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 the 30th June 2026.

I will now hand over to Malcolm Bull, Head of Australian Operations and Investor Relations, to conduct the proceedings.

Thank you, Stella. Uh 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 uh CFO uh Peter Born on the line, as well as our Director of Global Clinical Affairs, Émilie Rodenburger, on the line, and Managing Director Philippe Wolgen. Uh welcome, executives.

Thank you.

Good morning. Good morning.

Good.

The agenda today is to discuss our uh results for the financial year ending 30 June 2026, and we're going to have Philippe and Peter and Émilie involved in various aspects of the performance and operations of the business. Uh 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'll certainly get Philippe to talk to that.

We have several analysts on the line um who 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 hasn't quite covered. I should share a particular screen with you on our forward-looking statement.

We will be talking about intentions and plans, um and you should be aware that there's a range of risks that can materialize that affect those plans uh from coming to fruition. We will try our best as an executive team and work with the board to deliver the results that we're we're advising you.

I want to move into discussion of the results and strategy. Peter, I thought you could set the scene um to cover this year's results by providing an overview of how you manage quite deftly the uh finances of CLINUVEL, which enable us to build the strong foundation we have for the future.

Of course. No problem at all.

Thanks, Malcolm. Uh good up good afternoon and good morning.

Uh welcome to the webinar from wherever you're dialing in from. Uh it's great to have you uh have you here with us.

I guess, as Malcolm outlined, I'm I'll start with a strategic financial overview as to how we operate at CLINUVEL and the way we go about things. The uh 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 exp- 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 organ- our facility and expanding our laboratories over there where we're doubling the footprint.

Fourth and final is putting our surplus funds to work. We don't just leave them sitting in the bank.

We we know that we've been entrusted these funds by our shareholders, and it's really important to us that we put these to work. 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're protecting them from market forces, and we've 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've been entrusted those shareholder funds, and we want to make sure we put them to good use.

It also 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've 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 don't go our way, or from delays that might be experienced in programs. It's 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'd share a quote um that we recently received from one US investment banker that we've been talking to as part of our US expansion, and 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're often critiqued internally or or mainly externally from shareholders and or um other investors or uh people looking in at CLINUVEL that we're 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're to expand faster than we're capable of sustainably doing it, it increases risk.

If we diversify through M&A and then spread our focus of the organization, it increases risk. If we were to th- throw more dollars into programs, it doesn't necessarily amount to outcome improvement, in which case that increases risk.

All of these areas is why we have built a sustainably globally market- 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'll expand into a second indi- indication that often offers even considerably more market potential than what we have with EPP. I hope that helps, Malcolm, and and that's a good overview.

Oh,

I'm happy with that overview, because I can now ask you to summarize the uh the financial results, which I've put on screen for you.

Excellent. 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 claims to that. Shareholders reading our annual report today would have 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 US GAAP financials, which is required by the US 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 $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 return 9% of our net free cash flow from the financial period in the form of those dividends. Expenditure was slightly lower than than was forecast, but this is a good thing because we're still able to expand our R&D programs and other capital infrastructure projects that we've discussed.

Our EBIT actually would have 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 US dollar term deposits, 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 a actual economic loss because all of our financials in Australia in our ASX reports are presented in US dollars.

This $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 $28 million to $252 million.

The other aspect of this is that it would have been even larger. We would have had a $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 $12 million during the year. Normally, our tax payment goes out in one bulk lump sum in December.

During this current financial period, our pro- our reserves increased by $28 million, but we actually also paid nearly two years' worth of income tax payments, because we paid our FY25 in full in the first half of this year, and then we also paid the installments throughout the year of $12 million. That's where we would have had a $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 out- 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. Um and they say that a picture tells a 1,000 words, but I don't want you to use 1,000 words because we don't have enough time.

Um but please uh summarize that that profitability trend and and and the expenses and particularly the revenues, please.

Of course. As I touched on before, we're proud that we've achieved a $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 US sales and treatment numbers, and 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 US moderation of revenue was the European strength. We saw European treatment volumes increased by 13% during the financial period, which boosted our revenue by 9% on the prior year in Europe in Europe.

We see the market entrance in the US as being a temporary competitive effect rather than a product structural change to the market. The As I said, the EPP population and the EPP market in the US sustained these four competitors all in there.

Our disciplined financial management in these types of situations though, this is why it's important to come back to this, enabled us to dial up and dial down our discretionary expenditure as we started to see that US impact of sales. Therefore, we can match our sale our 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're 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. Let's move to uh the expenses side, and just go into a bit more detail on what was happening there.

Of course. 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'll be expending about $55 million Australian dollars.

Uh that was on average for every year for the next five years. We actually came in at $53.5 million.

Uh so, we're $1.5 million under that $55 million number. It's important to note the $55 million actually excluded CBM activities, because we see that as some just of the discretionary spend that we can ramp up and ramp down.

Our $53.5 million actually included our CBM activities. Our true underlying, if you like, expenditure was about $45 million when you exclude that CBM activity of about $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, uh which was in March earlier this year.

Again, building company brand and presence in the market so that people know what what we are and and what we do. Our general admin was $1.5 million higher than prior year, but sorry, was higher than prior year, but the $1.5 million of that actually related to one-off costs in relation to our NASDAQ um uplifting.

That re- amounts to legal fees, audit fees, and other aspects directly affected by that NASDAQ uplift. Our US dollars that 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 pull back of that program.

Really we'll start to see that starting to increase again as our CUV105 program in vitiligo starts to uh come online later this year, that I'm sure Philippe and Émilie 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- for self-funding sustainable business model, and built those cash reserves that help 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. Uh staying with you, Peter, since you've just mentioned uh the strong balance sheet,

Sure.

What comments would you like to make with regard to the uh the state of the balance sheet?

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. Um and touching on that comment made by the US um the US in the US institution recently um in the last couple of months, I think that really supports that.

Our cash reserves, as I touched on before, increased by $28 million to $252 million. Our total assets increased to $295 million, just a touch under $300 million in total.

I did touch on the fact that that $28 million increase would have been larger in cash reserves had we not prepaid the $12 million of income tax. That will obviously have a a back-end effect and improvement for our 20 first half of 2027 financial period.

Apart from investing in our R&D programs for our revenues of tomorrow, we're also investing in a number of other act- initiatives and 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.

That's a substantial asset on our on our balance sheet already, because we own that premises. We're really improving that asset for the future.

Then the final one is we're also establishing an integrated manufacturing and supply chain now. We're looking at those avenues to to in-house more of that activity and bring it closer to us.

We hold about $231 million in term deposits at the moment across multiple different currencies. As I mentioned before, that's returning 6.23% yield.

We really don't have a lazy balance sheet, even though we have this surplus of cash. We're deploying it for return for our shareholders.

We remain debt-free for that 20th consecutive year, and it's been 10 years since our last capital raise. Our balance sheet has really been built through profitable operations that we've run, and internally-generated net cash flows instead of the typical life sciences R&D-type process of repeated equity raisings and share and shareholder dilution.

We really entrust and protect our shareholder reserves. It's important not to underestimate this strength in our balance sheet.

It's 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 this 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'll 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.

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, uh the strong balance sheet, and the optionality we effectively have. Thanks that.

I'm going to switch now um to Philippe, because today we announced a major strategic intention, and I'm simply going to ask you, Philippe, to talk to that uh that announcement.

Yes, thank you, Malcolm. Um it's been a long time coming.

Um as most shareholders know, we've talked publicly about the option to uh list one day on NASDAQ, and we've taken uh 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.

Um unfortunately, we've never had a commercial footprint in Australia, and nor- uh North America will be our largest uh future market. Um so, we will need to have uh feet on the ground.

For this, we expand uh our US uh market access team, commercial team, and clinical teams. Uh we'll make it our headquarters uh on January 1.

Now, if you add towards the makeup of our registra- uh registry, uh the ownership of this company um has always historically been in foreign hands: 70% uh North Americans, uh Austral- uh Asians, uh Europeans, uh and only 30% Australian. That shift has never really taken place in favor of the Australian uh owners.

We've long prepared the company for a US listing. We made that public uh so there can't be any surprise.

The depth of the US market uh is well known in life sciences. Uh I also need to uh 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 the number of reports since 2019.

We believe that uh the company is now mature enough uh to have a place on um the NASDAQ Global Select Market. Um important, and questions that uh we received, what happens to the IP?

Most of the intellectual property resides outside Australia, uh in in the US, in Europe, in Singapore, where our research center has been located. Then, vitiligo of course is a global disease, uh however, vitiligo is most prominently treated in North America, in the United States.

This is an additional reason why we need to be there as of January 27. Um A comment was received as why CLINUVEL uh is seeking a single listing and not a dual listing.

Um and and the answer is, for companies that have a a considerably larger size than CLINUVEL, it would make sense to split the liquidity in and volume traded. At our size at the moment, it makes sense to have one single listing on um a uh US exchange, where we devote all our resources, uh compliance, and uh and personnel towards.

If you look numerically uh for the reasons why we opted to do that now, um in 2020, we traded a value of 1.7 billion annually, and that has receded to about 320 million in 2026. We've seen a decline in traded va- value and therefore volume in the the CUV stock.

In essence, we base ourselves where the chance of value creation is 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 in a nutshell.

Philippe, thanks. Um I'd like to turn to our pipeline, um but first just speak to our strategy, which has been to uh build and apply our expertise in melanocortin-based treatments for unmet needs.

We've certainly achieved that with SCENESSE for EPP. I think, as the participants to the call know, we're working on uh other indications.

Um we've made a leap forward on delivery methods, uh particularly on on how we administer peptides, arriving at uh controlled-release formulations. Um and this has been a keen interest of many uh shareholders um and some analysts as well, um not just in questions submitted to this webinar, but questions over recent months since we announced uh the progress of the uh uh liquid formulation peptide platform.

Um And we can tell you that we started this development, this in-house development, many years ago, attracting talent, progressing the development. 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've ever done in-house.

However, and the pipeline is on screen for people to see, uh the immediate and lead program is vitiligo. Now, dependent on the results um, and we will know that those results over time, that will determine the pathway to file for marketing authorization.

I wanted to bring Émilie in uh to talk more about uh vitiligo. So, Émilie, I thought you may have dropped off.

Are you here?

Yes, I'm here, Malcolm.

Oh, I'm so relieved, because I want to hear [laughter] hear you talk about vitiligo. Please, go ahead.

Yes. Absolutely.

I apologize for the coming off and on the screen. We've been hit by a storm in the UK and I think it's distracted and disturbed my internet.

The sky is blue almost now, I'm ready to talk about vitiligo. 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, um 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, patients of darker skin color, Fitzpatrick skin type IV, V, VI, for whom the impact of the disease is uh the greatest.

As a reminder, afamelanotide alone doesn't work since melanocytes and receptors are not yet present and expressed in the vitiligo lesions. We will always need light therapy, narrowband UVB phototherapy, to um be adjunct to the drug.

Uh light therapy as narrowband uh UVB is uh the standard of care for vitiligo and the cabins are available in many of US centers. The competitive landscape has much evolved from the time we uh signed off this first proof-of-concept study back in in the Melbourne office and where we were the only company in the world developing a treatment for vitiligo.

You've seen that company now have started to reposition their drugs for atopic dermatitis or other autoimmune diseases, uh the JAK inhibitors, in vitiligo. A couple of years ago, a topical version uh approved, and um very recently last month, the first oral systemic JAK inhibitor by an American company uh approved by the European Commission and likely uh later in in the US by the FDA.

The uh rise of the competitors and this opening of the vitiligo market is helping us enormously since the regulators are now becoming more and more familiar with the disease and the trial, they do not um they they no longer um have to look um at afamelanotide with narrowband UVB adjunct as um a first dossier. There are precedents and benchmark.

Um and this is what we experience at the time of scientific advice in Amsterdam with the EMA. Unlike EPP, where we were first, they are advantages of not being first.

Another advantage and the big difference uh of afamelanotide versus JAK inhibitor is that we do not suppress the immune system. Afamelanotide acts as a natural uh ligand to the cells that produce the pigments.

We mimic a physiological process. In our trial, we uh need to demonstrate that afamelanotide uh with narrowband UVB adjunct uh 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 off the break immune pedal.

Right. Mhm.

Of note, um JAK, um more and more, are openly JAK inhibitors are uh openly said to take too long to uh repigment, or for for treatment effect, and do not really work that well. The experts talk about that and about this result in conferences.

Um And you may have noticed it yourself looking at um the late um Phase 3 uh trial uh results and top-line results presented. Uh These trials um evaluating JAK inhibitors against placebo, despite reaching statistical significance, have quite a a modest effect on repigmentation.

That's good. Now, Émilie, we're going to move to catalysts.

Since you're talking about vitiligo, that that is to the fore of our catalysts. Can you please uh Yes.

talk to the vitiligo catalysts?

I will. I'll start with two significant milestones for Phase 3 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 um 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 in at the AAD earlier this year in Denver, repigmentation follows a temporal sequence: first, from uh the follicular response when you see little uh confettis inside the lesion, brown confettis, brown islands, meaning that the patient is responding to the treatment, to a confluence where where these uh small confettis and islands become bigger and merge, um to a towards homogeneity. Homogeneity is when the vitiligo lesion is fully repigmented, and the color is um homogeneous with the constitutive skin.

We call it color matching, and it's very, very important from a pa- patient satisfaction point of view. Uh A brief note on AI.

In parallel, our internal AI model that we presented at the AAD as well is ongoing um training to support this activities in in the near future.

Okay. Philippe, anything to add on vitiligo or the catalysts?

No. I think uh Émilie summarized this pretty well.

There's not much to add. We are um watching the the market evolve.

Um We witnessed the commentary on uh JAK inhibitors and the length it takes to see some effect. Um We also uh with eagerness are looking of how these oral JAK uh inhibitors are going to be priced in uh Europe first, and and perhaps in North America.

Uh But in the meantime, we um continue by training and accrediting centers, and uh our target 490 trained uh accredited centers by 2027 is on track. Um So, we are watching with eagerness.

Very good. Look, uh thank you, Philippe, uh Émilie, and uh Peter, in reverse order of in which you spoke.

Uh much appreciated. It's now time to turn uh the call over to uh the analysts that are on the line.

Uh Now, analysts, uh our briefing has uh been quite extensive, please keep your questions succinct. We're going to start with uh David Stanton from uh from from Jefferies.

David, please ask your question.

Thank you very much, team, for taking my questions. I've got two.

Um firstly, can you give us an update on your best guesses to when the CUV107 trial will read out, please?

For whom is this? Émilie, please.

Yes,

I'm I'm

taking this question, David. Thank you.

CUV107, from um 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 um data cleaning and analysis, expect uh 2029.

Understood. Thank you.

Second question, that price, should uh should SCENESSE be approved in vitiligo, how would the differential pricing for SCENESSE be between the disease indications and how and how will that be managed, please? Thank you.

Philippe. Um

Well, there's no no real surprise. The I think let's take uh take a step back for the the general shareholders on on the line.

Um We are pricing uh SCENESSE in EPP on a month bi-monthly basis uh perpetually, patients are on this product uh for life uh every year. Um and that gives you a um value per patient per annum um that is uh calculated and and borne by insurance companies and state payors.

In vitiligo, our assessment, uh depending on the bio- biological varia- variability that you see in patients, not everyone responds in the same manner and to the same intensity, it depends on the number of treatments uh that you are going to provide, but we assess that it's going to range between 7 and 12 implants per patient as a one-off treatment. That's a one-off treatment in vitiligo versus um annual, repetitive treatment cycles.

We also believe that um 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 don't believe that there will be too much um price erosion. It will be more or less in the same ballpark.

Okay.

Does this answer your question, David? Yeah.

It does. Thank you very much.

Thank you, David. Uh we'll now move on to uh Melissa Benson from Barrenjoey.

Melissa, hi. You want to ask a question?

Hi, everyone. Um I had a question just on interactions with the FDA.

Uh I know with the vitiligo program, you've had EMA scientific advice. I'm just wondering like interactions with the FDA you've had if you intend on having any meetings post the kind of CUV105 data at the end of this year or sooner.

Also, I guess, understanding how much FDA input has gone into the CUV107 protocol.

Thank you. Thanks, Melissa.

I take your question. Um yes, that's correct.

We we'll we'll meet uh with the FDA following the top-line results of CUV105, but which is after we commence CUV107. Um Unlike any other vitiligo program, we are focusing on on the use of a drug device combination, afamelanotide with uh narrowband UVB adjunct for for vitiligo.

While the EMA, interaction during scientific advice um appeared supportive and and we agreed on many points for the program and protocol, we believe that the FDA will need to be presented more more data um during this Type C meeting. Um However, and or in addition, the CUV107 design aligns with many of the FDA requirement features in the recent late-phase uh protocols for vitiligo that are being um for which results have been presented or are in review um by the FDA.

The design of this study is very much that we are mirroring mirroring mirroring the design of other systemic drugs, setting similar setting up similar endpoints, [F-VASI 50, F-VASI 75?] .

With FDA, we come quite a we've come quite a long way um 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 uh cancer in vitiligo, um we have we are still in an education mode and and need to present more data.

Thank you. Um could I fit in a second question?

All right, quick. [laughter] Um

it was just on the NEURACTHEL, the ACTH. We noted that you're ready for a filing with EMA in the second half of this calendar year.

I guess, again, another question on um potential plans for filing there with the US FDA for that program.

Philippe.

Yes, it's it's correct what Melissa says. The the sequence is Europe first, um filing uh NEURACTHEL, the ACTH, as a generic uh dossier.

Um and then, once we understand the the questions that will un- unvariably come from the European Medicines Agency, we will file in the European in uh in the FDA. Um we are filing the generic version of ACTH uh on a country-by-country basis, not through a centralized procedure.

Um if the FDA will follow after that.

Understood. Thanks.

Thanks, Melissa. We have an analyst uh who's dialing in from a long way away, Frankfurt, Germany.

We appreciate Thomas uh Schießle dialing in. Thomas, please ask your question.

Uh

hi. Could you could you hear me?

Yes, Thomas. Go ahead.

Wonderful. Thank you, Malcolm.

Uh hello, everybody, around the globe. Uh I have two questions.

Indeed, the first one is on NEURACTHEL. Uh could you share with us uh your go-to-market strategy concerning the timeline and the commercial effects in the in the new business year and uh in '28?

Uh The second question is on uh photocosmetics. I guess it's more It's a strategic importance to um to deliver the cosmetic line for for for patients.

Uh so what are your plans uh concerning the photocosmetics, please? Thank you.

Good.

These are for you, Philippe.

NEURACTHEL, I I just spoke about, it's it's it's a regulatory pathway through the mutual recognition principle. Um and then we choose the we have chosen a a number of first-tier countries, then the second-tier countries, and then uh FDA.

Uh We know most of the prescribers uh for these hormones in the European Union. We know the centers.

We know the indications. We uh intend to distribute it directly to hospitals first.

I think your question on photocosmetics is is related more or less uh to the vitiligo program uh and why it's sequenced like this. 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 in in lay terms, vitiligo is really and repigmenting in vitiligo is really the same as medical tanning.

Now, if you are able to provoke, induce the pigmentation in vitiligo patient 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 emulsion, to make sure that these peptides could penetrate the skin and be retained in the epidermis and provoke a self-bronzing effect. Now, we've been working on this for almost a decade, uh like many other cosmetic companies.

We've seen results uh that stand up, but we are not totally confident that the results we have seen in these formulations are uh commercial yet. We are not ready yet to launch these products.

I believe that it is worthwhile pursuing the quest to eventually arrive at a transdermal formulation that can be applied twice a day uh over a number of weeks uh that would provoke uh the tanning. We're not there yet, but that is the the research effort that we put in.

Does that answer your question, Thomas, or is there more?

Yes, indeed. Yeah.

Thank you very much. Thank you.

Thanks, Thomas. It's a good question to ask, because uh at least half a dozen questions from uh shareholders have been on on photocosmetics, thanks for that also uh, Philippe.

Moving to Madeleine Williams of Canaccord. Madeleine, hi.

Hi, team. Thanks for taking my question.

Um just uh maybe off the back of Thomas's uh question, um vitiligo is clearly a big opportunity. In the next couple of years, what do you see um uh happening in regards to the EPP business?

Like what are your expectations for growth there, cognizant that there is some competition. Um but then also on ACTH um and sort of other opportunities, what's your thoughts on on what that growth profile looks like in the lead up to then the vitiligo uh reading out and being uh becoming commercial?

Philippe, can you address that uh issue of competition in EPP and how we will fare head-to-head with them?

Thank you, Madeleine. Um Yeah, that word competition is so charged and loaded in the Australian markets.

Um We seldom ask that question overseas. Let's let's give a historical account.

The the first time that competition in in EPP was mentioned was in November 2021. We never had doubts internally that one day a competitor would enter the markets.

Since November '21, no one has yet entered the market. It's logical in the cycle of de- developing and finding new diseases, that you will not remain the first one.

The market of EPP patients, um the pool of EPP patients worldwide is well known uh by us, by patient advocacy groups, by companies are developing new products for it. By and large, you can say that um every year, there is a percentage of new patients reporting the disease to general practitioners, dermatologists, uh and we see that in the growth numbers, in the new patients added uh to our pool of treated patients in Europe and US.

If you look at um a finite number of patients, then we as a company uh calculated, what is our penetration, what is the number of patients that are on treatment and remain on treatment, and how many of these new patients are actually enrolled in other clinical trials. In 2025-26, we saw three companies uh running clinical trials, Phase 2, Phase 3, ranging from 50 to 175 patients uh each.

While these trials were conducted, CLINUVEL was growing its number of patients. In spite of what um Peter uh reported over the financial year '26 uh and ending June uh June 30th, we are privy to information first hand uh from our market access team, and if I look at um the pool of patients, the number of treatments supplied between January 1, 2026, and 31st of July '26, we are growing the number of patients and number of uh treatments in Europe and in the US, in spite of three other companies running the clinical trials.

Mathematically, you understand that there is uh space for three, four players without actually eroding yourself. There are many other diseases that are treated by pharmaceutical companies and and products that uh that see the same pattern.

I understand the anxiety of uh of many, but so far there is, from our point of view, no reason uh to share that that kind of angst. Uh The The The treatments uh are growing, the number of patients are growing, the number of patients remaining on treatments growing.

Yes, we saw a slight retreat where competitors were giving free uh drug free of charge to patients. At the same time, we also see some of these patients coming back.

Um we believe that the EPP market will continue to grow, yeah, probably not double-digit, but single-digit. Okay.

Which um I think Madeleine asked a question about the the size of the market of vitiligo in Europe and US. Is that correct?

Oh, certainly some shareholders have. Um can we reserve that to to the shareholder questions?

I want to answer Madeleine's question. Madeleine, can you repeat the vitiligo part?

Just um as it relates to the the the question that I asked with vitiligo was just um kind of what was the expectation around um the the growth between now and then. It wasn't directly about vitiligo, but I'm more than happy to hear the answer.

[laughter]

Okay. No, the the the um The conundrum is always that when you present a business case everyone emphasizes the first-mover advantage and being the first as the uh but in in 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 um and insurance companies, and and we will benefit from it. I think I've said in um publicly, and and some of our officers have said that in publicly, is that vitiligo, in in our view, will follow a pattern that you've seen in oncology.

It will be a combination therapy. Maybe a a double or triple co- therapy, where you need and the light, and the JAK inhibitors, and the the ultimate pigmentation agent uh in afamelanotide.

The the the oral JAK inhibitors are, for now, the only thing there is, but we understand from the medical community it's not the panacea. It's not the uh the drug they hoped for.

It takes too long, um compliance is an issue, the the suppression the suppressing of the immune system is an issue. We we continue to develop that market, and we're 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 to the floor as well. Um other sufferers out there learn about the disease that they might be suffering from that they haven't been diagnosed with.

I think that also helps to build a base of population as well.

Okay. Um Sarah Mann has been waiting patiently, Sarah from Moelis.

Please, ask your question, Sarah.

Can you hear me?

Yes, indeed. Um,

my question is just on the controlled-release uh 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 um the ideal initial applications being, and what the steps are between now and uh bringing that to market?

Good question. Philippe, please.

That's a difficult one, Sarah goes a bit deep always. Um I would say first, the handicap of a research-oriented company, uh certainly a a public one, is that it cannot reveal everything it does.

Uh 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 uh repetitive results.

You also want to gain and 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 the side-effect profile, in terms of release, in terms of pharmacokinetics, dynamics, attracts a team, uh and that team stays together, and the team gets better at it, um most experiments fail, uh but from the failed experiments, you hope to incrementally learn uh and progress. It's two steps forward and one step back, and that is the nature of our industry.

Every time you have readouts of data, you you make a decision as as management and as board, uh are we continuing 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, uh our team started to understand the optimum way to deliver these peptides in human body.

Um you can do it by injection, you can do it orally, you can do it by cream, uh you can do it rectally. We found through our work and through the afamelanotide, a product that we more or mostly developed with a contract manufacturer, that sustained release, controlled release, um gave significant advantages over any other formulation.

Naturally from peptides knowledge, we went to delivery knowledge. We've 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 um some key people in the world, um built the 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.

We are coming to a stage where we have sufficient confidence to understand that there is a commercial market for it. What we are doing is we are building new facilities in Singapore uh with uh upscale capacity, to experiment and manufacture at larger scale, with the assistance of the Singaporean government that clearly has seen the uh prospect and the market size that we trying to to to target.

I understand that Sarah wants to hear which peptides and how. It's a bit premature to say it, but it suffices to say that we believe that that business will be far bigger than anything else we have ever done, uh and that justifies the funding, and that is the excitement that we all have.

Probably the single reason why the the CSO and 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's very little competition in the world. From peptides to delivery platforms uh is probably the most exciting part I've seen in in this company, not notwithstanding the vitiligo opportunity, but we understand what we capable of and what this could lead to.

Thank you.

Something exciting to to continue to uh to track, Sarah. Uh Was Peter, were you going to add something, or not?

No? Okay.

Um We'll move to Thomas Wakeham from Bell Potter. Thanks for being patient and waiting, Thomas.

Thanks very much for taking my question. Um just want to follow up on EPP.

Um so you mentioned in the US as uh a bit of impact from some of these alternative products. Uh 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.

Philippe.

Again? Okay.

Um [laughter] I I I don't have a crystal ball, but I don't see the pressures will intensify. It is what it is now.

Um Some patients will prefer to stop at a petrol station every two months rather than uh refilling every day. I I I'm very skeptical about using anti-schizophrenic drugs in EPP, cuz it gives central nervous effects.

Um I'm very skeptical in synthetic compounds that haven't been used and tested for long time, as opposed to a drug that is administered every two months and that has been used for four decades. God knows what what the market how the market will evolve.

In general, as as I said before, I think there is um too much emphasis on the competitive pressure. It is true what Peter says, not not only in our case, but in orphan diseases, more attention to patients means that more patients will uh come out and seek diagnosis.

It normally it increases the pool of patients available, we we we we're pretty calm about this.

Thank you.

Thanks, Thomas. Uh Mark Purchase from Bioshares, would you like to ask uh a few questions, Mark?

Or has Mark had to depart?

Can you hear me now?

Oh, Mark. Yes.

Yeah.

Okay. Great, thanks for that.

Um two questions. One for Émilie is reasonably straightforward.

Um in vitiligo, um so I'm just getting some feedback here, in vitiligo, um um the duration of effect, how import- or how important will that be to measure?

Yeah. Sure.

Mark, um by the duration of effects, it's uh duration of effect or what I call maintenance of repigmentation achieved, indeed that's an extremely important consideration. At present, um while treatments on the market, narrowband UVB or some JAK, can provide some repigmentation, the effect uh doesn't last, and patients lose their pigment after they stop the treatment.

Um in our studies, we're comparing um treatment effect and maintenance of repigmentation against uh narrowband UVB as a monotherapy. Um we have also interesting observation from the 105 study that we presented in in our uh case studies where we see patients continuing to repigment after the stop the star- the after stopping the treatment with afamelanotide.

Um they are positive signs towards a sustained repigmentation with afamelanotide and narrowband UVB adjunct. As Philippe mentioned earlier when addressing pricing, the way we see uh treatment in the future will be as a um a course of treatment and then afamelanotide being given ad hoc as a as a boost at at at intervals to maintain and to keep uh the treatment effect.

Okay. Thanks.

Philippe, I have a question about NEURACTHEL. Um so how many um how many competitors are there in the market at the moment, and when can um meaningful revenues be expected from Europe?

I would say that there are about four competitors in the market in uh in ACTH, a larger one serving the North American markets and smaller ones in uh in Europe. Um We can only give guidance on uh meaningful revenues the moment we know the turnaround time by the EMA and uh the the the national competent authorities.

We don't have color on that yet. We We know that the average turnaround time should be 12 to 16 months uh after filing a dossier, but there are a number of clock stops in it where they they ask questions and and answers are provided within four four weeks.

That's that's a bit too early. The moment we know how um how we sail through the um the review process, we will provide guidance on when we expect the first uh revenues for ACTH.

Just a follow-up there, Philippe. Are you on approval, are you expecting reasonably um rapid penetration into that market?

I would say so. Because as as as you probably know, ACTH is a um drug with a label for 19 uh different diseases.

Um That means that the drug can be used uh for 19 different therapeutic indications, but is also used as a diagnostic. Um The majority of these diseases are not yet uh being treated by ACTH.

It it is it is a compound that um has a diversity of of therapeutic effects, and yeah, that appeal to us.

All right, thanks.

Thanks, Mark. Thanks to all the analysts.

I think uh we are a bit over time, but I do want to cover a few shareholder questions. Uh Fortunately, as we've uh gone through competition in EPP, NEURACTHEL, photocosmetics, what am I forgetting?

Ah, many questions on vitiligo. Um We've answered them, and that's uh satisfying, I hope, a number of shareholders.

I want to round out the webinar with a few questions: um one from Mr. Ketteler 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's not a typical area of our commentary, uh there are many interested in Philippe's views on the share price.

Philippe, why have we not yet scoped vitiligo TAM and presentation in Europe, since that is a regulatory market we're we're destined for as well, as well as the US? Um

When you talk about TAM, the total addressable market, I

Yes. Yes, fine.

Um

Vitiligo in Europe is treated mainly by expert centers, fine, not by every single dermatologist. Um The treatment guidance for vitiligo in Europe is slightly different than it is in the US, um and the population is more diverse, I would say, in in the various uh 27 European member states.

From the market research, there is such diversity in the size of the vitiligo market that we don't dare to put it out there, because the range is too large. We have an idea what the uh addressable market of vitiligo can be in in Europe, um but we we we try to stick with the lowest number.

It's very different than in the North American market. Um So, it is sizable, but um the range um of um patients reported with vitiligo in European Union um is so vast that we don't want to give a um a number to uh to our shareholders.

Okay. Moving on to that uh second question,

Yeah, go ahead. Go ahead.

Apart from your substantial ownership, Philippe, uh some have observed members of the board have low to no ownership of CLINUVEL. Whilst it's their own personal prerogative to determine their own investment uh strategy and and what they invest in, um can you comment on insider ownership?

Is that adequate? Do you think it needs to be higher, as some shareholders uh sometimes suggest?

No. I the I understand the question, and Yeah.

the ownership of this um of insiders, including officers, managers, executives, is about 11%. I uh I own uh just under 7% of this company.

Um Directors come and go. Some of them buy on-market, some though do not.

Um I generally see that as a sign of confidence. Um But we don't ask them uh proactively to do so.

I think it's, as you said, a prerogative of every director to make that decision. Um And um it's been higher in the past, and it's also been lower, it will evolve.

I'm pretty certain that, as the company evolves and moves into new territories, the the directors will um will seize the opportunity.

Thanks. Your views, even though as I said it's not something we typically do, your view on the uh 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 uh 2026, the decline over the year was minor.

Um Your views there, please.

I've spoken at two AGMs about share price. I I find it unusual for managing directors to talk about the share price of their own company, because by by and large, every CEO will think that it's too low.

Um [laughter] If you look at um objective metrics, and that's the only comments I will make, and then I I really wish that we didn't talk about share price of this company anymore, at least not me. Um If you look at objective metrics, um price-to-book value, uh price earnings, forward price earnings, we can and and the I leave the analysts to do that, take a view on whether it's fairly priced or underpriced.

If you benchmark it in various markets, and you look at the valuation multiple of CLINUVEL to other uh companies, you can also form a view whether um we are fairly priced, or punching above our weight, or underpriced. What I do know is that um sentiment also drives markets, and for that, I point shareholders to past events in the company where it was leading up to a regulatory outcome, EMA or FDA, and then you see slowly the share price uh moving up, because people are taking the bet, a binary bet, on whether you get an approval or not.

As soon as that binary bet is taken and uh the the the outcome um is effective, you also see the share price uh drifting. That that kind of volatility is probably uh specific to life sciences, where you have these uh important catalysts.

Um You have it probably more in smaller markets than in the larger markets, than in in the US market. I am um In 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 uh 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. Uh I'm now going to close the webinar.

Want to thank Philippe, and uh Peter, and uh Émilie, um for your enthusiastic participation; all analysts for their for their questions, much appreciated; and all participants uh for hanging in there and 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.

Um And I think we had a few technical issues where maybe a slide wasn't put up early and we'll try and fix that. It will also be on CLINUVEL's uh website as soon as possible.

Thank you.

Can I make one final

Yes, please. Yes.

I um We

We take many things for granted in life, um and in good health, I think it's important to get up with appreciation. Um I very much express my appreciation to the analysts on the line who voluntarily follow the company, spend hours in researching us and issuing these reports, and we don't take that for granted.

Thank you.

Indeed. Thank you, Philippe.

Thank you, everybody. Best wishes to all.