PART I — FINANCIAL INFORMATION Item 1. Financial Statements (Unaudited) This section presents the unaudited condensed consolidated financial statements for Assertio Holdings, Inc., including the balance sheets, statements of comprehensive income, shareholders' equity, and cash flows, along with detailed notes explaining significant accounting policies, revenue breakdown, asset and liability changes, debt structure, stock-based compensation, leases, commitments, contingencies, restructuring charges, earnings per share, fair value measurements, and income taxes Condensed Consolidated Balance Sheets | ASSETS / LIABILITIES AND SHAREHOLDERS' EQUITY | September 30, 2021 (in thousands) | December 31, 2020 (in thousands) | | :-------------------------------------------- | :-------------------------------- | :------------------------------- | | Total assets | $299,305 | $303,274 | | Total liabilities | $202,445 | $247,760 | | Total shareholders' equity | $96,860 | $55,514 | - Total assets decreased by $3.97 million from December 31, 2020, to September 30, 2021. Total liabilities decreased by $45.315 million, while total shareholders' equity increased by $41.346 million89 Condensed Consolidated Statements of Comprehensive Income | Metric (in thousands, except per share data) | Three Months Ended Sep 30, 2021 | Three Months Ended Sep 30, 2020 | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | | :------------------------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Total revenues | $25,472 | $34,565 | $77,686 | $76,099 | | Total costs and expenses | $19,538 | $41,240 | $76,243 | $125,158 | | Income (loss) from operations | $5,934 | $(6,675) | $1,443 | $(49,059) | | Net income (loss) | $3,737 | $(10,522) | $(5,887) | $(3,791) | | Basic net income (loss) per share | $0.08 | $(0.35) | $(0.14) | $(0.15) | | Diluted net income (loss) per share | $0.08 | $(0.35) | $(0.14) | $(0.15) | - For the three months ended September 30, 2021, total revenues decreased by $9.093 million (26.3%) YoY, while net income improved significantly from a loss of $10.522 million to a gain of $3.737 million. For the nine months ended September 30, 2021, total revenues increased by $1.587 million (2.1%) YoY, and net loss widened from $3.791 million to $5.887 million11 Condensed Consolidated Statements of Shareholders' Equity | Metric (in thousands) | Balances at Dec 31, 2020 | Balances at Sep 30, 2021 | | :---------------------------------------------------------------------------------- | :----------------------- | :----------------------- | | Common Shares | 28,392 | 44,622 | | Common Stock Amount | $3 | $4 | | Additional Paid-In Capital | $483,456 | $530,689 | | Accumulated Earnings (Deficit) | $(427,945) | $(433,833) | | Total Shareholders' Equity | $55,514 | $96,860 | - Total shareholders' equity increased by $41.346 million from December 31, 2020, to September 30, 2021, primarily driven by an increase in additional paid-in capital from stock offerings and stock-based compensation, partially offset by an increase in accumulated deficit12 Condensed Consolidated Statements of Cash Flows | Cash Flow Activity (in thousands) | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash from operating activities| $1,392 | $(59,590) | | Net cash from investing activities| $0 | $512,801 | | Net cash from financing activities| $36,548 | $(460,581) | | Net increase (decrease) in cash | $37,940 | $(7,370) | | Cash and cash equivalents at end | $58,726 | $34,737 | - The company generated $1.392 million in cash from operating activities for the nine months ended September 30, 2021, a significant improvement from a cash usage of $59.590 million in the prior year. Cash from investing activities was $0 in 2021, compared to $512.801 million provided in 2020 due to asset sales. Cash from financing activities was $36.548 million in 2021, a reversal from $460.581 million used in 202018 Notes to Condensed Consolidated Financial Statements NOTE 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - The financial statements are unaudited and prepared under SEC interim reporting requirements, condensing or omitting certain U.S. GAAP footnotes. All common stock share and per-share data have been retrospectively adjusted for a 1-for-4 reverse stock split effected on May 18, 2021. Revenue reclassifications were made in Q3 2021 to reflect net sales of current commercialized products, impacting prior period 'Product sales, net' and 'Other revenue' but not total net revenue202223 - The COVID-19 pandemic led to remote work arrangements and increased virtual visits with prescribers. The company experienced a decline and volatility in prescriptions tied to elective surgeries, with future impacts remaining uncertain24 NOTE 2. REVENUE | Revenue Type (in thousands) | Three Months Ended Sep 30, 2021 | Three Months Ended Sep 30, 2020 | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | | :-------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Product sales, net | $25,997 | $33,664 | $77,271 | $61,974 | | Royalties and milestones | $416 | $299 | $1,391 | $1,158 | | Other revenue | $(941) | $602 | $(976) | $1,709 | | Total revenues | $25,472 | $34,565 | $77,686 | $76,099 | - Product sales, net, for the three months ended September 30, 2021, decreased by $7.667 million (22.8%) YoY, while for the nine months, they increased by $15.297 million (24.7%) YoY. Commercialization agreement revenue for NUCYNTA ceased in February 2020 due to its sale2528 | Product (in thousands) | Three Months Ended Sep 30, 2021 | Three Months Ended Sep 30, 2020 | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | | :--------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | INDOCIN products | $14,541 | $13,773 | $42,214 | $19,207 | | CAMBIA | $5,038 | $7,449 | $17,628 | $21,503 | | Zipsor | $1,999 | $3,395 | $6,802 | $9,261 | | SPRIX | $2,272 | $5,642 | $6,911 | $7,244 | NOTE 3. ACCOUNTS RECEIVABLES, NET | Receivables (in thousands) | September 30, 2021 | December 31, 2020 | | :---------------------------------- | :----------------- | :---------------- | | Receivables related to product sales| $36,145 | $40,784 | | Receivables from Collegium | $0 | $3,566 | | Total accounts receivable, net | $36,145 | $44,350 | - Total accounts receivable, net, decreased by $8.205 million from December 31, 2020, to September 30, 2021, primarily due to the absence of receivables from Collegium33 NOTE 4. INVENTORIES, NET | Inventory Type (in thousands) | September 30, 2021 | December 31, 2020 | | :---------------------------- | :----------------- | :---------------- | | Raw materials | $1,480 | $1,136 | | Work-in-process | $204 | $1,340 | | Finished goods | $3,797 | $9,236 | | Total | $5,481 | $11,712 | - Total inventories, net, decreased by $6.231 million from December 31, 2020, to September 30, 2021, primarily driven by a reduction in finished goods and work-in-process34 NOTE 5. PROPERTY AND EQUIPMENT, NET | Property and Equipment (in thousands) | September 30, 2021 | December 31, 2020 | | :------------------------------------ | :----------------- | :---------------- | | Total gross carrying amount | $13,222 | $13,223 | | Less: Accumulated depreciation | $(11,544) | $(10,786) | | Property and equipment, net | $1,678 | $2,437 | - Net property and equipment decreased by $0.759 million from December 31, 2020, to September 30, 2021, primarily due to increased accumulated depreciation37 NOTE 6. INTANGIBLE ASSETS | Intangible Asset (in thousands) | September 30, 2021 Net Book Value | December 31, 2020 Net Book Value | | :------------------------------ | :-------------------------------- | :------------------------------- | | INDOCIN | $136,657 | $146,288 | | SPRIX | $31,432 | $35,611 | | CAMBIA | $9,938 | $15,197 | | Zipsor | $1,116 | $2,869 | | Oxaydo | $0 | $117 | | Total Intangible Assets | $179,143 | $200,082 | - Total intangible assets, net, decreased by $20.939 million from December 31, 2020, to September 30, 2021, primarily due to amortization. Amortization expense for the nine months ended September 30, 2021, was $20.9 million, up from $18.2 million in the prior year39 | Year Ending December 31, | Estimated Amortization Expense (in thousands) | | :----------------------- | :-------------------------------------------- | | 2021 (remainder) | $7,176 | | 2022 | $26,895 | | 2023 | $18,412 | | 2024 | $18,413 | | 2025 | $18,413 | | Thereafter | $89,834 | | Total | $179,143 | NOTE 7. OTHER LONG-TERM ASSETS | Other Long-Term Assets (in thousands) | September 30, 2021 | December 31, 2020 | | :------------------------------------ | :----------------- | :---------------- | | Investment, net | $1,579 | $1,579 | | Operating lease right-of-use assets | $912 | $1,955 | | Prepaid asset and deposits | $2,692 | $1,936 | | Other | $756 | $1,031 | | Total other long-term assets | $5,939 | $6,501 | - Total other long-term assets decreased by $0.562 million from December 31, 2020, to September 30, 2021, primarily due to a reduction in operating lease right-of-use assets44 - The company maintains a $1.579 million investment in medical research, structured as a long-term loan with a convertible feature, and has assessed an estimated $1.9 million expected credit loss on this investment44 NOTE 8. ACCRUED LIABILITIES | Accrued Liabilities (in thousands) | September 30, 2021 | December 31, 2020 | | :--------------------------------- | :----------------- | :---------------- | | Accrued compensation | $2,685 | $5,498 | | Accrued restructuring costs | $1,294 | $8,744 | | Other accrued liabilities | $9,803 | $12,829 | | Total accrued liabilities | $13,782 | $27,071 | - Total accrued liabilities decreased by $13.289 million from December 31, 2020, to September 30, 2021, primarily due to significant reductions in accrued restructuring costs and accrued compensation46 NOTE 9. DEBT | Debt Type (in thousands) | September 30, 2021 | December 31, 2020 | | :---------------------------------------- | :----------------- | :---------------- | | 13% Senior Secured Notes due 2024 | $75,500 | $80,250 | | Royalty rights obligation | $3,167 | $3,533 | | 2.50% Convertible Notes due 2021 | $0 | $335 | | Total principal amount | $78,667 | $84,118 | | Less: current portion of long-term debt | $(12,257) | $(11,942) | | Net, long-term debt | $66,410 | $72,160 | - Total principal debt decreased by $5.451 million from December 31, 2020, to September 30, 2021, primarily due to payments on the 13% Senior Secured Notes and the maturity of the 2.50% Convertible Notes due 20214858 | Interest Expense (in thousands) | Three Months Ended Sep 30, 2021 | Three Months Ended Sep 30, 2020 | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | | :-------------------------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Stated coupon interest | $2,454 | $2,938 | $7,624 | $7,714 | | Amortization of debt discount, royalty rights | $41 | $103 | $159 | $5,614 | | Total interest expense | $2,495 | $3,041 | $7,783 | $13,328 | NOTE 10. STOCK-BASED COMPENSATION | Expense Category (in thousands) | Three Months Ended Sep 30, 2021 | Three Months Ended Sep 30, 2020 | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | | :------------------------------------------ | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Selling, general and administrative expense | $866 | $1,491 | $2,596 | $5,735 | | Total stock-based compensation | $866 | $1,511 | $2,596 | $7,038 | - Total stock-based compensation expense decreased by $0.645 million (42.7%) for the three months and $4.442 million (63.1%) for the nine months ended September 30, 2021, compared to the same periods in 202064 - During the nine months ended September 30, 2021, the Company granted 1.7 million RSUs at an average fair market value of $3.54 per share64 NOTE 11. LEASES | Lease Metric (in thousands) | Three Months Ended Sep 30, 2021 | Three Months Ended Sep 30, 2020 | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | | :-------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Total lease cost | $202 | $572 | $699 | $1,240 | | Sublease Income | $347 | $347 | $1,040 | $1,040 | - Total lease cost decreased by $0.370 million (64.7%) for the three months and $0.541 million (43.6%) for the nine months ended September 30, 2021, compared to the same periods in 2020. Sublease income remained constant YoY for both periods67 | Lease Liabilities (in thousands) | September 30, 2021 | December 31, 2020 | | :------------------------------- | :----------------- | :---------------- | | Current operating lease liabilities| $2,252 | $2,683 | | Noncurrent operating lease liabilities| $772 | $2,815 | | Total lease liabilities | $3,024 | $5,498 | NOTE 12. COMMITMENTS AND CONTINGENCIES - The company has a manufacturing and supply agreement with Jubilant HollisterStier (JHS) for SPRIX, committing to purchase a minimum of 75% of annual requirements through July 2022, with total commitments of approximately $1.8 million70 - An agreement with Cosette Pharmaceuticals for INDOCIN Suppositories was extended to July 2028, requiring the company to purchase all its requirements with annual minimum commitments of approximately $6.3 million71 - The company recorded a legal contingency accrual of approximately $3.6 million as of September 30, 2021 (zero in Dec 2020), recognizing a $0.8 million gain and a $10.6 million loss on contingency provision for the three and nine months ended September 30, 2021, respectively72 - The company settled Glumetza antitrust claims with Retailer Plaintiffs for $3.15 million and preliminarily settled direct purchaser class claims for $3.85 million, denying all wrongdoing. It also reached an agreement to settle a federal securities class action and related shareholder derivative actions767880 - The company is involved in various opioid-related investigations and litigation, including Multidistrict Opioid Litigation and State Opioid Litigation, and is defending itself vigorously. It received $5.0 million in insurance reimbursement for previous opioid-related spend in Q1 202181828385 - The CAMBIA ANDA litigation was concluded with a confidential settlement agreement and a permanent injunction granted by the Court on March 10, 202187 NOTE 13. RESTRUCTURING CHARGES - The company implemented a December 2020 restructuring plan to reduce its operating footprint and workforce, substantially completing the reduction in Q1 2021. The Zyla Merger Reorganization activities were completed in 2020, with no significant costs expected in 202189132 | Restructuring Costs (in thousands) | Three Months Ended Sep 30, 2021 | Three Months Ended Sep 30, 2020 | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | | :--------------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Total restructuring costs | $0 | $268 | $1,089 | $6,787 | - Restructuring charges for the three months ended September 30, 2021, were zero, down from $0.268 million in 2020. For the nine months, charges decreased to $1.089 million from $6.787 million in 202090 NOTE 14. NET INCOME (LOSS) PER SHARE | EPS Metric (in thousands, except per share) | Three Months Ended Sep 30, 2021 | Three Months Ended Sep 30, 2020 | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | | :------------------------------------------ | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Net income (loss) | $3,737 | $(10,522) | $(5,887) | $(3,791) | | Weighted average common shares outstanding | 44,969 | 29,891 | 42,550 | 24,958 | | Basic net income (loss) per share | $0.08 | $(0.35) | $(0.14) | $(0.15) | | Diluted net income (loss) per share | $0.08 | $(0.35) | $(0.14) | $(0.15) | - Basic and diluted EPS for the three months ended September 30, 2021, improved to $0.08 from $(0.35) in 2020. For the nine months, both basic and diluted EPS were $(0.14), a slight improvement from $(0.15) in 202095 - Weighted average common shares and warrants outstanding increased significantly to 44,969 thousand for the three months and 42,550 thousand for the nine months ended September 30, 2021, compared to 29,891 thousand and 24,958 thousand respectively in 202095 NOTE 15. FAIR VALUE | Liabilities (in thousands) | September 30, 2021 Total | December 31, 2020 Total | | :-------------------------------------- | :----------------------- | :---------------------- | | Short-term contingent consideration | $7,200 | $6,776 | | Long-term contingent consideration | $30,759 | $31,776 | | Total contingent consideration | $37,959 | $38,552 | - Total contingent consideration liabilities decreased by $0.593 million from December 31, 2020, to September 30, 2021. These liabilities are classified as Level 3 fair value measurements due to unobservable inputs98101 - The fair value of contingent consideration is determined using an option pricing model based on estimated INDOCIN product revenues through January 2029, with key assumptions including revenue volatility of 40.0%, a discount rate of 6.5%, and a credit spread of 5.1%101 NOTE 16. INCOME TAXES - As of September 30, 2021, the company's net deferred tax assets are fully offset by a valuation allowance, which has been in place since Q4 2016. The company recorded an income tax expense of approximately $0.3 million for the nine months ended September 30, 2021103104 - The difference between the income tax expense and the statutory rate is primarily due to the recording of a valuation allowance for current year movement in deferred tax assets. The company expects to receive an $8.3 million tax refund in 2021 from a NOL carryback claim under the CARES Act104 Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's perspective on the company's financial performance, condition, and future outlook. It covers forward-looking statements, an overview of the business and its products, the impact of COVID-19, critical accounting policies, detailed analysis of revenues and expenses, and a discussion of liquidity and capital resources, including cash flow activities and recent financing efforts FORWARD-LOOKING INFORMATION - The company's forward-looking statements cover potential impacts of global pandemics (COVID-19), expected expense savings from the December 2020 restructuring plan, synergies from the Zyla Life Sciences merger, commercial success of products, outcomes of opioid-related and antitrust litigation, intellectual property protection, future capital requirements, and ability to generate cash flow for debt payments107 - Factors that could cause actual results to differ materially include risks detailed in the 'RISK FACTORS' section of the 10-Q and Annual Report on Form 10-K110 COMPANY OVERVIEW - Assertio Holdings, Inc. is a commercial pharmaceutical company focused on neurology, hospital, and pain and inflammation, with primary marketed products including INDOCIN, CAMBIA, SPRIX, and Zipsor112113 - The company adapted to COVID-19 by increasing virtual visits and implementing a December 2020 restructuring plan to streamline operations, but acknowledges continued uncertainty regarding the pandemic's future impact114115 - The business is managed within one reportable segment, with substantially all product sales revenues related to sales in the U.S116 CRITICAL ACCOUNTING POLICIES - Critical accounting policies involve significant judgment and estimates, particularly for revenue recognition, accrued liabilities, and the use of estimates. No significant changes to these policies have occurred since the 2020 Form 10-K filing117118 RESULTS OF OPERATIONS | Metric (in thousands) | Three Months Ended Sep 30, 2021 | Three Months Ended Sep 30, 2020 | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | | :--------------------------------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Total revenues | $25,472 | $34,565 | $77,686 | $76,099 | | Cost of sales | $3,050 | $6,462 | $10,936 | $13,099 | | Research and development expenses | $0 | $1,316 | $0 | $3,983 | | Selling, general and administrative expenses | $9,313 | $27,607 | $43,279 | $83,052 | | Amortization of intangible assets | $7,175 | $5,587 | $20,939 | $18,237 | | Restructuring charges | $0 | $268 | $1,089 | $6,787 | | Other (expense) income | $(2,151) | $(2,797) | $(7,036) | $38,894 | | Income tax (expense) benefit | $(46) | $(1,050) | $(294) | $6,374 | - Total revenues decreased by $9.093 million (26.3%) for the three months ended September 30, 2021, but increased by $1.587 million (2.1%) for the nine months, primarily due to product sales from the Zyla Merger in 2020119120 - Selling, general, and administrative expenses decreased significantly by $18.3 million (66.3%) for the three months and $39.8 million (47.9%) for the nine months, driven by lower employee costs from restructuring and non-recurring transaction costs in 2020, partially offset by a loss contingency provision in 2021129 - Other (expense) income shifted from a $38.894 million income in the nine months ended September 30, 2020, to a $7.036 million expense in 2021, primarily due to the non-recurrence of gains from asset sales and debt extinguishment in the prior year134 LIQUIDITY AND CAPITAL RESOURCES - The company's operations are financed primarily through product sales, equity securities sales, secured borrowings, and license fees. It completed registered direct offerings in February 2021, raising approximately $14.0 million and $34.3 million in gross proceeds, respectively, for general corporate purposes139140 - Management believes existing cash will be sufficient to fund operations for the next twelve months. The inability to raise additional capital could materially adversely affect the company141 | Cash Flow Activity (in thousands) | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash from operating activities| $1,392 | $(59,590) | | Net cash from investing activities| $0 | $512,801 | | Net cash from financing activities| $36,548 | $(460,581) | | Net increase (decrease) in cash | $37,940 | $(7,370) | - Cash provided by operating activities significantly improved to $1.4 million in 2021 from a $59.6 million usage in 2020. Cash from investing activities was $0 in 2021, compared to $512.8 million provided in 2020 due to asset sales. Cash from financing activities provided $36.5 million in 2021, a reversal from $460.6 million used in 2020142144145 Item 3. Quantitative and Qualitative Disclosures About Market Risk This section states that there are no applicable quantitative and qualitative disclosures about market risk for the reporting period Item 4. Controls and Procedures Management, including the CEO and CFO, evaluated the effectiveness of disclosure controls and procedures as of the end of the reporting period and concluded they were effective. The company finalized the integration of Zyla's operations into its internal control environment during Q1 2021, with no other significant changes to internal controls over financial reporting - Disclosure controls and procedures were evaluated and deemed effective as of September 30, 2021146 - The integration of Zyla's operations into the internal control environment was finalized in Q1 2021, with no other material changes to internal controls over financial reporting148 PART II — OTHER INFORMATION Item 1. Legal Proceedings This section refers to Note 12, 'Commitments and Contingencies - Legal Matters,' for a detailed description of the company's material pending legal proceedings - Material pending legal proceedings are detailed in Note 12. Commitments and Contingencies - Legal Matters149 Item 1A. Risk Factors This section incorporates by reference the risk factors from the company's Annual Report on Form 10-K for the year ended December 31, 2020, and states that there have been no material changes to these risk factors. It emphasizes that these risks, along with potential unknown risks, could materially and adversely affect the business - Risk factors from the 2020 Form 10-K are incorporated by reference, with no material changes reported since that filing150152 - The company acknowledges that additional unknown or currently immaterial risks could also impact its business, results of operations, and financial condition152 Item 2. Unregistered Sales of Equity Securities and Use of Proceeds This section reports that the company did not repurchase any common stock during the period, except for shares withheld to satisfy tax withholding obligations related to the vesting of equity awards - No common stock repurchases were made during the period, except for shares withheld to cover employee tax withholding liabilities upon equity award vesting153154 | Period | Total Number of Shares Purchased | Average Price Paid per Share | | :----------------------- | :------------------------------- | :--------------------------- | | July 1, 2021 - July 31, 2021 | 3,072 | $1.30 | | August 1, 2021 - August 31, 2021 | 2,812 | $1.32 | | September 1, 2021 - September 30, 2021 | 851 | $0.93 | | Total | 6,735 | $1.26 | Item 6. Exhibits This section lists the exhibits filed with the Form 10-Q, including an amendment to a collaborative license agreement, certifications from the CEO and CFO, and various Inline XBRL documents - Exhibits include Amendment No. 3 to Collaborative License, Exclusive Manufacture and Global Supply Agreement, Rule 13a-14(a) and 15d-14(a) certifications, 18 U.S.C. Section 1350 certifications, and Inline XBRL documents156157158 Signatures This section contains the required signatures of the company's authorized officers, including the President and Chief Executive Officer, Senior Vice President and Chief Financial Officer, and Senior Vice President and Chief Accounting Officer, certifying the filing of the report - The report is signed by Daniel A. Peisert (President and CEO), Paul Schwichtenberg (SVP and CFO), and Ajay Patel (SVP and Chief Accounting Officer)160161
Assertio (ASRT) - 2021 Q3 - Quarterly Report