Clinuvel Pharmaceuticals Limited

Hello everyone, thank you for joining CleanWell's investor webinar. I am Stella of Monsoon Communications. In today's webinar, CleanWell will share their financial year 2025 results and operational highlights for year ended on 30th June 2025. Many have asked questions as you registered for the webinar, which may still be tabled during the session through the Q&A function. 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 Monson 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 Plinyaville. 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 three 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 Walden, 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 two of the webinar, I will ask a few questions on their behalf. I'm also pleased to note that the number of analysts covering Cliniavel have increased over the past year from seven to ten 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 as some refer to it as a, say, artist statement. Please note there are many risks that can materialise 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 have 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 Klinevel 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 US and Europe, a 24% growth in sales reimbursements, which is otherwise known as special access scheme Our US 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 organisation. 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 3 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 Cleveland Real 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. And 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 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 off the higher sales volumes. But our biggest area of increase was this reinvestment in clinical and non-clinical programs. Our multiple programs all experienced this expenditure increase across CUV105, our ACTH program, our PRONUMBRA and URACTEL, 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 organisation. We've 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 Clinivel and Senesce. 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 CVM 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 Photo Medicine. Now, this pavilion was a 4,800-foot immersive experience, and it really brought people in that industry together with over 20,000 physicians, clinicians, and industry KOLs into that Clinevel environment, and they heard a lot of stories and presentations from people in the industry.

Excellent. Thanks, Peter. I'm sticking with you. I'm going to have you talk to my favourite graph. It could be yours too. I think it's a favourite of the analysts. 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 nine 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 cut-off 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. Correct. 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 organisational goals. In FY25 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 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 organisation going forward. Our net profit margin at 34% is approximately 8% higher than the average norm for biotechs of a similar life stage as Kunjabel and also a 16% return on equity really shows that we're bringing value to shareholders on top of the dividends over the last eight 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 five-year expenses plan to 30 June 2025. Just talk to this please and 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 three-month 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 five years. whereby the team underbid it by 3.8 million. So this graph speaks to me as an adherence to a 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 three-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 to 55 million expenditures each year. And so we are plateauing off 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 and 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 Getty LIGO in an advanced stage. But at no stage did we believe that we would come out of the five years with 224 million in cash, having expanded 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's more to come.

Thanks Philippe. 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 organisation 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 Klinevel still remains for the 20th consecutive year debt free. We've got considerable operational expenditure buffer and coverage for up to three to four 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 opportunities for revenue diversification, further vertical integration of our supply chains or of our operational structure, which is really the Clinebel 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 rationalised that or refocused it in November 2024, Philippe. Can you just talk to our priorities, which is important for us realization of incremental value going forward.

So that's a point. In 2024 we decided as a board and management that we wanted to prioritize these projects, these clinical developments that would stand the highest probability of coming to market and advance the use of SNES. I start with the expansion of the adult EPP market both in Europe and Europe that's ongoing and we see growth in both continents. The adolescents expansion of Senes in EPP envisaged a setback when the EMA didn't fully support the expansion. We did a study CEV052 where we subjected the adolescent patients between 12 and 18 years to Senes. 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 she knows about the 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 ACTA2 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, Philippe, 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 quarter, calendar quarter of 2026. I highlight a few. The outcome of Health Canada on the marketing authorization of SNES, which would oppose a new market. The regularity updates on Vitiligo in the last calendar quarter of 25. But of course the big one is the first readout of CVE-105 and Beta-Ligo 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 US 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.

I'm 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 regularly 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 organisation 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, it's sort of related to the elephant in the room, follows on from what Peter's been talking about, but I will premise that some shareholders and one analyst, I don't think that person's 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 the purposes that they are.

There are many adjectives you can assign to this company, but lazy is the last one. In all honesty, the cash reserves that we build provide us financial optionality. As most of the analysts will know, research and development is not a linear process. For every ten experiments, eight fail and two succeed. A financial buffer as we are building with intention gives 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 were 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 protecting shelves against downside risk with $4.80. to build value for shareholders, but also the high-end PV 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 it is not coincidence that it intentionally built that risk.

Excellent. Thanks, Philippe. I think the elephant in the room has moved on. Let's turn to analysts, and I'm sorry, analysts, we need to be succinct. Please ask one question. I'm going to go first to Dr. David Stanton from Jefferies. Go ahead, David.

Thank you. Can you hear me, gentlemen?

We can, yes.

Thank you. So my first question. So near to medium term, should a competitor get approval for their glycine transporter drug? Do you expect some top-line growth rates for Synest 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 vitoperitin, 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 Senes or Crinova would be affected and based on evidence we have grown the markets over the last nine years while competitors were conducting their phase 2 and phase 3 trials in US and European EPP patients. So that highlights the fact that you can have multiple players in a pharmaceutical market while the incumbent is growing its market. The second one which I think is much more relevant is that most of our patients in US and Europe had been on the drug for more than a decade. They started off in the clinical phase one, two and three trials. They continued once the drug was commercially available to them. And switching patients who had been more than a decade on an effective known drug where they know and they had the expected profile is not easy in medicine, and so switching them from a non-effective 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, it will succeed, and B, that this will affect us on a larger scale. But thank you for asking.

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

Yeah, 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 treat APP patients in North America six times a year. That's an annual cycle whereby there is an economic value for their treatment, both Medicare and insurance. We understand from the data we have generated over the years and most recently in CV105, I need to make a proviso for the fact that we haven't, we're still under database law. But from the data that we have derived from the 105 study, we can say that we anticipate that these Evita-Lipo 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 one to two 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, Wilson's Advisory. Shane, what would you like to ask? Can we unmute Shane?

Yeah, no, I've just done that there, Malcolm. Thanks. Thank you. Good evening, everyone. And thank you for opening up the call to live questions and that's changed. 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 you're doing anything different on the patient and the physician engagement side to You know in the inevitable case that competitors emerge.

Thanks Well the The answer is multifactorial, I think. The first part is that we are training and accrediting centers in Europe and in the US, 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 follow 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 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 that are treatable in Europe and in the US. And then there is the 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 and 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 the 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 Plinyville and the next to ask a question is Dr. Melissa Benson from Baron Joey.

Thank you Malcolm, evening team. I had a question regarding vitiligo and actually your follow on phase three program, the CUV107. We know that you expect to start patients kind of later this year or early calendar next. First thing is, does that mean there's a 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 timelines. and then I guess read out if we're thinking about the two phase three programs each supporting an approval, well, a filing rather.

Malcolm, I presume the question is to me.

Please go ahead.

The three elements that I pick up from you, Melissa, and welcome to the new team. timelines, recruitment speed and rate of recruitment and organization of the trials. Is that correct? Yes, that's correct. So, in running the first advanced trials, the CUV105, there are a great number of learnings. One of the learnings has been perhaps not to the surprise of the device standard, 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. And so we adapted quickly and we promised all the patients that were assigned monotherapy to have the dual therapy and that resulted in a high retention rate. So you have key learnings that you have to experience and adapt to the next trial. And there are a number of others, but this has been really a prominent one. Byproducts, 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 CV107 is that rather than using the traditional CROs, contract research organizations, which organize trials for these pharma companies, and like an 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 within LIGO. 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, all right.

Can we move on? Did I...

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 FDA to confirm the protocol before you move in to the first patient.

Well, it's not mandatory, but I would say it's 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 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 CDB107 protocol to be at the forefront of clinical development. It's not mandatory, but we will do it, yes.

Okay, let's turn to Mark Bashaz from BioShares who have covered Cliniovel since 2006. That's longevity for you. Mark, welcome. Please ask your question.

Thanks, Malcolm. Can you hear me?

Yes, Malcolm.

Yeah, welcome back, Philippe. Great to see you back. Just wanted to ask you, if you could just give us some colour just about the EPP market over the last year, just where the growth has come from. I know you indicated that the US has grown from additional centres coming on. Are you seeing growth in Europe? Is that from new... It's difficult to predict because I get it every year, I get it wrong.

In general, there is growth in the number of patients in both continents. There is growth in the number of centers. Two new countries will come on board in Europe. We see a growth in the number of implants supplied through the centers. And most importantly, I think we see a growth in the average usage per patient, so the average consumption, 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 Stanzen's question, the market is growing under influence of various factors in the EPP market. if the answer is how far does the growth, the current growth? I don't think it will be infinite. Nothing is infinite, but there is 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.

Thanks. Another new analyst in the last year is Dr. Thomas Seychell from Parmentier and Co. So, Thomas, are you on the line? Yes. Perhaps not. Can you hear me? Oh, Thomas, yes. You're a little bit faint, so... Try and speak up a bit. It's a long way from Germany.

Indeed, indeed. Thank you for taking my question. Actually, it is on photocosmetics. Cleanable's mission is to become the first company in the world to launch premium cosmetics on the melancholic biologics. approval and if so through which approval process and more specific is there a timeline and a cost trigger on it. Thank you.

That's for you Philippe.

Thank you Dr. Schiessle. I believe you call from Frankfurt.

Indeed.

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. They think they have to go through the rigorous phase 1, 2 and 3 in approval. In cosmetics, it's slightly different. I'm going to give 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. 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 inky and cast names and cast 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 have 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 or excipient. And then last but not least, 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 three 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 of excipient lichen melanocortin for cosmetic use, because no one on the planet had ever done that. And if you go back to most of our announcements the last two decades, it is no coincidence that in each and every announcement we emphasize safety as a key feature in anticipation that one day we would want to fulfill our ambition of introducing a melanocortin after melanotype 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 diseased populations it would provide the Council and the FDA on this voluntary scheme, the confidence that we've tested and evaluated the Milan Accordance 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 there's deliberate process of making sure that the end consumer, the cosmetic consumer, derives confidence from the safety of introducing melanocortis from our decades-long preparation.

Good. Thank you, Billy. We'll move to Thomas Wakeham from Bell Potter. Thanks for waiting on the line, Thomas.

Thanks.

Go ahead.

Thanks, Malcolm. Hopefully you can hear me all right. My question's on Neuraccel, 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 timeline expectations are towards a submission to the regulator for that product. Thanks very much.

Thank you, 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 STH and entered the US market with, would I say, a modest level of distribution and marketing efforts, but it's succeeding with an under-penetrated market. So this 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 US. and then follows a review, an end there, by the FDA is said to be taken nine months, but from our recent analysis nothing is reviewed under 12 months by the FDA at the moment due to the shortage in manpower. And so I can't give you definitive timelines. 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 timelines safe for the regulatory turnaround.

Thanks very much.

Thank you Thomas.

Thank you Thomas. We're going to move to, I think it's either Sinclair Currie or Lachlan Scott from MOLUS Australia, our last but by no means least analyst to ask a question.

Hi, thanks. Sinclair here.

Oh, good, Sinclair.

Thanks for taking the time to have a chat. Look, I was just interested to hear about your upcoming dermatology, well, the next American Dermatology Conference. Do you think you'll be able to present anything on CUV 105, and have you had any discussions about what sort of presentation slot or formats you might be able to host? Hmm.

Thank you 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 AAD is an important one. We've attended for years the AAD actively. Some physicians that wanted to present our data on EPP with the LIGO were consented. And what we've seen in the last year is that those physicians who are treating under the CV105 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 pigmentation expressed as patches, lesions on their skin, and you can also therefore see the impact of senesce after a number of weeks of treatment when the repigmentation starts to repopulate, to reoccur. And so we understand that there is a high level of attention of these physicians to be the first to present the AED. We can't stop that, we can't incentivize it either, but it happens as these results came through. Then there is the 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 AED has become increasingly important because among the 8,000 dermatology centers in the US and probably more than 16,000 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 ephemelenatide or its repigmentary effects. We have seen, I think, remarkable presentations, keynote lectures, the expert panels talking about different endotipes, the future treatments, and that warrants our larger presence at the AD. So it is important, and eventually we will follow the same model by training and accrediting these centers. We'll be administering the implant injection.

That's great. Thank you very much.

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 Cliniovel'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 asked 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'll 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.