Idorsia Pharmaceuticals Ltd

good day and thank you for standing by welcome to the full year financial results 2021 conference call at this time all participants are in a listen only mode after the speaker presentation there will be a question and answer session to ask a question during the session via the audio you will need to press star 1 on your telephone if you wish to ask a question via the webcast please use the q a box available on the webcast link anytime during the conference. I must advise you that this conference is being recorded today, Tuesday, the 8th of February, 2022. I would now like to hand the conference over to your speaker today, Andrew Weiss. Please go ahead.

Thank you, Heidi. Good morning. Good afternoon, everyone. My name is Andrew Weiss. I'm the Head of Investor Relations and Corporate Communications here at Adorsia. With me on the call today, To discuss our full year results and our outlook for the future are our CEO, Jean-Paul Closel, our CFO, Andre Muller, and our Chief Commercial Officer, Simon Joes. With that, I think we're ready to kick it off with our prepared remarks. Next slide. So in this call, we will be making forward-looking statements, and you have been adequately warned about the risks and benefits of investing in IDORSA shares. Next slide. Jean-Paul, the floor is yours.

Jean- Thank you, Andrew, and I'm very happy to really discuss what we have achieved in 21 and how is the outlook for 22 and the years to come. First, the big picture. In Asia, we have a common vision. The management and the collaborators want to create a sustainable midsize pharma company, which is based on innovation. Next slide. And from day one, which means about four and a half year ago, we had defined five key strategic priorities. We wanted to deliver three products to the market, build a world-class commercial organization, bring Eidosia to sustainable profitability, fuel our pipeline with new discoveries, and utilize state-of-the-art technology to drive innovation. Next slide. 2021, as I mentioned, was a very strong year for what we have achieved and executed. We entered and closed 2021 with a strong balance sheet thanks to a money raised that we could achieve. And Andre will discuss this fact. We filed a dairy direction in the different in the world. And we received, Johnson & Johnson received approval for Ponesimod an S1P1 drug that was discovered in Actelion and which was developed by our team for the larger part. We fight clazozentan in Japan, that was all at the beginning of the year, started the phase three of Celatogrel, and at the end of the year, we got the result for Lucerastat, for Cenarimod, and last but not least, this year, and the beginning of this year, thanks to all this work, we got PIVLAS approved in Japan, Clazo-Zentane approved in Japan, and QVVIC approved in the United States. Next slide. So, first goal was to deliver three products to the market. So, we are on good track. Dairy Directs and Clazo-Zentane approved. I think that abrocitantin will give results middle of this year. And many other drugs, as you can see, are either in late phase development or in phase two. So this goal, I think it's achievable within a short amount of time. Next slide. So last year, we obtained the result for lucerastat. Of course, we were disappointed by the fact that we couldn't show an effect on neuropathic pain, but we have seen very interesting other efficacy signal which really encourage us to continue the open-label phase of this study and to discuss with the authorities in view of the very strong effect, for example, on biochemical markers. and on some functions of the patients, like the renal function. For a scenario mode, we have, with our phase two, B, got the information we needed in terms of which is the dose, what is the efficacy, what are the safety, and what is the optimal endpoint. So, therefore, we are advancing scenario mode in phase three, and we are discussing the program with the regulatory authorities, especially the FDA. We, for apocytetan, patients are all recruited. We are doing, performing the study. We should have the results in the middle of this year. And I'm really very optimistic for this drug since the safety looks really good and we have a clear, I think, signal also of efficacy. Then, Selatogrel, as I mentioned, has under an SPA started the phase three. And for our selective orexin receptor antagonist, we have finished recruitment and we should have the results of binge eating is second quarter of 2022, this year. Next slide. So, of course, Dairy Dorexant has been the big news beginning of this year. And it's really going to be a global product. It has been approved in the US. We have five year market authorization in Canada. And we are waiting, I would say, any months or weeks, the authorization by the European Medical Agency. And also, we are waiting for the answer of Swiss Medic. And the phase three is ongoing in Japan and hopefully will be finished this year. Next slide. So the results of daridorexan, two studies, two phase three studies have been published in the Lancet Neurology. That's really the results, you know, as I said, it's one of the nicest set of results I have seen in my career. Next slide. Because not only the drug was working to really improve or decrease the time to fall asleep, but also to stay asleep. And the Wazo, which is a time that people are waking up after falling asleep during the night. this is the time that you want to decrease, which is increasing insomniac. And as you can see, you have a very nice dose-response effect on WASO. Next slide. But also on time or the time to fall asleep, which is called the latency to present on sleep. So you sleep faster, you sleep longer. Next slide. And if you ask, which is quite... Quite unique, I have to say. If you ask the patients how long they are feeling they have slept, you see also that subjectively they feel that they have slept longer. And this is highly statistically significant, especially with a high dose of, I would say it should not be the high dose, with a dose of 50 milligrams, which is the right dose, not the high dose. Next slide. So, very important evaluation we did in this program was to ask with a patient's reported outcome questionnaire, we have evaluated what are the consequences of this improvement of sleep on the day performance. First, domain, because we are grouped in three domains, dysfunctioning, was really what we call the sleepiness domain. And you can see the question was how, you know, the four main questions of this domain was asking the patient how they feel energetic, mentally tired, physically tired, or sleepy during the day. And as you can see, you have an improvement, which is mean a decrease of this domain score. And especially with a 50 milligram you have a very significant, the p-value is, as you say, is very low, very significant effect on this sleepiness domain with daridorexant. Next slide. And even more interesting in my mind is the fact that the other domain about mood, about cognition, alertness, how people memorize, how they feel that they can memorize events. This was also improved. This was exploratory endpoints, but very clear results. Next slide. So you could really, and that was the big question, with such a fantastic effect during the night and during the day, Is there a side effect which prevent, especially with the 50 milligram, prevent the use of this higher dose? And as you can see, that has been really, and this is absolutely unique to this product. You see that if you take, for example, the somnolence, the 50 milligrams is less, there is less somnolence in the morning as with 25 mg of daridorexant and about the same level as placebo. So by giving the dose of 50 mg, you do not have a price to pay by being groggy in the morning. And that's absolutely fantastic, and that has been recognized in our label, our U.S. label, by the fact that there is no recommendation of a dose saturation. The patient can be treated by 50 and should be treated by by 50 milligrams unless there is a special case like for example a liver problem where then the 25 milligram in this specific patient should be given. So a very, very, very good safety profile. Next slide. So I'm going to give with such a, first of all I'm going to give to the commercial organization of Eidosia, this fantastic drug, and Simon is going to tell us and to tell you how we are going to commercialize Daridorexat. And, of course, also Clazodentan, which, as I've mentioned, has been approved in Japan. So please, Simon.