Clinuvel Pharmaceuticals Limited (CUV) Earnings Call Transcript & Summary

Hello, everyone. Thank you for joining CLINUVEL's Investor webinar today. I'm Stella of Monsoon Communications. In today's webinar, CLINUVEL will share the results and operational highlights for the financial year ended on the 30th June 2026. I will now hand over to Malcolm Bull, Head of Australian Operations and Investor Relations, to conduct the proceedings.

Thank you, Stella, and thank you to monsoon for hosting yet another CLINUVEL results webinar. Welcome, everybody, on the line. There should be 130 of you very attentive to the news that we're going to provide to you. I have CFO, Peter Vaughan, on the line; as well as our Director of Global Clinical Affairs, Emilie Rodenburger on the line; and Managing Director, Philippe Wolgen. Welcome, executives.

Thank you.

Good morning.

Good morning.

The agenda today is to discuss our results for the financial year ending 30 June 2026. And we're going to have Philippe and Peter and Emilie involved in various aspects of the performance and operations of the business. We also announced some other news today, the consideration of listing all of our ordinary shares on the NASDAQ and delisting from the ASX, and we'll certainly get Philippe to talk to that. We have several analysts on the line who cover CLINUVEL, and we certainly appreciate their coverage, and we welcome their participation in this webinar. They will ask some questions of our executives. And then finally, time permitting, we will address a few shareholder questions that our discussion hasn't quite covered. So I should share a particular screen with you on our forward-looking statement. We will be talking about intentions and plans, and you should be aware that there's a range of risks that can materialize that affect those plans from coming to fruition. But we will try our best as an executive team and work with the Board to deliver the results that we're advising you. So I want to move into a discussion of the results and strategy. But Peter, I thought you could set the scene to cover this year's results by providing an overview of how you manage quite definitely the finances of CLINUVEL, which enable us to build the strong foundation we have for the future.

Of course, no problem at all. Thanks, Malcolm. Good afternoon and good morning. Welcome to the webinar from wherever you're dialing in from. It's great to have you here with us. I guess, as Malcolm outlined, I will start with a strategic financial overview as to how we operate at CLINUVEL and the way we go about things. The financial and strategic overview that we have in finance and what my team and I focus on are 4 key or core objectives. The first is to maintain profitability. We do this by ensuring our year-on-year profits continue, but also that we can dial up and dial down our expenditure and particularly our discretionary expenditure to ensure that we can match the revenues as we see them come through. The second area we focus on is building positive net cash flows. This is why the profit margin protection is so important. And then that positive net cash flow helps to build the cash reserves that we use as our protection for the organization. Next, we invest in our strategic priorities. Our R&D programs, in particular, our vitiligo program at the moment, but also our capital and infrastructure expansions. You would have seen announcements around our Singaporean facility and expanding our laboratories over there, where we're doubling the footprint. Fourth and final is putting our surplus funds to work. We don't just leave them sitting in the bank. We know that we've been entrusted these funds by our shareholders, and it's really important to us that we put these to work. And this is where we put them in term deposits that at the moment is attracting a 6.23% return. Overall, this financial strategy is designed to build a financial moat for the organization to shield and protect our shareholders. What are we protecting them from? We're protecting them from market forces, and we've seen those affect our industry significantly over the last 2 to 3 years. Investment has really pulled back out of biotech and life science companies. We also protect our shareholders from dilution using these cash reserves. We've been entrusted those shareholder funds, and we want to make sure we put them to good use. It -- our reserves also provide us with optionality. This optionality is for us to focus on opportunities and take initiatives that we see in front of us, whether they be organic or inorganic. This strength comes from that 10 years of consecutive profit growth, the 10th year being this year. We've established a pristine and strong balance sheet with no debt. This has been our strategy to help absorb shocks in the market or from results if they don't go our way or from delays that might be experienced in programs. It's built our independence from having to rely on the capital markets and the peaks and troughs and volatilities that come with it. I thought I'd share a quote that we recently received from one U.S. investment banker that we've been talking to as part of our U.S. expansion. And he said, and I can quote him here, he very seldomly sees a life science company with the financial strength that CLINUVEL has managed to build from one product in the market. We're often critiqued internally or mainly externally from shareholders or other investors or people looking in at CLINUVEL that we're too slow or stagnated. We see this as being part of our strategy because if we were to increase the pace of the organization faster than it can handle, it increases risk. If we were to expand faster than we're capable of sustainably doing it, it increases risk. If we diversify through M&A and then spread our focus of the organization, it increases risk. And if we were to throw more dollars into programs, it doesn't necessarily amount to outcome improvement, in which case that increases risk. So all of these areas is why we have built a sustainably globally marketed product in SCENESSE. We initially focused on one indication in EPP in one market in Europe and then moved to America and spread into the second market. And now through our vitiligo program, we'll expand into a second indication that offers even considerably more market potential than what we have with EPP. I hope welcome and that's a good overview.

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

Excellent. Yes. Look, again, this is our disciplined and financial strategy at work, where we've delivered our 10th year of consecutive profits. There aren't too many in the life sciences space that can lay claim to that. Shareholders reading our annual report today would have noticed that the presentation layout of our P&L has changed, and I thought I'd speak to that for a second. The reason being we've now moved from a by nature reporting layout to a by function reporting layout. This now aligns our presentation layout with our U.S. GAAP financials, which is required by the U.S. market. So therefore, we now have more of a standard or traditional P&L layout of revenue, cost of goods sold, gross profit and expenses. In looking at our revenue specifically at the moment, we've exceeded $100 million of total revenue for the second year running. This was able to then be used to return a ninth consecutive dividend to our shareholders this year, and we basically returned 9% of our net free cash flow from the financial period in the form of those dividends. Expenditure was slightly lower than was forecast, but this is a good thing because we were still able to expand our R&D programs and other capital infrastructure projects that we've discussed. Our EBIT actually would have been the same as prior year had it not been for the strengthening of the Australian dollar. The reason that this had an impact was we have a significant amount of U.S. dollar term deposits. So translating those back to Australian dollars actually amounts to a financial loss because the Australian dollar has appreciated. We have to translate everything back into Australian dollars. Just for reporting functionality, it's not an actual economic loss because all of our financials in Australia in our ASX reports are presented in U.S. dollars. So this $4 million unrealized translation loss is represented in our P&L, but it's not actually a bottom line economic loss. Our cash reserves for the period increased by $28 million to $252 million. The other aspect of this is that it would have been even larger. We would have had a $40 million increase. However, during the period, the Australian Taxation Office required us to start making installment payments towards our year-end tax bill, which we ended up having to pay $12 million during the year. Normally, our tax payment goes out in one bulk lump sum in December. So during this current financial period, our reserves increased by $28 million, but we actually also paid nearly 2 years' worth of income tax payments because we paid our FY '25 in full in the first half of this year. And then we also paid the installments throughout the year of $12 million. That's where we would have had a $40 million increase in our cash reserves. The silver lining in this is that now in the first half of next financial year, we won't have this bulk outlay of income tax being paid that we usually have in the first week of December every year. So therefore, our cash reserves will increase in the first half of the year because it's now smoothed throughout the year.

Okay. Thanks, Peter. I wanted to turn to long-term profitability. And I say that the picture tells a thousand words, but I don't want you to use a thousand words because we don't have enough time. But please summarize that profitability trend and the expenses and particularly the revenues, please.

Of course. So as I've touched on before, we're proud that we've achieved $100 million worth of revenue for the second year in a row. And this really came from the treatment volumes that we saw this year. So our SCENESSE treatment program globally had its largest number of treatments ever that we've experienced. That was up 6% on the prior year. We did see some moderation of the U.S. sales and treatment numbers. And we feel that this is because there were other competitors out there that were offering free product through the clinical trial programs that they were offering. The good news is that whilst these other entrants came into the market with free product, we still saw people return to SCENESSE after those treatments, but it also meant the market was able to sustain not only one player in the market being us, but also 3 entrants without it having a significant effect on our revenues. The flip side to the U.S. moderation of revenue was the European strength. We saw European treatment volumes increased by 13% during the financial period, which boosted our revenue by 9% on the prior year in Europe. We see the market entrance in the U.S. as being a temporary competitive effect rather than a product structural change for the market. As I said, the EPP population and the EPP market in the U.S. sustained these 4 competitors all in there. Our disciplined financial management in these types of situations, though, this is why it's important to come back to this, enabled us to dial up and dial down our discretionary expenditure as we started to see that U.S. impact of sales. So therefore, we can match -- we can match our expenditures to our revenues while still continuing to invest in our strategic priorities. With all that said, our gross profit margin was 83%, and our net profit margin was still 36%. These are the margins that we're guiding the business by to ensure that we can protect those reserves continuing to build. These sorts of results in a life science company are truly exceptional.

Indeed. Well, let's move to the expenses side and just go into a bit more detail on what was happening there.

Of course. So at the end of last financial year, everyone on the webinar may recall that we came out and said that on average, over the next 5 years, we'll be expending about AUD 55 million. That was on average for every year for the next 5 years. We actually came in at $53.5 million. So we're $1.5 million under that $55 million number. But it's important to note the $55 million actually excluded CBM activities because we see that as some of the discretionary spend that we can ramp up and ramp down. But our $53.5 million actually included our CBM activities. So our true underlying, if you like, expenditure was about $45 million when you exclude that CBM activity of about $8 million. Across the CBM, we did see it relatively steady or stable from the prior year. We still delivered our major program for the year, which is our AAD in Denver, which was in March earlier this year. Again, building company brand and presence in the market so that people know what we are and what we do. Our general admin was $1.5 million higher than prior year, but -- sorry, was higher than prior year, but the $1.5 million of that actually related to one-off costs in relation to our NASDAQ uplifting. So that amounts to legal fees, audit fees and other aspects directly affected by that NASDAQ uplift. Our U.S. dollars, that funding investment into our vitiligo program, our NEURACTHEL program, but then also our new controlled release injectable peptide platform that we're running from our Singaporean RD&I facility. The minor reduction in R&D just purely reflects the CUV105 study starting to wind down to completion. It's not actually a pullback of that program. And really, we'll start to see that starting to increase again as our CUV105 program in vitiligo starts to come online later this year that I'm sure Philippe and Emilie will talk about in a moment. Our R&D expenditure in total was 35% of our total expenditure, and we directly reinvested 20% of our revenues into R&D. Our first decade of commercialization has really built a self-funding sustainable business model and built those cash reserves that help to cement the business and its balance sheet. 10 years of profitability that's consistent year-on-year, it's really unheard of in life science.

Indeed, it is. And staying with you, Peter, since you just mentioned the strong balance sheet, what comments would you like to make with regard to the state of the balance sheet?

Well, I guess the first thing that I would say, Mal, is I think our balance sheet strength is actually one of the most underappreciated aspects of CLINUVEL's investment proposal. And touching on that comment made by the U.S. institution recently in the last couple of months, I think that really supports that. So our cash reserves that I touched on before, increased by $28 million to $252 million. Our total assets increased to $295 million, so just a touch under $300 million in total. I did touch on the fact that, that $28 million increase would have been larger in cash reserves had we not prepaid the $12 million of income tax, but that will obviously have a back-end effect and improvement for our first half of 2027 financial period. Apart from investing in our R&D programs for our revenues of tomorrow, we're also investing in a number of other initiatives and capital improvement projects. The first one being the doubling of our Singaporean RD&I facility that I mentioned before. So that is increasing the laboratory footprint, which gives it more capability and more capacity for those exploratory R&D activities. We are refurbishing our European office, which is really the head of our European area of our business. And that's a substantial asset on our balance sheet already because we own that premises. So we're really improving that asset for the future. And then the final one is we're also establishing an integrated manufacturing and supply chain now. So we're looking at those avenues to in-house more of that activity and bring it closer to us. We hold about $231 million in term deposits at the moment across multiple different currencies. And as I mentioned before, that's returning 6.23% yield. So we really don't have a lazy balance sheet, even though we have this surplus of cash, we're deploying it for return for our shareholders. And we remain debt-free for that 20th consecutive year, and it's been 10 years since our last capital raise. Our balance sheet has really been built through profitable operations that we've run and internally generated net cash flows instead of the typical life sciences R&D type process of repeated equity raisings and shareholder dilution. We really entrust and protect our shareholder reserves. It's important not to underestimate the strength in our balance sheet. It's really underappreciated because it significantly is the fundamental solid base that we can build from. It protects us through these market cycles that can affect other organizations. It gives us capital and optionality to invest, but it also provides us with opportunities without being forced back into the market to fund it. It allows our strategic initiatives to continue and us to continue investing in those without having to consider any shareholder dilution. I would say as an overarching comment in relation to the balance sheet in total, that this -- the first year of our disciplined financial business model, really, we were able to build it and show how it works from a commercial standpoint. And our next decade, we will use that strength to now build our infrastructure, our science and our commercial capabilities for future revenues of tomorrow in the pursuit of shareholder value.

Well, Peter, you've covered a lot of ground in a pretty succinct amount of time, the profitability of the company, how we've established that, your role, the finance team in helping to manage that, the strong balance sheet and the optionality we effectively have. So thanks for that. I'm going to switch now to Philippe because today, we announced a major strategic intention, and I'm simply going to ask you, Philippe, to talk to that announcement.

Yes. Thank you, Malcolm. It's been a long time coming. As most shareholders know, we've talked publicly about the option to list one day on NASDAQ. And we've taken the moment when we believe that the company is sufficiently mature to make that transition. And in essence, we need to be there with the current and the future economic activities will take place. Unfortunately, we've never had a commercial footprint in Australia and North America will be our largest future market. So we will need to have a feet on the ground. And for this, we expand our U.S. market access team, commercial team and clinical teams, and we'll make it our headquarters on January 1. Now if you add to it the makeup of our registry, the ownership of this company has always historically been in foreign hands, 70% North Americans, Asians, Europeans and only 30% Australian. And that shift has never really taken place in favor of the Australian owners. So we've long prepared the company for a U.S. listing. We made that public, so there can't be any surprise. The depth of the U.S. market is well known in life sciences. And I also need to devote a few words to the Australian analysts because it pains me to see how much time they've spent on CLINUVEL, the hours, the number of reports since 2019. But we believe that the company is now mature enough to have a place on the NASDAQ Global Select market. Important and questions that we received, what happens to the IP. Well, most of the intellectual property resides outside Australia, in the U.S., in Europe, in Singapore, where our research center has been located. Then vitiligo, of course, is a global disease. However, vitiligo is most prominently treated in North America, in the United States. So this is an additional reason why we need to be there as of January 27. A comment was received as why CIL is seeking a single listing and not a dual listing. And the answer is for companies that have a considerably larger size than, it would make sense to split the liquidity and volume traded. But in our size at the moment, it makes sense to have one single listing on a U.S. exchange where we devote all our resources, compliance and personnel to it. If you look numerically for the reasons why we opted to do that now, in 2020, we traded a value of $1.7 billion annually, and that has receded to about $320 million in 2026. So we've seen a decline in traded value and therefore, volume in the CUV stock. So in essence, we base ourselves where the chance of value creation is the highest and where one commands a valuation multiple, which is higher than normally in Australia but closer to the intrinsic value of the company. So these are the reasons, Malcolm, in a nutshell.

Okay, Philippe, thanks. I'd like to turn to our pipeline. But first, just speak to our strategy, which has been to build and apply our expertise in melanocortin-based treatments for unmet needs. And we've certainly achieved that with SCENESSE EPP. And I think as the participants of the call know, we're working on other indications. We've made a leap forward on delivery methods, particularly on how we administer peptides, arriving at controlled release formulations. And this has been a keen interest of many shareholders and some analysts as well, not just in questions submitted to this webinar, but questions over recent months since we announced the progress of the liquid formulation peptide platform. And we can tell you that we started this development, this in-house development many years ago, attracting talent, progressing the development, and we now have sufficient comfort to proceed to small-scale manufacturing dependent on progress, large-scale manufacturing is a potential. So these are all calculated risks, but we believe they hold more value than anything else we've ever done in-house. However, and pipeline is on screen for people to see, the immediate lead program is vitiligo. Now dependent on the results, and we will know that those results over time, that will determine the pathway to file for marketing authorization. But I wanted to bring Emilie in to talk more about vitiligo. So Emilie, I thought you may have dropped off. Are you here?

Yes. I'm here, Malcolm.

I'm so relieved because I want to hear you talk about vitiligo. Please go ahead.

Yes. Absolutely. I apologize for the coming off and on the screen. We've been this by a storm in the U.K., and I think it's distracted and disturb my Internet. So the sky is blue almost now. So I'm ready to talk about vitiligo. So vitiligo is a unique program, whereby the efficacy of the treatment is visible. So we do not rely on blood analysis or biomarker or x-rays in our trials, the efficacy of the treatment is visible, and we document this with light photography. When we started the program with the hypothesis that afamelanotide with narrowband UVB agent would dig on vitiligo, we saw the efficacy in the hands of 3 leading vitiligo experts in the world. We are focusing our efforts on the patient population with the highest need for treatment, patients of darker skin color, [indiscernible] skin type 456 for whom the impact of the disease is the greatest. So as a reminder, afamelanotide alone doesn't work since melanocytes and receptors are not yet present and expressed in the vitiligo lesions. So we will always need light therapy, narrowband phototherapy to be adjunct to the drug. And light therapy at narrowband UVB is the standard of care for vitiligo and the [indiscernible] are available in many of U.S. centers. The competitive landscape has much evolved from the time we signed up this first proof-of-concept study back in the Melbourne office and where we were the only company in the world developing a treatment for vitiligo. You've seen that company now have started to reposition their drugs for atopic dermatitis or other autoimmune diseases, the JAK inhibitors in vitiligo. A couple of years ago, a topical version approved and very recently, last month, the first oral systemic JAK inhibitors by an American company approved by the European Commission and likely later in the U.S. by the FDA. So rise of the competitors and this opening of the vitiligo market is helping us enormously since the regulators are now becoming more and more familiar with the disease and the trial. So they do not -- they no longer have to look at afamelanotide with our narrowband UVB agent as a third dossier. They are precedent and benchmark. So -- and this is what we experienced at the time of scientific advice in Amsterdam with the EMA. So unlike EPP where we were first, there are advantages of not being first. Another advantage and the big difference of afamelanotide versus JAK inhibitor is that we do not suppress the immune system acts as a natural ligand to the cell that produce the pigment. We mimic a physiological process. And in our trial, we need to demonstrate that afamelanotide with going to adjunct is providing faster and a deeper repigmentation. If I may use an image with afamelanotide, we have the foot on the pigment accelerator while the JAK inhibitors are taking the foot of the brake immune. Of note, JAK more and more are open JAK inhibitors are open to take too long for treatment effect and do not really work that well, and we expect to talk about that and about the results in conferences. And you may have noticed it yourself looking at the late Phase III trial results and top line results presented. The trials evaluating JAK inhibitors against placebo despite reaching statistical significance have quite a modest effect on repigmentation.

That's good. Now Emilie, we're going to move to catalysts. And since you're talking about vitiligo, that is to the fore of our catalysts. So can you please talk the vitiligo catalysts?

I will start with 2 significant milestones for our Phase III vitiligo clinical program. First, the top line results for the CV105 study and then the start of the CV107 study, both expected in Q4. A few words about top line results in CV105. We've been working internally and externally to retrieve and monitor all study data, generate queries, undertake cleaning activities as well as reviewing and assessing digital photographs. The study, the CV105 study has generated 110,000 photographs. The photography review undertakes 3 stages: first, a local review by the sites and physicians, then a central review by our clinical team. And lastly, an independent review by an expert panel, the central Photography Review Committee. In overview, we look at both the extent of repigmentation, how much the patients are repigmenting, but also the quality of the repigmentation. And as we presented in -- at the AAD earlier this year in Denver, repigmentation follows a temporal sequence, first from the follicular response when you see little inside the lesion, brown islands, meaning that the patient is responding to the treatment to a conference where these small cones and islands become bigger and merge towards homogeneity. Homogeneity is when the vitiligo lesion is fully repigmented and the color is homogeneous with the constitutive skin. We call it color matching and it's very, very important from a patient satisfaction point of view. A brief note on AI. In parallel, our internal AI model that we presented at the AAD as well is ongoing training to support these activities in the near future.

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

No, I think Emilie summarized it pretty well. There's not much to add. We are watching the market evolve. We witnessed the commentary on JAK inhibitors and the length it takes to see some effect. We also are looking of how these oral JAK inhibitors are going to be priced in Europe first and perhaps in North America. But in the meantime, we continue by training and accrediting centers and our target 490 trained accredited centers by 2027 is on track. So we are watching lead ins.

Very good. Look, thank you, Philippe, Emilie and Peter in reverse order of which you spoke, much appreciated.

It's now time to turn the call over to the analysts that are on the line. Now analysts, our briefing has been quite extensive. So please keep your questions seat. And we're going to start with David Stanton from Jefferies. So David, please ask your question.

I've got 2. Firstly, can you give us an update on your best guess as to when the CUV107 trial will read out, please?

Emilie, please?

I'm taking this question, David. Thank you. So CV107 from the start of recruitment in November 2026 to completion of the study, last patient last visit, the CV107 study is planned to run for approximately 2 years and readout will follow data cleaning and analysis, so expect 2029.

Understood. And second question about price. Should SCENESSE be approved in vitiligo, how would the differential pricing for SCENESSE be between the disease indications? And how would that be managed, please?

Yes. Philippe?

Well, there's no real surprise. I think let's take a step back for the general shareholders on the line. We are pricing SCENESSE and EPP on a bimonthly basis perpetually. So patients are on this product for life every year. And that gives you a value per patient per annum that is calculated and borne by insurance companies and state payers. In vitiligo, our assessment, depending on the biological variability that you see in patients, not everyone responds in the same manner at the same intensity -- it depends on the number of treatments that you're going to provide, but we assess that it's going to range between 7 and 12 implants per patient as a one-off treatment. So that's a one-off treatment in vitiligo versus annual repetitive treatment cycles. We also believe that vitiligo patients will benefit from 1 to 2 injections per year as maintenance treatment. And so the answer is that the value per patient in vitiligo is going to approximate the value per patient per year in EPP. So we don't believe that there will be too much price erosion. It will be more or less in the same ballpark.

Thank you, David. We'll now move on to Melissa Benson from Barrenjoey.

I had a question just on interactions with the FDA. I know with the vitiligo program, you've had EMA scientific advice. I'm just wondering like interactions with the FDA you've had, if you intend on having any meetings post the kind of CUV105 data at the end of this year or sooner? And also, I guess, understanding how much FDA input has gone into the CUV107 protocol?

Thanks, Melissa. I take your question. So yes, that's correct. We meet with the FDA following the top line results of CV105, which is after we commence CV107. Unlike any other vitiligo program, we are focusing on the use of a drug device combination, afamelanotide with narrowband UVB adjunct for vitiligo. And while the EMA interaction during scientific advice appeared supportive and then we agreed on many points for the program and protocol, we believe that the FDA will need to be presented more data during this Type C meeting. However, and in addition, the CV107 design aligns with many of the FDA requirements featured in the recent late-phase protocol for vitiligo that been which results have been presented or are in review by the FDA. So the design of this study is very much that we are mirroring the design of other systemic drugs setting up similar endpoints, [indiscernible]. With the FDA, we've come quite a long way from when they believe that narrowband UVB was dangerous and carcinogenic. Now they've learned that narrowband UVB is safe and doesn't increase the risk of cancer and vitiligo. So we are still in an education mode and need to present more data.

Could I fit in the second question?

All right. Quick.

It was just on the NEURACTHEL ACTH. We noted that you're ready for a filing with EMA in the second half of this calendar year. I guess, again, another question on potential plans for filing there with the U.S. FDA for that program.

Okay. Philippe?

Yes, it's correct what Melissa said. The sequence is Europe first, filing NEURACTHEL, the ACTH is a generic dossier. And then once we understand the questions that will invariably come from the European Medicines Agency, we will file in the European in the FDA. But we are filing the generic version of ACTH on a country-by-country basis, so not through a centralized procedure. But the FDA will follow after that.

Thanks, Melissa. So we have an analyst who's dialing in from a long way away, Frankfurt, Germany. We appreciate Thomas Schiessle dialing in. Thomas, please ask your question.

Could you hear me?