Clinuvel Pharmaceutical Aktie

Hello, everyone. Thank you for joining CLINUVEL's Investor Webinar. I'm Stella of Monsoon Communications. In today's webinar, CLINUVEL will share their half year results and operational highlights for the 6 months ended on 31st December, 2025.

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

Thank you, Stella, for the introduction. I'd first like to welcome members of CLINUVEL's management team to the webinar. Not surprisingly, reflecting the focus of the webinar on the financial results for the half year to December '25, we have Chief Financial Officer, Peter Vaughan. We are joined by 2 executives who are leading the business in key operational areas: Director of Clinical Affairs, Dr. Emilie Rodenburger; and Director of North American Operations, Dr. Linda Teng. We're also joined by our Managing Director, Philippe Wolgen.

I'd like to acknowledge there are several analysts on the line who cover CLINUVEL and we'll ask some questions in the webinar. It would be remiss of me if I didn't say on behalf of management and the Board that we appreciate your work on CLINUVEL, your role in telling our story to a wider audience than we could reach ourselves and your involvement in this webinar.

It's pleasing also that there are over 175 participants to the webinar, reflecting increasing interest in CLINUVEL. So welcome, one and all.

Before going further, I think it's appropriate to highlight why we have 5 executives in today's webinar. So you frequently see Philippe; our Chief Operations Officer, Lachlan Hay; Peter Vaughan; and Investor Relations presenting the company to a range of stakeholders.

We have received feedback that it would be good to have greater access and the opportunity to hear from other executives. So for today's webinar, noting this is not the forum for a strategic review, but as a courtesy to you all, we include Dr. Rodenburger and Dr. Teng to answer questions and provide their insights direct to you.

Today's webinar will be in 2 parts. First, a discussion of the half year results; and second, the analysts online will be called upon to ask questions of the CFO and management.

We will be talking today about plans and intended outcomes. So I'll draw your attention to the forward-looking statement or safe harbor statement on screen that identifies a range of risks that can materialize and impact their achievement. So I think 10 seconds to review that is enough, and that is on our website and on all of our announcements.

I now kindly invite the CFO to summarize the results. Peter?

Thanks, Malcolm. Good evening, and good morning, everyone, from wherever you're calling in from. It's another set of very consistent results at CLINUVEL, I'm pleased to announce, with our revenues up 4% on the prior year, maintaining a steady growth pattern.

Our expenses were up 22% for the period, and this really was part of the supporting the expansion initiatives that we'd foreshadowed previously that we were going to be undertaking during this period.

We continued our strong positive net operating cash flows, and this saw our cash reserves over the 6 months increase by $9 million to $233 million. We're closely monitoring all of our expenditures and any discretionary spending is being scrutinized really closely. And the good news is that our profitability for this period, whilst lower, continues to be maintained despite the increasing level of expenditure during this expansionary phase.

Thanks, Peter. I'll now ask Philippe to comment on the results.

Thanks, Malcolm. Welcome to all the analysts and shareholders. Well, in a nutshell, we follow a plan, a strategy, which is gradual and with purpose. And for this strategy to play out, we need to manage our finances tightly in a very controlled manner. In the past 12 months, we intentionally increased our expenses. And therefore, naturally, one expects to see the net profit decrease. These expenses towards R&D, the clinical trial in vitiligo and regulatory filings.

We are very much in line with our own forecast, so we're content with the results, and we will proceed on this basis. And with positive cash flows, we can expand the activities of the company, the group.

We gave expense guidance from 2021 to 2025. And for the financial year, we expect to spend about $55 million to $58 million, excluding the capital expenditures. So in summary, the business model we chose is playing out really well.

I agree. So let's delve into the results and call on Peter to look at in turn revenues, expenses, profit and indeed the balance sheet.

Thanks, Malcolm. So our revenues for the period continue to grow year-on-year. And this period, I'm pleased to say we saw our highest ever sales revenue result.

This period marks the 20th consecutive profit for CLINUVEL since the commencement of our commercial operations. And our expenditure, as I touched on before, whilst increasing, is very focused, controlled and targeted around the specific areas of the business that we're focusing on.

Our expansion saw key developments in our R&D activities across our ACTH-NEURACTHEL program; our vitiligo study, CUV105; and of course, our peptide drug platform that we developed at our Singapore Research Development and Innovation Center that we recently announced we'll be undertaking a large expansion of.

Now all of this expenditure and all of this growth has been achieved without sacrificing our overall profitability, which is really a fantastic result for the organization. Only 4% of biotechs deliver a profit and even fewer are able to sustain a profit for an extended period of time. So where CLINUVEL has done this for over a decade, it's truly a remarkable outcome.

In turning forward to our revenues, specifically, we saw our revenues from sales increased by 4% from the prior period to just under $37 million. As I mentioned before, this is our highest first half year sales results we've ever seen.

This reflects the increasing and continued demand for SCENESSE right across our sales regions. In particular, we saw strong growth in volume of sales across Europe. And as we announced in September 2025, the approval by the EMA, lifting the number of maximum implants per year from 4 to 6, has already seen some of the patients take up that extra initiative, and we expect other patients to follow suit as well.

In the U.S., our team and -- led by Linda has able to increase the number of sites to meet the target that we had for December, which was 120 sites across North America. The patient demand has been consistent throughout the period, and our U.S. team operates extremely well given the evolving U.S. medical reimbursement landscape that is constantly changing at the moment.

Perhaps at this point, Linda, as our Head of -- Director of North American Operations, I might ask you, could you provide some insight to the people listening in around the U.S. reimbursement process and in particular, the prior authorization scheme that enables us to have such a high success rate of reimbursement?

Sure, Peter. So first off, please excuse me for my raspy voice, as I'm still recovering from the flu. But thankfully, the technology allows me to share the insight without spreading the flu.

Linda, we can't hear you well. Linda, we can't hear you.

Can you hear me now?

No. It's very muffled.

Go off the headphones if you can.

Is that better?

No.

Not really.

Is that better? Can you hear me now?

Yes. Much better. Okay, let's move on.

Yes.

Can you now hear me?

Yes. Okay.

Can you hear me now?

Yes. Please proceed, Linda.

Yes?

Yes.

Okay. So all right. So we're going to continue with what Peter said about prior authorization. So in short, basically prior authorization is a way for health insurance companies to control their cost, by making sure that they are only paying for treatments that are medically necessary for their patients.

And so because SCENESSE is the only FDA-approved treatment for EPP, and it has a strong and also a long-standing safety records. We haven't seen any prior authorization denials for the EPP patient.

And we also have a dedicated in-house team that works very closely with the physicians to really streamline the submissions and also speed up the approvals. And for SCENESSE, most of our PAs that are already approved, they are only renewed annually. There really is minimal paperwork for the physician, and so they don't have to get approval for every single treatment visit.

And for those who are familiar with the U.S. healthcare system, you might notice that our approach is very unique. Most high-cost drugs, they go through the middleman or the pharmacy benefit managers or we call them the PBM. And they usually drive up prices up even more. So we made that deliberate decision to avoid the PBMs.

And I think that is moving like a smart moves, especially now because the government is increasingly the scrutiny of them. And we said the 2026 Consolidated Appropriations Act, which has really signed into law a few weeks ago, including the provisions aimed at the PBM industry.

And as for the patients, the feedback has been consistently positive. And I think the reason for the continued treatment year-after-year is because they are seeing real clinical benefit. And we even saw some patients are increasing their treatment dose within the year because of the clinical benefit.

And I do want to be clear that we don't pay physicians or patients for any testimonials. Everything is completely organic. The feedback from the patients are voluntary and genuine. And usually, they can share more within -- happily within their patient communities or directly with my team.

So I hope this gives you some insight into our prior auth process. Peter, handing back to you.

You're on silent, Peter.

Thank you, Linda. As we look forward to the other areas of revenue for the period, our interest income was up to $5.3 million this period, which was a 14% increase on the prior year. And this was really the result of a larger cash reserves balance that we continue to maintain.

We generally take our surplus funds that we have at the time and invest them into term deposits to help to build and grow on that balance. And at the moment, we're extending the length of our term deposits to be able to take longer-term maturities at higher yields. So we're seeing our average term deposit for about 300 days at the moment, and we're receiving an average yield of about 4.5% across the portfolio.

Our other income, now this number has swung the other way from the prior period, and it's a difference of about $4.6 million. Now just to explain, this is an unrealized foreign currency translation that occurs each balance date, so each reporting date.

It's really a non-cash transaction that's effective at balance date for accounting purposes. And it takes the process of taking all of our foreign currency balances and bringing them back to account at balance date into Australian dollars. So it's not a real loss. It's an unrealized loss just purely to be able to balance the books at balance date.

So if we look at our revenues overall, I would mark them as being stable, growing and also consistent. Historically, our second half of our financial period generally tends to be proportionately higher from a revenue perspective, with the EU and U.S. summers coming into effect through that second half of the year. So we're really excited to see how the second half of the year plays out given we've still got that maintaining growth.

Perhaps moving to expenses, Mel, now more specifically.

Yes.

So we saw a 16% increase in our personnel expenditure. And I'd probably -- I'd just like to provide some context around that for everyone to understand. This is a strategic part of our expansionary team and increasing the in-house capability of CLINUVEL.

It provides greater control and oversight of our activities. But at the same time, we're upgrading the skill and expertise within our organization.

Now as everyone will know, skill and expertise within the life sciences sector is really important. And recently, we've seen regulatory challenges and hurdles that some other life sciences and biotech companies have faced in just recent times. So this highlights the need to really develop and create the skill and expertise within that team and make sure we've got the right people around the decision-making process.

And when we look at CLINUVEL, CLINUVEL's never had a market authorization knock back in over 20 years of being active in the pharmaceutical sector.

Now if that was to occur in some shape or form, a regulatory rejection of some sort can really have a significant effect on an organization. It erodes shareholder and market confidence in the company. It raises doubts around management's decision-making and assessment of processes and events. It can push commercialization time frames back up to 3 years as seen in some of our peers where another study or more data may need to be gathered before a resubmission can take place.

And clinical trial designs and endpoints around the quality of data may suit one region, which brings in revenue, but not always both revenues -- both regions to bring in revenue across the globe. And this can really affect the total revenue pie that's available from the advancement and the approval.

Our people are really critical to the process. And in plotting the path forward, we're really confident that they'll be able to obtain the right outcome around our clinical programs.

In turning specifically to our clinical and non-clinical expenditure, the expansion of our CUV105 expenditures was somewhat offset by the orderly wind down of some of our earlier phase programs. We've reallocated and focused our resources towards our later stage and strategically significant programs aimed at achieving the nearest-term commercial results and prospects we can.

Preparation for CUV107 has already commenced and is well underway, and we'll start to see those expenditures flow through in the second half of the year also.

Commercial distribution, if we look at that area, that was up 42%, but this is predominantly off the back of increased volumes of shipments, particularly in Europe, as I touched on before. So it's all increased proportionately. There has been some temporary one-off costs that have been associated with some transitions that we've made in our supply chain to some of our warehouse providers to ensure the long-term stability of that supply chain as well as being able to scale with us for the future.

The other area that is somewhat affecting the commercial distribution area is also some of our regulatory fees. Previously we used to sit under an SME discounted scheme in some of those regions for the FDA and EMA annual fees. And now that our revenues have increased to the point that they are, we're no longer eligible for some of those discounts, so we're having to pay full annual service fees now to those organizations, which is also increasing the expenditure in that area.

The next area to touch on is really finance, corporate, and legal. Now this did increase proportionately from the prior year to up 47%. And really, this is the direct cost of a lot of it is being our ADR program uplift from Level 1 to Level 2 that I'm sure you're all aware of as we uplift that program for the U.S. to list on NASDAQ.

There's been a substantial amount of work undertaken across that area by the finance team, but also in conjunction with our accountants, auditors and legal firms, both here in Australia and in the U.S. And this process we had to go through undertook a 3-year reaudit of all of our financials into U.S. GAAP -- converted into U.S. GAAP financial presentation, and then that was submitted to the SEC for review.

Our other expenses, that's up 191%, and it's predominantly driven by the increase in our R&D programs and all the consumable materials that we use within those programs, whether it be ACTH, PRENUMBRA or NEURACTHEL, any of those developments.

Our non-cash expenditure was down for the period. This is usually a change in our inventories in our balance sheet differences from period to period, that's really what reflects quite a bit of that expenditure. This period, that's a lower number than it was previously because we've actually increased our manufacturing during the period, so therefore, there hasn't been as low a drop in our inventories. It stayed more on par.

Our share-based payments have also been much lower this period than in previous years, and we recently changed our share plan at the start of 2025, which meant the expenditures will now appear differently, but also it's now a 1-year plan instead of a 3-year plan.

Now I've spoken fairly at length around all of the expansionary activities that we're undertaking and some of the critical advancements to our program. But this expanding expenditure should really be seen as an investment in the organization rather than just being pure expenditure.

So from a financial perspective, it does take time to build up these resources internally, but it is cheaper than outsourcing to a CRO. CROs can add 25% or more costs to the bottom lines of a clinical trial program. But by having that skill and expertise in-house, it's critically important for us to maintain that control and oversight of the program.

We've got Emilie Rodenburger on the call, who's our Director of Global Clinical Affairs. Emilie, in speaking around our expansionary activities and what's been undertaken, I guess, would you be able to provide some insight into why that was necessary? And what are the specific advantages of doing them in-house?

Yes, absolutely, Peter. I can give some additional context to the numbers. So first of all, good morning, good afternoon, good evening, everyone. It's good to be here.

In my capacity as Director of Clinical Affairs, I really think more on the deliverable and how to achieve them, but it certainly ultimately impacts the numbers we report.

So clinical expansionary activities are twofold. It's talent growth and building the infrastructure into which the talents operate. As Peter mentioned, the company has taken a conscious decision to build our capabilities in-house, which is not the norm in our industry. Where most are relying on outsourcing their studies, we have chosen not to rely on these models and not to work with CROs. It increases cost and can result in loss of control and oversight over studies and data.

In order to deliver the CUV105 study, we had to invest in new talent and these professionals will be retained through the CUV107 and beyond. Currently, the clinical affair department that I lead is the largest department in the company spread across U.K. and U.S. with a great range of expertise, operations, data science with data management and statistics, and medical affairs and clinical quality.

In addition to bringing new talents in, we have also trained and upskilled existing talent. So building and retaining the expertise in-house. And again, I repeat what Peter said, it's really critical for the health of our business.

In terms of infrastructure, it's really the processes and the systems, and we've also been investing in this. This investment will continue further for us to be able to manage a significant data set that are coming from the vitiligo studies and deliver efficiently on the studies.

So when we build in-house, we both supporting the present and investing for the future. I mentioned the talents, the expertise, the ownership, processes and systems. They can be seen as a platform assets that is transferable to any studies and programs that we will be conducting in the future. So in a way, we're building a CRO in-house.

Excellent. Thank you, Emilie. In turning to our balance sheet, Malcolm.

If we look at our balance sheet, it keeps going year-by-year from strength to strength. As I touched on, our cash reserves increased by $9 million to just under $233 million, and it's the highest cash balance we've had in the company's history.

Our net assets have also increased by $8.2 million to just under $250 million, which again is the strongest point in the company's history. And we remain debt-free for the 21st consecutive year with no equity dilution since my March of 2016.

A strong balance sheet with positive net cash flows is really a strategic priority for CLINUVEL as it enables us to see clinical programs through to commercialization without any additional funding required. It also provides resilience for any unforeseen events or economic uncertainty, particularly in the current geopolitical times.

It provides flexibility to ensure expansionary opportunities, acquisitions or investments that align with our objectives, can be taken advantage of, which many peers in the industry aren't able to consider without having to raise additional capital.

It also enables strategic objectives to be delivered such as the expansion of our Singapore research and development facility, which we've slated for over the next 5 years to provide vertical integration of ongoing peptide and formula development and innovation.

A number of our peers have recently announced capital raisings, some as much as at a 45% discount to market to fund these sorts of activities that we can take on and that we can develop without having to raise any further capital.

Some of these peers are raising for clinical program developments, for raw material supplier scale-up or for product rollout into a new jurisdiction. As already touched on, CUV is funded for our full clinical trial program for vitiligo.

Thanks, Peter. I mean that was a comprehensive overview, I must say, but I'd like now to move to strategy. I mention and shared with you that a number of institutions, particularly in the U.S. have asked us why CLINUVEL stands out in its strategy. They even ask, are we a bit dogmatic and a bit rigid in our strategic focus and execution. Philippe, can you comment on this?

Well, I'll pick up the 2 words: dogmatic and rigid. The contrary, we've built in the flexibility and optionality in this business model, and that allows us to navigate markets and cycles in pharma.

But the objectives are really clear, they're fivefold. We need to expand the EPP commercial market, advance the vitiligo programs as a focal point of the company, advance the NEURACTHEL dossier, which is a large opportunity in the use of ACTH in a number of indications, advanced PhotoCosmetics, and bring in-house the manufacturing of the new and next formulation.

So in any given business model, there are a number of options. We can serially raise funds like most of our peers. We can change the business strategy altogether, step away from melanocortin and do something totally different. We can self-fund the program starting gradually as we've done.

And the fourth option is, we can cease operations and say, ladies and gentlemen, it's too difficult, it's too hard, and let's give the cash back to the shareholders. And we haven't chosen that because we believe that there are a number of opportunities that we worked on for decades that are worthwhile pursuing.

And there are a number of underlying assumptions that the Board and management take into account that we are privy to and no one else is. And first of all is, are we conducting an honest genuine business, no one indicated in further activities. Do we keep the teams in check? Do we have technologies that are safe and work? And third of all, do the patients -- do the investors have the patience to see out the strategies?

But the most important underlying assumption is whether there is perpetual funds available for this company. And we've come to the conclusion that this model is very appropriate for the way we need to reach the vitiligo and the ACTH markets.

So in summary, Malcolm, we needed to accumulate these funds to execute a program, which we all believe will lead to a sustainable multi-dollar a billion-dollar enterprise. But we also need to be conscious of the realistic risks that evolve around clinical, regulatory and execution. And for that, you need to have optionality and optionality is cash. And that will eventually lead to a diversified company. So that's how the company stands out.

Thanks, Philippe. So moving to another area where we've had numerous questions, and this is on the readout of vitiligo. And Emilie, it's good to have you here, and this is where you come in. What can you tell us about the regulatory process and path to market on vitiligo?

Thank you, Malcolm. I will address your question by providing a number of specific observations that support the regulatory process and path to market for SCENESSE in vitiligo. Some of these observations are unique to SCENESSE and some you might also be familiar with, but allow me to go through them.

The first one is SCENESSE is already on the market for another indication, EPP. It's a product for which we have accumulated 2.5 decades of safety data and a safety profile that has been maintained over time. The regulatory agencies know the product well from the Annual Report or regulatory and pharmacovigilance teams are and have submitted for 1 decade now.

In regards to vitiligo, vitiligo is a condition with visible symptomatology and the treatment effect -- skip that one. And the treatment effect that we desire, repigmentation, is visible. So from the cases we received and cases published by physician, one can gain much confidence that the effect of the treatment are visible.

From an operational point of view, the trials can't be blinded. The work -- the drug either works or not and physician and patient can see the effect very quickly, the visible efficacy. So what I'm trying to say here is that in vitiligo, the photographs do not lie. And part of the analysis is to have centrally assessed photographs up to 32 per patient, which is up to 6,000 assessments. Very importantly as well is the patient experience and how they appreciate the return of their pigments.

JAK inhibitors, some currently in Phase III, one recently submitted to the EMA and FDA for marketing approval, they take a long time to work, thereby suppressing the immune system. And last but not least, we are living in a very dynamic regulatory landscape where the concept of generating clinical evidence is evolving.

EMA speaks about totality of evidence for drug approval, while as I'm sure you've seen the FDA recently announced that single trial will now be the default for drug approval.

So what I really wanted to convey by all of this is that, these are positive considerations for SCENESSE to come to market for vitiligo, as we are continuing on the same trajectory. I can't tell you exactly when. But for sure, vitiligo is the natural home for afamelanotide, a pigment activating peptide, which is an analog of hormone that's naturally produced by our own body. Thanks, Malcolm.

Thanks, Emilie. So before we go to analyst questions, all stakeholders want to know what's next. Philippe, can you summarize that for us, please?

Sure. So there are a number of catalysts that we're approaching over the next 2 years. The most immediate ones are the top line results from vitiligo CUV105 in the second half of 2026, the start of the vitiligo CUV107 study, and the preclinical results on the peptide formulation in the latter half of this year and the listing of the ADRs on NASDAQ that we await the SEC answers for.

So the catalyst will naturally change the complexion of the company, and this is exciting, and we've navigated the waters over time to arrive at this point. And so we all need to get patients and see what the impacts are from these results. So there's much to look forward to, yes.

Indeed. Thank you, Philippe. So let's go to analyst questions. But thank you, Peter, Emilie, Linda, Philippe for the discussion. Some good insightful comments there, and I hope those on the line also have got some insights and appreciate that.

The first analyst to ask a question is Dr. David Stanton of Jefferies. Hello, David, are you there?

I am. Can you hear me?

Yes, David. Please go ahead.

So my question is, do you have to wait until you have the results of CUV105 -- sorry, CUV105 and CUV107 before you file for approval in vitiligo? And in which geography would you file in first and why, please?

I'm going to take this question, Malcolm.

Okay.

It's a -- yes, it's a good follow-up and from what I was mentioning a couple of minutes ago. So thank you, Dr. Stanton for this question, question that's relevant and often asked.

Our intention is to complete CUV105 and CUV107 before going to the EMA and FDA. And the recent announcement on single trial for drug approval from the FDA doesn't change this strategy. So based on the ongoing interactions we have with both agencies, EMA and FDA on the specificity of our work that we are conducting, we will need the CUV107 study to complete our program.

For the second part of the question, we opt to file with the EMA first and then FDA second. And this really -- this strategy really much follows the approach we had with EPP back in 2012.

I want to say more. I think it's important for me when we speak about regulatory agencies, I want to give a bit more color. An agency, as you know, it's a conglomerate of thousands of people, so at the EMA in Amsterdam, there are more than 1,000 permanent staff and more than 4,000 part-timers and experts. We are dealing with 2 European reporters that are representing the National Competent Authorities, which are Lithuania and Poland, with a scientific adviser representing the Scientific Advice Working Party, a very knowledgeable German physician.

At the FDA in Silver Spring, there are more than 8,000 permanent staff and another 6,000 elsewhere consultant part-timers. We interact with the Division of Dermatology and Dentistry now led by Dr. Jill Lindstrom in the Center of Drug Evaluation and Research. And we have a new Commissioner, as you know, Dr. Martin Makary, who has reshuffled the agency, bringing new procedures and new approach.

In our EMA reporters, we find willing listeners and may I say more supportive of our regulatory and market strategy. We are the only company focusing on patients of darker skin color and this point resonated very well in our recent discussions with the EMA.

The approach we have on vitiligo is so novel that we deem the European regulators to be the first protocol, and then it will make it easier for the FDA to assess similar data.

Okay. Thanks, Emilie. The next question is for -- from Dr. Melissa Benson of Barrenjoey. Hi, Melissa.

So I had a question in regards to the ACTH program, so NEURACTHEL. Just to help us understand, you've mentioned there later this year, you expect to file with EMA. A similar question to the lining of vitiligo, but understand like how does filing with Europe first and then the FDA, how does that kind of expedite the U.S. opportunity?

And then secondly, any color you can kind of provide on the differences, I guess, between the commercial landscape for a product like this in Europe versus the U.S.? Because I understand one market is quite a synthetic peptide-based and the other is a natural hormone based. So that would be great.

Philippe, for you.

Thanks, Melissa. Yes, we've talked about this in the past. NEURACTHEL will first be filed in Europe through the route of mutual recognition. And as you know, the analogues of ACTH, in our case, NEURACTHEL are used by many institutions, both as a therapeutic and as a diagnostic. And so we opted to go to Europe first and U.S. second.

Once you've filed through the mutual recognition procedure, you can file shortly in the U.S. after. ACTH products are mostly distributed to specialty centers in Europe. They prescribed by internal specialists, endocrinologists. And we believe that it's possible to make the first inroads directly to these centers in Europe.

Reimbursement in Europe is albeit lower than in the U.S. So both markets are sizable and are attractive, but we have experience in leveraging the European regulators and the resonance there is high. So it's a slightly different strategy than most of our competitors, but so far it worked.

Okay. Thanks, Philippe. We've just lost you on camera. So if you can try and get back to us, we'd like to continue to see you.

Let's move to Dr. Thomas Schiessle of Parmantier in Germany. Thomas, you're a long way away, but let's hope you're connected.

I would like to ask a question, what does the recent FDA decision on Disc Medicine's Bitopertin mean for your business and growth outlook, please?

Okay. Peter?

Sure. Yes. No problem. I can answer that one. So I guess thank you doctor for your question. From a finance perspective, I'm happy to answer that. So I see it from a way of increasing our monopoly in the market with the other player, obviously, not being able to enter that market yet as we're really the only approved drug treatment for EPP with a proven safety and efficacy record in the U.S.

So it could take them, I would estimate about 1 to 2 years to come back or even longer to enter the European market. So it could be quite an extended period of time that we still maintain a monopoly within that market. So I guess that's how I see it, doctor.

I'll come back to you, Thomas, to ask another question because we've covered that fairly succinctly. But I'd like Linda to make some comment because some shareholders have asked what's our reaction to the FDA's decision on this. So can you make some comment on that, please, Linda?

Sure. First, can you hear me okay?

Yes.

Okay. Right. So first, I definitely can comment. However, I do prefer not to comment on the setbacks of other companies or their management. And I will just leave that to the external observers.

And while competitors may have made critical remarks about our work, I don't consider it to be elegant to respond in kind. However, what I will say is that it is not easy to get a regulatory approval in one go. Our team have done this by working thoroughly and diligently. And at the end of the day, it is really all about the patients, making sure that the drug is safe and that it shows significant clinical improvement in their quality of life.

And the FDA really raised questions regarding the bioavailability and efficacy of Bitopertin, which, by the way, I'm sure most of you already know. This was actually originally developed for an antipsychotic drug for schizophrenia before it was abandoned by Roche.

And so for EPP, the company had then had to increase the dose from 20 milligrams to 60 milligrams to achieve a statistically significant reduction on the biomarker of the protoporphyrin level. But higher doses also mean that there's going to be extra stress on the patient's liver or kidneys. And this is very concerning, especially for EPP patients because they are already at a higher risk of liver disease.

And on top of that, oral pill higher dose also increased side effects, complications and drug-drug interactions with other medications. So as the pharmacist, I really cannot see how this is a benefit for the EPP patients.

And the other point that the FDA also raised, a very valid concern, was its primary endpoint. And this was based on the change in the biomarker protoporphyrin IX. So in case -- I don't know how much you guys know about biomarkers. Well, biomarkers are a very helpful tool for scientists, for physicians to really understand what's happening in our body, but it does not always reflect real-world meaningful clinical benefit.

And an example that comes to mind is there was a drug that was received an accelerated FDA approval back in 2016 for an advanced soft tissue sarcoma, and this was approved based on a biomarker endpoint. But once they came to real life, the real-world clinical outcomes did not show any survival benefit. And so at the end of the day, the FDA had to pull the approval soon after.

And from a bigger picture pharmacological perspective, it also seems very unusual to me to prescribe a lifelong oral pill that affects the central nervous system to lower the protoporphyrin IX marker -- biomarker levels. So I guess, I suppose, we'll really have to wait to see the results of their future trials to see whether this drug can really show both the efficacy and the meaningful clinical benefits for the patients.

Right. Very insightful. Coming back to you, Thomas, do you have a follow-up -- a quick follow-up question?

Yes, indeed. Thank you, Malcolm. Absolutely another issue. The FDA -- no, no, no, no. That's a second one. What impact does NASDAQ listing have on CLINUVEL's future regular reporting concerning frequency and content, please?

Okay. Peter, for you.

Sure. I can answer that one, Malcolm. So we'll be listing on the NASDAQ or uplisting our ADR program and listing over there as a foreign private issuer. So what that basically means is that we'll continue to lodge half year and full year financials.

In the U.S., we'll be reporting in U.S. dollars and also in U.S. GAAP accounting. But I guess, in short, Thomas, it's -- it will be exactly the same as what we currently do every 6 months and then every 12 months for the half year in the annual reporting. So no real change to the frequency.

Thanks for dialing in Thomas. I just mentioned that several shareholders have asked for an update on our listing application. So Peter, give us an update, please.

Sure. No problem. So we lodged our initial filing, which was a 20-F document to the SEC in mid-December or 18th of December to be specific. And we did foreshadow that there may be some delay in the turnaround time because it was also -- it was Christmas period, but also the government was -- had come out of shutdown mode and the SEC that obviously affected them. So they needed to catch up and clear the backload of filings and other documentation they had.

But we have had some further correspondence back and forward with the SEC, and we're refiling our response to them. So we're hoping to be able to receive clearance from them in the very near future and then move quickly to implement the ADR program uplift. So watch this space.

Okay. We sure will. Let's now call on Sarah Mann from Moelis. Sarah, please.

My first question is just on the EPP market. Could you provide us any details around what percent of your patients are covered under Medicaid? And just curious how you anticipate some of the cuts to Medicaid potentially impacting your ability to reach those patients?

Linda, for you.

Sure. I'll take this one. Sarah, thank you for your question. So we're actually seeing less than 5% of our U.S. EPP patients on Medicaid benefits. So in short, we don't really have a noticeable impact. And in fact, like you mentioned the One Big Beautiful Bill, it actually broadens the orphan drug exclusion. It now allows orphan drugs to -- with more than one rare diseases to remain exempt from Medicare price negotiations and potentially so far looking like it's indefinite unless the drug is later approved for a non-orphan indication.

So one can theoretically say that the TAM would increase through curing the federal programs. But given that most of our patients are commercial insurance patients, we don't really see a worthwhile impact in the U.S. market at this time.

Okay. Sarah, a follow-up question.

Just on a separate topic. Just curious if you could provide more color around the cosmeceutical strategy. Obviously, it's been in market for a couple of years in, I suppose, prototyping or early stage testing. Yes, just curious how you expect it to ramp up this year and any learnings that you've had over the past couple of years as well, please?

Philippe, can I call on you?

Sure. First of all, good to see you back, Sarah. It's been a long time. On numerous occasions, we mentioned that the PhotoCosmetics are in development, and they accompany a complement our pharmaceutical program. That's quite an unusual strategy to have both pharmaceuticals and the PhotoCosmetic franchise, not many pharmaceutical companies do that.

And so the first was the P line, the photoprotection lines, providing polychromatic photoprotection in population of the highest risk and extreme conditions. And then that will be followed by the M line, the melanocortin containing peptides. And they intend to provide assisted DNA repair and self-bronzing or the so-called sunless tanning.

And in all these properties, the endeavors goes really to launch products with a substantial marketing effort. And that needs to provide visibility to our products. And we started to gradually increase our marketing spending online to focus groups, advocates, target populations and channels. And so we are in the prelaunch phase where we get feedback on these products.

But ideally -- and nothing is ideal, but that was the anticipation and the model, when the vitiligo trials start to yield results, we then see a parallel large-scale effort to promote the M lines, because the concept was that the medical tanning that you see in vitiligo follows a parallel path to the PhotoCosmetic self-bronzing properties. So in short, we advance, but we're not really ready to launch these products, not from a scientific point of view and not from a marketing.

But what we aim to see is lotions and serums applied a number of times a day that assist the self-bronzing in the epidermis. And we're not quite there yet, but we're advancing.

The other part is in order to make this a commercial success, the company needs to differentiate itself in all aspects. The retail experience needs to be changed or disrupted, if you wish. The primary packaging, the secondary packaging, the way we distribute it, the retail store concept and all that at a reasonable large scale.

But thereby we are conscious of the spending and the budgets we put aside for this exercise while keeping the company profitable. So it's a balancing act that we do need to navigate all the obstacles, but to decrease the risk of failure and that we do that in a very gradual and deliberate manner.

Okay. So let's move to Madeleine Williams of Canaccord. Please, Madeleine.

So I think, firstly, I was just wanting to know, you've got a few things happening at the moment. Obviously, last year, Europe allowed the increased number of doses and then also in the U.S. as the Disc Medicine trial completes this year, I assume there's sort of going to be more patients available. Just thinking about how you're thinking about the growth in those jurisdictions and sort of the splits going forward.

Well, Peter, do you want to comment initially on...

For me? Yes, sure. No problem, I can comment on that. So I would say that there's a segment revenue note that we've included within the half year report that does show the breakdown. But I guess a quick summary would be the U.S. revenues have increased year-on-year.

And this period, we saw a rise more predominantly in the European volumes, partly spurred on by some patients taking up that increase from 4 implants being a maximum during the year up to 6 that was announced in September 2025. I guess at the moment, the current revenue split is about 53% U.S., 47% for the rest of the world. So that kind of -- that's the insight that I can provide there. I guess on the peptides side, that's probably more Philippe perhaps might be able to answer that one.

No, we'll park that. I think we'll move on to Mark Pachacz, because I think he's got to leave pretty soon. So Mark, if you're still there, can you ask your question?

Malcolm, looks like Mark is no longer here.

Okay. That's all right. Well, fortunately, we have another analyst, Thomas -- Thomas Wakim of Bell Potter. Do you want to ask a question please, Thomas?

Yes. It's a bit of a follow-on from the previous one actually. So in that revenue segment, the split between U.S. and non-U.S. sales for the period just gone, where we saw a decline in the U.S. and a significant increase outside the U.S. So can you just kind of explain in a bit more detail what those factors were that were at play there leading to that? And how does that look moving forward?

Sure. So there was some effect on the U.S. side from the government shutdown. So the government shutdown met delays in Medicare processing as well as also the processing of reimbursements. So in some instances, some of the smaller centers didn't want that longer-term delay on their payment cycles and things like that. So that did cause some headwind there for them. And then we also passed on a CPI increase in 2025 and some of those have caused some negative reimbursement pressure on some of the centers.

But overall, we anticipate that the U.S. is still stable and still growing across that, and that's where we've continued increasing the number of centers across North America. So we're seeing new centers come online and start to bring patients to the floor as well. So there is that difference between prior year and this year, but I think it's really explained by the U.S. government shutdown predominantly.

Okay, Peter, thanks. And as I was talking with Madeleine before and also with Mark Pachacz, there was a fair bit of interest in peptides. So let's come back to peptides and ask Philippe to comment on the potential of that new area of development.

Well, we spoke for a long time in public about the skill set of the company and how it was expanding concentrically. So we started off as a company focused on clinical affairs. We understood the melanocortin peptides really well. Then we focused on the delivery methods, the best way to deliver and administer a drug into a human body. And from that, we built our Singapore labs and progressed fundamental research into new formulations. We call it formulations of the next generation using liquid injectable peptide platforms.

And so naturally, once we mastered these technologies, it opened up the realm of fantasies of what other peptides could you use to deliver a product in a sustained or controlled manner. And that's where we are. So you're going to expect much more from that team and our activities in Singapore.

Thanks, Philippe. Very exciting. It's about time that we wrap up, but I didn't want to conclude without addressing a couple of shareholders who asked me about the company's dividend policy and whether we have one, and I can say we certainly do.

It's available on the CUV website, but I can tell you that it is the Board's intention to pay a dividend subject to the sufficiency of our funds and the operating and investment needs of the business and indeed future growth and needs to fund that growth. So the Board will determine that, and you can investigate, as I say, the dividend policy online.

So I want to say thank you to all the analysts online for asking their questions. Peter, Emilie, Linda, Philippe for their contributions, good insights and all attendees, thank you very much.

A link to the webinar will be posted to the CLINUVEL News website as soon as possible for other stakeholders to review. So I'll now close the webinar, wishing you all good health and fortune. Thank you.

Good morning, ladies and gentlemen. My name is Professor Jeffrey Rosenfeld, and I have the privilege of being the Chair of CLINUVEL Pharmaceuticals Limited.

As Chair of today's meeting, it is my pleasure to welcome you to CLINUVEL's 2025 AGM. I note that we have complied with the relevant requirements for convening this meeting and that a quorum is present. As the time is now 10:00 a.m. in Melbourne, just after, I formally declare the meeting open.

Before the formal business of the meeting, I'd like to acknowledge the traditional owners of the land on which we meet today. I would also like to pay respects to elders, past, present and emerging and celebrate the diversity of Aboriginal peoples and their ongoing cultures and connections to the lands and waters of Australia.

I also draw your attention to our legal notice which highlights that there are risks which can impact the plans and initiatives we will be discussing today.

I'm joined today by my fellow non-executive directors. 3 non-executive directors are here in person, Mr. Susan Smith, Mr. Matthew Pringle, Mr. Guy van Dievoet, Dr. Pearl Grimes and Dr. Karen Agersborg join us online from the United States of America.

I would also like to welcome our Managing Director and CEO, Dr. Philippe Wolgen; our Chief Operating Officer, Mr. Lachlan Hay, who's on the screen; in Singapore; our Chief Financial Officer, Mr. Peter Vaughan; who's at the back there. Our Head of Investor Relations, Mr. Malcolm Bull; and our Company Secretary, Ms. Claire Newstead-Sinclair at the end there.

The company's auditors, Grant Thornton, are represented here today by partner, Mr. Brock Mackenzie. The auditors will be available to answer questions during Item 1 on the agenda or at the end of the presentations regarding the conduct of the audit and the audit report for the year ended 30th of June 2025.

I would also like to welcome our Corporate Counsel, Arnold Bloch Leibler, who kindly offered to host the meeting today in their offices. I'd like to specifically acknowledge Mr. Jeremy Leibler in the front row there.

Finally, I would like to welcome representatives from our share registry, Computershare, who are present today, and I welcome all of you, shareholders and interested parties as well.

The notice of meeting has been given in accordance with the company's constitution and copies are available for you on the company's website, the ASX announcements platform and at the share registry's registration desk. I will take the notice of meeting and explanatory statement as read.

The format of the meeting will be a brief Chair address from myself, a formal consideration of the business on today's agenda with an opportunity to ask questions on the formal business, completion of the poll on the formal items of business and close of the formal part of today's meeting. Then there will be the Managing Director's update, and then there will be general questions from the floor. Shareholders will be able to ask questions and cast votes at the appropriate times while the meeting is in progress.

So before we commence with the formal part of the meeting, I would now like to provide my opening Chair's address. To open, this session is being recorded and will be made publicly available on CLINUVEL's website, ensuring full transparency and equal access to information for all shareholders.

Our successful financial position has been well covered recently and will be further presented at this AGM. Today, I will give you the Board's perspective on how our strategic planning translates directly into your financial returns. Our CEO will address the future following the formal business, and I will address the foundation upon which it has been built.

In the pharmaceutical industry, intent is cheap. Execution is everything. This brings me to a concept we treat as a core financial metric, longevity. It is not merely a measure of time but a quantifiable competitive advantage, a disciplined, capital-efficient execution of a long-term plan against relentless headwinds. You should not underestimate its value.

Allow me to crystallize this with 3 financial case studies briefly. Case study 1, the EMA, that's the European Medical Regulatory Authority approval is a lesson in strategic capital allocation. In biopharma, regulatory bodies hold ultimate veto power. For 3 consecutive years and despite robust evidence, the European Medicines Agency rejected our data for expanding the use of SCENESSE and aligning it with the U.S. FDA-approved label.

The Board faced a clear capital allocation decision, continue dedicating 7-figure resources to this pursuit or cut our losses and deploy that capital elsewhere. The opportunity cost was significant.

We analyzed the risk. Our team's conviction backed by irrefutable data versus the irrationality of the initial regulatory stance. We committed to our data and our team, and that commitment paid off. Last month, the EMA approved the expanded label and admitted errors and misjudgment in its assessment.

The result? An expanded revenue stream secured for the European business. This is not a story of perseverance. It is a case study in a Board making a disciplined, high-conviction investment in the face of uncertainty and winning.

Case study 2, the Singapore venture and owning the technology. 4 years ago, our internal R&D on sustained release formulations showed unconvincing data. We had a choice, shut down internal development and outsource this activity at a premium, surrendering future IP or continue funding our own laboratories.

External advisers rightly noted the low probability of success. But our CSO and CEO argued that success, however slim, would create an unassailable position. We, the Board, backed them.

The result? In January 2025, we saw that our faith and patients were being rewarded. We learned about breakthrough data emerging, leading to the bold decision to advance new liquid injectables formulations to the preclinical stage, the final step before manufacturing for human trials. We now own the foundational IP for next-generation liquid injectables. We own the asset outright. This disciplined internal capital allocation over a decade has created optionality and value that outsourcing never could.

Case study 3, financial discipline, the dividend versus growth calculus. We operate a singular model in biotech, profitable, dividend paying and fully self-funded. This is a deliberate capital strategy, not coincidence or luck.

We made a conscious decision to reinvest $175 million over 5 years into our pipeline, vitiligo, porphyrias, ACTH and new formulations. The market was informed. The discipline was absolute. We came in 3.1% under budget whilst advancing all programs over a 5-year period, financial year '21 to '25, 3.1% under budget.

The financial logic is simple. We chose to conserve profits, avoid capital raises, forgo a marginal increase in dividend payments and place share buybacks on hold. This is all in order to fund R&D that we believe will generate significant returns. We are building high-value assets inside a profitable company without diluting you, the shareholder. This financial stewardship is your structural advantage.

I'd now like to present a retrospective on execution. At last year's AGM, I committed to exploring acquisitions. From the 10 viable ideas our teams generate or receive annually, we commit to deeper diligence in a number of these. Our teams made 2 disciplined nonbinding offers for North American assets. Both were abandoned as we could not guarantee the levels of return that we seek from such opportunities.

We walk away from deals that do not meet our strict risk-adjusted return criteria. Instead, we redeployed that capital into our own higher-conviction pipeline. This is capital restraint in action. However, we continue to pursue further options for business acquisition in North America, particularly that would add value and pose low risk to our existing business. Furthermore, we have stress tested our operational resilience. At the time the CEO recovered from illness, our team delivered a ninth consecutive year of growth and profitability.

On PhotoCosmetics, we often get asked about this. As I reported in my recent Chairman's letter, we continue to refine our PhotoCosmetic formulations, which is a complex undertaking, I might say, in our Singapore laboratories. The time lines to regulatory approval and marketing will be presented by Dr. Wolgen. The Board's view is that PhotoCosmetics may well become an important revenue stream for CLINUVEL. And they, the PhotoCosmetic should be pursued with prudence, but also with vigor.

The road ahead. We are building a diversified portfolio of melanocortin-based assets designed to withstand the test of time and market cycles, developing a suite of drugs and PhotoCosmetics based on platform technologies. Looking after both patients and those who desire advanced skin care through the PhotoCosmetics is the driving force for the company. Providing long-term care and constructing close relationships with physicians and their patients as an integral part of our culture, so is our commitment to add value for our shareholders.

The Board carefully considers the chances of product development for the future where highest needs exist. We shut down development programs when we lose the conviction of commercial reality and end up with cash to be used for projects where returns are expected. The pipeline is being de-risked. Finances are secure and talent is retained. Are there further dangers left? Absolutely. But any sophisticated investor who has done their diligence understands that our premium valuation is not for hope. It is for a proven executable plan and a team that delivers on its capital commitments.

I stated when I became Chair that major changes would be made under my guidance, and we have made them. We attracted 3 new directors, and we have a Board challenging each other on major issues and taking well-analyzed and considered decisions, unafraid to speak their mind on critical topics to drive the company forward.

I spoke last year about the development of the business and the value created against a flat share price. Under threat of tariffs, major challenges in pharma, investors' fear of competition, we have delivered another year with significant progress on SCENESSE, ACTH, new formulations and vitiligo trials over recruitment of the trial to name a few.

More important to you, we retained talent and added new staff. We also presented ourselves in a memorable way to an American audience at the American Academy of Dermatology Meeting in Orlando in March '25. We will do so again in Denver in March '26.

In this address, I've given you many reasons to continue to support the Board, me as Chair and the management team. Can it all go wrong as we diversify the pipeline? Of course, it can. There are no certainties in our sector, but anyone who has done thorough research has silently assigned a percentage of value to our team executing their lifetime investment.

Lastly, some of you have asked me about the status of succession planning for our CEO, and I intend to share more with you about that in the new year.

I hope you perceive the same positive direction the company has been taking as I do. CLINUVEL is on track to deliver, perhaps taking longer than some would like, but we are certainly navigating the path and overcoming substantial challenges. I have no doubt that a bright future lies ahead for CLINUVEL, perhaps brighter than you can imagine. Thank you.

And now to the business of the meeting for the formal business. There are 4 items of business today, 3 of which require a formal resolution. This includes 1 nonbinding ordinary resolution and 2 binding ordinary resolutions. In order to ascertain the true intention of shareholders and to reflect our focus on transparent governance in accordance with the company's constitution as Chair, I have determined to call a poll on all resolutions to be considered at today's meeting.

The voting procedure is as follows: All valid proxies received have been recorded, and the votes for each resolution will be displayed on the screen behind me. And as such, I won't read out the numbers as we deal with each resolution.

As advised in the notice of meeting, where proxies have been properly nominated to be at the Chair's discretion, these proxy votes will be cast in favor of resolution 1 to 3. With regard to voting on resolutions, all shareholders, proxy holders and authorized corporate representatives who are entitled to vote should have been issued with a blue voting cards, as you can see on the screens. A voting card also entitles you to comment and ask questions in this meeting. If anyone present is entitled to vote and does not have a voting card, please see one of the Computershare staff at the registration table at the entrance door. They will assist you.

Nonvoting shareholders were issued with a yellow shareholder attendance admission card upon entering, as you can see on the screens. A shareholder attendance card will not allow you to vote. However, you may still comment and ask questions.

White cards are visitor cards and indicate a visitor. Visitors and media are reminded that whilst we welcome you at this meeting, it is a shareholder meeting, and you may not make comments or ask questions.

If I call on you, please raise your voting or nonvoting attendance card prior to speaking to identify yourself as a shareholder. If you are acting as a proxy, please state clearly who you are appointed to represent when introducing yourself to the meeting. We will provide the opportunity at the end of the formal items of business for shareholders to ask questions. Voting on all resolutions is allowed up until the time the poll is closed. A representative from our share registry, Mr. Peter Renda of Computershare will now provide details on the poll process. Peter?

Thank you, Mr. Chairman. Good morning, ladies and gentlemen. We'll now go through the process for the poll. We'll be conducting a poll on resolutions 1 through 3 on the reverse of your voting card of the 3 items of business. Please mark the box next to each item to find how you wish to cast your vote. I'll be bringing around a poll box. Please ensure you lodge your card in the poll box to make your votes counted. Thank you.

Thanks, Peter. When Computershare tallied the poll results, we will announce the results following conclusion of today's meeting on the ASX Market Announcements platform.

With regard to proxies, we have engaged the services of our share registry to compile and report on the proxy voting. Computershare has provided its formal report disclosing the proxy votes received.

Before opening the poll, I wish to remind shareholders that the poll will remain open for an additional minute after we have considered all resolutions. If you have any questions on the formal part of today's agenda, please follow the questions process as previously advised. I now declare the poll open.

I will move to the items of business to be considered today. Item 1, the first item of financial statements and reports of directors and auditors. The first item is to receive and consider the financial statements and reports of the directors and auditors for the financial year ended 30th of June '25. These items are contained in the annual report, so I will ask that they be taken as read. The annual report is available on the ASX announcement platform or on the company's website.

The Corporations Act requires the accounts and reports to be laid before shareholders at the Annual General Meeting. However, except as set out in resolution 1 to be considered later, there is no requirement for a vote of members to be taken on them. No written questions to the auditor were received by the cutoff date, 5 business days before this meeting.

The questions may be directed through myself to the auditor in relation to the conduct of the audit, the audit report, the company's accounting policies or the independence of the auditor. Does any shareholder have any questions or comments on the financial statements and reports? There being no questions, we will proceed with the agenda.

We will move to the formal resolutions that need to be considered. Proxies received in relation to the formal resolutions will be set out in the slides displayed on the screen behind me. Item 2 is resolution 1, which is the adoption of the remuneration report forming part of the directors' report for the financial year ended 30th of June 2025. The vote on this resolution is advisory only and does not bind the directors or the company.

I now invite Mrs. Susan Smith, Chair of the Remuneration Committee, to say a few words and chair the meeting for resolution 1 and 2. Thank you, Susan.

Thank you, Jeffrey, and good morning, shareholders. I have seen the proxy votes lodged, which are shown on the screen. Voting will shortly be finalized, and the record will show the will of this meeting. My purpose today is not to change that record, but to ensure its implications are understood with absolute clarity.

I also send -- I also seek to lend perspective to the thinking of an international Board of an Australian listed entity, an entity which generates all of its revenues and employs most of its teams outside of this country and my own views as a former CEO of large complex health care organizations.

From this latter vantage point, I have lived what an organization expects of their executive leadership and see how this needs to be considered by all stakeholders. The remuneration report is not an invoice. It is a strategic blueprint. It is the mechanism by which this Board secures and retains the leadership required to navigate a sector where failure is the norm and success is the exception.

As Board members, we are privy to complex and often critical existential decisions taken by the CEO and his team. Those decisions which have taken the right turn for our shareholders and those decisions which have prevented us from facing the wrong terms.

At the end of fiscal year '25, the result of those decisions is a company which is performing very well in a challenging environment of price cutting of pharmaceutical drugs, restrictions by health care insurers and competitors running scaremongering campaigns on SCENESSE and CLINUVEL. The committee pays for good decisions and the avoidance of really bad ones as well as the risks anticipated and communicated to us as a Board.

To those who voted against the remuneration report, you have registered a protest, but let us be precise about what you have protested against. You have voted against a structure where the majority of the CEO's compensation is contingent on delivering the long-term value you demand. You have voted against a structure which needs to be competitive on a global level to retain the current leadership while sufficient to attract new talent to steer CLINUVEL in the future. The business requires us to think and operate globally and structure our approach accordingly.

You have voted against the principle of paying for proven multifaceted performance, not just profitability, but the cultivation of talent, the stewardship of a robust pipeline and the strategic foresight that has consistently shielded this company from existential risk.

Let me just explain the committee's perspective on pay for performance. Performance is running a viable enterprise in each of the past 20 years, meeting the criteria of appointed auditors, performance as in investing and training people, retaining them and building the next generation of leaders. Performance as in making sure the highest likelihood of success comes out of research and development pipelines. Performance as in anticipating policy, legal and regulatory changes. Most of all, performance is being responsible for complex decisions that could easily have failed, leading to disastrous outcomes.

In simpler words, the company pays for the assessment and management of risk by its CEO. You have voted against the market reality because to attract and retain the caliber of leadership capable of building one of only two profitable melanocortin companies on the planet requires investment. The alternative is not a saving. It is a discount on mediocrity. Most critically, you have voted against stability in an industry defined by volatility.

The medium biotech CEO tenure is 4.7 years, a time line synonymous with abandoned strategies and vaporized value. Philippe's 20-year tenure is not a cost. It is your single greatest insurance policy against the cycle of decline that has consumed our peers.

Look at the landscape. According to Bioshares Research, 57% of Australian listed life science companies are now seeking funding as they have less than 1 year of cash reserves left. Global firms are seeking to offload assets or staff to stay afloat as they fail to execute on clinical or commercial objectives. We are not among them. We are profitable, dividend-paying and in control of our destiny. This is not an accident. It is the direct result of the leadership you have chosen to challenge. All shareholders have benefited from this leadership.

The conclusion this Board has reached based on data, analysis and the stark evidence of competitors who faltered is undeniable. The preservation of shareholder wealth is the direct byproduct of executive stability and quality.

Let me reiterate our 6 collective objectives for a CEO. Number one, establish and maintain a going concern. Two, strive for long-termism in executive decisions. Three, lay the foundation for a pharmaceutical group able to execute all research, development and innovation in-house. Four, adhere to prudent risk management of research and development and clinical programs. Five, commercialize products and services, which provide meaningful benefit. And six, establish a company which owns all or most parts of the supply and value chain.

Having executed as a CEO myself for nearly 3 decades, coached CEOs in large and small firms across a breadth of industries and as Chair of CLINUVEL's Remuneration Committee, I adopt the following in determining value of an executive and CEO.

There is no one-size-fits-all in pharmaceuticals. A CEO and their team are essential, particularly in innovative R&D companies. Stability of company and progress are inherently connected to each other. Not anticipating future changes in environment is often catastrophic in life sciences. One may hold different views on a remuneration package, but shareholders at a distance underestimate the impact of leadership.

Your vote against the remuneration report has the potential to undermine the leadership of CLINUVEL. History shows that companies whose leadership is undermined ultimately pay a far higher price than any remuneration package. They pay in lost opportunity in eroded value and in a long difficult climb back to credibility.

The Board is confident in its judgment to endorse a framework that pays for the performance that secures your future. The record will show your vote. The future will show the wisdom of the Board's approach to remuneration and ensuring continuity under the right leadership. Thank you.

I now draw your attention to the proxies received prior to the meeting as displayed on the screen behind me. I now move that shareholders consider and if thought fit, pass the ordinary resolution.

I now move to resolution 2. Item 3. We are going to take questions at the end, sir, not before. After I've gone through the resolutions.

Resolution 2 is reelection of Director, Professor Jeffrey Rosenfeld. The next item of business related to the reelection of Professor Jeffrey Rosenfeld as a Director of the company. I confirm that all directors other than Professor Rosenfeld recommend that shareholders vote in favor of his reelection.

I invite Jeffrey to come forward and speak to his background and election.

Thanks, Susan. I joined the Board of CLINUVEL in 2019. I was elected Chair at the end of 2023. And so I've been in place as Chair since then. I sit on the Remuneration Committee, the Audit and Risk Committee, and I am Chair of the Nominations Committee. I am strongly committed to CLINUVEL and its success. I have the expertise and experience to be Chair of a public company Board and a global pharmaceutical company.

I have had over 30 years' experience in leadership in the health and university sectors and in the Australian Defence Force, attaining the rank of Major General and Surgeon General of Australia. I have deep experience in organizational governance, culture, ethical behavior and practice and in strategic decision-making. I have a deep understanding of the business, of our business and medical science that CLINUVEL is engaged in. I have been an investigator on some very large international clinical trials in the health sector for many years.

CLINUVEL is now in a transition phase. I'm engaged in succession planning and the further development of our pharmaceutical products, pivotal clinical trials and our PhotoCosmetic development. It is, therefore, important to maintain continuity at Board level and for me to remain Chair.

Lastly, I am determined to get the best outcome for you, our shareholders, even if it takes longer than you would like. Thank you.

Thank you, Jeffrey. I move that Professor Jeffrey Rosenfeld be reelected as a director on the basis set out in the notice of Annual General Meeting. I refer you to the proxies received prior to the meeting as displayed on the screen.

I now move that shareholders consider and if thought fit, pass the ordinary resolution. I now pass back to Jeffrey, who will move to resolution 3.

Thank you, Sue. The reelection of Director Mr. Matthew Pringle as a director of the company. I confirm that all directors other than Mr. Pringle recommend that shareholders vote in favor of his election.

I invite Matthew to come forward and speak to his background and election.

Thanks very much, Jeffrey, and good morning, everybody, and thanks for the opportunity to speak in support of my reelection. Over the last 40 years, I've had the privilege of working across a range of industries, guiding organizations through growth, regulatory change and strategic opportunities. My experience includes leading IPOs, managing capital raisings and M&A transactions, driving governance reform and overseeing financial reporting risk and capital management. These are skills I've brought directly to my various roles as Chair of Audit and Risk Committees and as a Non-Executive Director, including here at CLINUVEL.

CLINUVEL truly is a remarkable business, one that combines scientific ambition with disciplined financial management. I've been particularly impressed by the company's balanced approach, maintaining strong cash reserves, funding growth from its own resources and delivering consistent fully franked dividends. These are qualities that set CLINUVEL apart in the biotech sector.

If reelected, my focus will remain on ambitious growth with disciplined financial and fiscal management and long-term value creation for all shareholders. I remain deeply committed to this company and really believe we have a very positive future. Thank you for your consideration and support.

Thanks very much, Matthew. I move that Mr. Matthew Pringle be reelected as director on the basis set out in the notice of Annual General Meeting. I refer you to the proxies received prior to the meeting as displayed on the screen. I now move that shareholders consider and, if thought fit, pass the ordinary resolution.

Do any shareholders have any questions or comments in relation to the resolutions today? If yes, please raise your hand. And if I call on you, raise your voting or nonvoting attendance card prior to speaking to identify yourself as a shareholder. Please state your name and the number of shares that you hold. If you are acting as a proxy, please state clearly who you are appointed to represent when introducing yourself to the meeting and the number of shares that you are representing. Please proceed. I proceed now to take questions and -- if you wish. Are there any questions on the resolutions? There will be time for open questioning at the end as well. Yes, sir.

My name is Harry [indiscernible]. A number of shares I've got -- I can't remember exactly, but you'll have to forgive me on that one. But I have roughly 15,000 held across various entities. Question I've got, in the resolutions, there's only 50 million-odd shares on issue, and it strikes me -- are you able to tell us how many people are voting against, not who they are, but what is the number?

Malcolm, would you like to?

And the reason why I asked...

Did you hear that question?

I'm not trying to be devious here. It's just a question, is it one block of some institution that's got themselves in a twist? Or is it multiple, multiple shareholders? It strikes me given that you only have 50 million shares on issue that it's a couple of big ins those who are sitting on the fence as were causing trouble.

Malcolm?

No. The number of voters, including registered voters and beneficial holders is well over 400 out of over 7,000 registered shareholders, which doesn't include beneficial holders. So there's a range of votes for and against from institutions, family offices, high net worth individuals and people -- other people.

So are you able to say what is their objection? Because if we go to the -- is it whatever the remuneration report is where there's a 63% of the votes already passed. Is that right? So what's that primary problem?

With the remuneration [ resolution ].

I'm not trying to be devious. I'm actually just -- I'm a huge supporter by the way.

I think the problem is that some shareholders and proxy advisers believe that the CEO's remuneration is beyond what it ought to be in the Australian context.

And note, I say the Australian context because that's the problem. We're dealing with here a global company with a global CEO. Most of our business is in U.S. and Europe. It's not here. Most of our staff are overseas. Our CEO is working mostly from overseas. Yes, we have an office in Melbourne. Yes, we're listed on the ASX, but our main business is elsewhere.

We are a global entity. And we need to attract a high functioning, high-performing CEO in the marketplace, we can't do that if we obey the -- particularly proxy advisers who are saying we should have a judge our CEO salary or remuneration based on Australian company standards. And we've done our analysis on Australian companies. And like overseas companies, particularly in the U.S., we know what the going rate is, and it's not the Australian rate. If we had the Australian rate, we would be doing exactly what Susan said and lowering ourselves to mediocrity, and the company would be in a worse position than what we are now with a successful well-performing company. And Philippe, being our CEO, we believe as a Board rightly deserves the salary that he's receiving.

Here. Here.

Any other questions? Yes, sir.

I don't know if I get this order right. Chris Williams. Bought and paid for more shares than are sitting in front of me. My question is to -- on the remuneration report. And I thank you for the lecture.

It's not a lecture. It's answering the previous question.

Not yours. The lecture that we got in relation to the defensive part of oh, I've got the vote, which is against me on the resolution. I've already voted. If I had to vote again, I wouldn't be changing the vote.

My question is and I've put my glasses on, you're currently accruing money in relation to the retention payment, which is to "facilitate and complete the company's strategic transition to a diversified biopharma," which has an end date of 30th of June 2026, 9 months or so. Does the accrual still stand? And are you accruing? And if so, what are the conditions that is needed to be satisfied? And I welcome that Philippe is here and in good health and that he gets to whatever the end dates are. But there must be something that has to be achieved in that time, specifically, which is mentioned also.

Beg your pardon. The plan is still in place, and therefore, the accruals will still be made.

It's to achieve something not a plan.

Ask your question. Now we'll let Susan answer the question. Thank you.

The requirement that is -- what we require is that the strategic plan is furthered and completed and that all of the items that are on the table at the moment that we've asked the MD to execute with his team, they all need to be completed. And that is what we are requiring. We also require that he actually remains in service until the end of June '26. That is obviously critical from what I'm saying.

And I would just add, I wasn't giving a lecture. I was actually trying to explain to shareholders that the Remuneration Committee really, really considers what is the best outcome for this company. And we believe that, that is to retain the fine leadership that we have enjoyed for the past 20 years and that it is critical that we continue to do that. So it wasn't a lecture, but it really was in response to people asking, well, what is it that the Remuneration Committee does? I have told you today what the Remuneration Committee does. Thank you.

Right. Are there any other questions? Thank you, Susan. Yes, sir. Can you pass the microphone, please, Caroline?

[indiscernible] Not sure there is the right question, this...

Tell us how many shares you hold before you asked the question.

10,000 to 15,000. Just if it is not the right context, please bear with me. I'm just trying to understand the vision from the management for the next 1 to 3 years and trying to understand maybe just the top risk and opportunities the company sees.

Okay. Good question. And that's exactly what our CEO is going to address for you shortly. So I won't preempt what he's going to say, but he'll cover vision and our objectives for the company over the next few years, yes. Are there any other questions? As I say, there will be open questions from the floor later on. Yes, sir.

Me again. 25,000 in case you're asking. Mine is to Mr. Pringle seeking reelection. You've been on the Board now for 18 months. Yes. So you had a good chance to see what the company has, the intellectual property it has. Have you come to a conclusion that PhotoCosmetics are feasible, exist and can be launched in the time frames that the company has been announcing?

Well, I'd have to say PhotoCosmetics feasibility isn't my area of expertise, but mine is more on a financial. I was in Singapore with the Board earlier this year, getting a presentation from the team on the PhotoCosmetics. And to be honest, some elements the Board was very happy with and some not, as you would expect in a normal organization. And Philippe might go into this a bit more in his presentation in terms of the direction we're heading in PhotoCosmetics.

So I focus more on not so much the technical aspects, but the financial, as you'd appreciate from my background in terms of their marketability and their commerciality and whether we're going to make a profit out of them. And at the moment, the product line, in my view -- I mean, cosmetics is a tough sector. But assuming the products meet our expectations, I think the future looks pretty good for them and for the company. It's pretty hard to go into much more detail than that, I'm sorry.

I think you'll hear more detail on this from our CEO report shortly. Are there any other questions? We probably should move on. We've got a fair bit to cover. There will be an opportunity to ask further questions later. But if there are no further questions or comments, that concludes the formal resolutions to be considered.

If you require further time to complete the poll, please indicate by raising your hand. I'm just pausing while the voting is concluded.

[Voting]

Thank you. I now declare the poll closed. Now on to other business. As the company has not received notice of any other business, I will now move to close the formal part of the meeting.

I now hand over to Dr. Wolgen to provide his Managing Director's address. I might just say that Philippe is a bit under the weather with the virus. So please bear that in mind. Philippe?

First of all, I need to acknowledge our auditors and ideal partner, ABL for hosting it, Bioshares for following us 20 years. We are going to do this slightly different today. This is my 20th AGM. And I'm not going to provide you glossy slides of financial projections. I'm going to tell you the story how it is in 4 chapters. And we'll talk about the value of time in science, and how that relates to CLINUVEL.

As MD, I see it as my primary task to figure out the durability of a business concept, but also to build moats around the science and making sure that every dollar that we spend has the highest probability of returns. And that is in an industry where the house wins in 87% of the time. Now that's not the investment that is gambling. And from that moment on, you ask yourself, well, if we're playing against odds that against us, why would that not occur to us? That's risk management.

As a Board, and I've been part of a number of boards in the last 20 years, I asked the Board at a number of times, but as our cash reserves grow, I asked them the irrevocable question, a very uncomfortable question, should we give it back to you all, every single penny of it? And at the moment, we're standing at $230 million. Or should we do something totally different? And the third option, should we continue what we do.

And that every of these 6 to 8 Board meetings a year, the answer is unequivocally that we should continue what we do. So I'm going to speak to you first on $4.90. $4.90 is the value of the cash in the company, non-diluted per share. And that doesn't take in account the premium, the pipeline or the fantasy. Ask yourself, well, if that is the bottom of the company, it's not what we're trading 2 or 3x the value of cash. What's wrong? Is it the norm in our industry? Well, cash serves a number of functions, certainly in our industry. It gives you a 3-year runway. And don't forget that in this business, time is option price on a breakthrough, a scientific breakthrough.

You also have the exclusivity and sovereignty, the ability to look your credit to suppliers and you in the eye and say, well, we can meet our obligations. It gives us a shock absorption. That means that in the industry where governments come to a standstill, public offices, FDA shutdown, turnaround is long with the ability to navigate these periods. And fourth, it gives us the privilege to fail. Many people and certainly my peers don't like that. But the privilege to fail means that a rejection, an obstacle is not an existential threat to the company when it carries its resources.

The second number that I want to share with you and on my way through this meeting, I reread what I call the bible that every investor in life sciences should read. That's a paper by the Massachusetts Institute of Health 2019 by Wang Xiao and everyone who touches biotech or MedTech ought to read that paper. And I'm going to speak very slowly. It's recorded so you could read it back in the transcripts, I hope.

MIT over 16 years, analyzed 406,000 clinical trials with 21,000 compounds and compounders drug products. Out of those 406,000 trials, only 13.8% met their objectives, and that is from Phase I to regulatory approval. I really recommend you to have that as bedside literature.

These are not favorable odds, as you understand. And we ask a question, are we belonging to that pool of 13.8% and how do we prolong that? Now if you take the graveyard of oncology out of it, which has a probability of success of 3.4%, you arrive at 20.9% overall success rate. If you then discount the 80% of companies that bring these products to market, there's a very small pool that actually generate revenues or come to a breakeven point. And I've seen that the last 20 years as my principal task to navigate and make sure that we increase the odds of success.

The third number I was thinking of to share with you today is $410 million. $410 million is the amount we spent over 20 years to come to this point in time. That's $20 million average spend per year. In our sector, that is ridiculous. To develop drugs to market, to develop a pipeline and increase its chance with a $20 million spend is in the eyes of U.S. institutions when I speak to them, almost an impossibility. They often ask us whether we cut corners or whether we've made rounding errors or we have off-balance sheet transactions, but that is the number that we spent over 20 years.

If you then translate that to what we do at the moment, that's about $1 million per employee in revenues or in USD 700,000. The median in the U.S. is between $200,000 and $400,000 revenues per employee.

We posted the last financial year, $35 million in profit over $55 million in expenses. That means for every dollar that we spend, we get $0.65 in profit. In the industry, that's about half.

Another metric that I always look at is and in managing the company and establishing it is fixed versus variable cost and the contribution margin of 60% means that operating leverage is such that we can switch off the fixed cost when we need it.

These financial metrics are not a hazard. It's not a coincidence that we started off by putting that in our adviser and said this is what we want to achieve in order to belong and remain to the very small pool of companies in the world that navigate on profitability. And that's a challenge. It's a business model that is somewhat exotic in biotech.

If I speak to blue-chip institutions in the U.S. as part of our non-deal roadshows, they say, well, [indiscernible] black swan. We don't see profitable companies. But to fund your R&D from your profits is almost an impossibility in the eyes of U.S. investors. That's not something that we glow or boast about, but the reality is we chose this business model in order to be able to self-fund our R&D, and we are exactly at that point. So we talked about $410 million.

Now what is the future and what are the inflection points? And I think that comes to your point. Well, we are at the stage where we have the emergence of SCENESSE advancing it in vitiligo, arguably the biggest market. We're doing something totally novel. We're repigmenting patients that have lost their color. We're advancing ACTH. You will see the filing update in 2026. So we're entering a generic market. Often, the question is, well, if you got a branded product, why are you entering generics? And the answer is because we diversify, we lower the risk.

But then there is the pipeline, the research and unfiltered and centered without bias, I will share with you and that this goes on record how that goes. You open labs, you build your own teams. And for 9 years, we were in despair because the results were not the way we wanted to go, and we expected much more from the teams in Singapore. And there were many times where the CSO, Dr. Dennis Wright and I said, well, let's call it a day. That's it.

The first glimpse of hope came in November 2024, but the breakthrough came in January 2025 because producing data is one thing, but the art and the skill in our field is to produce reproducible data or repetitive data that can be, and that's a big word, validated.

And we had a vision, also a big word, an idea, an ambition. By being a specialized company on peptides, proteins, hormones and understanding exactly the biometrics that we needed for these to be successful and one is bioavailability or therapeutic window, which is an expensive word is dosing at the right concentration such that you don't provoke intolerability or comorbidity, you need to keep patients safe and you want the drug to be effective.

Now in peptides, the therapeutic window is very small. If you then have a half-life of minutes and a low bioavailability, then you've got 3 challenges to meet in R&D. And many, many years, we knew that it could be done. But if the teams can't deliver it, you come to a point where you want to throw the towel in.

But a year ago, we started to see results after repetitive attempts and efforts. And that led to not only hope but somewhat the conviction that the idea, the concept that we had 10 years ago could actually be realized. And what happens gradually, and you probably don't see that in annual reports or you don't fully realize it when you look at the company, a company that specialized in hormones now shifts to being an expert in drug delivery. Now that is a whole new business.

And what you've seen a couple of weeks ago is that we had the audacity or the courage to announce that we are going to put the next generation of drug delivery. And our aim is controlled release. Controlled release means injecting a drug that has a release curve over weeks or months. That is quite important because it means that the patient doesn't need to seek the doctor's attendance on a daily basis. That has an enormous advantage as you've seen with the implant that we deployed over 2 decades. So suddenly, the ambition came through, as I think Professor Rosenfeld said, not by sheer persistence, but by putting the right people together.

We had a number of teams in Singapore, and we invested considerable money in Singapore. But we knew that we wanted to have one specific talent. And I share you the anecdote how this goes in drug development. And that specific talent was contacted in 2018. But he was comfortable in his pharmaceutical job and was not looking for a new employment, but we knew that this man was one of the very few on the planet that could actually formulate the way we wanted.

It took 3 years to talk to him and convince him to join the ranks. That is persistence. It's keeping in contact with the people you've identified on the planet and understanding that they make the difference. Now attracting is one, but the retention is second. He formed the team around him, and that's the team that is at the moment delivering and realizing our ambition. That is how it goes. And that is the value of time in research and pharmaceuticals.

What does the future look like? What are the catalyst or the points that you look at? A house with a branded and a generic product, a house that now is developing its own release formulations. And what we did, we answered to the demand from the market. Every investment banker over the last 20 years had asked us, but could you deliver this peptide transdermally through the skin?

Well, I've told you last year, and that was also on record, all the big cosmetic conglomerates on the planet had filed patents for melanocortins as early as the '90s at the turn of the century, but all of them walked away because it was so complex. But there was another reason -- there were 2 reasons actually.

The business of a cosmetic company like the big French ones and the American ones is not to pigment patients because pigmentation brings out freckles. It brings out sunspots. Their business is to bring the next generation of products every season in order to beautify the skin.

Then there was the risk -- the perceived risk of melanoma. Oh my word, if you induce melanocytes, could it be masking or inducing melanomas? These were enough reasons for the cosmetic companies to walk away from melanocortins. Now our onus, our work was actually to prove over 2 decades that the supply, the administration of melanocortins was not inducing melanomas. On the contrary, it rather has a protective effect.

The longevity, the time value in pharma is actually pursuing that mission in order to show the medical and dermatology community that is not hazardous or dangerous. Now if you say that at the beginning of the journey in an investor. No one would invest. You would chase all the investors out of the room. So silently, we worked to prove and disprove the notion that the activation of melanocytes, pigment-producing cells would be dangerous. I can say hand on heart today after 2 decades that we have proved that.

When safety is therefore no longer in contention, you proceed and realize the ambition that the investment community wanted, that is to get these melanocortins to the skin in order to induce, activate, assist [ self-broadening. ] And that is what we believe the holy grail in cosmetics.

But the black swan doesn't stop there because now we are a pharmaceutical company adding a cosmetic component to the business, which is holy alien. There is no competitor in the world that translates its technology from pharmaceutical to cosmetic. For that, to be successful, you need one word, visibility. And where do you start? Well, you start where the prescribers are and those that profess to be the experts, and that's the North American dermatology community, 20,000, of which 8,000 have practices or multi-physician practices in the United States.

So in the staged approach, we understood that for our franchise to be successful, we need visibility and we need an outreach to those that are actually going to dispel and disseminate the notion of melanocortins. And we're in the middle of that. Our presence at the American Academy of Dermatology in 2025 was the first in '26, we'll do the same.

The other part that I need to stress is innovation, performing novelty or in patent terms, finding the inventive step is not only on the level of technology, your entire approach has to be novel. The way you communicate, the way you market, the way you package, the way you distribute. It is a red line that has to go through the company because putting a novel product on the table is not sufficient.

To give you an example, with the liquid formulation that we are developing was the need since it didn't exist to our liking or to our needs to develop a device. So we have an in-house engineering team that is developing devices. If we believe that we're innovative in vitiligo, it also means that we seek avenues to use AI in order to optimize the process. So innovation is multifaceted. It is not just the science of the technology. It needs to be, call it, a culture in the company not to be afraid to do something. So a branded generic product, a formulation delivery platform and product cosmetics.

In terms of business, I downplay and I do that consciously, the importance of cosmetics to the pharma business. For me, it was always -- and I say that on a personal basis, it was a nice to have. It is answering to the market once. But what I've learned in this industry and this industry is cosmetics is that the products can be very efficacious. But what matters is really the marketing, the branding, the distribution. That is 99% of the success. And that is how I see this venture progressing.

Is it at the same pace that you wish to see? Probably not. But what it does, it cuts the risks in bite sizes. So this year, this calendar year, we had a number of publications in the Financial Time in the fashion and cosmetics section. We had the Vogue. We had the wired, Condé Nast, one of the largest publishing houses in the world.

And we now see that there is a demand created where Tatler, Cosmopolitan come to us and what are you developing in-house? Can we write an article about it? In my view, that is the beginning of visibility. But don't forget, a pharmaceutical house developing cosmetics is something like a misnomer that doesn't exist. So that's novelty again. And that's going to take time.

But what I've learned in life, my professional life and my personal life is that if you got an ambitious task or journey, you map it out and you do it step by step. And the requisite to succeed is not technology, it's people. If you got the right team to make the ascent. And in my view, we're not bad.

Then there's the question about share price. I hear more about share price here in Australia than elsewhere. I don't know if there is a disconnect between the value, the intrinsic value and share price. I talked about it at length last year. What I do know is that a number of factors don't aid, don't assist. But if you take a much wider view, in general, in innovative biotech, you see that these companies, certainly single platform companies go through an enormous appreciation when it leads up to an inflection point like an FDA approval or an EMA approval. But as soon as the balloon goes up, it also goes down after.

But earnings, revenues, generally, and I can't say that for all, but for most of the analysis, do not bring as much fantasy as the hope of a market that you can't yet model because once the model of the analysts is written, the reality kicks in. We have seen that in this company because at two occasions when we had any -- or hardly any assets where we hardly had any cash or revenues, the company ballooned up to $2.5 billion.

So I'm coming to the end of this dialogue with you. This is the 20th year, has been very good. It has been beyond my expectation with the melanocortin that already existed 25 years. But this team will continue because the science and the willingness or the eagerness to bring this forward is not abating.

But if you hold a thought that controlled release holds a promise in pharmaceuticals and medicine, not because I say so, but because it published and many of the large pharmaceutical companies write about the need to have one, then let your fantasy run riot and understand what kind of peptides and proteins and drugs you can put in a controlled release formulation. So I'm very privileged to see the beginning of that kind of work that took 10 years of funding actually to see progress. And I can assure you that every Christmas, I wanted to abandon the project, and I'm glad I didn't.

So on this note, I leave you and I'm sure you've got some questions.

Thank you very much, Philippe. Well, first, we will now come to the general questions. First, we will start with questions received prior to the meeting. We call on the Head of Investor Relations, Malcolm Bull, to read these out. And then I will -- actually, Malcolm will direct the question to the appropriate person for these. Thank you, Malcolm.

Thank you, Jeffrey. Good morning, everybody. There's a number of questions we have received as Jeffrey mentioned, and I've grouped them into several categories, and we'll go through them. Some of the questions may have been already answered or partly answered, so directors can add or ask me to move on.

First one is capital management. A frequent question focusing on the share buyback. Various questions such as, is the buyback still in play? Why have you not executed that to a significant extent? And can it -- if it's not in play, can it be restarted? So I think we'll ask Matthew Pringle to address that particular issue.

Yes. Thanks very much. Well, the share buyback expired last year and was automatically renewed for a further term. And its first tranche for reasons probably before my time, wasn't fully absorbed. And in the second term, we had some large blackout periods and also some periods where the Board made a conscious decision not to enact because of information we had, so we didn't act on market. So the buyback actually lapsed automatically through lack of use.

Now the mechanism we've got for a buyback, too, is that we just can't go on the market and buy $1 million worth of shares. Our capacity to buy and our timing is very restricted under the rules. We also felt that the impact that would have on the share price would be negligible because of those restrictions and the very low volumes we could actually enact at any point in time. And so we decided that a better course of action was to preserve the cash rather than use it through that buyback mechanism. It just wasn't an effective mechanism to really have an impact on share price or to benefit shareholders in our view.

Okay. Thank you. On the clinical pipeline and translation to commercial revenue streams, Philippe, this is for you. And I'll read it a little bit verbatim from the shareholder.

Given CLINUVEL is narrowing its clinical development focus to vitiligo, ACTH-related disorders and porphyrias, what are the key milestones or regulatory/reimbursement hurdles you anticipate in the next 12 to 24 months? And how will these milestones translate into materially diversified revenue streams beyond our existing business of SCENESSE for EPP.

Or ACTH -- there's a question to it?

Well, it's on how we will develop vitiligo, ACTH and porphyrias into commercial revenues and the milestones along the path, absolutely.

Well, let's start one by one. So vitiligo is advancing its trial. We completed the trial, the last patient last visit was last month. There's a 6-month follow-up, then there is 6 months for analysis. So that's going to be somewhere in the second half of '26.

We anticipate -- there are 2 agencies in the world. There's EMA and FDA. We slightly changed our tech because it's a very dynamic environment. From the interaction we've had with EMA, like in EPP, we believe that it's good to go to Europe first and U.S. second. We will have 2 interactions, one with European Medicines Agency and one with the Food and Drug Administration. Shortly after that, we will start the 107 study. We -- it's going to be quite a similar design as the 105. That takes you another year out plus analysis. And then it's to be seen whether the results stand up. I mean we're all assuming that the results are good. But if the results are good, as good as we've seen in the case report, then that leads to the submission.

ACTH is a bit close because we've completed the manufacturing. The drug master file is going to be incorporated in the submission. The submission is going to take place in the first country in 2026. And then it's about the regulatory turnaround. I don't know what it is at the moment. At the moment, everything in -- certainly in the U.S. is delayed because of the government shutdown. So I can't give you definitive time lines, but first is the submission in '26, the regulatory interactions and then the start of 107.

Okay. You may wish to stay there, Philippe, because we're going to move on to PhotoCosmetics. This is an interesting one because the shareholder is saying, is it possible that melanogenesis PhotoCosmetic product may be used in the future by a vitiligo patient when near total repigmentation is achieved through the vitiligo program treatment as an additional supplement on the face as an example.

It's a smart question. Smart question. It is. Melanogenesis is an expensive word for the natural tanning process. And what you do in vitiligo, what you try to do systemically with an injection is to bring back the pigmentation. That is medical tanning. So a transdermal that assists these patients is, of course, of value, and that was the idea. Because if you give vitiligo patients an additional transdermal, it gives credibility and trust to the consumer because you used it from medicine to consumerism. So the answer is yes.

Okay. On vitiligo, particular question on the vitiligo expert panel. Is it still active? And what is their assessment of CUV-105?

Yes, there are 2 panels. There's an expert panel and there's a scientific panel. They have 2 functions. An expert panel looks at the merit of a drug or new drug in a new disease. These are academics. They are head of a department. You form them around the table and once and twice a year, they convene and they issue an opinion.

The scientific expert panel in vitiligo has a different function. They have a say in the design of the protocols. And that's important because as a company, you want to rely on the medical community to have an input in the design of these protocols. And that has value when you go to a regulatory agency because every disease, whether it's cardiovascular or neurology or disease in neurology or vitiligo, there's a finite pool of experts in the world.

And these experts are either called as a witness by the regulatory authorities to provide an opinion or if they are on the side of the sponsor of the company, you take them along and you make your case. And so yes, that's still active, yes.

Okay. You can take a break, Philippe because the next few questions are to other directors. This shareholder is asking, and I think this is for you, Jeffrey, to clarify Philippe's actual intentions and time frame for departure.

I did address this in my own address to shareholders, but Dr. Wolgen's employment agreement does expire 30th of June '26, as has been said. The Board is overseeing his succession and will provide an update in 2026.

Last question relates to directors' ownership of CUV shares. And Sue we'll get you to answer this. So I was talking about the convictions of the directors to CUV, and we've heard statements from 2 directors seeking reelection where I think there's a lot of passion and commitment to the company. But they're saying, why has the Chair only over 3,000 shares? And why do none of the 3 newly appointed directors hold no shares?

Well, the investment in the company, of course, is up to personal judgement and of people's own financial stewardship. I think regardless of ownership of shares by the directors, it has nothing to do with their commitment and loyalty and the very hard work that they give for the success of the company regardless of any share ownership.

Right. We have a very professional Board who are committed regardless of share ownership. That concludes, Mr. Chair, the questions that have been pre-submitted.

Thank you, Malcolm. So we open the floor to questions from you, the shareholders. Who would like to ask a question? Yes. Could you -- again, I remind you to state your name, your shareholding?

Samantha Taylor. Can you hear me? 15,000 shares. My question is in regard to AI. And there's been a lot of change, a lot of change over the last couple of years and especially the last year. And how is that impacting on your ability to speed up the research process? Your analysis?

Yes. You're reading our minds as a Board because we discussed this at length yesterday, and I'm going to pass to Philippe to speak about AI in CLINUVEL's operations.

But just before you answer, so not only speeding up the research process and the analysis, but also those how you're going to implement AI for that process going forward. And I understand that's challenging, but I'm really interested in your response.

Okay. Thanks for that.

It's really -- I'm burning to tell you but I can't. The last 3 years I've been thinking how can we implement AI in our business. In pharmaceuticals, the first talk was can you do faster screening on molecules and peptides to speed up drug discovery. That's the very beginning. I didn't think the value would be there.

We -- without giving everything away because there is IP pending, but we are using AI in vitiligo, and that is enormously exciting because I see the results of the project. My estimate is that we will be the first company active in vitiligo that is presenting this to a regulatory agency, and that's all I can say. But it's not so much speeding up, but it's an assisting tool that adds value.

Yes. I mean I just -- in terms of machine learning, can you just give a bit more about what kind of AI you're using and in which part of the process, just to give us a bit more insight?

We hired 2 engineers that are programming and writing the annotations, but I can't tell you. I want to tell you but I can't. Yes.

It's in development. So any other questions? Yes.

Gavin Scott, 3,500 shares, recent shareholder. First, I've got 2 questions. First one really is around the capital allocation, and thank you, Professor Rosenfeld, for going on and explaining some of the capital allocation decisions. I understand we've now got $4.90 or thereabouts of cash in the company.

My question really, the first question is how much is enough? I understand we need a buffer in order to be able to progress our clinical development. As that figure keeps creeping higher, at what point do we say that this money is no longer required? I also understand the buyback is difficult. Have we -- has the Board considered an off-market buyback or another form of returning excess capital to shareholders? That's the first question.

Right. I might direct that to Philippe, the first part of your question, if I may.

I had a number of meetings this week in Melbourne, one with a larger investment bank and their analysts and the equity capital markets head said to me something that I've learned. He said there is no such as sufficient cash in the biotech, and that resonates with me.

You will see from us projections over 3 years in the new year like we've done in 2021 to '25, and we came under. Our estimate for the operational expenditure and capital expenditures, we just have enough, taking into account delays, objections, rejections that may or may not come in the future. We're getting to a point where we just have enough to execute all the plans.

The share buyback is really a contentious issue. The first principle to start off with, and I appreciate as a recent shareholder that you started, you're probably not privy to all the discussion we had in this room or elsewhere. But an R&D company in our life science -- in life sciences that does share buybacks is not staying really within their remit because the research money should be -- or the money should be replowed in research. So as a matter of principle, redistributing wealth at this stage is a bit bizarre. We're doing that now for 7 years, I think, Malcolm, in the forms of modest dividend.

This is not a lazy balance sheet. This is actively managed because we know what we want to achieve. And it gives you a runway that may be extended or out of your control factors that may affect the funding requirements. Now if you start buying back shares, a company of this size at this stage, there are really 2 assumptions that you make. The first assumption is that the company would have access to capital in the future. Well, there's no guarantee for that at all. If you look at the graveyard in the U.S. in biotech at the moment, funding is scarce.

The second assumption on doing a share buyback is that it will materially affect the share price. Well, Matt talked about this. Sometimes we have prior knowledge on who the sellers are or those that actually wish to exit. And it is a zero net exercise because you know that those were expressed to exit, are using the share buyback or the moment that you can trade, and it's about 20% per day that you can trade, are going to use that actually to exit. So you constrict your share capital, you, therefore, affect your liquidity adversely. If we use our millions and you don't see a significant rise in share price, then why are you doing it?

It's also a bad sign for two reasons, and I'm very sensitive to that because I'm at the call phase of this company. When you talk to insurers, and they are not stupid, they made a business in tracking pharmaceuticals and their products. And I remember sitting in Switzerland, where the counter side, the Swiss insurers at the annual report, the cash flow statement, the P&L in front of them, and they knew exactly how much profit we're making.

The moment you start issuing dividends and buying back shares, these insurers are going to lower the price. You're going to get the price pressure. So it's -- in this industry, unless you're Pfizer or Glaxo, that's a different matter altogether. But when you are at this end of the curve, I think a share buyback sends a very bad signal to those that actually matter, and that's the payers. So the totality is no, but it's not an absolute no because if the share price would drift to $2, $4, you'd be mad not to do it because you need to understand your intrinsic value. But at the moment.

Thanks very much, Philippe. Any other questions from the floor? You had the second one. Sorry, I thought the share buyback was the second one.

The other question is directed to Dr. Wolgen. Congratulations on a 20-year career building a remarkable company. And from my understanding and research, it's been done fairly unconventionally. You've taken a very different approach to many other people who may have taken on this company 20 years ago. My question is, what advice would you give to the Board about the characteristics that the next CEO ought to have in order to guide this company forward?

Well, the only advice I can give as the largest shareholder. I can't have any other capacity, but first of all, these are very kind words, but the word congratulations are never at place because the journey is not finished. So it's been good so far, but success is very frail. It can end the next day. And you've seen that in Enron and Parmalat and Lehman and that could happen to us. So I don't like celebrating. That's a principle.

But we succeeded thus far by default because every other avenue had been tried for 25 years because the story started in 1980. So there were only 1 or 2 avenues left. But the next girl or boy needs to be passionate and incessantly obsessed by bringing this forward and not see this as a job for 3 or 4 years, which is pretty standard in our industry. And he or she needs to have the capacity to keep the team together because that these are the assets. So it's going through the candidates and finding the right person.

Thank you, Philippe. Yes, sir.

Andrew Dixon, not sure why I need to reveal my shareholding, but a few thousand shares. Philippe, a question for you.

I actually direct the question.

Sorry.

I'm -- let's hear the question.

I asked a question to Philippe, I think it was 2 or 3 years ago. Time has flown by, whether CLINUVEL had developed afamelanotide as a cream to penetrate the skin. He wasn't able to answer for obviously, disclosure reasons. Does it still remain an idea? Or are we any closer to revealing some absolute certainty in that?

Okay. So...

One more after that too.

We'll ask Philippe that question about the penetration of afamelanotide through the skin.

I can't -- there has been overnight an article in the Financial Times where I was quoted. But he -- and I urge you to read it because that is answer. The assumption was that we would drive afamelanotide through the skin. We never said that. We said we would drive melanocortin through the skin. And that is our research efforts. And afamelanotide is a molecule of 1647 delta that will never go through the skin.

So our efforts as seeking the grail is to drive a melanocortin through the skin that then assist and activate the melanin, the melanogenesis. And that is ongoing and human testing is underway, but it's not as simple as you stated. It needs to have a lasting effect. You need to be able to apply it once or twice a day, not 6 times a day and so forth. So there are a number of kinetic challenges, but it's my life ambition to see that in some shape or form as CEO or shareholder, I don't mind, but it's technically possible.

Okay. And one follow-up. There seems some excitement about the breakthrough in January about the slow release liquid. Just in terms of the business value, again, I'm obviously not a biochemist. But in terms of comparing the slow release liquid to an implant, what's the sort of the wow factor which shareholders could potentially be excited about?

Again, I'll hand over to Philippe. But the advantage of the liquid or the gel is the variability in the dosage that you can put in the gel as opposed to a fixed dose in the implant. Would that be right, Philippe? I've answered the question. Does that answer it for you?

It's a bit sad because it happens at the very end, but my estimate is that this market could actually be bigger than vitiligo. So that's why I'm excited about it.

The flexibility is the key and what goes in the gel. Any other questions? Where -- yes, sir.

David Warren, I have 15,000 shares. I'm wondering, I think in CLINUVEL's recent history, a lot of time shareholders have been asking when the next revenue stream will come online. I know you're developing 3 different areas. Do you have any more visibility on when you expect the next -- which of the 3 areas you expect to produce revenue and your best estimate of when that might be?

Again, I might hand over to Philippe for the -- again, a question of time lines and which announcements we will come first. I would preface it by saying that whatever we do, it takes time. It takes patience. And sometimes the time lines stretch, and that's what happens in biopharma. But to give you more clarity on that, I'll hand over to Philippe.

The regulatory time lines are not in our control. And so to deviate a little bit, the expansion of the label took 1.5 years. Now if we would sit in this room and we would analyze what you needed to do to expand the label, it's very little work. On the basis of logic, you could do that in one afternoon, but it took 19 months.

These factors are not in my control or our control. But what I do know is you need sufficient -- have sufficient cash to navigate through it. My estimate where I am today, but don't hold me to it, but I would believe that the ACTH would be the first revenue stream as a generic. That is if the regulatory turnaround is fast enough.

All right. Thank you, Philippe. Any other questions? I think we've given everyone a good go. So I'd like to conclude this -- the Q&A, and we will announce the results later today on the ASX Market Announcements platform.

This concludes the meeting. I thank all those in attendance and wish you all good health and fortune. Thank you.

Hello, everyone. Thank you for joining CLINUVEL's investor webinar. I am Stella of Monsoon Communications. In today's webinar, CLINUVEL will share their financial year 2025 results and operational highlights for year ended on 30th June 2025. [Operator Instructions] I will now hand over to Malcolm Bull, Head of Investor Relations and Australian operations to conduct the proceedings.

Thank you for the introduction, Stella, and also thanks to Monsoon Communications, who are facilitating yet another investor webinar for us. It's pleasing we have more than 190 participants on the line from around the world, and we thank you for your interest in CLINUVEL. I will say that some shareholders have told us they prefer a shorter 30-minute type webinar, but we have extended today's webinar at the request of several institutions to 45 minutes. And that reflects the number of questions that we've received as well.

So our webinar will be in 3 parts. The first part is to discuss the financial and operating results of the 2025 financial year, as Stella mentioned, with Managing Director, Dr. Philippe Wolgen, and Chief Financial Officer, Peter Vaughan. Welcome, gentlemen.

Good morning and good evening.

Good morning.

Exactly. I can advise participants that we have weaved the answers to many questions received from shareholders into the discussion with our executives. But as part 2 of the webinar, I will ask a few questions on their behalf. I'm also pleased to note that the number of analysts covering CLINUVEL have increased over the past year from 7 to 10 worldwide. And following market practice in results webinars, the third part of our agenda will ask analysts on the line to ask a question. Now since we have several on the line, you will need to be succinct and ask one question with a follow-up related to that, if necessary.

I now need to draw your attention to our forward-looking statement or some refer to it as a safe harbor statement. Please note, there are many risks that can materialize to impact the achievement of the plans we will discuss in this webinar. So keep that in mind as part of your ongoing due diligence. We can now move into the webinar proper.

Peter, you've presided over your second set of annual accounts. First, congratulations. And two, what are the highlights from your perspective?

Thanks very much, Malcolm. If we just move to the next slide in the deck. So we can see here, it's another successful year for CLINUVEL with strong and consistent results. We've seen increases across all major profitability and financial markets. Our team, again, is very proud of our results, and it culminates in a ninth consecutive annual profit and an eighth consecutive annual dividend, the fourth, which is fully franked.

As we can see from the slide on the screen, revenues were up 10% to break through the $100 million barrier with $105 million in total. This represented a 6% growth in commercial sales, which saw increases in both the U.S. and Europe, a 24% growth in sales reimbursements, which is otherwise known as special access scheme. Our U.S. growth was predominantly driven by an increase in sites across North America. We're now up to 104 trained and accredited sites, and we're well on our way to the target that we set by the end of this calendar year of 120 sites.

When it comes to term deposits, we saw a 29% growth in interest income from our term deposits. And we've also actively increased the length of those term deposits to maintain current yields as forecast that investment interest rates will fall over the coming period.

Expenses increased as we had forecast. So yes, it's up, but we had alluded to this coming into this financial year, and they were up 20%. But there's a significant focus in that expenditure on reinvestment in the business to build broader and future revenues for the organization. This has seen us reinvest in our talented people, both through new employees and upskilling existing employees.

Our R&D programs, which I'll touch on in more detail in a moment, the main one being our Phase III CUV105 vitiligo clinical trial, which is now fully recruited. And our communications, branding and marketing efforts, otherwise known as CBM, which has really increased the visibility of the company to build that brand so that everyone knows who CLINUVEL is and what we stand for.

We've seen steady increase in net profit before tax and after tax despite the increase in our expenditures. We saw a 22% increase in our cash reserves, which has increased our free cash flow to build and secure our financial base for protection, but also enabling us to explore opportunities. Our net tangible asset backing has also increased, up 19%, and this is on top of a 5% dividend also being declared again this year.

Very good. So as you mentioned, Peter, we've been increasing expenses. That's supporting the expansion of the business. Can you look at the trends that's in the graph on the screen and give us your observations.

Of course, Malcolm. So we saw an increase in our expenditure, as I've already commented on and as we forecast at the start of this year, our expenditure was up 20%. We've seen our personnel costs increase 31%, which is partly due to additional skills added across our clinical area, our engineering, our scientific and also, we increased our Board and refreshed our Board. We've got a new Head of Regulatory Affairs in David Solomon, who's also joined the company. Our commercial distribution costs were up 10%, which is not unusual of the higher sales volumes. But our biggest area of increase was this reinvestment in clinical and nonclinical programs. Our multiple programs all experienced this expenditure increase across CUV105, our ACTH program, our PRÉNUMBRA and NEURACTHEL and also the formulation of the photocosmetics range.

Our CBM increased by 100% this year with significant increase, which obviously shareholders and investors would have seen in our social, physical, digital and all media presences across the organization. We're also supporting patient advocacy through sponsorship of a range of vitiligo, EPP and other skin disorder foundations and events to really build that brand awareness of CLINUVEL and SCENESSE. This is what we believe has led to an increase in our sales, but also supports our clinical trial recruitment efforts. Our largest activity in the CBM area during the year was the American Academy of Dermatology Annual Conference that was held in March this year, where we had our pavilion of photomedicine. Now this pavilion was a 4,800-foot immersive experience, and it really brought people in that industry with over 20,000 physicians, clinicians and industry KOLs into that CLINUVEL environment, and they heard a lot of stories and presentations from people in the industry.

Thanks, Peter. I'm sticking with you. I'm going to have you talk to my favorite graph. It could be yours too. I think it's a favorite of the analysts. I'm just showing, I mean, look at that trend, revenues and controlled expenses. But tell us a bit more about the pace of growth over the years and what other insights you'd like to share.

Of course. So as shown on the screen, 35% revenue CAGR over 9 years is quite exceptional. It shows consistent sustainable revenue that's being actively managed. Our revenues this period could have actually been stronger, but unfortunately, we have cutoff dates for our revenue recognition. And some of our sales that eventuated or some of our orders that came at the end of June, unfortunately, weren't delivered by the end of June. They fell into the first week of July. So unfortunately, some of those bulk orders out of Europe had to fall into the next financial year. But I guess that alludes to a good start for the next period.

Our expenditure CAGR of 20% was well controlled also. And this is really through the deployment of funds that is prudent, considered and very outcome-focused that's in line with our organizational goals. In FY '25, we also reinvested 20% of our revenue or 40% of our expenditure in R&D activities, which is really that reinvestment in RD&I line that's shown on the screen. This is the upper level of standard biotech industry normalization for reinvestment, which tends to be around the 15% to 20% mark.

This shows we haven't just rested on our laurels of being satisfied with a one revenue product company and provides shareholders with multiple shots on goal and also some security for the future. By building this diversification, this also helps to support the organization going forward.

Our net profit margin at 34% is approximately 8% higher than the average norm for biotechs of a similar life stage as CLINUVEL, and also a 16% return on equity really shows that we're bringing value to shareholders on top of the dividends over the last 8 years. This is really unprecedented in not only ASX biotechs, but also global biotechs. And there's been no capital raised or dilutionary events since 2016, which is also quite unusual for an Australian biotech.

Good summary. I'm going to turn to you, Philippe, and get you to address our expenses over a longer term, noting that we've just come in under our 5-year expenses plan to 30 June 2025. Just talk to this, please, on what can be expected in the current financial year 2026 and beyond.

Thank you, Malcolm and Peter. Well, first, the comments when I look at this graph, and having had a 3 months sick leave, I've got reasonable fresh eyes. This graph is not AI or Photoshop. This is a man-made linear reflection of our budgetary planning over the last 5 years, whereby the team underbidded by $3.8 million. So this graph speaks to me as an adherence to financial discipline over the years that provides me as a shareholder and as MD, a great level of confidence for the next few years. The 3-year budget will be released in the second half of this year. And we have internally targets but that needs to be stress tested of around $50 million to $55 million expenditures each year. And so we are plateauing of where we are now. In simpler terms, the teams that we've attracted to the company, the technologies that we're developing should be sufficient to bring the new products to the fore at these current budgets.

I also zoom out and look at the historical context in the context of our peers, our industry, where you typically have a company that has accumulated years of losses, scrambling for capital and when we set these budgets in 2021, we had an inkling, a view of where we would be at 2025 with the number of projects advanced with vitiligo in an advanced stage. But at no stage did we believe that we would come out after 5 years with $224 million in cash, having expended $171 million. So I congratulate our teams. However, as most shareholders know from us and from me, humility in life sciences is necessary. Otherwise, life science will show you humility. So we're doing well, but there is more to come.

Thanks, Philippe. And I'm going to move back to the balance sheet. Peter, you're on again. What would you like to draw our attention to?

I think the details on the screen speak a lot for themselves, Malcolm, but the total assets of the organization are up 18% this period. That's predominantly driven by, as Philippe alluded to, the 22% increase in our cash reserves or up $40 million, which is quite considerable. Our total liabilities increased slightly. This was mainly as a result of the area of our trade and other payables from our larger operations. So it's just scaled up proportionately. I'm pleased to announce that CLINUVEL still remains for the 20th consecutive year debt-free. We've got considerable operational expenditure buffer and coverage for up to 3 to 4 years, which really provides protection and surety of the delivery of our R&D programs without those dilutionary events for shareholders, which I mentioned before, or having to go and attract any external sources of funding, which really tend to erode shareholder value over that time. These cash reserves also provide us with opportunity and optionality to advance our multiple R&D programs at one time instead of having to just invest in one program at a time.

We also are exploring value-added acquisitions, whether that be revenue -- opportunities for revenue diversification, further vertical integration of our supply chains or of our operational structure, which is really the CLINUVEL way in recent times. With the CUV105 study, we've basically become our own CRO without having to outsource that as many of the biotechs do. And also gives us opportunity to explore other innovations that we can make, whether that's new formulations of existing products or different endpoint uses for existing products. It really insulates our company globally against what is quite a volatile geopolitical economic environment that we find ourselves in today.

Indeed. Okay. Our clinical program -- we rationalized that or refocused it in November 2024, Philippe. Can you just talk to our priorities, which is important for realization of incremental value going forward?

So it's a point. In 2024, we decided as a Board and management that we wanted to prioritize these projects, these CLINUVEL developments that would stand the highest probability of coming to market and advance the use of SCENESSE. I'll start with the expansion of the adult EPP market, both in U.S. and Europe that's ongoing, and we see growth in both continents. The adolescents expansion of SCENESSE in EPP envisage a setback when the EMA didn't fully support the expansion. We did a study CUV052, where we subjected the adolescent patients between ages 12 and 18 years to SCENESSE. In the meantime, we supplied adolescent patients in Europe with the drug fully reimbursed by the agencies. We started treating children. And so we are, in my view, in a much better position to resubmit to EMA and get the desired outcome to expand the market, which is about 21% adolescent population. We're advancing the trials in vitiligo, CUV105 ongoing, CUV107 in preparation, the bolt-on, the other variant of porphyria, that's called VP variegate. And last but not least, we're finalizing the manufacturing of the ACTH generic product to diversify our portfolio. And these programs can be self-sustained, self-funded with the results that you are learning of today.

Okay. What to look forward to? What do investors and analysts need to be cognizant of the leap in terms of completion of events and milestones going forward in the next financial year.

Well, I'm not sure about the next financial year. What you see here is the next quarter and the first calendar quarter of 2026. But I'll highlight a few, the outcome of Health Canada on the marketing authorization of SCENESSE, which would pose a new market, and the regulatory updates on vitiligo in the last calendar quarter of '25. And -- but of course, the big one is the first readout of CUV105 in vitiligo in the second half of 2026. And what you saw recently is our intention to upgrade the Level 1 to Level 2 ADR and list 8% of U.S. shareholdings on NASDAQ. So there are quite a number of activities that we engage in, exciting and that eventually will add value and transform the company.

Thanks, Philippe. So moving to a few shareholder questions. Frankly, I was going to ask you, Peter, to clarify priorities on the use of cash reserves. It's been a question from a few shareholders, but I think you answered that very well.

Happy to reiterate again, Malcolm, but you're right. We have said over a consistent message over time. Our intention is to deploy the cash as best we see fit, but also ensure the company for the long term to ensure that we can deliver on our R&D programs and promises for our shareholders without any further dilutionary events. So we're focused on deploying our cash and reinvesting it in our R&D programs or seeking a revenue diversification through an acquisition potentially, the vertical integration of other working activities within the business. We're also exploring a number of different IT and AI type initiatives to bring more efficiency into the organization. So there's a number of areas that we still want to explore internally, but there is that external focus of wanting to also find the right opportunity for the organization as well. And that's an active and ongoing process that we're still exploring opportunities that are out there for our business.

Got it. So the next question is sort of related to the elephant in the room, follows on from what Peter has been talking about, but I will premise at some shareholders. And one analyst, I don't think that person is online, suggests our balance sheet, Philippe, is lazy. Can you just comment on that and it may be a further reiteration of why the cash reserves are earmarked for what the purposes that they are?

I think there are many objectives you can assign to this company, but lazy is the last one. In all honesty, the cash reserves that we built provide us financial optionality. As most of the analysts will know, research and development is not a linear process. For every 10 experiments, 8 fail and 2 succeed. A financial buffer as we are building with intention give us the optionality to persevere where others would walk away from.

To give you an impromptu example, when I came back to the business, I was aware of the data and the results we generated in Singapore in our labs. We had persevered for 10 years on experiments that were providing lackluster results and the breakthrough came really in January, February this year. Without the cash that we would have had and with the hope of scrambling for capital, I believe that the transformative events that I see in Singapore would not have come to fruition. So cash provides us different modalities. One of them is to build a floor in protecting shareholders against downside risk with $4.80 NTA, you can say that we have demonstrated to build value for shareholders, but also the high NPV projects that you see on the slide are now sufficiently advanced in our view to assign future value to it. So do not underestimate the power of having cash in a biotech in a sector that is fraught with risk, and that is not coincidence that we intentionally built like this.

Excellent. Thanks, Philippe. I think the elephant in the room has moved on. Let's turn to analysts. [Operator Instructions] I'm going to go first to Dr. David Stanton from Jefferies.

So my first question. So near to medium term, should a competitor get approval for their glycine transporter drug, do you expect sort of top line growth rates for SCENESSE to change and why, please?

Thank you, David. It's good to have you today. What -- the assumption made is a big one, and that is that competitors or in this case, the Bitopertin will come to market. But let's stay with this hypothesis that this would be the case one day. We have not seen any data or indication to suggest that SCENESSE or CLINUVEL will be affected. And based on evidence, we have grown the market over the last 9 years, while competitors were conducting their Phase II and Phase III trials in U.S. and European EPP patients. So that highlights the fact that you can have multiple players in the pharmaceutical market while the incumbent is growing its market.

But the second one, which I think is much more relevant is that most of our patients in U.S. and Europe have been on the drug more than a decade. They started off in the clinical Phase I, II and III trials. They continued once the drug was commercially available to them and switching patients who have been more than a decade on an effective known drug where they know and the expected profile is not easy in medicine. And so switching them from a noneffective drug to a drug that has central effects because this drug in question was and has been used as an anti-schizophrenic. So a drug with central effects, in my view, is possible, but not very probable. So at the moment, David, there is no indication to say that, a, they will succeed and b, that this will affect us on a larger scale. But thank you for asking.

Understood. And then my follow-up is, look, longer term, should SCENESSE be approved in vitiligo. How would you cope with the differential pricing for SCENESSE between the different disease indications? And how would that be managed, please?

Yes, that's a good one. And that's also frequently asked and reviewed. The best way to think about this in the health economic modeling that we undertook, we understood over the last few years, the lifetime value of treating an EPP patient. And for those online, we're treating EPP patients in North America 6 times a year. That's an annual cycle, whereby there is an economic value for the treatment, both Medicare and the insurers. We understand from the data we have generated over the years and most recently in CUV105, I need to make a proviso for the fact that we haven't -- we're still under database lock. But from the data that we have derived from the 105 study, we can say that we anticipate that these vitiligo patients with extensive disease for more than 10% body surface area involvement, that they will receive 7 to 9 implants as a one-off treatment to reverse their loss of pigmentation. So in other words, to repigment them and the maintenance therapy for 1 to 2 injections per year. That has a health economic value that very much equates to the annual treatment cost for EPP. So we believe that the price will be reasonably constant in both continents.

Okay. Let's move along. Dr. Shane Storey. Wilsons Advisory. Shane, what would you like to ask?

So my question, I want to go back to what David was talking about a little bit. And I mean, I'm fully aware of that sort of loyal sort of patient pool effect that you described there, Philippe. But equally, I know that you're adding patients, and I know that your competitors will also be after that new patient cohort. So what I'm wondering though is whether you're anticipating doing anything different on the patient and the physician engagement side to -- in the inevitable case that competitors emerge.

Well, the answer is multifactorial. I think the first part is that we are training and accrediting centers in Europe and in the U.S., which are trained on the procedure on the administrative side, how to obtain reimbursement, how to obtain prior authorization. That's a whole process that physicians and patients eventually need to go through to obtain treatment. With that comes a pretty strict pharmacovigilance program, whereby we follow up patients for life. It's pretty unusual in North American pharmaceuticals, but we know the profile of each and every patient that is on drug. And we followed them for now close to a decade.

So in terms of what you call patient engagement, it is pretty intense and as intense as we had anticipated. In Europe, it's less intense because the rules and regulations are slightly different. But the pharmacovigilance is provided by the centers whereby the data are being entered in the disease and patient registry. So I believe that we've got a very good handle on the patient populations treatable in Europe and in the U.S.

And then there is a phenomenon of being a long time in the market and seeing that new patients previously not diagnosed are now seeking diagnosis and treatment. There has been a reasonable skeptic approach, certainly from North American patients initially, a new treatment on the drug, something that would affect them. And to convert a patient who has accepted his faith for Life and not being treated and living nocturnally to actually seeking an undergoing treatment has been a process for years in some of these patients. And so I can't guarantee you, but I feel that we are pretty close to understanding of that patient populations in both continents, and that gives you a head start over any future competitor.

Okay. Good. Just moving on, the newest analyst of CLINUVEL and the next to ask a question is Dr. Melissa Benson from Barrenjoey.

I had a question regarding vitiligo and actually your follow-on Phase III program, the CUV107. We noted you expect to start patients kind of later this year or early calendar next. First thing is, does that mean there's no requirement to meet with FDA prior and you've kind of aligned the protocol to the existing study?

And then the second is around kind of expectations for recruitment time lines and then I guess, readout if we're thinking about the 2 Phase III programs, each supporting an approval -- well, a filing rather?

Malcolm, I presume the question is for me.

Philippe, please go ahead.

The 3 elements that I pick up for you, Melissa, and welcome to the new team; time lines, recruitment speed and rate of recruitment and organization of the trials. Is that correct?

Yes, that's correct.

So in running the first advanced trial in CUV105, there are a great number of learnings. One of the learnings has been perhaps not to the surprise of the [indiscernible], but certainly to our surprise, is that when you have an effective drug that is so visible that is so prominent that patients who receive the monotherapy, only the narrowband UVB and some of them who have already received narrowband UVB in the past were not motivated to continue the trial and actually requested to have the active drug. So we adapted quickly and we promised all the patients that were assigned monotherapy to have the dual therapy, and that resulted in a really high retention rate.

So you have key learnings that you have to experience and adapt to the next trial. And then there are a number of others, but this has been really a prominent one. And the byproduct -- the happy byproduct of that is that you generate more data on your drug in a double pool of patients.

The second key learning that we're implementing in CUV107 is that rather than using traditional CROs, contract research organizations, which organize trials for these pharma companies, like in EPP, we set out to organize trials ourselves in North America and other parts of the world. And -- in the distribution of the centers, we see high recruiters, high deliveries, compliance. And that teaches you that some of the unlikely sites, some of the research centers are actually much better than the conventional sites, which are used by many of the competitors in vitiligo.

And so yes, I think it's fair to say that the rate of recruitment is going to be markedly improved in the next trial because many of the performing centers are already asking to be participating in the 107 trial.

Okay. right -- can we move on and ask...

Did I answer all the questions? Or is there one more, Melissa? I feel that I haven't fully answered everything.

I was just checking if you needed to meet with the FDA to confirm the protocol before you move in to the first patient.

Well, it's not mandatory, but I would say it's a good practice not to have a surprise at the end. And that's not only with FDA. We're also going to do it with the EMA. On protocol design, I think that's the underlying question. We see some changes from the FDA and the EMA towards for instance, oral JAK inhibitors where they slightly modify the protocols. And so we anticipate all these key learnings from regulators and have incorporated that in the CUV107 protocol to be at the forefront of clinical development. But it's not mandatory, but we will do it, yes.

Okay. Let's turn to Mark Pachacz from Bioshares who have covered CLINUVEL since 2006. That's longevity for you. Mark, welcome. Please ask you question.

Welcome back, Philippe, great to see you back. Just wanted to ask, if you could just give us some color just about the EPP market over the last year, just where the growth has come from? I know you indicated that the U.S. has grown from additional centers coming on. Are you seeing growth in Europe? Is that from new -- looking at new countries -- putting new countries on board there? And how are you -- is it -- are we -- should we be thinking -- I know it's Malcolm's favorite slide, but should we look at that curve, should we be thinking that it's pretty -- getting -- becoming a mature market now for you in EPP?

It's difficult to predict because I get it every year, I get it wrong. But in general, there is growth in the number of patients in both continents, this growth in the number of centers. Two new countries will come on board in Europe. We see a growth in number of implants supplied to the centers. And most importantly, I think we see a growth in the average usage per patient. So the average consumption is, if I may say so, of the implants increases per patient. So all the metrics point north.

So I don't have any data to indicate certainly alluding to David Stanton's question, the market is growing under influence of various factors in EPP market. So if the answer is how far does the curve grows, I don't think it will be infinite. Nothing is infinite, but there's ample room for growth, yes.

Okay. Just a follow-up and continuity of treatment for patients, is that still remaining quite high. I think in the past, it's been the high 90%.

Yes. We haven't done the analysis for the last financial year on that front yet. But the [indiscernible] is yes.

Another new analyst in the last year is Dr. Thomas [indiscernible]. So Thomas, are you on the line?

Can you hear me?

Thomas, yes, you're a little bit faint. So try and speak up a bit. It's a long way from Germany.

Actually, it is on photocosmetics. CLINUVEL's mission is to become the first company in the world to launch premium cosmetics on the [indiscernible] biologic. Will these cosmetic products require approval? And if so, through which approval process? And more specific, is there a time line and a cost trigger on it?

That's for you, Philippe.

In distinguishing between pharmaceuticals and cosmetics, we also have a very different regulatory process. I will not elaborate on pharmaceuticals. I assume that most of the attendees understand that we have to go through the rigorous Phase I, II and III approval. In cosmetics, it's slightly different. I'm going to just talk with you a number of the highlights that you need to go through in order to successfully bring a cosmetic to market. You need to obtain a CAS number from the American Chemical Society and an INCI name, which is granted by the Personal Care products Council. And the CAS and INCI ensure that the cosmetic ingredients or the newly introduced cosmetic ingredients as we intended to do with melanocortins are traceable and identifiable. Now the EMA and FDA don't regulate it, but they mandate the use of INCI and CAS names and CAS numbers.

Then you need a complete toxicology testing dossier that needs to be submitted to the scientific committee on consumer safety. And there, the safety is really on skin and eye irritation and genotoxicity, phototoxicity, which we had to go through.

And last but not least, you need a toxicology assessment by a certified toxicologist. So there is no mandatory regulatory registration process for new ingredients. But what we subject ourselves to is called a voluntary cosmetic registration program with the FDA, giving them more confidence that we're introducing a safe ingredient to excipients.

And then last but not least, by the Personal Care Product Council, there is then a cosmetic ingredient review that is published. So the entire process of getting the INCI names and the CAS numbers and the toxicology reports and the PCPC review takes about 3 years, which we had to go through, and we're now in the final stages.

But I think when I hear myself talking, the emphasis is really on safety of introducing a new ingredient or excipient like a melanocortin for cosmetic use because no one on the planet had ever done that.

And if you go back to most of our announcements in the last 2 decades, it is not coincidence that in each and every announcement, we emphasized safety as a key feature in anticipation that one day we would want to fulfill our ambition of introducing a melanocortin afamelanotide or its derivatives for cosmetics. And that is what we call the translational know-how or trajectory that we follow by emphasizing for years ahead of market entry of these cosmetics that the melanocortins have been safely used in disease populations, it would provide the council and the FDA on this voluntary scheme, the confidence that we've tested and evaluated the melanocortins in a different setting, and that is pretty unique. There are very few pharmaceuticals that are actually being translated in cosmetic. So in essence, there is no mandatory regulatory process, but this deliberate process of making sure that the end consumer, the cosmetic consumer derives confidence from the safety of introducing melanocortins from our decades-long preparation.

We'll move to Thomas Wakim from Bell Potter. Thanks for waiting on the line, Thomas.

My question is on NEURACTHEL, the ACTH product actually. So I see that one of your peers in the space, ANI has been making some pretty good traction with its early commercial launch of their ACTH product. So particularly interested how the program is tracking that you're working on and what the time line expectations are towards a submission to the regulator for that product?

Thomas, pleasure having you as always. You mentioned ANI, which is, I think, a really good benchmark, a company that started from scratch, obtained some rights to ACTH and entered the U.S. market with what I say a modest level of distribution and marketing efforts, but it's succeeding with an underpenetrated market. So that is one of the cases that gives us confidence that the ACTH market can be penetrated and served. The process of getting a generic version of ACTH on market follows the compilation of a new DMF that stands for Drug Master File, produced by a manufacturer that is exclusively engaged and contracted with us by us. And that process is coming to its final stages. That DMF is then a part of the dossier that needs to be filed in both continents, Europe and the U.S. and then follows a review and ANDA by the FDA that is set to be taken in 9 months. But from our recent analysis, nothing is reviewed under 12 months by the FDA at the moment due to the shortage of manpower.

So I can't give you definitive time lines. The only thing I will say is there will be an ACTH update as soon as we finalize the manufacturing process when we started the compilation of the DMF and then we will have a handle on the precise time lines, say, for the regulatory turnaround.

We're going to move to -- I think it's either Sinclair Currie or [indiscernible] Scott from Moelis Australia, our last but by no means least analyst to ask a question.

Sinclair here. Look, I was just interested to hear about your upcoming -- well, the next American Dermatology Conference. Do you think you'll be able to present anything on CUV105? And have you had any discussions about what sort of presentation slot or formats you might be able to host?

Sinclair, we haven't met in person yet, but welcome to the pool of analysts, and thank you for taking the time of investigating and researching us. Much appreciated. Now your question on AD is an important one. We've attended for years the AD actively. Some physicians that wanted to present our data on EPP or vitiligo were consented. And what we've seen in the last year is that those physicians who are treating under the CUV105 protocol are starting to release their results. Now strictly speaking, that's a violation because the data lock hasn't occurred. The analysis haven't been performed.

But in vitiligo, we have what I call quite an exceptional disorder. And what I mean by exceptional is that it's a disorder where the symptomatology, certainly in darker skin population is so prominent. You can see when patients start to lose the pigmentations expressed as patches, lesions on their skin. And you can also, therefore, see the impact of SCENESSE after a number of weeks of treatment when the repigmentation starts to repopulate or reoccur.

And so we understand that there is a high level of attention of these physicians to be the first to present at the AD. We can't stop that. We can't incentivize it either, but it happened as these results came through. Then there is a phenomenon of social media where patients are so enthused and excited that they start showing and sharing the images of the repigmentation online.

So the AD has become increasingly important because among the 8,000 dermatology centers in the U.S. and probably more than 16,000 board certified dermatologists that the company needs to be visible in anticipation that the drug will come to market one day. And believe it or not, the majority of dermatologists are not treating EPP patients, are not aware of afamelanotide or its repigmentary effects. But we have seen, I think, remarkable presentations, keynote lectures, the expert panels talking about afamelanotide as the future treatment, and that warrants our larger presence in the AD. So it is important. And eventually, we will follow the same model by training and accrediting the centers who will be administering the implant injection.

Very good. Thank you, and that concludes our analyst session on questions. I think we've well and truly come to the end of our time for the webinar. We have discussed a stellar set of results, which adds, I think, to CLINUVEL's rich library of annual results and operational achievements. On all participants behalf, I thank Philippe and Peter for their comments and insights, particularly the myriad of questions that we did have from the analysts across the range of business that Philippe answered.

Thanks also to our analysts and shareholders who ask questions. We will post the webinar recording through our website as there will be many others who want to listen and get the benefit of what we've covered, and we will do that within the next 24 hours. As follows the release of results and a results briefing, I can tell you and you know the next key meeting will be the Annual General Meeting, and we'll announce some details on that shortly. All that remains is for me to say thank you, and may you all remain in good health.