Assertio (ASRT)
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Spectrum Pharmaceuticals (SPPI) and Assertio Holdings (ASRT) Investor Alert: FINAL DEADLINE in Securities Lawsuit– Hagens Berman
Globenewswire· 2025-09-23 20:37
Core Points - A New York federal court has re-opened the lead plaintiff process in the Spectrum Pharmaceuticals (SPPI) securities class action, allowing new investors to apply by September 24, 2025 [1][2] - The class period for the lawsuit is from March 17, 2022, to September 22, 2022, and the case has survived a motion to dismiss [3][4] - The lawsuit alleges that Spectrum misled investors about the success of its cancer treatment drug, poziotinib, leading to a share price drop of over 37% when FDA concerns were revealed [3][4] Company Background - The federal class action, Christiansen v. Spectrum Pharmaceuticals, Inc., has been ongoing since late 2022, focusing on alleged misrepresentations regarding the efficacy of poziotinib [3][4] - Assertio Holdings (ASRT) acquired Spectrum Pharmaceuticals in July 2023, allowing investors who received ASRT shares post-acquisition to potentially represent the class [5] Legal Proceedings - The proceedings were previously stayed due to allegations of misconduct by the court-appointed lead plaintiff, which resulted in his disqualification [4] - Hagens Berman is actively encouraging investors who suffered significant losses to consider becoming the new lead plaintiff, emphasizing the importance of this role in overseeing litigation [6]
Spectrum Pharmaceuticals (SPPI) and Assertio Holdings (ASRT) Investor Alert: 3-DAY DEADLINE in Securities Lawsuit– Hagens Berman
Globenewswire· 2025-09-21 15:23
Core Viewpoint - A New York federal court has reopened the lead plaintiff process in the Spectrum Pharmaceuticals (SPPI) securities class action, allowing new investors to represent the class after the previous lead plaintiff was disqualified [1][4]. Group 1: Class Action Details - Investors who purchased Spectrum (SPPI) common shares during the Class Period (Mar. 17, 2022 – Sept. 22, 2022) and those who received shares of Assertio Holdings (ASRT) due to Assertio's acquisition of Spectrum may be eligible to represent the class [2][5]. - The federal class action, Christiansen v. Spectrum Pharmaceuticals, Inc., alleges that Spectrum misled investors about the success of its cancer treatment drug, poziotinib, leading to a share price drop of over 37% when FDA concerns were revealed [3][4]. Group 2: Legal Proceedings - The case has survived a motion to dismiss, and plaintiffs had moved for class certification, but proceedings were stayed due to allegations of misconduct by the court-appointed lead plaintiff [4]. - The new deadline for applying to be the lead plaintiff is September 24, 2025 [3]. Group 3: Hagens Berman's Role - Hagens Berman is actively investigating claims related to the case and encourages investors who suffered significant losses to consider becoming the new lead plaintiff [6]. - The firm has a history of representing investors and has secured over $2.9 billion in similar cases [7].
Spectrum Pharmaceuticals (SPPI) and Assertio Holdings (ASRT) Investor Alert: 6-DAY DEADLINE in Securities Lawsuit – Hagens Berman
Globenewswire· 2025-09-19 13:50
Group 1 - A New York federal court has re-opened the lead plaintiff process in the Spectrum Pharmaceuticals (SPPI) securities class action, allowing new investors to apply by September 24, 2025 [1][2] - The class period for the lawsuit is from March 17, 2022, to September 22, 2022, and the case has survived a motion to dismiss [3][4] - The lawsuit alleges that Spectrum misled investors about the success of its cancer treatment drug, poziotinib, leading to a share price drop of over 37% when FDA concerns were revealed [3][4] Group 2 - Assertio Holdings (ASRT) acquired Spectrum Pharmaceuticals in July 2023, allowing investors who received ASRT shares after acquiring SPPI shares during the class period to potentially represent the class [5] - Hagens Berman is encouraging investors who suffered significant losses to consider becoming the new lead plaintiff, emphasizing the importance of this role in overseeing litigation [6]
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 | $