Assertio (ASRT)
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Assertio Presents First-Ever Real-World Study Showing Patient Experience with SYMPAZAN® (clobazam) Oral Film, CIV
Globenewswire· 2025-09-15 13:00
Core Insights - Assertio Holdings, Inc. announced new data from a real-world study of SYMPAZAN (clobazam) Oral Film, highlighting its application in treating patients with Lennox-Gastaut Syndrome (LGS) [1][2][6] - The study provides valuable insights into the demographics, medication use, and comorbidities of patients with epilepsy or LGS using clobazam oral film [3][7] Group 1: Study Findings - The study identified 181 patients with epilepsy, including 29 patients specifically with LGS, using electronic health records from Stanford Health Care between 2015 and 2024 [3][4] - Patients in the LGS subset were younger (average age 13.6 years) compared to the overall epilepsy group (average age 21.1 years) and showed higher rates of switching from clobazam tablets or suspension [7] Group 2: Clinical Implications - The findings support the role of the oral film formulation in treating LGS patients who have difficulty swallowing, providing a practical solution for this patient population [2][6] - The study aims to enhance the medical community's understanding of how to incorporate SYMPAZAN into treatment regimens for LGS patients [2][3] Group 3: Product Information - SYMPAZAN is the only FDA-approved oral film formulation of clobazam for the adjunctive treatment of seizures associated with LGS in patients aged two years and older [10][11] - The oral film is available in 5 mg, 10 mg, and 20 mg dosages, designed to meet the needs of patients who may struggle with traditional tablet forms [10]
Assertio to Present New Data from Real-World Evidence Study of SYMPAZAN® at upcoming 150th Annual Meeting of the American Neurological Association
Globenewswire· 2025-09-10 11:30
Core Points - Assertio Holdings, Inc. will present new data for SYMPAZAN (clobazam) Oral Film at the 150th Annual Meeting of the American Neurological Association (ANA2025) from September 13-16, 2025 [1][2] - The poster presentation will focus on a real-world evidence study of patients with Lennox-Gastaut Syndrome taking clobazam Oral Soluble Film, detailing demographics, medications, and comorbidities [2][9] - SYMPAZAN is the first and only FDA-approved oral film formulation of clobazam for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in patients aged two years and older [6][9] Company Overview - Assertio is a pharmaceutical company with comprehensive commercial capabilities, focusing on differentiated products in oncology, neurology, and pain management [4] - The company aims to address patients' needs through its marketed products [4] Product Information - SYMPAZAN is available in berry flavor and offered in 5 mg, 10 mg, and 20 mg dosages, consistent with other clobazam formulations [6] - The product is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in patients aged two years and older [7] Disease Context - Lennox-Gastaut Syndrome (LGS) is a severe epilepsy syndrome affecting approximately 50,000 people in the United States, typically diagnosed between ages three and five [5] - Managing LGS is challenging due to treatment-resistant seizures and the need for individualized approaches [5]
Assertio to Participate in the HC Wainwright and Lake Street Conferences in September 2025
Globenewswire· 2025-09-03 12:15
Company Overview - Assertio Holdings, Inc. is a pharmaceutical company with comprehensive commercial capabilities, focusing on differentiated products to meet patients' needs [3] - The company's primary areas of focus include oncology, neurology, and pain management [3] Investor Engagement - Assertio management will host investor meetings at the HC Wainwright Conference on September 10, 2025, at the Lotte New York Palace Hotel [1] - The company will also participate in investor meetings at the Lake Street Capital Markets BIG9 Conference on September 11, 2025, at the Yale Club New York City [2]
New Strong Sell Stocks for August 26th
ZACKS· 2025-08-26 11:21
Group 1 - Assertio Holdings, Inc. (ASRT) is a specialty pharmaceutical company with a Zacks Consensus Estimate for its current year earnings revised 22.7% downward over the last 60 days [1] - Black Stone Minerals, L.P. (BSM) owns and manages oil and natural gas mineral interests, with its Zacks Consensus Estimate for current year earnings revised 12.4% downward over the last 60 days [1] - J&J Snack Foods Corp. (JJSF) is a packaged nutritional food and beverages company, and its Zacks Consensus Estimate for current year earnings has been revised 2.4% downward over the last 60 days [2]
Assertio (ASRT) Reports Q2 Loss, Beats Revenue Estimates
ZACKS· 2025-08-11 23:56
Company Performance - Assertio reported a quarterly loss of $0.17 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.10, and compared to a loss of $0.04 per share a year ago, indicating a significant decline in performance [1] - The company posted revenues of $29.22 million for the quarter ended June 2025, surpassing the Zacks Consensus Estimate by 4.55%, but down from $31.13 million in the same quarter last year [2] - Over the last four quarters, Assertio has surpassed consensus EPS estimates only once and has topped consensus revenue estimates two times [2] Stock Movement and Outlook - Assertio shares have declined approximately 16.3% since the beginning of the year, contrasting with the S&P 500's gain of 8.6% [3] - The company's earnings outlook is crucial for investors, as it includes current consensus earnings expectations for upcoming quarters and any recent changes to these expectations [4] - The current consensus EPS estimate for the upcoming quarter is -$0.02 on revenues of $31.2 million, and for the current fiscal year, it is -$0.27 on revenues of $117.81 million [7] Industry Context - The Medical - Drugs industry, to which Assertio belongs, is currently ranked in the top 35% of over 250 Zacks industries, suggesting a favorable environment for stocks in this sector [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5] - The estimate revisions trend for Assertio was mixed ahead of the earnings release, resulting in a Zacks Rank 3 (Hold) for the stock, indicating expected performance in line with the market [6]
Assertio (ASRT) - 2025 Q2 - Earnings Call Transcript
2025-08-11 21:30
Financial Data and Key Metrics Changes - Second quarter net product sales were $28.8 million, down from $30.7 million in the prior year quarter [17] - GAAP net income for the second quarter was $16.4 million compared to a loss of $3.7 million in the prior year [19] - Adjusted EBITDA for the second quarter was $5.6 million, up from $3.1 million in the prior year quarter [20] - Cash, cash equivalents, and short-term investments totaled $98.2 million as of June 30, 2025, an increase from $87.3 million as of March 31, 2025 [20] Business Line Data and Key Metrics Changes - ROLVOIDON sales were $16.1 million, up from $15.1 million in the prior year quarter, driven by higher volume and favorable returns reserve adjustment [17] - SYMPAZAN sales were $3.2 million, up from $2.7 million in the prior year period, reflecting higher volume and favorable payer mix [18] - INDOCIN sales were $3.0 million, down from $6.9 million in the prior year quarter due to expected generic competition [18] Market Data and Key Metrics Changes - Demand for ROLVOIDON and SYMPAZAN remains strong, with a nearly 20% increase in demand from Q1 to Q2 [27] - The company has finalized its third national agreement for ROLVOIDON with a leading national payer, indicating continued momentum in market access strategy [12] Company Strategy and Development Direction - The company is in the transformation phase of its three-part business strategy, focusing on actions intended to catalyze future growth potential [7] - The strategy includes reducing legal exposure, simplifying corporate structure, prioritizing investments in growth assets, and divesting non-core assets [9] - The company aims to pivot towards specialty pharma assets with long-term growth potential [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term business strategy, indicating that the company has reached an inflection point [15] - The updated guidance for net product sales is $108 million to $118 million, and for adjusted EBITDA is $11 million to $19 million [21] Other Important Information - The company has settled multiple legal matters, reducing ongoing operating costs and future uncertainty [10] - The decision to cease commercialization of OTREXUP is expected to free up resources for growth assets and improve profitability [13] Q&A Session Summary Question: Understanding ROLVOIDON sales in the quarter - Management confirmed that the true ROLVOIDON sales, after accounting for reserves, reflect a growth of 10.7% [25] Question: Market opportunities and potential deals - Management stated that they have not missed out on any significant opportunities but are being selective in pursuing deals that fit their model [28][30] Question: Guidance range and impact of generic competition - Management indicated that they will be in a better position to narrow the guidance range in November, with other strategic factors also influencing the range [32][34] Question: Remaining litigation matters - Most litigation matters have been closed, with only some shareholder lawsuits remaining [38] Question: Drivers of ROLVOIDON demand - Expanding the customer base has significantly driven demand growth, with expectations for continued growth into 2026 [39] Question: Cost savings from halting OTREXUP commercialization - Expected cost savings from OTREXUP are in the range of $2 million to $3 million, primarily from reduced marketing and PDUFA fees [45] Question: Same day dosing data impact - Increased interest in same day dosing is noted, with hopes for publication in a peer-reviewed journal this year [50] Question: Future sales levels for SYMPAZAN - Management anticipates that SYMPAZAN net sales could reach between $25 million and $30 million in the next several years [54]
Assertio (ASRT) - 2025 Q2 - Quarterly Report
2025-08-11 20:10
PART I — FINANCIAL INFORMATION [Item 1. Financial Statements (unaudited)](index=2&type=section&id=Item%201.%20Financial%20Statements%20%28unaudited%29) Presents Assertio Holdings, Inc.'s unaudited condensed consolidated financial statements for H1 2025, covering balance sheets, comprehensive loss, equity, cash flows, and notes [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to **$273.8 million** by June 30, 2025, while total liabilities increased, resulting in lower shareholders' equity | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :----------------------------- | :----------------------------- | :----------------------------- | | Cash and cash equivalents | $47,086 | $50,588 | | Total current assets | $210,209 | $202,549 | | Intangible assets, net | $62,006 | $80,471 | | Total assets | $273,780 | $284,732 | | Total current liabilities | $132,529 | $114,688 | | Total liabilities | $180,482 | $163,651 | | Total shareholders' equity | $93,298 | $121,081 | [Condensed Consolidated Statements of Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss) Net loss significantly increased for H1 2025, primarily due to the Assertio Therapeutics divestiture loss and higher intangible asset amortization | Metric (in thousands, except per share data) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total revenues | $29,222 | $31,126 | $55,712 | $63,574 | | Total costs and expenses | $37,257 | $34,743 | $76,977 | $71,528 | | Loss from operations | $(8,035) | $(3,617) | $(21,265) | $(7,954) | | Loss on Assertio Therapeutics divestiture | $(8,174) | — | $(8,174) | — | | Net loss and comprehensive loss | $(16,352) | $(3,674) | $(29,893) | $(8,184) | | Basic and diluted net loss per share | $(0.17) | $(0.04) | $(0.31) | $(0.09) | [Condensed Consolidated Statements of Shareholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Shareholders%27%20Equity) Shareholders' equity decreased significantly to **$93.3 million** by June 30, 2025, primarily due to a **$29.9 million** net loss | Metric (in thousands) | December 31, 2024 | June 30, 2025 | | :-------------------- | :---------------- | :------------ | | Common Stock (Shares) | 95,537 | 96,217 | | Additional Paid-In Capital | $794,196 | $796,306 | | Accumulated Deficit | $(673,124) | $(703,017) | | Total Shareholders' Equity | $121,081 | $93,298 | - Net loss for the six months ended June 30, 2025, was **$(29,893) thousand**, contributing to the decrease in accumulated deficit and total shareholders' equity[14](index=14&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Operating cash flow decreased to **$6.6 million** for H1 2025, while net cash used in investing activities significantly reduced | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash provided by operating activities | $6,553 | $14,895 | | Net cash used in investing activities | $(9,875) | $(43,320) | | Net cash used in financing activities | $(180) | $(281) | | Net decrease in cash and cash equivalents | $(3,502) | $(28,706) | | Cash and cash equivalents at end of period | $47,086 | $44,735 | - The decrease in operating cash flow was primarily due to lower net product sales and higher selling, general and administrative expenses, including increased legal expenses and one-time costs from the Otrexup decommercialization and Therapeutics Transaction[173](index=173&type=chunk) - Investing activities for H1 2025 included an **$8.2 million** outflow from the Assertio Therapeutics divestiture and **$59.3 million** in short-term investment purchases, partially offset by **$57.6 million** from maturities[177](index=177&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Detailed notes explain the company's organization, significant transactions, financial statement components, accounting policies, and estimates [NOTE 1. ORGANIZATION AND BASIS OF PRESENTATION](index=9&type=section&id=NOTE%201.%20ORGANIZATION%20AND%20BASIS%20OF%20PRESENTATION) Assertio Holdings, Inc. is a pharmaceutical company that divested Assertio Therapeutics and ceased Otrexup commercialization, with financials prepared under U.S. GAAP - Assertio Holdings, Inc. is a pharmaceutical company focused on oncology, neurology, and pain management, with products like ROLVEDON, Sympazan, INDOCIN, SPRIX, and CAMBIA[19](index=19&type=chunk)[20](index=20&type=chunk) - The company divested Assertio Therapeutics on **May 9, 2025**, transferring all equity interests to ATIH Industries, LLC, and ceased commercializing Otrexup starting **July 2025**[20](index=20&type=chunk)[24](index=24&type=chunk) - A reverse stock split proposal was approved by shareholders on **May 7, 2025**, allowing the Board to effect a split between **1-for-2** and **1-for-15**, though it has not yet been effected[23](index=23&type=chunk) [NOTE 2. DIVESTITURES AND STRATEGIC TRANSACTIONS](index=9&type=section&id=NOTE%202.%20DIVESTITURES%20AND%20STRATEGIC%20TRANSACTIONS) Assertio divested Assertio Therapeutics for an **$8.2 million** loss and ceased Otrexup commercialization, incurring **$3.8 million** in related expenses - Assertio Therapeutics was divested on **May 9, 2025**, transferring equity interests to ATIH Industries, LLC, resulting in a net loss of **$8.2 million** for the three and six months ended June 30, 2025, and removing Assertio Holdings from opioid-related litigation[24](index=24&type=chunk)[25](index=25&type=chunk)[26](index=26&type=chunk) - The company ceased commercialization of Otrexup in **July 2025**, incurring **$3.8 million** in expenses for the three and six months ended June 30, 2025, mainly from inventory write-offs (**$2.5 million** in Cost of sales) and an accrual for minimum purchase obligations (**$1.3 million** in SG&A)[27](index=27&type=chunk)[28](index=28&type=chunk) [NOTE 3. REVENUE](index=10&type=section&id=NOTE%203.%20REVENUE) Total revenues decreased to **$55.7 million** for H1 2025, mainly due to lower INDOCIN sales, partially offset by ROLVEDON and Sympazan, and a **$5.4 million** returns reserve adjustment | Product Sales, net (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | ROLVEDON | $16,128 | $15,144 | $29,249 | $29,622 | | INDOCIN products | $3,033 | $6,913 | $8,578 | $15,596 | | Sympazan | $3,244 | $2,668 | $5,423 | $5,285 | | SPRIX | $1,976 | $2,147 | $3,565 | $3,584 | | Other products | $4,441 | $3,823 | $8,003 | $8,470 | | Total product sales, net | $28,822 | $30,695 | $54,818 | $62,557 | | Royalty revenue | $400 | $
Assertio (ASRT) - 2025 Q2 - Quarterly Results
2025-08-11 20:08
[Executive Summary](index=1&type=section&id=Executive%20Summary) Assertio reported strong Q2 2025 net product sales and cash growth, narrowing full-year guidance amidst strategic transformation [Q2 2025 Performance Overview](index=1&type=section&id=Q2%202025%20Performance%20Overview) Assertio reported Q2 2025 total net product sales of $28.8 million, with cash and investments increasing to $98.2 million. The company narrowed its full-year guidance, reflecting first-half performance and improved operational efficiencies - Assertio reported Q2 2025 total net product sales of **$28.8 million**[1](index=1&type=chunk)[3](index=3&type=chunk) - Cash and investments increased to **$98.2 million** as of June 30, 2025[1](index=1&type=chunk)[3](index=3&type=chunk)[4](index=4&type=chunk) - The company is narrowing its full-year guidance for Net Product Sales and Adjusted EBITDA[1](index=1&type=chunk)[7](index=7&type=chunk) [Strategic Priorities and Transformation](index=1&type=section&id=Strategic%20Priorities%20and%20Transformation) Assertio is executing 2025 transformation priorities to achieve sustainable near-term growth and long-term value, including operational streamlining, divestment of Assertio Therapeutics, and product consolidation to optimize cost structure - The company is implementing 2025 transformation priorities to create sustainable near-term growth and increased long-term value[2](index=2&type=chunk) - Steps include streamlining operations, divesting Assertio Therapeutics, and consolidating products from previously acquired subsidiaries to optimize cost structure[2](index=2&type=chunk) [Financial Highlights (Unaudited)](index=1&type=section&id=Financial%20Highlights%20(Unaudited)) This section details Q2 2025 GAAP and Non-GAAP financial metrics, balance sheet position, cash flow, and product-specific sales performance [Key Financial Metrics (GAAP & Non-GAAP)](index=1&type=section&id=Key%20Financial%20Metrics%20(GAAP%20%26%20Non-GAAP)) For Q2 2025, Net Product Sales (GAAP) decreased to $28.8 million from $30.7 million YoY. Net Loss (GAAP) widened to $(16.4) million from $(3.7) million. Adjusted EBITDA (Non-GAAP) increased to $5.6 million from $3.1 million Three Months Ended June 30, 2025 vs. 2024 | Metric | June 30, 2025 (in millions) | June 30, 2024 (in millions) | Change (YoY) | | :----------------------------- | :------------ | :------------ | :----------- | | Net Product Sales (GAAP) | $28.8 | $30.7 | (6.19%) | | Net Loss (GAAP) | $(16.4) | $(3.7) | (343.24%) | | Loss Per Share (GAAP) | $(0.17) | $(0.04) | (325.00%) | | Adjusted EBITDA (Non-GAAP) | $5.6 | $3.1 | 80.65% | | Adjusted Earnings Per Share (Non-GAAP) | $0.02 | $0.01 | 100.00% | Six Months Ended June 30, 2025 vs. 2024 | Metric | June 30, 2025 (in millions) | June 30, 2024 (in millions) | Change (YoY) | | :----------------------------- | :------------ | :------------ | :----------- | | Net Product Sales (GAAP) | $54.8 | $62.6 | (12.46%) | | Net Loss (GAAP) | $(29.9) | $(8.2) | (264.63%) | | Loss Per Share (GAAP) | $(0.31) | $(0.09) | (244.44%) | | Adjusted EBITDA (Non-GAAP) | $5.9 | $10.4 | (43.27%) | | Adjusted Earnings Per Share (Non-GAAP) | $(0.03) | $0.05 | (160.00%) | [Balance Sheet and Cash Flow](index=1&type=section&id=Balance%20Sheet%20and%20Cash%20Flow) As of June 30, 2025, cash, cash equivalents, and short-term investments increased to $98.2 million from $87.3 million as of March 31, 2025, driven by Adjusted EBITDA performance and favorable working capital, despite an $8.2 million transfer due to the Assertio Therapeutics divestment. Debt remained at $40.0 million - Cash, cash equivalents, and short-term investments totaled **$98.2 million** as of June 30, 2025, an increase from **$87.3 million** as of March 31, 2025[4](index=4&type=chunk) - The increase in cash was driven by Adjusted EBITDA performance and favorable working capital, partially offset by an **$8.2 million** transfer related to the Assertio Therapeutics divestment[4](index=4&type=chunk)[5](index=5&type=chunk) - Debt as of June 30, 2025, was **$40.0 million**, consisting of 6.5% convertible notes with no maturities until September 2027[5](index=5&type=chunk) [Product Sales Performance](index=1&type=section&id=Product%20Sales%20Performance) Rolvedon net product sales increased to $16.1 million (YoY), driven by higher volume and a favorable adjustment, while Sympazan sales grew to $3.2 million due to increased sales support. Indocin sales decreased to $3.0 million due to generic competition, as expected Q2 2025 Product Net Sales Performance | Product | Q2 2025 Net Sales (in millions) | Q2 2024 Net Sales (in millions) | Change (YoY) | Key Drivers | | :-------- | :---------------- | :---------------- | :----------- | :---------- | | Rolvedon | $16.1 | $15.1 | 6.62% | Higher volume, $5.4 million favorable adjustment to prior period returns reserve, partially offset by lower pricing | | Sympazan | $3.2 | $2.7 | 18.52% | Impact of additional in-person sales support in key markets | | Indocin | $3.0 | $6.9 | (56.52%) | Previously announced generic competition affecting both volume and pricing, in line with expectations | [Operational Highlights and Strategic Execution](index=2&type=section&id=Operational%20Highlights%20and%20Strategic%20Execution) This section details core product performance, portfolio optimization efforts, cost savings initiatives, and ongoing corporate structure simplification for future growth [Core Product Performance](index=2&type=section&id=Core%20Product%20Performance) Rolvedon achieved its highest quarterly unit demand and market share, while Sympazan recorded its third consecutive quarter of new prescription growth, supported by an expanded prescriber base and upcoming presentation of new real-world evidence data - Rolvedon delivered the highest quarterly unit demand and achieved the highest market share to date in its competitive segment[11](index=11&type=chunk) - Sympazan produced its 3rd consecutive quarter of new prescription growth, driven by a substantial increase in the prescriber base during the first half of 2025[11](index=11&type=chunk) - Plans were announced to present a Sympazan abstract at ANA2025 in September, showcasing new real-world evidence data for patients with Lennox-Gastaut Syndrome[11](index=11&type=chunk) [Portfolio Optimization and Cost Savings](index=2&type=section&id=Portfolio%20Optimization%20and%20Cost%20Savings) Assertio ceased commercialization efforts for Otrexup to improve operating expenses and focus on core growth assets. The company also reduced legal exposure by resolving multiple prior legal matters and continued to simplify its corporate structure, leading to lower operating costs - Ceased commercialization efforts for Otrexup to improve operating expenses and focus on core growth assets[11](index=11&type=chunk) - Reduced legal exposure and associated operating expenses by resolving multiple prior legal matters[11](index=11&type=chunk) - Continued steps to simplify its corporate structure, resulting in a nimbler organization with lower operating costs[11](index=11&type=chunk) [Corporate Structure and Future Growth](index=2&type=section&id=Corporate%20Structure%20and%20Future%20Growth) Assertio is actively identifying and executing opportunities to integrate new growth drivers into its commercial platform through acquisitions, licensing, or other transactions, alongside its ongoing corporate simplification efforts - Continued strategic activities to identify and execute opportunities to bring new growth drivers into Assertio's commercial platform through acquisition, licensing or other transactions[11](index=11&type=chunk) [Outlook Update](index=2&type=section&id=Outlook%20Update) This section provides an updated full-year 2025 guidance for Net Product Sales and Adjusted EBITDA, reflecting recent performance and strategic decisions [Full-Year 2025 Guidance](index=2&type=section&id=Full-Year%202025%20Guidance) Assertio narrowed its full-year 2025 guidance for Net Product Sales and Adjusted EBITDA, reflecting strong first-half performance, the decision to cease Otrexup commercialization, and improved operational efficiencies Full-Year 2025 Guidance Update | Metric | Previous Guidance (in millions) | Updated Guidance (in millions) | | :----------------- | :---------------- | :--------------- | | Net Product Sales (GAAP) | $108.0 to $123.0 | $108.0 to $118.0 | | Adjusted EBITDA (Non-GAAP) | $10.0 to $19.0 | $11.0 to $19.0 | - The guidance narrowing reflects first-half performance, the decision to cease commercialization of Otrexup, and improved operational efficiencies[7](index=7&type=chunk) [Company Information](index=2&type=section&id=Company%20Information) This section provides an overview of Assertio's business, investor contact details, and information regarding the Q2 2025 conference call and webcast [About Assertio](index=2&type=section&id=About%20Assertio) Assertio is a pharmaceutical company with comprehensive commercial capabilities, offering differentiated products to address patient needs, primarily in oncology, neurology, and pain management - Assertio is a pharmaceutical company with comprehensive commercial capabilities[10](index=10&type=chunk) - The company focuses on marketing differentiated products in oncology, neurology, and pain management[10](index=10&type=chunk) [Investor Relations](index=3&type=section&id=Investor%20Relations) Investor inquiries are directed to Matt Kreps, Managing Director at Darrow Associates - Investor contact is Matt Kreps, Managing Director at Darrow Associates[12](index=12&type=chunk) [Conference Call and Webcast](index=2&type=section&id=Conference%20Call%20and%20Webcast) Assertio's management hosted a conference call on August 11, 2025, at 4:30 p.m. Eastern Time to discuss Q2 2025 financial results and corporate strategy, with webcast and dial-in details provided - A conference call was hosted on Monday, August 11, 2025, at 4:30 p.m. Eastern Time to discuss Q2 2025 financial results and corporate strategy[8](index=8&type=chunk)[9](index=9&type=chunk) - Webcast and replay information is available on Assertio's investor relations website[9](index=9&type=chunk) [Forward-Looking Statements](index=4&type=section&id=Forward%20Looking%20Statements) This section outlines the inherent risks and uncertainties associated with forward-looking statements, emphasizing that actual results may differ materially due to various factors, including market acceptance of products, generic competition, execution of strategic plans, and regulatory compliance - Forward-looking statements discuss future plans, trends, events, results, or financial condition based on current beliefs and involve risks and uncertainties[13](index=13&type=chunk) - Key risks include the ability to grow sales and commercial success of products (e.g., Rolvedon), impact of generic competition (e.g., Indocin), ability to execute corporate structure simplification and business development, and compliance with legal and regulatory requirements[13](index=13&type=chunk) - Assertio disclaims any obligation to update forward-looking statements, except as required by law[13](index=13&type=chunk) [Non-GAAP Financial Measures](index=5&type=section&id=Non-GAAP%20Financial%20Measures) This section defines non-GAAP financial measures, their purpose in supplementing GAAP results, and details specified items excluded from these calculations [Definition and Purpose](index=5&type=section&id=Definition%20and%20Purpose) Non-GAAP measures are used to supplement GAAP results, offering useful operating metrics for analysts, investors, lenders, and management to assess performance, and are not intended as substitutes for GAAP measures - Non-GAAP measures (EBITDA, Adjusted EBITDA, Adjusted Earnings, Adjusted EPS) supplement GAAP results as useful operating metrics[14](index=14&type=chunk) - These measures provide supplementary information for analysts, investors, lenders, and management to assess performance and are used internally for understanding, managing, and evaluating performance, including bonus determination[14](index=14&type=chunk) - Non-GAAP measures should be considered in addition to, not a substitute for, or superior to, GAAP financial measures[14](index=14&type=chunk) [Specified Items and Revisions](index=5&type=section&id=Specified%20Items%20and%20Revisions) Specified items, considered significant and non-indicative of current operations, are excluded from non-GAAP measures. Beginning Q1 2025, legal settlement costs are also excluded, with prior periods recast for consistency - Specified items, such as adjustments to interest, income tax, depreciation, amortization, sales reserves, stock-based compensation, legal settlements, divestiture losses, restructuring charges, and transaction-related costs, are excluded from non-GAAP measures[15](index=15&type=chunk) - Beginning Q1 2025, legal settlement costs incurred during the period are excluded from Adjusted EBITDA, and prior period amounts have been recast to conform to this presentation[16](index=16&type=chunk) [Condensed Consolidated Financial Statements (Unaudited)](index=6&type=section&id=Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated statements of comprehensive loss, balance sheets, and cash flows for the reported periods [Statements of Comprehensive Loss](index=6&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20COMPREHENSIVE%20LOSS) For Q2 2025, total revenues were $29.2 million, down from $31.1 million YoY. Net loss was $(16.4) million, significantly higher than $(3.7) million in Q2 2024, primarily due to a loss on Assertio Therapeutics divestiture Condensed Consolidated Statements of Comprehensive Loss (Three Months Ended June 30) | Metric (in thousands) | 2025 | 2024 | Change (YoY) | | :-------------------- | :--- | :--- | :----------- | | Product sales, net | $28,822 | $30,695 | (6.10%) | | Royalty revenue | $400 | $431 | (7.19%) | | Total revenues | $29,222 | $31,126 | (6.12%) | | Total costs and expenses | $37,257 | $34,743 | 7.24% | | Loss from operations | $(8,035) | $(3,617) | (122.14%) | | Loss on Assertio Therapeutics divestiture | $(8,174) | $0 | N/A | | Net loss and comprehensive loss | $(16,352) | $(3,674) | (344.99%) | | Basic and diluted net loss per share | $(0.17) | $(0.04) | (325.00%) | Condensed Consolidated Statements of Comprehensive Loss (Six Months Ended June 30) | Metric (in thousands) | 2025 | 2024 | Change (YoY) | | :-------------------- | :--- | :--- | :----------- | | Product sales, net | $54,818 | $62,557 | (12.45%) | | Royalty revenue | $894 | $1,017 | (12.19%) | | Total revenues | $55,712 | $63,574 | (12.37%) | | Total costs and expenses | $76,977 | $71,528 | 7.62% | | Loss from operations | $(21,265) | $(7,954) | (167.35%) | | Loss on Assertio Therapeutics divestiture | $(8,174) | $0 | N/A | | Net loss and comprehensive loss | $(29,893) | $(8,184) | (265.27%) | | Basic and diluted net loss per share | $(0.31) | $(0.09) | (244.44%) | [Balance Sheets](index=7&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) As of June 30, 2025, total assets were $273.8 million, a decrease from $284.7 million at December 31, 2024. Total liabilities increased to $180.5 million from $163.7 million, while total shareholders' equity decreased to $93.3 million from $121.1 million Condensed Consolidated Balance Sheets (as of June 30, 2025 vs. December 31, 2024) | Metric (in thousands) | June 30, 2025 | December 31, 2024 | Change | | :-------------------- | :------------ | :---------------- | :----- | | Cash and cash equivalents | $47,086 | $50,588 | (6.92%) | | Short-term investments | $51,097 | $49,466 | 3.30% | | Total current assets | $210,209 | $202,549 | 3.78% | | Intangible assets, net | $62,006 | $80,471 | (22.94%) | | Total assets | $273,780 | $284,732 | (3.85%) | | Total current liabilities | $132,529 | $114,688 | 15.56% | | Long-term debt | $39,046 | $38,813 | 0.60% | | Total liabilities | $180,482 | $163,651 | 10.29% | | Total shareholders' equity | $93,298 | $121,081 | (22.80%) | [Statements of Cash Flows](index=8&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20CASH%20FLOWS) For the six months ended June 30, 2025, net cash provided by operating activities was $6.6 million, a decrease from $14.9 million YoY. Net cash used in investing activities was $(9.9) million, significantly less than $(43.3) million YoY, primarily due to proceeds from maturities of short-term investments Condensed Consolidated Statements of Cash Flows (Six Months Ended June 30) | Metric (in thousands) | 2025 | 2024 | Change (YoY) | | :-------------------- | :--- | :--- | :----------- | | Net cash provided by operating activities | $6,553 | $14,895 | (55.99%) | | Net cash used in investing activities | $(9,875) | $(43,320) | 77.18% | | Net cash used in financing activities | $(180) | $(281) | 35.94% | | Net decrease in cash and cash equivalents | $(3,502) | $(28,706) | 87.79% | | Cash and cash equivalents at end of period | $47,086 | $44,735 | 5.26% | - The significant decrease in net cash used in investing activities in 2025 was partly due to **$57.6 million** in proceeds from maturities of short-term investments, compared to none in 2024[22](index=22&type=chunk) [Non-GAAP Reconciliations](index=9&type=section&id=Non-GAAP%20Reconciliations) This section provides detailed reconciliations of GAAP net loss and EPS to non-GAAP EBITDA, Adjusted EBITDA, Adjusted Earnings, and Adjusted EPS [GAAP Net Loss to Non-GAAP EBITDA and Adjusted EBITDA](index=9&type=section&id=RECONCILIATION%20OF%20GAAP%20NET%20LOSS%20TO%20NON-GAAP%20EBITDA%20and%20ADJUSTED%20EBITDA) For Q2 2025, GAAP Net Loss was $(16.4) million, leading to an EBITDA of $(6.3) million. After various adjustments, Adjusted EBITDA was $5.6 million, an increase from $3.1 million in Q2 2024 Reconciliation of GAAP Net Loss to Non-GAAP EBITDA and Adjusted EBITDA (Three Months Ended June 30) | Metric (in thousands) | 2025 | 2024 | Change (YoY) | | :-------------------- | :--- | :--- | :----------- | | GAAP Net Loss | $(16,352) | $(3,674) | (344.99%) | | EBITDA (Non-GAAP) | $(6,259) | $3,944 | (258.69%) | | Adjusted EBITDA (Non-GAAP) | $5,605 | $3,050 | 83.77% | Reconciliation of GAAP Net Loss to Non-GAAP EBITDA and Adjusted EBITDA (Six Months Ended June 30) | Metric (in thousands) | 2025 | 2024 | Change (YoY) | | :-------------------- | :--- | :--- | :----------- | | GAAP Net Loss | $(29,893) | $(8,184) | (265.27%) | | EBITDA (Non-GAAP) | $(9,523) | $6,019 | (258.20%) | | Adjusted EBITDA (Non-GAAP) | $5,890 | $10,428 | (43.52%) | - Significant adjustments for Q2 2025 included **$9.2 million** for loss on Assertio Therapeutics divestiture and related charges, and **$3.8 million** for expenses related to decommercialization of Otrexup[23](index=23&type=chunk)[25](index=25&type=chunk) [GAAP Net Loss and EPS to Non-GAAP Adjusted Earnings and EPS (Three Months)](index=10&type=section&id=RECONCILIATION%20OF%20GAAP%20NET%20LOSS%20and%20NET%20LOSS%20PER%20SHARE%20TO%20NON-GAAP%20ADJUSTED%20EARNINGS%20and%20ADJUSTED%20EARNINGS%20PER%20SHARE%20(Three%20Months)) For Q2 2025, GAAP Net Loss was $(16.4) million, resulting in Adjusted Earnings (Non-GAAP) of $1.5 million, or $0.02 per diluted share, an increase from $0.7 million, or $0.01 per diluted share, in Q2 2024 Reconciliation of GAAP Net Loss and EPS to Non-GAAP Adjusted Earnings and EPS (Three Months Ended June 30) | Metric | 2025 Amount (in thousands) | 2025 Diluted EPS | 2024 Amount (in thousands) | 2024 Diluted EPS | | :-------------------------------- | :------------------------- | :--------------- | :------------------------- | :--------------- | | Net loss (GAAP) | $(16,352) | $(0.17) | $(3,674) | $(0.04) | | Adjusted earnings (Non-GAAP) | $1,514 | $0.02 | $659 | $0.01 | - Key adjustments included amortization of intangible assets (**$9.2 million**), loss on Assertio Therapeutics divestiture and related charges (**$9.2 million**), and expenses related to decommercialization of Otrexup (**$3.8 million**)[27](index=27&type=chunk) [GAAP Net Loss and EPS to Non-GAAP Adjusted Earnings and EPS (Six Months)](index=11&type=section&id=RECONCILIATION%20OF%20GAAP%20NET%20LOSS%20and%20NET%20LOSS%20PER%20SHARE%20TO%20NON-GAAP%20ADJUSTED%20EARNINGS%20and%20ADJUSTED%20EARNINGS%20PER%20SHARE%20(Six%20Months)) For the six months ended June 30, 2025, GAAP Net Loss was $(29.9) million, leading to an Adjusted Loss (Non-GAAP) of $(2.4) million, or $(0.03) per diluted share, compared to Adjusted Earnings of $4.3 million, or $0.05 per diluted share, in the prior year Reconciliation of GAAP Net Loss and EPS to Non-GAAP Adjusted Earnings and EPS (Six Months Ended June 30) | Metric | 2025 Amount (in thousands) | 2025 Diluted EPS | 2024 Amount (in thousands) | 2024 Diluted EPS | | :-------------------------------- | :------------------------- | :--------------- | :------------------------- | :--------------- | | Net loss (GAAP) | $(29,893) | $(0.31) | $(8,184) | $(0.09) | | Adjusted (loss) earnings (Non-GAAP) | $(2,441) | $(0.03) | $4,349 | $0.05 | - Key adjustments for the six months included amortization of intangible assets (**$18.5 million**), loss on Assertio Therapeutics divestiture and related charges (**$9.3 million**), and expenses related to decommercialization of Otrexup (**$3.8 million**)[31](index=31&type=chunk)
Assertio Reports Second Quarter 2025 Financial Results
Globenewswire· 2025-08-11 20:05
Core Insights - Assertio Holdings, Inc. reported total net product sales of $28.8 million for the second quarter of 2025, a decrease from $30.7 million in the same period last year [1][3] - The company narrowed its guidance for net product sales and adjusted EBITDA for the full year, reflecting first-half performance and operational efficiencies [9] Financial Performance - Net product sales for the first half of 2025 totaled $54.8 million, down from $62.6 million in the first half of 2024 [3] - The net loss for the second quarter was $16.4 million, compared to a net loss of $3.7 million in the prior year quarter [3][20] - Adjusted EBITDA for the second quarter was $5.6 million, an increase from $3.1 million in the prior year quarter [3][20] Product Performance - Rolvedon achieved net product sales of $16.1 million, up from $15.1 million in the prior year quarter, driven by higher volume and favorable adjustments [6] - Sympazan's net product sales increased to $3.2 million from $2.7 million, attributed to additional sales support [6] - Indocin's net product sales decreased to $3.0 million from $6.9 million due to generic competition [6] Cost Management - Selling, general and administrative (SG&A) expenses decreased to $17.0 million from $18.4 million, aided by a one-time benefit from employee retention tax credits [6] - The company is streamlining operations and consolidating products from acquired subsidiaries to optimize costs [2][14] Balance Sheet and Cash Flow - As of June 30, 2025, cash and investments totaled $98.2 million, up from $87.3 million at the end of the first quarter [5] - The company reported a debt of $40.0 million, consisting of 6.5% convertible notes with no maturities until September 2027 [7] Strategic Initiatives - Assertio has ceased commercialization of Otrexup to focus on core growth assets and improve operating expenses [14] - The company plans to present new data on Sympazan at the American Neurological Association Annual Meeting in September [14]
Assertio Holdings, Inc. to Report Second Quarter 2025 Financial Results on August 11, 2025
GlobeNewswire News Room· 2025-08-05 12:30
Core Viewpoint - Assertio Holdings, Inc. is set to release its second quarter 2025 financial results on August 11, 2025, after market close, followed by a live webcast conference call to discuss the results and strategic plans for 2025 [1]. Group 1 - The financial results announcement is scheduled for August 11, 2025, after market close [1]. - A live webcast conference call will take place at 4:30 p.m. Eastern Time on the same day to discuss the financial results and provide updates on the company's strategic plans for 2025 [1]. - Investors can access the live webcast and related materials through Assertio's investor relations website [2]. Group 2 - Assertio is a pharmaceutical company focused on oncology, neurology, and pain management, offering differentiated products to meet patient needs [4]. - The company emphasizes its comprehensive commercial capabilities in the pharmaceutical sector [4]. Group 3 - A replay of the conference call will be available approximately two hours after the live event on Assertio's investor website [3]. - For those wishing to join by telephone, a specific dial-in number and call ID have been provided [2].