Coloplast As Sp/Adr

Thank you very much, operator. Good morning, everybody, and welcome to our half-year 23-24 conference call. My name is Christian Willemsen. I'm the CEO of Cold Plus, and I'm joined by our CFO, Anas Loningskoglu, and our investor relations team. We'll start like we usually do with a short presentation by Anders and myself, and then we will open up for questions. Please turn to slide number three. We delivered 8% organic growth and a reported EBIT margin before special items of 27% in the second quarter. Return on invested capital after tax and before special items was 15% reflecting impact from the acquisition of Kerasys. I'm satisfied with our performance. We continue to broadly outgrow the market, and more importantly, we continue to help more people who live with intimate healthcare needs. At the same time, we also continue with our year of launches. Today we announced four new launches in our chronic care businesses. One of the new products that we're launching is Halo. This is the world's first digital ostomy leakage notification system, and it has now received national reimbursement in the UK as of the 1st of July. And while this is a launch in only one market for now, it confirms the need for innovative and clinically relevant solutions in our category. This is how we continue to lead our categories by raising the bar and bringing differentiated technologies to the market. Before going into our usual half-year strategic update and the details of today's results, I'd like to provide our thoughts on the proposed local coverage determination policy for skin substitute grafts that was published on the 25th of April and is relevant for the newest member of the Cold Blast Group, Kerasys. Please turn to slide number four. Let me start with the facts. On the 25th of April, seven medical administrative contractors brought forward a draft local coverage determination policy in which two coverage qualifications for skin substitute grafts were introduced. The first qualification relates to a technical requirement which Kerasys meets. The second qualification relates to a clinical requirement which, based on the assessment, Kerasys does not meet and therefore Kerasys is not included in the draft coverage policy. The draft policy covers the Medicare portion of outpatient sales, which includes both physician offices and hospital outpatient departments, and it affects around 20% of CARES' revenue. The majority of the remaining 80% of sales are related to in-hospital sales, covered by DRG codes, where the reimbursement environment is stable. The process from here is the following. Until the 8th of June, there's a consultation period in which affected parties can provide their comments to the draft policy as is the norm. After the consultation period, there will be a final policy typically published at least 45 days before implementation date. The implementation date has not been announced. We expect that it will be up to half a year after the consultation period ending with a final decision to be published and implemented. My perspective on this draft policy is that this is a quality document. It sets out a sensible set of objectives for the category that are founded in good clinical practice. It explicitly reviews the clinical evidence for every single product in the category as a basis for recommendation to either include or exclude the product from the covered list. The decision to exclude Kerasys from the covered list is rational on the basis of the clinical evidence that is reviewed in the draft policy. Now, and this is important, the clinical evidence on Kerasys which was reviewed in the draft policy does not include a randomized control clinical study from 2023 by Lantus. We strongly believe that this study fully satisfied the LCD requirement for quality evidence that demonstrates the product's safety. effectiveness, and positive clinical outcomes in the function as a graft for diabetic foot ulcers. A 2023 Lancet study on chronic diabetic foot ulcers is a randomized control clinical trial with a sample size of 102 patients, and it provides high-quality evidence with a low risk of bias, demonstrating the safety, effectiveness, and positive clinical outcomes of the Kerasys fish skin graft compared to standard of care in the treatment of chronic diabetic foot ulcers. The study found significantly higher rates of complete wound closure at 12 weeks with caries