Idorsia Pharmaceuticals Ltd

Welcome to your publication of our results. The press release went out this morning at 7 a.m. Central European time. With me on this call are our CEO, Jean-Paul Cosell, our CFO, André Muller, and our Chief Commercial Officer, Simon Joes. Next slide, please. Just to remind you, we will be making forward-working statements in this call, so please be attentive to the disclaimer. You've therefore been adequately warned about the risks and benefits of owning or shorting out stock. Next slide, please. So, let's kick it off. Jean-Paul, the mic is yours.

Yes. So, yesterday, you have seen that we have informed the market that the REACT study did not meet the primary endpoint. And, of course, we are very disappointed and very sad, I have to say. But it should not really hide the achievement, next slide, that happened in 2022, which provide momentum for 2023. Next slide. A lot has been achieved in 2022. First, the QVDIC was approved in the U.S. FIVLAS was approved in Japan. and launched in Japan, Qvivic was launched in the U.S., Qvivic was approved in Europe, and we got the results of apocytantin showing a very significant blood pressure reduction. And then we got the results of daridorexant in insomnia in Japan, And Curivik, at the end of the year, was launched in Germany and Italy. And SceneryMod phase three in lupus was initiated. And finally, just before the end of the year, aproxytentin was filed for U.S. The NDA of aproxytentin was filed in the U.S. So Simon is going to describe our commercial plan, and the launch of our first two products. Next slide.

Thank you, Jean-Paul, and good morning and good afternoon, everyone. 2022 was indeed a transformative year. We obviously launched our first two products, and I believe we built a very strong foundation for future growth. And obviously, today, I'm pleased to be able to share with you the positive momentum we're seeing with the launches of Qvivic in the US and Europe and, of course, PIVLAS in Japan. Next slide, please. So I'll start with Qvivic, which, as you all know, was launched in the US in May and in the first two European markets in November, as Jean-Paul said, in Italy and Germany. In 2022, net sales totaled 6.5 million Swiss francs. Obviously, as I've mentioned before, net sales in the U.S. don't reflect demand or prescriptions dispensed. To enable early patient access to Qvivik, we continue to offer our strong copay program, including a free first 30-day prescription. And of course, demonstrating demand is critical to support our ongoing negotiations to expand payer coverage, and I'll provide an update on our progress there in a few minutes.