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Operator: Ladies and gentlemen, welcome to the Basilea Pharmaceutica Full Year Results 2025 Conference Call and Live Webcast. I am Mathilde, the Chorus Call operator. [Operator Instructions] And the conference is being recorded. [Operator Instructions] 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.
David Veitch: 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, global in-market sales up 27% to USD 693 million for the 12 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 III-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 III study with fosmanogepix, our lead clinical stage product in invasive fungal infections. Our current pipeline and product portfolio combines multiple R&D programs with 2 commercial products, Cresemba and Zevtera. Since October 2023, we have significantly expanded our anti-infective portfolio with 4 new assets, 2 of which are now in our Phase III pipeline. Fosmanogepix is being evaluated in 2 parallel Phase III studies designed to support a rare treatment label covering both invasive yeast and invasive mold infections. The recently added antibiotic ceftibuten-ledaborbactam is now in preparation for Phase III, which is scheduled to start in early 2027. In the Phase II and earlier pipeline, the antifungal BAL2062 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 will now hand over to Adesh.
Adesh Kaul: Thank you, David. I would like to start by highlighting that through our partner centered business model, we have truly global reach. 0.5 million 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 USD 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. launched by our partner, Innoviva Specialty Therapeutics. For novel hospital antibiotics, the key focus in the initial 9 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 nondilutive 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 USD 430 million, of which more than USD 100 million have already been committed. This nondilutive 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-on-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 progress our existing portfolio, but also the costs associated with the in-licensing of ceftibuten-ledaborbactam. With that, the $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 fully nondilutive 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 2 ongoing fosmanogepix 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 disproportional 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 goes on as both partners transition to manufacturing most of our 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 and 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 U.S. In the U.S., 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 U.S. 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 III 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 U.S. and to contribute to Basilea's growth until its loss of exclusivity in the U.S. 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 5 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 USD 330 million of potential additional nondilutive R&D funding remains available on the Basilea's existing border agreements. These funds may be committed in future tranches to support the development of fosmanogepix, BAL2062 and ceftibuten-ledaborbactam. Taken together, this provides Basilea with significant financial strength and flexibility to execute on 3 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 U.S. and Europe, new nondilutive 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 for our shareholders. I will now hand over to Marc for the portfolio update.
Marc Engelhardt: Thank you, Adesh. Today, we have 2 Phase III 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 2 global Phase III studies, fast IC and forward IM, both are expected to read out in 2028 with a subsequent regulatory process. The Phase III 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 III in early 2027. The readout of this program and regulatory process is expected in 2029. This program benefits from a well-established Phase III design, aligned with published FDA guidance for complicated urinary duct 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 USD 1 billion for fosmanogepix and about USD 500 million for ceftibuten-ledaborbactam. This means that together, our current Phase III pipeline has potential double to days in market sales with Cresemba and Zevtera, which are approximately USD 750 million. In the next slides, I will explain why these drug candidates addresses significant unmet medical needs, 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 yeasts and molds, including multidrug-resistant yeast strains such as Candida auris or Candida glabrata and against difficult-to-treat molds like aspergillosis and fusariosis. 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 factors. 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 III 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 II development, there has been 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, particularly notable example is the 2023 fusarium meningitis outbreak at the U.S. Mexican border where fosmanogepix, at that time, still in Phase II development was recommended as therapy by the U.S. Centers for Disease Control and Prevention. Adding fosmanogepix the standard antifungal treatment regimen in these patients resulted in a remarkable reduction in the in-hospital mortality and enabled managing patients in 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 material strains, especially in the order of gram-negative bacteria called Enterobacterales, have developed resistance to it. Ledaborbactam 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 developed as an oral option for infections that today often require intravenous therapy. This can avoid hospitalization or enable earlier discharge from the hospital both clinically and economically meaningful benefits. Ceftibuten-ledaborbactam is active against Enterobacterales including multidrug-resistance strains, such as extended spectrum beta-lactamase or ESBL producers in 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 cumulative settings and are associated with considerable morbidity and health care resource utilization. Gram-negative bacteria from the Enterobacterales, particularly uropathogenic E. coli are leading cause of cUTI, a significant proportion of multidrug 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 for strong market acceptance for these new therapies. For example, the intravenous antibiotic Avycaz has reached global sales of approximately USD 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.
David Veitch: 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 III study with fosmanogepix for invasive mold infections and new collaborations that bring new technologies or approaches into preclinical development. We also strengthened our Phase III pipeline by in-licensing the oral antibiotic ceftibuten-ledaborbactam, which is scheduled to enter Phase III in early 2027. In parallel, we secured USD 70 million in nondilutive 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 was expanding presence in the U.S. Our lead clinical program, fosmanogepix will continue progressing through Phase III development, while preparations are underway for the Phase III program of ceftibuten-ledaborbactam. We will also advance our Phase II and earlier stage pipeline programs is 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 nondilutive funding building on the successful collaborations we have established with BARDA and CARB-X. Let me close with 3 messages. First, Basilea is financially strong. Our cash position and expected future cash flows provide a solid foundation for sustained growth. Second, our Phase III 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.
Operator: [Operator Instructions] The first question comes from the line of Brian White from Calvine Partners.
Brian White: 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 highlighting in terms of the September date. I just wonder if there's anything ongoing in terms of litigation, which 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 fosmanogepix really answers most of the questions that you have in the antifungal field?
David Veitch: Yes. Thanks, Brian. I'll take the first one in terms of 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, 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 that would be between Astellas and other parties. But what we can say is that -- and I guess is what's behind your question, understanding how quickly sort of genomics might appear or the U.S. business might decline. And I think what I can say is that we're aware, obviously, we get -- whilst we're not actively evolved 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 they would be, I mean, 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 10 or 20 generics. It's clearly a handful where it could appear whether or not they do appear, it depends on if they're approved and depends on the timing of that approval and then whether they can then launch in the U.S. market from -- in that Q4 2027 period. So that's probably about all I can say really in terms of 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 Designations our understanding and our partners, Pfizer's understanding is that the generics cannot file until the end of LOE, which is why there's this sort of 9 month -- approximately a 9-month gap between the LOE in Europe and then the generics appearing in the second half of 2028, just to make that point clear. On to the subject of the deals -- number of deals and why have we recently been doing preclinical deals versus clinical. Adesh, do you want to take that?
Adesh Kaul: So thanks, Brian, for your question. So just as a reminder, there are basically 2 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 2 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 going to be an important drug, if it's successfully developed and delivers on their 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 to the bacteria, and that's really driving more or less the deal flow.
Operator: The next question comes from the line of Laurent Flamme from Zürcher Kantonalbank.
Laurent Flamme: Two questions. The first question relates to the CHF 600 million cumulative cash flow from Cresemba and Zevtera of '26-2030. From the guidance for '26 with CHF 200 million revenue to those 2 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 if you will be welcome. The second question is about the commercial milestones related to Cresemba across '26, 2030. What can you tell us to help us refine our modeling particularly for the 2 key geographies, U.S., Europe. And would you expect notably any milestones in '29-2030?
David Veitch: Yes. Thanks, Laurent. Adesh, why don't you start off with a clarification of the CHF 600 million and the CHF 170 million this year.
Adesh Kaul: 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 Cresemba and Zevtera. So you're exactly right, that sort of a gross profit even if it's under U.S. GAAP, not sort of gross profit per se. And then I think your second question was about milestones, '26 to 2030. Two points on that. One is, just as a reminder, we have been 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 million to CHF 40 million. So on average, somewhere in the CHF 34 million, CHF 35 million range over the last few years. What we expect over the coming years is at least for the next 4 years, I would say, because the visibility, of course, gets a little bit less pronounced going forward is we would remain in that range. So if you take '26, '27, '28, '29 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. And that means, if they don't happen, for instance, in December, they may be triggered in January. And 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 to CHF 40 million on average over the next 4 years.
David Veitch: Does that answer your question, Laurent?
Laurent Flamme: Yes. 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 '27 after full consumption of the loss tax loss carry forwards. Would you agree with that? And would you agree with the 12% rate for any cash outlays in the future?
Adesh Kaul: 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 '26, you would come to the conclusion that in 2027, that would be more or less like you start without the without expiring. On a full year basis, I would say probably that still means that we wouldn't have a cash outflow. We equivalent of 12% because partially, we would still be able to benefit from tax loss going forward in '27, but underlying also your assumption of 12%, maybe slightly on the higher end of expectations, but this varies probably anywhere between 11% and 12% is a reasonable assumption.
Operator: We now have a question from the line of Jyoti Prakash from Edison Group.
Jyoti Prakash: Congratulations on the results. My first question relates to Zevtera and we see that it's been securing some reinvestment in the U.S. Just want to understand the early cadence in terms of ordering and adoption is in line with the internal launch benchmarks?
David Veitch: 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 U.S. And -- but basically yes, it's exactly in line with -- as Adesh said, we get -- obviously, we're in regular communication, obviously, with Innoviva Specialty Therapeutics, our partner in the U.S. we get their KPI reports on -- and that's what Adesh was sort of reporting on in terms of the market access achievements. And then that's why what we understand from our partner is that 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. And 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.
Jyoti Prakash: Okay. And then just on ceftibuten-ledaborbactam moving well towards Phase III. So I just wanted to understand if there is more clarity on the trial design and plan? And if 2 trials will be required and can you provide some color on that?
David Veitch: Okay. So I think, Marc, it's about the trials that will be required for ceftibuten-ledaborbactam for the Phase III program.
Marc Engelhardt: Yes, Jyoti. So the Phase III 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 going to be discussed with FDA and EMA in the next months. And our plan is to conduct at least 100 study with approximately 1,500 patients comparing ceftibuten-ledaborbactam versus an IV carbapenem, and we will discuss with the regulators whether a second study may be required. So that's subject to the discussions with the regulators.
Operator: [Operator Instructions] The next question comes from the line of Ram Selvaraju from H.C. Wainwright.
David Veitch: Are you there, Ram?
Raghuram Selvaraju: Can you hear me?
David Veitch: Yes, we can now.
Raghuram Selvaraju: Sorry about that. Okay. So yes, so I wanted to ask, first of all, if you could comment on 2 aspects of the commercial side. Firstly, what your current expectations are regarding peak annual sales of Zevtera in the U.S. specifically? And with respect to Cresemba, how large do 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 III program and when you expect to reach full enrollment in the ceftibuten-ledaborbactam Phase III program?
David Veitch: 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 CHF 693 million IQVIA sales report from the in-market demand sales of Cresemba for the 12 months to September 2025. And if my memory says me correctly about CHF 36 million already in like the third year of launch of the product are already Japan. So when we talk about the growth rate globally being 27% if my memory serve me correctly, Japan is growing at about 220%. So that's why we're quite excited about Japan. China is growing at about 56% of that growth rate versus the 27% globally. So in terms of the more mature markets, obviously, U.S. 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 -- in terms of how big it can be. I mean it's very difficult to say because actually, it's probably gone past out an early expectations to 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 -- and it's got a long runway. It's got exclusivity to the early 2030s. So this can become really quite big in Jan, which is really quite exciting for us. In terms of the peak year sales for Zevtera in the U.S. Adesh?
Adesh Kaul: So here we'll have to resort to what we have been seeing in the past and due 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 sales is going to be. analysts have it at around CHF 200 million to CHF 300 million in the U.S., which is not entirely inconsistent, but other drugs have been doing in the U.S.
David Veitch: And then in terms of your fosmanogepix accrual and with the patients the crude into the Phase III studies, maybe Marc, you take.
Marc Engelhardt: Yes. Our projection is that we will complete the enrollment of the fosmanogepix Phase III studies in the second half of 2027. I have a readout in early 2028, and ceftibuten-ledaborbactam is approximately 9 to 12 months after this, so just add approximately year to it, and that will be the time line for ceftibuten-ledaborbactam.
Operator: [Operator Instructions] We have a follow-up question from the line of Laurent Flamme from Zürcher Kantonalbank.
Laurent Flamme: Yes. The question relates to BAL2062. When do you expect the -- to start the Phase II enrollment? And what kind of potential time line for the results of this Phase II? Also considering that BAL2062 is targeting as all 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 our future Phase III protocol. So would you select patients with as a resistant invasive aspergillosis as with a view for a second line indication? Or would you position this asset more as a first-line asset?
David Veitch: 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 III, ceftibuten-ledaborbactam we're progressing into preparing for Phase III. So our priorities as a company and we believe it's in the interest to create the sort of more midterm, long-term value is to push the Phase III 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 2 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 III compounds. And that in terms of timing would be the product immediately after the 2 Phase III assets. We have an ambition, and we've stated this in the press release that we are planning to -- we are finalizing -- we've been doing preclinical profiling over the last year, and we're now armed with that information. We are planning to go to the regulators this year to finalize the Phase II/III program. In terms of what it could look like timings and azole resistance or not first line. Maybe Marc, you can address the detail to Laurent's question.
Marc Engelhardt: So I think from a vision and goal for the development of BAL2062, our current approach is to develop it for a broader indication of invasive aspergillosis 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 I study and the lack of [ drug ] actions that we assume. So this would be a Phase III non-inferiority study larger study to get this into first line. Of course, due to the novel mechanism of action and the coverage of azole resistance 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 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.
Operator: [Operator Instructions] We have a follow-up question from the line of Laurent Flamme from Zürcher Kantonalbank.
Laurent Flamme: And maybe my last question relates to [indiscernible] we expect that Basilea would look for new agreement with BARDA for R&D funding of these assets or would be September '24 OTA envelope already signed with BARDA who suffice beyond the financing of fosmanogepix and BAL2062?
David Veitch: Yes. Thanks, Laurent. I think I got the question. So BAL2420, the LptA-Inhibitor, would we seek BARDA funding for that Phase I program. I think the short answer is actually BARDA tends to fund after Phase I. So Phase II, III studies rather than Phase I. But actually, CARB-X, which we've obviously currently got funding from for the preclinical work, they do fund Phase I work. So actually, we would seek to try and get funding from CARB-X for the Phase I 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. The technical thing won't be BARDA. It would be CARB-X if it was agreed that they would give us funding for that program, and we will seek that out. In terms of down the line after Phase I, if it's successful through Phase I and we push it into Phase II, the agreement, this OTA agreement, and I think you were implying this, and you're correct, the OTA agreement is such an agreement whereby product 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 new assets coming in that could fit that in agreement with BARDA, it could potentially fit into the OTA. But that would be -- I can't say that today because it will be a 2-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, in essence, the answer.
Operator: 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.
David Veitch: Well, thank you, everyone. Thank you for joining us today in our webcast and for your continued interest in Basilea. And yes, thank you, enjoy the rest of your day. Thank you very much.
Operator: 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.