US drug pricing policy

“In August 2023, HHS, through CMS, selected Imbruvica as one of 10 medicines subject to government-set prices in Medicare Part D beginning January 1, 2026, and in January 2025, selected Vraylar and Linzess as two of 15 medicines subject to government-set prices in Medicare Part D beginning January 1, 2027. In January 2026, Botox was selected as one of 15 medicines subject to government-set prices in Medicare Parts B and D beginning January 1, 2028. It is possible that more of our products, including products that generate substantial revenues, could be selected in future years, which could, among other things, accelerate revenue erosion prior to expiration of intellectual property protections.”

Annual report 2025A · The company itself

“In addition to the pricing mechanisms established under the IRA, governments and other payers may pursue or implement additional approaches intended to reduce pharmaceutical costs, including arrangements or frameworks that reference international prices, most-favored-nation (MFN) concepts, or other comparative pricing methodologies. Such approaches may be implemented through legislation, regulation, administrative action, negotiated arrangements, or other means, and their scope, structure, and application may continue to evolve.”

Annual report 2025A · The company itself

“In major markets worldwide, governments play a significant role in funding health care services and determining the pricing and reimbursement of pharmaceutical products. Consequently, in those markets, AbbVie is subject to government decision-making and budgetary actions with respect to its products. In particular, many European countries have ongoing government-mandated price reductions for many pharmaceutical products, and AbbVie anticipates continuing pricing pressures in Europe.”

Annual report 2025A · The company itself

“Pharmacy benefit managers and other supply chain intermediaries exert significant influence over pricing and patient access to our products, which could adversely affect our revenues and results of operations. Consolidation and vertical integration among PBMs, managed care organizations and other supply chain intermediaries has increased their purchasing power and ability to influence formulary placement and reimbursement levels. A limited number of these entities negotiate pricing, rebates and patient access terms on behalf of health plans and government programs that cover a significant portion of insured patients in the United States.”

Annual report 2025A · The company itself

“The Inflation Reduction Act of 2022 has and will continue to have a significant impact on how drugs are covered and paid for under the Medicare program, including through the creation of financial penalties for drugs whose price increases outpace inflation, the redesign of Medicare Part D benefits to shift a greater portion of the costs to manufacturers, and through government price-setting for certain Medicare Part B and Part D drugs.”

Annual report 2025A · The company itself

“Department of Health and Human Services, through Centers for Medicare and Medicaid Service, selected Imbruvica as one of 10 medicines subject to government-set prices in Medicare Part D beginning in 2026 and in 2025, selected Vraylar and Linzess as two of 15 medicines subject to government-set prices in Medicare Part D beginning in 2027.”

Annual report 2025A · The company itself

“AbbVie's global Imbruvica revenues decreased 14% in 2025 primarily driven by decreased demand and unfavorable pricing in the United States as well as decreased collaboration revenues.”

Annual report 2025A · The company itself

“Rebates AbbVie provides rebates to pharmacy benefit managers, state government Medicaid programs, insurance companies that administer Medicare drug plans, wholesalers, group purchasing organizations and other government agencies and private entities. Rebate and chargeback accruals are accounted for as variable consideration and are recorded as a reduction to revenue in the period the related product is sold.”

Annual report 2025A · The company itself

“Risks related to government and global factors •Actions, policy, or key leadership changes in government agencies, or changes to laws or regulations, including those related to tax, accounting, debt, derivatives, government spending, or funding (including those related to the FDA, the NIH, the SEC, and other agencies), support of early stage research, FDA effectiveness, tariffs, and drug and healthcare pricing, costs, and programs could have a significant negative impact on the overall economy, our tenants and companies in which we invest, and our business. •Partial or complete government shutdown resulting in temporary closures of agencies could adversely affect our tenants (some of which are also government agencies) and the companies in which we invest, including delays in the commercialization of such companies’ products, decreased funding of research and development (“R&D”), or delays surrounding approval of budget proposals.”

Annual report 2025A · The company itself

“Even if the tenant or venture investment portfolio company obtains regulatory approvals, marketed products will be subject to ongoing regulatory review and potential loss of approvals. •The ability of some of our life science industry tenants and venture investment portfolio companies to commercialize any future products successfully will depend in part on the coverage and reimbursement levels set by government authorities, private health insurers, and other third-party payors. Additionally, reimbursements may decrease in the future.”

Annual report 2025A · The company itself

“Actual and anticipated changes to the regulations of the healthcare system may have a negative impact on the pricing of drugs, the cost of healthcare coverage, and the reimbursement of healthcare services and products. The FDA and comparable agencies in other jurisdictions directly regulate many critical activities of life science, technology, and healthcare industries, including the conduct of preclinical and clinical studies, product manufacturing, advertising and promotion, product distribution, adverse event reporting, and product risk management.”

Annual report 2025A · The company itself

“In both domestic and foreign markets, sales of products depend in part on the availability and amount of reimbursement by third-party payors, including governments and private health plans. Governments may regulate coverage, reimbursement, and pricing of products to control cost or affect utilization of products. Private health plans may also seek to manage cost and utilization by implementing coverage and reimbursement limitations.”

Annual report 2025A · The company itself

“In 2025, the administration also initiated multiple healthcare‑system policy actions affecting drug pricing, federal agency operations, and reimbursement frameworks, creating materially increased uncertainty for tenants in the life science, healthcare, and pharmaceutical sectors.”

Annual report 2025A · The company itself

“In many countries outside the U.S., government agencies strictly control, directly or indirectly, the prices at which our pharmaceutical industry tenants’ products are sold. In a number of European Union (“EU”) member states, the pricing and/or reimbursement of prescription pharmaceuticals are subject to governmental control, and legislators, policymakers, and healthcare insurance funds continue to propose and implement cost-containing measures to keep healthcare costs down, due in part to the attention being paid to healthcare cost containment and other austerity measures in the EU.”

Annual report 2025A · The company itself

“In the U.S., our pharmaceutical industry tenants are subject to substantial pricing pressures from state Medicaid programs, private insurance programs, and pharmacy benefit managers. In addition, many state legislative proposals could further negatively affect pricing and/or reimbursement for our pharmaceutical industry tenants’ products.”

Annual report 2025A · The company itself

“Also, the pricing environment for pharmaceuticals continues to be in the political spotlight in the U.S. Pharmaceutical and medical device product pricing is subject to enhanced government and public scrutiny and calls for reform.”

Annual report 2025A · The company itself

“Some states have implemented, and other states are considering implementing, pharmaceutical price controls or patient access constraints under the Medicaid program, and some states are considering price-control regimes that would apply to broader segments of their populations who are not Medicaid eligible. We anticipate that pricing pressures from both governments and private payors inside and outside the U.S. will become more severe over time.”

Annual report 2025A · The company itself

“Drug pricing regulation — Most-Favored-Nation Executive Order On May 12, 2025, President Trump issued an executive order titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients,” directing the U.S. HHS to set U.S. drug price benchmarks at the lowest prices paid in comparable developed countries.”

Annual report 2025A · The company itself

“Although the President projected price reductions of 30%–80%, most reforms would require formal rulemaking and are likely to face legal obstacles. In July 2025, the White House sent letters to the chief executive officers of 17 major drug manufacturers, demanding compliance within 60 days and noting that noncompliance could result in the federal government's enforcement through "every tool in our arsenal."”

Annual report 2025A · The company itself

“Recently, the Trump administration and AstraZeneca and Pfizer reached public agreements under which both companies will offer many drugs at “most-favored-nation” (“MFN”) pricing through Medicaid and via a new direct-to-consumer platform, and in return AstraZeneca and Pfizer will receive a three-year tariff reprieve. While these developments signal accelerating 36 government pressure on industry pricing, they also inject significant ambiguity into commercial forecasts for pharmaceutical and biotechnology firms.”

Annual report 2025A · The company itself

“If widely adopted, MFN pricing could materially compress margins, reduce investment in R&D, and suppress expansions by our life science tenants, adversely impacting demand for laboratory and related technical office space and manufacturing space and thereby posing downside risk to property income and investment valuations.”

Annual report 2025A · The company itself

“We cannot predict the ultimate impact of this legislation or the content and outcome of future potential reforms and changes to the government’s ability to regulate and negotiate drug pricing. Changes in policy that limit prices may reduce the financial incentives for the research and development efforts that lead to discovery and production of new therapies and solutions to lifethreatening conditions. Negative impacts of new policies could adversely affect our tenants’ and venture investment portfolio companies’ businesses, including life science companies, which may reduce the demand for life science/laboratory space and negatively impact our operating results and our business.”

Annual report 2025A · The company itself

“RISKS RELATED TO GOVERNMENT REGULATIONS AND THIRD-PARTY POLICIES Our sales depend on coverage and reimbursement from government and commercial third-party payers, and pricing and reimbursement pressures have affected, and are likely to continue to affect, our profitability. Sales of our products depend on the availability and extent of coverage and reimbursement from third-party payers, including government healthcare programs and private insurance plans. Governments and private payers continue to pursue initiatives to manage drug utilization and contain costs. Payers are increasingly focused on costs, which has resulted, and is expected to continue to result, in lower reimbursement rates for our products and/or narrower patient populations for which payers will reimburse.”

Annual report 2025A · The company itself

“Continued intense public scrutiny of the price of drugs and other healthcare costs, together with payer dynamics, have limited, and are likely to continue to limit, our ability to set or adjust the price of our products based on their value, which can have a material adverse effect on our business.”

Annual report 2025A · The company itself

“In the United States, a number of legislative and regulatory proposals have been introduced and/or signed into law to lower drug prices. These include the IRA that enables the U.S. government to set prices for certain drugs in Medicare, redesigns Medicare Part D benefits to shift a greater proportion of the costs to manufacturers and health plans, and enables the U.S. government to impose penalties if drug prices are increased at a rate faster than inflation (IRA Inflation Penalties).”

Annual report 2025A · The company itself

“On July 4, 2025, OB3 was enacted and included several changes to Medicare, Medicaid and Affordable Care Act policies, including provisions affecting eligibility, that, when implemented, are expected to adversely affect coverage and reimbursement for our products.”

Annual report 2025A · The company itself

“On May 12, 2025, the Administration issued the Most-Favored-Nations (MFN) Prescription Drug Pricing Executive Order (MFN EO) aimed at using price benchmarks from other developed countries to set U.S. pricing targets. Subsequently, on July 31, 2025 the Administration sent letters to many pharmaceutical manufacturers, including Amgen (the July MFN Letter) as further described below, outlining steps that such manufacturers could take to advance actions consistent with elements of the MFN EO. In December 2025, we announced that we are taking actions that satisfy the components outlined in the July MFN Letter, including the Administration’s MFN pricing requests.”

Annual report 2025A · The company itself

“CMS has set Medicare Part D prices for ENBREL, effective January 1, 2026, and Otezla, effective January 2027, in each case at significantly lower prices that are expected to negatively impact their profitability in Medicare.”

Annual report 2025A · The company itself

“The IRA’s Medicare price setting and Medicare redesign have had, and are likely to have, an adverse effect on our sales, our business and our results of operations, and such impact is expected to increase through the end of the decade and will depend on factors including the extent of our portfolio’s exposure to Medicare reimbursement, the rate of inflation over time, the number of our products selected for Medicare price setting and the timing of market entry of generic or biosimilar competition.”

Annual report 2025A · The company itself

“Further, inappropriate expanded utilization of the 340B Program from broadened application of the 340B discounts has had, and is expected to continue to have, a negative impact on the Company’s product sales, business and results of operations.”

Annual report 2025A · The company itself

“Payers, including PBMs, have sought, and continue to seek, price discounts or rebates in connection with the placement of our products on their formularies or those they 32 manage, and to also impose restrictions on access to, or usage of, our products (such as Step Therapy), require that patients receive the payer’s prior authorization before covering the product, and/or to exclude certain indications for which our products are approved.”

Annual report 2025A · The company itself

“BioArctic och bolagets samarbetspartner påverkas av myndighetsbeslut såsom nödvändiga tillstånd för att bedriva kliniska prövningar och kommersialisera läkemedel samt regeländringar som kan komma att ske inom områden som prissättning, rabattering av läkemedel och ändrade förutsättningar för läkemedelsförskrivning.”

Annual report 2024A · The company itself

“Drug prices are under significant scrutiny in the markets in which our products are prescribed; for example the IRA has certain provisions related to drug pricing, including the ability for the U.S. government to set prices for certain drugs in Medicare.”

Annual report 2025A · The company itself

“The uncertainty about the future of the PPACA and healthcare laws may put downward pressure on drug pricing and increase our regulatory burdens and operating costs. For example, we expect the IRA's drug pricing controls and Medicare Part D redesign to have an adverse impact on sales, particularly for our products that are more substantially reliant on Medicare reimbursement.”

Annual report 2025A · The company itself

“Additionally, the current government administration has introduced various measures to address prescription drug pricing and access, including through issuance of an executive order aiming to establish an MFN drug pricing policy that would tie U.S. drug prices to the prices paid for drugs in other developed countries. If HHS sets MFN pricing targets for prescription drugs, including the use of international pricing reference to set drug prices in the U.S., or if legislation is passed enabling generic drug or biosimilar entry sooner than expected, our business could be materially harmed, including with respect to our ability to set adequate pricing for new drugs to recover our research and development costs.”

Annual report 2025A · The company itself

“In both the U.S. and foreign markets, the successful sale of a life sciences company’s product depends on the ability to obtain and maintain adequate coverage and reimbursement from third-party payers, including government healthcare programs and private insurance plans. Governments and third-party payers continue to pursue aggressive initiatives to contain costs and manage drug utilization and are increasingly focused on the effectiveness, benefits and costs of similar treatments, which could result in lower reimbursement rates and narrower populations for whom the products will be reimbursed by third-party payers.”

Annual report 2025A · The company itself

“Our products continue to be subject to increasing pressures across the portfolio from pharmaceutical market access and pricing controls, required rebates and other discounts, in the U.S., the EU and other regions around the world that result in lower prices, lower reimbursement rates and smaller populations for whom payers will reimburse. We expect that these market access constraints, pricing controls and discounting and other restrictions will become more acute as public and private payers continue to take aggressive steps to control their expenditures.”

Annual report 2025A · The company itself

“In particular, the IRA has and will continue to have the effect of reducing prices and reimbursements for certain of our products, which could significantly impact our business. Under the IRA, the HHS can effectively set prices for units of certain single-source drugs and biologics reimbursed under Medicare Part B, Medicare Advantage and Part D. Generally, these government prices apply nine years (for small molecule drugs) or 13 years (for biologics) following FDA approval and will be capped at a statutory ceiling price that is likely to represent a significant discount from average prices to wholesalers and direct purchasers.”

Annual report 2025A · The company itself

“In August 2024, as part of the first round of government price setting pursuant to the IRA, the HHS announced the "maximum fair price" for a 30-day equivalent supply of Eliquis, which applies to the U.S. Medicare channel effective January 1, 2026.”

Annual report 2025A · The company itself

“In November 2025, the HHS announced the "maximum fair price" for a 30-day supply of Pomalyst, which applies to the U.S. Medicare channel effective January 1, 2027.”

Annual report 2025A · The company itself

“In December 2025, we announced the U.S. Government Agreement pursuant to which we agreed to, among other things: (i) provide Eliquis for free to the Medicaid program effective January 1, 2026; (ii) donate more than seven tons of Eliquis API to fill the U.S. Strategic Active Ingredient Reserve; (iii) enable direct-to-patient access to Sotyktu, Zeposia, Reyataz, Baraclude and Orencia for cash-paying patients at discounts approximately 80% off current list prices; (iv) adopt a more balanced pricing approach for new launches across developed nations; and (v) continue to expand domestic production.”

Annual report 2025A · The company itself

“We participate in the 340B program, under which we must offer covered outpatient drugs to statutorily defined covered entities at no more than the 340B program “ceiling price”. The expanded utilization of the 340B program in recent years has negatively affected our revenues and profit margins.”

Annual report 2025A · The company itself

“Additionally, pharmacy benefit manager practices have come under increased scrutiny from U.S. policymakers at the federal and state level, who have proposed legislation intended to address concerns regarding the impact that these intermediaries have on drug pricing and patients’ out of pocket costs. If promulgated, such legislation could have resultant implications, costs or consequences for our business and how we interact with these entities.”

Annual report 2025A · The company itself

“The Inflation Reduction Act has and will continue to adversely impact our revenue by capping prices for certain drugs; however, our profitability has not been negatively impacted.”

Annual report 2026A · The company itself

“The Executive Order titled "Delivering Most-Favored Nation Prescription Drug Pricing to American Patients," may impact the sales or profitability of branded pharmaceutical products.”

Annual report 2026A · The company itself

“For example, the federal 340B drug pricing program requires pharmaceutical manufacturers to offer discounts on certain drugs purchased by covered entities, and some of our Pharma segment customers are covered entities or contract pharmacies for covered entities. Over a dozen pharmaceutical manufacturers have restricted sales under the 340B drug pricing program to a limited number of contract pharmacies. These practices are the subject of ongoing litigation; however, if manufacturers continue this practice and if courts uphold this practice, our customers may be adversely impacted, which could adversely impact our business.”

Annual report 2026A · The company itself

“Under the IRA, PDP plan costs increased significantly due to a reduction in members cost share (close of coverage gap, and the $2,000 cap on member out-of-pocket expenses) and a decrease in federal reinsurance (from 80% to 20%, while a greater portion of the plan drug costs fall into the catastrophic phase).”

Annual report 2025A · The company itself

“Contracts in the prescription drug industry, including our contracts with retail pharmacy networks and our pharmacy and specialty pharmacy clients, generally use pricing metrics published by third parties as benchmarks to establish pricing for prescription drugs. If these benchmarks are no longer published by third parties; if we, or our contractual partners, adopt other pricing benchmarks for establishing prices within the industry; if legislation or regulation requires the use of other pricing benchmarks; or if future changes in drug prices substantially deviate from our expectations, the short- or long-term impacts may have a material adverse effect on our business and results of operations.”

Annual report 2025A · The company itself

“Additionally, laws such as the Inflation Reduction Act have granted CMS the ability to negotiate drug prices for high-cost Medicare Part D and Part B drugs, and other federal and state legislative proposals and executive actions can lead to residual effects as drug companies adjust pricing strategies for broader marketplaces, impacting which medications are prioritized.”

Annual report 2025A · The company itself

“The Inflation Reduction Act of 2022 (IRA) continues to be implemented, with Medicare drug price negotiations expanding in scope. Beginning in 2026, negotiated prices for selected high-cost drugs will take effect, and the out-of-pocket cap for Medicare Part D enrollees will rise to $2,100. Additionally, manufacturers are subject to inflation-based rebates for price increases that exceed inflation benchmarks.”

Annual report 2025A · The company itself

“In addition, the prices for the first ten drugs in the Medicare Drug Negotiation Program (the “Negotiation Program”) take effect in 2026, and the program will grow over time as additional drugs are negotiated by the government each year, with up to 100 total Part B and D drugs selected for the Negotiation Program by 2031. The Negotiation Program mandates direct negotiation by the government of prices for certain drugs in Medicare and negotiated drugs must be covered on all plan formularies.”

Annual report 2025A · The company itself

“In addition, the Inflation Reduction Act, enacted in August 2022 contains changes to the Part D program that have and will shift more of the claim liability to plans and away from the government, including a complete redesign of the Part D standard benefit effective in 2025, which may reduce the Company’s flexibility to design competitive offerings.”

Annual report 2025A · The company itself

“Possible changes in industry pricing benchmarks and drug pricing generally can adversely affect our PBM and Pharmacy & Consumer Wellness businesses.”

Annual report 2025A · The company itself

“It is possible that the pharmaceutical industry, regulators, or federal policymakers may evaluate and/or develop an alternative pricing reference to replace AWP or WAC, which are the pricing references used for many of our PBM client contracts, drug purchase agreements, retail network contracts, specialty payor agreements and other contracts with third party payors in connection with the reimbursement of drug payments. In addition, many state Medicaid fee-for-service programs have established pharmacy network payments on the basis of Actual Acquisition Cost (“AAC”). The use of an AAC basis in fee for service Medicaid could have an impact on reimbursement practices in Health Care Benefits’ Commercial and other Government products. In addition, CMS also publishes the National Average Drug Acquisition Cost (“NADAC”) for certain drugs; NADAC pricing, which has exhibited recent volatility, is being adopted in an increasing number of states.”

Annual report 2025A · The company itself

“Third-party payers are increasingly reducing reimbursements for medical products and services and, in international markets, many countries have instituted price ceilings on specific products and therapies (for further discussion of governmental initiatives to reduce healthcare costs, please see “—Healthcare Reform” below). Price ceilings, decreases in third-party reimbursement for any product or a decision by a third-party payor not to cover a product may reduce usage and patient demand for the product.”

Annual report 2025A · The company itself

“Moreover, there has recently been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several Congressional inquiries and proposed and enacted legislation designed, among other things, to bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs and reform government program reimbursement methodologies for medical products. Individual states in the U.S. have also become increasingly active in implementing regulations designed to control product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures and, in some cases, mechanisms to encourage importation from other countries and bulk purchasing. Other countries, including China, have also introduced similar measures with the stated goals of containing healthcare costs, improving quality and/or expanding access.”

Annual report 2025A · The company itself

“For example, the Protecting Access to Medicare Act of 2014 (“PAMA”) introduced a multi-year pricing program for services payable under the Clinical Laboratory Fee Schedule (“CLFS”) that is designed to bring Medicare allowable amounts in line with the amounts paid by private payors. It is still unclear whether and to what extent these new rates will affect overall pricing and reimbursement for clinical laboratory testing services, but to the extent our customers conclude that Medicare reimbursement for these services is inadequate, it can adversely impact the prices at which we sell our products.”

Annual report 2025A · The company itself

“We have experienced, and anticipate that we will continue to experience, decreasing prices for our products due to future reimbursement changes under Medicare and pricing pressure from managed care organizations and other third-party payors. In the United States and other countries, government and private sector access to health care products continues to be a subject of focus, and efforts to reduce health care costs are being made by third-party payors. Most of our customers rely on third-party payors, including government programs and private health insurance plans, to cover the cost of the G6, G7, G-7 15 Day, Dexcom One, and Dexcom ONE+. We expect that these continuing cost reduction and containment measures could result in lower prices for these products and lower reimbursement rates, as well as could lead to patients being unable to obtain approval for coverage or payment from these third-party payors resulting in costs being shifted to patients for these products.”

Annual report 2025A · The company itself

“Additionally, we may experience pricing pressure if our products are increasingly subject to competitive bidding processes, which include substantial costs and managerial time to prepare bids and proposals for contracts that may not be awarded to us or may be split among competitors. For example, in June 2025, the Centers for Medicare & Medicaid Services published a proposed rule that would subject continuous glucose monitors to the competitive bidding process, which could negatively impact our reimbursement and result in price decreases.”

Annual report 2025A · The company itself

“In late 2025, CMS extended the DMEPOS competitive bidding program to include our CGMs and receivers, with contracting beginning in 2027 and payment changes taking effect in 2028. Under the program, DMEPOS suppliers compete to become Medicare contract suppliers by submitting bids to furnish certain items in CBAs. CMS anticipates that ten (10) contracts will be awarded for CGMs.”

Annual report 2025A · The company itself

“In any event, the bid process is expected to result in lower Medicare reimbursement for CGM systems, particularly because CMS is changing the pricing under the RID CBA by setting a single payment amount for covered items at the 75th percentile of the winning bids, rather than using the maximum winning bid. Further, CMS has reclassified CGMs and insulin infusion pumps to items that require frequent and substantial servicing and will phase in monthly rental payments for these items. CMS will bundle the rental amount for the receiver device with payment for the supplies and accessories in the new payment amount. The bid limit will be monthly fee schedule amounts for the supplies plus the average purchase fee schedule amounts for the CGM receiver device divided by 60 (intended to capture the 5-year useful life of the device.)”

Annual report 2025A · The company itself

“We face a number of regulatory and commercial hurdles relating to wide-scale sales where a government or commercial third-party payor provides reimbursement, including sales to Medicare beneficiaries. If we are unable to successfully address these hurdles, reimbursement of our products may be limited to a smaller subset of people with diabetes covered by Medicare or to those people with diabetes covered by other third-party payors that have adopted policies for CGM devices allowing for coverage of these devices if certain conditions are met. Adverse coverage or reimbursement decisions relating to our products, or rescission or limitation of favorable determinations, by CMS, its Medicare Administrative Contractors, other state, federal or international payors, and/or third-party commercial payors could significantly reduce reimbursement, which could have an impact on the acceptance of, and demand for, our products and the prices that our customers are willing to pay for them.”

Annual report 2025A · The company itself

“increased pressures by governmental and third-party payers to reduce healthcare costs”

Annual report 2025A · The company itself

“Genmab is subject to government regulations on pricing/public reimbursement as well as other healthcare payer cost-containment initiatives; increased pressures by governmental and third-party payers to reduce healthcare costs.”

Annual report 2025A · The company itself

“Competition We operate in a highly competitive environment. Our products compete with other commercially available products based primarily on efficacy, safety, tolerability, acceptance by doctors, ease of patient compliance, ease of use, price, insurance and other reimbursement coverage, distribution and marketing.”

Annual report 2025A · The company itself

“For example, the administration has taken a number of actions aimed at lowering U.S. drug prices and testing new Medicare and Medicaid payment models. President Trump also has pledged to impose tariffs on pharmaceuticals and other products, some of which have already started to be implemented.”

Annual report 2025A · The company itself

“Our existing products are subject to pricing and reimbursement pressures from government agencies and other third parties, including required discounts and rebates.”

Annual report 2025A · The company itself

“In January 2026, the Department of Health and Human Services selected Biktarvy for Medicare negotiation of Medicare prices that will be effective beginning in 2028, and more of our products may be selected in the future.”

Annual report 2025A · The company itself

“The administration has issued multiple executive orders and statements that illustrate the intent to require pharmaceutical manufacturers to offer U.S. prices based on most favored-nation (“MFN”) lowest prices and that direct specified agency heads to take certain actions if significant progress towards such MFN prices is not achieved. In July 2025, the President sent letters to Gilead and other pharmaceutical manufacturers outlining the steps the President believes pharmaceutical manufacturers must take to bring down the prices of prescription drugs in the U.S. to match the MFN price offered in other developed nations.”

Annual report 2025A · The company itself

“A substantial portion of our product sales is subject to significant discounts from list price, including rebates that we may be required to pay state Medicaid agencies and discounts provided to covered entities under 340B. Changes to the 340B program or the Medicaid program at the federal or state level could have a material adverse effect on our business.”

Annual report 2025A · The company itself

“The healthcare industry is subject to various federal, state and international laws and regulations pertaining to drug approval, manufacturing, reimbursement, rebates, price reporting, healthcare fraud and abuse, and data privacy and security. In the U.S., these laws include anti-kickback and false claims laws, the Federal Food, Drug, and Cosmetic Act, laws and regulations relating to the Medicare and Medicaid programs and other federal and state programs, such as the Medicaid Rebate Statute and the 340B statute, laws that regulate written and verbal communications about our products, individual state laws relating to pricing and sales and marketing practices, the Health Insurance Portability and Accountability Act and other federal and state laws relating to the privacy and security of health information, including the Department of Justice Final Rule on Preventing Access to U.S.”

Annual report 2025A · The company itself

“Changes in laws or policies, including drug pricing reform, tax credits and incentives, environmental, health and safety standards, or tariff, trade and sourcing rules, could reduce expected returns on our investments or increase investment or operating costs.”

Annual report 2025A · The company itself

“In December 2025, Gilead reached an agreement with the administration to (1) pause the imposition of Section 232 tariffs on Gilead for three years, (2) implement MFN prices in Medicaid for select existing and future launched products, (3) set a new direct-to-patient price for Epclusa and (4) return a portion of increased international revenues to the U.S. if the U.S. government is successful in increasing drug prices abroad.”

Annual report 2025A · The company itself

“Our ability to commercialize our current and any future approved products successfully will depend in part on the prices we are able to charge for these products and the extent to which adequate coverage and reimbursement levels for the cost of our products and related treatment are obtained from third-party payors, such as private insurers, government insurance programs, including Medicare and Medicaid, health maintenance organizations and other healthcare related organizations in the United States and abroad. We may not be able to sell our products on a profitable basis or our profitability may be reduced if we are required to sell our products at lower than anticipated prices or reimbursement is unavailable or limited in scope or amount. The costs of the drug products marketed by us are not insignificant and almost all patients will require some form of third-party coverage to afford their cost.”

Annual report 2025A · The company itself

“In many markets outside of the United States, including countries of the European Union (EU), drug pricing and reimbursement are subject to government control, and government authorities are making greater efforts to limit or regulate the price of drug products. Reimbursement systems in international markets vary significantly by country and by region, and reimbursement approvals must be obtained on a country-by-country basis. Reimbursement in the EU must be negotiated on a country-by-country basis and in many countries a drug product cannot be commercially launched until reimbursement is approved.”

Annual report 2025A · The company itself

“Third-party payors are increasingly challenging the prices charged for medical products and services, and payors and employers are adopting benefit plan changes that shift a greater portion of prescription drug costs to patients. Third party pharmacy benefit managers (PBMs), other similar organizations and payors can limit coverage to specific products on an approved list, or formulary, which might not include all of the approved products for a particular indication, and to exclude drugs from their formularies in favor of competitor drugs or alternative treatments, or place drugs on formulary tiers with higher patient co-pay obligations, and/or to mandate stricter utilization criteria. Formulary exclusion effectively encourages patients and providers to seek alternative treatments, make a complex and time-intensive request for medical exemptions, or pay 100% of the cost of a drug.”

Annual report 2025A · The company itself

“•Healthcare reform measures could impact the pricing and profitability of pharmaceuticals, and adversely affect the commercial viability of our or our collaborators’ products and drug candidates. If recent proposals for changes to Medicare and Medicaid reimbursement of drug prices are adopted into law, our results of operations and financial condition could be harmed. •Conflicts between us and our collaborators or the termination of our collaboration agreements could limit future development and commercialization of our drug candidates and harm our business. •If we are unable to establish collaborations to fully exploit our drug discovery and development capabilities or if such collaborations are unsuccessful, our future revenue prospects could be diminished. •If we fail to enter into additional in-licensing agreements or if these arrangements are unsuccessful, we may be unable to increase our number of successfully marketed products and our revenues.”

Annual report 2025A · The company itself

“If we market our products in a manner that violates various laws and regulations, we may be subject to civil or criminal penalties. In addition to FDA and related regulatory requirements, we are subject to healthcare “fraud and abuse” laws, such as the federal False Claims Act, the anti-kickback provisions of the federal Social Security Act, and other state and federal laws and regulations. Federal and state anti-kickback laws prohibit, among other things, knowingly and willfully offering, paying, soliciting or receiving remuneration to induce, or in return for purchasing, leasing, ordering or arranging for the purchase, lease or order of any healthcare item or service reimbursable under Medicare, Medicaid, or other federally- or state-financed healthcare programs. Federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal government, or knowingly making, or causing to be made, a false statement to get a false claim paid.”

Annual report 2025A · The company itself

“Although we believe that our promotional materials for physicians do not constitute improper promotion, the FDA or other agencies may disagree. If the FDA or another agency determines that our promotional materials or other activities constitute improper promotion, it could request that we modify our promotional materials or other activities or subject us to regulatory enforcement actions, including the issuance of a warning letter, injunction, seizure, civil fine and criminal penalties.”

Annual report 2025A · The company itself

“For example, the American Rescue Plan Act of 2021 includes a provision that became effective in January 2024 that eliminated the statutory cap on rebates that drug manufacturers pay to Medicaid. It is expected that this provision, as implemented by the Centers for Medicare and Medicaid Services (“CMS”) will have the effect of increasing Medicaid rebate liability, particularly in the case of medicines that have experienced price increases at a rate in excess of inflation.”

Annual report 2025A · The company itself

“Further, in August 2022, the Inflation Reduction Act of 2022 was enacted, which includes provisions allowing the federal government to negotiate prices for certain high-expenditure single source Medicare drugs, to impose penalties and to implement a potential excise tax for manufacturers that fail to comply with the negotiation by offering a price that is not equal to or less than the negotiated “maximum fair price” under the law, and to impose rebate liability on manufacturers that take price increases that exceed inflation.”

Annual report 2025A · The company itself

“The new law also reduced the out-of-pocket prescription drug costs for Medicare Part D beneficiaries, and to help pay for this change in benefit design, the law imposes a new discount program which started in 2025 in which manufacturers pay specified discounts on Medicare Part D utilization of their drugs as a condition of selling such drugs in the Medicare Part D program. The Inflation Reduction Act includes certain exemptions for small biotech drug manufacturers, including Incyte.”

Annual report 2025A · The company itself

“In addition, there has been an increasing legislative and enforcement interest in the United States with respect to drug pricing practices. This has resulted in significant legislative activity and proposals from the prior and current administrations relating to prescription drug prices and reimbursement, any of which, if enacted, could impose downward pressure on the prices that we can charge for our products and may further limit the commercial viability of our products and drug candidates.”

Annual report 2025A · The company itself

“In addition, the trend toward managed healthcare in the United States as well as legislative and regulatory proposals to reform healthcare or address the cost of government insurance programs may all result in lower prices for, or rejection of, our products. Managed healthcare organizations could control or significantly influence the purchase of healthcare services and products. Adoption of our products by the medical community and patients may be limited without adequate reimbursement for those products.”

Annual report 2025A · The company itself

“Table of Contents Changes in government pricing policies, including the enactment of “most favored nation” pricing legislation, could adversely affect our business. Our revenue, results of operations, and cash flows could be materially and adversely affected by changes in government pricing policies, including recently proposed or enacted “most favored nation” (MFN) pricing legislation or executive actions. For example, an executive order issued on May 12, 2025, directed the Department of Health and Human Services to establish MFN price targets, and, if progress toward these targets is insufficient, to pursue rulemaking that could require sale of certain products in the U.S. at prices no higher than those in comparable developed nations.”

Annual report 2025A · The company itself

“Actions taken by federal or local governments, legislative bodies and enforcement agencies with respect to these legal and regulatory compliance matters could also result in reduced demand for our products, reduced coverage of our products by healthcare payors, or both.”

Annual report 2025A · The company itself

“More recently, the One Big Beautiful Bill Act (the “OBBBA”), enacted on July 4, 2025, contains provisions that, among other changes, may cause a decrease in enrollment in Medicaid and ACA marketplace plans, which could adversely affect demand for our products.”

Annual report 2025A · The company itself

“Additionally, individual U.S. states are increasingly enacting laws to control product pricing, reimbursement, and marketing cost transparency.”

Annual report 2025A · The company itself

“Other federal or state healthcare reform measures that may be adopted in the future could have a material adverse effect on our business. Any regulatory or legislative developments in domestic or foreign markets that eliminate or reduce reimbursement rates for procedures performed with our products could harm our ability to sell our products or cause downward pressure on the prices of our products, either of which would adversely affect our business, financial condition, and results of business operations.”

Annual report 2025A · The company itself

“Our business has been and continues to be affected by federal and state legislation that alters the pricing, coverage, and reimbursement landscape. The federal Inflation Reduction Act of 2022 (IRA) includes provisions that effectively authorize the government to establish prices for certain high-spend single-source drugs and biologics reimbursed by the Medicare program, starting in 2026 for Medicare Part D drugs and 2028 for Medicare Part B drugs. In 2023, the Centers for Medicare & Medicaid Services (CMS) published the first “Selected Drug” list, which includes XARELTO and STELARA as well as IMBRUVICA, which is developed in collaboration and co-commercialized in the U.S. with Pharmacyclics LLC, an AbbVie company.”

Annual report 2025A · The company itself

“In January 2026, the Company reached an agreement with the U.S. Administration to improve access to medicines and lower costs for U.S. patients.”

Annual report 2025A · The company itself

“The most significant of these developments was PAMA. PAMA resulted in a net reduction in reimbursement revenue of approximately $245.0 million between 2018-2020 from all payers affected by the CLFS.”

Annual report 2025A · The company itself

“The pharmaceutical market will continue to feel the pressure to improve return on investment, increase R&D productivity, stay abreast of scientific advancements and comply with stringent government regulations and attempts to reduce and control the price of prescription drugs, all supporting the outsourcing model.”

Annual report 2025A · The company itself

“In 2022, the U.S. government enacted the Inflation Reduction Act of 2022 (IRA). Among other measures, the IRA requires HHS to effectively set prices for certain single-source drugs and biologics reimbursed under Medicare Part B and Part D. Currently, these government prices generally apply beginning at nine years (for medicines approved under a New Drug Application) or thirteen years (for medicines approved under a Biologics License Application) following FDA approval or licensure for the molecule and are set at a price that generally represents a significant discount from existing list prices to wholesalers and direct purchasers.”

Annual report 2025A · The company itself

“In August 2023, HHS selected Jardiance, which is part of our collaboration with Boehringer Ingelheim, as one of the first ten medicines subject to government-set prices effective in 2026. In August 2024, HHS announced the government-set prices for these medicines with Jardiance subject to a 66 percent discount compared to the 2023 U.S. calendar year list price for a 30-day supply.”

Annual report 2025A · The company itself

“In January 2026, HHS selected Trulicity and Verzenio as additional medicines subject to government-set prices to be effective in 2028.”

Annual report 2025A · The company itself

“Given our product portfolio, we expect additional of our significant products will be selected in future years, which would have the effect of accelerating revenue erosion prior to expiry of exclusivities.”

Annual report 2025A · The company itself

“Other IRA provisions require drug manufacturers to provide rebates for Medicare Part B and Part D medicines under certain circumstances and implemented Part D benefit redesign. The IRA has, and will continue to, meaningfully influence our business strategies and those of our competitors.”

Annual report 2025A · The company itself

“Furthermore, states continue to adopt laws that, among other things, expand the 340B program by purporting to compel manufacturers to sell their medicines at 340B prices to an unlimited number of contract pharmacies. Other manufacturers and trade associations continue to litigate the constitutionality of these laws in various federal courts.”

Annual report 2025A · The company itself

“Moreover, we cannot predict the extent to which our business may be affected by current or potential future legislative, regulatory, or private actor developments. However, in general we expect to see continued focus on regulating pricing, resulting in additional state, federal, and international legislative and regulatory developments that could have negative effects on pricing, access, and reimbursement for our products as well as overall operations.”

Annual report 2025A · The company itself

“Our business is subject to government price controls and other public and private restrictions on pricing, reimbursement, and access for our drugs, which could have a material adverse effect on our results of operations, reputation, or business. Public and private actors continue to take aggressive steps to control expenditures for pharmaceuticals by placing restrictions on pricing and reimbursement for, and patient access to, our medicines. These pressures have negatively affected and we expect will continue to negatively affect our consolidated results of operations.”

Annual report 2025A · The company itself

“Given the limited duration of patent and data protections, the speed with which we develop products, complete clinical testing, receive regulatory approvals, supply commercial products to the market, and obtain public and private payer access are important factors in recouping our development costs and generating financial returns, particularly given regulatory and market dynamics that have and may continue to put pressure on pricing, exclusivity periods, and competition.”

Annual report 2025A · The company itself

“The Inflation Reduction Act of 2022 (“IRA”) made meaningful changes affecting benefit design and how Medicare pays for drugs, which are all intended to reduce the price of drugs. Three central features of the IRA have authorized the government to negotiate drug prices for certain Medicare Part B and Medicare Part D drugs over time, establish an inflation rebate program, and cap patient cost sharing under Medicare Part D.”

Annual report 2026A · The company itself

“Executive Order 14297, “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients,” issued in May 2025, seeks to facilitate manufacturers’ sale of certain drugs in the U.S. at no higher than the lowest prices paid in other developed countries. It also directs HHS to enable direct-to-consumer purchasing programs for prescription drugs at most-favored-nation prices, which may bypass supply chain intermediaries.”

Annual report 2026A · The company itself

“There are ongoing developments with respect to the 340B Drug Pricing Program (the “340B program”) administered by the Health Resources and Services Administration (“HRSA”). The 340B program requires manufacturers to offer discounts on certain drugs purchased by “covered entities” such as safety-net providers, and some of our customers are covered entities or contract pharmacies for covered entities.”

Annual report 2026A · The company itself

“In the U.S., federal and state governments for many years have pursued methods to reduce the cost of drugs and vaccines for which they pay. For example, federal and state laws require the Company to pay specified rebates for medicines reimbursed by Medicaid and to provide discounts for medicines purchased by certain state and federal entities such as the Department of Defense, Veterans Affairs, Public Health Service entities and hospitals serving a disproportionate share of low income or uninsured patients.”

Annual report 2025A · The company itself

“Furthermore, the Company expects that Keytruda will be selected in 2027 for government price setting, which would become effective on January 1, 2029, and the Company expects that, as a result, U.S. sales of Keytruda will decline materially after that time.”

Annual report 2025A · The company itself

“Also, as noted above, in December 2025, the Company entered into the MFN Agreement with the U.S. government pursuant to which the Company will provide key products through a direct-to-patient program at affordable prices for eligible patients in the U.S. This currently includes Januvia, Janumet, and Janumet XR, and will be expanded in the future to include enlicitide decanoate pending FDA approval.”

Annual report 2025A · The company itself

“In addition, the Company has agreed that products launched during the term of the MFN Agreement (with certain exceptions) will be subject to “most-favored-nation” pricing in reference to prices for such products in the MFN Countries.”

Annual report 2025A · The company itself

“Outside the U.S., numerous major markets, including the EU, Japan and China have pervasive government involvement in funding health care and, in that regard, fix the pricing and reimbursement of pharmaceutical and vaccine products. Consequently, in those markets, the Company is subject to government decision making and budgetary actions with respect to its products.”

Annual report 2025A · The company itself

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

Annual report 2025A · The company itself

“Changes to the U.S. health care system as part of health care reform, as well as increased purchasing power of entities that negotiate on behalf of Medicare, Medicaid, and private sector beneficiaries, have contributed to pricing pressure. In several international markets, government-mandated pricing actions have reduced prices of generic and patented drugs.”

Annual report 2025A · The company itself

“In addition, the Company’s sales performance in 2025 was negatively affected by other cost-reduction measures taken by governments and other third parties to lower health care costs, including in the U.S., the expansion of the Federal 340B Drug Discount Program.”

Annual report 2025A · The company itself

“A new NRDL was recently completed in which new entries averaged approximately 60% price reductions. 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 the government’s VBP program.”

Annual report 2025A · The company itself

“•The Company’s research and development efforts may not succeed in developing commercially successful products and the Company may not be able to acquire commercially successful products in other ways; consequently, the Company may not be able to replace sales of successful products that lose patent protection. •The Company’s success is dependent on the successful development and marketing of new products, which are subject to substantial risks. •The Company faces continued pricing pressure with respect to its products in the public and private sectors. •Unfavorable or uncertain economic conditions, together with cost-reduction measures being taken by the U.S. and other countries, could negatively affect the Company’s operating results. •The Company faces intense competition from both lower cost generic and biosimilar products and competitors’ products.”

Annual report 2025A · The company itself

“In 2022, Congress passed the IRA, which made significant changes to how drugs are covered and paid for under the Medicare program, including the creation of financial penalties for drugs whose prices rise faster than the rate of inflation, redesign of the Medicare Part D program to require manufacturers to bear more of the liability for certain drug benefits, which has taken effect in 2025, and government price setting for certain Medicare Part D drugs, 36 Table of Contents starting in 2026, and Medicare Part B drugs starting in 2028. Furthermore, government price setting may also impact pricing in the private market, negatively affecting the Company’s performance.”

Annual report 2025A · The company itself

““Competition and the Health Care Environment,” in 2023, HHS selected Januvia for the first year of the IRA’s price setting program, which resulted in a government set price becoming effective on January 1, 2026. In 2025, HHS selected Janumet and Janumet XR for government price setting, the set price for which will become effective on January 1, 2027. In addition, in January 2026, HHS announced that Lenvima has been selected for government price setting, the set price for which will become effective on January 1, 2028.”

Annual report 2025A · The company itself

“Furthermore, the Company expects that in 2027 HHS will include Keytruda in a subsequent selection of products to undergo IRA price setting, with such price to become effective on January 1, 2029 and the Company expects that, as a result, U.S. sales of Keytruda will decline materially after that time.”

Annual report 2025A · The company itself

“•Pricing pressures in the public and private sectors, both in the U.S. and abroad, including rules and practices of managed care groups, judicial decisions and governmental laws and regulations related to Medicare, Medicaid and health care reform, pharmaceutical reimbursement and pricing in general. •Changes in government laws and regulations, including laws governing intellectual property, and the enforcement thereof affecting the Company’s business. •Efficacy or safety concerns with respect to marketed products, whether or not scientifically justified, leading to product recalls, withdrawals or declining sales. •Significant changes in customer relationships or changes in the behavior and spending patterns of purchasers of health care products and services, including delaying medical procedures, rationing prescription medications, reducing the frequency of physician visits and foregoing health care insurance coverage.”

Annual report 2025A · The company itself

“As previously disclosed, in June 2024, Merck received a Civil Investigative Demand (CID) from the DOJ, pursuant to a False Claims Act investigation, seeking documents and materials related to Steglatro, Januvia and certain related drugs. The CID states that it is investigating Merck’s price reporting under the Medicaid Drug Rebate Program as well as compliance with anti-kickback requirements in connection with patient assistance programs.”

Annual report 2025A · The company itself

“Inflation Reduction Act As previously disclosed, in June 2023, Merck filed a complaint in the U.S. District Court for the District of Columbia against the U.S. government regarding the Inflation Reduction Act’s “Drug Price Negotiation Program” for Medicare (the Program).”

Annual report 2025A · The company itself

“lower realised prices, including the MFN ("Most Favoured Nations") agreement in the US”

Annual report 2025A · The company itself

“Expanded affordability options to bring our GLP-1s to more Americans”

Annual report 2025A · The company itself

“our new agreement with the US Administration – once finalised – will lower prices across Medicare Part D and Medicaid programmes”

Annual report 2025A · The company itself

“This is countered by lower realised prices, including the MFN ("Most Favoured Nations") agreement in the US and the loss of exclusivity for the semaglutide molecule in certain markets in International Operations.”

Annual report 2025A · The company itself

“In addition, we have agreed to a framework with the US Administration to lower semaglutide prices across Medicare Part D (government insurance for seniors), Medicaid (government insurance for low-income Americans) and direct‑to‑patient channels from 2026 onwards, and to broaden coverage through a Medicare pilot programme for Part D beneficiaries with qualifying comorbidities.”

Annual report 2025A · The company itself

“The financial success of the Group requires obtaining marketing authorization and achieving an acceptable reimbursement price for its drugs.”

Annual report 2024A · The company itself

“Government designed to lower drug costs for U.S. patients and to include certain Pfizer products on the TrumpRx.gov platform, Pfizer’s plans to further invest in U.S. manufacturing and potential tariff impacts, including risks relating to entering into binding final agreements with the U.S.”

Annual report 2025A · The company itself

“In May 2025, the Trump Administration issued an Executive Order titled “Delivering Most-Favored Nation Prescription Drug Pricing to American Patients”, outlining a plan to reduce prescription drug costs in the U.S., which was followed by formal letters to major pharmaceutical companies (including Pfizer) in July 2025 outlining steps they should take to lower prescription drug costs to U.S. patients and taxpayers (collectively, the MFN Initiatives). In September 2025, Pfizer announced an agreement with the Trump Administration in which we voluntarily agreed to implement measures designed to make certain drug prices for U.S. patients more comparable to those in other developed countries. We are also participating in the TrumpRx.gov platform, which allows U.S. patients to purchase certain medicines at significant discounts to current retail prices.”

Annual report 2025A · The company itself

“The drug pricing provisions of the IRA have been and continue to be implemented. The IRA includes several provisions intended to lower prescription drug costs for Medicare patients and to reduce drug spending by the federal government. The IRA also made significant changes to the Medicare Part D benefit design (IRA Medicare Part D Redesign), which took effect beginning in 2025 and negatively impacted our 2025 revenues by approximately $1 billion.”

Annual report 2025A · The company itself

“The IRA also imposes rebates under Medicare Part B and Medicare Part D on drug price increases that outpace inflation, and directs HHS to set the prices of certain high-expenditure, single-source drugs and biologics covered under Medicare, known as the MDPNP. In August 2023, CMS published the first ten medicines subject to the MDPNP, which included Eliquis. In August 2024, the government released the new Medicare price for Eliquis, which, effective January 1, 2026, is required to be offered to all Medicare beneficiaries at the price established by the government (known as the Maximum Fair Price).”

Annual report 2025A · The company itself

“In January 2025, CMS announced the selection of another 15 drugs from Medicare Part D for the Maximum Fair Price, with prices to be set and effective on January 1, 2027. Ibrance and Xtandi were included in the list of 15 drugs selected. Another 15 drugs from Medicare Part B or Medicare Part D were selected on January 27, 2026, for the Maximum Fair Price to be set and effective on January 1, 2028. Xeljanz was included in the list of 15 drugs selected.”

Annual report 2025A · The company itself

“In addition, we must offer discounts or rebates on purchases of pharmaceutical products, and often voluntarily agree to supplemental rebates, under various government programs including Medicare, Medicaid, the Veterans Administration and the 340B Program. We also must report specific prices to state and federal government agencies. The calculations necessary to determine the prices reported are complex and the failure to do so accurately may expose us to enforcement measures.”

Annual report 2025A · The company itself

“Changes to the MDRP or the 340B Program also could have a material impact on our business. For example, certain changes finalized by CMS in a December 2020 final rule, including which products qualify as “line extension” drugs subject to increased rebate liability, may have a material adverse impact on our business. Additionally, in September 2024, CMS finalized a new rule that, among other items, expands the scope of medications considered to be “covered outpatient drugs” that could be subject to rebates under the MDRP and imposes penalties on covered outpatient drugs that CMS determines to be “misclassified.””

Annual report 2025A · The company itself

“States seek to control healthcare costs related to Medicaid and other state regulated healthcare programs. A majority of states use preferred drug lists to manage access to pharmaceutical products under Medicaid, including some of our products. States may seek to negotiate supplemental rebate agreements that are larger than the minimum federal requirement for preferred formulary access.”

Annual report 2025A · The company itself

“Certain governments, including in the different EU member states, the U.K., Japan, China, Canada and Australia provide healthcare at low-to-zero direct cost to consumers at the point of care and have significant power to regulate pharmaceutical prices or patient reimbursement levels to control costs for the government-sponsored healthcare system, particularly under global financing pressures.”

Annual report 2025A · The company itself

“RISKS RELATED TO GOVERNMENT REGULATION AND LEGAL PROCEEDINGS: PRICING AND REIMBURSEMENT Our future results could be adversely affected by new or changes in U.S. and international governmental regulations that mandate price controls, use international reference pricing, including MFN, increase required rebates, establish mandatory CMMI pilots (which are models designed to test certain payment and delivery systems to determine whether they result in cost savings), create coverage criteria, or limit patient access to our products.”

Annual report 2025A · The company itself

“Key Trends Reimbursement pressure driven by The Protecting Access to Medicare Act of 2014 (“PAMA”) Pursuant to PAMA, reimbursement rates for many clinical laboratory tests provided under Medicare were reduced during 2018 - 2020.”

Annual report 2025A · The company itself

“Congress passed the Inflation Reduction Act ("IRA"), which includes, among other items, provisions regarding the following: Table of Contents •Implementation of a Medicare Drug Price Negotiation Program (the "Medicare Drug Price Negotiation Program"). The Medicare Drug Price Negotiation Program requires the government to set prices for select high-expenditure drugs covered under Medicare Parts B and D.”

Annual report 2025A · The company itself

“For example, in May 2025, an executive order directed the U.S. Department of Health and Human Services ("HHS") and other federal agencies to take certain steps intended to, among other things, reduce the prices of drugs sold in the United States to match the lowest price available for the same drugs in comparably developed nations (commonly referred to as "most-favored-nation" ("MFN") pricing).”

Annual report 2025A · The company itself

“Pharmaceutical companies have been investigated and/or prosecuted under these laws for a variety of alleged promotional and marketing activities, such as allegedly providing free product to customers with the expectation that the customers would bill federal programs for the product; reporting to pricing services inflated average wholesale prices that were then used by federal programs to set reimbursement rates; engaging in promotion for uses that the FDA has not approved, known as off-label uses, that caused claims to be submitted to Medicaid for non-covered off-label uses; and submitting inflated best price information to the Medicaid Rebate program.”

Annual report 2025A · The company itself

“If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate program or other governmental pricing programs, we could be subject to additional reimbursement requirements, penalties, sanctions, and fines, which could have a material adverse effect on our business, financial condition, results of operations, and future prospects. We participate in the Medicaid Drug Rebate program, the Public Health Service's 340B program (which is administered by HRSA), the VA FSS pricing program, the Tricare Retail Pharmacy Program, and other federal and state government pricing programs.”

Annual report 2025A · The company itself

“Civil monetary penalties can be applied if we fail to pay the required rebate, if we are found to have knowingly submitted any false price or product information to the government, if we are found to have made a misrepresentation in the reporting of our average sales price, if we fail to submit the required price data on a timely basis, or if we are found to have knowingly and intentionally charged 340B covered entities more than the statutorily mandated ceiling price.”

Annual report 2025A · The company itself

“In September 2024, CMS modified the regulations governing the Medicaid Drug Rebate program, which could further increase our costs and the complexity of compliance, impact rebate liabilities, and be time-consuming to implement.”

Annual report 2025A · The company itself

“Statutory or regulatory changes or CMS guidance, including provisions included in the recent CMS calendar year 2026 Medicare Physician Fee Schedule final rule, could affect the average sales price calculations for our products and the resulting Medicare payment rate, and could negatively impact our results of operations.”

Annual report 2025A · The company itself

“The U.S. federal or state governments could carry out other significant changes in legislation, regulation, or government policy, including with respect to government reimbursement changes or drug price control measures or the PPACA or other healthcare reform laws. As discussed above under "Risks Related to Commercialization of Our Marketed Products, Product Candidates, and New Indications for Our Marketed Products - Product reimbursement and coverage policies and practices, pricing regulations and requirements, and our pricing strategy could change due to various factors beyond our control, which may adversely impact our business, prospects, operating results, and financial condition," the current U.S. administration is pursuing various measures to reduce the cost of drugs in the United States, and different or additional measures may be pursued in the future.”

Annual report 2025A · The company itself

“On July 4, 2025, President Trump signed into law the One Big Beautiful Bill Act (the Bill), which among other things, cuts federal Medicaid funding by $930 billion over ten years but provides reimbursement rate increases for providers. Notably, however, the Bill is projected to increase the federal deficit, which may lead to mandatory Medicare cuts and reduction in payments to providers in the future.”

Annual report 2026A · The company itself

“These factors may include medical cost inflation, increased use of services, increased provider billing intensity, business mix, unexpected differences among new customer populations, increased cost of individual services, costs to deliver care, large-scale medical emergencies, the potential effects of climate change, pandemics, the introduction of new or costly drugs or increases in drug prices, treatments and technology, new treatment guidelines, newly mandated benefits or other regulatory changes and insured population characteristics.”

Annual report 2025A · The company itself

“The U.S. government, state legislatures and foreign governments have shown significant interest in implementing cost-containment programs, including price controls, restrictions on reimbursement and requirements for substitution of generic products. Adoption of price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could limit our revenues.”

Annual report 2025A · The company itself

“Furthermore, certain states have enacted laws establishing Prescription Drug Affordability Boards (“PDABs”). Some state PDABs, including those in Colorado, Maryland, Washington, and Minnesota, either have the authority or have defined a pathway pursuant to which they may be granted the authority to establish upper payment limits for prescription drugs.”

Annual report 2025A · The company itself

“The containment of health care costs continues to be a priority for many governments, and drug pricing has been a focus in this effort. The U.S. federal government and state legislatures and foreign governments have shown significant and evolving interest in implementing cost-containment programs, including price controls, restrictions on reimbursement, value-based and reference pricing, compulsory licensing, including the pursuit of socalled “march in” rights, and mandatory substitution with generic products, all of which could limit the prices of, or access to, our products.”

Annual report 2025A · The company itself

“In the U.S., pricing and access is primarily governed by practices of private managed care providers and institutional and governmental purchasers, federal laws and regulations related to Medicare and Medicaid, including the ACA and the IRA, and state activities, including the establishment of PDABs and price transparency rules.”

Annual report 2025A · The company itself

“We have and may continue to experience pressure on the pricing of and reimbursements for certain of our products due to pricing controls, social or government pressure to lower the cost of drugs, and consolidation across the supply chain. We operate in a challenging environment, with significant pressures on the pricing of our products and on our ability to obtain and maintain satisfactory rates of reimbursement for our products by governments, insurers and other payors. We face numerous cost-containment measures by governments and other payors, including certain government-imposed industry-wide price reductions, caps on price increases, mandatory rebates or pricing, international reference pricing (i.e., the practice of a country linking its regulated medicine prices to those of other countries), VBP, tender systems, shifting of the payment burden to patients through higher co-payments, and requirements for increased transparency on pricing, all of which may have an adverse impact on the pricing of our products.”

Annual report 2025A · The company itself

“In 2022, the Inflation Reduction Act was enacted, which includes numerous Medicare reforms that will affect reimbursement for certain pharmaceuticals covered by Medicare and modify the Part D and Part B program structure, including shifting the liability for certain prescription drug costs shared between Medicare, pharmaceutical manufacturers, and Part D plans. These reforms include government price negotiation for certain high-spend, single-source Medicare drugs, out-of-pocket caps for Medicare beneficiaries using insulin products, and the application of inflation-based rebates for certain Medicare drugs. The implementation of the Inflation Reduction Act, including the drug price negotiation provision, inflation penalties, and Part D redesign is currently underway and could negatively affect certain Viatris portfolio products based on future pricing decisions, changes in the Consumer Price Index for All Urban Consumers (CPI-U), and the potential for shifting payor preferences based on the Part D redesign and requirements to cover drugs selected for negotiation.”

Annual report 2025A · The company itself

“In addition, there has been recent heightened governmental and public scrutiny of pharmaceutical product pricing, which has resulted in federal and state legislation and regulations, executive orders and other initiatives and proposals designed to increase transparency in pharmaceutical product pricing and reform government program reimbursement methodologies (for example, the Inflation Reduction Act, which includes, among other matters, policies designed to impact drug prices and reduce drug spending by the federal government).”

Annual report 2026A · The company itself

“Försäljningen av vissa av Bolagets produkter är beroende av olika ersättningssystem på de olika marknaderna. På flera av Bolagets marknader är det i många fall exempelvis patientens försäkringsbolag som inom ramen för befintliga politiska ersättningssystem finansierar eller subventionerar inköp av produkter för patientens vård. En del av framgången för försäljningen av AddLifes produkter på dessa marknader är beroende av huruvida dessa kvalificerar sig för att ersättas inom dessa olika ersättningssystem.”

Annual report 2023A · The company itself

“Divisionen är ledande i Norden med 3 700 Divisionen erbjuder ingenjörsoch konsulttjänster inom produktutveckling, produktionssystem, IT och försvarsteknik. Divisionen är verksam i alla industrisektorer med en tyngdpunkt inom fordon, livsmedel och läkemedel.”

Annual report 2024A · The company itself

“Apoteas omsättning består av receptbelagda läkemedel, receptfria läkemedel och handelsvaror samt tjänster. Under 2024 utgjorde receptbelagda läkemedel 37 procent av nettoomsättningen, medan receptfria läkemedel och handelsvaror stod för 61 procent och tjänster 2 procent.”

Annual report 2024A · The company itself

“Negative product mix effects from rising contributions of products with share of gross profit arrangements. Pricing adjustments, for example to sales reimbursed by the Medicare Part D programme in the US, diluted the Gross Margin.”

Annual report 2025A · The company itself

“For example, Congress and the U.S. administration have sought to impose changes to healthcare in the U.S., including government negotiation/regulation of drug prices paid by government programs. Such impacts could negatively impact certain markets we serve, resulting in an adverse impact on our sales revenue.”

Annual report unknown yearA · The company itself

“Additionally, the U.S. government’s negotiation of most favored nation pricing on certain prescription drugs, and the potential for expansion of this program, may impact the customers and industries we serve by increasing the cost of commercializing and/or limiting the profitability of commercialized products.”

Annual report unknown yearA · The company itself

“For example, many of our instruments are marketed to the pharmaceutical industry for use in discovering and developing drugs and diagnostic products. Changes in the U.S. FDA’s regulation of drug or medical device products, such as managing the price of certain prescription drugs or potentially increasing regulatory scrutiny of lab developed tests, could have an adverse effect on the demand for these products.”

Annual report unknown yearA · The company itself

“Government and private sector initiatives aimed at limiting the growth of health care costs (including price regulation), coverage and payment policies, comparative effectiveness of therapies, technology assessments, increasing price transparency and reforming health care delivery and payment structures, 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.”

Annual report 2025A · The company itself

“Ersättningen som en läkemedelsprodukt från tid till annan kan erhålla beror ofta på det värde produkten anses kunna tillföra patienten, sjuk - vårdssystemet och samhället i stort. Det finns en risk för att produkterna inte kvalificerar sig för sub - ventioner från privat och offentligt finansierade sjukvårdsprogram eller att ersättningen blir lägre än förväntat, vilket bland annat kan påverka mark - nadsupptaget för produkten eller vinstmarginalen.”

Annual report 2024A · The company itself

“Furthermore, if health insurers were to change their practices with respect to reimbursements for pharmaceutical products, our clients may spend less or reduce their growth in spending on R&D.”

Annual report 2025A · The company itself

“increased volatility in the biologics market, driven by US healthcare reforms in this specific treatment area being postponed”

Annual report 2025A · The company itself

“Kerecis continued volatility related to the expected changes to skin substitutes coverage and payment in the outpatient setting as of January 1, 2026”

Annual report 2025A · The company itself

“We also saw increased volatility in the biologics market, driven by US healthcare reforms in this specific treatment area being postponed, which led to a slowdown in the momentum for Kerecis in second half of the year.”

Annual report 2025A · The company itself

“At the same time, public healthcare budgets came under strain, and reimbursement reforms added new uncertainty and complexity in the US market.”

Annual report 2025A · The company itself

“The year-over-year revenue development reflects the transfer of U.S. sales operations to Takeda...as well as the Medicare Part D redesign impacts”

Annual report 2025B · From the report

“At the federal level, for example, the Inflation Reduction Act of 2022, among other things, requires drug manufacturers that raise certain of their drug prices faster than the rate of inflation to pay rebates to Medicare, and over time will authorize the federal government to negotiate directly with drug manufacturers to lower the prices of certain brand-name drugs covered by Medicare. These various evolving efforts create uncertainty and may adversely affect our business.”

Annual report 2025A · The company itself

“Further, we anticipate that recently enacted and proposed legislative changes affecting Medicare, Medicaid, and the Affordable Care Act may impact healthcare coverage, which, if implemented could adversely affect both demand for and pricing of our products.”

Annual report 2025A · The company itself

“For example, in May 2025, the Trump administration issued an executive order entitled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients,” which, among other things, directs the HHS and other agencies to communicate most-favored-nation price targets to pharmaceutical manufacturers to bring prices for U.S. patients in line with comparably developed nations and to facilitate direct-to-consumer purchasing programs. It is currently unclear whether and to what extent these measures will be implemented and what impact any such implementation would have on our business.”

Annual report 2025A · The company itself

“Changes in governmental regulations, such as policies reducing drug pricing like Most Favored Nation pricing, or a decline in government funding of research or education could reduce some customers’ ability to purchase our products.”

Annual report 2025A · The company itself

“Seulonta vaikuttaa HEDIS pisteisiin. Mikäli korvaustasoihin tai HEDIS pisteytykseen tulisi olennaisia muutoksia, se voi vaikuttaa haitallisesti yhtiön liikevaihto- ja kasvu kasvunäkymiin Yhdysvalloissa.”

Annual report 2025A · The company itself

“Prissättning Sobi verkar inom en starkt konkurrensutsatt marknad och ett marknadsföringstillstånd garanterar inte att läkemedlen beviljas prissättningsgodkännande eller läkemedelssubventioner i de nationella eller regionala hälso- och sjukvårdssystemen. I många länder påverkas marknaden också av påtryckningar från staten och andra sjukvårdsbetalare gällande priserna.”

Annual report 2024A · The company itself

“Det finns vidare en risk att framtida kommersialisering av SynActs läkemedelskandidater, inklusive dess huvudsakliga kandidat resomelagon, blir mer kostsam än vad SynAct räknat med, då det på förhand kan vara svårt att uppskatta framtida kommersialiseringskostnader. Även för det fall SynAct skulle erhålla relevanta myndighetstillstånd för marknadsföring och försäljning av bolagets läkemedelskandidater finns det en risk att försäljningen, lokalt eller globalt, inte kommer att motsvara dess förväntningar och att de kommersiella framgångarna uteblir.”

Annual report 2024A · The company itself

“Flera initiativ för att stävja stigande läkemedelskostnader har genomförts eller håller på att implementeras i USA och inom EU/EES, såväl som på andra relevanta marknader, vilket kan påverka framtida försäljning för läkemedelsföretag, inklusive SynAct.”

Annual report 2024A · The company itself

“Affärsenheten levererar utrustning till globala aktörer inom förpacknings-, livsmedels- och läkemedelsindustrin.”

Annual report 2024A · The company itself