Idorsia Pharmaceuticals Ltd

Good day and thank you for standing by. Welcome to the Eidosia Full Year 2025 Financial Results Conference Call and 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, one, one on your telephone keypad. You will then hear an automatic message advising your hand is raised. To withdraw a question, please press star, one, and one again. Please be advised that this conference is being recorded. I would now like to hand the conference over to our first speaker today, Srishti Gupta, CEO. Please go ahead.

Thank you, Nadia. Good afternoon and good morning, everyone, and welcome to our webcast to discuss the financial results of 2025. My name is Srishti Gupta. I'm the CEO of Idorsia, and I'll start the call today with an overview of the operational progress we made in 2025 and the exciting plans we have for 2026. I'll then hand it over to Arno Grunewald, our CFO. to walk you through the company's financial position. We'll then take your questions. Next slide, please. The information presented today contains forward-looking statements that involve known and unknown risks, uncertainties, and other factors. These may cause actual results to be materially different from any future results, performance, or achievements expressed or implied by such statements. Next slide, please. We entered 2025 facing significant financial pressure, but we leave the year stronger and more focused. 2025 was a year of stabilization and preparation. We reinforced our balance sheet, delivered disciplined commercial execution, and positioned our pipeline for decisive milestones ahead. Most importantly, we continued advancing medicines that address meaningful, unmet needs for patients. Our Idorsio-led QVIVC sales for 2025 have more than doubled compared to 2024, rising from 60 million to 134 million Swiss francs, just above our target, which we upgraded in May last year. This performance was a result of strong commercial traction and growing demand for QVIVC in Europe and Canada, the stabilization and optimized model in the U.S. I will share more on this later. Our non-GAAP operating results have improved from a loss of 308 million Swiss francs to a loss of 100 million. Key to this operational recovery has been our commercial strength paired with cost control. Arna will share more on our financial performance later. Next slide, please. Adorsia represents a rare combination of valuable assets. We are a commercial stage pharma company with two products that have blockbuster potential, We also have a rich pipeline of first or best-in-class medicines. We have a clear path to making Q-Vivic the standard of care in insomnia. In parallel, we are actively engaging in partnership discussions to maximize the value of Trivio-Durigo and change the treatment landscape of uncontrolled hypertension. We also have plans to advance our innovative pipeline, leading where we can and partnering where we should. Next slide, please. Let's start with Q-Vivic. As you know, Qvivik is a best-in-class dual-orexin receptor antagonist. It works by suppressing an overactive wake signal rather than sedation, as some older drugs tend to do. As a result of this mechanism and the best-in-class pharmacokinetic properties, we can confidently say that only Qvivik offers restorative sleep and revitalized days. Before we talk about the commercial performance of Qvivik, it's important to ground ourselves in the patient experience of insomnia. Infamia is not just the loss of a night's rest, and it does not end when the night is over. It infects the entire next day. Patients describe difficulty focusing, feeling emotionally depleted, and struggling to keep up with work and family responsibilities. What they value most is a treatment that helps restore their ability to function during the day. That next-day benefit is what matters to patients, and it's central to how we think about addressing this condition. Next slide, please. We continue to expect sales growth of QVIVIC in 2026 as we guide to sales of around 200 million Swiss francs. But this is just a step on our path to changing the treatment landscape and becoming a global blockbuster. We have a clear plan to achieve this. First, market expansion in Europe and Canada. Second, unlock the true value of QVIVIC in the U.S. And third, continue to build a global brand. Let's look at the progress we are making on this and what's ahead. Next slide, please. In Europe, Tubavik is the only pharmacological treatment for long-term management of insomnia disorder. Our three-pronged approach to market expansion in Europe and Canada is proving very successful. First, we secure public reimbursement. Second, we invest in focused promotional efforts targeting psychiatrists, neurologists, and sleep specialists. Finally, we expand into primary care with co-promotion partnerships. Starting 2025, we had secured reimbursements in France, Germany, the U.K., and the private insurance markets in Switzerland and Canada. We continued to focus on reimbursement, and during the year, we obtained public reimbursement in Austria, successfully negotiated premium reimbursed price in Germany, entered price negotiations in Quebec, while submitting in Finland and continuing our discussions in Spain. This continues to be our top priority for additional markets. And in 2026, we expect to secure public reimbursements in Spain, Finland, and Quebec while preserving our price corridor. Submit in the Republic of Ireland and continuing discussions in Sweden, Italy, and the rest of Canada. Our promotional efforts targeting psychiatrists, neurologists, and sleep specialists are leading to strong positioning in retail and hospital settings. We've expanded into primary care with co-promotion partnerships with Menorini in France in October 2024. and Germany in April 2025. And in February 2026, we added the UK. This is having an incredible effect on our reach, and we continue to look for partners who have established presence and relationships with GPs in other countries. The results of these efforts has been an outstanding trajectory, particularly in France, but closely followed by Germany, the UK, and Switzerland when considering the relative market sizes. And that trajectory can continue. Just to highlight a few markets, demand in the final quarter of 2025 increased by 25% in Germany, 38% in Canada, and 45% in the UK. Next slide, please. In the U.S. in 2025, we executed a targeted digital marketing strategy with Zinio's Health to stabilize sales and maintain our core patient base. Going forward, ensuring more patients have access to Qvivic remains a priority. To achieve this, we are advancing three key initiatives. First, descheduling the DORA class, recognizing the safety in the same way as it is recognized in all other countries. This would simplify prescribing, facilitate access, expand the prescriber base, and improve the patient experience, especially with regards to refills. Second, we will conduct a streamlined label-enhancing clinical study agreed with the FDA to have QVIVX benefits on daytime functioning recognized in the U.S. label, again, in the same way as it is recognized in all other countries. This would reinforce our differentiated profile with physicians, patients, and payers. Third, we will be launching a direct-to-patient digital distribution model aligned with the evolving U.S. market and to increase access. Next slide, please. In 2025, we continue to expand Cuvivic's global reach and change the standard of care for insomnia with new approvals, launches, and strategic commercial partnerships. Several license agreements help cover markets shown here in green. Cuvivic is available in Japan through our partner, Nexera, and they recently saw positive phase three results in South Korea. Our partner, Sincere, has had a very strong uptake in China, within the private setting with three to 400,000 patients treated within the first six months. In June, we signed the licensing and supply group with CTS in Israel and more recently in 2026 with EMS in Latin America. In Brazil, the regulatory dossier has been submitted to NVISA marking an important step forward towards market entry in that region. In red, you can see the next wave of planned distribution agreements focused on Central and Eastern Europe as well as the Middle East and North Africa. These partnerships are part of our strategy to broaden geographic reach efficiently. We expect to make further progress through mid-2026, and we'll keep you updated as these agreements are finalized. Next slide, please. In 2025, we completed the recruitment into our pediatric study of daridurexan, enrolling children aged 10 to 18, with data expected in early Q2, 2026. This will be an exciting readout that can pave the way for the first therapeutic option for children suffering from insomnia. Pediatric insomnia is a major unmet need, with an estimated 12 million children in the U.S. affected and no FDA-approved therapies available. Insomnia is more prevalent in children with neurodevelopmental disorders like autism spectrum disorders and attention deficit hyperactivity disorder, and our study includes these patients. Diredurexan is the only DORA in pediatric development, and as a new standard of care, could revolutionize the treatment paradigm. We are particularly excited to share the results in the coming weeks and discuss the path forward with regulators. Next slide, please. Our second approved product is Aprocitantan, commercially available under the trade name Trivio in the U.S. and Gerigo in EU. We secured regulatory approvals in the UK, Switzerland, and Canada during 2025. It is the first and only endothelial receptor antagonist approved for the systemic hypertension market. We are actively engaged in partnership discussions, evaluating global and regional deals. Our objective is to expand access for patients while creating value for all stakeholders. Next slide, please. TrivioGerigo is uniquely placed in the treatment landscape for difficult-to-control or resistant hypertension. Its efficacy and safety profile differentiates it to existing therapies and any of those in development. Our registration trial, Precision, remains the only hypertension study to enroll true resistant hypertensive patients, all on three, four, or more drugs when entering the study. Notably, there was no exclusion based on any antihypertensive drug class. It also had the broadest inclusion criteria, including patients with EGFRs as low as 15. APROSI 1010 delivered a double digit blood pressure reduction of 15.4 millimeters of mercury in just four weeks, on top of a standardized triple therapy administered as a fixed dose combination pill. APROSI 1010 has an excellent safety profile with low discontinuation rates observed over 40 weeks, no drug-drug interactions, and no increased risk of hyperkalemia, hypotension, or decline in EGFR. The FDA approval provided a broad U.S. label that indicates Trivio is suitable for use in all patients who are not adequately controlled on other therapies, with the cardiovascular outcome benefits cited within the indication statements. Trivia benefited from several important de-risking milestones in 2025. In March, the FDA removed the REMS requirement, simplifying prescribing and distribution. Then in August, a ProC1010 was incorporated into the updated Comprehensive Hypertension Guidelines issued jointly by the American College of Cardiology and the American Heart Association, which was an important step in reinforcing its role in clinical practice. Our recently published CKD subgroup data shows strong blood pressure lowering plus significant reductions in proteinuria. Supporting Trivio is a compelling and differentiated option for these patients. Market access work for Gerigo is also underway in Europe to support our partnering efforts. Next slide, please. Thrivio is currently being prescribed at more than 25 of the top hypertension centers as part of our focused prelaunch activities to generate on-market experience. In the clinical setting, we see consistent double-digit blood pressure lowering across subgroups, including CKD stages 3 to 4, with excellent safety and tolerability. We see prescriptions coming from key specialties, including nephrology and cardiology. Early on-market experience is translating into increasing new patient starts and improving refill rates, reflecting growing physician confidence in the therapy. Prescribers report meaningful and reliable blood pressure control and comfort using Trivio across diverse comorbid patient types. Trivio's early real-world experience confirms and reinforces the pivotal trial data from Precision. Next slide, please. Our U.S. label allows us to target patients with uncontrolled hypertension despite treatment on two or more therapies. Within this broad patient population, there are clear and identifiable patient subgroups that would be the natural initial choice for prescribers. These include patients who remain uncontrolled despite treatment with three or more therapies, truly resistant to hypertension by definition. This is a group with significant unmet need and high clinical urgency. Second, patients with uncontrolled hypertension and comorbidities where endothelin is known to play a role, such as diabetes and obesity. Third, there is a clear need among patients with uncontrolled hypertension and chronic kidney disease, including those with EGFR down to 15. In this setting, Trivio offers a differentiated option. without the hyperkalemia risk or EGFR decline that often limits other therapies. Importantly, our on-market experience shows strong uptake across these same patient segments. Notably, given the significant unmet need and clear medical value in these patient populations, the prior authorization process has been very smooth. Next slide, please. Let's turn now to our pipeline. 2025 was a year of meaningful progress, laying the foundations for long-term growth. We are making deliberate, focused investments to accelerate our most value-creating assets, supported by a leaner and more streamlined R&D organization. We have advanced our first-in-class immunology portfolio of three chemokine receptor antagonists. The study for our CCR6 receptor antagonist is already enrolling in psoriasis with broad potential in T helper 17-driven autoimmune disorders. A study to show anti-inflammatory and remyelinating properties of our CXCR7 receptor antagonist is in progress, and progressive multiple sclerosis will start shortly. And a study for our CXCR3 receptor antagonist as an oral precision treatment for vitiligo will begin later in the year. 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. Next slide, please. We recently announced the exciting news that we have established a clear route to registration for leucerous dot in Fabry disease. Fabry disease is a serious and progressive condition affecting around 16,000 people today, a number expected to rise to 21,000 by 2034. There is a high need for treatments capable of addressing disease biology across the full FABRI population as existing therapies are partially effective, have cumbersome intravenous administration, or are limited to specific mutation types. Lucerastat's mutation-independent mechanism, oral delivery, and long-term data make it a uniquely differentiated option in a market expected to reach $4 billion U.S. dollars. The body of evidence we have generated to date shows that long-term treatment with Lucerostat consistently reduces the glycosphingolipid substrates that accumulate in FABRE disease. We also observe a slower decline in kidney function compared with patients' prior historical trajectories. Importantly, kidney biopsy data from patients receiving long-term treatment demonstrate low to no levels of characteristic glycosomal deposits. for our related data recently published at World Symposium 2026. Next slide, please. Following constructive interactions with regulatory authorities, we now have a clearly defined clinical program for Lucerestat. This program builds on the substantial body of data already generated and outlines the agreed path towards future NDA in the U.S. and in line with feedback from the European Medicines Agency. The agreed development plan includes a pivotal baseline-controlled biopsy study supported by a second study designed to demonstrate that an oral therapy has the potential to deliver clinical benefits comparable to enzyme replacement therapy, which is complex and burdensome for patients. This developmental program is structured to reinforce the serostats potential as the first oral monotherapy suitable for all FABRE patients, regardless of mutation type. If successful, the data are expected to support regulatory submissions as early as 2029. With that, I will hand it over to Arno to take you through the financial results and our guidance for 2026. Next slide, please.

Thank you, Christy. Good afternoon and good morning to everyone on the call. In my first slide, you can really see the impact of our increased QVC sales and contract revenue. together with our cost saving measures, resulting in a significantly improved operating results. Net revenue of 214 million includes 134 million from QVivec product sales, excluding partner sales. A significant increase compared to the 61 million of sales in 2024. The main driver of the sales increase is the EU-Can region, where sales increased from 32 to 108 million. The sales in the U.S. remained flat, despite a significant reduction in sales and marketing costs. As mentioned by Srishti, the aim is to maintain our U.S. prescriber and patient base in a cost-efficient manner to bridge to a potential de-scheduling. Non-GAAP contract revenue of 72 million includes the 35 million U.S. dollar exclusivity fee from the undisclosed partner for Aprocitantam that was received in Q4-24 but recognized in Q125 after the exclusivity period ended without resulting in the deal. As a reminder, the undisclosed partner was not able to close the deal for reasons absolutely unrelated to our proceedent time. In addition, we received a 40 million Swiss franc signing and approval milestone from CIMSIR related to the outlicensing of QVVIC in China. The cost rationalization efforts initiated in 2024 and 2025 further improved our operational cost base with savings of more than $80 million compared to 2024. As a result, the non-GAAP operating results improved from a loss of $308 million in 2024 to a loss of $100 million in 2025. Based on successful negotiations with Viatris in Q1 2025, Eidosia's cost-sharing commitments were reduced by 100 million US dollar against a reduction of potential future regulatory milestones. This resulted in a gain of 90 million Swiss franc. Other non-gap-to-gap differences mainly include depreciation and amortization and stock price compensation. This resulted in a US gap EBIT loss of 33 million. The US GAAP net loss of $112 million also includes the financial expenses of $72 million, which also includes a $61 million non-cash expense related to the convertible bond restructuring and the new money facility. And we had an income tax expense of $6 million. Next slide, please. In addition to an outstanding operational performance in 2025, we were also able to successfully strengthen our financial position and access to liquidity. As you know, we started the year with 106 million in cash. Operational cash inflows included 142 from QVV product sales, including sales to partners, and operational cash outflows included 250 million of SG&A and 93 million of R&D costs. The 11 million other cash outflows mainly included working capital movements. Further, as announced in May 25, we secured a 150 million Swiss franc funding facility from our bondholders. And in June 25, we drew the first tranche of 70 million. We also raised 68 million net of cost through an equity raise in October 25, by way of an accelerated book building process, as well as the sale of some of our treasury shares to bondholders. We were very happy with the over subscribed demand from the top tier institutional investors that participated in the book building process. This resulted in a liquidity of $8 million at the end of the year. And in addition to that, we still have access to a further $80 million from the new money facility, which totals $169 million liquidity available to Eidosia. All in all, I think we can conclude that we finished the year with a strong liquidity that puts us in a good position to fund our activities going forward and leading to next reflection points. Next slide, please. Here we come to the comparison against the guidance. We are proud of our strong performance against an ambitious guidance target, which was significantly upgraded in May 2025. Our cumulative sales of 134 million exceeded the guidance sales of 130 million due to an excellent execution of our commercial strategy, as we already alluded to. The company also delivered on the announced reset of the cost base, and as a result, the operating expenses, net of other income, were in line with the guidance that we provided in May 25. The US GAAP operating loss or US GAAP loss of 33 million is lower than the guidance mainly due to one of lower stock price compensation costs. Equally important compared to achieving the financial guidance for 2025 is that we've built the structures to transition this momentum into the future. Next slide, please. We continue to guide on IDOR-CLF sales excluding sales to partners because this is the performance that we can actively steer and have control over. We expect a continuous QMVIC sales growth, and with sales of 200 million, we will have a positive commercial contribution for the first time. Our 2026 OPEX, including cost of goods sold, will be flat compared to 2025. A little bit higher than might be anticipated in the market, but purposefully so, focused on creating shareholder value and within strategic guardrails. Our 2026 OPEX is fully consistent with a disciplined plan that supports the next wave of growth drivers. These expenditures are targeted, program specific, and clearly tied to our medium term value creation plans, such as Lucerastat program and the proof of concept studies with our Immunology portfolio. In a nutshell, sales are going up, OPEX remains flat, and overall losses are going down, reflecting the improved underlying business performance and the embedded operational leverage within our business model. And with that, I hand over to Srishti.