Financial Performance - ROLVEDON net product sales decreased by $1.4 million from $14.5 million in Q1 2024 to $13.1 million in Q1 2025, primarily due to lower net pricing, partially offset by higher volume [125]. - Total revenues for Q1 2025 were $26.5 million, down from $32.4 million in Q1 2024, reflecting a decrease of approximately 18.2% [124]. - Loss from operations increased to $13.2 million in Q1 2025 compared to a loss of $4.3 million in Q1 2024 [124]. - INDOCIN net product sales decreased by $3.1 million from $8.7 million in Q1 2024 to $5.5 million in Q1 2025 due to lower volume and pricing from generic competition [126]. - Sympazan net product sales decreased by $0.4 million from $2.6 million in Q1 2024 to $2.2 million in Q1 2025, primarily due to unfavorable payor mix and lower volume [127]. Expenses - Cost of sales decreased from $11.2 million in Q1 2024 to $7.8 million in Q1 2025, a reduction of approximately 30.0% [124]. - Selling, general and administrative expenses rose to $22.0 million in Q1 2025 from $18.5 million in Q1 2024, an increase of approximately 19.8% [124]. - Amortization of intangible assets increased significantly from $5.6 million in Q1 2024 to $9.2 million in Q1 2025, reflecting a rise of approximately 63.5% [124]. - Research and development expenses were $0.4 million in Q1 2025, down from $0.7 million in Q1 2024, reflecting reduced costs associated with ongoing clinical activity for ROLVEDON [134]. - Selling, general and administrative expenses increased by $3.5 million from $18.5 million in Q1 2024 to $22.0 million in Q1 2025, driven by higher legal charges [136]. - Amortization of intangible assets increased by $3.6 million from $5.6 million in Q1 2024 to $9.2 million in Q1 2025, primarily due to changes in estimated useful lives of ROLVEDON and INDOCIN [137]. Cash Flow and Working Capital - Cash and cash equivalents totaled $87.3 million as of March 31, 2025, expected to be sufficient for operations and debt payments over the next 12 months [146]. - Net cash used in operating activities was $12.5 million in Q1 2025, compared to net cash provided of $7.5 million in Q1 2024 [151]. - Cash used in operating activities was $12.5 million for Q1 2025, a decrease from cash provided of $7.5 million in Q1 2024, primarily due to lower net product sales and higher expenses [152]. - Net working capital was a net use of cash of $10.1 million in Q1 2025, compared to a net cash provided of $3.6 million in Q1 2024, reflecting a $13.7 million change [152]. - Cash used in investing activities was $2.9 million in Q1 2025, consisting of $31.4 million in purchases of short-term investments, offset by $28.5 million from maturities [155]. - Cash used in financing activities was $0.1 million in Q1 2025, slightly down from $0.2 million in Q1 2024, related to employee stock awards [156]. Tax and Accounting - The company recorded an income tax expense of $0.2 million in Q1 2025, compared to $0.1 million in Q1 2024, with a full valuation allowance against net deferred tax assets [144]. - There were no material changes to the company's cash requirements from contractual obligations since the last filing [157]. - Critical accounting policies related to revenue recognition and impairment of long-lived assets remain unchanged since the last filing [158]. - The company is classified as a smaller reporting company and is not required to provide additional market risk disclosures [159]. Product and Market Strategy - ROLVEDON is indicated to decrease the incidence of infection in adult patients receiving anti-cancer drugs, targeting both hospitals and community oncology clinics [118]. - The company acquired ROLVEDON through a merger with Spectrum Pharmaceuticals on July 31, 2023, enhancing its product portfolio [118]. - The company is focusing on expanding its commercial capabilities through a patient-centric approach and omni-channel promotional model [121]. - The company anticipates that the average sales price for ROLVEDON will be negatively impacted in the remainder of 2025 due to increased discounts and rebates [125]. Restructuring - Restructuring charges were $0.3 million in Q1 2025, down from $0.7 million in Q1 2024, related to efficiency improvements in the sales and marketing department [141].

Financial Performance - Total net product sales for the first quarter of 2025 were $26.0 million, down from $31.9 million in the same quarter of 2024, reflecting a decrease of approximately 18.3% year-over-year[5] - Rolvedon net sales were $13.1 million, a decrease from $14.5 million in the prior year quarter, driven by lower pricing, partially offset by higher volume[8] - Indocin net product sales were $5.5 million, down from $8.7 million in the prior year quarter, due to generic competition affecting both volume and pricing[8] - The company reported a net loss of $13.5 million for the first quarter of 2025, compared to a net loss of $4.5 million in the same quarter of 2024[5] - Adjusted EBITDA for the first quarter was $0.2 million, a significant decrease from $7.4 million in the prior year quarter, primarily reflecting lower net product sales[8] - Adjusted EBITDA for the three months ended March 31, 2025, was $158,000, down from $7,379,000 in the same period of 2024, showing a decline of approximately 97.9%[22] Expenses and Costs - Selling, general and administrative expenses increased to $22.0 million from $18.5 million in the prior year quarter, primarily due to higher legal charges[8] - The company incurred stock-based compensation expenses of $1,101,000 for the three months ended March 31, 2025, slightly down from $1,207,000 in the same period of 2024[22] Cash and Investments - Cash, cash equivalents, and short-term investments totaled $87.3 million as of March 31, 2025, down from $100.1 million as of December 31, 2024[8] - Cash and cash equivalents decreased to $35,004,000 at the end of the period, down from $50,588,000 at the beginning of the year, representing a decrease of about 30.7%[21] - The company reported a net cash used in operating activities of $12,538,000 for the three months ended March 31, 2025, compared to net cash provided of $7,508,000 in the same period of 2024[21] Assets and Liabilities - Total current assets increased to $213,550,000 as of March 31, 2025, up from $202,549,000 as of December 31, 2024, reflecting a growth of about 5.0%[19] - Total liabilities rose to $177,896,000 as of March 31, 2025, compared to $163,651,000 as of December 31, 2024, indicating an increase of approximately 8.7%[19] - The company’s total current liabilities increased to $128,832,000 as of March 31, 2025, compared to $114,688,000 as of December 31, 2024, indicating an increase of approximately 12.3%[19] - The total shareholders' equity decreased to $108,530,000 as of March 31, 2025, down from $121,081,000 as of December 31, 2024, reflecting a decline of about 10.4%[19] Strategic Focus - The company is prioritizing investment in growth assets and divesting declining or non-core assets as part of its long-term business strategy[2] - The company has settled multiple legal matters, reducing future legal costs and focusing resources on the business[4] Accounts Receivable - The company experienced a significant increase in accounts receivable, net, which rose to $66,292,000 as of March 31, 2025, compared to $54,120,000 as of December 31, 2024, marking an increase of approximately 22.5%[19]

Core Insights - Assertio Holdings, Inc. reported first quarter total net product sales of $26.0 million, aligning with its 2025 outlook for sustainable growth and increased long-term value [1][2] - The company is focused on reducing legal exposure, simplifying corporate structure, prioritizing growth investments, and divesting non-core assets as part of its transformation strategy [2][5] Financial Performance - Net sales for the first quarter were $26.0 million, down from $31.9 million in the same quarter last year, with a net loss of $13.5 million compared to a loss of $4.5 million in the prior year [4][11] - Adjusted EBITDA was $0.2 million, significantly lower than $7.4 million in the previous year, primarily due to decreased net product sales and increased costs associated with higher Rolvedon volumes [4][11] - Rolvedon net sales were $13.1 million, a decrease from $14.5 million year-over-year, while Sympazan prescriptions increased by 6.5% year-over-year [3][11] Legal and Corporate Developments - The company settled multiple legal matters, including a DOJ False Claims Act lawsuit and an antitrust action, which is expected to reduce future legal costs [5] - Assertio has begun simplifying its corporate structure by transferring interests in its subsidiary Assertio Therapeutics, which held approximately $8.2 million in cash and certain legal liabilities [5] Balance Sheet and Cash Flow - As of March 31, 2025, Assertio had cash, cash equivalents, and short-term investments totaling $87.3 million, down from $100.1 million at the end of 2024 [12] - The company reported a net cash used in operating activities of $12.5 million for the quarter, compared to a net cash provided of $7.5 million in the same period last year [22] Strategic Focus - Assertio is reallocating resources to focus on growth assets, particularly Rolvedon and Sympazan, while progressing towards divesting non-core assets [5][11] - The management plans to host a conference call to discuss the financial results and provide further details on the corporate strategy for 2025 [7]

Core Viewpoint - Assertio Holdings, Inc. is set to release its first quarter 2025 financial results on May 12, 2025, after market close, followed by a live webcast conference call to discuss the results and update on strategic plans for 2025 [1]. Group 1 - The financial results announcement is scheduled for May 12, 2025, after market close [1]. - A live webcast conference call will take place at 4:30 p.m. Eastern Time on the same day [1]. - The company encourages participants to connect at least 10 minutes prior to the webcast for any necessary software downloads [2]. Group 2 - Assertio is a commercial pharmaceutical company with capabilities in marketing, market access, and distribution [4]. - The company has built its commercial portfolio through acquisitions or licensing of approved products [4]. - For more information about Assertio, the company’s website is provided [4].

Core Points - Assertio Holdings, Inc. will present at the iAccess Alpha Best Ideas Spring Investment Conference on March 25, 2025, at 1:30 pm Eastern Time [1] - Investors can request one-on-one meetings on March 26, 2025, through conference representatives or Assertio investor relations [2] - Assertio is a pharmaceutical company focused on oncology, neurology, and pain management, offering differentiated products to meet patient needs [3]

Group 1 - Assertio Holdings, Inc. will present at the iAccess Alpha Best Ideas Spring Investment Conference on March 25, 2025, at 1:30 pm Eastern Time [1] - Investors can request one-on-one meetings on March 26, 2025, through conference representatives or Assertio investor relations [2] - Assertio is a pharmaceutical company focused on oncology, neurology, and pain management, offering differentiated products to meet patient needs [3]

Financial Data and Key Metrics Changes - Assertio reported a positive cash flow from operations of $11.5 million, while adjusted EBITDA was negative at $500,000, indicating a discrepancy primarily driven by working capital adjustments and excess inventory charges [33][36] - The company provided a broad guidance range for 2025, estimating revenues between $108 million and $123 million, influenced by various operational factors [7][8] Business Line Data and Key Metrics Changes - The company highlighted a significant legal reserve taken in Q4 related to ongoing opioid legal exposure, which remains a known issue [12] - Assertio experienced an inventory write-down of approximately $4 million due to excess inventory of Indosin, indicating potential challenges in inventory management [29] Market Data and Key Metrics Changes - The ASP (Average Selling Price) for Rolodin showed a slight uptick, with management discussing strategies to manage ASP effectively [13] Company Strategy and Development Direction - The company outlined four strategic priorities for 2025, focusing on simplifying structure and processes, which is part of a broader transformation initiative [5] - Assertio aims to position itself for sustainable near-term growth, leveraging its proven platform and sound strategy [39] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the ongoing opioid legal exposure but emphasized that there were no new developments impacting the legal front in the recent quarter [26] - The CEO expressed confidence in the company's ability to unlock growth through a strong balance sheet and an excellent team [39] Other Important Information - The impairment of Otracip intangible assets was attributed to accounting evaluations based on the gap between book value and fair value, rather than specific issues with the franchise [30][32] Q&A Session Summary Question: Factors influencing revenue guidance range - Management acknowledged the broad guidance range and indicated various operational factors could influence the final revenue outcome [7][8] Question: Likelihood of acquisitions in the next twelve months - Management indicated that the odds of making an acquisition are above fifty-fifty, supported by a strengthened balance sheet [9] Question: Details on legal exposure and reserves - Management confirmed ongoing opioid legal exposure and discussed the relatively large legal reserve taken in Q4 [12] Question: ASP management for Rolodin - Management confirmed an uptick in Rolodin's ASP and discussed strategies for managing it [13] Question: Generics competition for Indosin - Management noted the launch of the first generic formulation of Indosin and discussed the competitive landscape [23] Question: Clarification on opioid legal exposure - Management stated there were no new developments regarding opioid legal exposure, maintaining that the situation has been steady [26] Question: Inventory write-down reasons - Management explained the $4 million write-down was due to excess inventory of Indosin [29] Question: Impairment of Otracip intangible assets - Management clarified that the impairment was related to accounting evaluations rather than specific franchise issues [30][32] Question: Discrepancy between cash flow and EBITDA - Management attributed the discrepancy between positive cash flow and negative EBITDA to working capital adjustments and excess inventory charges [33][36]

Regulatory and Compliance Risks - Future product candidates are subject to regulatory approval risks, and failure to obtain such approvals could limit commercialization opportunities [193]. - The regulatory approval process is lengthy and costly, with potential delays impacting the ability to bring products to market [200]. - The company relies on third-party organizations for clinical trials, and any failure in their performance could delay regulatory approvals [201]. - The company is subject to compliance with the FDA's good clinical practices, and any non-compliance could result in unreliable clinical data [202]. - The company may face challenges in meeting rapidly evolving regulatory standards related to privacy and data security in AI/ML applications [232]. Financial and Market Risks - The company faces significant risks related to product liability and ongoing litigation, which may adversely impact its financial condition and operations [191]. - The company has obtained product liability insurance, but inadequate coverage could hinder product commercialization and lead to significant expenses [192]. - The company's common stock is at risk of delisting from Nasdaq due to non-compliance with the Bid Price Rule, with a deadline to regain compliance by July 21, 2025 [209]. - The company may need to consider a reverse stock split to regain compliance with Nasdaq listing standards [209]. - The company has faced past compliance issues with Nasdaq, requiring grace periods and reverse stock splits to maintain its listing [209]. - Any delisting from Nasdaq could adversely affect market liquidity, stock price, and financing capabilities, potentially leading to a fundamental change under the 2027 Convertible Notes [212]. - The company's stock price has historically been volatile, influenced by various factors beyond its control, which may continue to affect trading prices [213]. - Significant drops in stock price could lead to shareholder lawsuits, impacting capital-raising efforts [214]. - Activist shareholders have caused legal and other fees, potentially disrupting the company's strategic plans and relationships with stakeholders [217]. - The company is subject to risks from unsolicited takeover attempts, which could distract management and incur significant costs [219]. - Conversions of the 2027 Convertible Notes or future sales of common stock could lower the market price of the company's stock [220]. - The potential for increased costs due to macroeconomic factors could affect the company's ability to raise capital on favorable terms [230]. Operational and Strategic Risks - The company is currently not engaged in any material clinical trials, which may affect future product development and market entry [194]. - Changes in the executive management team, including recent leadership transitions, may disrupt business operations and strategic planning [221]. - The company faces risks related to cybersecurity incidents, which could lead to significant operational disruptions and financial losses [226]. - The adequacy of the company's cybersecurity risk management protocols is uncertain, and breaches could expose sensitive information and incur substantial costs [229]. - Recent supply chain constraints have led to higher inflation, impacting the acquisition of APIs and manufacturing costs [230]. - The company is exposed to reputational harm and liability risks associated with the use of evolving technologies [231]. Macroeconomic and Geopolitical Risks - Macroeconomic conditions, including inflation and high interest rates, can adversely affect the company's business operations and financial results [230]. - The company faces potential changes to trade agreements and tariffs due to shifts in U.S. policy, which could negatively influence global economic growth [230]. - Geopolitical tensions and trade conflicts may have a material adverse effect on the company's financial condition and market value [230]. Technology and Innovation Risks - The use of AI and ML technologies presents new risks, including security threats to sensitive data and potential intellectual property issues [231]. - Regulatory challenges related to AI/ML may require the company to alter business practices or face fines, impacting operational efficiency [232].

Financial Performance - Fourth quarter net product sales reached $29.6 million, an increase from $28.7 million in the previous quarter[6] - Full year net product sales totaled $120.8 million, with Rolvedon sales exceeding $60.0 million[1] - Total revenues for the three months ended December 31, 2024, were $32,182 thousand, a decrease of 2.4% compared to $32,985 thousand for the same period in 2023[17] - Product sales, net for the year ended December 31, 2024, were $120,849 thousand, down 19.2% from $149,451 thousand in 2023[17] - Net loss for the year ended December 31, 2024, was $21,581 thousand, significantly improved from a net loss of $331,942 thousand in 2023[21] - Basic and diluted net loss per share for the year ended December 31, 2024, was $0.23, compared to $4.67 in 2023[17] - For the three months ended December 31, 2024, the company reported a net loss of $10,476,000, translating to a diluted loss per share of $0.11, compared to a net loss of $57,384,000 and a diluted loss per share of $0.61 for the same period in 2023[25] Cash Flow and Assets - Cash flow from operations for the fourth quarter was $11.5 million, contributing to a full year total of $26.4 million[1] - Assertio's cash, cash equivalents, and short-term investments totaled $100.1 million as of December 31, 2024[10] - Cash and cash equivalents at the end of the year were $50,588 thousand, down from $73,441 thousand at the end of 2023[19] - Total current assets increased to $202,549 thousand as of December 31, 2024, compared to $171,062 thousand in 2023[19] - The company reported a net cash provided by operating activities of $26,408 thousand for the year ended December 31, 2024, down from $49,604 thousand in 2023[21] Expenses and Margins - Gross margin for the fourth quarter was 61%, down from 74% in the third quarter, primarily due to $2.9 million in higher inventory write-downs[10] - Adjusted EBITDA loss for the fourth quarter was $0.5 million, compared to adjusted EBITDA of $5.3 million in the prior quarter[10] - SG&A expenses in the fourth quarter increased to $21.4 million, largely due to a $5.4 million rise in litigation contingencies[10] - Research and development expenses for the three months ended December 31, 2024, were $1,286 thousand, an increase from $1,024 thousand in the same period of 2023[17] - Adjusted EBITDA for the year ended December 31, 2024, was $17,143 thousand, compared to $67,743 thousand in 2023[22] Liabilities and Debt - Total liabilities rose to $163,651 thousand in 2024, up from $148,416 thousand in 2023[19] - The company incurred approximately $8.8 million in debt-related expenses and $1.1 million in direct transaction costs related to the privately negotiated exchange of $30 million principal amount of Convertible Senior Notes due 2027 in Q1 2023[24] Other Income and Charges - Total other income for the three months ended December 31, 2024, was $(920,000), compared to $(887,000) for the previous quarter[24] - The company reported a change in fair value of contingent consideration of $(544,000) for the three months ended December 31, 2024, and $(25,538,000) for the twelve months ended December 31, 2023[33] - The company recognized a loss of $5,217,000 for impairment of intangible assets during the three months ended December 31, 2024, and a total of $279,639,000 for the twelve months ended December 31, 2023[33] - Restructuring charges for the twelve months ended December 31, 2024, amounted to $720,000, while for the twelve months ended December 31, 2023, it was $5,476,000[33] - The company’s total other income for the twelve months ended December 31, 2024, was $2,820,000, compared to $1,203,000 for the twelve months ended December 31, 2023[24] Future Guidance and Strategy - The company announced initial 2025 operating guidance for net product sales between $108.0 million and $123.0 million[7] - Assertio is actively pursuing an acquisition strategy to enhance its commercial assets and scale[4]

Core Insights - Assertio Holdings, Inc. reported fourth quarter net product sales of $29.6 million, a slight increase from $28.7 million in the previous quarter, and full year net product sales of $120.8 million, down from $149.5 million in 2023 [1][4][11] - The company generated cash flow from operations of $11.5 million in the fourth quarter and $26.4 million for the full year, with cash and investments totaling $100.1 million at year-end [1][11] - Assertio's CEO highlighted 2024 as a year of stabilization, focusing on Rolvedon as the primary asset and enhancing the leadership team [2][3] Financial Performance - Fourth quarter net loss was $10.5 million, compared to a net loss of $2.9 million in the previous quarter and a net loss of $57.4 million in the same quarter of 2023 [4][11] - Adjusted EBITDA for the fourth quarter was a loss of $0.5 million, down from a gain of $5.3 million in the prior quarter [11][25] - Gross margin decreased to 61% in the fourth quarter from 74% in the third quarter, primarily due to higher inventory write-downs [4][11] Product Sales - Rolvedon net product sales reached $15.4 million in the fourth quarter, an increase of $0.4 million from the previous quarter, while Indocin net product sales were $5.5 million, down from $5.7 million [4][11] - The company expects 2025 to be transformational, focusing on revenue growth initiatives for Rolvedon and Sympazan [3][4] Strategic Initiatives - Assertio is pursuing an acquisition strategy to enhance its commercial assets and scale for near-term growth [4][3] - The company aims to manage legal exposure and associated costs while simplifying its structure [3][4] Balance Sheet and Guidance - Assertio's initial guidance for 2025 includes net product sales between $108 million and $123 million and adjusted EBITDA between $10 million and $19 million [6] - As of December 31, 2024, the company had total assets of $284.7 million and total liabilities of $163.7 million [19][21]