In today's webinar, CLINUVEL will share their half year results and operational highlights for the six months ended on 31st December, 2025. I will now hand over to Malcolm Bull, Head of the Australian Operations and Investor Relations, to conduct the proceedings. Well, thank you, Stella, for the introduction. I'd first like to welcome members of CLINUVEL's management team to the webinar. Not surprisingly, reflecting the focus of the webinar on the financial results for the half year to December 2025, we have Chief Financial Officer, Peter Vaughan. We are joined by two executives who are leading the business in key operational areas. Director of Clinical Affairs, Dr. Emilie Rodenburger, and Director of North American Operations, Dr. Linda Teng. We're also joined by our Managing Director, Philippe Wolgen. I'd like to acknowledge there are several analysts on the line who cover CLINUVEL, and will ask some questions in the webinar. It would be remiss of me if I didn't say, on behalf of management and the board, that we appreciate your work on CLINUVEL, your role in telling our story to a wider audience than we could reach ourselves, and your involvement in this webinar. It's pleasing also that there are over 175 participants to the webinar, reflecting increasing interest in CLINUVEL. Welcome, one and all. Before going further, I think it's appropriate to highlight why we have five executives in today's webinar. You frequently see Philippe, our Chief Operations Officer, Lachlan Hay, Peter Vaughan, and Investor Relations presenting the company to a range of stakeholders. We have received feedback that it would be good to have greater access and the opportunity to hear from other executives. For today's webinar, noting this is not the forum for a strategic review, but as a courtesy to you all, we include Dr. Emilie Rodenburger and Dr. Linda Teng to answer questions and provide their insights direct to you. Today's webinar will be in two parts: First, a discussion of the half year results, and second, the analysts online will be called upon to ask questions of the CFO and management. We will be talking today about plans and intended outcomes, draw your attention to the forward-looking statement or Safe Harbor statement on screen that identifies a range of risks that can materialize and impact their achievement. I think 10 seconds to review that is enough, and that is on our website and on all of our announcements. I now kindly invite the CFO to summarize the results. Peter? Thanks, Malcolm. Good evening and good morning, everyone, from wherever you're calling in from. It's another set of very consistent results at CLINUVEL, I'm pleased to announce. With our revenues up 4% on the prior year, maintaining a steady growth pattern. Our expenses were up 22% for the period, and this really was part of supporting the expansion initiatives that we'd foreshadowed previously that we were gonna be undertaking during this period. We continued our strong positive net operating cash flows, and this saw our cash reserves over the six months increase by AUD 9 million- AUD 233 million. We're closely monitoring all of our expenditures, and any discretionary spending is being scrutinized really closely. The good news is that our profitability for this period, while lower, continues to be maintained despite the increasing level of expenditure during this expansionary phase. Thanks, Peter. I'll now ask Philippe to comment on the results. Thanks, Malcolm. Welcome to all the analysts and shareholders. Well, in a nutshell, we follow a plan, a strategy, which is gradual and with purpose. For this strategy to play out, we need to manage our finances tightly and in a very controlled manner. In the past 12 months, we intentionally increased our expenses. Therefore, naturally, one expects to see the net profit decrease. These expenses towards R&D, the clinical trial, vitiligo, and regulatory filings. We are very much in line with our own forecasts, so we're content with the results, and we will proceed on this basis. With positive cash flows, we can expand the activities of the company, the group. We gave expense guidance from 2021 to 2025. For the financial year, we expect to spend about AUD 55 million-AUD 58 million, excluding the CapEx. In summary, the business model we chose is playing out really well. I agree. let's delve into the results and call on Peter to look at in turn, revenues, expenses, profit, and indeed, the balance sheet. Thanks, Malcolm. Our revenues for the period continue to grow year-on-year, and this period, I'm pleased to say, we saw our highest ever sales revenue result. This period marks the 20th consecutive profit for CLINUVEL since the commencement of our commercial operations. Our expenditure, as I touched on before, while increasing, is very focused, controlled, and targeted around the specific areas of the business that we're focusing on. Our expansion saw key developments in our R&D activities across our ACTH NEURACTHEL program, our vitiligo study, CUV105, and of course, our peptide drug platform that we developed at our Singapore Research Development and Innovation Centre, that we recently announced we'll be undertaking a large expansion of. All of this expenditure and all of this growth has been achieved without sacrificing our overall profitability, which is really a fantastic result for the organization. Only 4% of biotechs deliver a profit, even fewer are able to sustain a profit for an extended period of time. Where CLINUVEL's done this for over a decade, it's truly a remarkable outcome. In turning forward to our revenues, specifically, we saw our revenues from sales increase by 4% from the prior period to just under $37 million. As I mentioned before, this is our highest first half year sales results we've ever seen. This reflects the increasing and continued demand for SCENESSE right across our sales regions. In particular, we saw strong growth in volume of sales across Europe, and as we announced in September 2025, the approval by the EMA, lifting the number of maximum implants per year from four to six, has already seen some of the patients take up that extra initiative, and we expect other patients to follow suit as well. In the U.S., our team, and led by Linda, has able to increase the number of sites to meet the demand, the target that we had for December, which was 120 sites across North America. The patient demand has been consistent throughout the period, and our U.S. team operates extremely well, given the evolving U.S. medical reimbursement landscape that is constantly changing at the moment. Perhaps at this point, Linda, as our Director of North American Operations, I might ask you, could you provide some insight to the people listening in around the U.S. reimbursement process, in particular, the prior authorization scheme that enables us to have such a high success rate of reimbursement? Sure, Peter. First off, excuse me for my raspy voice, as I'm still recovering from the flu, but thankfully, the technology allows me to share the insights without spreading. Linda, we can't hear you well, Linda. We can't hear you. Can you hear me now? No, it's very muffled. Go off the headphones, if you can. Is that better? No. Not really. Better? Can you hear me now? Yeah, much better. Okay, let's move on. Yeah. Can you not hear me? Yes. Okay. No? Yeah. Can you hear me now? Yes. Please proceed, Linda. No? Yes. Yes? Yes. Okay. We're going to continue with what Peter said about prior authorization. In short, basically, prior authorization is a way for health insurance companies to control their cost by making sure that they are only paying for treatments that are medically necessary for their patient. Because SCENESSE is the only FDA-approved treatment for EPP, it has a strong and also a long-standing safety records. We haven't seen any prior authorization denials for the EPP patient. We also have a dedicated in-house team that works very closely with the physicians to really streamline the submissions and also speed up the approvals. For SCENESSE, most of our PAs that are already approved, they are only renewed annually. There really is minimal paperwork for the physician, they don't have to get approval for every single treatment visit. For those not familiar with the U.S. healthcare system, you might notice that our approach is very unique. You know, most high-cost drugs, they go through the middleman or the Pharmacy Benefit Managers, or we call them the PBMs, and they usually drive up prices even more. We made that deliberate decision to avoid the PBMs, and I think that is looking like a smart move, especially now, because the government is increasingly the scrutiny of them. We said the 2026 Consolidated Appropriations Act, which has really signed into law a few weeks ago, including the provisions aimed at the PBM industry. As for the patients, the feedback has been consistently positive, and I think the reason for the continued treatment year after year is because they are seeing real clinical benefit. We even saw some patients are increasing their treatment dose, you know, within the year, you know, because of the clinical benefit. I do want to be clear that we don't pay physicians or patients for any testimonials. Everything is completely organic. You know, the feedback from the patients are voluntary and genuine, and usually they do share it more within, I believe, within their patient communities or directly with my team. I hope this gives you some insight into our prior off the process. Peter, handing back to you. You're on silent, Peter. Thank you, Linda. As we look forward to the other areas of revenue for the period, our interest income was up to AUD 5.3 million this period, which was a 14% increase on the prior year. This was really the result of a larger cash reserves balance that we continued to maintain. We generally take our surplus funds that we have at the time and invest them into term deposits to help to build and grow on that balance. At the moment, we're extending the length of our term deposits to be able to take longer-term maturities at higher yields. We're seeing our average term deposit for about 300 days at the moment, we're receiving an average yield of about 4.5% across the portfolio. Our other income, this number has swung the other way from the prior period, and it's a difference of about AUD 4.6 million. Just to explain, this is an unrealized foreign currency translation that occurs each balance date, so each reporting date. It's really a non-cash transaction that's effective at balance date for accounting purposes, and it takes the process of taking all of our foreign currency balances and bringing them back to account at balance date into Australian dollars. It's not a real loss, it's an unrealized loss, just purely to be able to balance the books at balance date. If we look at our revenues overall, I would mark them as being stable, growing, and also consistent. Historically, our second half of our financial period generally tends to be proportionately higher from a revenue perspective, with the E.U. and U.S. summers coming into effect through that second half of the year. We're really excited to see how the second half of the year plays out, given we've still got that maintaining growth. Perhaps moving to expenses, Mal, now, more specifically? Yeah. We saw a 16% increase in our personnel expenditure, and I'd just like to provide some context around that for everyone to understand. This is a strategic part of our expansionary team and increasing the in-house capability of CLINUVEL. It provides greater control and oversight of our activities, but at the same time, we're upgrading the skill and expertise within our organization. Now, as everyone will know, skill and expertise within the life sciences sector is really important, and recently, we've seen regulatory challenges and hurdles that some other life sciences and biotech companies have faced in just recent times. This highlights the need to really develop and create the skill and expertise within that team and make sure we've got the right people around the decision-making process. When we look at CLINUVEL's never had a market authorization knockback in over 20 years of being active in the pharmaceutical sector. If that was to occur in some shape or form, a regulatory rejection of some sort can really have a significant effect on an organization. It erodes shareholder and market confidence in the company. It raises doubts around management's decision-making and assessment of processes and events. It can push commercialization timeframes back up to three years, as seen in some of our peers, where another study or more data may need to be gathered before a resubmission can take place. Clinical trial designs and endpoints around the quality of data may suit one region, which brings in revenue, but not always both regions, to bring in revenue across the globe. This can really affect the total revenue pie that's available from the advancement and the approval. Our people are really critical to the process, and in plotting the path forward, we're really confident that they'll be able to obtain the right outcome around our clinical programs. In turning specifically to our clinical and non-clinical expenditure, the expansion of our CUV105 expenditures was somewhat offset by the orderly wind down of some of our earlier phase programs. We've reallocated and focused our resources towards our later stage and strategically significant programs, and at achieving the nearest term commercial results and prospects we can. Preparation for CUV107 has already commenced and is well underway, and we'll start to see those expenditures flow through in the second half of the year also. Commercial distribution, if we look at that area, that was up 42%. This is predominantly off the back of increased volumes of shipments, particularly in Europe, as I touched on before. It's all increased proportionately. There has been some temporary one-off costs that have been associated with some transitions that we've made in our supply chain to some of our warehouse providers to ensure the long-term stability of that supply chain, as well as being able to scale with us for the future. The other area that is somewhat affecting the commercial distribution area is also some of our regulatory fees. Previously, we used to sit under an SME discounted scheme in some of those regions for the FDA and EMA annual fees. Now that our revenues have increased to the point that they are, we're no longer eligible for some of those discounts, so we're having to pay full annual service fees now to those organizations, which is also increasing the expenditure in that area. The next area to touch on is really finance, corporate, and legal. Now, this did increase proportionately from the prior year to up 47%. Really, this is the direct cost of a lot of it is being our ADR program uplift from level 1 to level 2, that I'm sure you're all aware of, as we uplist that program for the U.S. to list on Nasdaq. There's been a substantial amount of work undertaken across that area by the finance team, but also in conjunction with our accountants, auditors, and legal firms, both here in Australia and in the U.S. This process we had to go through undertook a three-year re-audit of all of our financials into U.S. GAAP, converted into U.S. GAAP, financial presentation, and then that was submitted to the SEC for review. Our other expenses, that's up 191%, and it's predominantly driven by the increase in our R&D programs and all the consumable materials that we use within those programs, whether it be ACTH, PRÉNUMBRA, or NEURACTHEL, any of those developments. Our non-cash expenditure was down for the period. This is usually a change in our inventories in our balance sheet differences from period to period. That's really what reflects quite a bit of that expenditure. This period, that's a lower number than it was previously because we've actually increased our manufacturing during the period, therefore, there hasn't been as low a drop in our inventories. It stayed more on par. Our share-based payments have also been much lower this period than in previous years, we recently changed our share plan at the start of 2025, which meant that the expenditures will now appear differently, but also that it's now a one-year plan instead of a three-year plan. I've spoken fairly at length around all of the expansionary activities that we're undertaking and some of the critical advancements to our program, this expanding expenditure should really be seen as an investment in the organization rather than just being pure expenditure. From a financial perspective, it does take time to build up these resources internally, but it is cheaper than outsourcing to a CRO. CROs can add 25% or more costs to the bottom lines of a clinical trial program. By having that skill and expertise in-house, it's critically important for us to maintain that control and oversight of the program. We've got Emilie Rodenburger on the call, who's our Director of Global Clinical Affairs. Emilie, in speaking around our expansionary activities and what's been undertaken, I guess, Would you be able to provide some insight into why that was necessary, and what are the specific advantages of doing them in-house? Yes, absolutely, Peter. I can give some additional context to the numbers. First of all, good morning, good afternoon, good evening, everyone. It's good to be here. In my capacity as Director of Clinical Affairs, I really think more on the deliverable and how to achieve them, but it certainly ultimately impacts the numbers we report. Clinical expansionary activities are twofold: it's talent growth and building the infrastructure into which the talents operate. As Peter mentioned, the company has taken a conscious decision to build our capabilities in-house, which is not the norm in our industry, where most are relying on outsourcing their studies. We have chosen not to rely on these models and not to work with CROs. It increases cost and can result in loss of control and oversight over studies and data. In order to deliver the CUV105 study, we had to invest in new talent. These professionals will be retained through the CUV107 and beyond. Currently, the Clinical Affair Department that I lead is the largest department in the company, spread across U.K. and U.S., with a great range of expertise, operations, data science with data management and statistics, and medical affairs, and clinical quality. In addition to bringing new talents in, we have also trained and upskilled existing talents, so building and retaining the expertise in-house. Again, I repeat what Peter said, is really critical for the health of our business. In term of infrastructure, it's really the processes and the systems. We've also been investing in this. This investment will continue further for us to be able to manage a significant data set that are coming from the vitiligo studies and deliver efficiently on the studies. When we build in-house, we both supporting the present and investing for the future. I mentioned the talents, the expertise, ownership, processes, and systems. They can be seen as a platform asset that is transferable to any studies and programs that we will be conducting in the future. In a way, we're building a CRO in-house. Excellent. Thank you, Emilie. In turning to our balance sheet, Malcolm, if we look at our balance sheet, it keeps going year by year from strength to strength. As I touched on, our cash reserves increased by AUD 9 million to just under AUD 233 million. It's the highest cash balance we've had in the company's history. Our net assets have also increased by AUD 8.2 million to just under AUD 250 million, which again, is the strongest point in the company's history. We remain debt-free for the 21st consecutive year, with no equity dilution since May, March of 2016. A strong balance sheet with positive net cash flows is really a strategic priority for CLINUVEL, as it enables us to see clinical programs through to commercialization without any additional funding required. It also provides resilience for any unforeseen events or economic uncertainty, particularly in the current geopolitical times. It provides flexibility to ensure expansionary opportunities, acquisitions, or investments that align with our objectives can be taken advantage of, which many peers in the industry aren't able to consider without having to raise additional capital. It also enables strategic objectives to be delivered, such as the expansion of our Singapore research and developments facility, which we've slated for over the next five years, to provide vertical integration of ongoing peptide and formula development and innovation. A number of our peers have recently announced capital raisings, some as much as at a 45% discount to market, to fund these sorts of activities that we can take on and that we can develop without having to raise any further capital. Some of these peers are raising for clinical program developments, for raw material supplier scale-up, or for product rollout into a new jurisdiction. As I've already touched on, CUV is funded for our full clinical trial program for vitiligo. Thanks, Peter. I mean, that was a comprehensive overview, I must say, but I'd like now to move to strategy. Mention and share with you that a number of institutions, particularly in the U.S., have asked us why CLINUVEL stands out in its strategy. They even ask, are we a bit dogmatic and a bit rigid in our strategic focus and execution? Philippe, can you comment on this? Well, I pick up the two words, dogmatic and rigid. The contrary, we've built in the flexibility and optionality in this business model. That allows us to navigate markets and cycles in pharma. The objectives are really clear. They're fivefold. We need to expand the EPP commercial market, advance the vitiligo programs as a focal point of the company, advance the new NEURACTHEL dossier, which is a large opportunity in the use of STH in a number of indications, advance PhotoCosmetics, and bring in-house the manufacturing of the new and next formulation. You know, in any given business model, there are a number of options. We can seriously raise funds like most of our peers. We can change the business strategy altogether, step away from melanocortins, and do something totally different. We can self-fund the program steadily and gradually, as we've done. The fourth option is we can cease operations and say, "Listen, ladies and gentlemen, it's too difficult, it's too hard, and let's give the cash back to the shareholders." We haven't chosen that because we believe that there are a number of opportunities that we worked on for decades that are worthwhile pursuing. There are a number of underlying assumptions that a board and management take into account that we are privy to and no one else is. First of all, are we conducting an honest and genuine business? No one implicated in fraudulent activities. Do we keep the teams in check? Do we have technologies that are safe and work? Third of all, do the patients... Do investors have the patience to see out the strategies? The most important underlying assumption is whether there is perpetual funds available for this company. We've come to the conclusion that this model is very appropriate for the way we need to reach the vitiligo and STH markets. In summary, Malcolm, we needed to accumulate these funds to execute a program which we all believe will lead to a sustainable, multi-dollar, billion-dollar enterprise. We also need to be conscious of the realistic risks that evolve around clinical, regulatory, and execution, and for that, you need to have optionality, and optionality is cash. And that will eventually lead to a diversified company. That's how the company stands out. Thanks, Philippe. Moving to another area where we've had numerous questions, and this is on the readout of vitiligo. Emilie, it's good to have you here, and this is where you come in. What can you tell us about the regulatory process and path to market on vitiligo? Thank you, Malcolm. I will address your question by providing a number of specific observations that support the regulatory process and path to market for SCENESSE in vitiligo. Some of these observations are unique to SCENESSE, and some you might also be familiar with. Allow me to go through them. The first one is SCENESSE is already on the market for another indication, EPP. It's a product for which we have accumulated two and a half decades of safety data and a safety profile that has been maintained over time. The regulatory agencies know the product well from the annual reports our regulatory and pharmacovigilance teams are and have submitted for one decade now. In regards to vitiligo is a condition with visible symptomatology. The treatment effect that we desire, repigmentation, is visible. From the cases we receive and cases published by physician, one can gain much confidence. The effects of the treatment are visible. From an operational point of view, the trials can't be blinded. The work either— The drug either works or not, and physician and patient can see the effect very quickly. It's a visible efficacy. What I'm trying to say here is that in vitiligo, the photographs do not lie, and part of the analysis is to have centrally assessed photographs, up to 32 per patient, which is up to 6,000 assessments. Very importantly as well is the patient experience and how they appreciate the return of their pigments. JAK inhibitors, some currently in phase III, one recently submitted to the EMA and FDA for marketing approval. They take a long time to work, thereby suppressing the immune system. Last but not least, we are living in a very dynamic regulatory landscape, where the concept of generating clinical evidence is evolving. EMA speaks about totality of evidence for drug approval, while, as I'm sure you've seen, the FDA recently announced that single trial will now be the default for drug approval. Yeah. What I really wanted to convey by all of this is that, these are positive considerations for SCENESSE to come to market for vitiligo as we are continuing on the same trajectory. I can't tell you exactly when, but for sure, vitiligo is the natural home for afamelanotide, a pigment-activating peptide, which is an analog of a hormone that's naturally produced by our own body. Thanks, Malcolm. Thanks, Emilie. Before we go to analyst questions, all stakeholders want to know what's next. Philippe, can you summarize that for us, please? Sure. There are a number of catalysts that we're approaching over the next two years. The most immediate ones are the top-line results from vitiligo CUV105 in the second half of 2026, the start of the vitiligo CUV107 study, the preclinical results on the peptide formulation the latter half of this year, and the listing of the ADRs on Nasdaq that we await the SEC answers for. The catalyst will naturally change the complexion of the company. Yeah. This is exciting, we've navigated the waters over time to arrive at this point, we all need to bear patience, and see what the impacts are from these results. There's much to look forward to. Yeah. Indeed. Thank you, Philippe. Let's go to analyst questions, thank you, Peter, Emilie, Linda, and Philippe for the discussion. Some good, insightful comments there, I hope those on the line also have got some insights and appreciate that. The first analyst to ask a question is Dr David Stanton of Jefferies. Hello, David, are you there? I am. Can you hear me? Yes, David. Go, please, go ahead. Thank you. My question is, do you have to wait until you have the results of CUV105 and CUV107 before you file for approval in vitiligo? Which geography would you file in first, and why, please? I'm gonna take this question, Malcolm. Okay. It's a, yeah, it's a good follow-up. From what I was mentioning a couple of minutes ago. Thank you, Dr. Stanton, for this question. Question that's relevant and often asked. Our intention is to complete CUV105 and CUV107 before going to the EMA and FDA. The recent announcement on single trial for drug approval from the FDA doesn't change this strategy. Based on the ongoing interactions we have with both agencies, EMA and FDA, on the specificity of our work that we are conducting, we will need the CUV107 study to complete our program. For the second part of the question, we opt to file with the EMA first and then FDA second. This really, this strategy really much follows the approach we had with EPP back in 2012. Thank- No. Thank you. Oh. Sorry. Sorry. No, no, I want to say more. Please. I think it's important for me, when we speak about regulatory agencies, is I want to give a bit more color. An agency, as you know, it's a conglomerate of thousands of people. At the EMA in Amsterdam, there are more than 1,000 permanent staff and more than 4,000 part-timers and experts. We are dealing with two European reporters that are representing their national competent authorities, which are Lithuania and Poland, with a scientific advisor representing the scientific advice working party, a very knowledgeable German physician. At the FDA in Silver Spring, there are more than 8,000 permanent staff and another 6,000 elsewhere, consultant part-timers. We interact with the Division of Dermatology and Dentistry, now led by Dr. Jill Lindstrom in the Center for Drug Evaluation and Research. We have a new Commissioner, as you know, Dr. Marty Makary, who has reshuffled the agency, bringing new procedures and a new approach. In our EMA reporters, we find willing listeners and may I say, more supportive of our regulatory and market strategy. We are the only company focusing on patients of darker skin color. This point resonated very well in our recent discussions with the EMA. The approach we have on vitiligo is so novel that we deem the European regulators to be the first port of call. It will make it easier for the FDA to assess similar data. Okay. Thanks, Emilie. The next question is for, or from Dr. Melissa Benson of Barrenjoey. Hi, Melissa. Hi, Malcolm. Hi, team. I had a question in regards to the ACTH program, so NEURACTHEL. Just to help us understand, you've mentioned there later this year you expect to file with EMA. A similar question to the lining of vitiligo, but understand, like, how does filing with Europe first and then the FDA, how does that kind of expedite the U.S. opportunity? Secondly, any color you can kind of provide on the differences, I guess, between the commercial landscape for a product like this in Europe versus the U.S., 'cause I understand, you know, one market is quite a synthetic peptide-based and the other is a natural hormone-based. That would be great. Thanks. Philippe, to you. Thanks, Melissa. Yeah, we talked about this in the past. NEURACTHEL will first be filed in Europe through the route of mutual recognition. As you know, the analogues of ACTH, in our case, NEURACTHEL, are used by many institutions, both as a therapeutic and as a diagnostic. We opted to go to Europe first and U.S. second. Once you've filed through the mutual recognition procedure, you can file shortly in the U.S. after. ACTH products are mostly distributed to specialty centers in Europe. They prescribe an internal specialist endocrinologist, and we believe that it's possible to make the first inroad directly to these centers in Europe. Reimbursement in Europe is albeit lower than in the U.S. Both markets are sizable and are attractive, but we have experience in leveraging the European regulators, and the resonance there is high. It's a slightly different strategy than most of our competitors, but so far it worked. Okay. Thanks, Philippe. We've just lost you on camera, so if you can try and get back to us, we'd like to continue to see you. Let's move to. Yes. Let's move to Dr. Thomas Schießle of EQUI.TS GmbH in Germany. Thomas, you're a long way away, but let's hope you're connected. Hello, Malcolm. Hi. Oh, wonderful to hear you. Yeah, good morning and good evening, everybody on the phone. I would like to ask a question. What does the recent FDA decision on Disc Medicine bitopertin mean for your business and growth outlook, please? Okay, Peter? Sure. Yep, no problem. I can answer that one. I guess, thank you, Doctor, for your question. From a finance perspective, I'm happy to answer that. I see it from a way of increasing our monopoly in the market with the other player, obviously not being able to enter that market yet. As we're really the only approved drug treatment for EPP with a proven safety and efficacy record in the U.S. It could take them, I would estimate about one to two years to come back, or even longer, to enter the European market. It could be quite an extended period of time that we still maintain a monopoly within that market. I guess that's how I see it, Doctor. I'll come back to you, Thomas, to ask another question because we've covered that fairly succinctly. I'd like, Linda to make some comment, because some shareholders have asked what's our reaction to the FDA's decision on Disc. Can you make some comment on that, please, Linda? Sure. first, can you hear me okay? Yeah. Yes. Yes. Okay. Right. First, you know, I definitely can comment. However, I do prefer not to comment on the setbacks of other companies or their management, and I will just leave that to the external observers. While competitors may have made critical remarks about our work, I don't consider it to be elegant to respond in kind. However, what I will say is that it is not easy to get a regulatory approval in one go. Right. Our team have done this by working thoroughly and diligently, you know, at the end of the day, it is really all about the patients, making sure that the drug is safe and that it shows significant clinical improvement in their quality of life. The FDA really raised questions regarding the bioavailability and efficacy of bitopertin, which, by the way, I'm sure most of you already know, this was actually originally developed for an antipsychotic drug for schizophrenia before, you know, it was abandoned by Roche. For EPP, the company had then had to increase the dose from 20 mg- 60 mg to achieve a statistically significant reduction on the biomarker of the protoporphyrin level. You know, higher doses also means that, you know, there's gonna be extra stress on the patient's liver or the or kidneys. This is very concerning, especially for EPP patients, because they are already at a higher risk of liver disease. On top of that, oral pill, higher dose also increased side effects, complications, and drug-drug interactions with other medications. As a pharmacist, I really cannot see how this is a benefit for the EPP patients. Right. The other point that the FDA also raised, a very valid concern, was its primary endpoint, and this was based on the change in the biomarker protoporphyrin IX. In case, y ou know, I don't know how much you guys know about biomarkers. Well, biomarkers are a very helpful tool for scientists, for physicians to really understand what's happening in our body, but it does not always reflect real-world, meaningful clinical benefit. An example that comes to mind is there was a drug that was received an accelerated FDA approval back in 2016 for an advanced soft tissue sarcoma, and this was approved based on a biomarker endpoint. But once they came to real life, the real-world clinical outcomes did not show any survival benefit. At the end of the day, the FDA had to pull the approval soon after. From a bigger picture pharmacological perspective, it also seems very unusual to me to prescribe a lifelong oral pill that affects the central nervous system to lower the protoporphyrin IX marker, biomarker levels. I guess I suppose we'll really have to wait to see the results of their future trials to see whether this drug can really show both the efficacy and the meaningful clinical benefits for the patients. Right. Very insightful. Coming back to you, Thomas, do you have a follow-up, a quick follow-up question? Yeah, indeed. Thank you, Malcolm. Okay. Absolutely another the issue. The FDA. No. The second one. What impact does Nasdaq listing have on CLINUVEL's future regular reporting concerning frequency and content, please? Okay. Peter, for you? Sure, I can answer that one, Malcolm. We'll be listing on the Nasdaq or uplisting our ADR program and listing over there as a foreign private issuer. What that basically means is that we'll continue to lodge half-year and full-year financials. In the U.S., we'll be reporting in U.S. dollars and also in U.S. GAAP accounting. I guess in short, Thomas, it'll be exactly the same as what we currently do every six months, and then every 12 months for the half year and the annual reporting. No real change to the frequency. Thanks for dialing in, Thomas. Thank you. I'll just mention that several shareholders have asked for an update on our listing application. Peter, give us an update, please. Sure, no problem. We lodged our initial filing, which was a 20-F document to the SEC in mid-December, or 18th of December, to be specific. We did foreshadow that there may be some delay in the turnaround time because it was also, it was Christmas period, but also the government had come out of shutdown mode and the SEC, that obviously affected them, so they needed to catch up and clear the backlog of filings and other documentation they had. We have had some further correspondence back and forward with the SEC, and we're refiling our response to them. We're hoping to be able to receive clearance from them in the very near future and then move quickly to implement the ADR program uplift. Watch this space. We sure will. Let's now call on Sarah Mann from Moelis. Sarah, please. Good morning, good afternoon, everybody. My first question is just on the EPP market. Could you provide us any details around what percent of your patients are covered under Medicaid? Just curious how you anticipate some of the cuts to Medicaid potentially impacting your ability to reach those patients? Well, Linda, for you. Sure, I'll take this one. Hi, Sarah. Thank you for your question. We're actually seeing less than 5% of our U.S. EPP patients on Medicaid benefits. In short, we don't really have a noticeable impact, and in fact, you know, that you mentioned all the One Big Beautiful Bill. It actually broadens the orphan drug exclusion. It now allows orphan drugs to, with more than one rare diseases, to remain exempt from Medicare price negotiations. You know, potentially, so far looking like it's indefinite, unless the drug is later approved for a non-orphan indication. One can theoretically state that the TAM would increase through curving the federal programs, but given that most of our patients are commercial insurance patients, we don't really see a worthwhile impact in the U.S. market at this time. Okay. Sarah, a follow-up question? Thank you. Just on a separate topic. Just curious if you could provide more color around the cosmeceutical strategy. Obviously, it's been in market for a couple of years in, I suppose, prototyping or early stage testing. Yeah, just curious how you expect it to ramp up this year and any learnings that you've had over the past couple of years as well, please. Philippe, can I call on you? Sure. First of all, good to see you back, Sarah. It's been a long time. On numerous occasions, we mentioned that the PhotoCosmetics are in development, and they accompany a complement our pharmaceutical program. That's quite an unusual strategy to have both Pharmaceuticals and the PhotoCosmetic franchise. Not many pharmaceutical companies do that. The first was the P-line, the photoprotection lines, providing polychromatic photoprotection in populations with highest risk in extreme conditions. That will be followed by the M-line, the melanocortin containing peptides. They intend to provide assist the DNA repair and assist self-bronzing or the so-called sunless tanning. In all these properties, the endeavors goes really to launch products with a substantial marketing effort. That needs to provide visibility to our products. We started to gradually increase our marketing spending online to focus groups, advocates, target populations and channels. We are in a pre-launch phase where we get feedback on these products. Ideally, and nothing is ideal, but that was the anticipation and the model. When the vitiligo trials start to yield results, we then see a parallel large-scale effort to promote the M-lines, because the concept was that the medical tanning that you see in vitiligo follows a parallel path to the PhotoCosmetic self-bronzing properties. In short, we advance, but we're not really ready to launch these products, not from a scientific point of view and not from a marketing. What we aim to see is lotions and serums applied a number of times a day that assist the self-bronzing in the epidermis, and we're not quite there yet, but we're advancing. The other part is in order to make this a commercial success, the company needs to differentiate itself in all aspects. The retail experience needs to be changed or disrupted, if you wish. The primary packaging, the secondary packaging, the way we distribute it, the retail store concept, and all that at a reasonably large scale. With that buy, we are conscious of the spending and the budgets we put aside for this exercise while keeping the company profitable. It's a balancing act that we do need to navigate all the obstacles, but to decrease the risk of failure, and that we do that in a very gradual and deliberate manner. Okay. let's move to Madeleine Williams of Canaccord. Please, Madeleine. Hi, team. Thanks for taking my question. I think firstly, I was just wanting to know, you've got a few things happening at the moment. Obviously last year, Europe allowed the increased number of doses. Also in the U.S., as the Disc Medicine trial completes this year, I assume there's sort of going to be more patients available. Just thinking about how you're thinking about the growth in those jurisdictions and sort of the splits going forward. Well, Peter, you want to comment initially on? For me? Yep, sure. No problem. I can comment on that. I would say that there's a segment revenue note that we've included within the half-year report that does show the breakdown. I guess a quick summary would be the U.S. revenues have increased year-on-year, and this period we saw a rise more predominantly in the European volumes, partly spurred on by some patients taking up that increase for implants being a maximum during the year up to six. That was announced in September 2025. I guess at the moment, the current revenue split is about 53% U.S., 47% for the rest of the world. That kind of, that's the insight that I can provide there. I guess on the peptides side, that's probably more Philippe perhaps might be able to answer that one. Oh, no, we'll park that. I think, we'll move on to Mark Pachacz, because I think he's got to leave pretty soon. Mark, if you're still there, can you ask your question? Hi, Malcolm. Looks like Mark is no longer here. Okay. That's all right. Well, fortunately, we have another analyst, Thomas Wakim of Bell Potter. Do you want to ask a question, please, Thomas? Hey. Yes. Thanks for taking my question. It's a bit of a follow on from the previous one, actually. Yeah. Saw in that revenue segment, the split between U.S. and non-U.S. sales for the period just gone, we saw a decline in the U.S. and a significant increase outside the U.S. Can you just kind of explain in a bit more detail what those factors were that were at play there leading to that, and how does that look moving forward? Thank you. Sure. There was some effect on the U.S. side from the government shutdown. The government shutdown meant delays in Medicare processing, as well as also the processing of reimbursements. In some instances, some of the smaller centers didn't want that longer term delay on their payment cycles and things like that. That did cause some headwind there for them. We also passed on a CPI increase in 2025, and some of those have caused some negative reimbursement pressure on some of the centers. Overall, we anticipate that the U.S., you know, it's still stable, it's still growing across that, and that's where we've continued increasing the number of centers across North America. We're seeing new centers come online and start to bring patients to the fore as well. You know, there is that difference between prior year and this year, but I think it's really explained by the U.S. government shutdown predominantly. Okay, Peter, thanks. As I was talking with Madeleine, before, and also with Mark Pachacz, there was a fair bit of interest in peptides. Let's come back to peptides and ask Philippe to comment on the potential of that new area of development. Well, we spoke for a long time in public about the skill set of the company and how it was expanding concentrically. We started off as a company, focused on clinical affairs. We understood the melanocortin peptides really well. Then we focused on the delivery methods, the best way to deliver and administer a drug into a human body. From that, we built our Singapore labs, and progressed fundamental research into new formulations. We call it formulations for, of the next generation, using a liquid injectable peptide platforms. Naturally, once we mastered these technologies, it opened up the realm of fantasies of what other peptides could you use to deliver a product in a sustained or controlled manner, and that's where we are. You're going to expect much more from that team and our activities in Singapore. Thanks, Philippe. Very exciting. It's about time that we wrap up. I didn't want to conclude without addressing a couple of shareholders who asked me about the company's dividend policy and whether we have one, and I can say we certainly do. It's available on the CUV website. I can tell you that it is the board's intention to pay a dividend subject to the sufficiency of our funds and the operating and investment needs of the business, and indeed, future growth and needs to fund that growth. The board will determine that, and you can investigate, as I say, the dividend policy online. I want to say thank you to all the analysts online for asking their questions. Peter, Emilie, Linda, Philippe, for their contributions, good insights, and all attendees. Thank you very much. A link to the webinar will be posted to the CLINUVEL News website as soon as possible for other stakeholders to review. I'll now close the webinar, wishing you all good health and fortune. Thank you.