Good morning, everybody. I'm James Quigley, European pharma and biotech analyst from JPMorgan. It's my pleasure to be here today to introduce Basilea. In a second, David Veatch, CEO, is going to come up and talk you through the business. After David's presentation, there is a Q and A in the Kent Room, which is all the way to the end, turn left, and then there are signs.
It's a bit of a track, but I hope you get there. So with that, David, up to come.
Thank you. Good morning, everyone, and I'd just like to start by thanking JPMorgan for inviting us to present at the conference. We're delighted to be here. In terms of the start of my presentation, I'll give you just a brief overview of the company, and then we'll move into details as we go through. We issued a couple of press releases during the course of the last week with our preliminary financials.
So we're a revenue generating commercial stage Swiss biotech company. At the end of twenty eighteen, we had CHF223 million of cash. We focus on the areas of oncology and also anti infectives, in particular, and antifungals. We've got two marketed commercial stage assets, Cresemba, our invasive fungal infection drug and Zevtera, our antibiotic. These are commercialized, licensed in certain geographies of the world but not in others, and I'll come back to that later.
We see that we've got the potential for long term value generation through our commercial stage assets and the increase in revenues, but also through our exciting clinical pipeline, which we're building all the time. In terms of the portfolio, in summary, this shows you on this slide a depiction of the portfolio. And as I said, there's two commercial stage assets at the top of this slide, Cresemba and Zevtera. As I said, in some markets of the world, these are launched. In other markets, these are not launched, and I'll come back to that.
And in terms of the clinical pipeline, about ten years ago, Basilea made a decision to move out of its sort of starting frame, which was anti infective. As I said a moment ago, we are a commercial stage company. We bought three products to market. One, we actually sold to GSK, so we've got two products, commercial products left. We originated from Roche when Roche moved out of anti infectives back in February, and we built an oncology pillar over the last ten years.
And the results of that are the three clinical stage assets you see on this chart here. Behind this, at the bottom, we also have a number of preclinical candidates, which obviously we hope to see into the clinic in the coming years. In terms of what we've our model, the commercial stage assets that we have, Cresemba and Zevtera, we have a number of partners, and these are shown on this slide here. These are our some of these are large global players. Some of these are more local, strong regional players.
And these are very important for us because they it's through these partnerships that we're going to maximize the commercial potential of our two commercial stage assets. Some of these are license agreements and some of these distribution agreements. The difference being whether we manufacture or not for our partner. So in the distribution agreements, we manufacture in the license partners, the partner manufactures products. In terms of the coverage of these partnerships, we cover all the major markets of the world, we believe, with our partnerships for these two commercial assets.
That's obviously very important because then we can realize the full potential of these two assets. There's one exception, which I'll come back to, which we haven't partnered, which is The U. S. For Zevtera, and I'll come back to that in a moment. Just then a couple of points on each of our assets to give you an overview of where we are with each asset.
So Cusemba, our invasive fungal infection product, this is a very high unmet medical need area. Actually, are not many treatments used in the treatment of invasive fungal infections. Mortality rates are high. When we talk about invasive fungal infections, it's really categorized into sort of two areas. There's the yeast infections, the candidiasis and the mold infections, which is aspergillosis and the more rare molds like mucoales, where particularly Quessemba has indicated for the mold infections, so aspergillosis and mucormycosis.
In terms of how is the product doing, the product this is in market sales of Cresemba. And you can see from this slide the early launch years of the product. And you can see it's a nice strong early uptake. We're very pleased, and our partners are very pleased with the early uptake of Cresemba. In the twelve months to the September, the IQVIA sales, 145,000,000, so the in market sales.
We participate in those sales, and that contributes obviously to our revenues. The reason why The U. S. Is a significant proportion at this point in time is The U. S.
Was launched first. They launched Cresemba, April 2015. Whereas in Europe, we launched initially ourselves as Basilea in the major markets of Europe, but then we entered a license agreement with Pfizer, who basically now commercialize the product in Europe actually, and then they extended the agreement to cover Asia Pacific as well, including China. But the early signs, early uptake, we don't forget this graph is just a few markets. It's really just The U.
S. And the sort of EU major markets of Europe. We've got a lot of growth to go in these markets, but also then lots of additional markets to add on to this. And actually, if you look at the next slide, this slide is just showing a sort of the size that these compounds can get to. So the previous gold standard before isoproconazole in the treatment of particularly invasive mold infections was voriconazole.
Voriconazole peaked at just under $1,000,000,000 about $900,000,000 of sales. Now it's $719,000,000 because there's been generic competition with voriconazole. And actually, that's probably worth bearing in mind that the Cresemba uptake has been in the environment of generic voriconazole on both sides of The Atlantic. So that shows you, I think, the value people, physicians think of the product types of oconazole vis a vis voriconazole. And then to use another example, the second largest compound in this class, posaconazole, MSD product, that's $729,000,000 of sales, again, in the twelve months to the September.
So for a company of our size, these can become very meaningful compounds, and Cresemba is well on track in the initial stages of its life. In terms of just moving forward. Just in terms of why the product is doing so well, I mean this slide outlines some of the key features. But really, I think the major two reasons are the fact that in the pivotal largest ever invasive aspergillosis study, over 600 patients where voriconazole was compared with isofoconazole, there was similar efficacy but a significantly better safety profile of isoconazole. Clearly, that when you've got similar efficacy but better side effect profile, that's driving the use largely of isoconazole, plus the fact that we have a broader spectrum of activity and indications than valroxil in terms of these molds I talked about earlier.
So we can be used in mucor mycosis whereas valroxil can't. And for physicians who find it difficult to differentiate the diagnostically between different molds, that's an important feature for Cresemba. In terms of probably important other point, just one point from this slide, the exclusivity. So whilst the product started well, we have a good runway of exclusivity, so to speak, in terms of The U. S.
2027 is when the exclusivity expires. And in Europe, as long as we complete the pediatric program which we're doing as we speak and we're planning to do, that would take the exclusivity from 2025 to 2027. It's an orphan drug. That's why we get the two years of extra exclusivity. So both sides of the Atlantic, we have exclusivity through to 2027.
In terms of shifting gear to the antibiotic, so fifth generation cephalosporin bactericidal, rapidly acting, launched in many European markets and selected other markets around the globe. Importantly, though, not licensed, not launched in The U. S. And what I would just say in terms of The U. S, if I can just The U.
S, on this graph here, what it's a bit complicated. But on the right hand side, what I'm trying to show you here is that the a particular useful utility of ceftobiprole is its activity in gram positive, particularly MRSA pathogens. And looking at we picked a couple of analogs here, linezolid and daptomycin, just to show you the point that this was looking at the final year of sales of these two MRSA agents before they went lost exclusivity to look at where the sales were distributed. And you can see on these graphs on the right that The U. S, which is the blue section of these pie charts, is a dominant part of the commercial potential of, we believe, ceftobiprole.
Therefore, we need a plan for The U. S. And what this slide talks to is that we have a plan agreed with the FDA. We have special protocol assessments for skin study and for a bacteremia study. Both studies are ongoing.
They started in 2018. The skin study will recruit very quickly and will complete later this year, we believe. It's on target to complete later this year. The Staph aureus bacteremia study is a more difficult patient more difficult study to recruit patients for. That will take longer.
That will take into, we believe, mid-twenty twenty one. But the important point here is, again, related to exclusivity that with the QIDP designation, we would get ten years of exclusivity following the approval. So if the study completes, as we believe, in the middle of twenty twenty one, drug would be approved. It needs both studies for the approval, for the submission and the approval. So it could be approved in mid-twenty twenty two, but the exclusivity then would start from that point, 2022 through to 02/1932.
And that's the way that works. And the important point here, and additionally, is that about 70% approximately 70% of the funding of these two Phase III studies is provided through the U. S. Government through BARDA, yes? So we've got a commitment of about £128,000,000 of non dilutive funding for these two studies.
And then Basilea pays the remaining 30% over the years of these two studies. In terms of shifting gear then, so that was our sort of the origins of our company in terms of And then like I said about ten years ago, we made the strategic decision to move into oncology, which I think was is now starting to bear the fruits through both external actually and internal development. We've now got these three clinical stage assets and a number of assets behind them. In terms of the lead oncology compound now, actually is when we licensed in April, derazantinib.
This is an FGFR kinase inhibitor, which is actually currently in a potentially registrational Phase II study for intrahepatic cholangiocarcinoma or bile duct cancer. And like I said, this was licensed in from ArQule in April. We've now taken over full sponsorship of the ongoing registrational study. And ICCA, or intrahepatic cholangiocarcinoma, like I said, is the proof of concept indication. And in terms of we licensed in the product, some of the data that we saw that really was appealing to us about the compound, you can see in this slide here, this waterfall plot, this is effectively the this is the Phase IIIa study that ArQule carried out, where each bar on this chart is a patient, and you can see the tumor reduction.
And just by eyeballing this chart, you can see that generally patients benefited in terms of from the agent derazantinib. So this led us to believe this is an active single agent drug in this indication. And importantly, this is second line iCCA. So first line treatment is usually with chemotherapy, like gemcitabine with a platinum agent. Second line treatment, there's no established recognized second line treatment for ICCA, and that's the area we're planning.
You can see the data here from the Phase IIIa with a twenty one percent objective response rate and seventy two percent either had a response or disease stabilization. I should say, it's not on this slide because it's sort of hot off the press, but we this week, we released the interim analysis from the ongoing larger Phase II study that we've taken over from ArQule. And actually, very encouragingly, the data from that mirrors the data from this Phase IIIa study. So we had actually exactly the same objective response rate, twenty one percent, but with a disease control rate of eighty three percent. So what I'm talking about is this study here.
This is the registrational potentially registrational Phase patient study, and this is what we just this week announced the interim analysis on. This was on 29 efficacy evaluable patients was the interim analysis. And as I said, the objective response rate was twenty one percent, and the disease control rate was eighty three percent. So we're very encouraged by that because it looks like the study is well on track to potentially deliver the results that we're looking for in terms of indication. In terms of, though, the future for derazantinib after ICCA, we're currently doing lots of work.
Like I said, it's our key priority in our clinical development portfolio. We're doing lots of work to understand where we think the potential utility for derazantinib is in other tumor types in the future. And we plan on starting in the middle of this year a multi cohort study in other tumor types. And we're doing the preclinical work. We're talking to our advisers.
We're analyzing the data on other FGFR inhibitors, trying to understand where we think we will most likely or best luck that we could best get a chance of a hit on goal in terms of other tumor types that we should be looking at our product in. It's probably worth saying we believe strongly that the FGFR is there's no licensed FGFR in the market. Other companies have FGFR in clinical development. But actually, we believe that these are different, have a different profile, and therefore, potential utility could be in different tumor types. But we don't know.
We need to find that out. And importantly, also another point worth saying for transparency is we also don't know whilst we know there are FGFR aberrations in many different tumors, we actually don't know the extent to which FGFR aberrations are oncogenic drivers in these tumors. And that's one of the objectives of our studies to try and find out if derazantinib has an efficacy in other types of tumors listed here. That's the lead oncology compound in our pipeline. And then we have two earlier compounds, BAL101553.
And this is shown just here very quickly. This is earlier, so I'll spend less time talking about this. This is a it destabilizes the microtubule scaffold. It binds at a unique location on the microtubule, and it has a particular feature around blood, the blood brain barrier and penetration of that. So actually, not surprisingly, and through preclinical analysis, we think that it potentially could have utility in glioblastoma.
So actually, I've just summarized on the next slide here three studies that are ongoing, Phase I, Phase II. And largely, you'll see here in either recurrent or newly diagnosed glioblastoma. These are these three studies here. And we expect later this year to start to generate the results from two of these studies. The daily oral study and the continuous infusion study should report by the end of the year, we should have data from those two studies to understand if there is activity of the compound in glioblastoma or advanced ovarian cancer.
And then just in terms of even earlier, we've just got one other clinical development compound, BAL3833. This is has just completed a Phase I study. It's a pan RAF sarc kinase inhibitor that we licensed in from a U. K. Consortium involving the Wellcome Trust, Institute of Cancer Research, etcetera.
And we've just completed a Phase I study there. And basically, the Phase I study, there was an MTD was not established with the formulation we use. So we're currently looking, though, with our partners on reformulating the compound to actually understand if we can get the right level of exposure in the body with different formulations of the agent. In terms of bringing it all together, in terms of the numbers, I mean, what I would just focus on, on this slide and again, we just this week released in a press release preliminary financials for 2018. And on this slide, I'll just bring your attention to the maybe a couple of points.
In 2000 at the end of twenty seventeen, we had CHF310 million of cash, and we had revenues of CHF101 million. And then if I go forward one slide, this has been updated with this week's announcement. We in the middle of the year, our half year results, we updated our guidance. We increased our revenue guidance of 120,000,000 to £130,000,000 We actually exceeded that. So we came in at the end of the year 2018, which we announced this week, pounds 133,000,000 of revenues.
The important point is the revenues are made up of sort of three components: the CresembaZevtera revenues that I talked about earlier from the commercial stage assets. We have some revenue recognition, which actually ended last year from the deal we did where we sold our third commercial asset, TocTino, to GSK Stifel. So the revenue recognition disappears this year now for that, but that's the red section on this chart. And the third section, the green section what we call our contract revenues, and that's the way in which when we expense it, we have expenses with our ceftobiprole Phase three program. The U.
S. Government through BARDA reimburses us. We recognize that as revenue in the revenue line. That's the three elements. Obviously, in terms of for the strategic future of the company in generating cash, the important piece is the Cresemba and Zevtera increase in revenues.
And what we're very pleased about is that you can see on this chart that in 2017, Cresemba and Zevtera contributed £52,000,000 and now they're contributing £82,000,000 at the end of last year. So that's a 56% growth. And that, as I say, is key for the company because that's the long term cash generating revenues, which will help us fund our clinical pipeline in oncology. And you can see some of the starting of the exciting clinical data we're getting from the clinical oncology pipeline. In terms of next milestones for the company, as I said, this week has been a busy week for us with press releases.
So the first half of twenty nineteen has already started, and we've the interim analysis from the Phase II ICCA study, as I alluded to, has already has come out. And again, we wanted to see mirroring of the data we got from the ArQule that previously got from the Phase IIIa study, which we've seen. And then as I said, the next value inflection points or important milestones for us as a company are the other ones shown on this slide, so BAL101553. We've got a couple of data readouts during the course of the year on two of those studies I showed you. Derazantinib, the FGFR inhibitor, the start of this multicohort other tumor study, that's critically important for us because, as I said, that will then allow us to understand the full utility of this brand in the years to come.
So we plan on starting that, as I said, in the middle of the year. And I think I also said that towards the second half of this year, we expect the results from the first of the two ceftobiprole Phase III studies, which we need for this U. S. Approval. The skin study should we should have top line results towards the end of twenty nineteen.
So with that said, that's a whistle stop tour of Basilea, and thank you for your attention, and thank you for your interest.