Good evening. I'm Verity Wai Smith from Monsoon Communications. Thank you for joining us for Clinuvel's full year results investor presentation. Please note that this webinar is currently being recorded. I'll now hand over to Malcolm Bull, Head of Australian Operations and Investor Relations, to begin the presentation.
Thank you, Verity, and, welcome to everyone joining us today for Clinuvel's investor webinar on the results for the 2023 financial year. As Verity said, I'm Malcolm Bull. I head Australian Operations and Investor Relations, and I'm joined by our Managing Director, Philippe Wolgen, and Chief Financial Officer, Darren Keamy. Welcome, gentlemen. Today's focus is very much on the great results achieved in the financial year, ended 30 June 2023, while addressing also some of the questions asked by investors. I want us to cover some headlines first, then recap the strategy and activities that have delivered the results before delving into the results themselves. Since we will be looking forward, I draw everyone's attention to the slide currently on screen. It's our forward-looking statement.
This highlights that investors need to remain aware of various business risks that can arise, affecting the realization of planned outcomes, and a copy of this statement is also available on the company's website. With that said, Darren, could you please tell us the headline results?
Thanks, Malcolm. In terms of headlines, revenues and other income for the year rose 24% to AUD 83 million. The profit before tax rose by 33% to AUD 45.6 million, and the profit after tax 47% increased to AUD 30.6 million, marking the seventh consecutive annual profit since the commencement of our commercial distribution of our drug product, SCENESSE. These results reflect a group performing well in the prevailing operating environment.
Thanks, Darren. They are impressive, impressive results. Now, before we discuss the results, I'd like to turn to Philippe to summarize the company's strategy and overview the activities of the year, because this provides context to the results achieved.
Sure. Thank you, Malcolm and Darren. Good morning to all of you. So let's cover the company's strategy and activities first. I would need to acknowledge from this place the outstanding results, which are owing to the hard work of the Clinuvel team, who made this all possible, no exception. These results are really not a constant. We take that, not take that for granted at all. Each patient, each physician, each shipment is subject to intense labor and scrutiny, and the year-on-year growth is entirely attributable to the work of the growing teams. Now, on Clinuvel's strategy, its evolution should well be, well be understood by now.
We've developed the business over the years from 2005 to 2016 to focus on development of a family of melanocortin hormones, which would need to be used with care in certain diseases, and from 2016 to 2023, we focused on increasing the commercial footholds of the company in Europe, U.S., Israel, and recently, Canada. In summarizing our strategy, we started off by developing the lead product in a relatively new field, photomedicine, and gradually expanded from skin to brain disorders. In essence, our chosen path is to concentrically expand our activities around the family of hormones, making us specialists in this field, and thereby adding a specialized consumer business to our quiver. We call that PhotoCosmetics. So photomedicine and PhotoCosmetics go hand in hand. These are two domains that complement each other.
And our long-term objectives are to expand, one, the use of melanocortins with SCENESSE, PRÉNUMBRA Instant, and NEURACTHEL Instant, and more melanocortins to come from our pharmaceutical division. The use of new formulations, that's the ways of delivering molecules to our body. And third, the venturing into specialized PhotoCosmetics, giving us an advantage of using the peptides in consumer products for three categories: people with highest need for photoprotection, those that needs a DNA-assisted repair, and those that seek an MSH response. So in contrast to many other biopharmaceutical companies, we did not open our R&D register from the word go, but gradually turned Clinuvel profitable and thereby diversified our business from our core competencies. It's almost a reverse strategy for of what one is used to in our industry.
We focus in the beginning, we widen our register midway and when the earnings allow it, and then full throttle on R&D towards the end game. So another way to summarize really the strategy and activities for the past year, 2023, is that we focused on the ongoing distribution of SCENESSE in Europe, Switzerland, Israel, U.S., and now Canada. We advanced the use of afamelanotide in clinical trials for DNA repair, repigmentation, and the central nervous system disorders, stroke. The development of the melanocortin drug portfolio, its expansion, the ongoing development of the PhotoCosmetic product range... and we needed a discipline to advance the portfolio, grow the company with the increasing profitability annually. And to put all this in context, we spent around AUD 10 million in 2017.
The revenues were, at the time, AUD 16 million , and seven years on, we have increased our expenses by a factor of 3.7, while the revenues grew by a factor of five. So that summarizes, Malcolm, the strategy and the direction of the company.
It certainly does, Philippe. But with reference to these areas of activity,
Mm-hmm.
Can I ask you, what achievement stood out this year for you, Philippe?
Well, the many activities that stood out, some of them are public, some of them are in-house, since they're commercially sensitive. But some of the highlights were, we established a standard of care in EPP with SCENESSE, with a increasing demand year on year. More centers, more physicians, more patients, the average number of prescriptions has gone up. It was also very encouraging to see the first case reports on the use of the drug in adolescent EPP patients in Europe, and we're now working to enable the broader access for the drug to these patients. We progressed studies in DNA repair, XP and stroke, and vitiligo. We saw the first stride made towards the CUV105, the larger vitiligo study in Europe and U.S.
PRÉNUMBRA Instant formulation was first used in the second stroke study, 803. We progressed key manufacturing steps for the program ACTH and NEURACTHEL. We launched the first pilot study for our PhotoCosmetic product, CYACÊLLE, a polychromatic solar protection. On the communications front, the company maintained a peer-leading frequency and diversified its communications avenues. So all in all, it's been a pretty successful year so far.
Great. Thanks, Philippe. So let's turn back to the financial results, because I know, Darren, you'd like to provide us some more details, so please go ahead.
Yeah, certainly, Mal. Look, I'll take some time to highlight some of the key elements. Please bear in mind that the figures are expressed in Australian dollars, and they are rounded for ease of reference. So, look, as mentioned earlier, in addition to the total revenues and the profit outcomes, our total expenses of the business rose 15% to AUD 37.4 million. Net assets increased by 31% to AUD 164.6 million. With the key change to the balance sheet being the substantial rise in the cash balances, where there was a 29% increase to AUD 156.8 million. Two other key measures of performance that are worth mentioning is the return of equity result of 19%, as well as earnings per share of AUD 0.62.
To cap off these results, and to recognize the support of our shareholders, as the board has declared another annual dividend, this is the 6th year running. This year it is AUD 0.05 per share, so that's a 25% increase to last year's dividend distribution result, and which was in turn a 60% increase to the AUD 0.025 per share back in financial year 2021.
Right. Thanks, Darren. So yes, seven consecutive annual profits and six consecutive annual dividends. I'd say they're results to be proud of. What are your thoughts on the results?
Yeah, well, I'm happy with the outcome, and it certainly is an outcome that has exceeded our own internal expectations. I'd just like to take this opportunity, too, to say thanks to my finance team, who worked very hard to pull these results together, but also to thank my colleagues across Clinuvel, who worked extremely hard throughout the year to deliver these results.
Yes, very much a team result. Can you talk to the details on revenues, expenses and profit for the year? But as you do, also the trend over the past seven years since the commencement of commercial distribution of SCENESSE.
Okay. Okay. So, well, with revenues, there was continuing growth through the year, and that was driven by further progress in increasing our patient base and the number of treatment centers and continuing high patient retention throughout, not only in Europe, but also in the U.S. Other revenues was also boosted by higher returns through our passive income from our high returns on our cash balances in an environment of increasing interest rate yields. And in turn, from the expense side of things, with an increase of 15%, as previously noted, the increases was really across all of our expense categories, and that is reflective of the group's growth and expansion initiatives.
So consequently, our profits have increased with both the net profit before and after tax, and those levels were at the highest that the company has achieved on an annual basis. So when you talk about over the longer term, the past several years, we've seen from the time of our, the commencement of our commercial distribution programs, that the group has achieved a consistent growth, not only in revenues, but also in profits. And in turn, that has seen our cash balances consistently increase through our net cash inflows. Now, our compound annual growth rates over the last seven years has been 42% for our revenues and 20% growth for our expenses. And that this growth reflects the increase in the number of patients treated, more physicians that are prescribing, high patient retention, and more demand.
It also reflects the efficiencies that have been gained throughout the Clinuvel business, that and of its team to proactively support our distribution through active collaboration with our physicians, but also with the ultimate payors, the insurers, the accredited centers, and to patients themselves. So this control of the value chain is the consequence of our integrated business model, which is really to ensure that we undertake as much of the key functions in-house, and ultimately with the aim to translate to better results than what would have otherwise been incurred had we utilized more of an outsourced business model.
Okay. On expenses then, Darren, what drove that 15% increase?
Well, the 15% increase was really driven across all of our expense categories, and that's certainly to support the expansion of the group's activities. You know, embedded within all that is the general inflationary impacts. The increase of personnel that we've required to bring in new skills and related expenses is clearly continues to be our largest category, and that rose by 17%. And we also saw a large increase in the materials and related expenses throughout the business that was offset by our changes in inventories. In addition to all of that, our commercial distribution expense category, as well as our finance in general, rose by 26% and 40%, respectively.
Okay, so sticking with expenses, as you know, we've projected a positive trend in expenses over the five years to the 30th of June 2025, to support growth and expansion. We've now completed three of the five years, so where do we stand, Darren, in relation to the plan to incur the expenses up to AUD 175 million by June 2025?
Well, we have incurred AUD 93 million, or 53% of the projected amount. We're at the end of year three of the five-year plan, so we are on track on hitting the target of AUD 175 million. Please bear in mind that this does not include CapEx, nor expenses that might be associated with the branding and marketing of the PhotoC osmetic product range. Also, bear in mind that when the plan was formed, the inflation rate was far more modest than what we see it now, and this has increased higher than what we had originally anticipated.
Right. Now, turning to the balance sheet, and a very strong one at that, what would you like to say about it?
Well, this time last year, our balance sheet saw our assets certainly tower over our liabilities, and it's much the same this year. In fact, it's accentuated. We've increased our net assets by 31% in the past year, and that's predominantly been driven by our increase in cash reserves. The balance sheet continues to be absent of any debt or leverage, and our high liquidity is really due to, you know, all of our cash reserves. Our liabilities has certainly grown. That's is predominantly reflected in trade payables and our short-term tax obligations, and that this is clearly more than covered by our cash reserves.
We actively manage the balance sheet with particular focus on our trade receivables and our trade payables, and we certainly focus on ensuring that our accumulated cash reserves works well for us through our term deposits. And that's certainly working to aid in funding our future business growth.
Right. So looking forward, we've been asked about the key catalysts for 2024 and beyond, and there are a few that I want to highlight. Philippe mentioned the use of SCENESSE in adolescent patients, and we do expect updates on the proposed European label expansion. Clinically, there's a lot going on. There should be further results from the DNA repair and stroke programs, and the commencement and progress of something I'm very interested in, and I know many other shareholders are, CUV105, a late-stage study in vitiligo. In PhotoCosmetics, there will be global launch events of CYACÊLLE and ongoing development of the DNA repair and melanogenesis product lines. And all this will crystallize to ensure that Clinuvel becomes a widely disseminated name.... Now, we can now turn to some specific questions, and I'll get straight into them.
First, for you, Philippe, on the pace of commercial growth, what can be expected? It's the questions. Given similar questions were posed last year, I guess you can say growth is always on the mind of our investors and our analysts. So can you address this, please?
Well, the appreciation is there to, to focus on growth. And then I stress again, although we don't provide forward guidance, we believe that we could see robust growth paths ahead of us in the distribution of SCENESSE®, in EPP, and that goes for all markets. We continue to expect growth in patient numbers, prescribing doctors, treatment centers. So there is, at this stage, there is no information, there's no reason to believe that growth should stagnate or flatten out at all.
Okay. We've also received questions on the pace of scientific growth and research and development. So can you comment on what we can expect from CUV in the next few years, Philippe?
Yeah, again, so the keyword growth in pharmaceuticals comes with considerable risk, especially when it comes to concerns, innovation and innovative technologies. Failing in innovation comes at a high price, value disruption, and then often irreversible loss of confidence. So therefore, we've always tried, and do that now, to minimize development risks by gradually increasing our knowledge and data, and trying to find solutions to technological problems, which we believe can and need to be solved in time. We've recently seen in Australian life science markets and also in the U.S., how failure to deliver novel technologies can decimate one's value one day, and recover is then really different from that position. So therefore, risks of innovation should better be taken when the balance sheet can afford it.
In other words, when one is not dependent on equity or debt, and when the share price is not exuberantly priced. So the pace of R&D can and should be higher, for sure, but it's more a function of the complexity of working with melanocortins and its bioavailability than resources. So I'm pretty confident the team will continue to deliver that these three pharmaceutical products, three PhotoC osmetic products and new markets, and vitiligo and XP will be the new additions to our existing market. Yeah.
Some questions have been on our clinical progress and timelines. Speaking with you, Philippe, what can you say or what would you like to say about that?
Well, those that make comments are not always in the best position to appreciate the issues associated with undertaking clinical studies involving ill people and the external factors that can impact the pace of the studies. As a matter of fact, one should carefully select with whom a company wishes to work because the prescribing physicians in clinical trials may well become the prescribers commercially when the drug comes to market. So to give you a concrete example, and the word strategy is loaded with an important notion. In the U.S., we've chosen for direct distribution business unlike most pharmaceuticals. That has both advantage and disadvantages, but it played out well for us.
In the EPP market, we selected and trained accredited, prescribing centers, and each center requires diligence, careful qualification, selection, and we now have over 60 centers trained and accredited to prescribe SCENESSE. But in addition, we anticipated the vitiligo market. So in expanding our foothold in the EPP, we were already thinking about vitiligo and the distribution of SCENESSE once it would come to market for the, the second indication, vitiligo. So whereas most market experts had said that we would not be able to set up this and distribute, negotiate the pricing in the U.S. and Europe, our teams have delivered on both fronts. So the same critique we've heard about the vitiligo market, but our aim is to train and accredit 120 centers spread over the U.S., such that we actually will be able to directly distribute SCENESSE to vitiligo centers worldwide.
In doing so, you try to steer away from the current and future competitors. So pace, yes, that's an important part of the strategy. There's execution along an adjustable path until we reach our target, and then we proceed to the next set of objectives. Time is of essence, for sure, since we are moving on in time, but it's subservient to the objectives to building strength, intrinsic value. So for instance, having 120 prescribers believing in the product and willing to prescribe it is perhaps not reflected in one's share price, but it surely provides much value to a company. So I hope that this explicit example gives you an idea of how we think and how we work.
I'm gonna return to expenses, and that's focused on you, Darren. Can you tell us what proportion of our total expenses is R&D, and why we don't report our R&D expenses as a separate line item?
Well, Clinuvel's R&D expenses is not just the clinical and non-clinical, research and development line that appears in the income statement within our annual report. Our R&D expenses are really spread across a number of different expense categories. That's, for example, we can reflect that the R&D center in Singapore is nearly wholly R&D in nature, and the expenses that is incurred within that business is spread across a range of the line items: materials and related expenses, depreciation, finance, corporate, general, and most notably, personnel expenses. So this reflects our integrated business model, in which we've got key functions undertaken in-house, and I raised this earlier. And you know, many of these functions do harbor R&D components in it.
So this gives us more control over our costs, and, you know, we believe it heightens the quality of outcomes that is achieved. So our R&D-related expenses in any given year can range from between 20%-40% of total annual expenses, and that just depends on the intensity of the activities in that particular year and along with the timing of the expenses.
Okay. So you just broke up a little bit there. So you said that, R&D can range from 30%-40% of total annual expenses?
Yeah.
As you said, depending on the intensity.
Yeah.
So, yeah, that, that answers the question. And, I'm gonna turn back to you, Philippe, because we've had questions, generally on how we are managing the diversification strategy. Some take on your point about the risk associated with that. So comment on how we're managing our diversification.
Well, with great care, but also remaining conscious of the risks that come with rapid expansion. Yet we are advancing on all fronts against our scorecard. I think that the key success lies in the people you attract, the new skills, engineers, biochemists, financial managers, controllers, in-house lawyer, specialists, and that talent needs to have its time to learn the ropes within the company, grow into the specific subjects, and be retained over a longer period of time. And once that foundation is laid, the rest falls into place.
All right. So comment also on the expansion of our business. Some investors are a bit uncertain about the direction of the business. So give you the opportunity to clarify that, Philippe.
Well, there should not be any reason to be uncertain. I'm happy to speak about direction, expansion, and diversification of the pharmaceutical companies and exactly how we're doing and what we're doing. And we've divided that among management and board into nine steps. And we first undertook the launch of the first-in-class molecule, afamelanotide, in a genetic disorder. The second, we diversified by working the life cycle of the molecule and coming up with next generations of the molecule in new formulations. Third, we expanded by bringing in generic melanocortin, NEURACTHEL, ACTH, which gives us exposure to larger markets. The fourth step, we introduced smaller molecules for transdermal use. Fifth, we enter in consumer markets as a pharmaceutical company. As a sixth step, we enhance our skill base by growing the company organically, so from within.
Seventh, we bring in manufacturing. The eighth step is we set up a communication, branding, marketing team, which is pretty specific to Clinuvel, in order to reach more audiences and turn Clinuvel into a globally recognized name in consumer markets. And ninth, we diversify by by merge and acquisition. So there's a stepwise and gradual expansion. And this is, in our view, the way to withstand market oscillations, and in doing so, we are at the same time increasing our cash buffers for further investments. And the one word that then jumps out is discipline across all functions, and our teams have shown this now for two decades, and there's no reason why it shouldn't continue.
So, this is a moment to answer the risk, and in answering it, in the previous perception of building a company on one product company needed to be mitigated. We stepped away from this risk and are building a group in a deliberate manner by having nine different avenues of expansion, and thereby you lower the business risks, which is notoriously high in bioinnovators. So our people count has increased by 95% over the last four years. We've expanded the executive management team to nine, with a median tenure of 16 years, and then it's up to us for the next generation of talent to integrate them across all the functions. And for all this to occur, you need focus, discipline, and continuity, as we've shown the last two decades.
Well, that is a comprehensive answer, so thanks for that, Philippe. And I move to a final question, and it's to you, Philippe, about your tenure as CEO, which expires 30 June 2025. Many would like an update on your position and/or replacement.
Well, first of all, I intend to serve out my employment agreement, which ends on the 30th of June 2025. And thereafter, the board will find its successor, and that work will be ongoing, so there's a smooth transition. There's not much more to say about it. We've got a task ahead. We've got a painting to complete, and we're well on track, so it's probably the best day to talk about it. But we are talking at the day at the greatest achievement of the company in its history, so I'm looking forward.
Yes, I know you are. But it is time now for us to conclude the investor webinar. With thanks to Darren and Philippe for their informative comments and frank answers to questions.
Thanks, Phil.
Pleasure. Thank you, Malcolm, for hosting it.
My pleasure, and thank you to all attendees of the webinar and to those who submitted questions. We grouped them together, put them in themes, and tried to address as many of them as we could. We do appreciate your support throughout the year, and we trust all shareholders welcome the dividend payment coming your way. A transcript of this investor webinar will be released to the Australian Securities Exchange for all stakeholders to read at their convenience. Now, the next key shareholder event is the Annual General Meeting 2023, which will be held late in October in Melbourne, and this will be an in-person meeting and provide an opportunity for shareholders, wherever they are, to dial in and view the meeting.
So at this time, we wish you all good health and progress in your individual objectives, and thank you again for your support of Clinuvel.
Thank you.
Thank you very much.