Idorsia Pharmaceuticals Ltd

Good day and thank you for standing by. Welcome to the Eidosia Half-Year 2024 Financial Results webcast. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be the question and answer session. To ask a question during the session, you need to press star 11 on your telephone keypad. You will then hear an automated message advising your hand is raised. To withdraw a question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to our speaker today, Andrew Weiss. Please go ahead.

Thank you, Nadia. Good afternoon. Good morning to you all. My name is Andrew Weiss. I'm the head of investor relations and corporate communications here at Adorsia. And welcome to our webcast conference call to discuss our first half results 2024 today. On the call are our CEO, Andre Muller, and our chief financial officer, Arno Grunewald. who are both with me for the first time in their new roles to give you additional color on what we announced this morning. Then, for the Q&A session, we will have our General Manager and President of IDORSA US, Tosh Butt, and our President of the IDORSA UCAN region, Benjamin Limal. Next slide, please. Before handing over the microphone, I need to remind everyone that we will be making forward-looking statements. You have therefore been appropriately warned about the risks and opportunities of investing in Eidosia shares. With that, I hand over to André for his introductory remarks. Next slide.

Thank you, Andrew. Good afternoon. Good morning, everyone. Chris, 11 years at Actelion in Eidosia. I had several opportunities to be presenting to you, but actually it's the first time as CEO of Eidosia. So it's good to be back on regular reporting cycles after the delayed publication of the full year 23 and first quarter 2024, which was published just eight weeks ago. As a result, it's not surprising that there are no groundbreaking news, but I'm happy to be reporting that we are on track with the activities we described at that time. I want to start with saying a very big thank you to Jean-Paul, who I'm sure is listening in. We owe him a big debt of gratitude for his leadership as CEO and as a long-term significant shareholder, as he and Martine invested north of the 1 billion Swiss franc in Eidosia. Without him, without them, I'm not sure we would be there. My immediate focus as CEO is, of course, getting the best possible deal for Aprocitemtan, making sure that we maximize the short to mid-term potential of QVIVIC, and conduct a portfolio review to ensure our R&D priorities match also our funding situation. I'll give you more information on these activities later in the year. Until then, let's have a look at the highlights of this first half of 2024. First, we announce the Viatris collaboration for Selato Gel and Senerimod. This deal secures the future of two very promising developmental programs, retaining long-term shareholder value through potential milestone royalties. We have also secured the approval of aprositantin, so Trivio in the US, Jerego in the EU. We strongly believe that aprositantin has the potential to revolutionize a serious and growing public health problem, commonly known as resistant hypertension. Loan preparation is underway, and in parallel, we are actively engaging with potential partners, as I already alluded to. We have also restricted the convertible bond, which was originally due mid-July. hence extending our cash runway. Having secured the bondholders agreement and the Swiss court decision, we are now waiting for the final confirmation, which is expected by the end of August. Curivic is making progress globally. We'll give a little more detail on the US, Europe, and Canada. But as you can see here, our partner, CIMCIR, has also submitted an NDA in China. At the recent AGM, mid-June, all resolutions were approved, including the new governance structure. I would like to thank our previous board members who did not stand for re-election. So, Yon, Aldac, Felix, Erhard and Peter Kellogg. I want also to welcome our new board member, Bart Filius, and of course congratulate all the other board members who stood for re-election, which of course includes Jean-Paul, who is our new chairman, and Mathieu, who is now the vice chairman and lead independent board member. And lastly, we've seen a new compound enter into clinical development. It's our first synthetic glycan vaccine to be tested for Clostridium difficile infection. Next slide, please. So as you can see, a lot has been achieved in the first half. But there is still a lot to be done in the second half of 2024. We need to extend the cash runway. The best viable option is closing a collaboration with APROSI 1010, with potential partners. We'll continue to prepare for the launch of TriView in the US. We'll continue to increase sales for Qvevic, and we'll continue to innovate. We'll go in more detail for some of these points. Next slide, please. At the end of June 2024, more than 155,000 US patients have been treated with Qvevic since launch. Almost 450,000 prescriptions have been dispensed, and product has been prescribed by more than 45,000 healthcare professionals. The chart on the left shows the quarterly evolution of the QIVIC sales. The chart on the right shows how our salesforce numbers have decreased in the same period. and we had to downsize Salesforce to 100 sales reps, which we feel is now the right number based on the access we have and on our scheduled status. Having optimized our resources and promotional efforts and adjusted our commercial approach towards a payer-paid model, Setting a new baseline for sales in the U.S., I am pleased that we have been able to maintain a demand for QEVIC and even see growth in sales. We continue to remain hopeful that our citizen petition can lead to a de-scheduling of the dual rational receptor antagonistic class for insomnia medicines. This would remove a significant barrier to prescribing QV in the US. Next slide. Trivio. We are on track to make Trivio commercially available in early Q4 2024 and plan for a full commercial launch in early 2025. As you can see, commercial supply, ramps program, distribution network, first wave of the MSL routine will be up and running by the beginning of Q4. As you know, APRO-CITENTAN is the first innovation targeting a novel pathway in hypertension in almost 40 years. And these needs, as any innovation, physician education through the MSL and the Congress that we will be attending during the course of this year. As a reminder, Trivio is one daily tablet. It's one dose. It's easy to use for patients and easy to prescribe for physicians. And very important, it can be used in patients with renal impairments. We've been encouraged by the initial conversation with the payers who understand that Tribio is addressing a significant patient need, and that treating the patient who remain uncontrolled at a much higher risk of serious cardiovascular events. Next slide. So moving to Europe and Canada, so what we call the UCAN region. You remember that in Q4 2020, we had a 2.4 million impact of the negotiation with the first Amnok price negotiation in Germany. Apart from that, sales have shown a steady increase since launch, and then you see the recent acceleration. with 3.5 in Q1 2024 and 6 million in Q2 2024. This is the effect of additional markets and it's also driven by a great performance in Germany and an outstanding launch in France where we are starting to see the need for an effective, safe insomnia treatment translating into a demand. It's still very early days in many countries, but I'm confident that we'll continue on this trend in the coming months as we aim to expand access in key European markets. So let's have a look now how these access activities are progressing. Next slide, please. Germany, as you know, QERIC is now the only insomnia treatment that does not have the four-week limitation, meaning that we are able to have, and now we are really having another round of negotiation, so-called Unlock 2 process, which should end by the end of Q1 next year. In the UK, Q-Vivic is reimbursed, is recommended as a first-line pharmaceutical treatment for patients with chronic insomnia after or as an alternative to CBT-I. Coverage through the ICBs, integrated care boards, continues to grow and reach 78% by the end of Q2. Friends, Tuvivik, as you know, was launched by the end of March 2024 as the first and only pharmacotherapy recommended for the treatment of chronic insomnia disorders. And as already said, we had an excellent launch in Q2. In the other countries, we have launched in the self-pay market. So Canada, QVVIC is available to private market patients since November 2023. Almost 70% of the private Canadian lives are covered, which represents approximately 55% of the insomnia market. In Nepal, we are also working on the submission of QVVIC to public Canadian payers. with a possible decision in H1 2025. Switzerland was launched to see a self-pay market in June 2023, and there are some ongoing discussions regarding reimbursement. Italy, we launched QEVIC in November 2022. A self-pay market, again, with a restriction to specialists, psychs and neurologists, which accounts for roughly 20% of the insomnia market. So the reimbursement dossier, but also the request for the expansion of the prescriber base to GPs have been also submitted in Italy. Austria, we very recently launched in the self-paying market, and our reimbursement dossier has also been recently submitted. In Spain, we launched in September 2023. Demand is high. Reimbursement dossier has just been submitted last week. And finally, for now, We are also discussing in Sweden where our dossier has been submitted in May of this year. And with that, I will hand over to our new CFO, Arno, to take you through the numbers. He may be new to the position, but we've been working together for 10 years. And I can assure you that CF Finance are in very capable hands with Arno.