OGN 10-K & 10-Q changes, risk factors and insider trading
Organon & Co. · NYSE · Pharmaceutical Preparations · CIK 1821825 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
New heading “The imposition of tariffs on, or other trade restrictions or domestic sourcing requirements in, the territories and countries where we, our partners, suppliers, or customers do business, as well as any retaliatory actions with respect to such actions, could have a material adverse effect on our business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, or stock price.”
New heading “Changes in tax laws or other tax guidance could adversely affect our effective tax rates, financial condition or results of operations.”
New heading “The completion of the self-initiated Audit Committee internal investigation and the subsequent implementation of our remediation plan has been time-consuming and expensive and may result in significant additional expense and/or litigation.”
New heading “We identified material weaknesses in our internal control over financial reporting, which could impact our ability to report our results of operations and financial condition accurately and in a timely manner.”
New heading “The use of AI and its legislative and regulatory landscape continues to evolve and makes it difficult to fully understand and assess related risks.”
New heading “We may not be able to successfully execute our plan to deleverage our business or otherwise reduce our debt level, which could adversely affect our operating flexibility, business, financial condition, results of operations, or cash flows.”
New heading “Recent global healthcare reform initiatives, and U.S. judicial decisions, laws, regulations, executive orders and political actions could adversely affect our future revenues and profitability.”
New heading “If we fail to appoint, hire and retain a permanent CEO, other members of our senior management, or other key employees, our business may suffer.”
New heading “We have limited in-house discovery and limited cash to pursue early research capabilities and any expansion of our innovative pipeline and early discovery and research capabilities through future external acquisitions, partnerships and collaborations, which may limit our ability to discover or develop new products or expand our existing products into new markets to replace the sales of products that lose patent protection.”
New heading “Our growth could be limited by the scope of our intellectual property licenses.”
New heading “We may experience difficulties in connection with future acquisitions, divestitures and other strategic actions. Even if completed, we may have difficulty integrating or otherwise realizing the benefits of such transactions.”
New heading “Our research and development of new pharmaceutical product candidates or medical devices going forward will be limited, and for those development projects we elect to pursue we and/or our partners may fail to adequately demonstrate the safety and efficacy of any product in pre-clinical studies and clinical trials, which would prevent or delay development, regulatory approval or marketing authorization and commercialization of our product candidates.”
New heading “We may experience difficulties or delays or incur unforeseen difficulties, delays and expenses in connection with the manufacturing of certain of our products.”
New heading “We rely on our commercialization agreements with Samsung Bioepis, Henlius and Biothera for the successful development and manufacture of our biosimilars products and expect to do so for the foreseeable future.”
New heading “The FDA’s shift toward “radical transparency,” including plans to release future complete response letters promptly after they are issued to sponsors and increase enforcement in advertising and promotion, could have an adverse impact on our business and adversely affect our commercial prospects.”
New heading “Our global business could be negatively impacted by corporate citizenship and sustainability matters, which are viewed differently by the U.S. presidential administration and certain U.S. states than under various EU frameworks.”
Removed heading “We face continued pricing pressure with respect to our products.”
Removed heading “We have limited in-house discovery and early research capabilities and will continue to rely on future acquisitions, partnerships and collaborations to expand our innovative pipeline and early discovery and research capabilities, which may limit our ability to discover or develop new products or expand our existing products into new markets to replace the sales of products that lose patent protection, and therefore we may not be able to maintain our current levels of profitability.”
Removed heading “Our growth could be limited by the scope of our intellectual property licenses for certain women’s health care products.”
Removed heading “We may experience difficulties identifying future acquisition opportunities or completing such transactions. Even if we complete such transactions, we may have difficulty integrating or otherwise realizing the benefits of such acquisitions.”
Removed heading “We and/or our partners may fail to adequately demonstrate the safety and efficacy of any of our pharmaceutical product candidates or medical devices in pre-clinical studies and clinical trials, which would prevent or delay development, regulatory approval or marketing authorization and commercialization of our product candidates.”
Removed heading “We have incurred substantial indebtedness, which could adversely affect our financial condition and results of operations.”
Removed heading “The health care industry in the United States has been, and will continue to be, subject to judicial decisions and increasing laws, regulation, executive orders and political action.”
Removed heading “We may experience difficulties or delays or incur unforeseen expenses in connection with the manufacturing certain of our products.”
Removed heading “Our reputation and promising pipeline render our products prime targets for counterfeiters.”
Removed heading “If we or our third-party suppliers, logistics, and manufacturers do not comply with ethical business practices or with related laws and regulations, including relating to AI use, our reputation, business, financial condition, results of operations and prospects could be harmed. Our third-party suppliers use of AI that does not comply with ethical standards, industry recognized AI frameworks or related laws and regulations will expose us to various risks including those relating to privacy, cybersecurity, intellectual property, inaccuracy of data, exposure of our confidential information, producing bias outcomes and overreliance on AI by those third-party suppliers without human oversight.”
Removed heading “Our business could be negatively impacted by corporate citizenship and sustainability matters.”
Removed heading “We rely on our collaboration with Samsung Bioepis and Henlius for the successful development and manufacture of our biosimilars products and expect to do so for the foreseeable future.”
Removed heading “Social media and mobile messaging platforms present risks and challenges.”
Removed heading “Our corporate restructuring and the associated headcount reduction may not result in anticipated savings, could result in total costs and expenses that are greater than expected and could disrupt our business.”
Largest changes
“We rely on third parties to manufacture, distribute and conduct certain preclinical and clinical testing activities for our products. …”see in full comparison
“We rely on third parties to manufacture, distribute and conduct certain preclinical and clinical testing activities for our products. …”see in full comparison
“In connection with the Audit Committee investigation described in Item 9A. “Controls and Procedures”, we identified material weaknesses in our internal control over financial reporting. For a description of these material weaknesses, see “Controls and Procedures” in Part II, Item 9A. “Controls and Procedures” of this 2025 Form 10-K. …”see in full comparison
“Our quantitative goodwill impairment analysis relies on projected cash flows and market assumptions. A significant decline in forecasted performance, whether due to external economic factors or internal operational challenges, could result in the fair value of either the U.S. or international reporting unit falling below its carrying amount. In such cases, we would be required to recognize a non-cash impairment charge, which could materially impact our financial condition and results of operations. …”see in full comparison
“In February 2022, in response to the armed conflict between Ukraine and Russia, trade sanctions, travel bans and asset/financial freezes were announced by the United States, the EU and other countries against Russian entities and designated individuals. Such restrictions have impacted, and may continue to impact, many global businesses in direct and indirect ways (including, but not limited to, product shipping delays, supply shortages, delays in regulatory approvals and audits and currency exchange rates). …”see in full comparison
“We are currently subject to a number of laws and regulations and, in the future, we will likely become subject to new laws and regulations. The costs of compliance with such laws and regulations, or the negative results of non-compliance, could adversely affect our business, cash flow, results of operations, financial condition or prospects. …”see in full comparison
Full comparison: every changed paragraph (213)
You should carefully consider the following risks and other information in this Annual Report on2025 Form 10-K in evaluating usthe Company and deciding whether to invest in our Common Stock. Any of the following risks could materially and adversely affect our results of operations, financial condition and the price of our Common Stock.
The following is a summary of the principal risks that could significantly and negatively affect our business, prospects, financial conditions,condition, or operating results. For a more complete discussion of the material risks facing our business, please see below:
•We have significant global operations, which expose us to additional risks, and any adverse event could adversely affect our results of operations and financial condition.
•The imposition of tariffs on, or other trade restrictions or domestic sourcing requirements in, the territories and countries where we, our partners, suppliers, or customers do business, as well as any retaliatory actions with respect to such actions, could have a material adverse effect on our business, financial condition, results of operations, cash flows, ability to pay dividends or repurchase shares, or stock price.
•Adverse developments in the global economy or in one or more of our local markets could impact our ability to grow our business.
•Changes in tax laws or other tax guidance could adversely affect our effective tax rates, financial condition or results of operations.
•We are exposed to market risk from fluctuations in currency exchange rates and interest rates.
•The completion of the self-initiated Audit Committee (as defined below) internal investigation and the subsequent implementation of our remediation plan has been time-consuming and expensive and may result in significant additional expense and/or litigation.
•We identified material weaknesses in our internal control over financial reporting, which could impact our ability to report our results of operations and financial condition accurately and in a timely manner.
•The use of artificial intelligence (“AI”) and its legislative and regulatory landscape continues to evolve and makes it difficult to fully understand and assess related risks.
•We depend on sophisticated software applications and computing infrastructure. Cyberattacks affecting our IT systems could result in exposure of confidential information, the modification of critical data or the disruption of our worldwide operations, including manufacturing and sales operations.
•We may not be able to successfully execute our plan to deleverage our business or otherwise reduce our debt level, which could adversely affect our operating flexibility, business, financial condition, results of operations, or cash flows.
•Our substantial indebtedness could adversely affect our financial condition and results of operations.
•We are subject to a number of restrictive covenants under our indebtedness, including customary operating restrictions and financial covenants, which could restrict our ability to pay dividends or adversely affect our financing options and liquidity position.
•We are subject to a significant number of privacy and data protection laws and regulations globally, many of which place restrictions on our ability to transfer, access and use personal data across our business.
•Recent global healthcare reform initiatives and U.S., judicial decisions, laws, regulations, executive orders and political actions could adversely affect our future revenues and profitability.
•If we fail to appoint, hire and retain a permanent CEO, other members of our senior management, or other key employees, our business may suffer.
•An impairment of our Goodwill could materially impact our financial condition and results of operations.
•We may not realize benefits from our investments in China and emerging markets.
•We face continued pricing pressure with respect to our products.
•We have limited in-house discovery and limited cash to pursue early research capabilities and willany continueexpansion to rely on future acquisitions, partnerships and collaborations to expandof our innovative pipeline and early discovery and research capabilities,capabilities through future external acquisitions, partnerships and collaborations, which may limit our ability to discover or develop new products or expand our existing products into new markets to replace the sales of products that lose patent protection and therefore we may not be able to maintain our current levels of profitability.protection.
•Our growth could be limited by the scope of our intellectual property licenses for certain women’s health care products.licenses.
•We may experience difficulties identifyingin connection with future acquisitionacquisitions, opportunitiesdivestitures orand completingother suchstrategic transactions.actions. Even if we complete such transactions,completed, we may have difficulty integrating or otherwise realizing the benefits of such acquisitions.transactions.
•WeOur research and development of new pharmaceutical product candidates or medical devices going forward will be limited, and for those development projects we elect to pursue we and/or our partners may fail to adequately demonstrate the safety and efficacy of any of our product candidates in pre-clinical studies and clinical trials, which would prevent or delay development, regulatory approval or clearance,marketing authorization and commercialization of our product candidates.
•We have incurred substantial indebtedness, which could adversely affect our financial condition and results of operations.
•The health care industry in the United States has been, and will continue to be, subject to judicial decisions and increasing laws, regulation, executive orders and political action.
•We may experience difficulties or delays or incur unforeseen difficulties, delays and expenses in connection with the manufacturing of certain of our products.
•We may be unable to obtain sufficient components or raw materials on a timely basis or for a cost-effective price, or we may experience other supply difficulties that could adversely affect both our ability to deliver our products and our results of operations and financial condition.
•Reliance on third-party relationships and outsourcing arrangements could materially adversely affect our business.
•If we or our third-party suppliers, logistics providers, and manufacturers do not comply with ethical business practices or with related laws and regulations, including relating to AI use, our reputation, business, financial condition, results of operations or prospects could be harmed. Our third-party suppliers’ use of AI that does not comply with ethical standards, industry recognized AI frameworks or related laws and regulations will expose us to various risks including those relating to privacy, cybersecurity, intellectual property, inaccuracy of data, exposure of our confidential information, producing bias outcomes and overreliance on AI by those third-party suppliers without human oversight.
•The markets for our products, including the women’s health market, may not develop as expected.
•Biosimilars carry unique regulatory risks and uncertainties, which could adversely affect our results of operations and financial condition.
•We rely on our commercialization agreements with Samsung Bioepis, Henlius and Biothera for the successful development and manufacture of our biosimilars products and expect to do so for the foreseeable future.
•The FDA’s shift toward “radical transparency,” including plans to release future complete response letters promptly after they are issued to sponsors and increase enforcement in advertising and promotion, could have an adverse impact on our business and adversely affect our commercial prospects.
•Our global business could be negatively impacted by corporate citizenship and sustainability matters, which are viewed differently by the U.S. presidential administration and certain U.S. states than under various EU frameworks.
•We or our third-party suppliers, logistics, and manufacturers may not comply with ethical business practices or with related laws and regulations, including relating to AI use.
•Our business could be negatively impacted by corporate citizenship and sustainability matters.
•Our corporate restructuring and the associated headcount reduction may not result in anticipated savings, could result in total costs and expenses that are greater than expected and could disrupt our business.
•The price and trading volume of our Common Stock may be volatile, and stockholders could lose all or part of their investment in us.
•The price and trading volume of our Common Stock may be volatile, and stockholders could lose all or part of their investment in our Company.
•Our amended and restated bylaws designate the Court of Chancery of the State of Delaware as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, and the United States federal district courts as the exclusive forum for claims under the Securities Act of 1933, as amended (the “Securities Act”),Act, which could limit our stockholders’ ability to obtain what such stockholders believe to be a favorable judicial forum for disputes with us or our directors, officers or employees.
Our ability to generate profits and operating cash flow depends largely upon the continued profitability of our key products, such as Nexplanon, Arcoxia, Singulair and the ezetimibe family of products. As a result of our dependence on key products, any event that adversely affects any of these products or the markets for any of these products could adversely affect our sales, results of operations or cash flows. These adverse events could include increased costs associated with manufacturing, product shortages, increased generic or over-the-counter availability of our products or competitive products, the discovery of previously unknown side effects, results of post-approval trials, increased competition from the introduction of new, more effective treatments and discontinuation or removal from the market of these products for any reason. We also expect that competition will continue to adversely affect the sales of these products (including generic competition as a result of LOE in 2024 for Atozet and, if we are unable to obtain an additional period of market exclusivity for Nexplanon).
We face continued pricing pressure with respect to our products.
We face continued pricing pressure in the United States and globally and, particularly in the EU, the United Kingdom, China and Japan, from managed care organizations, government agencies and programs that could adversely affect our sales and profit margins. We expect pricing pressure to continue in the future.
Changes to the health care system due to health care reform in the United States, as well as increased purchasing power of entities that negotiate on behalf of Medicare, Medicaid, and private sector beneficiaries, could result in further pricing pressures.
In addition, in the United States, larger customers have received higher rebates on drugs in certain highly competitive categories. We must also compete to be placed on formularies of managed care organizations and other payors. Exclusion of a product from a formulary can lead to reduced usage in the population covered by the managed care organization or other payor. Outside the United States, numerous major markets, such as the EU, the United Kingdom, China and Japan, have active government involvement including extensive pricing and reimbursement mechanisms and processes for pharmaceutical products affecting our products. Cost containment efforts by governments and private organizations are described in greater detail in the Business-Regulatory section above.
We have limited in-house discovery and early research capabilities and will continue to rely on future acquisitions, partnerships and collaborations to expand our innovative pipeline and early discovery and research capabilities, which may limit our ability to discover or develop new products or expand our existing products into new markets to replace the sales of products that lose patent protection, and therefore we may not be able to maintain our current levels of profitability.
We have limited in-house discovery and early research staff and facilities, and we do not currently intend to extensively hire or acquire such staff or facilities in the near future. Instead, we intend to continue to rely on future acquisitions, partnerships and collaborations with third parties to expand our innovative pipeline, existing portfolio and innovation and early research capabilities. However, we may be unable to establish any agreements with third-party developers or manufacturers or do so on favorable terms. Further, should we be able to enter into such agreements, these agreements may pose risks, including that we would be reliant on and accountable for the third-party’s knowledge and capabilities, data, quality of operations and compliance with regulations, and other systems to conduct clinical trials, prepare regulatory application submissions and required post-approval reports, manufacture or distribute product, or other activities.
Our growth could be limited by the scope of our intellectual property licenses for certain women’s health care products.
We intend to grow our business through new indications or formulations of our existing products or expansion of existing products into new markets or new geographies. However, our ability to do so could be limited by the scope of our limited intellectual property licenses for certain women’s health products. We may not be able to offset any sales losses for products that lose or do not have exclusivity by growing sales in other markets. If we cannot produce sufficient revenues from expansion into new products, new indications or formulations of our existing products or expansion of existing products into new markets or new geographies, then we may not be able to maintain our current levels of profitability, and this could adversely affect our business, cash flow, results of operations, financial condition or prospects.
We rely on third parties to manufacture, distribute and conduct certain preclinical and clinical testing activities for our products. Oversight of these third parties can require substantial resources and creates potential risks to us, including: we may be unable to establish agreements with third parties, including third party manufacturers, on acceptable terms or even at all; we may not have sufficient quantities of product; third parties may fail to perform delegated responsibilities to an acceptable level of quality, or may fail to comply with regulatory requirements; or third parties may misappropriate or disclose our proprietary information, including trade secrets and know-how. Our reliance on third parties for research and development activities will also reduce our control over these activities but does not relieve us of our responsibilities, including that we must ensure that clinical trials are conducted in accordance with the general investigational plan and protocols for the trial; ensure compliance with regulatory standards like good clinical practices; and register ongoing clinical trials and results to government-sponsored databases. Our failures, or the failure of third parties, to comply with applicable regulations could result in sanctions being imposed on us, including clinical holds, fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocations, seizures or recalls of product candidates or products, operating restrictions and criminal prosecutions. Further, issues related to manufacture of product, preclinical testing, and/or clinical testing may affect our ability to obtain or maintain marketing approval for our products in a timely manner, or at all. This may hinder or delay efforts to successfully commercialize our product candidates.
We may experience difficulties identifying future acquisition opportunities or completing such transactions. Even if we complete such transactions, we may have difficulty integrating or otherwise realizing the benefits of such acquisitions.
As part of our business strategy to expand our product offerings and geographic presence, we intend to continue pursuing acquisitions of complementary businesses, licensing arrangements and strategic partnerships such as our acquisition of Dermavant and our agreements with Centergene and Lilly to promote Emgality and Rayvow in Europe. However, we may experience difficulties identifying future acquisition opportunities or completing such transactions. Many of our competitors for these opportunities are well established and have extensive experience identifying and effecting these types of strategic acquisitions. Moreover, some of these competitors may possess greater financial, technical, human and other resources than we do.
Further, any future transactions may not be completed in a timely manner, on a cost-effective basis, or at all, and we may not realize the expected benefits of any acquisition, license arrangement or strategic partnerships. For example, there are risks associated with regulatory approval of any product we may acquire, and even if approved, such approvals may not be secured in the timeframes we anticipate. See “We may be unable to market our pharmaceutical products or medical devices if we do not obtain and maintain required regulatory approvals or marketing authorizations” below. In addition, such acquisition opportunities may relate to products, technologies or operations with which we have limited or no historical experience.
Even if we are successful in making acquisitions or entering into other business development arrangements, the products and technologies we acquire may not be successful or may require significantly greater resources and investments than we originally anticipate, including due to material issues that we fail to identify in connection with our due diligence of the counterparty and its products or product candidates. We could experience negative effects on our results of operations and financial condition from acquisition-related charges, amortization of intangible assets and asset impairment charges. Integrating acquired businesses could lead us to experience numerous risks related to combining geographically separated organizations, systems and facilities and personnel with diverse backgrounds, as well as encountering unforeseen cybersecurity risks and breaches from the businesses acquired or their manufacturers and vendors and unforeseen product liability matters. Any of the foregoing could materially and adversely affect our business, financial condition, results of operations or cash flows.
It is possible that the FDA could issue complete response letters indicating that any of our applications for our pharmaceutical products are not ready for approval. Even if the requisite approvals are obtained, we must maintain such approvals or marketing authorizations as long as we plan to market products in each jurisdiction where approval or marketing authorization is required. For instance, we currently market one product in the United States regulated as a medical device, Jada. We currently market Jada outside of the United States in a number of international markets and it is subject to the regulatory requirements imposed in those jurisdictions. In the future, we also plan to continue to sell Jada in additional major international markets and it will be subject to the regulatory requirements imposed in those jurisdictions. For example, in order to sell medical devices in the EU, we will need to comply with the EU’s Medical Device Regulation.
We and/or our partners may fail to adequately demonstrate the safety and efficacy of any of our pharmaceutical product candidates or medical devices in pre-clinical studies and clinical trials, which would prevent or delay development, regulatory approval or marketing authorization and commercialization of our product candidates.
Before obtaining regulatory approval from the FDA or other comparable regulatory authorities outside the United States for the sale of our pharmaceutical product candidates, we must demonstrate through pre-clinical studies and clinical trials, that our product candidates are both safe and effective for use in each target indication and population. Obtaining marketing authorization for our devices may also require pre-clinical and clinical trials. Pre-clinical and clinical trials are difficult to design and implement, and can take many years to complete, and their ultimate outcome is uncertain. Failure can occur at any time during the pre-clinical study and clinical trial processes. Accordingly, there is a high risk of failure, and we may never succeed in obtaining regulatory approval or marketing authorization of our product candidates.
Even after a pharmaceutical product or medical device reaches the market, we continue to be subject to significant post-marketing regulatory requirements and oversight. The regulatory approvals or marketing authorizations that we may receive for our pharmaceutical products and medical devices will require the submission of reports to regulatory authorities and on-going surveillance to monitor the safety and efficacy of our products, may contain significant limitations related to use restrictions for specified groups, warnings, precautions or contraindications, and may include burdensome post-approval study or risk management requirements. In addition, even after a pharmaceutical product or device has obtained marketing authorization or clearance, the manufacturing processes, labeling, packaging, distribution, adverse event and device malfunction reporting, storage, advertising, promotion, import, export, recalls and recordkeeping for our products will be subject to ongoing regulatory requirements, and we will be subject to periodic inspections. Failure to comply with any of these requirements could subject us to a variety of formal or informal enforcement actions by the FDA or other regulators, result in a recall or market withdrawal of our products, require us to cease manufacturing and distribution of the products, trigger product liability or other litigation, or otherwise impact our ability to realize revenues for our products. For example, in January 2023, we voluntarily initiated market actions, including recalls, in certain markets with respect to our suspension injections Diprospan, Celestone ChronodoseTM 1 (betamethasone) and Celestone Soluspan® (betamethasone) related to a non-conforming component of a manufacturing line at our Heist, Belgium plant. It is possible that future recalls or similar developments could materially and adversely impact our business, result of operations, and financial condition. Although to date, any market actions to which we have been subject have not had a material impact on our business, such actions could in the future have a materially adverse impact on our business, results of operations, and financial condition.
•scrutiny of advertising and promotion;
Management's Discussion & Analysis (MD&A)
New heading “Laborie Medical Technologies Corporation (“Laborie”)”
New heading “Biogen Inc. (“Biogen”)”
New heading “General Medicines”
New heading “Goodwill impairment”
Removed heading “Dermavant Sciences Ltd. (“Dermavant”)”
Removed heading “Suzhou Centergene Pharmaceuticals (“Centergene”)”
Removed heading “Eli Lilly (“Lilly”)”
Removed heading “(1) Sales of the authorized generic version of NuvaRing were previously included in Other Women’s Health.”
Removed heading “(1) Sales of the authorized generic version of Zetia were previously included in Other Cardiovascular.”
Removed heading “(1) Sales of the authorized generic version of Nasonex were previously included in Other Respiratory.”
Largest changes
“Our quantitative goodwill impairment analysis relies on projected cash flows and market assumptions. Key assumptions used in projected cash flows include projected revenue growth rates, operating margins, terminal growth rates, and discount rates. These assumptions require significant judgment and are based on our best estimates of future economic and market conditions. A significant decline in forecasted performance, whether due to external economic factors or internal operational challenges, could result in the fair value of either the U.S. …”see in full comparison
“Cost of sales increased 8% for the year ended December 31, 2025, compared to 2024. Cost of sales for the year ended December 31, 2025, includes amortization associated with the inventory fair value adjustment related to the Dermavant acquisition of $49 million, an impairment charge related to a currently marketed women’s health product of $9 million, estimated unavoidable losses associated with a long-term vendor supply contract of $7 million and amortization of intangible assets of $205 million. …”see in full comparison
“Goodwill represents the excess of the consideration transferred over the fair value of net assets of businesses acquired. Goodwill is evaluated for impairment as of October 1 each year, or more frequently if impairment indicators exist, by first assessing qualitative factors to determine whether it is more likely than not that fair value is less than carrying value. …”see in full comparison
“For the year ended December 31, 2025, we recognized a $301 million impairment of goodwill which represents the amount by which the carrying value of goodwill exceeded its implied fair value. The goodwill impairment resulted from the decline of the Company’s patent protected products in the U.S. in the fourth quarter for 2025 that it is expected to result in a continuing impact on the products’ future forecast. The goodwill impairment recorded reflects continued pressure on the U.S. …”see in full comparison
“Goodwill represents the excess of the consideration transferred over the fair value of net assets of businesses acquired. Some of the factors considered in the assessment include general macroeconomic conditions, conditions specific to the industry and market, cost factors which could have a significant effect on earnings or cash flows, and overall financial performance. If we conclude it is more likely than not that fair value is less than carrying value, a quantitative fair value test is performed. …”see in full comparison
Full comparison: every changed paragraph (143)
We make statements in this Annual Report on2025 Form 10-K, and we may from time to time make other written reports and oral statements, regarding our outlook or expectations for financial, business or strategic matters regarding or affecting us that are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, all of which are based on management’s current expectations and are subject to risks and uncertainties which change over time and may cause results to differ materially from those set forth in the statements. One can identify these forward-looking statements by their use of words such as “anticipates,” “expects,” “plans,” “will,” “estimates,” “forecasts,” “projects,” “believes,” “would,” “potentially,” “intends,” “seeks,” “future,” “might,” “likely,” “target,” “predict,” “continue,” “should,” and other words of similar meaning, or negative variations of any of the foregoing. One can also identify them by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements include, but are not limited to, statements relating to our growth and acquisition strategies, financial results, product development, product approvals, product potential and development programs. One must carefully consider any such statement and should understand that many factors could cause actual results to differ materially from our forward-looking statements. These factors may be based on inaccurate assumptions and are subject to a broad variety of other risks and uncertainties. No forward-looking statement can be guaranteed and actual future results may vary materially. The factors described in Part I.I, Item 1A. Risk Factors of this report2025 Form 10-K or otherwise described in our filings with the SEC,SEC provide examples of risks, uncertainties and events that may cause our actual results to differ materially from the expectations expressed in our forward-looking statements, including, but not limited to:
•the impact of tariffs and other trade restrictions or domestic sourcing requirements;
•the impact of our substantial levels of indebtedness;
•our ability to execute on our capital allocation priorities and to deleverage our business;
•the failure of any supplier to provide substances, materials, or services as agreedagreed, or otherwise meet their obligations to us;
•any failure by us to retain market exclusivity tofor Nexplanon or to obtain an additional period of exclusivity in the United States for Nexplanon subsequent to the expiration of the rod patents in 2027;
•the success of our efforts to adopt our business and sales strategies to address the changing market and regulatory landscape in order to achieve our business objectives and remain competitive;
•restructuring or other disruptions at the FDA, the SEC and other U.S. and comparable foreign government agencies;
•pricing pressures globally, including rules and practices of managed care groups, judicial decisions and governmental laws and regulations related to or affecting Medicare, Medicaid and health carehealthcare reform, pharmaceutical reimbursementpricing and reimbursement, access to our products, international reference pricing, including MFN drug pricing, and other pricing inrelated generalinitiatives and policy efforts;
•our inability to remediate the material weaknesses in our internal control over financial reporting;
•efficacy, safety or other quality concerns with respect to our marketed products, whether or not scientifically justified, leading to product recalls, withdrawalswithdrawals, labeling changes or declining sales;
•reduced research and development investment and increased reliance on fewer research and development programs for new products to generate future revenue and replace existing products that come to the end of their market life cycle;
•future actions of third-parties, including significant changes in customer relationships or changes in the behavior and spending patterns of purchasers of health carehealthcare products and services, including delaying medical procedures, rationing prescription medications, reducing the frequency of physician visits and forgoing health carehealthcare insurance coverage;
•lost market opportunity resulting from delays and uncertainties in clinical trials and the approval or clearance process of the US FDA and other regulatory authorities;
•our ability to hire and retain a permanent CEO, other members of our senior management, or other key employees;
•loss of key employees or inability to identify and recruit new employees;
•changes in accounting pronouncements promulgated by standard-setting or regulatory bodies, including the Financial Accounting Standards Board and the SEC, that are adverse to us; and
•volatility of commodity prices, fuel, and shipping rates that impact the costs and/or ability to supply our products;
•uncertainties surrounding matters relating to the Audit Committee investigation and any related investigations, inquiries, claims, proceedings or actions, as described elsewhere in this 2025 Form 10-K; and
The following Management’s Discussion and Analysis of Financial Condition and Results of Operations is intended to assist the reader in understanding our financial condition and results of operations for the years ended December 31, 20242025 and 20232024 and should be read in conjunction with our Consolidated Financial Statements included in Part II, Item 8 of this Annual Report on Form 10-K to enhance the understanding of our results of operations, financial condition and cash flows. Additionally, this section should be read in connection with Part II, Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2023,2024, filed with the SEC andon February 28, 2025 (the “Original 2024 Form 10-K”), as amended by Amendment No. 1 thereto, filed on November 10, 2025 (“Amendment No. 1” and, together with the Original 2024 Form 10-K, the “Prior Form 10-K”), which are available on the SEC’s website at www.sec.gov,www.sec.gov. whichThe Prior Form 10-K includes a discussion regarding our financial condition and results of operations for the years ended December 31, 20232024 and 2022.2023.
We are a global healthcare company with a primary focus on improving the health of women throughout their lives. We develop and deliver innovative health solutions through a portfolio of prescription therapies and medical devices within our women’s health, biosimilarshealth and establishedgeneral brands.medicines portfolios. We have a portfolio of more than 70 medicines and products across a range of therapeutic areas. We sell these products through various channels including drug wholesalers and retailers, hospitals, government agencies and managed health carehealthcare providers such as health maintenance organizations, pharmacy benefit managers and other institutions. We operate six manufacturing facilities,facilities which are located in Belgium, Brazil, Indonesia, Mexico,around the Netherlands and the United Kingdom. Unless otherwise indicated, trademarks appearing in italics throughout this document are trademarks of, or are used under license by our companies.world.
•Generic Competition: Except for Emgality, RayvowEmgality and Vtama, our established brands products are beyond market exclusivity. Although these products continue to represent a valuable opportunity to generate significant operating profit relative to low promotional and development expenses, they are subject to competition from generic versions of these products. For instance, we have been negatively impacted bysince late 2024 from the September 2024 LOE for Atozet,Atozet in France, Spain and Japan, and we expect those negativethese impacts to continue or intensify in 2025.2026 driven by increased competition and further price erosion. In addition, Nexplanon is anthe important Organonlargest brand we commercialize that continues to have good market exclusivity,exclusivity; especiallyhowever, in the United States. This complex drug-device combination has different components with different patent exclusivities. In the United States, patents claiming key aspects of the Nexplanon applicator will expire in 2030 and patents for the Nexplanon rod will expire in late 2027. Patents for the majorityOutside of countries where Nexplanon is commercialized outside the United StatesStates, willwe expirehave betweenlost exclusivity in Nexplanon in certain markets beginning in 2025 and 2026.will continue to lose market exclusivity in other geographies in the near future. See Note 18 “Contingencies—Other Matters” to the Consolidated Financial Statements in this report.2025 Form 10-K.
•Historical Shift Towards Long-Acting Reversible Contraceptives: Daily contraceptive pills are by far the largest contraception market segment, with almost half of all women choosing a hormonal contraceptive electing this particular method. However, the Long-Actinglong-acting Reversiblereversible Contraceptives (“LARC”)contraceptives market, including Nexplanon, is expected to continue to be an important and large segment of the overall contraceptive market. Despite an increasingly diverse market of contraception methods (including the over-the-counter birth control pill), payors, providers, and patients continue to believe in the benefits of long-acting and highly effective options such as Nexplanon. Nexplanon is available for prescription under controlled distribution once the healthcare provider has completed a clinical training program (“CTP”) demonstrating safe and effective insertion and removal of Nexplanon. During the recent label update in January 2026, the FDA expanded the duration of use for Nexplanon from three years to five years, and also enhanced the CTP program by adding a Risk Evaluation and Mitigation Strategy (REMS) program, which contains additional proactive measures to certify healthcare providers in the proper insertion and removal of Nexplanon.
•Increased Access to Fertility Solutions: With the global trend toward declining birthrates, governments and payors are implementing favorable policies across major markets that, in turn, improve access to carefertility and drivesmaternal growth for infertility therapies.care.
•Growing Acceptance of Biosimilars: The market for biologics continues to experience strong growth trends. Given the high cost of many of these biologics treatments, biosimilars are a potentially more affordable alternative and represent a significant opportunity for patients, providers, and payors once a biologics product loses patent protection. Moreover, a significant number of biologics are expected to lose exclusivity over the next decade, representing a large opportunity for more biosimilar approvals.
•Other Macroeconomic Considerations: Geopolitical developments including changes to the political orientation of the governments in key countries, global trade issues such as tariffs imposed by or on the United States, shifting U.S. federal and state government policies, policies hindering market access, and worsening macroeconomic conditions could impact our business and results of operations and may stress our working capital resources. While tariffs have not, to date, had a material impact on our business, future tariff actions could potentially have a significant effect on our supply chain and operating costs. Regulatory agency developments, including disruptions at the FDA and other agencies, could increase the time needed for review and approval of new drugs and medical devices, potentially impacting our ability to develop new drugs, delaying our product launches and impacting our business operations. Additionally, proposed cuts to Medicaid and changes in federal funding policies could reduce access to healthcare services for low-income individuals. International reference pricing frameworks, including MFN mandates, may further constrain our pricing flexibility and commercial strategy. Voluntary price concessions in certain European markets and increased rebate negotiations across the EU have introduced additional pressure on net pricing and margins. These developments may influence our commercial strategy, constrain pricing flexibility and delay product launches. For additional information, please refer to Item 1A — Risk Factors.
Laborie Medical Technologies Corporation (“Laborie”)
In January 2026, we divested the Jada System to Laborie for an aggregate payment of up to $465 million, comprised of consideration of $440 million, subject to certain closing adjustments, plus potential earnout payments of up to $25 million based on the achievement of certain 2026 net sales targets. Approximately 100 employees transferred to Laborie as part of this transaction.
Biogen Inc. (“Biogen”)
In March 2025, we acquired from Biogen the regulatory and commercial rights in the United States for Tofidence, a biosimilar to Actemra2 (tocilizumab), for intravenous infusion. Tofidence, launched in the U.S. market in May 2024, is indicated in certain patients for the treatment of moderately to severely active rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19. Under the terms of the agreement with Biogen, we paid an upfront payment of $51 million in July 2025, and are obligated to pay tiered royalty payments based on net sales and tiered annual net sales milestone payments of up to $45 million from a previous in-license arrangement with Bio-Thera Solutions Ltd., the product developer for Tofidence. In the first quarter of 2025, we recognized an intangible asset of $51 million, related to the upfront payment to Biogen, which will be amortized over 10 years.
Dermavant Sciences Ltd. (“Dermavant”)
On October 28, 2024, we acquired Dermavant, a company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology. Dermavant’s novel product, Vtama, for the topical treatment of mild, moderate, and severe plaque psoriasis in adults, was approved by the U.S. Food and Drug Administration (the “FDA”) in May 2022. In December 2024, the FDA approved Vtama for the treatment of atopic dermatitis, also known as eczema, in adults and children two years of age and older. Atopic dermatitis is one of the most common inflammatory dermatological conditions in adults, presenting a higher disease burden for women compared to men. The acquisition allows us to further expand our existing portfolio of established brands and biosimilar dermatology treatments.
Consideration for Dermavant consists of the upfront payment of $175 million and a $75 million milestone payment upon regulatory approval, as well as payments of up to $950 million for the achievements of certain commercial milestones, tiered royalties on net sales, and the assumption of liabilities, including certain debt obligations, which were accounted for at fair value on the acquisition date.
During the fourth quarter of 2024, the regulatory milestone related to Vtama’s atopic dermatitis indication, which was recorded as part of contingent consideration at fair value, was achieved and recorded in Accrued and other current liabilities. In January 2025, we paid $75 million related to the milestone.
In the fourth quarter of 2024, we recognized an additional intangible asset of $24 million, related to a sales-based milestone that was deemed probable and was related to an assumed licensing agreement. The intangible asset will be amortized over 11 years.
Suzhou Centergene Pharmaceuticals (“Centergene”)
In September 2024, we entered into license and supply agreements with Centergene, pursuant to which we acquired the exclusive commercialization rights to Centergene’s investigational asset, SJ02, in China. SJ02 is a long-acting recombinant human follicle-stimulating hormone carboxyl-terminal peptide fusion protein (FSH-CTP) designed for controlled ovarian stimulation (“COS”) in combination with a GnRH antagonist. It is used to facilitate the development of multiple follicles in women undergoing ART programs. Under the terms of the agreement, we will pay $12 million, of which $6 million was paid in the fourth quarter of 2024. In addition, the remaining $6 million is payable upon obtaining the manufacturing license, which is refundable if thereafter either the regulatory approval is not obtained or marketing authorization cannot be transferred. We may owe additional regulatory and sales-based milestones to Centergene of up to $170 million under the terms of the license and supply agreements. We will recognize regulatory and sales-based milestones when the achievement is probable.
Eli Lilly (“Lilly”)
In December 2023, we announced an agreement with Lilly to become the sole distributor and promoter of the migraine medicines Emgality and Rayvow in Europe. Lilly will remain the marketing authorization holder and will manufacture the products for sale. Under the terms of the agreement, we paid an upfront payment of $50 million upon closing of the transaction in January 2024, and will recognize sales-based milestones when the achievement is deemed probable. In the first quarter of 2024, we recognized an intangible asset of $220 million, comprised of the $50 million upfront payment and $170 million of sales-based milestones that were deemed probable. The intangible asset will be amortized over 10 years.
In August of 2024, we expanded our agreement with Lilly to become the sole distributor and promoter for Emgality in the following additional markets: Canada, Colombia, Israel, South Korea, Kuwait, Mexico, Qatar, Saudi Arabia, Taiwan, Turkey, and the United Arab Emirates. We paid an upfront payment of $23 million for the expansion of territory upon closing of the transaction in August 2024, and will recognize sales-based milestones when the achievement is deemed probable. In the third quarter of 2024, we recognized an additional intangible asset of $113 million, comprised of the $23 million upfront payment and $90 million related to the sales-based milestones that were deemed probable. The intangible asset will be amortized over 10 years.
As of December 31, 2024, we had accrued $20 million in Accrued and Other current liabilities and $240 million in Other noncurrent liabilities in total related to the probable sales-based milestones. In January 2025, we paid $20 million related to the milestones.
Worldwide sales were $6.4$6.2 billion for the year ended December 31, 2024,2025, ana increasedecrease of 2%,3%, compared to 2023.2024. Worldwide sales during the year ended December 31, 20242025 were negativelypositively impacted by approximately 1%,$36 million, or $77approximately million,1%, due to unfavorablefavorable foreign exchange.exchange rates.
Excluding the impact of foreign exchange,exchange rates, sales increasesdecreases for the year ended December 31, 2024,2025, primarily reflect thelower performancesales of:
•Nexplanon, due to increased demand, favorable price and discount rates in the United States, increased demand and favorable price in international markets and an increase in demand in our institutional business in Africa;
•Emgality and Rayvow, due to the acquisition of the distribution and promotion rights from Lilly in 2024 in certain markets outside of the United States;
•Hadlima, due to the launch in the United States in July 2023 and a modest increase in international markets; and
•Diprospan, due to recovery from the manufacturing issues resulting from the regulatory inspection finding at the Heist manufacturing location that impacted the manufacturing of selected injectable steroid brands in the first quarter of 2023 (the “Market Action”).
This performance was offset by decreases for the year ended December 31, 2024 in:
•NuvaRing, due to ongoing generic competition and the negative impact of increased government discount rates in the United States;
•Atozet, primarily due to LOE in France, Spain and Japan and the timing of tenders in the Latin America region,Japan, partially offset by increased demand in certainAsia marketsPacific, Latin America and the product launch in Europe, prior to LOE in September 2024China;
•Singulair, primarily attributable to price reductions in China and Japan, as well as lower demand outside of the United States resulting from increased competition and less favorable medical guidelines; and
•Dulera, primarily due to the loss of a customer contract in the first part of the year combined with increased discount rate pressure in the United States.
This decrease in the above sales was offset by sales increases for the year ended December 31, 2025 in:
•Vtama, as a result of our acquisition of Dermavant in the fourth quarter of 2024, launch of the atopic dermatitis indication for adults and children two years of age and older in the United States and launch of the topical treatment of plaque psoriasis in adults in Canada in the third quarter of 2025;
•Hadlima, due to sales ramp up since its launch in July 2023 in the United States and a modest increase in demand in Canada and other international markets;
•Emgality, as a result of our acquisition of the distribution and promotion rights from Lilly in 2024 in certain markets outside of the United States; and
•Follistim, due to increased demand in the United States, partially offset by a decrease in demand in China. Comparability of sales for the year ended December 31, 2025, is impacted by a one-time buy-in that occurred in the fourth quarter of 2023. This buy-in, a consequence of exiting our interim operating model agreement with Merck, resulted in a reduction of sales in the first half of 2024.
•Singulair due to decreased demand in China and Japan and price decreases in Japan; and
•Cozaar and Hyzaar, driven by the negative impact of volume-based procurement (“VBP”) in China and unfavorable pricing in Japan.
LOE negatively impacted sales of certain of our products by approximately $57$197 million during the year ended December 31, 2024,2025, based on the decrease in sales volume periodcompared overto period,2024. whichThis was primarily driven by the LOE of Atozet in France, Spain,Spain and Japan and Rosuzet in Japan. VBP in China had aan $13 million negativeimmaterial impact on our sales during the year ended December 31, 2024.2025. WeHowever, we expect VBP to continue to negatively impact our establishedgeneral brandsmedicines product portfolio for the next several quarters.
What changed in the latest 10-Q
Risk Factors
There have been no material changes in our risk factors from those disclosed in Item 1A. Risk Factors, in our Annual Report on Form 10-K for the year ended December 31, 2025 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2026.
Removed heading “Risks Related to the Merger with Sun Pharma”
Removed heading “The closing of our proposed merger with and into Sun Pharma is subject to a number of conditions, many of which are largely outside of the parties’ control, and, if these conditions are not satisfied or waived on a timely basis, the merger agreement may be terminated and the transaction may not be completed.”
Removed heading “Failure to complete the merger could adversely affect our stock price and future business and financial results, and our ability to continue as a going concern may be adversely affected.”
Removed heading “The announcement and pendency of the merger could adversely affect our business, financial results and/or operations.”
Removed heading “The Merger Agreement limits our ability to pursue alternative transactions, which could deter, but does not prevent, a third party from proposing an alternative transaction that the Company could consider within the parameters set forth in the Merger Agreement.”
Removed heading “Litigation may arise in connection with the merger, which could be costly and divert management’s attention and otherwise materially harm our business.”
Largest changes
“Failure to raise significant amounts of funding to repay our 2028 debt at maturity would adversely affect our financial condition and could result in a going concern qualification with respect to our annual audited financial statements. We could also be required to raise capital via equity transactions (which may be dilutive to existing investors or provide new investors with rights, preferences, or privileges senior to our common stock), sale of significant assets, and significant cost reduction measures. …”see in full comparison
“On April 26, 2026, we entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Sun Pharma and the additional parties thereto, relating to the merger. …”see in full comparison
“Failure to complete the merger could adversely affect our stock price and future business and financial results, and our ability to continue as a going concern may be adversely affected.”see in full comparison
“Litigation may arise in connection with the merger, which could be costly and divert management’s attention and otherwise materially harm our business.”see in full comparison
“Lawsuits may be filed challenging the disclosures contained in the proxy statement and/or challenging other aspects of the merger. Regardless of the outcome of any future litigation related to the merger, such litigation may be time-consuming and expensive and may distract our management from running the day-to-day operations of our business. The litigation costs and diversion of management’s attention and resources to address the claims and counterclaims in any litigation related to the merger may materially adversely affect our business, financial condition and operating results. …”see in full comparison
“The closing of our proposed merger with and into Sun Pharma is subject to a number of conditions, many of which are largely outside of the parties’ control, and, if these conditions are not satisfied or waived on a timely basis, the merger agreement may be terminated and the transaction may not be completed.”see in full comparison
Full comparison: every changed paragraph (17)
Except as set forth below, thereThere have been no material changes in our risk factors from those disclosed in Item 1A. Risk Factors, in our Annual Report on Form 10-K for the year ended December 31, 2025.2025 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2026.
Risks Related to the Merger with Sun Pharma
The closing of our proposed merger with and into Sun Pharma is subject to a number of conditions, many of which are largely outside of the parties’ control, and, if these conditions are not satisfied or waived on a timely basis, the merger agreement may be terminated and the transaction may not be completed.
On April 26, 2026, we entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Sun Pharma and the additional parties thereto, relating to the merger. The consummation of the merger is subject to various conditions, including, among others, customary conditions relating to: the adoption of the Merger Agreement by the holders of a majority of the outstanding shares entitled to vote on such matter at a stockholders’ meeting duly called and held for such purpose; the expiration or termination of any applicable waiting periods (and any extension thereof) under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the “HSR Act”), and the receipt of certain non-U.S. antitrust and foreign direct investment approvals; the absence of any law or order making unlawful or restraining, enjoining or otherwise prohibiting consummation of the Merger; the absence of any “Company Material Adverse Effect” (as defined in the Merger Agreement) having occurred since the signing that is continuing as of the closing; the filing or receipt of required regulatory approvals without the imposition of any term, condition or consequence the acceptance of which would constitute a “Substantial Detriment” (as defined in the Merger Agreement) and other customary conditions relating to the accuracy of representations and warranties and performance of covenants.
The governmental authorities from which authorizations under antitrust and foreign investment laws, including the HSR Act, are required have broad discretion in administering the governing laws and regulations. These governmental authorities may initiate proceedings seeking to prevent, or otherwise seek to prevent, the merger.
The failure to satisfy all of the required conditions could delay the completion of the merger by a significant period of time or prevent it from occurring. Any delay in completing the merger could cause the parties to not realize some or all of the benefits that are expected to be achieved if the merger is successfully completed within the expected timeframe. There can be no assurance that the conditions to the closing of the merger will be satisfied or waived or that the merger will be completed within the expected timeframe or at all.
Failure to complete the merger could adversely affect our stock price and future business and financial results, and our ability to continue as a going concern may be adversely affected.
There can be no assurance that the conditions to the closing of the merger will be satisfied or waived or that the merger will be completed. If the Merger is not completed within the expected timeframe or at all, our ongoing business could be adversely affected and we will be subject to a variety of risks and possible consequences associated with the failure to complete the merger, including the following: following, or in connection with, the termination of the Merger Agreement, in certain circumstances, we will be required to pay Sun Pharma a termination fee of $120,000,000; we will incur certain transaction costs, including legal, accounting, financial advisor, filing, printing and mailing fees, and substantial acquisition-related costs, including employee retention expenses, regardless of whether the merger closes; under the Merger Agreement, we are subject to certain restrictions on the conduct of our business prior to the closing of the merger, which may adversely affect our ability to execute certain of our business strategies; and the proposed merger, whether or not it closes, will divert the attention of certain of our management and other key employees from ongoing business activities, including the pursuit of other opportunities that could be beneficial to us as an independent company.
In addition, the Merger Agreement restricts our ability to conduct certain significant financing transactions prior to the closing of the merger, and we may therefore be unable to raise the capital required to execute certain of our business strategies. Further, while we believe that our existing cash resources and cash generated by operations, supplemented as necessary by periodic utilization of our revolving credit facility, provide sufficient liquidity to support our near-term working and capital expenditure needs, service the ongoing principal and interest payments on our existing indebtedness, and satisfy our other funding and investment requirements for the next 24 months, we do not expect to generate sufficient cash from operations to repay at maturity the entirety of the then-outstanding balances of our term loan, 4.125% secured notes, and 2.875% euro-denominated secured notes, all of which mature in 2028 (collectively, our “2028 debt”). If the proposed merger does not close, we would be dependent upon our ability to access the credit markets or source additional equity investments to repay or refinance the outstanding balances of our 2028 debt. In addition, our ability to service our indebtedness and to fund our other liquidity requirements will depend on our ability to generate and access cash in the future, which is subject to general economic, financial, contractual, competitive, legislative, regulatory and other factors.
Failure to raise significant amounts of funding to repay our 2028 debt at maturity would adversely affect our financial condition and could result in a going concern qualification with respect to our annual audited financial statements. We could also be required to raise capital via equity transactions (which may be dilutive to existing investors or provide new investors with rights, preferences, or privileges senior to our common stock), sale of significant assets, and significant cost reduction measures. Even if we are able to reduce or refinance our existing debt, we expect that such actions would result in increased interest expenses, subject us to additional financial covenants and other lender protections, and require significant use of our other available liquidity and capital resources. Any of these measures may have an adverse impact on our ability to execute our business plan, take advantage of future opportunities, including our ability to raise capital, fund our business development initiatives, maintain relationships with third parties with whom we conduct business, including customers, vendors and lenders, or respond to competitive pressures or unanticipated financial requirements. The ultimate success of any such actions in sustaining our ability to continue as a going concern cannot be assured, and no assurance can be given that such financing or asset sales will be available or, if available, that they will be on commercially favorable terms.
If the merger is not completed, these risks could materially affect our business and financial results and our stock price, including to the extent that the current market price of our common stock is positively affected by a market assumption that the merger will be completed.
The announcement and pendency of the merger could adversely affect our business, financial results and/or operations.
Our efforts to complete the merger could cause substantial disruptions in, and create uncertainty surrounding, our business, which may materially adversely affect our results of operation and our business. For example, we may forego opportunities we may have otherwise pursued absent the proposed merger. Uncertainty as to whether the merger will be completed may also affect our ability to recruit prospective employees or to retain and motivate existing employees. Employee retention may be particularly challenging while the merger is pending because employees may experience uncertainty about their roles following the merger. A substantial amount of our management’s and employees’ attention is being directed toward the completion of the merger and therefore is being diverted from our day-to-day operations. Uncertainty as to our future could adversely affect our business and our relationship with vendors, suppliers, regulators and other business partners. For example, vendors, suppliers, and other counterparties may defer decisions concerning working with us, or seek to change existing business relationships with us. Changes to or termination of existing business relationships could adversely affect our results of operations and financial condition, as well as the market price of our common stock. The adverse effects of the pendency of the merger could be exacerbated by any delays in completion of the merger or termination of the Merger Agreement.
The Merger Agreement limits our ability to pursue alternative transactions, which could deter, but does not prevent, a third party from proposing an alternative transaction that the Company could consider within the parameters set forth in the Merger Agreement.
The Merger Agreement contains a customary “no-shop” provision which, subject to certain exceptions, restricts our ability to initiate, solicit or knowingly encourage or knowingly facilitate any inquiry or the making of any proposal or offer that constitutes, or would reasonably be expected to lead to, an Acquisition Proposal (as defined in the Merger Agreement) or to engage in discussions or negotiations relating to an Acquisition Proposal. It is possible that these or other provisions in the Merger Agreement might discourage a potential competing acquirer that might have an interest in acquiring all or a significant part of the outstanding shares of our common stock from considering or proposing an acquisition or might result in a potential competing acquirer proposing to pay a lower per share price to acquire our common stock than it might otherwise have proposed to pay.
Litigation may arise in connection with the merger, which could be costly and divert management’s attention and otherwise materially harm our business.
Lawsuits may be filed challenging the disclosures contained in the proxy statement and/or challenging other aspects of the merger. Regardless of the outcome of any future litigation related to the merger, such litigation may be time-consuming and expensive and may distract our management from running the day-to-day operations of our business. The litigation costs and diversion of management’s attention and resources to address the claims and counterclaims in any litigation related to the merger may materially adversely affect our business, financial condition and operating results. If the merger is not consummated for any reason, litigation could be filed in connection with the failure to consummate the merger. Any litigation related to the merger may result in negative publicity or an unfavorable impression of us, which could adversely affect the price of our common stock, impair our ability to recruit or retain employees, damage our relationships with our partners, or otherwise materially harm our operations and financial performance.
Management's Discussion & Analysis (MD&A)
New heading “Sun Pharma Transaction”
New heading “Samsung Collaboration”
Removed heading “* Calculation not meaningful.”
Largest changes
Some statements and disclosures in this document are forward-looking statements. Forward-looking statements include all statements that do not relate solely to historical or current facts and can be identified by the use of words such as “may,” “believe,” “will,” “expect,” “project,” “potential,” “possible,” “probable,” “outcome,” “likely,” “could,” “should,” “estimate,” “anticipate,” “plan,” “intend,” “would,” “future,” “target,” “seek,” “continue,” and other words of similar meaning, or negative variations of any of the foregoing. These forward-looking statements are based on our current plans and expectations and are subject to a number of risks and uncertainties that could cause our plans and expectations, including actual results, to differ materially from the forward-looking statements. Risks and uncertainties that may affect our future results include, but are not limited to, uncertainties as to the timing of thesee in full comparisoncompletionproposedof the pending merger (the “merger”)transaction with Sun Pharmaceutical Industries Limited (together with its subsidiaries and/or associated companies, “Sun Pharma”); the risk that themergerproposed transaction may not be completed on the anticipated terms in a timely manner or at all; the failure to satisfy any of the conditions to the consummation of the merger, including receiving, on a timely basis or otherwise, the minimum vote required by our stockholders to approve the merger; the possibility that competing offers or acquisition proposals for Organon will be made; the possibility that any or all of thevariousremaining conditions to the consummation of themergerproposed transaction may not be satisfied or waived, including the failure to receive any required regulatory approvals from any applicable governmental entities (or any conditions, limitations or restrictions placed on such approvals); the occurrence of any event, change or other circumstance that could give rise to the termination of the definitive agreement, including in circumstanceswhichthat would require us to pay a termination fee; the effect of theannouncement orpendency of themergerproposed transaction on our ability to retain and hire key personnel, our ability to maintain relationships with our customers, suppliers and others with whom we do business, or our operating results and business generally; risks related to diverting management’s attention from our ongoing business operations; the risk that stockholder litigation in connection with themergerproposed transaction may result in significant costs of defense, indemnification and liability; certain restrictions during the pendency of themergerproposed transaction that may impact our ability to pursue certain business opportunities or strategic transactions; the risk that any announcements relating to themergerproposed transaction could have adverse effects on the market price of our common stock, including if themergerproposed transaction is not consummated; risks that the benefits of themergerproposed transaction are not realized when and as expected; expanded brand and class competition in the markets in which we operate; trade protection measures and import or export licensing requirements, including the direct and indirect impacts of tariffs (including pharmaceutical sector tariffs), trade sanctions or similar restrictions by the United States or other governments; changes in U.S. and foreign federal, state and local governmental funding allocations including the timing and amounts allocated to our customers and business partners; the impact of global business, political and macroeconomic conditions, including inflation, interest rate fluctuations, recessionary pressures, foreign currency exchange rates, volatile market conditions, and instability in the global banking system; global events, such as regional conflicts in the Middle East and elsewhere; our ability toremediate the material weaknesses in internal control over financial reporting and the related costs and management resources, as well as our ability to maintain effective internal control over financial reporting and disclosure controls and procedures in the future; our ability toaccess the public securities and other capital and credit markets in accordance with our financial plans, the cost of such capital, and overall condition of the capital and credit markets; actions that may be taken by credit rating agencies that could negatively affect either our access to or terms of financing or our financial condition and liquidity; our ability to meet our revenue and growth expectations and outlook; our ability tohire and/orretain members of our senior management(including a permanent CEO)and other key employees; the failure of any supplier to provide substances, materials, or services as agreed, or otherwise meet their obligations to us; the increased cost of supply, manufacturing, packaging, and operations; difficulties developing and sustaining relationships with commercial counterparties; competition from generic products as our products lose patent protection; any failure by us to retain market exclusivity for Nexplanon or to obtain an additional period of exclusivity in the United States for Nexplanon subsequent to the expiration of the rod patents in 2027; the success of our efforts to adapt our business and sales strategies to address the changing market and regulatory landscape in order to achieve our business objectives and remain competitive; restructurings or other disruptions at the U.S. Food and Drug Administration (“FDA”), the SEC and other U.S. and comparable foreign government agencies; difficulties in connection with future strategic transactions, including as a result of the impact of macroeconomic or geopolitical developments; pricing pressures globally, including rules and practices of managed care groups, judicial decisions and governmental laws and regulations related to or affecting Medicare, Medicaid and healthcare reform, pharmaceutical pricing and reimbursement, access to our products, international reference pricing, including Most-Favored-Nation drug pricing, and other pricing-related initiatives and policy efforts; the impact of higher selling and promotional costs; changes in government laws and regulations in the United States and other jurisdictions, including laws and regulations governing the research, development, approval, clearance, manufacturing, supply, distribution, and/or marketing of our products and related intellectual property, environmental regulations, and the enforcement thereof affecting our business; efficacy, safety or other quality concerns with respect to our marketed products, whether or not scientifically justified, leading to product recalls, withdrawals, labeling changes, or declining sales; delays or failures to demonstrate adequate efficacy and safety of our product candidates in pre-clinical and clinical trials, which may prevent or delay the development, approval, clearance, or commercialization of our product candidates; reduced research and development investment and increased reliance on fewer research and development programs for new products to generate future revenue and replace existing products that come to the end of their market life cycle; future actions of third-parties, including significant changes in customer relationships or changes in the behavior and spending patterns of purchasers of healthcare products and services, including delaying medical procedures, rationing prescription medications, reducing the frequency of physician visits and forgoing healthcare insurance coverage; legal factors, such as product liability claims, stockholder litigation, governmental investigations, and patent disputes; lost market opportunity resulting from delays and uncertainties in clinical trials and the approval or clearance process of the FDA and other regulatory authorities; the failure by us or our third party collaborators and/or their suppliers to fulfill our or their regulatory or quality obligations, which could lead to a delay in regulatory approval or commercial marketing of our products; cyberattacks on, or other failures, accidents, or security breaches of, our or third-party providers’ information technology systems, which could disrupt our operations and those of third parties upon which we rely; increased focus on privacy issues in countries around the world, including the United States, the European Union, and China, and a more difficult legislative and regulatory landscape for privacy and data protection that continues to evolve with the potential to directly affect our business, including recently enacted laws in a majority of states in the United States requiring security breach notification; changes in tax laws including changes related to the taxation of foreign earnings; the impact of any future pandemic, epidemic, or similar public health threat on our business, operations and financial performance; changes in accounting pronouncements promulgated by standard-setting or regulatory bodies, including the Financial Accounting Standards Board and the SEC, that are adverse to us; volatility of commodity prices, fuel, and shipping rates that impact the costs and/or ability to supply our products; and other factors discussed in our most recently filed Annual Report on Form10-K10-K, Quarterly Report on Form 10-Q, and subsequent filings, including those discussed in the “Business,” “Risk Factors,” “Cautionary Statement Regarding Forward-Looking Statements” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of those reports.
Combined global sales ofsee in full comparisonZetia® (ezetimibe),Zetia, which is marketed as Ezetrol™ in most countries outside the United States; andVytorin®of(ezetimibe / simvastatin),Vytorin, which is marketed as Inegy™ outside the United States, which are medicines for lowering LDL cholesterol, increased1%16% and 8% for the three and six months endedMarchJune31,30, 2026, compared to 2025, respectively, primarily driven byfavorable foreign exchange andincreased demand inChina, partially offset by less tender volume and the timing of shipments in the Middle East.China.
Cost of salessee in full comparisonincreaseddecreased 1% and less than 1% for the three and six months endedMarchJune31,30, 2026, compared to 2025, respectively, driven by our productmix.mix and the impact of unfavorable foreign exchange. Cost of sales for the three and six months endedMarchJune31,30, 2026comparedincludes amortization associated with the inventory fair value adjustment related to the Dermavant acquisition of $0 and $7 million, respectively, and amortization of intangible assets of $46 million and $93 million, respectively. Cost of sales for the three and six months ended June 30, 2025, includes amortization associated with the inventory fair value adjustment related to the Dermavant acquisition of$7$10 million and$9$19 million, respectively, an impairment charge related to a currently marketed women’s health product of $9 million and amortization of intangible assets of$47$53 million and$50$103 million, respectively.
Full comparison: every changed paragraph (85)
Some statements and disclosures in this document are forward-looking statements. Forward-looking statements include all statements that do not relate solely to historical or current facts and can be identified by the use of words such as “may,” “believe,” “will,” “expect,” “project,” “potential,” “possible,” “probable,” “outcome,” “likely,” “could,” “should,” “estimate,” “anticipate,” “plan,” “intend,” “would,” “future,” “target,” “seek,” “continue,” and other words of similar meaning, or negative variations of any of the foregoing. These forward-looking statements are based on our current plans and expectations and are subject to a number of risks and uncertainties that could cause our plans and expectations, including actual results, to differ materially from the forward-looking statements. Risks and uncertainties that may affect our future results include, but are not limited to, uncertainties as to the timing of the completionproposed of the pending merger (the “merger”)transaction with Sun Pharmaceutical Industries Limited (together with its subsidiaries and/or associated companies, “Sun Pharma”); the risk that the mergerproposed transaction may not be completed on the anticipated terms in a timely manner or at all; the failure to satisfy any of the conditions to the consummation of the merger, including receiving, on a timely basis or otherwise, the minimum vote required by our stockholders to approve the merger; the possibility that competing offers or acquisition proposals for Organon will be made; the possibility that any or all of the variousremaining conditions to the consummation of the mergerproposed transaction may not be satisfied or waived, including the failure to receive any required regulatory approvals from any applicable governmental entities (or any conditions, limitations or restrictions placed on such approvals); the occurrence of any event, change or other circumstance that could give rise to the termination of the definitive agreement, including in circumstances whichthat would require us to pay a termination fee; the effect of the announcement or pendency of the mergerproposed transaction on our ability to retain and hire key personnel, our ability to maintain relationships with our customers, suppliers and others with whom we do business, or our operating results and business generally; risks related to diverting management’s attention from our ongoing business operations; the risk that stockholder litigation in connection with the mergerproposed transaction may result in significant costs of defense, indemnification and liability; certain restrictions during the pendency of the mergerproposed transaction that may impact our ability to pursue certain business opportunities or strategic transactions; the risk that any announcements relating to the mergerproposed transaction could have adverse effects on the market price of our common stock, including if the mergerproposed transaction is not consummated; risks that the benefits of the mergerproposed transaction are not realized when and as expected; expanded brand and class competition in the markets in which we operate; trade protection measures and import or export licensing requirements, including the direct and indirect impacts of tariffs (including pharmaceutical sector tariffs), trade sanctions or similar restrictions by the United States or other governments; changes in U.S. and foreign federal, state and local governmental funding allocations including the timing and amounts allocated to our customers and business partners; the impact of global business, political and macroeconomic conditions, including inflation, interest rate fluctuations, recessionary pressures, foreign currency exchange rates, volatile market conditions, and instability in the global banking system; global events, such as regional conflicts in the Middle East and elsewhere; our ability to remediate the material weaknesses in internal control over financial reporting and the related costs and management resources, as well as our ability to maintain effective internal control over financial reporting and disclosure controls and procedures in the future; our ability to access the public securities and other capital and credit markets in accordance with our financial plans, the cost of such capital, and overall condition of the capital and credit markets; actions that may be taken by credit rating agencies that could negatively affect either our access to or terms of financing or our financial condition and liquidity; our ability to meet our revenue and growth expectations and outlook; our ability to hire and/or retain members of our senior management (including a permanent CEO) and other key employees; the failure of any supplier to provide substances, materials, or services as agreed, or otherwise meet their obligations to us; the increased cost of supply, manufacturing, packaging, and operations; difficulties developing and sustaining relationships with commercial counterparties; competition from generic products as our products lose patent protection; any failure by us to retain market exclusivity for Nexplanon or to obtain an additional period of exclusivity in the United States for Nexplanon subsequent to the expiration of the rod patents in 2027; the success of our efforts to adapt our business and sales strategies to address the changing market and regulatory landscape in order to achieve our business objectives and remain competitive; restructurings or other disruptions at the U.S. Food and Drug Administration (“FDA”), the SEC and other U.S. and comparable foreign government agencies; difficulties in connection with future strategic transactions, including as a result of the impact of macroeconomic or geopolitical developments; pricing pressures globally, including rules and practices of managed care groups, judicial decisions and governmental laws and regulations related to or affecting Medicare, Medicaid and healthcare reform, pharmaceutical pricing and reimbursement, access to our products, international reference pricing, including Most-Favored-Nation drug pricing, and other pricing-related initiatives and policy efforts; the impact of higher selling and promotional costs; changes in government laws and regulations in the United States and other jurisdictions, including laws and regulations governing the research, development, approval, clearance, manufacturing, supply, distribution, and/or marketing of our products and related intellectual property, environmental regulations, and the enforcement thereof affecting our business; efficacy, safety or other quality concerns with respect to our marketed products, whether or not scientifically justified, leading to product recalls, withdrawals, labeling changes, or declining sales; delays or failures to demonstrate adequate efficacy and safety of our product candidates in pre-clinical and clinical trials, which may prevent or delay the development, approval, clearance, or commercialization of our product candidates; reduced research and development investment and increased reliance on fewer research and development programs for new products to generate future revenue and replace existing products that come to the end of their market life cycle; future actions of third-parties, including significant changes in customer relationships or changes in the behavior and spending patterns of purchasers of healthcare products and services, including delaying medical procedures, rationing prescription medications, reducing the frequency of physician visits and forgoing healthcare insurance coverage; legal factors, such as product liability claims, stockholder litigation, governmental investigations, and patent disputes; lost market opportunity resulting from delays and uncertainties in clinical trials and the approval or clearance process of the FDA and other regulatory authorities; the failure by us or our third party collaborators and/or their suppliers to fulfill our or their regulatory or quality obligations, which could lead to a delay in regulatory approval or commercial marketing of our products; cyberattacks on, or other failures, accidents, or security breaches of, our or third-party providers’ information technology systems, which could disrupt our operations and those of third parties upon which we rely; increased focus on privacy issues in countries around the world, including the United States, the European Union, and China, and a more difficult legislative and regulatory landscape for privacy and data protection that continues to evolve with the potential to directly affect our business, including recently enacted laws in a majority of states in the United States requiring security breach notification; changes in tax laws including changes related to the taxation of foreign earnings; the impact of any future pandemic, epidemic, or similar public health threat on our business, operations and financial performance; changes in accounting pronouncements promulgated by standard-setting or regulatory bodies, including the Financial Accounting Standards Board and the SEC, that are adverse to us; volatility of commodity prices, fuel, and shipping rates that impact the costs and/or ability to supply our products; and other factors discussed in our most recently filed Annual Report on Form 10-K10-K, Quarterly Report on Form 10-Q, and subsequent filings, including those discussed in the “Business,” “Risk Factors,” “Cautionary Statement Regarding Forward-Looking Statements” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of those reports.
Sun Pharma Transaction
On April 26, 2026, we entered into a definitive agreement with Sun Pharma under which Sun Pharma will acquire all of our outstanding shares of common stock for $14.00 per share in cash. Completion of the transaction is subject to customary closing conditions, including receipt of required regulatory approvals and approval by the Company’s stockholders. On July 23, 2026, the Company received stockholder approval at its special meeting of stockholders. The Company and Sun Pharma are continuing to work to satisfy the other conditions to closing. The transaction is expected to close in early 2027.
Other Matters
On April 26, 2026, our Board of Directors appointed Joseph Morrissey our Interim CEO, to such role on a permanent basis.
Samsung Collaboration
On May 22, 2026, the Samsung Agreement was amended to include commercialization rights for Pyzchiva (ustekinumab biosimilar) in Canada. Samsung Bioepis retains full development, manufacturing, and regulatory responsibilities (“Amendment No. 8”). Pyzchiva is expected to launch in Canada in the second half of 2026.
On May 26, 2026, the Samsung Agreement was amended to extend commercialization rights for certain biosimilar products, including Renflexis and Brenzys, in specified markets for up to seven years beyond the original contract term (“Amendment No. 9”).
In connection with Amendment No. 9, the Company is required to make fixed payments totaling $30 million over a nine-year period from 2026 through 2034. The Company recorded an intangible asset and corresponding liability of $20.8 million, the present value of the future payments. The intangible asset will be amortized over nine years.
The liability is accreted to its contractual value over time using the effective interest method, with accretion recognized within Interest expense to reflect the nature of the underlying arrangement.
Amendment No. 9 also includes the return of commercialization rights to Samsung for certain oncology biosimilars, including Ontruzant and Aybintio, in specified ex‑U.S. markets such as Europe, Canada, and Brazil. These returns of rights are subject to defined, phased transition and cutover periods extending from 2026 through 2029, during which the Company may continue to commercialize products and fulfill contractual obligations.
On June 2, 2026, the Samsung Agreement was amended to include commercialization rights for Epyztek in Australia. Samsung Bioepis retains full development, manufacturing, and regulatory responsibilities (“Amendment No. 10”). Epyztek is expected to launch in Australia in the second half of 2026.
On February 19, 2026, we entered into an exclusive license agreement with Sebela for the global rights to Miudella,Miudella®, a hormone-free copper intrauterine device (“IUD”) that was approved by the FDA on February 24, 2025.2025 and is estimated to launch commercials sales in the United States in late 2026. Under the terms of the agreement, we will paypaid $27.5 million atin closing,June 2026, with potential sales-based milestone payments of up to $505 million, as well asand tiered double-digit royalties based on net sales. TheIn transactionthe closingsecond is subject to regulatory approvals and FDA approvalquarter of alternate2026, supplythe chainCompany entitiesrecognized foran Miudella,intangible andasset otherof customary$27.5 closing conditions. There can be no assurance that such regulatory approvals and other closing conditions will be received or satisfied.million.
In January 2026, we divested the Jada System to Laborie for an aggregate payment of up to $465 million, comprised of consideration of $440 million, subject to certain closing adjustments, plus potential contingent consideration payments of up to $25 million based on the achievement of certain 2026 net sales targets. Approximately 100 Company employees transferred to Laborie as part of this transaction.
Upon the closing of the divestiture, we recognized a net gain on the sale of the Jada System of $81 million recognized in Other expense (income) expense,, net in the Condensed Consolidated Statement of Income asfor ofthe Marchsix 31,months ended June 30, 2026.
Worldwide sales were $1.5$1.6 billion for the three months ended MarchJune 31,30, 2026, a decrease of 4%,2%, compared to 2025. Worldwide sales during the three months ended March 31, 2026 were positively impacted by approximately $76$42 million,million or approximately 5%,3%, due to favorable foreign exchange rates.
Excluding the impact of foreign exchange rates, sales decreases for the three months ended MarchJune 31,30, 2026,2026 primarily reflect the lower sales of:
•Nexplanon, primarily due to decreased physician demand in the United States following the five-year label approval as reinsertions have been delayed and there has been uncertainty around federal funding. Outside of the U.S., sales declined due to the timing of shipments in selective emerging markets, partially offset by increased demand and access in Brazil;
•Singulair® (montelukast sodium), primarily attributable to decreased demand due to less favorable medical guidelines in certain international markets, most recently in China, as well as temporary supply constraints in Japan and mandatory price reductions in China and Japan;
•Marvelon™¹ (desogestrel and ethinyl estradiol pill) and Mercilon™¹ (desogestrel and ethinyl estradiol pill), as a result of decreased demand and market contraction in China and the timing of shipments in Asia Pacific; and
•Ontruzant, due to increased competition in international markets and lower tendered volume from Brazil’s Ministry of Health when compared with the same period in 2025.2025;
•Singulair® (montelukast sodium), primarily attributable to decreased demand due to less favorable medical guidelines in certain international markets, most recently in China, as well as temporary supply constraints in Japan and mandatory price reductions in China and Japan; and
•Jada, due to no longer having sales following the sale of the Jada System to Laborie in January 2026.
TheThis foregoing decreaseperformance was partially offset by sales increases for the three months ended MarchJune 31,30, 2026 in:
•Emgality, as a result of continued uptake following the acquisition of the distribution and promotion rights from Lilly in January of 2024 in certain markets outside of the United States;
•Hadlima, due to stronger demand in the United States and increased demand in Puerto Rico;
•Zetia® (ezetimibe)/Vytorin® (ezetimibe / simvastatin), primarily driven by increased demand in China; and
•Emgality, as a result of increased demand in various international markets.
Worldwide sales were $3.0 billion for the six months ended June 30, 2026, a decrease of 3%, compared to 2025. Worldwide sales during the six months ended June 30, 2026 were positively impacted by approximately $118 million, or approximately 4%, due to favorable foreign exchange rates.
Excluding the impact of foreign exchange rates, sales decreases for the six months ended June 30, 2026, primarily reflect lower sales of:
•Nexplanon, primarily due to decreased physician demand in the United States following the five-year label approval as reinsertions have been delayed and there has been uncertainty around federal funding;
•Singulair, primarily attributable to decreased demand due to less favorable medical guidelines in certain international markets, most recently in China, as well as temporary supply constraints in Japan and mandatory price reductions in China and Japan;
•Ontruzant, due to lower tendered volume from Brazil’s Ministry of Health when compared with the same period in 2025; and
•Jada, due to no longer having sales following the sale of the Jada System to Laborie in January 2026.
This performance was offset by sales increases for the six months ended June 30, 2026 in:
•Hadlima, due to stronger demand in the United States and Puerto Rico;
•Emgality, as a result of increased demand in various international markets; and
•Zetia/Vytorin, primarily driven by increased demand in China.
•Atozet™¹ (ezetimibe and atorvastatin), primarily due to increased demand in China, due to the product launch in 2025, and in Asia Pacific as well as volume uptake in certain countries in Europe, partially offset by unfavorable pricing in Europe; and
•Brenzys, as a result of the timing of prior year tenders in Brazil.
Loss of exclusivity (“LOE”) negatively impacted sales of certain of our products by approximately $4$6 million and $10 million during the three and six months ended MarchJune 31,30, 2026, respectively, based on the decrease in sales volume of those products compared to 2025. Volume-based procurement (“VBP”) in China negatively impacted sales by approximately $2$5 million and $7 million during the three and six months ended MarchJune 31,30, 2026.2026, respectively. We expect VBP to continue to negatively impact our general medicines product portfolio for the next several quarters.
Due to changing market conditions, including ongoing conflicts,regional conflicts in the Middle East and elsewhere, new and evolving U.S. and international tariffs, U.S. tax law changes and regulatory uncertainty that impact our business, as well as the pharmaceutical industry, we have been and will continue to adapt our business and sales strategies to address this changing landscape in order to achieve our business objectives and remain competitive. Such strategies may include implementing or continuing to assess product discount programs and wholesaler inventory levels under the relevant agreements or waivers of their terms for certain key products.
Highlights of the sales of our products for the three and six months ended MarchJune 31,30, 2026 and 2025 are provided below. See Note 5 “Product and Geographic Information” to the Condensed Consolidated Financial Statements for further details on sales of our products.
Worldwide sales of Nexplanon, a single-rod subdermal contraceptive implant, declined 19%4% and 12% for the three and six months ended MarchJune 31,30, 2026, compared to 2025, respectively, primarily due to decreased physician demand in the United States following the five-year label approval as reinsertions have been delayed and there has been uncertainty around federal funding. We estimate that expanding use from the new label will begin to favorably offset the reinsertion headwind beginning in the second half of 2026. In 2025, we submitted a similar application for a five-year duration period of use to the EU and UK Health Authorities. The application for five-year duration was approved for the UK in April, 2026. The EU application is currently under review, with potential approval in 2027, subject to health authority review and approval. Outside of the U.S., sales declinedwere duepositively to the timing of shipments in selective emerging markets, partially offsetimpacted by increased demand and access in Brazil.Brazil, which we expect to continue for the remainder of 2026.
Worldwide sales of NuvaRing, a vaginal contraceptive product, increaseddeclined 10%4% for the three months ended MarchJune 31,30, 2026, compared to 2025, due to decreased demand in various international markets, partially offset by lower discount rates in the United States. Sales of NuvaRing, increased 2% for the six months ended June 30, 2026, compared to 2025, due to the favorable impact of foreign exchange and lower discount rates in the United States.States, offset by decreased demand in various international markets.
Worldwide sales of Marvelon™¹ (desogestrel and Mercilon,ethinyl estradiol pill) and Mercilon™¹ (desogestrel and ethinyl estradiol pill), combined oral hormonal daily contraceptive pills not approved or marketed in the United States, but available in certain countries outside the United States, declined 34%4% and 20% for the three and six months ended MarchJune 31,30, 2026, compared to 2025, respectively, as a result of decreased demand and market contraction in China and the timing of shipments in Asia Pacific. In the second quarter of 2026, we received regulatory approval in Japan for Mercilon Combination Tablets, a low-dose estrogen-progestin (LEP) product for the treatment of dysmenorrhea.
Worldwide sales of Follistim AQ, a fertility treatment, declined 12%19% and 16% for the three and six months ended MarchJune 31,30, 2026, compared to 2025, respectively, as a result of competitive drivencompetitive-driven price reduction in the United StatesStates. partiallyWe offsetexpect bysales modestto marketcontinue growthto decline compared to 2025 for the remainder of the year, reflecting the material price decrease implemented in China.February 2025. We anticipate that year-over-year comparisons will stabilize once a furtherfull declineyear duehas toelapsed following the price reductionreduction, andassuming increasedno competitiveadditional landscapestructural price decreases occur in the U.S.interim.
In January 2026, we completed the sale of the Jada System to Laborie.Laborie and, thereafter, we were no longer actively selling the Jada System. As a result, worldwide sales of Jada, a device intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted, significantly declined 66% for the three and six months ended MarchJune 31,30, 2026, compared to 2025.2025, respectively.
Renflexis is a biosimilar to Remicade2(infliximab) for the treatment of certain autoimmune conditions. Sales increased 1%4% and 2% for the three and six months ended MarchJune 31,30, 2026, compared to 2025, respectively, primarily due to favorable foreign exchange and increased demand in CanadaCanada, partially offset by the competitive pressure and unfavorable discount rates in the United States.
Hadlima is a biosimilar to Humira2 (adalimumab) for the treatment of certain autoimmune and autoinflammatory conditions. Sales increased 44%59% and 51% for the three and six months ended MarchJune 31,30, 2026, compared to 2025, respectively, due to stronger demand in the United States and increased demand in Puerto Rico. We have commercialization rights to Hadlima in countries outside of the European Union, South Korea, China, Turkey, and Russia. Hadlima is currently approved in the United States, Australia, CanadaCanada, and Israel.
Ontruzant is a biosimilar to Herceptin2 (trastuzumab) for the treatment of HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Sales for the three and six months ended MarchJune 31,30, 2026, compared to 2025, declined 71%,81% and 77%, respectively, due to increased competition in international markets and lower tendered volume from Brazil’s Ministry of Health when compared with the same period in 2025. We have commercialization rights to Ontruzant in all countries except in South Korea and China.
Brenzys is a biosimilar to Enbrel2 (etanercept) for the treatment of certain inflammatory diseases. Sales for the three and six months ended MarchJune 31,30, 2026, compared to 2025, increaseddeclined 39%,34% and 5%, respectively, as a result of the timing of prior year tendersshipments in Brazil. We have commercialization rights to Brenzys in countries outside of the United States, Europe, South Korea, China, and Japan.
Bildyos injection 60 mg/mL and Bilprevda injection 120 mg/1.7 mL, are biosimilars to Prolia and Xgeva, respectively, for all indications of the reference products. Sales were $19 million and $35 million for the three and six months ended June 30, 2026, respectively, as a result of the product launch in the third quarter of 2025.
Sales of Atozet,Atozet™¹ (ezetimibe and atorvastatin), a medicine for lowering LDL cholesterol, increaseddecreased 11%7% for the three months ended MarchJune 31,30, 2026 compared to 2025, due to unfavorable pricing in Europe, partially offset by increased demand in Korea. Sales of Atozet increased 1% for the six months ended June 30, 2026, compared to 2025, primarily due to favorable foreign exchange, increased demand in China, due to the product launch in 2025, and in Asia Pacific and Korea as well as volume uptake in certain countries in Europe, partially offset by unfavorable pricing in Europe.
Combined global sales of Zetia® (ezetimibe),Zetia, which is marketed as Ezetrol™ in most countries outside the United States; and Vytorin®of (ezetimibe / simvastatin),Vytorin, which is marketed as Inegy™ outside the United States, which are medicines for lowering LDL cholesterol, increased 1%16% and 8% for the three and six months ended MarchJune 31,30, 2026, compared to 2025, respectively, primarily driven by favorable foreign exchange and increased demand in China, partially offset by less tender volume and the timing of shipments in the Middle East.China.
Combined global sales of Cozaar® (losartan) and Hyzaar® (losartan / hydrochlorothiazide), which are medicines for the treatment of hypertension, increaseddeclined 4%10% and 3% for the three and six months ended MarchJune 31,30, 2026, compared to 2025, respectively, driven by favorable foreign exchange and increased demand in China, partially offset by decreased demand in various international markets.
Worldwide sales of Singulair, a once-a-day oral medicine for the chronic treatment of asthma and for the relief of symptoms of allergic rhinitis, declined 46%27% and 37% for the three and six months ended MarchJune 31,30, 2026, compared to 2025.2025, respectively. This decline during these periods was primarily attributable to decreased demand due to less favorable medical guidelines in certain international markets, most recently in China, as well as temporary supply constraints in Japan and mandatory price reductions in China and Japan.
Global sales of Nasonex,Nasonex® (mometasone furoate), an inhaled nasal corticosteroid for the treatment of nasal allergy symptoms, declined 9%12% and 10% for the three and six months ended MarchJune 31,30, 2026, compared to 2025, respectively, due to competitive pressure in various international markets.
Global sales of Dulera® (formoterol/fumarate dihydrate), which is also marketed as Zenhale™ in certain markets outside of the United States, a combination medicine for the treatment of asthma, declinedincreased 20%1% for the three months ended MarchJune 31,30, 2026, compared to 2025, primarily due to increasedthe discountfavorable rateimpact pressureof andforeign exchange, offset by decreased demand in the United States. Global sales of Dulera declined 10% for the six months ended June 30, 2026, compared to 2025, primarily due to decreased demand in the United States.
* Calculation not meaningful.
OGN insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 1 Form 4 filing (1 insider, 1 trade date, 26,448 shares, about $353.1K) and open-market sales in 2 filings (2 insiders, 2 trade dates, 41,209 shares, about $553.4K). Net open-market shares: -14,761 (purchases minus sales); net value about -$200.3K.Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
| Trade date | Insider | Transaction | Shares | Price | Value |
|---|---|---|---|---|---|
| 2026-08-11 | Arjona Ferreira Juan Camilo |
Option exercise | 11,519 | — | — |
| 2026-08-11 | Arjona Ferreira Juan Camilo |
Shares withheld for tax | 4,134 | $13.62 | $56.3K |
| 2026-08-05 | Drinane Juliana Papa |
Open-market sale | 14,761 | $13.57 | $200.3K |
| 2026-05-06 | Holzbaur Lynette |
Open-market sale | 26,448 | $13.35 | $353.1K |
| 2026-05-06 | Holzbaur Lynette |
Other | 46 | — | — |
| 2026-05-06 | Holzbaur Lynette |
Open-market purchase | 26,448 | $13.35 | $353.1K |
Well-known investors holding OGN (13F)
| Investor | Quarter | Shares | Reported value | % of their 13F | Change vs prior quarter |
|---|---|---|---|---|---|
| Millennium Management (Israel Englander) | 2026-06-30 | 3,442,430 | $46.6M | 0.03% | Reduced 49% |
| AQR Capital Management (Cliff Asness) | 2026-06-30 | 1,245,588 | $16.8M | 0.01% | Reduced 64% |
| Gotham Asset Management (Joel Greenblatt) | 2026-06-30 | 1,032,313 | $14.0M | 0.03% | Reduced 18% |
| D. E. Shaw & Co. | 2026-06-30 | 718,753 | $9.7M | 0.01% | Reduced 73% |
| Citadel Advisors (Ken Griffin) | 2026-06-30 | 344,359 | $4.7M | 0.0% | Reduced 83% |
| Bridgewater Associates | 2026-06-30 | 594,483 | $3.6M | — | Sold out |
| Two Sigma Investments | 2026-06-30 | 241,392 | $3.3M | 0.0% | Reduced 92% |
| Point72 Asset Management (Steve Cohen) | 2026-06-30 | 238,000 | $1.4M | — | Sold out |