknowledge that I may discover facts different from or in addition to those which I now know or believe to be true and that this Waiver and Release shall be and remain effective in all respects notwithstanding such different or additional facts or the discovery thereof.
Should any of the provisions set forth in this Waiver and Release be determined to be invalid by a court, agency or other tribunal of competent jurisdiction, it is agreed that such determination shall not affect the enforceability of other provisions of this Waiver and Release. I acknowledge that this Waiver and Release and the Management Continuity Agreement set forth the entire understanding and agreement between me and the Company or any other member of the Corporate Group concerning the subject matter of this Waiver and Release and supersede any prior or contemporaneous oral and/or written agreements or representations, if any, between me and the Company or any other member of the Corporate Group on the same subject matter. I understand that for a period of seven (7) calendar days following the date that I sign this Waiver and Release, I may revoke my acceptance of the offer, provided that my written statement of revocation is received on or before that seventh day by the Human Resources Department, Assertio Holdings, Inc., 100 S. Saunders Road, Suite 300, Lake Forest, IL 60045, in which case the Waiver and Release will not become effective. In the event I revoke my acceptance of this offer, the Company shall have no obligation to provide me Benefits. I understand that failure to revoke my acceptance of the offer within seven (7) calendar days from the date I sign this Waiver and Release will result in this Waiver and Release being permanent and irrevocable.
I acknowledge that I have read this Waiver and Release, have had an opportunity to ask questions and have it explained to me, have been advised to and have had the opportunity to consult with legal counsel, and that I understand that this Waiver and Release will have the effect of knowingly and voluntarily waiving any action I might pursue, including breach of contract, personal injury, retaliation, discrimination on the basis of race, age, sex, national origin, or disability and any other claims arising prior to the date of this Waiver and Release. By execution of this document, I do not waive or release or otherwise relinquish any legal rights I may have which are attributable to or arise out of acts, omissions, or events of the Company or any other member of the Corporate Group which occur after the date of the execution of this Waiver and Release.
Employee’s Name Company Representative’s Signature
Employee’s Signature and Title Company’s Representative’s Name
Employee’s Signature Date Company’s Execution Date
Exhibit 10.4
ASSERTIO HOLDINGS, INC.
NONEMPLOYEE DIRECTOR COMPENSATION AND
GRANT POLICY
1. Annual Cash Retainer. All nonemployee directors of the Company receive an annual cash retainer of $55,000.
2. Additional Retainer — Chairman of the Board. A non-employee chairman of the Board of Directors receives an additional annual cash retainer of $50,000.
3. Additional Retainer — Audit Committee. The chair of the audit committee receives an additional annual cash retainer of $25,000. Each other member of the audit committee receives an additional annual cash retainer of $12,500.
4. Additional Retainer — Compensation Committee. The chair of the compensation committee receives an additional annual cash retainer of $20,000. Each other member of the compensation committee receives an additional annual cash retainer of $10,000.
5. Additional Retainer — Nominating and Corporate Governance Committee. The chair of the nominating and corporate governance committee receives an additional annual cash retainer of $15,000. Each other member of the nominating and corporate governance committee receives an additional annual cash retainer of $6,000.
6. Additional Retainer — Special Committees. Each member of any special committee of the Board of Directors receives an additional annual cash retainer of $6,000.
7. Payments. Payments under the policy are made quarterly in arrears.
8. Automatic Grant of Restricted Stock Unit and Stock Option Awards. Restricted stock unit awards and stock option grants shall be made in accordance with the Company’s Amended and Restated 2014 Omnibus Incentive Plan (the “2014 Plan”), as follows:
(a) on the date of each Annual Meeting of Stockholders held in calendar year 2024 and thereafter, each nonemployee director then in office (and if a newly appointed or elected nonemployee director, a director whose service commenced prior to January 1 of such calendar year) automatically receives (A) an award of restricted stock units having a value of $107,500 (based on the Fair Market Value (as defined in the 2014 Plan) of the Company’s common stock as of the date of grant) that vest on the earlier of (i) the first anniversary of the date on which such award of restricted stock units were made and (ii) the next Annual Meeting of Stockholders which is at least 50 weeks after the date of grant (the “Continuing Director Vesting Date”); and (B) an award of non-qualified stock options having a value of $107,500 (based the grant date fair value of the options (i.e., Black-Scholes value) determined in accordance with the reasonable assumptions and methodologies employed by the Company for calculating the fair value of options under Accounting Standards Codification 718 “Compensation-Stock Compensation”) that (x) vest on
the Continuing Director Vesting Date; (y) have a per share exercise price equal to the Fair Market Value (as defined in the 2014 Plan) of the Company’s common stock on the date of grant; and (z) expire no more than ten years from the date of grant; and
(b) each newly elected nonemployee director automatically receives, on the date of the director’s initial election or appointment, (A) an award of restricted stock units having a value of $107,500 (based on the Fair Market Value (as defined in the 2014 Plan) of the Company’s common stock as of the date of grant) that vest in three equal installments on the first three anniversaries of the director’s election or appointment; and (B) an award of non-qualified stock options having a value of $107,500 (based the grant date fair value of the options (i.e., Black-Scholes value) determined in accordance with the reasonable assumptions and methodologies employed by the Company for calculating the fair value of options under Accounting Standards Codification 718 “Compensation-Stock Compensation”) that (x) vest in three equal installments on the first three anniversaries of the director’s election or appointment; (y) have a per share exercise price equal to the Fair Market Value (as defined in the 2014 Plan) of the Company’s common stock on the date of grant; and (z) expire no more than ten years from the date of grant;
provided, however, that directors’ total annual equity compensation will be subject to any cap specified in the 2014 Plan, and the Board of Directors may otherwise elect to (i) reduce the dollar value thresholds specified in (a) and (b) above or (ii) forgo such grants, in each case as it may deem appropriate.
Approved: May 8, 2024
Effective: May 8, 2024
Exhibit 31.1
CERTIFICATION OF THE CHIEF EXECUTIVE OFFICER
I, Brendan P. O’Grady, 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: August 7, 2024 | By: | /s/ Brendan P. O’Grady |
| | Brendan P. O’Grady |
| | Chief Executive Officer (Principal Executive Officer) |
Exhibit 31.2
CERTIFICATION OF THE CHIEF FINANCIAL OFFICER
I, Ajay Patel, 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: August 7, 2024 | By: | /s/ Ajay Patel |
| | Ajay Patel |
| | Senior Vice President and Chief Financial Officer (Principal Financial and Accounting 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 June 30, 2024 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Brendan P. O’Grady, 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: August 7, 2024 | | /s/ Brendan P. O’Grady |
| | Brendan P. O’Grady |
| | 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 June 30, 2024 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Ajay Patel, 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: August 7, 2024 | | /s/ Ajay Patel |
| | Ajay Patel |
| | Senior Vice President and Chief Financial Officer (Principal Financial and Accounting Officer) |
v3.24.2.u1
COVER PAGE - shares
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6 Months Ended |
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Jun. 30, 2024 |
Aug. 01, 2024 |
Cover [Abstract] |
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Entity Registrant Name |
ASSERTIO HOLDINGS, INC.
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Entity Incorporation, State or Country Code |
DE
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Entity Tax Identification Number |
85-0598378
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100 South Saunders Road
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Suite 300
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Lake Forest
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Common Stock, $0.0001 par value
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ASRT
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NASDAQ
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v3.24.2.u1
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands |
Jun. 30, 2024 |
Dec. 31, 2023 |
Current assets: |
|
|
Cash and cash equivalents |
$ 44,735
|
$ 73,441
|
Short-term investments |
43,644
|
0
|
Accounts receivable, net |
39,913
|
47,663
|
Inventories, net |
39,080
|
37,686
|
Prepaid and other current assets |
10,480
|
12,272
|
Total current assets |
177,852
|
171,062
|
Property and equipment, net |
664
|
770
|
Intangible assets, net |
99,030
|
111,332
|
Other long-term assets |
1,897
|
3,255
|
Total assets |
279,443
|
286,419
|
Current liabilities: |
|
|
Accounts payable |
15,271
|
13,439
|
Accrued rebates, returns and discounts |
58,424
|
58,137
|
Accrued liabilities |
15,124
|
18,213
|
Contingent consideration, current portion |
2,700
|
2,700
|
Other current liabilities |
665
|
954
|
Total current liabilities |
92,184
|
93,443
|
Long-term debt |
38,729
|
38,514
|
Other long-term liabilities |
16,377
|
16,459
|
Total liabilities |
147,290
|
148,416
|
Commitments and contingencies (Note 15) |
|
|
Shareholders’ equity: |
|
|
Common stock, $0.0001 par value, 200,000,000 shares authorized; 95,333,214 and 94,668,523 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively. |
9
|
9
|
Additional paid-in capital |
791,871
|
789,537
|
Accumulated deficit |
(659,727)
|
(651,543)
|
Total shareholders’ equity |
132,153
|
138,003
|
Total liabilities and shareholders' equity |
$ 279,443
|
$ 286,419
|
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v3.24.2.u1
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares
|
Jun. 30, 2024 |
Dec. 31, 2023 |
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) |
95,333,214
|
94,668,523
|
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95,333,214
|
94,668,523
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.24.2.u1
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE (LOSS) INCOME - USD ($) shares in Thousands, $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Revenues: |
|
|
|
|
Total revenues |
$ 31,126
|
$ 40,991
|
$ 63,574
|
$ 83,457
|
Costs and expenses: |
|
|
|
|
Cost of sales |
8,889
|
4,772
|
20,066
|
10,239
|
Research and development expenses |
798
|
503
|
1,531
|
503
|
Selling, general and administrative expenses |
18,385
|
16,771
|
36,909
|
33,675
|
Change in fair value of contingent consideration |
0
|
241
|
0
|
9,408
|
Amortization of intangible assets |
6,671
|
6,284
|
12,302
|
12,568
|
Restructuring charges |
0
|
0
|
720
|
0
|
Total costs and expenses |
34,743
|
28,571
|
71,528
|
66,393
|
(Loss) income from operations |
(3,617)
|
12,420
|
(7,954)
|
17,064
|
Other income (expense): |
|
|
|
|
Debt-related expenses |
0
|
0
|
0
|
(9,918)
|
Interest expense |
(758)
|
(751)
|
(1,515)
|
(1,873)
|
Interest income |
842
|
650
|
1,554
|
1,109
|
Other gain |
8
|
11
|
12
|
354
|
Total other income (expense) |
92
|
(90)
|
51
|
(10,328)
|
Net (loss) income before income taxes |
(3,525)
|
12,330
|
(7,903)
|
6,736
|
Income tax expense |
(149)
|
(3,860)
|
(281)
|
(1,750)
|
Net (loss) income |
$ (3,674)
|
$ 8,470
|
$ (8,184)
|
$ 4,986
|
Basic net (loss) income per share(in dollars per share) |
$ (0.04)
|
$ 0.15
|
$ (0.09)
|
$ 0.09
|
Diluted net (loss) income per share (in dollars per share) |
$ (0.04)
|
$ 0.13
|
$ (0.09)
|
$ 0.09
|
Shares used in computing basic net (loss) income per share (in shares) |
95,240
|
56,142
|
95,110
|
53,588
|
Shares used in computing diluted net (loss) income per share (in shares) |
95,240
|
70,144
|
95,110
|
58,010
|
Product sales, net |
|
|
|
|
Revenues: |
|
|
|
|
Total revenues |
$ 30,695
|
$ 40,083
|
$ 62,557
|
$ 81,852
|
Royalties and milestones |
|
|
|
|
Revenues: |
|
|
|
|
Total revenues |
431
|
723
|
1,017
|
1,420
|
Other revenue |
|
|
|
|
Revenues: |
|
|
|
|
Total revenues |
$ 0
|
$ 185
|
$ 0
|
$ 185
|
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v3.24.2.u1
CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY - USD ($) $ in Thousands |
Total |
Common Stock |
Additional Paid-In Capital |
Accumulated Deficit |
Balances (in shares) at Dec. 31, 2022 |
|
48,320,000
|
|
|
Balances at Dec. 31, 2022 |
$ 225,725
|
$ 5
|
$ 545,321
|
$ (319,601)
|
Increase (Decrease) in Stockholders' Equity |
|
|
|
|
Induced exchange of convertible notes (in shares) |
|
6,990,000
|
|
|
Induced exchange of convertible notes |
26,699
|
|
26,699
|
|
Common stock issuance and other impacts of the vesting and settlement of equity awards (in shares) |
|
1,093,000
|
|
|
Common stock issuance and other impacts of the vesting and settlement of equity awards |
(7,947)
|
|
(7,947)
|
|
Issuance of common stock upon exercise of options (in shares) |
|
110,000
|
|
|
Issuance of common stock upon exercise of options |
157
|
|
157
|
|
Stock-based compensation |
4,651
|
|
4,651
|
|
Net (loss) income |
4,986
|
|
|
4,986
|
Balances (in shares) at Jun. 30, 2023 |
|
56,513,000
|
|
|
Balances at Jun. 30, 2023 |
254,271
|
$ 5
|
568,881
|
(314,615)
|
Balances (in shares) at Mar. 31, 2023 |
|
55,662,000
|
|
|
Balances at Mar. 31, 2023 |
250,664
|
$ 5
|
573,744
|
(323,085)
|
Increase (Decrease) in Stockholders' Equity |
|
|
|
|
Common stock issuance and other impacts of the vesting and settlement of equity awards (in shares) |
|
741,000
|
|
|
Common stock issuance and other impacts of the vesting and settlement of equity awards |
(7,225)
|
|
(7,225)
|
|
Issuance of common stock upon exercise of options (in shares) |
|
110,000
|
|
|
Issuance of common stock upon exercise of options |
157
|
|
157
|
|
Stock-based compensation |
2,205
|
|
2,205
|
|
Net (loss) income |
8,470
|
|
|
8,470
|
Balances (in shares) at Jun. 30, 2023 |
|
56,513,000
|
|
|
Balances at Jun. 30, 2023 |
$ 254,271
|
$ 5
|
568,881
|
(314,615)
|
Balances (in shares) at Dec. 31, 2023 |
94,668,523
|
94,669,000
|
|
|
Balances at Dec. 31, 2023 |
$ 138,003
|
$ 9
|
789,537
|
(651,543)
|
Increase (Decrease) in Stockholders' Equity |
|
|
|
|
Common stock issuance and other impacts of the vesting and settlement of equity awards (in shares) |
|
664,000
|
|
|
Common stock issuance and other impacts of the vesting and settlement of equity awards |
(281)
|
|
(281)
|
|
Stock-based compensation |
2,615
|
|
2,615
|
|
Net (loss) income |
$ (8,184)
|
|
|
(8,184)
|
Balances (in shares) at Jun. 30, 2024 |
95,333,214
|
95,333,000
|
|
|
Balances at Jun. 30, 2024 |
$ 132,153
|
$ 9
|
791,871
|
(659,727)
|
Balances (in shares) at Mar. 31, 2024 |
|
95,115,000
|
|
|
Balances at Mar. 31, 2024 |
134,494
|
$ 9
|
790,538
|
(656,053)
|
Increase (Decrease) in Stockholders' Equity |
|
|
|
|
Common stock issuance and other impacts of the vesting and settlement of equity awards (in shares) |
|
218,000
|
|
|
Common stock issuance and other impacts of the vesting and settlement of equity awards |
(75)
|
|
(75)
|
|
Stock-based compensation |
1,408
|
|
1,408
|
|
Net (loss) income |
$ (3,674)
|
|
|
(3,674)
|
Balances (in shares) at Jun. 30, 2024 |
95,333,214
|
95,333,000
|
|
|
Balances at Jun. 30, 2024 |
$ 132,153
|
$ 9
|
$ 791,871
|
$ (659,727)
|
X |
- DefinitionAmount of increase to additional paid-in capital (APIC) for recognition of cost for award under share-based payment arrangement.
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v3.24.2.u1
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Operating Activities |
|
|
Net (loss) income |
$ (8,184)
|
$ 4,986
|
Adjustments to reconcile net (loss) income to net cash from operating activities: |
|
|
Depreciation and amortization |
12,407
|
12,964
|
Amortization of debt issuance costs and Royalty Rights |
215
|
248
|
Accretion of interest income from short-term investments |
(338)
|
0
|
Recurring fair value measurements of assets and liabilities |
15
|
9,408
|
Debt-related expenses |
0
|
9,918
|
Provisions for inventory and other assets |
3,877
|
1,390
|
Stock-based compensation |
2,615
|
4,651
|
Deferred income taxes |
0
|
(1,385)
|
Changes in assets and liabilities: |
|
|
Accounts receivable |
7,750
|
3,749
|
Inventories |
(5,271)
|
(6,511)
|
Prepaid and other assets |
3,150
|
4,289
|
Accounts payable and other accrued liabilities |
(1,627)
|
4,906
|
Accrued rebates, returns and discounts |
286
|
(6,569)
|
Interest payable |
0
|
(726)
|
Net cash provided by operating activities |
14,895
|
41,318
|
Investing Activities |
|
|
Purchases of property and equipment |
0
|
(528)
|
Purchase of Sympazan |
0
|
(280)
|
Purchases of short-term investments |
(43,320)
|
0
|
Net cash used in investing activities |
(43,320)
|
(808)
|
Financing Activities |
|
|
Payments in connection with 2027 Convertible Notes |
0
|
(10,500)
|
Payment of direct transaction costs related to convertible debt inducement |
0
|
(1,119)
|
Payment of contingent consideration |
0
|
(15,408)
|
Payment of Royalty Rights |
0
|
(459)
|
Proceeds from exercise of stock options |
0
|
157
|
Payments related to the vesting and settlement of equity awards, net |
(281)
|
(7,947)
|
Net cash used in financing activities |
(281)
|
(35,276)
|
Net (decrease) increase in cash and cash equivalents |
(28,706)
|
5,234
|
Cash and cash equivalents at beginning of year |
73,441
|
64,941
|
Cash and cash equivalents at end of period |
44,735
|
70,175
|
Supplemental Disclosure of Cash Flow Information |
|
|
Net cash paid for income taxes |
1,384
|
2,295
|
Cash paid for interest |
$ 1,300
|
$ 2,351
|
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v3.24.2.u1
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
|
6 Months Ended |
Jun. 30, 2024 |
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 pharmaceutical company with comprehensive commercial capabilities offering differentiated products to patients. The Company has built its product portfolio through the acquisition or licensing of approved products. The Company’s commercial capabilities include marketing through both a sales force and a non-personal promotion model, market access through payor contracting, and trade and distribution. The Company’s primary marketed products include ROLVEDONTM (elflapegrastim-xnst) injection for subcutaneous use, INDOCIN® (indomethacin) Suppositories, INDOCIN® (indomethacin) Oral Suspension, Sympazan® (clobazam) oral film, Otrexup® (methotrexate) injection for subcutaneous use, SPRIX® (ketorolac tromethamine) Nasal Spray, CAMBIA® (diclofenac potassium for oral solution), and Zipsor® (diclofenac potassium) liquid filled capsules. To date, substantially all of the Company’s revenues are related to product sales in the United States (“U.S.”).
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.
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 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, consisting only of normal and recurring adjustments, necessary for a fair presentation of the information for the periods presented. The results for the three and six months ended June 30, 2024, are not necessarily indicative of results to be expected for the entire year ending December 31, 2024.
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, 2023, included in Assertio Holdings, Inc.’s Annual Report on Form 10-K filed with the SEC on March 11, 2024 (the “2023 Form 10-K”). The Condensed Consolidated Balance Sheet as of December 31, 2023, has been derived from the audited financial statements at that date, as filed in the Company’s 2023 Form 10-K. Reclassifications During the second quarter of 2024, the Company reclassified interest income from Other gain to Interest income on the Company’s Condensed Consolidated Statements of Comprehensive (Loss) Income. Prior period amounts were also reclassified to conform with the current period presentation.
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v3.24.2.u1
ACQUISITIONS
|
6 Months Ended |
Jun. 30, 2024 |
Business Combination, Asset Acquisition, and Joint Venture Formation [Abstract] |
|
ACQUISITIONS |
ACQUISITIONS Spectrum Pharmaceuticals
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”). The Spectrum Merger was completed pursuant to an Agreement and Plan of Merger (the “Merger Agreement”), dated as of April 24, 2023, through a merger of a wholly-owned subsidiary of the Company with and into Spectrum, 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) or were 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 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 included as part of the consideration transferred. (2)Represents the Effective Date fair value of 223,397 CVRs at $0.0176 per CVR issued to holders of Spectrum common stock, employee stock awards and warrants.
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 18, 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 fair values of the assets acquired and liabilities assumed at the Effective Date (in thousands). The fair values were based on management’s estimates and assumptions. Management’s determination of the fair values of the assets acquired and liabilities assumed was completed as of March 31, 2024.
| | | | | | | | | | | | | | | | | | | | | | | Initial Preliminary Purchase Price Allocation to Fair Value | | Adjustments to Purchase Price Allocation to Fair Value (2) | | Final Purchase Price Allocation to Fair Value | Assets: | | | | | | | Cash and cash equivalents | | $ | 34,600 | | | $ | — | | | $ | 34,600 | | Marketable securities | | 2,194 | | | — | | | 2,194 | | Accounts receivable | | 50,975 | | | — | | | 50,975 | | Inventories | | 22,244 | | | 61 | | | 22,305 | | Prepaid and other current assets | | 1,287 | | | 698 | | | 1,985 | | Property and equipment | | 100 | | | — | | | 100 | | Intangible assets | | 234,000 | | | (13,500) | | | 220,500 | | Other long-term assets | | 1,396 | | | — | | | 1,396 | | Total | | $ | 346,796 | | | $ | (12,741) | | | $ | 334,055 | | | | | | | | | Liabilities: | | | | | | | Accounts payable | | $ | 10,108 | | | $ | — | | | $ | 10,108 | | Accrued rebates, returns and discounts | | 21,025 | | | — | | | 21,025 | | Accrued liabilities | | 36,509 | | | (2,343) | | | 34,166 | | Other current liabilities | | 784 | | | — | | | 784 | | Deferred taxes | | 34,250 | | | (30,254) | | | 3,996 | | Other long-term liabilities | | 11,103 | | | — | | | 11,103 | | Total | | $ | 113,779 | | | $ | (32,597) | | | $ | 81,182 | | | | | | | | | Total Spectrum net assets acquired (1) | | $ | 233,017 | | | $ | 19,856 | | | $ | 252,873 | | Goodwill | | $ | 19,856 | | | $ | (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. (2)Adjustments made to the preliminary purchase price allocation to fair value primarily reflect completion of studies and other analyses necessary to determine the income tax effects of the net identifiable assets acquired and further refinement of the assumptions used in the valuation supporting the ROLVEDON product rights. These adjustments did not materially impact the Consolidated Statement of Comprehensive (Loss) Income.
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 recognized for the three and six months ended June 30, 2023, were $3.4 million and $5.8 million, respectively. There were no acquisition costs related to the Spectrum Merger recognized for the three and six months ended June 30, 2024. 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, 2023, (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 total revenues and net income (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 | | Six Months Ended | | | June 30, 2023 | | June 30, 2023 | Total revenues | | $ | 64,729 | | | $ | 122,810 | | Net income (loss) | | 4,938 | | | (9,006) | |
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v3.24.2.u1
REVENUE
|
6 Months Ended |
Jun. 30, 2024 |
Revenue from Contract with Customer [Abstract] |
|
REVENUE |
REVENUE Disaggregated Revenue The following table reflects total revenues for the three and six months ended June 30, 2024 and 2023 (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended June 30, | | Six Months Ended June 30, | | | 2024 | | 2023 | | 2024 | | 2023 | Product sales, net: | | | | | | | | | ROLVEDON | | $ | 15,144 | | | $ | — | | | $ | 29,622 | | $ | — | | INDOCIN products | | 6,913 | | | 28,075 | | | 15,596 | | | 58,421 | | Sympazan | | 2,668 | | | 2,627 | | | 5,285 | | | 5,129 | | Otrexup | | 2,014 | | | 3,594 | | | 4,896 | | | 6,416 | | SPRIX | | 2,147 | | | 2,373 | | | 3,584 | | | 4,262 | | CAMBIA | | 1,403 | | | 1,805 | | | 2,660 | | | 4,069 | | | | | | | | | | | Other products | | 406 | | | 1,609 | | | 914 | | | 3,555 | | Total product sales, net | | 30,695 | | | 40,083 | | | 62,557 | | | 81,852 | | Royalties and milestone revenue | | 431 | | | 723 | | | 1,017 | | | 1,420 | | Other revenue | | — | | | 185 | | | — | | | 185 | | Total revenues | | $ | 31,126 | | | $ | 40,991 | | | $ | 63,574 | | | $ | 83,457 | |
Product Sales, net
As a result of the Spectrum Merger, the Company began recognizing ROLVEDON sales in August 2023.
Other product sales, net, for the three and six months ended June 30, 2023 include product sales for OXAYDO and Zipsor. As the Company ceased OXAYDO product sales beginning in September 2023, other net product sales for the three and six months ended June 30, 2024 represent only net product sales of Zipsor. Royalties and Milestone Revenue
In November 2010, the Company entered into a license agreement granting Tribune Pharmaceuticals Canada Ltd. (now known as Miravo Pharmaceuticals, or “Miravo”) the rights to commercially market CAMBIA in Canada. Miravo independently contracts with manufacturers to produce a specific CAMBIA formulation in Canada. The Company recognized royalties revenue related to the CAMBIA licensing agreement of $0.4 million and $1.0 million for the three and six months ended June 30, 2024, respectively, and $0.4 million and $1.0 million for the three and six months ended June 30, 2023, respectively.
The Company recognized no milestone revenue associated with the completion of certain service milestones for the three and six months ended June 30, 2024, and $0.3 million and $0.5 million and for the three and six months ended June 30, 2023, respectively.
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ACCOUNTS RECEIVABLES, NET
|
6 Months Ended |
Jun. 30, 2024 |
Receivables [Abstract] |
|
ACCOUNTS RECEIVABLES, NET |
ACCOUNTS RECEIVABLES, NET As of June 30, 2024 and December 31, 2023, accounts receivable, net, consisted entirely of receivables related to product sales, net of allowances for cash discounts for prompt payment of $0.5 million and $0.9 million, respectively.
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INVENTORIES, NET
|
6 Months Ended |
Jun. 30, 2024 |
Inventory Disclosure [Abstract] |
|
INVENTORIES, NET |
INVENTORIES, NET The following table reflects the components of inventories, net as of June 30, 2024 and December 31, 2023 (in thousands): | | | | | | | | | | | | | June 30, 2024 | | December 31, 2023 | Raw materials | $ | 19,159 | | | $ | 10,537 | | Work-in-process | 870 | | | 2,239 | | Finished goods | 19,051 | | | 24,910 | | Total inventories, net | $ | 39,080 | | | $ | 37,686 | |
The Company writes down the value of inventory for potential excess or obsolete inventories based on an analysis of inventory on hand and projected demand. As of June 30, 2024 and December 31, 2023, inventory reserves were $6.1 million and $6.8 million, respectively.
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v3.24.2.u1
PREPAID AND OTHER CURRENT ASSETS
|
6 Months Ended |
Jun. 30, 2024 |
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 June 30, 2024 and December 31, 2023 (in thousands):
| | | | | | | | | | | | | June 30, 2024 | | December 31, 2023 | Prepaid assets and deposits | $ | 10,179 | | | $ | 11,973 | | Other current assets | 301 | | | 299 | | | | | | Total prepaid and other current assets | $ | 10,480 | | | $ | 12,272 | |
In August 2018, the Company entered into a Convertible Secured Note Purchase Agreement (the “Note Agreement”) with NES Therapeutic, Inc. (“NES”), pursuant to which it purchased a Convertible Secured Promissory Note (the “NES Note”). The Company’s investment in the NES Note, which is included in other current assets, is accounted for as a loan receivable and is valued at amortized cost. As of both June 30, 2024 and December 31, 2023, the Company recorded a $3.5 million credit loss reserve on its investment based on its evaluation of the probability of default that exists at NES. The credit loss reserve recorded in each period represents the entire aggregate principal amount and outstanding interest incurred on the NES Note as of both June 30, 2024 and December 31, 2023.
On August 2, 2024, the NES Note was amended to extend the maturity date to August 16, 2024. All other terms of the existing Note Agreement were unchanged by the extension.
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v3.24.2.u1
PROPERTY AND EQUIPMENT, NET
|
6 Months Ended |
Jun. 30, 2024 |
Property, Plant and Equipment [Abstract] |
|
PROPERTY AND EQUIPMENT, NET |
PROPERTY AND EQUIPMENT, NET The following table reflects property and equipment, net as of June 30, 2024 and December 31, 2023 (in thousands):
| | | | | | | | | | | | | June 30, 2024 | | December 31, 2023 | Furniture and office equipment | $ | 1,412 | | | $ | 1,908 | | Laboratory equipment | 20 | | | 20 | | Leasehold improvements | 2,551 | | | 2,945 | | Construction in progress | — | | | 528 | | | 3,983 | | | 5,401 | | Less: Accumulated depreciation | (3,319) | | | (4,631) | | Property and equipment, net | $ | 664 | | | $ | 770 | |
Depreciation expense was less than $0.1 million and $0.1 million for the three and six months ended June 30, 2024, respectively, and $0.2 million and $0.4 million for three and six months ended June 30, 2023, 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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v3.24.2.u1
INTANGIBLE ASSETS
|
6 Months Ended |
Jun. 30, 2024 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
INTANGIBLE ASSETS |
INTANGIBLE ASSETS The following table reflects the gross carrying amounts and net book values of intangible assets as of June 30, 2024 and December 31, 2023 (dollar amounts in thousands):
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | June 30, 2024 | | December 31, 2023 | Products rights: | | Remaining Useful Life (In years) | | Gross Carrying Amount | | Accumulated Amortization | | | | | | Net Book Value | | Gross Carrying Amount | | Accumulated Amortization | | Impairment | | Net Book Value | ROLVEDON | | 9.1 | | $ | 63,405 | | | $ | (8,303) | | | | | | | $ | 55,102 | | | $ | 220,500 | | | $ | (5,270) | | | $ | (157,095) | | | $ | 58,135 | | INDOCIN | | 1.0 | | 65,605 | | | (51,052) | | | | | | | 14,553 | | | 154,100 | | | (44,814) | | | (88,494) | | | 20,792 | | Sympazan | | 10.3 | | 14,550 | | | (2,020) | | | | | | | 12,530 | | | 14,550 | | | (1,415) | | | — | | | 13,135 | | Otrexup | | 5.5 | | 16,364 | | | (10,625) | | | | | | | 5,739 | | | 44,086 | | | (10,103) | | | (27,723) | | | 6,260 | | SPRIX | | 2.9 | | 32,673 | | | (21,567) | | | | | | | 11,106 | | | 39,000 | | | (19,663) | | | (6,327) | | | 13,010 | | Total intangible assets | | | | $ | 192,597 | | | $ | (93,567) | | | | | | | $ | 99,030 | | | $ | 472,236 | | | $ | (81,265) | | | $ | (279,639) | | | $ | 111,332 | | | | | | | | | | | | | | | | | | | | | | |
Amortization expense was $6.7 million and $12.3 million for the three and six months ended June 30, 2024, respectively, and $6.3 million and $12.6 million for three and six months ended June 30, 2023, respectively.
Effective April 1, 2024, the Company revised the remaining estimated useful life of the INDOCIN product rights intangible asset to 1.3 years, which better reflects the realization of the economic benefit of the intangible asset. The impact of this change in estimate is reflected in expected future amortization expense disclosed below.
The following table reflects future amortization expense the Company expects for its intangible assets (in thousands):
| | | | | | | | | Year Ending December 31, | | Estimated Amortization Expense | 2024 (remainder) | | 13,342 | | 2025 | | 19,407 | | 2026 | | 12,130 | | 2027 | | 9,909 | | 2028 | | 8,322 | | Thereafter | | 35,920 | | Total | | $ | 99,030 | |
During each of the three months ended June 30, 2024 and March 31, 2024, the Company’s market capitalization was below the book value of the Company’s equity, which management determined 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 at each date. Similar to its previous assessment in the fourth quarter of 2023, as described in the Company’s 2023 Form 10-K, the Company concluded that it was appropriate to group its assets at the product level. After grouping the long-lived assets at the lowest level for which there are identifiable cash flows that are largely independent of the cash flows of other assets and liabilities, the Company estimated the future net undiscounted cash flows expected to be generated from the use of the long-lived asset groups and their eventual disposition at each of the three months ended June 30, 2024 and March 31, 2024. The Company then compared the estimated undiscounted cash flows to the carrying amounts of the long-lived asset groups at each date. Based on these tests, the Company determined that the estimated undiscounted cash flows were in excess of the carrying amounts for all of the long-lived asset groups as of both June 30, 2024 and March 31, 2024 and, accordingly, the Company concluded that the long-lived asset groups are fully recoverable and no adjustment to their carrying values was required.
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v3.24.2.u1
OTHER LONG-TERM ASSETS
|
6 Months Ended |
Jun. 30, 2024 |
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 June 30, 2024 and December 31, 2023 (in thousands):
| | | | | | | | | | | | | June 30, 2024 | | December 31, 2023 | Operating lease right-of-use assets | $ | 1,198 | | | $ | 1,269 | | | | | | Other | 699 | | | 1,986 | | Total other long-term assets | $ | 1,897 | | | $ | 3,255 | |
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v3.24.2.u1
ACCRUED LIABILITIES
|
6 Months Ended |
Jun. 30, 2024 |
Accounts Payable and Accrued Liabilities, Current [Abstract] |
|
ACCRUED LIABILITIES |
ACCRUED LIABILITIES The following table reflects accrued liabilities as of June 30, 2024 and December 31, 2023 (in thousands):
| | | | | | | | | | | | | June 30, 2024 | | December 31, 2023 | Accrued compensation | $ | 1,772 | | | $ | 2,438 | | Accrued restructuring costs (See Note 20) | 2,330 | | | 4,378 | | Other accrued liabilities | 8,936 | | | 9,492 | | | | | | Interest payable | 867 | | | 867 | | Accrued royalties | 1,219 | | | 1,038 | | Total accrued liabilities | $ | 15,124 | | | $ | 18,213 | |
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DEBT
|
6 Months Ended |
Jun. 30, 2024 |
Debt Disclosure [Abstract] |
|
DEBT |
DEBT As of June 30, 2024 and December 31, 2023, long-term debt, net, consisted entirely of the carrying value of the Company’s 6.5% Convertible Senior Notes due 2027 (the “2027 Convertible Notes”) of $38.7 million and $38.5 million, respectively.
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. 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.
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”). 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 six months ended June 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.
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 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 June 30, 2024.
The following table reflects the carrying value of the 2027 Convertible Notes as of June 30, 2024 and December 31, 2023 (in thousands):
| | | | | | | | | | | | | June 30, 2024 | | December 31, 2023 | Principal balance | $ | 40,000 | | | $ | 40,000 | | Derivative liability for embedded conversion feature | 308 | | | 308 | | Unamortized debt issuance costs | (1,579) | | | (1,794) | | Carrying value | $ | 38,729 | | | $ | 38,514 | |
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%. The Company amortized $0.1 million and $0.2 million of the debt discount on the 2027 Convertible Notes during the three and six months ended June 30, 2024, respectively, and $0.1 million and $0.2 million during the three and six months ended June 30, 2023, respectively. During the six months ended June 30, 2023, $1.6 million of unamortized issuance costs related to the Convertible Note Exchange 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 18, Fair Value, for further details around the estimated fair value of the derivative liability. 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. Interest Expense
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 six months ended June 30, 2024 and 2023 (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended June 30, | | Six Months Ended June 30, | | 2024 | | 2023 | | 2024 | | 2023 | Interest on 2027 Convertible Notes | $ | 650 | | $ | 650 | | $ | 1,300 | | $ | 1,625 | Amortization of debt issuance costs | 108 | | 101 | | 215 | | 248 | Total interest expense | $ | 758 | | $ | 751 | | $ | 1,515 | | $ | 1,873 | | | | | | | | | | | | | | | | |
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OTHER LONG-TERM LIABILITIES
|
6 Months Ended |
Jun. 30, 2024 |
Other Liabilities Disclosure [Abstract] |
|
OTHER LONG-TERM LIABILITIES |
OTHER LONG-TERM LIABILITIES The following table reflects other long-term liabilities as of June 30, 2024 and December 31, 2023 (in thousands): | | | | | | | | | | | | | June 30, 2024 | | December 31, 2023 | ROLVEDON product royalties | $ | 9,224 | | | $ | 9,224 | | Noncurrent operating lease liabilities | 1,254 | | | 1,470 | | Liability for uncertain tax provisions | 4,687 | | | 4,553 | | Deferred employee retention credits | 1,212 | | | 1,212 | | | | | | Total other long-term liabilities | $ | 16,377 | | | $ | 16,459 | |
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STOCK-BASED COMPENSATION
|
6 Months Ended |
Jun. 30, 2024 |
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 stock options, as well as performance-based RSUs and stock options.
Stock-based compensation of $1.4 million and $2.6 million for the three and six months ended June 30, 2024, respectively, and $2.2 million and $4.7 million for three and six months ended June 30, 2023, respectively, was recognized in Selling, general, and administrative expenses in the Company’s Condensed Consolidated Statements of Comprehensive (Loss) Income.
During the six months ended June 30, 2024, the Company granted 1.7 million RSUs at a weighted-average fair market value of $0.89 per share, and 5.3 million stock options at a weighted-average fair market value of $0.82 per share. During the six months ended June 30, 2023, the Company granted 0.7 million RSUs at a weighted-average fair market value of $5.64 per share, and 0.6 million stock options at a weighted-average fair market value of $4.49 per share.
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v3.24.2.u1
LEASES
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6 Months Ended |
Jun. 30, 2024 |
Leases [Abstract] |
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LEASES |
LEASESThe 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. Additionally, in connection with the Spectrum Merger, the Company assumed leases for two facilities and certain office equipment which Spectrum had previously been the lessee (See Note 20, Restructuring Charges).
The following table reflects lease expense for the three and six months ended June 30, 2024 and 2023 (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended June 30, | | Six Months Ended June 30, | | Financial Statement Classification | | 2024 | | 2023 | | 2024 | | 2023 | Operating lease cost | Selling, general and administrative expenses | | $ | 65 | | | $ | 57 | | | $ | 131 | | | $ | 96 | |
The following table reflects supplemental cash flow information related to leases for the three and six months ended June 30, 2024 and 2023 (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended June 30, | | Six Months Ended June 30, | | | 2024 | | 2023 | | 2024 | | 2023 | Cash paid for amounts included in measurement of liabilities: | | | | | | | | Operating cash flows from operating leases | $ | 258 | | | $ | 104 | | | $ | 540 | | | $ | 208 | |
The following table reflects supplemental balance sheet information related to leases as of June 30, 2024 and December 31, 2023 (in thousands): | | | | | | | | | | | | | | | | | | | Financial Statement Classification | | June 30, 2024 | | December 31, 2023 | Assets | | | | | | Operating lease right-of-use assets | Other long-term assets | | $ | 1,198 | | | $ | 1,269 | | Liabilities | | | | | | Current operating lease liabilities | Other current liabilities | | $ | 665 | | | $ | 928 | | Noncurrent operating lease liabilities | Other long-term liabilities | | 1,254 | | | 1,470 | | Total lease liabilities | | | $ | 1,919 | | | $ | 2,398 | |
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LEASES |
LEASESThe 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. Additionally, in connection with the Spectrum Merger, the Company assumed leases for two facilities and certain office equipment which Spectrum had previously been the lessee (See Note 20, Restructuring Charges).
The following table reflects lease expense for the three and six months ended June 30, 2024 and 2023 (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended June 30, | | Six Months Ended June 30, | | Financial Statement Classification | | 2024 | | 2023 | | 2024 | | 2023 | Operating lease cost | Selling, general and administrative expenses | | $ | 65 | | | $ | 57 | | | $ | 131 | | | $ | 96 | |
The following table reflects supplemental cash flow information related to leases for the three and six months ended June 30, 2024 and 2023 (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended June 30, | | Six Months Ended June 30, | | | 2024 | | 2023 | | 2024 | | 2023 | Cash paid for amounts included in measurement of liabilities: | | | | | | | | Operating cash flows from operating leases | $ | 258 | | | $ | 104 | | | $ | 540 | | | $ | 208 | |
The following table reflects supplemental balance sheet information related to leases as of June 30, 2024 and December 31, 2023 (in thousands): | | | | | | | | | | | | | | | | | | | Financial Statement Classification | | June 30, 2024 | | December 31, 2023 | Assets | | | | | | Operating lease right-of-use assets | Other long-term assets | | $ | 1,198 | | | $ | 1,269 | | Liabilities | | | | | | Current operating lease liabilities | Other current liabilities | | $ | 665 | | | $ | 928 | | Noncurrent operating lease liabilities | Other long-term liabilities | | 1,254 | | | 1,470 | | Total lease liabilities | | | $ | 1,919 | | | $ | 2,398 | |
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- DefinitionThe entire disclosure for operating leases of lessee. Includes, but is not limited to, description of operating lease and maturity analysis of operating lease liability.
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- DefinitionThe entire disclosure for lessor's operating leases.
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v3.24.2.u1
COMMITMENTS AND CONTINGENCIES
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6 Months Ended |
Jun. 30, 2024 |
Commitments and Contingencies Disclosure [Abstract] |
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COMMITMENTS AND CONTINGENCIES |
COMMITMENTS AND CONTINGENCIES COMMITMENTS
Jubilant HollisterStier Manufacturing and Supply Agreement
In connection with the Company’s merger with Zyla Life Sciences (“Zyla”) in May 2020 (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 annual commitments to JHS are approximately $1.5 million.
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.
Hanmi Supply Agreement
In connection with the Spectrum Merger, the Company assumed a Manufacturing and Supply Agreement (the “Hanmi Agreement”) with Hanmi Pharmaceutical Co. Ltd. (“Hanmi”) pursuant to which the Company engaged Hanmi to provide certain services related to the manufacture and supply of ROLVEDON for the Company’s commercial use. The Company has agreed to purchase a minimum number of batches totaling approximately $19.1 million in 2024 and $3.8 million in 2025. The Company purchased $12.6 million of inventory from Hanmi during the six months ended months ended June 30, 2024. CONTINGENCIES
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. 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 Superior Court of the State of California for the County of Alameda (“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 alleged, 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. Discovery has now been completed in these California state cases, and on June 18, 2024, the Company moved for summary judgment. Trial is scheduled for December 2024.
The Company intends to defend itself vigorously in the consolidated California state court lawsuits. A liability for this matter has been recorded, which is not material to the Condensed Consolidated 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 sought 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 in May 2023, 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 (one of which remains pending in Georgia). Plaintiffs may file additional lawsuits in which the Company may be named, and plaintiffs may also seek leave to add the Company to lawsuits already on file in the MDL Court. 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 for 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, New York, Pennsylvania, Texas and Utah. Plaintiffs may file additional lawsuits in which the Company may be named. In the pending cases involving Assertio Therapeutics, plaintiffs are asserting state common law and statutory claims against the defendants, and the majority of those cases are 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. Discovery has begun in one of the state court cases (Tarnopol, et al. v. Janssen Pharmaceuticals, Inc, et al., Case No. 002584, in the Court of Common Pleas of Philadelphia County, First Judicial District of Pennsylvania, Civil Trial Division), and the court in that case has entered an order providing that the case shall be ready for trial by April 7, 2025. The other state lawsuits in which Assertio Therapeutics has been served are generally each at an early stage of proceedings. Assertio Therapeutics intends to defend itself vigorously in these matters.
Qui Tam Litigation
The Company has learned that on October 30, 2017, a qui tam lawsuit was filed against Depomed in the United States District Court for the District of Columbia (United States of America ex rel. Webb, et al. v. Depomed, Inc., Case No. 1:17-cv-02309-JDB). The case was filed under seal and remained under seal until after an order was entered by the district court on July 12, 2024, which followed a notice from the DOJ electing to intervene, in part, and declining to intervene, in part, and which granted the DOJ’s request to unseal the complaint, the DOJ’s notice concerning intervention, and DOJ’s proposed order concerning its intervention. The district court order gives DOJ and the relator until October 10, 2024, to serve their respective complaints on Depomed.
The relator’s complaint alleges that Depomed violated the federal False Claims Act, 31 U.S.C. § 3729, as well as similar laws in California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Montana, Nevada, New Jersey, New Mexico, New York, North Carolina, Oklahoma, Rhode Island, Tennessee, Texas, Vermont, Virginia, Washington, and the District of Columbia; the federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7(b)(2)(B); the United States Food, Drug and Cosmetic Act, 21 U.S.C. §§ 331(d), 355(a); and laws in California and Illinois concerning fraudulent insurance claims. The relator’s complaint generally alleges that Depomed marketed off-label uses for its drugs Gralise and Lazanda, which were divested in 2020 and 2017, respectively, and that Depomed paid illegal kickbacks to physicians to induce them to write Gralise and Lazanda prescriptions. The relator also alleges that Depomed retaliated against her for complaining about Depomed’s alleged unlawful conduct. On behalf of herself, the United States, the several states whose laws the Complaint alleges to have been violated, and certain unnamed insurance companies, the relator seeks, among other things, actual damages, treble damages, back pay, two times back pay, special damages, civil penalties, pre- and post-judgment interest, attorneys’ fees, costs, and expenses.
The DOJ filed its notice of intervention on July 3, 3024, stating that the United States was intervening on the allegations that Depomed knowingly marketed Lazanda in a manner that caused the submission of false claims for Lazanda to Medicare and TRICARE. The DOJ noted that the United States declined to intervene on all other allegations not related to Lazanda. Therefore, the DOJ has declined to intervene with respect to the relator’s allegations concerning Gralise. The DOJ stated that it would file its complaint in intervention within 90 days of its notice. The Company is not currently aware of any involvement in the lawsuit of any of the governments of the states (or the District of Columbia) on whose behalf the relator purports to act.
The Company has not yet been served with process in the lawsuit. If served, the Company intends to vigorously defend itself in this matter.
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 California Superior Court 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 against its former insurance broker, Woodruff-Sawyer & Co. (“Woodruff”), in the California Superior Court of Alameda (Case No. 22CV009380). Assertio Therapeutics alleged claims for negligence and breach of fiduciary duty in connection with Woodruff’s negotiation and procurement of products liability insurance coverage for Assertio Therapeutics.
During the second quarter of 2024, Assertio Therapeutics settled with Woodruff and received $1.9 million in connection with its claims for insurance reimbursement for previous opioid-related legal expenses, which was recognized within Selling, general and administrative expenses in the Company’s Condensed Consolidated Statements of Comprehensive (Loss) Income for the three and six months ended June 30, 2024.
Stockholder Actions
Shapiro v. Assertio Holdings, Inc., et al., U.S. District Court, Northern District of Illinois, Case No. 1:24-cv-00169. On January 5, 2024, this putative securities class action lawsuit was filed by a purported shareholder, alleging that Assertio and certain of its current and former executive officers made false or misleading statements and failed to disclose material facts regarding the likely impact of INDOCIN sales and the Spectrum Merger on Assertio’s profitability in violation of Sections 10(b) (and Rule 10b-5 promulgated thereunder) and 20(a) of the Exchange Act of 1934, as amended (the “Exchange Act”). On April 11, 2024, the court appointed Continental General Insurance Company as the lead plaintiff. The plaintiffs filed an amended complaint on June 10, 2024, that names as defendants Assertio and certain of its current and former officers and directors, and Spectrum and certain of its former officers and directors. It alleges violations of Sections 10(b) and 20(a) of the Exchange Act between March 9, 2023 and January 3, 2024, and violations of Sections 14(a) and 20(a) of the Exchange Act in connection with the proxy statement issued in connection with the Spectrum Merger. The defendants are scheduled to file their motion to dismiss on August 9, 2024. The Company intends to vigorously defend itself in this matter.
Edwards v. Assertio Holdings, Inc., et al., Court of Chancery of the State of Delaware, Case No. 2024-0151. On February 19, 2024, this putative securities class action lawsuit was filed by a purported shareholder, alleging that certain former officers and directors of Spectrum breached their fiduciary duties in connection the Spectrum Merger and that Guggenheim Securities LLC and Assertio aided and abetted such fiduciary duty breaches. The defendants moved to dismiss the Edwards complaint on June 29, 2024. The plaintiff’s answering brief is due on August 28, 2024, and the defendants’ reply brief is due on September 27, 2024. The Company intends to vigorously defend itself in this matter.
Jung v. Peisert, et al., U.S. District Court, Delaware, Case No. 1:24-cv-00383-UNA. On March 26, 2024, this putative stockholder derivative action was filed against the Company (as a nominal defendant) and certain of its current and former executive officers and directors. The stockholder derivative complaint alleges, inter alia, that certain of the Company’s current and former executive officers and directors are liable to the Company, pursuant to Section 10(b) and 21(d) of the Exchange Act for contribution and indemnification, relating to allegedly false or misleading statements and alleged failure to disclose material facts regarding the likely impact of INDOCIN sales and the Spectrum Merger on the Company’s profitability. The complaint further alleges that certain of the Company’s current and former officers and directors breached their fiduciary duties, and that certain of the Company’s 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 such matters. The allegations state that as a result of the violations, certain of the Company’s current and former executive officers and directors committed acts of gross mismanagement, abuse of control, or were unjustly enriched. The plaintiff generally seeks corporate reforms, damages, interest, costs, attorneys’ fees, and other unspecified equitable relief. The defendants’ deadline to respond to the complaint is September 6, 2024.
Hollin v. Mason, et al., U.S. District Court, Delaware, Case No. 1:24-cv-00785-UNA. On July 3, 2024, this putative stockholder derivative action was filed against the Company (as a nominal defendant) and certain of its current and former executive officers and directors. The stockholder derivative complaint is largely duplicative of the Jung stockholder derivative complaint described above.
Jung v. Lebel, et al., Court of Chancery of the State of Delaware, Case No. 2024-0821. On August 5, 2024, alleged former Spectrum stockholder and current Assertio stockholder Jung (the same plaintiff who previously filed Jung v. Peisert, et. al., in Delaware federal court, as discussed above) filed a stockholder derivative complaint in the Delaware Chancery Court against certain former Spectrum officers and directors and naming both Assertio and Spectrum as nominal defendants. The complaint is largely duplicative of the allegations in the ongoing Christiansen shareholder class action in the Southern District of New York (discussed below), alleging that Spectrum officers made various alleged misstatements regarding Spectrum’s application for FDA approval of poziotinib. Jung previously raised these allegations in a demand letter to Assertio’s Board of Directors (“the Board”), demanding that the Board take legal action against the individuals now named in this complaint. In response to Jung’s demand letter, the Board retained independent counsel, considered Jung’s demand, and provided a substantive response explaining the Board’s reasons for denying Jung’s demand. The complaint now alleges that the Board wrongfully refused his demand. Neither the Company nor the individual defendants have been served with the complaint and there is no schedule in place for responding to the complaint.
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 Biologic License Application (“BLA”) to the FDA for eflapegrastim (ROLVEDON) in violation of Section 10(b) (and Rule 10b-5 promulgated thereunder) and 20(a) of 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. On February 6, 2024, the Court held a hearing on the motion to dismiss and issued an order dismissing the lawsuit without prejudice to the lead plaintiff’s ability to replead their claims. The lead plaintiff filed a further amended complaint on March 29, 2024. On May 13, 2024, the defendants filed a motion to dismiss that further amended complaint, which was fully briefed as of July 22, 2024. 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. On January 23, 2024, the Court granted the motion to dismiss in part as to five of the challenged statements but denied the motion to dismiss as to two specific statements. The Company filed its answer to the complaint on March 8, 2024. Discovery is currently ongoing. 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) and 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 these derivative actions until there is a decision in the Luo Nevada securities class action either denying a motion to dismiss in whole or in part, or dismissing that securities class action with prejudice.
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v3.24.2.u1
SHAREHOLDERS EQUITY
|
6 Months Ended |
Jun. 30, 2024 |
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) and the CVRs. 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
In connection with 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 partial settlement of the 2027 Convertible Notes (the “Exchanged Notes”). 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 six months ended June 30, 2023, related to the common stock share issuance, net of approximately $1.6 million of unamortized issuance costs related to the Exchanged Notes.
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v3.24.2.u1
NET (LOSS) INCOME PER SHARE
|
6 Months Ended |
Jun. 30, 2024 |
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 equivalents and convertible debt are considered to be potential common shares and are only included in the calculation of diluted net (loss) income per share when their effect is dilutive. The 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. The Company’s potentially dilutive stock-based awards and convertible debt were not included in the computation of diluted net loss per share for the three and six months ended June 30, 2024, because to do so would be anti-dilutive. For the three months ended June 30, 2023, the Company’s potentially dilutive convertible debt was included in the computation of diluted net income per share. However, for the six months ended June 30, 2023, the Company’s potentially dilutive convertible debt was not included in the computation of diluted net income per share, because to do so would be anti-dilutive.
The following table reflects the calculation of basic and diluted (loss) income per common share for the three and six months ended June 30, 2024 and 2023 (in thousands, except for per share amounts):
| | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended June 30, | | Six Months Ended June 30, | | 2024 | | 2023 | | 2024 | | 2023 | Basic net (loss) income per share | | | | | | | | Net (loss) income | $ | (3,674) | | | $ | 8,470 | | | $ | (8,184) | | | $ | 4,986 | | Weighted-average common shares outstanding | 95,240 | | | 56,142 | | | 95,110 | | | 53,588 | | Basic net (loss) income per share | $ | (0.04) | | | $ | 0.15 | | | $ | (0.09) | | | $ | 0.09 | | | | | | | | | | Diluted net (loss) income per share | | | | | | | | Net (loss) income | $ | (3,674) | | | $ | 8,470 | | | $ | (8,184) | | | $ | 4,986 | | | | | | | | | | Add: Convertible debt interest expense, net of tax | — | | | 563 | | | — | | | — | | Adjusted net (loss) income | (3,674) | | | 9,033 | | | (8,184) | | | 4,986 | | Weighted-average common shares and share equivalents outstanding | 95,240 | | | 56,142 | | | 95,110 | | | 53,588 | | Add: effect of dilutive stock-based awards and equivalents | — | | | 4,234 | | | — | | | 4,422 | | Add: effect of dilutive convertible debt under if-converted method | — | | | 9,768 | | | — | | | — | | Denominator for diluted net (loss) income per share | 95,240 | | | 70,144 | | | 95,110 | | | 58,010 | | Diluted net (loss) income per share | $ | (0.04) | | | $ | 0.13 | | | $ | (0.09) | | | $ | 0.09 | |
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 six months ended June 30, 2024 and 2023 (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended June 30, | | Six Months Ended June 30, | | 2024 | | 2023 | | 2024 | | 2023 | Convertible notes | 9,768 | | | — | | | 9,768 | | | 12,116 | | Stock-based awards and equivalents | 9,624 | | | 721 | | | 9,023 | | | 548 | | Total potentially dilutive common shares | 19,392 | | | 721 | | | 18,791 | | | 12,664 |
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v3.24.2.u1
FAIR VALUE
|
6 Months Ended |
Jun. 30, 2024 |
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 June 30, 2024 and December 31, 2023 (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | June 30, 2024 | | Financial Statement Classification | | Level 1 | | Level 2 | | Level 3 | | Total | Assets | | | | | | | | | | | | | | | | | | | | | | Cash equivalents: | | | | | | | | | | | U.S. Treasuries | | Cash and cash equivalents | | $ | — | | | $ | 7,761 | | | $ | — | | | $ | 7,761 | | | | | | | | | | | | | Money market funds | | Cash and cash equivalents | | 35,896 | | | — | | | — | | | 35,896 | | Short-term investments: | | | | | | | | | | | Commercial paper | | Short-term investments | | — | | | 3,964 | | | — | | | 3,964 | | U.S. Treasuries | | Short-term investments | | — | | | 39,680 | | | — | | | 39,680 | | Total | | | | $ | 35,896 | | | $ | 51,405 | | | $ | — | | | $ | 87,301 | | Liabilities | | | | | | | | | | | Short-term contingent consideration | | Contingent consideration, current portion | | $ | — | | | $ | — | | | $ | 2,700 | | | $ | 2,700 | | | | | | | | | | | | | Derivative liability | | Long-term debt | | — | | | — | | | 308 | | | 308 | | Total | | | | $ | — | | | $ | — | | | $ | 3,008 | | | $ | 3,008 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | December 31, 2023 | | Financial Statement Classification | | Level 1 | | Level 2 | | Level 3 | | Total | Assets | | | | | | | | | | | | | | | | | | | | | | Cash equivalents: | | | | | | | | | | | U.S. Treasuries | | Cash and cash equivalents | | $ | — | | | $ | 35,458 | | | $ | — | | | $ | 35,458 | | U.S. Government agencies | | Cash and cash equivalents | | — | | | 3,294 | | | — | | | 3,294 | | Money market funds | | Cash and cash equivalents | | 32,534 | | | — | | | — | | | 32,534 | | Total | | | | $ | 32,534 | | | $ | 38,752 | | | $ | — | | | $ | 71,286 | | Liabilities | | | | | | | | | | | Short-term contingent consideration | | Contingent consideration, current portion | | $ | — | | | $ | — | | | $ | 2,700 | | | $ | 2,700 | | | | | | | | | | | | | Derivative liability | | Long-term debt | | — | | | — | | | 308 | | | 308 | | Total | | | | $ | — | | | $ | — | | | $ | 3,008 | | | $ | 3,008 | |
Cash and Cash Equivalents
The Company considers all highly liquid investments with a maturity date at 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, 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 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.
Short-Term Investments
The Company considers all highly liquid investments with a maturity date at purchase of more than three months and less than one year to be short-term investments. The Company’s short-term investments consist of marketable securities, including commercial paper and U.S. Treasury securities. The Company has classified its short-term investments as trading securities. The short-term investments are recorded at fair value using Level 2 inputs, 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. Gains and losses on short-term investments are included in Interest income in the Condensed Consolidated Statements of Comprehensive (Loss) Income.
The Company recognized no unrealized gains from its short-term investments classified as trading securities for the three and six months ended June 30, 2024, and unrealized losses from short-term investments classified as trading securities recognized for the three and six months ended June 30, 2024 were immaterial. The Company had no short-term investments classified as trading securities during the three and six months ended June 30, 2023.
Contingent Consideration Obligations
Spectrum Merger Contingent Variable Rights
In connection with the Spectrum Merger, the Company issued CVRs (See Note 2, Acquisitions) that represent a contingent consideration obligation which is measured at fair value.
As of both June 30, 2024 and December 31, 2023, the fair value of the Company’s CVR liability related to the Spectrum Merger was determined by the Company to be zero. Accordingly, the Company recognized no expense or benefit for the change in fair value of the CVR contingent consideration during the three and six months ended June 30, 2024. 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 June 30, 2024 included 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
In connection with 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 Level 3, due to the lack of relevant observable inputs and market activity. As of both June 30, 2024 and December 31, 2023, the fair value of the INDOCIN product contingent consideration was determined to be $2.7 million and has been classified as Contingent consideration, current in the Company’s Condensed Consolidated Balance Sheets.
During each of the three and six months ended June 30, 2024, the Company recognized an expense of zero for the change in fair value of contingent consideration. During the three and six months ended June 30, 2023, the Company recognized an expense of $0.2 million and $9.4 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. The fair value of the contingent consideration incurred in the Zyla Merger is determined using an option pricing model under the income approach based on estimated INDOCIN product net sales through January 2029 and discounted to present value. The significant assumptions used in the calculation of the fair value as of June 30, 2024 included updated projections of future INDOCIN product net sales.
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 six months ended June 30, 2024 and 2023 (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended June 30, | | Six Months Ended June 30, | | 2024 | | 2023 | | 2024 | | 2023 | Fair value, beginning of the period | $ | 2,700 | | | $ | 51,058 | | | $ | 2,700 | | | $ | 48,500 | | | | | | | | | | Change in fair value of contingent consideration recorded within costs and expenses | — | | | 241 | | | — | | | 9,408 | | Cash payment related to contingent consideration | — | | | (8,799) | | | — | | | (15,408) | | Fair value, end of the period | $ | 2,700 | | | $ | 42,500 | | | $ | 2,700 | | | $ | 42,500 | |
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 $0.3 million as of both June 30, 2024 and December 31, 2023, 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. The significant assumption used in the binomial lattice model is a credit spread of 8.8%.
There was no change in the fair value of the derivative liability for the three and six months ended June 30, 2024 or 2023.
Financial Instruments Not Required to be Remeasured at Fair Value
The Company’s other financial assets and liabilities are not remeasured to fair value, as the carrying cost of each approximates its fair value. As of June 30, 2024, the estimated fair value of the 2027 Convertible Notes, excluding the bifurcated embedded conversion option, was approximately $34.7 million, compared to a par value of $40.0 million. As of December 31, 2023, the estimated fair value of the 2027 Convertible Notes, excluding the bifurcated embedded conversion option, was approximately $35.7 million, compared to a par value of $40.0 million. The Company estimated the fair value of its 2027 Convertible Notes as of June 30, 2024 and December 31, 2023 based on a market approach, which represents a Level 2 valuation.
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v3.24.2.u1
INCOME TAXES
|
6 Months Ended |
Jun. 30, 2024 |
Income Tax Disclosure [Abstract] |
|
INCOME TAXES |
INCOME TAXES As of June 30, 2024, the Company has concluded that it is not more likely than not that it will realize the net deferred tax asset recorded as of June 30, 2024. As a result, the Company has recorded a full valuation allowance against the net deferred tax asset recorded as of June 30, 2024. 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 Company primarily relied on its reversing taxable temporary differences to assess its valuation allowance, which resulted in recording a full valuation allowance against its net deferred tax assets during the quarter. 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 six months ended June 30, 2024, the Company recorded an income tax expense of $0.1 million and $0.3 million, respectively, which represents an effective tax rate of (4.2)% and (3.6)%, respectively. The difference between the income tax expense 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 and state income taxes.
For the three and six months ended June 30, 2023, the Company recorded an income tax expense of $3.9 million and $1.8 million, respectively, which represents an effective tax rate of 31.3% and 26.0%, 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 state taxes, disallowed officer’s compensation, and capital expenses, offset by a partial reversal of previously recorded valuation allowance in those periods.
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- DefinitionThe entire disclosure for income tax.
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v3.24.2.u1
RESTRUCTURING CHARGES
|
6 Months Ended |
Jun. 30, 2024 |
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 does not expect to recognize any additional restructuring charges related to the Spectrum Reorganization Plan. The Company expects all cash payments under the Spectrum Reorganization Plan to be completed by the end of 2025.
The staff reductions under the Spectrum Reorganization Plan were the result of a distinct severance plan approved by the Board and were not executed as part of established Company policies or plans. Total employee compensation costs recognized under the Spectrum Reorganization Plan through June 30, 2024, were approximately $3.3 million. In addition, the leased facilities and office equipment referenced above are not expected to be used for any business purpose, and the Company will not sublease the facilities and office equipment due to the short remaining lease terms. 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 recognized under the Spectrum Reorganization Plan through June 30, 2024, were approximately $1.3 million. There are no remaining facility exit costs expected to be recognized by the Company under the Spectrum Reorganization Plan as of June 30, 2024.
Effective January 2, 2024, the Company separated from the service of its former President and Chief Executive Officer. Pursuant to his then existing Management Continuity Agreement with the Company, the former President and Chief Executive Officer was entitled to severance compensation and benefits of approximately $1.5 million, which was recognized as Restructuring charges within the Condensed Consolidated Statement of Comprehensive (Loss) Income for year ended December 31, 2023, the period in which the separation and related severance benefit was determined to be probable. The Company does not expect to recognize any additional restructuring charges related to the separation from the former President and Chief Executive Officer.
The Company recognized restructuring charges of zero and $0.7 million for the three and six months ended June 30, 2024, respectively, all of which related to employee compensation costs. The Company recognized no restructuring charges for the three and six months ended June 30, 2023.
The following table summarizes the changes in the Company’s accrued restructuring liability for employee compensation costs, which is classified within Accrued liabilities in the Condensed Consolidated Balance Sheets (in thousands): | | | | | | | | | | | Employee compensation costs | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Balance as of December 31, 2023 | $ | 4,378 | | | | | | | | | | | | Restructuring charges | 720 | | | | | | Cash paid | (2,768) | | | | | | Balance as of June 30, 2024 | $ | 2,330 | | | | | |
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- DefinitionThe entire 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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v3.24.2.u1
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)
|
6 Months Ended |
Jun. 30, 2024 |
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 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, consisting only of normal and recurring adjustments, necessary for a fair presentation of the information for the periods presented. The results for the three and six months ended June 30, 2024, are not necessarily indicative of results to be expected for the entire year ending December 31, 2024.
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, 2023, included in Assertio Holdings, Inc.’s Annual Report on Form 10-K filed with the SEC on March 11, 2024 (the “2023 Form 10-K”). The Condensed Consolidated Balance Sheet as of December 31, 2023, has been derived from the audited financial statements at that date, as filed in the Company’s 2023 Form 10-K.
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Reclassifications |
Reclassifications During the second quarter of 2024, the Company reclassified interest income from Other gain to Interest income on the Company’s Condensed Consolidated Statements of Comprehensive (Loss) Income. Prior period amounts were also reclassified to conform with the current period presentation.
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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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v3.24.2.u1
ACQUISITIONS (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Business Combination, Asset Acquisition, and Joint Venture Formation [Abstract] |
|
Schedule of Consideration Transferred |
The following table reflects the components of the consideration transferred in the Spectrum Merger (in thousands, except 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 included as part of the consideration transferred. (2)Represents the Effective Date fair value of 223,397 CVRs at $0.0176 per CVR issued to holders of Spectrum common stock, employee stock awards and warrants.
|
Schedule of Assets Acquired and Liabilities Assumed |
The following table reflects the fair values of the assets acquired and liabilities assumed at the Effective Date (in thousands). The fair values were based on management’s estimates and assumptions. Management’s determination of the fair values of the assets acquired and liabilities assumed was completed as of March 31, 2024.
| | | | | | | | | | | | | | | | | | | | | | | Initial Preliminary Purchase Price Allocation to Fair Value | | Adjustments to Purchase Price Allocation to Fair Value (2) | | Final Purchase Price Allocation to Fair Value | Assets: | | | | | | | Cash and cash equivalents | | $ | 34,600 | | | $ | — | | | $ | 34,600 | | Marketable securities | | 2,194 | | | — | | | 2,194 | | Accounts receivable | | 50,975 | | | — | | | 50,975 | | Inventories | | 22,244 | | | 61 | | | 22,305 | | Prepaid and other current assets | | 1,287 | | | 698 | | | 1,985 | | Property and equipment | | 100 | | | — | | | 100 | | Intangible assets | | 234,000 | | | (13,500) | | | 220,500 | | Other long-term assets | | 1,396 | | | — | | | 1,396 | | Total | | $ | 346,796 | | | $ | (12,741) | | | $ | 334,055 | | | | | | | | | Liabilities: | | | | | | | Accounts payable | | $ | 10,108 | | | $ | — | | | $ | 10,108 | | Accrued rebates, returns and discounts | | 21,025 | | | — | | | 21,025 | | Accrued liabilities | | 36,509 | | | (2,343) | | | 34,166 | | Other current liabilities | | 784 | | | — | | | 784 | | Deferred taxes | | 34,250 | | | (30,254) | | | 3,996 | | Other long-term liabilities | | 11,103 | | | — | | | 11,103 | | Total | | $ | 113,779 | | | $ | (32,597) | | | $ | 81,182 | | | | | | | | | Total Spectrum net assets acquired (1) | | $ | 233,017 | | | $ | 19,856 | | | $ | 252,873 | | Goodwill | | $ | 19,856 | | | $ | (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. (2)Adjustments made to the preliminary purchase price allocation to fair value primarily reflect completion of studies and other analyses necessary to determine the income tax effects of the net identifiable assets acquired and further refinement of the assumptions used in the valuation supporting the ROLVEDON product rights. These adjustments did not materially impact the Consolidated Statement of Comprehensive (Loss) Income.
|
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, 2023, (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 total revenues and net income (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 | | Six Months Ended | | | June 30, 2023 | | June 30, 2023 | Total revenues | | $ | 64,729 | | | $ | 122,810 | | Net income (loss) | | 4,938 | | | (9,006) | |
|
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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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v3.24.2.u1
REVENUE (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Revenue from Contract with Customer [Abstract] |
|
Schedule of Net Revenue |
The following table reflects total revenues for the three and six months ended June 30, 2024 and 2023 (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended June 30, | | Six Months Ended June 30, | | | 2024 | | 2023 | | 2024 | | 2023 | Product sales, net: | | | | | | | | | ROLVEDON | | $ | 15,144 | | | $ | — | | | $ | 29,622 | | $ | — | | INDOCIN products | | 6,913 | | | 28,075 | | | 15,596 | | | 58,421 | | Sympazan | | 2,668 | | | 2,627 | | | 5,285 | | | 5,129 | | Otrexup | | 2,014 | | | 3,594 | | | 4,896 | | | 6,416 | | SPRIX | | 2,147 | | | 2,373 | | | 3,584 | | | 4,262 | | CAMBIA | | 1,403 | | | 1,805 | | | 2,660 | | | 4,069 | | | | | | | | | | | Other products | | 406 | | | 1,609 | | | 914 | | | 3,555 | | Total product sales, net | | 30,695 | | | 40,083 | | | 62,557 | | | 81,852 | | Royalties and milestone revenue | | 431 | | | 723 | | | 1,017 | | | 1,420 | | Other revenue | | — | | | 185 | | | — | | | 185 | | Total revenues | | $ | 31,126 | | | $ | 40,991 | | | $ | 63,574 | | | $ | 83,457 | |
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v3.24.2.u1
INVENTORIES, NET (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Inventory Disclosure [Abstract] |
|
Schedule of Inventories, Net |
The following table reflects the components of inventories, net as of June 30, 2024 and December 31, 2023 (in thousands): | | | | | | | | | | | | | June 30, 2024 | | December 31, 2023 | Raw materials | $ | 19,159 | | | $ | 10,537 | | Work-in-process | 870 | | | 2,239 | | Finished goods | 19,051 | | | 24,910 | | Total inventories, net | $ | 39,080 | | | $ | 37,686 | |
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v3.24.2.u1
PREPAID AND OTHER CURRENT ASSETS (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
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 June 30, 2024 and December 31, 2023 (in thousands):
| | | | | | | | | | | | | June 30, 2024 | | December 31, 2023 | Prepaid assets and deposits | $ | 10,179 | | | $ | 11,973 | | Other current assets | 301 | | | 299 | | | | | | Total prepaid and other current assets | $ | 10,480 | | | $ | 12,272 | |
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v3.24.2.u1
PROPERTY AND EQUIPMENT, NET (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Property, Plant and Equipment [Abstract] |
|
Schedule of Property and Equipment |
The following table reflects property and equipment, net as of June 30, 2024 and December 31, 2023 (in thousands):
| | | | | | | | | | | | | June 30, 2024 | | December 31, 2023 | Furniture and office equipment | $ | 1,412 | | | $ | 1,908 | | Laboratory equipment | 20 | | | 20 | | Leasehold improvements | 2,551 | | | 2,945 | | Construction in progress | — | | | 528 | | | 3,983 | | | 5,401 | | Less: Accumulated depreciation | (3,319) | | | (4,631) | | Property and equipment, net | $ | 664 | | | $ | 770 | |
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v3.24.2.u1
INTANGIBLE ASSETS (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
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 June 30, 2024 and December 31, 2023 (dollar amounts in thousands):
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | June 30, 2024 | | December 31, 2023 | Products rights: | | Remaining Useful Life (In years) | | Gross Carrying Amount | | Accumulated Amortization | | | | | | Net Book Value | | Gross Carrying Amount | | Accumulated Amortization | | Impairment | | Net Book Value | ROLVEDON | | 9.1 | | $ | 63,405 | | | $ | (8,303) | | | | | | | $ | 55,102 | | | $ | 220,500 | | | $ | (5,270) | | | $ | (157,095) | | | $ | 58,135 | | INDOCIN | | 1.0 | | 65,605 | | | (51,052) | | | | | | | 14,553 | | | 154,100 | | | (44,814) | | | (88,494) | | | 20,792 | | Sympazan | | 10.3 | | 14,550 | | | (2,020) | | | | | | | 12,530 | | | 14,550 | | | (1,415) | | | — | | | 13,135 | | Otrexup | | 5.5 | | 16,364 | | | (10,625) | | | | | | | 5,739 | | | 44,086 | | | (10,103) | | | (27,723) | | | 6,260 | | SPRIX | | 2.9 | | 32,673 | | | (21,567) | | | | | | | 11,106 | | | 39,000 | | | (19,663) | | | (6,327) | | | 13,010 | | Total intangible assets | | | | $ | 192,597 | | | $ | (93,567) | | | | | | | $ | 99,030 | | | $ | 472,236 | | | $ | (81,265) | | | $ | (279,639) | | | $ | 111,332 | | | | | | | | | | | | | | | | | | | | | | |
|
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 | 2024 (remainder) | | 13,342 | | 2025 | | 19,407 | | 2026 | | 12,130 | | 2027 | | 9,909 | | 2028 | | 8,322 | | Thereafter | | 35,920 | | Total | | $ | 99,030 | |
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v3.24.2.u1
OTHER LONG-TERM ASSETS (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
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 June 30, 2024 and December 31, 2023 (in thousands):
| | | | | | | | | | | | | June 30, 2024 | | December 31, 2023 | Operating lease right-of-use assets | $ | 1,198 | | | $ | 1,269 | | | | | | Other | 699 | | | 1,986 | | Total other long-term assets | $ | 1,897 | | | $ | 3,255 | |
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v3.24.2.u1
ACCRUED LIABILITIES (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Accounts Payable and Accrued Liabilities, Current [Abstract] |
|
Schedule of Accrued Liabilities |
The following table reflects accrued liabilities as of June 30, 2024 and December 31, 2023 (in thousands):
| | | | | | | | | | | | | June 30, 2024 | | December 31, 2023 | Accrued compensation | $ | 1,772 | | | $ | 2,438 | | Accrued restructuring costs (See Note 20) | 2,330 | | | 4,378 | | Other accrued liabilities | 8,936 | | | 9,492 | | | | | | Interest payable | 867 | | | 867 | | Accrued royalties | 1,219 | | | 1,038 | | Total accrued liabilities | $ | 15,124 | | | $ | 18,213 | |
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v3.24.2.u1
DEBT (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Debt Disclosure [Abstract] |
|
Schedule of Carrying Values Convertible Notes |
The following table reflects the carrying value of the 2027 Convertible Notes as of June 30, 2024 and December 31, 2023 (in thousands):
| | | | | | | | | | | | | June 30, 2024 | | December 31, 2023 | Principal balance | $ | 40,000 | | | $ | 40,000 | | Derivative liability for embedded conversion feature | 308 | | | 308 | | Unamortized debt issuance costs | (1,579) | | | (1,794) | | Carrying value | $ | 38,729 | | | $ | 38,514 | |
|
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 six months ended June 30, 2024 and 2023 (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended June 30, | | Six Months Ended June 30, | | 2024 | | 2023 | | 2024 | | 2023 | Interest on 2027 Convertible Notes | $ | 650 | | $ | 650 | | $ | 1,300 | | $ | 1,625 | Amortization of debt issuance costs | 108 | | 101 | | 215 | | 248 | Total interest expense | $ | 758 | | $ | 751 | | $ | 1,515 | | $ | 1,873 | | | | | | | | | | | | | | | | |
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v3.24.2.u1
OTHER LONG-TERM LIABILITIES (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Other Liabilities Disclosure [Abstract] |
|
Schedule of Other Long-term Liabilities |
The following table reflects other long-term liabilities as of June 30, 2024 and December 31, 2023 (in thousands): | | | | | | | | | | | | | June 30, 2024 | | December 31, 2023 | ROLVEDON product royalties | $ | 9,224 | | | $ | 9,224 | | Noncurrent operating lease liabilities | 1,254 | | | 1,470 | | Liability for uncertain tax provisions | 4,687 | | | 4,553 | | Deferred employee retention credits | 1,212 | | | 1,212 | | | | | | Total other long-term liabilities | $ | 16,377 | | | $ | 16,459 | |
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v3.24.2.u1
LEASES (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Leases [Abstract] |
|
Schedule of Lease Expense |
The following table reflects lease expense for the three and six months ended June 30, 2024 and 2023 (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended June 30, | | Six Months Ended June 30, | | Financial Statement Classification | | 2024 | | 2023 | | 2024 | | 2023 | Operating lease cost | Selling, general and administrative expenses | | $ | 65 | | | $ | 57 | | | $ | 131 | | | $ | 96 | |
The following table reflects supplemental cash flow information related to leases for the three and six months ended June 30, 2024 and 2023 (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended June 30, | | Six Months Ended June 30, | | | 2024 | | 2023 | | 2024 | | 2023 | Cash paid for amounts included in measurement of liabilities: | | | | | | | | Operating cash flows from operating leases | $ | 258 | | | $ | 104 | | | $ | 540 | | | $ | 208 | |
|
Schedule of Supplemental Balance Sheet Information |
The following table reflects supplemental balance sheet information related to leases as of June 30, 2024 and December 31, 2023 (in thousands): | | | | | | | | | | | | | | | | | | | Financial Statement Classification | | June 30, 2024 | | December 31, 2023 | Assets | | | | | | Operating lease right-of-use assets | Other long-term assets | | $ | 1,198 | | | $ | 1,269 | | Liabilities | | | | | | Current operating lease liabilities | Other current liabilities | | $ | 665 | | | $ | 928 | | Noncurrent operating lease liabilities | Other long-term liabilities | | 1,254 | | | 1,470 | | Total lease liabilities | | | $ | 1,919 | | | $ | 2,398 | |
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v3.24.2.u1
NET (LOSS) INCOME PER SHARE (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
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) income per common share for the three and six months ended June 30, 2024 and 2023 (in thousands, except for per share amounts):
| | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended June 30, | | Six Months Ended June 30, | | 2024 | | 2023 | | 2024 | | 2023 | Basic net (loss) income per share | | | | | | | | Net (loss) income | $ | (3,674) | | | $ | 8,470 | | | $ | (8,184) | | | $ | 4,986 | | Weighted-average common shares outstanding | 95,240 | | | 56,142 | | | 95,110 | | | 53,588 | | Basic net (loss) income per share | $ | (0.04) | | | $ | 0.15 | | | $ | (0.09) | | | $ | 0.09 | | | | | | | | | | Diluted net (loss) income per share | | | | | | | | Net (loss) income | $ | (3,674) | | | $ | 8,470 | | | $ | (8,184) | | | $ | 4,986 | | | | | | | | | | Add: Convertible debt interest expense, net of tax | — | | | 563 | | | — | | | — | | Adjusted net (loss) income | (3,674) | | | 9,033 | | | (8,184) | | | 4,986 | | Weighted-average common shares and share equivalents outstanding | 95,240 | | | 56,142 | | | 95,110 | | | 53,588 | | Add: effect of dilutive stock-based awards and equivalents | — | | | 4,234 | | | — | | | 4,422 | | Add: effect of dilutive convertible debt under if-converted method | — | | | 9,768 | | | — | | | — | | Denominator for diluted net (loss) income per share | 95,240 | | | 70,144 | | | 95,110 | | | 58,010 | | Diluted net (loss) income per share | $ | (0.04) | | | $ | 0.13 | | | $ | (0.09) | | | $ | 0.09 | |
|
Schedule of Potentially Dilutive Common Shares |
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 six months ended June 30, 2024 and 2023 (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended June 30, | | Six Months Ended June 30, | | 2024 | | 2023 | | 2024 | | 2023 | Convertible notes | 9,768 | | | — | | | 9,768 | | | 12,116 | | Stock-based awards and equivalents | 9,624 | | | 721 | | | 9,023 | | | 548 | | Total potentially dilutive common shares | 19,392 | | | 721 | | | 18,791 | | | 12,664 |
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v3.24.2.u1
FAIR VALUE (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
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 June 30, 2024 and December 31, 2023 (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | June 30, 2024 | | Financial Statement Classification | | Level 1 | | Level 2 | | Level 3 | | Total | Assets | | | | | | | | | | | | | | | | | | | | | | Cash equivalents: | | | | | | | | | | | U.S. Treasuries | | Cash and cash equivalents | | $ | — | | | $ | 7,761 | | | $ | — | | | $ | 7,761 | | | | | | | | | | | | | Money market funds | | Cash and cash equivalents | | 35,896 | | | — | | | — | | | 35,896 | | Short-term investments: | | | | | | | | | | | Commercial paper | | Short-term investments | | — | | | 3,964 | | | — | | | 3,964 | | U.S. Treasuries | | Short-term investments | | — | | | 39,680 | | | — | | | 39,680 | | Total | | | | $ | 35,896 | | | $ | 51,405 | | | $ | — | | | $ | 87,301 | | Liabilities | | | | | | | | | | | Short-term contingent consideration | | Contingent consideration, current portion | | $ | — | | | $ | — | | | $ | 2,700 | | | $ | 2,700 | | | | | | | | | | | | | Derivative liability | | Long-term debt | | — | | | — | | | 308 | | | 308 | | Total | | | | $ | — | | | $ | — | | | $ | 3,008 | | | $ | 3,008 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | December 31, 2023 | | Financial Statement Classification | | Level 1 | | Level 2 | | Level 3 | | Total | Assets | | | | | | | | | | | | | | | | | | | | | | Cash equivalents: | | | | | | | | | | | U.S. Treasuries | | Cash and cash equivalents | | $ | — | | | $ | 35,458 | | | $ | — | | | $ | 35,458 | | U.S. Government agencies | | Cash and cash equivalents | | — | | | 3,294 | | | — | | | 3,294 | | Money market funds | | Cash and cash equivalents | | 32,534 | | | — | | | — | | | 32,534 | | Total | | | | $ | 32,534 | | | $ | 38,752 | | | $ | — | | | $ | 71,286 | | Liabilities | | | | | | | | | | | Short-term contingent consideration | | Contingent consideration, current portion | | $ | — | | | $ | — | | | $ | 2,700 | | | $ | 2,700 | | | | | | | | | | | | | Derivative liability | | Long-term debt | | — | | | — | | | 308 | | | 308 | | Total | | | | $ | — | | | $ | — | | | $ | 3,008 | | | $ | 3,008 | |
|
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 six months ended June 30, 2024 and 2023 (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended June 30, | | Six Months Ended June 30, | | 2024 | | 2023 | | 2024 | | 2023 | Fair value, beginning of the period | $ | 2,700 | | | $ | 51,058 | | | $ | 2,700 | | | $ | 48,500 | | | | | | | | | | Change in fair value of contingent consideration recorded within costs and expenses | — | | | 241 | | | — | | | 9,408 | | Cash payment related to contingent consideration | — | | | (8,799) | | | — | | | (15,408) | | Fair value, end of the period | $ | 2,700 | | | $ | 42,500 | | | $ | 2,700 | | | $ | 42,500 | |
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v3.24.2.u1
RESTRUCTURING CHARGES (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Restructuring and Related Activities [Abstract] |
|
Schedule of Accrued Restructuring and Severance Costs |
The following table summarizes the changes in the Company’s accrued restructuring liability for employee compensation costs, which is classified within Accrued liabilities in the Condensed Consolidated Balance Sheets (in thousands): | | | | | | | | | | | Employee compensation costs | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Balance as of December 31, 2023 | $ | 4,378 | | | | | | | | | | | | Restructuring charges | 720 | | | | | | Cash paid | (2,768) | | | | | | Balance as of June 30, 2024 | $ | 2,330 | | | | | |
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v3.24.2.u1
ACQUISITIONS - Narrative (Details) - Spectrum Pharmaceuticals, Inc. $ / shares in Units, $ in Millions |
|
3 Months Ended |
6 Months Ended |
|
|
Jul. 31, 2023
USD ($)
$ / shares
|
Jun. 30, 2024
USD ($)
|
Jun. 30, 2023
USD ($)
|
Jun. 30, 2024
USD ($)
|
Jun. 30, 2023
USD ($)
|
Dec. 31, 2025
USD ($)
$ / shares
|
Dec. 31, 2024
USD ($)
$ / shares
|
Business Acquisition [Line Items] |
|
|
|
|
|
|
|
Business acquisition, fixed exchange ratio |
0.1783
|
|
|
|
|
|
|
Business acquisition, contingent consideration, per share, maximum (in dollars per share) | $ / shares |
$ 0.20
|
|
|
|
|
|
|
Acquired finite-lived intangible assets, useful life |
10 years
|
|
|
|
|
|
|
Acquisition costs related to the transaction |
|
$ 0.0
|
$ 3.4
|
$ 0.0
|
$ 5.8
|
|
|
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) | $ / shares |
|
|
|
|
|
$ 0.10
|
$ 0.10
|
Business combination, contingent consideration arrangements, range of outcomes, value, high |
|
|
|
|
|
$ 225.0
|
$ 175.0
|
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v3.24.2.u1
ACQUISITIONS - Schedule of Consideration Transferred (Details) - Spectrum Pharmaceuticals, Inc. $ / shares in Units, $ in Thousands |
Jul. 31, 2023
USD ($)
$ / shares
shares
|
Business Acquisition [Line Items] |
|
Assertio shares issued (in shares) | shares |
38,013,000
|
Assertio closing price per share as of the Effective Date (in dollars per share) | $ / shares |
$ 5.69
|
Fair value of Assertio shares issued |
$ 216,294
|
Repayment of Spectrum's long-term debt |
32,647
|
CVRs |
3,932
|
Total fair value of consideration transferred |
$ 252,873
|
Business combination, contingent consideration liability, number of shares (in shares) | shares |
223,397
|
Business acquisition, contingent consideration, per share (in dollars per share) | $ / shares |
$ 0.0176
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v3.24.2.u1
ACQUISITIONS - Schedule of Assets Acquired and Liabilities Assumed (Details) - Spectrum Pharmaceuticals, Inc. - USD ($) $ in Thousands |
5 Months Ended |
|
Dec. 31, 2023 |
Jul. 31, 2023 |
Assets: |
|
|
Cash and cash equivalents |
$ 34,600
|
$ 34,600
|
Marketable securities |
2,194
|
2,194
|
Accounts receivable |
50,975
|
50,975
|
Inventories |
22,305
|
22,244
|
Prepaid and other current assets |
1,985
|
1,287
|
Property and equipment |
100
|
100
|
Intangible assets |
220,500
|
234,000
|
Other long-term assets |
1,396
|
1,396
|
Total |
334,055
|
346,796
|
Liabilities: |
|
|
Accounts payable |
10,108
|
10,108
|
Accrued rebates, returns and discounts |
21,025
|
21,025
|
Accrued liabilities |
34,166
|
36,509
|
Other current liabilities |
784
|
784
|
Deferred taxes |
3,996
|
34,250
|
Other long-term liabilities |
11,103
|
11,103
|
Total |
81,182
|
113,779
|
Total Spectrum net assets acquired |
252,873
|
233,017
|
Goodwill |
0
|
$ 19,856
|
Adjustments to Purchase Price Allocation to Fair Value |
|
|
Inventories |
61
|
|
Prepaid and other current assets |
698
|
|
Intangible assets |
(13,500)
|
|
Total |
(12,741)
|
|
Accrued liabilities |
(2,343)
|
|
Deferred taxes |
(30,254)
|
|
Total |
(32,597)
|
|
Total Spectrum net assets acquired |
19,856
|
|
Goodwill |
$ (19,856)
|
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v3.24.2.u1
REVENUE - Schedule of Net Revenue (Details) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Disaggregation of Revenue [Line Items] |
|
|
|
|
Total revenues |
$ 31,126
|
$ 40,991
|
$ 63,574
|
$ 83,457
|
Total product sales, net |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Total revenues |
30,695
|
40,083
|
62,557
|
81,852
|
ROLVEDON |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Total revenues |
15,144
|
0
|
29,622
|
0
|
INDOCIN products |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Total revenues |
6,913
|
28,075
|
15,596
|
58,421
|
Sympazan |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Total revenues |
2,668
|
2,627
|
5,285
|
5,129
|
Otrexup |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Total revenues |
2,014
|
3,594
|
4,896
|
6,416
|
SPRIX |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Total revenues |
2,147
|
2,373
|
3,584
|
4,262
|
CAMBIA |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Total revenues |
1,403
|
1,805
|
2,660
|
4,069
|
Other products |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Total revenues |
406
|
1,609
|
914
|
3,555
|
Royalties and milestone revenue |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Total revenues |
431
|
723
|
1,017
|
1,420
|
Other revenue |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Total revenues |
$ 0
|
$ 185
|
$ 0
|
$ 185
|
X |
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Jun. 30, 2024 |
Dec. 31, 2023 |
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|
|
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|
$ 10,537
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Dec. 31, 2023 |
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|
|
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|
$ 5,401
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|
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664
|
770
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|
|
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|
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|
1,908
|
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|
|
Property, Plant and Equipment [Line Items] |
|
|
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20
|
20
|
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|
|
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|
|
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|
2,945
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|
|
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|
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|
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v3.24.2.u1
INTANGIBLE ASSETS -Schedule of Gross Carrying Amounts and Net Book Values of Intangible Assets and Goodwill (Details) - USD ($) $ in Thousands |
Jun. 30, 2024 |
Dec. 31, 2023 |
Intangible assets |
|
|
Gross Carrying Amount |
$ 192,597
|
$ 472,236
|
Accumulated Amortization |
(93,567)
|
(81,265)
|
Impairment |
|
(279,639)
|
Total |
$ 99,030
|
111,332
|
ROLVEDON | Product Rights |
|
|
Intangible assets |
|
|
Remaining Useful Life (In years) |
9 years 1 month 6 days
|
|
Gross Carrying Amount |
$ 63,405
|
220,500
|
Accumulated Amortization |
(8,303)
|
(5,270)
|
Impairment |
|
(157,095)
|
Total |
$ 55,102
|
58,135
|
INDOCIN | Product Rights |
|
|
Intangible assets |
|
|
Remaining Useful Life (In years) |
1 year
|
|
Gross Carrying Amount |
$ 65,605
|
154,100
|
Accumulated Amortization |
(51,052)
|
(44,814)
|
Impairment |
|
(88,494)
|
Total |
$ 14,553
|
20,792
|
Sympazan | Product Rights |
|
|
Intangible assets |
|
|
Remaining Useful Life (In years) |
10 years 3 months 18 days
|
|
Gross Carrying Amount |
$ 14,550
|
14,550
|
Accumulated Amortization |
(2,020)
|
(1,415)
|
Impairment |
|
0
|
Total |
$ 12,530
|
13,135
|
Otrexup | Product Rights |
|
|
Intangible assets |
|
|
Remaining Useful Life (In years) |
5 years 6 months
|
|
Gross Carrying Amount |
$ 16,364
|
44,086
|
Accumulated Amortization |
(10,625)
|
(10,103)
|
Impairment |
|
(27,723)
|
Total |
$ 5,739
|
6,260
|
SPRIX | Product Rights |
|
|
Intangible assets |
|
|
Remaining Useful Life (In years) |
2 years 10 months 24 days
|
|
Gross Carrying Amount |
$ 32,673
|
39,000
|
Accumulated Amortization |
(21,567)
|
(19,663)
|
Impairment |
|
(6,327)
|
Total |
$ 11,106
|
$ 13,010
|
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3 Months Ended |
6 Months Ended |
|
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Apr. 01, 2024 |
Intangible assets |
|
|
|
|
|
Amortization expense |
$ 6,671
|
$ 6,284
|
$ 12,302
|
$ 12,568
|
|
INDOCIN products | Product Rights [Member] |
|
|
|
|
|
Intangible assets |
|
|
|
|
|
Useful life (in years) |
1 year
|
|
1 year
|
|
|
Intangible Assets, Amortization Period | INDOCIN products | Product Rights [Member] |
|
|
|
|
|
Intangible assets |
|
|
|
|
|
Useful life (in years) |
|
|
|
|
1 year 3 months 18 days
|
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v3.24.2.u1
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Jun. 30, 2024 |
Dec. 31, 2023 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
|
2024 (remainder) |
$ 13,342
|
|
2025 |
19,407
|
|
2026 |
12,130
|
|
2027 |
9,909
|
|
2028 |
8,322
|
|
Thereafter |
35,920
|
|
Total |
$ 99,030
|
$ 111,332
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OTHER LONG-TERM ASSETS (Details) - USD ($) $ in Thousands |
Jun. 30, 2024 |
Dec. 31, 2023 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] |
|
|
Operating lease right-of-use assets |
$ 1,198
|
$ 1,269
|
Other |
699
|
1,986
|
Total other long-term assets |
$ 1,897
|
$ 3,255
|
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ACCRUED LIABILITIES (Details) - USD ($) $ in Thousands |
Jun. 30, 2024 |
Dec. 31, 2023 |
Accounts Payable and Accrued Liabilities, Current [Abstract] |
|
|
Accrued compensation |
$ 1,772
|
$ 2,438
|
Accrued restructuring costs |
2,330
|
4,378
|
Other accrued liabilities |
8,936
|
9,492
|
Interest payable |
867
|
867
|
Accrued royalties |
1,219
|
1,038
|
Total accrued liabilities |
$ 15,124
|
$ 18,213
|
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DEBT - Narrative (Details) $ / shares in Units, $ in Thousands |
|
|
3 Months Ended |
6 Months Ended |
|
Feb. 27, 2023
USD ($)
|
Aug. 22, 2022
USD ($)
$ / shares
Rate
|
Jun. 30, 2024
USD ($)
|
Jun. 30, 2023
USD ($)
|
Jun. 30, 2024
USD ($)
|
Jun. 30, 2023
USD ($)
|
Dec. 31, 2023
USD ($)
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
Direct transaction costs |
|
|
$ 0
|
$ 0
|
$ 0
|
$ 9,918
|
|
Amortization of debt issuance costs |
|
|
108
|
101
|
215
|
248
|
|
Convertible Notes |
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
Unamortized issuance costs recognized in Additional paid-in-capital |
|
|
|
|
|
1,600
|
|
Convertible Senior Notes, 6.5% | Convertible Notes |
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
Interest rate (as a percent) |
|
6.50%
|
|
|
|
|
|
Carrying value |
|
|
38,700
|
|
38,700
|
|
$ 38,500
|
Aggregate principal amount |
$ 30,000
|
$ 60,000
|
|
|
|
|
|
Additional purchase capacity |
|
$ 10,000
|
|
|
|
|
|
Number of days to cover over allotment (in days) |
|
13 days
|
|
|
|
|
|
Induced conversion of convertible debt expense |
8,800
|
|
|
|
|
|
|
Direct transaction costs |
$ 1,100
|
|
|
|
|
|
|
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
|
$ 100
|
$ 200
|
$ 200
|
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v3.24.2.u1
OTHER LONG-TERM LIABILITIES (Details) - USD ($) $ in Thousands |
Jun. 30, 2024 |
Dec. 31, 2023 |
Other Liabilities Disclosure [Abstract] |
|
|
ROLVEDON product royalties |
$ 9,224
|
$ 9,224
|
Noncurrent operating lease liabilities |
1,254
|
1,470
|
Liability for uncertain tax provisions |
4,687
|
4,553
|
Deferred employee retention credits |
1,212
|
1,212
|
Other long-term liabilities |
$ 16,377
|
$ 16,459
|
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LEASES -Schedule of Supplemental Balance Sheet Information (Details) - USD ($) $ in Thousands |
Jun. 30, 2024 |
Dec. 31, 2023 |
Assets |
|
|
Operating lease right-of-use assets |
$ 1,198
|
$ 1,269
|
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible Enumeration] |
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|
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|
Liabilities |
|
|
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$ 665
|
$ 928
|
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|
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$ 1,254
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$ 1,470
|
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NET (LOSS) INCOME PER SHARE - Schedule of Calculation of Basic and Diluted Earnings Per Common Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Basic net (loss) income per share |
|
|
|
|
Net (loss) income |
$ (3,674)
|
$ 8,470
|
$ (8,184)
|
$ 4,986
|
Weighted-average common shares outstanding (in shares) |
95,240
|
56,142
|
95,110
|
53,588
|
Basic net (loss) income per share (in dollars per share) |
$ (0.04)
|
$ 0.15
|
$ (0.09)
|
$ 0.09
|
Diluted net (loss) income per share |
|
|
|
|
Net (loss) income |
$ (3,674)
|
$ 8,470
|
$ (8,184)
|
$ 4,986
|
Add: Convertible debt interest expense, net of tax |
0
|
563
|
0
|
0
|
Adjusted net (loss) income |
$ (3,674)
|
$ 9,033
|
$ (8,184)
|
$ 4,986
|
Weighted-average common shares and share equivalents outstanding (in shares) |
95,240
|
56,142
|
95,110
|
53,588
|
Add: effect of dilutive stock-based awards and equivalents (in shares) |
0
|
4,234
|
0
|
4,422
|
Add: effect of dilutive convertible debt under if-converted method (in shares) |
0
|
9,768
|
0
|
0
|
Denominator for diluted net (loss) income per share (in shares) |
95,240
|
70,144
|
95,110
|
58,010
|
Diluted net (loss) income per share (in dollars per share) |
$ (0.04)
|
$ 0.13
|
$ (0.09)
|
$ 0.09
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v3.24.2.u1
NET (LOSS) INCOME PER SHARE - Schedule of Potentially Dilutive Common Shares (Details) - shares shares in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Total potentially dilutive common shares (in shares) |
19,392
|
721
|
18,791
|
12,664
|
Convertible notes |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Total potentially dilutive common shares (in shares) |
9,768
|
0
|
9,768
|
12,116
|
Stock-based awards and equivalents |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Total potentially dilutive common shares (in shares) |
9,624
|
721
|
9,023
|
548
|
X |
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v3.24.2.u1
FAIR VALUE - Schedule of Fair Value Hierarchy for Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis (Details) - USD ($) $ in Thousands |
Jun. 30, 2024 |
Dec. 31, 2023 |
Liabilities |
|
|
Short-term contingent consideration |
$ 2,700
|
$ 2,700
|
Derivative liability |
300
|
|
Recurring |
|
|
Assets |
|
|
Total |
87,301
|
71,286
|
Liabilities |
|
|
Short-term contingent consideration |
2,700
|
2,700
|
Derivative liability |
308
|
308
|
Total |
3,008
|
3,008
|
Recurring | U.S. Treasuries |
|
|
Assets |
|
|
Cash and cash equivalents |
7,761
|
35,458
|
Short-term investments |
39,680
|
|
Recurring | Money market funds |
|
|
Assets |
|
|
Cash and cash equivalents |
35,896
|
32,534
|
Recurring | U.S. Government agencies |
|
|
Assets |
|
|
Cash and cash equivalents |
|
3,294
|
Recurring | Commercial paper |
|
|
Assets |
|
|
Short-term investments |
3,964
|
|
Recurring | Level 1 |
|
|
Assets |
|
|
Total |
35,896
|
32,534
|
Liabilities |
|
|
Short-term contingent consideration |
0
|
0
|
Derivative liability |
0
|
0
|
Total |
0
|
0
|
Recurring | Level 1 | U.S. Treasuries |
|
|
Assets |
|
|
Cash and cash equivalents |
0
|
0
|
Short-term investments |
0
|
|
Recurring | Level 1 | Money market funds |
|
|
Assets |
|
|
Cash and cash equivalents |
35,896
|
32,534
|
Recurring | Level 1 | U.S. Government agencies |
|
|
Assets |
|
|
Cash and cash equivalents |
|
0
|
Recurring | Level 1 | Commercial paper |
|
|
Assets |
|
|
Short-term investments |
0
|
|
Recurring | Level 2 |
|
|
Assets |
|
|
Total |
51,405
|
38,752
|
Liabilities |
|
|
Short-term contingent consideration |
0
|
0
|
Derivative liability |
0
|
0
|
Total |
0
|
0
|
Recurring | Level 2 | U.S. Treasuries |
|
|
Assets |
|
|
Cash and cash equivalents |
7,761
|
35,458
|
Short-term investments |
39,680
|
|
Recurring | Level 2 | Money market funds |
|
|
Assets |
|
|
Cash and cash equivalents |
0
|
0
|
Recurring | Level 2 | U.S. Government agencies |
|
|
Assets |
|
|
Cash and cash equivalents |
|
3,294
|
Recurring | Level 2 | Commercial paper |
|
|
Assets |
|
|
Short-term investments |
3,964
|
|
Recurring | Level 3 |
|
|
Assets |
|
|
Total |
0
|
0
|
Liabilities |
|
|
Short-term contingent consideration |
2,700
|
2,700
|
Derivative liability |
308
|
308
|
Total |
3,008
|
3,008
|
Recurring | Level 3 | U.S. Treasuries |
|
|
Assets |
|
|
Cash and cash equivalents |
0
|
0
|
Short-term investments |
0
|
|
Recurring | Level 3 | Money market funds |
|
|
Assets |
|
|
Cash and cash equivalents |
0
|
0
|
Recurring | Level 3 | U.S. Government agencies |
|
|
Assets |
|
|
Cash and cash equivalents |
|
$ 0
|
Recurring | Level 3 | Commercial paper |
|
|
Assets |
|
|
Short-term investments |
$ 0
|
|
X |
- DefinitionFair value portion of asset recognized for present right to economic benefit.
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v3.24.2.u1
FAIR VALUE - Narrative (Details) $ in Thousands |
3 Months Ended |
6 Months Ended |
|
Jun. 30, 2024
USD ($)
|
Jun. 30, 2023
USD ($)
|
Jun. 30, 2024
USD ($)
Rate
|
Jun. 30, 2023
USD ($)
|
Dec. 31, 2023
USD ($)
|
Schedule of Cash and Cash Equivalents and Marketable Securities [Line Items] |
|
|
|
|
|
Contingent consideration, current portion |
$ 2,700
|
|
$ 2,700
|
|
$ 2,700
|
Change in fair value of contingent consideration |
0
|
$ 241
|
0
|
$ 9,408
|
|
Derivative liability |
300
|
|
300
|
|
|
Level 2 |
|
|
|
|
|
Schedule of Cash and Cash Equivalents and Marketable Securities [Line Items] |
|
|
|
|
|
Debt conversion option value |
34,700
|
|
34,700
|
|
35,700
|
Convertible notes, par value |
$ 40,000
|
|
$ 40,000
|
|
40,000
|
Option Pricing Model | Credit Spread |
|
|
|
|
|
Schedule of Cash and Cash Equivalents and Marketable Securities [Line Items] |
|
|
|
|
|
Embedded derivative liability, measurement input |
0.088
|
|
0.088
|
|
|
INDOCIN |
|
|
|
|
|
Schedule of Cash and Cash Equivalents and Marketable Securities [Line Items] |
|
|
|
|
|
Contingent payment consideration, future royalties covenant, product net sales (over) |
|
|
$ 20,000
|
|
|
Contingent consideration, royalty percentage | Rate |
|
|
20.00%
|
|
|
Contingent consideration, current portion |
$ 2,700
|
|
$ 2,700
|
|
$ 2,700
|
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v3.24.2.u1
FAIR VALUE - Schedule of Changes in Fair Value (Details) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
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
|
|
|
Level 3 | Contingent Consideration |
|
|
|
|
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] |
|
|
|
|
Fair value, beginning of the period |
$ 2,700
|
$ 51,058
|
$ 2,700
|
$ 48,500
|
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0
|
241
|
0
|
9,408
|
Cash payment related to contingent consideration |
0
|
(8,799)
|
0
|
(15,408)
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$ 2,700
|
$ 42,500
|
$ 2,700
|
$ 42,500
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v3.24.2.u1
v3.24.2.u1
RESTRUCTURING CHARGES - Narrative (Details) - USD ($)
|
3 Months Ended |
6 Months Ended |
12 Months Ended |
Jun. 30, 2024 |
Mar. 31, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Dec. 31, 2023 |
Restructuring Cost and Reserve [Line Items] |
|
|
|
|
|
|
Restructuring charges |
$ 0
|
|
$ 0
|
$ 720,000
|
$ 0
|
|
Employee compensation costs |
|
|
|
|
|
|
Restructuring Cost and Reserve [Line Items] |
|
|
|
|
|
|
Restructuring charges |
|
|
|
720,000
|
|
|
Employee compensation costs | Chief Executive Officer |
|
|
|
|
|
|
Restructuring Cost and Reserve [Line Items] |
|
|
|
|
|
|
Restructuring charges |
|
|
|
|
|
$ 1,500,000
|
Spectrum Reorganization Plan | Employee compensation costs |
|
|
|
|
|
|
Restructuring Cost and Reserve [Line Items] |
|
|
|
|
|
|
Cost incurred, cumulative |
3,300,000
|
|
|
3,300,000
|
|
|
Spectrum Reorganization Plan | Facility exit costs |
|
|
|
|
|
|
Restructuring Cost and Reserve [Line Items] |
|
|
|
|
|
|
Restructuring charges |
|
$ 1,300,000
|
|
|
|
|
Restructuring and related cost, expected cost remaining |
$ 0
|
|
|
$ 0
|
|
|
X |
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v3.24.2.u1
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