Ladies and gentlemen, welcome to the webcast on the positive top-line results of phase III ERADICATE study in SAB. I'm Alice, the Chorus Call operator. I would like to remind you that all participants will be in listen-only mode, and the conference is being recorded. The presentation will be followed by a Q&A session. You can register for questions at any time by pressing star and one on your telephone. For operator assistance, please press star and zero. The conference must not be recorded for publication or broadcast. At this time, it's my pleasure to hand over to David Veitch, Chief Executive Officer. Please go ahead, sir. Thank you. Hello. I'd like to welcome you to our conference call and webcast reviewing our phase III ceftobiprole data and the next steps, and we will also highlight our progress with the implementation of our strategy to become a leading global anti-infectives company. For further detailed information, please see the ad hoc announcement issued this morning and the updated investor presentation. These documents are both available on our website at basilea.com. Joining me presenting on the call today is Dr. Marc Engelhardt, our Chief Medical Officer. Also available to answer questions is Adesh Kaul, our Chief Financial Officer. I would like to mention that this call contains forward-looking statements. Before handing over to Marc to go through the clinical update, I would like to make a few brief comments on our company. As we announced in February this year, we will be focused in the future on the treatment of serious bacterial and fungal infections. We have two revenue-generating brands, CRESEMBA for the treatment of invasive mold infections and ZEVTERA, or ceftobiprole, for the treatment of hospital bacterial infections. We have a proven team and capabilities to progress anti-infective assets from research through development to the market. We also have a number of preclinical assets in our pipeline, which we are working hard to progress towards the clinic. To now provide an update on the ceftobiprole phase III program, I will hand over to Marc. Thank you, David. Our regulatory strategy for access in the U.S. market is to seek approval for two indications, which means for two bacterial skin and skin structure infections or ABSSSI, and for Staphylococcus aureus bacteremia, SAB. This is based on our two recent phase III studies, TARGET in ABSSSI and ERADICATE in SAB. In addition, we'll also explore the possibility of gaining approval for community-acquired bacterial pneumonia or CABP as a third indication based on a phase III study performed several years ago that formed the basis for the approval of this indication in Europe. Our commercial strategy is to license ceftobiprole to a commercial partner in the U.S. and not commercialize ourselves. I'd also like to mention that the recent ceftobiprole program, including TARGET and ERADICATE, has been funded for approximately 70% of total program costs by BARDA in the U.S. The TARGET study in ABSSSI was a randomized double-blind phase III non-inferiority study, which enrolled 679 patients and was conducted at more than 30 clinical centers in the U.S. and Europe. Patients received either ceftobiprole or vancomycin plus aztreonam. Ceftobiprole met the pre-specified primary efficacy endpoint of early clinical response at 48-72 hours after start of study drug administration in the intent-to-treat population. This is the key endpoint according to the FDA guidance for the U.S. To achieve this endpoint, the initial skin lesion size had to decrease by 20% or more from baseline. Response rates were 91.3% with ceftobiprole versus 88.1% for the comparator. Let me also briefly remind you on our study in community-acquired bacterial pneumonia. This was a randomized double-blind phase III non-inferiority study and enrolled 638 patients in the ITT population comparing ceftobiprole versus ceftriaxone. Ceftobiprole met the pre-specified primary efficacy endpoint of clinical cure at the test-of-cure visit at seven to 14 days after the end of treatment in the co-primary intent-to-treat and the clinically evaluable populations against a non-inferiority margin of 10%. Since the FDA has changed their guidance after the study was completed, we had also reanalyzed the study according to the new FDA endpoints of an early success after three to five days and have found consistent results with the original study endpoint. As mentioned earlier, following initial discussions with FDA, we intend to explore the possibility of gaining approval for CABP as a third indication based on this phase III study. Now moving on to Staphylococcus aureus bacteremia or SAB. SAB is an area of high medical need with about 120,000 SAB infections every year in the U.S. alone, with high morbidity and a 30-day mortality of approximately 20%. The ERADICATE study has been targeting complicated SAB, which is characterized by concomitant or metastatic infections such as bone, joint, or heart valve infections, persistent bacteremia, or bacteremia in patients on dialysis. There are limited antibiotic treatment options, with only two approved treatments in the U.S., which are vancomycin and daptomycin, that cover both methicillin-susceptible and methicillin-resistant Staphylococcus aureus or MSSA and MRSA. Ceftobiprole, if approved, will address an important medical need in this area. The ERADICATE study was a randomized double-blind multicenter study to establish the efficacy and safety of ceftobiprole compared with daptomycin with or without aztreonam in the treatment of adult patients with complicated SAB, including infective endocarditis. ERADICATE is the largest randomized study ever conducted for registration purposes of a new antibiotic treatment in SAB. 390 patients were randomized, and 387 patients were in the modified intent to treat our MITT population, which included patients that received study medication and had a positive blood culture for Staph aureus at baseline. The primary endpoint is the overall success rate at seven days, 70 days after randomization. Meeting the endpoint of overall success requires survival, absence of metastatic foci or other SAB complications, resolution or improvement of SAB-related signs and symptoms, and Staph aureus bloodstream clearance. The study was designed to determine whether ceftobiprole's non-inferiority to daptomycin at a non-inferiority margin of 15%. The primary study objective was achieved, and non-inferiority demonstrated for ceftobiprole compared to daptomycin with or without aztreonam. 69.8% of patients in the ceftobiprole group showed overall success at 70 days post-randomization, compared to 68.7% of patients in the daptomycin group. The statistically adjusted difference on the overall success rate with ceftobiprole minus daptomycin was 2%, and the corresponding 95% confidence interval for that difference was -7.1% to 11.1%. For the study hypothesis, the lower bound of this confidence interval, meaning -7.1%, is compared to the -15% non-inferiority margin and is therefore clearly above that margin, confirming the non-inferiority assumption of ceftobiprole versus daptomycin with or without aztreonam. Secondary efficacy endpoints such as all-cause mortality, microbiological eradication, or the development of SAB-related complications post-randomization were consistent with the primary study outcome. No significant differences were observed in the initial review of subgroup analysis. The overall percentage of patients with adverse events were similar between the ceftobiprole and the daptomycin group. We've seen a higher rate of gastrointestinal side effects with ceftobiprole, driven by mainly mild and manageable nausea events compared to daptomycin. Similar differences were already observed in previous phase III studies, so this result in ERADICATE was not unexpected. In summary, ERADICATE was a positive study, meeting its primary and secondary efficacy endpoints and confirming the known safety profile of ceftobiprole. This study now provides us with the required data to pursue an NDA filing with a robust supportive package that will include the ERADICATE and TARGET studies. We'll also further explore the potential utility of our phase III data in community-acquired bacterial pneumonia, as mentioned earlier. Ceftobiprole provides several key attributes for differentiation. It is a beta-lactam antibiotic with rapid bactericidal activity against gram-positive pathogens, including MSSA and MRSA, but also provides coverage against many gram-negative bacteria. Ceftobiprole has demonstrated efficacy in phase III clinical studies in Staphylococcus aureus bacteremia, acute bacterial skin and skin structure infections, and in pneumonia with daptomycin is not effective. Ceftobiprole has a low propensity for resistance development, and ceftobiprole has an established clinical safety profile that is consistent with its cephalosporin class. I'll hand it now back to David. Thank you, Marc. Our future anti-infective strategy is built on the strong foundation we have established. From the commercial stage assets, CRESEMBA has been driving our revenues over recent years, as shown by the 29% royalty income growth in 2021 and the global in-market sales of $324 million in 2021. CRESEMBA progress continues in 2022 with the IV approval in China to add to the previously approved oral formulation. CRESEMBA is now launched in China, which is the second largest market in potential. We are also expecting a CRESEMBA approval in Japan before the year end. Marc has explained the progress with ceftobiprole phase III program to potentially access the U.S. market. We believe this represents around 80%-90% of the global potential for the brand. We are now focused on preparing the U.S. NDA submission and in parallel, conducting a partnering process to ensure we have a partner fully on board for the subsequent U.S. launch. Also, importantly, as we stated in February, we believe we will be sustainably profitable from 2023 onwards. In summary, during 2022, we've been executed on our stated priorities for the anti-infective business. In addition to the objective of increasing our revenues from CRESEMBA and ZEVTERA, we are focused on advancing our preclinical assets towards the clinic and looking to in-license clinical and preclinical stage anti-infective assets, as evidenced by the novel preclinical anti-infective, antifungal program we in-licensed this year. For completeness, as we recently announced, we are also progressing the transactions for the oncology assets, which once completed, will allow us to be fully focused on anti-infective treatment research, development, and commercialization going forwards. Thank you for listening, and I would now like to turn the floor over to you for any questions you may have. We will now begin the question- and- answer session. Anyone who wishes to ask a question may press star and one on the touch-tone telephone. You will hear a tone to confirm that you have entered the queue. If you wish to remove yourself from the question queue, you may press star and two. Participants are requested to unmute only when asking a question. Only three questions might be asked in a row, then the line will be open to others. You can get back in line again for any follow-up questions. Anyone who has a question may press star and one at this time. The first question comes from the line of Ram Selvaraju with H.C. Wainwright. Please go ahead. Hello there. This is Muzz speaking on behalf of Ram. I'll ask three of our questions. Firstly, how significant is the market opportunity in CABP versus bacteremia? Okay. I mean, from our point of view, the biggest opportunity actually, and it's not a simple answer, in terms of what the research we've done on the different indications and what would drive the usage of the product in the U.S. Clearly, the Staphylococcus aureus bacteremia indication with, I mean, obviously, we don't know what the final label will be, but with infective endocarditis, with MRSA in the label, we believe this will be the driving indication rather than the skin or the CABP indication. Not purely just because of the size of the bacteremia indication, but the fact that it would stimulate usage in other concomitant sort of infections like osteomyelitis or other type of serious consequences of bacteremia. Very much, we believe that the bacteremia will be the driving indication. Okay. Thank you. Does the presence of daptomycin generics potentially curtail the market opportunity for ceftobiprole? If so, to what extent and in what way do you think? I think, I mean, I'll make an answer to that, and then I'll also ask Adesh to comment. Our view is that, again, as I alluded to a second ago, it very much depends in part on the final label we end up with, but it's all about differentiation. I think we've seen in antibiotics, like in other therapy areas, if you've got a differentiated product, and we believe we've got points of differentiation versus daptomycin, and other compounds that would be used instead of ceftobiprole. Actually, it's all about the value proposition versus, you know, the differentiated position of the product versus the other compounds. For us, things like... Marc, I think, touched on this, like the use, the gram-positive, gram-negative spectrum, the lack of ability to use daptomycin in pneumonia is clearly some advantages versus daptomycin. A generic daptomycin which exists in the world is not an issue if our value proposition is strong enough. Maybe Marc or Adesh, you want to add to that? Yes. I completely agree. I think it's really the gram-negative spectrum. Resistance development, on treatment, is really not a problem with ceftobiprole. I think if the exploration of the community-acquired bacterial pneumonia indication comes through, that would certainly be another point of differentiation. The only thing I would add is that ceftobiprole, if approved for the indication, would be the first beta-lactam that covers actually MSSA and MRSA in the indications. It's also a different class of compounds from a class that is actually standard of care for non-MRSA SAB. Okay. Thanks for highlighting those differentiating factors. One final one before I jump back in the queue. How long is the review period likely to be for the ceftobiprole NDA? Yeah. That actually is quite clear. Because of the QIDP designation, we have this priority review, which is eight months. It's an eight-month standard review cycle for the priority review cycle. Obviously in terms of the launch date, that depends very much on our submission date, which as we guide, is around the year-end. Perfect. I'll get back in the queue. Thank you. Thanks for the questions. The next question comes from the line of Louise Chen with Cantor. Please go ahead. Hi. Congratulations on the data, and thanks for taking my questions. First question I had for you is, why do you expect your launch to be successful, when other people have failed, in some of these new anti-infective launches? Secondly, when do you expect to announce a partner for the U.S., and how far along are you with these discussions? Last question is, do you expect any updates to pricing for anti-infectives here in the U.S.? Thank you. Okay. Thank you very much, Louise. So I'll kick off with the why do we think we're successful. It's a little bit linked to the previous answers and the previous questions we've had in that, we believe that and I think there's even examples now, I mean, there have been examples of antibiotics that have not done well and examples of antibiotics that are doing well now in the U.S. market. I think it's all around, is the product differentiated? We believe we've got a product for the reasons we've all commented on in answer to previous questions that we can differentiate. Obviously, a slight caveat I would say there is obviously it depends in part on the final label we end up with and the indications we end up with. At the end of the day, I think we think we've got advantages over other compounds such as daptomycin, which obviously is a standard in terms of bacteremia. We've got advantages, for example, versus vancomycin in skin infections. We think we've got clear advantages. That would be the reason why we think we can be successful. In terms of the partnering process, maybe I'll let Adesh, who's in charge of that process, comment on that. Thank you, David. Hi, Louise. Maybe one more comment on what David said before on your first question is that it is known that the space is. That's a therapeutic area that's promotionally sensitive. I think also what we have seen in the recent past is that the more successful anti-infective launches were done by companies that have probably a broader reach or have the corresponding commercial infrastructure. That's certainly something that we will also consider in our partnering discussions, because that's also partially a reason why we wouldn't move forward and build our own infrastructure in the U.S., but actually try to leverage an existing infrastructure from a commercial partner, ideally with a broad reach. From a partnering perspective, we are certainly looking at having the compound partnered as soon as possible in order to allow a partner also to participate in the pre-launch activities, so certainly before approval, but also, to be quite frank, we expect now actually the whole discussions to gain really momentum. Because up to this point in time, we had to say it was almost like a binary situation. If the study had not been positive, the path to the U.S. would have been, I would say, unclear if not impossible with the existing data package. Only now that we have the readout from ERADICATE, the opportunity is fully visible. It's de-risked to a certain degree, and hence the scope of partnering discussions that we're having now broaden significantly. Yeah. On your pricing point, I mean, what I would say is that, you know, recent antibiotic launches have been, you know, priced at several hundred dollars a day for the price per day of the antibiotic. What I would say is that, obviously, don't forget our bacteremia indication, as Marc alluded to, is not like a five-day course necessarily as complicated as Staphylococcus aureus bacteremia. It's for quite a long period of time. If you want to think of it like that, the value of the patient is quite a lot higher than, for example, for a skin infection patient. In terms of the final discussion around the pricing, I mean, that would be our partner would also have obviously clearly that it will be their responsibility in terms of the pricing. We can't dictate the price for the partner. You know, our partner, for example, for CRESEMBA in the U.S., Astellas, who's doing a great job with CRESEMBA, you know, a bit like one of our previous answers, you know, one of our jobs is to make sure we pick a partner that we believe has got the competence to price the product well in terms of the U.S., in terms of a good value proposition. That would be a key part of what they would do in terms of the pre-launch planning for the product in the U.S. Obviously, the other aspect is about for antibiotics around sort of pull incentives and while there's no legislation specifically on a pull incentive, as you're aware, there's lots of discussion in terms of potential legislation that could result in a pull incentive for antibiotics in the U.S. That's another important factor that while it's not in place today, may well change to make the environment better for antibiotics in the future. Thank you. The next question comes from the line of Bob Pooler with valuationLAB. Please go ahead. Thank you. Good afternoon, gentlemen. First of all, congratulations on the positive ERADICATE trial results. Just going back on the partnering there, again, are you looking for a partner before or after U.S. approval? And do you have any preferences, for instance, specific partner? You're working very close together in success with Pfizer. And are you partnering a local or a global deal? Oh, it's U.S. for that one. Strike that last one. Yeah. No, thanks, Bob. I understand the question. Adesh, do you wanna comment on that? Yeah. We are certainly aiming at having a transaction done before the approval. That's certainly what we are working towards. Never a guarantee, but that's certainly the aim. Secondly, what are we aiming for? It is really driven by capabilities. As I said, this is a space that is promotionally sensitive, and hence for us it will be important to have a partner that has the commercial capabilities and the infrastructure to really sort of tap into the full potential of the drug. That will really drive, at the end of the day, the decision, what are the commercial capabilities of the partner to really unlock the full value of the compound. Just to build on that, we're not being restrictive. We're actually going a bit like our standard approach is we've got obviously a broad number of companies ranging from the company you sort of suggested, so the large pharma down to smaller companies. It's a whole spectrum of different companies on our list that we've already approached in the past. We're now, in the light of these SAB results, the partnering process moves to a new level in terms of hopefully also the partner's response, as well as our ability to sort of go wide and out with the good news that we've got the two phase III studies both positive. Okay, clear. The ZEVTERA trials were done under a Special Protocol Assessment. What are the implications of the SPA on the upcoming FDA review? I think the main reasons to an SPA is to get a bit more binding basis that the endpoint's agreed and the study design agreed is not gonna be challenged, for example, in case of guidance change. I don't think we'll have a big discussion with FDA. You know, about the design elements of the study and whether the design elements are suitable, you know, to support an indication or a claim. Is either actually sort of pre-agreed endpoints that you had with the FDA when you made this last claim? It is like an agreement on key study design elements and that they are considered appropriate by FDA to support an NDA filing. Okay. If I may, just on you had the strategy update yesterday on derazantinib. Does that mean that the upcoming trials interim results and so will they now be stopped? Can we await any news from that, or is that now actually discontinued completely? From operational perspective, the studies are ongoing, but as we announced yesterday, we will be returning the rights back to Merck. As such, we are unlikely to actually make the announcement around the data, but the data will just as it is appropriate, then be published, I suppose, under the responsibility of Merck as the drug goes back to Merck. Okay. Very clear. More from a perspective of based on the decision that we have taken to [audio distortion]. Th e data is not gonna have any impact on that decision because t hat's happened. Yeah. The decision has been made, huh? Yes. Okay. Thank you. Thank you. The next question comes from the line of Harry Shrives with Edison Investment Research. Please go ahead. Hi, Marc. Hi, David. Hi, Adesh. Congratulations on your results. Really nice to see. I wanted to start off by asking, can we get any extra detail on the sort of subgroup analysis that was involved in ERADICATE, in particular sort of MSSA versus MRSA subgroups? If you don't have any information or can't tell us, when can we expect that? Well, we are preparing for presenting this data at one of the next major scientific conferences, and that's where relevant subgroups, the one you mentioned, but also others, like we had quite different, you know, underlying conditions for complicated Staph aureus bacteremia in this study, including patients with osteomyelitis, septic arthritis, and right-side infective endocarditis, but also demographic variables, that is gonna be covered by upcoming publications. We plan to present at one of the next major conferences and also have a manuscript in preparation. Okay, thanks. I suppose leading on from that, it sounds like the that analysis could tell you quite a lot about possibly other indications. Would you be open to pursuing other indications with ZEVTERA? I think the one part is from the population that has been studied in the SAB study, you know, whether there's an opportunity for including some of this information into a labeling. We currently have no plans to run another phase III study for an entirely new indication. Yeah. Just to build on that, this goes back to the question about, you know, the differentiated sort of product positioning, and I alluded to the fact that some of it depends on the label. Marc's just pointed out that we wouldn't get another indication. It would be for, you know, Staphylococcus aureus bacteremia. Marc's saying in the label it might include right-sided infective endocarditis potentially, and it could highlight MRSA as well as MSSA, but it wouldn't be an additional indication, just to be clear. Thanks. Finally, there was the announcement yesterday, gave us the update on the oncology assets, and obviously with ZEVTERA moving closer and closer towards approval. Can you give us a bit of an update on what's next for the pipeline? Yes. I mean, what I would just say is that don't forget that ceftobiprole, if it's approved, and we hope it will be given the data we've got so far. Obviously it's gonna go through now the regulatory process and, if approved, we would have 10 years of exclusivity from the approval date. Just to point out that point, that if it's approved, say second half of 2023, if we submit it around the end of the year, then we would have 2023- 2033 of exclusivity. That's market exclusivity independent of the patent situation. That's one point. Point two is, don't forget CRESEMBA. We have a CRESEMBA exclusivity in the U.S. and Europe to 2027, pending the completion of the pediatric study for Europe, which is well on track. Then obviously we have a tail in places like China and Japan, which would go beyond 2027. We have a number of pre-clinical assets, antifungal and antibacterial assets. Then what we're focus is on now, and I alluded to this in my comments, that we analyzed just a pre-clinical antifungal program earlier this year. What the focus now of the BD&L team is to add assets, antibacterial and antifungal assets to our clinical stage pipeline. Between our pre-clinical assets and the ceftobiprole U.S. opportunity, that's the focus of our in-licensing efforts on, in terms of in-licensing compounds in the anti-infective space, and that's very much the priority as we speak. Okay. Thank you, David, and congratulations again. No, thank you. The next question comes from the line of Brian White with Calvine Partners. Please go ahead. Yeah, thanks for taking my questions. I may have missed this, but I was just trying to work out exactly what the timing was on the submission for the pneumonia indication in the U.S. Secondly, you're thinking about what other geographies you can take the SAB and severe skin infection data too. Also just thinking about the partnering process, and I just wondered if the current availability of ZEVTERA outside of the U.S. complicates those partnering discussions in any way. Thank you. Yeah. I'll clarify the first point, which is that. Just to be clear, Brian, the CABP, the community-acquired bacterial pneumonia indication, is not a separate NDA, yeah? It's not a separate package. It's actually, we would submit it as part of the one NDA submission at the end of the year. It's not a separate filing, just in case that your question was unclear about that. Just, it's one filing for SAB, for skin infections and for potentially CABP as well. Just to be clear, it's one NDA. That answers that on the timing of that one. In terms of what other geographies could we use the SAB data for, maybe Adesh, right? Do you wanna take that one? Yeah. There I would simply say that actually for both, for SAB and for ABSSSI, what we will do or what we are, what we already started doing is discuss with our existing partners in all the other major jurisdictions about how to best leverage that data. That can be in the context of a medical communication, for instance. In some instances, it may be sufficient and appropriate to move forward with publications and with educational aspects. In other jurisdictions, it may really be the approach that we pursue an indication. That's really in close collaboration with our partners, existing partners. Your second point was about whether there would be any complications through that with the, well, for our partnering process. The only sort of remaining territory is in the U.S. From that perspective, that is a package that is complete in itself. Other geographies are not really relevant in the context of the discussions that we are having with regard to the U.S. It's not gonna g reatly matter. I guess what I meant, Adesh, was really from the perspective of a partner not being able to globalize. You're suggesting that the availability of U.S. rights would be sufficient for our particular partner. Absolutely. I think for several reasons. One, actually a lot of parties that we are talking to are actually, in essence, just commercializing in the U.S. Not necessarily. They have a segregated or they have a dedicated U.S. infrastructure. I think that's one point. Secondly, I think is these kind of geographical transactions happen all the time, and the U.S. r epresents almost like 80%, give or take, of the global potential. In itself, the U.S. has critical mass. Is from a commercial perspective. Highly interesting, also given the exclusivity period. To some degree, I would even say it probably makes it easier to be discussing only about the U.S. Right. Okay. Okay, that's good. Excellent. Thanks so much. Thanks. The next question comes from the line of Eric Le Berrigaud with Bryan, Garnier. Please go ahead. Hello. Congrats on the positive data. I have question. First question is, love to hear more detail about the royalty income growth in 2022. What really drove that, and what's gonna drive that for both 2 and 2022? The second question would be an update on the reimbursement pricing in China recently, and also your market access plan for ZEVTERA in Japan. Yeah. Actually, Eric, thanks for the question. It was a bit difficult to hear. There was a bit of background noise, but I think the royalty income, what drove the royalty income, in last year, maybe Adesh? The way I understood it was for actually 2022. Just as a reminder, in our case, actually, there are two different streams, actually, of revenue. We have structures and geographies that are royalty-based, and that's primarily the transactions that we have with Pfizer, CRESEMBA, and for Astellas in the U.S. for CRESEMBA. In the other geographies, it's actually more product sales. It's a distribution setup that we have. We'll be reporting the growth in those territories from product sales. Looking at royalty growth alone doesn't give the full picture. Maybe to answer your question about 2022, we guided for a double-digit, actually continuous double-digit royalty growth in 2022, driven by a continued growth in the existing markets, including the U.S., for instance, and EU, with actually new country launches. By the end of 2022, we expect CRESEMBA to be launched in 70 markets, whereas at the end of 2021, it was available in about 55, 56 markets. Significant growth of additional markets, so to say. 30 specifically, I think I heard were the questions about China and about Japan. Maybe first about Japan. For Japan, we are expecting a regulatory decision in the second half of this year. For 2022, the direct contribution from in-market sales and associated royalties will be probably more limited. That's not gonna be a key driver for 2022. For China, the drug has recently been approved in its second formulation, so for the IV formulation, and is launched now. I think the biggest contribution will be coming once the drug is on the national reimbursement list, which is in essence a process that takes time. Here again, in the context of 2022, we expect contributions from China for CRESEMBA, but actually the significant growth contributions will be coming once the drug is approved on the national reimbursement list, which we can't really indicate when exactly that may be happening. Where actually our partner, Pfizer, is very well managing the process and has the experience of managing the process. We are confident that this is a matter of time until this happens. Hopefully, Eric, we answered your questions. It was a bit difficult to hear them. That's perfect. Thank you very much. Just one more question about Japan. Is there any updates on the market access or from your partners? With regard to Japan, since the drug is not approved yet, there is no real update on market access. It's under regulatory review in Japan. Perfect. Gotcha. Thank you. Okay. Thanks, Eric. The next question comes from the line of Arsène Guekam with Kepler Cheuvreux. Please go ahead. Hello. Hello, gentlemen. Thank you. Thank you for taking my question. Two, if I may. First of all, in order to limit the potential resistance, is there any risk that ceftobiprole will not be used in the first- line during blood infection? The second one is more related to your strategy. Do you want to be involved in the U.S. marketing of this drug? Actually, I'll answer the second one then Marc will come back to the first- line usage question. In terms of do we want to be involved in the marketing, I mean, I think, Arsène, what we've done with all our partners, we have a small alliance management group who work closely with our partners, whether it be Pfizer, Astellas, or whoever, even the smaller partners. We work with them all on trying to spread best practice around the different partners. If we see good strategies, good positioning, good tactics working, then we spread best practice to all our partners. It's actually the responsibility of a partner, though, ultimately, for the marketing and the medical affairs activities with regard to the product in their territory. You know, we can influence, but it's not, you know. We will be involved, and we will be very interested to be involved, a bit like we are with CRESEMBA in the U.S. and CRESEMBA in Europe. We'll be very keen to be involved, but ultimately, it's the final responsibility of the partner to develop the marketing strategy. You know, usually we find our partners are very receptive to our input because we know our products very well, and obviously we've got years of know-how with ceftobiprole. Any partner we finally do a deal with for the U.S., I'm sure they would take our input. It is ultimately the responsibility of the commercial and the medical affairs strategy for the compound in their territory with the partner. Just to give you a sort of insight there. In terms of your first question around the sort of lines of limitations or restrictions that would cause it not being used first line or second line, maybe Marc. Arsène, was the question in relation to bacteremia or just generally? No, generally. Well, it depends on, you know, the antibiotic stewardship concepts, which are sometimes countrywide, sometimes local. In general, the study is done with ceftobiprole based on studies on empiric treatment. We haven't really targeted specifically a group of multi-resistant pathogens. All the studies we've done in SAB, in ABSSSI, and in pneumonia were empiric use studies, so we would expect that it will also reflect the utilization in the U.S. and in other countries. Whether there are, in certain areas, specific rules on how to use certain antibiotics based on their antibiotic stewardship programs, that's hard to predict. From a study evidence, this is more a compound for really empiric use. Yeah. What I would just add to that is that what you have to bear in mind is with in this antibiotic market is it's a huge volume market, and there are. You know, when a patient comes into the hospital and they need gram-positive or gram-negative coverage, the sort of the go-to drugs might be piperacillin-tazobactam or vancomycin, depending if you're trying to cover the gram-negative and gram-positive areas. And these drugs are often the first- line. Even daptomycin, which sort of peaked around $1 billion of peak year sales in the U.S., that was less the first- line and more the first branded line when you actually suspected gram-positive MRSA involvement. Actually, you know, in this marketplace, it's quite unusual in terms of you can get a relatively small share of empiric use up front or second- line, and it can be a very, very big product just based on the volumes of usage. It's quite unusual in that respect in terms of a market. Yeah. Okay, thank you for your answer and congrats again. No, thank you. Just a reminder. Sorry, go ahead. Carry on, operator. As a reminder, if you wish to register for a question, please press star and one on your phone. Star followed by one. We have a follow-up question from Mr. Ram Selvaraju. Please go ahead. Yeah. You said that the sales and marketing infrastructure will be the responsibility of the partners. Just wondering if you have any idea what the sales and marketing infrastructure could look like and how you think it would be commercialized in the U.S. Yeah, I mean, allude to previous answers that we've given. I mean, we obviously, Adesh touched on this, we actually believe that, you know, this is a promotionally sensitive market, the antibiotic marketplace. So actually we believe we need a partner that has the sort of broad reach. I mean, don't forget, this is hospital serious infections, so it's not retail GP product. It's a hospital serious infection product. So actually the reach doesn't need to be global, but it needs to cover the majority of the key institutions that would use potentially the product. So actually we need a partner that has that infrastructure in place. We obviously... You know, my answer to the fact that the previous answer was that it's ultimately the responsibility of the partner to market and develop the medical affairs strategy for the compound for the U.S. Clearly we've had a number of years of experience, as I mentioned, so we have an alliance management group that work closely to provide our insights from the markets that we've got data on that we've launched. We're launched in around almost 20 markets around the globe. We've got quite a lot of valuable experience on ceftobiprole, and we're actually in terms of the positioning and the messaging of the product, we've got a pretty large amount of data that we would pass on to a partner once we've got a partner in place. Yeah, that's. We would certainly input and provide input, and we would want a partner that provides the right amount of what we believe expertise and sort of, size, to enable us to achieve what we think we can achieve with this product. Adesh or Marc, would you add anything else? No. It's really. Since it is hospitals, so covering really in essence the broadest possible range of relevant hospitals in the U.S. Yeah. Does that answer your question? Yeah. I appreciate the extra detail. Thanks very much. Thank you. There are no more questions at this time. Okay. On behalf of the board of Basilea, thank you for your interest and thank you for joining the call. 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