LAKE FOREST, Ill., March 20, 2025 (GLOBE NEWSWIRE) -- Assertio Holdings, Inc. ("Assertio" or the "Company") (NASDAQ:ASRT) today announced that Brendan O'Grady, Chief Executive Officer, will present at the iAccess Alpha Best Ideas Spring Investment Conference taking place virtually March 25-26, 2025. The Company will present at 1:30 pm Eastern Time on Tuesday, March 25, 2025. To join the presentation, please visit the webcast available online at https://investor.assertiotx.com/. Additionally, investors parti ...

LAKE FOREST, Ill., March 20, 2025 (GLOBE NEWSWIRE) -- Assertio Holdings, Inc. (“Assertio” or the “Company”) (Nasdaq: ASRT) today announced that Brendan O’Grady, Chief Executive Officer, will present at the iAccess Alpha Best Ideas Spring Investment Conference taking place virtually March 25-26, 2025. The Company will present at 1:30 pm Eastern Time on Tuesday, March 25, 2025. To join the presentation, please visit the webcast available online at https://investor.assertiotx.com/. Additionally, investors part ...

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]

Fourth Quarter Net Product Sales $29.6 Million, Cash Flow from Operations of $11.5 Million Full Year Net Product Sales $120.8 Million, Rolvedon Sales Exceed $60.0 Million Full Year Cash Flow from Operations of $26.4 Million, Cash and Investments Increases to $100.1 Million LAKE FOREST, Ill., March 12, 2025 (GLOBE NEWSWIRE) -- Assertio Holdings, Inc. (“Assertio” or the “Company”) (Nasdaq: ASRT) today reported financial results for the fourth quarter and full year ended December 31, 2024. Said Brendan O’Grady ...

Core Viewpoint - Assertio Holdings, Inc. is set to release its fourth quarter and full year 2024 financial results on March 12, 2025, after market close, followed by a live webcast of the earnings conference call [1]. Group 1: Financial Results Announcement - The financial results for the fourth quarter and full year 2024 will be announced on March 12, 2025 [1]. - A live webcast of the earnings conference call will take place at 4:30 p.m. Eastern Time on the same day [1]. Group 2: Access Information - Investors can access the live webcast and conference call information through Assertio's investor relations website [2]. - It is recommended to connect at least 10 minutes prior to the webcast for any necessary software downloads [2]. - For those preferring to join by telephone, a specific dial-in number and call ID are provided [2]. Group 3: Webcast Replay - A replay of the earnings call will be available approximately two hours after the live call on Assertio's investor website [3]. Group 4: Company Overview - Assertio is a pharmaceutical company focused on marketing differentiated products in oncology, neurology, and pain management [4].

LAKE FOREST, Ill., Dec. 17, 2024 (GLOBE NEWSWIRE) -- Assertio Holdings, Inc. (“Assertio” or the “Company”) (Nasdaq: ASRT), a pharmaceutical company with comprehensive commercial capabilities offering differentiated products to patients, announced today that Mark Reisenauer has been appointed as an independent director to the Company’s Board of Directors. Mr. Reisenauer will serve as a member of the Compensation Committee. “Mark is a highly accomplished commercial leader in complex, competitive therapeutic a ...

Core Insights - Assertio Holdings, Inc. announced positive results from a clinical trial of Rolvedon® (eflapegrastim-xnst) injection for early stage breast cancer patients, presented at the San Antonio Breast Cancer Symposium [1][2] Group 1: Clinical Trial Results - The open-label, single-arm study involved 13 sites in the US, where patients received Rolvedon 30 minutes post-chemotherapy [2] - Rolvedon demonstrated a neutrophil count recovery time of 1.8 days and a febrile neutropenia rate of 2%, with no patients requiring hospitalization for febrile neutropenia [2] - No new safety signals were identified during the trial [2] Group 2: Company Statements - The CEO of Assertio expressed satisfaction with the trial results, emphasizing the potential of Rolvedon to improve the lives of patients undergoing chemotherapy [3] - The Senior Vice President of Medical highlighted the encouraging safety and efficacy profile of Rolvedon, supporting its potential to enhance patient outcomes and quality of life [4] Group 3: Company Overview - Assertio is a commercial pharmaceutical company with capabilities in marketing, market access, and distribution, built through acquisition or licensing of approved products [5]

Core Insights - Five stocks have been added to the Zacks Rank 1 (Strong Buy) List, indicating strong potential for investment Group 1: Company Earnings Estimates - Makita Corporation (MKTAY) has seen a 6% increase in the Zacks Consensus Estimate for its current year earnings over the last 60 days [1] - Assertio Holdings, Inc. (ASRT) has experienced an 11.8% increase in the Zacks Consensus Estimate for its current year earnings over the last 60 days [1] - Choice Hotels International, Inc. (CHH) has reported a 6.1% increase in the Zacks Consensus Estimate for its current year earnings over the last 60 days [2] - Leonardo DRS, Inc. (DRS) has seen a 7% increase in the Zacks Consensus Estimate for its current year earnings over the last 60 days [2] - Brookline Bancorp, Inc. (BRKL) has experienced a 6.5% increase in the Zacks Consensus Estimate for its current year earnings over the last 60 days [3]

Financial Performance - Total revenues for Q3 2024 were $29,204, a decrease of 18.5% compared to $35,627 in Q3 2023[7] - Product sales, net for Q3 2024 were $28,705, down 18.2% from $35,137 in Q3 2023[7] - Net loss for Q3 2024 was $2,921, significantly improved from a net loss of $279,544 in Q3 2023[7] - Basic net loss per share for Q3 2024 was $(0.03), compared to $(3.42) in Q3 2023[7] - Total revenues for the three months ended September 30, 2023, were $36,718, and for the nine months ended September 30, 2023, were $159,528[32] - The net loss for the three months ended September 30, 2023, was $(314,282), and for the nine months ended September 30, 2023, was $(323,288)[32] - For the three months ended September 30, 2024, the Company reported a net loss of $2.9 million, with a basic and diluted net loss per share of $(0.03)[109] Expenses and Costs - Total costs and expenses for Q3 2024 were $32,252, a decrease from $263,898 in Q3 2023[7] - Research and development expenses for Q3 2024 were $1,005, down from $1,316 in Q3 2023[7] - Selling, general and administrative expenses for Q3 2024 were $16,726, a decrease from $21,005 in Q3 2023[7] - Amortization expense for the three months ended September 30, 2024, was $6.7 million, compared to $10.2 million for the same period in 2023, a decrease of 34.3%[43] - Selling, general and administrative expenses decreased by $4.3 million from $21.0 million for the three months ended September 30, 2023, to $16.7 million for the same period in 2024[172] - Research and development expenses rose to $2.5 million for the nine months ended September 30, 2024, up from $1.8 million in the same period of 2023, mainly due to ongoing clinical activities for ROLVEDON[200] - Selling, general and administrative expenses decreased to $53.6 million for the nine months ended September 30, 2024, from $54.7 million in the same period of 2023, attributed to lower transaction-related expenses and other cost reductions[201] Cash and Equity - Cash and cash equivalents at the end of the period were $37,981, down from $76,888 at the end of the previous year[14] - The company experienced a net decrease in cash and cash equivalents of $35,460 during the reporting period[14] - Shareholders' equity as of September 30, 2024, was $130,518, down from $192,873 as of September 30, 2023[9] - The company had 95,361 common shares outstanding as of September 30, 2024, an increase from 94,553 shares as of September 30, 2023[9] - The company’s total cash and cash equivalents as of September 30, 2024, amounted to $78.577 million, with $25.792 million classified as Level 1 and $52.785 million as Level 2[115] Acquisitions and Mergers - The acquisition of Spectrum Pharmaceuticals was completed on July 31, 2023, with a total fair value of consideration transferred amounting to $252,873, which includes $216,294 in Assertio shares issued[20][23] - The company completed the acquisition of Spectrum Pharmaceuticals on July 31, 2023, with Spectrum becoming a wholly-owned subsidiary[148] - Acquisition costs related to the Spectrum Merger recognized for the nine months ended September 30, 2023, were $8.5 million, with no costs recognized for the same period in 2024[29] - The contingent value rights (CVRs) associated with the Spectrum acquisition could result in additional payments of up to $44.7 million based on achieving specific sales milestones for the product ROLVEDON[24] - The contingent value rights (CVR) related to the Spectrum Merger could yield up to $0.20 based on future sales milestones of ROLVEDON, with specific targets set at $175 million for 2024 and $225 million for 2025[150] Legal Matters - The company is involved in multiple opioid-related litigations, including over 2,000 cases in the Multi-District Litigation court, with no trial dates set yet[79] - The company intends to vigorously defend itself in the qui tam lawsuit filed against it, which alleges violations of the federal False Claims Act and other laws[83] - The company is currently in negotiations with the DOJ regarding a potential settlement of the qui tam lawsuit, with mediation scheduled for December 2, 2024[85] - Assertio is involved in multiple securities class action lawsuits alleging false or misleading statements regarding the impact of INDOCIN sales and the Spectrum Merger on profitability[93] - The company has been named in several lawsuits across various states, asserting opioid-drug related claims against it[81] - The company has recorded a liability for a settlement agreement in principle regarding California state court lawsuits, which is not expected to materially impact its financial statements[76] Product Sales - ROLVEDON product sales for the three months ended September 30, 2024, were $15,021, compared to $7,132 for the same period in 2023, representing a 110% increase[33] - Total product sales for Q3 2024 were $28.7 million, a decrease of 6.5% from $30.7 million in Q2 2024, and a decrease of 18.2% from $35.1 million in Q3 2023[153] - INDOCIN net product sales for Q3 2024 were $5.7 million, a decrease of 17.4% from $6.9 million in Q2 2024, and a decrease of 68.5% from $17.9 million in Q3 2023[155] - ROLVEDON net product sales increased to $44.6 million for the nine months ended September 30, 2024, from $7.1 million in the same period of 2023, driven by the acquisition of Spectrum and higher volume[189] - Total product sales, net, decreased to $91.3 million for the nine months ended September 30, 2024, from $117.0 million in the same period of 2023, reflecting a shift in product mix and increased sales allowances[196] Future Expectations - The company expects total future amortization expense for its intangible assets to be $92,359, with the highest expected in 2025 at $19,407[44] - The company expects cost of sales as a percentage of sales to be negatively affected due to changes in product volume and mix for the remainder of 2024[167] - The company anticipates ongoing challenges for INDOCIN sales due to increasing competition from generic products[190] - The company expects continued negative impact on average selling prices for ROLVEDON due to higher discounts and rebates for the remainder of 2024[189]