Ladies and gentlemen, welcome to The Basilea Pharmaceutica Full Year Results 2025 Conference Call and Live Webcast. I am Matilde, the conference call operator. I would like to remind you that all participants will be in listen-only mode, and the conference is being recorded. The presentation will be followed by a Q&A session. You can register for questions at any time by pressing Star and One on your telephone. For operator assistance, please press Star and Zero. The conference must not be recorded for publication or broadcast. At this time, it's my pleasure to hand over to David Veitch, Chief Executive Officer. Please go ahead. Thank you. Hello, I'm David Veitch, CEO of Basilea, and I would like to welcome you to our conference call and webcast, presenting our financial results and key achievements for the full year 2025, as well as highlighting our priorities and future value drivers for 2026 and beyond. For further detailed information, please see the ad hoc announcement issued this morning and also our annual report. These documents are both available on our website at basilea.com. I would like to mention that this call contains forward-looking statements. Joining me on our call today are Adesh Kaul, our Chief Financial Officer, and Dr. Marc Engelhardt, our Chief Medical Officer. Looking back at 2025, this was a year of great execution across our business. Starting with our commercial portfolio, Cresemba continued its strong momentum, with global in-market sales up 27% to $693 million for the twelve months to September 2025. Our second commercial brand, Zevtera, was successfully launched in the U.S., and we expect to see increasing commercial uptake from the second quarter of 2026. We also delivered a robust financial performance. Royalty income grew by 15% year-on-year, reflecting continued strong demand from Cresemba. In addition, we received significant non-dilutive funding for our research and development projects. These contributed to total revenue of CHF 232 million, an 11% increase versus 2024. We continue to substantially reduce our convertible debt, which now stands at CHF 76 million. At the same time, our net cash position has more than tripled. Overall, our 2025 financial results surpassed guidance and reflect a strong performance. Our financial position also enabled us to expand our pipeline by in-licensing the phase 3-ready asset, ceftibuten-ledaborbactam. This is intended for the treatment of complicated urinary tract infections and opens a new market for Basilea. In parallel, we advanced other pipeline programs, including the initiation of a second phase 3 study with fosmanogepix, our lead clinical stage product in invasive fungal infections. Our current pipeline and product portfolio combines multiple R&D programs with two commercial products, Cresemba and Zevtera. Since October 2023, we have significantly expanded our anti-infective portfolio with four new assets, two of which are now in our phase 3 pipeline. Fosmanogepix is being evaluated in two parallel phase 3 studies, designed to support a broad treatment label covering both invasive yeast and invasive mold infections. The recently added antibiotic, ceftibuten-ledaborbactam, is now in preparation for phase 3, which is scheduled to start in early 2027. In the phase 2 and earlier pipeline, the antifungal BAL-2062 and the antibiotic BAL2420 are progressing forward to their next milestones. Overall, this represents a diversified and well-balanced pipeline, built to deliver value consistently over time. I'll now hand over to Adesh. Thank you, David. I would like to start by highlighting that through our partner-centered business model, we have truly global reach. 500,000 patients in more than 75 countries have been treated with Cresemba and Zevtera to date. We partner with leading companies that manage commercialization and ensure broad patient access, while we focus on our core strength in developing clinically relevant and commercially sustainable assets. This low-risk, partnership-based model minimizes operating costs and has the potential to provide attractive return on investment for our assets. Cresemba is an excellent example of how a global brand can be successfully built through partnerships with regional and local champions. Cresemba's global in-market sales in the 12-month period to the end of September 2025 amounted to $693 million, representing a 27% year-on-year increase. Growth remains strong in established markets, while China and Japan increasingly contribute as both markets have moved beyond the launch phase. As a result, Cresemba is now the global market leader by value. Let me turn to Zevtera. The U.S. market represents the most important commercial opportunity for Zevtera. The key milestone for Zevtera in 2025 was therefore the U.S. launch by our partner, Innoviva Specialty Therapeutics. For novel hospital antibiotics, the key focus in the initial nine months to 12 months of the launch phase is on establishing broad market access and on supporting positive clinical experience. Against this metric, our partner has made very solid progress since launching the drug in July 2025. Zevtera has achieved multiple important formulary wins, gained inclusion in Medicaid and 340B pricing programs, received a new technology add-on payment designation to support affordability, and obtained a J-Code to support outpatient billing. There were also repeat orders from major hospitals, which is a positive indicator of customer experience and acceptance. We are therefore pleased with the progress in this initial launch phase. In 2025, we have been successful in securing new non-dilutive funding for our R&D portfolio. All our clinical programs, as well as BAL2420, which is expected to enter clinical development this year, are supported through existing contracts with BARDA and CARB-X, respectively. Under these agreements, we have been awarded more than $430 million, of which more than $100 million have already been committed. This non-dilutive funding is attractive from the financial perspective. It preserves shareholder value by avoiding dilution, enhances return on investment by reducing our own R&D spend, and lowers financial risk as it's not debt and does not require repayment. Moving now to key financial figures for 2025. Unless otherwise stated, all numbers from here on are in Swiss francs. 2025 was another year of strong financial performance for Basilea. We surpassed our financial guidance and delivered our fourth consecutive year of net profit and positive operating cash flow. Cresemba and Zevtera-related revenue totaled CHF 194.4 million. Within this, royalty income grew by 15.4% year-on-year to CHF 111.6 million, driven by strong market demand for Cresemba. Milestone and upfront payments totaled CHF 32 million, broadly in line with the average annual level seen in recent years. Other revenues rose to CHF 38 million, bringing total revenue to CHF 232.4 million, up 11.4% year-over-year. Cost of products sold was CHF 39.3 million, and operating expenses were CHF 141.5 million, reflecting increased investments in R&D. As a result, we achieved an operating profit of CHF 51.5 million and a net profit of CHF 40.2 million. Finally, cash and cash equivalents and restricted cash increased by 30% to CHF 162.3 million. After deducting outstanding convertible bonds, this results in a net cash position of CHF 86.9 million at year-end, tripling the net cash at the end of 2024. Cash flows from operating activities remained strong at CHF 62.1 million. We did not only absorb increasing R&D investments as we progressed our existing portfolio, but also the costs associated with the in-licensing of ceftibuten-ledaborbactam. Without the CHF 12 million upfront and milestone payments related to this transaction, our operating cash flow would have remained at the same level as in 2024. Alongside funding the expansion and progression of our pipeline, we further strengthened our balance sheet. Since January 2022, we have reduced our debt by CHF 145 million in a fully non-dilutive way, including CHF 21 million in the reporting period, bringing our outstanding convertible debt down to CHF 76 million. We expect 2026 to be another strong year from a financial perspective. We expect continued growth in Cresemba and Zevtera-related revenue to around CHF 200 million, driving an increase in total revenue of approximately 10%. Research and development expenses are expected to increase by approximately 20%, reflecting our investments into our two ongoing fosmanogepix and Zevtera phase III studies, the start of a new phase I study with BAL2420, as well as phase III preparations for ceftibuten-ledaborbactam. The strong commercial performance, combined with non-dilutive funding, is expected to offset our increased R&D investments. As a result, we anticipate a disproportionate increase in operating profit of around 20%. To fully understand the strength of our commercial business, it is important to have a closer look at our revenue mix, which is expected to shift towards higher margin revenue streams. Royalties and milestones are expected to increase, while product revenue is expected to decrease due to the previously announced reduction in product supply to Pfizer and Gosun, as both partners transition to manufacturing most of their own supply. The lower product revenue is expected to result in a decrease in cost of products sold. As a result, we expect to increase the cash contribution from our commercial business from CHF 155 million in 2025 to CHF 170 million in 2026. In the next few minutes, I would like to look beyond 2026. When looking at the anticipated impact of the loss of exclusivity for Cresemba on Basilea's revenues, one needs to take into consideration the geographic distribution of our revenues and the timing of the impact from generics. Our revenue doesn't perfectly align with the geographic distribution of in-market sales. In 2025, the U.S. accounted for almost 50% of in-market sales, while only 35% of our Cresemba revenues were based on U.S. sales. This means that 65% of our revenues were related to Cresemba sales outside of the US. In the US, we expect Cresemba to continue growing through a significant portion of 2027, with the impact from generics anticipated from Q4 2027 onwards. In Europe, we expect growth to continue throughout 2027 and through the first half of 2028, with generic impact beginning in the second half of 2028. As a result, the full year impact of Cresemba's loss of exclusivity in both the US and Europe on Basilea's revenues is expected to become fully visible only in 2029. Importantly, revenues from Japan and other markets are expected to keep on growing beyond 2028. We therefore expect Cresemba to keep on making significant cash contributions well beyond the initial loss of exclusivity. It is, however, clear that we need to look beyond Cresemba to ensure long-term growth for Basilea. As David mentioned earlier, our portfolio is now well-balanced with commercial products generating value today, while our phase 3 pipeline is well-positioned to deliver the next wave of product launches and midterm growth. Assuming successful clinical outcomes, fosmanogepix is expected to be our next major launch. It could enter the market in early 2029. ceftibuten-ledaborbactam is expected to follow around a year later, further expanding our commercial portfolio as our fourth product. In the meantime, we expect Zevtera to gain further traction, especially in the US, and to contribute to Basilea's growth until its loss of exclusivity in the US in 2034. We are therefore well-positioned for sustained growth for years to come. Let me conclude by bringing all this together and highlighting how well Basilea is positioned for sustainable growth under our Agenda 2030. As of December 31, 2025, Basilea held CHF 162 million in cash, cash equivalents, and restricted cash. Over the next five years, we expect to generate approximately CHF 600 million in cumulative cash flow from Cresemba and Zevtera, supported by strong market demand and continued commercial execution. Furthermore, approximately $330 million of potential additional non-dilutive R&D funding remains available under Basilea's existing BARDA agreements. These funds may be committed in future tranches to support the development of fosmanogepix, BAL 2062, and ceftibuten-ledaborbactam. Taken together, this provides Basilea with significant financial strength and flexibility to execute on three key priorities. First, to bring our next growth drivers, fosmanogepix and ceftibuten-ledaborbactam, successfully to the market. Second, to continue advancing our earlier stage pipeline to secure long-term growth. And third, to seize external growth opportunities by acquiring or in-licensing new high-potential assets. On top of that, there are several potential upsides not reflected in these figures. These include a later than anticipated entry of Cresemba generics in the US and Europe, new non-dilutive R&D funding agreements, and first revenues from fosmanogepix and ceftibuten-ledaborbactam. Our financial strength allows us to focus on strong execution to ensure sustainable growth and long-term value creation of our shareholders. I will now hand over to Marc for the portfolio update. Thank you, Adesh. Today, we have two phase 3 programs, fosmanogepix and ceftibuten-ledaborbactam, which we expect to read out in 2028 and 2029, as mentioned by Adesh. fosmanogepix is currently being evaluated in two global phase 3 studies, FAST-IC and FORWARD-IM. Both are expected to read out in 2028 with a subsequent regulatory process. The phase 3 program is supported by compelling real-world evidence, which provides important insights into the potential benefits of fosmanogepix, and which I will present shortly in more detail. ceftibuten-ledaborbactam, which we in-licensed in August 2025, is expected to enter phase 3 in early 2027. The readout of this program and regulatory process is expected in 2029. This program benefits from a well-established phase 3 design, aligned with published FDA guidance for complicated urinary tract infections, which provides a well-defined clinical development path for this program. Based on our knowledge of the antifungal and antibacterial space, we estimate peak sales of about $1 billion for fosmanogepix, and about $500 million for ceftibuten-ledaborbactam. This means that together, our current phase 3 pipeline has potential double today's end market sales with Cresemba and Zevtera, which are approximately $750 million. In the next slides, I will explain why these drug candidates address significant unmet medical needs, which we believe translate into substantial commercial potential. fosmanogepix is the product of manogepix, a first-in-class antifungal, with a novel mechanism of action that reduces pathogenicity and causes fungal cell death. It demonstrates broad-spectrum activity against both yeast and molds, including multi-drug-resistant yeast strains such as Candida auris or Candida glabrata, and against difficult-to-treat molds like Aspergillus and Fusarium species. These pathogens are challenging to treat and represent a growing global health concern... Fosmanogepix has wide tissue distribution, including difficult-to-reach sites, such as the central nervous system, and is available in both IV and oral formulations, which is an important advantage for clinical practice. Fosmanogepix has received QIDP, Fast Track, and Orphan Drug designations from the FDA, enabling accelerated review and extending U.S. market exclusivity for a longer commercial runway. Beyond the ongoing clinical phase 3 program in invasive candidiasis and invasive mold infections, Fosmanogepix is available through a global expanded access program for patients with severe invasive fungal infections who have no other treatment options. As you can see on the graph, since the program started in 2020, when Fosmanogepix was still in phase 2 development, there has been an extraordinary and unprecedented global demand for Fosmanogepix for a broad range of resistant or refractory mold and yeast infections. To date, more than 430 patients from 20 countries have been treated with Fosmanogepix through this program. A particularly notable example is the 2023 Fusarium meningitis outbreak at the U.S.-Mexican border, where Fosmanogepix, at that time still in phase 2 development, was recommended as therapy by the U.S. Centers for Disease Control and Prevention. Adding Fosmanogepix to the standard antifungal treatment regimen in these patients, resulted in a remarkable reduction in the in-hospital mortality and enabled managing patients in an outpatient setting with oral Fosmanogepix until resolution of the infection. These real-world experiences underscore the life-saving potential of fosmanogepix, and reinforce our confidence in the future success of this drug candidate. Turning now to ceftibuten-ledaborbactam. Ceftibuten is an established beta-lactam antibiotic. However, various bacterial strains, especially in the order of gram-negative bacteria called Enterobacterales, have developed resistance to it. Ledaborbactam, a novel beta-lactamase inhibitor, when added to Ceftibuten, enables restoration of the activity of Ceftibuten against these resistant strains, resulting in potent activity and bacterial killing. Importantly, this combination is being developed as an oral option for infections that today often require intravenous therapy. This can avoid hospitalization or enable early discharge from the hospital, both clinically and economically meaningful benefits. Ceftibuten-ledaborbactam is active against Enterobacterales, including multi-drug-resistant strains, such as extended-spectrum beta-lactamase or ESBL producers and carbapenem-resistant Enterobacterales, pathogens that have become increasingly resistant to current therapies and present significant treatment challenges. Complicated urinary tract infections, or cUTIs, are infections that extend beyond the bladder, accompanied by local and systemic symptoms. They are among the most common bacterial infections in both hospital and community settings, and are associated with considerable morbidity and healthcare resource utilization. Gram-negative bacteria from the order of Enterobacterales, particularly uropathogenic E. coli, are a leading cause of cUTI. A significant proportion are multi-drug resistant, and this resistant profile is effectively addressed by ceftibuten-ledaborbactam. Ceftibuten-ledaborbactam is being developed specifically as an oral therapy for cUTI caused by Enterobacterales. It addresses a clear medical need, and recent launches of beta-lactam antibiotics in the gram-negative space show strong market acceptance for these new therapies. For example, the intravenous antibiotic Avycaz has reached global sales of approximately $680 million to date. This supports the significant commercial opportunity for ceftibuten-ledaborbactam as an oral cUTI treatment that complements IV options. The program holds QIDP and Fast Track designations, providing accelerated regulatory review and extended market exclusivity in the U.S. With this, I'll hand it back to David. Okay, thank you, Marc. During the last year, we've made significant progress and delivered on every goal we set for 2025. A key commercial milestone was the successful U.S. launch of Zevtera, bringing the brand to its highest value market. In parallel, Cresemba continues to perform extremely well, with strong and growing in-market demand, translating into consistently increasing revenues. On the R&D side, we advanced our portfolio across both clinical and preclinical programs. This includes the initiation of the second phase 3 study with fosmanogepix for invasive mold infections, and new collaborations that bring new technologies or approaches into preclinical development. We also strengthened our phase 3 pipeline by in-licensing the oral antibiotic, ceftibuten-ledaborbactam, which is scheduled to enter phase 3 in early 2027. In parallel, we secured $70 million in non-dilutive funding to support our R&D activities during the year. Taken together, these achievements reflect disciplined and focused execution. They reinforce our strategy of creating a continuous stream of future product launches, setting the stage for substantial value growth in the years ahead. Looking ahead, our priority remains clear: delivering sustainable growth and long-term value. We aim to further increase revenue from Cresemba and Zevtera, leveraging Cresemba's strong global momentum and Zevtera's expanding presence in the US. Our lead clinical program, fosmanogepix, will continue progressing through phase 3 development, while preparations are underway for the phase 3 program of ceftibuten-ledaborbactam. We will also advance our phase 2 and earlier stage pipeline programs, each moving towards their next milestones. In parallel, we will actively pursue additional in-licensing and acquisition opportunities to further strengthen and diversify our portfolio. And as always, we will look to secure additional non-dilutive funding, building on the successful collaborations we have established with BARDA and CARB-X. Let me close with three messages. First, Basilea is financially strong. Our cash position and expected future cash flows provide a solid foundation for sustained growth. Second, our phase three portfolio is a major growth driver. Fosmanogepix and ceftibuten-ledaborbactam have the potential to double today's in-market sales level, creating significant value in the future. Third, we have the ability and the opportunity to do more. Through targeted acquisition and in-licensing of additional high-quality assets, we can accelerate growth well beyond the existing pipeline. Together, these elements reflect our focus on innovation, execution, and delivering value to our shareholders, not just today, but consistently into the future. Thank you for your attention, and we'll now open the line to any of your questions. We will now begin the question and answer session. Anyone who wishes to ask a question may press star and one on their telephone. You'll hear a tone to confirm that you have entered the queue. If you wish to remove yourself from the question queue, you may press star and two. Questioners on the phone are requested to disable the loudspeaker mode and eventually turn off the volume from the webcast while asking a question. In the interest of time, please limit yourself to two questions. Anyone who has a question may press star and one at this time. The first question comes from the line of Brian White from Calvine Partners. Please go ahead. Hello, and thanks very much for taking my questions. A very quick one, firstly, on Cresemba and loss of exclusivity. Is there any reason not to expect generics in the U.S.? I know that's certainly what you've been, you know, highlighting in terms of the September date. I just wondered if there was anything ongoing in terms of litigation, which you might change that and that you could share with us. And then just separately on the in-licensing activity, a lot of which has been in the antibacterial field more recently. Is that because you see more programs there which are available for licensing, or is it because, you know, fosmanogepix really answers most of the questions that you have in the antifungal field? Thank you. Yeah, thanks, Brian. I'll take the first one in terms of, yeah, the timings that Adesh went through in terms of the loss of exclusivity versus the appearance of generics. I think, the easiest way. Well, first of all, in terms of technically, if, for example, in the U.S., which obviously is the first market where we believe that generics will enter, I mean, in terms of ongoing, you mentioned sort of ongoing litigation and things. I mean, obviously, we're not the MAH in the U.S., so- Yeah. So that would be between Astellas and other parties. But what we can say is that, and I guess this is what's behind your product - your question, understanding how quickly sort of generics might appear and might, you know, the US business might decline. And I think, what I can say is that, you know, we're aware, obviously, whilst we're not actively involved in any potential litigations, what we could say is that a generic will not be sort of approved until the LOE date. And as to how many there would be, I mean, you know, we're not talking more than a handful that we're aware of, but that doesn't mean there won't be any. But it's not like, you know, 10 or 20 generics. It's, it's clearly a handful we're aware of that could appear. But whether or not they do appear depends on if they're approved, and depends on the timing of that approval, and then whether they can then launch in the US market from in that Q4 2027 period. So that's probably about all I can say, really, in terms of sort of- Mm-hmm that situation. And just to reinforce the point about Europe, it's sort of subtly but importantly different, which is that with the orphan drug designation, our understanding and our partners, Pfizer's understanding is that, you know, the generics cannot file until the end of LOE. Which is why there's this sort of nine-month, approximately nine-month gap between the LOE in Europe and then the generics appearing in the second half of 2028. Just to make that point clear. Yeah. Onto the subject of, you know, the deals, the numbers of deals and, you know, why have we recently been doing preclinical deals versus clinical. Adesh, do you want to- Yeah. -take that? So, thanks, Brian, for your question. Just as a reminder, there are basically two things that drive transactions. One is medical needs, clinical benefit that we're seeing, and therefore differentiated positioning that would allow for commercial success. And secondly, it's the number of assets being available, because you can desire a lot, but are there any assets available? And I think if you take these two things together, probably the answer to the first question is: we still see actually medical need and opportunity for providing clinical benefit in the antifungal space post fosmanogepix. While we believe that fosmanogepix is gonna be an important drug if it's successfully developed and delivers on its promises, there is still room for more drugs there. Which basically is then the point that there are simply not as many assets available on the antifungal space for partnering that would tick all the boxes as compared- Yeah. to the antibacterial. That's really driving more or less the deal flow. Okay, that makes sense. Thanks, Adesh. The next question comes from the line of Laurent Flamme, from Zürcher Kantonalbank. Please go ahead. Good afternoon, David and Adesh. Two questions. The first question relates to the CHF 600 million cumulative cash flow from Cresemba, etc., across 2026-2030. From the guidance for 2026 with CHF 200 million revenue to those two assets and CHF 170 million cash flow. I would infer that the CHF 600 million cumulative cash flow is based on the gross profit, but a clarification here would be welcome. The second question is about the commercial milestone related to Cresemba across 2026-2030. What can you tell us to help us refine our modeling, particularly for the two key geographies, U.S., Europe? And would you expect notably any milestones in 2029-2030? Thank you. Yeah, thanks, Laurent. Adesh, why don't you start off with a clarification on the CHF 600 million and the CHF 117 actually- Yep. This year. Thank you, Laurent, for your question, and you're exactly spot on. So in essence, the way that you have to look at it is, we are looking at product and contract revenue, which is basically CHF 200 million to take this year's number, and we deduct from that the cost of products sold, which is basically expected to be about CHF 30 million this year. Which delivers CHF 170 million in cash contribution from Zevtera. So you're exactly right. That's sort of a gross profit, even if it's on a US GAAP, not sort of gross profit per se. And then, I think your second question was about milestones 2026 to 2030. Two points on that. One is just as a reminder, we have been actually fairly consistent with milestone payments across our partners in the recent years, within a certain range. So we have always sort of been between CHF 30- CHF 40 million, so on average, somewhere in the CHF 34- CHF 35 million range over the last few years. And what we expect over the coming years is, at least for the next four years, I would say, because the visibility of course gets a little bit less, less pronounced going forward, is we would remain in that range. So if you take 2026, 2027, 2028, 2029, on average, that would probably be in the same order of magnitude. When exactly the milestones will happen remains to be seen. Because as a reminder, especially the milestones with Pfizer, are on a cumulative basis. That means if they don't happen, for instance, in December, they may be triggered in January. Here again, the further out we go, the more the question is, where exactly do they fall period-wise? But I think the important point is, from a value perspective, to factor in about CHF 30 million-CHF 40 million on average over the next four years. Does that answer your question, Laurent? Yes. No, that's perfect. And maybe a follow-up question on the taxation rate. I think in the recent past, you mentioned that we could factor a 12% tax rate going forward. From my calculation, I assume that Basilea would have the first cash outlays related to corporate tax in 2027, after full consumption of the tax loss carryforwards. Would you agree with that? And would you agree with the 12% rate for any cash outlays in the future? So yes, thank you for the follow-up question. Indeed, we have about CHF 11 million in deferred tax assets remaining. And if you do, if you follow basically our guidance for 2026, you would come to the conclusion that in 2027, that would be more or less like you said, without them without expiring. On a full year basis, I would say probably that still means that we wouldn't have a cash outflow in the equivalent of 12%, because partially we would still be able to benefit from tax loss carry forwards in 2027. But underlying also your assumption of 12%, maybe slightly on the higher end of expectations, but this varies probably anywhere between 11%-12% is a reasonable assumption. Thank you. We now have a question from the line of Jyoti Prakash from Edison Group. Please go ahead. So, congratulations on the results, and thank you for taking my questions. My first question relates to Zevtera, and we see that it's been securing some early wins and new investment in the US. Just want to understand how the early cadence in terms of ordering and adoption is in line with your internal launch benchmarks? Yeah, yeah. Hi, Jyoti. Actually, it wasn't easiest to hear your question, but I think you were talking about the sort of uptake and the cadence of Zevtera in the US. And, but basically- Yeah. Yes, it's exactly in line with our. As Adesh said, that, you know, we get obviously we're in regular communication, obviously, with Innoviva Specialty Therapeutics, our partner in the US. So we get their KPI reports on the, and that's what Adesh was sort of reporting on in terms of the market access achievements. And then that's why, you know, what we understand from our partner is that, you know, we should start to see a real movement in net sales from the Q2 onwards going forward. So actually, that's always been sort of like our expectation, and so we've been hitting the targets in terms of market access. Then, as we want to see and our partner wants to see, then we expect the net sales to start really increasing from Q2 onwards. Okay, and then, just on ceftibuten and ledaborbactam, moving well towards phase 3. So just want to understand if there is more clarity on the trial design and plan, and if the two trials will be required, and could you provide some color on that? Okay. So I think, Marc, it's about the trials that will be required for ceftibuten-ledaborbactam for the phase three program. Yes, absolutely. So the phase 3 program will be performed in complicated urinary tract infections, and will be aligned with current health authority recommendations. As I said, there are guidelines to follow, that are clear. The program is gonna be discussed with, FDA and EMA in the next months. And, our plan is to conduct at least one non-inferiority study with approximately 1,500 patients comparing ceftibuten-ledaborbactam versus an IV carbapenem. And we'll discuss with the regulators whether a second study may be required, so that's subject to the, discussions with the regulators. Okay. Thank you. No further questions. Well, thank you, Jyoti. As a reminder, if you wish to register for a question, please press Star and One on your telephone. The next question comes from the line of Ram Selvaraju from H.C. Wainwright. Please go ahead. Are you there, Ram? Mr. Ram, your line is now open. You may go ahead with your question. Can you hear me? Oh, yes, we can now. Hi, Ram. Sorry about that. Okay. So, yes. So, I wanted to ask, first of all, if you could comment on two aspects of the commercial side. Firstly, what your current expectations are regarding peak annual sales of Zevtera in the US specifically, and with respect to Cresemba, how large you think the market opportunity is for this drug in Japan? And then secondly, on the clinical development front, I was wondering if you could provide us with some additional details on the timing to reach full enrollment in the fosmanogepix phase 3 program, and when you expect to reach full enrollment in the ceftibuten-ledaborbactam phase 3 program. Thank you. Okay. I mean, in terms of Japan, let me take the middle question, actually, for myself, which is the Japan. I mean, actually, the IQVIA sales, so the $693 million IQVIA sales report from the in-market demand sales of Cresemba for the 12 months to September 2025. If my memory serves me correctly, about $36 million already in Japan, like, the third year of launch of the product. So when we talk about the growth rate globally being 27%, if my memory serves me correctly, Japan's growing at about 220%. So, you know, that's why we're quite excited about Japan. China's growing at about 56% in of that growth rate versus the 27 globally. So, you know, in terms of the more mature markets, obviously, US and Europe, they're still growing healthy, double digit, but they're not at the rates of Japan and China. So we are. So that gives you a sort of feel for it. In terms of how big it can be, I mean, it's very difficult to say, because actually it's probably gone past our, an early expectations where we thought it would be. So we're not quite sure where it will end up, but what we do know is it's growing really fast, and it's already above expectations of ours and our partners. So, so, you know. And it's got a long runway. It's got exclusivity to the early 2030s. So, this can become really quite big in Japan, which is really quite exciting for us. In terms of the peak year sales for Zevtera in the US, Adesh, do you want to- Yep. So here we'll have to resort to what we have been saying in the past and to analyst reports, because to some degree, I think we'll have to say that Innoviva Specialty Therapeutics has to give some indication about what they believe the peak sales is gonna be. Analysts have it at around $200 million-$300 million in the US, which is not entirely inconsistent what other drugs have been doing in the US. Then in terms of your fosmanogepix accrual, when will the patients all be accrued into the phase 3 studies? Maybe, Marc, you take this one. Yes. So our projections is that we will complete the enrollment of the fosmanogepix phase 3 studies in the second half of 2027, and have a readout in early 2028. And ceftibuten-ledaborbactam is approximately 9-12 months after this. So just add approximately a year to it, and that would be the timeline for ceftibuten-ledaborbactam. Thank you very much. Yeah, thanks. Thank you, Ram. Once again, to ask a question, please press Star and One on your telephone. We have a follow-up question from the line of Laurent Flamme from Zürcher Kantonalbank. Please go ahead. Yes. Merci. My question relates to BAL2062. When do you expect to start the phase 2 enrollment? And what kind of potential timeline for the results of this phase 2? Also, considering that BAL2062 is targeting azole-resistant invasive aspergillosis, that would be interesting to hear from you, what kind of level of resistance you see in invasive aspergillosis currently with Cresemba in the key geographies, if you have any data on that? And what kind of perspective would you have for future phase 3 protocol? So would you select patient with azole-resistant invasive aspergillosis as with a view for second-line indication? Or would you position this asset more as a first-line asset? Thank you. No, thanks, Laurent. I mean, just from a sort of big picture point of view, then Marc can come back with the detail to your question. But obviously, when we acquired or in-licensed ceftibuten-ledaborbactam last year, clearly with one, fosmanogepix is already in phase 3, ceftibuten-ledaborbactam we're progressing into preparing for phase 3. So our priorities as a company, and we believe that it's in the interest to create the sort of more midterm, long-term value, is to push the phase 3 assets as quickly as possible to the market to replace Cresemba and Zevtera. So clearly, that's been our priority for the last, definitely since we had the two compounds. So actually, in terms of for BAL2062, it's also important, as we've said, to have a pipeline behind our late-stage phase 3 compounds, and that in terms of timing, would be the product immediately after, the 2 phase 3 assets. We have an ambition, and we've stated this in the press release, that we are planning to... We've been doing preclinical profiling over the last year, and we are, we're now armed with that information. We are planning to go to the regulators this year to finalize the phase 2 and 3 program. In terms of, you know, what it could look like, timings and, azole resistance or not first line, maybe, Marc, you can, you can address the detail of Laurent's question. So I think from a vision and, goal for the development of BAL-2062, our current approach is to develop it for a broader indication of invasive aspergillosis, and so to not solely focus this on an azole-resistant, population. And this is based on the potent efficacy in vivo, the good safety profile in the clinical phase 1 study, and the lack of drug interactions that we assume. So this would be a phase 3 non-inferiority study, a larger study to get this into first line. Of course, due to the, novel mechanism of action and the coverage of, azole-resistant aspergillosis, it will be used for, resistant pathogens, too. The occurrence of azole resistance varies, largely between different regions. So, in Europe, in Belgium and the Netherlands, there are regions where up to 30% of aspergillosis, clinical aspergillosis isolates are azole-resistant. The latest numbers from the U.S. go up to 26%, and we believe this will be an increasing problem and then will constitute, you know, a portion of the use of BAL2062. But, our current development strategy is really to develop it for first-line due to the efficacy and the safety profile. Thank you. For any further questions, please press star and one on your telephone. We have a follow-up question from the line of Laurent Flamme from Zürcher Kantonalbank. Please go ahead. Yeah, and maybe my last question relates to the LptA. Sorry. Do we expect that Basilea would look for new agreement with BARDA for our funding of these assets? Or, would the September 2024 OTA envelope already signed with BARDA would suffice beyond the financing of fosmanogepix and the BAL2062? Yeah. Thanks, Laurent. I think I've got the question. So BAL-2420, the LptA inhibitor, would we seek BARDA funding for that phase one program? I think the short answer is actually, BARDA tends to fund after phase one, so phase two, three studies rather than phase one. But actually, CARB-X, which we've obviously currently got funding from for the preclinical work, they do fund phase one work. So actually, we would seek to try and get funding from CARB-X to for the phase one study, which we're planning to start in the first half of this year. So yes, that's the short answer. We are seeking funding. Well, the technical thing is it won't be BARDA, it would be, CARB-X, if it was agreed that we-- they would give us funding for that program, and we will seek that out. In terms of, down the line after phase one, if it's successful through phase one and we push it into phase two, the agreement, this OTA agreement, and I think you were implying this, and you're correct. The OTA agreement is such an agreement whereby products can go in and go out of this funding sort of package, so to speak. So actually, depending on the progress of the existing assets and the new assets coming in, that could fit the, you know, in agreement with BARDA, it could potentially fit into the OTA. But that would be... I can't say that today, 'cause it would be a two-way discussion with BARDA based on the funding required, the progress of the product, and the progress of the other portfolio compounds in the OTA. So that's the answer. Well, thank you, David. That's pretty clear. Thank you. Okay, thanks, Laurent. Ladies and gentlemen, that was the last question. I would now like to turn the conference back over to David Veitch for any closing remarks. Yeah. Well, thank you. Thank you, everyone. Thank you for joining us today in our webcast and for your continued interest in Basilea. Yeah, thank you. Enjoy the rest of your day. Thank you very much. Ladies and gentlemen, the conference is now over. Thank you for choosing Chorus Call, and thank you for participating in the Basilea Pharmaceutica full year results 2025 conference call. You may now disconnect your lines. Goodbye.