Good evening. I'm Verity Wei Smith from Monsoon Communications. Thank you for joining us for Clinuvel's full year results investor presentation. Please note that this webinar is being recorded and will be uploaded onto Clinuvel's website. Before we begin, I'd like to remind everyone that you can submit questions using the Q&A chat function. I'll now hand over to Malcolm Bull to begin the presentation. Thank you, Verity. Welcome to everyone joining us today for this briefing on the financial results of Clinuvel Pharmaceuticals for the financial year ending 30 June 2021. As mentioned, I'm Malcolm Bull, head of investor relations for Clinuvel. Joining me to discuss the results is Dr. Philippe Wolgen, Managing Director, and Mr. Darren Keamy, Chief Financial Officer. Welcome, Philippe and Darren. Hi, Malcolm. Good morning. Okay. You just need to know that we're streaming this webinar at 6:00 P.M. in Melbourne, so European visitors can dial in at the start of their business day. Noting it's very early morning for U.S. attendees. The format of today's webinar is to ask Darren Keamy, Chief Financial Officer, to provide details of the results for the year ending 30 June 2021, and I will also invite Dr. Wolgen to comment on the results from his MD operational and strategic viewpoint. We have received a number of questions from shareholders and analysts, which are covered in this webinar, and although questions may still be posted during this webinar, we may not be able to address them all in the time we have today. Please also note the financial year 2021 results were posted eight hours ago to the Australian Stock Exchange with news communique number 4 and a general corporate presentation. Clinuvel has received a number of requests for press interviews, and our Managing Director has presented today to TV and print media, and will address the German-speaking shareholders on Friday via a YouTube interview. Finally, note that all figures mentioned and reported are in Australian dollars. Attendees are advised to refer to the Appendix 4E preliminary financial report on our website for more information. Without further ado, Mr. Keamy, Darren, can you first provide a summary of the results as announced to the ASX earlier today? Yeah. It's my pleasure. Thank you. To start off with the headline revenues, expenses, and profit figures. In the 2021 financial year, the Clinuvel group achieved record annual revenues of AUD 48.45 million. It's a 43% increase compared to the 2020 financial year. At AUD 22.73 million, expenses were relatively constant, with an increase of only 2% to the previous year. Net profit before tax was also a record AUD 25.71 million. The after-tax profit result was AUD 24.72 million. Another high for Clinuvel. Thanks, Darren. Before we delve into the results, the audience today may well like to know how you interpret these results as the longstanding CFO of the company. Look, it's an excellent result. FY 2021 is our fifth consecutive year of positive cash flows and profits since we commenced commercial operations back in June 2016 in Europe, following the marketing authorization from the EMA. It also marks the first full year of commercial operations in the U.S., which have made a meaningful contribution to this year's results. It's extremely satisfying to be part of the growth story in Clinuvel, where the journey's taken me through the R&D phase, right through to commercialization of SCENESSE, and now to be working on the growth of commercial operations and expanding the R&D program to treat other patient groups, but also to develop new products. I agree with you. These are excellent results and should fill all stakeholders of Clinuvel with pride. I now wish to invite our Managing Director, Dr. Philippe Wolgen, to comment on the results for financial year 2021. Thank you, Mr. Bull, Mr. Keamy, and also for the hard work done the past 12 months. It has been exceptional and much appreciated. The Clinuvel 2021 performance asks for a fundamental discussion on its operations and underlying business model. That's why I'd like to start with the financial year 2021. We have aggressively increased our staff, working from seven countries, four continents, and that was really done to ensure that we better control the distribution and market access. We increased the group's research, development, and innovation capabilities in Singapore. In doing so, we continued to invest with a modest 2% increase in expenses. The rise was modest since we had already increased from financial year 2019 to 2020. In accounting for the direct and indirect costs, we generally reinvest about 40% of our revenues to enable further organic growth. In keeping with our mission to select, train, and accredit prescribing centers and monitor these patients and physicians long- term. We continue direct distribution to all hospitals and special medical centers in Europe and in the U.S., very much reflecting the decision we made in 2014 to establish this and follow the business model. We not only managed to grow the number of credit centers, we also managed to grow the number of patients, the number of SCENESSE administrations. In the U.S., our team managed to secure novel treatment codes, which facilitated the automatic processing by the insurers to allow the new hormonal treatment to reach Porphyria centers faster. As a result of making these resources available at times when the world was actually constricting, we actually grew global revenues by 47%, yielding our EBIT, which increased by 123% to AUD 25.7 million. I'm generally more interested in the long range effects of our strategic measures, not just the 12 months results. I want us to keep in mind a much longer horizon. We zoomed in on the compounded annual growth rates since 2016, with a CAGR of 46% over the last 12 months, as you see on slide. The solid trend in revenues since the percentage of orders and payments occurred prior to the book year of 2020. In all, we witness a linear compounded growth five consecutive years with double-digit expansion rates. In the next graph, you see the orientation of expenditures reflecting our gradual and controlled increase in research, development, and innovation. As the shareholders of Clinuvel are used to us, the expenditures have been scrupulously controlled, and the financial management of capital has largely contributed to the strong balance sheet of the group that we enjoy today to withstand the cyclicality in the markets. Our expenditures have grown year-on-year, but leveled off from 2020 to 2021. Taking these considerations further, we now zero in on the net profits after tax as found of the last five years. Again, here one sees a double-digit increase year-on-year to 2021, a CAGR of 51% for the last 12 months in net profits. As alluded to moments ago, we chose in 2014, a distinct commercial approach, which would provide Clinuvel a competitive advantage. Yet it was not habitual in our pharmaceutical sector and certainly not a familiar path in Australia. We established our own team in Europe and in the U.S. to execute a formal hospital monitoring program and providing us essential long-term safety and measures of efficacy. Staying with the same anthem, we instituted the market access and distribution team in-house in both continents to directly engage with the hospitals and the insurers on both sides of the Atlantic. For the new attendees today and the shareholders that know us, in 2014, we judged the 3 core production, were the idea to sell the company and to realize the value then, to enter a license agreement to distribute SCENESSE, or to integrate all the commercial functions in-house and go ourselves. As you know, we opted for the third options to go ourselves. Today's glowing results not only fortify once more the linear trajectory of Clinuvel, but the numbers directly correlate with the risk analysis we made in 2014 and the decisions we took as a board to set up in Europe and the U.S., the operations. This very decision has greatly benefited patients and the families and the overwhelming majority of shareholders at Clinuvel today. At this point in time, I must really publicly acknowledge all my staff and board, and I call it all the cogs in the wheel, the small and the large, who have made Clinuvel, and it's a timepiece. Tick with an incredible precision in an environment where we lived under restricted and constricted conditions. These results provide a foundation for more activities, further expansions, both organically and inorganically. Over to you, Mr. Bull. Thank you, Dr. Wolgen. Great context of the strategy and ongoing operations. Mr. Keamy, we're going to stick with you for a few questions. You commented in the past on the sustainability of the business. Can you give us your thoughts on this topic? Well, as I previously mentioned, we've just posted our 5th consecutive profit, and our cash reserves have increased to a level that should be sufficient to self-finance our planned expansion. Now, this indicates fiscal sustainability, but it's not just about what we've achieved financially. It's also how evolved the business processes have gone to achieve long-term sustainability. We strive to be able to operate independently without risk of insolvency. We've come a long way since when I first joined the company where we had around two quarters of cash in the bank. We feel well placed to continue serving our patients and all our stakeholders. We are committed to grow the commercial part of the business and translate our pharmaceutical technology to other indications, and also to wider populations who have an unaddressed need of protection and DNA repair. These are potentially larger markets than the existing pharmaceutical business based on the treatment of EPP patients. We're working in parallel on long-term growth to progress our recent track record for many more years of positive performance. Okay. Now, let's delve into the results. Something a number of shareholders have asked, but starting with revenues, what's driven the significant rise in revenues? Well, I'll cover Europe and then move to the U.S. In Europe, revenues were impacted towards the end of the last financial year by the initial COVID outbreak that spread across the European continent. During the current financial year, or FY 2021, we saw patients who had found it previously difficult to get treatment return to the expert centers, and we also saw new patients receive treatment for the first time. Overall, there was a rise in revenues across the European economic area, although the impact was constrained when we converted European revenues to our Australian dollar reporting currency, which had strengthened year- on- year. Now, if I go to the U.S., where we commenced commercial operations with initial orders in April 2020, that was towards the end of the prior financial year. The completed financial year, however, gives us a good 12-month overview of our revenues, and it's a good measure of how we've entered a new continent where we've implemented a system to run our U.S. commercial operations. In the U.S., we've experienced strong physicians' willingness to prescribe the new treatment. Training and accreditation has required much of our resources and time. We've expanded the number of specialty centers throughout the U.S., and the insurances needed to be engaged in each state with their own rules and regulations. As Dr. Wolgen had stated, we'd secured novel treatment codes for a prescriptive treatment, which had not existed before for these insurers, so we needed to educate each and every insurer in all the U.S. states. In general, there was a lot of red tape that we had to navigate through to get a new treatment onto the insurer's list. Now, we feel that we've executed well, and we've obtained faster prior authorization status for many individual insurers than what we had previously done at the start of the launch, at the tail end of FY 2020. This has resulted in a faster turnaround times, less travel time for patients, and faster booking of appointments by the patients. In addition to that, our team in the U.S., led by Dr. Linda Teng, has done an outstanding job in distributing and assisting the insurers and patients, much in the same way that our European team have done through Mrs. Gallucci, Dr. Azza Hamila, and Mr. Lachlan Hay had accomplished in Europe over the past five years. The U.S. team have trained and accredited over 40 centers, which that compares to our plan of 30 centers that we had initially earmarked by the end of 2021. We have over 60 national and state-based private insurers reimbursing the cost of treatment under prior authorization. The sum of our U.S. patients have now experienced year-round treatment. This reflects a willingness from those patients to continue treatment. It does demonstrate the value that our drug does provide to our patients. Can I add that in addition to Europe and the U.S., that we've also entered a new region, being the Middle East, where we've obtained a breakthrough in Israel, where we have the right to distribute SCENESSE to patients who live all year round in an isolated state such as Israel due to the intensity of the lights and intense heat. Yes. I hope that answers that question. Yes, Darren, and we've got more for you. Shareholders are very interested in the U.S. rollout, so let's continue that theme. Can you provide more information on U.S. cash receipts as well as the receipt cycle in Europe compared to the U.S.? Yeah. In the U.S., what we've seen so far is our cash receipts are expected to be less seasonal since the approval of the FDA does allow treatment every 60 days, all year round. This means for the same number of patients, the frequency of treatments provided could be higher in some states all year round than what we generally see in Europe, and the cash receipts tend to follow that trend. We'll see a more constant cash receipt stream coming out of the U.S. than what we have in Europe. The cash receipts cycle in Europe is fairly short, with payment being made to Clinuvel in around 30-60 days from placement of order. In the U.S., apparently that cycle is longer. With the new unique treatment codes that have recently been implemented, we're optimistic that this period will reduce further. Okay. A shareholder has asked simply, what is the pricing policy of the company? Well, we operate a uniform net price for SCENESSE within each continent, and that reflects our frequent communication on this topic, covering the values of fairness and equitability to patients, to insurers, and to physicians as well. We have two different distribution systems, one for the U.S. and one across Europe, and the pressure's on us to treat the insurers in an equitable manner in both U.S., and also treating European insurers consistently. The reception from U.S. insurers and European payers has been very positive since the company has behaved differently than most other pharmaceutical companies. We find ourselves now working to implement a CPI increase in the price across Europe, since the price has not changed since we commenced operations back in early 2017, and our underlying cost base has increased year-on-year. Okay, let's turn to expenses. Again, shareholder comments received that expenses have grown by 2%, far less than the previous financial year. Why is this? Yeah given that Clinuvel has increased its commercial operations and expanded our clinical programs? Last year we'd already spent much on the capital infrastructure and expenditures in our new facilities in Singapore. This year, that 2% increase is owing to reinvestment in R&D, in our innovation, appointing new qualified and experienced managers, and towards expenditures in raw materials and supplies. There was also increases across the business, particularly in the freight and handling. These were also partly offset by savings in other areas. Key items that we saw was cost savings in responding to regulatory audits and bringing communication programs in-house. We also saw a large reduction in local and international staff travel due to COVID, and that had an impact on our expense result. The increase this year was modest compared to what we saw last year, where we had a significant 55% increase in expenses from the year previous to last year. The costs therefore on balance remained the same over the two years, but nonetheless, they have increased, as I said, by over 50% to support the growth and the expansion of the group's activities. I know Dr. Wolgen will be covering more about this, certainly in regards to the outlook for our expenses in our next strategic update later in September. Thus, investors, shareholders, and analysts can get further insight there. Okay. Not taking away from that forthcoming analysis from Dr. Wolgen, do you foresee, though, an increase in costs in the clinical program since the world and hospitals start to pay more attention and undertake more clinical trials? Well, yeah. The short answer is yes. Certainly, the commencement of a larger vitiligo study will see R&D expenses increase. Bearing in mind that the forthcoming phase II clinical studies in XP and in AIS are much smaller in size. Over time, larger studies will have an impact across our total absolute value of our R&D expenses. Our R&D expenses certainly will increase as we further progress in our product and formulation development program. Whether R&D expenses will rise as a proportion of total expenses completely depends on the need to incur expenses to support the overall growth across all areas of our business. I know we'll be working hard on the revenue side of the business to ensure those classic scissors of revenues and expenses will go in favor of further positive outcomes in the coming years. This time last year, you said that you see your task as CFO of an ASX 200 company to operate as a going concern, as well as providing the company a robust financial buffer as the best foundation for growth. Darren, this is not your performance assessment, but how are you going on this? Well, if it was part of my performance assessment, I think I'd have a star by my name, so that's great. However, a record profit should be celebrated when everyone has achieved one. I certainly congratulate my colleagues here at Clinuvel for their role in the outcome that's just occurred, and certainly thank all our stakeholders for their support. It's good to know that the foundation of growth is there for the company. We have in excess of AUD 80 million in cash, which is certainly sufficient to self-finance our planned expansion, and certainly there to allow us to manage any potential economic adversity that may not necessarily foreseen at this stage. It's an enviable position that we find ourselves in, and one that benefits all shareholders. Okay. Thanks, Darren. We'll give you a little break and focus on Dr. Wolgen in respect of a question we've received about growth through acquisition, like inorganic growth. Perhaps, Dr. Wolgen, you can comment on this. Well, that's a good question, and a relevant one at the moment. For a number of years, we've publicly discussed our quest to add more technologies to Clinuvel and to our portfolio of R&D projects. To put this in context, we invest in what we know and what we need, we translate our technologies in a DNA repair program with Oligonucleotide, brain disease search, and stroke. By and large, an acquisition needs to be accretive and complement our existing activities, and they need to meet our objectives. We're continuously scanning and are doing diligence at present on a variety of companies, and we're closing in on some others. Yes, it is one of our objectives, and I'm pretty confident that we will grow inorganically, too. In the forthcoming strategic update 3, we will discuss some of these aspects, but also our own organic growth and why we are aiming to complement the transition from a single-focused company to a diversified group. Our aim is really to arrive at a minimum of 2 pharmaceutical products, which is asenapine and PRÉNUMBRA, and 4 non-prescription products to a much wider market to complement and widen our pharmaceutical franchise. Management obtained the mandates to really establish a number of revenue centers, and in a methodical way, that's what we are working towards. Okay. Thanks, Dr. Wolgen. Perhaps I can turn this around if I can ask you a question. Can you summarize how our communications with shareholders have been in the past year? How has it evolved? Yeah, sure. Happy to explain. We have seen the past 24 months a significant increase in communications reflecting the activities of the group. We've built on our sector leadership in the frequency of communications through the regular news communiques and other announcements on the progress of the company. We do distinguish ourselves as an ASX 200 listed company by issuing 6 news communiques per annum, where the MD is quite involved in what we are saying about the company and how we update, as well as a number of letters from the chair. You can see in this slide, I'll just flick onto the Hang on. Here we go. You can see in the slide the range of communications that we have been involved in, and particularly the trend in press mentions. Just know that last bar is to mid-August, and so we've yet to complete the year to show a rise I would expect over 2020. We continue to address also the large pool of German-speaking shareholders by translating the news communiques into German, and well-received that is. We have also diversified the way we communicate. We've done more webinars, videos, conference presentations in the last year, ranging from the first operations webinar, already two strategic updates, and video interviews involving the CEO and the Chair. We've also presented our evolving story to more key conferences than before, and held many meetings around the conferences, and also throughout the year, whether they be with one-on-one or in group forums. Indeed, around the release of our results, we've already had a number of individual conversations with investors, group conversations, and there will be many more. For example, we leverage our relationship with the expanded number of independent analysts of Clinuvel who host investor meetings, which bring their clients to the discussion room. They are also our existing or potential investors in Clinuvel. Our communications team also are very active at using social media channels to communicate our story. I think on communications, more frequent and more diverse is the short answer. Now, since you gave me the floor, Darren, I'd like to just change tack and draw attention to the benefit of shareholders of Clinuvel's performance over the years. There is a chart here that shows the significance of total shareholder return based on the change in the share price over one year, five, 10, and 15 years. I just have to say, I think they're outstanding returns for shareholders. Yeah. Thanks, Malcolm. I do agree with that. Good. I think we have covered the excellent financial results well in this session. At this point, I thank our managing director and CFO for your insights. I'd also like to thank our independent analysts, and particularly Messrs David Blake and Mark Pachacz of Bioshares, Sarah Mann of Moelis, Stanton and Vanessa Thomson of Jefferies, Shane Storey and Melissa Benson of Wilsons, as well as Chad Trojer at Lonsec Research and Graham Witcomb at Intelligent Investor, for their combined efforts to keep investors informed on Clinuvel over the year. Yeah. Thanks, Malcolm. Look, I look forward to the next opportunity to talk about our company, and like to thank all those who have joined us tonight. Thank you, boss. Pleasure. Yes. Thank you to everyone who has joined in. We expect over the coming month to provide another strategic update, number 3, from the Managing Director, and a second operations update webinar. See you all soon. Thank you. Thank you.