Drug approvals

“Socialt arbete Särläkemedelsstatus AKTIEN FDA har beviljat särläkemedelsstatus för tasquinimod vid behandling av multipelt myelom samt i myelofibros. Sådan status ges till läkemedelskandidater avsedda för säkra och effektiva behandlingar, diagnoser eller förebyggande av ovanliga sjukdomar som drabbar färre än 200 000 människor i USA. Denna särläkemedelsstatus ger sju års marknadsexklusivitet vid marknadsgodkännande samt vissa andra fördelar.”

Annual report 2024A · The company itself

“MARKNAD Verksamhetsrelaterade risker Växande marknader Immateriella rättigheter Forskning och utveckling HÅLLBARHET Miljöarbete Produktansvar och försäkringar Forskning och läkemedelsutveckling är förknippad med hög risk då stora finansiella resurser investeras i en produkt som kanske aldrig blir ett färdigt läkemedel. Majoriteten av startade projekt kommer aldrig att nå marknadsregistrering.”

Annual report 2024A · The company itself

“Life Sciences and Diagnostics Markets - Government Regulation Some of the products the Life Sciences and Diagnostics Markets segment sells are subject to regulatory approval by the FDA and other regulatory bodies throughout the world. These regulations govern a wide variety of product related activities, from quality management, design and development to labeling, manufacturing, promotion, sales and distribution.”

Annual report 2025A · The company itself

“Regulatory Affairs A number of our products and services are subject to regulation by the U.S. Food and Drug Administration, the U.S. Department of Health and Human Services, the Centers for Medicare and Medicaid Services and certain similar foreign regulatory agencies. These regulations govern a wide variety of product and service related activities, from quality management, design and development to manufacturing, labeling, promotion, sales and distribution.”

Annual report 2025A · The company itself

“We are subject to extensive regulation by the Food and Drug Administration and certain similar foreign regulatory agencies, and failure to comply with such regulations could harm our reputation, business, financial condition and results of operations. A number of our products and services are subject to regulation by the Food and Drug Administration, the U.S.”

Annual report 2025A · The company itself

“For example, in May 2022, the EU began enforcing the EU In Vitro Diagnostic Regulation, which imposes stricter requirements for the marketing and sale of in vitro diagnostics in the EU. These new regulations are more stringent in a variety of areas, including clinical evidence requirements, quality management systems and post-market surveillance activities. Failure to meet these requirements could adversely impact our business in the EU and other regions that tie their product registrations to the EU requirements.”

Annual report 2025A · The company itself

“STAKEHOLDER GROUP MATERIALITY AND PURPOSE RELATED RISK KEY POINTS OF MEANINGFUL ENGAGEMENT GOVERNMENTS AND REGULATORY BODIES Regulatory approvals are essential for bringing our products to market. Compliance with food and dietary supplement regulations ensures product safety, market access, and business continuity.”

Annual report 2024A · The company itself

“Key commercial milestones in 2024 included the formalization of a long-term distribution partnership with Barentz International in Europe, securing a third health claim approval from the South Korean Ministry of Food and Drug Safety for joint health, signing a important contract for PL+ with a leading European customer, and establishing a strategic partnership in China with Function, the region’s largest Superba customer, which includes the licensing of Kori krill oil.”

Annual report 2024A · 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

“Our life science industry tenants and venture investment portfolio companies are subject to a number of risks unique to their industry, including (i) changes in technology, patent expiration, and intellectual property rights and protection, (ii) high levels of regulation, (iii) failures in the safety and efficacy of their products, and (iv) significant funding requirements for product research and development. These risks may adversely affect our tenants’ ability to make rental payments or satisfy their other lease obligations to us or may impact our venture investment portfolio companies’ value and consequently may materially adversely affect our business, results of operations, financial condition, and stock price.”

Annual report 2025A · The company itself

“Even if a product developed by a life science industry tenant or venture investment portfolio company is proven safe and effective in human clinical trials, and the requisite regulatory approvals are obtained, subsequent discovery of safety issues with these products could cause product liability events, additional regulatory scrutiny and requirements for additional labeling, loss of approval, withdrawal of products from the market, and the imposition of fines or criminal penalties.”

Annual report 2025A · The company itself

“We also face risks related to potential furloughs or shutdown contingency operations of government employees, which could delay regulatory approvals and impact tenant operations.”

Annual report 2025A · The company itself

“Domestic and international policy shifts may introduce considerable uncertainty to the macroeconomic and regulatory landscape in which we, our tenants, and our venture investment portfolio companies operate. Our tenants and our venture investment portfolio companies include entities in the pharmaceutical, biotechnology, medical device, life science, and related industries, academic and private institutions, and government institutions that determine their R&D budgets based on several factors, including the availability of government and other funding and the reliability and operational efficiency of public regulatory institutions. Since January 2025, the U.S. administration has implemented and proposed substantial policy changes that affect federal health agencies, research funding, public health priorities, and international trade. Several of these actions were later modified, paused, or limited by courts or subsequent agreements, but they continue to create material uncertainty for planning, capital allocation, and tenant demand across the life science ecosystem.”

Annual report 2025A · The company itself

“Reductions in FDA workforce In 2025, the FDA laid off approximately 3,500 employees, representing approximately 19% of its workforce at the beginning of the year, with certain actions later modified or reversed. These reductions have created additional uncertainty and delay in drug and device approval processes, which may negatively impact our tenants’ operations and demand for our life science space. Such disruptions could lead to setbacks in research and development timelines, negatively impacting life science companies’ ability to advance their pipelines, secure investor funding, or achieve commercial viability, which could severely affect their operations and financial performance and, as a result, adversely impact our operating and financial results.”

Annual report 2025A · The company itself

“Prolonged or repeated shutdowns or short-term Congressional budget resolutions could adversely affect business operations of some of our tenants that depend on federal funding, contracts, or regulatory actions to sustain their operations. Our tenants may experience delays in submitting or advancing new drug applications, or receiving device approvals should the operations at the FDA and other oversight bodies be reduced.”

Annual report 2025A · The company itself

“The NIH may pause peer-review meetings, issuance of new grants, and many program activities, and its Clinical Center will be unable to launch new trials during the funding lapse. The FDA’s operations may become limited to work deemed “safety-critical” and activities supported by carryover user fees, and the agency has stated it will be unable to accept certain new submissions requiring fees until funding resumes. These outcomes could impede R&D progress, postpone commercialization milestones, and delay anticipated financing.”

Annual report 2025A · The company itself

“The healthcare and technology markets are also highly regulated and subject to evolving political, economic and regulatory influences and government actions. Global regulators are expanding and changing regulations and guidance for products and services, which can limit their potential benefits and cause protracted review timelines for new products and services.”

Annual report 2025A · The company itself

“Furthermore, we frequently must obtain regulatory clearance or approval before we can sell a new medical device or market a new use of, or claim for, an existing product. For instance, in the United States, FDA regulations are wide-ranging and govern, among other things, product design, product materials, development, manufacturing and testing, product labeling and product storage. It takes significant time, effort, and expense to obtain and maintain clearances and approvals of products and 30 services, and there is no guarantee we will timely succeed, if at all, in the countries in which we do business.”

Annual report 2025A · The company itself

“Moreover, these laws may change, resulting in additional time, expense or loss of market access. If the requirements to market our products or services are delayed, we may be unable to offer them in markets we deem important.”

Annual report 2025A · The company itself

“Additionally, we may be held liable if our products or services cause injury or are otherwise found unhealthy. If our products and services are safe but they are promoted for use or used in unintended or unexpected ways or for which we have not obtained clearance (“off-label” usage), we may be investigated, fined or have our products or services enjoined or approvals rescinded or we may be required to defend ourselves in litigation.”

Annual report 2025A · The company itself

“Further, the EU is currently undergoing a review and revision of its general pharmaceutical legislation that, while full implementation is not expected before 2027, has led to proposals that would reduce intellectual property protection for new products (including potentially shortening the duration of regulatory data exclusivity and orphan drug exclusivity protections), as well as change the reimbursement and regulatory landscape.”

Annual report 2025A · The company itself

“Our business is subject to extensive regulation by numerous state and federal government authorities in the United States, including the FDA, and by foreign regulatory authorities, including the EMA. We are required in the United States and in the other regions and countries in which we, or our partners and affiliates, sell to obtain approval from regulatory authorities before we manufacture, market and sell our products.”

Annual report 2025A · The company itself

“Obtaining and maintaining regulatory approvals have been, and will continue to be, increasingly difficult, time-consuming and costly. Legislative bodies or regulatory agencies could enact new laws or regulations, change existing laws or regulations or change their interpretations of laws or regulations at any time, which could affect our ability to obtain or maintain approval of our products or product candidates.”

Annual report 2025A · The company itself

“Recent initiatives to reduce the size and budgets of government agencies, including the HHS, FDA and NIH, may adversely impact our operations. In particular, reductions in staffing and resources at the FDA could result in delays in regulatory review timelines and marketing application and supplement approvals.”

Annual report 2025A · The company itself

“If we are unable to fulfill the regulators’ requirements that were conditions of a product’s accelerated or conditional approval and/or if regulators reevaluate the data or risk-benefit profile of our product, the conditional approval may not result in full approval or may be revoked or not renewed. Alternatively, we may be required to change the product’s labeled indications, conduct an additional confirmatory clinical trial, or even withdraw the product from the market.”

Annual report 2025A · The company itself

“Safety problems or signals can arise as our products and product candidates are evaluated in clinical trials, including investigator sponsored studies, or as our marketed products are used in clinical practice. We are required continuously to collect and assess adverse events reported to us and to communicate to regulatory agencies these adverse events and safety signals regarding our products.”

Annual report 2025A · The company itself

“If the FDA is not satisfied with the results of the periodic assessment reports we submit for any of our REMS, the FDA may also modify our REMS or take other regulatory actions, such as implementing revised or restrictive labeling.”

Annual report 2025A · The company itself

“Our product candidates and marketed products can also be affected by safety problems or signals occurring with respect to products that are similar to ours or that implicate an entire class of products.”

Annual report 2025A · The company itself

“For example, after an imbalance in positively adjudicated cardiovascular serious adverse events was observed in one of the phase 3 clinical trials for EVENITY but not in another, larger phase 3 study, in April 2019 the FDA approved EVENITY for the treatment of osteoporosis in postmenopausal women at high risk for fracture, along with a post-marketing requirement. The requirement includes a five-year observational feasibility study that could be followed by a comparative safety study or trial.”

Annual report 2025A · The company itself

“In some regions, including the United States, regulatory authorities may require contemporaneous approval of the companion diagnostic device and the therapeutic product; in others the regulatory authorities may require a separate study of the companion diagnostic device. Our product candidates or expanded indications of our products used with such devices may not be approved or may be substantially delayed in receiving regulatory approval if development or approval of such devices is delayed, such devices do not also gain or maintain regulatory approval or clearance, or if such devices do not remain commercially available. When approval of the product and device is sought under a single marketing drug application, the increased complexity of the review process may delay receipt of regulatory approval.”

Annual report 2025A · The company itself

“It can take longer than five years to build, validate and license another manufacturing plant, and it can take longer than three years to qualify and license a new contract manufacturer or service provider. If we elect or are required to make changes to our manufacturing processes because of new regulatory requirements, new interpretations of existing requirements or other reasons, this could increase our manufacturing costs and result in delayed shipments, delays in our clinical trials, supply constraints, stock-outs, adverse event trends or contract negotiations or disputes.”

Annual report 2025A · The company itself

“For example, the FDA has approved LUMAKRAS under accelerated approval for the treatment of adult patients with KRAS G12C-mutated local advanced or metastatic NSCLC.”

Annual report 2025A · The company itself

“Orviglance, som har beviljats särläkemedelsstatus av amerikanska läkemedelsmyndigheten Food and Drug Administration (FDA), har i den registreringsgrundande fas 3-studien framgångsrikt uppfyllt det primära effektmåttet och visat att bolagets kontrastmedel för magnetkameraundersökning (MRI), Orviglance, signifikant förbättrar visualiseringen av fokala leverlesioner jämfört med icke-förstärkt MR. NDA-ansökan förväntas lämnas in i mitten av 2025.”

Annual report 2024A · The company itself

“Vi fokuserar nu på att föra Orviglance genom den regulatoriska ansökningsoch godkännandeprocessen. Vi räknar med att lämna in NDAansökan till FDA i mitten av 2025 för att få ett regulatoriskt godkännande.”

Annual report 2024A · The company itself

“Failure to meet regulatory or ethical requirements for medicine development or approval We are subject to laws and regulations that control our ability to market our pharmaceutical products. Delays in regulatory approvals could delay our ability to market our products and may adversely affect our revenue.”

Annual report 2025A · The company itself

“Specific new products must undergo lengthy and rigorous testing and other extensive, costly, and time-consuming procedures mandated by FDA and foreign regulatory authorities. The same testing and procedures sometimes apply to our products that require authorization or renewal or are subject to changes in laws or regulations.”

Annual report 2025A · The company itself

“As a medical products company, our operations and many of the products manufactured or sold by us are subject to extensive regulation by numerous government agencies, both within and outside the United States. These regulations (as described in Item 1, Government Regulation, of this Annual Report on Form 10-K) require that we obtain specific approval from FDA or the applicable non-U.S. regulatory authorities before we can market and sell most of our products in a particular country.”

Annual report 2025A · The company itself

“To provide alternate sources, BD must complete a rigorous qualification process, which most often includes completion of regulatory registration and approval. If clinical trials are not required, this qualification process can take 3-18 months depending on the criticality of the change. When clinical trials are required, this process may lengthen the qualification phase from one to three years.”

Annual report 2025A · The company itself

“BD’s medical technology products and operations are subject to regulation by the U.S. Food and Drug Administration (“FDA”) and various other federal and state agencies, as well as by foreign governmental agencies. These agencies enforce laws and regulations that govern the development, testing, manufacturing, labeling, advertising, marketing and distribution, and market surveillance of BD’s medical products.”

Annual report 2025A · The company itself

“BD actively maintains quality systems that establish standards for its product design, manufacturing, and distribution processes, in accordance with International Organization for Standardization standards and FDA regulations. Regulatory agencies engage in periodic reviews and inspections of BD’s quality systems, as well as product performance and advertising and promotional materials. These regulatory controls, as well as any changes in agency policies, can affect the time and cost associated with the development, introduction and continued availability of new and existing products.”

Annual report 2025A · The company itself

“In addition, CareFusion 303, Inc. received an additional Form 483 Notice in May 2024 following an FDA inspection (“2024 Form 483 Notice”) that contained observations related to the site’s compliance with the FDA’s quality system regulation (“QSR”) for its Infusion quality management system (covered by the Consent Decree) and QSR and MDR regulation for its separate Dispensing quality management system (which is not subject of the Consent Decree). On November 22, 2024, BD received a Warning Letter from the FDA, which is limited to CareFusion 303, Inc.’s Dispensing quality management system and BD PyxisTM products (“Dispensing Warning Letter”).”

Annual report 2025A · The company itself

“Leqembis (lecanemab) framgångar på den globala marknaden fortsatte under 2024 och läkemedlet godkändes på ytterligare sex marknader.”

Annual report 2024A · The company itself

“Den europeiska läkemedelsmyndigheten EMA:s kommitté för humanläkemedel, CHMP, gav i november en positiv rekommendation om att godkänna lecanemab som behandling av Alzheimers sjukdom i vuxna patienter som är heterozygoter eller icke-bärare av ApoE ε4-genen efter en omprövning av en tidigare negativ rekommendation i juli.”

Annual report 2024A · 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

“att erhålla myndighetsgodkännande för kommersiell försäljning av bolagets läkemedelskandidater krävs att bolaget eller dess samarbetspartners visar att de potentiella produkterna är säkra och effektiva på människor för varje given indikation. utsträckning produkten utgör en säker och effektiv behandling, förekomsten och svårighetsgraden av skadliga biverkningar, kostnaden för behandlingen i förhållande till alternativa behandlingar samt tillgången till adekvata ersättningssystem och subventioner. Om BioInvent i sin forskning eller utveckling nyttjar substanser, metoder eller teknologier som är patenterade eller som kommer att beviljas patent eller skyddas av andra rättigheter, skulle ägare av dessa patent eller andra rättigheter kunna hävda att BioInvent gör intrång.”

Annual report 2024A · The company itself

“The Company is currently conducting a clinical trial to obtain regulatory clearance for adult use of NGAL in the US. Timing of future clinical trials depends on many factors outside of the Company’s control, including regulatory pathways and their conditions associated with submissions presently under review that will serve as predicates to other submissions.”

Annual report 2025A · The company itself

“Further, there is no guarantee that the submission will be approved by the FDA and result in a regulatory clearance.”

Annual report 2025A · The company itself

“Following the first FDA clearance, the Company can conduct validation work and file to expand the marketing authorization to include additional instruments for the US market. These subsequent submissions will follow FDA guidance offered through pre-submission meetings.”

Annual report 2025A · The company itself

“In addition, several countries that previously did not have regulatory requirements for medical devices have established such requirements in recent years and other countries have expanded, or plan to expand, existing regulations, including requiring local clinical data in addition to global clinical data.”

Annual report 2025A · The company itself

“Some of the factors that could affect the success of our acquisitions include, among others, the effectiveness of our due diligence process, our ability to execute our business plan for the acquired companies, the strength of the acquired technology, results of clinical trials, regulatory approvals and reimbursement levels of the acquired products and related procedures, the continued performance of critical transition services, our ability to adequately fund acquired in-process research and development projects and retain key employees and our ability to achieve synergies with our acquired companies, such as increasing sales of our products, achieving cost savings and effectively combining technologies to develop new products.”

Annual report 2025A · The company itself

“We are subject to extensive and dynamic medical device regulation, which may impede or hinder the approval or sale of our products and, in some cases, may ultimately result in an inability to obtain approval of certain products or may result in the recall or seizure of previously approved products. Our products, marketing, sales and development activities and manufacturing processes are subject to extensive and rigorous regulation by the FDA pursuant to the Federal Food, Drug and Cosmetic Act (FDC Act), by comparable agencies in foreign countries and by other regulatory agencies and governing bodies. Under the FDC Act, medical devices must receive FDA clearance or approval or an exemption from such clearance or approval before they can be commercially marketed in the U.S.”

Annual report 2025A · The company itself

“Some countries do not have medical device regulations, but in most countries, medical devices are regulated. Frequently, regulatory approval may first be obtained in a foreign country prior to application in the U.S. due to differing regulatory requirements; however, other countries, such as China for example, require approval in the country of origin or legal manufacturer first.”

Annual report 2025A · The company itself

“Most countries outside of the U.S. require that product approvals be renewed or recertified on a regular basis, generally every four to five years. The renewal or recertification process requires that we evaluate any device changes and any new regulations or standards relevant to the device and conduct appropriate testing to document continued compliance.”

Annual report 2025A · The company itself

“Our global regulatory environment is becoming increasingly stringent and unpredictable, which could increase the time, cost and complexity of obtaining regulatory approvals, as well as the clinical and regulatory costs of supporting those approvals. Several countries that did not previously have regulatory requirements for medical devices have established such requirements in recent years and other countries have expanded on existing regulations.”

Annual report 2025A · The company itself

“Om Boule inte erhåller myndighetsgodkännanden för framtida produkter eller klarar av att behålla dessa för nuvarande produkter, kan Boule inte bedriva försäljning på de aktuella marknaderna.”

Annual report 2024A · The company itself

“REGULATORISKA För övergång till IVDR på befintliga produkter är Boule beroende av granskning av IVDR anmält organ. Att anmält organ har nödvändiga resurser tillgängliga för Boule är en extern risk.”

Annual report 2024A · The company itself

“Boule har under de senaste åren kontinuerligt stärkt sina regulatoriska och kvalitetssäkrande resurser såväl internt som med externt stöd. Arbetet med denna satsning fortlöper även framåt för att säkerställa att Boule kan lansera nya produkter och bedriva effektiv försäljning på respektive marknad.”

Annual report 2024A · The company itself

“En ny registeringsansökan (NDA) för Oclaiz™ (CAM2029) i akromegali accepterades för gransk - ning av FDA i USA i mars 2024. Vid datum för marknadsgodkännande (PDUFA), den 21 oktober 2024, utfärdade FDA en begäran om ytterligare information (CRL) relaterad till en cGMP-inspek - tion av en kontraktstillverkares anläggning. • En ansökan om marknadsgodkännande (MAA) för CAM2029 för behandling av akromegali skickades in till och accepterades för gransk - ning av EMA under andra kvartalet 2024 • Positiva fas 3-resultat från ACROINNOVA 2- studien i patienter med akromegali meddelades under tredje kvartalet 2024.”

Annual report 2024A · The company itself

“Projekten kräver fortsatt forskning och utveckling och är därmed föremål för sed - vanliga risker kopplade till läkemedelsutveckling, såsom att produktutvecklingen försenas och att kostnaderna blir högre än förväntat. Vidare kan det visa sig att produktkandidaterna inte visar sig vara tillräckligt effektiva eller säkra och att Camurus inte erhåller nödvändiga myndighets - godkännande. Kliniska prövningar och regulatoriska godkännanden Innan en läkemedelskandidat kan lanseras på marknaden måste Camurus eller dess samarbetspartner genomföra prekliniska och kliniska studier för att i dessa dokumentera och påvisa att produktkandidaten ger upphov till en signifikant behandlingseffekt och har en acceptabel säkerhetsprofil.”

Annual report 2024A · The company itself

“Sådana godkännande från myndigheter är inte enbart under Camurus kontroll.”

Annual report 2024A · The company itself

“Non-GAAP operating earnings for fiscal 2026 increased 30% to $3.6 billion from the prior year, primarily driven by the increased contribution from branded and specialty pharmaceuticals and the performance of our generics program in our Pharma segment and the impact of the acquisitions of MSO platforms and ADS.”

Annual report 2026A · The company itself

“Generics Program The performance of our Pharma segment generics program positively impacted the year-over-year comparison of Pharma segment profit during fiscal 2026. The Pharma segment generics program includes, among other things, the impact of generic pharmaceutical product launches, customer volumes, pricing changes, the Red Oak Sourcing, LLC venture ("Red Oak Sourcing") with CVS Health Corporation ("CVS Health"), and generic pharmaceutical contract manufacturing and sourcing costs.”

Annual report 2026A · The company itself

“Gross Margin Gross Margin (in millions) 2026 2025 Change Gross margin $ 9,774 $ 8,168 20 % Gross margin for fiscal 2026 increased 20 percent to $9.8 billion from the prior year, primarily due to the acquisitions of MSO platforms and ADS, increased contribution from branded and specialty pharmaceutical products, and the performance of our generics program.”

Annual report 2026A · The company itself

“Total consolidated operating earnings Pharma segment profit for fiscal 2026 increased 23 percent to $2.8 billion from the prior year, primarily due to the increased contribution from branded and specialty pharmaceutical products, the performance of our generics program, and the acquisition of MSO platforms.”

Annual report 2026A · The company itself

“Pharmaceutical and Specialty Solutions Segment Our Pharma segment distributes branded and generic pharmaceutical, specialty pharmaceutical, and over-the-counter healthcare and consumer products in the United States.”

Annual report 2026A · The company itself

“Overview Consolidated Results Fiscal 2026 Overview Revenue Revenue for fiscal 2026 increased 14 percent to $254.2 billion from the prior year, primarily due to branded and specialty pharmaceutical sales growth from existing and new customers.”

Annual report 2026A · The company itself

“Regulatoriska Regulatoriskt godkännande krävs för att få sälja produkter på olika marknader och är beroende av att företagets produkter och processer uppfyller rådande regulatoriska krav inom både kvalitet och dataskydd. Om dessa krav inte uppfylls kan det leda till att godkännandet dras in.”

Annual report 2024A · The company itself

“Godkännandeprocesser kan vara tidskrävande, och förseningar i att få godkännande för nya produkter riskerar att resultera i uppskjutna eller förlorade intäkter.”

Annual report 2024A · The company itself

“Lagstiftning och regelverk Tillverkning, marknadsföring och distribution av medicintekniska produkter och utrustning sker på en reglerad marknad där bland andra FDA (US Food and Drug Administration) och EU har regler för klinisk utvärdering, godkännande och kvalitetsprövning. CellaVision uppfyller idag gällande krav i Europa och USA för bolagets system. Om CellaVisions verksamhet skulle omfattas av restriktioner från myndigheter eller om bolaget inte erhåller nödvändiga framtida myndighetsgodkännanden kan detta komma att påverka CellaVision negativt kommersiellt och finansiellt. - - Not A6.”

Annual report 2024A · The company itself

“The FDA and foreign regulatory agencies require that the safety and efficacy of most new drug candidates be tested on research models like ours prior to testing in humans. As a result, our research models are an essential part of the drug discovery and development process.”

Annual report 2025A · The company itself

“We provide analytical characterization, lot release and safety testing support for chemistry, manufacturing and controls and investigational new drug (IND) filings and confirm that biomanufacturing of clinical drug candidates and commercial drugs are consistent, correctly defined, stable and essentially contaminant free. This testing is required by the FDA, EMA and other international regulatory authorities for our clients to obtain new drug approvals, to maintain government-licensed manufacturing facilities and to manufacture and release market-approved therapeutic products for patient treatment.”

Annual report 2025A · The company itself

“We also operate businesses which depend upon the regulatory approval of the products they manufacture for their CDMO clients. As such, if these clients experience a suspension, delay in, or failure to receive, approval for any of their product candidates or fail to maintain regulatory approval of their products that we develop or manufacture, our revenue and profitability could be materially adversely affected.”

Annual report 2025A · The company itself

“In January 2025, a CDMO client disclosed that, as a result of observations made during pre-license inspections at a Company facility, (1) one biologics license application for a specific therapeutic treatment had received a complete response letter from the FDA, and (2) the FDA had placed clinical holds on that client’s Investigational New Drug applications. In addition, subsequently the FDA conducted an inspection at the same Company facility resulting in the Company receiving a Form FDA 483 Notice of Inspectional Observations. In October 2025, a successful pre-license inspection was performed and we are closely partnered with this client through the remaining steps of their biologics license resubmission.”

Annual report 2025A · The company itself

“Our DSA segment is comprised of Discovery Services and Safety Assessment services. We provide regulated and non-regulated DSA services to support the discovery, development, and regulatory-required safety testing of potential new drugs, including in vitro (non-animal) and in vivo (in research models) studies, laboratory support services, including bioanalytical and strategic non-clinical consulting and program management to support product development.”

Annual report 2025A · The company itself

“Development and marketing of our products are subject to strict governmental regulation by foreign regulatory agencies, and failure to receive, or delay in receiving, foreign qualifications or certifications could have a material adverse effect on our business. In many of the foreign countries in which we market our products, we are subject to regulations affecting, among other things, product standards, packaging requirements, labeling requirements, import restrictions, tariff regulations, the reporting of certain payments to health care practitioners in certain markets (for example, the French anti-gift legislation), duties and tax requirements.”

Annual report 2025A · The company itself

“On May 6, 2024, the FDA published a final rule on the regulation LDTs, making explicit that LDTs are medical devices under the FDCA. Although since then the FDA has rescinded its prior rule regulating LDTs as medical devices, it is unclear whether the FDA may seek greater oversight of LDTs in other ways, which could increase costs and expenses or otherwise negatively affect our business.”

Annual report 2025A · The company itself

“Under such circumstances, many IH-Tests may continue to be exempt from regulation indefinitely or until 2030 in circumstances where commercially available CE marked options exist. Our genetic tests may be subject to the full application of the EU IVDR with respect to some or all of our existing, as well as future, tests if our tests do not qualify for an IH-Test exemption. We may be required to expend additional time and resources to comply with the requirements of the EU IVDR, resulting in additional expenses for offering our current and any future tests as well as possibly delaying or suspending development or commercialization of such tests.”

Annual report 2025A · The company itself

“However, HCT/Ps regulated as 361 HCT/Ps are currently subject to requirements relating to registering facilities and listing products with the FDA, as well as stringent requirements relating to processing, storing, labeling and distributing HCT/Ps, including, screening and testing for tissue donor eligibility, providing required labeling information, record keeping and adverse event reporting. If we fail to comply with these requirements, we could be subject to FDA allegations of noncompliance or enforcement action, including, for example, warning letters, fines, injunctions, product recalls or seizures, and, in the most serious cases, criminal penalties.”

Annual report 2025A · The company itself

“However, the FDA could disagree with our determination that these human tissue products are 361 HCT/Ps and could determine that these products are biologics requiring a BLA or medical devices requiring 510(k) clearance or PMA approval, and could require that we cease marketing such products and/or recall them pending appropriate clearance, approval or licensure from the FDA, which would adversely affect our business. In addition, the FDA may in the future modify the scope of its enforcement discretion with respect to 361 HCT/Ps or change its position on which current or future products qualify as 361 HCT/Ps, or determine that some or all of our HCT/P products may not be lawfully marketed without a marketing authorization.”

Annual report 2025A · The company itself

“Disruptions at the FDA and other government agencies or notified bodies caused by funding shortages or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, cleared or approved or commercialized in a timely manner or at all, which could negatively impact our business. The ability of the FDA, foreign agencies and notified bodies to review and clear, approve or certify new products can be affected by a variety of factors, including government budget and funding levels, statutory, regulatory, and policy changes, the FDA’s, foreign agencies’ and notified bodies’ ability to hire and retain key personnel and accept the payment of user fees, and other events that may otherwise affect the FDA’s, foreign agencies’ and notified bodies’ ability to perform routine functions.”

Annual report 2025A · The company itself

“Disruptions at the FDA, foreign agencies and notified bodies and other agencies may also slow the time necessary for new drugs and medical devices or modifications to cleared or approved drugs and medical devices to be reviewed, approved and/or certified by necessary government agencies or notified bodies, which would adversely affect our business. For example, over the last several years, the United States government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical employees and stop critical activities.”

Annual report 2025A · The company itself

“Ongoing federal efforts to streamline government operations, including agency-wide efficiency programs, may further impact the resources and staffing levels available to the FDA. These changes could result in longer review times for our regulatory submissions. Any delays or disruptions in FDA review processes could adversely affect our product development timelines, market entry strategies, and overall business performance.”

Annual report 2025A · The company itself

“Recent funding and staff reductions, including at the EPA, the USDA, the FDA and the U.S. Department of Health and Human Services ("HHS"), could hinder our ability to receive timely regulatory approvals.”

Annual report 2025A · The company itself

“Significant staff or funding reductions, along with any extended shutdown of the federal government, may significantly impact the timelines for reviewing our regulatory submissions and re-registrations. Longer-term structural changes at relevant federal agencies, including shifts in enforcement focus, review processes, evidentiary standards and resource allocation, may extend the time it takes to commercialize our products, thereby having a material adverse effect on our business, results of operations, and the value of our intellectual property.”

Annual report 2025A · The company itself

“Medicare bundles certain pharmaceuticals and the use of certain medical equipment and supplies into the ESRD PPS payment rate at industry average doses and prices. Variations above the industry average may be subject to partial reimbursement through the PPS outlier reimbursement policy. As a result, our ability to obtain sufficient reimbursement levels for the care we provide depends in part on changes to industry averages or increased utilization of certain pharmaceuticals whose costs are included in a bundled reimbursement rate. We are therefore subject to risks relating to potential drivers of changes to these industry averages or utilization rates, including among other things, changes in physician prescribing practices, including in response to the introduction of new drugs, treatments or technologies, changes in best and/or accepted clinical practice, changes resulting from the use of artificial intelligence to support clinical practices, changes in private payor or governmental payment criteria or changes in administration policies regarding pharmaceuticals and/or devices.”

Annual report 2025A · The company itself

“Regulations and processes impacting reimbursement for pharmaceuticals and/or devices and any changes thereto could similarly affect our operating results. Among other things, as new kidney care drugs, treatments or technologies, medical equipment or supplies are introduced over time, we expect that the use of transitional payment adjustments to incorporate certain of these items as defined by the CMS policy into the bundled Medicare Part B ESRD payment may lead to fluctuations in associated levels of operating income and risk that the reimbursement levels of such drugs, treatments or technologies may not adequately cover our cost to obtain the item or other associated costs. Drivers of these risks include, among other things, the risk that CMS may not provide adequate funding in the Medicare Part B ESRD payment in the transitional or post-transitional period or that such items are not covered by transitional add on pricing, in which case there may be less clarity on the reimbursement.”

Annual report 2025A · The company itself

“For example, under current CMS regulation, certain oral-only drugs were paid separately under Medicare Part D until January 1, 2025, at which time they were incorporated in the ESRD bundled payment. We cannot predict, at this time, whether CMS' TDAPA amounts for oral phosphate binders or other TDAPA eligible drugs adequately account for the inclusion of these oral medications or other TDAPA eligible drugs and the additional costs associated with dialysis providers having to supply such drugs.”

Annual report 2025A · The company itself

“Similar operating and clinical rigor and appropriate processes will be needed for other potential new drugs, treatments or technologies that are approved and come onto the market, as well as for drugs, treatments or technologies, medical equipment or supplies that we contract to receive from third party suppliers. Any failure to successfully contract with manufacturers for such items, sufficiently and timely access competitive pricing, failure to successfully contract with the government or other payors for appropriate reimbursement, or failure to prepare, develop and implement processes that provide for appropriate availability and use in our clinics in compliance with applicable laws, including those related to controlled substances, could have a material adverse impact on our business, results of operations, financial condition and cash flows and could materially harm our reputation.”

Annual report 2025A · The company itself

“We may also be subject to increased inquiries or audits from governmental bodies or claims by third parties related to pharmaceuticals or the incorporation of new technologies, treatments, therapies, medical equipment or supplies, which would require management's attention and could result in significant legal expense and other adverse results in the event of any negative findings. Any negative findings could result in, among other things, substantial financial penalties or repayment obligations, the imposition of certain obligations on and changes to our practices and procedures as well as the attendant financial burden on us to comply with the obligations, or exclusion from future participation in the Medicare and Medicaid programs, and could have a material adverse effect on our business, results of operations, financial condition, and cash flows and could materially harm our reputation.”

Annual report 2025A · The company itself

“•If we are unable to successfully complete the pre-clinical studies or clinical trials necessary to support additional PMA, de novo, or 510(k) applications or supplements, we may be unable to commercialize our CGM systems under development, which could impair our business, financial condition and operating results. •Health care policy changes, including U.S. health care reform legislation, may have a material adverse effect on our business. •We are subject to claims of infringement or misappropriation of the intellectual property rights of others, which could prohibit us from shipping affected products, require us to obtain licenses from third parties or to develop non-infringing alternatives, and subject us to substantial monetary damages and injunctive relief.”

Annual report 2025A · The company itself

“In March 2025, we received an FDA warning letter following inspections of our facilities in San Diego, California, and Mesa, Arizona. In the warning letter, the FDA cited deficiencies in the response letters sent by us to the FDA following the Form 483, List of Investigational Observations that was delivered to us in connection with the inspection of our San Diego, California facility that occurred from October 2024 through November 2024, and the inspection of our Mesa, Arizona facility that occurred in June 2024. The warning letter describes observed non-conformities in manufacturing processes and our quality management system.”

Annual report 2025A · The company itself

“We may not obtain international regulatory authorizations or approvals on a timely basis, if at all.”

Annual report 2025A · The company itself

“We may never receive approval, marketing authorization or clearance from the U.S. FDA and other governmental agencies to market additional CGM systems, expanded indications for use of current and future generation CGM systems, future software platforms, or any other products under development.”

Annual report 2025A · The company itself

“Any delay in, or failure to receive or maintain, clearance or approval for our products could prevent us from generating revenue from these products. The uncertain timing of regulatory approvals for future generations of our products could subject our current inventory to excess or obsolescence charges, which could have an adverse effect on our business, financial condition and operating results.”

Annual report 2025A · The company itself

“To support current and any future additional PMA, 510(k), de novo applications or supplements, we together with our partners, must successfully complete pre-clinical studies, bench-testing, and in some cases clinical trials that will demonstrate that the product is safe and effective. Product development, including pre-clinical studies and clinical trials, is a long, expensive and uncertain process and is subject to delays and failure at any stage.”

Annual report 2025A · The company itself

“Som vi tidigare kommunicerat kommer vi att uppdatera marknaden så snart rekryteringen stängs och vid det tillfället kommer vi även att informera när topline resultat förväntas och när vi planerar att lämna in ansökan om marknadsgodkännande (NDA) till FDA under 2025.”

Annual report 2024A · The company itself

“I februari 2025 godkände EU-kommissionen Emcitate som den första och enda behandlingen för MCT8-brist i EU.”

Annual report 2024A · The company itself

“Hitintills har 19 Det planerade utvecklingsprogrammet för 2025–2026: 2025 • Genomförande och utvärdering av den placebokontrollerade ReTRIACt studien Rare Pediatric Disease-status beviljades i november 2020, vilket potentiellt berättigar till en Priority Review Voucher (PRV) vid godkännande i USA. Denna PRV kan säljas till ett annat bolag och under de senaste tre åren har priset varit mellan $100-$158 miljoner för sålda PRVs. Emcitate har också erhållit ’Fast Track’ status från FDA, vilket kan påskynda den regulatoriska processen.”

Annual report 2024A · The company itself

“På basen av resultaten från denna fas Ib/IIa studie har en registreringsgrundande studie utformats, men studiestarten har parkerats tills dess ansökningarna om marknadsgodkänannde för Emcitate har avklarats.”

Annual report 2024A · The company itself

“Dessutom visar forskning att sannolikheten för att ett särläkemedel ska erhålla marknadsgodkännande är högre jämfört med ett läkemedel som inte är särläkemedel. Enligt resultat från en studie som publicerades 2014, är sannolikheten att ett läkemedel (särläkemedel såväl som andra läkemedel) i fas I erhåller marknadsgodkännande 10,4 %, innefattande samtliga indikationer. Om endast särläkemedel beaktas ökar sannolikheten till 32,9 %.”

Annual report 2024A · The company itself

“Marknadsgodkännande och regulatoriska krav Det finns en risk att relevanta myndigheter inte godkänner de läkemedelskandidater som utvecklas av Bolaget eller dess samarbetspartners och att dessa produkter därför inte kan lanseras, vilket skulle innebära att Bolagets förmåga att generera intäkter väsentligt försämras.”

Annual report 2024A · The company itself

“Myndigheterna kan också ställa krav på utökade studier och ytterligare dokumentation av en läkemedelskandidat innan godkännandet lämnas eller villkora godkännandet av att uppföljande studier genomförs eſter att läkemedlet lanserats.”

Annual report 2024A · The company itself

“Pharmaceutical products and services are a significant component of our healthcare costs. Evolving regulations and state and federal mandates regarding coverage may impact the ability of our health plans to continue to receive existing price discounts on pharmaceutical products for our members. Other factors affecting our pharmaceutical costs include, but are not limited to, existing prices, geographical variation in utilization of new FDA-approved pharmaceuticals and new FDA-approved indications for existing pharmaceuticals, current and potential future tariffs and changes in discounts.”

Annual report 2025A · The company itself

“Negativa, oklara eller otillräckliga resultat av en klinisk prövning kan öka risken för att bolaget inte erhåller nödvändiga tillstånd och det kan även leda till svårigheter för bolaget att marknadsföra produkterna. Det är därför svårt att bedöma och förutse tids- och kostnadsaspekter samt försäljningspotentialen av bolagets produkter.”

Annual report 2024A · The company itself

“Om bolagets produkter på vissa marknader inte får ersättning från det nationella ersättningssystemet och inte erhåller klinisk acceptans för metoderna kan det ha en väsentlig negativ påverkan på framtida försäljningstillväxt och därmed också på koncernens verksamhet, resultat och finansiella ställning Myndighetsgodkännande För att kunna marknadsföra och sälja medicintekniska produkter måste tillstånd och godkännanden erhållas och registrering ske hos berörda myndigheter på respektive marknad.”

Annual report 2024A · The company itself

“Episurfs verksamhet regleras av lagar och förordningar samt av interna och externa regler, däribland regelverk som utfärdats av FDA (Food and Drug Administration) i USA, ISO13485:2016-certifiering och Europaparlamentets och rådets förordning (EU) 2017/745 om medicintekniska produkter ("MDR"). Den 5 april 2017 antogs MDR som ska ersätta Rådets direktiv 93/42/EEG om medicintekniska produkter ("MDD").”

Annual report 2024A · The company itself

“För att marknadsföra och sälja medicintekniska produkter kan Episurf Medical, dess affärspartners och underleverantörer krävas att ha eller erhålla relevanta tillstånd från tillsynsmyndigheter för olika marknader. Det kan till exempel vara CE-märkning i Europa eller FDA-godkännande för den amerikanska marknaden.”

Annual report 2024A · The company itself

“Medical Device Regulations Many of our products in the Advanced Healthcare Solutions segment are classified as medical devices and are subject to restrictions under domestic and foreign laws, rules, regulations, self-regulatory codes, circulars, and orders, including, but not limited to, the U.S. Food, Drug, and Cosmetic Act (the “FDCA”). The FDCA requires these products, when sold in the United States, to be safe and effective for their intended uses and to comply with the regulations administered by the U.S.”

Annual report 2025A · The company itself

“Market access, sales, and marketing of medical devices in non-U.S. countries are subject to foreign regulatory requirements that vary widely from country to country. For example in the European Economic Area (“EEA”), a medical device must meet the Medical Devices Directive’s (“MDD”) Essential Requirements or, for new devices placed on the market after May 26, 2021, the Medical Devices Regulation’s (“MDR”) General Safety and Performance Requirements as well as other requirements set out in the MDD/MDR, depending on the device’s risk class.”

Annual report 2025A · The company itself

“That or other circumstances related to our collection, use, and transfer of personal data could cause a loss of reputation in the market and/or adversely affect our business and financial position; •certain of our products are medical devices that are subject to regulation by the U.S. FDA, by other federal and state governmental agencies, by comparable agencies of other countries and regions, and by certain accrediting bodies. To varying degrees, these regulators require us to comply with laws and regulations governing the development, testing, manufacturing, labeling, marketing, distribution, and post-marketing surveillance of our products.”

Annual report 2025A · The company itself

“FDA approval of EPKINLY in combination with R2 for the treatment of adult patients with relapsed or refractory FL”

Annual report 2025A · The company itself

“The financial guidance assumes that no significant new agreements are entered into during 2026 that could materially affect the results. The factors discussed above, as well as other factors that are currently unforeseeable, may result in further material adverse impacts on Genmab’s business and financial performance, including unfavorable impacts on the sales of Tivdak and EPKINLY/TEPKINLY, and on the net sales of DARZALEX, Kesimpta, TEPEZZA, RYBREVANT, TECVAYLI, and TALVEY by Genmab’s collaboration partners and on Genmab’s royalties, collaboration revenue and milestone revenue therefrom.”

Annual report 2025A · The company itself

“The identification and development of successful products is expensive and includes time-consuming clinical trials with uncertain outcomes and the risk of failure to obtain regulatory approval in one or more jurisdictions. • • • • Access and inclusion in clinical trials Potential Negative Impact Persistent inequities in cancer incidence and care continue to drive underrepresentation in clinical research.”

Annual report 2025A · The company itself

“Genmab is subject to extensive legislative, regulatory, and other requirements during preclinical and clinical development, commercialization, and post-marketing approval, including healthcare, marketing/labeling/promotion, fraud and abuse, competition/antitrust laws, and regulations, as well as transparency, privacy, and data protection and other requirements. • • • • Responsible and ethical marketing Potential Negative Impact Without responsible, ethical marketing, patients and healthcare professionals could receive incomplete or misleading information about Genmab’s therapies. This could undermine trust in our science, contributing to improper medicine use, and negatively affect patient well-being. It can also distort treatment decisions and harm the integrity of the broader healthcare ecosystem. • • • • Personal safety and information of consumers and/or end user Consumers and End-Users - Personal safety and information of consumers and/or end user Patient voice Actual Positive Impact Genmab incorporates patient and caregiver perspectives across the full product lifecycle, ensuring our innovations address the realities of serious illness.”

Annual report 2025A · The company itself

“• Submissions, reports, and regular meetings – Advisory consultations • Ensure compliance and patient safety – Clarify approval pathways • Regulatory approvals – Streamlined development and improved safety data Investors Shareholders supporting Genmab’s financial growth and long-term strategy.”

Annual report 2025A · The company itself

“Pharmacovigilance risks as a biotech company Access to quality information 4.0 Consumers & End-Users IRO Management Policies related to Consumers and End-Users (S4-1) Policy/ Commitment Scope Accountability Stakeholder Consideration Communication Code of Conduct Access and inclusion in clinical trials; Responsible and ethical marketing Defines our commitment to conducting business ethically and in compliance with applicable legal, regulatory, and industry code requirements. The objective is to translate the principles of the Code into clear global compliance expectations, guiding interactions with healthcare professionals, healthcare organizations, patients, patient advocacy groups, public officials, and other stakeholders, and supporting consistent, lawful, and ethical conduct across all business activities. employees, Board members, and third parties.”

Annual report 2025A · The company itself

“Genmab has established a Code of Conduct that sets high ethical standards for employees, reinforced through regular training. This ensures that all marketing and sales efforts align with local and national regulations, which may limit direct engagement with consumers and endusers. Ethical marketing practices are the responsibility of our Chief Commercial Officer.”

Annual report 2025A · The company itself

“Our internal Global Compliance Policy, owned by our head of Global Compliance, outlines our standards on interactions and engagements with HCPs, healthcare organizations, patients, patient association groups and government officials consistent with applicable industry codes and standards. The policy aligns with the values and principles articulated in our Code of Conduct and is complemented by an associated Global Fair Market Value Policy and a Compliance Playbook tool to ensure stakeholder engagement is conducted in an ethical, compliant manner. Our compliance program focuses on our commercialization efforts to assure ethical market-based and customer-focused business practices.”

Annual report 2025A · The company itself

“EU Drug Development In the EU, our products are subject to a variety of EU and EU member state regulations governing clinical trials, commercial sales and distribution. We are required to obtain a marketing authorization in the EU before we can market our medicinal products on the relevant market.”

Annual report 2025A · The company itself

“Failure to obtain broad approvals on a timely basis or to maintain compliance, including if significant safety issues arise for our marketed products or our product candidates, could delay or halt commercialization of our products. The products we develop must be approved for marketing and sale by regulatory authorities and, once approved, are subject to extensive regulation by FDA, EMA and comparable regulatory agencies in other countries.”

Annual report 2025A · The company itself

“For example, under FDA rules, we are often required to conduct post-approval clinical studies to assess a known serious risk, signals of serious risk or to identify an unexpected serious risk. In certain circumstances, we may be required to implement a Risk Evaluation and Mitigation Strategy program for our products, which could include a medication guide, patient package insert, a communication plan to healthcare providers, restrictions on distribution or use of a product and other elements FDA deems necessary to assure safe use of the drug.”

Annual report 2025A · The company itself

“Table of Contents If we fail to comply with applicable laws and regulations, we could lose our approval to market our products or be subject to other governmental enforcement activity. We cannot guarantee that we will be able to maintain regulatory approval to market our products in the jurisdictions in which they are currently marketed. If we do not maintain our regulatory approval to market our products, our results of operations will be materially harmed.”

Annual report 2025A · The company itself

“The commercialization of our products is subject to post-regulatory approval product surveillance, and our products may have to be withdrawn from the market or subject to restrictions if previously unknown problems occur. Regulatory agencies may also require additional clinical trials or testing for our products, and our products may be recalled or may be subject to reformulation, additional studies, changes in labeling, warnings to the public and negative publicity. For example, from late 2013 through 2014, ICLUSIG was subject to review by the European Medicines Agency (“EMA”), of the benefits and risks of ICLUSIG to better understand the nature, frequency and severity of events obstructing the arteries or veins, the potential mechanism that leads to these side effects and whether there needed to be a revision in the dosing recommendation, patient monitoring and a risk management plan for ICLUSIG.”

Annual report 2025A · The company itself

“In the event of any new risks or adverse effects discovered as new patients are treated and as our products are studied in or used by patients for off-label indications, regulatory authorities may delay or revoke their approvals, we may be required to conduct additional clinical trials, make changes in labeling of our products, reformulate our products or make changes and obtain new approvals. We may also experience a significant drop in the sales of our products, experience harm to our reputation and the reputation of our products in the marketplace or become subject to lawsuits, including class actions. Any of these results could decrease or prevent sales of our products or substantially increase the costs and expenses of commercializing our products.”

Annual report 2025A · The company itself

“During the course of treatment, patients may suffer adverse events, including death, for reasons that may or may not be related to our products. Such events could subject us to costly litigation, require us to pay substantial amounts of money to injured patients, delay, negatively impact or end our opportunity to receive or maintain regulatory approval to market our products, or require us to suspend or abandon our commercialization efforts.”

Annual report 2025A · The company itself

“In order to commercialize drug products in the United States, drug candidates will have to obtain regulatory approval from the FDA. Satisfaction of regulatory requirements typically takes many years.”

Annual report 2025A · The company itself

“Many companies in the pharmaceutical and biopharmaceutical industry, including our company, have suffered significant setbacks in advanced clinical trials, even after achieving promising results in earlier clinical trials. In addition, regulatory authorities may refuse or delay approval as a result of other factors, such as changes in regulatory policy during the period of product development and regulatory agency review.”

Annual report 2025A · The company itself

“In April 2017, we and our collaborator Lilly announced that the FDA had issued a complete response letter for the NDA of OLUMIANT as a once-daily oral medication for the treatment of moderate-to-severe rheumatoid arthritis. The letter indicated that additional clinical data were needed to determine the most appropriate doses and to further characterize safety concerns across treatment arms.”

Annual report 2025A · The company itself

“In addition, in January 2022, we announced that we withdrew the NDA seeking approval of parsaclisib for the treatment of patients with relapsed or refractory follicular lymphoma, marginal zone lymphoma and mantle cell lymphoma. The decision to withdraw the NDA followed discussions with FDA regarding confirmatory clinical trials that we determined cannot be completed within the time period to support the investment.”

Annual report 2025A · The company itself

“For example, in January 2020 we stopped our Phase 3 trial of itacitinib for the treatment of acute graft-versus-host-disease.”

Annual report 2025A · The company itself

“Even if any of our applications receives an FDA Fast Track or priority review designation (including based on a priority review voucher, one of which we recently acquired and used in connection with our submission seeking FDA approval of ruxolitinib cream for atopic dermatitis), these designations may not result in faster review or approval for our product candidate compared to product candidates considered for approval under conventional FDA procedures and, in any event, do not assure ultimate approval of our product candidate by the FDA. For example, in June 2021 we were informed by the FDA that the FDA had extended by three months the review period for the NDA for ruxolitinib cream for atopic dermatitis.”

Annual report 2025A · The company itself

“Also, in July 2021, we announced that the FDA issued a complete response letter for the BLA of retifanlimab for the treatment of squamous cell carcinoma of the anal canal, in which the FDA stated it cannot approve the BLA and that additional data are needed.”

Annual report 2025A · The company itself

“Outside the United States, our and our collaborators’ ability to market a product is contingent upon receiving a marketing authorization from the appropriate regulatory authorities. This foreign regulatory approval process typically includes all of the risks associated with the FDA approval process described above and may also include additional risks.”

Annual report 2025A · The company itself

“The FDA and comparable agencies in other jurisdictions directly regulate many of our most critical business activities, 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

“Unless an exemption applies, each medical device we seek to commercially distribute in the United States will require either prior 510(k) clearance or pre-market approval (“PMA”) from the FDA. A 510(k) pre-market notification filing must contain information establishing that the device to be sold is substantially equivalent to a device commercially distributed prior to May 28, 1976 or to a device that has been determined by the FDA to be substantially equivalent.”

Annual report 2025A · The company itself

“Both the 510(k) clearance and PMA processes can be expensive and lengthy and entail significant user fees. We have obtained 510(k) clearance for Classic Omnipod, Omnipod DASH, and Omnipod 5.”

Annual report 2025A · The company itself

“Clinical trials are almost always required to support a PMA application and may also be required to support 510(k) submissions. If the device presents a “significant risk” to human health as defined by the FDA, the FDA requires the device sponsor to submit and obtain Investigational Device Exemption ("IDE") approval prior to commencing human clinical trials.”

Annual report 2025A · The company itself

“Obtaining such regulatory clearance can be expensive and lengthy. Delays in obtaining or inability to obtain clearances could adversely affect our ability to introduce new or enhanced products in a timely manner, which in turn could harm our revenue and profitability.”

Annual report 2025A · The company itself

“The FDA and similar governmental bodies in other countries have the authority to require the recall of our products if we or our contract manufacturer fails to comply with relevant regulations pertaining to manufacturing practices, labeling, advertising, or promotional activities, or if new information is obtained concerning the safety or efficacy of our products.”

Annual report 2025A · The company itself

“RISKS RELATING TO OUR REGULATORY ENVIRONMENT •Complying with FDA and foreign regulations is a complex process, and our failure to fully comply could subject us to significant enforcement actions. •Our products are subject to a lengthy and uncertain domestic regulatory review process. If we do not obtain and maintain the necessary domestic regulatory authorizations, we will not be able to sell our products in the U.S. •Our products may cause or contribute to adverse medical events or be subject to failures or malfunctions that we are required to report to the FDA and foreign regulatory authorities and, if we fail to do so, we would be subject to sanctions that could harm our reputation, business, financial condition, or results of operations.”

Annual report 2025A · The company itself

“If we do not obtain and maintain the necessary regulatory requirements, we will not be able to sell our products in other countries. •Changes in healthcare legislation and policy may have an adverse effect on our business, financial condition, or results of operations. •We are subject to federal, state, and foreign laws governing our business practices, which, if violated, could result in substantial penalties.”

Annual report 2025A · The company itself

“Regulation FDA Our products are subject to regulation as medical devices in the United States under the Federal Food, Drug, and Cosmetic Act (“FFDCA”), as implemented and enforced by the FDA. The FDA regulates the development, design, non-clinical and clinical research, manufacturing, safety, efficacy, labeling, packaging, storage, installation, recordkeeping, complaint and adverse event reporting, clearance, approval, certification, promotion, marketing, export, import distribution, and service of medical devices in the U.S. to ensure that medical devices distributed domestically are safe and effective for their intended uses.”

Annual report 2025A · The company itself

“The PMA process is more demanding than the 510(k) premarket notification process. In a PMA application, the manufacturer must demonstrate that the device is safe and effective, and the PMA application must be supported by extensive data, including data from preclinical studies and human clinical trials. The FDA, by statute and regulation, has 180 days to review a PMA application, although the review more often occurs over a significantly longer period of time and can take up to several years.”

Annual report 2025A · The company itself

“After a device receives 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that would constitute a major change or modification in its intended use, will require a new 510(k) clearance or, depending on the modification, PMA approval or de novo classification. The FDA requires each manufacturer to determine whether a proposed change requires submission of a 510(k), de novo classification, or a PMA or PMA supplement in the first instance, but the FDA can review any such decision and disagree with a manufacturer’s determination. If the FDA disagrees with a manufacturer’s determination, the FDA can require the manufacturer to cease marketing and/or request the recall of the modified device until it receives the appropriate marketing authorization.”

Annual report 2025A · The company itself

“China China has its own regulatory agency, the National Medical Products Administration (“NMPA”). They require regulatory approvals and compliance with extensive safety and quality system regulations. Failure to obtain regulatory approval or failure to comply with any regulation may negatively impact our ability to generate revenue and harm our business.”

Annual report 2025A · The company itself

“Table of Contents Japan Most medical devices must undergo thorough safety examinations and demonstrate medical efficacy before they receive regulatory approval to be sold in Japan. We obtained approval from the Japanese Ministry of Health, Labor, and Welfare (“MHLW”) for our da Vinci Si surgical system in October 2012, for our da Vinci Xi surgical system in March 2015, and for our da Vinci X surgical system in April 2018. In September 2022, we received regulatory clearance for the da Vinci SP surgical system in Japan for the same set of procedures as can be performed on the da Vinci Xi surgical system in Japan. In July 2025, we received regulatory clearance for our latest da Vinci 5 surgical system for use in all surgical specialties and procedures indicated for da Vinci Xi, except for cardiac indications.”

Annual report 2025A · The company itself

“European Union The EU has adopted specific directives and regulations regulating the design, manufacture, clinical investigation, conformity assessment, labeling, and adverse event reporting for medical devices. Until and including May 25, 2021, medical devices were regulated by Council Directive 93/42/EEC (the “EU Medical Devices Directive” or “EU MDD”), which has been repealed and replaced by Regulation (EU) No 2017/745 (the “EU Medical Devices Regulation” or “EU MDR”).”

Annual report 2025A · The company itself

“Pursuing marketing of medical devices in the EU will notably require that our devices be certified under the new regime set forth in the EU MDR. In the EU, there is currently no premarket government review of medical devices.”

Annual report 2025A · The company itself

“Compliance with the general safety and performance requirements of the EU MDR is a prerequisite for European Conformity (“CE”) marking, without which medical devices cannot be marketed or sold in the EU. To demonstrate compliance with the general safety and performance requirements, medical device manufacturers must undergo a conformity assessment procedure, which varies according to the type of medical device and its (risk) classification.”

Annual report 2025A · The company itself

“All manufacturers placing medical devices on the market in the EU must comply with the EU medical device vigilance system, which has been reinforced by the EU MDR. Under this system, serious incidents and Field Safety Corrective Actions (“FSCAs”) must be reported to the relevant authorities of the EU member states.”

Annual report 2025A · The company itself

“Brexit and the UK Regulatory Framework Since January 1, 2021, the Medicines and Healthcare Products Regulatory Agency (“MHRA”) has been the sovereign regulatory authority responsible for Great Britain (i.e., England, Wales, and Scotland) medical device clearances. Following the end of the Brexit transitional period on January 1, 2021, new regulations require all medical devices to be registered with the MHRA before being placed on the Great Britain market. From January 1, 2022, non-UK manufacturers were required to appoint a UK Responsible Person for the purposes of registering devices placed on the Great Britain market.”

Annual report 2025A · The company itself

“Other countries Regulations in other countries, including the requirements for approvals, certification, or clearance and the time required for regulatory review, vary from country to country. Certain countries, such as South Korea, Brazil, Australia, India, and Canada, have their own regulatory agencies. These countries typically require regulatory approvals and compliance with extensive safety and quality system regulations included in the MDSAP (Medical Device Single Audit Program) that we comply with every year as part of our annual audit program.”

Annual report 2025A · The company itself

“The QMSR, which became effective on February 2, 2026, incorporates certain elements of ISO 13485:2016 by reference and covers, among other things, the methods used in, and the facilities and controls used for, the design, testing, controlling, documenting, manufacture, packaging, labeling, storage, installation, and servicing of all medical devices intended for human use.”

Annual report 2025A · The company itself

“For instance, on December 13, 2021, the EU Regulation No 2021/2282 on HTA, amending Directive 2011/24/EU, was adopted. While the Regulation entered into force in January 2022, it will only begin to apply from January 2025 onwards, with preparatory and implementation-related steps to take place in the interim. Once applicable, it will have a phased implementation depending on the concerned products. This Regulation intends to boost cooperation among EU member states in assessing health technologies, including certain high-risk medical devices, and provide the basis for cooperation at the EU level for joint clinical assessments in these areas.”

Annual report 2025A · The company itself

“Many of our products to date have been or would be considered significant risk devices requiring IDE approval prior to investigational use.”

Annual report 2025A · The company itself

“Certainty that clinical trials will meet desired endpoints, produce meaningful or useful data, and be free of unexpected adverse effects or that the FDA will accept the validity of foreign clinical study data cannot be assured, and such uncertainty could preclude or delay market clearance or authorizations resulting in significant financial costs and reduced revenue. Failure to obtain such approvals or to comply with such regulations could have a material adverse effect on our business, financial condition, or results of operations.”

Annual report 2025A · The company itself

“In the United States, certain of our services are subject to numerous federal and state laws pertaining to promotional activities involving pharmaceutical products and medical devices. Certain of our services are subject to the FDA’s regulations against “off-label promotion,” which require sales representatives to restrict promotion of the approved product they are detailing to the approved labeling for the product.”

Annual report 2025A · The company itself

“Such services are complex and subject to contractual requirements, regulatory standards and ethical considerations. For example, we must adhere to applicable regulatory requirements such as those required by the FDA, the EMA and the competent authorities of the member states of the EU, and the MHRA in the UK, and Good Laboratory Practice and GCP requirements, which govern, among other things, the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials.”

Annual report 2025A · The company itself

“Foreign and domestic government bodies have adopted and may continue to adopt new healthcare legislation or regulations that are more burdensome than existing regulations. For example, product safety concerns and recommendations by the Drug Safety Oversight Board could change the regulatory environment for drug products, and new or heightened regulatory and licensing requirements may increase our expenses or limit or delay our ability to offer some of our services. We might have to incur additional costs to comply with these or other new regulations, and failure to comply could harm our financial condition, results of operations, cash flows, and reputation, and result in adverse legal action(s).”

Annual report 2025A · The company itself

“Actions by government regulators or clients to limit a prescription’s scope or withdraw an approved drug from the market could adversely affect our business and result in a loss of revenues. Government regulators have the authority, after approving a drug, to regulate or limit its scope of prescription or withdraw it from the market completely based on safety concerns.”

Annual report 2025A · The company itself

“End-of-Phase 2-möte med FDA samt erhållit vetenskaplig rådgivning från EMA (februari 2025) Myndigheterna anser att de studier som genomförts och de data som genererats hittills är adekvata för att föra programmet vidare in i Fas III. Det har även bekräftats att FDA, EMA och IRLAB har samsyn gällande nyckelkomponenterna i Fas III-programmet för mesdopetam.”

Annual report 2024A · The company itself

“Medicinska nyttan och en betydande marknadspotential för mesdopetam I oktober meddelade bolaget att en fördjupad prisundersökning i USA och Europa visar på att sjukvårdsorganisationer har en hög betalningsvilja för ett anti-dyskinetiskt läkemedel med en ny och effektiv verkningsmekanism. Detta indikerar en betydande kommersiell potential för mesdopetam på båda marknaderna.”

Annual report 2024A · The company itself

“Framgångsrika studier är underlag för en ansökan om marknadsgodkännande Fas I Studier i friska frivilliga forskningspersoner med syfte att bekräfta läkemedelskandidatens säkerhet och tolerabilitet i människa IRL757 pirepemat ( IRL752) mesdopetam (IRL790) Klinisk fas Klinisk ”proof of concept” uppnådd Återkopplingar inom ISP-processen Illustration av IRLAB, april 2024 INN-namn (beslutas av WHO) Vid Parkinson försvinner nervcellerna som använder signalsubstansen dopamin långsamt och orsakar en minskad nivå av dopamin i hjärnan.”

Annual report 2024A · The company itself

“Myndighetsgodkännanden För att få genomföra kliniska studier, tillverka, marknadsföra och sälja läkemedel krävs godkännanden från eller registreringar hos relevanta myndigheter för varje geografisk marknad där IRLAB har för avsikt att vara aktiv. Det finns risk att myndigheters bedömningar avviker från IRLAB:s bedömningar, krav kan skilja sig åt mellan länder och myndigheter kan även inbördes göra olika bedömningar. Vidare kan de regler och tolkningar som för närvarande gäller för att läkemedel ska godkännas komma att ändras i framtiden, vilket kan komma att påverka tidsramarna eller möjligheterna att erhålla nödvändiga godkännanden.”

Annual report 2024A · The company itself

“Efter ett framgångsrikt End-of-Phase 2 möte med både den amerikanska läkemedelsmyndigheten FDA och dess europeiska motsvarighet EMA sker aktiviteter parallellt för att säkerställa finansieringen av Fas III.”

Annual report 2024A · The company itself

“Portföljbolagen och deras samarbetspartners kommer inte att kunna marknadsföra någon av sina produkter utan att först erhålla erforderliga tillstånd från behöriga myndigheter. Den regulatoriska processen för att erhålla tillstånd för en ny läkemedelsprodukt kan ta flera år och kräver ofta avsevärda finansiella och andra resurser. För att erhålla myndighetstillstånd för kommersialisering av portföljbolagens produkter krävs det att portföljbolagen och deras samarbetspartners slutför kliniska studier för att påvisa produkternas säkerhet och effektivitet.”

Annual report 2024A · The company itself

“Both the clinical laboratory and biopharma laboratory businesses are subject to significant governmental regulation at the international, national, state, and local levels. As described below, certain regulations concern licensure and operation of clinical laboratories, claims submission and reimbursement for laboratory services, healthcare fraud and abuse, biopharma laboratory services, security and confidentiality of health information, quality, and environmental and occupational safety.”

Annual report 2025A · The company itself

“TABLE OF CONTENTS Regulatory Agency Laws and Regulations Various regulatory agencies, including CMS and the FDA in the U.S., regulate the development, testing, manufacturing, marketing, distribution, storage, import, export, and performance of the Company’s diagnostic and therapeutic offerings. These agencies also regulate key aspects of BLS’s therapeutic product development-related services that comprise the majority of its business.”

Annual report 2025A · The company itself

“The FDA and other regulatory agencies periodically inspect and review the manufacturing processes and performance of diagnostic and therapeutic products, while CMS, certain state programs, and accreditation entities inspect and review the facilities, personnel, and procedures of clinical laboratories and their laboratory operations. The FDA and other regulatory agencies also periodically inspect test facilities that perform tests on samples from preclinical studies and on human subjects enrolled in such clinical studies of drugs, biologics, and medical devices.”

Annual report 2025A · The company itself

“BLS supports pharmaceutical, biotechnology, and medical device companies in navigating the regulatory approval and post-approval compliance requirements process. Changes in government regulations, whether easing or tightening requirements and changes in government operations, including staff reductions and reorganization efforts, could reduce the demand for BLS’s services or make them less competitive.”

Annual report 2025A · The company itself

“Government Regulation of Our Operations and Products Our operations are regulated extensively by numerous government agencies. The lengthy process of laboratory and clinical testing, data analysis, manufacturing development, and regulatory review necessary for governmental approvals of our products is extremely costly and can significantly delay product introductions and revenue generation. In addition, our operations are subject to complex federal, state, local, and foreign laws and regulations concerning relationships with healthcare providers and suppliers, pricing and reimbursement for our products, the environment, occupational health and safety, data privacy and security, and other matters.”

Annual report 2025A · The company itself

“Of particular importance to our business is regulation by the FDA in the U.S. Pursuant to laws and regulations that include the Federal Food, Drug, and Cosmetic Act (FDCA) and the Public Health Service Act (PHSA), the FDA exercises jurisdiction over all of our products and devices in the U.S. and administers requirements covering the testing, safety, effectiveness, manufacturing, quality control, distribution, labeling, marketing, promotion, advertising, dissemination of information, and post-marketing surveillance of those products and devices. The FDA holds broad discretion under the FDCA to interpret the conditions and evidence necessary for timely approval of and ability to market our products and devices as well as those of our competitors.”

Annual report 2025A · The company itself

“The FDA may withdraw approval of a product if compliance with regulatory requirements and standards is not maintained or if problems occur after a product reaches the market, including as may be identified through market surveillance or third-party studies involving our products. The FDA may also mandate labeling changes, post-marketing studies, or risk management programs at any point in a product's life cycle based on new safety information or as part of a labeling change to a particular class of products.”

Annual report 2025A · The company itself

“Government Regulation Our operations and products are subject to extensive regulation by numerous government agencies, including the U.S. FDA, European regulatory authorities such as the Medicines and Healthcare products Regulatory Agency in the United Kingdom, the Health Products Regulatory Authority in the Republic of Ireland and the Federal Institute for Drugs and Medical Devices in Germany, the China National Medical Product Administration (NMPA), and other government agencies inside and outside the U.S.”

Annual report 2026A · The company itself

“Product Approval and Monitoring In many jurisdictions where we do business, including the U.S., the E.U., Japan, and China, our products are subjected to approval and other regulatory requirements regarding performance, safety, and quality. For instance, authorization to commercially distribute a new medical device in the U.S. is generally obtained in one of two primary ways. The first, known as pre-market notification or the 510(k) process, requires us to demonstrate that our medical device is substantially equivalent to a legally marketed medical device.”

Annual report 2026A · The company itself

“We expect this global regulatory environment will continue to evolve, which could impact the cost, the time needed to approve, and ultimately, our ability to maintain existing approvals or obtain future approvals for our products.”

Annual report 2026A · The company itself

“In addition, workforce reductions and agency reorganization at the U.S. FDA have, and could continue to have, an impact on product approval timelines and other types of agency oversight.”

Annual report 2026A · The company itself

“Our medical devices and technologies, as well as our business activities, are subject to a complex set of regulations and rigorous enforcement, including by the U.S. FDA, U.S. Department of Justice, Health and Human Services Office of the Inspector General, and numerous other federal, state, and non-U.S. governmental authorities in the countries where we operate.”

Annual report 2026A · The company itself

“FDA and other applicable non-U.S. government agency regulations. For instance, many of our facilities and procedures, and those of our suppliers, contract manufacturers, and other third-party vendors, are subject to periodic inspections by the U.S.”

Annual report 2026A · The company itself

“Pilot program eligibility requires alignment with one or more critical national health priorities, which include addressing a health crisis in the U.S., bringing innovative therapies to the American people, addressing a large unmet medical need, promoting domestic manufacturing, and increasing affordability. The pilot program is intended to enable enhanced communications with the FDA and action on an application within one to two months.”

Annual report 2025A · The company itself

“•The Company’s products, including products in development, cannot be marketed unless the Company obtains and maintains regulatory approval or authorization.”

Annual report 2025A · The company itself

“Those potential changes include some related to vaccines and vaccine development, as well as personnel and policy changes at the FDA and other government agencies, committees, and programs. For example, HHS could undergo changes that could make it more difficult for the FDA to grant regulatory approvals for drugs and vaccines.”

Annual report 2025A · The company itself

“The Company’s activities, including research, preclinical testing, clinical trials and the manufacturing and marketing of its products, are subject to extensive regulation by numerous federal, state and local governmental authorities in the U.S., including the FDA, and by foreign regulatory authorities, including in the EU, Japan and China. In the U.S., the FDA administers requirements covering the testing, approval, safety, effectiveness, manufacturing, labeling and marketing of prescription pharmaceuticals and vaccines.”

Annual report 2025A · The company itself

“Even after a product reaches the market, certain developments following regulatory approval may decrease demand for the Company’s products, including the following: •results in post-approval Phase 4 trials or other studies; •the re-review of products or indications that are already marketed; •the recall or loss of marketing approval of products that are already marketed; •changing government standards or public expectations regarding safety, efficacy, quality or labeling changes; •scrutiny of advertising and promotion; and •the withdrawal of indications granted pursuant to accelerated approvals. In the past, clinical trials and post-marketing surveillance of certain marketed drugs of the Company and of competitors within the industry have raised concerns that have led to recalls, withdrawals or adverse labeling of marketed products.”

Annual report 2025A · The company itself

“In addition, following in the wake of product withdrawals and other significant safety issues, health authorities such as the FDA, the EMA, Japan’s PMDA and China’s NMPA have increased their focus on safety when assessing the benefit/risk balance of drugs. Some health authorities appear to have become more cautious when making decisions about approvability of new products or indications. If previously unknown side effects are discovered or if there is an increase in negative publicity regarding known side effects of any of the Company’s products, it could significantly reduce demand for the product or require the Company to take actions that could negatively affect sales, including removing the product from the market, restricting its distribution or applying for labeling changes.”

Annual report 2025A · The company itself

“•The development, manufacturing and marketing of biologics and vaccines are subject to regulation by the FDA, the EMA and other regulatory bodies. These regulations are often more complex and extensive than the regulations applicable to other pharmaceutical products. For example, in the U.S., a BLA, including both preclinical and clinical trial data and extensive data regarding manufacturing procedures, is required for human vaccine candidates, and FDA approval is generally required for the release of each manufactured commercial human vaccine lot. •Manufacturing biologics and vaccines, especially in large quantities, is complex and may require the use of innovative technologies to handle living micro-organisms.”

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

“The Group will need approvals from the FDA to market its products in the US, and from the European Medicines Agency (EMA) to market its products in Europe, as well as equivalent regulatory authorities in other worldwide jurisdictions to commercialize in those regions.”

Annual report 2024A · The company itself

“As a participant in the healthcare industry, certain of our products, operations and relationships, and those of our customers, are regulated by several U.S. federal, state, local and foreign governmental entities. These regulations impact us both directly and indirectly, including government program requirements applicable to our customers for the use of health IT. There are significant, wide-ranging and rapidly evolving regulations worldwide, covering healthcare fraud, information sharing, e-prescribing, medical claims processing and transmission, healthcare devices, the use of AI in healthcare, the security and privacy of patient data and interoperability standards, that may be directly or indirectly applicable to our products, operations and relationships or the business practices of our customers.”

Annual report 2026A · The company itself

“Certified electronic health record technology (CEHRT) requirements continue to evolve and remain necessary to participate in federal healthcare programs to receive reimbursement for health items and services provided by certain of our customers to Medicare and Medicaid beneficiaries. Certification involves complex and specific requirements related to various types of requests for the access, exchange or use of Electronic Health Information.”

Annual report 2026A · The company itself

“Ett CRL kommer försena FDA:s godkännande av OX124 I juli utfärdade FDA ett så kallat Complete Response Letter för OX124, ett högdosläkemedel vid opioidöverdos, efter inlämnandet av en registreringsansökan under 2023. FDA begärde justeringar i användarinstruktionen och en validering av motsvarande i en ny Human Factor-studie, vilket framgångsrikt slutfördes under sommaren.”

Annual report 2024A · The company itself

“2023, men lanseringen har försenats på grund av att myndigheten har utfärdat ett Complete Response Letter. FDA har begärt tekniska data från kommersiell tillverkning samt att en ny Human Factor (HF) studie ska slutföras.”

Annual report 2024A · The company itself

“The balance of benefits and risks related to the use of medicinal products is continuously assessed in light of cumulative information about the product. Orion reports the information and assessments to authorities, and continuous dialogue is maintained between authorities and Orion regarding the benefit/risk assessment of the products. Actions are taken, if necessary, e.g., to minimise risks.”

Annual report 2025A · The company itself

“Orion conducts continuous benefit-risk assessment of the products, which starts from the product development and continues through the entire life cycle of the product. Decisions on benefit-risk are made based on the cumulative safety information collected though the life cycle of the product.”

Annual report 2025A · The company itself

“Orion collects safety information globally. Orion’s pharmacovigilance organisation collects data from all Orion locations and business partners for continuous safety assessment, monitoring and reporting.”

Annual report 2025A · The company itself

“Orion tracks the quality of its good manufacturing processes related to product quality, safety, efficacy, through GxP inspections conducted by the authorities. Level of ambition is zero critical observations, and the base period is the previous year.”

Annual report 2025A · The company itself

“Orion has developed an understanding of how particularly vulnerable end-user populations, or end-users using particular products may be at greater risk of harm, through conducting a careful analysis and assessment, which is based on pharmaceutical industry ethical and legal requirements in the EU and globally. All of the material risks and opportunities are related to all end-users pharmaceutical products.”

Annual report 2025A · The company itself

“Coverage and cost sharing for certain insurance programs including Medicare, Medicaid and Children’s Health Immunization Program (CHIP) can depend on recommendations from advisory committees, including the U.S. Preventive Services Taskforce (USPSTF) and the ACIP. Changes in the recommendations or structure of those committees may affect the use of our medicines and vaccines.”

Annual report 2025A · The company itself

“New Drug Approvals. In the EU, the EMA conducts the scientific evaluation, supervision and safety monitoring of our innovative medicinal products that are eligible for the centralized marketing authorization procedure. Through the centralized procedure, pharmaceutical companies may submit to the EMA a single application for a marketing authorization valid in all the EU and the European Economic Area (EEA) countries. The EC grants marketing authorization by issuing a legally binding decision based on the EMA's recommendation.”

Annual report 2025A · The company itself

“Drug and Biologic Regulation. The FDA, pursuant to the FFDCA, the Public Health Service Act and other federal statutes and regulations, extensively regulates pre- and post-marketing activities related to our biopharmaceutical products and devices. The statutes and regulations govern areas such as safety and efficacy, clinical trials, advertising and promotion, quality control, manufacturing, labeling, distribution, post-marketing safety surveillance and reporting, and record keeping.”

Annual report 2025A · The company itself

“•Regulatory decisions or feedback could impact the future development of our product candidates, including our vaccine candidates such as our next generation pneumococcal conjugate vaccine candidate. •We may need to amend our clinical trial protocols or conduct additional clinical trials under certain circumstances, for example, to further assess appropriate dosage or collect additional safety data. •We may not be able to meet anticipated pre-clinical or clinical endpoints, commencement and/or completion dates for our pre-clinical or clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates. •We may not be able to successfully address all the comments received from regulatory authorities such as the FDA and the EMA, or be able to obtain approval for new products and indications from regulators.”

Annual report 2025A · The company itself

“•We may experience increasing inconsistencies and unexpected changes in the evaluations and determinations made by the FDA during the process of applying for marketing approvals of our products due to reductions in workforce, personnel movements, and policy changes.”

Annual report 2025A · The company itself

“As a result of regulatory interpretations and assessments or other developments that may occur during the review process, or even after a product is authorized or approved for marketing, a product’s commercial potential could be adversely affected by potential emerging concerns or regulatory decisions regarding or impacting the scope of indicated patient populations, labeling or marketing, manufacturing processes, safety issues and/or other matters, including decisions relating to developments regarding potential product impurities.”

Annual report 2025A · The company itself

“We may not be able to receive or maintain favorable recommendations by technical or advisory committees, such as the ACIP or an FDA Advisory Committee, which may impact the availability or commercial potential, or insurance coverage of our products and product candidates.”

Annual report 2025A · The company itself

“For example, as discussed above, in January 2026 the CDC unilaterally reduced the number of immunizations routinely recommended for all children in the U.S.”

Annual report 2025A · The company itself

“Further, claims and concerns that may arise regarding the safety and/or efficacy of in-line products and product candidates can negatively impact current or future product sales, as applicable, and potentially lead to regulator-directed risk evaluations and assessments, asset impairments, and/or consumer fraud, product liability and other litigation and claims, as well as product recalls or withdrawals, including our voluntary withdrawal of all lots of Oxbryta in all markets where it is approved, and any regulatory or other impact on Oxbryta or other sickle cell disease assets.”

Annual report 2025A · The company itself

“The results generated in these trials have in the past impacted certain of our products and could impact our products in the future, such as by resulting in the loss of marketing approval, changes in labeling, and/or new or increased concerns about safety and/or efficacy, including newly discovered adverse events.”

Annual report 2025A · The company itself

“Post-marketing studies and clinical trials, whether conducted by us or by others, whether mandated by regulatory agencies or conducted voluntarily, and other emerging data about products, such as adverse event reports, may also adversely affect the availability or commercial potential of our products.”

Annual report 2025A · The company itself

“Further, if safety or efficacy concerns are raised about a product in the same class as one of our products, those concerns could implicate the entire class; and this, in turn, could have an adverse impact on the availability or commercial viability of our product(s) or product candidates as well as other products in the class.”

Annual report 2025A · The company itself

“In September 2024, we made the decision to voluntarily withdraw Oxbryta in all markets where it was approved based on the totality of clinical data that indicated at that time the overall benefit of Oxbryta no longer outweighed the risk in the approved sickle cell patient population. Following a comprehensive process, in October 2025, the EMA adopted a negative opinion on benefit-risk for Oxbryta for the treatment of hemolytic anemia due to SCD, recommending that the marketing authorization for the product remain suspended.”

Annual report 2025A · The company itself

“Presidential administration, Congress and states, including, among others, increased or new regulatory requirements, including heightened requirements for licensure, changes, delays or failure to receive recommendations, reimbursement and regulatory approvals and coverage for our vaccines and medicines could have a material adverse effect on our business, earnings, cash flows, liquidity and financial guidance.”

Annual report 2025A · The company itself

“On 1 September 2025, the company announced in company announcement no. 10 that Reponex has received regulatory approval to initiate a pivotal Phase 2 study with RNX-011. The approval is a key milestone for the company and a validation of the scientific strategy for RNX-011.”

Annual report 2025A · The company itself

“In the United States, we (which, for purposes of this risk factor, includes our collaborators, unless otherwise stated or required by the context) must obtain and maintain approval from the FDA for each drug and biologic we intend to sell.”

Annual report 2025A · The company itself

“We must obtain and maintain similar regulatory approvals from comparable foreign regulatory authorities in order to sell drugs and biologics outside the United States.”

Annual report 2025A · The company itself

“Obtaining FDA or comparable foreign regulatory authority approval for a new drug or biologic or indication is typically a lengthy and expensive process, and approval is highly uncertain.”

Annual report 2025A · The company itself

“In certain instances (such as when we use a biomarker-based test to identify and enroll specific patients in a clinical trial), regulatory approval of a companion diagnostic to our therapeutic product candidate may be required as a condition for regulatory approval of the therapeutic product candidate. We may need to rely on third parties to provide companion diagnostics for use with our product candidates. Such third parties may be unable or unwilling on terms acceptable to us to provide such companion diagnostics or to obtain timely regulatory approval of or product labeling updates for such companion diagnostics, which could negatively impact regulatory approval of our product candidates or may result in increased development costs or delays.”

Annual report 2025A · The company itself

“The FDA may also require us to conduct additional clinical trials after granting approval of a product. The FDA has the explicit authority to require post-marketing studies (also referred to as post-approval studies), labeling changes based on new safety information, and compliance with FDA-approved REMS. Post-approval studies, whether conducted by us or by others and whether mandated by regulatory agencies or voluntary, and other data about our marketed products (or data about products similar to our marketed products that implicate an entire class of products or are perceived to do so) may result in changes in product labeling, restrictions on use, product withdrawal or recall, loss of approval, or lower sales of our products.”

Annual report 2025A · The company itself

“For example, efforts implemented or commenced in 2025 to reduce the size and budgets of U.S. government agencies, downsize the federal workforce, and restructure parts of the executive branch of the federal government have directly or indirectly impacted agencies that support research and development activities or are otherwise important to our business, including the HHS and the FDA. If legislation, administrative action, or changes in policy prevent the FDA or other regulatory authorities from conducting routine inspections, reviews, or other regulatory activities, it could significantly impact the ability of the FDA to provide feedback on our clinical programs, meet with or engage in other informal interactions with us, and review and process our regulatory submissions (including our pending regulatory submissions) in a timely manner.”

Annual report 2025A · The company itself

“Furthermore, changes in FDA personnel and policy (such as the 2025 reductions in communication and policymaking roles) may negatively impact the transparency of agency actions, lead to modifications in FDA approval requirements, and alter the FDA's existing guidance pertinent to the development strategy for our products and product candidates.”

Annual report 2025A · The company itself

“A prolonged government shutdown or a widespread freeze on federal funding could significantly impact the ability of the FDA to timely review and process our regulatory submissions or cause other agencies that support the FDA to slow their work.”

Annual report 2025A · The company itself

“If we believe we meet eligibility requirements, we may apply for various regulatory incentives in the United States, such as breakthrough therapy designation, fast track designation, accelerated approval, priority review, or the Commissioner's National Priority Voucher (CNPV) program, where potentially available, that serve to expedite drug development and/or review, and we 47 Table of Contents may also seek similar designations elsewhere in the world. Often, regulatory agencies have broad discretion in determining whether or not product candidates qualify for such regulatory incentives and benefits, and we may fail to obtain beneficial regulatory designations from the FDA or other regulatory agencies. Even if obtained, such designations may not result in faster development processes, reviews, or approvals compared to drugs or biologics considered for approval under conventional FDA procedures.”

Annual report 2025A · The company itself

“The FDA and comparable foreign regulatory authorities enforce GCPs and other regulations and legal requirements through periodic inspections of trial sponsors, clinical research organizations ("CROs"), principal investigators, and trial sites. If we or any of the third parties conducting our clinical studies are determined to have failed to fully comply with GCPs, the study protocol or applicable regulations, the clinical data generated in those studies may be deemed unreliable. This and similar instances of non-compliance with GCPs could result in non-approval of our product candidates by the FDA or foreign regulatory authorities such as the EC, or we or the FDA or such other regulatory authorities may decide to conduct additional inspections or require additional clinical studies, which would delay our development programs, require us to incur additional costs, and could substantially harm our business, prospects, operating results, and financial condition.”

Annual report 2025A · The company itself

“We have recently received several CRLs from the FDA for regulatory submissions concerning our products or product candidates due to the FDA's findings from inspections at third-party manufacturers responsible for filling drug product. These include the July 2025 CRL concerning the BLA for odronextamab in relapsed/refractory FL, which has delayed further any potential FDA approval of odronextamab in this indication; and the October 2025 CRL concerning our regulatory application seeking approval of the EYLEA HD pre-filled syringe (as discussed in Part I, Item 1. "Business - Programs in Clinical Development - Additional Information - Clinical Development Programs - EYLEA HD"), which has delayed further any potential FDA approval of the EYLEA HD pre-filled syringe.”

Annual report 2025A · The company itself

“The foreign regulatory approval process is similarly a lengthy and expensive process, the result of which is highly uncertain, and foreign regulatory requirements generally include the risks associated with FDA approval as well as jurisdiction-specific regulations.”

Annual report 2025A · The company itself

“If concerns arise about the safety of a product candidate or non-compliance with the protocol or applicable regulatory requirements, the FDA or other regulatory authorities can delay or suspend a clinical trial by placing it on a full or partial "clinical hold" pending receipt of additional data or the satisfaction of other conditions. A clinical hold may require us to spend significant resources to address the underlying causes of the clinical hold and may result in a delay in the clinical program, which may be significant.”

Annual report 2025A · The company itself

“The success of our products and product candidates may depend to a significant extent on the performance of such devices, some of which may be novel or comprised of complex components. Given the increased complexity of the review process when approval of the product and device is sought under a single marketing application and the additional risks resulting from a product candidate's designation as a combination product discussed below, our product candidates used with such drug-delivery devices may be substantially delayed in receiving regulatory approval or may not be approved at all.”

Annual report 2025A · The company itself

“For example, in October 2025, the FDA issued a CRL for the regulatory application seeking approval of the EYLEA HD pre-filled syringe, which has delayed further any potential FDA approval of the EYLEA HD pre-filled syringe.”

Annual report 2025A · The company itself

“Unless an exemption applies, the FDA requires that a manufacturer introducing a new medical device, certain modifications thereof, or a new indication for use of an existing medical device obtain either a Section 510(k) premarket notification clearance, a premarket approval, or PMA, or a de novo approval, and pay a user fee, before introducing it into the U.S. market. The type of marketing authorization is generally linked to the classification of the device, as well as whether or not a similar or “predicate” device exists to support a 510(k) application.”

Annual report 2026A · The company itself

“Any new product introduction or existing product modification could be subjected to a lengthier, more rigorous FDA examination process. For example, in certain cases we may need to conduct clinical trials of a modified or new product before submitting a 510(k) notice.”

Annual report 2026A · The company itself

“Indeed, recent trends in the FDA’s review of premarket notification submissions suggest that the FDA is often requiring manufacturers to provide new, more expansive, or different information regarding a particular device than what the manufacturer anticipated upon 510(k) submission. This has resulted in increasing uncertainty and delay in the premarket notification review process.”

Annual report 2026A · The company itself

“The FDA’s ongoing review of the 510(k) program may make it more difficult for us to make modifications to our previously cleared products, either by imposing stricter requirements on when a manufacturer must submit a new 510(k) for a modification to a previously cleared product, or by applying more onerous review criteria to such submissions. FDA continues to review its 510(k) clearance process which could result in additional changes to regulatory requirements or guidance documents which could increase the costs of compliance or restrict our ability to maintain current clearances.”

Annual report 2026A · The company itself

“The requirements of the more rigorous premarket approval process and/or significant changes to the 510(k) clearance process could delay product introductions and increase the costs associated with FDA compliance.”

Annual report 2026A · The company itself

“The definition of “device” in the FD&C Act was amended in 2016 to exclude certain software functions. Our software offerings may include functions that fall under FDA’s jurisdictional definition of a medical device, while there may be software offerings that are considered exempt from the “device” definition even when utilizing data coming from an FDA regulated medical device.”

Annual report 2026A · The company itself

“We are subject to substantial regulation related to quality standards applicable to our manufacturing and quality processes. Our failure to comply with these standards could have an adverse effect on our business, financial condition, or results of operations.”

Annual report 2026A · The company itself

“In February 2026, the FDA implemented the Quality Management System Regulation (QMSR), which replaces the prior FDA Quality System Regulation in setting forth the current good manufacturing practice (cGMP) requirements for medical devices, and incorporates ISO 13485 into U.S. law. The QMSR introduces changes to documentation, terminology, and inspection approaches, including expanded FDA visibility into internal audit, supplier oversight, and management review activities.”

Annual report 2026A · The company itself

“As a device manufacturer, we are required to register with the FDA and are subject to periodic inspection by the FDA for compliance with the FDA’s QMSR, requirements, which require manufacturers of medical devices to adhere to certain regulations, including testing, quality control and documentation procedures.”

Annual report 2026A · The company itself

“Disruptions at the FDA and other government agencies caused by funding shortages, personnel reductions, or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, cleared or approved or commercialized in a timely manner or at all, which could negatively impact our business. The ability of the FDA to review and clear or approve new products can be affected by a variety of factors, including government budget and funding levels, staffing reductions, statutory, regulatory, and policy changes, the FDA’s ability to hire and retain key personnel and accept the payment of user fees, and other events that may otherwise affect the FDA’s ability to perform routine functions.”

Annual report 2026A · The company itself

“Off-label marketing of our products could result in substantial penalties. The FDA strictly regulates the promotional claims that may be made about FDA-cleared products.”

Annual report 2026A · The company itself

“If the FDA determines that we have marketed our products for off-label use, we could be subject to fines, injunctions or other penalties. It is also possible that other federal, state or foreign enforcement authorities might take action if they consider our business activities to constitute promotion of an off-label use, which could result in significant penalties, including, but not limited to, criminal, civil and administrative penalties, damages, fines, disgorgement, exclusion from participation in government healthcare programs, and the curtailment of our operations.”

Annual report 2026A · The company itself

“Some of our products are subject to regulation by the FDA and similar foreign agencies. These regulations govern a wide variety of our product activities, and if we fail to comply with those regulations or standards, we may face, among other things, warning letters; adverse publicity; investigations or notices of non-compliance, fines, injunctions, and civil penalties; import or export restrictions; partial suspensions or total shutdown of production facilities or the imposition of operating restrictions; increased difficulty in obtaining required FDA clearances or approvals or foreign equivalents; seizures or recalls of our products or those of our customers; or the inability to sell our products.”

Annual report 2025A · The company itself

“De huvudsakliga risker och osäkerhetsfaktorer som Saniona exponeras för har att göra med läkemedelsutveckling, kapitalbehov, samarbetsavtal, immateriella rättigheter, regulatoriska krav, produktansvar och konkurrens.”

Annual report 2024A · The company itself

“Bortsett från ett potentiellt regulatoriskt godkännande av tesofensin har Saniona och dess partners hittills inte slutfört den kliniska utvecklingen av någon produktkandidat och det finns ingen garanti för att Bolaget någonsin kommer att ha säljbara läkemedelsprodukter. Samtliga av Bolagets program kräver fortsatt forskning och utveckling och är därmed föremål för sedvanliga risker kopplade till läkemedelsutveckling, såsom att produktutvecklingen kan komma att försenas och att kostnaderna kan komma att bli högre än förväntat eller att produktkandidaterna i något skede av utvecklingen inte visar sig vara tillräckligt effektiva eller säkra.”

Annual report 2024A · The company itself

“Innan en produktkandidat kan lanseras på marknaden måste Bolaget eller dess samarbetspartners genomföra prekliniska och kliniska studier för att dokumentera och påvisa att produktkandidaten har en tillräcklig behandlingseffekt och en acceptabel säkerhetsprofil.”

Annual report 2024A · The company itself

“Bolaget kan inte med säkerhet förutsäga när planerade kliniska studier kan inledas eller när pågående studier avslutas, då det finns flera faktorer utanför Bolagets direkta kontroll som kan påverka detta, såsom behovet av och tidpunkten för regulatoriska godkännanden och tillstånd från etikprövningsnämnder, tillgång till patienter och studieplatser samt överväganden hos Bolagets samarbetspartners.”

Annual report 2024A · The company itself

“Risker som rör myndighetstillstånd och registrering Bolaget måste erhålla, bibehålla och efterleva myndighetstillstånd och övriga regulatoriska tillstånd från relevanta myndigheter för fortsatt utveckling och potentiell kommersialisering av sina produktkandidater. Även om Bolaget har erhållit särläkemedelsstatus i USA för Tesomet avseende HO och PWS kan det komma att ansöka om särläkemedelsstatus eller andra regulatoriska beteckningar för ytterligare någon av sina nuvarande eller framtida produktkandidater.”

Annual report 2024A · The company itself

“För att få genomföra prekliniska och kliniska studier och/eller för att marknadsföra och sälja läkemedelsprodukter måste registrering ske och tillstånd erhållas från relevanta myndigheter på respektive marknad, såsom exempelvis Food and Drug Administration (”FDA”) i USA och European Medicines Agency (”EMA”) inom EU. Att erhålla erforderliga tillstånd från FDA och EMA eller andra jämförbara utländska myndigheter är kostsamt, tidskrävande och till sin natur osäkert vad gäller resultatet.”

Annual report 2024A · The company itself

“Som exempel kan nämnas att Bolagets produkt, tesofensin, har varit föremål för regulatoriskt godkännande i fem år, delvis beroende på att tillsynsmyndigheten i Mexiko har tagit längre tid på sig än de lagstadgade tidsramarna för att fatta beslut om ansökningar om marknadsgodkännande.”

Annual report 2024A · The company itself

“Utvecklingen av Bolagets program kan komma att försenas eller förhindras om exempelvis Bolaget eller dess samarbetspartners inte anses uppfylla gällande krav för kliniska studier eller läkemedelstillverkning eller om myndig-heter gör andra bedömningar än Bolaget och dess samarbetspartners i fråga om tolkning av klinisk studiedata. I sådana fall kan Bolaget behöva genomföra ytterligare kliniska prövningar, tillhandahålla ytterligare data och information och uppfylla ytterligare standarder för myndighetsgodkännande vilket kan vara kostsamt och tidskrävande.”

Annual report 2024A · The company itself

“Den långa processen för att erhålla godkännande samt oförutsebarheten i framtida kliniska prövningsresultat kan leda till att Bolaget misslyckas med att erhålla myndighetsgodkännande för att kommersialisera någon av sina produktkandidater, vilket avsevärt skulle skada Bolagets framtidsutsikter och intjäningsförmåga. Vidare är ett erhållet myndighetsgodkännande av Bolagets produktkandidater i en jurisdiktion inte någon garanti för ett myndighetsgodkännande i någon annan jurisdiktion.”

Annual report 2024A · The company itself

“KLINISKA STUDIER • USA I december 2024 kunde bolaget meddela att fas IIIstudien INSPiRE-ICU 1 uppnått sitt primära effektmått: att visa att inhalationssedering med isofluran är en effektiv sederingsmetod genom att uppnå non-inferiority jämfört med intravenös sedering med propofol.”

Annual report 2024A · The company itself

“I början av 2025 mottogs liknande positiva resultat även för bolaget andra studie; INSPiRE-ICU 2.”

Annual report 2024A · The company itself

“I januari 2023 beviljade FDA Fast Track Designation (FTD) för utvärdering av isofluran administrerat via Sedaconda ACD-S för sedering av mekaniskt ventilerade intensivvårdspatienter i USA. Fast Track är en process för att underlätta utveckling och påskynda granskningen av behandlingar som adresserar allvarliga tillstånd och som uppfyller medicinska behov som ännu inte är tillgodosedda.”

Annual report 2024A · The company itself

“Utöver bolagets USA-studier har under de senaste åren en pediatrisk studie genomförts i Europa (IsoCOMFORT), med målet att kunna erbjuda inhalationssedering även till barn. I slutet av 2024 resulterande denna studie i ett positivt besked från myndigheten, och vi går nu vidare med nationella marknadsgodkännanden.Utöver egna kliniska studier stöttar Sedana Medical oberoende forskning inom inhalationssedering.”

Annual report 2024A · The company itself

“Strax därpå kunde Sedana Medical meddela att EMA:s (European Medicines Agency) pediatriska kommitté gett ett positivt besked gällande efterlevnad av den pediatriska utredningsplanen vilket bekräftar data exklusivitet och marknadsskydd för Sedaconda (isofluran) till 2031. Sedana Medical ansökte om en pediatrisk indikation i december 2023 och erhöll i december 2024 positivt besked från myndig heterna i samtliga involverade länder att den pediatriska indika tionen för Sedaconda (isofluran) är redo för godkännande i Europa.”

Annual report 2024A · The company itself

“Mot lansering i USA Med studieprogrammet INSPiRE-ICU som grund avser Sedana Medical att lämna in en ansökan om amerikanskt marknadsgodkännande för Sedaconda ACD och isofluran. Förutsatt ett godkännande från FDA, är målet en potentiell amerikansk lansering 2027.”

Annual report 2024A · The company itself

“Koncernens verksamhet omfattar utveckling, tillverkning och försäljning av medicintekniska produkter och läkemedel samt utveckling av produkter som bygger på eller har synergier med Sedaconda-teknologin för inhalationssedering. Teknologin möjliggör enkel och säker omvandling av flytande vätska till gas (förgasning) och återanvändning (reflektering) av flyktiga anestetika för användning inom anestesi- och intensivvård. Koncernens produktportfölj omfattar i dagsläget Sedaconda ACD med tillbehör samt Sedaconda (isofluran), koncernens läkemedel som bygger på den välkända substansen isofluran.”

Annual report 2024A · The company itself

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

Annual report 2025A · The company itself

“Läkemedels- och marknadsgodkännande Innan lansering måste varje läkemedel uppfylla de stränga krav på kvalitet, säkerhet och effekt som myndigheterna ställer. Ett misslyckande kan leda till en försenad eller inställd lansering och kan väsentligt negativt påverka verksamheten och den finansiella ställningen.”

Annual report 2024A · The company itself

“EU-kommissionen beviljade marknadsgodkännande för Altuvoct i juni 2024, två månader tidigare än förväntat. Kommissionen följde också EMA:s rekommendation om bibehållen särläkemedelsstatus för Altuvoct som ger tio års marknadsexklusivitet.”

Annual report 2024A · The company itself

“I augusti 2024 lämnade Sobi in en ansökan om marknadsgodkännande för Doptelet till den japanska läkemedelsmyndigheten vid behandling av ITP. I december 2024 validerade FDA inlämnandet av en tilläggsansökan (sNDA) för användning av Doptelet i en pediatrisk population.”

Annual report 2024A · The company itself

“I mars 2024 erhöll Sobi FDA:s beviljande av Under 2024 uppnåddes många milstolpar inom den kliniska utvecklingen.”

Annual report 2024A · The company itself

“Risker relaterade till myndighetstillstånd och registrering För att bolaget ska kunna genomföra kliniska studier samt marknadsföra och/eller sälja läkemedel måste tillstånd erhållas och registrering ske hos berörda myndigheter på respektive marknad, exempelvis Läkemedelsverket i Sverige, den amerikanska läkemedelsmyndigheten Food and Drug Administration (FDA) och europeiska läkemedelsmyndigheten (EMA) inom EU. Att erhålla erforderliga tillstånd är tids- och kostnadskrävande och till sin natur osäkert vad gäller resultat, vilket kan fördyra, försena eller förhindra utvecklingen av SynActs läkemedelskandidater, inklusive bolagets huvudsakliga läkemedelskandidat resomelagon.”

Annual report 2024A · The company itself

“Även synpunkter på SynActs föreslagna upplägg på kommande kliniska studier kan leda till förseningar och/eller ökade kostnader för bolaget, och SynAct skulle kunna behöva genomföra ytterligare kliniska prövningar, tillhandahålla ytterligare data och information och uppfylla ytterligare standarder för myndighetsgodkännande vilket kan vara kostsamt och tidskrävande. Vidare kan gällande regler och tolkningar av dessa komma att ändras, vilket kan komma att påverka bolagets förutsättningar för att uppfylla myndighetskrav i framtiden.”

Annual report 2024A · The company itself

“Other Laws and Regulations Our operations, and some of the products and services we offer, are subject to a number of complex and stringent laws and regulations governing the development, testing, approval, production, handling, transportation and distribution of chemicals, drugs and other similar products, including the operating and security standards of the Food and Drug Administration, the Drug Enforcement Administration, the Bureau of Alcohol, Tobacco, Firearms and Explosives, and various state boards of pharmacy as well as comparable state and foreign agencies.”

Annual report 2025A · The company itself

“For example, we manufacture pharmaceuticals and many of our instruments are marketed to the pharmaceutical industry for use in discovering and developing drugs. Changes in the U.S. Food and Drug Administration’s (the FDA) regulation of the drug discovery and development process could have an adverse effect on the demand for these products, and increased FDA regulation of laboratory-developed tests could delay and add to the cost of commercialization of these products, as well as subject us to additional regulatory controls.”

Annual report 2025A · The company itself

“Life Sciences Solutions Segment Through our Life Sciences Solutions segment, we provide an extensive portfolio of reagents, instruments and consumables used in biological and medical research, discovery and production of new drugs and vaccines as well as diagnosis of disease. These products and services are used by customers in pharmaceutical, biotechnology, agricultural, clinical, healthcare, academic, and government markets.”

Annual report 2025A · The company itself

“The research and development, clinical testing, manufacture and marketing of some of our tenants’ products require federal, state and foreign regulatory approvals. The approval process is typically long, expensive and uncertain.”

Annual report 2025A · The company itself

“For example, in December 2024 the FDA issued a warning letter and import alert related to our oral finished dose manufacturing facility in Indore, India. The warning letter and import alert restrict our ability to distribute certain products into the U.S. and have also negatively impacted our ability to sell products made at this facility to customers in other regions. The warning letter and import alert at our Indore facility negatively impacted our financial condition, results of operations and cash flows in fiscal year 2025, and we may not be able to fully recover these lost revenues in current or future periods.”

Annual report 2025A · The company itself

“Reductions in personnel at the FDA or other health agencies as a result of changing legislative or regulatory priorities could result in slower response times or reduced resources and, as a result, review of regulatory submissions, inspections, resolution of warning letters or import alerts, approval of new products and other timelines important to our business may be materially impacted, which could have a material adverse effect on our business.”

Annual report 2025A · The company itself

“The process of obtaining regulatory approval to manufacture and market new branded and generic pharmaceutical products is rigorous, time consuming, costly, and inherently unpredictable. In addition, these regulatory agencies may be delayed in reviewing and approving products as a result of lapsed or insufficient funding, insufficient staffing, travel or work restrictions, or other factors beyond our control.”

Annual report 2025A · The company itself

“Such studies, which increasingly employ sophisticated methods and techniques, can call into question the utilization, safety, and efficacy of previously marketed as well as future products. In some cases, such studies have resulted, and may in the future result, in the discontinuation or variation of product marketing authorizations or requirements for risk management programs, such as a patient registry.”

Annual report 2025A · The company itself

“If we, our partners and suppliers, or our products or brands suffer from negative publicity, are subject to market withdrawal or recall or are proven to be, or are claimed to be, ineffective or harmful to consumers, then this could have a material adverse effect on our reputation and business. Negative publicity related to the receipt of a warning letter, import alert, or similar restrictions from the FDA or other regulatory authorities, such as the restrictions at our Indore facility, have damaged and could continue to damage our reputation among customers, lead customers to seek other suppliers of our products, or lead to additional inquiries from other regulatory authorities.”

Annual report 2025A · The company itself

“In addition, actual or alleged quality deficiencies in the products which we or our suppliers provide, or at our or their manufacturing facilities, including with respect to warning letters and import alerts, for example at our Indore facility, have in the past and could in the future adversely impact our manufacturing and supply capabilities, cause supply interruptions, or lead to voluntary market withdrawals or product recalls.”

Annual report 2025A · The company itself

“The regulatory approval processes of the U.S. Food and Drug Administration (U.S. FDA), the European Medicines Agency (EMA), and other regulatory authorities can be lengthy and inherently unpredictable.”

Annual report 2025A · The company itself

“We operate under a Manufacturing and Importation Authorization from the Danish Health Authorities, and ongoing evaluation of our quality system is performed through both internal audits and external inspec-tions from relevant health authorities, including the Danish Medicines Agency, the European Medicines Agency, and the U.S. Food and Drug Administration.”

Annual report 2025A · The company itself

“Regarding our corporate and individual employee commu-nications, we follow a strict set of guidelines to ensure that no illegal promotional activities of e.g., clinical candidates, products, or projects, occur. Corporate communication is handled by our Corporate Communications, Media Relations, and Investor Relations departments to ensure compliant and consistent communication to all external stakeholders and to shareholders.”

Annual report 2025A · The company itself

“We embed quality and product governance across the full lifecycle, from clinical development through post marketing, to ensure product quality, protect patients, uphold scientific integrity, and sustain trust. We work in accord-ance with current Good Practice (GxP), through a clearly defined Quality Management System and policy framework that commits us to protecting patient health and safety and ensuring product quality.”

Annual report 2025A · The company itself

“Medical Product and Medical Device Regulation In the U.S., numerous laws and regulations govern the processes by which our products are brought to market. These include the Federal Food, Drug and Cosmetic Act, as amended (“FDCA”), and associated regulations. U.S. Food and Drug Administration (“FDA”) regulations control all aspects of the development, manufacturing, advertising, promotion, marketing, distribution and post-market surveillance of medical products and medical devices.”

Annual report 2025A · The company itself

“The FDA conducts announced and unannounced periodic and on-going inspections of medical device manufacturers to determine compliance with its Quality System, and other applicable, regulations. If in connection with these inspections the FDA believes the manufacturer has failed to comply with applicable regulations and/or procedures, it may issue inspectional observations on Form FDA-483 (“Form 483”) that would necessitate prompt corrective action. If FDA inspectional observations are not addressed and/or corrective action is not taken in a timely manner and to the FDA’s satisfaction, the FDA may issue a warning letter (which would similarly necessitate prompt corrective action) and/or proceed directly to other forms of enforcement action, including the imposition of operating restrictions, including ceasing operations on one or more facilities, enjoining and restraining legal violations pertaining to products, seizing products, negotiating the entry of a consent decree and permanent injunction against us, recommending prosecution to the U.S.”

Annual report 2025A · The company itself

“The paediatric approvals of ACARIZAX ® and ITULAZAX ® added to the tablets’ strong momentum”

Annual report 2025A · The company itself

“The actions and inaction of regulators, including the FDA, can result in competitive challenges. For example, unpredictable and lengthy regulatory review periods complicate efforts to strategize and plan with respect to commercialization of new products, and we cannot predict or influence the speed with which the FDA reviews PMTAs.”

Annual report 2025A · The company itself

“Som tillverkare av medicintekniska produkter styrs Bactiguards verksamhet av de krav och standarder som bestämts av tillsynsmyndigheter på respektive marknad där Bactiguard och bolagets licenspartner bedriver verksamhet och säljer produkter. Regulatoriska processer i olika länder kan innebära en risk för förseningar i processen med att introducera produkter i dessa länder.”

Annual report 2024A · The company itself

“Bolaget har identifierat följande hållbarhetsrisker som de mest centrala: Produktsäkerhet Vi måste leverera säkra produkter till patienter, kunder och hälsovården. Vi följer alla legala och regulatoriska krav vad beträffar kliniska studier, produktutveckling, produktion, varudeklarationer, försäljning och marknadsföring.”

Annual report 2024A · The company itself

“The FDA approved the freeze-dried version of JYNNEOS, supporting the ongoing contract with the U.S. government”

Annual report 2025A · 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

“Data generated after initial approval and regulatory changes to standards regarding safety, efficacy or labeling may result in product label changes or other measures that could reduce the product’s market acceptance and result in declining revenues. These include additional clinical trials, such as head-to-head studies against alternative or emerging standard of care, studies that generate data in specific populations or identify biomarkers (objective characteristics that can indicate a particular response to a product or therapy) as well as real-world data analyses and post-approval safety surveillance following the use of our products over longer periods of time.”

Annual report 2025A · The company itself

“We also offer mission-critical fibre channel storage area networking (“FC SAN”) products and related software in the form of modules, switches and subsystems incorporating multiple semiconductor products.”

Annual report 2025A · The company itself

“Samtidig godkendes der fortsat nye terapier, ligesom stadig flere terapier sættes i produktion”

Annual report 2025A · The company itself

“Strong competition within the pharmacy benefit business has generated greater demand for lower product and service pricing, increased revenue sharing, and enhanced product and service offerings. These competitive factors have historically applied pressure on our operating margins and caused many companies, including us, to reduce the prices charged for products and services while sharing with clients a greater portion of the formulary rebates and related fees received from pharmaceutical manufacturers.”

Annual report 2025A · The company itself

“Principal Products and Services Pharmacy Benefit Services •Pharmacy Benefits. We drive high-quality, cost-effective pharmacy care through a range of services. We adjudicate drug claims from retail network participants and provide retail pharmacy network administration, benefit design consultation, drug utilization review, drug formulary management and other services. ◦Retail Pharmacy Network Administration.”

Annual report 2025A · The company itself

“In particular, the Company's acquisition of GOJO has expanded its portfolio of products subject to FDA oversight, including products regulated as cosmetics and over-the-counter drugs, which are subject to distinct regulatory requirements. Changes in FDA regulations, priorities, or enforcement approaches applicable to these product categories could have a disproportionate impact on the Company's operations.”

Annual report 2025A · The company itself

“The Health Services segment’s revenues are primarily generated from the sale and managing of prescription drugs to eligible members in benefit plans maintained by clients. Pharmaceuticals are provided to eligible members in benefit plans maintained by clients and utilize the Company’s information systems, among other things, to help perform safety checks, drug interaction screening and identify opportunities for generic substitution.”

Annual report 2025A · The company itself

“The profitability of our Pharmacy & Consumer Wellness and Health Services segments is dependent upon the utilization of prescription drug products. We dispense significant volumes of brand name and generic drugs from our retail, specialty and mail order pharmacies, and the retail pharmacies in our PBM’s network also dispense significant volumes of brand name and generic drugs.”

Annual report 2025A · The company itself

“•We are subject to, or otherwise responsible for, a variety of litigation and other legal and regulatory proceedings in the course of our business that can adversely affect our business and financial statements. •With respect to the regulated medical devices we offer, product introductions or modifications can require regulatory clearance or authorizations and we can be required to recall or cease marketing such products; off-label marketing can result in penalties; and clinical trials can have results that are unexpected or are perceived unfavorably by the market, all of which can adversely affect our business and financial statements. •Our operations, products and services also expose us to the risk of environmental, health and safety liabilities, costs and violations that can adversely affect our business and financial statements.”

Annual report 2025A · The company itself

“The global healthcare regulatory environment has become increasingly stringent and unpredictable. Several countries that did not have regulatory requirements for medical devices have established such requirements in recent years, and other countries have expanded, or plan to expand, their existing regulations.”

Annual report 2025A · The company itself

“Our ability to obtain such regulatory clearances or approvals will depend on many factors, for example our ability to obtain the necessary clinical trial results, and the process for obtaining such clearances or approvals could change over time and may require the withdrawal of products from the market until such clearances are obtained. Even after initial regulatory clearance or approval, we are subject to periodic inspection by these regulatory authorities, and when safety issues arise we can be required to amend conditions for use of a product, such as providing additional warnings on the product’s label or narrowing its approved intended use, which could reduce the product’s market acceptance.”

Annual report 2025A · The company itself

“In addition, some of the products we design and develop, including in the automotive and healthcare industries, must satisfy safety and regulatory standards and some must receive government certifications. If we fail to obtain these approvals or certifications on a timely basis, we would be unable to sell these products, which would harm our sales, profitability and reputation.”

Annual report 2026A · The company itself

“There is always a risk that the critical medical hypothesis, efficacy or safety, cannot be supported by data from the development activities”

Annual report 2025A · The company itself

“the FDA has completed its review but cannot approve the application in its current form, as the application does not provide substantial evidence of effectiveness”

Annual report 2025A · The company itself

“Specialistläkemedel hade ett väsentligt mer utmanande år.”

Annual report 2024A · The company itself

“Unimedic marknadsför egna och inlicensierade läkemedel för både barn och vuxna. Bolaget är väletablerat och har en stark position inom flera terapiområden på den nordiska marknaden.”

Annual report 2024A · The company itself

“Koncernen tillverkar och säljer läkemedel samt medicin teknisk utrustning i form av EKG -utrustning, radiologiutrustning, renluftsaggregat och hjälpmedel för personer med funktionsnedsättningar.”

Annual report 2024A · The company itself

“Vår förvärvsstrategi är tydlig: vi söker bolag med starka marknadspositioner, god lönsamhet och en kultur som passar vår decentraliserade affärsmodell.”

Annual report 2024A · The company itself

“Investeringen i en ny maskin för laserskärning och fortsatt uppgradering av produktionsutrustning har bidragit till att förbättra kapaciteten och möta höga krav från kunder inom strukturellt växande segment som livsmedel och läkemedel.”

Annual report 2024A · The company itself

“Wegovy ® pill for weight management approved in the US and submitted in the EU”

Annual report 2025A · The company itself

“Vuonna 2024 kädessä pidettävä tekoälykamera Optomed Aurora AEYE sai Yhdysvaltain Food and Drug Administrationin (FDA:n) hyväksynnän, mikä mahdollisti tuotteen myynti ja markkinointitoimet Yhdysvalloissa. Vuoden 2025 aikana Optomed on keskittynyt erityisesti USA:n markkinaan ja Aurora-AEYE:n myyntiin.”

Annual report 2025A · The company itself

“Innan en medicinteknisk produkt kan lanseras på marknaden måste kliniska studier genomföras. Kraven på sådana studier varierar mellan olika geografiska marknader. Kliniska studier är kostnads- och tidskrävande och förenade med risker såsom svårigheter i att hitta kliniska samarbetsparter och samla in tillräckliga mängder patientprover, att kostnaderna för studien överskrider budget och att de kliniska samarbetsparterna brister i utförande av studien.”

Annual report 2024A · The company itself

“Bolaget är skyldigt att uppfylla regulatoriska krav, innefattande erhållande av regulatoriskt godkännande enligt tillämpliga lagar och regler, innan Bolaget kan marknadsföra och sälja sina produkter på respektive marknad. Processen för att erhålla regulatoriskt godkännande för medicintekniska produkter kan vara lång, omfattande och osäker.”

Annual report 2024A · The company itself

“Godkännandeprocessen för medicintekniska produkter varierar mellan olika länder och sjukvårdssystem, vilket innebär att det kan vara svårt för Bolaget att förutsäga vilka resurser i form av tid och kostnader som kommer att krävas för att erhålla produktgodkännande, inte minst vid eventuell lansering av produkter utanför Europa och USA (som är Bolagets tilltänkta huvudmarknader för ASTar). Om Bolaget inte lyckas erhålla godkännande för ASTar eller framtida produkter på relevanta marknader (i tid eller överhuvudtaget), eller inte lyckas behålla sådana godkännanden, kan marknadsföringen och försäljningen av ASTar och eventuella framtida produkter försenas eller utebli på vissa marknader, vilket skulle kunna få väsentligt negativa effekter för Bolagets verksamhet, finansiella ställning och resultat.”

Annual report 2024A · The company itself

“Healthcare Regulations The manufacture, sale, lease, and service of medical diagnostic and surgical devices intended for commercial use are subject to extensive governmental regulation by the Food and Drug Administration (“FDA”) in the U.S. and by a variety of regulatory agencies in other countries for some of our businesses. Under the Federal Food, Drug, and Cosmetic Act, known as the FD&C Act, manufacturers of medical products and devices must comply with certain regulations governing the design, testing, manufacturing, packaging, servicing, and marketing of medical products.”

Annual report 2025A · The company itself

“The European Union enacted the European Union Medical Device Regulation in May 2017 with an original effective date of May 2022, which imposes stricter requirements for the marketing and sale of medical devices, including in the areas of clinical evaluation requirements, quality systems, labeling and postmarket surveillance. Extended transition timelines were published in 2023 which range from May 2026 through December 2028 depending on the type of device and we are on track to meet these timelines.”

Annual report 2025A · The company itself

“We manufacture instruments that are used by pharmaceutical scientists to evaluate the release rate characteristics and physical properties of various dosage forms to ensure the safety and efficacy of medicines worldwide.”

Annual report 2025A · The company itself

“The FDA can employ several tools to facilitate the development of certain drugs or expedite certain applications, including fast track designation, Breakthrough Therapy designation, regenerative medicine advanced therapy designation, priority review, accelerated approval, incentives for orphan drugs developed for rare diseases and others.”

Annual report 2025A · The company itself

“For example, as part of FDA approval for CASGEVY, we are required to conduct post-marketing safety studies to assess certain long-term risks associated with the treatment.”

Annual report 2025A · The company itself

“In January 2026, we secured reimbursed access to CASGEVY for eligible people with SCD in Scotland, consistent with the reimbursement agreement reached in 2025 for people with TDT. •We expect to begin global regulatory submissions for approvals for CASGEVY in children 5 to 11 years of age, in the first half of 2026. The FDA awarded Vertex with a Commissioner’s National Priority Voucher for this pediatric submission, indicating an accelerated timeline for review once the submission is complete.”

Annual report 2025A · The company itself

“We expect to release interim analysis data in the first half of 2026 and we expect to complete the submission in the first half of 2026, if data from the interim analysis are supportive.”

Annual report 2025A · The company itself

“Life science är redan idag en mycket stark sektor i Danmark. I Danmarks life science-strategi, som presenterades i november, finns ett mål om att exporten av life science-produkter ska fördubblas till 350 miljarder danska kronor till 2030.”

Annual report 2024A · The company itself

“Under 2024 förvärvade XANO Graniten Engineering, en ledande aktör inom högteknologiska automationslösningar för kunder inom främst läkemedel och medicinteknik i Europa.”

Annual report 2024A · The company itself

“Förutsättningarna inom läkemedel och medicinteknik har stabiliserats men beslutsprocesserna är ofta utdragna.”

Annual report 2024A · The company itself

“Huvuddelen av verksamheten omfattar utveckling och tillverkning av automationslösningar för produktionslinjer inom sektorer som förpackning, livsmedel och läkemedel.”

Annual report 2024A · The company itself

“Kunderna finns huvudsakligen i Europa och utgörs av ledande företag inom läkemedel och medicinteknik samt hälso- och sjukvård.”

Annual report 2024A · The company itself

“Vidare skickade vi åter in ansökan om marknadsgodkännande till FDA i december 2024. Vi förväntar oss att FDA fastställer ett BsUFA-datum i april 2025, även om det råder osäkerhet kring huruvida en återinspektion av produktionsanläggningen kommer att krävas. Vår förhoppning är att erhålla ett godkännande under mitten av året och kommer att uppdatera marknaden i april, då vi förväntar oss mer klarhet i frågan.”

Annual report 2024A · The company itself

“FDAs granskning av bolagets ansökan om marknadsgodkännande för Dasynoc ® är pågående vid denna årsredovisnings publicering. I ett så kallat Complete response letter (CRL), som bolaget erhöll i juli 2024, efterfrågade FDA information till följd av den inspektion som genomförts på tredjeparts tillverkningsanläggning i juni 2024 samt ytterligare information om hur läkemedlet ska märkas.”

Annual report 2024A · The company itself

“De affärsmässiga riskerna är främst kopplade till utvecklingsarbetet. Om de bioekvivalensstudier på friska försökspersoner som Xspray Pharma utför inte påvisar bioekvivalens, eller om säkerhetsprofilen inte godkänns av myndigheter finns det en risk för förseningar.”

Annual report 2024A · The company itself

“The European Medicines Agency (EMA) is the centralized medicines regulatory agency of the EU. The agency is responsible for the scientific evaluation of medicines developed by healthcare companies seeking centralized approval for use in the EU. The agency has a distinct veterinary review section. The Committee for Veterinary Medicinal Products (CVMP) is responsible for scientific and technical review of the submissions for innovative pharmaceuticals, biopharmaceuticals and vaccines.”

Annual report 2025A · The company itself

“Reglering och regelefterlevnad ökar inom en bred palett; miljö- och hälsoskydd (EHS), ESG (hållbarhet), IT-reglering, företagsförvärv, konkurslagstiftning, läkemedelslagstiftning och offentlig verksamhet.”

Annual report 2024A · The company itself

“For example, regulatory changes with respect to life sciences advertising, such as limitations on or the elimination of the ability of pharmaceutical companies to engage in direct-to-consumer advertising, could negatively impact certain of our product offerings, including our Crossix business.”

Annual report 2026A · The company itself