Hello, everyone. Thank you for joining CLINUVEL's investor webinar today. I'm Stella of Monsoon Communications. In today's webinar, CLINUVEL will share their results and operational highlights for the financial year ended on 30 June 2026. I will now hand over to Malcolm Bull, Head of Australian Operations and Investor Relations, to conduct the proceeding.
Thank you, Stella, and thank you to Monsoon for hosting yet another CLINUVEL results webinar. Welcome everybody online. There should be 130 of you very attentive to the news that we're going to provide to you. I have CFO Peter Vaughan on the line, as well as our Director of Global Clinical Affairs, Emilie Rodenburger on the line, and Managing Director, Philippe Wolgen. Welcome executives.
Thank you.
Hello.
Good morning.
The agenda today is to discuss our results for the financial year ending 30 June 2026, and we are going to have Philippe and Peter and Emilie involved in various aspects of the performance and operations of the business. We also announced some other news today, the consideration of listing all of our ordinary shares on the Nasdaq, and delisting from the ASX, and we will certainly get Philippe to talk to that. We have several analysts on the line who cover CLINUVEL, and we certainly appreciate their coverage and we welcome their participation in this webinar. They will ask some questions of our executives. Then finally, time permitting, we will address a few shareholder questions that our discussion has not quite covered. I should share a particular screen with you on our forward-looking statement. We will be talking about intentions and plans.
You should be aware that there is a range of risks that can materialize that affect those plans from coming to fruition. We will try our best as an executive team and work with the board to deliver the results that we are advising you. I want to move into discussion of the results and strategy, but Peter, I thought you could set the scene to cover this year's results by providing an overview of how you manage, quite deftly, the finances of CLINUVEL, which enable us to build the strong foundation we have for the future.
Of course. No problem at all. Thanks, Malcolm. Good afternoon and good morning, and welcome to the webinar from wherever you are dialing in from. It is great to have you here with us. I guess, as Malcolm outlined, we will start with a strategic financial overview as to how we operate at CLINUVEL and the way we go about things. The financial and strategic overview that we have in finance and what my team and I focus on are four key or core objectives. The first is to maintain profitability. We do this by ensuring our year-on-year profits continue, but also that we can dial up and dial down our expenditure, and particularly our discretionary expenditure, to ensure that we can match the revenues as we see them come through. The second area we focus on is building positive net cash flows.
This is why the profit margin protection is so important, and then that positive net cash flow helps to build the cash reserves that we use as our protection for the organization. Next, we invest in our strategic priorities. Our R&D programs, in particular, our vitiligo program at the moment, but also our capital and infrastructure expansions. You would have seen announcements around our Singaporean facility, and expanding our laboratories over there, where we are doubling the footprint. Fourth and final is putting our surplus funds to work. We do not just leave them sitting in the bank. We know that we have been entrusted these funds by our shareholders, and it is really important to us that we put these to work, and this is where we put them in term deposits that, at the moment, is attracting a 6.23% return.
Overall, this financial strategy is designed to build a financial moat for the organization to shield and protect our shareholders. What are we protecting them from? We are protecting them from market forces, and we have seen those affect our industry significantly over the last two to three years. Investment has really pulled back out of biotech and life science companies. We also protect our shareholders from dilution using these cash reserves. We have been entrusted with those shareholder funds, and we want to make sure we put them to good use. Our reserves also provide us with optionality. This optionality is for us to focus on opportunities and take initiatives that we see in front of us, whether they be organic or inorganic. This strength comes from that 10 years of consecutive profit growth, the 10th year being this year. We have established a pristine and strong balance sheet with no debt.
This has been our strategy to help absorb shocks in the market or from results if they do not go our way, or from delays that might be experienced in programs. It has built our independence from having to rely on the capital markets and the peaks and troughs and volatilities that come with it. I thought I would share a quote that we recently received from one U.S. investment banker that we had been talking to as part of our U.S. expansion. He said, and I can quote him here, he "Very seldomly sees a life science company with the financial strength that CLINUVEL has managed to build from one product in the market." We are often critiqued internally or mainly externally from shareholders or other investors, or people looking in at CLINUVEL, that we are too slow or stagnated.
We see this as being part of our strategy, because if we were to increase the pace of the organization faster than it can handle, it increases risk. If we were to expand faster than we are capable of sustainably doing it increases risk. If we diversify through M&A and then spread our focus of the organization, it increases risk. If we were to throw more dollars into programs, it does not necessarily amount to outcome improvement, in which case that increases risk. All of these areas is why we have built a sustainably, globally marketed product in SCENESSE. We initially focused on one indication in EPP, in one market in Europe, and then moved to America and spread into the second market. Now through our vitiligo program, we will expand into a second indication that offers even considerably more market potential than what we have with EPP. I hope that helps, Malcolm, and that is a good overview.
I'm happy with that overview because I can now ask you to summarize the financial results, which I've put on screen for you.
Excellent. Yeah, look, again, this is our disciplined and financial strategy at work, where we've delivered our 10th year of consecutive profits. There aren't too many in the life sciences space that can lay claim to that. Shareholders reading our annual report today would've noticed that the presentation layout of our P&L has changed, and I thought I'd speak to that for a second. The reason being, we've now moved from a by nature reporting layout to a by function reporting layout. This now aligns our presentation layout with our U.S. GAAP financials, which is required by the U.S. market. Therefore, we now have more of a standard or traditional P&L layout of revenue, cost of goods sold, gross profit, and expenses. In looking at our revenue, specifically at the moment, we've exceeded AUD 100 million of total revenue for the second year running.
This was able to then be used to return a ninth consecutive dividend to our shareholders this year, and we basically returned 9% of our net free cash flow from the financial period in the form of those dividends. Expenditure was slightly lower than was forecast, but this is a good thing because we were still able to expand our R&D programs and other capital infrastructure projects that we've discussed. Our EBIT actually would've been the same as prior year had it not been for the strengthening of the Australian dollar. The reason that this had an impact was we have a significant amount of U.S. dollar term deposits, so translating those back to Australian dollars actually amounts to a financial loss because the Australian dollar has appreciated. We have to translate everything back into Australian dollars just for a reporting functionality. It's not an actual economic loss.
Because all of our financials in Australia in our ASX reports are presented in U.S. dollars. So this AUD 4 million unrealized translation loss is represented in our P&L, but it's not actually a bottom-line economic loss.
Our cash reserves for the period increased by AUD 28 million to AUD 252 million. The other aspect of this is that it would've been even larger. We would've had a AUD 40 million increase. However, during the period, the Australian Taxation Office required us to start making installment payments towards our year-end tax bill, which we ended up having to pay AUD 12 million during the year. Normally, our tax payment goes out in one bulk lump sum in December. So during this current financial period, our reserves increased by AUD 28 million, but we actually also paid nearly two years' worth of income tax payments because we paid our FY 2025 in full in the first half of this year. Then we also paid the installments throughout the year of AUD 12 million. That's where we would've had a AUD 40 million increase in our cash reserves.
The silver lining in this is that now in the first half of next financial year, we won't have this bulk outlay of income tax being paid that we usually have in the first week of December every year. Therefore, our cash reserves will increase in the first half of the year because it's now smoothed throughout the year.
Okay. Thanks, Peter. I want you to turn to long-term profitability. They say that a picture tells a thousand words, but I don't want you to use a thousand words because we don't have enough time. Please, summarize that profitability trend and the expenses, and particularly the revenues.
Of course. As I touched on before, we're proud that we've achieved AUD 100 million worth of revenue for the second year in a row. This really came from the treatment volumes that we saw this year. Our SCENESSE treatment program globally had its largest number of treatments ever that we've experienced. That was up 6% on the prior year. We did see some moderation of the U.S. sales and treatment numbers. We feel that this is because there were other competitors out there that were offering free product through the clinical trial programs that they were offering. The good news is that whilst these other entrants came into the market with free product, we still saw people return to SCENESSE after those treatments.
It also meant the market was able to sustain not only one player in the market being us, but also three entrants without it having a significant effect on our revenues. The flip side to the U.S. moderation of revenue was the European strength. We saw European treatment volumes increase by 13% during the financial period, which boosted our revenue by 9% on the prior year in Europe. We see the market entrants in the U.S. as being a temporary competitive effect rather than a product structural change to the market. As I said, the EPP population and the EPP market in the U.S. sustained these four competitors all in there.
Our disciplined financial management in these types of situations, though, this is why it is important to come back to this, enabled us to dial up and dial down our discretionary expenditure as we started to see that U.S. impact of sales. Therefore, we can match our expenditures to our revenues, whilst still continuing to invest in our strategic priorities. With all that said, our gross profit margin was 83% and our net profit margin was still 36%. These are the margins that we are guiding the business by to ensure that we can protect those reserves continuing to build. These sorts of results in a life science company are truly exceptional.
Indeed. Well, let us move to the expense side and just go into a bit more detail on what was happening there.
Of course. So at the end of last financial year, everyone on the webinar may recall that we came out and said that on average over the next five years, we will be expending about AUD 55 million. That was on average for every year for the next five years. We actually came in at AUD 53.5 million, so we were AUD 1.5 million under that AUD 55 million number. It is important to note the AUD 55 million actually excluded CBM activities because we see that as some of the discretionary spend that we can ramp up and ramp down. But our AUD 53.5 million actually included our CBM activities, so our true underlying, if you like, expenditure was about AUD 45 million, when you exclude that CBM activity of about AUD 8 million. Across the CBM, we did see it relatively steady or stable from the prior year.
We still delivered our major program for the year, which is our AAD in Denver, which was in March earlier this year. Again, building company brand and presence in the market so that people know what we are and what we do. Our general admin was AUD 1.5 million higher than prior year, but sorry, was higher than prior year, but the AUD 1.5 million of that actually related to one-off costs in relation to our Nasdaq uplifting. So that amounts to legal fees or audit fees and other aspects directly affected by that Nasdaq uplift. Our U.S. dollars, that funding investment into our vitiligo program, our NEURACTHEL program, but then also our new controlled release injectable peptide platform that we're running from our Singaporean RD&I facility. The minor reduction in R&D just purely reflects the CUV105 study starting to wind down to completion. It's not actually a pullback of that program.
Really, we'll start to see that starting to increase again as our CUV105 program in vitiligo starts to come online later this year, that I'm sure Philippe and Emilie will talk about in a moment. Our R&D expenditure in total was 35% of our total expenditure, and we directly reinvested 20% of our revenues into R&D. Our first decade of commercialization has really built a self-funding, sustainable business model and built those cash reserves that helped to cement the business and its balance sheet. 10 years of profitability that's consistent year on year, it's really unheard of in life science.
Indeed, it is. Staying with you, Peter, since you just mentioned the strong balance sheet.
Sure.
What comments would you like to make with regard to the state of the balance sheet?
Well, I guess the first thing that I would say, Mal, is I think our balance sheet strength is actually one of the most underappreciated aspects of CLINUVEL's investment proposal. Touching on that comment made by the U.S. institution recently, in the last couple of months, I think that really supports that. Our cash reserves that I touched on before increased by AUD 28 million to AUD 252 million. Our total assets increased to AUD 295 million, just a touch under AUD 300 million in total. I did touch on the fact that that AUD 28 million increase would have been larger in cash reserves had we not prepaid the AUD 12 million of income tax, but that will obviously have a back-end effect and improvement for our first half of 2027 financial period.
Apart from investing in our R&D programs for our revenues of tomorrow, we are also investing in a number of other initiatives and capital improvement projects. The first one being the doubling of our Singaporean RD&I facility that I mentioned before. That is increasing laboratory footprint, which gives it more capability and more capacity for those exploratory R&D activities. We are refurbishing our European office, which is really the head of our European area of our business, and that is a substantial asset on our balance sheet already because we own that premises. We are really improving that asset for the future. The final one is we are also establishing an integrated manufacturing and supply chain now. We are looking at those avenues to in-house more of that activity and bring it closer to us. We hold about AUD 231 million in term deposits at the moment across multiple different currencies.
As I mentioned before, that is returning 6.23% yield. We really do not have a laggy balance sheet even though we have this surplus of cash. We are deploying it for return for our shareholders. We remain debt-free for that 20th consecutive year, and it has been 10 years since our last capital raise. Our balance sheet has really been built through profitable operations that we have run and internally generated net cash flows instead of the typical life sciences R&D type process of repeated equity raisings and shareholder dilution. We really entrust and protect our shareholder reserves. It is important not to underestimate this strength in our balance sheet. It is really underappreciated because it significantly is the fundamental solid base that we can build from. It protects us through these market cycles that can affect other organizations.
It gives us capital and optionality to invest, but it also provides us with opportunities without being forced back into the market to fund it. It allows our strategic initiatives to continue and us to continue investing in those without having to consider any shareholder dilution. I would say as an overarching comment in relation to the balance sheet in total, that the first year of our disciplined financial business model, really, we were able to build it and show how it works from a commercial standpoint. Our next decade, we will use that strength to now build our infrastructure, our science, and our commercial capabilities for future revenues of tomorrow in the pursuit of shareholder value.
Well, Peter, you've covered a lot of ground in a pretty succinct amount of time. The profitability of the company, how we've established that, your role, the finance team in helping to manage that, the strong balance sheet, and the optionality we effectively have. So thanks to that. I'm going to switch now to Philippe because today we announced a major strategic intention. I'm simply going to ask you, Philippe, to talk to that announcement.
Yes. Thank you, Malcolm. It's been a long time coming. As most shareholders know, we've talked publicly about the option to list one day on Nasdaq. We've taken the moment when we believe that the company is sufficiently mature to make that transition. In essence, we need to be there where the current and the future economic activities will take place. Unfortunately, we've never had a commercial footprint in Australia. North America will be our largest future market. So we will need to have feet on the ground. For this, we expand our U.S. market access team, commercial team, and clinical teams, and we'll make it our headquarters on January 1. If you add towards the makeup of our registry, the ownership of this company has always historically been in foreign hands, 70% North Americans, Asians, Europeans, and only 30% Australian.
That shift has never really taken place in favor of the Australian owners. So we've long prepared the company for a U.S. listing. We made that public, so there can't be any surprise. The depth of the U.S. market is well- known in life sciences. I also need to devote a few words to the Australian analysts because it pains me to see how much time they've spent on CLINUVEL, the hours, the number of reports since 2019. But we believe that the company is now mature enough to have a place on the Nasdaq Global Select Market. Important and questions that we received, what happens to the IP? Well, most of the intellectual property resides outside of Australia, in the U.S., in Europe, in Singapore, where our research center has been located. Then vitiligo, of course, is a global disease.
However, vitiligo is most prominently treated in North America, in the United States. So this is an additional reason why we need to be there as of January 27. A comment was received as why CLINUVEL is seeking a single listing and not a dual listing. The answer is for companies that have a considerably larger size than CLINUVEL, it would make sense to split the liquidity and volume traded. But at our size at the moment, it makes sense to have one single listing on a U.S. exchange where we devote all our resources, compliance, and personnel to it. If you look numerically for the reasons why we opted to do that now, in 2020, we traded a value of AUD 1.7 billion annually, and that has receded to about AUD 320 million in 2026. So we've seen a decline in traded value and therefore volume in the CUV stock.
So in essence, we base ourselves where the chance of value creation is the highest and where one commands a valuation multiple, which is higher than normally in Australia, but closer to the intrinsic value of the company. These are the reasons, Malcolm, in a nutshell.
Okay, Philippe. Thanks. I would like to turn to our pipeline, but first, just speak to our strategy, which has been to build and apply our expertise in melanocortin-based treatments for unmet needs. We have certainly achieved that with SCENESSE EPP. I think as the participants to the call know, we are working on other indications. We have made a leap forward on delivery methods, particularly on how we administer peptides, arriving at controlled release formulations. This has been a keen interest of many shareholders, and some analysts as well, not just in questions submitted to this webinar, but questions over recent months since we announced the progress of the liquid formulation peptide platform. We can tell you that we started this in-house development many years ago, attracting talent, progressing the development, and we now have sufficient comfort to proceed to small-scale manufacturing.
Dependent on progress, large-scale manufacturing is a potential. These are all calculated risks, but we believe they hold more value than anything else we have ever done in-house. However, and the pipeline is on screen for people to see, the immediate and lead program is vitiligo. Now, dependent on the results, and we will know those results over time, that will determine the pathway to file for marketing authorization. But I wanted to bring Emilie in to talk more about vitiligo. Emilie, I thought you may have dropped off. Are you here?
Yes, I am here, Malcolm.
Oh, I am so relieved because I want to hear you talk about vitiligo. Please go ahead.
Yes, absolutely. Apologize for the coming off and on the screen. We have been hit by a storm in the U.K., and I think it has distracted and disturbed my internet. The sky is blue almost now, so I am ready to talk about vitiligo.
Okay, excellent.
Vitiligo is a unique program whereby the efficacy of the treatment is visible. We do not rely on blood analysis or biomarker or X-rays in our trials. The efficacy of the treatment is visible, and we document this with light photography. When we started the program with the hypothesis that afamelanotide with narrowband UVB adjunct would repigment vitiligo, we saw the efficacy in the hands of three leading vitiligo experts in the world. We are focusing our efforts on the patient population with the highest need for treatment, patient of darker skin color, Fitzpatrick skin type 4, 5, 6, for whom the impact of the disease is the greatest. As a reminder, afamelanotide alone does not work since melanocyte and receptors are not yet present and expressed in the vitiligo lesions. We will always need light therapy, narrowband UVB phototherapy, to be adjunct to the drug.
Light therapy, as narrowband UVB, is the standard of care for vitiligo, and the cabins are available in many of the U.S. centers. The competitive landscape has much evolved from the time we signed off this first proof of concept study back in the Melbourne office, and where we were the only company in the world developing a treatment for vitiligo. You've seen that companies now have started to reposition their drugs for atopic dermatitis or other autoimmune diseases, the JAK inhibitors in vitiligo. Couple of years ago, a topical version approved, and very recently, last month, the first oral systemic JAK inhibitor by an American company, approved by the European Commission, and likely, later in the U.S. by the FDA.
The rise of the competitors and this opening of this vitiligo market is helping us enormously since the regulators are now becoming more and more familiar with the disease and the trial. They no longer have to look at afamelanotide with narrowband UVB adjunct as a first dossier. There are precedents and benchmarks. This is what we experienced at the time of scientific advice in Amsterdam with the EMA. Unlike EPP, where we were first, there are advantages of not being first. Another advantage and the big difference of afamelanotide versus JAK inhibitor is that we do not suppress the immune system. Afamelanotide acts as a natural ligand to the cell that produce the pigments. We mimic a physiological process, and in our trial, we need to demonstrate that afamelanotide with narrowband UVB adjunct is providing faster and a deeper repigmentation.
If I may use an image, with afamelanotide, we have the foot on the pigment accelerator, while the JAK inhibitors are taking the foot of the brake immune pedal.
Right. Mm-hmm.
Of note, JAK and more and more are openly—JAK inhibitors are openly said to take too long to repigment or for treatment effect and do not really work that well, and the experts talk about that and about this result in conferences. You may have noticed it yourself looking at the late phase III trial results and top-line result presented. These trials evaluating JAK inhibitors against placebo, despite reaching statistical significance, have quite a modest effect on repigmentation.
That is good. Now Emilie, we are going to move to catalysts, and since you are talking about vitiligo, that is to the fore of our catalysts. Can you please talk to the vitiligo catalysts?
I will. I'll start with two significant milestones for phase III vitiligo clinical program. First, the top-line results for the CUV105 study, and then the start of the CUV107 study, both expected in Q4. A few words about top-line results in CUV105. We've been working internally and externally to retrieve and monitor all study data, generate queries, undertake cleaning activities, as well as reviewing and assessing digital photographs. The study, the CUV105 study, has generated 110,000 photographs. The photography review undertakes three stages. First, a local review by the sites and physicians, then a central review by our clinical team, and lastly, an independent review by an expert panel, the Central Photography Review Committee. In our review, we look at both the extent of repigmentation, how much the patients are repigmenting, but also the quality of the repigmentation.
As we presented at the AAD earlier this year in Denver, repigmentation follows a temporal sequence. First, from the follicular response, when you see little confettis inside the lesion, brown confetti, brown islands, meaning that the patient is responding to the treatment. To a confluence, where these small confettis and islands become bigger and merge, towards homogeneity. Homogeneity is when the vitiligo lesion is fully repigmented and the color is homogeneous with the constitutive skin. We call it color-matching, and it's very, very important from a patient satisfaction point of view. A brief note on AI. In parallel, our internal AI model that we presented at the AAD as well is ongoing training to support these activities in the near future.
Okay. Philippe, anything to add on vitiligo or the catalysts?
No, I think Emilie summarized this pretty well. There's not much to add. We are watching the market evolve. We witnessed the commentary on JAK inhibitors and the length it takes to see some effects. We also, with eagerness, are looking of how these oral JAK inhibitors are going to be priced in Europe first and perhaps in North America. But in the meantime, we continue by training and accrediting centers, and our target for 190 trained, accredited centers by 2027 is on track. We are watching with eagerness.
Very good. Well, look, thank you, Philippe, Emilie, and Peter, in reverse order of which you spoke. Much appreciated. It is now time to turn the call over to the analysts that are on the line. Now, analysts, our briefing has been quite extensive, so please keep your questions succinct. We are going to start with David Stanton from Jefferies. So David, please ask your question.
Thank you very much, team, for taking my questions. I have two. Firstly, can you give us an update on your best guess as to when the CUV107 trial will read out, please?
For whom please?
Yes.
Emilie, please.
I am taking this question, David. Thank you. CUV107, from the start of recruitment in November 2026 to completion of the study, last patient, last visit, the CUV107 study is planned to run for approximately two years. Readout will follow data cleaning and analysis, so expect 2029.
Understood. Thank you. Second question, about price. Should SCENESSE be approved in vitiligo, how would the differential pricing for SCENESSE be between the disease indications, and how would that be managed, please? Thank you.
Yeah. Philippe?
Well, there's no real surprise. I think let's take a step back for the general shareholders on the line. We are pricing SCENESSE in EPP on a bimonthly basis perpetually. So patients are on this product for life every year. That gives you a value per patient per annum that is calculated and borne by insurance companies and state payers. In vitiligo, our assessment, depending on the biological variability that you see in patients, not everyone responds in the same manner at the same intensity. It depends on the number of treatments that you're going to provide, but we assess that it's going to range between seven and 12 implants per patient as a one-off treatment. So that's a one-off treatment in vitiligo versus annual repetitive treatment cycles. We also believe that vitiligo patients will benefit from one to two injections per year as maintenance treatment.
The answer is that the value per patient in vitiligo is going to approximate value per patient per year in EPP. We do not believe that there will be too much price erosion. It will be more or less in the same ballpark.
Okay. All right.
Does this answer your question then, David?
It does. Thank you very much.
Thank you, David. We'll now move on to Melissa Benson from Barrenjoey. Melissa, hi. You want to ask a question?
Hi, everyone. I had a question just on interactions with the FDA. I know with the vitiligo program, you've had EMA scientific advice. I'm just wondering, interactions with the FDA you've had, if you intend on having any meetings post the CUV105 data at the end of this year or sooner, and also, I guess understanding how much FDA input has gone into the CUV107 protocol.
Thank you. Thanks, Melissa. I take your question. Yes, that's correct. We'll meet with the FDA following the top line result of CUV105, which is after we commence CUV107. Unlike any other vitiligo program, we are focusing on the use of a drug device combination, afamelanotide with narrowband UVB adjunct for vitiligo. While the EMA interaction during scientific advice appeared supportive, and then we agreed on many points for the program and protocol, we believe that the FDA will need to be presented more data during this Type C meeting. However, in addition, the CUV107 designs aligns with many of the FDA requirements featured in the recent late phase protocols for vitiligo for which results have been presented or are in review by the FDA.
The design of this study is very much that we are mirroring the design of other systemic drugs, setting up similar endpoints, T-VASI50, F-VASI75 . With FDA, we've come quite a long way from when they believed that narrowband UVB was dangerous and carcinogenic. Now they've learned that narrowband UVB is safe and doesn't increase the risk of cancer and vitiligo. We are still in an education mode and need to present more data.
Thank you. Could I fit in a second question?
All right. Quick.
It was just on the NEURACTHEL, the ACTH. We noted that you are ready for filing with EMA in the second half of this calendar year. I guess again, another question on potential plans for filing there with the U.S. FDA for that program.
Okay. Philippe?
Yes. It is correct what Melissa says. The sequence is Europe first, filing NEURACTHEL or the ACTH as a generic dossier. Once we understand the questions that will invariably come from the European Medicines Agency, we will file in the FDA. We are filing the generic version of ACTH on a country-by-country basis, so not through a centralized procedure. The FDA will follow after that.
Understood. Thanks.
Thanks, Melissa. We have an analyst who is dialing in from a long way away, Frankfurt, Germany. We appreciate Thomas Schießle dialing in. Thomas, please ask your question.
Hi. Could you hear me?
Yes, Thomas. Go ahead.
Wonderful. Thank you, Malcolm. Hello, everybody around the globe. I have two questions. Indeed, the first one is on NEURACTHEL. Could you share with us your go-to-market strategy concerning the timeline and the commercial effect in the new business year and in 2028? The second question is on PhotoCosmetics. I guess it's a strategic importance to deliver the cosmetic line for patients. So what are your plans concerning the PhotoCosmetics, please? Thank you.
These are for you, Philippe.
Well, in NEURACTHEL, I just spoke about, so it is a regulatory pathway through the mutual recognition principle. Then we have chosen a number of first-tier countries, then the second-tier countries, and then FDA. We know most of the prescribers for these hormones in the European Union. We know the centers, we know the indications, so we intend to distribute it directly to hospitals first. I think your question on PhotoCosmetics is related more or less to the vitiligo program and why its sequence like this. First of all, I need to explain what our intention is and has been. We see vitiligo and many of the medical practitioners as the natural way of using a hormone to bring back pigmentation. In lay terms, repigmenting in vitiligo is really the same as medical tanning.
Now, if you are able to provoke, induce the pigmentation in vitiligo patients that have an affliction that needs that repigmentation, then the five-decades-long quest from many cosmetic companies and CLINUVEL was to use these melanocortins in a transdermal formulation, in a topical formulation, a cream, a lotion, an emollient, to make sure that these peptides could penetrate the skin and be retained in the epidermis and provoke a self-bronzing effect. Now, we have been working on this for almost a decade, like many other cosmetic companies. We have seen results that stand up, but we are not totally confident that the results we have seen in these formulations are commercial yet.
So we are not ready yet to launch these products, and I believe that it is worthwhile pursuing the quest to eventually arrive at a transdermal formulation that can be applied twice a day, over a number of weeks that would provoke the tanning. But we are not there yet. But that is the research effort that we put in. Does that answer your question, Thomas, or is there more?
Yes, indeed. Thank you very much. Thank you.
Thanks, Thomas, and it's a good question to ask because at least half a dozen questions from shareholders have been on PhotoCosmetics, so thanks for that also, Philippe. Moving to Madeleine Williams of Canaccord. Madeleine, hi.
Hi, team. Thanks for taking my question. Just maybe off the back of Thomas's question. Vitiligo is clearly a big opportunity. In the next couple of years, what do you see happening in regards to the EPP business? What are your expectations for growth there, cognizant that there is some competition, but then also on ACTH, and sort of other opportunities. I mean, what's your thoughts on what that growth profile looks like in the lead-up to then the vitiligo reading out and becoming commercial?
Philippe, can you address that issue of competition in EPP and how we will fare head-to-head with them?
Yeah. Thank you, Madeleine. Yeah, that word competition is so charged and loaded in the Australian markets. We seldom ask that question overseas. Let's give a historical account. The first time that competition in EPP was mentioned was in November 2021. We never had doubts internally that one day a competitor would enter the markets. Well, since November 2021, no one has yet entered the market, but it's logical in the cycle of developing and finding new diseases that you will not remain the first one. The market of EPP patients, the pool of EPP patients worldwide is well-known by us, by patient advocacy groups, by companies that developing new products for it.
By and large, you can say that every year there is a percentage of new patients reporting their disease to general practitioners, dermatologists, and we see that in the growth numbers, in the new patients added to our pool of treated patients in Europe and U.S. If you look at a finite number of patients, then we as a company calculated what is our penetration, what is the number of patients that are on treatment and remain on treatment. How many of these new patients are actually enrolled in other clinical trials? In 2025/2026, we saw three companies running clinical trials, phase II and phase III, ranging from 50- 175 patients each. While these trials were conducted, CLINUVEL was growing its number of patients.
In spite of what Peter reported over the financial year 2026 ending June 30th, we are privy to information firsthand from our market access team. If I look at the pool of patients, the number of treatments supplied between January 1, 2026 and 31st of July 2026, we are growing the number of patients and number of treatments in Europe and in the U.S., in spite of three other companies running the clinical trials. Mathematically, you understand that there is space for three, four players without actually eroding yourself. Then there are many other diseases that are treated by pharmaceutical companies and products that see the same pattern. I understand the anxiety of many, but so far there is, from our point of view, no reason to share that kind of angst. The treatments are growing. The number of patients are growing.
The number of patients remaining on treatment are growing. But yes, we saw a slight retreat where competitors were giving drug free of charge patients. At the same time, we also see some of these patients coming back. So, we believe that the EPP market will continue to grow. Probably not double- digit, but single- digit.
Which, I think Madeleine asked a question about the size of the market of vitiligo in Europe and U.S. Is that correct?
Oh, certainly some shareholders have. Can we reserve that to the shareholder questions?
Yeah, but I want to answer Madeleine's question. Madeleine, can you repeat the vitiligo part?
Just as it relates to the question that I asked with vitiligo was just kind of what was the expectation around the growth between now and then. It wasn't directly about vitiligo, but I'm more than happy to hear the answer.
Okay. The conundrum is always that when you present a business case, everyone emphasizes the first-mover advantage and being the first. But in our case actually it's really good to be the second. We've been the first in EPP, but being the second in vitiligo means that others need to do the work with regulators and insurance companies, and we will benefit from it. I think I've said publicly, and some of our officers have said that publicly, is that vitiligo, in our view, will follow a pattern that you've seen in oncology. It will be a combination therapy and maybe a double or a triple therapy where you need and the light and the JAK inhibitors and the ultimate pigmentation agent in afamelanotide. The oral JAK inhibitors are, for now, the only thing there is.
But we understand from the medical community, it is not the panacea, it is not the drug they hoped for. It takes too long. Compliance is an issue. The suppressing of the immune system is an issue. We continue to develop that market, and we are pretty hopeful to reach it.
If I could also suggest, I think more competitors in a market also helps to bring the prevalence of the disease to the floor as well. Other sufferers out there learn about the disease that they might be suffering from that they have not been diagnosed with. I think that also helps to build a base of population as well.
Okay. Sarah Mann has been waiting patiently. Sarah from Moelis. Please ask your question, Sarah.
Can you hear me?
Yes, indeed.
My question is just on the controlled release injectable liquid peptide platform. As you kind of do more work there and develop the product, can you just talk us through where you see the ideal initial applications being and what the steps are between now and bringing that to market?
Good question. Philippe, please.
Well, that's a difficult one. Sarah goes a bit deep always. I would say first, the handicap of a research-oriented company, certainly a public one, is that it cannot reveal everything it does. You do that because you want to shield yourself from competitors. You don't want the information to be out too fast. You want to have certainty on the data and repetitive results. You also want to gain and keep an advantage over future competitors. I will share with you a rationale for most shareholders to follow a thought process, and then I will let you fill out the blank dots.
A company that spends a decade or more on understanding the behavior of peptides in human biology, how peptides are optimized in terms of side effect profile, in terms of release, in terms of pharmacokinetics, dynamics, attracts a team. That team stays together, and the team gets better at it. Most experiments fail, but from the failed experiments, you hope to incrementally learn and progress. It is two steps forward and one step back, and that is the nature of our industry. Every time you have readouts of data, you make a decision as management and as board, how we continue to invest and fund these kind of research projects and experiments, yes or no, and what is the ultimate market? From the knowledge of peptides, our team started to understand the optimum way to deliver these peptides in the human body.
You can do it by injection, you can do it orally, you can do it by cream, you can do it rectally. We found through our work and through the afamelanotide peptide, a product that we mostly developed with a contract manufacturer, that sustained release, controlled release, gave significant advantages over any other formulation. Naturally, from peptides knowledge, we went to delivery knowledge. We have said many times in public that technology is important, but most important is to find the talent that can do something with it and to retain the talent. We found some key people in the world, built labs around them in Singapore, and they started to expand their teams and become experts in platform delivery. From a single product peptide, you learn the skills how to optimize the delivery of this peptide and other peptides. Yeah.
We are coming to a stage where we have sufficient confidence to understand that there is a commercial market for us. What we are doing is we are building new facilities in Singapore, with upscale capacity, so to experiment and manufacture at larger scale with the assistance of the Singaporean government that clearly has seen the prospect and the market size that we are trying to target. I understand that Sarah wants to hear which peptides and how. It is a bit premature to say it, but it suffices to say that we believe that that business will be bigger than anything else we have ever done.
That justifies the funding, and that is the excitement that we all have, and probably the single reason why the CSO and I continue in this business is we see the data, we see the readouts, we see the teams getting better at it, and we also see that there is very little competition in the world. From peptides to delivery platforms, is probably the most exciting part I have seen in this company, notwithstanding the vitiligo opportunity, but we understand what we are capable of and what this could lead to.
Thank you.
Well, something exciting to continue to track, Sarah. Peter, were you going to add something or not? No? Okay. We will move to Thomas Wakim from Bell Potter. Thanks for being patient and waiting, Thomas.
Thanks very much for taking my question. Just want to follow up on EPP. You mentioned in the U.S. there is a bit of impact from some of these alternative products. I just want to, I guess, understand a bit better, firstly, why some of the patients who are on SCENESSE seem to be switching and trying some of these alternative therapies. Secondly, if any of them do eventually get formal approval, do you expect those pressures to continue to intensify? Thanks very much.
Well, Philippe.
Again? Okay. I don't have the crystal ball, but I don't see the pressures will intensify. It is what it is now. Some patients will prefer to stop at the petrol station every two months rather than refilling every day. I'm very skeptical about using anti-schizophrenic drugs in EPP because it gives central nervous effects. I'm very skeptical in synthetic compounds that haven't been used and tested for a long time, as opposed to a drug that is administered every two months and has been used for four decades. God knows how the market will evolve. In general, as I said before, I think there is too much emphasis on the competitive pressure. It is true what Peter says, not only in our case but in orphan diseases, more attention to patients means that more patients will come out and seek diagnosis.
Normally it increases the pool of patients available. So we're pretty calm about this.
Thank you.
Thanks, Thomas. Mark Pachacz from Bioshares. Would you like to ask a few questions, Mark? Or has Mark had to depart?
Can you hear me now?
Oh, Mark. Yes. Go ahead.
Okay. Great. Thanks for that. Two questions. One for Emilie, which is reasonably straightforward. In vitiligo, I am just getting some feedback here. In vitiligo, the duration of effect, how important will that be to measure?
Yeah, sure. Mark, by the duration of effect, it's duration of effect or what I call maintenance of repigmentation achieved. Indeed, that's an extremely important consideration. At present, while treatments on the market, on narrowband UVB or some drug can provide some repigmentation, the effect doesn't last and patients lose their pigment after they stop the treatment. In our studies we're comparing treatment effect and maintenance of repigmentation against narrowband UVB as a monotherapy. We have also interesting observation from the 105 studies that we presented in our case studies where we see patients continuing to repigment after stopping the treatment with afamelanotide. There are positive signs towards a sustained repigmentation with afamelanotide and narrowband UVB adjuncts.
As Philippe mentioned earlier when addressing pricing, the way we see treatment in the future would be as a course of treatment and then afamelanotide being given ad hoc as a boost at intervals to maintain and to keep the treatment effect.
Okay, thanks. Philippe, I have a question about NEURACTHEL. How many competitors are there in the market at the moment, and when can meaningful revenues be expected from Europe?
I would say that there are about four competitors in the market in ACTH. A larger one serving the North American markets, smaller ones in Europe. We can only give guidance on meaningful revenues the moment we know the turnaround time by the EMA and the national competent authorities. We don't have a call on that yet. We know that the average turnaround time should be 12-16 months after filing a dossier, but there are a number of clock stops in it where they ask questions and answers are provided within four weeks. That's a bit too early. The moment we know how we sail through the review process, we will provide guidance on when we expect the first revenues for ACTH.
Just to follow up there, Philippe, on approval, are you accepting reasonably rapid penetration into that market?
Yeah, I would say so. Because as you probably know, ACTH is a drug with a label for 19 different diseases. That means that the drug can be used for 19 different therapeutic indications, but it is also used as a diagnostic. The majority of these diseases are not yet being treated by ACTH. But it is a compound that has a diversity of therapeutic effects and, yeah, that appeal to us.
All right. Thanks.
Thanks, Mark. And thanks to all the analysts. I think we are a bit over time, but I do want to cover a few shareholder questions. Fortunately, as we have gone through competition in EPP, NEURACTHEL, PhotoCosmetics, what am I forgetting? Many questions on vitiligo. We have answered them and that is satisfying, I hope, a number of shareholders. But I want to round out the webinar with a few questions. One from Mr. Kettler and Mr. Singer on vitiligo TAM in Europe. One from Mr. Waller on board and management market buying of shares and total insider ownership of the company. And whilst it is not a typical area of our commentary, there are many interested in Philippe's views on the share price.
Philippe, why have we not yet scoped vitiligo TAM presentation in Europe, since that is a regulatory market we are destined for as well, as well as the U.S.?
When you talk about TAM, the total addressable market, I presume?
Yes. Sorry.
Vitiligo in Europe is treated mainly by expert centers, not by every single dermatologist. The treatment guidance for vitiligo in Europe is slightly different than it is in the U.S. And the population is more diverse, I would say, in the various 27 European member states. From the market research, there is such diversity in the size of the vitiligo market that we do not dare to put it out there because the range is too large. We have an idea what the addressable market of vitiligo can be in Europe, but we try to stick with the lowest number. It is very different than in the North American market. It is sizable, but the range of patients reported with vitiligo in European Union is so vast that we do not want to give a number to our shareholders.
Okay. Moving on to that second question.
Yeah, go ahead.
Apart from your substantial ownership, Philippe, some of observed members of the board have low to no ownership of CLINUVEL. Whilst it's their own personal prerogative to determine their own investment strategy and what they invest in. Can you comment on insider ownership? Is that adequate? Do you think it needs to be higher, as some shareholders sometimes suggest?
No, I understand the question. The ownership of insiders, including officers, managers, executives, is about 11%. I own just under 7% of this company. Directors come and go. Some of them buy on market, some do not. I generally see that as a sign of confidence. But we don't ask them proactively to do so. I think it's, as you said, a prerogative of every director to make that decision. And it's been higher in the past and it's also been lower, so it will evolve. I'm pretty certain that as the company evolves and moves into new territories, the directors will seize the opportunity.
Okay, thanks. Your views, even though, as I said, it's not something we typically do, your view on the share price. It's been quite volatile. There has been a declining trend. There has been some improvement in recent months. I know in 2026, the decline over the year was minor. Your views there, please.
Well, first of all, I've spoken at two AGMs about share price. I find it unusual for Managing Directors to talk about the share price of their own company, because by and large, every CEO will think that it's too low.
If you look at objective metrics, that's the only comments I will make, then I really wish that we didn't talk about share price of this company anymore. At least not me. If you look at objective metrics, price to book value, price earnings, forward price earnings, we can, I leave the analyst to do that, take a view on whether it's fairly priced or underpriced. If you benchmark it in various markets, you look at the valuation multiple of CLINUVEL to other companies, you can also form a view whether we are fairly priced, punching above our weight, or underpriced. What I do know is that sentiment also drives markets. For that, I point shareholders to past events in the company where it was leading up to a regulatory outcome, an EMA or FDA, then you see slowly the share price moving up because people are taking the bet, a binary bet, whether you get an approval or not.
But as soon as that binary bet is taken and the outcome is effective, you also see the share price drifting. So that kind of volatility is probably specific to life sciences, where you have these important catalysts. You will have it probably more in the smaller markets than in the larger markets, than in the U.S. markets. But generally, I am confident that when a company diversifies, when it provides data that instill confidence in the markets, when the gap between what we know and the knowledge that shareholders are able to know at a given point of time, when that gap is closed, that the share price will be higher than it is now.
Thank you, Philippe. I am now going to close the webinar. I want to thank Philippe and Peter and Emilie for your enthusiastic participation, all analysts for their questions, much appreciated. And all participants for hanging in there, listening to every bit of what we can impart on the company and its outlook. The link to this webinar will be announced to the ASX. And I think we had a few technical issues where maybe a slide wasn't put up early, and we will try and fix that. It will also be on CLINUVEL's website as soon as possible. So thank you.
Can I make one comment?
Yes, Philippe. Yes.
We take many things for granted in life. In good health, I think it's important to get up with appreciation. I very much express my appreciation to the analysts on the line who voluntarily follow the company, spent hours in researching us and issuing these reports, and we don't take that for granted. Thank you.
Indeed. Yeah. Thank you, Philippe. Thank you, everybody. Best wishes to all.