Coloplast

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

Annual report 2025A · The company itself

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

Annual report 2025A · The company itself

“Our chronic business areas are characterised by solid reimbursement (more than 90% of sales covered by reimbursement), risk of healthcare reforms, and a stable competitive environment.”

Annual report 2025A · The company itself

“In the US, the recent opening of Medicare reimbursement creates a multi-year opportunity to expand access, as all Medicare-covered patients become eligible for transanal irrigation.”

Annual report 2025A · The company itself

“Sales to hospital systems are not directly reimbursement driven, as hospitals pay for Biologics products from diagnoses related payments from insurance companies. In the out-patient segment Biologics enjoys wide product specific reimbursement coverage from public and private insurers, with future growth being dependent on continued coverage.”

Annual report 2025A · The company itself

“HyperlinkHy perlinkHyper linkHyperlink Hyperlink Other matters Proposed update to DMEPOS Competitive Bidding Program announced by CMS On June 30, 2025, the Centers for Medicare and Medicaid Services (CMS) in the US announced a proposed rule 1) , which, among other, included an update on the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program (CBP). The commenting period ended August 29, 2025 and we expect an update to be published in late 2025, and for any potential changes to take effect at the earliest in 2028 based on internal assessment.”

Annual report 2025A · The company itself

“Expected changes to skin substitutes coverage and payment in the US out-patient setting as of January 1, 2026 As of January 1, 2026 we expect two new policies to be implemented in the skin substitutes outpatient setting; the Local Coverage Determination (LCD) 2) policy and the Calendar Year 2026 Medicare Physician Fee Schedule 3) . Around 20% of Kerecis total revenue comes from the out-patient setting and is covered by Medicare. Kerecis currently has two product brands, MariGen® and Shield®, affected by CMS payment and coverage policies, with a current average price for the outpatient setting of $110/cm .”

Annual report 2025A · The company itself

“On October 31, 2025 the CMS announced a finale rule on the Calendar Year 2026 Medicare Physician Fee Schedule, where the Average Selling Price (ASP) pricing model for the physicians private office in the outpatient setting is replaced by a fixed payment of $127.28/cm for all products effective January 1, 2026.”

Annual report 2025A · The company itself

“Pricing and reimbursement A large part of Coloplast’s products is sold in markets that are subsidised and eligible for reimbursement from healthcare authorities. As a result, prices are influenced by the economic and political developments in national and regional markets, budgetary constraints of governments, healthcare reforms, bargaining power of wholesalers and distributors, as well as the ability to convince buyers of the economic value of its products based on clinical evidence, costs, and patient outcomes. • Lower reimbursements and increasing price pressure due to healthcare and price reforms. • Lack of or inadequate clinical evidence to support reimbursement levels. • Claw back or other repayment schemes introduced by healthcare authorities retroactively. • Biologics is not getting the local coverage determination (LCD) reimbursement coverage.”

Annual report 2025A · The company itself

“MDR certification of product portfolio within Voice & Respiratory Care in newly acquired businesses The European Medical Device Regulation (EU MDR) ensures medical devices sold in Europe are safe and effective, requiring Coloplast to meet specific requirements before marketing. This necessitates increased documentation and reporting to demonstrate compliance.”

Annual report 2025A · The company itself

“In adverse events related to product health and safety, we engage directly with authorities and affected consumers or end-users, following legislation and formal processes.”

Annual report 2025A · The company itself

“Other policies supporting Coloplast’s business conduct Global Anti-Bribery, Anti-Corruption and Anti-Money Laundering Policy The global policy ensures Coloplast’s business practices are compliant with anti-bribery, anticorruption and anti-money laundering laws, as well as Coloplast policies and guidance on how to identify and combat anti-bribery, anti-corruption, and anti-money laundering risks. It applies to all directors, officers, managers, employees and contract workers employed within the Coloplast Group as well as third parties acting on behalf of Coloplast, whether directly or indirectly.”

Annual report 2025A · The company itself

“Coloplast is committed to continuously reducing emissions across all activities, from sourcing raw materials to product disposal.”

Annual report 2025A · The company itself

“Coloplast’s targets for resource use and circular economy were defined by the Strive25 strategy. They applied from 2019/20 to 2024/25, which makes this year the final year, completing our targets concerning packaging and waste.”

Annual report 2025A · The company itself

“For the Strive25 period, we invested DKK 245 million in sustainability initiatives from 2022 to 2025. DKK 100 million was dedicated to Capex for phasing out natural gas and transitioning to renewable energy, while DKK 150 million covered Opex for staffing.”

Annual report 2025A · The company itself

“Coloplast’s Supplier Sustainability Programme has been implemented as part of our decarbonisation levers, focusing on improving data quality, encouraging target setting among our topemitting suppliers and integrating climate action requirements into supplier contracts.”

Annual report 2025A · The company itself

“Currently, our plastic usage mainly consists of fossilbased virgin materials for safety and quality reasons. To transition, we need to identify new materials and support the development of sustainable technologies.”

Annual report 2025A · The company itself

“People living with intimate healthcare conditions are particularly vulnerable to health impacts, and depend on the quality of information supplied by Coloplast.”

Annual report 2025A · The company itself

“Our advanced dressings and biologics products are both used for the treatment of wounds. This includes a variety of wound types: chronic wounds (diabetic foot ulcers, venous leg ulcers, pressure ulcers), acute wounds (surgical and trauma wounds) and burn wounds.”

Annual report 2025A · The company itself

“With our PVC and PVdC Policy, Coloplast is committed to using chlorine-free polymers in new products and using PVC or PVdC only when essential for product performance. We aim to modify existing products to replace these materials when possible.”

Annual report 2025A · The company itself

“Coloplast’s targets for resource use and circular economy were defined by the Strive25 strategy. They applied from 2019/20 to 2024/25, which makes this year the final year, completing our targets concerning packaging and waste.”

Annual report 2025A · The company itself

“90% of packaging is recyclable 80% of packaging consists of renewable materials 75% of production waste is recycled 1) The unit in which the targets are measured is percentage.”

Annual report 2025A · The company itself

“Coloplast initiated a preventative and voluntary product return in Q3 of all Biatain® Adhesive foam dressings in China, following a local inspection where three product lots did not meet a technical requirement. Product safety was not compromised, and the dressings continue to meet standards in other markets.”

Annual report 2025A · The company itself

“In Kidney & Bladder Health, the thulium fiber laser, Coloplast TFL Drive continued to deliver a solid growth contribution, however, the segment overall detracted significantly from growth in full year 2024/25, impacted by the voluntary product recall. The impact of the product recall amounted to around DKK 85 million in full year 2024/25, of which around DKK 15 million in Q4.”

Annual report 2025A · The company itself

“The primary packaging is closely tied to their clinical performance, offering essential functionalities like usability and sterility. This connection makes packaging innovation complex in the medical device industry.”

Annual report 2025A · The company itself

“With the wound & tissue repair business, Coloplast is combining advanced wound dressings and Kerecis biologics to create a more comprehensive and clinically differentiated offering within Wound & Tissue Repair. The business is built on Coloplast’s established infrastructure and reputation in Europe and Emerging Markets, complemented by Kerecis’ innovation engine and robust US footprint.”

Annual report 2025A · The company itself

“Over the Impact4 period, we expect the new Wound & Tissue Repair unit to deliver around double-digit organic revenue growth and profitability improvement, underpinned by disciplined execution, clinical evidence, and a strong innovation engine.”

Annual report 2025A · The company itself

“In Women’s Health the strategy centers on transformation through the anticipated launch of Intibia™ in 2026/27, pending FDA approval. Intibia is designed to offer a minimally invasive, durable therapy for overactive bladder, expanding third-line treatment options.”

Annual report 2025A · The company itself

“Growth in this segment is supported by the thulium fiber laser, Coloplast TFL Drive and a disciplined approach to portfolio management.”

Annual report 2025A · The company itself

“In managing material impacts on product quality and safety, direct engagement with consumers and endusers is not the primary focus of our quality processes. However, their perspectives shape health and safety management in post-market surveillance and clinical evaluation studies.”

Annual report 2025A · The company itself

“For all market-released products, we conduct usability studies and clinical evaluations on safety and usage with test populations reflecting our consumers and end-users. These inform design corrections as needed.”

Annual report 2025A · The company itself

“Coloplast's post-market surveillance (PMS) ensures medical device safety and quality throughout its lifecycle. It involves collecting and analysing data on performance, quality, and safety from complaints, clinical data, and market feedback.”

Annual report 2025A · The company itself

“Through quality control, we take proactive measures to prevent negative safety impacts on consumers and end-users, ensuring products meet global safety and performance standards. The quality controls cover our downstream activities globally.”

Annual report 2025A · The company itself

“We take appropriate measures to limit the use of animal testing and discomfort. Therefore, we have a Global Animal Testing Policy dedicated to ensuring commitment to conduct business ethically and with the highest integrity in all its operations.”

Annual report 2025A · The company itself

“Wound & Tissue Repair includes three businesses: advanced dressings, biologics and contract manufacturing. Advanced dressings are the largest business, accounting for around 55% of the total Wound & Tissue Repair sales, while biologics is the second largest business, accounting for around 35% of sales. The remaining 10% of sales are derived from the contract manufacturing of plasters for blisters and cold sores.”

Annual report 2025A · The company itself

“Our portfolio consists of the brands Biatain® Silicone, an advanced foam dressing with a 3DFit Technology, Biatain Superabsorber, Biatain Fiber, Biatain and Comfeel®.”

Annual report 2025A · The company itself

“Most xenografts are derived from porcine or bovine skin, while Kerecis is the only company that markets products based on fish-skin. The patented fish-skin technology that Kerecis has developed is gently processed, clinically differentiated, sustainable, and scalable. The absence of viral disease transmission risk from cold water fish to humans allows for gent processing preserving and the natural structure and components of the skin, with natural elements such as proteins, elastin, glycans and lipid structures remaining intact. This results in a product that is highly similar to human skin, which is a key enabler of improved wound and tissue healing and documented by a compelling body of clinical evidence.”

Annual report 2025A · The company itself

“Titan® Touch, an inflatable penile implant for the management of erectile dysfunction.”

Annual report 2025A · The company itself

“In Women’s Health, Coloplast markets vaginal slings, used to restore continence, and synthetic mesh products, used to treat a weak pelvic floor. Key brands within this segment are Altis® and Restorelle®.”

Annual report 2025A · The company itself

“Within Kidney & Bladder Health, Coloplast offers solutions for kidney stone disease, bladder drainage, voiding dysfunction and prostate disorders. Solutions include flagship brands that provide capital equipment and a comprehensive portfolio of single-use devices.”

Annual report 2025A · The company itself

“In 2022, Coloplast launched its first laser equipment, the thulium fiber laser, Coloplast TFL Drive, for the surgical treatment of kidney stones via ureteroscopy.”

Annual report 2025A · The company itself

“In 2026/27, we expect to enter a fourth segment - the overactive bladder (OAB) segment - with the launch of Intibia™, our implantable tibial nerve stimulator, an Investigational device currently under development with premarket approval submission to the FDA expected in 2025/26. Our anticipated entry into the overactive bladder market will significantly increase the addressable market. The market for third-line therapies for overactive bladder is estimated at around USD 1 billion, with high single-digit growth.”

Annual report 2025A · The company itself

“Revenue from Kerecis amounted to DKK 1,254 million in full year 2024/25, with organic growth of 24%. Growth was broad-based, with continued market share gains and solid contributions across settings.”

Annual report 2025A · The company itself

“In the DMA, and in the context of our products and waste, we considered Ostomy Care, Interventional Urology, Continence Care, Voice & Respiratory Care, and Wound & Tissue Repair as the business areas associated with the impacts and risks.”

Annual report 2025A · The company itself

“Running from February 2024 to June 2025, the SpeediCath Short project sought to launch a shorter version of the SpeediCath® Standard female catheter. The project aimed to launch a product using less material compared to the SpeediCath Standard product range.”

Annual report 2025A · The company itself

“Material reduction and promoting circularity with Luja TM female Luja female is the first and only female intermittent catheter with Micro-hole Zone Technology, enabling complete bladder emptying in one free flow and reducing the risk of urinary tract infections.”

Annual report 2025A · The company itself

“The integration of Atos Medical is progressing according to plan and will be finalised in 2025/26. geographical revenue split 65% 24% 11% 2.3 bn Reported revenue in DKK for 2024/25 % % Reported growth in DKK Reported revenue included a negative effect from FX rates HyperlinkHy perlinkHyper linkHyperlink Hyperlink An introduction to Acute Care Acute Care commercial model Acute Care is our newly formed business unit, which includes Wound & Tissue Repair and Interventional Urology. In Acute Care, we serve patients with acute or temporary conditions within treatment areas characterised by premium products, in Interventional Urology within Men and Womens health with products such as Coloplast’s penile implants and the to be launched Intibia™ for stress urinary incontinence, the Kerecis fish-skin portfolio, and our wound dressings.”

Annual report 2025A · The company itself

“Coloplast is present in three segments of the Interventional Urology market: Men’s Health, Women’s Health, and Kidney & Bladder Health.”

Annual report 2025A · The company itself

“Sales to hospital systems are not directly reimbursement driven, as hospitals pay for Biologics products from diagnoses related payments from insurance companies. In the out-patient segment Biologics enjoys wide product specific reimbursement coverage from public and private insurers, with future growth being dependent on continued coverage.”

Annual report 2025A · The company itself

“We seek to enhance access to care across our business areas and geographies. By promoting reimbursement schemes, we positively impact consumers and end-users, aiming to eliminate barriers for those with intimate healthcare needs.”

Annual report 2025A · The company itself

“In the financial year 2024/25, we continued to deliver on our mission as we helped more than two million users worldwide, while simultaneously progressing on our sustainability ambition to reduce emissions, especially scope 1 and 2.”

Annual report 2025A · The company itself

“In 2024/25, we supported over two million users across 140 countries and welcomed more than 260,000 new participants to our patient support programmes Coloplast Care and Atos Care.”

Annual report 2025A · The company itself

“Management’s Report | Business model and strategy | Group Strategy HyperlinkHy perlinkHyper linkHyperlink Hyperlink An introduction to Chronic Care Chronic Care commercial model Chronic Care is our largest business unit, which includes Ostomy Care, Continence Care, and Voice & Respiratory Care. In Chronic Care we serve users with chronic conditions, where products are mostly used after discharge from the hospital.”

Annual report 2025A · The company itself

“Underlying conditions, users and products In Ostomy Care we serve users with a stoma. A stoma is a surgically created opening in which part of the digestive or urinary system is redirected to an opening in the abdominal wall, allowing output to be removed from the body.”

Annual report 2025A · The company itself

“In Continence Care, Coloplast helps people that have bladder control issues related to urinary retention and incontinence, as well as people that are unable to control bowel movements. Within Continence Care, Intermittent Catheters is the largest category, accounting for around 70% of total sales.”

Annual report 2025A · The company itself

“Coloplast is the market leader in Laryngectomy care.”

Annual report 2025A · The company itself

“The integration of Atos Medical is progressing according to plan and will be finalised in 2025/26. geographical revenue split 65% 24% 11% 2.3 bn Reported revenue in DKK for 2024/25 % % Reported growth in DKK Reported revenue included a negative effect from FX rates HyperlinkHy perlinkHyper linkHyperlink Hyperlink An introduction to Acute Care Acute Care commercial model Acute Care is our newly formed business unit, which includes Wound & Tissue Repair and Interventional Urology. In Acute Care, we serve patients with acute or temporary conditions within treatment areas characterised by premium products, in Interventional Urology within Men and Womens health with products such as Coloplast’s penile implants and the to be launched Intibia™ for stress urinary incontinence, the Kerecis fish-skin portfolio, and our wound dressings.”

Annual report 2025A · The company itself

“Coloplast is present in three segments of the Interventional Urology market: Men’s Health, Women’s Health, and Kidney & Bladder Health.”

Annual report 2025A · The company itself

“Within Women’s Health, women are treated for pelvic organ prolapse and stress urinary incontinence.”

Annual report 2025A · The company itself

“In the DMA, and in the context of our products and waste, we considered Ostomy Care, Interventional Urology, Continence Care, Voice & Respiratory Care, and Wound & Tissue Repair as the business areas associated with the impacts and risks.”

Annual report 2025A · The company itself

“Coloplast products are used for intimate healthcare and are disposed of as domestic waste.”

Annual report 2025A · The company itself

“We define consumers of our products as the individuals who use our products for personal use. This includes, but is not limited to, people living with an ostomy, people who have bladder control issues, people who have lost the ability to control bowel movements, people living with a laryngectomy or tracheostomy, patients in need of wound treatment, and people with various urological conditions.”

Annual report 2025A · The company itself

“We define end-users of our products as healthcare professionals who typically use the products to treat patients. Examples of endusers include surgeons, nurses, urologists etc.”

Annual report 2025A · The company itself

“In 2026/27, we expect to enter a fourth segment - the overactive bladder (OAB) segment - with the launch of Intibia™, our implantable tibial nerve stimulator, an Investigational device currently under development with premarket approval submission to the FDA expected in 2025/26. Our anticipated entry into the overactive bladder market will significantly increase the addressable market. The market for third-line therapies for overactive bladder is estimated at around USD 1 billion, with high single-digit growth.”

Annual report 2025A · The company itself

“Across all markets, we partner with healthcare professionals, key opinion leaders, patient associations, and payers to define standards, secure reimbursement, and ensure access to high-quality solutions.In our largest markets - the UK, US, France, and Germany - we complement this with direct-to-user engagement.”

Annual report 2025A · The company itself

“The US represents our largest growth opportunity, with a market share of 15–20% versus 35–40% globally. We aim to win across the patient pathway in the US through stronger commercial execution, improved access in acute and post-acute accounts, and targeted innovation, including SenSura Mio two-piece click coupling and SenSura Mio in black.”

Annual report 2025A · The company itself

“Today, Bowel Care represents less than 5% of our Chronic Care sales in the US, although we hold nearly 100% market share in this segment.”

Annual report 2025A · The company itself

“From a geographical perspective, growth was broadbased, driven by Europe and the US.”

Annual report 2025A · The company itself

“Today, Coloplast is present in the advanced dressings market in Europe and Emerging Markets, while our presence in the US dressings market is limited.”

Annual report 2025A · The company itself

“The biologics tissue segment consists of tissue-derived products, which are used to mimic the form and function of human tissue and thus support wound closure and tissue repair. The biologics segment is US-centric, with good availability of reimbursement and a solid level of clinical acceptance in the US.”

Annual report 2025A · The company itself

“From a geographical perspective, the strategy is focused on building US market share for the combined portfolio, with North America expected to account for around 60% of total revenues by the end of the strategy period. Within Biologics, around 70% of the US sales are to hospitals, while remaining around 30% are to outpatient clinics.”

Annual report 2025A · The company itself

“From a geographical perspective, Kerecis continues to be almost exclusively a US business.”

Annual report 2025A · The company itself

“The Men’s Health business in the US delivered a strong year and was the main contributor to growth. Our flagship product within Men’s Health, the Titan® penile implant, continued to perform well, with the patient funnel positively impacted by our patient support programme targeted at prospective patients.”

Annual report 2025A · The company itself

“The product was launched in May 2024, and is already available in several European countries, Australia and the United States.”

Annual report 2025A · The company itself

“Workers' performance can be negatively impacted by EHS and labour conditions, which could lead to situations of supply or distribution interruptions due to strikes or turnover contagion.”

Annual report 2025A · The company itself

“To manage the material impacts and risks associated with the workers in our value chain, we require our suppliers and distributors to adhere to our Global Human Rights Policy and Codes of Conduct.”

Annual report 2025A · The company itself

“It outlines the expectations for compliance concerning material topics, including ensuring equal treatment and promoting diversity, requiring fair compensation and reasonable working hours, and ensuring safe working environments.”

Annual report 2025A · The company itself

“The general process for engagement with our value chain workers is primarily done through the supplier third-party audit programme in high-risk countries. The programme addresses actual and potential impacts.”

Annual report 2025A · The company itself

“Currently, we do not have any strategic targets to track the effectiveness of our policies and actions regarding our workers in the value chain.”

Annual report 2025A · The company itself

“At Coloplast, the sales and marketing, as well as regulatory functions, may face certain challenges related to corruption and bribery, given the nature of our industry; however, we ensure all employees are trained in Coloplast BEST and as part of the Strive25 strategy, we aimed for 100% of white collars trained in the code.”

Annual report 2025A · The company itself

“Our Supplier Code of Conduct outlines our expectations to all Coloplast’s suppliers and sets out requirements and expectations for their business ethics and compliance with labour and human rights. For high-risk approved and conditionally approved Bill of Materials (BOM) suppliers, Contract Manufactures and Upstream Distributors we conduct audits and inspections to verify compliance with the Supplier Code of Conduct.”

Annual report 2025A · The company itself

“With our Impact4 strategy we are setting a new direction for the company with a strong focus on customers and value creation, and we have taken significant steps this year to ensure strong strategy execution; a new Executive Leadership team with a balanced mix of commercial and technical expertise, a reorganisation of our businesses into Chronic and Acute Care, and a new long-term financial ambition with focus on organic growth and value creation.”

Annual report 2025A · The company itself

“Impact4 focuses on four priorities: delivering innovative customer offerings, driving next-level efficiency, leveraging technology - including AI - to enhance user experience and scale, and fostering a high-performance, sustainable culture.”

Annual report 2025A · The company itself

“Embrace technology to elevate user experience and scale We are making a significant, company-wide commitment to technology, including AI, during Impact4; one of the most important enablers for delivering a better user experience and driving scale. Over the next five years, we will invest substantially in dedicated technology programs, with a strong focus on AI, to enhance the customer experience and drive efficiency across the company.”

Annual report 2025A · The company itself

“Towards our customers, we will advance the user experience by accelerating automation and AI to enable a step-up in service and deliver a best-in-class user experience.”

Annual report 2025A · The company itself

“The strategy is to grow through innovative customer offerings and to set a new clinical paradigm in Wound & Tissue Repair. Continuous innovation is at the core of the strategy, with launches in both Advanced Wound Dressings and Biologics expected to drive growth.”

Annual report 2025A · The company itself

“Product innovation and development It is essential that Coloplast maintains a competitive and innovative product pipeline that meets the needs of the users. To achieve this, Coloplast relies on its ability to interact with end users and healthcare professionals to protect intellectual property against infringement from competitors and to understand the surgical and medical trends that may impact or limit sales.”

Annual report 2025A · The company itself

“Altering packaging materials or formats involves developing new technologies and significant changes to long-term production equipment optimized for specific formats. These systems represent considerable investments and are not easily or quickly replaced.”

Annual report 2025A · The company itself

“Material risks include high dependence on a variety of raw materials, sourced from a variety of suppliers used in a lean, highly optimised, high-volume production setup at Coloplast factories.”

Annual report 2025A · The company itself

“We diversified our manufacturing footprint, expanded capacity, and invested in automation to boost resilience and competitiveness.”

Annual report 2025A · The company itself

“Firstly, we plan to improve efficiency in Global Operations to help offset external headwinds and deliver gross margin accretion, as well as Capex and inventory reductions. Secondly, we aim to drive scalability across the Group with our Coloplast Business Support Centre in Poland and the establishment of a Business Support Centre in Costa Rica to support growth and scale in the US.”

Annual report 2025A · The company itself

“Towards our customers, we will advance the user experience by accelerating automation and AI to enable a step-up in service and deliver a best-in-class user experience.”

Annual report 2025A · The company itself

“The Global Climate Position Statement commits to reducing emissions per product, improving products and packaging, and engaging our key suppliers in a Supplier Sustainability Programme.”

Annual report 2025A · The company itself

“With the Eco Design Principles, we aim to establish a framework for product evaluation across all innovation projects. This applies to all Innovation Value Stream (IVS) projects within Coloplast's AIM (Accelerated Ideas to Market) model, including contract-manufactured final products.”

Annual report 2025A · The company itself

“Sustainable sourcing includes actively exploring renewable alternatives and engaging with suppliers to identify viable options. Coloplast encourages suppliers to propose renewable resources such as cardboard or recycled plastics, fostering collaboration across the value chain to drive meaningful change.”

Annual report 2025A · The company itself

“We have reached above our Strive25 targets, with 83% of production waste being recycled.”

Annual report 2025A · The company itself

“With our Impact4 strategy we are setting a new direction for the company with a strong focus on customers and value creation, and we have taken significant steps this year to ensure strong strategy execution; a new Executive Leadership team with a balanced mix of commercial and technical expertise, a reorganisation of our businesses into Chronic and Acute Care, and a new long-term financial ambition with focus on organic growth and value creation.”

Annual report 2025A · The company itself

“Impact4 focuses on four priorities: delivering innovative customer offerings, driving next-level efficiency, leveraging technology - including AI - to enhance user experience and scale, and fostering a high-performance, sustainable culture.”

Annual report 2025A · The company itself

“The strategy is to grow through innovative customer offerings and to set a new clinical paradigm in Wound & Tissue Repair. Continuous innovation is at the core of the strategy, with launches in both Advanced Wound Dressings and Biologics expected to drive growth.”

Annual report 2025A · The company itself

“Product innovation and development It is essential that Coloplast maintains a competitive and innovative product pipeline that meets the needs of the users. To achieve this, Coloplast relies on its ability to interact with end users and healthcare professionals to protect intellectual property against infringement from competitors and to understand the surgical and medical trends that may impact or limit sales.”

Annual report 2025A · The company itself

“Firstly, we plan to improve efficiency in Global Operations to help offset external headwinds and deliver gross margin accretion, as well as Capex and inventory reductions. Secondly, we aim to drive scalability across the Group with our Coloplast Business Support Centre in Poland and the establishment of a Business Support Centre in Costa Rica to support growth and scale in the US.”

Annual report 2025A · The company itself

“Transition to renewable energy is one of our decarbonisation levers, focusing on eliminating natural gas use. Our approach involves phasing out natural gas, primarily through electrification, and where viable using renewable energy sources, such as geothermal or district heating.”

Annual report 2025A · The company itself

“With the Eco Design Principles, we aim to establish a framework for product evaluation across all innovation projects. This applies to all Innovation Value Stream (IVS) projects within Coloplast's AIM (Accelerated Ideas to Market) model, including contract-manufactured final products.”

Annual report 2025A · The company itself

“The combination of gentle processing and an inexpensive raw material results in a highly costefficient manufacturing setup, with a gross margin of around 90%.”

Annual report 2025A · The company itself

“To improve our products and services, we process the personal data of our consumers and end-users, posing a potential impact on their right to privacy.”

Annual report 2025A · The company itself

“Our commitment to this culture is driven by strong leadership that exemplifies our purpose and values. To reinforce our commitment, we conduct periodic global awareness campaigns that highlight business ethics and compliance as visible priorities within our organisation.”

Annual report 2025A · The company itself

“Coloplast’s Code of Conduct - BEST Our commitment to conducting business responsibly and acting with integrity is outlined in Coloplast BEST. It supports our understanding of our responsibility in navigating the complexities of the ever-changing rules and regulations we face daily as we deliver on our mission.”

Annual report 2025A · The company itself

“There are various channels to report concerns while employees can speak with their managers or a trusted support function, such as Legal, Compliance or People & Culture teams, anyone can also raise their concerns via Coloplast’s whistleblowing channel, Ethics Hotline. The Ethics Hotline, managed by an independent third party, enables anonymous reporting of concerns and is accessible to both internal and external stakeholders in all languages spoken in the countries where Coloplast operates.”

Annual report 2025A · The company itself

“Coloplast is committed to continuously reducing emissions across all activities, from sourcing raw materials to product disposal.”

Annual report 2025A · The company itself

“Through the innovative design and deployment of the Eco Design Principles during product development, the product achieved a 36% reduction in material in the catheter and primary packaging and a 23% reduction in product carbon footprint compared to SpeediCath Standard Female (Based on externally validated carbon footprint according to ISO14067).”

Annual report 2025A · The company itself

“The product was designed with the user and sustainability in mind, using 28% less plastic and having a 22% lower carbon footprint compared to its reference product, SpeediCath® Compact Eve (based on externally validated carbon footprint according to ISO14067).”

Annual report 2025A · The company itself

“Reported growth in DKK Reported revenue included a negative effect from FX rates HyperlinkHy perlinkHyper linkHyperlink Hyperlink Voice & Respiratory Care generated 9% organic sales growth for the financial year 2024/25. Reported revenue in DKK grew by 8% to DKK 2,280 million, in line with our acquisition case.”

Annual report 2025A · The company itself

“Laryngectomy delivered high single-digit growth in full year 2024/25. Growth was driven by an increase in the number of patients served in existing and new markets and an increase in patient value driven by the Provox Life portfolio, Voice & Respiratory Care’s product line launched in 2019, which allows for a personalised regime.”

Annual report 2025A · The company itself

“Tracheostomy delivered double-digit growth, driven by solid demand and an increase in the number of patients served.”

Annual report 2025A · The company itself

“Additionally, our resource outflow of single-use products and waste generated from operations also contributes to environmental impacts.”

Annual report 2025A · The company itself

“Recyclable content in products and packaging: Products after use are considered non-recyclable because of the use phase and contamination with bodily fluids.”

Annual report 2025A · The company itself

“Coloplast’s business areas are single-use products, where the concept of durability and reparability is different from traditional long-lasting products. Single-use products are designed for one-time or short-term use and are typically discarded after fulfilling their purpose.”

Annual report 2025A · The company itself

“HyperlinkHy perlinkHyper linkHyperlink Hyperlink Intermittent catheters People suffering from urinary retention are unable to empty their bladder, which can be due to a spinal cord injury, multiple sclerosis, congenital spina bifida or benign prostatic hyperplasia in men.”

Annual report 2025A · The company itself

“In Chronic Care, we launched Luja™, an intermittent catheter platform that addresses a major unmet need - reducing urinary tract infection risk. Supported by strong clinical evidence, Luja is the most significant Continence Care launch in a decade, and its rollout in key markets has received positive feedback from healthcare professionals and users.”

Annual report 2025A · The company itself

“Today, 69% of our energy consumption is from renewable sources. When electricity isn't sourced from renewables, Coloplast uses renewable energy certificates (RECs).”

Annual report 2025A · The company itself

“Transition to renewable energy is one of our decarbonisation levers, focusing on eliminating natural gas use. Our approach involves phasing out natural gas, primarily through electrification, and where viable using renewable energy sources, such as geothermal or district heating.”

Annual report 2025A · The company itself

“Atos Medical (2022) established Voice & Respiratory Care as a new chronic area, characterised by high entry barriers and significant untapped potential. Atos brings a strong commercial presence, and sustained growth of 8–10% p.a.”

Annual report 2025A · The company itself

“Kerecis (2023) marked our entry into biologics wound care. Its differentiated fish-skin technology offers unique clinical value and a strong US platform, creating opportunities to transform wound care through attractive growth and profitability expansion.”

Annual report 2025A · The company itself

“Our advanced dressings and biologics products are both used for the treatment of wounds. This includes a variety of wound types: chronic wounds (diabetic foot ulcers, venous leg ulcers, pressure ulcers), acute wounds (surgical and trauma wounds) and burn wounds.”

Annual report 2025A · The company itself

“Finally, we will simplify our product portfolios and finalise the integrations of Atos Medical and Kerecis to reduce structural complexity and capture synergies.”

Annual report 2025A · The company itself

“In the DMA, and in the context of our products and waste, we considered Ostomy Care, Interventional Urology, Continence Care, Voice & Respiratory Care, and Wound & Tissue Repair as the business areas associated with the impacts and risks.”

Annual report 2025A · The company itself

“Growth in Wound & Tissue Repair was negatively impacted by a preventative and voluntary product return of all Biatain® Adhesive dressings in China, while Interventional Urology was affected by a voluntary product recall in the Kidney & Bladder Health business.”

Annual report 2025A · The company itself

“China, once anticipated as a key growth engine, saw growth reduced to low single-digit by the end of the Strive25 period.”

Annual report 2025A · The company itself

“As we enter the Impact4 strategic period, China will no longer be a material contributor to our global Ostomy Care growth. Performance during Strive25 was muted, reflecting weaker consumer sentiment and competitive pressures, and we do not anticipate a Management’s Report | Business area | Chronic Care strategy HyperlinkHy perlinkHyper linkHyperlink Hyperlink recovery towards 2030.”

Annual report 2025A · The company itself

“in isolation delivered -1% organic growth in full year 2024/25 with negative growth in Emerging markets, driven by China, which detracted significantly from growth due to the product return initiated in Q3.”

Annual report 2025A · The company itself

“In the financial year 2024/25 we conducted audits in China, and have previously conducted similar audits in India, Mexico and North Macedonia.”

Annual report 2025A · The company itself

“The scope of the project is limited to our operations in Zhuhai, China, and Cartago, Costa Rica, and the final products distributed and sold across markets downstream.”

Annual report 2025A · The company itself

“Covid-19, geopolitical tensions, persistent inflation, and a fundamentally changed market landscape in China created new headwinds that challenged our original assumptions and strategic ambitions.”

Annual report 2025A · The company itself

“Inflation and rising interest rates, especially in Europe, increased input costs and placed pressure on our gross profit margins.”

Annual report 2025A · The company itself

“The gross margin was positively impacted by a favourable development in input costs, price increases, and country and product mix.”

Annual report 2025A · The company itself

“The current global macroeconomic trends like high inflation, disrupted supply chains, weakening consumer sentiment in especially China, tightening monetary policies, US tariffs, and geopolitical risks like the war in Ukraine are challenging the operating environment, and have resulted in an increased level of challenges on the short- to medium-term. In the long-term direct and indirect implications could negatively impact sales and operations.”

Annual report 2025A · The company itself

“Renewable materials incur higher costs and face supply chain challenges, leading Coloplast to depend on virgin and non-renewable resources. This reliance may result in increased costs, reduced availability and compliance risks in the future, potentially leading to operational costs and supply disruptions if not addressed.”

Annual report 2025A · The company itself

“Covid-19, geopolitical tensions, persistent inflation, and a fundamentally changed market landscape in China created new headwinds that challenged our original assumptions and strategic ambitions.”

Annual report 2025A · The company itself

“• Disruption of the supply chain due to shortfalls in delivery, quality issues, force majeure situations, change in market conditions, strikes, political instability, or other events beyond our control, resulting in price increases, inability to source critical materials, components, and finished products, and loss in revenue. • Emergency response and contingency plans, physical separation of critical processes and workflows, and certification of relevant facilities to the Highly Protected Risk (HPR) industry standard. • Contingency plans for high-risk suppliers, including built up inventories, collaboration to mitigate physical risks at their facilities, dual source for critical raw materials and components, and qualification of substitute materials where applicable.”

Annual report 2025A · The company itself

“The current global macroeconomic trends like high inflation, disrupted supply chains, weakening consumer sentiment in especially China, tightening monetary policies, US tariffs, and geopolitical risks like the war in Ukraine are challenging the operating environment, and have resulted in an increased level of challenges on the short- to medium-term. In the long-term direct and indirect implications could negatively impact sales and operations.”

Annual report 2025A · The company itself

“In the short- to medium-term primarily in Russia, Ukraine, and Iran due to sanctions. In Argentina, Brazil, and Türkiye due to economic instability and inflation. • Economic and political instability and emerging geopolitical areas of concern negatively affecting our costs and result in disruptions of operations, commercial activities, and supply chain, and impact our ability to conduct business globally.”

Annual report 2025A · The company itself

“x x x x Gender equality & equal pay Suppliers or distributors not providing equal gender representation or equal payment for work of equal value to their workers Pot. neg. impact x x x x Diversity Suppliers’ or distributors’ lack of measures to ensure general diversity in the workplace Pot. neg. impact x x x x S2 Workers in the value chain SBM-3 Impacts, risks and opportunities Coloplast collaborates with upstream suppliers and downstream distributors on a global scale.”

Annual report 2025A · The company itself

“The above-mentioned positive drivers were partly offset by ramp-up costs in Costa Rica and Portugal.”

Annual report 2025A · The company itself

“Material risks include high dependence on a variety of raw materials, sourced from a variety of suppliers used in a lean, highly optimised, high-volume production setup at Coloplast factories.”

Annual report 2025A · The company itself

“Our value chain workforce features various types of employees, of whom we have gained insight through our continuous collaboration and audits. The workforce includes but is not limited to: blue-collar workers in manufacturing companies of raw materials or semi-finished goods in our upstream value chain; people maintaining Coloplast facilities, such as electricians, painters, gardeners and other trades, and warehouse workers and truck drivers in our downstream value chain.”

Annual report 2025A · The company itself

“Our financial guidance for the 2025/26 financial year has been prepared on the basis of the following assumptions for the company’s principal currencies: Overview of exchange rates for key currencies against DKK GBP USD HUF Average exchange rate 2023/24 872 688 1.92 Average exchange rate 2024/25 882 676 1.85 Change in average exchange rates for 2024/25 versus 2023/24 1 % -2 % -4 % Spot rate on 31 October 2025 849 646 1.92 Change in spot rates compared with average exchange rate 2024/25 -4 % -4 % 4 % Revenue is particularly exposed to developments in USD and GBP relative to DKK.”

Annual report 2025A · The company itself

“Fluctuations in HUF against DKK impact the operating profit because a substantial part of our production, and thus of our costs, are in Hungary, whereas our sales in the market are limited.”

Annual report 2025A · The company itself

“Effect over 12 months of a 10% initial drop in exchange rates for key currencies (DKK million) Revenue EBIT USD -740 -290 GBP -400 -240 HUF – 160 Management’s Report | Highlights | 2025/26 Outlook and financial guidance Impact4 Financial ambition 7-8 % organic growth (5-year CAGR) in line with or above revenue growth EBIT growth over the period In constant exchange rates, before special items more than 20 % Return on Invested Capital in 2029/30 After tax, before special items.”

Annual report 2025A · The company itself

“The EBIT margin also included a small negative impact from currencies, related to the depreciation of the USD and a basket of Emerging markets currencies against the DKK, offset by the depreciation of the HUF against the DKK.”

Annual report 2025A · The company itself

“The condition disproportionately affects older people because the sphincter muscle and the pelvic muscles gradually weaken as people grow older.”

Annual report 2025A · The company itself

“Market growth drivers include demographics, such as an ageing population and rising prevalence of chronic conditions, as well as increasing treatment compliance and product usage.”

Annual report 2025A · The company itself

“Market growth is supported by demographic trends such as an ageing population and lifestyle-related conditions, alongside increasing demand for advanced and evidence-based treatment solutions in hospitals and surgical settings.”

Annual report 2025A · The company itself

“Covid-19, geopolitical tensions, persistent inflation, and a fundamentally changed market landscape in China created new headwinds that challenged our original assumptions and strategic ambitions.”

Annual report 2025A · The company itself

“The addressable market in which Coloplast operates is expected to continue growing at 4-5%.”

Annual report 2025A · The company itself

“In the short- to medium-term primarily in Russia, Ukraine, and Iran due to sanctions. In Argentina, Brazil, and Türkiye due to economic instability and inflation. • Economic and political instability and emerging geopolitical areas of concern negatively affecting our costs and result in disruptions of operations, commercial activities, and supply chain, and impact our ability to conduct business globally.”

Annual report 2025A · The company itself

“Inflation and rising interest rates, especially in Europe, increased input costs and placed pressure on our gross profit margins.”

Annual report 2025A · The company itself

“The net expense includes interest expenses of DKK 722 million, compared to DKK 762 million last year, mostly related to the financing of the Atos Medical acquisition.”

Annual report 2025A · The company itself

“At 30 September 2025, Coloplast had net interestbearing debt of DKK 21,692 million, against DKK 21,841 million at 30 September 2024. The gearing ratio at the end of the period was 2.4x EBITDA (before special items).”

Annual report 2025A · The company itself

“The following resources are considered priority due to their extensive use in the Coloplast products and their packaging: • Plastics • Adhesives • Cardboard • Aluminium Coloplast’s use of inflows and non-renewable and virgin resources results in an environmental impact.”

Annual report 2025A · The company itself

“Specific substances and materials addressed through dedicated policies are phthalates and PVC/PVdC. These are materials with superior properties, serving as standards in many applications on the market.”

Annual report 2025A · The company itself

“Our inflow-related risk concerns our dependence on non-renewable or virgin resources. While manufacturing medical devices requires strict patient safety and functionality standards, most non-virgin/ recycled materials lack sufficient traceability documentation for use.”

Annual report 2025A · The company itself

“Our financial guidance for the 2025/26 financial year has been prepared on the basis of the following assumptions for the company’s principal currencies: Overview of exchange rates for key currencies against DKK GBP USD HUF Average exchange rate 2023/24 872 688 1.92 Average exchange rate 2024/25 882 676 1.85 Change in average exchange rates for 2024/25 versus 2023/24 1 % -2 % -4 % Spot rate on 31 October 2025 849 646 1.92 Change in spot rates compared with average exchange rate 2024/25 -4 % -4 % 4 % Revenue is particularly exposed to developments in USD and GBP relative to DKK.”

Annual report 2025A · The company itself

“Effect over 12 months of a 10% initial drop in exchange rates for key currencies (DKK million) Revenue EBIT USD -740 -290 GBP -400 -240 HUF – 160 Management’s Report | Highlights | 2025/26 Outlook and financial guidance Impact4 Financial ambition 7-8 % organic growth (5-year CAGR) in line with or above revenue growth EBIT growth over the period In constant exchange rates, before special items more than 20 % Return on Invested Capital in 2029/30 After tax, before special items.”

Annual report 2025A · The company itself

“The EBIT margin also included a small negative impact from currencies, related to the depreciation of the USD and a basket of Emerging markets currencies against the DKK, offset by the depreciation of the HUF against the DKK.”

Annual report 2025A · The company itself

“The following resources are considered priority due to their extensive use in the Coloplast products and their packaging: • Plastics • Adhesives • Cardboard • Aluminium Coloplast’s use of inflows and non-renewable and virgin resources results in an environmental impact.”

Annual report 2025A · The company itself

“Information security Coloplast operates in a dynamic information risk environment with regulatory and legislative data compliance obligations. Business operations depend on a wide range of information technology systems, operational technology systems, people, and suppliers. Coloplast processes highly confidential information and legally protected personal health information through multiple channels and sell digitally connected devices.”

Annual report 2025A · The company itself

“The following resources are considered priority due to their extensive use in the Coloplast products and their packaging: • Plastics • Adhesives • Cardboard • Aluminium Coloplast’s use of inflows and non-renewable and virgin resources results in an environmental impact.”

Annual report 2025A · The company itself

“Chronic Care incl. Voice & Respiratory Care ex. China delivered a solid year, while Interventional Urology and Advanced Wound Dressings faced notable performance challenges, with unprecedented negative impact from product recalls.”

Annual report 2025A · The company itself

“Interim President, of the Board of Directors CEO Management’s Report | Highlights | Chair and CEO’s letter HyperlinkHy perlinkHyper linkHyperlink Hyperlink 2024/25 in brief Organic growth was 7%, driven by good contribution from our chronic care businesses, Ostomy Care, Continence Care and Voice & Respiratory Care, which grew 6%, 8% and 9% respectively, driven by a good momentum.”

Annual report 2025A · The company itself

“Wound & Tissue Repair - improved momentum compared to last year, driven by Kerecis growth of around 25%, partly offset by the negative impact from the product return in Advanced Wound Dressings in China in Q1-Q3.”

Annual report 2025A · The company itself

“Innovation, product choice and portfolio breadth are therefore critical to allow users to find a personalised solution.”

Annual report 2025A · The company itself

“Across our chronic businesses, the demand for advanced solutions continues to rise, creating further opportunities for market expansion.”

Annual report 2025A · The company itself

“• Disruption of the supply chain due to shortfalls in delivery, quality issues, force majeure situations, change in market conditions, strikes, political instability, or other events beyond our control, resulting in price increases, inability to source critical materials, components, and finished products, and loss in revenue. • Emergency response and contingency plans, physical separation of critical processes and workflows, and certification of relevant facilities to the Highly Protected Risk (HPR) industry standard. • Contingency plans for high-risk suppliers, including built up inventories, collaboration to mitigate physical risks at their facilities, dual source for critical raw materials and components, and qualification of substitute materials where applicable.”

Annual report 2025A · The company itself

“Coloplast continuously evaluates dependencies like supply chain reliability and regulatory compliance for potential health and safety risks.”

Annual report 2025A · The company itself

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

Annual report 2025A · The company itself

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

Annual report 2025A · The company itself

“Production and business continuity Coloplast operates facilities all over the world. Most production takes place at centralised facilities and, in some cases, Coloplast purchases raw materials, components used in production and finished products from sole source suppliers for reasons of availability, quality assurance and cost effectiveness. • Disruption at a manufacturing or distribution facility due to natural disasters or other emergencies (e.g. fires or warlike situations) may compromise the availability of products for our users.”

Annual report 2025A · The company itself

“Currently, electric vehicles (EVs) comprises 16% % of the total fleet with an increase from 11% last year. Despite these efforts emissions from company cars has increased by 13% from base year.”

Annual report 2025A · The company itself

“Emerging markets, excluding China, represent the fastest-growing region in Ostomy Care, driven by rising awareness, improved diagnosis, and demographic shifts.”

Annual report 2025A · The company itself

“Emerging markets, excluding China, represent the fastest-growing region in Ostomy Care, driven by rising awareness, improved diagnosis, and demographic shifts.”

Annual report 2025A · The company itself

“In chronic care product utilisation per capita remains low in most markets outside Northern Europe, and many patients lack access to advanced technologies and tailored support.”

Annual report 2025A · The company itself

“Across all markets, we partner with healthcare professionals, key opinion leaders, patient associations, and payers to define standards, secure reimbursement, and ensure access to high-quality solutions.In our largest markets - the UK, US, France, and Germany - we complement this with direct-to-user engagement.”

Annual report 2025A · The company itself

“From a geographical perspective, growth was broadbased, driven by Europe and the US.”

Annual report 2025A · The company itself

“Today, Coloplast is present in the advanced dressings market in Europe and Emerging Markets, while our presence in the US dressings market is limited.”

Annual report 2025A · The company itself

“The product was launched in May 2024, and is already available in several European countries, Australia and the United States.”

Annual report 2025A · The company itself

“A key action this year was completing MDR-certification for our Voice & Respiratory Care product portfolio.”

Annual report 2025A · The company itself

“The trays are made by an external supplier and used for packaging in our production facility in Hungary.”

Annual report 2025A · The company itself

“In Emerging markets, our focus is on scaling hydrophilic-coated intermittent catheters (HCIC) by addressing structural barriers to adoption.”

Annual report 2025A · The company itself

“in isolation delivered -1% organic growth in full year 2024/25 with negative growth in Emerging markets, driven by China, which detracted significantly from growth due to the product return initiated in Q3.”

Annual report 2025A · The company itself

“In the financial year 2024/25 we conducted audits in China, and have previously conducted similar audits in India, Mexico and North Macedonia.”

Annual report 2025A · The company itself

“Immaterial impact from tariffs, as we expect our products to remain exempted.”

Annual report 2025A · The company itself

“On September 2, 2025 the Secretary of Commerce initiated an investigation 4) to determine the effects on the national security of imports of personal protective equipment (PPE), medical consumables, and medical equipment including devices.”

Annual report 2025A · The company itself

“The scope of the project is limited to our operations in Zhuhai, China, and Cartago, Costa Rica, and the final products distributed and sold across markets downstream.”

Annual report 2025A · The company itself

“Across all markets, we partner with healthcare professionals, key opinion leaders, patient associations, and payers to define standards, secure reimbursement, and ensure access to high-quality solutions.In our largest markets - the UK, US, France, and Germany - we complement this with direct-to-user engagement.”

Annual report 2025A · The company itself