Idorsia Pharmaceuticals Ltd

good afternoon good morning everyone my name is andrew weiss i'm the head of investor relations and corporate communications at adorcia i want to welcome everyone to our webcast to discuss the publication of the first quarter results published this morning 7 a.m central european summertime with me on the call are our ceo jean-paul cosel our chief commercial officer simon jose and our chief financial officer andre miller you're all here to provide more color on the press release that was issued Next slide, please. As customary, before handing over the microphone, I need to remind everyone that we will be making forward-looking statements. We have therefore been appropriately warned about the risks and opportunities of investing in Eidosia shares. With that, Jean-Paul, the floor is yours.

Thank you, Andrew. So soon, Eidosia is going to be six years old. And within these six years, we have accomplished a lot. We have developed, registered, and launched two products worldwide, at least in the U.S., Europe, and in Japan. We have a third product, which is filed, and this is April 7th, and the PEDUFA should be in December this year. We have built a commercial organization, starting in Japan, in U.S., and we are starting in Europe. We have beat the pipeline with several late-stage products, but we have also discovered several new products, and unfortunately, we will not have the time today to discuss the very early product that we have discovered. Next slide. Clearly, what is key for us is Qvivik, or insomnia drug. And I would like, in a few words, to explain the strategy we have to make it a really blockbuster drug. First, we had to establish Qvivik as a leading brand in insomnia in the US. And we have spent last year and this year a lot of energy to really build the QVDIC. QVDIC has this brand and now Simon will show you that indeed we are the leading brand in insomnia in the U.S. And this increase of demand has helped us and is helping us to expand the reimbursement. And this was a prerequisite and this is why we have spent so much effort to increase the demand. But as you have seen, we got in the first quarter of the year ESI reimbursement and we are continuing with several other payers to work and to find a solution to expand this reimbursement. Then now we are launching and we want to establish QVDIC as also the leading brand in insomnia in Europe. We are in Europe, as you know, there have been no other orexin receptor antagonists, and we have launched in the beginning of the year in Germany and Italy, and we hope in several other European countries is the second part of the year. Then we want, with QVD, to change the treatment paradigm in insomnia. That means to, for example, to promote and to use QVVIC chronically every night because we have shown that the benefits of QVVIC increases with time. We have filed recently a citizen petition to really de-scatter QVVIC in the United States. Therefore, we are making now, and we have, I think, many opportunities to explain to the prescriber that insomnia is indeed a very serious issue, that patients should be treated chronically, and that indeed they should choose a drug which not only improves the night, but also has some impact on the day performance. is what can be achieved with Qvivik. Finally, the fifth effort will concentrate on expanding the medical utility of Qvivik. We have worked up to now mainly in adults and in patients with chronic insomnia. We are now starting, we have started a project a pediatric to use QBVIC in children. We are doing studies in patients with nocturia, with sleep apnea. So we want to really show that indeed the very good profile of QBVIC allows to use it in several type of patients. So, now, I am going to let Simon explain you the progress we are making with Qvivik on the market.

Thank you, Jean-Paul. Can you just move to the next slide, please? Thank you. Good afternoon, everyone, and good morning to those of you in the U.S. So, building on the objectives that Jean-Paul outlined, I'd like to share with you today the progress we're making on the launch of Qvivik in the U.S. and Europe and, of course, PIVLAS in Japan. Next slide, please. As most of you know, of course, we launched Qvivik in the U.S. in May last year and Germany and Italy in November. In the first quarter of 2023, net sales were 4.3 million Swiss francs. And of course, to enable patient access to Qvivik in the U.S. ahead of broad payer coverage, Odossia continues to offer a strong copay program including a free 30-day first prescription. And as I've said before, due to this approach, net sales in the U.S. do not reflect actual dispensed prescriptions or the product demand that we're generating. Next slide, please. So moving then to demand generation in the U.S., we achieved a very strong 40% growth in total prescriptions in the first quarter compared to Q4 last year. with over 22,000 prescriptions dispensed in March alone. The 50 milligram dose, the dose which shows the greater effectiveness of the two doses, continues to be prescribed at a three to one ratio over the 25 milligram dose, confirming that our messaging is reaching and being acted on by our customers. The chart on the right shows the channel breakdown of TRXs, which we've shown you before. And here now you can see that the IQVIA line is converging with the VitaCare line, which is a positive sign of increasing access and paid prescriptions. This is naturally something that we're tracking very carefully as we focus our efforts on increasing the proportion of scripts that go through the retail channel and on generating paid prescriptions. Next slide, please. And I'm very pleased that Qvivik is now the leading branded insomnia medication in new to brand prescriptions in the US across all market segments, whether that's the commercial and all the government segments. We crossed Belsombra in the first quarter after less than one year on the market. And given that more than 50% of Belsombra prescriptions come from Medicare Part D, where we are not currently contracted, this is an even greater achievement. And then as you can see on the right, the continuing prescriptions or refills are growing strongly and increased by nearly 60% in Q1 this year over Q4 last year. And this is consistent with the positive feedback we hear from physicians and patients about Qvivik, particularly with the 50 milligram strength. Next slide, please. As I just mentioned, Belsomra is overweighted in Part D, where Qvivic is, of course, underweight due to its current access position. So looking at the commercial market only, where we can compete on equal terms, you can see that Qvivic has passed the other DORAs in total prescriptions, not just MBRXs, and now has nearly 40% share of the commercial market. We have in less than one year shown we can compete differentiate Qvivic, and establish it as the leading DORA in the U.S. market. As Jean-Paul mentioned, our imperative now is to expand payer coverage, which I'll return to shortly, and transform this old generic market into one where the DORAs and Qvivic in particular are central to the treatment of insomnia and not relegated to use after the older addictive benzos and drugs have failed. Next slide, please. And expanding the DORA market is exactly what we're doing. As you can see here, Qvivic is not only gaining market share, but it is expanding the class. Following the launch of Qvivic last May, DORA TRXs have grown by 42% and MBRXs are up 93%, with Qvivic prescriptions being almost all additive to the class. We continue to see the source of business for QDIVIC coming from the older, widely used sleep medicines such as Trazodone, Zed drugs, and Benzos, with only a small number of patients coming from the other doors. Next slide, please. So coming then to access and reimbursement, which is clearly essential to convert our prescription demand into net revenue, following the launch last year, payer contracting in the U.S. has developed more slowly than we anticipated, but we are making good progress. Today, Qvivic is covered by Express Script's National Preferred Formulary and TRICARE Uniform Formulary, which together represent over 32 million lives in the U.S. Following the contract with ESI for its National Preferred Formulary, we're working closely with the ESI downstream accounts to pull the ESI rate through and add additional contracts and covered lives. There are a few small accounts totaling around 2 million lives that have already added Qvivic and have taken the ESI rate, but the larger ones have their own procedures and timelines that we have to work through with them, which does take some time. Furthermore, we are in very active communication and negotiation with CVS Caremark, which represents just under 30 million commercial lives. Though we remain laser focused on driving more access and gaining coverage for Qvivic, including the Medicare Part D formulary for 2024, for which we've submitted bids. Next slide, please. Returning now to Europe, where we launched Qvivic in Germany and Italy, as I said, late last year. While it's still relatively early days, demand is growing well, as shown here with the weekly unit sales from wholesalers to pharmacies. So, this essentially represents pharmacy purchases. As pack sizes differ between the two countries, we've normalized units to tablets, which is what you're seeing here. And this picture represents and reflects the positive feedback we hear from physicians and patients on the differentiated profile of Qvivic, the first and only DORA available in Europe. In Germany, the AMNOG process is to set pricing and reimbursement after the free price period, is ongoing, as well as the GBA review of the potential exemption of Qvivic from the four-week prescription limit on hypnotics. In Italy, all sleep medicines are C-class or privately paid by patients, and Qvivic has launched into the same C-class. Prescribing is currently limited to specialists only at this stage, where the feedback on their experience to date has also been excellent. Next slide, please. So looking further across Europe, following the launches in Italy and Germany, we are next preparing to launch in our home market of Switzerland in June. We will initially launch in the private market, focusing on specialists, while the reimbursement process is running. In the UK, the NICE assessment is also underway, and we anticipate launching there later this year. And our local teams in Spain and France are preparing for subsequent launches in those markets. Next slide, please. So finally, just to finish with Piblas in Japan, we launched pretty much to the day one year ago. It was the 20th of April last year. And next slide, please. You can see that the first quarter sales were 13.5 million Swiss francs. Net sales in the first quarter continue to be impacted by the strong Swiss franc. as well as by wholesale ordering patterns related to the end of the calendar year and the fiscal year in Japan. Neurosurgeons continue to incorporate PIV-LAS into treatment protocols, and awareness amongst our target customers is now greater than 95%. Approximately 27% of patients were treated with PIV-LAS in March, based on the estimated incidence of ASAH. Now, as I've mentioned before, the initial rapid uptake seen last year benefited from study investigators' fast adoption of PIVLAS, and we are now entering a period of more moderate growth as new accounts build experience with the product. So, in summary, I'm very pleased to see Qvivik is now the leading insomnia brand in the U.S. commercial market in terms of prescriptions. Although payer access has been slower than anticipated, we have secured access with ESI and TRICARE, and our inactive discussions with other major payers. As further reimbursement is secured, we expect paid prescriptions to continue to increase, boosting net sales. In Europe, demand is growing with our first launches in Germany and Italy, and we're preparing for additional launches later this year. And equally important to establishing Qvivic as the leading treatment for insomnia is transforming and modernizing the entrenched generic market we have entered, creating a future where erectile antagonism and cuvivic are central to the treatment of chronic insomnia. Thank you, and I'll now hand over to Andre. Next slide, please.