Good morning, everybody. I'm James Quigley, European Pharma and Biotech analyst from JP Morgan. It's my pleasure to be here today to introduce Basilea. In a second, David Veitch, CEO, is going to come up and talk you through the business. After David's presentation, there is a Q&A in the Kent Room, which is all the way to the end, turn left and there are signs. It's a bit of a trek, but I hope you'll get there. With that, David, up you come.
Thank you. Good morning, everyone. I'd just like to start by thanking JP Morgan for inviting us to present at their 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've issued a couple of press releases during the course of the last week with our preliminary financials. We're a revenue-generating, commercial-stage Swiss biotech company. At the end of 2018, we had CHF 223 million of cash. We focus on the areas of oncology and also anti-infectives. In particular, antibiotics 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. 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. In terms of the clinical pipeline, about 10 years ago, Basilea made a decision to move out of its sort of starting frame, which was anti-infectives. As I said a moment ago, we are a commercial-stage company. We brought three products to market. One we actually sold to GSK, so we've got two commercial products left.
We originated from Roche when Roche moved out of anti-infectives back in 2000, and we built an oncology pillar over the last 10 years. 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 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. Some of these are large global players, some of these are more local, strong regional players. These are very important for us because 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 are distribution agreements.
The difference being whether we manufacture or not for our partner. In the distribution agreements we manufacture, in the license partners, the partner manufactures the 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 is obviously very important, we can realize the full potential of these two assets. There is one exception, which I will come back to, which we haven't partnered, which is the U.S. for Zevtera. I will come back to that in a moment. A couple of points on each of our assets, to give you an overview of where we are with each asset. Cresemba, our invasive fungal infection product. This is a very high unmet medical need area. There are not many treatments used in the treatment of invasive fungal infections.
Mortality rates are high. When we talk about invasive fungal infections, it is really categorized into two areas. There is the yeast infections, the candidiasis, and the mold infections, which is aspergillosis and the more rare molds like Mucorales. We are particularly, Cresemba, is indicated for the mold infections, so aspergillosis and mucormycosis. In terms of how is the product doing. This is in-market sales of Cresemba. You can see from this slide the early launch years of the product. You can see it is a nice, strong early uptake. We are very pleased and our partners are very pleased with the early uptake of Cresemba. In the 12 months to the end of September last year, the IQVIA sale is $145 million, so the in-market sales. 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. We launched initially ourselves, as Basilea in the major markets of Europe. We entered a license agreement with Pfizer, who basically now commercialize the product in Europe. They extended the agreement to cover Asia Pacific as well, including China. The early signs, early uptake, do not forget this graph is just a few markets. It is really just the U.S. and the EU major markets of Europe. We have got a lot of growth to go in these markets, lots of additional markets to add on to this. If you look at the next slide. This slide is just showing the size that these compounds can get to.
The previous gold standard before isavuconazole in the treatment of particularly invasive mold infections was voriconazole. Voriconazole peaked at just under a billion, about $900 million of sales. Now it is $719 million because there has been generic competition with voriconazole. That is probably worth bearing in mind that the Cresemba uptake has been in the environment of generic voriconazole on both sides of the Atlantic. That shows you, I think, the value people, physicians think of the product isavuconazole, vis-a-vis voriconazole. To use another example, the second-largest compound, in this class, posaconazole MSD product, that is $729 million of sales, again, in the 12 months to the end of September last year. For a company of our size, these can become very meaningful compounds. 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's doing so well, this slide outlines some of the key features. 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 isavuconazole, there was similar efficacy, but a significantly better safety profile for isavuconazole. Clearly, that when you've got similar efficacy but better side effect profile, that's driving the use largely of isavuconazole, plus the fact that we have a broader spectrum of activity and indications than voriconazole in terms of these molds I talked about earlier. We can be used in mucormycosis, whereas voriconazole can't. For physicians who find it difficult to differentiate diagnostically between different molds, that's an important feature for Cresemba.
In terms of, probably an important other point, just one point from this slide, the exclusivity. 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. 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. Both sides of the Atlantic, we have exclusivity through to 2027. In terms of shifting gear to the antibiotic. 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.
What I would just say in terms of the U.S., if I can just The U.S., on this graph here, it's a bit complicated, but on the right-hand side, what I'm trying to show you here is that a particular useful utility of cefepime is its activity in gram-positive, particularly MRSA pathogens. 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 lost exclusivity to look at where the sales were distributed. 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 what we believe ceftobiprole. Therefore, we need a plan for the U.S.
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 Staphylococcus aureus bacteremia study is a more difficult study to recruit patients for. That will take longer. That will take into, we believe, mid-2021. The important point here is, again, related to exclusivity, that with the QIDP designation, we would get 10 years of exclusivity following the approval. If the study completes, as we believe, in the middle of 2021, drug would be approved. It needs both studies for the approval, for the submission and the approval.
It could be approved in mid-2022, but the exclusivity then would start from that point, 2022 through to 2032. That's the way that works. The important point here additionally is that approximately 70% of the funding of these two phase III studies is provided through the U.S. government through BARDA. We've got a commitment of about CHF 128 million of non-dilutive funding for these two studies. Basilea pays the remaining 30% over the years of these two studies. In terms of shifting gear then, that was the origins of our company in terms of anti-infectives. Like I said, about 10 years ago, we made the strategic decision to move into oncology, which I think 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 last year, 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. Like I said, this was licensed in from ArQule in April last year. We've now taken over full sponsorship of the ongoing registrational study. iCCA, intrahepatic cholangiocarcinoma, like I said, is a proof of concept indication. In terms of why 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 the Phase I/IIa study that ArQule carried out, where each bar on this chart is a patient.
You can see the tumor reduction. Just by eyeballing this chart, you can see that generally, patients benefited in terms of from the agent derazantinib. This led us to believe this is an active single agent drug in this indication. Importantly, this is second-line iCCA. First-line treatment is usually with chemotherapy, like gemcitabine with a platinum agent. Second-line, there's no established, recognized second-line treatment for iCCA, and that's the area we're playing. You can see the data here from the Phase I/IIa with a 21% objective response rate and 72% 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 this week we released the interim analysis from the ongoing larger Phase II study that we've taken over from ArQule. Very encouragingly.
The data from that mirrors the data from this Phase I/IIa study. We had actually exactly the same objective response rate, 21%, but with a disease control rate of 83%. What I'm talking about is this study here. This is the registrational, potential registrational Phase II study in iCCA, 100-patient study. This is what we just this week announced the interim analysis on. This was on 29 efficacy-evaluable patients, was the interim analysis. As I said, the objective response rate was 21% and the disease control rate was 83%. 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 the iCCA initial indication. In terms of, though, the future for derazantinib after iCCA, we're currently doing lots of work.
Like I say, 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. We plan on starting in the middle of this year a multicohort study in other tumor types. We're doing the preclinical work, we're talking to our advisors, we're analyzing the data on other FGFR inhibitors, trying to understand where we think we will most likely or 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 FGFRs, there's no licensed FGFR in the market. Other companies have FGFRs in clinical development. Actually, we believe that these are different.
They have a different profile and therefore the potential utility could be in different tumor types. We don't know. We need to find that out. 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. 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. 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. It destabilizes the microtubule scaffold.
It binds at a unique location on the microtubule, and it has a particular feature around the blood-brain barrier and penetration of that. Actually, not surprisingly, and through preclinical analysis, we think that it potentially could have utility in glioblastoma. 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 in newly diagnosed glioblastoma. These are these three studies here. 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.
Just in terms of even earlier, we've just got one other clinical development compound, BAL-3833. This has just completed a phase I study. It's a pan-RAF/SRC kinase inhibitor that we licensed in from a U.K. consortium involving the Wellcome Trust, Institute of Cancer Research, et cetera. We've just completed a phase I study there. Basically, the phase I study, MTD was not established with the formulation we used. 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, what I would just focus on on this slide, and again, we just this week released in a press release the preliminary financials for 2018.
On this slide, I'll just bring your attention to maybe a couple of points. At the end of 2017, we had CHF 310 million of cash, and we had revenues of CHF 101 million. If I go forward one slide, this has been updated with this week's announcement. In the middle of the year, our half year results, we updated our guidance. We increased our revenue guidance CHF 120 million-CHF 130 million. We actually exceeded that, so we came in at the end of the year 2018, which we announced this week, CHF 133 million of revenues. The important point is the revenues are made up of sort of three components. The Cresemba, Zevtera 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 Stiefel. The revenue recognition disappears this year now for that, but that's the red section on this chart. The third section, the green section, is what we call our contract revenues, and that's the way in which when we have expenses with our ceftobiprole phase III 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, Zevtera increase in revenues.
What we're very pleased about is that you can see on this chart that in 2017, Cresemba, Zevtera contributed CHF 52 million, and now they're contributing CHF 82 million at the end of last year. 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. 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's been a busy week for us with press releases. The first half of 2019's already started, and the interim analysis from the phase II iCCA study, as I alluded to, has come out.
Again, we wanted to see mirroring of the data we got from the ArQule had previously got from the phase I-A study, which we've seen. As I said, the next value infection points or important milestones for us as a company are the other ones shown on this slide. 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 multi-cohort 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. We plan on starting that, as I said, in the middle of the year.
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, we should have top-line results towards the end of 2019. With that said, that's a whistle-stop tour of Basilea. Thank you for your attention, and thank you for your interest.