Organon & Co. ("Organon"Organon," the "Company," "we," "our," or the "Company""us") is a global health care company with a focus on improving the health of women throughout their lives. Organon developsWe develop and deliversdeliver innovative health solutions through a portfolio of prescription therapies and medical devices within women's health, biosimilars and established brands (the "Organon Products"). Organon hasbrands. We have a portfolio of more than 60 medicines and products across a range of therapeutic areas. The Company sellsWe sell these products through various channels including drug wholesalers and retailers, hospitals, government agencies and managed health care providers such as health maintenance organizations, pharmacy benefit managers and other institutions. The Company operatesWe operate six manufacturing facilities, which are located in Belgium, Brazil, Indonesia, Mexico, 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, the Organon group of companies.

The Company'sOur operations include the following product portfolios:

Led by the women's health portfolio, coupled with an expanding biosimilars business and stable franchise of established medicines, Organon'sour products produce strongsufficient cash flows to support investments in innovation and future growth opportunities

Organon hasWe have expanded its women's health and biosimiliars portfolioour product portfolios through the following recent2023 acquisitions and licenses:

In 2022, Organon2023, we recorded revenues of $6.2$6.3 billion. Organon operatesWe operate on a global scale and Organon'sour global network enables itus to distribute products to patients in more than 140 countries and territories, with approximately 77%76% of 20222023 revenues, or $4.7$4.8 billion, generated outside the United States.

The following highlights key products in our portfolios:

Organon'sOur contraception portfolio currently consists of the following products, which work to prevent pregnancy primarily by suppressing ovulation:

Organon'sOur fertility brands include the following products, which are primarily used for in vitro fertilization ("IVF") treatment cycles:

In 2022, Organon's2023, our biosimilars portfolio accounted for $481$593 million, or approximately 8%9%, of our total revenues, with $237$295 million, or approximately 49%50%, generated outside the United States. The assets in Organon'sour biosimilars portfolio, and Organon'scoupled with our commercial experience in biosimilars, providesprovide an opportunity to benefit from future growth anticipated in this area.

Established brands represents a broad portfolio of mature brands across multiple therapeutic areas and geographies that are generally beyond market exclusivity. Organon'sOur established brands portfolio contributed approximately $3.9$3.8 billion of our total revenues in 2022, of which2023, with approximately 92%93%, or $3.6 billion, generated outside the United States. Generic competition varies significantly across geographies.

In 2022, Organon's2023, our cardiovascular portfolio accounted for $1.5 billion, or approximately 24%23%, of our total revenues, nearly all of which were generated outside the United States.

In 2022, Organon's2023, our respiratory portfolio accounted for $1.0$1.1 billion, or approximately 17% of our total revenues, with approximately 80%79%, or $826$843 million, generated outside the United States.

As of December 31, 2022, Organon has2023, we have licenses to commercialize the following development stage products:

Organon hasWe have approximately 3,8504,000 employees worldwide focused on commercialization activities, such as marketing, direct selling,sales, digital and omni-channel and insight generation, covering data stewardship, data analytics and data science. Organon hasWe have a global team of experienced marketers, pricing and access professionals, and data scientists across geographies that Organon is implementing localization and execution of its global brand and business strategies. Organon believes itsscientists. We believe our commercialization capabilities allow itus to execute customer engagement strategies optimized across preferred channels and aimed at health care providers, patients and payors. Organon'sOur global and local marketing employees focus on building an integrated digital ecosystem that coordinates engagement across all channels. These engagements include direct face–to–faceface-to-face engagement, virtual engagement, email, social media and Organon'sour websites. In addition, Organon believes it haswe believe we have the knowledge, capabilities, and resources to achieve optimal local market access for itsour portfolio in a changing external environment.

Organon hasWe have a trade channel strategy that provides a robust capability framework for Organon'sour activities, including in the selection of channel partners, commercial terms and supportive health care services that promote the efficient, safe and cost-effective delivery of Organon'sour products. Organon hasWe have significant insight into the use of newer technologies and the use of valuable patient services such as patient adherence programs that can further drive value in collaboration with Organon'sour trade partners.

Organon doesWe do not have any single customer that, if such customer were lost, would have a material adverse effect on Organon'sour business.

Organon'sOur global network enables itus to distribute products directly and indirectly to patients in more than 140 countries and territories, including through Organon'sour regional distribution centers. Organon sells itsWe sell our pharmaceutical products primarily to drug wholesalers and retailers, hospitals, clinics, government agencies, pharmacies, and managed health care providers, such as health maintenance organizations, pharmacy benefit managers and other institutions. OrganonWe also sells itssell our pharmaceutical products through third-party distributors and agents for smaller markets. Organon'sOur professional representatives communicate the effectiveness, safety and value of Organon'sour pharmaceutical products to health care professionals in private practice, group practices, hospitals and managed care organizations.

Organon hasWe have high quality manufacturing capabilities, including development and improvement of manufacturing processes. Organon'sOur principal manufacturing capabilities include formulation, fill-and-finishing of products, packaging of products, and distribution and supply to patients in more than 140 countries and territories.

Organon manages itsWe manage our global supply chain through a centralized supply planning organization and regional demand management, with distribution and logistics teams structured around North America, Europe, Middle East and Africa, Asia-Pacific and Latin America. Organon's global commercial and manufacturing teams collaborate on various operational efficiency initiatives, including yield improvements, procurement savings, site synergies, manufacturing support rationalization and supply chain distribution optimization, each intended to improve Organon's leverage position.

In order to satisfy the manufacturing and regulatory requirements for the breadth of products in Organon's portfolio, aA number of Organon'sour materials and components are sole-sourced. Certain of these sole-sourced materials are critical to Organon'sour key products, including women's health and legacyestablished brands. Organon sources 100% of its active pharmaceutical ingredients externally and portions of its drug product. While the majority are single sourced, they are from established pharmaceutical suppliers with whom Organon has significant experience. In particular, Organon relieswe rely heavily on one supplier for formulation and/or packaging as Organon'sour gateway to sales in both Japan and China.

To mitigate supply risk, Organon aims to havewe maintain a conservative inventory posture and to keepkeeps an internal function focused on maintaining an external manufacturing network with operational, quality, technology and procurement capabilities. This function is responsible for identifying, developing and assessing the performance of Organon's suppliers such that they meet quality expectations and satisfy their contractual obligations to Organon. In addition, this function provides rapid response support for potential supply issues. Organon also has an established risk management framework, which is intended to assess and mitigate risk elements across Organon's supply chain.

Organon'sOur facilities and supporting functions, along with itsour external contractors, suppliers, and partners, make up an integrated, interdependent global network. This network that is dedicated to consistently delivering compliant, reliable product supply to health care providers and patients. Organon hasWe have one quality management system deployed globally that enables the development, manufacturing, packaging, labeling, handling, and distribution of Organon'sour products, such that they conform to applicable regulatory requirements in every country it serves. Organon'swe serve. Our quality management system is designed to promote and facilitate regulatory and operational excellence, anticipate risks, and prepare the network to effectively respond and adapt to emerging trends.

Organon'sOur human resources organization is led by an experienced team that monitors itsour employee base and sets annual targets for managing itsour human capital, includingcapital. These include employee retention, engagement, and training targets. The Talent Committeetalent committee of Organon'sour Board regularly reviews and discusses with management Organon'sour diversity, inclusion and leadership development initiatives, objectives, and progress.progress with management.

Organon hasWe have established benefit and incentive compensation plans, including comprehensive medical and life insurance coverage, 401(k) matching programs and other incentive compensation programs that Organon believes alignwe believe aligns employee incentives directly with Organon'sour future performance.

As of December 31, 2022, Organon2023, we had approximately 10,000 employees worldwide with approximately 1,650 (16.5%1,700 (16%) employees in the United States (including Puerto Rico). Approximately 86%85% of Organon'sour employees work in key functional areas (Commercial, Research & Development, and Manufacturing/Supply) and 14%15% are in support functions. Organon hasWe have approximately 3,8504,000 employees worldwide focused on commercialization activities, such as marketing, direct selling,sales, digital and omni-channel and insight generation, covering data stewardship, data analytics and data science, and approximatelyscience. Approximately 900 employees are focused on clinical development, safety, and medical affairs and product registration.

Organon strivesWe strive to build a strong culture with inclusion and belonging at itsour core, believing that this is fundamental to success and future innovation. More than 30% of Organon's U.S.our employees in the United States identify as part of an underrepresented ethnic group. Organon supports itsWe support our workforce through innovative talent and performance programs and havehas additionally founded ten Employee Resource Groups. OrganonWe also regularly assesses itsour employees' experience, including measures of engagement, well-being, inclusion, and core cultural values through annual surveys and regular check-ins.

Organon'sOur employees are at the core of itsour mission to improve the health of women and, given Organon'sour global nature, it haswe have a strong focus on female representation. Globally, over 50% of Organon'sour employees are female, and women comprise approximately 40%60% of Organon'sour senior leadership (nearly 70%75% of theour Board of Directors; 40% of our Executive Committee).

Patent protection is important to the marketing of certain of Organon'sour products in the United States and in most major foreigninternational markets. Patents may cover products per se, pharmaceutical formulations, processes for, or intermediates useful in, the manufacture of products, devices for delivering products, or the uses of products. Protection for individual products extends for varying periods in accordance with the legal life of patents in the various countries, and may be extended in some jurisdictions based upon the period of time a patented product is under regulatory review by the relevant health authority. The protection afforded, which may also vary from country to country, depends upon the type of patent and its scope of coverage.

Additions to market or data exclusivity are sought in the United States and other countries through all relevant laws, including laws increasing patent life. Some of the benefits of increases in patent life have been partially offset by an increase in the number of incentives for and use of generic products. Additionally, improvements in intellectual property laws are sought in the United States and other countries through reform of patent and other relevant laws and implementation of international treaties.

For further information with respect to Organon'sour patents, see the sections entitled "Risk Factors" and Note 1220 "Contingencies—Patent Litigation" to the Financial Statements included in this report.

Worldwide, all of Organon'sour important products are sold under trademarks that are considered in the aggregate to be of material importance. Trademark protection continues in some countries as long as used; in other countries, as long as registered. Registration is for fixed terms and can be renewed indefinitely.

Royalty income in 20222023 on patent and know-how licenses and other rights amounted to $3$6 million. OrganonWe also incurred royalty expenses totaling $13$6 million in 20222023 under patent and know-how licenses Organon holds.we hold.

To remain competitive, the additional resources required to meet market challenges include quality control, flexibility to meet buyer specifications, an efficient distribution system and a strong technical information service. Organon plansWe plan to continue to acquire and market products through external alliances, such as licensing arrangements and collaborations, and hashave designed itsour sales and marketing efforts to address changing industry conditions. However, the introduction of new products and processes by competitors may result in price reductions and product displacements, even for products protected by patents.

In the United States private sector, consolidation and integration among health care providers is a major factor in the competitive marketplace for pharmaceutical products. Health plans and PBMs have been consolidating into fewer, larger entities, thus enhancing their purchasing strength and importance.products marketplace. Private third-party insurers, as well as federal and state governments, employ formularies to control costs by negotiating discounted prices in exchange for formulary inclusion. Failure to obtain timely or adequate pricing or formulary placement for Organon's products or obtaining such placement at unfavorable pricing could adversely affect revenue. In addition to formulary tier co-pay or co-insurance differentials, private health insurance companies and self-insured employers have been raising co-payments and co-insurance required from beneficiaries, particularly for branded pharmaceuticals and biotechnology products. Private health insurance companies are also increasingly imposing utilization management tools, such as clinical protocols requiring prior authorization for a branded product if a generic product is available or requiring the patient to first fail on one or more generic products before permitting access to a branded medicine. These same management tools are also used in treatment areas in which the payor has taken the position that multiple branded

Pricing and reimbursement of medicinal products isare not harmonized at the EU level, but rather controlled by individual EU Member States. In addition, a majority of countries in the EU attemptThese Member States have attempted to contain drug costs by engaging in reference pricing. Reference pricing in whichallows authorities to examine pre-determined markets for published prices of drugs. Reference pricing may either compare a product's prices in other markets (external reference pricing) or compare a product's price with those of other products in a national class (internal reference pricing). The authorities then use the price data to set new local prices for brand-name drugs, including Organon's. Guidelines for examining reference pricing are usually set in local markets and can be changed pursuant to local regulations. Some EU Member States have established free-pricing systems, but regulate the pricing for drugs through profit control plans. Others seek to negotiate or set prices based on the cost-effectiveness of a product or an assessment of whether it offers a therapeutic benefit over other products in the relevant class. The downward pressure on health care costs in general, particularly prescription drugs, has become intense.intensified. As a result, manufacturers are erecting increasingly high entry barriers are being erected to the entry of new products. In some EU Member States, cross-border imports from low-priced markets also exert competitive pressure that may reduce pricing within an EU Member State.

In Japan, the pharmaceutical industry is subject to government-mandated biennial price reductions of pharmaceutical products. Furthermore, the government can order re-pricings for specific products if it determines that use of such products will exceed certain thresholds defined under applicable re-pricing rules.

While pricing pressure has always existed in China, health care reform has increased this pressure in part due to the acceleration of generic substitution through volume-based procurement ("VBP"). In 2019, the government implemented theThe Chinese VBP program operates through a tendering process for mature products that have generic substitutes with a Generic Quality Consistency Evaluation ("GQCE") approval. Mature products that have entered into the first sevennine rounds of VBP have had, on average, a price reduction of approximatelyover 50%. Organon expects VBP to be

has been a roughly semi-annual process that will have a significant impact on mature products moving forward, which Organon expectswe expect to increase pricing pressure on itsour products in China. There are 300374 molecules currently included under VBP, and it is expected that an aggregate of 500 molecules will be subject to VBP by 2025.

The pharmaceutical and medical device industries are also subject to regulation by regional, country, state and local authorities around the world, focused on standards and processes for determining drug and device safety and effectiveness, as well as conditions for sale or reimbursement. In the United States, the FDA administers requirements covering the testing, approval, safety, effectiveness, manufacturing, labeling and marketing of pharmaceuticals and medical devices.

The EU the EEAhas also adopted directives and other European Jurisdictions, Organon submitslegislation concerning the classification, approval for marketing, applicationslabeling, advertising, manufacturing, wholesale distribution, integrity of the supply chain, pharmacovigilance and safety monitoring of medicinal products for human use. These provide mandatory standards throughout the EU, which may be supplemented or implemented with additional regulations by the EU Member States.

Industry practice and government regulations in the United States and most foreign countries provide for the determination of effectiveness and safety of new chemical compounds suitable for pharmaceutical use through pre-clinical tests and controlled clinical evaluation. Before a new drug may be marketed in the United States, recorded data on pre-clinical and clinical investigations are included in the NDA for a drug or the Biologics License Application ("BLA") for a biologic, and submitted to nationalthe FDA for the required approval, which can be a phased process. As a manufacturer and distributor of drug products, our activities are regulated under various federal and state statutes and state manufacturer and wholesaler laws. Manufacturers and distributors of controlled substances must also maintain registration with the Drug Enforcement Agency ("DEA"), and comply with various regulatory authorities. Examples ofrequirements, including maintaining records and inventory, reporting to the DEA, and meeting certain security and operational safeguards. Similar requirements exist in most states.

The FDA imposes medical device regulations that govern requirements for design, development, testing, manufacturing, labeling, clinical trials, and pre-market clearance and approval, among other requirements. Marketed devices are also subject to ongoing FDA regulation. Requirements include those related to establishment registration and device listing, labeling and advertising, unique device identification, and good manufacturing practices. Although physicians are permitted to use their medical judgment to use medical devices for indications other than those cleared or approved by the FDA, we may not promote our products for such include the National Medical Products Administration ("NMPA") in China, the Ministry of Health, Labour"off-label" uses and Welfare in Japan, Health Canada, Agência Nacional de Vigilância Sanitária in Brazil, Koreacan only market our products for cleared or approved uses.

Before our pharmaceutical products can be marketed outside the United States, they are also subject to regulatory approvals in South Korea and Therapeutic Goods Administration in Australia.those countries. Each country has a separate and independent review process and timeline.timeline, which varies significantly between jurisdictions. In many markets,certain countries, the sales price of a product must also be approved by the applicable regulator.

Failure by us or by any of our third-party partners, including suppliers, manufacturers and distributors, to comply with laws governing the conduct of clinical trials, manufacturing approval, times can be longermarketing authorization of pharmaceutical products and marketing of such products, both before and after grant of marketing authorization, statutory health insurance, bribery and anti-corruption or other applicable regulatory requirements, may result in administrative, civil or criminal penalties. These penalties could include delays or refusal to authorize the conduct of clinical trials or to grant marketing authorization, product withdrawals and recalls, product seizures, suspension, withdrawal or variation of the marketing authorization, total or partial suspension of production, distribution, manufacturing or clinical trials, operating restrictions, injunctions, suspension of licenses, fines and criminal penalties.

We and our third-party manufacturers are also subject to other good manufacturing practices, which are extensive regulations governing manufacturing processes, stability testing, record keeping and quality standards as defined by the regulatory authority requires approval in a major market, such as the United Statesauthorities. Companies may be subject to civil, criminal or the EUadministrative sanctions if they fail to comply with these practices.

The advertising and issuancepromotion of a Certificateour products are also subject to laws, rules, regulations, and industry self-regulatory codes of Pharmaceutical Product from that market before initiating their local review process.conduct concerning promotion of pharmaceutical products, interactions with health care providers, misleading and comparative advertising and unfair commercial practices.

Organon believesWe believe that climate change couldwill present riskssome degree of risk to itsour business. Some of the potential effects of climate change to Organon'sour business could include increased operating costs due to additional regulatory requirements, changes in supply and suppliers due to regulatory requirements, physical risks to Organon'sour facilities, water limitations and disruptions to Organon'sour supply chain. Some potential risks are integrated into Organon'sour business planning, including investment in reducing energy, water use and greenhouse gas emissions. Organon doesWe do not believe these potential risks are material to itsour business at this time.

Organon isWe are not aware of any compliance issues associated with applicable environmental laws and regulations that would have a material adverse effect on Organon'sour business. Expenditures for remediation and environmental liabilities are estimated to be approximately $16$15 million in the aggregate for the years 20232024 through 2027.2028. For additional information, please see "Management's Discussion and Analysis of Financial Condition and Results of Operations — Critical Accounting Estimates" and Note 1220 "Contingencies —Environmental Matters" to the Financial Statements included in this report. Notwithstanding the foregoing, various legislation, regulations and international accords pertaining to climate change have been implemented or are being considered for implementation, particularly as they relate to the reduction of greenhouse gas emissions, such as the EU's Corporate Sustainability Reporting Directive ("CSRD"), California's Climate Corporate Data Accountability Act and Climate Related Financial Risk Act, and similar regulations under consideration by the SEC.

Under the Samsung Bioepis Agreement, Samsung Bioepis is responsible for pre-clinical and clinical development, process development and manufacturing, clinical trials and registration of product candidates. Organon'sOur access rights to each product under the Samsung Bioepis Agreement last for ten years from each such product's launch date on a market-by-market basis. Unless the parties agree to extend the term, the agreement expires upon the expiration of the last such ten-year period. OrganonWe may terminate the agreement with respect to a particular region or product if a product fails to meet certain milestones in such region. OrganonWe may terminate the agreement upon 60 days' written notice to Samsung Bioepis for a particular presentation of a product in a region if Samsung Bioepis's revenue share for such product presentation in such region exceeds a certain

contractual threshold. OrganonWe may also terminate the agreement upon 60 days' written notice in the event of a third-party infringement claim that Samsung Bioepis decides to litigate despite Organon'sour opposition to such litigation.

The Samsung Bioepis Agreement may be terminated by either party on 30 days' written notice for a particular product or region if the parties fail to agree upon a strategy regarding third-party patents within six months following written notice by either party of the existence of such patents. The agreement may also be terminated by either party upon written notice if the other party commits a material breach of its obligations by specified actions within its reasonable control and has not cured such breach within 90 calendar days after notice requesting cure of the breach.

The Samsung Bioepis Agreement provides that gross profits are shared equally in all markets except for certain markets in Brazil where gross profits are shared 65% to Samsung Bioepis and 35% to Organon.us. The Samsung Bioepis Agreement also provides for payment of certain milestone license fees associated with pre-specified clinical and regulatory milestones to Samsung Bioepis, payment of the supply price for each product to Samsung Bioepis, and an upfront payment to Samsung Bioepis that was completed by Merck at the commencement of the agreement. As of December 31, 2022,2023, there were $25 million in potential future regulatory milestone payments remaining under the agreement. For further information related to the Samsung Bioepis collaboration, see Note 418 "Samsung Collaboration" to the Consolidated Financial Statements included in this report and the Samsung Bioepis Agreement, which is filed as an exhibit to this report.

Organon isWe are a Delaware corporation incorporated on March 11, 2020. Organon's2020, and was spun off from Merck in 2021. Our corporate offices are located at 30 Hudson Street, 33rd Floor, Jersey City, New Jersey 07302.

The following is a summary of the principal risks that could significantly and negatively affect Organon'sour business, prospects, financial conditions, or operating results. For a more complete discussion of the material risks facing Organon'sour business, please see below:

We face continued pricing pressure in the United States and globally and, particularly in the EU, the UK, China and Japan, from managed care organizations, government agencies and programs that could incur substantial additional costsadversely affect our sales and experience temporary business interruptions.profit margins. We expect pricing pressure to continue in the future.

In connectionaddition, 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, including the EU, the UK, China and Japan, have pervasive government involvement in health care funding and, in that regard, extensive pricing and reimbursement mechanisms and processes for pharmaceutical products. Consequently, in those markets, we are subject to government decision-making and budgetary actions with respect to our products. Cost containment efforts by governments and private organizations are described in greater detail in the Business-Regulatory section above.

We rely on third parties to manufacture and 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 spinoff, Organon installedgeneral investigational plan and implemented information technology infrastructureprotocols for the trial; ensure compliance with regulatory standards like good clinical practices; and register ongoing clinical trials and results to support its criticalgovernment-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.

Failure to comply with the requirements of the GDPR and the related national data protection laws of the EU Member States may incur substantially higher costs forresult in significant monetary fines and other administrative penalties as well as civil liability claims from individuals whose personal data was processed. Data protection authorities from the different EU Member States may still enforce the GDPR differently, reflecting variations that arise under national-level regulations and guidelines (e.g., labor laws, processing of national identification numbers), which adds to the complexity of processing personal data in the EU. Guidance at both EU level and at the national level in individual EU Member States concerning implementation than currently anticipated. Potential operational interruptions impacting Organonand compliance practices is often updated or otherwise revised, resulting in a challenging regulatory environment.

In the ordinary course of business, we and our third-party providers collect, store and transmit large amounts of confidential information technology services,(including trade secrets or Organon's failureother intellectual property, proprietary business information and personal information), and we must do so in a secure manner to implementmaintain the newconfidentiality and integrity of such confidential information. The size

and complexity of we and our third-party providers' systems and replace Merck's services successfully,the large amounts of confidential information present on them also makes them potentially vulnerable to security breaches from inadvertent or intentional actions by our employees, partners or vendors, or from attacks by malicious third parties. Maintaining the confidentiality, integrity, and availability of this confidential information (including trade secrets or other intellectual property, proprietary business information and personal information) is important to our competitive business position. However, such information can be difficult to protect and could disrupt Organon's business be compromised.

While we have taken steps to protect such information, and to ensure that the third-party providers on which we rely have taken adequate steps to protect such information, there can be no assurance that our efforts to protect our data and IT systems or the efforts of third-party providers to protect their IT systems will be successful in preventing disruptions. A breach of our IT systems or our third-party providers' IT systems, such as cloud-based systems, or the accidental loss, inadvertent disclosure, unapproved dissemination, misappropriation or misuse of trade secrets, proprietary information, or other confidential information, whether as a result of theft, hacking, fraud, trickery, other forms of deception, or any other cause, could enable others to produce competing products, use our proprietary technology or information, and/or adversely affect itsour business position.

We expect recent changes in tax laws around the world, including as led by the Organization for Economic Cooperation and Development ("OECD"), such as the adoption by the EU and the enactment by additional countries of a global minimum tax, to negatively impact our effective tax rate and results of operations. Other changes in tax laws or regulations around the world, including in the United States, could negatively impact our cash tax liability, and will likely have a negative impact on our effective tax rate, and results of operations.

The inappropriate and/or unauthorized use of certain social media and mobile messaging channels could cause brand damage or information leakage or could lead to legal implications, including from the improper collection and/or dissemination of personally identifiable information. In addition, ifnegative or inaccurate posts or comments about us or our products on any social networking platforms could damage our reputation, brand image and goodwill. Further, the disclosure of non-public Organon-sensitive information by our workforce or others through external media channels could lead to information loss. Although there are internal Organon is unablepolicies that guide employees on appropriate personal and professional use of these platforms for communication about us, it may not completely secure and protect information. Identifying new points of entry as new communication tools expand also presents new challenges.

Merck may not satisfy its obligations under various transaction agreements that have been or will be executed as part of the spinoff, Organonwe may experience delays with approvals relating to the separation from Merck, or Organonwe may not have necessary systems and services in place when certain of the transition agreements expire.

In addition, in connection with the spinoff, Organon haswe have established operations in certainmost markets, but is unable to import, distribute, or trade certain products in thosesome markets due to pending licenses, permits, and regulatory approvals, among other requirements. Until all required approvals are received, Organon relieswe rely upon Merck to perform certain activities in these markets. Organon We

may incur additional costs during the period of time before all necessary approvals are granted, which may affect Organon'sour business and result in additional costs in these markets.

If Organon doeswe do not have itsour own systems and services in place, or if Organon doeswe do not have agreements with other providers of these services, when these agreements terminate, Organonwe may not be able to operate itsour business effectively and itsour profitability may decline. Organon isWe are in the process of creating itsour own, or engaging third parties to provide, systems and services to replace many of the systems and services Merck is providing, and is expected to provide, during the transition period to Organon. Organonus. We may not be successful in effectively or efficiently implementing these systems and services or in transitioning data from Merck's systems to Organon'sour systems. These systems and services may also be more expensive or less efficient than the systems and services Merck is expected to provide during the transition period.

There could be significant income tax liability if the spinoff or certain related transactions are determined to be taxable for U.S. federal income tax purposes.

Prior to completion of the spinoff, Merck received the tax opinions from its tax advisors that concluded, among other things, that the distribution of all of the outstanding Organon shares to Merck stockholders and certain related transactions qualify as tax-free to Merck and its stockholders under Sections 355 and 368 of the U.S. Internal Revenue Code, except to the extent of any cash received in lieu of fractional shares of Organonour Common Stock. The Tax Opinions are not binding on the Internal Revenue Service ("IRS"). Accordingly, the IRS may reach conclusions with respect to the spinoff that are different from the conclusions reached in the Tax Opinions. The Tax Opinions rely on certain facts, assumptions, representations and undertakings from Merck and Organon regarding the past and future conduct of the companies' respective businesses and other matters, which, if incomplete, incorrect or not satisfied, could alter the conclusions of the party giving such Tax Opinion.

Contractual restrictions limit Organon'sour ability to engage in certain corporate transactions.transactions that stockholders may consider favorable.

Certain of Organon'sour executive officers and directors may have actual or potential conflicts of interest because of their previous positions at Merck.

Because of their former positions with Merck, certain of Organon'sour executive officers and directors own shares of Merck Common Stock and continue to participate in certain Merck benefit programs. Even though Organon'sour Board of Directors consists of a majority of directors who are independent, and Organon'sour executive officers who were previously employees of Merck ceased to be employees of Merck in connection with the spinoff, some Organonof our executive officers and directors continue to have financial interests in Merck. Continuing ownership of Merck Common Stock and continued participation in Merck benefit programs could create, or appear to create, potential conflicts of interest if Organonwe and Merck pursue the same corporate opportunities or face decisions that could have different implications for Organonus and Merck.

The price and trading volume of Organon'sour Common Stock may be volatile, and stockholders could lose all or part of their investment in Organon.us.

The trading volume and market price of Organon'sour Common Stock may be volatile. This volatility could negatively impact Organon'sour ability to raise additional capital or utilize equity as consideration in any acquisition transactions Organonwe may seek to pursue, and could make it more difficult for existing stockholders to sell their shares of theour Common Stock at a price they consider acceptable or at all. This volatility is caused by a variety of factors, including, among the other risks described in this report:

In addition, the stock market in general, and the market for stock of companies in the life sciences and pharmaceutical industries in particular, has experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of comparable companies. In the past, following periods of volatility in the overall market and the market price of a particular Company's securities, securities class action litigation has often been instituted against a company. This type of litigation, if instituted against Organon,us, could result in substantial costs and a diversion of itsour management's attention and resources.

OrganonWe cannot guarantee the timing, amount or payment of any dividends on theour Common Stock.

OrganonWe currently expectsexpect that itwe will continue to pay quarterly cash dividends. The timing, declaration, amount and payment of any future dividends to stockholders will fall within the discretion of Organon'sour Board of Directors. The Board of Directors' decisions regarding the payment of dividends will depend on many factors, such as Organon'sour financial condition, earnings, corporate strategy, capital requirements, debt service obligations, industry practice, legal requirements, regulatory constraints, and other factors that the Board deems relevant. Organon'sour ability to pay any dividends will depend on itsour ongoing ability to generate cash from operations and access capital markets.

Certain provisions in Organon'sour amended and restated certificate of incorporation and bylaws, and of Delaware law, may prevent or delay an acquisition of Organon,us, which could decrease the trading price of theour Common Stock.

Organon isWe are a Delaware corporation, and itsour amended and restated certificate of incorporation, bylaws, and Delaware law each contain provisions that are intended to deter coercive takeover practices and inadequate takeover bids by making such practices or bids unacceptably expensive to the bidder and encouraging prospective acquirors to negotiate with Organon'sour Board of Directors rather than to attempt a hostile takeover. Specifically, because Organon haswe have not chosen to be exempt from Section 203 of the Delaware General Corporation Law, this provision could also delay or prevent a change of control that stockholders may favor.

Section 203 provides that, subject to limited exceptions, persons that acquire, or are affiliated with a person that acquires, more than 15% of the outstanding voting stock of a Delaware corporation may not engage in any business combination with that corporation, including by merger, consolidation or acquisitions of additional shares, for a three-year period following the date on which that person or their affiliates becomes the holder of more than 15% of the corporation's outstanding voting stock.

In addition, Organon'sour amended and restated certificate of incorporation and bylaws include additional provisions that may have anti-takeover effects and may delay, deter or prevent a takeover attempt that Organon'sour stockholders might consider in their best interests. For example, Organon'sour amended and restated certificate of incorporation and bylaws:

Organon believesWe believe these provisions will protect itsour stockholders from coercive or otherwise unfair takeover tactics by requiring potential acquirors to negotiate with Organon'sour Board of Directors and by providing itsour Board of Directors with more time to assess any acquisition proposal. These provisions are not intended to make Organonus immune from takeovers. However, these provisions will apply even if the offer may be considered beneficial by some stockholders and could delay or prevent an acquisition that Organon'sour Board of Directors determines is not in the best interests of Organonus and itsour stockholders. These provisions may also prevent or discourage attempts to remove and replace incumbent directors. In addition, these limitations may adversely affect the prevailing market price and market for Organon'sour Common Stock if they are viewed as limiting the liquidity of itsour stock or discouraging takeover attempts in the future.

Organon'sOur amended and restated bylaws provide that, unless Organon selectswe select or consentsconsent to the selection, in writing, of an alternative forum, all internal corporate claims, which include claims in the right of Organon company (i) that are based upon a violation of a duty by a current or former director, officer, employee or stockholder in such capacity or (ii) as to which the Delaware General Corporation Law confers jurisdiction upon the Court of Chancery, will, to the fullest extent permitted by law, be exclusively brought in the Court of Chancery of the State of Delaware or, if such court does not have jurisdiction, another state court or a federal court located within the State of Delaware.

Furthermore, unless Organon selectswe select or consentsconsent to the selection of an alternative forum, the federal district courts of the United States of America will be the exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act. Organon'sOur exclusive forum provision does not apply to suits brought to enforce any liability or duty created by the Exchange Act, and investors cannot waive compliance with the federal securities laws and the rules and regulations thereunder.

These exclusive provisions may limit a stockholder's ability to bring a claim in a judicial forum that he, she or it believes to be favorable for disputes with Organonus or itsour directors, officers or other employees, which may discourage such lawsuits. It is possible

that a court could find these exclusive forum provisions inapplicable or unenforceable with respect to one or more of the specified types of actions or proceedings, and Organonwe may incur additional costs associated with resolving such matters in other jurisdictions, which could materially adversely affect Organon'sour business, financial condition and results of operations and result in a diversion of the time and resources of itsour management and board of directors.

Not applicable.

Organon'sOur corporate headquarters is located in Jersey City, New Jersey. OrganonWe also maintainsmaintain operational headquarters in Pennsylvania. Organon ownsWe own and operatesoperate six manufacturing facilities in Campinas, Brazil, Cramlington, United Kingdom, Heist, Belgium, Oss, Netherlands, Panaan,Pandaan, Indonesia and Xochimilco, Mexico.

We are from time to time subject to claims and litigation arising in the ordinary course of business. These claims and litigation may include, among other things, claims or litigation relating to intellectual property, product liability, securities law, breach of contract and tort, or allegations of violation of United States and foreign competition law, labor laws, consumer protection laws and environmental laws and related regulations. We operate in multiple jurisdictions and, as a result, claims in one jurisdiction may lead to claims or regulatory penalties in other jurisdictions. There can be no assurance as to the ultimate outcome of a legal proceeding; however, we intend to defend vigorously against any pending or future claims and litigation, other than matters deemed appropriate for settlement. We accrue a liability for legal claims when payments associated with the claims become probable and the costs can be reasonably estimated. The actual costs of resolving legal claims may be substantially higher or lower than the amounts accrued for those claims. For a discussion of legal matters as of December 31, 2022,2023, please See Note 1220 "Contingencies" to our financial statements included in this report, which is incorporated into this item by reference.

Not applicable.

Organon'sOur Common Stock is listed on the New York Stock Exchange under the symbol "OGN." As of February 22, 2023,20, 2024, there were 74,82969,973 holders of record of Organon'sour Common Stock. This number does not include persons who hold Organon'sour Common Stock in nominee or "street name" accounts through brokers or banks.

The declaration of dividends is subject to the discretion of Organon'sour Board. TheOur Board is committed to continuing to pay regular cash dividends; however, there can be no assurance as to future dividends. TheOur Board will consider factors such as financial results, capital requirements, financial condition and any other factors it deems relevant. For additional information, see "Risk Factors—OrganonWe cannot guarantee the timing, amount or payment of any dividends on theour Common Stock".

The following graph compares the cumulative total stockholder returns for the period from June 2, 2021 (the effective date of Organon'sour Separation from Merck) to December 31, 20222023 for (i) Organon'sour Common Stock; (ii) the S&P 500 Index; and (iii) the NYSE Arca Pharmaceutical Index ("DRG").; and the S&P 600 Index. The graph assumes an investment of $100 on June 2, 2021 through the last trading day of 2022.2023. The calculation of cumulative stockholder return on our Common Stock, the S&P 500 Index, DRG and the NYSE Arca PharmaceuticalS&P 600 Index include reinvestment of dividend.dividends. The performance shown is not necessarily indicative of future performance. Effective October 18, 2023, we were deleted from the S&P 500 index and added to the S&P SmallCap 600 index.

See Part III, Item 12 "Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters."

Organon makesWe make statements in this Annual Report on Form 10-K, and Organonwe may from time to time make other written reports and oral statements, regarding itsour outlook or expectations for financial, business or strategic matters regarding or affecting Organonus 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""projects," "believes," "would," "potentially," "intends," "seeks," 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 Organon'sour 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 Organon'sour 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. Item 1A. Risk Factors of this report or otherwise described in Organon'sour filings with the SEC, provide examples of risks, uncertainties and events that may cause Organon'sour actual results to differ materially from the expectations expressed in itsour forward-looking statements, including, but not limited to:

It is not possible to predict or identify all such factors. Consequently, one should not consider the above list or any other such list to be a complete statement of all potential risks or uncertainties. Further, any forward-looking statement speaks only as of the date on which it is made, and Organon undertakeswe undertake no obligation to update or revise any forward-looking statement to reflect events or circumstances after the date on which the statement is made or to reflect the occurrence of unanticipated events, except as otherwise may be required by law.

Organon & Co. ("Organon" or the "Company") isWe are a global health care company with a focus on improving the health of women throughout their lives. Organon developsWe develop and deliversdeliver innovative health solutions through a portfolio of prescription therapies and medical devices within women's health, biosimilars and established brands (the "Organon Products"). Organon hasbrands. We have a portfolio of more than 60 medicines and products across a range of therapeutic areas. The Company sellsWe sell these products through various channels including drug wholesalers and retailers, hospitals, government agencies and managed health care providers such as health maintenance organizations, pharmacy benefit managers and other institutions. The Company operatesWe operate six manufacturing facilities, which are located in Belgium, Brazil, Indonesia, Mexico, 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 the Organon group ofour companies.

Organon remains focused on protecting the safety of its employees and supporting Organon's communities in response to the COVID-19 pandemic. COVID-19-relatedrelated disruptions, including patients' inability to access health care providers, prioritization of COVID-19 patients, as well as social distancing measures have negatively affected our results during 20212022 and 2022.