Clinuvel Pharmaceuticals Limited (CUV) Earnings Call Transcript & Summary

Good evening, everyone. I'm Verity from Monsoon Communications. Thank you for joining us for CLINUVEL's half [indiscernible]. I'll now hand over to Head of Australian Operations and Investor Relations, Malcolm Bull, to begin the presentation.

Thank you for that kind introduction, Verity. At the outset, I would like to welcome everyone on the line to the webinar on CLINUVEL's financial results for the half year ended 31 December 2023. It's pleasing to advise that we have over 150 participants to the webinar today, and you are all from around the world, from New Zealand to Australia through Asia across Europe and over to the United States. We also have a wide range of stakeholders on the line, including representatives of the 7 independent analysts of CLINUVEL and institutional and private investors. It's my pleasure to introduce CLINUVEL executives: Mr. Darren Keamy, our CFO; and Mr. Lachlan Hay, our Director of Global Operations, who will join me to discuss the financial results and operations of the company for the reporting period. As I mentioned, we will be discussing the financial results and also taking your questions. Many questions have been submitted as you registered, and we'll look during the meeting to see what other questions have been put forward. First, however, I draw your attention to the forward-looking statement on the screen, which highlights that investors need to be aware of various risks that can arise and affect the realization of planned outcomes. And I'm sure you are proficient in taking those factors into account in determining your investment in CLINUVEL. A copy of this statement is also available on the company's website if you wish to peruse it in more detail. Please also note that all references to dollars are Australian dollars, the company's reporting currency, and are rounded for ease of reference. With these preliminaries covered, I'd now like to call on Darren to provide a summary of the headline results. Over to you, Darren.

Thanks, Malcolm. Thanks, everybody, for joining. I'm pleased to walk you through the headline results, where for the 6 months to December 2023, relative to the prior corresponding period of 2022, we've recorded a total revenue and other income result of 15%. And within that, the commercial sales and sales reimbursement revenue grew by 9.9%. Expenses have grown by 28%. That's to reflect the expanded activities of the group. Profit before tax rose 1% to $14.8 million and -- due to an increased tax expense compared to the prior period, our profit after tax declined by 4% to $10.9 million, and that's an earnings per share of $0.221. In terms of the balance sheet, when we compare it to the 30th of June 2023, we've had an 8.5% increase in our net asset position to $178.6 million. $211.7 million in total assets, and of that our cash and term deposits grew 11% to AUD 174.5 million. I'd say that if we look at what we had promised as part of our 5-year projections that we announced to the market back in January 2021, we projected expenditures over a 5-year period of June 2025 of $175 million. Of that timescale, we've got 18 months to go. And of the 70% of time passed, we've spent 65% of that projection. What's important to note that we have still registered a growth in our cash and surplus cash reserves to $174.6 million. That wasn't entirely anticipated at the time offsetting out that projection. So overall, we feel that's a pleasing result.

Well, very pleasing, Darren. And Lachlan, from your perspective, as Director of Global Operations, would you like to provide some operational context before we delve further into the numbers.

Yes, of course. No, I think, firstly, it's congratulations to Darren and congratulations to the rest of the team. You've delivered another period where revenues have increased. You've delivered another period of profit. I think there's a tendency for market participants to lose a bit of perspective on the results that we do deliver as a business, more of a focus on building models. We're aware of what the market consensus is. We're also aware of what our internal consensus is, which is the intention to build a sustainable and profitable business. From a financial management perspective, the team -- Darren and his team are doing exactly what we said we do. It's our 15th consecutive half year profit. We're increasing the revenues, 15% and 10% in terms of sales. And I look around us and say, "Well, I don't see this in the biopharma peer group, either in Australia or anywhere else in the world very often." So I think that, that certainly should be comfort to shareholders in terms of where we are. The figures that Darren mentioned, $175 million over 5 years, 65% of that spend, 18 months to go in terms of that projection, we are exactly on target with what it is that we wanted to do. If I -- where my operations had and the expenditures themselves, there's 3 categories here: it's product, it's people and it's pipeline. We're increasing our inventory. And the reason we're increasing our inventory is we anticipate growing demand for the product. We're adding our headcount. We're adding new talent. We're adding new skills and a much bigger team. And from a pipeline perspective, yes, we are making progress in vitiligo. We're making progress in DNA repair, in stroke and in porphyria. And so there's an awful lot happening within the business that certainly justifies that expenditure. Now profitability, as Darren said, it leads to an increase in our cash, it leads to an increase in our investments, our net assets. But as a management team, it gives us options. And that's the fantastic component here that we perhaps don't talk about often enough, but needs to be acknowledged today. The other thing that's really unspoken is that this is beyond what we thought we could achieve. Certainly, when I joined the business in 2007, when we commercialize the product in Europe and in the U.S. in '16 and in 2020. And January '21, when we first announced these projections in the middle of a pandemic, you have to say that you're ahead of where you thought you'd be. Now at that point in time, I think that there was an expectation of the need for more equity at the end of that period, at the end of that 5-year period. Instead, and I say this with my CFO on the line, but this is not guidance, but it's reasonable to expect that you're going to have $150 million, $175 million, $200 million in the bank to be able to grow the business. So I'm not euphoric, and yes, there are things we could have done better, but I have to say I'm pretty content today.

Well, Lachlan, that's excellent context. Thank you very much for that. And Darren, would you like to go into the results in more detail, starting with what Lachlan was mentioning, the revenues and profits that we've generated.

Now look, I'm happy to. It's important to note that we did achieve growth in our revenues through the distribution of SCENESSE in both Europe and the U.S.A. We've seen further patients come on to the treatment, more treatment centers enrolled in our distribution programs. We've now got 70 treatment centers and growing in the U.S.A., and we still maintain a high patient retention rate. That's all underpinning the revenue growth that has been achieved in a 6-month period. It is important to note that there was some impacts to our revenue result through earlier ordering of the implant earlier in the 2023 year that has even a timing impact compared to the prior corresponding period. But from a calendar year perspective, certainly, in the European area, we still maintained a strong single-digit growth rate there, which may not necessarily be flowing through in the underlying numbers that one might see in the results that was announced today. In addition to the revenue result, our other revenues was underpinned by strong interest income result that is consequent of our growing cash balances in this prevailing strong term deposit rate environment that we currently find ourselves in. So overall, that's a 15% revenue and other income result. Profit before tax, as I said, was a 1% increase, but with a slight decline with our after-tax result where it's a 4% decline to the prior period. And that's a consequence of our income tax expense, where we recorded a greater degree of deferred tax benefits in the prior period. So certainly, as you can see on the graph on the screen, this shows the consistency of the business and what it's delivering in terms of its financial performance. We've got over the last 7 comparative period-on-periods, we've got consistent growth both across our revenues and through our profit result.

Indeed. Sorry, Darren.

No. So I think it's important to balance that out with our expenses. So I'm happy to also provide further color on our expense result. So...

Please do. So what drove that increase there?

Yes. So the increase in our expense result was really across just about all of our expense categories that we report. Certainly, underpinning that is in addition to inflationary impacts from 2022 through to 2023 was a 32% growth in our largest expense category, which is our personnel expenses. Now we're no different to many other businesses where our people are the better rock of the success of the company, and we're certainly no different. And were important -- extremely important that we continue to incentivize and ensure that our remuneration remains competitive. And that's flowed through with our expense result where it's a 32% increase driven by an average headcount increase of 10% across the entire business where we're putting on new staff, new roles. On average, a more senior level of roles and ensuring that we remain competitive in the market. That's also been driven by salary increases in the high single digits. Naturally, you're bringing more people on board, our talent acquisition fees also had an impact. In addition to our personnel expenses is the growth in our noncash charge -- accounting charge for our share-based payments. That's also linked to personnel and ensuring that our senior management but also a wider workforce are incentivized to think like their owners of the company. The period-on-period expense charge was a 47% increase. But bearing in mind that the number of the performance rights that underpin the share-based payments expense that were on issue at the end of the reporting period is nearly 90% less than at the start of the reporting period. So that will flow through and deliver a positive impact to this expense category for the second half of the year. Another key driver was the finance, corporate and general result. Now that rose 59%, but much of that is a factor of our increased travel in a post-COVID environment where we are moving around to make sure that we are getting ourselves in front of all -- as many stake over as we can, not only locally but professionally. So locally, but also internationally. In addition, is professional fees and IT fees, it also had an impact on those expenses. So Mal, I hope I answered that question.

That's very comprehensive and a good overview of the revenues and the expenses and the profit after tax of just under $11 million is certainly very creditable. We're going to turn to the balance sheet now, Darren. So first question here, how would you describe our balance sheet position?

Well, I described that as being an exceptionally strong position. Something that our balance sheet is rarely mirrored by our peers both here in Australia and elsewhere. During the 6 months, we witnessed a further rise in our overall assets. Most of that is driven by our generation of cash inflows. That has resulted in increases to our cash and term deposits. And that's -- as you can see by what's been illustrated graphically, it's a strong growth.

Indeed. And effect on the balance sheet, it has been said that it can be described as flawless. I like yours, exceptionally strong. I'll take flawless as well. Look, I do note on the balance sheet, there's a change in classification of cash reserves, and there's a bit of expenditure on our assets. We have a property in the U.K. Can you just comment on those 2 factors?

Well, in relation to the cash and term deposits, we've -- over the past several years, we've obviously, generated a sizable cash position that has resulted in a total amount of $174.6 million for the period up to 31 December. We do put a sizable portion of our cash into term deposits that are held with banks in different maturities and with different interest rates. And these term deposits are mostly liquid and they can be withdrawn prior to the maturity date without an adjustment to their principal. But taking in consideration, what we do commonly see reported by other disclosing entities considering the size of our cash position relative to the rest of our assets on the balance sheet, we have taken the decision to revise our accounting policy as to how we disclose our term deposits. And we've decided to take that out separately from cash and cash equivalents, but in doing so, that did require a reclassification of our prior period numbers to ensure comparability across periods. You also mentioned about the purchase of the property assets. So I guess this does slightly change the makeup of the company's asset mix. We purchased a commercial office property in the U.K. back in July of this year. And that's for the primary purpose to house our growing workforce that is based there in Europe and it's -- obviously, under a post-COVID environment, we wish to encourage our staff to come together, collaborate more effectively and for the company to really offer the best possible environment for our staff to productively work. And as a result, we've -- we made this investment.

And a good one it is. I think, very good to provide the means for our people to collaborate effectively. We're going to turn to Lachlan now on what investors can expect in terms of news from the company for the remainder of this calendar year, Lachlan.

Sure. I think those who follow us closely will know the catalyst -- there we go. You've got them up on screen now. There's 8 different disciplines here. And what I would say is you'll hear more from other members -- the senior members of the team from a company on these in the course of the year. Maybe if I drill down on one, which is the vitiligo program. I think that's where you've had the most questions, Mal, is that right?

Yes. We have a few.

Okay. Let's tackle that. In order to get that program up and running, we obviously had to have the conditions in place. And really, that was to make sure that you had regulatory support for the use of your product and the use of the combination therapy, which is where we are now. So that's the use of SCENESSE alongside narrowband UVB -- you need to pay a support. And so your regulatory approvals are nice, but unless there is somebody willing to pay for this treatment that you really don't have a commercial program. And so you're now seeing that there is an acceptance by insurers in the U.S., which obviously, vitiligo is important, but also in other countries as well to provide treatment for vitiligo patients. And the third thing is, and perhaps even most importantly is, are there physicians who are willing to use this treatment? Is there support in the clinic? Is there support from vitiligo experts to use the product? So with all of that in place, you've now been able to commence the program in CUV105, the Phase III study that started late last year. I'm not going to go into granular detail, except to say that we are making good progress in that program. In parallel, the team is working to make sure that the CUV107 study takes any early learnings from 105 and that they can put that into place and get that study started a little bit later this year. So there's progress across all of these catalysts. If vitiligo is the one where we've had the most interest today, then without going into too much detail, you've made progress. The other thing that I'd say is over time and coming back to the cash position and the strength and the earnings of the business -- I think someone's already challenging the Q&A. Could we have done better? Yes, I think you can -- if you step back and objectively say, could we have done better here? But the flip side is you do have a position, which is strong. You have a good foundation for the business. That's not by accident. That's by design. And it also wasn't certain. So as a shareholder myself, I don't have anxiety towards the business' ability to overcome potential failures, not that I want them, but you need to be in a position to overcome them. You've seen that in much larger businesses of late, but also to tackle any kind of market conditions. So in the context of the catalysts and we've talked about these ones at length and we'll readdress them again, we're pretty confident of the strategy and our ability to execute them.

Yes, indeed. And let's move to some questions. And I'm going to stick with you, Lachlan, because the first question we've received and want to answer is, what can you advise by way of update on the ACTH manufacturing progress and the record free filing time line.

Okay. Yes, good one. I think for those who really want details here, Professor Rosenfeld and Dr. Wolgen really delved into this in great detail at the AGM. So I won't retread that ground. But for those who are interested, jump on to the website, have a look at the AGM, the recording is up there. What I would say is that the time line that was given at that point in time 4 months ago, nearly 5 months ago is that would be about 2 to 3 years to get that product to market. So those time lines still stand. I don't think there's any change in that. But what I would say is that behind the scenes, yes, we're making good progress. The company has really made progress with the validation of manufacturing processes, with the validation of chemistry and the analytical chemistry that goes alongside those processes to get us to a point where we can show bioequivalence of our products and ultimately get to a filing. And that works both with the API manufacturing, which I think we've talked about before, but also with the final product manufacturing.

Right, right. Thanks, Lachlan. Another question is what progress are we achieving to make CLINUVEL a household name by 2026, and I'll take that one. And I think I can tell you that we do have a detailed program to reach audiences to promote the CLINUVEL brand. Those who follow us would know that the Investor Relations and broader communications programs actually have been outlined in detail quite recently. We do believe you will see in coming months progress in all of these areas to progressively bring the CLINUVEL brand to households with a focus on health care, skin care and their own personal well-being. So monitor us and you'll see how we go. Sticking with you, Lachlan, I think you have answered it, but I'll ask it anyway. The status of recruitment of vitiligo. When can we expect an update to be provided on that?

I think I get asked this one every day, Malcolm. I don't know about you, but things have not improved yet. No, we're not going to publish a scoreboard or anything of that nature. But I think that -- yes, an update is due in the not-too-distant future, both in terms of where we are with 105 and where we are at 107. So a bit later this year, we'll get some update on that. But as I say, making good progress with those programs and both Linda Teng and Pilar Balboa are working diligently to make sure that we achieve what we need to achieve.

Well, I can see in your face that we're making progress, Lachlan, and that says a lot. Darren, let's bring you back into the fray. There's a question here and a few questions on the rate of growth of our revenues, on the distribution of SCENESSE, the EPP. Comment is that, that seems to have slowed in recent half years. Can you just provide a bit more color on that?

Yes. I guess what we have seen today is level of concern perhaps about the revenue growth, but it's important to note now that we're more than 8 years into a distribution program that's in an orphan market. So it's important to note that one can't sustain growth rates of 20% to 30% and sustained growth rates at a level that one achieves immediately after market launch. Nevertheless, we are still achieving growth. And we are aware of the underlying demand that still remains firm through interactions that we have with treatment centers and through registered patients interested to receive our drug. So there is clearly an ongoing demand, but one can't expect significant growth and would expect some maturation in the growth rates over time. And that's what we're seeing right now. And I also wish to remind that well, through my -- what I say earlier about the result for in our revenues for the 6 months did have some impact through timing as well. So that just needs to be kept in mind.

Okay. And in that review, Darren, on pricing of SCENESSE. We haven't specifically mentioned too much about that. What's the status update there?

The pricing remain consistent throughout the 6 months, and there's no material change in price across our jurisdictions.

Okay. Fair enough. Discussions during the day with institutions and analysts were on expenses and what we can expect particularly beyond the period of our expenses plan to June of 2025. What can we expect now?

Well, we have obviously given projections through to June 2025, and we're still on track to get those -- to hit those projections. Beyond that we haven't given any additional color. We're obviously extremely reluctant to at this stage. But bear in mind that we are expanding the business, growing the business, widening our R&D programs. And as we do provide more information, we'll give greater insight as to what our longer-term expense projections may be. So yes, we are committed to certainly support and fund all of our expanding programs beyond 2025. And obviously, that would be balanced through continued generation of revenues through our operations.

Okay. All right. So just looking at questions that have been posed. One question was, are we talking about 2024 financial year or calendar year? The catalysts are for the calendar year, for everybody's information. Vitiligo recruitment, would that be done by 6/24? Well, I think we clearly stated in October '23 that it would take until October '24 for recruitment. Correct, Lachlan?

Yes. I mean -- yes.

Yes. Okay. Looking at a few others. All right. Question here on the outlook for CapEx. Darren, would you like to take that?

Yes, that's a good one. Clearly, CapEx will be impacted if there's a material M&A that we would commit to. It will be ongoing CapEx of a smaller scale as part of the continuing reinvestment into our Singapore laboratory operations. And if the -- if it makes sense, we will also consider further CapEx in future office facilities -- in other areas if that makes the right business sense.

Well, it does make sense that we expand for the clinical programs and premises all for the right reasons to expand the business. Look, final question here. Lachlan, has sort of been answered, but when will people get updates on progress of clinical programs?

The short answer is when it comes, but I appreciate that's not helpful now.

Well, you have the catalyst, right?

Well, vitiligo program, yes, we've already stated the intention is to fully enroll 105 by October and to commence 107 this year. And as I said, we're on track. You would expect results from the DNA repair program, the stroke program, the porphyria program. And then as we've said, there are other things that for various commercial reasons we haven't announced yet, but it's certainly coming and may will be this year. And my hope is that we can share that with -- I know there's a lot of interest in it. So I hope we can share that with the rest of our stakeholders pretty soon. But no, this is a year where you will have clinical results and lots of updates from CLINUVEL. And that reflects where we're going in terms of the expenditure, too. So there we go.

Okay. Thank you. Well, I will conclude the meeting and thank Darren and Lachlan for their contribution to the discussion. I always get insights when we get you gentlemen together, and I'm sure all those online appreciate that. I want to thank all the attendees to the webinar, particularly those who submitted questions. We do appreciate your support, and we extend our thanks to the independent analysts on the line. We're pleased to now have 7 analysts covering CLINUVEL, and we acknowledge the diligence you need to exercise and do exercise to provide the ongoing reports on the progress of the company. Want to let everybody know that we will release a summary of this investor webinar to the Australian Securities Exchange for all stakeholders to read at their convenience. I'll now close the webinar. And on behalf of CLINUVEL -- all of us at CLINUVEL, wish all participants good health, progress in their individual objectives. Thank you all.

Thank you, Mal. Thank you, everyone, for attending.