What the changes say
- Internal investigation over Nexplanon sales practices and material weaknesses in financial controls dominate the new disclosures.
- Capital allocation priority shifted to deleveraging $8.6 billion in debt, resulting in a 90% dividend cut.
- Goodwill impairment of $301 million recorded for the U.S. reporting unit due to lower-than-expected financial performance.
What changed since the prior 10-K
New
- NewRisks Related to Our Business
allocations, we may encounter challenges receiving key regulatory approvals or maintaining business relationships with third parties that depend on government funding, which could materially adversely affect our business, financial condition, results of operations, or reputation
Geopolitical instability, social unrest, and global economic conditions could disrupt our operations and affect patients' ability to afford healthcare.
- NewRisks Related to Our Business
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
An Audit Committee investigation into Nexplanon sales practices and resulting remediation have been expensive and could cause additional expenses or litigation.
- NewRisks Related to Our Business
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
Material weaknesses in internal control over financial reporting could impact our ability to report financial results accurately and timely.
- NewRisks Related to Our Business
The use of AI and its legislative and regulatory landscape continues to evolve and makes it difficult to fully understand and assess related risks
The use of artificial intelligence and its evolving regulatory landscape create risks regarding data privacy, security, and compliance costs.
- NewRisks Related to Our Business
In the ordinary course of business, we and our third-party providers collect, store and transmit large amounts of confidential
Security breaches of confidential information and trade secrets held by us or third-party providers could compromise our competitive position.
- NewRisks Related to Our Business
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
We have $8.6 billion of debt and may fail to deleverage, which could lead to lower credit ratings, asset sales, and further dividend cuts.
- NewRisks Related to 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
Global healthcare reform and aggressive pricing and reimbursement pressures in the U.S., EU, UK, China, and Japan could reduce revenues.
- NewRisks Related to Our Business
In the United States, there have been significant and wide-ranging federal policy and legislative reforms impacting drug pricing
U.S. legislative reforms including the IRA and OBBBA, along with HHS restructuring, increase drug pricing pressures and formulary competition.
- NewRisks Related to Our Business
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
Failure to hire and retain a permanent CEO and key senior management could disrupt our strategic and operational objectives.
- NewRisks Related to Our Business
We have experienced, and may continue to experience, attrition among our senior management team and key employees. Our
Senior management attrition and executive departures could disrupt execution of our financial and strategic objectives.
- NewRisks Related to Our Business
An impairment of our Goodwill could materially impact our financial condition and results of operations
A $301 million goodwill impairment was recorded for the U.S. reporting unit, which remains susceptible to future non-cash impairment charges.
- NewRisks Related to Our Business
China significantly contributes to our global pharmaceutical sales, and its continued growth depends on a favorable regulatory environment, sustained availability of our currently marketed products within China, and our ability to mitigate the impact of any trade impediments or adverse pricing controls
China's VBP and URPS pricing programs, regulatory changes, and our planned pivot to the private retail segment could hurt our sales.
- NewRisks Related to Our Business
Any expansion of our product offerings and geographic presence would likely rely on acquisitions of complementary businesses, licensing arrangements and strategic partnerships. In addition, our current strategy includes potential divestitures of certain products or business lines
- NewRisks Related to Our Business
existing products unless and until we have obtained all required regulatory approvals or marketing authorizations in each relevant jurisdiction. Our applications or submissions for regulatory approval or marketing authorization may be rejected or otherwise delayed by the FDA or other regulatory authorities
- NewRisks Related to Our Business
There has been recent regulatory activity and enforcement in the United States stemming from an announced shift by FDA toward “radical transparency” resulting in increased scrutiny and transparency in the pharmaceutical drug space that may impact our business
- NewRisks Related to Our Business
one, we intend to coordinate closely with the FDA to protect proprietary information, there is no assurance that such efforts will be successful or that any inadvertent disclosures will be remedied. Moreover, once published, we may have limited ability to correct or contextualize the FDA’s statements
- NewRisks Related to Our Business
Nevertheless, these new policies of radical transparency and increased enforcement could result in unforeseen reputational, operational, financial regulatory and legal consequences for our Company and have the potential to impact our business and how we market our products
Dropped
- DroppedRisks Related to Our Business
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
- DroppedRisks Related to Our Business
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
U.S. healthcare reform and increased purchasing power of entities negotiating for beneficiaries.
- DroppedRisks Related to Our Business
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
- DroppedRisks Related to Our Business
Our reputation and promising pipeline render our products prime targets for counterfeiters
- DroppedRisks Related to Our Business
Inflation could materially adversely affect our business and operations
- DroppedRisks Related to Our Business
Our business could be negatively impacted by corporate citizenship and sustainability matters
Difficulties identifying acquisition opportunities or integrating transactions like Dermavant.
- DroppedRisks Related to Our Business
Social media and mobile messaging platforms present risks and challenges
- DroppedRisks Related to Our Business
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
Reworded
- 91% rewrittenRisks Related to Our Business
Our substantial indebtedness could adversely affect our financial condition and results of operations
Updated debt figures to $8.6 billion including $3.6 billion maturing in 2028, noting the priority to use cash flow to repay debt rather than fund growth.
Was: We have incurred substantial indebtedness, which could adversely affect our financial condition and results of operations
- 80% rewrittenRisks Related to Our Business
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
Added minor punctuation and formatting changes while retaining core regulatory approval risks across global jurisdictions.
- 80% rewrittenRisks Related to Our Business
Key products generate a significant amount of our profits and cash flows, and any events that adversely affect the markets for our leading products could adversely affect our results of operations and financial condition
Updated key product examples to include Vtama, Emgality, and biosimilars while adding enhanced safety measures and warnings as potential adverse events.
- 76% rewrittenRisks Related to Our Business
Changes in tax laws or other tax guidance could adversely affect our effective tax rates, financial condition or results of operations
Added specific reference to the enactment of the OBBBA in July 2025 and its corporate tax provisions affecting interest deductibility and R&D expenses.
Was: Changes in tax laws or other tax guidance could adversely affect our effective tax rates, financial condition and results of operations
- 71% rewrittenRisks Related to Our Business
We may not realize benefits from our investments in China and emerging markets
Changed healthcare spelling from 'health care' to 'healthcare' in the discussion of emerging markets and global financial instability.
- 67% rewrittenRisks Related to Our Business
We face intense competition from competitors’ products
Maintained identical core text regarding intense competition from generic versions and competitors' products.
- 67% rewrittenRisks Related to Our Common Stock
We cannot guarantee the timing, amount or payment of any dividends on our Common Stock
Added lead-in stating we cannot guarantee dividend payments and updated reliance on generating adequate cash and accessing capital markets.
- 66% rewrittenRisks Related to Our Business
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
Updated international revenue figures for 2025 to $4.6 billion representing 74% of total revenues, down from $4.8 billion and 75% in 2024.
- 64% rewrittenRisks Related to Our Business
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
- 63% rewrittenRisks Related to Our Business
We are subject to minimum purchase obligations under certain supply agreements, and if we fail to meet those minimum purchase requirements, our financial results may be unfavorably impacted
- 58% rewrittenRisks Related to Our Business
Our business and operations are subject to risks related to climate change and natural disasters
- 56% rewrittenRisks Related to Our Business
We may experience difficulties or delays or incur unforeseen difficulties, delays and expenses in connection with the manufacturing of certain of our products
Was: We may experience difficulties or delays or incur unforeseen expenses in connection with the manufacturing certain of our products
- 43% rewrittenRisks Related to Our Business
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
Was: 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
- 37% rewrittenRisks Related to Our Business
We are subject to a variety of laws and regulations, and we may face serious consequences for violations if we fail to meet the applicable legal and regulatory requirements
- 33% rewrittenRisks Related to Our Common Stock
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
Was: The price and trading volume of our Common Stock may be volatile, and stockholders could lose all or part of their investment in us
- 31% rewrittenRisks Related to Our Business
The legislative and regulatory landscape for privacy and, data protection continues to evolve
Was: The legislative and regulatory landscape for privacy, data protection and artificial intelligence (“AI”) continues to evolve
- 26% rewrittenRisks Related to Our Business
Developments following regulatory approval or marketing authorization may adversely affect sales of our pharmaceutical products or medical devices
- 24% rewrittenRisks Related to Our Business
Issues with product quality could have an adverse effect on our business or cause a loss of customer confidence in us or our products, among other negative consequences
- 20% rewrittenRisks Related to Our Business
Our growth could be limited by the scope of our intellectual property licenses
Was: Our growth could be limited by the scope of our intellectual property licenses for certain women’s health care products
All 47 risk factors
Headings as the filing states them, in filing order.
Risks Related to Our Business
- 01We have significant global operations, which expose us to additional risks, and any adverse event could adversely affect our results of operations and financial condition66% rewritten
- 02allocations, we may encounter challenges receiving key regulatory approvals or maintaining business relationships with third parties that depend on government funding, which could materially adversely affect our business, financial condition, results of operations, or reputationNew
- 03Adverse developments in the global economy or in one or more of our local markets could impact our ability to grow our business
- 04Changes in tax laws or other tax guidance could adversely affect our effective tax rates, financial condition or results of operations76% rewritten
- 05We are exposed to market risk from fluctuations in currency exchange rates and interest rates
- 06The 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 litigationNew
- 07We 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 mannerNew
- 08The use of AI and its legislative and regulatory landscape continues to evolve and makes it difficult to fully understand and assess related risksNew
- 09We 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 operations64% rewritten
- 10In the ordinary course of business, we and our third-party providers collect, store and transmit large amounts of confidentialNew
- 11We 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 flowsNew
- 12Our substantial indebtedness could adversely affect our financial condition and results of operations91% rewritten
- 13We 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
- 14The legislative and regulatory landscape for privacy and, data protection continues to evolve31% rewritten
- 15Key products generate a significant amount of our profits and cash flows, and any events that adversely affect the markets for our leading products could adversely affect our results of operations and financial condition80% rewritten
- 16Recent global healthcare reform initiatives, and U.S. judicial decisions, laws, regulations, executive orders and political actions could adversely affect our future revenues and profitabilityNew
- 17In the United States, there have been significant and wide-ranging federal policy and legislative reforms impacting drug pricingNew
- 18If we fail to appoint, hire and retain a permanent CEO, other members of our senior management, or other key employees, our business may sufferNew
- 19We have experienced, and may continue to experience, attrition among our senior management team and key employees. OurNew
- 20An impairment of our Goodwill could materially impact our financial condition and results of operationsNew
- 21We may not realize benefits from our investments in China and emerging markets71% rewritten
- 22China significantly contributes to our global pharmaceutical sales, and its continued growth depends on a favorable regulatory environment, sustained availability of our currently marketed products within China, and our ability to mitigate the impact of any trade impediments or adverse pricing controlsNew
- 23We face intense competition from competitors’ products67% rewritten
- 24We are subject to minimum purchase obligations under certain supply agreements, and if we fail to meet those minimum purchase requirements, our financial results may be unfavorably impacted63% rewritten
- 25Our growth could be limited by the scope of our intellectual property licenses20% rewritten
- 26We rely on third parties for activities related to preclinical and clinical testing
- 27Any expansion of our product offerings and geographic presence would likely rely on acquisitions of complementary businesses, licensing arrangements and strategic partnerships. In addition, our current strategy includes potential divestitures of certain products or business linesNew
- 28We may be unable to market our pharmaceutical products or medical devices if we do not obtain and maintain required regulatory approvals or marketing authorizations80% rewritten
- 29existing products unless and until we have obtained all required regulatory approvals or marketing authorizations in each relevant jurisdiction. Our applications or submissions for regulatory approval or marketing authorization may be rejected or otherwise delayed by the FDA or other regulatory authoritiesNew
- 30Developments following regulatory approval or marketing authorization may adversely affect sales of our pharmaceutical products or medical devices26% rewritten
- 31Issues with product quality could have an adverse effect on our business or cause a loss of customer confidence in us or our products, among other negative consequences24% rewritten
- 32Patent protections are important to the marketing and sale of certain of our products, particularly certain of our women’s health products, as such protection provides market exclusivity
- 33Additionally, court decisions relating to other companies’ patents, potential legislation in both the United States and certain other markets relating to patents, as well as regulatory initiatives, may result in a more general weakening of intellectual property protection
- 34We are subject to a variety of laws and regulations, and we may face serious consequences for violations if we fail to meet the applicable legal and regulatory requirements37% rewritten
- 35We may experience difficulties or delays or incur unforeseen difficulties, delays and expenses in connection with the manufacturing of certain of our products56% rewritten
- 36We 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
- 37Reliance on third-party relationships and outsourcing arrangements could materially adversely affect our business
- 38The markets for our products, including the women’s health market, may not develop as expected
- 39Biosimilars carry unique regulatory risks and uncertainties, which could adversely affect our results of operations and financial condition
- 40We 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 future43% rewritten
- 41There has been recent regulatory activity and enforcement in the United States stemming from an announced shift by FDA toward “radical transparency” resulting in increased scrutiny and transparency in the pharmaceutical drug space that may impact our businessNew
- 42one, we intend to coordinate closely with the FDA to protect proprietary information, there is no assurance that such efforts will be successful or that any inadvertent disclosures will be remedied. Moreover, once published, we may have limited ability to correct or contextualize the FDA’s statementsNew
- 43Nevertheless, these new policies of radical transparency and increased enforcement could result in unforeseen reputational, operational, financial regulatory and legal consequences for our Company and have the potential to impact our business and how we market our productsNew
- 44Our business and operations are subject to risks related to climate change and natural disasters58% rewritten
Risks Related to Our Common Stock
- 45We cannot guarantee the timing, amount or payment of any dividends on our Common Stock67% rewritten
- 46The price and trading volume of our Common Stock may be volatile, and stockholders could lose all or part of their investment in our Company33% rewritten
- 47Certain provisions in our amended and restated certificate of incorporation and bylaws, and of Delaware law, may prevent or delay an acquisition of us, which could decrease the trading price of our Common Stock
Other Organon 10-Ks
- FY2024 10-K risk factors38 risks
Organon relies heavily on key products like Nexplanon and Singulair, generating 75 percent of its 6.4 billion dollar revenue outside the US.
Filed Feb 28, 2025
About this page
The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.