Basilea Pharmaceutica AG (BSLN) Earnings Call Transcript & Summary

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. [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, 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 2 indications, which means for acute bacterial skin and skin structure infections or ABSSI. And for Staphylococcus aureus bacteremia SAB, and this is based on our two recent Phase III studies, TARGET in ABSSI and ERADICATE in SAB. In addition, we will also explore the possibility of gaining approval for community-acquired bacterial pneumonia, or CABP, as a third indication based on the 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 commercial partner in the U.S. and not commercialize ourselves. I would 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 ABSSI was a randomized double-blind Phase III non-inferiority study, which enrolled 679 patients. 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 prespecified primary efficacy endpoint of early clinical response at 48 to 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 prespecified primary efficacy endpoint of clinical cure at the test-of-cure visit at 7 to 14 days after the end of treatment in the co-primary intent to treat and the clinically evaluable population against a non-inferiority margin of 10%. Since FDA has changed their guidance after the study was completed, we had also reanalyzed the study according to new FDA endpoints of early success after 3 to 5 days and have found consistent results with 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 our 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 effective 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 or mITT population, which included patients that received study medication and had a positive blood culture for Staphylococcus aureus at baseline. The primary endpoint is the overall success rate at 7 days -- 70 days after randomization, meeting the endpoint of overall success required 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 is non-inferiority to daptomycin at 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 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 up to margin of 2% and the corresponding 95% confidence interval the difference of minus 7.1% to 11.1%. For the study hypothesis, the lower bound of this confidence in development, meaning minus 7.1% is compared to the minus 15% non-inferiority margin, [Indiscernible] clearly above that margin, confirming the non-inferiority assumption of ceftobiprole verses daptomycin with or without aztreonam. Secondary efficacy endpoints such as all-cause mortality, microbiologic eradication or the development of SAB related complications post-randomization were consistent with the primary study outcome, no significant differences were observed in an initial review of subgroup analysis. The overall percentage of patients with adverse events were similar between the ceftobiprole daptomycin group. We've seen a higher rate of gastrointestinal side effects with ceftobiprole driven by mainly mild and [ indiscernible] 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 pro-supportive package that will include the ERADICATE and TARGET studies. We will also further explore the potential utility of our Phase III data in community-acquired bacterial pneumonia, as mentioned earlier. ceftobiprole provide 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 demonstrated efficacy in Phase III clinical studies in Staphylococcus aureus bacteremia, acute bacterial skin and skin structure infections, and in pneumonia, where daptomycin is not effective. Ceftobiprole has a low propensity for resistance development and ceftobiprole has an established clinical safety profile that is consistent with the 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 end 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% to 90% of the verbal potential for the brand. So 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 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 forward. Thank you for listening. And I would now like to turn the floor over to you for any questions you may have.

[Operator Instructions] The first question comes from the line of Ram Selvaraju with H.C. Wainwright.

This is [indiscernible] speaking on behalf of Ram. I'll ask 3 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. And 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. So very much we believe that the bacteremia will be the driving indication.

Okay. And then does the presence of daptomycin generics potentially curtail the market opportunity for ceftobiprole? And 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. But 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 we'll be using instead of ceftobiprole. So actually, it's all about the value proposition versus the differentiated position of the product versus the other compounds. So 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. It's clearly some advantages versus daptomycin. So a generic daptomycin, which exists in the world, is not an issue if our value proposition is strong enough. But 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 is obviously not a problem with ceftobiprole and then I think if the exploration of the community-acquired bacterial pneumonia indication comes through, that would certainly be another point of differentiation.

[ Sam ] the only thing I would add is that ceftobiprole is approved for the indication would be the first beta-lactam that covers actually MSSA and MRSA indications. So as 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?

Yes. So that actually is quite clear because of the QIDP designation. We have this priority review, which is 8 months. So it's an 8-month standard review cycle for the priority review cycle. So obviously, in terms of the launch date, then that depends very much on our submission date, which as we guide is around the year-end.

The next question comes from the line of Louise Chen with Cantor.

Congratulations on the data. So 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? And then secondly, when do you expect to announce a partner for the U.S.? And how far along are you with these discussions? And then last question is, do you expect any updates to pricing for anti-infectives here in the U.S.?

Okay. Thank you very much, Louise. So I'll kick off with 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 the examples of antibiotics that are doing well now in the U.S. market. And I think it's all around is the product differentiated. And 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, as the carrier, I would say that obviously, it depends in part on the final label we end up with and the indications we end up with. But 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 and we've got advantages, for example, what is vancomycin and skin infections. So we think we've got clear advantages, and that will 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.

Louise. So maybe one more comment on what David said before. And your first question is that it is known that the space is -- that's a therapeutic area that's promotionally sensitive. And I think also what we have seen in the recent past is that the more successful and infective launches were done by companies that have probably a broader reach or have the corresponding commercial infrastructure. And 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 our partner also to participate in the prelaunch 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. And only now that we have the readout from ERADICATE, the opportunity is fully visible. It's derisked to a certain degree and hence, the scope of partnering discussions that we're having now broaden significantly.

Yes. And then on your pricing point, I mean what I would say is that recent -- again, recent antibiotic launches have been 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 5-day course necessarily. This complicated Staphylococcus aureus bacteremia is for quite a long period of time. So that if you want to think of it like that the value of the patient is quite a lot higher than, for example, for skin infection patients. But in terms of the final discussion around the pricing, I mean, that would be -- our partner would also have, obviously, clearly, it will be their responsibility in terms of the pricing. We can't dictate the price for the partners. So our partner, for example, Cresemba in the U.S., Astellas, who's doing a great job with Cresemba. We would -- a bit like one of our previous answers, 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, and that would be a key part of what they would do in terms of the prelaunch planning for the product in the U.S. I mean, obviously, there's no -- the other aspect is about for antibiotics is around sort of pull incentives and whilst 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. And that's another important factor to the worst. It's not in place today. It may well change to make the environment better for antibiotics in the future.

The next question comes from the line of Bob Pooler with ValuationLAB.

First of all, congratulation 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? It's U.S., sorry for that and [Indiscernible] that last one.

Yes. No. Thanks, Bob. I understand the question. Adesh, do you want to comment on that?

Yes. So we are certainly aiming at having a transaction done before the approval. So that's certainly what we are working towards. Never guarantee, but that's certainly the aim. Secondly, what are we aiming for? It is really driven by capabilities. As 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. And 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.

And just to build on that, and 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 suggested. So the large pharma down to smaller companies, but it's a whole spectrum of different companies on our list that we've already approached in the past. And 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 widen out with the good news that we've got the 2 Phase III studies, both positive.

Okay, clear. The Zevtera trials were done under a Special Protocol Assessments. So what are the implications of the SPA on the upcoming FDA review?

I think the main reasons to FDA is to get a bit more binding basis that the endpoints agreed and the study design agreed is not going to be a challenge, for example, in case of guidance changes. So we have -- I don't think we'll have a big discussion with FDA about the design elements of the study and whether the design are suitable to support an indication or a claim.

Because these are actually sort of pre-agreed endpoints that you had with the FDA?

It is like an agreement on key study design elements and that they are considered appropriate by FDA to support an NDA.

Okay. And then if I may, just on -- you had the strategy update yesterday on derazantinib, does that mean that the upcoming trial interim results and so, will they now be stopped? Can we take any news from that? Or is that now actually discontinued completely?

So from an operational perspective, the studies are ongoing. But as we announced yesterday, we will be returning the rights at -- to Merck. And as such, we are unlikely to actually make the announcements around the data, but the data will just as it is appropriate, can be published, I suppose, on the responsibility of Merck as the drug goes back to Merck. More from a perspective of -- from -- based on the decision that we have taken to determine [Indiscernible], it's not -- the data is not going to have any impact on that decision because that's how [indiscernible].

Yes. The decision has been made.

Yes.

Next question comes from the line of Harry Shrives with Edison Investment Research.

Marc, David, and Adesh, congratulations on your results, really nice to see. I want to start off by asking, can we get any extra detail on the sort of subgroup analysis that was involved in ERADICATE, in particular, for MSSA versus MRSA subgroups. And if you don't have any information you can't tell us when we expect that?

Well, we are preparing for presenting these data at one of the next major scientific conferences. And that's relevant subgroups, the one you mentioned, but also others, we had quite different underlying conditions for complicated Staph aureus bacteremia in this study, including patient osteomyelitis and septic arthritis and right-sided infective endocarditis, but also demographic variables that is going to be covered by coming publications and we plan to present at one of the next major conferences and also have a manuscript [ interpretation ].

Okay. And I suppose moving on from that, it sounds like that analysis could tell you quite a lot about possibly other indications. Would you be open to pursuing other indications with Zevtera?

Well, I think the one part is from the population that study -- that has been studied in the SAB study, whether there is an opportunity for including some of this information into the labeling, we currently have no plans to run another Phase III study for an entirely new indication.

Yes. So just to build on that, this goes back to the question about the differentiated sort of product position. And I alluded to the fact that some of it depends on the label. And Marc just pointed out that we wouldn't get another indication. It would be Staphylococcus aureus bacteremia. But Marc is saying, in the label, it might include right-sided impact of 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.

Okay. Finally, [indiscernible] announcing [indiscernible] update on the oncology assets and obviously, with Zevtera move in patient focus 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. But obviously, it's going to go through now the regulatory process. And if approved, we would have 10 years of exclusivity from the approval date. So just to point out that point, that if it's approved, say, second half of 2023, if we submit it at the end of -- around the end of the year, then we would have 2023 to 2033 of exclusive and that's market exclusivity independent of the patent situation. So 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. And then obviously, we have a tail in cases like China and Japan, which would go beyond 2027. And then we have a number of preclinical assets, antifungal and antibacterial assets. And then what we're focus is on now, and I alluded to this in my comments that we in-licensed a preclinical antifungal program earlier this year, what the focus now of the BD&L team is to add assets, antibacterial, antifungal assets to our clinical stage pipeline. So between our preclinical 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.

The next question comes from the line of Brian White with Calvine Partners.

I may have missed this, but I was just trying to what kind of exactly -- what the timing was and the submission for the pneumonia indication in the U.S.? And then secondly, you're thinking about what other geographies you can take the SAB and severe skin detection data to. And also just thinking about the partnering process. And I just wondered if the [ coming ] availability of Zevtera, either the U.S. complicates those partnering discussions in any way?

Yes. I'll clarify the first point, which is the -- just to be clear, Brian, and yes, the CABP, the community-acquired bacterial pneumonia, indication is not a separate NDA, yes. 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. So it's not a separate filing just in case that your question was unclear about that. So just it's one filing for SAB, for skin infections and for potentially CABP as well. Just to be clear, it's one NDA. So that answers that on the timing of that one. In terms of what are the geographies could we use the SAB data, for -- maybe Adesh do you want to take that?

The I would simply say that actually for both for SAB and for ABSSI, what we will do or what we already started doing is discuss with our existing partners and all the other jurisdictions about how to best leverage that data and 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. But that's really in close collaboration with our partners, existing partners. Then your second point was about whether there would be any complications through that with the -- well, for our partnering process. So the only sort of remaining territory is in the U.S. And from that perspective, that is a package that is complete in itself. So the other geographies are not really relevant in the context of the discussions that we are having with regard to the U.S. So it's not going to quite matter.

Okay. And I guess what I meant, Adesh, was really from the perspective of a partner not being able to globalize. Are you suggesting the availability of U.S. right, 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., so not necessarily, but they have a segregated or they have a dedicated U.S. infrastructure, I think that's one point. Secondly, I think these kind of geographical transactions happen all the time and the U.S. represents almost like 80% give or take of the global potential. So in itself, the U.S. is -- has critical mass and is from the commercial perspective highly interesting, also given the exclusivity period. So to some degree, I would even say it probably makes it easier to be discussing only about the U.S.

The next question comes from the line of Eric Hughes with [indiscernible].

Congrats on [indiscernible]. First question is [ what you showed was ] detail about the royalty income growth in 2022, what we [indiscernible] and what's going to drive in quarter 2 and quarter 3? The second question would be any update around reimbursement pricing in China and [ what's your market access plan Zevtera in Japan? ]

Yes. actually, Eric, thanks for the question. It was a bit difficult to hear. There was a bit of background noise, but I think -- so I think the royalty income, what drove the royalty income in last year, maybe Adesh?

The way I understood it was for [ royalty growth in 2022 ] a, we have, just as a reminder. So in our case, actually, there are two different streams actually of revenues. So 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 productive. It's a distribution setup that we have. So we'll be reporting the growth in those territories from product there. So looking at royalty growth alone doesn't give the full picture. But maybe to answer then your question about 2022, we guided for a double-digit -- as a continued double-digit royalty growth in 2022, driven by, a, continued growth in the existing markets, including the U.S., for instance, and EU with new -- 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. So significant growth of additional markets, so to say. Thirdly, specifically, I think I heard word of 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. So for 2022, the direct contribution from in-market sales and associated royalties will be probably more limited. So that's not going to 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. But the biggest -- 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. So 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 in the national reimbursement list, which we can't really indicate when exactly that may be happening. But where actually our partner, Pfizer, is very well managing the process and has the experience of managing the process, so 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. And just one more question about Japan. Is there any update on the market access from your partners?

So with regard to Japan, if the drug is not approved yet, there is no really update on market access. So it's under regulatory review in Japan.

The next question comes from the line of Arsene Guekam with Kepler Cheuvreux.

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 first line during blood inflection. And the second one is more relative 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 about the first-line usage question. So in terms of -- do we want to be involved in the marketing, I mean, I think, saying what we all our plans, 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 worked with them all on trying to spread best practice around the different parts. If we see good strategies, good position, 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 that territory. So we can influence, but it's not -- and 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. 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 now experience with ceftobiprole. So any partner we finally do a deal with for the U.S., I'm sure they would take our input. But 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 the -- your first question around the sort of lines, limitations or restrictions that would cause it not being used first line or second line, maybe Marc -- was the question in relation to bacteremia or just generally?

No, no. Generally, generally.

Well, it depends on the antibiotic stewardship concepts of trial, which are sometimes country wise sometimes local. In general, the study is done with ceftobiprole baseline studies on a [ daily ] treatment. We haven't really targeted specifically a group of multi-resistant pathogens. This is -- all the studies we have done in SAB and ABSSI and in pneumonia, where produce study. So we would expect that the -- it will also reflect the utilization in the U.S. and in other countries. But whether there are, in certain areas, specific rules on how to use certain antibiotics based on their andibiotic stewardship programs, that's hard to predict. But from a study evidence, this is more a compound for [indiscernible].

Yes. So 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 -- when a patient comes into the hospital and they need Gram-positive, gram-negative coverage there's 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 [ bactomycin ], which sort of peaked around $1 billion of peak year sales in the U.S., that was less first line and more the first branded line when you actually suspected Gram-positive MRSA involvement. So actually, in this marketplace, it's quite unusual in terms of you can get a relatively small share of empiric use upfront or second line, and it can be a very, very big product just based on the volumes of usage. So it's quite unusual in that respect in terms of a market.

[Operator Instructions] And we have a follow-up question from Mr. Ram Selvaraju.

You've said that the sales and marketing infrastructure will be the responsibility of the partners. Just wondering if you have any idea of what the sales and marketing infrastructure could look like? And how you think it would be commercialized in the U.S.?

Yes. I mean, alluded to previous answers that we've given, I mean, we obviously -- and Adesh touched on this, we actually believe that 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 -- my answer to the fact -- the previous answer was that it's ultimately the responsibility to partner to market and develop the medical affairs strategy for the compound for the U.S. But clearly, we've had a number of years of experience, as I mentioned, so we have an alliance management group to work closely to provide our insights from the markets that we've got data on that we've launched. We launched in around almost 20 markets around the globe. So we've got quite a lot of building experience on ceftobiprole. And so 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 our partner, once we've got a partner in place. So yes, that we would certainly input and provide it, 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. But Adesh or Marc, would you add anything else?

No. So its really -- since it is hospitals, so covering, in essence, the broadest possible range of relevant hospitals in the U.S.

There are no more questions at this time.

Okay. On behalf of all of us at Basilea, thank you for your interest, and thanks for joining the call. Have a good rest of the day.

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