Idorsia Pharmaceuticals Ltd

Good morning, good afternoon, everyone, and welcome to the IDORSIA First Half 2022 webcast. With me on this call are our CEO, Jean-Paul Closel, our CFO, André Muller, and our Chief Commercial Officer, Simon Joes. They're all here to provide additional color to the press release and First Half 2022 financial report published today at 7 a.m. Central European summertime. Next slide, please. We will first be making prepared remarks, and then we will address all of your questions at the bottom half of this call. But before kicking it off, I need to remind everybody about our disclaimer. We will be making forward-looking statements in this call. Hence, you have been adequately warned about the risks associated in investing in Eidosia shares. Next slide. With this said, Jean-Paul, the floor is yours.

So we are on slide three. When we created iDorsia five years ago, we had a clear goal to become a fully-fledged biopharmaceutical company. And just five years after the creation of iDorsia, I am very pleased to report that we are really on a very good track to achieve this goal. Next slide. We are set up from day one, and we have not changed this priority list. We had defined five key priorities. First, deliver three products to the market within a midterm time. Number two was to build a world-class commercial organization to be able to retain the value for our discoveries. Number three, to bring as fast as possible Eidosia to sustainable profitability. To continue to fuel our pipeline with new discoveries. And finally, to utilize state-of-the-art technologies to drive innovation within the company. So slide number five. Let's look at what we have achieved within these five years. First, two products are on the market, QVVIC in the U.S., PIVLAS in Japan. But we have got results of, very good results of Aprocitanzan, which I will describe briefly afterwards. So we are on a good track to get, soon, three products on the market. The US, Japan, and European organizations are now established, and we are starting to have revenues, and I do believe that we are on the path, as we have mentioned, to reach profitability in 2025. We have also continued to discover drugs, And on top of the existing drugs that we had five years ago, we have now a very rich pipeline with some new products moving to phase two or to phase three. And finally, and we don't have time today to go into the details, but I can tell that we're using state-of-the-art technologies in research. but also in marketing, where all the most modern tools, including artificial intelligence, are used in order to optimize our revenues for marketing, but also our ability to discover new drugs. Slide number six. So we want, and that's a very clear goal, we don't want to be one of these biotech companies which are not profitable after 20 years. We want to become profitable as soon as possible. And in order to achieve that, we want to combine not only revenues from our commercial products, and we intend to commercialize QVV, PIVLISE, but also Lucerastat, Cenerimod, and Celatogram. But we want also to have revenues from milestones, and royalty streams. As you know, we get 8% of the sales of Ponesimod, which is Ponvory, marketed by Johnson & Johnson. We will have a significant part of the revenues of Apocytentan. We are awaiting the results of the T-type calcium channel blocker, which has been licensed or partnered with... neurocrime, and we are also expecting that Vamorolon is going to be approved in not a too distant future and bring also milestones and revenues to Eidosia. So now let's start with the first part of this revenue, slide number seven, and I would like to give the word to Simon Jones who has been very efficient to beat the commercial organization all around the world. He was the first person to have this task and to have to do and I have to say that he has done a fantastic work and is going first to discuss the results of his efforts and the efforts of the US team with the launch of QVVIC but of course he will also describe the launch of PIVLAS in Japan.

Thank you, Jean-Paul. And as Jean-Paul has said, it's a very exciting time for Eidosia as we launch our first two products. I'm very pleased to be able to share with you today the positive early momentum we're seeing with both Qvivic in the US and with PIVLAS in Japan. Next slide, please. So starting with Qvivic, which, as you know, was launched in May, The feedback we have received from healthcare professionals and patients has been very positive, and we're very encouraged by the steady growth in prescriptions and physician adoption, which I'll share with you in a few minutes. But of course, before any of this can happen, we need to build awareness amongst prescribers. And as you can see here on the right, we are making good progress here, with physician awareness of Qvivic already at 52% in June, just the second month into the launch. Next slide, please. So awareness is building, but what about physician receptivity to the profile of Qvivic? This slide shows the results of some market research we conducted prior to launch with a blinded product profile. It shows physicians were highly attracted to using Qvivic compared to the other medications they used to treat insomnia. And as you can see, 60% of physicians were passionate about using Q-Vivic, that's the green segment, or attracted to using Q-Vivic, the blue segment. And of course, this was significantly greater than all other products in the category, and importantly, nearly twice the level of the other two DORAs in the panel. Next slide, please. And the feedback we have gained from market research about the product profile is translating into positive feedback from doctors about their experience with the product. These quotes are just a few examples of the dozens that we have received with similar themes. And I'll just give you a moment to read them. In fact, I was in the US last week and spent a day with one of our sales representatives in Washington, DC, where I received similar comments and feedback. Interestingly, I had one doctor tell me she had switched 13 patients from Ambien to Qvivik and hadn't heard a thing back from any of them. And when she saw the slightly puzzled expression on my face, she quickly went on to say this was very good news. She was perfectly clear that these patients would have got straight on the phone if it wasn't working out. So in many cases, no news is good news in this category. Next slide, please. So turning now to the numbers, as you've seen in the press release, net sales in the second quarter were 0.4 million Swiss francs. This clearly is not reflective of actual prescriptions dispensed or of product demand, as to enable patient access and generate early demand, we are providing a robust patient support and co-pay program, including a first 30-day prescription free. As you're aware, patient support programs are becoming commonplace now to support new launches during the period where insurance coverage is being built. Furthermore, you should also note that we did not actively stop the channel at launch. Next slide, please. Now, as many of you know, we are partnering with a specialty pharmacy services company, VitaCare, to manage a key component of our patient support program. Now, whilst this makes it easier for patients to get their prescriptions filled, it makes the reporting of Qvivic prescriptions more difficult. IQVIA does not currently include VitaCare in its sample bank, and therefore its syndicated report under-reports prescriptions for Qvivic. We have full transparency of the VitaCare data and combined VitaCare and IQVIA without over- or under-counting. And as we communicated in early May, we will report these data during our quarterly earnings calls. So here you're seeing the first set of them from launch through July 15th, with the VitaCare data being added to the IQVIA numbers in the chart. So you're essentially seeing the IQVIA line at the bottom, then the VPS number, VitaCare, and then the total prescriptions in black. I think as you can see, we have good momentum in the growth of prescriptions dispensed with the most recent data point exceeding 1,100 prescriptions for the week ending July 15th. You'll also notice a few dips during the weeks where there was a national holiday in the US. This is a normal pattern created by vacations, reduced doctor visits, and reduced pharmacy hours during the weeks in question. Next slide, please. Now, taking a closer look at some of the early data, we are particularly pleased with the adoption of the higher 50 milligram dose. You will see on the left that around 75% of prescriptions are for the 50 milligram dose, which is expected to offer the best efficacy for the majority of patients. We believe this, along with the 30-day first prescription-free and a clear nightly dosing message, will help enable a successful trial, something we know is critical in insomnia. Additionally, we are seeing around 60% of prescriptions being written with at least one refill, with over 20% having four or five refills attached. And repeat scripts are starting to be filled. The chart on the right shows the number of writers per week, the number of physicians or nurse practitioners. You can see the strong growth in total writers as we add new writers every week. We now have nearly 2,700 writers after 10 weeks on the market. You'll note the data on writers is only through July 8th. There is a weak lag in obtaining these data versus the total prescription data where we have through July 15th. Next slide, please. This is perhaps the most important slide I'll show you today. It's showing the NBRXs of the three DORA products from our launch in May through July 15th. As you can see, Qvivic went past Davego after only six weeks on the market. Now think about that for a minute. Devigo has been on the market for two years, and after only six weeks, more new patients are being put onto Q-Vivic than are being put onto Devigo. And with the current trajectory, it won't be long before we are through Belsomra 2. Now this matters a lot, not because the existing DORAs are a material source of business for Q-Vivic, they are too small, but because it is the ultimate proof that doctors are responding to the differentiated profile of the drug and that our messaging is resonating. In fact, less than 5% of our source of business is coming from the DORAs, and the majority of Qvivic is coming from new patients at around 40%, or switches from benzos, Zed drugs, or Trazodone around 47%. This is a very encouraging profile. Next slide, please. So we're off to a good start, but what comes next? We have long maintained that consumer awareness and activation will be critical to the long-term success of Qvivic, and our strategy is centered around this, as you've already seen with our pre-launch partnership with Jennifer Aniston. We believe branded DTC and consumer activation will be an important momentum-building catalyst going forward, and we have recently announced our partnership with two celebrities as Qvivic patient ambassadors, actor Taye Diggs and former Olympian and champion skier Lindsey Vonn. Both Tay and Lindsay are taking Qvivic and have positive experiences on the product. They've already participated in a number of media interviews. Last week, Lindsay was on the Today Show sharing her insomnia story, which then got picked up by other outlets, including People magazine. After this interview, web traffic to Qvivic.com tripled from the previous days. Together, Tay and Lindsay have already reached tens of millions of consumers with their messages, many Qvivic-branded. And in the late summer and early fall, DTC television commercials featuring Tay and Lindsey are planned to start airing. We expect this to have a substantial impact on consumer awareness and motivating potential patients to talk to their doctor about Q-Vivic. So overall, we are pleased with the start we have made in the first couple of months in the US and are confident that as we exit the summer months and activate our branded DTC, we will see a further positive shift in momentum. Next slide, please. Looking beyond the US, Qvivik is on track to become a global brand. Following the EU approval in April, launch preparations are underway in the top five European markets, with the first launch in Germany expected before the end of the year. The local teams are actively engaging with medical experts, policymakers, and payers to introduce Eidosia and raise awareness about the significant burden of chronic insomnia. As the first dual-orexin receptor antagonist approved in Europe, there is a high level of interest among medical experts in the differentiated clinical profile of the product. We have also filed Q-Vivic in Switzerland and Canada, where we have recently appointed general managers on our establishing local affiliates. Finally, we have now completed recruitment of the phase three study in Japan and expect the top line results later this year. Next slide, please. So to finish off and just turn briefly to PIV-LAS in Japan, we launched PIV-LAS or clazacentan in Japan in April for the prevention of vasospasm following an aneurysmal subarachnoid hemorrhage, a life-threatening condition which has an incidence in Japan that is two to three times higher than in the rest of the world. Next slide, please. There has been no new innovation in this field for over 20 years, so the availability of a new product with high quality evidence is creating a good deal of excitement within the neurosurgeon community in Japan. Neurosurgeons have responded very favorably to the robust Japanese phase three data demonstrating the safety and efficacy of TIVLAS, which was published in the Journal of Neurosurgery in April this year. Next slide, please. I'm very pleased with the positive early results of TIVLAS since the launch in April. Net sales in the second quarter reached 11.4 million Swiss francs, and of this, nearly 70% has already been purchased by hospitals from wholesalers, and we have been receiving reorders since the beginning of May. Approximately 60% of our target hospitals have placed at least one order for Clair de Saint Anne, and as we estimate that, based on the incidence of ASAH in Japan, Approximately 10% of patients were treated with PIV-LAS in June of 2022. We expect this positive trajectory to continue as PIV-LAS is included in more hospital formularies and treatment protocols, and neurosurgeons gain more experience with the product. So in summary, our commercial organization is fully focused on executing against our ambitious launch plans for both QVIVIC and PIV-LAS. We're hearing positive feedback from our customers about both of these innovative products, and we are seeing the number of prescribers and prescriptions dispensed increase steadily week over week. I'm confident that the positive momentum will continue to build after the summer months as we ramp up our consumer activation in the US and continue to gain patient share for PIVLAS in Japan. And with that, I'll now hand over to Andre.