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Item 1. Business

2026-02-27 compared with 2025-02-28 · 106 added, 155 removed, 302 unchanged (46% of the section changed)

Solventum Corporation (“Solventum, ” or the “Company ” ), is a leading global healthcare company developing, manufacturing, and commercializing a broad portfolio of solutions that leverages deep material science, data science, and digital capabilities to address critical customer and patient needs.

Solventum Corporation ("Solventum," "we," "our," "us," or the "Company"), is a leading global healthcare company developing, manufacturing, and commercializing a broad portfolio of solutions that leverages deep material science, data science, and digital capabilities to address critical customer and patient needs.

We constantly seek to enable the improvement of standards of care and move healthcare forward with innovation powered by insights, clinical intelligence, technology, and manufacturing expertise.

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Our business possesses strong customer relationships, a broad, wide-ranging, and well-known portfolio of brands, differentiated technology, and manufacturing expertise.

We serve a diverse customer base, ranging from multidisciplinary hospitals and local clinics/practices to biopharmaceutical manufacturers.

We serve a diverse customer base, ranging from multidisciplinary hospitals to local clinics/practices.

Our long-tenured and collaborative customer relationships globally give us unique insights into their needs and preferences.

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Business Segments

We are organized into four operating business segments that are aligned with the markets we serve.

MedSurg (56.2% of 2024 total sales) is a provider of solutions including negative pressure wound therapy, advanced wound dressings, advanced skin care, I.V.

We are organized into three reportable operating business segments that are aligned with the markets we serve.

MedSurg (57.9% of 2025 total sales) is a provider of solutions including negative pressure wound therapy, advanced wound dressings, advanced skin care, synthetic tissue matrices, I.V.

site management, sterilization assurance, temperature management, surgical supplies, medical tapes and wraps, stethoscopes, medical electrodes, and medical technologies Original Equipment Manufacturer ("OEM" ) .

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These solutions are designed to ensure accuracy of reimbursement and reduce the administrative burden that clinicians face.

Purification and Filtration (11.6% of 2024 total sales) is a provider of purification and filtration technologies including filters, purifiers, cartridges, and membranes.

These solutions are designed to simplify purification processes, reduce debris and bioburden in fluids, and remove contaminants to enable the development and manufacturing of biopharmaceutical and medical technology treatments and provide cleaner water.

As part of our business strategy, Solventum intends to monitor its business portfolio and organizational structure and may make acquisitions that expand or enhance its organizational structure.

Acquisitions and Divestitures

As part of our business strategy, Solventum intends to monitor its business portfolio and organizational structure and may make acquisitions and divestitures that expand or enhance its organizational structure.

In 2025, the Company acquired Acera Surgical ("Acera"), a privately held bioscience company.

Also in 2025, the Company sold its Purification and Filtration business to Thermo Fischer Scientific Inc.

Refer to Note 3, "Acquisitions and Divestitures" for additional information on acquisitions and divestiture activity in periods presented in this Annual Report on Form 10-K.

Research and Development Activities

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Our cross-segment capabilities include building new shared technologies and advancing existing shared technologies.

We believe that collaboration across our organization further enhances our R&D capabilities by encouraging the sharing of best practices, enabling collaborative development and issue resolution, promoting synergies in development and manufacturing, and creating a broad culture of exploration.

Our R&D team consists of approximately 2,000 employees, including research scientists, chemical engineers, data scientists, software engineers, application development engineers and product developers.

They are supported by a team of accomplished clinicians from our medical affairs group.

We partner with our medical affairs group to enhance our clinical insight and expand awareness of clinical studies regarding our solutions by increasing both the number of peer-reviewed publications and the visibility for existing publications that address our solutions.

We believe that collaboration across our organization further enhances our R&D capabilities by standardization of common processes and sharing of best practices, enabling consistent and collaborative development and issue resolution, promoting synergies in development and manufacturing, and creating a broad culture of solving what matters.

Our R&D team consists of approximately 2,000 employees, including research scientists, chemical engineers, data scientists, software engineers, and product developers.

They are supported by a team of accomplished clinicians from our medical affairs.

We partner with our medical and scientific affairs to enhance our clinical insight and expand awareness of clinical studies regarding our solutions by increasing both the number of peer-reviewed publications and the visibility for existing publications that address our solutions.

Intellectual Property

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Our ability to compete effectively is contingent upon several factors, including but not limited to our ability to deliver differentiated clinical and economic outcomes for our customers.

In the MedSurg segment, our advanced wound care market is highly competitive, particularly in the United States and Europe, with our principal competitors including Smith & Nephew, Medela, Mölnlycke, Coloplast, and Convatec.

In the MedSurg segment, the advanced wound care market is highly competitive, particularly in the United States and Europe, with our principal competitors including Smith & Nephew, Medaxis, Mölnlycke, Coloplast, and Convatec.

Our infection prevention and surgical supplies solutions are offered in highly competitive and fragmented end markets, especially in the United States and Europe.

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The health care software technology market in which we conduct our business, and the healthcare information technology ("HCIT") industry in general, is highly competitive and dynamic, characterized by the continual introduction of new products and technologies.

Principal competitors include Optum, Microsoft (Nuance), Epic, Cerner, Athena, and a host of start-up technologies actively working to disrupt the areas of revenue cycle management and clinician productivity.

Principal competitors include Optum, Microsoft (Nuance), Epic, Oracle (Cerner), Waystar, Athena, and a host of start-up technologies actively working to disrupt the areas of revenue cycle management and clinician productivity.

In the United States, the market for value-based care software solutions is highly fragmented and subject to continuous entry of new competitors.

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Outside the U.S., we compete primarily with local players in the respective country or region, in addition to new market entrants.

The Purification and Filtration segment competes against a diverse spectrum of competitors.

Established global filtration competitors such as Danaher, Merck KGaA, Sartorius, Pentair, Repligen, and Entegris compete on a variety of factors across product lines, including breadth of offering, product performance, customer service, product availability, distribution capabilities, innovation, name recognition and price.

Human Capital

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Of our employees, approximately 4,000 are production employees working in plants across the globe.

We have approximately 80 employees who are represented by a union in the U.S., all of whom are in one manufacturing facility and are covered by a three-year collective bargaining agreement that expires on November 1, 2027.

Our relationship with employee-representative

organizations outside the U.S.

We do not have any unionized facilities in the US.

Our relationship with employee-representative organizations outside the U.S.

takes many forms, including in European Union countries where we engage with representative bodies for employees, such as employee forums, works councils and trade unions, in accordance with local law.

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Whether we are attracting or advancing talent, we focus on conveying our intent for leaders and employees to thrive.

Engaging talent such as those who are involved in our Employee Resource Networks, which are open to everyone, has proven to be a way to empower and inspire our workforce as they drive innovation in unique ways.

Engaging talent such as those who are involved in our Employee Impact Groups, which are open to everyone, has proven to be a way to empower and inspire our workforce as they drive innovation in unique ways.

• Compensation and Benefits :

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Environmental, Health, and Safety Matters

We are subject to various laws, regulations, ordinances, customer requirements, and industry standards related to environment, health, and safety ( “ EHS ” ) matters.

Solventum benefits from having both an Environmental Health and Safety (EHS) organization and a Product Stewardship (PS) organization which collaborate to ensure environmental, health and safety ("EHS") considerations are proactively managed across facilities and products.

We are subject to various laws, regulations, ordinances, customer requirements, and industry standards related to EHS matters.

These include, but are not limited to, permitting, licensing, and authorization requirements, and regulatory obligations.

These laws, regulations, ordinances, requirements and standards affect a significant portion of our activities globally across each of our segments and product lines and require compliance related to, among other things:

These affect a significant portion of our activities globally across each of our segments and product lines and require compliance related to, among other things:

(a) occupational health, safety, and well-being;

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EHS laws and regulations also vary widely by jurisdiction, may be established at supranational, international, national, state, and/or local levels, and are constantly evolving, often to become more stringent.

Compliance with EHS laws, regulations, customer requirements, and industry standards requires, among other things, that we maintain and operate our equipment safely;

Compliance with EHS laws, regulations, customer requirements, and industry standards require, among other things, that we maintain and operate our equipment safely;

obtain and keep current environmental permits, radioactive material licenses, and radiation machine registrations;

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or other sanctions.

Solventum also is subject to extensive and evolving regulations regarding the manufacturing, processing, distribution, importing, exporting, and labeling of its products and their raw materials.

In the European Union, for instance, the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulations came into effect in 2007, with implementation rolling out over time.

Registered chemicals then can be subject to further evaluation and potential restrictions.

Since the promulgation of REACH, other countries have enacted or are in the process of implementing similar comprehensive chemical regulations.

Some of Solventum’s products utilize third-party purchased components that contain PFAS.

Use is critically evaluated on an on-going basis, and non-PFAS alternatives are utilized, when possible.

Solventum also is subject to a broad and continually evolving set of regulations governing the manufacture, processing, distribution, import, export, and labeling of its products and their raw materials.

Examples include various chemical control regulations, such as European Union ("EU") Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), and global variations, which require registration, evaluation including potential testing, reporting and possible restrictions.

In addition, Solventum complies with global Extended Producer Responsibility (EPR) reporting requirements for products containing electronics and batteries;

electrical safety regulations;

Globally Harmonized System of Classification and Labeling of Chemicals (GHS);

and various other chemical, material, product, and packaging requirements including communication and reporting obligations.

Beyond safety and compliance, Solventum practices responsible chemical use, working to minimize hazards wherever possible.

As an example, a specific chemical category of interest is Per - and polyfluoroalkyl substances ("PFAS").

A small number of Solventum’s products utilize and/or contain PFAS.

Use is critically evaluated on an on-going basis, and non-PFAS alternatives

are utilized when possible.

Regulatory and legislative activities concerning PFAS are accelerating in the United States, Europe and elsewhere.

These regulatory activities include gathering of exposure and use information, risk assessment activities, and increasingly strict restrictions on various uses of PFAS in products and on PFAS in manufacturing emissions and in water, soil and air, in some cases moving towards setting non-detectable limits for certain PFAS compounds.

Governments, including in the United States, are also increasingly proposing changes to existing environmental regulations to specifically apply to PFAS.

In February 2023, the European Chemicals Agency published a proposal under REACH, which has not yet been finalized, that aims to restrict the manufacture, placing on the market and use of PFAS, subject to certain exceptions.

Solventum’s operations are also subject to regulation under the federal Occupational Safety and Health Act (“OSHA ” ) and parallel state and local occupational health and safety standards, as well as occupational health and safety standards applicable to its operations in other jurisdictions.

Solventum diligently tracks and analyzes these global emerging regulations for applicability to both products and operations, taking a proactive approach and ensuring preparedness.

Solventum’s operations are also subject to various laws governing occupational health and safety.

An example in the US is the federal Occupational Safety and Health Act ("OSHA") and parallel state and local occupational health and safety standards.

These standards establish certain employer responsibilities, including requirements to maintain a workplace free of recognized hazards likely to cause serious injury or death, certain medical and hygiene standards, licensing and permitting obligations and various recordkeeping, disclosure and procedural requirements.

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Failure to comply with applicable occupational health and safety standards, even if no work-related serious injury or death occurs, could result in civil or criminal enforcement and substantial penalties, significant capital expenditures or suspension or limitation of Solventum’s operations.

In addition to REACH and OSHA, Solventum manufacturing facilities are also subject to additional environmental, health and safety statutes, regulations and permit requirements, including, but not limited to, applicable requirements under the Clean Air Act, the Clean Water Act, the Resource Conservation and Recovery Act, the Seveso-III Directive (Directive 2012/18/EU), the European Machinery Directive (Directive 2006/42/EC), the EU Industrial Emissions Directive (Directive 2010/75/EU), and the European Pollutant Release and Transfer Register.

In addition, Solventum manufacturing facilities are also subject to environmental, health and safety statutes, regulations and permit requirements, including, but not limited to, applicable requirements under the Clean Air Act, the Clean Water Act, the Resource Conservation and Recovery Act, the Seveso-III Directive (Directive 2012/18/EU), the European Machinery Directive (Directive 2006/42/EC), the EU Industrial Emissions Directive (Directive 2010/75/EU), and the European Pollutant Release and Transfer Register.

Sales and Marketing

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These teams provide high-quality customer support serving as the clinical and/or technical expert for the customer.

To expand our market coverage into emerging geographies in the Latin America ("LATAM"), Europe, Middle East and Africa ("EMEA"), and Asia regions, we employ an export commercial model and leverage local partners to market and sell our products.

To expand our market coverage into emerging geographies in the Latin America, Europe, Middle East and Africa, and Asia regions, we employ an export commercial model and leverage local partners to market and sell our products.

Our local third-party partners facilitate regulatory and cross-border import compliance and distribute directly to the customer.

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Global Supply Chain and Sourcing

Our sourcing, production, and distribution network is managed globally.

We believe we have advanced manufacturing and assembly production capabilities across our global manufacturing network.

Our Global Supply Chain strategy is designed to ensure speed, reliability, and cost efficiency, with the flexibility and resilience to navigate market changes.

Our sourcing, production, and distribution network is managed globally, supported by advanced manufacturing and assembly capabilities across our worldwide footprint.

Our manufacturing is supported by a global distribution network.

Our distribution network is strategically designed as a “hub and spoke” model.

This approach optimizes route planning and increases the speed of deliveries to our customers in all regions.

In addition, our distribution network footprint meets the needs of our customers in a cost-effective model.

As we separate from 3M, we continue to leverage 3M's distribution networks and manufacturing sites across certain geographies.

The use of both distribution network and manufacturing sites are covered under a Transition and Distribution Agreement and a Transition Contract Manufacturing Agreement, respectively, with 3M.

Our sourcing practices prioritize sustainable suppliers and comply with global regulatory standards.

Our distribution network is strategically designed using a "hub-and-spoke" model.

This approach optimizes route planning and accelerates delivery times to customers across all regions.

This footprint is "purpose-built" to meet customer needs in a cost-effective manner.

As we separate from 3M, we continue to leverage 3M's established infrastructure across certain geographies ensuring continuity and reliability during our transition, while we invest in expanding our independent capabilities.

The use of both distribution networks and manufacturing sites is covered under a Transition and Distribution Agreement and a Transition Contract Manufacturing Agreement, respectively, with 3M.

Our supply chain resiliency program consisting of regional sources of supply, dual-source manufacturing capabilities and vertically integrated operations presents a competitive advantage by providing a reliable supply of products to our customers.

In 2025, the United States government announced new tariffs on imported goods from certain countries, and in response, foreign governments have threatened or imposed tariffs or other actions.

On February 20, 2026, the United States Supreme Court issued a decision concluding that the International Emergency Economic Powers Act does not provide authority for the

President to impose tariffs.

During 2025, certain tariffs that affected us were imposed under this statute pursuant to presidential executive order.

The ultimate financial impact of this decision cannot be reasonably estimated at this time.

The extent and timing of any potential recoveries of tariffs previously paid remain subject to further legal interpretation and administrative processes.

We will continue to monitor developments and will evaluate the effect of the ruling on future reporting periods as additional information becomes available.

Health Care Policies

Political, economic, technological and regulatory influences around the world continue to subject the health care industry to potential fundamental changes that could substantially affect our results of operations.

We maintain a global Government Affairs presence to actively monitor and advocate on a myriad of legislation and policies that may potentially impact us, both on a domestic and an international front.

The Government Affairs office works closely with members of Congress and committee staff, the White House and administration offices, state governors, legislatures and regulatory agencies, embassies and global governments on issues affecting our business.

The Government Affairs office also advocates for public policy that benefits our employees and the patients we serve and supports the communities in which we live.

Our products are purchased principally by hospitals, physicians and other health care providers around the world that typically bill various third-party payers, including government programs (e.g., Medicare and Medicaid in the U.S.) and private insurance payers, for the items and services provided to their patients.

Government and private sector initiatives related to limiting the growth of health care costs (including price regulation), coverage and payment policies, comparative effectiveness reviews of therapies, technology assessments, price transparency, health care delivery and payment structure reforms and localization or regionalization of supply, are continuing in many countries where we do business.

We believe that these changes are causing the marketplace to place increased emphasis on the delivery of treatments that can reduce costs, improve efficiencies and/or increase patient access.

Implementation of cost containment initiatives and health care reforms in significant markets such as the U.S., China and other markets may limit the price of, or the level at which reimbursement is provided for, our products or procedures using our products, which in turn may make it less likely that a hospital or physician will select our products to treat patients.

The regulations applicable to Solventum are promulgated and enforced by government bodies in individual countries and govern the methods and controls used for the design, manufacture, packaging labeling, storage, safety, sales and distribution, marketing clearance or approval, advertising and promotion, sterilization, installation, servicing, performance and effectiveness of the products Solventum sells globally.

These regulations apply to all facilities of Solventum’s business that conduct the foregoing activities, regardless of where the facilities are located.

These regulations apply to the activities performed by most of Solventum’s employees, including but not limited to sales and marketing, research and development, regulatory affairs, quality assurance, medical affairs, and operations, both before and after a product is commercially distributed.

These regulations differ by country and/or region and are dynamic.

Solventum commits a significant amount of resources to maintain compliance with these regulations.

In addition, Solventum is subject to other complex and varying regulations related to anti-trust, anti-corruption, export control, privacy and data protection, emerging technologies, such as AI, and other areas.

These regulations are dynamic and

• apply to all facilities of Solventum’s business that conduct the foregoing activities, regardless of where the facilities are located;

• apply to the activities performed by most of Solventum’s employees, including but not limited to sales and marketing, research and development, regulatory affairs, quality assurance, medical affairs, and operations, both before and after a product is commercially distributed;

• differ by country and/or region.

Solventum commits a significant amount of resources to maintain compliance with these regulations, to monitor evolving or new regulations, to respond to requests, inspections, and/or audits from governing bodies that monitor compliance with relevant regulations, and develop products that adhere to regulatory requirements in order to obtain regulatory clearances and/or approvals.

Compliance with these regulations requires Solventum to create systems, processes, and procedures that are aligned with the regulations in all markets Solventum serves.

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As these regulations change, Solventum must adapt its systems, processes, and procedures to comply with the new regulations.

Governing bodies monitor compliance, among other ways, by conducting regularly occurring and unexpected audits of Solventum’s facilities.

These audits are conducted to determine if Solventum’s systems, processes, and procedures comply with the current regulations in the markets it serves.

After each audit, the governing body typically provides a report of their findings.

The report describes the observations made during the audit.

Sometimes these observations describe minor non-compliance issues in Solventum’s systems, processes, and procedures.

Often, these gaps require commensurate modifications but have no impact to Solventum’s ability to continue operations and commercialization of its products.

In rare situations, the governing body may find significant or major non-compliance issues in Solventum’s systems, processes, and procedures.

If a governing body concludes, through these audits or otherwise, that Solventum is not in compliance with applicable laws or regulations or that any of its products are defective, ineffective, or pose an unreasonable risk for patients, users, or others, the governing body may require Solventum to recall a product or products, retract promotional materials, and/or cease shipment of products, among other required actions;

these requirements may remain in place until Solventum can demonstrate adequate compliance.

Failure to demonstrate adequate modifications to Solventum’s systems, processes, and procedures and continued compliance or repeat findings may result in more significant enforcement actions, including but not limited to warning letters, revocation of product approvals and licenses, injunctions, product seizure, penalties and fines, consent decrees, and criminal prosecution, among other actions.

These actions may have a negative impact on Solventum’s consolidated results of operations, financial condition or competitive position.

As discussed in more detail below under “Regulation of Medical Devices and Pharmaceutical Products,” to market its products internationally in compliance with applicable medical device and pharmaceutical regulations, Solventum must obtain approvals for products and product modifications.

The regulations promulgated by the governing bodies also require Solventum to submit data to demonstrate that its products meet the safety and effectiveness requirements to support the intended uses described in its labeling.

This data is reviewed by the governing bodies to determine if Solventum has provided the necessary and sufficient information to demonstrate the safety and effectiveness of its products for the intended use described in its labeling.

In many cases, the governing bodies request additional information to make this determination.

The additional information requested by the governing bodies sometimes requires Solventum to conduct new testing, delaying the approval and commercialization of the product.

In rare instances, the governing body will disapprove the application, prohibiting Solventum’s ability to commercialize the product in that market.

In these instances, Solventum may decide to cease commercialization efforts for the product in that (or those) market(s) or it may decide to modify the product or retest the products and resubmit the data to the governing bodies.

Delays to product approvals or disapproval of Solventum’s applications may have a negative impact on Solventum’s consolidated results of operations, financial condition or competitive position.

Failure to establish, follow or comply with any of the above requirements could have a negative impact on Solventum’s consolidated results of operations, financial condition or competitive position.

This global regulatory environment will likely continue to evolve, which could impact Solventum’s ability, or increase the time and cost, to obtain future approvals for its products.

The process of obtaining regulatory clearances and/or approvals to market and sell Solventum’s products can be rigorous, costly and time-consuming and the clearances and/or approvals might not be granted timely or result in limitations on the indicated uses of products.

See "Item 1A.

Risk Factors" for a description of the risks related to the regulations that are applicable to Solventum.

Regulation of Medical Devices and Pharmaceutical Products

The products Solventum develops, manufactures, and commercializes are regulated in most of the markets Solventum serves.

Some of these products meet the definition of medical devices or pharmaceuticals and are regulated, as such, by various governmental bodies, globally.

All products produced by the MedSurg and Dental Solutions segments, with very few exceptions, meet the definition of a medical device or pharmaceutical product.

Some of these products meet the definition of medical devices, pharmaceuticals or combination products and are regulated, as such, by various governmental bodies, globally.

All products produced by the MedSurg and Dental Solutions segments, with

very few exceptions, meet the definition of a medical device or pharmaceutical product.

Accordingly, the development, manufacture, and commercialization of these products must comply with the regulations governing medical devices or pharmaceuticals in the markets we serve.

Conversely, none of the products produced by the Health Information Systems and Purification and Filtration segments meet the definition of medical devices or pharmaceuticals.

The product portfolio of each segment is dynamic and changes with time, depending on the needs of the customers served.

While the Health Information Systems and Purification and Filtration segments do not currently include medical devices or pharmaceutical products, this may change in the future.

Determinations of the safety and efficacy of our products are solely within the authority of the FDA or other applicable regulatory authorities in jurisdictions outside the United States.

Additionally, 3M™ Promogran™ Collagen Dressing and 3M™ Tegaderm™ CHG Chlorhexidine Gluconate IV Securement Dressing, which are products of the MedSurg segment, are regulated by the FDA’s Center for Device and Radiological Health as a combination product category.

Conversely, none of the products produced by the Health Information Systems segment meet the definition of medical devices or pharmaceuticals.

The product portfolio of the segment is dynamic and changes with time, depending on the needs of the customers served.

While the Health Information Systems segment does not currently include medical devices or pharmaceutical products, this may change in the future.

Determinations of the safety and efficacy of our products are solely within the authority of the United States Food and Drug Administration ("FDA") or other applicable regulatory authorities in jurisdictions outside the United States.

United States

In the United States, the Food, Drug, and Cosmetic Act (“FDA”) authorizes the FDA to oversee and regulate the production, sale, and distribution of food, drugs, medical devices, and cosmetics.

In the United States, the Food, Drug, and Cosmetic Act authorizes the Food and Drug Administration to oversee and regulate the production, sale, and distribution of food, drugs, medical devices, and cosmetics.

Medical Devices

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Class III devices typically require pre-market approval.

Most medical devices are cleared by FDA through the Pre-Market Notification, or 510(k), process.

Most medical devices are cleared by the FDA through the Pre-Market Notification, or 510(k), process.

This process requires medical device manufacturers to demonstrate that their devices are as safe and effective as (i.e., substantially equivalent to) a legally marketed medical device.

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Solventum’s pharmaceutical products are brought to market through the NDA and OTC pathways.

the FDA of an investigational new drug application which must become effective before human clinical trials may begin and must be updated annually.

The NDA process typically begins with the completion of extensive preclinical laboratory tests and preclinical animal studies, which may need to be performed in accordance with the Good Laboratory Practices regulations, followed by the submission to the FDA of an investigational new drug application which must become effective before human clinical trials may begin and must be updated annually.

Before each clinical study may be initiated, an independent Institutional Review Board or ethics committee representing each clinical site must approve such study.

The clinical studies must be adequate, well-controlled and conducted in accordance with Good Clinical Practice ( " GCP " ) requirements.

After the completion of the clinical trials, an NDA is submitted to the FDA to demonstrate that a drug is safe and effective in its proposed use(s), the benefits of the drug outweigh the risks, the drug’s proposed labeling (package insert) is appropriate, and the methods used to manufacture the drug are adequate to preserve the drug’s identity, strength, quality, and purity.

the methods used to manufacture the drug are adequate to preserve the drug’s identity, strength, quality, and purity.

Following the completion of the clinical trials, the NDA process with the FDA generally involves the following:

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OTC monograph products that do not comply with these standards can be deemed unapproved new drugs and can be required to be withdrawn from the market.

The Over-the-Counter Monograph Safety, Innovation, and Reform Act, enacted in March 2020, is expected to introduce significant reform to the OTC monograph system, including by replacing the FDA’s existing rulemaking process with an administrative order process for issuing, revising and amending OTC monographs.

European Union

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Classification is dependent on a variety of factors, including duration of use, whether the device is invasive or non-invasive, and whether the device is considered "active." Notified bodies are responsible for ensuring that manufacturers comply with the requirements of the Medical Device Regulation.

All medical devices in Solventum’s current portfolio are regulated as medical devices in the European Union.

Pharmaceutical Products

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With limited exceptions, Solventum may not market, promote, or sell regulated products prior to regulatory authority clearance or approval.

Regulatory authorities, including the FDA, strictly regulate the indications for use and associated promotional safety and effectiveness claims that may be made about approved or cleared products.

If regulatory authorities determine that Solventum has promoted or marketed a product for off-label use, including through external-facing materials, oral statements, or physician training, Solventum could be subject to fines, injunctions or other penalties.

In addition, the National Advertising Division (“NAD”) of the Better Business Bureau administers a self-regulatory program of the advertising industry to ensure truth and accuracy in national advertising.

NAD monitors national advertising and entertains inquiries and challenges from competitors and consumers.

Solventum may also be subject to various state consumer protection laws, including California’s Proposition 65, which requires a specific warning on any product that contains a substance listed by California as having been found to cause cancer or birth defects, unless the level of such substance in the product is below a safe harbor level.

Solventum must also comply with advertising, marketing, and promotion rules in all countries in which it markets its products .

In the European Union, advertising of products is subject both to general consumer advertising requirements pursuant to the Unfair Commercial Practices Directive (Directive 2005/29/EC), which imposes a general prohibition on misleading and aggressive advertising, as well as more specific regulations in respect of various product classifications.

For example, pursuant to Directive 2001/83/EC, advertisements of Solventum’s OTC products must, among other requirements, (1) make clear that the message is an advertisement and that the product is clearly identified as a medicinal product, (2) not refer to claims of

recovery in improper, alarming or misleading terms and (3) not suggest that the effects of taking the medicine are guaranteed, are unaccompanied by adverse reactions or are better than, or equivalent to, those of another treatment or medicinal product.

In China, advertisements of OTC products must, among other requirements, include an “OTC” marking and must not contain difficult or confusing medical or pharmaceutical terms that could mislead the public about a product’s efficacy or safety.

A failure to comply with these regulations could expose Solventum to legal liability, such as enforcement actions, investigations by a governmental authority, civil fines or criminal actions, lawsuits brought by competitors or company whistleblowers, or other actions.

Regulatory authorities, including the FDA and other government bodies in the jurisdictions where Solventum markets its products, strictly regulate the indications for use and associated promotional safety and effectiveness claims that may be made about approved or cleared products.

Data Privacy Laws

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Federal health information privacy laws, such as HIPAA, and consumer protection laws impose requirements for the collection, use, storage, access, transfer and protection of health-related and other sensitive and personal information, and failure to comply may result, such as with respect to any CCPA violations, in civil penalties.

The CCPA has been amended by the California Privacy Rights Act (“CPRA”), which came into effect, in most material respects, on January 1, 2023.

The CPRA significantly modifies the CCPA, including by expanding consumers’ rights with respect to certain sensitive personal information.

The CCPA has been amended by the California Privacy Rights Act ("CPRA"), which came into effect, in most material respects, on January 1, 2023, and was most recently updated again in 2025.

The most recent updates address cybersecurity audits, risk assessments, and automated decision-making technology.

GDPR and the U.K.

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In China, Solventum is subject to PIPL, which applies to the secure processing of personal information of natural persons within China, and Solventum is also subject to CBDT for the processing of personal information outside China where the purpose is to provide products and services within China and the analysis or assessment of the activities of individuals within China.

Consequences of non-compliance may include monetary fines of up to five percent of the previous year’s revenue, termination of data transfers and personal liability imposed on those directly responsible.

Consequences of non-compliance with PIPL may include monetary fines of up to five percent of the previous year’s revenue, termination of data transfers and personal liability imposed on those directly responsible.

Solventum is also subject to similar privacy and data protection frameworks in other developed and emerging markets.

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These laws apply to many of Solventum’s customer interactions, as healthcare professionals in other countries are or are often considered government officials, and in some cases lay out specific requirements of how to comply or demonstrate compliance with the legal requirements.

Failure to comply with these laws may expose Solventum to monetary fines and penalties, criminal and civil enforcement actions and reputational damage.

Quality and Safety

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Solventum’s products are required to be manufactured in facilities that operate in accordance with current cGMPs.

Compliance with cGMPs requires Solventum to establish and follow quality systems that are designed to ensure that its products consistently meet applicable requirements and specifications.

The scope of cGMP includes, but is not limited to, production and process controls, document

controls, acceptance activities, labeling and packing controls, handling, storage, distribution, and installation activities, among others.

The FDA and comparable authorities in other jurisdictions periodically inspect Solventum’s manufacturing facilities for compliance with cGMP or similar manufacturing standards in the applicable country.

Failure to comply with cGMPs could disrupt Solventum’s ability to manufacture or supply its products.

Solventum is also required to establish and follow quality systems to comply with certain post-market surveillance requirements, specifically those pertaining to adverse event reporting for medical devices and pharmaceuticals.

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Solventum’s activities are subject to a variety of price control laws, regulations and government mandates in some of the markets in which it operates.

In certain markets the pricing for certain Solventum’s products may be subject to prior approval, including in jurisdictions where Solventum’s products are subject to government reimbursement, whereas in other markets Solventum may be able to set its own prices for its products subject to certain degrees of monitoring and control by the applicable governmental authority.

These price control mechanisms, and mechanisms in other markets, including long-term price commitments as the result of market dynamics, may restrict the amount Solventum is able to charge for its products, which may reduce its profits and otherwise adversely affect its business, results of operations or financial condition.

In addition, price control laws, regulations or government mandates may be enacted or become more stringent during times of uncertain or unfavorable economic or market conditions, such as during times of economic slowdown, recession or inflation.

In certain markets the pricing for certain of Solventum’s products may be subject to prior approval, including in jurisdictions where Solventum’s products are subject to government reimbursement, whereas in other markets Solventum may be able to set its own prices for its products subject to certain degrees of monitoring and control by the applicable governmental authority.

Environmental, Health, and Safety Laws

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56 Chief Financial Officer

59 Chief Strategy & Corporate Development Officer

52 Executive Vice President and Group President, Medical Surgical

Heather Knight 54 Chief Commercial Officer

54 Chief Human Resources Officer

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Marcela Kirberger

58 Chief Legal Affairs Officer

50 Chief Information and Digital Officer

Garri Garrison

65 President, Health Information Systems

Vaughn Grannis

61 President, Purification and Filtration

Karim Mansour

51 President, Dental Solutions

59 Chief Corporate & Legal Affairs Officer

51 Chief Information & Digital Officer

The following are brief biographies describing the backgrounds of our executive officers.

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McMillan earned his Bachelor of Science in Business Administration from Merrimack College and an MBA from Bentley University McCallum Graduate School of Business.

Sanjiv Arora .

Arora has served as the Chief Strategy and Corporate Development Officer of Solventum since 2024.

Before joining Solventum, Mr.

Arora was Vice President, Business Development & Strategy, Cardiac Surgery, Cardiovascular Diagnostics at Medtronic from February 2021 to March 2024 and as Vice President of Corporate Development from January 2018 to February 2021.

His expertise was also honed from working at Edwards LifeSciences, Covidien, Cargill Ventures, RBC Capital Markets and Boston Scientific throughout his career.

Arora earned his Bachelor of Science in Chemical Engineering from the University of Minnesota and an MBA from Duke University.

Chris Barry .

Barry has served as the Executive Vice President and Group President of our Medical Surgical business since 2024.

Prior to joining Solventum, Mr.

Barry was Chief Executive Officer and a member of the NuVasive Board of Directors from November 2018 to September 2023.

Prior to that role, he served as Senior Vice President and President of Surgical Innovations at Medtronic from January 2015 to October 2018, its second largest business unit.

Before the acquisition of Covidien by Medtronic, Mr.

Barry was President of Advanced Surgical Technologies of Covidien, where he led global strategy, product portfolio, and U.S.

commercial teams for the global business unit.

He also spent more than 15 years increasing commercial and executive leadership roles at Covidien.

Currently, Mr.

Barry serves as a member of the LivaNova Board of Directors.

Barry earned his Bachelor of Science in Environmental Science from Texas Tech University.

McMillan currently serves on the board of directors of Hologic Inc.

Heather Knight .

Knight has served as Chief Commercial Officer of Solventum since November 2025.

Knight has more than 30 years of experience in the healthcare industry.

Prior to joining Solventum, she served as Chief Operating Officer of Baxter International, where she was responsible for global sales across three business segments, as well as research and development, supply chain, and medical and regulatory affairs.

From 2019 to 2025, Ms.

Knight held several senior leadership positions at Baxter, including interim Group President of its Medical Products and Therapies segment, Regional Division President, and Global Business Unit President for Medication Delivery, Clinical Nutrition and Acute Therapies.

Earlier in her career, she held leadership roles in general management, upstream innovation, and commercial strategy at Medtronic plc, Covidien plc, Tyco International plc, and Kendall Healthcare Products Company.

Knight earned her bachelor's degree in Biological Sciences from the University of Buffalo and completed the Executive Sales and Management program from the University of Chicago Booth School of Management.

Knight currently serves on the board of directors of Waters Corporation.

Tammy Gomez .

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Marcela Kirberger .

Kirberger has served as the Chief Legal Affairs Officer of Solventum since 2024 after serving as the Chief Legal Affairs Officer of 3M’s Health Care Business Group since November 2023.

Kirberger has served as the Chief Corporate and Legal Affairs Officer and Corporate Secretary of Solventum since 2026, and was previously the Chief Legal Affairs Officer since 2024.

Previously she served as the Chief Legal Affairs Officer of 3M’s Health Care Business Group since November 2023.

Previously, Ms.

Kirberger was Executive Vice President, General Counsel and Corporate Secretary at Elanco, a pharmaceutical company in the animal health field, from June 2021 to November 2023, where she was responsible for the global strategy and operations of the legal function and had responsibility for Corporate Affairs, Ethics & Compliance and ESG.

Prior to joining Elanco, Ms.

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Landucci earned her Bachelor of Arts in Environmental Studies from Gustavus Adolphus College.

Garri Garrison .

Garrison has served as the President of Solventum’s Health Information Systems business since 2024.

Garrison has more than 35 years of experience in healthcare, including more than 27 years spent at 3M.

Starting in April 1999, she served in a variety of positions for 3M’s Health Information Systems division, including director of consulting services, director of performance management, integration manager, chief operating officer, Lean Six Master Black Belt and area division leader for the U.S.

Garrison earned her Bachelor’s degree in nursing from Western Kentucky University.

Vaughn Grannis .

Grannis has served as the President of Solventum’s Purification and Filtration business since 2024.

Focusing his career on technology enterprises including diversified manufacturers and businesses dealing in high-technology applications and customer groups, Vaughn took the helm of the global P&F at 3M business in 2023, leading the business’ four segments:

Bioprocessing Filtration, Drinking Water Filtration, Industrial Filtration and Membranes OEM.

Grannis has more than 38 years of experience creating new business growth, profitability and operational performance across several business sectors and verticals, all of which were with 3M, where he started in 1985.

He holds a Bachelor’s Degree and a Master’s Degree in mechanical engineering from the University of Minnesota and an MBA from the University of St.

Karim Mansour .

Mansour has served as the President of Solventum’s Dental Solutions business since 2024.

With more than 25 years of international healthcare and medical device experience, Karim has acquired industry expertise within the

public and private sectors, academia, as well as healthcare economics, all of which were with 3M.

Karim has held leadership roles of increasing responsibility, including his most recent previous role as President of Dental Solutions, Senior Vice President of 3M Health Care EMEA, Global Strategy and Business Development Director, as well as global operational and financial leadership roles across Europe, U.S.

and Latin America.

Mansour earned his Cycle Formation Supérieur au Management (FSM) and a Master’s Degree in Business from IPAG Business School.

Ethics and Governance

All of Solventum's employees, including its Chief Executive Officer, Chief Financial Officer, Controller and Chief Accounting Officer, are required to abide by Solventum’s Code of Conduct to ensure that its business is conducted in a consistently legal and ethical manner.

The Code of Conduct forms the foundation of a comprehensive process that includes compliance with corporate policies and procedures and a company-wide focus on uncompromising integrity in every aspect of Solventum’s operations.

Solventum’s Code of Conduct covers many topics, including antitrust and competition law, conflicts of interest, financial reporting, protection of confidential information, and compliance with all laws and regulations applicable to the conduct of its business.

Employees are required to report any conduct that they believe in good faith to be an actual or apparent violation of the Code of Conduct.

Solventum Ethics and Compliance maintains processes to receive, retain, and address concerns received from internal, external or anonymous sources.

Solventum takes all reported concerns about business conduct seriously and employs a team of experienced investigators who review each concern thoroughly and conduct investigations when necessary.

Solventum maintains the confidentiality of all reported concerns in accordance with legal requirements and in the best interest of the organization and those involved.

Solventum Legal Affairs team maintains processes to receive, retain, and address concerns received from internal, external or anonymous sources.

Solventum employs a team of experienced investigators who review the reported concerns and conduct investigations when necessary.

Solventum maintains the confidentiality of reported concerns in accordance with legal requirements and in the best interest of the organization and those involved.

Solventum does not tolerate retaliation for anyone who raises a genuine concern in good faith and educates employees on this policy.

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What changed 10-K

Item 1. Business