Assertio (ASRT) - 2025 Q2 - Quarterly Results

Executive Summary Assertio reported strong Q2 2025 net product sales and cash growth, narrowing full-year guidance amidst strategic transformation Q2 2025 Performance Overview 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][3] - Cash and investments increased to $98.2 million as of June 30, 2025[1][3][4] - The company is narrowing its full-year guidance for Net Product Sales and Adjusted EBITDA[1][7] Strategic Priorities and Transformation 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] - Steps include streamlining operations, divesting Assertio Therapeutics, and consolidating products from previously acquired subsidiaries to optimize cost structure[2] Financial Highlights (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) 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 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] - 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][5] - Debt as of June 30, 2025, was $40.0 million, consisting of 6.5% convertible notes with no maturities until September 2027[5] Product Sales Performance 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 This section details core product performance, portfolio optimization efforts, cost savings initiatives, and ongoing corporate structure simplification for future growth Core Product Performance 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] - 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] - 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] Portfolio Optimization and Cost Savings 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] - Reduced legal exposure and associated operating expenses by resolving multiple prior legal matters[11] - Continued steps to simplify its corporate structure, resulting in a nimbler organization with lower operating costs[11] Corporate Structure and Future Growth 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] Outlook Update 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 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] Company Information This section provides an overview of Assertio's business, investor contact details, and information regarding the Q2 2025 conference call and webcast About Assertio 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] - The company focuses on marketing differentiated products in oncology, neurology, and pain management[10] Investor Relations Investor inquiries are directed to Matt Kreps, Managing Director at Darrow Associates - Investor contact is Matt Kreps, Managing Director at Darrow Associates[12] Conference Call and Webcast 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][9] - Webcast and replay information is available on Assertio's investor relations website[9] Forward-Looking Statements 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] - 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] - Assertio disclaims any obligation to update forward-looking statements, except as required by law[13] Non-GAAP Financial Measures This section defines non-GAAP financial measures, their purpose in supplementing GAAP results, and details specified items excluded from these calculations Definition and Purpose 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] - 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] - Non-GAAP measures should be considered in addition to, not a substitute for, or superior to, GAAP financial measures[14] Specified Items and Revisions 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] - 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] Condensed Consolidated Financial Statements (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 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 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 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] Non-GAAP Reconciliations 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 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][25] GAAP Net Loss and EPS to Non-GAAP Adjusted Earnings and EPS (Three Months) 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] GAAP Net Loss and EPS to Non-GAAP Adjusted Earnings and EPS (Six Months) 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]