Earnings call transcript: Idorsia Q2 2025 shows strong revenue growth

Idorsia Ltd reported its Q2 2025 earnings, revealing significant revenue growth and notable improvements in its financial performance. The company recorded net revenue of €130 million, driven by strong sales of its Quvivic product. The stock surged by 25.09% following the earnings announcement, closing at €3.39, reflecting positive investor sentiment. According to InvestingPro data, the company has achieved a remarkable 279% price return over the past six months, though current analysis suggests the stock is trading above its Fair Value.

Key Takeaways

• Idorsia’s net revenue reached €130 million, with Quvivic sales contributing €58 million.
• The company secured a €150 million funding facility, extending its cash runway to 2026.
• Non-GAAP operating results improved significantly, with a reduction in losses from -€170 million to -€15 million.
• The stock price increased by 25.09%, indicating strong market confidence.

Company Performance

Idorsia demonstrated robust performance in Q2 2025, with net revenue climbing to €130 million, a substantial increase driven by the success of its Quvivic product. The company’s strategic focus on expanding its market presence in the EU and Canada paid off, with sales in these regions rising from €9 million to €44 million. This growth underscores Idorsia’s ability to capture market share in the competitive insomnia treatment landscape.

Financial Highlights

• Revenue: €130 million, up from previous periods.
• Quvivic sales: €58 million, up from €24 million year-over-year.
• Non-GAAP operating loss: Improved from -€170 million to -€15 million.
• New funding facility: €150 million, extending cash runway to 2026.

Outlook & Guidance

Looking ahead, Idorsia maintains a positive outlook, with expected sales of €130 million and a non-GAAP EBIT loss of €175 million. The company is focused on unlocking the full value of Quvivic, expanding strategic partnerships, and accelerating its high-value pipeline assets. Idorsia aims to achieve commercial profitability by 2026 and overall profitability by 2027. InvestingPro data shows revenue growth of 14.08% in the last twelve months, though analysts do not anticipate profitability this year. The company’s Financial Health Score stands at 2.36, rated as "FAIR" by InvestingPro’s comprehensive analysis system.

Executive Commentary

CEO Srishi Gupta emphasized the company’s strategic vision, stating, "Our goal is to balance ambition with accountability." He also highlighted the importance of partnerships, saying, "Partnerships and alliances would be an important source of revenue." Gupta reiterated Idorsia’s commitment to being a science-based company with a deep pipeline across major unmet needs.

Risks and Challenges

• Market competition: Intense competition in the insomnia and hypertension markets could impact market share.
• Regulatory hurdles: Navigating regulatory requirements for new product approvals remains a challenge.
• Financial discipline: Maintaining financial discipline while pursuing growth initiatives is crucial.
• Economic conditions: Macroeconomic pressures could affect consumer spending and healthcare budgets.

Q&A

During the earnings call, analysts inquired about the descheduling process for the DORA class and its potential market impact. Executives also addressed questions on the difference between commercial and overall profitability, highlighting the company’s strategic roadmap towards achieving these milestones. Potential partnership opportunities for Aprocytantan were also discussed, indicating a focus on collaborative growth.

Idorsia’s Q2 2025 results reflect strong operational execution and strategic market positioning, with positive investor sentiment driving a notable stock price increase. The company’s commitment to innovation and strategic partnerships positions it well for future growth.

Full transcript - Idorsia Ltd (IDIA) Q2 2025:

Nadia, Conference Operator: Welcome to the iDOSIA Half Year twenty twenty five Financial Results Webcast and Conference Call. At this time, all participants are in listen only mode. After the speakers’ presentation, there will be the question and answer session. Please be advised that today’s conference is being recorded.

I would now like to hand the conference over to our first speaker today, Andrew Jones, Head of Corporate Communications. Please go ahead.

Andrew Jones, Head of Corporate Communications, Idorsia: Thank you, Nadia. Good afternoon, and good morning, everyone, and welcome to our webcast to discuss the financial results for the 2025. Presenting on the call today, we have our new CEO, Srishi 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 and 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 Yukon Region, Benjamin Limahl, our president of The US, Michael Moy and chief scientific officer, and newly appointed head of research, Martin Clozell and Alberto Gimona, global head of clinical develop 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.

Srishi Gupta, CEO, Idorsia: 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 is a bit of background for those of you who I have 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, I Dorcia led QVIVIK net sales in the 2025 more than doubled compared to last year, rising from CHF 23,000,000 to CHF 56,000,000. This demonstrates strong commercial traction and growing demand. It is driven by Europe and Canada and a stabilization of an optimized model in The U. S.

We also see an improvement in our non GAAP operating results from negative CHF 170,000,000 to negative CHF 15,000,000. Arna will share our financials in more detail later on. I commend the team on the strong performance. The results confirmed the commercial acceleration of Qubic, coupled with the financial discipline implemented over the past twelve months, have successfully delivered on an operational turnaround. A few other highlights to share.

QUVIVIC is a truly global brand with rapidly growing sales. Most recently, we worked with our partner, Simsir, for approval and the national reimbursement drug listing in China. I will share more on Trivio 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 Lucerastat, which supports further Phase III investigation in Fabry 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 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 and 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 QVIC. We have demonstrated that QVIC is the driver of growth for our business.

To realize the full potential of QVIC, 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. Kivivik is not a best 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 descheduling of the DORA class in The US, which I will touch upon later. We are receiving extremely positive feedback from both health care 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 QVIVIC’s global footprint is expanding. Idorsia commercializes QVIVIC in North America and Europe. It is available in Japan through our partner Nexera, and it will soon be available in China. We have worked out with our partner, Sinsere, to establish the regulatory pathway for approval in China and leverage the wealth of data we generated in our global program.

Simsere did an outstanding job of rapidly advancing this to approval so that QVIC will be available to patients. I think it’ll actually be available to patients as soon as the 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 Qvivac is poised to fundamentally reshape the insomnia treatment landscape in Europe. In the first half of twenty twenty five, 25,000,000 restorative nights and revitalized dates have been prescribed in Europe. QUVIVIC 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 1. 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 better to build trust in our clinical evidence. And finally, we continue to expand into primary care with co promotion partnerships, such as with Menarini in France and in Germany, as well as omnichannel 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 Qvivix 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 QVIC 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 QVIVIK to maintain its availability and sales until the potential descheduling of the DORA class. Syneos Health 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 gross margin driven by a greater proportion of payor paid scripts. We continue to advocate for descheduling 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 are 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 Daridorexant is delivering meaningful value in clinical practice. We are very excited to be advancing the recruitment of our phase two 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 Daridorexant positions it as an ideal candidate to address this treatment gap. The study is expected to complete enrollment by the 2025 with a readout expected around mid-twenty twenty six. 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 QVIC 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 QVIC 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 QVIC 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 creation. Next slide, please. We collaborate with partners who share our belief that science can transform lives. Partnerships take many forms. Copromotion partners expanding QVIVX reach to general practitioners, like our partnership with Menarini, distribution partners opening new markets, and codevelopment partners enabling approvals in specific geographies, like our recent success in China with SimSier.

We aim to secure new partners across these models to bring QVIC to more patients around the world. We also pursue partnerships to accelerate R and D, like our collaboration with Viatris. We have licensed two Phase III products to Viatris, selatogrel and sunerimod. This is a great example of how we 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. Myatris is executing well on recruitment.

And if all goes to plan, we look forward to data readouts next year. Next slide, please. Partnering remains a top priority, and we are actively engaging in partnership discussions. As a reminder, aprocytantan is approved under the trade name Trivio in The US and Draigo in The EU and UK. It is the first and only endothelin receptor antagonist approved for the 12 uncontrolled and resistant hypertension market.

And until the approval of Trevyo, the last new drug class for hypertension was over thirty years ago. It is estimated that fifty percent of adults in The US live with hypertension, and fifty percent of those patients are not well controlled despite being on medication. Trevyo therefore meets a significant unmet need. The FDA has granted an indication that includes patients on one or more antihypertensive drug, a less restrictive criteria than we set for ourselves for the PRECISION pivotal study, making the addressable patient population significantly larger. The label for Trevyo 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 fifteen milliliters per minute with no risk of hyperkalemia. Trevyo has an excellent safety profile with low discontinuation rate observed over forty weeks.

No drug drug interactions, hypotension, or hypokalemia, 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 cause of hospital acquired diarrhea. It is responsible for approximately half a million infections and close to thirty thousand 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’s 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.

Lucerastat is our oral substrate reduction therapy with the potential for organ protection in all adult patients with Fabry disease. End organ protection remains an unmet need and is essential in Fabry 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 III extension study where patients have been treated for at least forty two months and a kidney biopsy substudy are supportive of further investigation for patients with Fabry disease. And we are in continued discussion with the U. S.

FDA to agree on the optimal regulatory pathway to approval. As I mentioned earlier, we are doing a dose finding Phase II study with Daridorexant in pediatric populations. And during the full year 2024 webcast, we also shared that we will advance three first in class chemokine receptor antagonists into Phase II. 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 CXCR7 for remyelination and progressive multiple sclerosis, CXCR3 for precision treatment of vitiligo, and CCR6 for T helper seventeen 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 laser focused on smart resource allocation, growth oriented cost discipline, and value driven decisions.

And with that, let me hand it over to Arno. You, Next slide, please.

Arno Grunewald, Chief Financial Officer, Idorsia: You, Kristi. Good afternoon, good morning to everyone following on the call. Let’s start by looking at the operating results. Here, you can really see the huge impact of our cost saving measures together with the greater commercial contribution and higher contract revenue. Net revenue of €130,000,000 includes €58,000,000 from total Curevivic product sales, a significant increase compared to the 24,000,000 in the 2024.

The main driver of the sales increase is the EU Can region, where sales increased from 9,000,000 to €44,000,000 The sales in The U. S. Remained relatively flat despite a significant reduction in sales and marketing costs. As already mentioned by Swishti, the aim is to maintain our U. S.

Prescriber and patient base in a cost efficient manner to bridge to potential descheduling of the drug. Contract revenues of €72,000,000 also includes $35,000,000 exclusivity fee from the undisclosed partner for aproxitentan that was received in Q4 twenty twenty four, but recognized in Q1 twenty twenty five after the exclusivity period ended without resulting in a deal. As we already mentioned before, the undisclosed partner was not able to close the deal for reasons absolutely unrelated to aprocitentan. In addition to the exclusivity fee, we also recognized a €40,000,000 signing and approval milestone from Simsere related to the out licensing of Qvivik for the Chinese market that will be received in Q3 twenty twenty five. The cost rationalization efforts initiated in Q4 twenty twenty four further improved our operational cost base with savings of close to €50,000,000 compared to the 2024.

We will continue to balance necessary investments in Curevix expansion and our R and D pipeline with the objective of reaching overall profitability starting from the 2027. As a result, the non GAAP operating results improved from a loss of €170,000,000 for the 2024 to a loss of €15,000,000 for the 2025. Next slide please. Let’s now look at the bridge from non GAAP operating results to U. S.

GAAP net income. Based on the successful negotiations with Viatris in Q1 twenty twenty five, iDorsia’s cost sharing commitments were reduced by US100 million dollars against the reduction of future regulatory milestones. This resulted in a gain of CHF90 million. Other non GAAP to GAAP differences of about CHF 10,000,000 mainly include depreciation and amortization and stock based compensation. Together this resulted in a U.

S. GAAP operating profit of CHF 64,000,000. The US GAAP net income of €52,000,000 includes also the financial expenses of €8,000,000 and an income tax expense of €4,000,000 Next slide please. We started the year with €106,000,000 in cash. Operational cash inflows included the €58,000,000 from Cuvivic product sales and the operational cash outflows included €101,000,000 of SG and A and €46,000,000 of R and D costs.

The €15,000,000 other cash outflows mainly include working capital movements. Further as announced in May 25, we secured €150,000,000 funding through a new money facility from bondholders. In June 25, we drew the first tranche of €70,000,000 This resulted in the liquidity of 72,000,000 at the June 2025. Note that this liquidity does not include yet the €40,000,000 milestone from Simsere, which we expect to receive in Q3. And there’s also an undrawn amount of €80,000,000 under the new money facility.

So if we would consider also these items, the cash runway now goes out to the 2026. Next slide please. The guidance for the Idorsia led business remained unchanged from the improved guidance that we published in May, with expected sales of €130,000,000 and a non GAAP EBIT loss of 175,000,000 We’ve updated the guidance for the Partner led business due to the higher milestone payments from SimSphere, which result in an overall non GAAP EBIT loss of €100,000,000 and a U. S. GAAP EBIT loss of 55,000,000 This guidance puts us on track to reach commercial profitability in 2026 and overall profitability as from the 2027.

And with that, I hand back to Kristine.

Srishi Gupta, CEO, Idorsia: Next slide, please. Thank you, Arno. Finally, we continue to focus on building an organization with a strong culture. Our ambition is to invest in a high performance organization grounded in clarity, collaboration, and ownership. We want to enable teams to move with speed, adapt with agility, and deliver meaningful results.

Next slide, please. Our science makes a difference because of the people behind it, their expertise, dedication, and drive to turn innovation into impact. We combine deep r and d capabilities with seasoned commercial teams who ensure that our medicines reach the patients who need them. I’m consistently struck by the talent and commitment of our people. They are our greatest asset, united by a shared purpose and focused on delivering long term value for patients, partners, and shareholders.

Next slide, please. I don’t have this slide. I want to thank the Idorsia Executive Committee and their teams for the progress we have made over the past half year and also take a moment to highlight some recent changes. Martine has served as the Chief Scientific Officer since the start of Idorsia. Under Martine’s scientific leadership, Idorsia’s discovery engine has produced one of the richest pipelines in biotech, grounded in rigorous science and a deep understanding of unmet medical need.

As she now also takes on the role of head of research, she will bring renewed focus to advancing our most promising early stage assets. In addition, Julien, our legal officer has also our chief legal officer has also will also lead corporate development to support strategy, strengthen internal governance, and promote partnerships and alliances by overseeing our business development efforts. As we live the principle of leading where we can and partnering where we should, partnerships and alliances would be an important source of revenue as we find ways to accelerate development and as pathways to reach more patients around the world. Next slide, please. In conclusion, the 2025 reflects delivering sales guidance for QVIC and well executed financial discipline, putting us on the path to commercial profitability in 2026 and overall profitability starting from the 2027.

Moving forward, we will work with urgency to deliver on the five strategic priorities we have laid out today. I look forward to providing updates on our progress in the quarters to come. Thank you so much for your time, and I will hand it back to Andrew.

Andrew Jones, Head of Corporate Communications, Idorsia: Thank you both. And now we have time to take your questions. As I mentioned at the beginning, we’re also joined by Julian, Benjamin, Michael, Martin, and Alberto. With that, operator, please could you open the line for questions?

Nadia, Conference Operator: Thank you so much, dear participants. Please standby. We’ll compile the Q and A roster. This will take a few moments. Once again, if you wish to ask a question, please press 11.

And now we’re going to take our first question, and it comes from the line of Sushila Hernandez from Van Lansert and Kempen. I

Sushila Hernandez, Analyst, Van Lansert and Kempen: have a few, if I may. To start off, could you help us understand what the difference is between commercial profitability and overall profitability and what is needed to fill in the gap? And then I have a few more follow-up questions.

Andrew Jones, Head of Corporate Communications, Idorsia: Thank you, Sushila. Maybe I’ll hand over to Arnaud to take us through that.

Arno Grunewald, Chief Financial Officer, Idorsia: Sure. So commercial profitability means net sales and commercial OpEx. So that should be positive in 2026 for the full year. And overall company profitability also includes the R and D expenditure and SG and A. Does that answer your Yes,

Sushila Hernandez, Analyst, Van Lansert and Kempen: sure. And could you walk us through how the descheduling process works? What could be the outcome of the update that we’re expecting soon?

Andrew Jones, Head of Corporate Communications, Idorsia: Great. Thanks, Sheila. Michael, would you take that and take us through the process as we understand it?

Michael Moy, President of US, Idorsia: Yeah. Sure, Andrew, and thanks, Sheila, for the question. The process of rescheduling is ongoing. The next steps we expect to hear from the FDA is them sharing their scientific opinion with the DEA. This we hope this will happen soon, and this would be a significant milestone and a positive sign to the market.

At this point, the DEA would then post the scientific opinion for public comment and evaluation for decision. So the the the kind of underlying important piece of this is, you know, how does this all develop? And that is based on the advert event profiles related to the abuse potential of the dora class. So the FDA looks at their adverse event database called Fares. It is much, less than that seen for other you know, the dora class, much less seen for widely used insomnia products in The US, notably zolpidem and even trazodone, which we know is not even indicated for insomnia.

So the analysis that the FDA has done, you know, out of their own database confirms the safety profile of the dora class and, in particular, area direction. So, you know, as Trishee said earlier, we really are hoping, and and have a a strong feeling that that, analysis is progressing, and that we hope to hear, from the FDA very soon.

Srishi Gupta, CEO, Idorsia: And then maybe I just to add oh, sorry. Sorry. Did just wanted to add that, yeah, the in addition to the FDA’s analysis, Idurisa has also reviewed the adverse event profile related to the abuse by looking through the FAERS database, the FDA Adverse Events database, and we noticed that it’s very much less than the other widely used insomnia products, including zolpidem and trazodone. So we’ve done independent analysis, so we remain hopeful that the analysis will be consistent with the FDA’s analysis. So we haven’t just left this to the FDA to do an independent analysis.

Like we have been looking at this since 2023 when we first filed the Census petition for the descheduling of the DORA class. And it’s our understanding that ESI and Merck have also continued to monitor both their adverse events and think about the descheduling of the class as well. So we’re fairly confident that the in totality, the evidence base exists that we will be able to achieve the the sched the descheduling of the class. I think it’s just a matter of the process playing itself out.

Sushila Hernandez, Analyst, Van Lansert and Kempen: Okay. That’s clear. And then just maybe I missed that that, Austin, here’s a timeline. So we’re awaiting this analysis. So once this analysis is in, what are the timelines that we can think of in terms of the doracast being actually rescheduled?

Srishi Gupta, CEO, Idorsia: It it’s not a 100% transparent in terms of the process, but what we understand is that there is an FDA clearance process where the analysis moves its way through the FDA and then it is then submitted to the DEA. The DEA then puts it up for public comment in case there’s public commentary on the view of the descheduling and that can be positive where people are supportive of the descheduling of the class. And then upon that, the DEA makes the final recommendation. So while we know that there is a timeline of an estimated eight to ten weeks in terms of the FDA clearance process, we don’t have visibility on the timeline that the DEA puts out for public comment and for their final decision. Based on the analogs that we’ve looked at for other descheduled products, we think that after the submission to the DEA, we’re probably on a timeline of around six to nine months.

Of course, I think that it’s important to note, Susheela, that the government looks very different in The United States now than it did under any of those other analogs. So I think we’re trying to remain agile and flexible around that. And, actually, Michael and I will be in Washington, DC in early September, and we look forward to providing an update in q three on on what we learned from our our time with HHS.

Sushila Hernandez, Analyst, Van Lansert and Kempen: Okay. That’s clear.

Arno Grunewald, Chief Financial Officer, Idorsia: And then just one last question. To to that sorry. Maybe maybe maybe to add to that, also, the the scheduling of QVIVIC in The US is an upside in our in our model. So

Srishi Gupta, CEO, Idorsia: Not included in guidance.

Arno Grunewald, Chief Financial Officer, Idorsia: It’s not included in the guidance. So Okay.

Sushila Hernandez, Analyst, Van Lansert and Kempen: That’s clear. And then for Aquisite and so on, so the REMS are removed. What else are you doing to make this product more attractive? What market preparations are you currently conducting, and what are you looking for in a partner? Thank you.

Srishi Gupta, CEO, Idorsia: Thank you for the question. We’re very excited actually right now. There’s quite a drumbeat around resistant and uncontrolled hypertension from some of the other products in development. And I think the thing that we’re most trying to emphasize in addition to the REMS removal is that this product is already approved. So there is actually no uncertainty as to what the label will say.

There’s no uncertainty as to what payers will say. Payers are actually giving us the positive feedback that there will be utilization management that is consistent with being on one or more therapies which is what is in the label. So we are just trying to communicate with a sharp messaging that without the REMS, this is a product that has easy distribution and prescription without monitoring. We’re communicating what our real world experiences with prescribers who are the product is available by medical exception in The United States right now. And one of those, the things that’s being highlighted in its current use is the potential in patients with chronic kidney disease without having to monitor for hypokalemia because of the eGFR levels going down to 15.

So we think that there’s differentiation to products that are currently available and anything in development because of this our CKD data. And even before a deal, I think what we’re hoping for is that our data on CKD will actually be published in scientific literature and that The US hypertension guidelines will be updated, I think, in the next few weeks. And we’re hoping the mention of the novel class of the new drug class for the treatment of systemic hypertension will be recognized by the hypertension guidelines.

Sushila Hernandez, Analyst, Van Lansert and Kempen: Okay. Thank you. Those were my questions.

Nadia, Conference Operator: Thank you.

Srishi Gupta, CEO, Idorsia: Thank you for your questions, Toshela.

Nadia, Conference Operator: Dear participants, as a reminder, if you wish to ask a question, please press star one one on your telephone keypad and wait for a name to be announced. Dear speakers, there are no questions over the phones at this moment.

Andrew Jones, Head of Corporate Communications, Idorsia: Okay. Thank you, Nadia. I mean, in that case, maybe I can put a question to you based on the request that we see coming through the investor relations mailbox recently. Srishi, I think everyone can see that you’ve gotten up to speed in record time. On this basis, what catalysts are you most excited about over the next six to twelve months?

Srishi Gupta, CEO, Idorsia: Thank you for the question, Andrew. So over the next six to twelve, maybe a little bit longer, fifteen months, I think let’s talk about a few key things. This one may seem obvious, but I think we need to continue to deliver on our ambitious QVIVIX sales target quarter after quarter. And this is for us to just keep on track to achieve our commercial profitability and our overall profitability. In Europe, this means continuing to secure access and reimbursement in the public markets as well as expanding to the primary care partnership that we discussed.

And then as Arno mentioned, capturing any potential upsides that we would have from the descheduling of the class. And then I think as we also mentioned, we’re really looking to make sure that this product is available to patients worldwide and we think that there’s large unmet needs in markets like Latin America, The Middle East and North Africa. So I think if we can stay on target for QVIVI quarter after quarter that will actually be a catalyst for us. Again, we talked about APRO. I think that’s another significant opportunity for us to both enhance the value of the company’s science and sort of recognize science that we have out there as well as start to pay back some of our debt that’s sitting in the special purpose vehicle.

We expect to, as I mentioned, they publish some data in CKD as well as see the updated guidelines coming out of The US. And then we also talked about the regulatory milestones that we’re hoping for coming out of our pipeline. So the FDA, we’re hoping to have an agreed upon path forward for the phase III registration work for Lucerastat. We hope to initiate the Phase II proof of concept studies for R3 chemokines over the next six to twelve months. And we are continuing our Phase I program of our vaccine platform and we’re hoping to have identified a partner to help us take that one forward.

And finally, we’re very excited about our partnership with Viatris which holds the assets selatogrel and sonarimod and recruitment into those Phase III studies are ongoing. So over the next six to twelve months, I think we’re also hoping to see, some of the readouts from that work, which actually continues to contribute additional upside for Idarcia shareholders.

Andrew Jones, Head of Corporate Communications, Idorsia: Great. Thanks, Christy. Nadia, do we have anybody who’s joined into the queue?

Nadia, Conference Operator: Not at this moment.

Andrew Jones, Head of Corporate Communications, Idorsia: Okay. If we’re not seeing any other questions coming in, I think I understand it’s summer holidays for for many people, including quite a few of the people joining the call today on our side. So thank you very much to our team for doing that. I would say in that case, if anybody comes up with questions afterwards, we’re always on standby to help you, and then we’ll conclude the call for today. We have third quarter results coming out in October 30, and you’ll see that the management team will be traveling more in the next few months.

So hopefully, we’ll an opportunity to meet with more of you in the near future. With that, Nadia, please close down the lines.

Srishi Gupta, CEO, Idorsia: Thank you, everyone. This

Nadia, Conference Operator: concludes today’s conference call. Thank you for participating. You may now all disconnect. Have a nice day.

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