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What changed in Assertio Holdings, Inc.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of Assertio Holdings, Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+398 added−413 removedSource: 10-K (2026-03-16) vs 10-K (2025-03-12)

Top changes in Assertio Holdings, Inc.'s 2025 10-K

398 paragraphs added · 413 removed · 278 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

71 edited+30 added−25 removed102 unchanged
Biggest changeConsolidated Revenue Accounts Receivable related to product shipments For the years ended December 31, As of December 31, 2024 2023 2024 2023 Cencora (formerly AmerisourceBergen Corporation) 40 % 35 % 33 % 57 % McKesson Corporation 30 % 21 % 42 % 12 % Cardinal Health 8 % 18 % 6 % 14 % Other significant customer 7 % 10 % 13 % 10 % All others 15 % 16 % 6 % 7 % Total 100 % 100 % 100 % 100 % The changes in the percentage of consolidated revenue by customer and the percentage of accounts receivable related to product shipments by customer for the years ended December 31, 2024 and December 31, 2023 were primarily driven by the impact of change in product mix, including the addition of ROLVEDON as a result of the acquisition of Spectrum on July 31, 2023, which resulted in a full year of ROLVEDON net product sales being included in the year ended December 31, 2024, compared to five months of net product sales included in the year ended December 31, 2023, and the decrease in INDOCIN net product sales due to generic launches.
Biggest changeConsolidated revenue Accounts receivable related to product sales Year ended December 31, As of December 31, 2025 2024 2025 2024 Cencora 45 % 40 % 44 % 33 % McKesson Corporation 31 % 30 % 39 % 42 % Cardinal Health 10 % 8 % 10 % 6 % All others 14 % 22 % 7 % 19 % Total 100 % 100 % 100 % 100 % The changes in the percentage of consolidated revenue by customer and the percentage of accounts receivable related to product sales by customer for the years ended December 31, 2025 and December 31, 2024 were primarily driven by the higher sales of ROLVEDON during 2025, including the sales made in the third quarter of 2025 noted above, and the continued shift in product mix towards ROLVEDON from our other products.
“physicians” (defined to include doctors, dentists, optometrists, podiatrists and chiropractors); certain other “healthcare providers” (including physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, certified nurse-midwives); and “teaching hospitals.” The Open Payments program also requires that manufacturers and applicable group purchasing organizations report annually to HHS ownership and investment interests held in them by physicians (as defined above) and their immediate family members.
“physicians” (defined to include doctors, dentists, optometrists, podiatrists and chiropractors); certain other “healthcare providers” (including physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, and certified nurse-midwives); and “teaching hospitals.” The Open Payments program also requires that manufacturers and applicable group purchasing organizations report annually to HHS ownership and investment interests held in them by physicians (as defined above) and their immediate family members.
Hatch-Waxman Act The Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”) establishes two abbreviated approval pathways for pharmaceutical products that are in some way follow-on or bioequivalent versions of drugs approved through the NDA process, including (i) the filing of an ANDA, and (ii) obtaining FDA approval under Section 505(b)(2).
Hatch-Waxman Act The Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”) establishes two abbreviated approval pathways for pharmaceutical products that are in some way follow-on or bioequivalent versions of drugs 12 approved through the NDA process, including (i) the filing of an ANDA, and (ii) obtaining FDA approval under Section 505(b)(2).
Additionally, the federal Open Payments program, created under Section 6002 of the Affordable Care Act and its implementing regulations, requires that manufacturers of prescription drugs for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) report annually to HHS information related to “payments or other transfers of value” provided to U.S.
Additionally, the federal Open Payments program, created under Section 6002 of the Affordable Care Act and its implementing regulations, requires that manufacturers of prescription drugs for which payment is available under Medicare, 16 Medicaid or the Children’s Health Insurance Program (with certain exceptions) report annually to HHS information related to “payments or other transfers of value” provided to U.S.
Department of Veterans Affairs’ Federal 15 Supply Schedule Program, and (iv) the Health Resources and Services Administration’s 340B Drug Pricing Program. These rebates are subject to our active participation in the respective programs. We must also report specific prices to government agencies under healthcare programs, such as the Medicaid Drug Rebate Program and Medicare Part B Program.
Department of Veterans Affairs’ Federal Supply Schedule Program, and (iv) the Health Resources and Services Administration’s 340B Drug Pricing Program. These rebates are subject to our active participation in the respective programs. We must also report specific prices to government agencies under healthcare programs, such as the Medicaid Drug Rebate Program and Medicare Part B Program.
Although there are several statutory exceptions and regulatory safe harbors protecting 16 certain business arrangements from prosecution, the exceptions and safe harbors are drawn narrowly and practices that involve remuneration intended to induce referrals, prescribing, purchasing, or recommending covered products may be subject to scrutiny if they do not qualify for an exception or safe harbor.
Although there are several statutory exceptions and regulatory safe harbors protecting certain business arrangements from prosecution, the exceptions and safe harbors are drawn narrowly and practices that involve remuneration intended to induce referrals, prescribing, purchasing, or recommending covered products may be subject to scrutiny if they do not qualify for an exception or safe harbor.
HITECH also increased the civil and criminal penalties that may be imposed against covered entities, business associates, and possibly other persons, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorney’s fees and costs associated with pursuing federal civil actions.
HITECH also increased the civil and criminal penalties that may be imposed against covered 17 entities, business associates, and possibly other persons, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorney’s fees and costs associated with pursuing federal civil actions.
Risk Factors” in this Annual Report on Form 10-K that we believe are material to our investors and a reader should carefully consider them. Those risks are not all of the risks we face and other factors not presently known to us or that we currently believe are immaterial may also affect our business if they occur.
Risk Factors” in this Annual Report on Form 10-K that we believe are material to our investors and a reader should carefully consider them. Those risks are not all the risks we face and other factors not presently known to us or that we currently believe are immaterial may also affect our business if they occur.
For example, if an NDA is submitted for a product candidate that is not an NCE, but that seeks approval for a new indication, and clinical data were required to demonstrate the safety or effectiveness of the product candidate for that new application, the FDA could not approve an ANDA or 505(b)(2) application for another product candidate with that active moiety for that use.
For example, if an NDA is submitted for a product candidate that is not an NCE, but that seeks approval for a new indication, and clinical data were required to demonstrate the 13 safety or effectiveness of the product candidate for that new application, the FDA could not approve an ANDA or 505(b)(2) application for another product candidate with that active moiety for that use.
We make available, free of charge through our website, our Annual Reports on Form 10‑K, Quarterly Reports on Form 10‑Q, Current Reports on Form 8‑K, and other periodic Securities and Exchange Commission (“SEC”) reports, along with amendments to all of those reports, as soon as reasonably practicable after we file the reports with the SEC.
We make available, free of charge through our website, our Annual Reports on Form 10‑K, Quarterly Reports on Form 10‑Q, Current Reports on Form 8‑K, and other periodic Securities and Exchange Commission (“SEC”) reports, along with amendments to those reports, as soon as reasonably practicable after we file the reports with the SEC.
Also, third‑party payors continue to control costs by limiting coverage through the use of formularies and other cost‑containment mechanisms, and the amount of reimbursement for particular procedures or drug treatments. The cost of pharmaceutical products continues to generate substantial governmental and third‑party payor interest.
Also, third‑party payors continue to control costs by limiting coverage through the use of formularies and other cost‑containment mechanisms, and the amount of reimbursement for particular procedures or drug treatments. 14 The cost of pharmaceutical products continues to generate substantial governmental and third‑party payor interest.
Certain parties who have entered into settlement agreements with us began to market generic versions of CAMBIA in January 2023. Government Regulation FDA Approval Process In the U.S., pharmaceutical and biological products are subject to extensive regulation by the FDA.
Certain parties who have entered into settlement agreements with us began to market generic versions of CAMBIA starting in January 2023. Government Regulation FDA Approval Process In the U.S., pharmaceutical and biological products are subject to extensive regulation by the FDA.
Complexities associated with the larger, and 14 often more complex, structures of biological products, as well as the processes by which such products are manufactured, pose significant hurdles to implementation of the abbreviated approval pathway that are still being addressed by the FDA.
Complexities associated with the larger, and often more complex, structures of biological products, as well as the processes by which such products are manufactured, pose significant hurdles to implementation of the abbreviated approval pathway that are still being addressed by the FDA.
Even for products that have been approved, the FDA may still limit the 12 approved indications for use of the product, require that contraindications, warnings or precautions be included in the product labeling, require that post-marketing safety Phase 4 clinical studies be conducted, require surveillance programs to monitor the product after commercialization, or impose other conditions, including distribution and use restrictions or other risk management mechanisms under a Risk Evaluation and Mitigation Strategy (“REMS”), which can materially affect the potential market and profitability of the product.
Even for products that have been approved, the FDA may still limit the approved indications for use of the product, require that contraindications, warnings or precautions be included in the product labeling, require that post-marketing safety Phase 4 clinical studies be conducted, require surveillance programs to monitor the product after commercialization, or impose other conditions, including distribution and use restrictions or other risk management mechanisms under a Risk Evaluation and Mitigation Strategy, which can materially affect the potential market and profitability of the product.
Our sales have been, and will continue to be, impacted by the loss of demand for our products, the lowering of our prices to retain market share for our products, and changes in customer mix (wholesalers, clinics, hospitals).
Our sales have been, and will continue 10 to be, impacted by the loss of demand for our products, the lowering of our prices to retain market share for our products, and changes in customer mix (wholesalers, clinics, hospitals).
Drugs approved under 13 an ANDA are commonly referred to as “generic equivalents” to the listed drug and often can or are required to be substituted by pharmacists fulfilling prescriptions written for the original listed drug.
Drugs approved under an ANDA are commonly referred to as “generic equivalents” to the listed drug and often can or are required to be substituted by pharmacists fulfilling prescriptions written for the original listed drug.
Satisfaction of FDA pre-market approval requirements typically takes many years and the actual time required may vary substantially based upon the type, complexity, and novelty of the product or disease.
Satisfaction of FDA pre-market approval requirements 11 typically takes many years and the actual time required may vary substantially based upon the type, complexity, and novelty of the product or disease.
ROLVEDON is the first, long-acting myeloid growth factor that has a unique molecular structure that combines a granulocyte colony-stimulating factor (“G-CSF") analog with a Fc fragment of human immunoglobulin G4 (IgG4). ROLVEDON is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients receiving anti-cancer drugs.
ROLVEDON is the first, long-acting myeloid growth factor that has a unique molecular structure that combines a granulocyte colony-stimulating factor (“G-CSF") analog with an Fc fragment of human immunoglobulin G4. ROLVEDON is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients receiving anti-cancer drugs.
In addition, there is one new molecular entity that has been approved by the FDA but is not currently marketed that may compete with ROLVEDON.
In addition, there is one molecular entity that has been approved by the FDA but is not currently marketed that may compete with ROLVEDON.
Upon approval of a drug, each of the listed patents covering the approved drug is then published in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the “Orange Book”. Drugs listed in the Orange Book can, in turn, be cited by potential generic competitors in support of approval of an ANDA.
Upon approval of a drug, each of the listed patents covering the approved drug is then published in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the “Orange Book.” Drugs listed in the Orange Book can, in turn, be cited by potential generic competitors in support of approval of an ANDA.
Risks Related to Future Product Development • Future product candidates may not be approved for marketing or, if approved, may not achieve market acceptance. • We customarily depend on third-party contract research organizations, clinical investigators and clinical sites to conduct clinical trials with regard to product candidates, and we may not obtain necessary regulatory approvals. • We are subject to risks associated with New Drug Applications we submit under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act. 20 Risks Related to Share Ownership • Our common stock may be delisted from The Nasdaq Capital Market if we are unable to regain and maintain compliance with its continued listing standards. • The market price of our common stock historically has been volatile. • We are subject to risks from future proxy fights or the actions of activist shareholders. • We are subject to risks related to unsolicited takeover attempts in the future. • Conversions of the 2027 Convertible Notes or future sales of our common stock could adversely impact the prices of the 2027 Convertible Notes and common stock.
Risks Related to Future Product Development • Future product candidates may not be approved for marketing or, if approved, may not achieve market acceptance. • We customarily depend on third-party contract research organizations, clinical investigators and clinical sites to conduct clinical trials with regard to product candidates, and we may not obtain necessary regulatory approvals. • We are subject to risks associated with New Drug Applications we submit under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act. 19 Risks Related to Share Ownership • Our common stock may be delisted from The Nasdaq Capital Market if we are unable to maintain compliance with its continued listing standards. • The market price of our common stock historically has been volatile. • We are subject to risks from proxy contests or the actions of activist shareholders. • We are subject to risks related to unsolicited takeover attempts in the future. • Conversions of the 2027 Convertible Notes or future sales of our common stock could adversely impact the prices of the 2027 Convertible Notes and common stock.
ROLVEDON is a novel long-acting G-CSF that employs a proprietary technology that is designed to prolong the duration of biologics, reducing the frequency of administration. Currently, one other novel long-acting G-CSF and six biosimilar G-CSFs marketed in the U.S. compete with ROLVEDON.
ROLVEDON is a novel long-acting G-CSF that employs a proprietary technology that is designed to prolong the duration of biologics, reducing the frequency of administration. Currently, two other novel long-acting G-CSF and six biosimilar G-CSFs marketed in the U.S. compete with ROLVEDON.
We have manufacturing, packaging, and supply agreements with sole commercial suppliers for each of our marketed products and we seek to mitigate potential supply risks for all of our marketed products through inventory management and through exploring additional manufacturers to provide our marketed products.
We have manufacturing, packaging, and supply agreements with sole commercial suppliers for each of our marketed products and we seek to mitigate potential supply risks for all our marketed products through inventory management and through identifying potential additional manufacturers to provide our marketed products.
Risks Related to Commercial Matters • We may not be able to maintain attractive reimbursement of ROLVEDON through government programs such as Medicare and Medicaid. • We may not be successful in driving the growth in sales and profitability of ROLVEDON. • We depend on one qualified supplier for the active pharmaceutical ingredient in each of our products and single source suppliers to manufacture our products. • Competition from generics has adversely affected and could continue to have further adverse effects on our business. • Failure to successfully commercialize our other products. • Commercial disputes may adversely affect the commercial success of our products. • We may be unable to compete successfully in the pharmaceutical and biological product industry. • We may be unable to negotiate acceptable pricing or obtain adequate reimbursement for our products. • We may be impacted by our customer concentration.
Risks Related to Commercial Matters • We may not be able to maintain attractive reimbursement of ROLVEDON through government programs such as Medicare and Medicaid. • We may not be successful in driving the growth in sales and profitability of ROLVEDON. • Failure to successfully commercialize our products could adversely impact our business, financial condition and results of operations. • We depend on one qualified supplier for the active pharmaceutical ingredient in each of our products and single source suppliers to manufacture our products. • Competition from generics has adversely affected and could continue to have further adverse effects on our business. • Commercial disputes may adversely affect the commercial success of our products. • We may be unable to compete successfully in the pharmaceutical and biological product industry. • We may be unable to negotiate acceptable pricing or obtain adequate reimbursement for our products. • We may be impacted by our customer concentration.
Currently, all of our products are approved to be marketed in the U.S.
Currently, all our products are approved to be marketed in the U.S.
Three large, national wholesale distributors represent the majority of our revenues from net product sales. The following table reflects the percentage of consolidated revenue by customer and the percentage of accounts receivable by customer related to product shipments for the years ended December 31, 2024 and 2023.
Three large, national wholesale distributors represent the majority of our revenues from net product sales. The following table reflects the percentage of consolidated revenue and accounts receivable by customer related to product sales for the years ended December 31, 2025 and 2024.
Risks Related to our Corporate Organization and General Business Risks • Our success is dependent in large part upon continued services of our executive management team. • Our corporate structure may not prevent veil piercing. • We may be unable to satisfy regulatory requirements relating to internal controls. • Business interruptions can adversely impact our ability to operate our business. • Data breaches and cyber-attacks can adversely impact our ability to operate our business. • Macroeconomic conditions can impact our business and operations. • The use of new and evolving technologies may pose security and other risks to our sensitive data, and we may be exposed to reputational harm, other adverse consequences, and liability.
Risks Related to our Corporate Organization and General Business Risks • Our success is dependent in large part upon continued services of our executive management team. • Our corporate structure may not prevent veil piercing or other similar claims. • We may be unable to satisfy regulatory requirements relating to internal controls. • Business interruptions can adversely impact our ability to operate our business. • Data breaches and cyber-attacks can adversely impact our ability to operate our business. • The use of new and evolving technologies may pose security and other risks to our sensitive data, and we may be exposed to reputational harm, other adverse consequences, and liability.
Website references are provided throughout this document for convenience. The content on the referenced websites does not constitute a part of and is not incorporated by reference into this Annual Report on Form 10-K. 19 RISK FACTOR SUMMARY The following is a summary of the risks more fully described in “Item 1A.
Website references are provided throughout this document for convenience. The content on the referenced websites does not constitute a part of and is not incorporated by reference into this Annual Report on Form 10-K. 18 RISK FACTOR SUMMARY The following is a summary of the risks more fully described in “ Item 1A .
Sympazan® (clobazam) oral film A benzodiazepine indicated for the adjunctive treatment of seizures associated with LGS in patients aged two years of age or older. Sympazan is the only product to offer clobazam in a convenient film with PharmFilm technology. Sympazan is taken without water or liquid, adheres to the tongue, and dissolves to deliver clobazam.
Sympazan® (clobazam) oral film A benzodiazepine indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (“LGS”) in patients aged two years of age or older. Sympazan is the only product to offer clobazam in a convenient film with PharmFilm® technology. Sympazan is taken without water or liquid, adheres to the tongue, and dissolves to deliver clobazam.
However, in 2024 the manufacturers of certain of our marketed products produced batches of our products that did not meet our quality standards, leading to the loss of salable product, which unfavorably impacted our cost of sales in 2024 due to inventory write-downs.
However, in 2024 and 2025, the manufacturers of certain of our marketed products produced batches of our products that did not meet our quality standards, leading to the loss of salable product, which unfavorably impacted our cost of sales in both years due to inventory write-downs.
An NDA approved under Section 505(b)(2) may in turn serve as an RLD for subsequent applications from other sponsors. The Hatch-Waxman Act provides periods of regulatory exclusivity for products that would serve as reference-listed drugs (“RLDs”) for products that are subject of an ANDA or 505(b)(2) application.
An NDA approved under Section 505(b)(2) may in turn serve as an RLD for subsequent applications from other sponsors. The Hatch-Waxman Act provides periods of regulatory exclusivity for products that would serve as RLDs for products that are subject of an ANDA or 505(b)(2) application.
Manufacturing Requirements We, our suppliers, contract manufacturers, and other entities involved in the manufacturing and distribution of approved drugs and biological products are required to comply with certain post-approval requirements and are subject to periodic unannounced inspections by the United States Food and Drug Administration (the “FDA”) and state agencies to assess compliance with current Good Manufacturing Practice (“cGMP”) requirements.
CAMBIA us es diclofenac potassium as the API, which we source from suppliers in Italy. 9 Manufacturing Requirements We, our suppliers, contract manufacturers, and other entities involved in the manufacturing and distribution of approved drugs and biological products are required to comply with certain post-approval requirements and are subject to periodic unannounced inspections by the United States Food and Drug Administration (the “FDA”) and state agencies to assess compliance with current Good Manufacturing Practice (“cGMP”) requirements.
Our other products include Otrexup, which was acquired in December 2021, SPRIX and INDOCIN, which were acquired through a merger with Zyla Life Sciences (“Zyla”) in May 2020 (the “Zyla Merger”), and CAMBIA, which was acquired in December 2013.
Our other products include Sympazan, which was acquired in October 2022, SPRIX and INDOCIN, which were acquired through a merger with Zyla Life Sciences (“Zyla”) in May 2020 (the “Zyla Merger”), and CAMBIA, which was acquired in December 2013. Prior to July 2025, our other products included Otrexup, which was acquired in December 2021.
In addition, we also face competition for compounded INDOCIN suppositories from hospitals and other institutions, including a 503B outsourcing facility (commonly referred to as a 503B compounder), which began compounding 100 mg indomethacin suppositories in 2022 in what we believe to be violation of state and federal requirements for new drugs and labeling requirements related to adequate directions for use. 11 Sympazan competes with other generic and branded products in the treatment of LGS, including clobazam tablets and oral solution options.
In addition, we also face competition for compounded INDOCIN suppositories from hospitals and other institutions, including a 503B outsourcing facility (commonly referred to as a 503B compounder), which began compounding 100 mg indomethacin suppositories in 2022 in what we believe to be violation of state and federal requirements for new drugs and labeling requirements related to adequate directions for use.
Financial Statements and Supplemental Data – Note 8 , Commitments and Contingencies.” We intend to vigorously defend ourselves in these legal matters, and seek to manage them in an efficient and cost-effective manner, while working towards a timely resolution. 8 Customers To date, substantially all of our revenues are related to product sales in the U.S.
Commitments and Contingencies.” We plan to continue our strategy of vigorously defending ourselves in these legal matters and seeking to manage them in an efficient and cost-effective manner, while working towards a timely resolution. 8 Customers To date, substantially all our revenues are related to product sales in the U.S.
Risks Related to Our Regulatory Environment • We incur significant costs and devote significant management focus on governmental investigations and inquiries, regulatory actions and lawsuits regarding Assertio Therapeutics’ historical commercialization of opioids. • We are impacted by changes in laws and regulations applicable to, and increased scrutiny and investigations of, the pharmaceutical and biological product industry. • We may fail to comply with applicable statutes or regulations. • We may incur significant liability if it is determined that we are promoting or have promoted “off-label” use of our products. • Healthcare reform may reduce our revenues, increase our expenses and impact our products. • We are not always able to protect our intellectual property and are subject to risks from liability for infringing the intellectual property of others.
Risks Related to Our Regulatory Environment • We are impacted by changes in laws and regulations applicable to, and increased scrutiny and investigations of, the pharmaceutical and biological product industry. • We may fail to comply with applicable statutes or regulations. • We may incur significant liability if it is determined that we are promoting or have promoted “off-label” use of our products. • Healthcare reform may reduce our revenues, increase our expenses and impact our products. • We are not always able to protect our intellectual property and are subject to risks from liability for infringing the intellectual property of others. • Macroeconomic conditions can adversely impact our business and operations.
We offer discounted pricing or rebates on purchases of pharmaceutical products under various federal and state healthcare programs, including: (i) Centers for Medicare & Medicaid Services’ (“CMS”) Medicaid Drug Rebate Program, (ii) Medicare Part B Program and Medicare Part D Coverage Gap Discount Programs, (iii) the U.S.
The pricing and reimbursement of our pharmaceutical products is partially dependent on government regulation. We offer discounted pricing or rebates on purchases of pharmaceutical products under various federal and state healthcare programs, including: (i) CMS Medicaid Drug Rebate Program, (ii) Medicare Part B Program and Medicare Part D Coverage Gap Discount Programs, (iii) the U.S.
Recently, there has been considerable public and government scrutiny of pharmaceutical pricing, resulting in proposals to address the perceived high cost of pharmaceuticals, and drug pricing continues to be an agenda item at both the federal and state level. The U.S. pharmaceutical industry has already been significantly affected by major legislative initiatives, including, for example, the ACA.
Recently, there has been considerable public and government scrutiny of pharmaceutical pricing, resulting in proposals to address the perceived high cost of pharmaceuticals, and drug pricing continues to be an agenda item at both the federal and state level. For example, in May 2025, the current U.S.
Fraud and Abuse The Foreign Corrupt Practices Act (“FCPA”), prohibits any U.S. individual or business from paying, offering or authorizing payment or offering of anything of value, directly or indirectly, to any foreign official, political party or candidate for influencing any act or decision of the foreign entity to assist the individual or business in obtaining or retaining business.
These efforts to reduce aggregate beneficiary spending are expected to shift some costs to drug manufacturers. 15 Fraud and Abuse The Foreign Corrupt Practices Act (“FCPA”) prohibits any U.S. individual or business from paying, offering or authorizing payment or offering of anything of value, directly or indirectly, to any foreign official, political party or candidate for influencing any act or decision of the foreign entity to assist the individual or business in obtaining or retaining business.
Our Patents and Proprietary Rights We are either a licensee or owner of U.S. and foreign patents and applications covering ROLVEDON, including patents and applications drawn to its composition of matter, method of manufacture, method of treatment, dosing, and formulation. If not otherwise invalidated, our U.S. patents for ROLVEDON, including any pending patents, expire between 2031 and 2042.
Our Patents and Proprietary Rights We are either a licensee or owner of U.S. and foreign patents and applications covering ROLVEDON, including patents and applications drawn to its composition of matter, method of manufacture, method of treatment, dosing, and formulation.
Collaboration and License Agreements Searchlight: We have a license agreement with Tribute Pharmaceuticals Canada Ltd. (later known as Aralez Pharmaceuticals, Miravo Healthcare, and now Searchlight Pharma, or “Searchlight,” now owned by Apotex Inc.) granting them the rights to commercially market CAMBIA in Canada. Searchlight independently contracts with manufacturers to produce a specific CAMBIA formulation in Canada.
(later known as Aralez Pharmaceuticals, Miravo Healthcare, and Searchlight Pharma, or “Searchlight,” owned by Apotex Inc.) granting them the rights to commercially market CAMBIA in Canada. Searchlight independently contracts with manufacturers to produce a specific CAMBIA formulation in Canada. We receive royalties on net sales on a quarterly basis.
We also rely on trade secrets and proprietary know how, which are difficult to protect. We seek to protect such information, in part, through entering into confidentiality agreements with employees, consultants, collaborative partners and others before such persons or entities have access to our proprietary trade secrets and know how.
We seek to protect such information, in part, through entering into confidentiality agreements with employees, consultants, collaborative partners and others before such persons or entities have access to our proprietary trade secrets and know how. Collaboration and License Agreements Searchlight: We have a license agreement with Tribute Pharmaceuticals Canada Ltd.
There are no patents covering the INDOCIN products and we are facing generic competition for both our INDOCIN suppositories and INDOCIN oral suspension, including a new generic competitor for INDOCIN suppositories that launched in January 2025.
There are no patents covering the INDOCIN products, and we are facing generic competition for both our INDOCIN suppositories and INDOCIN oral suspension.
We have built our product portfolio through the acquisition or licensing of approved products, including our lead product, ROLVEDON, which we acquired on July 31, 2023, through a merger with Spectrum Pharmaceuticals, Inc. (“Spectrum”, and the merger with Spectrum the “Spectrum Merger”).
Our focus is on supporting patients by marketing products primarily in the oncology market. We have built our product portfolio through the acquisition or licensing of approved products, including our lead product, ROLVEDON, which we acquired on July 31, 2023, through a merger with Spectrum (the “Spectrum Merger”).
Each wholesale distributor purchases a different amount of each product, therefore the change in product mix impacts the percentage of consolidated revenue and the percentage of accounts receivable related to product shipments by customer. We sell our products to our customers noted in the table above, who are primarily wholesalers.
As wholesale distributors purchase different quantities of each product, changes in product mix impact the percentage of consolidated revenue and the percentage of accounts receivable related to product sales by customer. We sell our products to our customers noted in the table above, who are primarily wholesalers.
Risks Related to Our Financial Position • Our existing capital resources may not be sufficient to fund our future operations or execute attractive product acquisitions and strategic transactions. • We may be unable to generate sufficient cash flow from our business to make interest payments on and repay our 2027 Convertible Notes. • We have incurred operating losses in the past and may incur operating losses in the future. • We have significant amounts of long-lived assets which depend upon future positive cash flows to support the values recorded in our balance sheet. • We have significant amounts of inventory which are stated at the lower of cost or net realizable value.
Risks Related to Our Financial Position • Our existing capital resources may not be sufficient to fund our future operations or execute attractive product acquisitions and strategic transactions. • We may be unable to make interest payments on and repay our 2027 Convertible Notes. • We have incurred operating losses in the past and may incur operating losses in the future. • We have significant amounts of long-lived assets which depend upon future positive cash flows to support the values recorded in our balance sheet. • We have significant amounts of inventory, and we have recognized inventory write-off charges in the past and may recognize write-off charges in the future. • Our financial results are impacted by management’s assumptions and use of estimates. • We may not be able to adequately insure ourselves from product liability losses and other litigation liability. • Our ability to use our net operating loss (“NOL”) carryforwards may be limited.
Additionally, our executive leadership team has extensive commercial execution and business development experience that supports our commercial capabilities and our sales force. 6 Our primary marketed products are: ROLVEDON TM (eflapegrastim-xnst) injection for subcutaneous use A long-acting granulocyte colony-stimulating factor (“G-CSF”) with a novel formulation that is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia.
We ceased commercialization of Otrexup in July 2025. 6 Our primary marketed products are: ROLVEDON TM (eflapegrastim-xnst) injection for subcutaneous use A long-acting “G-CSF with a novel formulation that is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia.
We are either a licensee or owner of U.S. and foreign patents for certain of our other products, including U.S. patents covering Sympazan through 2040, U.S. patents covering Otrexup through 2030, and U.S. patents covering CAMBIA through 2026.
We are either a licensee or owner of U.S. and foreign patents for certain of our other products, including U.S. patents covering Sympazan through 2040, U.S. patents covering Otrexup through 2030, and U.S. patents covering CAMBIA through 2026. Certain parties who have entered into settlement agreements with us began to market generic versions of CAMBIA in January 2023.
We have a set of policies explicitly setting forth our expectations for nondiscrimination and a harassment-free work environment. We are also a proud equal opportunity employer and cultivate a highly collaborative, fast paced, and entrepreneurial culture. Corporate Information The address of our website is http://www.assertiotx.com .
We are also an equal opportunity employer, and we seek to cultivate a highly collaborative, fast paced, and entrepreneurial culture. Corporate Information The address of our website is http://www.assertiotx.com .
As such, we are dependent on our contract manufacturing partners for timely supply of our products, and our success depends on our ability to maintain good working relationships with our manufacturers. We are responsible for the supply and distribution of our marketed products. Our approved products are manufactured at contract manufacturing facilities in the U.S., Canada, Italy, and South Korea.
We are responsible for the supply and distribution of our marketed products. Our approved products are manufactured at contract manufacturing facilities in the U.S., Canada, Italy, and South Korea.
We believe that ROLVEDON’s profile provides opportunities in both hospitals and community oncology clinics. We are working to identify further opportunities for ROLVEDON commensurate with the successful completion of our same-day dosing clinical study, which was completed in the fourth quarter of 2024.
We believe that ROLVEDON’s profile provides opportunities in both hospitals and community oncology clinics, and we are working to identify further opportunities for ROLVEDON. For example, we presented the results of our same-day dosing trial in December 2024 and March 2025.
In evaluating potential products for acquisition or licensing, we primarily seek assets that provide (i) commercial synergies with our current products, with a particular focus on oncology and neurology, (ii) on-market products that have significant remaining patent life or exclusivity, and/or (iii) products that are, or will be, accretive to our operating margins and cash flows.
We primarily seek: (i) assets that provide commercial synergies with our current products, (ii) marketed products with significant remaining patent life or exclusivity, and (iii) products that are accretive to our operating margins and cash flows in the near or medium term.
While we have taken steps to mitigate these quality issues, they may continue to impact cost of sales in 2025. 9 Drug Substances The active pharmaceutical ingredient (“API”) used in ROLVEDON is eflapegrastim-xnst, which is sourced by our supplier in South Korea. Both INDOCIN oral suspension and suppositories use indomethacin as the API.
Drug Substances The active pharmaceutical ingredient (“API”) used in ROLVEDON is eflapegrastim-xnst, which is sourced by our supplier, Hanmi, in South Korea. Both INDOCIN oral suspension and suppositories use indomethacin as the API.
We believe that our relations with our employees are good. Our core values are passion, integrity, professionalism, collaboration, and tenacity, which supports our vision of improving lives through better medicine.
None of our employees are represented by a collective bargaining agreement, and we have not experienced any work stoppages. We believe that our employee relations are good. Our core values are passion, integrity, professionalism, collaboration, and tenacity, which support our vision of improving lives through better medicine.
Our success depends in part on our ability to obtain and maintain patent protection for our products and technologies. Our policy is to seek to protect our proprietary rights, by among other methods, filing patent applications in the U.S. and foreign jurisdictions to cover certain aspects of our technology.
Our policy is to seek to protect our proprietary rights, by among other methods, filing patent applications in the U.S. and foreign jurisdictions to cover certain aspects of our technology. We also rely on trade secrets and proprietary know how, which are difficult to protect.
Under the license agreement, our royalties on net sales are reduced upon the launch of a generic version of CAMBIA in Canada. On February 22, 2024, Searchlight commenced a patent infringement action in Canadian federal court against a generic company seeking approval of a generic version of CAMBIA in Canada.
Under the license agreement, our royalties on net sales are reduced upon the launch of a generic version of CAMBIA in Canada.
The false statements statute prohibits knowingly and willfully falsifying, concealing, or covering up a material fact or making any materially false, fictitious, or fraudulent statement about the delivery of or payment for healthcare benefits, items or services. 17 Because of the breadth of these laws and the narrowness of available statutory and regulatory exemptions, from time to time some of our business activities are subject to challenge under one or more of such laws.
The false statements statute prohibits knowingly and willfully falsifying, concealing, or covering up a material fact or making any materially false, fictitious, or fraudulent statement about the delivery of or payment for healthcare benefits, items or services.
We also believe we offer competitive compensation for our employees and strongly embrace a pay for performance culture underpinned by our commitment to ethics and compliance. 18 Our Employee Handbook and Code of Business Conduct and Ethics outline our commitment to inclusion, where all employees are welcomed in an environment designed to make them feel comfortable, respected, and accepted.
Our Employee Handbook and Code of Business Conduct and Ethics outline our commitment to inclusion, where all employees are welcomed in an environment designed to make them feel comfortable, respected, and accepted. We have a set of policies explicitly setting forth our expectations for nondiscrimination and a harassment-free work environment.
Competition in the LGS marketplace includes branded and generic anti-seizure medications, surgery, neuromodulations, and changes in diet. SPRIX competes with currently marketed oral opioids, transdermal opioids, local anesthetic patches, stimulants and implantable and external infusion pumps that can be used for infusion of opioids and local anesthetics, non-narcotic analgesics, local and topical analgesics and anti-arthritics.
SPRIX competes with currently marketed oral opioids, transdermal opioids, local anesthetic patches, stimulants and implantable and external infusion pumps that can be used for infusion of opioids and local anesthetics, non-narcotic analgesics, local and topical analgesics and anti-arthritics. CAMBIA competes with a number of triptans that are used to treat migraines and certain other headaches.
On August 29, 2023, HHS announced the list of the first ten drugs that will be subject to price negotiations. These price negotiations occurred in 2024. In January 2025, CMS announced a list of fifteen additional Medicare Part D drugs that will be subject to price negotiations.
In January 2025, CMS announced a list of fifteen additional Medicare Part D drugs that will be subject to price negotiations. To date, none of our products have been selected to be subject to price negotiations.
SPRIX ® (ketorolac tromethamine) Nasal Spray A prescription NSAID indicated in adult patients for the short-term (up to five days) management of moderate to moderately severe pain that requires analgesia at an opioid level.
Both products are nonsteroidal anti-inflammatory drugs (“NSAIDs”), indicated for: • Moderate to severe rheumatoid arthritis including acute flares of chronic disease • Moderate to severe ankylosing spondylitis INDOCIN ® (indomethacin) Oral Suspension • Moderate to severe osteoarthritis • Acute painful shoulder (bursitis and/or tendinitis) • Acute gouty arthritis SPRIX ® (ketorolac tromethamine) Nasal Spray A prescription NSAID indicated in adult patients for the short-term (up to five days) management of moderate to moderately severe pain that requires analgesia at an opioid level.
While we generally do not sell directly to the wholesaler’s customers, we build, maintain, and manage relationships with these entities and health care professionals through our sales force and/or omni-channel product promotion model in order to generate demand for our products. Manufacturing We neither own nor operate, and currently have no plans to own or operate, any manufacturing facilities.
These wholesalers, in turn, sell our products to their customers, which include but are not limited to, hospitals, outpatient clinics, and pharmacies. While we generally do not sell directly to the wholesaler’s customers, we build, maintain, and manage relationships with these entities and health care professionals through our sales force in order to generate demand for our products.
Our net loss from operations in 2024 was $24.5 million and our comprehensive loss was $21.6 million, compared with net loss from operations of $254.1 million and comprehensive loss of $331.9 million in 2023.
Our net loss from operations was $21.5 million and our comprehensive loss was $30.4 million in 2025, compared with net loss from operations of $24.5 million and comprehensive loss of $21.6 million in 2024. Our net loss from operations and comprehensive loss were impacted by the items noted in the “2025 Transactions” section above.
Additionally, effective since 2024, the IRA eliminated the 5% coinsurance for catastrophic coverage under Medicare Part D; in 2025, the IRA will cap the beneficiary annual out-of-pocket expenditure. These efforts to reduce aggregate beneficiary spending are expected to shift some costs to drug manufacturers.
A separate provision requires drug manufacturers to pay rebates to Medicare if their drug prices increase at a higher rate than the rate of inflation (the so-called inflation rebate provision). Additionally, in 2024, the IRA eliminated the 5% coinsurance for catastrophic coverage under Medicare Part D. In 2025, the IRA will cap the beneficiary annual out-of-pocket expenditure.
We have incurred a significant amount of expense on legal matters related to various legal proceedings as further described in “Item 8.
We evaluate potential products, both on-market and in development, that meet these criteria using a disciplined approach that utilizes both internal and external resources. We have recently incurred a significant amount of expense on legal matters related to various legal proceedings as further described in “Item 8. Financial Statements and Supplemental Data – Note 8 .
OTREXUP uses methotrexate as the API, which is sourced by our supplier from a manufacturer based in Germany. The API used in SPRIX is ketorolac tromethamine, which we acquire from European-based manufacturers. CAMBIA us es diclofenac potassium as the API, which we source from suppliers in Italy.
The API used in SPRIX is ketorolac tromethamine, which we acquire from European-based manufacturers.
We believe we are uniquely positioned to leverage these strengths in a rapidly evolving pharmaceutical landscape to create sustainable value for patients, healthcare providers, and shareholders alike. Our sales force directly markets ROLVEDON.
Our Business Strategy We believe we are uniquely positioned to create value for patients, providers, and shareholders in an evolving pharmaceutical landscape. Our strategy is to focus on finding products that leverage our existing capabilities to build an oncology portfolio.
Certain parties who have entered into settlement agreements with us are able to market and have begun marketing generic versions of CAMBIA starting January 2023. We also have U.S. patents directed to the processes of manufacture related to SPRIX through 2029, which excludes any potential patent term adjustments.
We also have U.S. patents directed to the processes of manufacture related to SPRIX through 2029, which excludes any potential patent term adjustments. Our success depends in part on our ability to obtain and maintain patent protection for our products and technologies.
Our royalties from Searchlight’s net sales of CAMBIA in Canada will be reduced if Searchlight’s patent infringement litigations fail to keep the generic companies from launching before the relevant patents expire. Competition We face competition from several sources, including pharmaceutical and biotechnology companies, generic drug companies, compounding pharmacies, and medical devices and drug delivery companies.
Competition We face competition from several sources, including pharmaceutical and biotechnology companies, generic drug companies, compounding pharmacies and medical devices and drug delivery companies.
We generated $26.4 million and $49.6 million of operating cash flow during 2024 and 2023, respectively, and our cash, cash equivalents and short-term investments exceeded $100 million as of December 31, 2024.
We used $28.2 million of operating cash flow during 2025, compared with $26.4 million of operating cash flow generated during 2024, primarily as a result of the large purchases by several national distributors in the third quarter of 2025 noted above. Our cash, cash equivalents and short-term investments totaled $63.4 million as of December 31, 2025.
While some of the data we process may be exempt from certain of these laws, other data may be covered, requiring compliance. Human Capital As of March 7, 2025 we h ad 58 fu ll‑time employees, all employed in the U.S. None of our employees are represented by a collective bargaining agreement, nor have we experienced any work stoppage.
While some of the data we process may be exempt from certain of these laws, other data may be covered, requiring compliance. Human Capital As of March 9, 2026, we had 53 f ull‑time employees in the U.S. Our workforce primarily consists of professionals engaged in commercial operations, medical affairs, market access, regulatory, and corporate support functions.
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ITEM 1. BUSINESS Overview We are 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.
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ITEM 1. BUSINESS Overview Unless otherwise noted or required by context, use of “Assertio,” the “Company,” “we,” “our” and “us” refer to Assertio Holdings and/or its applicable subsidiary or subsidiaries. Reference to “Assertio Specialty” refers to Assertio Specialty Pharmaceuticals, LLC, and “Spectrum” refers to Spectrum Pharmaceuticals, Inc. and/or its applicable subsidiary or subsidiaries.
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Sympazan, which we acquired in October of 2022, utilizes clobazam and is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (“LGS”) for patients older than two years of age.
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Both Assertio Specialty and Spectrum are wholly-owned subsidiaries of the Company. Additionally, the use of “Assertio Therapeutics” refers to Assertio Therapeutics, Inc., and/or its applicable subsidiary or subsidiaries. Assertio Therapeutics was divested on May 9, 2025. We are a pharmaceutical company with comprehensive commercial capabilities offering differentiated products designed to address patients’ needs.
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Sympazan differentiates itself from other clobazam products through its use of PharmFilm® technology to provide clobazam in a convenient film that adheres to the tongue and which may be beneficial for patients that experience trouble swallowing traditional oral clobazam.
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In January 2026, the full manuscript was accepted for publication in the peer-reviewed journal, The Oncologist, and the data is widely available via open access.
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Our commercial capabilities include marketing through a sales force for ROLVEDON, both a sales force and omni-channel promotional model for Sympazan and an omni-channel promotional model for our other products. This omni-channel sales platform supports Sympazan and our other products through a non-personal promotion model that blends digital channels, remote virtual representatives, and machine learning (“ML”).
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CAMBIA is not a pill; it is a powder, and combining CAMBIA with water activates the medicine in a unique way. 2025 Transactions On May 9, 2025, we transferred all the equity interests in Assertio Therapeutics to an established purchaser of legacy litigation matters, resulting in Assertio Therapeutics being owned by the purchaser’s related company, ATIH Industries, LLC (the “Therapeutics Transaction”).
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Key aspects of our commercial model include (i) a patient-centric approach, (ii) differentiated products in oncology, neurology, and pain management that set us apart in a competitive market, (iii) patient/provider services to improve adoption of our products and enhance the overall patient experience, and (iv) increased accessibility, which is vital to reaching a broader patient population.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeWith respect to shareholder litigation, we have provided notice to our insurance carriers with respect to such litigation and anticipate receiving some amount of insurance coverage with respect to such litigation; there is, however, no guarantee that our shareholder litigation insurance coverage will adequately protect us from our pending or future shareholder litigation claims.
Biggest changeThere is, however, no guarantee that our shareholder litigation insurance coverage will adequately protect us from our pending or future shareholder litigation claims. If any of these legal proceedings, inquiries or 34 investigations were to result in an adverse outcome, the impact could have an adverse effect on our competitive position, business, financial condition, results of operations and cash flows.
While indomethacin it is included on the FDA’s Category 1 list of bulk substances it is evaluating, it is not on the FDA’s list of bulk substances for which there is a clinical need and INDOCIN suppositories are not on the FDA’s drug shortage list either.
While indomethacin is included on the FDA’s Category 1 list of bulk substances it is evaluating, it is not on the FDA’s list of bulk substances for which there is a clinical need and INDOCIN suppositories are not on the FDA’s drug shortage list either.
Third-party payors have in the past and may in the future limit coverage to specific products on an approved list, or formulary, which might not include all of the approved products for a particular indication, including one or more of our products.
Third-party payors have in the past and may in the future limit coverage to specific products on an approved list, or formulary, which might not include all the approved products for a particular indication, including one or more of our products.
Conditions that could indicate impairment of long-lived assets include, but are not limited to, our market capitalization declining below the book value of our equity, a significant adverse change in market conditions, significant competing product launches by our competitors, significant adverse change in the manner in which the long-lived asset is being used, and adverse legal or regulatory outcomes.
Conditions that could indicate impairment of long-lived assets include, but are not limited to, our market capitalization declining below the book value of our equity, a significant adverse change in market conditions, significant competing product launches by our competitors, a significant adverse change in the manner in which the long-lived asset is being used, and adverse legal or regulatory outcomes.
For example, it could: • limit our ability to borrow additional amounts for working capital and other general corporate purposes, including funding possible acquisitions of, or investments in, new and complementary businesses, products and technologies, which is a key element of our corporate strategy; • make it more difficult for us to meet our payment and other obligations under our indebtedness; • require the dedication of a substantial portion of our cash flow from operations to service our indebtedness, thereby reducing the amount of our cash flow available for other purposes, including working capital, business development activities, any future clinical trials and/or research and development, capital expenditures and other general corporate purposes; • result in other events of default under our indebtedness, which events of default could result in all of our debt becoming immediately due and payable; • make us more vulnerable to adverse changes in general economic, industry and competitive conditions and adverse changes in government regulation; • limit our flexibility in planning for, or reacting to, changes in our business and our industry; and 33 • put us at a disadvantage compared to our competitors who have less debt.
For example, it could: • limit our ability to borrow additional amounts for working capital and other general corporate purposes, including funding possible acquisitions of, or investments in, new and complementary businesses, products and technologies, which is a key element of our corporate strategy; • make it more difficult for us to meet our payment and other obligations under our indebtedness; • require the dedication of a substantial portion of our cash flow from operations to service our indebtedness, thereby reducing the amount of our cash flow available for other purposes, including working capital, business development activities, any future clinical trials and/or research and development, capital expenditures and other general corporate purposes; • result in other events of default under our indebtedness, which events of default could result in all our debt becoming immediately due and payable; • make us more vulnerable to adverse changes in general economic, industry and competitive conditions and adverse changes in government regulation; • limit our flexibility in planning for, or reacting to, changes in our business and our industry; and • put us at a disadvantage compared to our competitors who have less debt.
These cost-containment measures may include, among other measures: requirements for pharmaceutical companies to negotiate prescription drug prices with government healthcare programs; controls on government-funded reimbursement for drugs; new or increased requirements to pay prescription drug rebates to government healthcare programs, including if drug prices increase at a higher rate than inflation; controls on healthcare providers; challenges to or limits on the pricing of drugs, including pricing controls or limits or prohibitions on 29 reimbursement for specific products through other means; requirements to try less expensive products or generics before a more expensive branded product; and public funding for cost effectiveness research, which may be used by government and private third-party payors to make coverage and payment decisions.
These cost-containment measures may include, among other measures: requirements for pharmaceutical companies to negotiate prescription drug prices with government healthcare programs; controls on government-funded reimbursement for drugs; new or increased requirements to pay prescription drug rebates to government healthcare programs, including if drug prices increase at a higher rate than inflation; controls on healthcare providers; challenges to or limits on the pricing of drugs, including pricing controls or limits or prohibitions on reimbursement for specific products through other means; requirements to try less expensive products or generics before a more expensive branded product; and public funding for cost effectiveness research, which may be used by government and private third-party payors to make coverage and payment decisions.
Engaging in strategic transactions, such as acquisitions of product rights, businesses combinations and 31 divestitures, and commercialization arrangements, have in the past and may in the future require us to incur non-recurring and other charges, increase our near- and long-term expenditures, pose integration challenges and fail to achieve the anticipated results or synergies or distract our management and business, which may harm our business.
Engaging in strategic transactions, such as acquisitions of product rights, businesses combinations and divestitures, and commercialization arrangements, have in the past and may in the future require us to incur non-recurring and other charges, increase our near- and long-term expenditures, pose integration challenges and fail to achieve the anticipated results or synergies or distract our management and business, which may harm our business.
A Section 505(b)(2) application may also not be approved until any non-patent exclusivity, such as exclusivity for obtaining approval of a new chemical entity, listed in the Orange Book for the referenced product has expired. The FDA may also require us to perform one or more additional clinical studies or measurements to support the change from the approved product.
A 37 Section 505(b)(2) application may also not be approved until any non-patent exclusivity, such as exclusivity for obtaining approval of a new chemical entity, listed in the Orange Book for the referenced product has expired. The FDA may also require us to perform one or more additional clinical studies or measurements to support the change from the approved product.
The manufacturing process for pharmaceutical products is highly regulated, and regulators may from time to time shut down manufacturing facilities that they believe do not comply with their regulations. 22 Our third-party manufacturers and suppliers are independent entities who are subject to their own operational and financial risks which are out of our control.
The manufacturing process for pharmaceutical products is highly regulated, and regulators may from time to time shut down manufacturing facilities that they believe do not comply with their regulations. Our third-party manufacturers and suppliers are independent entities who are subject to their own operational and financial risks which are out of our control.
Most of our principal competitors have substantially greater financial, sales, marketing, personnel and research and development resources than we and our commercial partners do. ROLVEDON is a novel long-acting G-CSF that employs a proprietary technology that is designed to prolong the duration of biologics, reducing the frequency of administration.
Most of our principal competitors have substantially greater financial, sales, marketing, personnel and research and development resources than we and our commercial partners do. 24 ROLVEDON is a novel long-acting G-CSF that employs a proprietary technology that is designed to prolong the duration of biologics, reducing the frequency of administration.
In addition, federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal government. Under these laws, in recent years, the federal government has brought claims against drug manufacturers alleging 28 that certain marketing activities caused false claims for prescription drugs to be submitted to federal programs.
In addition, federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal government. Under these laws, in recent years, the federal government has brought claims against drug manufacturers alleging that certain marketing activities caused false claims for prescription drugs to be submitted to federal programs.
Additionally, several U.S. jurisdictions have proposed, enacted, or are considering, laws 42 governing the development and use of AI/ML. Additionally, certain privacy laws extend rights to consumers (such as the right to delete certain personal data) and regulate automated decision making, which may be incompatible with our use of AI/ML.
Additionally, several U.S. jurisdictions have proposed, enacted, or are considering, laws governing the development and use of AI/ML. Additionally, certain privacy laws extend rights to consumers (such as the right to delete certain personal data) and regulate automated decision making, which may be incompatible with our use of AI/ML.
In addition, if competitors reduce the prices of their products, or otherwise demonstrate that they are better or more cost effective than our products, this may result in a greater level of reimbursement for their products relative to our products, which would reduce sales of our products and harm our results of operations.
In addition, if competitors reduce the prices of their products, or otherwise demonstrate that they are better or more cost effective than our products, this may result in a greater level of reimbursement for their products relative to our products, 25 which would reduce sales of our products and harm our results of operations.
In addition, any third-party payor decision to impose restrictions, limitations or conditions on prescribing or reimbursement of our products, including on the dosing or duration of prescriptions for our products, would harm our business, financial condition and results of operations. 26 Our customer concentration can materially adversely affect our financial condition and results of operations.
In addition, any third-party payor decision to impose restrictions, limitations or conditions on prescribing or reimbursement of our products, including on the dosing or duration of prescriptions for our products, would harm our business, financial condition and results of operations. Our customer concentration can materially adversely affect our financial condition and results of operations.
Significant assumptions utilized in our projections include, but are not limited to, our evaluation of the market 34 opportunity for our products, the current and future competitive landscape and resulting impacts to product pricing, future regulatory actions, planned strategic initiatives and the realization of benefits associated with our existing patents.
Significant assumptions utilized in our projections include, but are not limited to, our evaluation of the market opportunity for our products, the current and future competitive landscape and resulting impacts to product pricing, future regulatory actions, planned strategic initiatives and the realization of benefits associated with our existing patents.
We also rely on trade secrets and proprietary know-how, which are difficult to protect. We seek to protect such information, in part, by entering into confidentiality 30 agreements with employees, consultants, collaborative partners and others before such persons or entities have access to our proprietary trade secrets and know-how.
We also rely on trade secrets and proprietary know-how, which are difficult to protect. We seek to protect such information, in part, by entering into confidentiality agreements with employees, consultants, collaborative partners and others before such persons or entities have access to our proprietary trade secrets and know-how.
For instance, recent supply chain constraints have led to higher inflation, which if sustained could have a negative impact on the acquisition of our APIs or the cost to manufacture and purchase our products, as well as our business and results of operations.
For instance, recent 29 supply chain constraints have led to higher inflation, which if sustained could have a negative impact on the acquisition of our APIs or the cost to manufacture and purchase our products, as well as our business and results of operations.
In addition, our vendors may in turn incorporate AI/ML tools into their own offerings, and the providers of these AI/ML tools may not meet existing or rapidly evolving regulatory or industry standards, including with respect to privacy and data security.
In addition, our vendors may in 41 turn incorporate AI/ML tools into their own offerings, and the providers of these AI/ML tools may not meet existing or rapidly evolving regulatory or industry standards, including with respect to privacy and data security.
We may not be able to anticipate all types of security threats, and we may not be able to implement preventive measures effective against all such security threats. The techniques used by cyber criminals change frequently and may not be recognized until or after they are launched.
We may not be able to anticipate all types of security threats, and 40 we may not be able to implement preventive measures effective against all such security threats. The techniques used by cyber criminals change frequently and may not be recognized until or after they are launched.
Moreover, negotiating commercialization, collaborative and/or licensing arrangements may cause us to enter into less favorable agreement terms that delay or defer recovery of our 24 development costs and reduce the funding available to support key programs.
Moreover, negotiating commercialization, collaborative and/or licensing arrangements may cause us to enter into less favorable agreement terms that delay or defer recovery of our development costs and reduce the funding available to support key programs.
As part of an effort to acquire a product or company or to enter into other strategic transactions, we conduct due diligence with the goal of identifying, evaluating and assessing material risks involved in the transaction.
As part of an effort to acquire a product candidate, product or company or to enter into other strategic transactions, we conduct due diligence with the goal of identifying, evaluating and assessing material risks involved in the transaction.
Agreements with clinical investigators and clinical sites for clinical testing and for trial management services place substantial responsibilities on these parties, which could result in delays in, or termination of, clinical trials if these parties fail 37 to perform as expected.
Agreements with clinical investigators and clinical sites for clinical testing and for trial management services place substantial responsibilities on these parties, which could result in delays in, or termination of, clinical trials if these parties fail to perform as expected.
We and certain of the third parties for which we depend on to operate our business may, and certain of such third parties have, experienced cybersecurity incidents, including third-party unauthorized access to and misappropriation of personal information, and may experience similar 41 incidents in the future.
We and certain of the third parties for which we depend on to operate our business may, and certain of such third parties have, experienced cybersecurity incidents, including third-party unauthorized access to and misappropriation of personal information, and may experience similar incidents in the future.
These covenants may make it more difficult for us to incur indebtedness to fund our operations on attractive terms or at all. We may seek to refinance all or a portion of our outstanding indebtedness in the future.
These covenants may make it more difficult for us to incur indebtedness to fund our operations on attractive terms or at all. 32 We may seek to refinance all or a portion of our outstanding indebtedness in the future.
A number of companies in the pharmaceutical and biological product industry have suffered significant setbacks in clinical trials, even in later clinical trials after showing positive results in preclinical studies or earlier clinical trials.
A number of companies in the pharmaceutical and biological 35 product industry have suffered significant setbacks in clinical trials, even in later clinical trials after showing positive results in preclinical studies or earlier clinical trials.
We are, or may be, involved in various legal proceedings, lawsuits and certain government inquiries and investigations, including with respect to, but not limited to, securities class action lawsuits, Medicare and Medicaid reimbursement claims, patent infringement, product liability, personal injury, antitrust matters, breach of contract, opioid-related matters, promotional practices and compliance with laws relating to the manufacture and sale of controlled substances.
We are, or may be, involved in various legal proceedings, lawsuits and certain government inquiries and investigations, including with respect to, but not limited to, securities class action lawsuits, Medicare and Medicaid reimbursement claims, patent infringement, product liability, personal injury, antitrust matters, breach of contract, promotional practices and compliance with laws relating to the manufacture and sale of controlled substances.
The risks or uncertainties described in this Annual Report on Form 10‑K can materially and adversely affect our business, reputation, stock price, results of operations, cash flows or financial condition. The risks and uncertainties described below have been grouped under general risk categories, one or more of which categories may be applicable to the risk factors described.
The risks or uncertainties described in this Annual Report on Form 10‑K can materially and adversely affect our business, reputation, stock price, results of operations, cash flows or financial condition. While the risks and uncertainties described below have been grouped under general risk categories, one or more of the categories may be applicable to the risk factors described.
Given the international scope of our operations, any of the above factors, including sanctions, export controls, tariffs, trade wars and other governmental actions, can have a material adverse effect on our business, financial condition, cash flows and results of operations and can cause the market value of our common shares and/or debt securities to decline.
Given the international scope of our supply chain, any of the above factors, including sanctions, export controls, tariffs, trade wars and other governmental actions, can have a material adverse effect on our business, financial condition, cash flows and results of operations and can cause the market value of our common shares and/or debt securities to decline.
ASP data are calculated by the manufacturer based on a formula defined 21 by statute and regulation and are then submitted to the Centers for Medicare and Medicaid Services (“CMS”), the agency responsible for administering the Medicare program, on a quarterly basis. CMS uses those ASP data to determine the applicable reimbursement rates for ROLVEDON under Medicare Part B.
ASP data are calculated by the manufacturer based on a 20 formula defined by statute and regulation and are then submitted to the Centers for Medicare and Medicaid Services (“CMS”), the agency responsible for administering the Medicare program, on a quarterly basis. CMS uses those ASP data to determine the applicable reimbursement rates for ROLVEDON under Medicare Part B.
In addition, we are aware of other drug companies that have had interactions with regulatory agencies including the FDA relating to indomethacin, which could indicate the development of one or more additional INDOCIN product generics or other formulations of indomethacin and, as a result, we could face competition from additional generics.
In addition, we are aware of other drug companies that have had interactions with regulatory agencies including the FDA relating to indomethacin, which could indicate the development of additional INDOCIN product generics or other formulations of indomethacin and, as a result, we could face competition from additional generics.
For instance, the NDA for CAMBIA relies on the FDA’s previous findings of safety and efficacy of Cataflam, the diclofenac initially approved by the FDA. For NDAs submitted under Section 505(b)(2) of the FDCA, the patent certification and related provisions of the Hatch-Waxman Act apply.
For example, the NDA for CAMBIA relies on the FDA’s previous findings of safety and efficacy of Cataflam, the diclofenac initially approved by the FDA. For NDAs submitted under Section 505(b)(2) of the FDCA, the patent certification and related provisions of the Hatch-Waxman Act apply.
Currently, one other novel long-acting G-CSF and six biosimilar G-CSFs marketed in the U.S. compete with ROLVEDON. In addition, there is one new molecular entity that has been approved by the FDA but is not currently marketed that may compete with ROLVEDON.
Currently, two other novel long-acting G-CSF and six biosimilar G-CSFs marketed in the U.S. compete with ROLVEDON. In addition, there is one molecular entity that has been approved by the FDA but is not currently marketed that may compete with ROLVEDON.
The commercial success of ROLVEDON will depend on a number of factors, including the following: • our ability to successfully develop and execute a commercial strategy focusing on clinics and hospitals; • patient demand for ROLVEDON; • the extent to which the results from the ROLVEDON same-day dosing trial is recognized in National Comprehensive Cancer Network guidelines, which may support or enhance our commercialization efforts; • our partners’ ability to consistently manufacture ROLVEDON on a timely basis and supply product to us on commercially acceptable terms; • achieving and maintaining, and, where applicable, ensuring that our third-party contractors achieve and maintain, compliance with our contractual obligations and with all regulatory requirements applicable to ROLVEDON; • the prevalence, duration and severity of potential side effects or other safety issues that patients may experience with ROLVEDON; • the differentiation of ROLVEDON from other available approved or investigational drugs and treatments for patients with chemotherapy-induced neutropenia, and the willingness of physicians, operators of hospitals and clinics and patients to adopt and utilize ROLVEDON; • our ability to establish and enforce intellectual property rights in and to ROLVEDON; and • our ability to avoid third-party patent interference, intellectual property challenges or intellectual property infringement claims.
The commercial success of ROLVEDON depends on a number of factors, including the following: • our ability to successfully execute a commercial strategy focusing on clinics and hospitals; • patient demand for ROLVEDON; • the extent to which the results from the ROLVEDON same-day dosing trial is recognized in the National Comprehensive Cancer Network guidelines, which may support or enhance our commercialization efforts; • coverage and reimbursement from third-party payors; • our partners’ ability to consistently manufacture ROLVEDON on a timely basis and supply product to us on commercially acceptable terms; • achieving and maintaining, and, where applicable, ensuring that our third-party contractors achieve and maintain, compliance with our contractual obligations and with all regulatory requirements applicable to ROLVEDON; • the prevalence, duration and severity of potential side effects or other safety issues that patients may experience with ROLVEDON; • the differentiation of ROLVEDON from other available approved or investigational drugs and treatments for patients with chemotherapy-induced neutropenia, and the willingness of physicians, operators of hospitals and clinics and patients to adopt and utilize ROLVEDON; • our ability to establish and enforce intellectual property rights in and to ROLVEDON; and • our ability to avoid third-party patent interference, intellectual property challenges or intellectual property infringement claims.
We have incurred net losses in many of the years of our existence, including in the past two years. We may incur operating losses in future years. Any such losses may have an adverse impact on our total assets, shareholders’ equity and working capital.
We have incurred net losses in many of the years of our existence, including in the past three years. We may incur operating losses in future years. Any such losses may have an adverse impact on our total assets, shareholders’ equity and working capital.
Our ability to successfully integrate any business, product or technology we acquire depends on a number of factors, including, but not limited to, our ability to: • maintain existing agreements with customers, suppliers, distributors and vendors, avoid delays in entering into new agreements with prospective customers, suppliers, distributors and vendors, and leverage relationships with such third parties; • obtain and maintain adequate coverage, reimbursement and pricing from managed care, government and other third-party payors with respect to any acquired product; • maintain and increase sales of our existing products; • establish or manage the transition of the manufacture and supply of any acquired product, including the necessary active pharmaceutical ingredients, excipients and components; • integrate and unify the offerings and services available to customers; • integrate the owned and licensed technologies from third parties; • integrate personnel from the acquired business; • combine our and the acquired business’ operations and corporate functions, if any; • address possible differences in business backgrounds, corporate cultures and management philosophies, if any; • meet the capital requirements of the acquired business in a manner that permits us to achieve any cost savings or other synergies anticipated to result from the acquisition; • identify and add the necessary sales, marketing, manufacturing, regulatory and other related personnel, capabilities and infrastructure that are required to successfully integrate any acquired business, product or technology; • minimize the disruption and distraction of our management and other employees in connection with the integration of any acquired business, product or technology; • harmonize our and the acquired business’ operating practices, compensation programs, internal controls and other policies, processes and procedures; • manage the transition and migration of all commercial, financial, legal, clinical, regulatory and other pertinent information relating to any acquired business, product or technology; • identify and eliminate redundant and underperforming functions and assets; • comply with legal, regulatory and contractual requirements applicable to any acquired business, product or technology; and • maintain and extend intellectual property protection for any acquired product or technology. 32 If we are unable to perform the above functions or otherwise effectively integrate any acquired businesses, products or technologies, our business, financial condition and operating results will suffer.
Our ability to successfully integrate any business, product or technology we acquire depends on a number of factors, including, but not limited to, our ability to: • maintain existing agreements with customers, suppliers, distributors and vendors, avoid delays in entering into new agreements with prospective customers, suppliers, distributors and vendors, and leverage relationships with such third parties; • obtain and maintain adequate coverage, reimbursement and pricing from managed care, government and other third-party payors with respect to any acquired product; • maintain and increase sales of our existing products; • establish or manage the transition of the manufacture and supply of any acquired product, including the necessary active pharmaceutical ingredients, excipients and components; • integrate and unify the offerings and services available to customers; • integrate the owned and licensed technologies from third parties; • integrate personnel from the acquired business; • combine our and the acquired business’ operations and corporate functions, if any; • address possible differences in business backgrounds, corporate cultures and management philosophies, if any; 31 • meet the capital requirements of the acquired business in a manner that permits us to achieve any cost savings or other synergies anticipated to result from the acquisition; • identify and add the necessary sales, marketing, manufacturing, regulatory and other related personnel, capabilities and infrastructure that are required to successfully integrate any acquired business, product or technology; • minimize the disruption and distraction of our management and other employees in connection with the integration of any acquired business, product or technology; • harmonize our and the acquired business’ operating practices, compensation programs, internal controls and other policies, processes and procedures; • manage the transition and migration of all commercial, financial, legal, clinical, regulatory and other pertinent information relating to any acquired business, product or technology; • identify and eliminate redundant and underperforming functions and assets; • comply with legal, regulatory and contractual requirements applicable to any acquired business, product or technology; and • maintain and extend intellectual property protection for any acquired product or technology.
Risks Related to Our Business Development Activities Our success is dependent on our ability to successfully execute business development strategies, strategic partnerships, acquisitions of businesses, products or technologies, and investment opportunities to build and grow for the future . Failure to do so will limit our business growth and prospects.
Risks Related to Our Business Development Activities Our success is dependent on our ability to successfully execute business development strategies, strategic partnerships, acquisitions of businesses, product candidates, products, or technologies, and investment opportunities to build and grow for the future. Our failure or inability to do so will limit our business growth and prospects.
Data breaches and cyberattacks or other failures in our telecommunications or information technology systems, or those of our third-party vendors or other contractors or consultants, could result in information theft, data corruption and significant disruption of our business operations. Securities breaches can adversely impact our operations and financial results.
Data breaches and cyber-attacks or other failures in our telecommunications or information technology systems, or those of our third-party vendors or other contractors or consultants, could result in information theft, data corruption and significant disruption of our business operations. Securities breaches can adversely impact our operations and financial results.
Cybersecurity incidents, including phishing attacks and attempts to misappropriate or compromise confidential or proprietary information or sabotage enterprise IT systems are becoming increasingly frequent and more sophisticated. Cybersecurity incidents increasingly involve the use of artificial intelligence (“AI”) and ML to launch more automated, targeted and coordinated attacks on targets.
Cybersecurity incidents, including phishing attacks and attempts to misappropriate or compromise confidential or proprietary information or sabotage enterprise IT systems are becoming increasingly frequent and more sophisticated. Cybersecurity incidents increasingly involve the use of artificial intelligence (“AI”) and machine learning (“ML”) to launch more automated, targeted and coordinated attacks on targets.
On January 27, 2025, in response to an Executive Order issued by President Trump on January 21, 2025, on Diversity, Equity and Inclusion programs, the FDA removed this draft guidance from its website. This action raises questions about the applicability of statutory obligations to submit DAPs and the agency’s current thinking on best practices for clinical development.
In January 2025, in response to an Executive Order issued by the President of the United States on Diversity, Equity and Inclusion programs, the FDA removed this draft guidance from its website. This action raises questions about the applicability of statutory obligations to submit DAPs and the agency’s current thinking on best practices for clinical development.
For example, the ACA includes numerous provisions that affect pharmaceutical companies. For example, the ACA seeks to expand healthcare coverage to the uninsured through private health insurance reforms and an expansion of Medicaid.
For example, the ACA includes numerous provisions that affect pharmaceutical companies, including provisions intended to expand healthcare coverage to the uninsured through private health insurance reforms and an expansion of Medicaid.
We have in the past and may in the future be subject to unsolicited attempts to gain control of our company. Responding to any such attempt would distract management attention away from our business and would require us to incur significant costs.
We are subject to risks related to unsolicited takeover attempts in the future. We have in the past and may in the future be subject to unsolicited attempts to gain control of our company. Responding to any such attempt would distract management attention away from our business and would require us to incur significant costs.
Any significant drops in our stock price, including those we experienced in 2023 and 2024, have and could give rise to shareholder lawsuits, which are costly and time-consuming to defend against and which may adversely affect our ability to raise capital while the suits are pending, even if the suits are ultimately resolved in our favor.
Any significant drops in our stock price, including those we experienced in 2024 and 2025, have and could g ive rise to shareholder lawsuits, which are costly and time-consuming to defend against and which may adversely affect our ability to raise capital while the suits are pending, even if the suits are ultimately resolved in our favor.
Moreover, if the patents covering ROLVEDON (which expire in 2042), Sympazan (which expire in 2040) and/or Otrexup (which expire in 2031) are not upheld in litigation or if a generic competitor is found not to infringe these patents, the resulting generic competition for ROLVEDON, Sympazan and/or Otrexup would have a further adverse effect on our business, financial condition and results of operations.
Moreover, if the 23 patents covering Sympazan (which expire in 2040) are not upheld in litigation or if a generic competitor is found not to infringe these patents, the resulting generic competition for Sympazan would have a further adverse effect on our business, financial condition and results of operations.
If we or any third-party manufacturer or supplier fails to perform as required or fails to comply with the regulations of the FDA and other applicable governmental authorities, our ability to deliver adequate supplies of our products to our customers on a timely basis and on commercially reasonable terms, or to conduct clinical trials, could be adversely affected.
If we or any third-party manufacturer or supplier fails to perform as required or fails to comply with the regulations of the FDA and other applicable governmental authorities, or if our manufacturers and/or their suppliers demand higher prices, our ability to deliver adequate supplies of our products to our customers on a timely basis and on commercially reasonable terms, or to conduct clinical trials, could be adversely affected.
Interest rates, the liquidity of the credit markets and the volatility of the capital markets could also affect the operation of our business and our ability to raise capital on favorable terms, or at all, in order to fund our operations.
Interest rates, the liquidity of the credit markets and the volatility of the capital markets could also affect the operation of our business and our ability to raise capital on favorable terms, or at all, in order to fund our operations, business development efforts and other business plans.
We write down the value of potentially excess, dated or obsolete inventory, or inventory with quality issues impacting its salability, when evidence of these conditions exist. For the years ended December 31, 2024 and 2023, we recognized $9.0 million and $3.3 million of inventory write-downs, respectively.
We write down the value of potentially excess, dated or obsolete inventory, or inventory with quality issues impacting its salability, when evidence of these conditions exist. For the years ended December 31, 2025 and 2024, we recognized $4.5 million and $9.0 million of inventory write-downs, respectively.
To the extent that our existing capital resources and revenues from ongoing operations are insufficient to fund our future operations, including our litigation-related costs, product acquisitions and strategic transactions that we may pursue, we will have to raise additional funds through the sale of our equity securities, through additional debt financing, from development and licensing arrangements and/or from the sale of assets.
To the extent that our existing capital resources and operating cash flows are insufficient to fund our future operations, including our litigation-related costs, product acquisitions and strategic transactions that we may pursue, we will have to seek to raise additional funds through the sale of our equity securities, through additional debt financing, from development and licensing arrangements and/or from the sale of assets.
In addition to the risks discussed elsewhere in this section, our ability to successfully commercialize and generate revenues from our products depends on a number of factors, including, but not limited to, our ability to: • develop and execute our sales, marketing and promotion strategies for our products using our capability to market products through both a sales force and an omni-channel promotion model; • achieve, maintain and grow market acceptance of, and demand for, our products; • obtain and maintain adequate coverage, reimbursement and pricing from managed care, government and other third-party payors; • adapt our commercial strategies while minimizing disruption of relationships with prescribers and other decision-makers; • maintain, manage or scale the necessary sales, marketing, manufacturing, managed markets and other capabilities and infrastructure that are required to successfully integrate and commercialize our products; • obtain adequate supply of our products; • maintain and extend intellectual property protection for our products; and • comply with applicable legal and regulatory requirements.
In addition to the risks discussed elsewhere in this section, our ability to successfully commercialize and generate revenues from our products depends on a number of factors, including, but not limited to, our ability to: • develop and execute our sales, marketing and promotional strategies for our products; 21 • achieve, maintain and grow market acceptance of, and demand for, our products; • obtain and maintain adequate coverage, reimbursement and pricing from managed care, government and other third-party payors; • adapt our commercial strategies while minimizing disruption of relationships with prescribers and other decision-makers; • maintain, manage or scale the necessary sales, marketing, manufacturing, managed markets and other capabilities and infrastructure that are required to successfully integrate and commercialize our products; • obtain adequate supply of our products; • maintain and extend intellectual property protection for our products; and • comply with applicable legal and regulatory requirements.
Other factors could delay or result in the termination of our future clinical trials and related development programs, including: • negative or inconclusive results; • patient enrollment requirements and rates; • patient noncompliance with the protocol; • adverse medical events or side effects among patients during the clinical trials; • any findings resulting from FDA inspections of clinical operations; • failure to meet FDA preferred or recommended clinical trial design, end points or statistical power; • failure to comply with current good clinical practices; • our failure, and the failure of third-party clinical trial vendors to comply with applicable regulatory laws and regulations; • inability of third-party clinical trial vendors to satisfactorily perform their contractual obligations, comply with applicable laws and regulations or meet deadlines; • delays or failures in obtaining clinical materials or manufacturing sufficient quantities of the product candidate for use in clinical trials; and • unexpected external medical threats such as epidemics, pandemics, or other disease outbreaks. 36 We are unable to predict whether any future product candidates will receive regulatory clearances or be successfully manufactured or marketed.
Other factors could delay or result in the termination of our future clinical trials and related development programs, including: • negative or inconclusive results; • patient enrollment requirements and rates; • patient noncompliance with the clinical trial protocol; • adverse medical events or side effects among patients during the clinical trials; • any findings resulting from FDA inspections of clinical operations; • failure to meet FDA preferred or recommended clinical trial design, end points or statistical power; • failure to comply with current good clinical practices; • our failure, and the failure of third-party clinical trial vendors to comply with applicable regulatory laws and regulations; • inability of third-party clinical trial vendors to satisfactorily perform their contractual obligations, comply with applicable laws and regulations or meet deadlines; • delays or failures in obtaining clinical materials or manufacturing sufficient quantities of the product candidate for use in clinical trials; and • unexpected external medical threats such as epidemics, pandemics, or other disease outbreaks.
In the past, we have acquired ROLVEDON, Otrexup, Sympazan, CAMBIA, the INDOCIN products, SPRIX, NUCYNTA and NUCYNTA ER (both NUCYNTA products were subsequently divested to Collegium in February 2020).
In the past, we have acquired ROLVEDON, Otrexup, Sympazan, CAMBIA, the INDOCIN products, SPRIX, NUCYNTA and NUCYNTA ER (both NUCYNTA products were subsequently divested to Collegium in February 2020 and we ceased commercializing Otrexup in July 2025).
In addition, if our executive management team is not able, in a timely manner, to develop, implement and execute successful business development strategies and plans to maintain and increase our product revenues, our business, financial condition and results of operations will be materially and adversely affected, and the existing business may be required to take further steps to reduce its costs at some point in time.
If we are unable to enhance and broaden our product offerings, our business and prospects will be limited. 30 In addition, if our executive management team is not able to develop, implement and execute successful business development strategies and plans to maintain and increase our product revenues in a timely manner, our business, financial condition and results of operations will be materially and adversely affected, and the existing business may be required to take further steps to reduce its costs at some point in time.
We cannot be certain that we will be able to successfully identify, pursue, finance and complete any future acquisitions or whether we would be able to successfully integrate or develop any acquired business, product or technology, successfully commercialize and realize the anticipated benefits from acquired products or retain any key employees.
We cannot be certain that we will be able to successfully identify, pursue, finance and complete any future acquisitions or whether we would be able to successfully obtain regulatory approvals and launch, if applicable, integrate or develop any acquired business, product candidate, product or technology, successfully commercialize and realize the anticipated benefits from acquired products or retain any key employees.
Further, a substantial portion of our ROLVEDON business relies on reimbursement to customers by the U.S. federal government at ROLVEDON’s Medicare Part B Average Sales Price (“ASP”), which declines based on discounts and other pricing concessions made by manufacturers. These discounts and other pricing concessions are necessary to remain competitive in the long-acting G-CSF market.
Further, a substantial portion of our ROLVEDON business relies on reimbursement to customers by the U.S. federal government utilizing ROLVEDON’s Medicare Part B ASP payment methodology, which declines based on discounts and other pricing concessions made by manufacturers. These discounts and other pricing concessions are necessary to remain competitive in the long-acting G-CSF market.
To the extent these risks materialize and adversely affect such third-party manufacturers’ and/or suppliers’ performance obligations to us, and we are unable to contract for a sufficient supply of required products on acceptable terms, or if we encounter delays and difficulties in our relationships with manufacturers or suppliers, our business, results of operations and financial condition could be adversely affected.
To the extent these risks materialize and adversely affect such third-party manufacturers’ and/or suppliers’ performance obligations to us, and we are unable to contract for a sufficient supply of required products on acceptable terms, or if we encounter delays and difficulties in our relationships with manufacturers or suppliers, our business, results of operations and financial condition could be adversely affected. 22 A number of our products, including the INDOCIN products and Cambia, are facing competition from generics, which adversely affects our business.
There are a number of continued listing requirements that we must satisfy in order to maintain our listing on Nasdaq, including the requirement to maintain a minimum bid price of at least $1.00 (the “Bid Price Rule”).
Our common stock is listed on The Nasdaq Capital Market (“Nasdaq”). There are a number of continued listing requirements that we must satisfy in order to maintain our listing on Nasdaq, including the requirement to maintain a minimum bid price of at least $1.00 (the “Bid Price Rule”).
As a result of the generic competition, we have lost significant market share and have had to provide pricing concessions to certain customers of INDOCIN products.
As a result of the generic competition, net product sales of INDOCIN have declined as we have lost significant market share and have had to provide pricing concessions to certain customers.
There are no patents covering our INDOCIN products (which accounted for 21% and 57% of our revenue in 2024 and 2023, respectively), which allows a generic drug company to introduce a generic alternative for these drugs at any time.
There are no patents covering our INDOCIN products (which accounted for 16% and 21% of our Total revenues in 2025 and 2024, respectively), which allows a generic drug company to introduce a generic alternative for these drugs at any time.
The potential of additional proxy contests or other continuing actions by these or other activist investors could result in costly and time-consuming litigation, interfere with our ability to execute our strategic plan, give rise to perceived uncertainties as to our future direction, adversely affect our relationships with customers, suppliers, investors, prospective and current team members and others, result in the loss of potential business opportunities, or make it more difficult to attract and retain qualified personnel, any of which could materially and adversely affect our business and operating results. 39 We are subject to risks related to unsolicited takeover attempts in the future.
The potential for additional proxy contests, vote-no campaigns or other continuing actions by activist investors could result in further costly and time-consuming litigation, interfere with our ability to execute our strategic plan, give rise to perceived uncertainties as to our future direction, adversely affect our relationships with customers, suppliers, investors, prospective and current team members and others, result in the loss of potential business opportunities, or make it more difficult to attract and retain qualified personnel, any of which could materially and adversely affect our business and operating results.
If our submitted ASP data are incorrect, we may become subject to substantial fines and penalties or other government enforcement actions, which could have a material adverse impact on our business and results of operations.
If our submitted ASP or other government price reporting data are incorrect, we may need to restate previously reported data and could become subject to substantial fines and penalties or other government enforcement actions, which could have a material adverse impact on our product sales, business and results of operations.
There are other products prescribed for or under development for the treatment or prevention of migraines that are now or may become competitive with CAMBIA, including CGRP inhibitor products. Certain parties who have entered into settlement agreements with us began to market generic versions of CAMBIA in January 2023.
(almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, sumatriptan-naproxen and zolmitriptan). There are other products prescribed for or under development for the treatment or prevention of migraines that are now or may become competitive with CAMBIA, including CGRP inhibitor products. Certain parties who have entered into settlement agreements with us began to market generic versions of CAMBIA starting in January 2023.
If third parties were to bring a successful product liability or other claims, or series of claims, against us for uninsured liabilities, or in excess of our insured liability limits, our business, results of operations and financial condition could be adversely affected.
If third parties were to bring a successful product liability or other claims, or series of claims, against us for uninsured liabilities, or in excess of our insured liability limits, our business, results of operations and financial condition could be adversely affected. Our ability to use NOLs to offset future taxable income may be limited.
We have significant indebtedness under our 6.5% Convertible Senior Notes, which mature on September 1, 2027 with interest payable semi-annually in arrears on March 1 and September 1 of each year (the “2027 Convertible Notes”).
We have $40 million aggregate principal amount outstanding under our 6.5% Convertible Senior Notes, which mature on September 1, 2027, with interest payable semi-annually in arrears on March 1 and September 1 of each year (the “2027 Convertible Notes”).
Food and Drug Administration (“FDA”) can approve an abbreviated new drug application (“ANDA”) for a generic version of a branded drug without the ANDA applicant undertaking the clinical testing necessary to obtain approval to market a new drug.
Under the FDCA, the FDA can approve an abbreviated new drug application (“ANDA”) for a generic version of a branded drug without the ANDA applicant undertaking the clinical testing necessary to obtain approval to market a new drug.
We have significant amounts of inventory which are stated at the lower of cost or net realizable value. We have recognized inventory write off charges in the past and may recognize write-off charges in the future. Inventories are stated at the lower of cost or net realizable value, with cost determined by specific manufactured lot.
We have significant amounts of inventory, and we have recognized inventory write-off charges in the past and may recognize write-off charges in the future. Inventories are stated at the lower of cost or net realizable value, with cost determined by specific manufactured lot. Inventories consist of costs of the active pharmaceutical ingredient, contract manufacturing and packaging costs.
Inventories consist of costs of the active pharmaceutical ingredient, contract manufacturing and packaging costs. We review for potentially excess, dated or obsolete inventories based on an analysis of inventory on hand and projected demand, as well as inventory that may not be salable because it does not meet our quality standards.
We review for potentially excess, dated or obsolete inventories based on an analysis of inventory on hand and projected demand, as well as inventory that may not be salable because it does not meet our quality standards.
In addition, any public announcements related to litigation or interference proceedings initiated or threatened against us, even if such claims are without merit, could cause our stock price to decline.
In addition, any public announcements related to litigation or interference proceedings initiated or threatened against us, even if such claims are without merit, could cause our stock price to decline. Macroeconomic conditions can materially impact our business and operations.
We have also been unable to comply with the Bid Price Rule in the past and for periods in 2021 our continued listing on Nasdaq required the grant of a grace period from Nasdaq and the implementation of a one-for-four reverse 38 stock split.
We have been unable to comply with the Bid Price Rule in the past and for periods in 2021 and 2025 our continued listing on Nasdaq required the granting of a grace period from Nasdaq and the implementation of reverse stock splits.
If a court were to allow a creditor to pierce the corporate veil and reach the assets of such other entities within our corporate structure, despite such entities not being directly liable for the underlying claims, it could have a material adverse effect on us and our operating results, results from continued operations, and financial condition. 40 If we are unable to satisfy regulatory requirements relating to internal controls, our stock price could suffer.
If a court were to allow a creditor to pierce the corporate veil and reach the assets of such other entities within our corporate structure, despite such entities not being directly liable for the underlying claims, it could have a material adverse effect on us and our operating results, results from continued operations, and financial condition.
We and our collaborative partners customarily depend on third-party contract research organizations, clinical investigators and clinical sites to conduct clinical trials with regard to product candidates, and if they do not perform their regulatory, legal and contractual obligations, or successfully enroll patients in and manage our clinical trials, we and our collaborative partners may not be able to obtain regulatory approvals for future product candidates.
Even if we receive regulatory approval, this approval may entail limitations on the indicated uses for which we can market a product. 36 We and our collaborative partners customarily depend on third-party contract research organizations, clinical investigators and clinical sites to conduct clinical trials with regard to product candidates, and if they do not perform their regulatory, legal and contractual obligations, or successfully enroll patients in and manage our clinical trials, we and our collaborative partners may not be able to obtain regulatory approvals for future product candidates.
Macroeconomic conditions can materially impact our business and operations. Adverse economic conditions, including inflationary pressures, economic slowdown or recession, relatively high interest rates, changes in monetary policy, potential U.S. federal government shutdowns, geopolitical conflicts, financial institution instability and similar events beyond our control can affect our business and financial results.
Adverse economic conditions, including inflationary pressures, economic slowdown or recession, relatively high interest rates, government shutdowns, changes to fiscal and monetary policy or government budget dynamics (particularly in the pharmaceutical and biotechnology areas), potential U.S. federal government shutdowns, geopolitical conflicts, financial institution instability and similar events beyond our control can affect our business and financial results.
Further, we are subject to pending antitrust litigation and pending and potential future shareholder litigation relating to the Spectrum Merger and/or the approval and launch of generic indomethacin suppositories in the second half of 2023, and Spectrum is named in several securities class action and shareholder derivative lawsuits filed by former Spectrum stockholders.
For example, we are subject to shareholder litigation relating to the Spectrum Merger and/or the approval and launch of generic indomethacin suppositories in the second half of 2023, and Spectrum is named in several securities class action and shareholder derivative lawsuits filed by former Spectrum stockholders. Such litigation and related matters are described in “Item 8.
There have been, and there will continue to be, legislative, regulatory and third-party payor proposals to change the healthcare system in ways that could impact our ability to commercialize our products profitably.
Healthcare reform can reduce our revenues, increase our expenses and adversely affect the commercial success of our products. There have been, and there will continue to be, legislative, regulatory and third-party payor proposals to change the healthcare system in ways that could impact our ability to commercialize our products profitably.
There can be no assurance that our efforts to preclude corporate veil-piercing, alter ego, control person, or other similar claims by creditors of any one particular entity within our corporate structure from reaching the assets of the other entities, including Assertio Holdings, within our corporate structure to satisfy claims will be successful.
There can be no assurance that our efforts to preclude corporate veil-piercing, alter ego, control person, or other similar claims by creditors of any one particular current or former entity within our corporate structure (including Assertio Therapeutics, which was sold in May 2025 to an independent company that is not affiliated with us) from reaching the assets of the other entities, including Assertio Holdings, within our corporate structure to satisfy claims will be successful.
The ACA also includes provisions known as the Physician Payments Sunshine Act, which require manufacturers of drugs, biologics, devices and medical supplies covered under Medicare and Medicaid to record any transfers of value to physicians and teaching hospitals and to report this data to the CMS for subsequent public disclosure.
The ACA also includes provisions known as the Physician Payments Sunshine Act, which require manufacturers of drugs, biologics, devices and medical supplies covered under Medicare and Medicaid to record any transfers of value to certain U.S. healthcare providers (including, but not limited to, physicians, physician assistants, nurse practitioners, dentists, optometrists, podiatrists, chiropractors and other healthcare providers) and teaching hospitals and to report this data to the CMS annually for subsequent public disclosure.
Generic versions of our INDOCIN products have been approved and launched, including one in January 2025, and as a result, we are currently facing competition from these generics.
Over the past several years, generic versions of our INDOCIN products have been approved and launched, and as a result, we are currently facing competition from these generics.
Management’s Discussion and Analysis of Financial Condition and Results of Operations.” We face risks relating to product liability losses and other litigation liability for which we may be unable to maintain or obtain adequate insurance.
For additional information, please refer to the Critical Accounting Policies and Significant Estimates section within “ Item 7 . Management’s Discussion and Analysis of Financial Condition and Results of Operations.” We face risks relating to product liability losses and other litigation liability for which we may be unable to maintain or obtain adequate insurance.
The manufacture, marketing, sale, promotion, and distribution of our products are subject to comprehensive government regulation. Changes in laws and regulations applicable to, and increased scrutiny and investigations of, the pharmaceutical industry, including the opioid market, could adversely affect our business and our ability to commercialize our products, thereby adversely affecting our financial condition and results of operations.
Risks Related to Our Regulatory Environment We are subject to risks from changes in laws and regulations applicable to, and increased scrutiny and investigations of, the pharmaceutical industry, which can adversely affect our business, financial condition and results of operations. The manufacture, marketing, sale, promotion, and distribution of our products are subject to comprehensive government regulation.
If we are not successful in driving the growth in sales and profitability of ROLVEDON, our business, financial condition and results of operations will be materially and adversely affected. In 2024, ROLVEDON became our lead product. As a result, there is greater focus on ROLVEDON sales and profitability for the Company going forward.
If we are not successful in driving the growth in sales and profitability of ROLVEDON, our business, financial condition and results of operations will be materially and adversely affected. Our future success is highly dependent on the commercial success of ROLVEDON, and there is greater reliance on ROLVEDON sales and profitability for the Company.
For the assessment performed for the three months ended December 31, 2024, we determined that the estimated undiscounted cash flows and fair value of the Otrexup asset group were less than its carrying value and recognized an impairment loss for this asset group of approximately $5.2 million, reducing its carrying value to zero.
For the assessment performed for the three months ended December 31, 2024, we determined that the estimated undiscounted cash flows and fair value of the Otrexup asset group were less than its carrying value and recognized an impairment for this asset group of $5.2 million during the fourth quarter of 2024, reducing its carrying value to zero. 33 For all the assessments for our other asset groups performed during each quarter in 2025 and 2024, we determined that the estimated undiscounted cash flows were in excess of the carrying amounts for all our long-lived asset groups at each impairment testing date.
Our products, including the marketing of our products, is subject to substantial regulation in the U.S. and any failure by us or our commercial and collaborative partners to comply with applicable statutes or regulations can adversely affect our business.
If any of these events should occur, it may have a material adverse effect on our business, financial condition and results of operations. 26 Our products, including the marketing of our products, is subject to substantial regulation in the U.S. and any failure by us or our commercial and collaborative partners to comply with applicable statutes or regulations can adversely affect our business.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeThe Board also receives updates from management and the Audit Committee on cybersecurity risks on at least an annual basis. Our Senior Vice President of Human Resources and Administration, who reports directly to our Chief Executive Officer and has been responsible for overseeing the assessment and management of cybersecurity risks at Assertio for approximately a year and a half.
Biggest changeOur Vice President and Controller, who reports directly to our Chief Financial Officer, has been involved in overseeing the assessment and management of cybersecurity risks at Assertio for approximately two years and has an additional four years of experience managing financial systems at another public company.
The Audit Committee, which is comprised solely of independent directors, has been designated by our Board of Directors to oversee cybersecurity risks.
The Audit Committee, which is comprised solely of independent directors, has been designated by our Board to oversee cybersecurity risks.
We have an incident response plan designed to mitigate and remediate identified cybersecurity incidents at both Assertio and our customers and vendors and escalate certain incidents to management and, as appropriate, the Audit Committee. We also conduct periodic employee trainings on cyber and information security, among other topics.
We have an incident response plan designed to mitigate and remediate identified cybersecurity incidents at both Assertio and our customers and vendors and escalate certain incidents to senior management and, as appropriate, the Audit Committee. We also conduct periodic employee trainings on cybersecurity and information security, among other topics.
Governance The Board of Directors, as a whole and at the committee level, has oversight for the most significant risks facing us and for our processes to identify, prioritize, assess, manage, and mitigate those risks. The Board oversees the ERM program and oversees an enterprise-wide approach to risk management, including risks related to cybersecurity.
Governance The Board of Directors (the “Board”), as a whole and at the committee level, has oversight over the most significant risks facing us and over our processes to identify, prioritize, assess, manage, and mitigate those risks. The Board oversees the ERM program and oversees an enterprise-wide approach to risk management, including risks related to cybersecurity.
Since the beginning of the last fiscal year, there were no identified risks from known cybersecurity threats, including as a result of any prior cybersecurity incidents, that have materially affected us, bu t we face certain ongoing cybersecurity risks threats that, if realized, are reasonably likely to materially affect us.
Since the beginning of the last fiscal year, there were no identified risks from known cybersecurity threats, including as a result of any prior cybersecurity incidents, that have materially affected us, but we face certain ongoing cybersecurity risks threats that, if realized, are reasonably likely to materially affect us.
The Audit Committee receives, at a minimum, quarterly updates on cybersecurity and information technology matters and related risk exposures from our Senior Vice President of Human Resources and Administration as well as other members of the senior leadership team, including, if necessary, the Chief Financial Officer.
The Audit Committee receives, at a minimum, quarterly updates on cybersecurity and information technology matters and related risk exposures from our Vice President and Controller as well as other members of the senior leadership team, including, if necessary, the Chief Financial Officer.
These processes are managed and monitored by a third-party information technology team, which reports to our Senior Vice President of Human Resources and Administration, and includes mechanisms, controls, technologies, systems, and other processes designed to prevent or mitigate data loss, theft, misuse, or other security incidents or vulnerabilities affecting the data while also maintaining a stable information technology environment.
These processes are managed and monitored by a third-party information technology team, which reports to our Vice President and Controller, and includes mechanisms, controls, technologies, systems, and other processes designed to prevent or mitigate data loss, theft, misuse, or other security incidents or vulnerabilities affecting the data while also maintaining a stable information technology environment.
Additional information on cybersecurity risks we face is 43 discussed in Part I, Item 1A , “Risk Factors,” under the heading “Business interruptions, including data breaches an d cyber-attacks can compromise our intellectual property or other sensitive information and cause significant damage to our business, can limit our ability to operate our business, and adversely impact the success of our commercialization partners.”
Additional information on cybersecurity risks we face is discussed in Part I, Item 1A , “Risk Factors,” under the heading “Data breaches and cyber-attacks or other failures in our telecommunications or information technology systems, or those of our third-party vendors or other contractors or consultants, could result in information theft, data corruption and significant disruption of our business operations. 42
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The Board also receives updates from management and the Audit Committee on cybersecurity risks on at least an annual basis.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeFinancial Statements and Supplementary Data - Note 7 , Leases.” Additionally, in connection with the Spectrum Merger, we assumed leases for two facilities which Spectrum had previously been the lessee. For additional information regarding these leases, see “Item 8. Financial Statements and Supplementary Data - Note 16 . Restructuring Charges.
Biggest changeLeases.” Additionally, in connection with the Spectrum Merger, we assumed leases for two facilities (whose terms ended in the third quarter of 2025) and certain office equipment (which term ends in September 2026) for which Spectrum had previously been the lessee. For additional information regarding these leases, see “Item 8. Financial Statements and Supplementary Data - Note 16 .
ITEM 2. PROPERTIES Our corporate headquarters is located in Lake Forest, Illinois, where we lease approximately 20,000 square feet of office space (the “Lake Forest Lease”) through December 31, 2030. Our facility is used for office purposes only and no commercial manufacturing takes place at our facility. For additional information regarding the Lake Forest Lease , see “Item 8.
ITEM 2. PROPERTIES Our corporate headquarters is located in Lake Forest, Illinois, where we lease approximately 20,000 square feet of office space through December 31, 2030. Our facility is used for office purposes only and no commercial manufacturing takes place at our facility. For additional information , see “Item 8. Financial Statements and Supplementary Data - Note 7 .

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeThese shares may be deemed to be “issuer purchases” of shares. 45 ITEM 6. [RESERVED]
Biggest changeThese shares may be deemed to be “issuer purchases” of shares. (2) Adjusted to reflect the 1-for-15 reverse stock split effected on December 26, 2025. 44 ITEM 6. [RESERVED]
All of the shares of common stock held by brokerage firms, banks, and other financial institutions as nominees for beneficial owners are deposited into participant accounts at DTC and are therefore considered to be held of record by Cede & Co. as one shareholder.
All the shares of common stock held by brokerage firms, banks, and other financial institutions as nominees for beneficial owners are deposited into participant accounts at DTC and are therefore considered to be held of record by Cede & Co. as one shareholder.
MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED SHAREHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market Information and Holders of Common Stock Our common stock trades on The Nasdaq Capital Market under the symbol “ASRT.” As of December 31, 2024, there were 268 shar eholders of record for our common stock, one of which is Cede & Co., a nominee for The Depository Trust Company, or DTC.
MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED SHAREHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market Information and Holders of Common Stock Our common stock trades on The Nasdaq Capital Market under the symbol “ASRT.” As of December 31, 2025, there were 145 shareholders of record for our common stock, one of which is Cede & Co., a nominee for The Depository Trust Company, or DTC.
(a) Total Number of Shares (or Units) Purchased (1) (b) Average Price Paid per Share (c) Total Number of Shares (or Units) Purchased as Part of Publicly Announced Plans or Programs (d) Maximum Number (or Approximate Dollar Value) of Shares (or Units) that May Yet Be Purchased Under the Plans or Programs October 1, 2024 - October 31, 2024 52,833 $1.15 N/A N/A November 1, 2024 - November 30, 2024 — — N/A N/A December 1, 2024 - December 31, 2024 — — N/A N/A Total 52,833 $1.15 (1) Consists of shares withheld to pay employees’ tax liability in connection with the vesting of restricted stock units granted under our stock-based compensation plans.
(a) Total Number of Shares (or Units) Purchased (1)(2) (b) Average Price Paid per Share (2) (c) Total Number of Shares (or Units) Purchased as Part of Publicly Announced Plans or Programs (d) Maximum Number (or Approximate Dollar Value) of Shares (or Units) that May Yet Be Purchased Under the Plans or Programs October 1, 2025 - October 31, 2025 164 $13.72 N/A N/A November 1, 2025 - November 30, 2025 — — N/A N/A December 1, 2025 - December 31, 2025 — — N/A N/A Total 164 $13.72 (1) Consists of shares withheld to pay employees’ tax liability in connection with the vesting of restricted stock units granted under our stock-based compensation plans.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeThe results of operations of Spectrum are included in our consolidated financial statements as of the Effective Date. 47 RESULTS OF OPERATIONS The following table reflects our results of operations for the years ended December 31, 2024 and 2023 (in thousands): Year ended December 31, 2024 2023 Revenues: Product sales, net $ 120,849 $ 149,451 Royalties and milestones 2,012 2,433 Other revenue 2,100 185 Total revenues 124,961 152,069 Costs and expenses: Cost of sales 39,227 27,020 Research and development expenses 3,822 2,843 Selling, general and administrative expenses 75,051 78,638 Change in fair value of contingent consideration (244) (25,538) Amortization of intangible assets 25,644 27,527 Loss on impairment of intangible assets 5,217 279,639 Restructuring charges 720 5,476 Total costs and expenses 149,437 395,605 Loss from operations (24,476) (243,536) Other income (expense): Debt related expenses — (9,918) Interest expense (3,039) (3,380) Interest income 3,221 2,403 Other gain, net 2,765 377 Total other income (expense) 2,947 (10,518) Net loss before income taxes (21,529) (254,054) Income tax expense (52) (77,888) Net loss and comprehensive loss $ (21,581) $ (331,942) 48 Revenues The following table reflects total revenues, net for the years ended December 31, 2024 and 2023 (in thousands): Year ended December 31, 2024 2023 Product sales, net: ROLVEDON $ 60,090 $ 18,175 INDOCIN products 26,761 87,217 Sympazan 10,457 9,938 Otrexup 8,842 12,026 SPRIX 7,624 9,150 CAMBIA 5,556 8,070 Other products 1,519 4,875 Total product sales, net 120,849 149,451 Royalties and milestone revenue 2,012 2,433 Other revenue 2,100 185 Total revenues $ 124,961 $ 152,069 Product sales, net ROLVEDON net product sales were $60.1 million and $18.2 million for the years en ded December 31, 2024 and 2023, respectively .
Biggest changeThe Reverse Stock Split also affected our outstanding stock-based awards and convertible senior notes due 2027 and resulted in the shares underlying such instruments being reduced and the exercise price or conversion price being increased proportionately. 46 RESULTS OF OPERATIONS The following table reflects our results of operations for the years ended December 31, 2025 and 2024 (in thousands): Year ended December 31, 2025 2024 Revenues: Product sales, net $ 117,100 $ 120,849 Royalty revenue 1,613 2,012 Other revenue — 2,100 Total revenues 118,713 124,961 Costs and expenses: Cost of sales 35,383 39,227 Research and development expenses 1,690 3,822 Selling, general and administrative expenses 69,000 75,051 Change in fair value of contingent consideration (276) (244) Amortization of intangible assets 29,863 25,644 Impairment of intangible assets 1,700 5,217 Restructuring charges 2,889 720 Total costs and expenses 140,249 149,437 Loss from operations (21,536) (24,476) Other (expense) income: Loss on Assertio Therapeutics divestiture (8,174) — Interest expense (3,075) (3,039) Interest income 2,665 3,221 Other gain, net 180 2,765 Total other (expense) income (8,404) 2,947 Net loss before income taxes (29,940) (21,529) Income tax expense (435) (52) Net loss and comprehensive loss $ (30,375) $ (21,581) 47 Revenues The following table reflects total revenues, net for the years ended December 31, 2025 and 2024 (in thousands): Year ended December 31, 2025 2024 Product sales, net: ROLVEDON $ 68,225 $ 60,090 INDOCIN products 18,905 26,761 Sympazan 11,349 10,457 SPRIX 7,952 7,624 Other products 10,669 15,917 Total product sales, net 117,100 120,849 Royalty revenue 1,613 2,012 Other revenue — 2,100 Total revenues $ 118,713 $ 124,961 Product sales, net ROLVEDON net product sales increased $8.1 million from $60.1 million for the year ended December 31, 2024 to $68.2 million for the year ended December 31, 2025, primarily due to higher volume, the adjustment of a prior period returns reserve of $5.4 million established in connection with our merger with Spectrum (the “Spectrum Merger”), partially offset by lower net pricing.
We expect our cash needs will be met by our existing cash, cash equivalents, and short-term investments, including funding our future operations, ongoing legal expenses and settlement payments, payments due under our debt agreement, or product acquisitions and strategic transactions that we may pursue.
We expect our cash needs will be met by our existing cash, cash equivalents, and short-term investments, including funding our future operations, payments due under our debt agreement, ongoing legal expenses and settlement payments, or product acquisitions and strategic transactions that we may pursue.
The preparation of our consolidated financial statements requires us to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosures of contingent assets and liabilities. On an ongoing basis, we evaluate our estimates.
The preparation of our consolidated financial statements requires us to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosures of contingent assets and liabilities. We evaluate our estimates on an ongoing basis.
Government Rebates - We offer discounted pricing or rebates on purchases of pharmaceutical products under various federal and state healthcare programs, including Centers for Medicare & Medicaid Services’ Medicaid Drug Rebate Program and Medicare Part B Program and Medicare Part D Coverage Gap Discount Programs.
Government Rebates - We offer discounted pricing or rebates on purchases of pharmaceutical products under various federal and state healthcare programs, including Centers for Medicare & Medicaid Services’ Medicaid Drug Rebate Program, Medicare Part B Program and Medicare Part D Coverage Gap Discount Programs.
We believe that our estimates related to gross‑to‑net sales adjustments for wholesaler and pharmacy fees and discounts, prompt payment discounts, patient discount programs and chargebacks do not have a high degree of estimation complexity or uncertainty, as the related amounts are settled within a relatively short period of time.
We believe that our estimates related to gross‑to‑net sales adjustments for wholesaler and pharmacy discounts, prompt payment discounts, patient discount programs and chargebacks do not have a high degree of estimation complexity or uncertainty, as the related amounts are settled within a relatively short period of time.
Because of the shelf life of our products and our return policy of issuing credits with respect to product that is returned within six months before and up to 12 months after our product expiration date, there may be a significant period of time between when the product is shipped and when we issue credit on a returned product.
Because of the shelf life of our products and our return policy of issuing credits with respect to product that is returned within six months before and 12 months after our product expiration date, there may be a significant period of time between when the product is shipped and when we issue credit on a returned product.
Estimating future cash flows and fair value related to an intangible asset involves significant estimates and assumptions. If our assumptions are not correct, there could be an impairment loss or, in the case of a change in the estimated useful life of the asset, a change in amortization expense.
Estimating future cash flows and fair value related to an intangible asset involves significant estimates and assumptions. If our assumptions are not correct, there could be an impairment or, in the case of a change in the estimated useful life of the asset, a change in amortization expense.
An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of the asset and its eventual disposition are less than its carrying amount. The impairment loss is calculated as the excess of the carrying amount over the fair value.
An impairment would be recognized when the estimated undiscounted future cash flows expected to result from the use of the asset and its eventual disposition are less than its carrying amount. The impairment is calculated as the excess of the carrying amount over the fair value.
When we determine that it is more-likely-than-not that some portion or all of the deferred tax assets will not be realized in the future, the deferred tax assets are reduced by a valuation allowance. The valuation allowance is sufficient to reduce the deferred tax assets to the amount that we determine is more-likely-than-not to be realized.
When we determine that it is more-likely-than-not that some portion or all the deferred tax assets will not be realized in the future, the deferred tax assets are reduced by a valuation allowance. The valuation allowance is sufficient to reduce the deferred tax assets to the amount that we determine is more-likely-than-not to be realized.
We consider product sales allowances to be variable consideration and estimate and recognize product sales allowances as a reduction of product sales in the same period the related revenue is recognized. Product sales allowances are based on actual or estimated amounts owed on the related sales.
We 54 consider product sales allowances to be variable consideration and estimate and recognize product sales allowances as a reduction of product sales in the same period the related revenue is recognized. Product sales allowances are based on actual or estimated amounts owed on the related sales.
The timing of ultimate settlement of returns and chargebacks-related allowances can be prolonged by our process to validate such adjustments before settlement is finalized. Product Returns - We allow customers to return product for credit with respect to that product within six months before and up to 12 months after the product expiration date.
The timing of ultimate settlement of returns- and chargebacks-related allowances can be prolonged by our process to validate such adjustments before settlement is finalized. Product Returns - We allow customers to return product for credit with respect to that product generally within six months before and 12 months after the product expiration date.
We believe the following critical accounting policies reflect the more significant judgements and estimates used in the preparation of our consolidated financial statements. A more detailed discussion of our significant accounting policies may be found in “ Note 1 .
We believe the following critical accounting policies reflect the more significant judgments and estimates used in the preparation of our consolidated financial statements. A more detailed discussion of our significant accounting policies may be found in “ Note 1 .
Financial Statements and Supplemental Data - Note 6 , Note 13 , Note 1, Note 8 and Note 7 ,” respectively. We generally expect to satisfy these requirements and commitments with cash on hand and cash provided by operating activities.
Financial Statements and Supplemental Data - Note 1, Note 6 , Note 7 , Note 8 and Note 16 ,” respectively. We generally expect to satisfy these requirements and commitments with cash on hand and cash provided by operating activities.
In evaluating our ability to realize our deferred tax assets, we consider available positive and negative evidence, including past operating results and forecasts of future taxable income, and the potential Internal Revenue Code section 382 limitation on the net operating loss carryforwards due to a change in control.
In evaluating our ability to realize our deferred tax assets, we consider available positive and negative evidence, including past operating results and forecasts of future taxable income, and the potential Internal Revenue Code section 382 limitation on NOL carryforwards due to a change in control.
It further requires that a change in judgment related to the expected ultimate resolution of uncertain tax positions be recognized in earnings in the period of such change. As of December 31, 2024, we have recorded a full valuation allowance against our net deferred tax assets.
It further requires that a change in judgment related to the expected ultimate resolution of uncertain tax positions be recognized in earnings in the period of such change. 56 As of December 31, 2025, we have recorded a full valuation allowance against our net deferred tax assets.
Accordingly, we may have to adjust these estimates, which could have an effect on product sales and earnings in the period of adjustments. Managed Care Rebates - We offer discounts under contracts with certain managed care providers. We generally pay managed care rebates one to three months after prescriptions subject to the rebate are filled.
Accordingly, we may have to adjust these estimates, which could affect product sales and earnings in the period of adjustments. Managed Care Rebates - We offer discounts under contracts with certain managed care providers. We generally pay managed care rebates one to three months after prescriptions subject to the rebate are filled.
We expect that ongoing legal expenses will, and any settlements that we are able to negotiate may, continue to be a significant usage of cash in 2025. We may be required to raise additional capital if our cash needs vary significantly from current expectations.
We expect that ongoing legal expenses will, and any settlements that we are able to negotiate may, continue to be a significant usage of cash in 2026. We may be required to raise additional capital if our cash needs increase significantly from current expectations.
As a result of many factors, including those factors set forth in the “Risk Factors” section of this Annual Report on Form 10-K, our actual results could differ materially from the results described in or implied by the forward‑looking statements contained in the following discussion and analysis.
As a result of many factors, including those factors set forth in Part I, Item 1A “Risk Factors” section of this Annual Report on Form 10-K, our actual results could differ materially from the results described in or implied by the forward‑looking statements contained in the following discussion and analysis or elsewhere in this Annual Report on Form 10-K.
Cost of Sales Cost of sales consists of costs of the active pharmaceutical ingredient, contract manufacturing and packaging costs, royalties payable to third parties, inventory write downs, product quality testing, internal employee costs related to the manufacturing process, distribution costs, and shipping costs related to our product sales. Cost of sales excludes the amortization of intangible assets.
Cost of Sales Cost of sales consists of costs of the active pharmaceutical ingredient, contract manufacturing and packaging costs, royalties payable to third parties, inventory write-downs and scrap, product quality testing, distribution costs, and shipping costs related to our product sales. Cost of sales excludes the amortization of intangible assets.
In addition to historical information, some of the information contained in this discussion and analysis or set forth elsewhere in this Annual Report on Form 10-K, including information with respect to our plans and strategy for our business and related financing, includes forward‑looking statements that involve risks and uncertainties.
In addition to historical information, some of the information contained in this discussion and analysis or set forth under Part I, Item 1 , “Business” and elsewhere in this Annual Report on Form 10-K, including information with respect to our plans and strategy for our business and related financing, includes forward‑looking statements that involve risks and uncertainties.
We believe that our existing cash, cash equivalents and short-term investments, which totaled $100.1 million at December 31, 2024, will be sufficient to fund our operations and make the required payments under our debt agreements due for the next 12 months from the date of this filing.
We believe that our existing cash, cash equivalents and short-term investments, which totaled $63.4 million at December 31, 2025, will be sufficient to fund our operations and make the required payments under our debt agreements due for the next 12 months from the date of this filing.
Contractual Obligations Our principal material cash requirements consist of obligations related to our debt, our contingent consideration obligations, payments for rebates, returns and discounts, non-cancelable contractual obligations for our purchase commitments, 55 and non-cancelable leases for our office space. Refer to “Item 8.
Contractual Obligations Our principal material cash requirements consist of obligations related to our payments for rebates, returns and discounts, payments for debt, non-cancelable leases for our office space, non-cancelable contractual obligations for our purchase commitments, and cash payments for our restructuring activities. Refer to “Item 8.
Due to the complexity of some of these uncertainties, the ultimate resolution may result in a payment that is materially different from our current estimate of the tax liabilities. These differences are reflected as increases or decreases to income tax expense in the period in which they are determined. Refer to “ Note 14 .
Due to the complexity of some of these uncertainties, the ultimate resolution may result in a payment that is materially different from our current estimate of the tax liabilities. These differences are reflected as increases or decreases to income tax expense in the period in which they are determined. See “Item 8.
Refer to “Results of Operations” within this 57 Item 7 and “Item 8. Financial Statements and Supplemental Data – Note 5 , Intangible Assets” for a discussion of the results of our 2023 and 2024 assessments of the recoverability and impairment of our long-lived assets.
Refer to “Results of Operations – Impairment of Intangible Assets ” within this Item 7 and “Item 8. Financial Statements and Supplemental Data – Note 5 . Intangible Assets” for a discussion of the results of our 2025 and 2024 assessments of the recoverability and impairment of our long-lived assets.
Cash Flows from Financing Activities Cash used in financing activities for the year ended December 31, 2024, was $0.4 million, which consisted entirely of cash used for employees’ withholding tax liability upon the vesting of stock awards.
Cash Flows from Financing Activities Cash used in financing activities for the year ended December 31, 2025 and December 31, 2024 was $0.2 million and $0.4 million, respectively, and consisted entirely of cash used from employees’ withholding tax liability upon the vesting of employee stock awards.
Sales adjustments for reserves recorded in prior periods for previously divested products resulted in an increase to total revenue of $2.1 million and $0.2 million for the years ended December 31, 2024 and December 31, 2023, respectively.
Sales adjustments for reserves recorded in prior periods for previously divested products resulted in an increase to total revenue of $2.1 million for the year ended December 31, 2024.
On August 22, 2022, we issued $70.0 million aggregate principal amount of 2027 Convertible Notes which mature on September 1, 2027 and bear interest at a rate of 6.5% per annum, payable semi-annually in arrears on March 1 and September 1 of each year. On February 27, 2023, we completed the Convertible Note Exchange.
On August 22, 2022, we issued $70.0 million aggregate principal amount of convertible senior notes which mature on September 1, 2027 and bear interest at a rate of 6.5% per annum, payable semi-annually in arrears on March 1 and September 1 of each year (the “2027 Convertible Notes”).
We recognize tax liabilities in accordance with ASC Topic 740, Tax Provisions, and we adjust these liabilities when our judgment changes as a result of the evaluation of new information not previously available.
We recognize tax liabilities in accordance with Accounting Standards Codification Topic 740, Income Taxes , and we adjust these liabilities when our judgment changes as a result of the evaluation of new information not previously available.
The remaining balance of $76.3 million and $58.1 million as of December 31, 2024 and 2023, respectively, is recognized in Accrued rebates, returns and discounts in the Company’s Consolidated Balance Sheets.
The remaining balance of $99.4 million and $76.3 million as of December 31, 2025 and 2024, respectively, is recognized in Accrued rebates, returns and discounts in the Company’s Consolidated Balance Sheets.
Other revenue Other revenue consists of sales adjustments for previously divested products, which includes adjustments to reserves for product s ales allowances (gross-to-net sales allowances) and can res ult in a reduction to or an increase to total revenue during the period.
Other revenue Other revenue consists of sales adjustments for previously divested products, which includes adjustments to reserves for product s ales allowances (gross-to-net sales allowances) and can res ult in a reduction to or an increase to total revenue in the period of recognition. There was no other revenue for the year ended December 31, 2025.
Fluctuations in any of these will impact our cash flows from operating activities recognized in future periods. Cash Flows from Investing Activities Cash used in investing activities was $48.9 million for the year ended December 31, 2024, which consisted of $98.6 million of purchases of short-term investments, partially offset by $49.7 million of proceeds from maturities of short-term investments.
Cash used in investing activities was $48.9 million for the year ended December 31, 2024, which consisted of $98.6 million of purchases of short-term investments, partially offset by $49.7 million of proceeds from maturities of short-term investments.
It should be noted that we have generated a top-line and as-adjusted cumulative loss for the thirty-six month period ended December 31, 2024. All of our deferred tax assets (“DTA”) are recorded by our U.S. operations, and the U.S. does not permit carryback of losses.
We have generated a top-line and as-adjusted cumulative loss for the three year period ended December 31, 2025. All our deferred tax assets (“DTA”) are recorded by our U.S. operations, and the U.S. does not permit carryback of losses.
As of December 31, 2024, we concluded that it is not more likely than not that we will realize the net deferred tax asset recorded as of December 31, 2024. As a result, we have recorded a full valuation allowance against the net deferred tax asset as of December 31, 2024.
As of December 31, 2025 and December 31, 2024, we concluded that it is not more likely than not that the net deferred tax asset recorded as of those dates will be realized. As a result, we recorded a full valuation allowance against our net deferred tax asset as of both December 31, 2025 and December 31, 2024.
Additionally, we noted no tax planning strategies or tax planning actions which would allow for the use of the net domestic DTAs recorded as of December 31, 2024.
Additionally, we did not identify any tax planning strategies or tax planning actions which would allow for the use of the net domestic DTAs recorded as of December 31, 2025.
Our performance obligation is to deliver product to the customer, and the performance obligation is completed upon delivery. The transaction price consists of a fixed invoice price and variable product sales allowances, which include rebates, discounts and returns. Product sales revenues are recorded net of applicable sales tax and reserves for these product sales allowances (gross-to-net sales allowances).
Our performance obligation is to deliver product to the customer, and the performance obligation is typically completed upon delivery. The transaction price consists of a fixed invoice price and variable product sales allowances, which include rebates, discounts and returns.
For the assessments performed for each of the three months ended September 30, 2024, June 30, 2024 and March 31, 2024, we determined that the estimated undiscounted cash flows were in excess of the carrying amounts for all of our long-lived asset groups at each impairment testing date.
For all the assessments for our other asset groups performed during each quarter in 2025 and 2024, we determined that the estimated undiscounted cash flows were in excess of the carrying amounts for all our long-lived asset groups at each impairment testing date.
We do not assume financial responsibility for returns of any of our currently marketed products if those returns relate to sales of that product prior to or after the period of our ownership of the respective product, which are identified by specific lot numbers. 56 Shelf lives for our products, from the respective manufacture dates, range from 24 months to 48 months.
We do not assume financial responsibility for returns of any of our currently marketed products acquired through product rights acquisitions if those returns relate to sales of that product prior to or after the period of our ownership of the respective product, which are identified by specific lot numbers.
Sympazan net product sales increased $0.5 million from $9.9 million for the year ended December 31, 2023 to $10.5 million for the year ended December 31, 2024, primarily due to higher volume.
Sympazan net product sales increased $0.9 million from $10.5 million for the year ended December 31, 2024 to $11.3 million for the year ended December 31, 2025, primarily due to higher volume, partially offset by unfavorable payor mix.
We generally pay government rebates three to 12 months after prescriptions subject to the rebate are filled. These rebates are subject to our active participation in the respective programs.
We generally pay government rebates three to 12 months after prescriptions subject to the rebate are filled.
Commitments and Contingencies”; • milestone and royalty revenue we receive under our collaborative development arrangements; • interest and principal payments on our current and future indebtedness; • acquisitions or licenses of complementary businesses, products, technologies or companies; • financial terms of definitive license agreements or other commercial agreements we may enter into; • changes in the focus and direction of our business strategy and/or research and development programs; • potential expenses, including termination expenses if a decision is made to cease development of Spectrum’s de-prioritized development asset poziotinib; and • expenditures related to future clinical trial costs.
Commitments and Contingencies;” • potential payments required as a result of ceasing commercialization of Otrexup in July 2025; • potential payments for income and other taxes to the extent that they cannot be offset against our net operating loss (“NOL”) carryforwards; 52 • acquisitions or licenses of complementary businesses, products, technologies or companies; • financial terms of definitive license agreements or other commercial agreements we may enter into; • milestone and royalty revenue we receive under our collaborative development arrangements; • changes in the focus and direction of our business strategy and/or research and development programs; • potential expenses, including termination expenses if a decision is made to cease development of Spectrum’s de-prioritized development asset poziotinib; and • expenditures related to future clinical trial costs.
(4) Consists of sales adjustments for previously divested products recognized in Other revenue in the Consolidated Statements of Comprehensive Loss. (5) Balance includes allowances for cash discounts for prompt payment of $1.2 million and $0.9 million as of December 31, 2024 and 2023, respectively, which are recognized in Account receivable, net in the Company’s Consolidated Balance Sheets.
(5) Balance includes allowances for cash discounts for prompt payment of $3.0 million and $1.2 million as of December 31, 2025 and 2024, respectively, which are recognized in Account receivable, net in the Company’s Consolidated Balance Sheets.
For a discussion and analysis of our results of operations for the year ended December 31, 2023 compared to the year ended December 31, 2022, please refer to Part II, Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2023. 46 Overview We are a pharmaceutical company with comprehensive commercial capabilities offering differentiated products designed to address patients’ needs.
For a discussion and analysis of our results of operations for the year ended December 31, 2024 compared to the year ended December 31, 2023, please refer to Part II, Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2024.
We expect expenses associated with this clinical trial to be significantly reduced in future periods. 50 Selling, General and Administrative Expenses Selling, general and administrative expenses primarily consist of personnel, contract personnel, marketing and promotion expenses, personnel expenses to support our administrative and operating activities, facility costs, and professional expenses, such as legal and accounting fees.
Selling, General and Administrative Expenses Selling, general and administrative expenses primarily consist of personnel, contract personnel, marketing and promotion expenses, personnel expenses to support our administrative and operating activities, facility costs, and professional expenses, such as legal and accounting fees.
(2) Other Sales Allowances consist of wholesaler and pharmacy discounts, prompt pay discounts, patient discount programs, and chargebacks. (3) Includes adjustments to revenue recognized as a result of changes in estimates for the Company’s gross-to-net sales allowances for products sold in previous periods, which were approximately 3% and 3% for the years ended December 31, 2024 and 2023.
(3) Includes adjustments to revenue recognized as a result of changes in estimates for the Company’s gross-to-net sales allowances for products sold in previous periods, which were approxima tely 7% a nd 3% for the years ended December 31, 2025 and 2024, respectively.
Our focus is on supporting patients by marketing products in oncology, neurology, and pain management.
Our focus is on supporting patients by marketing products primarily in the oncology market.
Any significant unfavorable changes in the estimated undiscounted future cash flows may also impact the related assets, such as inventory, leading to 51 potential charges in addition to a potential impairment.
Any significant unfavorable changes in the estimated undiscounted future cash flows may also impact the related assets, such as inventory, leading to potential charges in addition to a potential impairment. Any future impairment of our long-lived assets may result in material charges that could have a material adverse effect on our business and financial results.
For the assessment performed for the three months ended December 31, 2024, we determined that the estimated undiscounted cash flows and fair value of the Otrexup asset group were less than its carrying value and recognized an impairment loss for this asset group of approximately $5.2 million, reducing its carrying value to zero.
For the assessment performed for the three months ended September 30, 2025, we determined that the undiscounted cash flows and the fair value of the SPRIX asset group were less than its carrying value and recognized an impairment for this asset group of $1.7 million during the third quarter of 2025, reducing its carrying value to $4.6 million.
The following table reflects activity relating to the Company’s provision for product sales allowances as of December 31, 2024 and 2023 (in thousands): Product Returns Rebates (1) Other Sales Allowances (2) Total (4) Balance as of December 31, 2022 $ 31,287 $ 7,685 $ 11,340 $ 50,312 Provisions made in current period to Product Sales, net (3) 7,842 24,901 51,782 84,525 Provisions made in current period to Other revenue (4) — — (185) (185) Payments and credits made in current period (9,340) (18,083) (48,183) (75,606) Balance as of December 31, 2023 $ 29,789 $ 14,503 $ 14,754 $ 59,046 Provisions made in current period to Product Sales, net (3) 5,796 59,107 105,998 170,901 Provisions made in current period to Other revenue (4) (2,100) — — (2,100) Payments and credits made in current period (11,130) (52,696) (86,553) (150,379) Balance as of December 31, 2024 $ 22,355 $ 20,914 $ 34,199 $ 77,468 (1) Rebates consist of managed care rebates, commercial rebates and government rebates.
These rebates are subject to our active participation in the respective programs. 55 The following table reflects activity relating to the Company’s provision for product sales allowances as of December 31, 2025 and 2024 (in thousands): Product Returns Rebates (1) Other Sales Allowances (2) Total (5) Balance as of December 31, 2023 $ 29,789 $ 14,503 $ 14,754 $ 59,046 Provisions made in current period to Product Sales, net (3) 5,796 59,107 105,998 170,901 Provisions made in current period to Other revenue (4) (2,100) — — (2,100) Payments and credits made in current period (11,130) (52,696) (86,553) (150,379) Balance as of December 31, 2024 $ 22,355 $ 20,914 $ 34,199 $ 77,468 Provisions made in current period to Product Sales, net (3) (1,644) 80,267 143,077 221,700 Payments and credits made in current period (4,165) (79,560) (113,095) (196,820) Balance as of December 31, 2025 $ 16,546 $ 21,621 $ 64,181 $ 102,348 (1) Rebates consist of managed care rebates, commercial rebates and government rebates.
Research and development expenses w ere $3.8 million and $2.8 million for the years ended December 31, 2024 and 2023, respectively, primarily representing costs directly associated with the same-day dosing clinical trial of ROLVEDON, which we concluded in the fourth quarter of 2024.
Research and development expenses were $1.7 million and $3.8 million for the years ended December 31, 2025 and 2024, respectively, primarily representing costs directly associated with ongoing clinical activity for the ROLVEDON pediatric safety trial in 2025 and 2024, as well as the same-day dosing trial in 2024.
Otrexup net product sales decreased $3.2 million from $12.0 million for the year ended December 31, 2023 to $8.8 million for the year ended December 31, 2024, primarily due to unfavorable payor mix and lower volume.
SPRIX net product sales increased $0.3 million from $7.6 million for the year ended December 31, 2024 to $8.0 million for the year ended December 31, 2025, primarily due to favorable payor mix, partially offset by lower volume.
We recognized no expense or benefit for the change in fair value of the CVR contingent consideration obligation during the year ended December 31, 2024, and a benefit of $3.9 million during the year ended December 31, 2023.
We recognized no expense or benefit for the change in fair value of the CVR contingent consideration obligation during the years ended December 31, 2025 or December 31, 2024, as the milestones triggering payment of the obligation were not met.
Our estimates related to gross‑to‑net sales adjustments for product return allowances and rebates are judgmental and are subject to change based on our historical experience and certain quantitative and qualitative factors.
If actual future results vary from our estimates, we may need to adjust the estimates, which could affect product sales and earnings in the period of adjustment. Our estimates related to gross‑to‑net sales adjustments for product return allowances and rebates are judgmental and are subject to change based on our historical experience and certain quantitative and qualitative factors.
The December 31, 2023 income tax expense also included the valuation allowance for utilization of our deferred tax assets to offset the deferred tax liabilities of Spectrum recorded through acquisition accounting. 53 LIQUIDITY AND CAPITAL RESOURCES We have financed and continue to finance our operations and business development efforts primarily from product sales, public sales of equity securities, including convertible debt securities, and the proceeds of secured borrowings.
LIQUIDITY AND CAPITAL RESOURCES We have financed, and continue to finance, our operations and business development efforts primarily from product sales, the proceeds of secured borrowings, and public sales of equity securities, including convertible debt securities.
SPRIX net product sales decreased $1.5 million from $9.2 million for the year ended December 31, 2023 to $7.6 million for the year ended December 31, 2024, primarily due to lower volume.
INDOCIN net product sales decreased $7.9 million from $26.8 million for the year ended December 31, 2024 to $18.9 million for the year ended December 31, 2025, primarily due to lower volume from previously announced generic competition.
For the year ended December 31, 2024, the amount recognized for gross-to-net sales allowances on product sales increased by $86.4 million compared to the year ended December 31, 2023, primarily due to a shift in product mix from INDOCIN to ROLVEDON, which resulted in a higher rate of commercial and governmental rebates recognized for 49 ROLVEDON.
For the year ended December 31, 2025, the amount recognized for gross-to-net sales allowances on product sales increased by $50.8 million compared to the year ended December 31, 2024, primarily due to higher ROLVEDON sales volumes and a continued shift in product mix toward ROLVEDON, which carries a higher contractual rebate rate than our other products.
Our cash needs may vary materially from our current expectations because of differences between the actual cash impacts and our expected impacts related to numerous factors, including: • expenditures related to the commercialization of our products, including our efforts to manage supply costs and enhance the long-term prospects of ROLVEDON product sales; • the timing of our purchases of inventory pursuant to our supply agreements, such as the increased purchases of ROLVEDON inventory that occurred in 2024, and the impact this may have on our inventory purchases in future periods; • declines in sales of our marketed products, including those resulting from the entry and sales of generics and/or other products competitive with any of our products; • potential additional expenses relating to any litigation matters, as discussed in “Item 8.
Our cash needs may vary materially from our current expectations because of numerous factors, including: • reductions in net product sales and gross margin in the first quarter of 2026 due to the transition of ROLVEDON from Spectrum to Assertio Specialty; • changes in our working capital needs, including the timing of purchases and manufacturing of our inventories, the timing of payment of our accounts payable and accrued rebates, returns and discounts, and the timing of accounts receivable collections, due to the large purchases of ROLVEDON inventory by several national distributors in the third quarter of 2025 noted above; • interest and principal payments on our current and future indebtedness; • our level of expenditures related to the commercialization of our products, including our efforts to manage supply costs and enhance the long-term prospects of ROLVEDON product sales; • the timing of our purchases of inventory pursuant to our supply agreements, including those that may be required under the Amendment to the Hanmi Agreement, and the impact this may have on our inventory purchases in future periods; • declines in sales of our marketed products, including those resulting from the entry and sales of generics and/or other products competitive with any of our products; • potential additional expenses relating to any litigation matters, as discussed in “Item 8.
SPRIX ® (ketorolac tromethamine) Nasal Spray A prescription NSAID indicated in adult patients for the short-term (up to five days) management of moderate to moderately severe pain that requires analgesia at an opioid level.
Both products are nonsteroidal anti-inflammatory drugs (“NSAIDs”), indicated for: • Moderate to severe rheumatoid arthritis including acute flares of chronic disease • Moderate to severe ankylosing spondylitis INDOCIN ® (indomethacin) Oral Suspension • Moderate to severe osteoarthritis • Acute painful shoulder (bursitis and/or tendinitis) • Acute gouty arthritis SPRIX ® (ketorolac tromethamine) Nasal Spray A prescription NSAID indicated in adult patients for the short-term (up to five days) management of moderate to moderately severe pain that requires analgesia at an opioid level.
The difference between the income tax expense of $0.1 million and the tax at the statutory rate of 21.0% on current year operations is primarily due to the impact of the valuation allowance and net operating losses recognized in the current year, partially offset by state income taxes.
The difference between the income tax expense and the tax at the federal statutory rate of 21.0% in each period was primarily due to changes in the valuation allowance due to our net loss, partially offset by state tax expense and the loss recorded on sale of Assertio Therapeutics.
Other net product sales for the year ended December 31, 2023 of $4.9 million include net product sales for Zipsor of $3.5 million and net product sales for OXAYDO of $1.4 million.
Other net product sales for the year ended December 31, 2025 and December 31, 2024 included net product sales of Otrexup of $4.5 million and $8.8 million, respectively, net product sales of CAMBIA of $5.7 million and $5.6 million, respectively, and net product sales of Zipsor of $0.5 million and $1.5 million, respectively.
Loss on Impairment of Long-Lived Assets Dur ing each of the three months ended December 31, 2024, September 30, 2024, June 30, 2024 and March 31, 2024, we determined that the book value of our equity exceeded our market capitalization, which management determined represented an indicator of impairment with respect to our long-lived assets.
Impairment of Intangible Assets During each quarter of 2025 and 2024, our market capitalization was below the book value of our equity, which management determined represented an indicator of impairment with respect to our long-lived assets.
Organization and Summary of Significant Accounting Policies” for additional information on recent accounting pronouncements.
Financial Statements and Supplemental Data - Note 14 . Income Taxes” for additional information. RECENT ACCOUNTING PRONOUNCEMENTS See “Item 8. Financial Statements and Supplemental Data - Note 1 . Organization and Summary of Significant Accounting Policies” for additional information on recent accounting pronouncements.
Amortization of Intangible Assets The following table reflects amortization of intangible assets for the years ended December 31, 2024 and 2023 (in thousands): Year ended December 31, 2024 2023 Amortization of intangible assets—ROLVEDON $ 6,066 $ 5,270 Amortization of intangible assets—INDOCIN 13,514 11,321 Amortization of intangible assets—Sympazan 1,212 1,213 Amortization of intangible assets—Otrexup 1,044 4,592 Amortization of intangible assets—SPRIX 3,808 5,131 Total amortization of intangible assets $ 25,644 $ 27,527 Amortization expense decreased $1.9 million from $27.5 million for the year ended December 31, 2023 to $25.6 million for the year ended December 31, 2024, primarily as a result of a decrease in amortization expense o f $9.4 mi llion attributable to the lower carrying value of intangible assets due to impairment charges recognized in the third and fourth quarters of 2023, partially offset by (i) an increase of $0.8 million due to additional amortization of ROLVEDON product rights, acquired in July 2023, and (ii) an increase in amortization expense of $6.7 m illion , which was due to revisions to decrease the remaining estimated useful life of the INDOCIN product rights intangible assets.
Amortization of Intangible Assets The following table reflects amortization of intangible assets for the years ended December 31, 2025 and 2024 (in thousands): Year ended December 31, 2025 2024 Amortization of intangible assets—ROLVEDON $ 17,356 $ 6,066 Amortization of intangible assets—Sympazan 1,213 1,212 Amortization of intangible assets—SPRIX 4,017 3,808 Amortization of intangible assets—INDOCIN 7,277 13,514 Amortization of intangible assets—Otrexup — 1,044 Total amortization of intangible assets $ 29,863 $ 25,644 Amortization expense increased $4.2 million from $25.6 million for the year ended December 31, 2024 to $29.9 million for the year ended December 31, 2025, primarily due to an increase of $11.3 million related to a change in the remaining estimated useful life of the ROLVEDON product rights intangible assets effective December 31, 2024, as well as a $0.2 million increase related to a change in the remaining estimated useful life of the SPRIX product rights intangible assets effective October 1, 2025.
We were in compliance with our covenants with respect to the 2027 Convertible Notes as of December 31, 2024. 54 The following table reflects summarized cash flow activities for the years ended December 31, 2024 and 2023 (in thousands): Year ended December 31, 2024 2023 Net cash provided by operating activities $ 26,408 $ 49,604 Net cash (used in) provided by investing activities (48,911) 3,097 Net cash used in financing activities (350) (44,201) Net (decrease) increase in cash and cash equivalents (22,853) 8,500 Cash and cash equivalents at beginning of year 73,441 64,941 Cash and cash equivalents at end of year $ 50,588 $ 73,441 Cash Flows from Operating Activities C a sh provided by operating activities was $26.4 million for the year ended December 31, 2024 compared to $49.6 million for the year ended December 31, 2023, primarily due to lower net product sales and a change in product mix for the year ended December 31, 2024 compared to the year ended December 31, 2023.
The following table reflects summarized cash flow activities for the years ended December 31, 2025 and 2024 (in thousands): Year ended December 31, 2025 2024 Net cash (used in) provided by operating activities $ (28,182) $ 26,408 Net cash used in investing activities (11,988) (48,911) Net cash used in financing activities (189) (350) Net decrease in cash and cash equivalents (40,359) (22,853) Cash and cash equivalents at beginning of year 50,588 73,441 Cash and cash equivalents at end of year $ 10,229 $ 50,588 Cash Flows from Operating Activities Cash used in operating activities was $28.2 million for the year ended December 31, 2025 compared to cash provided by operating activities of $26.4 million for the year ended December 31, 2024.
The following table reflects interest expense for the years ended December 31, 2024 and 2023 (in thousands): Year ended December 31, 2024 2023 Interest on 2027 Convertible Notes $ 2,600 $ 2,925 Amortization of debt issuance costs 439 455 Total interest expense $ 3,039 $ 3,380 Total interest expense decreased $0.3 million from $3.4 million for the year ended December 31, 2023 to $3.0 million for the year ended December 31, 2024, primarily due to a lower principal balance of our outstanding 6.5% Convertible Senior Notes due 2027 as a result of the Convertible Note Exchange.
The following table reflects interest expense for the years ended December 31, 2025 and 2024 (in thousands): Year ended December 31, 2025 2024 Interest on 2027 Convertible Notes $ 2,600 $ 2,600 Amortization of debt issuance costs on 2027 Convertible Notes 475 439 Total interest expense $ 3,075 $ 3,039 Income Tax Provision We recorded income tax expense of $0.4 million and $0.1 million for the years ended December 31, 2025 and December 31, 2024, respectively.
In 2025, we expect INDOCIN net product sales to continue to be impacted unfavorably by increasing competition as a result of existing generic entrants, new and expected future generic entrants, including the new generic entrant that launched in January 2025, and other competitive products.
In 2026, we expect INDOCIN net product sales to continue to decline as a result of continued competition from existing generic entrants, as well as new and expected future generic entrants.
The sum of the undiscounted cash flows could continue to decrease in the event of significant unfavorable changes in their estimated undiscounted future cash flows due to increased competition and, in the case of INDOCIN, due to potential future generic entrants.
Although the SPRIX asset group was written down to its fair value as of September 30, 2025, the sum of the undiscounted cash flows could continue to decrease in the event of significant unfavorable changes in their estimated undiscounted future cash flows due to increased competition.
Change in fair value of contingent consideration represents the change in fair value, if any, of our contingent consideration obligations which are remeasured each reporting period. During the years ended December 31, 2024 and 2023, we recognized benefits of $0.2 million and $21.6 million, respectively, for the change in fair value of contingent consideration obligation incurred in the Zyla Merger.
We recognized a benefit of $0.3 million and $0.2 million during the years ended December 31, 2025 and December 31, 2024, respectively, for the change in f air value of contingent consideration incurred in the Zyla Merger.
Cost of sales are impacted by both product volume and mix, changes in which will have an impact on Cost of sales recognized by us in future periods . In 2025, we expect Cost of sales, as a percentage of sales, to continue to be negatively affected by changes in product volume and mix.
Cost of sales are impacted by both product volume and mix, changes in which will have an impact on Cost of sales recognized by us in future periods. Research and Development Expenses Research and development expenses include salaries, costs for clinical trials, consultant fees, supplies, and allocations of corporate costs.
The counterparty to the license agreement independently contracts with manufacturers to produce a specific CAMBIA formulation in Canada. We recognized royalties revenue related to the CAMBIA license agreement of $2.0 million for each of the years ended December 31, 2024 and 2023.
We recognized royalty revenue related to the CAMBIA licensing agreement of $1.6 million and $2.0 million for the years ended December 31, 2025 and 2024, respectively.
Selling, general, and administrative expenses decreased $3.6 million from $78.6 million for the year ended December 31, 2023 to $75.1 million for the year ended December 31, 2024, primarily due to: (i) $8.9 million of transaction-related expenses, primarily legal and professional fees, associated with the Spectrum Merger that were recognized in the prior year, of which there were none in the current year, (ii) a $4.1 million decrease in stock-based compensation expense, (iii) a $3.0 million decrease in operating expenses from cost savings initiatives implemented following the Spectrum Merger, and (iv) a $1.0 million decrease in sales and marketing expenses.
Selling, general, and administrative expenses decreased $6.1 million from $75.1 million for the year ended December 31, 2024 to $69.0 million for the year ended December 31, 2025, primarily due to (i) a $4.7 million net decrease in legal charges and settlements of certain litigation items, (ii) $2.4 million of income recognized during the year ended December 31, 49 2025 related to the lapsing of the statute of limitations for employee retention tax credits, of which there was none in 2024, (iii) a $1.6 million decrease in stock-based compensation expense, primarily driven by forfeitures related to our 2025 restructuring actions, and (iv) a $0.2 million decrease in other general operating expenses.
Prior to this, payments made for contingent consideration up to the INDOCIN contingent consideration liability recognized at the acquisition date were classified as cash flows from financing activities. Cash flows from operating activities are impacted by, among other things, product revenue, operating profit and changes in working capital.
Cash flows from operating activities are impacted by, among other things, product revenue, operating profit and changes in working capital. Fluctuations in any of these will impact our cash flows from operating activities recognized in future periods.
The Spectrum Reorganization Plan was primarily focused on the reduction of staff at our headquarters office and the exit of certain leased facilities. We do not expect to recognize any additional restructuring charges related to the Spectrum Reorganization Plan. We expect all cash payments under the Spectrum Reorganization Plan to be completed by the end of 2025.
We do not expect to recognize any additional restructuring charges related to this restructuring effort, and a ll related cash payments were completed by the third quarter of 2025.
Pursuant to the Convertible Note Exchange, 6,990,000 shares of the Company’s common stock, plus an additional $10.5 million in cash, were issued in a partial settlement of the 2027 Convertible Notes. The terms of the 2027 Convertible Notes are governed by an indenture dated August 25, 2022 (the “2027 Convertible Note Indenture”).
On February 27, 2023, we completed a privately negotiated exchange of $30.0 million principal amount of the 2027 Convertible Notes. The terms of the 2027 Convertible Notes are governed by an indenture dated August 25, 2022 (the “2027 Convertible Note Indenture”).
Cost of sales increased $12.2 million from $27.0 million for the year ended December 31, 2023 to $39.2 million for the year ended December 31, 2024, primarily due a $6.2 million increase in cost of sales related to changes in product mix, primarily fr om INDOCIN to ROLVEDON, and $6.0 million of higher inventory write-downs, primarily for INDOCIN and ROLVEDON, due to lower demand for INDOCIN and the manufacture of batches of ROLVEDON that did not meet our quality standards.
Cost of sales decreased $3.8 million from $39.2 million for the year ended December 31, 2024 to $35.4 million for the year ended December 31, 2025, primari ly due to (i) a $6.6 million decrease in inventory write-downs, primarily for INDOCIN due to lower demand for INDOCIN products, (ii) a $4.6 million of ROLVEDON inventory step-up amortization included in the year ended December 31, 2024, which did not recur in the year ended December 31, 2025, (iii) a $1.9 million decrease in Otrexup cost of sales primarily due to ceasing commercialization of Otrexup in July 2025, (iv) a $0.9 million decline in INDOCIN cost of sales due to lower INDOCIN sales volume, and (v) a $0.2 million decrease in other cost of sales.
As we ceased OXAYDO product sales beginning in September 2023, other net product sales of $1.5 million for the year ended December 31, 2024 represent only net product sales of Zipsor. The decrease in other net product sales of Zipsor of $2.0 million was primarily due to unfavorable payor mix and lower volume.
The change was primarily due to higher net working capital needs and lower net product sales. Operating assets and liabilities resulted in a net cash use of $45.3 million for the year ended December 31, 2025 compared to net cash provided of $5.2 million for the year ended December 31, 2024.
Applying the relevant accounting guidance, management first assessed the recoverability of our long-lived assets at the product level at each date.
For the three months ended September 30, 2025, we also recognized an additional indicator of impairment in our SPRIX asset group related to a change in the expected timing of cash flows from SPRIX net product sales. Applying the relevant accounting guidance, we first assessed the recoverability of our long-lived assets at the product level at each date.
Removed
Both products are nonsteroidal anti-inflammatory drugs (“NSAIDs”), indicated for: • Moderate to severe rheumatoid arthritis including acute flares of chronic disease • Moderate to severe ankylosing spondylitis INDOCIN ® (indomethacin) Oral Suspension • Moderate to severe osteoarthritis • Acute painful shoulder (bursitis and/or tendinitis) • Acute gouty arthritis Otrexup ® (methotrexate) injection for subcutaneous use A once weekly single-dose auto-injector containing methotrexate.
Added
Overview Unless otherwise noted or required by context, use of “Assertio,” the “Company,” “we,” “our” and “us” refer to Assertio Holdings and/or its applicable subsidiary or subsidiaries. Reference to “Assertio Specialty” refers to Assertio Specialty Pharmaceuticals, LLC, and “Spectrum” refers to Spectrum Pharmaceuticals, Inc. and/or its applicable subsidiary or subsidiaries.
Removed
Otrexup is a folate analog metabolic inhibitor indicated for the: • Management of patients with severe, active rheumatoid arthritis (“RA”) and polyarticular juvenile idiopathic arthritis (“pJIA”), who are intolerant of or had an inadequate response to first-line therapy. • Symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy.
Added
Both Assertio Specialty and Spectrum are wholly-owned subsidiaries of the Company. Additionally, the use of “Assertio Therapeutics” refers to Assertio Therapeutics, Inc., and/or its applicable subsidiary or subsidiaries. Assertio Therapeutics was divested on May 9, 2025. We are a pharmaceutical company with comprehensive commercial capabilities offering differentiated products designed to address patients’ needs.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

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Biggest changeITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK We are a smaller reporting company, as defined by Rule 12b-2 of the Exchange Act, and therefore are not required to provide the information called for by this Item 7A in this report. 59
Biggest changeITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK We are a smaller reporting company, as defined by Rule 12b-2 of the Exchange Act, and therefore are not required to provide the information called for by this Item 7A in this report. 57

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