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.

Thank you, Christine. Next slide

please.

Thank you, Christine. 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 million includes 58 million from total QVIP product sales, a significant increase compared to the 24 million in the first half of 2024. The main driver of the sales increase is the EU can region where sales increased from nine to 44 million. The sales in the US remain relatively flat despite a significant reduction in sales and marketing costs. As already mentioned by Srishti, the aim is to maintain our US prescriber and patient base in a cost-efficient manner to bridge to potential de-scheduling of the drug. Contract revenues of 72 million also includes 35 million US dollar exclusivity fee from the undisclosed partner for appr. Tintin. That was received in Q4-24, but recognized in Q1-25 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 appr. Tintin. In addition to the exclusivity fee, we also recognized a 40 million signing and approval milestone from SimSir related to the out licensing of QVVIC for the Chinese market that will be received in Q3-2025. The cost rationalization efforts initiated in Q4-24 further improved our operational cost base with savings of close to 50 million compared to the first half of 2024. We will continue to balance necessary investment in QVVIC expansion and our R&D pipeline with the objective of reaching overall profitability starting from the end of 2027. As a result, the non-GAAP operating results improved from a loss of 170 million for the first half of 2024 to a loss of 15 million for the first half of 2025. Next slide, please. Let's now look at the bridge from non-GAAP operating results to US GAAP net income. Based on the successful negotiations with Viatris in Q1-2025, Eidosia's cost sharing commitments were reduced by a hundred million US dollars against the reduction of future regulatory milestones. This resulted in a gain of 90 million Swiss franc. Other non-GAAP to GAAP differences of about 10 million mainly include depreciation and amortization and stockpile compensation. Together, this resulted in a US GAAP operating profit of 64 million. The US GAAP net income of 52 million includes also the financial expenses of 8 million and an income tax expense of 4 million. Next slide, please. We started the year with 106 million in cash. Operational cash inflows included the 58 million from QVIP product sales and the operational cash outflows included 101 million of SG&A and 46 million of R&D costs. The 15 million other cash outflows mainly include working capital movements. Further, as announced in May 25, we secured 150 million funding through a new money facility from bondholders. In June 25, we drew the first tranche of 70 million. This resulted in the liquidity of 72 million at the end of June, 2025. Note that this liquidity does not include yet the 40 million milestone from SimSare, which we expect to receive in Q3. And there's also an undrawn amount of 80 million under the new money facility. So if we would consider also these items, the cash runway now goes out to the end of 2026. Next slide, please. The guidance for the Eidosia led business remained unchanged from the improved guidance that we published in May this year with expected sales of 130 million and a non-GAAP EBIT loss of 175 million. We've updated the guidance for the partner led business due to the higher milestone payments from SimSare, which result in an overall non-GAAP EBIT loss of 100 million and a US GAAP EBIT loss of 55 million. This guidance puts us on track to reach commercial profitability in 2026 and overall profitability as from the end of 2027. And with that, I hand back to Christine.

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&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 I-Dorsey 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 I-Dorsey. Under Martine's scientific leadership, I-Dorsey'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, Julian, our Chief Legal Officer 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 first half of 2025 reflects delivering sales guidance for QVVIC and well-executed financial discipline, putting us on the path to commercial profitability in 2026 and overall profitability starting from the end of 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.

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, Martín, and Alberto. With that, operator, please could you open the line for questions?

Thank you so much. Dear participants, as your 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. To withdraw a question, please press star one, one again. Mr. Mba will compile the Q&A and all studies. We'll take a few moments. Once again, if you wish to ask a question, please press star one, one. And now we're going to take our first question, and it comes from the line of Susila Hernandez from Van Lanschot Kampen. Your line is open. Please ask your question.

Yes, thank you for taking my questions. I 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.

Thank you Susila. Maybe I'll hand over to Arnold to take us through that.

Sure, so commercial profitability means net sales and commercial op-ex. So that should be positive in 2026 for the full year. And overall company profitability also includes the R&D expenditure and the G&A. Does that answer your question?

Okay, thank you. Yeah, sure. And could you walk us through how the de-scheduling process works? What could be the outcome of the update that we're expecting soon? Thank you.

Great, thanks Susila. Michael, would you take that and take us through the process so that we understand it?

Yeah, sure, Andrew. And thanks, Sheila, for the question. The process of de-scheduling is ongoing. The next steps we expect to hear from the FDA is them sharing their scientific opinion with the DEA, as 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 could then post the scientific opinion for public comment and evaluation for the decision. So the kind of underlying important piece of this is, how does this all develop? And that is based on the adverse event profiles related to the abuse potential of the DORA class. So the FDA looks at their adverse event database called FAERS. It is much less than that seen for other, the DORA class, much less seen for widely used insomnia products in the US, notable Zolpidem and even Trazodone, which we know is not even indicated for insomnia. So the analysis that the FDA has done out of their own database confirms the safety profile of the DORA class and in particular, theory direction. So as Tracey said earlier, we really are hoping and have a strong feeling that that analysis is progressing and that we hope to hear from the FDA very soon.

And then maybe I missed a part. Oh, sorry, sorry.

I just wanted to add that, yeah, in addition to the FDA's analysis, I, Doris, 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 citizen's petition for the de-scheduling of the DORA class. And it's our understanding that the ESI and Merck have also continued to monitor both their adverse events and think about the de-scheduling of the class as well. So we're fairly confident that in totality, the evidence base exists that we will be able to achieve the de-scheduling of the class. I think it's just a matter of the process playing itself out.

Okay, that's clear. And then just maybe I missed that, that also in terms of 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 DORA class being actually de-scheduled?

It's not 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 de-scheduling. And that can be positive where people are supportive of the de-scheduling 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 10 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 de-scheduled products, we think that after the submission to the DEA, we're probably on a timeline of around six to nine months. But of course, I think that it's important to note, Sushila, 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, D.C. in early September and we look forward to providing an update in Q3 on what we learned from our time with HHS.

Okay, that's clear. And then the next question is, to add

to that, sorry, maybe to add to that, also the de-scheduling of QVVIC in the U.S. is an upside in our model.

So- Not included in guidance.

Not included in the guidance.

Okay, that's clear. And then for -and-sons, 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.

Thank you for the question. We're very excited actually right now. There's quite a drum beat 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 experience is with prescribers who are, with the product is available by medical exception in the United States right now. And one of those, the things that's being highlighted in this 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 AHA's Hypertension Guidelines.

Okay, thank you. Those were my questions. Thank you.

Thank

you

for your questions, Tashayla. 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.

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. Srishti, 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 12 months?

Thank you for the question, Andrew. So over the next six to 12, maybe a little bit longer, 15 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 QVIVIC 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 partnerships that we've discussed. And then as Arno mentioned, capturing any potential upsides that we would have from the de-scheduling 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 QVIVIC quarter after quarter, that will actually be a really big 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, to 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, the regulatory milestones that we're hoping for coming out of our pipeline. So the FDA, we are hoping to have an agreed upon path forward for the phase three registration work for Lucerostat. We hope to initiate the phase two proof of concept studies for our three chemokines over the next six to 12 months. And we are continuing our phase one 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 Beatrice, which holds the assets for Latigroup and Senaramod, and recruitment into those phase three studies are ongoing. So over the next six to 12 months, I think we're also hoping to see some of the readouts from that work, which actually continue to contribute additional upside for IDARCIA shareholders.

Great, thanks Srishti. Nadia, do we have anybody who's joined into the queue?

Not at this moment, dear participants, once again, if you wish to ask a question or just leave a comment, please press

star, one, one, or the telephone keypad. Okay, if we're not seeing any other questions

coming in, I think I understand it's summer holidays 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 on October 30th. And you'll see that the management team will be traveling more in the next few months. So hopefully we'll get an opportunity to meet with more of you in the near future. With that, Nadia, please close down the lines.

Thank you everyone. This concludes today's conference call. Thank you for participating. You may now all disconnect. Have a nice day.