Clinuvel Pharmaceuticals Limited (CUV) Earnings Call Transcript & Summary

Well there's a lot to look forward to in 2025. It's a privilege to be able to sit in this position because we intention deliberately worked for years towards a point where we could fund all these initiatives simultaneously in the company without subjecting shareholders to more leverage or equity funding. And with AUD 200 million more in cash at the moment, we're able to fund the clinical programs, the regulatory programs, but also translate the technology into PhotoCosmetics and sustainable level of marketing of 3 to 4 years without jeopardizing the company. And the first examples of these heightened increased activities will be seen in Q1 2025, where the company is for the first time being written up by editorials and newspapers, industry press, magazines, videos, and that will culminate between the 6th and the 11th of March to the biggest dermatology conference in the world, the American Academy of Dermatology in Orlando with 450 square meters floor space and showcase its technology, its present and future status in vitiligo and thereby calling the attention of 20,000 delegates in dermatology, bringing home the technology that came from the U.S. but it is going to provide a solution for vitiligo patients of dark skin color, 3, 4, 5 and 6. It is the largest exhibition and the largest showcase in the history of the company. And that will attract visibility in the company, no doubt. Well, off the back, I need to say that the objectives of the company are being met as we speak over and beyond our own expectations and over and beyond our own beliefs. The first objective was to make the company solvent and make sure that the company would be able to remain independent capital markets. Now that objectives went further because we then adjusted our goals and said, well, this is not sufficient. We also want the company to be able to self-fund its initiatives. And those initiatives that would generate value to shareholders long term, but also those initiatives that would stand the highest chance of passing regulatory scrutiny, FDA and EMA, and we assigned at the AGM in October 2024, a probability of more than 60% for vitiligo coming to market and attracting reimbursement funding from insurers and state insurers. And the same goes for STH as a generic and branded version of the existing drug. The second objective was to be able to fund the new research development in molecules, formulations and the third one to translate the know-how and these technologies important to transdermal formulations, a long quest that many companies have abandoned because they did not possess the abundance of clinical data that the company generated over decades. But fourth and not last, the requisite to be able to execute all these plans in the future is the ability to attract high caliber of talent joining a company that has sufficient funding to execute the plans of 5 years or more. And we are nearing that point. But it is true that we've seen a decline in share price. Actually, we've seen a fluctuation in markets for a decade. At points where the company's fundamentals were weak, we commanded a price earnings ratio of 90% or more. At times where we were uncertain whether we will get regulatory approval or reimbursement, the company's share price surge. But the company is today at its strongest point in history. It has its highest cash reserves and the prospect of more to come in future years. And we see a disparity in value. And therefore, I can only say to you, we've been there before and the temporary decline in share price is no reflection of what we intend to do with the cash in the company in the future for its technologies. It is correct that we initiated an on-market buyback program given confidence to shareholders that we believe that the share price and the value of the company is not commensurate to the progress of the company. We are privy to technology. We're privy to information data, we're privy to for sellers. And we also blocked at certain times of trading our own shares. In general, the Board and I are fan of share buybacks. It boost the confidence and it boost the share price. However, it does constrict the share capital. They make the stock somehow illiquid. However, in biotechnology, where there is a finite -- a limited pool of resources with an unlimited need for resources, it's a different matter altogether. And we've proven and we are precise in being able to forecast our expenditures, our needs in the future. We're also able to forecast the cash flows coming to us in the next couple of years. And that's aggregation of information and planning and budget-free requirements make that we first and foremost need to protect shareholders from the long-term perils and jeopardies of companies like Clinuvel. We have a long-term view of how to execute the plan, how to bring SCENESSE to market for vitiligo, being able to market and distribute it ourselves. We've got a long-term view of how executes STH as a generic and branded generic. We've got a long-term view of how to increase the visibility in consumer markets for the photo cosmetics. And we have no short-term view of how to use our cash. Now I speak to you both as Managing Director, but also as the largest single shareholder of this company. It would be absolutely beneficial to me to redistribute wealth to shareholders to not only buyback shares, but to issue special dividends. But the interest of the company prevail long term, and we will surprise the market when and if appropriate to redistribute wealth. Well, that is the most exhilarating part. It's a privileged position to be able to talk about expansion to contemplate how you're going to expand and when because you intentionally worked for decades towards that point that you're able to finance it. You're able to finance the research and development innovation in-house of molecules, formulations, clinical programs, regulatory programs, but you're also able to fund the acquisitions needed to fortify the supply chain of the company and attract the talent. And so in spite of a temporary decline of share price, we are internally more confident than ever that we are going to reach our objectives. And in Q1 2025, those that support the company will see the fruits of labor of years preparation. So we did want to leave you on a high note with a smile at Christmas and perhaps an even better story to tell during the Christmas dinner. And we will share with you an image that we frequently receive from physicians who finally have an answer to their patients of color, those patients that are diagnosed with vitiligo or the loss of pigmentation total body. And first of all, the 3 benefits that we propose with our medicinal product is that we offer a systemic solution for systemic disease, a disease that affects the total body. The second, that we do not affect the immune system like our competitors. And therefore, we control the side effects short and midterm. And third of all, and that is the real bonus and the real benefit of the treatment we provide, the process of repigmentation in a matter of weeks and months and not like our competitors do in a matter of years. And I share with you these images on the left-hand side is the baseline. It's the status of the patient before she enters treatment. She's getting isolated from society because she doesn't want to participate in daily social activities because she fears that the pigmentation -- this depigmentation is threatened. And what you see on the left-hand side is the baseline is the starting point of the patient before she enters the treatment. She shows gradual increase of loss pigmentation on the face. On the right-hand side, you see 4 months later after providing the medicinal products, and we exaggerate the pigmentation. We make patients darker temporarily before they return back to baseline at the end of the treatment, but by which time they would have repigmented totally, and we restore their confidence and self-esteem. This is very rare in pharmaceutical drug development. It's very rare in pharmaceutical drug development to see a treatment whereby the visible impact, the visible efficacy is seen within weeks and months. And that gives a lot of confidence to physicians and patients to prolong the treatment. And on this note, I wish you happy holidays, time of reflection and hope to see you at the other end in 2025.