Assertio Reports Fourth Quarter and Full Year 2024 Financial Results

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, Chief Executive Officer, "In line with our strategy for Assertio's long-term growth, 2024 was a year of stabilization as we transitioned to Rolvedon as our primary asset. We enhanced our leadership team and board with additional expertise in legal, commercial, and strategy areas, optimized our cost structure, and strengthened our balance sheet with over $26 million in cash flow generated by the performance of our assets.

"We expect 2025 will be a transformational year focused on initiatives designed to drive revenue growth in Rolvedon and Sympazan by investing to unlock new opportunities, continuing to manage our legal exposure and associated costs, while simplifying our structure.

"We are also actively pursuing our acquisition strategy, seeking to deploy our balance sheet into appropriate commercial assets that fit our model, enhance our scale and better position ourselves for near-term growth. We remain diligent in these efforts with regard to finding the proper fit and pricing of assets that can deliver results within our targeted metrics as we work to build on the commercial platform at Assertio.”

Financial Highlights (unaudited):

Fourth quarter results included the following highlights (our discussion below focuses on a comparison of fourth quarter 2024 to third quarter 2024 given the acquisition of Spectrum and the generic competition of Indocin introduced in 2023):

• Net product sales were $29.6 million in the fourth quarter, increased from $28.7 million in the third quarter. 
  • Rolvedon net product sales were $15.4 million in the fourth quarter, a $0.4 million increase from the prior quarter, driven by higher volume, partially offset by changes in pricing.
  • Indocin net product sales in the fourth quarter were $5.5 million, compared to $5.7 million in the prior quarter, reflecting pricing changes following a generic entrant late in 2023.
• Gross margin² was 61% in the fourth quarter, compared to 74% in the third quarter, reflecting the impact of $2.9 million in higher inventory write downs, primarily for Indocin. Excluding these charges, gross margin was 71%, with the change driven by product mix. 
• SG&A expense in the fourth quarter was $21.4 million, compared to $16.7 million in the third quarter, primarily reflecting a net $5.4 million increase in litigation contingencies, which was partially offset by lower general operating expenses.
• Adjusted EBITDA³ loss was $0.5 million, compared to adjusted EBITDA of $5.3 million in the prior quarter, primarily due to the effect of inventory write downs and litigation contingency charges noted above.
• Fourth quarter 2024 included a charge of $5.2 million for loss on impairment of Otrexup intangible assets.

Balance Sheet and Cash Flows

• Assertio generated $11.5 million in cash flow from operations in the fourth quarter, and $26.4 million in cash flow from operations for the full year 2024.
• At December 31, 2024, cash, cash equivalents and short-term investments totaled $100.1 million.
• Debt at December 31, 2024 was $40.0 million, comprised of the Company's 6.5% convertible notes, with no maturities until September 2027.

2025 Full Year Financial Guidance

Assertio announced its initial 2025 operating guidance as follows:

Conference Call and Investor Presentation Information

Assertio's management will host a conference call to discuss its fourth quarter and full year 2024 financial results today:

To access the live webcast, the recorded conference call replay, and other materials, please visit Assertio's investor relations website at http://investor.assertiotx.com/overview/default.aspx. Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. The replay will be available approximately two hours after the call on Assertio's investor website.

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¹ Non-GAAP measures are reconciled to the corresponding GAAP measures in the schedules attached.

² Gross margin represents the ratio of net product sales less cost of sales to net product sales.

³ See "Non-GAAP Financial Measures” below for information about reconciling our Adjusted EBITDA to Net Loss.

About Assertio

Assertio is a pharmaceutical company with comprehensive commercial capabilities offering differentiated products designed to address patients' needs. Our focus is on supporting patients by marketing products in oncology, neurology, and pain management. To learn more about Assertio, visit www.assertiotx.com.

Investor Contact

Matt Kreps, Managing Director

Darrow Associates

M: 214-597-8200

[email protected]

Forward Looking Statements

The statements in this communication include forward-looking statements. Forward-looking statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs. Forward-looking statements speak only as of the date they are made or as of the dates indicated in the statements and should not be relied upon as predictions of future events, as there can be no assurance that the events or circumstances reflected in these statements will be achieved or will occur. Forward-looking statements can often, but not always, be identified by the use of forward-looking terminology such as "anticipate,” "approximate”, "believe,” "could,” "estimate,” "expect,” "goal,” "intend,” "may,” "might,” "opportunity,” "plan,” "potential,” "project,” "prospective,” "pursue,” "seek,” "should,” "strategy,” "target,” "will,” or the negative of these words and phrases, other variations of these words and phrases or comparable terminology. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the statements, including: Assertio's ability to grow sales and the commercial success and market acceptance of Rolvedon and Assertio's other products, including the coverage of our products by payors and pharmacy benefit managers; Assertio's ability to successfully develop and execute its sales, marketing and promotion strategies using its sales force and omni-channel promotion model capabilities; the impact on sales and profits from the entry and sales of generics of Assertio's products and/or other products competitive with any of Assertio's products, including biosimilars and indomethacin suppositories compounded by hospitals and other institutions including a 503B compounder which we believe is violating certain provisions of the Federal Food, Drug and Cosmetic Act; the timing and impact of additional generic approvals and uncertainty around the recent approvals and launches of generic Indocin products, which are not patent protected and now face generic competition; Assertio's ability to successfully identify and execute business development and other strategic transactions; risks that any new businesses will not be integrated successfully or that the combined company will not realize estimated cost savings, value of certain tax assets, synergies and growth, or that such benefits may take longer and/or cost more to realize than expected; expectations regarding changes in product volume and mix and the impact those changes may have on Assertio's operating results; expectations regarding the recovery of long-lived assets; expected industry trends, including pricing pressures and managed healthcare practices; Assertio's ability to attract and retain executive leadership and key employees; the ability of Assertio's third-party manufacturers to manufacture adequate quantities of commercially salable inventory and active pharmaceutical ingredients for each of Assertio's products on commercially reasonable terms and in compliance with their contractual obligations to Assertio, and Assertio's ability to maintain its supply chain which relies on single-source suppliers; the outcome of, and Assertio's intentions with respect to, any litigation or government investigations, including pending and potential future shareholder litigation relating to the Spectrum Merger and/or the recent approval and launch of generic indomethacin suppositories, opioid-related government investigations and opioid-related litigation, Spectrum's legacy shareholder and other litigation, and other disputes and litigation, including Assertio's antitrust and unsealed qui tam litigation for which settlements in principle were reached in the third and fourth quarters, respectively, of 2024, as well as the costs and expenses associated therewith; Assertio's financial cost and results of its clinical studies and other research and development efforts, including the extent to which data from the Rolvedon same-day dosing trial, which was completed in the fourth quarter of 2024, may support ongoing commercialization efforts; Assertio's compliance or non-compliance with, or being subject to, legal and regulatory requirements related to the development or promotion of pharmaceutical products in the United States; the extent to which the current U.S. federal administration may impose or seek to impose leadership, rule and/or policy changes impacting Assertio's business, as well as legal challenges and uncertainty around the funding, functioning, regulatory and policy priorities of U.S. federal regulatory agencies; variations in revenues obtained from commercialization agreements and the accounting treatment with respect thereto; Assertio's common stock regaining and maintaining compliance with The Nasdaq Capital Market's minimum closing bid requirement of at least $1.00 per share, in light of the deficiency notification received on January 22, 2025; Assertio's ability to obtain and maintain intellectual property protection for its products and operate its business without infringing the intellectual property rights of others; and the impacts of potential changes to existing trade agreements and new tariffs, including tariffs on imported pharmaceuticals into the U.S. For a discussion of additional factors that could cause actual results to differ materially from those contemplated by forward-looking statements, see the risks described in Assertio's Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Many of these risks and uncertainties may be exacerbated by public health emergencies and general macroeconomic conditions. Assertio does not assume, and hereby disclaims, any obligation to update forward-looking statements, except as may be required by law.

Non-GAAP Financial Measures

To supplement the Company's financial results presented on a U.S. generally accepted accounting principles ("GAAP”) basis, the Company has included information about non-GAAP measures of EBITDA, adjusted EBITDA, adjusted earnings, and adjusted earnings per share as useful operating metrics. The Company believes that the presentation of these non-GAAP financial measures, when viewed with results under GAAP and the accompanying reconciliation, provides supplementary information to analysts, investors, lenders, and the Company's management in assessing the Company's performance and results from period to period. The Company uses these non-GAAP measures internally to understand, manage and evaluate the Company's performance, and in part, in the determination of bonuses for executive officers and employees. These non-GAAP financial measures should be considered in addition to, and not a substitute for, or superior to, net income or other financial measures calculated in accordance with GAAP. Non-GAAP financial measures used by us may be calculated differently from, and therefore may not be comparable to, non-GAAP measures used by other companies.

This release also includes estimated full-year non-GAAP adjusted EBITDA information, which the Company believes enables investors to better understand the anticipated performance of the business, but should be considered a supplement to, and not as a substitute for or superior to, financial measures calculated in accordance with GAAP. No reconciliation of estimated non-GAAP adjusted EBITDA to estimated net income is provided in this release because some of the information necessary for estimated net income such as income taxes, fair value change in contingent consideration, and stock-based compensation is not yet ascertainable or accessible and the Company is unable to quantify these amounts that would be required to be included in estimated net income without unreasonable efforts.

Specified Items

Non-GAAP measures presented within this release exclude specified items. The Company considers specified items to be significant income/expense items not indicative of current operations. Specified items may include adjustments to interest expense and interest income, income tax expense (benefit), depreciation expense, amortization expense, sales reserves adjustments for products the Company is no longer selling, stock-based compensation expense, fair value adjustments to contingent consideration or derivative liability, restructuring charges, amortization of fair value inventory step-up as a result of purchase accounting, transaction-related costs, gains, losses or impairments from adjustments to long-lived assets and assets not part of current operations, changes in valuation allowances on deferred tax assets, and gains or losses resulting from debt refinancing or extinguishment.