Ladies and gentlemen, welcome to the Basilea Pharmaceutica Half-Year Results 2024 conference call and live webcast. I am Sandra, the conference call operator. I would like to remind you that all participants are 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, and hello, everyone. I would like to welcome you to our conference call and webcast, reviewing our financial results and key achievements for the H1 year, 2024, as well as highlight our upcoming key milestones. For further detailed information, please see the ad hoc announcement issued this morning and also our half-year report. These documents are both available on our website at basilea.com. I'd also 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. I would like to start with our key achievements since the beginning of the year. Starting with our most important commercial product, Cresemba, our antifungal for invasive mold infections.
Cresemba continues to perform very well, as demonstrated by the 24% increase of global in-market sales, according to the latest available data for the 12-month period to March 2024. This continued strong performance translates into a 16.6% year-on-year growth in Cresemba royalty income for Basilea. We also report a strong financial performance for the first six months of 2024, with CHF 73.3 million revenue from Cresemba and Zevtera, our two commercial products. We remain profitable and report a positive operating result of CHF 9.3 million for the period, during which we used our free cash flow to further reduce our debt level. Earlier this year, the FDA approved Zevtera in the U.S. for a broad range of indications, and we have been working towards securing a partnership for the commercialization of Zevtera in the U.S.
We are currently in negotiations with a number of potential partners. For Cresemba, we received a positive opinion by the European Medicines Agency's Committee for Medicinal Products for Human Use, or CHMP, recommending the approval of Cresemba in Europe for pediatric patients. We expect the European Commission's formal decision still in the Q3. Through this, Cresemba would gain two additional years of market exclusivity in Europe until October 2027. We also added to our portfolio in the H1 of the year. We acquired a preclinical-stage antibiotic program from a novel class, the LptA inhibitors, which target gram-negative bacteria, also securing CARB-X non-dilutive funding for the initial preclinical activities for this program.
In a final step of our refocused strategy to anti-infectives, we have also successfully partnered our last remaining oncology asset, Lisavanbulin, with the Glioblastoma Foundation, hence making sure that patients continue to have access to this promising anti-cancer drug candidate. When we now look at our portfolio, we can see that we have significantly expanded our anti-infective pipeline since October 2023, with four separate transactions. With our pipeline, we are positioning ourselves as a leading anti-infectives company, advancing anti-infective drugs from research through clinical development to commercial success. I will now hand over to Adesh.
Thank you, David. I would like to start first with an update on the commercial performance of Cresemba, a key driver of our strong set of financials. I will then highlight some of the key financial figures that we published today. I'd like to mention that all figures I refer to are in Swiss francs, unless specifically stated otherwise. Cresemba in-market sales in the twelve-month period to end of March 2024 amounted to $489 million, which is a 24% increase year-on-year, and we see continued significant growth potential for the brand going forward. Cresemba continues to grow in established markets, and we are seeing increasing contributions from China and Japan, where Cresemba was launched more recently. These two countries alone represent approximately 25% of the global market opportunity for Cresemba.
Earlier this year, we obtained the approval of Zevtera in the U.S. for Staphylococcus aureus bacteremia, acute bacterial skin and skin structure infections, and community-acquired bacterial pneumonia. The approval was based on successfully completed phase III studies. The SAB and ABSSI studies were supported by and received significant funding from BARDA. Zevtera has 10 years of market exclusivity in the U.S. In line with our business model, we plan to commercialize Zevtera in the U.S. through a partner. We have been working towards securing a partnership for the commercialization of Zevtera in the U.S. and are in negotiations with a number of potential partners. The commercial success of Cresemba is reflected in our strong financial results for the H1 year, 2024. Cresemba and Zevtera-related revenue amounted to CHF 73.3 million....
The 16.6% year-on-year increase in royalty income to CHF 42.8 million directly reflects the continued healthy growth of Cresemba in market sales. This year, most milestone events are expected in the H2 of the year. Therefore, milestone payments amounted to only CHF 2.9 million in the reporting period, which is the key reason why revenues have been lower in the H1 of 2024 than in the H1 of 2023. As you will see in a moment, when we come to our increased financial guidance for 2024, we expect on a full year 2024 basis to report overall higher milestone payments as compared to 2023. Cost of products sold increased to CHF 18.1 million, reflecting the significant increase in product revenue. Operating expenses amounted to CHF 48.9 million.
Overall, this resulted in an operating result of CHF 9.3 million. Based on our sustained profitability and positive midterm financial outlook, we recognize deferred tax assets of CHF 13.4 million, which contributed to a net profit of CHF 20.7 million. In addition, we further reduced our debt from our positive cash flow, resulting in a net debt reduction to CHF 26.2 million as of June 30, 2024. Considering that 2023 has been a transition year in which we only started to expand our portfolio in the H2 of the year, it is helpful to look at the trend in our costs, expenses, and profitability over several reporting periods. The general trend of growing cost of products sold reflects our increase in product sales to our partners.
SG&A expenses are fairly stable, and R&D expenses have some volatility based on transactions and progress in the R&D pipeline, but overall remain stable. Both operating and net results show an upwards trend as a result of our strongly growing revenues. Cash flows from operating activities have further increased, and at CHF 17.9 million in the H1 year 2024, already exceed the CHF 14.2 million for the full year 2023. Besides investing into the expansion and progression of our pipeline, we have used the cash flows from our commercial business to strengthen our balance sheet. Since January 2022, we have significantly reduced our debt by CHF 124 million in a completely non-dilutive way, so that our only remaining debt are our CHF 97 million convertible bonds, which will mature in mid-2027.
Based on our performance in the H1 of 2024 and the overall strong sales growth trajectory for Cresemba, we increase our guidance for the full year 2024. Compared to full year 2023, we now expect a 26% increase in Cresemba and Zevtera-related revenue to approximately CHF 190 million. Total revenue is expected to increase by 24% year-on-year to approximately CHF 196 million. As a result of increasing product sales, cost of products sold is expected to increase to approximately CHF 40 million, and operating expenses are expected to be around CHF 120 million. We expect an 88% increase in the operating result to approximately CHF 36 million, and a 300% increase in net profit to approximately CHF 42 million.
The disproportionate increase in net profit versus operating profit is partially related to the recognition of deferred tax assets. Our healthy financial situation allows us to progress our expanded R&D pipeline to support the long-term growth of Basilea. I would like to provide a little bit more granularity on the Cresemba and Zevtera-related revenue in order to give you more context for our financial guidance. We expect to see continued growth in royalty income and product sales in the H2 of 2024. It is important to point out, though, that we expect a sharp increase in milestone payments in the H2 of 2024 as compared to the H1 of 2024. On a full year basis, we expect milestone payments to increase by approximately 25% versus 2023.
As a result of the robust growth trajectory driven by Cresemba, we assume that total Cresemba and Zevtera-related revenue will grow 26% year-on-year. I will now hand over to Marc for the portfolio update.
Thank you, Adesh. As already mentioned, we have significantly expanded our portfolio by adding 4 new programs since October 2023. The most advanced clinical asset is Fosmanogepix. Fosmanogepix is a novel broad-spectrum antifungal that is targeting the treatment of invasive yeast and mold infections. With its potent broad-spectrum antifungal activity and its excellent tissue penetration, including the eye and central nervous system, Fosmanogepix addresses urgent unmet medical needs and has the potential to become our next lead commercial product and value driver in the midterm. Fosmanogepix is differentiated against existing antifungals and other novel compounds in development. If we can successfully develop it, it could have an important place in the therapy of fungal infections. Fosmanogepix is the product of the active compound manogepix.
Manogepix inhibits the GPI-anchored wall transfer protein 1, or Gwt1, which is responsible for keeping important fungal surface protein, such as cell wall mannoproteins, attached to the fungal cell membrane. By interfering with the anchoring of these cell wall proteins, manogepix causes multiple and unique effects that lead to fungal cell disintegration and death. The spectrum of fosmanogepix includes multi-drug-resistant fungal species, essentially covering all fungi that the WHO has included in their list of critical priority pathogens. The urgent and unmet medical need for developing new treatment options for patients infected with these pathogens is evident when looking at the high mortality rates that had remained at 25%-40% or higher over the last decade in these yeast and mold infections.
The FDA has acknowledged fosmanogepix's potent broad-spectrum activity and granted it fast track and orphan drug designations for seven separate indications, including invasive candidiasis, invasive aspergillosis, scedosporiosis, phaeohyphomycosis, mucormycosis, cryptococcosis, and coccidioidomycosis. In addition, it has received QIDP designations. Because fosmanogepix is available IV and oral with high oral bioavailability, it can be used in both inpatient and outpatient settings. It also has a favorable drug-drug interaction profile with lower cytochrome P450 inhibition and may be synergistic with amphotericin B and echinocandins, which provides additional options in difficult-to-treat patients. Fosmanogepix is ready for the start of the first phase III study in the coming weeks, a double-blind, non-inferiority study in candidemia invasive candidiasis. This study will include approximately 450 patients randomized to initial intravenous therapy with fosmanogepix or caspofungin.
The study includes an oral step-down option to fosmanogepix in the fosmanogepix group and to fluconazole in the caspofungin group. The primary endpoint for the FDA is 30-day survival, and for the EMA, is overall response at the end of study treatment. It is a non-inferiority study with a non-inferiority margin of 15%. We anticipate starting a second phase III study in invasive mold infections around year-end. This study will include a total of approximately 200 patients. Patients will be enrolled in an open-label, randomized portion, comparing fosmanogepix with the respective best available therapies for separate cohorts of patients with invasive mold infections caused by difficult-to-treat Aspergillus species, Fusarium species, Scedosporium species, Lomentospora prolificans, and Mucorales fungi. In addition, patients requiring salvage therapy will be enrolled in a separate cohort.
If successful, this phase III program will provide a comprehensive data set supporting broad use of fosmanogepix in yeast and mold infections as primary therapy and as a salvage therapy option. Moving to our second clinical asset. BAL2062 is a first-in-class cyclic hexapeptide antifungal targeting patients with invasive aspergillosis. Our development plan aims at positioning BAL2062 as a first-line intravenous treatment with the potential to deliver superior efficacy to standard of care. It has FDA QIDP, orphan drug, and fast track designation for invasive aspergillosis. It has a new mode of action as it is actively transported into fungal cells through the siderophore iron transporter one or Sit1, which is not present in mammalian cells. BAL2062 does not show any cross-resistance with marketed antifungal agents.
One of the key attributes of this compound is its potent, rapid fungicidal activity against Aspergillus species, shown in preclinical studies with the potential to provide superior efficacy in invasive aspergillosis. It is active against azole and Amphotericin B-resistant Aspergillus species and has a low propensity for drug-drug interactions. We are currently conducting preclinical profiling studies to define the optimal positioning and the most efficient clinical development path for this asset. If successfully completed, we expect to start the phase II program in 2025. Turning to our third new program, Tonabacase. Tonabacase is a potent bactericidal endolysin derived from bacteriophages, with potential utility as adjunctive therapy to standard of care antibiotics for the treatment of complicated staphylococcal infections, such as infective endocarditis.
Tonabacase is characterized by a rapid bactericidal activity in staphylococcal infections, and endolysins have shown activity to degrade bacterial biofilms and have a low risk of resistance development. We are currently conducting preclinical studies, including PK/PD investigations, under an exclusive evaluation license and option agreement. Based on the results, we will decide on the definitive licensing option around year-end 2024. Finally, moving to our fourth new asset, the LptA inhibitor program. LptA inhibitors are a new approach to the treatment of infections caused by gram-negative bacteria, and we acquired the rights to this preclinical program in January this year. We believe that this new class of antibacterial has the potential to become a new important treatment option for infections caused by Enterobacteriaceae, including carbapenem-resistant isolates. This includes bacteria such as E. coli or Klebsiella pneumoniae, which are the most frequent pathogens causing bloodstream infections.
The compounds have a new mode of actions by inhibiting LptA, which is a part of the lipopolysaccharide transport bridge in gram-negative bacteria, hence resulting in a loss of integrity of the outer cell membrane. High potency and rapid bactericidal activity have been shown in vitro and in vivo, and no cross-resistance has been observed to other antibiotic classes. We're currently conducting preclinical work with the goal of nominating a candidate for clinical development. If successful, we expect to start first human studies in 2026. I will now turn over to David.
Thank you, Marc. Let me close with a quick summary and outlook. We reported strong financial results for the H1 year, 2024, and significantly increased our guidance for the full year as we expect continued strong in-market sales of Cresemba and significant milestone payments from our existing commercial partners in the H2 of 2024. An immediate focus for 2024 is to keep working towards executing a commercial partnership for Zevtera in the U.S. At the same time, we are progressing our clinical and preclinical assets through research and development. Specifically, our first phase III study with fosmanogepix for the treatment of candidemia, invasive candidiasis, is planned to start in the coming weeks. Thank you for your attention, and we'll now open the line up 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 handsets while asking a question. Only three questions may be asked in a row, then the line will be open to others. You can get back in the queue again for any follow-up questions. The first question comes from Brian White, from Calvine. Please go ahead.
Yes, good afternoon, and thanks for taking my questions. I've got two, kind of two, three linked, so interlinked questions. Just on ceftobiprole or Zevtera in the U.S. the negotiations appear to us to be a bit more protracted, perhaps, than the company initially thought. And I guess, just in terms of the company's experience so far, has it been? Have you been pleased with the level of interest and the quality or ambition of potential partners? And I just wondered also just the kind of ongoing limited commercial potential or perception of limited commercial potential for antibiotics, has that been... How much of an issue has that been so far? And then thinking about fosmanogepix, we're about to go into some fairly extensive phase III clinical evaluation. Have you had any more thoughts regarding the potential for non-dilutive funding?
You know, is the company quite happy to fund all of that from current resources, given the performance of Cresemba? I guess also just finally looking out there for other assets, would funding the phase III program yourself limit your ambitions in that direction? Thank you.
Yeah, no, thanks, Brian. So, I'll take the Zevtera question, then I'll maybe hand over to Marc and Adesh on the fosmanogepix questions. But in terms of Zevtera, now, I think we said back in March, April time, that actually we had some new partners came into the process when the label became clearer of Zevtera in the U.S. and the label was broad and a good label. And basically, at that point, we thought we could close a deal by the middle of the year. You're correct, in terms of it's taken a bit longer, but we believe it's just a matter of time, and we definitely...
We've got multiple partners in the process, and we're at the negotiation stage, and that obviously takes two parties to sort of come to an agreement and sign a document. So that's just taken a bit longer than we had originally planned back in March, April. You're correct.
Okay.
We're confident that will be done. It's just we can't say exactly when, 'cause it takes both parties to sort of sign the final agreement. But that's definitely-
Sure.
-that's working pro, in process and a priority for us, as a, as a company. In terms of whether or not the, the environment for antibiotics has sort of changed or, you know, I think, it, it's definitely not changed during the course of the process, we've been going through here with Zevtera. I think, you know, we've gone on record and said that, you know, we believe sort of antibacterials, you know, have a potential, probably about half that of antifungals. So I think the, you know, Cresemba is, has got a potential of... If you look at other, you know, antifungals, it, it can be $700-$900 million sort of dollars peak year sales, whereas a, you know, a, a good antibacterial is probably, you know, half that order of magnitude.
So I think that sort of hasn't changed over the course of the last, the process of us going through the Ceftobiprole partnering. So I don't think that's a factor, and like I said, we're just hoping to get this over the line as soon as we can. In terms of the fosmanogepix question about whether or not we would continue in terms of, you know, if we don't get any non-dilutive funding, maybe I'll hand that over to Marc and Adesh to answer that one.
Yeah. So, we will-
Thank you.
Yeah. Thank you. Thanks, Brian. So this is Marc. We will continue the phase III studies. I think we have communicated consistently that the fosmanogepix program is not dependent on external or non-dilutive funding. At the same time, you know that Basilea has long-standing and successful collaboration with various groups that support anti-infectives development, and especially with BARDA and CARB-X. We also believe that our pipeline, especially fosmanogepix, addresses high unmet medical needs in fungal infections, and we have also antibacterials in our pipeline, and we believe this portfolio could meet the criteria to potentially access non-dilutive funding, and we are certainly seeking non-dilutive funding for all our assets in our pipeline.
... Yes, so maybe, maybe just adding from really from a financial perspective, I think our full year 2024 guidance shows that we have the ability to absorb the R&D expenses or investments that we have to take to expand and progress our pipeline. And the growth trajectory, as indicated for Cresemba, is very healthy. So we are very confident that we are able to actually fund anything that we need. But needless to say, that any potential non-dilutive financial funding would provide significant additional upside. So we would certainly consider it to be quite positive, and that's why we're also focusing on trying to achieve that. But it's not getting in the way of us pushing forward with the development programs.
Just to be maybe it's abundantly clear, but just to be to stress the point, our updated, revised financial guidance that does not take into account any, any additional non-dilutive funding. So if that was to happen, that would be... We would revise our guidance accordingly.
Great. Thanks. Thanks for that.
The next question comes from Ram Selvaraju from HC Wainwright. Please, go ahead.
Hi, this is Yi Chen for Ram Selvaraju. Thank you for taking my questions. Regarding fosmanogepix, how do you intend to optimize the value while also minimizing risk? And will you consider the possibility of identifying a potential partner prior to concluding pivotal development of the drug?
Yeah, maybe. Thank you for the question. Adesh, do you want to take that?
Yeah. So maybe just as a reminder, so we acquired basically fosmanogepix on the basis of quite extensive availability of phase II data. So from a risk perspective, I'd say we believe that we have a good understanding of the compound, that it has actually quite convincing clinical data, and that we, from Cresemba, we perfectly understand the space. So we are, we are quite confident in the way we are moving forward. With regard to partnering, I would also like to remind you that, when we acquired the program from Pfizer last year, actually, the structure is in a way that Pfizer retains the right of first negotiations once the phase III program is completed.
So from our perspective, it is very clear, and that, that was also planned from the beginning, that we would complete the phase III program. We would add, in essence, value by conducting the phase III program broadly, and then in line with our business model, would be planning on commercializing with a partner. In this case, the first, first party to talk to would be Pfizer, an existing partner for Cresemba. So we are quite comfortable with the path forward for, for fosmanogepix.
Got it. So, with respect to BAL2062 and Tonabacase, are you committed to conducting clinical trials of these assets independently all the way to approval, or would you seek to potentially license them earlier?
No, I think in any event, we believe that we are really uniquely positioned to take assets in our focus areas all the way through clinical development to the market. And we also believe that that's actually the phases of development where you're truly adding value. So we would consider that to be our core competence, that we take these assets, look through a commercial lens as well, when we are designing the clinical development programs, to really come up with differentiated profiles in order to then really partner for the commercialization. So the current plan is to basically take the programs forward ourselves if they are successful in meeting our bar for taking programs forward.
The only partnership that we would consider at this point in time, prior to completion of phase III, would be, of course, to get potentially some non-dilutive financing, which we would also consider to be partnering. That would be more from a, not from an operational perspective, but purely from a financing perspective.
In terms of timings, I think Marc alluded to it in his words, but BAL2062 and Tonabacase, we have sort of decision points towards the end of this year, where we complete the preclinical profiling before pressing the button or not, depending on what the preclinical profiling results look like in terms of either starting a phase II study next year. And Tonabacase has a slight sort of derivation of that, because at the moment we've got an evaluation license, and if things are all positive, then we would press the button and move ahead with a definitive licensing agreement, and then before the phase II. But that's in terms of timings.
Got it. My last question is, what are the principal drivers for the increase in operating profit guidance? Also, what are your views on the optimal use of debt in the company's cap structure? Thank you.
So the driver, in essence, is the increase in revenues. So we're increasing revenues, and that flows through in our model quite nicely to the profit line. And that's reflected then in the year-on-year guidance. It probably also shows really the leverage in our model. So as sales increase, given that we are commercializing through partners, actually, we are not incurring a corresponding increase in operating expenses. And your second question was-
Debt and the capital.
debt and capital.
Optimal use of debt, yeah.
... So from our perspective, where we stand today, we believe that we would actually, for the time being, we continue to seek to reduce our debt level. We have been doing that for the last two years, so we have reduced our debt level by CHF 124 million. We have now just one convertible bond outstanding, and the intention would be actually to also repay that or to have it converted.
All right. Thank you very much.
The next question comes from Soo Romanoff from Edison Group. Please go ahead.
Hi, thank you for taking my questions. Congratulations on the quarter. It was nice to see the guidance raised. For my first question, I just wanted to for Zevtera, does that increase guidance include any upfront payments that you expect from the Zevtera partner or not?
Thank you, Soo. So, for two things.
Hi.
First, response is our guidance for 2024 does not include any material, I'd say, contributions from a partnership in the US. We would actually be looking at having more meaningful contributions in 2025. The reason with regards to the upfront payment is that, again, it depends on the details of how the agreement is structured. But given the precedents that we have, we would probably defer the recognition of the upfront payment anyway over the lifetime of the agreement.
And hence, the short-term impact or the annual impact of an upfront payment would not be that significant, especially as we have highlighted also in the past, that we are looking at not necessarily front-loading a transaction with the highest possible upfront, but to ensure that we have a maximum participation in the overall value creation over the whole ten-year period of Zevtera being on the market. So we are looking at having a structure that allows us to participate on the one hand, in the risk, but then also in the upside of the drug in the market.
Yeah, that's super helpful. It was right, it was really nice to hear Marc's update for both, BAL2062 and Tonabacase, and I think we've asked some questions already, but, based on the preclinical profiling, is there anything you can kinda give us? Like, how is it progressing and is there any initial data or insight you could share with us?
So we're making good progress with the preclinical profiling. We are confident this will enable us to make a decision as to whether and how to move forward with BAL2062 and Tonabacase. And as we said before, we'll make that decision around year end 2024. Compared to Fosmanogepix, the two compounds, BAL2062 and the special Tonabacase, are somewhat higher risk projects, but they also offer potentially really high return. So once we have all the data from the preclinical profiling studies, we'll review these projects based on their capacities to address unmet clinical needs and then consider the risk and the returns, the potential returns, and then we're gonna make a decision and communicate it.
Yeah, and just one thing to add, Sue, from my side, 'cause obviously we can't be specific with the sort of data that we're generating as we go.
Yeah.
At the moment, but what I would say is that a bit like was said earlier, I believe, is that we are. We will seek - we think these products, as Marc said, you know, fulfill the sort of requirements of non-dilutive funding bodies such as BARDA. So actually, we will apply for, you know, non-dilutive funding, not just for Fosmanogepix, but for, you know, other compounds like these in our portfolio and CARB-X for the earlier compounds. We, you know, we believe that there's types of compounds that we have in our portfolio, and we look forward to attracting to our portfolio are the types of products that should fulfill the need of non-dilutive funding bodies.
My last question, thank you for that. Last one is, you've invested heavily in building this portfolio in 2023, and you had multiple asset purchases. Is the strategic focus developing existing pipelines now, or are we still looking at further acquisitions? I know you're in a niche market, but any color and any particular category or stage of assets you're targeting would be super helpful. Thank you.
Yeah. I mean, at the high level, and then Adesh, you want to jump in as well, but from my side, you know, we've stated since we had our strategy refocus in 2022, we've stated that we look at, you know, the treatment of bacterial infections, severe bacterial infections and severe fungal infections. We think that's for us, for this time in our life, that's a sort of broad enough area. We've built quite a nice portfolio over the last 10 months on top of Cresemba Zevtera, and actually, we are continuing to look at assets in that area. We're not-- we haven't finished, 'cause as we said, there will be attrition in every, in our portfolio, like there is in every biotech's portfolio. So we are still looking for assets in this area.
So at the moment that we think the area is big enough for us to find the assets that we like, and we can bring into our company. But maybe, Adesh, you want to-
Yeah, the only thing I would add to that is that just the fact that maybe for a few months or a few quarters, we don't do a transaction doesn't mean that we are not that we don't keep on looking for opportunities. We have a list of a short list, in essence, of assets that we're interested in. Not every project or every asset is available at any given time, but you still monitor it, and it may become available. So we will certainly look at any assets that we believe we can add value to in our focus areas, and we'll transact whenever they become available.
Thank you for that. Great, great quarter. Thank you.
Thank you.
The next question comes from Xian Deng, from Pareto Securities. Please go ahead.
Hi, good afternoon. So a few questions from me. So, first, just want to elaborate a bit on the fosmanogepix, non-dilutive funding, because if I understand correctly, you think that fosmanogepix ticks all the box for potential BARDA reimbursement. But, if the BARDA will be able to grant the petition, do you have any estimated timeline?
I think I'll make a comment, and then, Marc, maybe you want to comment as well. Yeah, we— You're correct, in that we do believe that fosmanogepix ticks the boxes in terms of the type of product that, BARDA could fund. Obviously, we are seeking to try and get funding for fosmanogepix, along with, like I said, our other compounds. In terms of, specifically where we are in a process, I wouldn't comment on that exactly now. But just to say, what I would say is that, you know, we are seeking to get funding for, a number of our compounds in development, including fosmanogepix. And I can't really say much more than that at this exact point in time. But we are, we are...
We're not just thinking about it, we're actively trying to get funding for our three compounds, actually, in clinical development.
Okay, thank you. Just a follow-up question on Soo’s previous question. So, do you think there’s a more pressing need to acquire or in-license more later-stage assets, since Zevtera may alone may not be able to basically bridge the gap for Cresemba’s revenue loss beyond 2027, and fosmanogepix can take another 3-4 years to start generating material sales? Is it still your focus to basically replenish your pipeline by adding more late-stage assets?
Yeah. So just to remind you of one point, in terms of the, you know, Adesh touched on earlier about our model. So our model is that we, you know, we in-license compounds and, you know, from late preclinical to the end of phase II. So, you know, but actually, to get to sort of in-license something after phase III, if you think about it, sort of from us, makes no sense. Because the person that's trying to, you know, license that compound out should really then go straight to the company that's gonna commercialize rather than... You know, we can baselayer in that model, with our model of commercializing through partners as well.
You know, fosmanogepix really is probably the latest compound in terms of development stage that fits with our model. Because we can bring it in at the end of phase II, add value through phase III, then we could look for a commercial partner with all the benefits we think about doing that. And that, you know, maybe one day in the future, you know, our model changes 'cause we have critical mass, and we can commercialize ourself in selected markets. But as for now, this model doesn't fit really it doesn't fit having a later than phase II portfolio, but.
And I would just add two things to that. So first of all, also just as a reminder, we don't necessarily believe that Cresemba revenues will right away drop across the board.
Mm-hmm.
Because countries that, or regions that we expect will contribute to growth beyond 2027, so the end of exclusivity in the, expected end of exclusivity in the EU and U.S. So that's one thing. Secondly, maybe also a little bit underappreciated, is that if you look from a cash flow perspective and operating profit perspective, the benefit of our business model is, in essence, that, we are actually able to generate positive cash flows, even if revenues will be declining to a certain degree, because we are not incurring the cost of commercialization. So as long as Cresemba remains on the market, in essence, it's from our perspective, cash flow, cash flow positive. And that's also reflected in our SG&A costs.
So if you just look over the last couple of years, our SG&A costs have remained fairly stable, irrespective of how many countries or how broadly, Cresemba and Zevtera were launched. And I think that's one of the benefits also of our, our business model, that we probably don't have the same level of exposure when it comes to profit and also bottom line and cash flows, to loss of exclusivity as maybe some companies that are directly marketing themselves and have fixed costs that they have to cover.
Okay, thanks. Yeah, I think that makes total sense for me. Thanks for taking my question.
Thank you.
As a reminder, if you wish to register for a question, please press star followed by one. The next question comes from Laurent Flamme from ZKB. Please go ahead.
Yes, good afternoon. So the first question relates to fosmanogepix. The first two, the phase III, already referenced under ClinicalTrials.gov, indicates primary readout in January 2028. Is there any chance that we get a faster enrollment than what is suggested by this timeline? The second question relates to the operating cash flow for the full year. We had a significant swing in working capital requirements in H1, with a positive CHF 8 million contributing to the CHF 18 million around free cash flow. What should we expect for the H2 of this year, considering notably the milestone to be received in relation with Cresemba in the H2 this year?
Yeah, that's. Thanks, Laurent. Marc, why don't you take the-
Yeah.
It's my Japanese one.
I mean, for you know, predicting exact timelines for large phase III studies, prior to having some data on the progress, there's always a level of uncertainty with these timelines. They can, in principle, go in both directions. We've estimated the timeline that's given on ClinicalTrials.gov, based on previous studies that we've performed and other sponsors have performed, and we consider this as a realistic timeline. I think this will be better informed when we have visibility, you know, after the study has started accruing patients, then you know, the trajectories get kind of substance, and we can then come up with with precise estimate. But from our perspective, what we've put into ClinicalTrials.gov is a realistic timeline based on our past experience and the experience of other sponsors.
With regard to your operating cash flow guidance, we're not guiding on operating cash flow for also the reason that a lot depends on when exactly milestones are being triggered and basically when you're invoicing. But in general terms, probably the best proxy to use is look at our operating result guidance for 2024, and take that as a baseline and then deduct from that the interest payments that we're doing related to our convertible bond, and that would get you probably somewhere close to CHF 33 million, in essence, in cash flow for operating cash flow for 2024.
Maybe another question, if I may. The supply service agreement with Pfizer for Cresemba stipulate that you deliver semi-finished products until December this year, and you had booked already a bit more than 10 million product sales in relation to Cresemba with Pfizer in the H1. Can we infer that from next year there won't be any more sales to be booked for Cresemba with Pfizer?
That's correct. According to our agreement with Pfizer, we would no longer be selling product to Pfizer. But then also, as a reminder, as a result of that, our cost of product sold would go down significantly because basically, the economics of our agreement with our license partners is usually that we sell product more or less with a minor markup to the production costs, and the real economics are coming from the royalties and the milestone payments. So from that perspective, yes, on top line, there will be an impact from product revenues to Pfizer, but they will be offset by lower costs of product sold.
Superb. Thanks. Thanks very much.
Okay.
Thank you.
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Okay, then, thank you for your interest and your questions, everyone, and enjoy the rest of your day. Thanks so much.
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