Ladies and gentlemen, welcome to the Basilea Pharmaceutica Half Year Results 2025 Conference Call and Live Webcast. I am Sandra, the Chorus Call operator. [Operator Instructions] The conference is being recorded. The presentation will be followed by a Q&A session. [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, sir.

Thank you. Hello. I'm David Veitch, CEO of Basilea. Thank you for joining us today on our conference call and webcast. We're going to review our financial results and key achievements for the first half year 2025 as well as highlight our priorities going forwards. For further detailed information, please see the ad hoc announcement issued this morning at our half year report. These documents are both available on our website at basilea.com. I would like to mention that this call contains certain forward-looking statements. Joining me on our call today are Adesh Kaul, our Chief Financial Officer; and Dr. Marc Engelhardt, our Chief Medical Officer. Before we dive into the detailed portfolio update and financial performance, I would like to start with our key achievements since the beginning of the year. This period has truly been a remarkable time for Basilea. We have made outstanding progress across all dimensions of our business from strategy to execution. Starting with our leading commercial product, Cresemba, our antifungal for invasive mold infections. Its excellent sales performance is driven by a 24.8% increase in global in-market sales, according to the latest available data for the 12-month period to March 2025. This continued strong in-market performance is reflected by the 21.7 percentage increase year-on-year in royalty income. We report a strong financial performance for the first 6 months of 2025 and a positive operating result of CHF 24 million for the period. We used some of the operating cash flow we generated to further reduce our debt level. Furthermore, we secured an additional tranche of USD 39 million in nondilutive funding from BARDA, which will support the continuing development of our antifungal candidates, fosmanogepix and BAL2062. Our antibiotic, Zevtera, was recently launched in the U.S. through our partner, Innoviva Specialty Therapeutics. We've also initiated the second of 2 Phase III studies for our antifungal fosmanogepix with the goal of securing a broad label covering both yeast and mold infections. Additionally, we strengthened our portfolio by the in-licensing of ceftibuten-ledaborbactam, a Phase III-ready novel oral antibiotic for the potential treatment of complicated urinary tract infections. When we now look at our expanding portfolio, you can see that we have 2 commercial assets, 2 Phase III assets and 2 Phase II or early assets. Our pipeline targets multiple indications across both fungal and bacterial infections, positioning ourselves as a leading anti- infectives company with near term, medium-term as well as long-term value drivers. I will now hand over to Marc for the portfolio update.

Thank you, David. As David already mentioned, we have significantly expanded our portfolio by adding 4 new programs since October 2023. These include both early- and late-stage programs. The most advanced program is our antifungal asset, fosmanogepix. Fosmanogepix is a first-in-class antifungal product that's rapidly converted into its active form, manogepix. Manogepix inhibits Gwt1, a fungal specific enzyme essential for the maturation of cell wall proteins called mannoproteins. Fosmanogepix's mode of access novel and distinct from all existing antifungal therapies, offering a new approach to treating invasive fungal infections. Fosmanogepix demonstrates broad spectrum activity against both yeast and molds, including multidrug-resistant yeast strains, such as Candida auris or Candida glabrata and its difficult-to-treat molds like Aspergillus and Fusarium species as well as other rare fungi. These pathogens are challenging to treat and represent a growing global health concern. Fosmanogepix is available both IV and oral, providing clinicians with the flexibility to manage severe infections in hospital settings and transition patients to outpatient care. This is a key advantage in improving treatment continuity and reducing health care burden. To support a potential broad label reflecting its broad spectrum activity, fosmanogepix is currently being evaluated in 2 parallel clinical trials. Beyond the clinical study program I just briefly mentioned, there is an ongoing global expanded access program with fosmanogepix for patients with serious or life-threatening invasive fungal infections who have no approved treatment options. So far, more than 300 patients in more than 10 countries have received fosmanogepix via expanded access. These include individuals suffering from a broad range of fungal diseases, such as invasive fusariosis, aspergillosis, lomentospora, scedosporium infections, mucormycosis, Candida infections and coccidioidomycosis, among others. A particularly notable example of fosmanogepix impact comes from the 2023 Fusarium meningitis outbreak linked to clinics in Matamoros, Mexico. This outbreak affected primarily young, previously healthy individuals from the U.S. who had undergone surgical procedures involving epidural anesthesia. The Fusarium strain identified was resistant to all approved antifungal agents. Fosmanogepix, still in Phase II development at the time, emerged as active and following CDC recommendation, it was added to treatment regimens, resulting in a reduction in in-hospital mortality from approximately 65%, the standard of care alone to 14% after the introduction and addition of fosmanogepix. This case series has garnered significant media and scientific attention, including publications in the New England Journal of Medicine, highlighting how investigational therapies like fosmanogepix can play a life-saving role in such situations. The median treatment duration in these cases was around 6 months, underscoring fosmanogepix potential for long-term management of severe fungal infections. This real-world data not only reinforces the potential clinical benefit of fosmanogepix but also highlights its utility and outbreak scenarios and rare fungal diseases where treatment options are limited or ineffective. And now moving to our global clinical program. The first Phase III study, FAST-IC, is a double-blind noninferiority study evaluating fosmanogepix in candidemia and invasive candidiasis. This study will include approximately 450 patients, randomized to initial intravenous therapy with fosmanogepix or caspofungin. The study includes an oral step-down option for fosmanogepix -- to fosmanogepix in the fosmanogepix group in to fluconazole in to caspofungin group with a treatment duration of up to 6 weeks. The primary endpoint for the FDA's 30-day survival and for the EMA's overall response at the end-of-study treatment. This is a global study and patient enrollment is on track. Our second global Phase III study, FORWARD-IM is evaluating fosmanogepix in invasive mold infections and was initiated approximately 1 month ago. This is an open-label trial, including 2 distinct cohorts. Cohort A focuses on primary therapy and will enroll approximately 160 patients across 4 sub-cohorts categorized by infection type, aspergillus species, lomentospora prolificans, fusarium species, and mucorales fungi. Patients in this cohort will be randomized in the 2

1 ratio to receive either fosmanogepix or the best available antifungal therapy, allowing us to assess efficacy in a range of high-risk mold infections. Cohort B will enroll around 60 patients who require salvage therapy due to intolerance, toxicity, lack of clinical response, or whose fungal isolate is resistant to standard-of-care therapy. Treatment in both cohorts may continue for up to 180 days depending on clinical need. The primary endpoint for the study is all-cause mortality at day 42. Both Phase III clinical trials are expected to read out in early 2028. Upon successful completion, we plan to submit the data to regulatory authorities for review and approval. This Phase III program is designed to generate a comprehensive data set supporting the broad use of fosmanogepix across both yeast and mold infections, positioning it as a primary treatment and the salvage therapy option for patients with limited alternatives. Importantly, the program is backed up by a robust foundation of evidence, including extensive nonclinical data, completed Phase I and Phase II clinical trials, clinical pharmacology studies and the real-world clinical experience from the expanded access program I spoke about earlier. The regulatory pathway is streamlined, supported by multiple designations, enabling accelerated regulatory review and providing the standard market exclusivity in the U.S., enhancing the strategic value of the program. And now moving to our new program, ceftibuten-ledaborbactam. Ceftibuten-ledaborbactam is a novel oral antibiotic in development for the treatment of complicated urinary tract infections. It demonstrates potent activity against Enterobacterales including multidrug- resistant strains such as extended spectrum beta-lactamase or ESBL producers and carbapenem-resistant Enterobacterales or CRE. Pathogens that are increasingly resistant to current therapies and present significant treatment challenges. This compound combines a beta-lactam antibiotic with a novel beta-lactamase inhibitor offering rapid bactericidal activity. It was safe and well tolerated in Phase I studies and offers convenience in terms of dosing, administration and storage. We are currently preparing the Phase III program with a potential start in approximately 18 months. This asset benefits from FDA Fast Track and QIDP designations for both complicated and uncomplicated urinary tract infections, enabling accelerated regulatory review and extended market exclusivity in the U.S. We expect the Phase III program takes about 1.5 years to completion, which would enable an NDA filing around year-end 2028. Urinary tract infections, including complicated UTIs or cUTIs are among the most common bacterial infections in both hospital and community settings. However, rising resistance rates are increasingly limiting the effectiveness of currently available oral antibiotics, often leaving intravenous therapy as the only viable treatment options. Each year, cUTIs lead to over 600,000 hospital admissions in the U.S. and more than 700,000 hospital-acquired cases in Europe with additional cases occurring globally. Multidrug-resistant pathogens such as ESBL-producing and carbapenem-resistant Enterobacterales already account for 10% to 20% of cases in the U.S. and Europe, limiting available treatment options. Ceftibuten-ledaborbactam has the potential to be the first oral beta- lactam/beta-lactamase inhibitor combination addressing the significant unmet medical need by offering an effective and convenient oral treatment option for resistant cUTIs. I will now hand over to Adesh for the commercial and financial update.

Thank you, Marc. I would like to start with a commercial update. Our business model is designed for scalability, focusing on our core strength in the clinical development of assets and partnering with the leading companies to commercialize them. This low-risk approach minimizes operating expenses and capital requirements while unlocking significant market potential. With Cresemba and Zevtera, we have built a strong network of global partnerships that now extends our reach to more than 100 countries. Turning first to Zevtera in the U.S. As seen with daptomycin, the U.S. represents the most significant commercial opportunity for branded anti-MRSA hospital antibiotics, accounting for approximately 80% to 90% of the global market. To access this important market, we established a new commercial partnership with Innoviva Specialty Therapeutics, and in late May, we could announce that Zevtera is now commercially available in the U.S. Innoviva Specialty Therapeutics has a strong track record of recent successful hospital antibacterial launches, backed by a robust U.S. commercial infrastructure and a highly experienced medical affairs team. Importantly, Zevtera benefits from market exclusivity to April 2034, offering substantial commercial runway to maximize value. All key activities for Zevtera's U.S. commercialization are in place, covering marketing and sales execution, market access, medical affairs and product availability. These efforts have been successfully rolled out by our commercial partner, ensuring an effective launch. Moving now to Cresemba and its commercial performance, a key driver of our strong financial results. Cresemba in-market sales in the 12-month period to end of March 2025 amounted to USD 612 million, representing an about 25% year-on-year increase. Growth remains strong in established markets, and we are seeing quickly increasing contributions from China and Japan, where Cresemba has moved beyond the initial launch phase. Cresemba, with a 22% market share by value, is the leading brand for the treatment of invasive fungal infections worldwide. Even out of this already strong position, there is still ample growth potential for the brand going forwards. Let's now turn to the financial results, where you'll see how the progress of our brands in the market is translating into a strong revenue performance, which combined with nondilutive R&D funding and disciplined cost management is putting us in an overall strong financial position. Please note that all figures I mention are in Swiss francs unless stated otherwise. Cresemba and Zevtera related revenue totaled CHF 90.5 million, representing a 23.5% year-on-year increase. This included royalty income of CHF 52.1 million, which grew by 21.7% year-on-year, primarily reflecting the continued double-digit in-market sales growth of Cresemba. Milestone and upfront payments have also increased to CHF 6.9 million as compared to CHF 2.9 million in the first half of 2024. Other revenue amounted to CHF 13.5 million, including CHF 11.1 million BARDA reimbursements and CHF 1.9 million CARB-X funding. This brings total revenue to CHF 104 million, an increase of about 36% compared to the first half of 2024. Operating expenses amounted to CHF 55.7 million, increasing mainly due to costs associated with the ongoing fosmanogepix Phase III program. Overall, this resulted in an operating profit of CHF 24 million, a significant increase compared to the first half of 2024. We report a net profit of CHF 15.8 million compared to CHF 20.7 million in the first half of 2024. The decrease is due to a onetime income tax benefit in the first half of 2024 from releasing the deferred tax valuation allowance. Compared to a net debt position of CHF 26.2 million in the first half of 2024, we closed the period with a positive net cash position of CHF 50.7 million as of June 30, 2025. The operational leverage of our unique business model continued to deliver increasing operating cash flows in the first half of 2025. We report that a positive cash flow of CHF 23.1 million was provided by operating activities compared to CHF 17.9 million reported in the first half of 2024. This strong cash generation reinforces our financial flexibility and supports ongoing investment in growth initiatives and pipeline development. With the recent in-licensing of ceftibuten- ledaborbactam serving as an example. As already mentioned, we are strengthening the company's balance sheet through debt reduction. During the reporting period, we have used our strong cash position to repurchase convertible bonds June, July 2027 in the amount of CHF 14.3 million. Therefore, we have reduced our total debt level from 2022 through June 30, 2025 by CHF 138.3 million. Earlier, Marc provided you with our rationale for in-licensing ceftibuten-ledaborbactam. I would now like to provide the key financial terms of the agreement. We are making an upfront payment along with potential near-term milestone payments in 2025. Together with the incremental expected R&D expenses in 2025, this will result in approximately CHF 15 million of additional expenses in 2025, which we will book entirely under the R&D expense line. Only after the start of commercialization, VenatoRx will be eligible for tiered mid-single-digit royalties and commercial milestone payments of up to USD 325 million in total if all milestone events are achieved over the term of the agreement. Strategically, ceftibuten-ledaborbactam strengthens our anti-infective pipeline by adding a promising asset in a high need indication, which could start making revenue contributions shortly after fosmanogepix, thereby providing us with an exciting growth trajectory in the years to come. Let's turn now to our full year 2025 financial guidance. We are updating our guidance in 2 steps. Firstly, we are fully on track from an operational perspective. We slightly increased our total revenue guidance to reflect the expected increase in BARDA reimbursements due to the good operational progress we are making with fosmanogepix and BAL2062. Secondly, we are considering the impact of our in-licensing of ceftibuten-ledaborbactam, which is limited to the R&D expense line. This now means the following for 2025. Cresemba and Zevtera related revenue is projected at around CHF 190 million, including royalty income growth of 14% to CHF 110 million, driven primarily by the continued strong double-digit sales growth of Cresemba in key markets. Total revenue is now expected to increase by about 8% to CHF 225 million, higher than the CHF 220 million previously communicated. R&D expenses are projected to rise to CHF 105 million. The increase as compared to the previous guidance of CHF 88 million is almost exclusively driven by our in-licensing transaction, which adds CHF 15 million of primarily upfront and potential milestone payments. As a result, we expect to report an operating profit of approximately CHF 50 million, which underscores our financial ability to not only progress our growing pipeline but to keep on expanding the pipeline with the right assets in the future. Finally, from a tax perspective, we do not expect any material cash outflow, thanks to the use of tax loss carryforwards. However, we will see a 10.7% income tax expense reflected in net profit. To further contextualize our 2025 financial guidance, I would like to provide more detail on Cresemba and Zevtera related revenue. We anticipate a 17% reduction in product revenue to about CHF 48 million year-on-year due to a decrease in product supply to Pfizer. However, this is expected to be offset by continued growth in royalty income to CHF 110 million. Following a year of exceptionally high milestone payments in 2024, milestone and upfront payments in 2025 are expected to normalize to prior year levels of approximately CHF 32 million. Overall, Cresemba continues to experience strong in-market demand as reflected in the sustained double-digit growth in royalty income since 2015. This positive trend is expected to continue. I will now turn it over to David for a summary and final comments.

Thank you, Adesh. Since the beginning of the year, we've made significant progress delivering on the goals we set out. A key commercial milestone was the launch of Zevtera in the U.S., expanding the brand's presence to its most important commercial market. This launch marks a pivotal moment in the brand's history and a major milestone for our infectious disease portfolio. In parallel, Cresemba continues to perform strongly with increasing revenue driven by robust in-market demand. On the R&D front, we advanced both preclinical and clinical anti-infective assets, including the initiation of the second Phase III study with fosmanogepix for invasive mold infections. We further strengthened our pipeline through the in-licensing of the oral antibiotic ceftibuten-ledaborbactam, which we target to enter Phase III clinical development within the next 18 months. In parallel, we continue to secure nondilutive funding to support our R&D efforts, reflected by the recent USD 39 million of BARDA funding. Together, these achievements reflect our focused execution and support our strategy of maintaining a continuous stream of potential new product launches in the near to midterm future, positioning us for substantial revenue growth versus where we are today. Looking ahead, we remain focused on driving sustainable growth and long-term value. We aim to further increase revenue from Cresemba and Zevtera, leveraging Cresemba's strong market performance and the momentum from Zevtera's U.S. launch. We are actively exploring further in-licensing and acquisition opportunities to expand our anti-infectives portfolio. At the same time, we continue to pursue additional nondilutive funding to support our R&D efforts, building on our successful collaborations with BARDA and CARB-X. Our lead clinical stage antifungal asset fosmanogepix will continue progressing through Phase III development, while preparations are also underway for the Phase III program of our new pipeline asset, ceftibuten-ledaborbactam. We also aim to advance our Phase II and earlier stage programs, each moving towards next decision points. Together, these priorities reflect our focus on innovation, strategic execution and delivering meaningful value to our shareholders. Thank you very much for your attention, and I'll now open the line up for your questions.

[Operator Instructions] Our first question comes from Brian White from Calvine Partners.

I've got 2. The first is one on the recent in-licensing of the combination antibiotic. And your 18 months seems quite a long time until the beginning of Phase III. And I guess, why is that? And does that give you a bit of time to access further nondilutive funding from the existing OTA or from additional sources? And here, I'm just thinking about the sheer quantum of the BARDA funding of the similar combination ceftibuten-ledaborbactam. I just wondered whether or not there's additional opportunities there? And next secondly on fosmanogepix, where you seem to be in a position, given you've got over 300 people in the expanded access program already, where you may have more patients in a real-world setting by 2028 than you have in the clinical program and what are the implications of that from a regulatory perspective, if any?

Okay. Thank you, Brian. Yes, good questions. I mean, first of all, just to say, and I'll let Marc comment on the specifics of why the 18 months between now and the start of the Phase III for ceftibuten-ledaborbactam, he'll comment on that. But just to say that the reason for this 18-month is nothing to do with trying to secure BARDA funding, just to be clear. That's not any -- it's not a limiting step. It's not a step at all. I mean, we will seek to try and get BARDA funding for the program. But as we've always said, we made, with all our acquisitions or licensing agreements, where they have to make sense without any nondilutive funding. And then if we can secure nondilutive funding, then it's obviously upside for us. But we have to make sure in the base case, they make sense anyway. So we are definitely, just to be clear, not holding up any program, this Phase III program because of a lack of BARDA funding in place as of today when we in- licensed the product. But Marc, maybe you could give some color as to what is the reason for the 18 months. Why aren't we starting quicker, I guess, is the implication in the question.

Yes. I think there's 3 elements to this. One is, we need to have the health authority interactions with the FDA and the EMA to agree on a program, so that will take some time. We'll then need to operationally set the study up. But also these are the cUTI studies are reasonably large studies of 1,000 or more patients, and we need to have the supply to enroll this in a very short period of time. So I think the cUTI studies, if you go back to the ceftobiprole program, they are more like ABSSSI from an operational perspective. So we will need to have sufficient supply to enroll a relatively large number of patients in a short period of time. These are the main reasons. I can come to your first one, [indiscernible] this question which is really interesting about the numbers in the expanded access program. I agree, this is a significant number. The regulatory utility of this will need to be discussed with the FDA. There is guidance on single pivotal studies, which -- from the FDA, which contain the conditions when expanded access data can be helpful, and one of them is that the data need to be fairly complete. And I think we're currently collecting a large series of data. We are starting to implement also cohort approaches now. We're moving away from the pure emergency access, which will make requesting physicians entering actually into a database. And then I think there will be a key component to identify groups of patients that can be put into a literature or historical context to demonstrate that their outcome was much better than what would have been expected based on context from external controls. And if we are able to show this, which I think I'm quite positive that this will work, then the EAP data can serve as confirmatory evidence in an NDA filing.

Okay, that makes sense.

But I guess just to complete this, but it won't replace the current -- the 2 phase, the pivotal Phase III studies.

Correct. It will complement the available data. It will not replace the available Phase III cohort.

The next question comes from Jyoti Prakash from Edison Group.

Congratulations on the acquisition of the new late-stage antibacterial asset. My question relates to how this -- how do you see this oral treatment fitting into the entire treatment algorithm in the complicated UTI space, given that it's dominated by IV? Is it going to be like a replacement or more complementary, like a step-down treatment? And am I correct in assuming that the R&D will not be covered under the current BARDA OTA agreement? That's my first question. And then I have another question related to product revenues, which were quite strong in the first half, CHF 31.5 million. But looking at your full year guidance of CHF 48 million, it seems that there will be some softness in the second half. Is that entirely related to Pfizer or is there any other reason for this conservatism? So these are my 2 questions.

Okay. Thank you, Jyoti. Actually, let me take 1 part of the first question in terms of the -- the ceftibuten-ledaborbactam, just to be clear, that when you ask is, could it be funded as part of the current OTA? I mean, I think what I said earlier was that we will look definitely and we are looking at trying to secure some nondilutive funding for ceftibuten-ledaborbactam. And whether or not that ends up if we were successful as part of the existing OTA or currently VenatoRx had a BARDA funding agreement in place and whether that agreement effectively we can inherit that from them, that agreement, we don't know yet which way this will go. We're in early discussions. We've only had the product, obviously, for sort of less than a week. So we are in active discussions. We're trying to work our way through that. So it's too early to say exactly the format of any potential funding. And obviously, as of yet, we haven't agreed any funding, but we are obviously trying to, as we've got a history of doing, trying to source funding for that program. In terms of the place for oral, is it -- when it's an IV dominated cUTI market, maybe Marc, you can take that and where you see this.

Yes. So it will have utility in both in initial or empiric therapy as well as in a step-down from IV antibiotics. The Phase III program will compare oral ceftibuten-ledaborbactam versus an IV carbapenem and this will be empiric first-line antibiotic treatment. So the data from the Phase III will support an empiric treatment position. But in clinical practice, we anticipate that ceftibuten-ledaborbactam will primarily be initiated in the hospital. And here, it's going to be either as empiric primary therapy or it's going to be used as an oral step-down in patients with urinary tract infections caused by resistant Enterobacterales who have been initiated on IV antibiotic. So there will be utility in both and the clinical program will support an empiric treatment position.

And then maybe the question about the product revenues, H1 versus H2. Adesh, do you want to take that trend?

Yes, happy to do that. I think you can't really interpret too much into really H1 versus H2. It's just a matter of product delivery schedules in essence. So there's nothing really to say in particular about that except that in H1 2025, we had initial supplies, of course, related to the U.S. launch. We had also some additional supplies related to late supplies, you could say, to Pfizer because there were some supplies that were scheduled to be going out end of 2024 that moved into 2025, and then also some initial, also, supplies to Gosun for China, Zevtera, because with the inclusion of Zevtera in the NRDL last year, volumes are increasing and basically, there was some supplies related to that. So H1 was indeed very strong but we have seen similar patterns in the past. You mentioned Pfizer. I think it is important to see that actually the effect of our -- of the end of the supply to Pfizer for our supply agreement with Pfizer ending largely is on a full year basis, indeed, CHF 14 million, but you are seeing the effect distributed over the full year comparison. As a matter of fact, you would expect actually that we have CHF 14 million less product sales as compared to 2024.

Does that answer your question, Jyoti?

Yes.

The next question comes from Ram Selvaraju from H.C. Wainwright.

Just 3 quick ones. Firstly, I was wondering if you could comment on what factors, if any, might influence acceleration of the pace of enrollment in the fosmanogepix Phase III program. Not sure whether any such factors do exist, but wanted to see if, indeed, there might be some elements that could make the enrollment time line shorter than you currently anticipate? Secondly, I just wanted to see if you could share with us some clarity, some granularity around the nature and scope of the sales and marketing infrastructure that Innoviva Specialty Therapeutics is currently deploying in support of Zevtera rollout in the United States? And then lastly, with respect to the VenatoRx oral compound for combination antibiotic for use in complicated UTIs, I was just wondering if from a clinical development and regulatory perspective. There are likely to be any similarities in consideration and design parameters and endpoints for the envisaged clinical development program. Between this candidate and the oral carbapenem that is currently being advanced by GSK, is there any parallel or comparison that could be drawn with that program, mainly because it's also in the cUTI indication?

Yes. Thanks, Ram. Good questions. Actually let me just take the -- I'll take the second -- the middle question, and then I'll hand over to probably Marc to comment on the fosmanogepix accrual and the UTI and how it compares with the GSK compound. But the -- in terms of Innoviva Specialty Therapeutics, I mean, what we can say is that we attended, we're working with them. We supported them on the launch at the end of June in terms of the commercial launch. And what we would say is that they have got, as you may well be aware, they have a lot of experience in selling antibacterials and hospital products and recent experience. And what we felt coming away or attending and coming away from that launch meeting was that this they've got a global coverage of the U.S. They've got sales force. They've got a medical -- a strong medical sales or medical -- sorry, medical affairs organization. They've got a commercial organization. They've got an access organization. So I think the contemporary experience of launching antibiotics and understanding the process you go through in terms of medical education, in terms of formulary access, in terms of then pull-through, key account management, et cetera, all the traits and the skills you would need, we left the meeting feeling very strongly that this is a great partner for us in terms of -- and like I said, they cover all the key centers that we would have hoped they would cover. And like I said, they've got the experience of launching and selling antibiotics in the U.S. market. So from a sort of -- call it, at the moment, admittedly, it's more of a qualitative data set than a quantitative because literally, the sales force have only been selling since the beginning of July. So we are in very, very early days, but they seemed excited and we definitely left the launch meeting ourselves very excited. So that's probably what I would say about the IST or Innoviva Specialty Therapeutics sort of launch of ceftobiprole, Zevtera in the U.S. In terms of fosmanogepix. And Marc, how we can -- are there things we can do to speed up accrual with the Phase III studies?

Yes. I think it's a great question, Ram. And it's actually -- we always need a few months to understand the enrollment pattern geographically. I mean, we have a footprint in this space for decades. And what we do is we analyze where are the geographic areas where the enrollment is fast. And then those who -- and those we foster further by our operation CRO, but this is more the easy going part. And the ones that are below expectations, we put more sponsor engagement into this or directly reach out to the site to bring them up to speed. And this kind of you can develop a rolling machine to maximize the enrollment really running these complex clinical trials, a lot of having the right level of engagement from the CRO side and the sponsor side. I think this is really the key factor in keeping the sites engaged. Your other question, I think, was about the ceftibuten-ledaborbactam program and how it's similar or different to the tebipenem. From a clinical trial design perspective and the Phase III design, there will be similarities because there's an FDA guidance, there's also European guidance about endpoints and non-inferiority margins, and also I think the choice of comparators is probably be very similar in IV carbapenem. We've looked into this, how ceftibuten-ledaborbactam will be differentiated from tebipenem, which is likely to be on the market earlier than ceftibuten-ledaborbactam. And it's really elements of spectrum but also concerns of physicians using oral carbopenem due to resistance development. It's also related to pill burden. Tebipenem is 4 times a day. Ceftibuten-ledaborbactam will be 2 to 3 times per day. So we've put this into our market research, and this indicates that even in a market where tebipenem already exists, there will be a substantial market share with ceftibuten-ledaborbactam in the complicated UTI space as a novel oral antibiotic.

Hopefully that answers your question. Thanks.

The next question comes from Laurent Flamme from ZKB.

First question on the line order expense in the P&L. There is a significant swing as compared to the first half last year. So from CHF 1.3 million to CHF 5 -- a bit more than CHF 5 million in the first half of this year. Could you provide any granularity behind that swing? Second question on the ceftibuten-ledaborbactam project. We see that VenatoRx lead compound, ceftibuten-ledaborbactam seems to have a broader spectrum of activity. How do you see the positioning versus the lead compound of VenatoRx?

Yes. Laurent, thank you for the questions. Maybe Adesh, you want to try?

So on the financial sides, actually, which is below the operating profit level, the simple answer is that's actually currency. So at the end of the day, these are noncash impact of currency movements, the devaluation of the U.S. dollar primarily versus the Swiss franc.

So to be sure, that has no impact on the cash flow development?

No, it doesn't have. So unless at some point, realized. So at some point, of course, if we have U.S. dollars sort of or we are invoicing in U.S. dollars, at some point, we are going to be paid in U.S. dollars. Some of the U.S. dollars we're using because of operational purposes, so in that case, we would not realize the losses there. It wouldn't have any cash flow impact net. But if we are getting paid in U.S. dollars and we, at some point, decide that we would exchange that into Swiss francs, then we would incur some of the exchange losses.

And the question about the other VenatoRx product, Marc?

Yes. So I think ceftibuten-ledaborbactam is an IV drug. That's really the -- one of the main differences, and ceftibuten-ledaborbactam is an orally available drug. It's correct that the spectrum of ceftibuten-ledaborbactam is somewhat broader so if there is a concern pseudomonas for example, this will be covered by ceftibuten-ledaborbactam more than by -- or it will not be covered by ceftibuten- ledaborbactam. But I think the 2 cannot really be compared one-to-one because the one is oral, the other is IV. And the oral availability of ceftibuten- ledaborbactam opens just a wider market segment than the IV products that are really in-hospital drugs that will not allow transition into ambulatory settings.

I understand. You sound [ certainly ] the same way. If I may ask a follow-up. But you will test versus an IV product and/or IV oral step-down protocol in Phase III. Maybe probably with noninferiority because it's not required to for superiority. So you will compare at some point for usage versus an IV at some point based on the Phase III. Even if you have more flexibility for ambulatory use, you compete with IV either the patients stay in hospital under an IV or it takes potentially ceftibuten-ledaborbactam oral at home. But it's more or less substitutive. I am right?

Well, I think clinical trial design to show noninferiority is one question and clinical practice then is the other question. Yes, from a trial design perspective, what needs to be shown is the equivalence or noninferiority of an oral beta-lactam/beta-lactamase inhibitor to a standard of care IV, which is usually a carbapenem, IV carbapenem. So this is to demonstrate there is equivalent efficacy. And then the utilization will -- is, I think, another interesting question. It may be used just as an IV carbapenem in the empiric treatment, but if there's evidence that they are equivalent, of course, this will lead in clinical practice to a switch and to a transition into an ambulatory setting or to using an oral drug primarily and not admitting a patient to a hospital because otherwise, if that option wasn't available, they would need IV treatment in the hospital.

So maybe I could just build on that and just, Laurent, just to say that the point is and the sort of opportunity we see in this marketplace is that for these resistant types of pathogens, the current standard of care is for cUTI is IV antibiotics. And so we would be, we believe, the first oral BL/BLI compound that could treat this group of resistant pathogens in this subset of the cUTI population. We have to compare ourselves, as Marc said, with standard of care in this area, which is an IV drug, like he said. But then that means that as we said to a previous answer that we would -- we could be used or we would be used both in the first-line setting in place in some patients for an IV patient. And other times, through our market research, it did show, even though the clinical study doesn't lead you to this, but in terms of in utilization, what our market research showed us is that the idea of transferring a patient quickly on to an oral drug that's effective instead of an IV drug would obviously be very interesting for the hospital to get the patient out of the hospital quicker than if they were maintained on an IV product. Hopefully, that clarifies it.

Thank you, David, for -- I have the impression, depending on the -- because at some point, if VenatoRx lead compound goes to the market with a broader spectrum at some point, you would trade lower cost as ambulatory usage with ceftibuten versus a potentially broader spectrum of activity of an IV product in hospital. Is it a fair way to put it?

Yes, that could be -- yes. I mean, obviously, I don't know if this other product that makes it to the market, I mean, because there are an existing numbers of products that are used IV, that are effective IV products in this area. And I think basically, ceftibuten- ledaborbactam could be a step down from lots of these different agents, not just the one you're mentioning. It could be from a whole number of agents or it could be used in place for some.

[Operator Instructions] The next question comes from Thomas Meyer from Baader-Helvea.

At this point of the Q&A, I just have one. I just wanted to know if it was possible to get a bit more flavor on the evolvement of the performance in APAC and Japan for Cresemba. And if you could comment a bit on how you see it moving forward to kind of dampen the curve that's going to happen with the loss of exclusivity plan through 2027?

Yes. Thomas, thanks for the question. It's a good question. And actually, yes, I mean just at a general point, and then I'll let Adesh might comment on a specific number or 2. But from a general point, you're right that actually, as we've said many times that the exclusivity of Cresemba in U.S. and Europe ends at the end of 2027. So in 2028, we will start to see a decline in certain geographies. Japan is -- you mentioned Japan, that is one of the markets where we believe the product will continue to grow. So it won't be so much of a cliff as more of a sort of cone-shaped decline than a cliff because there are several markets, including Japan, where exclusivity, for example, goes on for longer in Japan. And so it's important that in Japan and China and these later launch countries that they are growing at a high rate now and that they continue to do so. Maybe, Adesh, you could give some color with a number or 2.

Yes. So if you -- happy to. So if you look at the contribution of Asahi Kasei to our overall revenues in the first half 2025 versus the previous year, that has grown from CHF 3.3 million in 2024 to CHF 12.1 million now in the first half of 2025. So that has, of course, several components. Product revenues is going up significantly almost by a factor of -- in essence, by a factor of 3. But then also milestones where we had the first milestones that we have been reporting for this year as the product has moved beyond its international launch phase. But then probably the best proxy for in-market sales is that royalties have also increased by a factor of 4. They are still, on a stand- alone basis, not as significant. They moved from CHF 0.5 million to CHF 2 million, but it's basically a year-on-year a factor of 4 that the royalty income has been growing. And that's actually against the background of the yen devaluing versus the Swiss franc. So overall, that's the sales dynamic that we're seeing. And we are seeing no reason why there would be any slowdown in the growth and the contributions that we'll be seeing from Japan.

Okay. That about answers it. Just what I wanted to hear.

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.

No, thank you. I have no more remarks other than thank you for the questions, and thank you for your attention. And yes, 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 conference. You may now disconnect your lines. Goodbye.