Basilea Pharmaceutica Aktie

Ladies and gentlemen, welcome to the Basilea Pharmaceutica Half Year Results 2026 Conference Call and Live Webcast. I am Chorus Call operator. [Operator Instructions]

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. Thank you for joining us today on our conference call and webcast. We'll be reviewing our financial results and key achievements for the first half year 2026 as well as highlighting our priorities going forward. For further detailed information, please see the ad hoc announcement issued this morning and our half year report. These documents, together with the webcast presentation, all 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 Adesh Kaul, our Chief Financial Officer; and Dr. Marc Engelhardt, our Chief Medical Officer.

We had a great start to the year, delivering strong financial results and continued execution across the business. Let me briefly summarize some of the key highlights from the first half of 2026. Starting with our strong financial performance. Basilea's total revenue grew 14% year-on-year to CHF 119 million, resulting in an operating profit of CHF 32 million, an increase of 32% year-on-year. Our net cash position doubled to CHF 105 million. During the first 6 months of 2026, we were awarded $61 million of non-dilutive funding which offsets a significant proportion of our R&D costs. Portfolio highlights include continued strong in-market sales of our lead commercial product, Cresemba, which are now close to $800 million and growing almost 30% year-on-year. The Phase III program of fosmanogepix, our lead antifungal in development is progressing as planned. evidenced by the recent BARDA funding award for achievement of a particular enrollment milestone.

Also, our novel antibiotic BAL2420 has started its first in human Phase I study. We also continue to invest in our earlier pipeline. In this context, we signed a collaboration agreement with Prokaryotics for the preclinical development of a novel broad spectrum antifungal candidate. Basilea's pipeline today combines two commercial products, Cresemba and Zevtera with a diversified portfolio of development stage anti-infective assets, all added over the last three years. We have now two Phase III assets, fosmanogepix and ceftibuten-ledaborbactam, which together have the potential to generate peak sales of approximately $1.5 billion, roughly doubling our current in-market sales level. Our earlier stage programs, BAL2062 and BAL2420 continue to advance towards their next decision points, adding further depth to the pipeline. Overall, we have built a balanced anti-infective portfolio, combining commercial growth drivers, late stage of value creation opportunities and early stage innovation.

Behind these assets, we also have preclinical research programs developed both internally and from external collaborations. We announced two early-stage collaborations in the last 8 months that further expand our innovative research pipeline. The first is a partnership with Phare Bio, which applies generative artificial intelligence to the discovery of novel antibiotics aiming to improve the efficiency of identifying and developing a new antibiotic candidate. Then we entered the collaboration with prokaryotic to develop a first-in-class broad spectrum antifungal candidate. The program aims to deliver an effective, safe and easy to administer treatment for severe invasive fund infections. Together, these partnerships expand our access to innovative technologies and new approaches with limited upfront investment from Basilea.

I'll now hand over to Adesh for the commercial and financial update.

Thank you, David. Starting with Cresemba, which remains the cornerstone of our current commercial business. Global in-market sales in the 12-month period to the end of March 2026 amounted to USD 782 million. This 27% increase year-on-year underscores the continued strong demand across all key markets and is driven by continued gain in market share even in markets where Cresemba is already market leader.

Let me turn to Zevtera, which was commercially launched in the U.S. about a year ago by our partner Innoviva Specialty Therapeutics. For novel hospital antibiotics, the key focus in the initial 12-month period of launch phase is on establishing broad market access and on supporting positive clinical experience. The KPIs we track in this early phase reflect these focus areas. Zevtera continues to make good progress in securing access across the health care system with important wins in group purchasing organizations, formularies and reimbursement programs, helping to support future uptake. At the same time, increasing account numbers and repeat ordering trends, combined with encouraging medical community feedback provide early evidence of positive clinical experience and acceptance.

Innoviva has also further expanded its field force to increase hospital coverage from which Zevtera is expected to benefit. We are, therefore, pleased with the progress in this launch phase and are looking forward to seeing these encouraging key lead indicators translate into increasing adoption and sales in the quarters and years to come, especially as Zevtera has market exclusivity in the U.S. until April 2034. All of our clinical programs continue to be supported through BARDA and CARB-X agreements which provide non-dilutive funding for our R&D portfolio. Across these contracts, more than USD 440 million has been committed to Basilea. Approximately USD 165 million has been awarded to date, out of which USD 61 million was awarded in the first half of 2026. This non-dilutive funding enables us to advance our clinical programs in a capital-efficient manner.

Moving now to the financial results for the first 6 months of 2026. Unless otherwise stated, all numbers are in Swiss francs. Cresemba and Zevtera related revenue totaled CHF 92.3 million. This included royalty income of CHF 57.8 million, which grew by about 11% year-on-year. Milestone and upfront payments were CHF 4.7 million. Other revenue, which includes mainly reimbursements from BARDA and CARB-X, rose to CHF 26.7 million. This brings total revenue to CHF 119 million, an increase of 14% compared to the first half of 2025. Cost of products sold decreased to CHF 15.4 million in the first half of 2026, positively impacted by the customer and product mix. Operating expenses amounted to CHF 72 million, increasing mainly due to costs associated with the progress of the fosmanogepix Phase III program, preparations for the ceftibuten-ledaborbactam Phase III program as well as the Phase I study for BAL2420.

As a result, we achieved an operating profit of CHF 31.6 million and a net profit of CHF 27.9 million, both significantly increasing year-on-year. Finally, cash and cash equivalents and restricted cash rose to CHF 176 million. The cash flow from operating activities amounted to CHF 19 million, including the impact from a temporary increase in receivables and inventory, reflecting the continued growth of our commercial business and strong operational execution in the first half of the year. The receivables are expected to be collected within their respective due dates in Q3 2026. And the inventories will allow us to address the increased product demand in the second half of 2026. We also continued to strengthen our balance sheet through debt reduction. During the reporting period, we repurchased CHF 5 million in nominal value of our convertible bonds, reducing the outstanding nominal balance to CHF 71 million. The convertible bond is due to mature in July 2027.

Let me now turn to our updated full year guidance. Based on the strong performance in the first half of this year and the continued positive outlook we now expect total revenue for full year 2026 to grow by approximately 15%. Within this, Cresemba and Zevtera related revenue is expected to reach around CHF 210 million compared to our previous guidance of around CHF 200 million. This is expected to translate into a cash contribution of approximately CHF 180 million from our commercial business. We continue to expect an increase of 20% year-on-year of our investments into R&D. Driven by the higher expected revenue, we are raising our operating profit guidance and now expect an increase by approximately 40% year-on-year compared with our previous expectation of around 20% increase. This demonstrates the strength of our business model and our ability to maintain solid profitability while increasing investments in our growth pipeline.

Looking at the components of our full year guidance on Cresemba- and Zevtera-related revenues, we expect approximately CHF 125 million from royalties, CHF 35 million from milestone payments and CHF 50 million from product revenue. We expect the revenue mix to keep on shifting towards higher-margin royalties and milestones resin a significantly higher cash flow contribution from our commercial business in the second half of the year.

I will now hand over to Marc for the portfolio update.

Thank you, Adesh. As David mentioned earlier, we currently have two Phase III programs, fosmanogepix and ceftibuten-ledaborbactam, advancing these programs efficiently and successfully through development remains a key priority for Basilea. Ceftibuten-ledaborbactam, which we [ in lies ] in August 2025 is now in preparation for a global Phase III program with study initiation expected in mid-2027. This program benefits from a well-established study design in line with public FDA guidance for complicated urinary tract infections. Fosmanogepix is currently being evaluated in two global Phase III studies, fosmanogepix has seen invasive candidiasis in candidemia and forward IM in invasive mold infections.

We expect both studies to read out in 2028. Importantly, the fosmanogepix Phase III program is supported by a growing body of real-world experience, which I will discuss in more detail shortly. Fosmanogepix has truly differentiated profile combining a first-in-class mechanism of action with broad spectrum activity against both molds and yeast, and in addition, it has demonstrated excellent tissue penetration and offers both intravenous and oral formulations, providing important flexibility for patient management. We continue to make good progress with the Phase III development program that I mentioned earlier, which remains on track.

At the same time, we continue to gain valuable real-world experience with fosmanogepix through a global expanded access program. This program provides access to fosmanogepix for patients with serious of life-threatening and waste fungal infections who have limited or no alternative treatment options. To date, nearly 600 patients have been treated across 22 countries and the continuous increase in patient numbers and the geographic reach reflect the significant global medical need addressed by fosmanogepix. Additionally, this growing body of real-world experience may complement clinical data package and support future market access following regulatory approval. BAL2420 is our first-in-class antibiotic targeting highly resistant gram-negative bacteria. These infections remain a major global health challenge, including those caused by carbapenem-resistant Enterobacteriaceae, where treatment options are often limited and patient outcomes can be poor.

BAL2420 offers a novel mechanism of action based on inhibition of LPTA, which then leads to rapid bacterial cell death. Importantly, this mechanism is distinct from existing antibiotic classes, creating the potential to overcome resistance. We've initiated the first new Phase I dose escalation study in the first quarter of 2026, and I'm pleased to report that the study is progressing as planned. In addition to fosmanogepix and BAL2420, we are also progressing our other clinical stage antibacterial and antifungal programs towards the next milestones. The antibiotic ceftibuten-ledaborbactam is being developed as a potential first oral beta lactam/beta lactamase inhibitor combination for complicated urinary tract infections caused by Enterobacteriaceae.

The program addresses a significant need for new treatment options for multidrug-resistant or negative infections and benefits from both fast track and QIDP designations from the FDA. BAL2062 is a novel antifungal candidate for the treatment of invasive aspergillosis, including resistant strains. Following encouraging Phase I safety and tolerability data discussions with regulatory authorities regarding the optimal Phase II and III development pathway are ongoing.

With this, I'll hand back to David.

Thank you, Marc. Building on what Marc told you, we expect our commercial portfolio to expand over time. Cresemba will continue to generate substantial revenues while with the U.S. launch of Zevtera, we expect increasingly meaningful revenues over the coming years. Assuming successful clinical and regulatory outcomes, fosmanogepix could become our third commercial product in 2029, followed by ceftibuten-ledaborbactam as our fourth commercial product approximately a year later. Together, these two assets are expected to become important future growth drivers for Basilea and diversify our revenue streams. At peak, they could generate combined in-market sales equivalent to approximately twice the level of today's sales, illustrating the significant value creation opportunity in our late-stage pipeline.

Earlier this year, we announced our agenda 2030, our road map for Basilea's next phase of development. We communicated that at the end of 2025, we had CHF 162 million in cash, and we expect approximately CHF 600 million in cumulative cash flow from Cresemba and Zevtera alone between 2026 and 2030. In addition, more than $350 million of potential non-dilutive R&D funding remained available under existing agreements. These resources provide the foundation for the next phase of growth of Basilea. They allow us to advance fosmanogepix and ceftibuten-ledaborbactam towards commercialization, continue investing in our earlier-stage pipeline and further strengthen our portfolio through targeted business development opportunities.

Currently, we are fully on track to deliver on these targets set out in our agenda 2030. This is evidenced by our progress in the first half of 2026. We delivered another strong operational and financial performance with double-digit growth in Cresemba revenue leading to an increase in our full year operating profit guidance. Across the pipeline, both fosmanogepix Phase III studies continue to advance as planned. Also preparations for the ceftibuten-ledaborbactam Phase III program continue, and we initiated the first-in-human study of BAL2420. We entered into a new preclinical collaboration and secured $61 million in non-dilutive funding for our clinical programs.

With a strong first half of 2026, we look forward to continue building on this momentum for the remainder of the year. Thank you for your attention, and we'll now open the line for your questions.

[Operator Instructions] The first question comes from the line of Brian White from Calvine Partners.

The first one is on fosmanogepix and just thinking about the commentary on enrollment. And we still are seeing an exclusion of resistant candida auris the U.S. And I just wonder the fact you're seeing a positive impact on enrollment there. And just also if you could remind us if do you need both studies to read out for filing and approval or if one was faster than the other, could you go ahead with one ahead of the second. And then also on the ceftibuten-ledaborbactam program. I know you're obviously looking forward to the initiation of Phase III next year. It's early days since the approval of in the U.S. And I wonder have you seen anything from the label or the approval that has given you some insight into the positioning of ceftibuten-ledaborbactam than CUTI.

Okay. Thank you, Brian. Actually, Marc, why don't you take the one about candida auris and the impact potentially on our study and also the are both studies needed. You take that question first.

Yes, Brian, thank you very much for the question. So usually, outbreaks do not have such a great impact on clinical trial enrollment there, often localized. And then for primary therapy of candida infection which is the study, it's restricted to no more than 48 hours of prior antifungal treatments. Otherwise, patients cannot be enrolled and that's often our outbreaks they have already started for a couple of days of treatment. So in principle, it could support enrollment at in practice the number of outbreaks is relatively small compared to the overall prevalence of candida infections. The second question was about the two Phase III studies. So we could file them separately, but we will need the candidemia study completed because of the required safety database for the NDA. So there are several options we filed candidemia and mold together or with candidemia first and then mold infections depending on completion.

And then on your tebipenem question, actually, it's interesting. I mean, obviously, all we've read is what's public, but it looks like GSK [ Spiro ] position in tebipenem as an oral carbapenem, which obviously wouldn't directly overlap with ceftibuten-ledaborbactam that's an novel beta lactam/beta lactamase inhibitor. But obviously, in terms of the concept, the value proposition of an oral step-down or alternative to IV carbapenems, it will be similar. So actually, from that point of view, it would actually, I think, be quite helpful for us in terms of GSK [ Spiro ] doing a lot of the groundwork in terms of educating the market in terms of the oral complicated UTI concept, which I think we would benefit from if and when we come to market with ceftibuten-ledaborbactam. So that's how we're sort of initially thinking about it. But obviously, we'll see what happens when they launch and the positioning going forward and the response to that.

Next question comes from the line of Hyoti Prakash from Edison Group.

Congratulations on the strong first half. So my first question is related to the guidance, and I'm just trying to reconcile the numbers here. So the operating profit is now expected to grow by 40% versus 20% previously, which is, if I do the math around CHF 10 million increase and CHF 5 million of that would obviously come from the increase in royalties. So just trying to understand where the other growth is going to come from, given that the milestone is payments are not expected to gain from us guidance. That's the first question. And the second question is again on royalties. If you just look at the pickup of royalties in the first half, it looks to be -- the growth looks to be primarily driven by Astellas. How do we think about this for the second half of the year?

Yes. Thanks, Jyoti, for those questions. Adesh, do you want to take those?

Yes. Thank you, Jyoti. So maybe initially on the -- on your first question on how the guidance works, we are, in essence, guiding for an increase in CHF 12 million in revenues, you could say. As you correctly pointed out, CHF 5 million is the increase in royalties that we expect, CHF 5 million in product revenues. So Cresemba and Zevtera related revenues are expected to increase from CHF 200 million previously guided to CHF 210 million in the new guidance. And then there is sort of the residual value of CHF 2 million that is coming from other revenues in essence. And out of those CHF 12 million basically CHF 10 million flow all the way down to the operating profit. So as you correctly pointed out, our operating profit guidance increases from CHF 62 million to CHF 72 million. And I think the structure basically how this works, reflects also how our business model works, that we have actually quite high translation of revenue growth into profit. And then with regard to your second question on the royalty breakdown, I would point you simply to the -- first of all, to the full year guidance. So in essence, we are guiding for CHF 125 million in royalties for the full year. And hence, yes, there will be quite a lot of, I would say, positive dynamic in the second half of the year, driven by the underlying growth of Cresemba that we're seeing in the market. One point to bear in mind, when you're just looking at the year-on-year comparison in the first half is that the first half of last year was, to some degree, positively impacted by some, I would say, mitigation measures that some of our partners took with regard to the tariffs and tax situation that was announced in April 2025. So the first half of the year saw some mitigation measures. Therefore, the royalties in the first half of 2025 as a baseline, we're probably a little bit higher than they would have been on a run rate that normalized in the second half. And now if you're comparing the full year '25 to the full year '26, you're seeing the healthy double-digit growth in royalties that reflects on the in-market performance that we also see with Cresemba.

Yes. So to build on that, so therefore, when you asked the question, would the second half of the year, the royalty rate growth come from Astellas, which you observed in the first half of the year. I think the point is it will come from more than just Astellas. It will come from both Pfizer and Astellas.

We now have a question from the line of Joris Simaman from Octavian.

Congratulations on the strong set of results in H1. Two questions, if I may. One is also related to revenues, specifically to product sales. With almost CHF 30 million, those have been significant despite some of your partners actually shifting to in-house production. And I think also for the guidance -- full year guidance now, you expect a slight increase. Could you maybe talk a little bit to the drivers behind that? And then on ceftibuten-ledaborbactam and the Phase III initiation, which you confirmed for mid '27, I was wondering where you stand in terms of the meeting with the regulators, FDA, EMA? And then if you already have more clarity, if indeed, it will be one study or it might still be multiple studies?

Yes. Thanks, Joris, for those questions. I mean do you want to take on the product sales on why we have the levels we have in Q1 -- sorry, half year versus full year?

Yes, also on the full year. So thank you, Joris, for your question. So maybe just give me a little bit of background initially. Indeed, Pfizer and Gosun as two big partners have moved to their largely to supplying themselves as it was always planned, and that was also reflected in our initial guidance for 2026. We had guided for product sales of CHF 45 million for the full year versus about CHF 50 million that we had in 2025. Now we increased our guidance to basically CHF 50 million, in essence, flat product sales, compensating fully for the product sales that we are no longer doing to Pfizer and go soon. And that is really driven by the underlying demand that our distribution partners and other partners that we are supplying have primarily for Cresemba. So on the one hand, you're seeing the positive dynamic in the increase in royalties. So that's why the royalty guidance has gone up. And correspondingly, our partners are also ordering basically more, and that is then reflected in the product sales guidance. Product sales, just as a reminder, do not perfectly go late with the in-market sales because we recognize product sales whenever we do the delivery. So they are sort of more distinct wherever we do a delivery, then basically we recognize the full amount. And that's why it's not a clear linear growth rate. But I think the dynamic is clear. Underlying demand is increasing, and that's why our product sales across the partners that we're applying is increasing as well. Maybe as the last remark, I would like to make which you didn't ask, but I'm volunteering the answer is basically that our product mix on -- or our revenue mix on product sales is improving as well because we are selling more to partners where we have a higher margin in essence, and that's also being reflected in our overall guidance.

Yes. Thank you, Adesh. Hope that answers your question there. And then the ceftibuten-ledaborbactam one, and Marc, maybe your best place to comment on discussions with FDA or EMA and how many studies are required, et cetera. Can you just comment on that?

Yes. So we've entered into an active discussion and a formal process with FDA and EMA for the program. The discussion include the overall scope of the program critical design elements, regimen selection compare end points. And our objective is to agree on a Phase III program that provides a clear and efficient path forward to registration and also to have the data to optimize the commercial positioning. That is a process and programs that we have not yet come to a conclusion on, for example, the number of required studies, but we'll communicate once we have come to a conclusion.

But the idea is that we -- this process goes in parallel with our other preparation activities so that we can start the study mid-2027. So that's a on process that runs in parallel with the operational preparation.

The next question comes from the line of Chien-Hsun Lee from Pareto Securities.

Congrats on the strong results. Just two questions for me. So one is a follow-up question on fosmanogepix enrollment. So earlier this year, in your business update, you announced that you are activating 21 new centers in China. For FSIC, do you see any trends in this Chinese side, and do you see any impact on the overall time line? And the second question is about the cash position. So with it continue improving, how are you thinking about the allocation between bond buybacks, funding the clinical development and any additional BD activities?

Yes. So maybe, Marc, you could comment on how is the inclusion of China in the invasive candidiasis fosmanogepix study to change the trend in any way? I think that was Chien's first question.

Yes. So yes, thanks for the question. I think we are on track with the program. There's no change really in the time lines and as expected, opening China contributes to the enrollment of the study. So I think there's nothing really unexpected from land.

I think on your cash position question basically, the use of capital, I think, as we've said, at the moment, for 2026, 2027, it's clear that our focus, as we laid out in Agenda 2030 is basically investing in our R&D, so that both the late-stage programs and the earlier stage programs. And in addition to selectively licensing, acquiring assets like we've done for the last three years, assets that are both innovative but have what we believe is commercial potential. And that's the focus of our capital allocation now. And then what we've always -- what we've said publicly up until now, and it's still the current thinking is that when we get more visibility following the maturity of the convertible bond mid-2027, and we get visibility on the results, the initial results from fosmanogepix at the beginning of 2028 for the Phase III studies, then we'll be in a position to assess capital distribution in terms of whether it be buybacks or dividends. in addition to the other uses of capital that I've just mentioned. That's the way we're thinking of it, Chien, at this moment.

[Operator Instructions] We now have a question from the line of Jasmin Spörri from Zürcher Kantonalbank.

Congratulations from my side. I have two questions. One is related to Zevtera and the other one to your Phase I asset BAL2420. The first one about Zevtera is mainly that the U.S. launch of Zevtera appears to be progressing. Could you provide more details on maybe hospital adaptation, and how you see this translating into revenue growth over the next 12 until 18 months. And second BAL2420 has entered Phase I trials. Could you share any early insights or time lines for when we might expect initial data readout, or how do you see this asset fitting into your broader portfolio strategy time-wise?

Yes. Thanks, Jasmin, for the question. Maybe, Adesh, you comment on the Zevtera sort of 12- to 18-month sort of vision?

Yes. So I'll go beyond that. So just as a reminder, Zevtera has exclusivity in the U.S. until April 2034. And the way that we have structured the transaction and also the way that we philosophically think about our assets is that we look at optimizing the value over the entire product lifestyle. And hence, for us, the focus when we're looking at the key performance indicators that we are tracking at this point in time is, are we, together with our partner, of course, Innoviva Specialty Therapeutics, setting the ground for long-lasting success, basically. And in this respect, we have done indeed indicated, we have seen a good good progress. We believe that market access has been established very well. We believe that the hurdles have been overcome that may have been there barriers with regard to affordability broad adoption, positive clinical -- initial clinical experience and so on. And the expansion of the field force by Innoviva Specialty Therapeutics also plays into the expectation that we will see an increasing dynamic now going forward. However, to manage expectations, for us, again, more material impact or more material visibility on revenues from Zevtera are probably going to come in the '28 to '29 time frame. That's when we start to really look at do these early indicators translate into tangible revenues that we're seeing and now we are on a good trajectory to achieving our goal of maximizing the value.

And just the 2420 question mark about where are we, data readout time lines and thinking about next steps. Could you comment on that?

Yes. I think first in human study, time line is always not exactly to be predictable because we don't know how many dose levels will have to go until getting to ineffective and save those. But our current expectation is that this study could be completed in around mid-2027. But I said, it depends on the number of dose levels and dose cohorts. So this is single dose and multiple doses, and they go on in parallel with multiple doses starting sometime after single doses have been qualified. And from a portfolio perspective, it's a complete novel mechanism of action overcoming resistance. One of the indications we are currently thinking about for this compound is from negative bloodstream infections, which are frequent with a higher unmet medical need. And I think that kind of discussed the portfolio that will be our development direction.

Ladies and gentlemen, there are no more questions at this time. I would now like to turn the conference back over to David Veitch for any closing remarks.

Yes. Thank you. Thanks for your questions. Before we close, I'd just like to remind you of our Capital Markets Day, which will take place on October 28 in Zurich. During the event, we provide a more comprehensive update on our strategy, our development portfolio and future value creation opportunities. In addition, we'll have two globally renowned infectious disease physicians will share their insights on the medical need in serious fungal and bacterial diseases, which underpins our portfolio's development programs. So hopefully, you can join us at that meeting. But thank you very much for your time today.

Ladies and gentlemen, the conference is now over. Thank you for joining chorus call, and thank you for participating in Basilea Pharmaceutica half year result 2026 conference call. You may now disconnect your lines. Goodbye.

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.

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.

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.

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.

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 Instructions] The first question comes from the line of Brian White from Calvine Partners.

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?

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?

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.

The next question comes from the line of Laurent Flamme from Zürcher Kantonalbank.

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?

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.

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.

Does that answer your question, Laurent?

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?

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.

We now have a question from the line of Jyoti Prakash from Edison Group.

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?

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.

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?

Okay. So I think, Marc, it's about the trials that will be required for ceftibuten-ledaborbactam for the Phase III program.

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 Instructions] The next question comes from the line of Ram Selvaraju from H.C. Wainwright.

Are you there, Ram?

Can you hear me?

Yes, we can now.

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?

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?

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.

And then in terms of your fosmanogepix accrual and with the patients the crude into the Phase III studies, maybe Marc, you take.

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 Instructions] We have a follow-up question from the line of Laurent Flamme from Zürcher Kantonalbank.

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?

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.

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 Instructions] We have a follow-up question from the line of Laurent Flamme from Zürcher Kantonalbank.

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?

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.

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.

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.

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.