Idorsia Pharmaceuticals Ltd

Welcome to the iDOSIA Half Year 2025 Financial Results webcast and conference call. 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 a session, you need to press star one one on your telephone keypad. You will hear an automatic message advising your hand is raised. To withdraw a question, please press star one one again. Please be advised that this conference is being recorded. I would not like to hand the conference over to our first speaker today, Andrew Jones, head of corporate communications. Please go ahead.

Thank you Nadia. Good afternoon and good morning everyone and welcome to our webcast to discuss the financial results for the first half of 2025. Presented on the call today, we have our new CEO Srishti Gupta, who will share her impressions of her first weeks in the new position and the company's revised strategic priorities. Also presenting, we have Arnold Grunewald, our chief financial officer. Then joining us for the Q&A session, we have a big selection of management. We've got Julian Gander in his new role of chief legal and corporate development officer. Our president of the UCAN region, Benjamin Limahl. Our president of the US, Michael Moy and chief scientific officer and newly appointed head of research, Martin Kozell. And Alberto Gimona, our global head of clinical development and medical affairs. Next slide. Before handing over, I need to remind everyone that we will be making forward looking statements. You have therefore been warned appropriately about the risks and opportunities of investing in iDorSia. And with that, I will hand over to our new CEO, Srishti Gupta. Next slide.

Good morning, good afternoon everyone. Thank you for joining the call today. It is an absolute pleasure to be presenting to you today as the CEO of iDorSia. Here's a bit of background for those of you who I've not yet met. I joined the board of iDorSia in 2021, most recently serving as the chair of the nominating governance and compensation committee. So I'm very familiar with the company, its portfolio of products and pipeline assets and the excellent passionate team working here. Though I've only been in the role for about a month, being on the board helped me quickly get a sense of where we are and where we need to go. I've been focused on setting clear strategic priorities with the teams and I'm excited to share those with you today. Next slide, please. Before we jump into those, I wanted to reflect on where we are now compared to where we were a year ago. From a performance perspective, iDorSia led QVVIC net sales in the first half of 2025, more than doubled compared to last year, rising from 23 million to 56 million Swiss francs. This demonstrates strong commercial traction and growing demand. It is driven by Europe and Canada and a stabilization of an optimized model in the US. We also see an improvement in our non-GAAP operating results from negative 170 million Swiss francs to negative 15 million. Arno will share our financials in more detail later on. I commend the team on the strong performance. The results confirmed the commercial acceleration of QVVIC coupled with the financial discipline implemented over the past 12 months have successfully delivered on an operational turnaround. A few other highlights to share, QVVIC is a truly global brand with rapidly growing sales. Most recently, we worked with our partner, SIMS-SR for approval and the national reimbursement drug listing in China. I will share more on Tri-Vio later on, but I can already tell you that the removal of the REMs by the FDA and the positive real world experience collected so far highlights the significant commercial opportunity. We are making focused investments in advancing our pipeline, which I will also share today. Notably in the first half, we have seen new data with Lucerostat, which supports further phase three investigation in Favre disease and the first results with our synthetic glycan vaccine. We have secured additional financial stability with the extension of our cash runway to the end of 2026. And this puts us on track to commercial profitability in 2026 and overall profitability in 2027. Next slide, please. In my first four weeks in the role, I had the chance to meet with teams across the organization. I also had the opportunity to conduct an initial review of commercial plans and portfolio programs. I wanted to lay out an early view of the strategic priorities for the company, which we will continue to refine in the coming months. First, we must unlock the full value of QVivic, as this medicine is unique and can drive significant value for patients around the world. It is also a key driver of our profitability. Second, expanding our strategic partnership will be critical to advance both our commercial and our pipeline objectives. Third, at our core, we are a science-based company that has a deep pipeline across many major unmet needs. Accelerating these high-value medicines is a top priority for our R&D organization. Fourth, we need to continue balancing our commercial and pipeline ambitions with strong financial discipline. And finally, we need an inspired and engaged organization to reach our full potential for our patients and our shareholders. Next slide, please. Let's start with unlocking the full value of QVivic. We have demonstrated that QVivic is the driver of growth for our business. To realize the full potential of QVivic, we will accelerate commercial momentum by expanding reach to patients, optimize our market presence globally, and continue to generate evidence supporting medical utility. Next slide, please. QVivic is not a -in-class dual-orexin receptor antagonist or DORA by accident. It is the result of the team designing a dual antagonist with the goal of a rapid onset of effect and a duration of action sufficient to cover the night, but short enough to avoid any negative next morning residual activity. There is a large market opportunity for the treatment of insomnia disorder, and DORAs have made limited inroads in many markets, so there is significant growth potential. We have, however, seen DORAs make significant growth in other markets, such as in Japan, where they constitute around 30% of the insomnia market. So there is potential for this to change. The expanding demand and accelerating sales from commercial execution is putting us on the path to profitability with multiple upside opportunities. For example, the de-scheduling of the DORA class in the US, which I will touch upon later. We are receiving extremely positive feedback from both healthcare professionals and patients who confirm the excellent sleep efficacy, the improvement of next day functioning, and an excellent safety and tolerability profile. Next slide, please. We are excited that QVVIC's global footprint is expanding. iDORSIA commercializes QVVIC in North America and Europe. It is available in Japan through our partner, NXERA, and it will soon be available in China. We have worked with our partner, SINCEER, to establish the regulatory pathway for approval in China and leverage the wealth of data we generated in our global program. SINCEER did an outstanding job of rapidly advancing this to approval so that QVVIC will be available to patients. I think it'll actually be available to patients as soon as the end of August. We're also discussing distribution agreements in Latin America and the Middle East and North Africa, and I look forward to updating you on those in the near future. Next slide, please. So now for the headline news. I'm excited to share how QVVIC is poised to fundamentally reshape the insomnia treatment landscape in Europe. In the first half of 2025, 25 million restorative nights and revitalized aids have been prescribed in Europe. QVVIC is the only pharmacological treatment for long-term management of insomnia disorder, improving both nighttime sleep and daytime functioning, with an established safety profile designed for chronic use. Our approach in Europe is to address access upfront, and we have secured public reimbursement in the UK, France, Germany, and in Austria, which recently happened on June 1st. Our top priority is securing public reimbursement in additional markets, as this is how value is unlocked and scale achieved. Alongside access, we invest in focused promotional efforts targeting psychiatrists, neurologists, and sleep specialists to build trust in our clinical evidence. And finally, we continue to expand into primary care with co-promotion partnerships, such as with Menorini in France and in Germany, as well as omni-channel initiatives to reach general practitioners. We look for partners who have established presence and relationships with the GP prescribers. By doing these three things well, we will grow QVVIC's reach and position it as a key contributor to our commercial profitability goal in 2026. Next slide, please. Since the launch in the US, over 620,000 QVVIC prescriptions have been dispensed, and the product has been prescribed by more than 56,000 healthcare professionals. At the beginning of 2025, the company implemented a streamlined, focused, and more cost-efficient commercialization approach for QVVIC to maintain its availability and sales until the potential rescheduling of the DORA class. CINEO's help is executing a highly targeted digital marketing plan supporting 20 virtual sales reps. While sales remain relatively flat with a slight decline, we're seeing a very meaningful improvement in growth margin, driven by a greater proportion of -or-paid scripts. We continue to advocate for the scheduling of the DORA class, and we believe that the FDA review of the abuse potential of the DORA class, also known as the eight-factor analysis, is actively moving forward. We're hoping to hear the results of their analysis and the next steps from the FDA and the DEA soon. Next slide, please. Let's turn now to the growing data showing how DORA directs that it's delivering meaningful value in clinical practice. We are very excited to be advancing the recruitment of our Phase II dose-finding study in pediatric insomnia. The initiation of this program is driven by two critical observations. One is the undeniable unmet medical need for pediatric populations, as there are no currently approved medications in the US, and only a subset of patients in the EU are eligible for medications in insomnia. And two, the profile of DORA directs that positions it as an ideal candidate to address this treatment gap. The study is expected to complete enrollment by the end of 2025, with a readout expected around mid-2026. Physicians often see patients with insomnia who also face challenging comorbid conditions, such as anxiety, depression, obstructive sleep apnea, nocturia, and menopausal symptoms. While the insomnia of all these patients can already be treated with QVVIC on label, we are supporting ongoing research to build a robust evidence base for the treatment in these medically complex populations. Real-world observation studies are demonstrating effectiveness of QVVIC in patients with psychiatric comorbidities, such as anxiety or depression, supporting its use even in polypharmacy settings. We are also supporting the creation of an evidence base for the use of QVVIC in insomnia with concomitant substance abuse disorders, and these studies underscore our commitment to furthering the science of sleep and insomnia. Next slide, please. Moving to expanding strategic partnerships. Our goal is to both strengthen current alliances and actively pursue new high-impact partnerships. These allow us to scale access and commercialization, to accelerate development, and to enhance long-term value creations. Next slide, please. We collaborate with partners who share our belief that science can transform lives. Partnerships take many forms. Co-promotion partners expanding QVVIC's reach to general practitioners, like our partnership with Manarini, distribution partners opening new markets, and co-development partners enabling approvals in specific geographies, like our recent success in China with SimSphere. We aim to secure new partners across these models to bring QVVIC to more patients around the world. We also pursue partnerships to accelerate R&D, like our collaboration with Viatris. We have licensed two phase three products to Viatris, Salada Girl and Scenarimod. This is a great example of how we've partnered with a company committed to building an innovation-based portfolio and capable of advancing large scale clinical studies while allowing us to retain value of our discovery efforts. Viatris is executing well on recruitment, and if all goes to plan, we look forward to data readouts next year. Next slide, please. Partnering Apricotentan remains a top priority, and we are actively engaging in partnership discussions. As a reminder, Apricotentan is approved under the trade name Trivio in the US and Gerigo in the EU and UK. It is the first and only endothelin receptor antagonist approved for the $12-plus billion uncontrolled and resistant hypertension market. And until the approval of Trivio, the last new drug class for hypertension was over 30 years ago. It is estimated that 50% of adults in the US live with hypertension, and 50% of those patients are not well-controlled despite being on medication. Trivio, therefore, meets a significant unmet need. The FDA has granted an indication that includes patients on one or more antihypertensive drugs, a less restrictive criteria than we set for ourselves for the precision pivotal study, making the addressable patient population significantly larger. The label for Trivio reflects both its double-digit blood pressure lowering effect and the clinical outcomes benefit linked to that reduction, as you see on the slides. That label was improved in March 2025 when the FDA removed the REMS requirement, making it easier to prescribe and to distribute. Its efficacy and safety profile, particularly in patient populations with difficult comorbidities, differentiates it to existing therapies and any of those in development. Specifically, Trivio offers clinical differentiation in patients with comorbid hypertension and chronic kidney disease, as patients with hypertension and renal impairment have significantly fewer treatment options due to contraindications and safety concerns. Trivio can be prescribed to patients with an EGFR as low as 15 milliliters per minute with no risk of hyperkalemia. Trivio has an excellent safety profile with low discontinuation rate observed over 40 weeks. No drug-drug interactions, hypertension or hyperkalemia. Again, seen on the adverse reaction table from the label as shown on the slide. Prescribers and KOLs, many of whom are at hypertension centers of excellence, confirm interest and the need for a new mechanism of action, especially in patients whose hypertension is difficult to treat and those patients who have chronic kidney disease. Finally, early feedback from payers is that they are receptive and are working to establish reasonable utilization management criteria to ensure patients will have access. Trivio is ready to launch to the millions of patients who could benefit from this outstanding drug and I look forward to keeping you updated on the efforts to find a partner who has the capabilities and the capital to maximize its impact. Next slide, please. We recently shared positive news on the phase one study, which included safety and immunogenicity for our C. diff vaccine. As a reminder, C. difficile is the most common cause of healthcare associated infections in the United States and the leading costs of hospital acquired diarrhea. It is responsible for about approximately half a million infections and close to 30,000 deaths annually, along with significant morbidity from recurring infection and complications like colitis and sepsis. Vaccine development in this space has proven difficult due to C. diff complex biology because of the hard to eliminate spores and the toxins that impair the body's immune response. Our vaccine candidate targets the bacteria and the spores. It also importantly validates the approach of using synthetic glycan antigen technology to target a range of complex pathogens that have been resistant to more traditional vaccine approaches. We are looking for a partner to realize the full potential of our synthetic glycan approach. Next slide, please. Turning to our pipeline, we are focused now on advancing our highest value assets in a disciplined and an efficient manner. Next slide, please. We are advancing four investigational clinical assets with the potential to transform treatment paradigms. Lacerostat is our oral substrate reduction therapy with the potential for organ protection in all adult patients with Favre disease. And organ protection remains an unmet need and is essential in Favre disease because it helps delay or prevent the irreversible damage that ultimately drives disability and early mortality. The results of both interim analysis of the open label phase three extension study, where patients have been treated for at least 42 months and a kidney biopsy sub study are supportive of further investigation for patients with Favre disease. And we are in continued discussion with the US FDA to agree on the optimal regulatory pathway to approval. As I mentioned earlier, we are doing a dose finding phase two study with direct sent in pediatric populations. And during the full year 2024 webcast, we also shared that we will advance three first and class chemokine receptor antagonists into phase two. Each will be a proof of concept in the specific indication under investigation, as well as a proof of mechanism for a range of related disorders. These include CXC7 for remyelination and progressive multiple sclerosis, CXCR3 for precision treatment of vitiligo and CCR6 for T helper 17 driven psoriasis and related autoimmune disorders. We will provide more details on these programs as these studies progress. Next slide please. Turning our focus to financial discipline, our goal is to balance ambition with accountability. We will stay labor-zir focused on smart resource allocation, growth-oriented cost discipline and value-driven decisions. And with that, let me hand it over to Arno.