Ladies and gentlemen, welcome to the Basilea Pharmaceutica half-year results 2022 conference call and live webcast. I am Sandra, the conference 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 very much. I'd like to welcome you all to our conference call and webcast, reviewing our financial results and key achievements for our half year 2022. We will also outline the progress we've made in the implementation of our strategy to become a leading global anti-infectives company and highlight the upcoming milestones. For further detailed information, please see the ad hoc announcement issued this morning and also our half year report 2022. These documents are both available on our website at basilea.com. I would like to mention that this call contains forward-looking statements. Joining me on our call today are Adesh Kaul, our Chief Financial Officer, and Dr. Marc Engelhardt, our Chief Medical Officer.
Before Adesh Kaul goes into the details of the financials and Marc Engelhardt will report on the progress and the implementation of our anti-infective strategy, I would like to just start with a brief summary of our key achievements year-to-date in 2022. This morning, we reported strong financial results for the half year 2022, with a 22.5% year-on-year increase in royalty income, which is most directly linked to the commercial success of Cresemba in the key regions. We also reported continued improvement of our operating cash flow, resulting in a solid cash position of CHF 142 million. We confirmed our financial guidance for the full year and reiterate our expectation to reach sustainable profitability from 2023. The foundation for these strong financial results are Cresemba revenues, which continue to develop favorably.
On a global scale, $344 million have been reported as in-market sales for the 12- months ending March 2022. This is a 31% increase compared to the previous 12- months. In June, we also released positive top-line results from the phase III ERADICATE study with our antibiotic, ceftobiprole. This significant data now paves the way for an NDA submission and potential marketed approval in the U.S. Thus, ceftobiprole is on track to become our second important commercial brand. In addition, we've also complemented our early-stage anti-infective pipeline by in-licensing a novel first-in-class antifungal program for which we are currently completing a preclinical profiling. Accessing new markets is an important factor for the continued long-term growth of our Cresemba business.
Therefore, we're very pleased that Cresemba has been launched recently in China, which we estimate represents about 20% of the global market for the best-in-class antifungals. We have successfully proven our expertise in advancing anti-infectives through research and development to the market. We have a portfolio of early-stage anti-infectives and plan to selectively further expand our pipeline in our aim to become a global leader in anti-infectives company. There is also significant long-term potential for our two commercialized brands. In addition to continuing significant growth from launched markets, we have additional very important future markets such as Japan for Cresemba and the U.S. for Zevtera, which have yet to be accessed. The U.S. is by far the most important market for the commercialization of branded hospital antibiotics and is estimated to account for up to 90% of global cash sales for anti-MRSA treatments.
This can be shown by daptomycin or ceftaroline. This is why one of our key priorities is to gain access to the U.S. market for ceftobiprole. I'll now hand over to Adesh.
Thank you, David. I will highlight some of the key financial figures that were published today. I would like to mention that all figures I refer to are in Swiss francs. With the increasing underlying demand for our commercialized brands, product revenue, reflecting our product sales to our partners, has increased by 43.1% compared to the first half of 2021. Contract revenue decreased by 5.9% year-on-year, solely due to higher milestone payments in the first half of 2021, which could not be fully offset by the 22.5% increase in royalty income year-on-year. Other revenue components amounted to CHF 7.5 million. They mainly comprise BARDA reimbursements, which are offsetting a substantial portion of the ceftobiprole phase III development expenses. Considering all these elements, total revenue increased by 8.2% to CHF 58.6 million.
We continue to diligently manage our costs and expenses. Cost of products sold increased to CHF 14.9 million, reflecting the higher product sales to our partners. SG&A expenses and R&D expenses amounted to CHF 15.6 million and CHF 37.1 million, respectively. We reported a significantly improved operating result with an operating loss of CHF 9 million for the first half year compared to CHF 15.4 million in the same period last year. Correspondingly, our net loss was reduced by 38.6% to CHF 12.2 million from CHF 19.9 million in the previous year. Net cash from operating activities continued to improve in line with the long-term underlying trend, as we will see in a moment.
As of June 30, 2022, our combined cash, restricted cash and investment amounted to CHF 141.9 million, compared to CHF 150 million at the end of 2021. The consistent long-term growth trend of Cresemba royalty income is most clearly seen when one looks separately at royalty income in the first half year and in the second half year periods. Due to the tiered nature of our royalty structure in our agreement with Astellas, the weighted average royalty rate tends to be higher in the second half of a given year compared to the first half. The increase in revenue contributions from our marketed drugs has significantly contributed to the consistent improvement of our net cash used for operating activities over the past years. We expect the positive trend to continue and to report positive cash flow from operating activities from 2023.
We confirm our guidance for 2022. We expect continued strong in-market sales growth of our key brand, Cresemba. Cresemba and ceftobiprole related revenue is expected to amount to CHF 98 million-CHF 104 million. The decrease versus 2021 is solely due to fewer milestone events expected in 2022, thus bringing the milestone payments closer to the level seen in previous years. R&D and SG&A expenses are expected to decrease to approximately CHF 110 million, mainly due to lower anticipated costs related to the ceftobiprole phase III program, which is nearing completion. This results in an expected operating loss of CHF 20 million-CHF 25 million in 2022. Net cash used in operating activities is expected to improve further year-on-year from CHF 32 million to CHF 10 million-CHF 15 million on the back of a strong top line performance and the anticipated decrease in operating expenses.
We also confirm that for 2023, we expect continued growth of Cresemba and ceftobiprole-related revenue and a reduction of around 30% in operating expenses versus 2022, mainly due to the fact that we do not expect to incur any material expenses related to oncology activities beyond 2022. This would result in us reaching sustainable profitability and generating positive cash flow from operating activities from 2023. Our strong cash position, combined with the positive financial prospects going forward, put us in a good position for the implementation of our growth strategy, including the in-licensing of anti-infective assets and for managing our maturing convertible bond. Our focus here is on reducing our overall debt level and on minimizing potential dilution. We therefore do not intend to make use of the CHF 2 million conditional capital approved by our shareholders at the annual general meeting in 2022.
I will now hand over to Marc for the development update.
Thank you, Adesh. As mentioned by David, the most important news for the implementation of our anti-infective strategy was the top-line results from the phase III ERADICATE study with our antibiotic, ceftobiprole. Let me start with ceftobiprole. Our regulatory strategy for accessing the U.S. market is to seek approval for acute bacterial skin and skin structure infections, or ABSSSI, and for Staphylococcus aureus bacteremia, or SAB, 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 previously that formed the basis for the approval of this indication in Europe. ceftobiprole has qualified infectious disease product or QIDP designation in the U.S. for ABSSSI, SAB, and CABP.
Therefore, it will benefit from a priority review of the NDA, which means we expect a regulatory decision eight months after the submission of the NDA. Also, due to the QIDP.
Ladies and gentlemen, please hold the line.
That the recent ceftobiprole program, including TARGET and ERADICATE, has been funded for approximately 70% of the total program cost by BARDA. The TARGET study in ABSSSI was a randomized, double-blind, phase III non-inferiority study and enrolled 679 patients. It 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 endpoint of early clinical response at 48-72 hours after the 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% with ceftobiprole versus 88% for the comparator, and the lower bound of the 95% confidence interval for the difference between ceftobiprole and the comparator was within the pre-specified non-inferiority margin of 10%. SAB is an area of high medical need with about 120,000 infections per year in the U.S. alone, with high morbidity and a 30-day mortality of approximately 20%. The ERADICATE study targets 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 relevance of SAB and the high medical need in this area has been recently highlighted in a large contemporary study from Canada, showing that SAB is associated with the highest disease burden and with significant attributable mortality among bloodstream infections. ERADICATE was a phase III 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 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 70 days after randomization.
In the ERADICATE study, the primary 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. The lower bound of this confidence interval is clearly within the 15% non-inferiority margin, confirming that the primary objective of the study was met. Secondary efficacy endpoints, such as all-cause mortality, microbiological eradication, or the development of SAB-related complications, were consistent with the primary study outcome.
Based on its pharmacology, the antibacterial spectrum, the data from several phase III studies, and the post-marketing experience, we consider ceftobiprole an excellent treatment options in difficult to treat patients presenting to the hospital with severe infections, especially when the clinician suspects involvement of gram-positive pathogens, including Staphylococcus aureus. For these patients, ceftobiprole provides a single agent, first-line bactericidal broad-spectrum therapy with proven efficacy in SAB, ABSSSI, and CABP, enabling to treat these vulnerable patients effectively early in their disease in order to increase the chances of recovery. Ceftobiprole is differentiated versus competitors in various clinically important aspects, including the strong bactericidal activity against MSSA and MRSA, a robust gram-negative coverage, efficacy demonstrated in pulmonary infections in phase III studies, the renal safety profile, and the low propensity for resistance development. I will now turn over to David.
Thank you, Marc. We've already achieved a number of significant milestones in the first half of 2022. Going forward, we are working towards the submission of the ceftobiprole U.S. NDA around year-end. We're also looking forward to the regulatory decision on the Cresemba marketing authorization for Japan, expected later this year. By the year-end, we expect Cresemba to be launched in approximately 70 countries. In parallel, we are seeking to complete transactions on our oncology assets. This will then allow us to fully focus on anti-infectives from 2023. In summary, we are on an excellent path towards our goal of becoming a leading global anti-infectives company, supported by increasing product sales and significant potential ahead. The progress in our pre-clinical anti-infective compounds and our efforts to in-license additional anti-infective compounds also form an important part of our future strategy.
Thank you for your attention, and we'll now open the line to your questions.
We will now begin the question and answer session. Anyone who wishes to ask a question may press star and one on the touchtone telephone. You will hear a tone to confirm that you have entered a queue. If you wish to remove yourself from the question queue, you may press star and two. Participants are requested to use only hands-free while asking a question. Only three questions may be asked in a row, then you will open up the line for others. You can get back in the line again for any follow-up questions. Anyone with a question may press star and one at this time. The first question comes from Brian White from Calvine Partners. Please go ahead.
Yes. Thanks for taking my question. I've got a couple of questions. First one really is about the sustainable profitability from 2020 onwards, and that's always a very impressive attainment. Is this the ultimate goal for the company financially? Or would you consider increasing R&D substantially if you could find the right asset as you try and become a global leading anti-infectives business? Then secondly, just thinking about that leading role again in anti-infectives and obviously the investing testing and partnering products so far, but would you think about taking on, for example, a rare disease anti-infective asset where a more limited investment in sales and marketing would be sufficient for you to attain more of the margin than you would in partnering these programs? Thank you.
Yeah. Thanks, Brian, for your questions. I mean, Adesh, do you want to take the first one around the sustainable profitability?
Yep, sure. Hi, Brian. Thanks for your question.
Thank you.
Net, we don't think that it's either/or. We think we can achieve both. Actually on one hand, we expect to be sustainably profitable really based on the continued commercial success of Cresemba and the potential contributions from Zevtera, if approved in the U.S., and have actually the ability to make the investments in the pipeline that we need to do in order to ensure long-term growth. Both parts actually of your question will remain part of the overall strategy.
Right.
Then on the second one, what I take that in terms of, you know, would we focus on sort of rare diseases where we would need a limited direct sales force effort. I think it's fair to say that our strategy is around focusing on the treatment of serious hospital infections in areas of sort of higher unmet medical need. We would allocate the resources and the structures necessary for those assets rather than be driven by necessarily the size of a commercial structure being the driver for that decision-making process. It will be more.
Sure.
We would focus more on the unmet medical need and then resourcing appropriately. Obviously, that doesn't mean necessarily we'll do it ourselves or I'm just saying in terms of we're not driven by the size of the sales force that would be needed and therefore we need a small sales force to go after a small opportunity. That's not how we think about it. We start with the unmet medical need and then understanding how we would resource that appropriately.
Got it. Okay, thanks. Thanks for that.
Thank you.
The next question comes from Simon Goodwin from Edison Investment Research. Please go ahead.
Hi, David Veitch. Hi, Adesh Kaul. Hi, Marc Engelhardt. Congratulations on the results. Really seems like things are falling into place for the new strategy. Could you update us on a key lever we see that's Cresemba's uptake in China and maybe its potential inclusion on the NRDL, and comment on how the NDA preparations for Zevtera in the U.S. are coming along? Thanks.
Yeah. In terms of the China question, Adesh, you wanna take that, and Marc on the NDA?
Yeah. For China, what we can say is that, actually the oral formulation, which was a little bit earlier approved than the intravenous formulation, as you know, Harry, has been launched. There are first sales coming out of China. The process around inclusion in the national reimbursement list are managed by Pfizer in essence, and in any event take some time to fall into place. From that perspective, the next milestone is now really the focus is on getting into Chinese market. This is happening right now. With the oral formulation, we're looking forward to the launch of the IV formulation in the coming months.
In parallel, Pfizer is sort of working through the process of taking the appropriate steps for the inclusion in the national reimbursement list where and how appropriate. This will be evolving over time, but we are already seeing the impact.
In terms of the NDA submission and the progress there, Mark, do you wanna comment on that?
As said, our goal is to submit the NDA around year-end 2022. There will be three studies that we intend to include into the NDA. It's the TARGET study in ABSSSI, ERADICATE and SAB. These two studies were discussed with the FDA, and we've obtained a Special Protocol Assessment. The third study is a study that was the basis for the CABP approval in Europe. We will have another discussion with the FDA in the context of a pre-NDA meeting, and this will confirm the path we're going ahead with three studies with the objective to obtain three indications, so SAB, ABSSSI and CABP, and UMP.
Okay, thank you very much. A couple more quick questions. On the cost side, the decrease in R&D spend we've seen this half, it was anticipated, but I wanted to get a little bit more granularity on the split between whether that's due to sort of the winding down of the oncology activities or whether sort of the wrap-up of ERADICATE is feeding into that as well.
Actually, as of now, through 2022, we have not included any, or we are not assuming any winding down costs related to the oncology assets. What you're seeing is, on the one hand, natural fluctuation anyway on an annual basis or on a half-yearly basis, depending on how progress is being made in recruitment in the individual studies. Also bearing in mind that certain studies have indeed reached their end of recruitment. For instance, the FIDES-01 study of their derazantinib had sort of completed recruitment. You mentioned ERADICATE. It's a combination of factors in essence. The actual effect of really focusing on anti-infectives from an R&D perspective will then be seen in 2023.
Our guidance for a decrease in operating expenses of 30% in 2023 then factors in, to a large degree, the effect of us exiting the oncology space.
Okay, thank you very much. One final question. I realize you can't speak directly to discussions around the oncology transaction, but could you give us some context such as sort of the number of discussions or the overall interests or trends you've seen from triggering these out?
Yeah. Maybe I'll refer back to what we announced in June, or let me take a step back. We have started right away by the way, when we make the announcement in February this year, a very broad partnering process, and we're open to explore all kind of different avenues. In June, we provided an update, and as a result of that process, which was really broad, we on the one hand decided to return the rights to derazantinib to Merck, and at the same time related to lisavanbulin, basically not expand the ongoing studies, but to continue to explore partnering opportunities.
For the other three assets, which are BAL0891 and two preclinical assets that we have not disclosed in detail, we are in contract negotiations with potential partners with the goal still to complete those transactions in the second half of 2022. That's in essence where we stand currently, and we continue to believe that our aim remains to have taken all the decisions by the end of the year, so that in 2023, we would not be incurring any material costs related to the oncology activities anymore and would be focusing almost exclusively actually on the anti-infectives activities.
Great. Thank you very much, and congratulations again.
Thank you.
The next question comes from Bob Pooler from valuationLAB. Please go ahead.
Good afternoon, gentlemen. Congratulations also another strong first half. Just on Cresemba, that's the strong, yeah, product with the underlying growth there. You mentioned that you're eligible for more than CHF 1 billion in potential milestones that are remaining. What kind of peak sales does Cresemba need to reach to capture all these remaining milestones?
Okay. Thank you, Bob, for your question. Maybe also as a reminder, the structure of having CHF 1 billion or more than CHF 1 billion in milestones from the partnerships is across all our partnerships. This includes the Zevtera partnerships that we have, the Cresemba partnerships in all the different regions. As you pointed out, it actually depends on the performance in each of those regions. There's not like a single number where we'd say like, "This will trigger the amount X." It's almost like the performance across all partnerships.
What we can say currently is that I think we are very pleased with the performance of Cresemba in all the markets, or all the regions where it has been launched, and we are on a good track to keep on recognizing milestones as we have been doing regularly over the past years. It's almost like every year through some of the agreements that we have, we have recognized some milestones, and we expect this to continue as we move forward.
Any areas or peak sales that you expect the drug maybe to reach? Maybe give a ballpark number.
Yeah. Yeah. Bob, it's David here. Obviously, we don't give guidance on peak year sales, but what we do actually say is that, you know, if you look at analysts' forecasts for Cresemba, it's anything from peak year sales from sort of $550 million -$850 million. Voriconazole, which is you could argue is the key competitor that we've been taking share from, that peaked at about $900 million. That's the sort of range. And, and, you know, already as you heard from what we said a moment ago, you know, sort of halfway through its life in the U.S. and in Europe, it's already at $344 million, so it's on a nice trajectory in the markets it's launched in. We've got major markets still to even.
You know, China's just starting. Japan, we hope to get an approval at the year-end. There's still even in the U.S. the most, you could argue, the most mature market, it's still double-digit growth. This product's got a lot of potential. It's on a good track. Where it ends up it's difficult to exactly forecast or for us to predict, but obviously linked to your previous question, and then the milestones obviously are get bigger as you get towards the top end of that range than the lower end of that range. We're very happy with the track we're on, and that's all I can say in terms of, you know, the range of forecasts that it probably could end up.
Okay. Thank you. I agree that it's growing very steadily and very consequently also over time. On Zevtera, when do you expect to present more detailed results of the positive ERADICATE trial?
We intend to publish data from ERADICATE at one of the next major infectious diseases conferences, and the earliest possible would be IDWeek, which takes place in Washington on 19th-23rd of October 2021. It depends on the-
2022.
2022, sorry. It depends on the acceptance of the submitted abstract, but IDWeek would be the earliest.
Okay. Just a final question on the CABP, third indication for Zevtera in the U.S., The line wasn't very clear. Have you had talks with the FDA or are you planning a pre-NDA meeting with the FDA on this third indication?
We had interactions with the FDA last year, where we raised that topic. Based on that interaction, we decided to include the CABP study into the NDA, and we look forward for a pre-NDA meeting later this year, and we'll see whether, you know, that strategy is maintained.
Okay. Thanks for answering the questions and congrats again.
Thank you.
Thank you.
The next question comes from Louise Chen from Cantor Fitzgerald. Please go ahead.
Hi, this is Wayne on for Louise. Thanks for taking our questions and congrats on the progress this quarter. Just a couple from us. First one is what's your latest thinking on potential partner in the U.S. for ceftobiprole, and what type of partner would this be ideal? Maybe if you could share with us any thoughts you might have on the U.S. pricing environment for anti-infectives. Thank you.
Yeah. Thanks for the question. In terms of the partner, I mean, essentially the antibiotic market, we believe is a promotionally sensitive market. I think there's lots of evidence to support that statement. Actually we're looking for a partner that has got the presence, the sort of commercial presence, the medical affairs support presence to actually cover the major hospitals that this product would be used in. For us, it's not. We're going broad in terms of discussions with a variety of partners from larger companies to more medium-sized companies.
At the end of the day, the key requisite for us is that they need to have the structure in place to be able to promote successfully our product, because, you know, and preferably with a track record of success of launching it and commercializing antibiotics in the U.S. That's a little bit about the partner that we're looking for.
Maybe related to pricing, really in the recent if you look at the recent launches, the antibiotic pricing has been in the range of $250 to about $1,200 per day. That seems to be the generally accepted range for hospital antibiotics, a little bit depending of course on the market you're targeting and the pathogens, the coverage. Generally that's the range. Probably even more important than thinking about the range in general is also thinking about the business environment and the whole question about what kind of pull incentives may be introduced in the U.S. in the medium term, so to say, and whether there are opportunities to benefit from that as well.
That will probably have a more of an impact than the actual pricing, which is within this, I would say, generally accepted range of CHF 250 on the really low end to up to CHF 1200 per day on the high end.
Got it. Thank you so much and congrats on the progress again. Thank you.
Thank you.
Thanks.
As a reminder, if you wish to register for a question, please press star and one. The next question comes from Raghuram Selvaraju from H.C. Wainwright. Please go ahead.
Hi. Thanks very much for taking my questions. I have three. Firstly, I was wondering if you could provide us with a little bit more granularity regarding the sustainable profitability that you believe you could report in 2023. Are you talking about sustainable profitability on a full year basis or to reach sustainable profitability before the end of the year? Do you expect the timeline to effectively be more on the second half of the year versus the first half? The second question is with respect to the development and regulatory pathway for ceftobiprole in CABP, if you could provide us with some clarity on that along with the expected timeline. Then lastly, this is in somewhat reference to earlier questions.
I was wondering if you could give us a sense of how you see the legislative and regulatory landscape evolving for anti-infective drugs, particularly in the U.S. market, within the context of all of these multi-drug resistant infections and pathogens? Whether or not that might also play a role in your decision-making process when it comes to thinking about allocating capital to doing further development work in this arena, possibly even with novel agents that are not currently part of your pipeline? Thank you.
Okay. Thank you, Ram, for those questions. Adesh, why don't you take the profitability question again?
Here I would simply say that we expect to report on a full year basis to be profitable and to have positive cash flow. When exactly on which month and so on, I think that's a little bit difficult to predict, but on a full year reported basis, we would be profitable and c ash flow positive.
In terms of the development regulatory pathway for the CABP indication, Marc, just-.
Yeah.
Do you want to comment a bit more on that?
Yes. The initial program that was done under a Special Protocol Assessment obtained with FDA back in 2017 included the TARGET and the ERADICATE studies, so ABSSSI and SAB. The CABP study was performed earlier, and as mentioned, formed the basis for the approval of this indication in Europe. We are planning to submit all three studies together in the initial NDA or in this one NDA that we intend to submit around year-end. That's not gonna be a sequential submission. If we get positive signals in the pre-NDA meeting to proceed with the CABP study, we will include this into the NDA that we intend to be submitting around the end. Does that answer your question?
It's an integrated approach, in other words.
The study will be integrated into the NDA. I think from-.
It's not a separate submission.
It's not a separate submission. From an efficacy perspective, these are three different indication, but the CABP study, for example, would also be included in the safety pooling in the ISS.
Great.
That's good, Ram, moving on to your third question, which is, I'll try and make this succinct. The legislative and regulatory landscape in relation to antibiotics. I mean, that's a, in terms of, you know, what we believe is that and you said particularly as it relates to the U.S., To answer your question, we believe that, you know, clearly, if you look at analyst reports, if you look at independent and other types of reports, you see that the peak year forecast for ceftobiprole is anything from CHF 350 million-CHF 550 million. That gives you an order of magnitude from those sources.
That's independent of any sort of pull incentive being put in place because as you know, as we sit here today, there's no clear pull incentive for antibiotics in the U.S., but there's a lot of discussion around PASTEUR, DISARM, about making more meaningful pull incentives for antibiotic developers. We don't know exactly how those will end up in terms of materializing, but we do believe that the environment is such that it's a matter of time rather than if it will happen. I mean, other countries like U.K., Sweden, there are pull incentive pilots in place for antibiotic developers. We just think it's a matter of time.
Obviously, if these pull incentives do appear in the foreseeable future, then actually I think that will only particularly with the types of pathogens that ceftobiprole plays into, I think it could potentially help ceftobiprole on top of what the forecasts are already. Then in terms of, your question is very valid, and I think you touched on this at the end in terms of, you know, novel antibiotics in development and that would clearly have an impact in what we're looking at in terms of licensing in. If we think that these pull incentives are in place and, we're looking at assets then that could potentially comply within the rules of these pull incentives, that makes them, I think, only more attractive. Clearly that's going to be.
As we get more color on when and exactly what these incentives will look like, then that will impact on our BD&L activity as well as our own internal activity. If that sort of answers your question as succinctly as I can really.
Yes. No, very helpful. Thank you.
Gentlemen, so far there are no more questions from the phone.
Okay. If there are no more questions, thank you very much for your interest and enjoy the rest of your day. Thank you.
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