Basilea Pharmaceutica's (BPMUF) CEO Ronald Scott on Full Year 2017 Results - Earnings Call Transcript

Basilea Pharmaceutica AG (OTC:BPMUF) Full Year 2017 Earnings Conference Call February 27, 2018 10:00 AM ET

Executives

Ronald Scott - Chief Executive Officer

Marc Engelhardt - Chief Medical Officer

David Veitch - Chief Commercial Officer and Chief Executive Officer-designate

Donato Spota - Chief Financial Officer

Analysts

Bob Pooler - ValuationLAB

Bruno Bulic - Baader-Helvea

Operator

Ladies and gentlemen, good morning or afternoon. Welcome to the Basilea Pharmaceutical’s Conference Call on Full Year Results 2017. I’m Alister, the Chorus Call Operator. The conference must not be recorded for publication or broadcast.

At this time, it's my pleasure to hand over to Mr. Ronald Scott, Chief Executive Officer. Please go ahead, sir.

Ronald Scott

Thank you. Hello. This is Ron Scott, CEO of Basilea, and I welcome you to our 2017 full results conference call. To update you on our progress, upcoming milestones, and guidance for 2018, to be followed by questions and answers session.

Joining me on this conference call are Marc Engelhardt, our Chief Medical Officer; David Veitch, our Chief Commercial Officer and our CEO-designate; and Donato Spota, our Chief Financial Officer.

I would also like to mention that this call contains forward-looking statements. For those on the call who are not familiar with Basilea we are one of the few companies, focused on new for medicines to overcome resistance in the areas of infectious diseases and oncology, our two strategic pillars in the hospital sector.

Basilea has a proven track record at up-bringing drugs from research into clinical development and onto the market. We have brought two anti-infective drugs from research to the market, our antifungal Cresemba, and Zevtera, our broad-spectrum antibiotic also covering MRSA.

2017 was a good year for us. We were able to finalize transactions to maximize the value of both our commercial stage drugs. This morning we announced significantly increased revenue and substantially improved financial result as we move closer to profitability.

We established partnerships from both our branded drugs and important territories. With several leading pharmaceuticals companies, our partnerships cover more than 100 countries worldwide. We received approximately CHF80 million in upfront payment and are also eligible for around US$1 billion in potential regulatory and sales milestone payments from our license partnerships going forward.

In addition to royalties on sales, we continue to play an important role in supporting our partners in the registration processes around the world and closely collaborate with them to create synergies in the manufacturing development and commercialization of our products on a global level.

Cresemba offers significant medical treatment benefits to patients with life threating invasive mold infections. Last year, we entered into a license agreement for Europe and Asia, including China with Pfizer, a leading, anti-infective commercialization partner.

Cresemba is now marketed in all top five European countries and in the US. Regarding our antibiotic ceftobiprole we secured additional funding of $54.8 million from BARDA for our ongoing Phase 3 clinical program, the additional funding was awarded after Basilea agreed with the FDA on a special protocol assessment for two Phases 3 studies planned to support the potential regulatory filings in the United States.

The total value of our BARDA contract could reach approximately $108 billion in non-diluted funding if predefined milestones are met. The Phase 3 program is designed to bring Ceftobiprole to patients in the U.S., which is the largest market for new branded hospital antibiotics worldwide. We also made further progress in our clinical programs in oncology.

Our most advanced oncology compound, BAL101553, is a novel small-molecule tumor checkpoint controller. We established the maximum tolerated dose in our oral and IV Phase 1 dose escalation studies. We also intensified our activities in the field of glioblastoma, the most common and severe form of Brain Cancer for which patients urgently need new treatment options.

We have started a clinical Phase 1 study with BAL101553 in combination with standard radiotherapy and patients with newly diagnosed glioblastoma in collaboration with the US Adult Brain Tumor Consortium, which is funded by the US National Cancer Institute. For our panRAF/SRC kinase inhibitor, BAL3833, dose escalation is ongoing in the Phase 1 study in patients with advanced solid tumors.

Marc will now provide you with further information on the progress of our clinical development programs, after which David will give you more insight on our commercial activities and partnerships; then Donato will provide you with financial highlights for 2017 and also our guidance for 2018.

Marc Engelhardt

Thank you, Ron. Let me start with our antibiotic, Ceftobiprole. Our aim is to bring Ceftobiprole to the commercially-important U.S. market and under the BARDA contract, we're implementing two cross-supportive Phase III studies, one in acute bacterial skin and skin structure infections, also known as ABSSSI, and one in staphylococcus aureus bacteremia.

We could also potentially file for these additional indications in Europe and other territories where Ceftobiprole is already approved picking up pneumonia. We reached an agreement with the FDA on special protocol assessments for both studies. The skin study is a global study to enroll approximately 680 patients and has started. The study compares Ceftobiprole to vancomycin for early clinical response.

Patients in the vancomycin group receive aztreonam in addition to vancomycin to cover gram-negative bacteria, which is not needed for ceftobiprole, because ceftobiprole unlike vancomycin is active against gram-negative bacteria.

Moving to bacteremia, or bloodstream infections, which is a bacterial infection with a high unmet medical need and associated with high morbidity and mortality. Preclinical and clinical data indicate that ceftobiprole is rapidly bactericidal, which could be particularly beneficial for patients with staphylococcus aureus bacteremia. Like the skin study the bacteremia study will also be global study and is estimated to start mid-2018 and enroll approximately 390 patients.

The study compares ceftobiprole to daptomycin for overall success in the treatment of staphylococcus aureus bacteremia, including endocarditis. We currently estimate that the study will take around three years to complete. And this estimate is based on previous study with daptomycin in this indication.

The competitive clinical trial environment in bacteremia is favorable with only few industry points of study currently ongoing in Phase 2 or Phase 3, which therefore possess no barriers to patient enrollment from that prospective. For a potential filing in the U.S., both the skin study and bacteremia study have to be successful.

Turning now to our anti-fungal, Cresemba, also known as Isavuconazole, which is a proof for the treatment of invasive aspergillosis and mucormycosis both in Europe and in the U.S. In Japan, our license partner Asahi Kasei Pharma, successfully completed a Phase I clinical study with Isavuconazole in healthy subjects. This was an important first step towards bringing the anti-fungal to patients in Japan and Asahi Kasei is now preparing to start a Phase 3 clinical study in the first half of 2018.

Now to our second therapeutic area oncology. As Ron mentioned, we continue to make progress in our two Phase 1/2a studies with our tumor checkpoint controller BAL101553, exploring oral administration and weekly 48-hour infusion in solid tumor patients. The phase 1 dose escalation part of both these studies for patients with solid tumors was completed in 2017 and the maximum tolerated dose has been established.

We are planning to present data from these studies at scientific conferences later this year. Basilea also plans to initiate a Phase 2 expansion with weekly 48-hour infusion in patients with recurrent glioblastoma or ovarian. The oral study was expanded already in late 2016 by a separate arm with patients suffering from recurrent or progressive glioblastoma. We expect the patient recruitment to be completed in the first half of 2018 in the study.

We further expanded our clinical trial activities in glioblastoma through a collaboration with the Adult Brain Tumor Consortium, or ABTC. We recently started a clinical Phase 1 study with BAL101553 in combination with standard radiotherapy in patients with newly diagnosed glioblastoma. If the study is successful this may provide the proof of concept important for entering in the partnerships for later stage clinical development in glioblastoma.

Glioblastoma is one of the most common and aggressive types of brain cancer in adults. And this is associated with a very poor prognosis. Preclinical studies shows that BAL101553 is efficiently distributed into the brain with potent anticancer activity in glioblastoma brain cancer models.

Our second oncology compound BAL3833 is currently in the Phase 1 clinical study in adult patients with advanced solid tumors, including metastatic melanoma. The completion of dose escalation is anticipated in 2018. As far as I know, BAL3833 is the only compound in clinical development with an inhibition profile that covers ERAF, CRAF, and SRC kinases at the same time.

David will now provide you with information on our commercial activities.

David Veitch

Thank you, Marc. In 2017, we continued to make significant progress in the commercialization of our two hospital anti-infective brands Cresemba and Zevtera. We are pleased to report revenue contribution from both these brands of CHF 53 million for full year 2017. This reflects a very strong initial ramp-up in product sales and we anticipate strong growth to continue in the years to come based on both increase in market shares in existing countries and contribution from many new launches worldwide.

Both Cresemba and Zevtera are now marketed in Germany, Italy, U.K., France, Austria and the Nordics. Zevtera is also additionally marketed in Switzerland. Cresemba was launched most recently in Spain by Pfizer in October last year, and we expect Pfizer would launch Cresemba in additional markets during 2018. This means Cresemba is now commercially available in all top five European countries through Pfizer in addition to the Nordic countries through our partner Uni-medic, and in the US by Astellas.

Astellas recently reported US Cresemba sales of $77 million for the calendar year 2017, which is a 67% increase year-over-year. This resulted in increased royalties for Basilea of CHF 13.3 million. In addition, the strong sales performance in the U.S. also triggered a first sales milestone payment to Basilea of CHF 5 million.

In December 2017, we extended the existing license agreement with Pfizer for Cresemba. The agreement with Pfizer initially covered Europe, excluded the Nordic's, Russia, Turkey and Israel. And now it also includes China and 16 countries in the Asia Pacific region.

Basilea receives mid-2018 royalties on sales and is eligible for up to $650 million in regulatory and sales milestone payments. Following the partnering of Cresemba with Pfizer, Basilea entered into an exclusive distribution agreement with a huge cash specialist company, Cardiome, for Zevtera in Europe and Israel.

In addition to our existing European markets, Cardiome plans to launch in further countries. In June, Basilea also entered into a distribution agreement for Cresemba and Zevtera with Avir Pharma for Canada, adding to our existing distribution agreements for Latin America, Europe, the Middle East, and North Africa regions.

Our licenses and distribution partnerships for both products now cover more than 100 countries worldwide. For our Anti-biotic Zevtera, we believe the key market for accessing the full commercial value will be the U.S. and China. The U.S. alone represents around 70% of the current global market for branded hospital antibiotics by value. And China, the resistant rates are amongst the highest in the world, which drives the significant market potential for novel hospital antibiotics in this region.

We have established partnerships with BARDA for the U.S., and with Gosun for China, putting us in an excellent position to access these two important markets for Zevtera. Our current partnerships for Cresemba and Zevtera play an important role in the execution of our global commercialization strategy and provide a strong basis for the future revenue growth of our brands.

Our commercial aim is to continue to grow our revenues from Cresemba and Zevtera and to maximize the opportunity for both these brands through our network of partnerships, for the benefit of patients and Basilea.

I will now turn over to Donato, who will update you on our financials.

Donato Spota

Thank you, David. I will now highlight some of the financial key figures that were published in more detail in today’s press release and the annual report 2017. I would like to mention that all the figures I will refer to on Swiss francs.

In 2017, we significantly increased our revenues and substantially improved our financial results. 2017 marks a major milestone in the history of Basilea as revenue from our operational activities for the first time exceeded 100 million. Total revenue, which includes product revenue, revenue recognition from upfront and milestone payments, royalties received from Astellas and Pfizer as well as BARDA reimbursements amounted to CHF101.5 million.

This represents a 54% increase over 2016, a major driver of this increase with the revenue contributions from Cresemba and Zevtera, which in total increased by more than 90% year-on-year to CHF53 million, particularly based on Cresemba's strong sales performance in Europe and the U.S.

Moving to expenses. Following the agreements of Pfizer and Cardiome, we transitioned our commercial activities to our partners and completed the transition in December last year. Thus, our SG&A expenses, which mainly includes cost related to the commercialization of both our products in major European markets, as well as general and administration expenses amounted to CHF53.1 million compared to CHF56.1 million in 2016.

The decrease in the expenses represent initial savings in commercialization costs. The savings will be more substantial going forward. Research and development expenses amounted to CHF53.5 million and were mainly related to investments in the Phase 3 program for the antibiotic, Ceftobiprole; the Phase I/IIA development of oncology drug candidate BAL101553, to Phase 1 clinical development of our oncology drug candidate BAL3833 and costs for the pediatric program for ceftobiprole, as well as activities related to Isavuconazole and compounds in our research portfolio.

Compared to 2016, we increased our R&D investments by approximately 10%, primarily related to the Ceftobiprole U.S. program and the development of our oncology assets. In 2017, we substantially decreased our operating loss by 68% year-and year to 14.1 million, reflecting the strong increase in revenues outlined before.

Our operating activities generated net cash of 19 million and a combined cash and investments amounted to $310.7 million as of December 31, 2017. This improvement in cash position in comparison to 2016 is mainly due to upfront and milestone payments received from our licensing and distribution partners in the amount of 86 million, as well as higher revenue from product sales and royalties.

Coming to the financial outlook for 2018, we anticipate to further increase total revenues to between 105 million to 115 million, revenue contributions from Cresemba and Zevtera are estimated to raise to between 60 million to 65 million, mainly driven by anticipated 50% growth in product revenue and royalties. We initiated the Phase 3 program for Ceftobiprole and plan to expand our development activities in oncology, which we anticipate will lead to an increase in R&D expenses. Thus, the operating loss in 2018 is estimated to be at a comparable level to 2017 in the range of approximately 10 million to 20 million.

Ronald Scott

Thank you, Donato. To summarize our focus for 2018, we will continue to support our partners in order to grow revenues from both our marketed products Cresemba and Zevtera. We initiated the Ceftobiprole Phase III trial in severe skin infections and are preparing the initiation of the bacteremia trial to allow us to potentially enter the U.S. market with the support of BARDA.

We will move forward with our clinical programs in oncology. We intent to complete patient recruitment in the glioblastoma arm of the oral study for BAL101553. We also expect to start a Phase 2/a expansion with BAL101553 IV treatment in the current glioblastoma and ovarian cancer.

In addition, we expect completion of the ongoing Phase 1 study for BAL3833. We are also focused on strengthening our pipeline in our core areas of anti-infectives and oncology through the internal and external innovation. As in the past, we will continue our prudent management of our expenses as we move closer to profitability.

Thank you for your interest in Basilea. We will now open the line to you for your questions.

Question-and-Answer Session

Operator

The first question is from Bob Pooler, Valuation LAB. Please go-ahead sir.

Bob Pooler

Good afternoon, gentlemen. First of all, congrats on the excellent results and the frenzy [ph] deals last year. I'm still struggling to [indiscernible] financial model, but I'll survive that one. Just before I start my three questions, I first want to thank Ron for answering all my questions since the article in 2004, and for the nice co-operation, so I wish you really a happy retirement, but also successfully new role as a member of the Basilea's Board.

I'd also like to congratulate David becoming the new CEO, but also Marc in his new role as CMO. Just on my question First of all, on the guidance, if you look at the guidance components there, the growth Cresemba and Zevtera growing this year, also the MNS going down as well, the SGNA, do you believe it is feasible that you will break even or be profitable next year in 2019?

Donato Spota

Hi Bob, this is Donato speaking. Well, I actually know there are a number of factors that impact the time to breaking even and one is certainly revenue growth, and as we've outlined, we expect continuous growth there, and the guidance is reflecting that, on the other hand side, we've also said that we want to continue to invest and actually expand our investments in our pipeline. So, taking those to major factors together, we will expect and target to each probability within the next 24 months.

Bob Pooler

Okay then just on skin trial, could you give a timeline there maybe, when that will conclude?

Marc Engelhardt

Yes, this is Marc. The study has started in February 2018. We anticipate a duration of 18 months to 24 months for that study. So, we expected to complete in Q3, Q4 2019.

Bob Pooler

Okay. And then just one question also on Zevtera there. How much do you estimate that BARDA will contribute in 2018?

Donato Spota

This is Donato. While the contribution of BARDA will depend on our expenses that we will have for this study. So, we have not disclosed a particular amount, but as you know generally speaking the BARDA contribution for the entire program is about 70% of the total cost.

Bob Pooler

Okay. You got [indiscernible] this year so we could expect - or last year so we could expect that this year would go up?

Donato Spota

That's a fair assumption.

Bob Pooler

Okay, thank you. Thanks for the questions.

Operator

The next question comes from [indiscernible]. Please go ahead.

Unidentified Analyst

Good afternoon. I think I’ll better ask my first three questions first, and then you can fix it answering those, so I will get off. And the first one is on the Zevtera and Cresemba commercialization agreements altogether. Now that they have been in place for quite some time and presumably you are having regular calls with these companies to keep your ears close to the ground, I was wondering if you could share some of the feedback you have been hearing from these partners in terms of how the products are developing in their markets and perhaps how this compares with the partners expectations at the time? They find the deals busy and as a follow-up, do you expect all the relevant markets to be covered in terms of products being launched by the end of this year, excluding of course China where you have to, where more trials have to be done, but just wondering if it will have everything covered by the end of this year. And as a third question, I will ask is on the Zevtera and the potential for third trial. How has your thinking evolved with potentially conducting a third trial for Ceftobiprole in collaboration with BARDA, I am just wondering if it is sort of a free option to you given that the cost would be covered, and it gives you the opportunity of having three trials in case, something doesn't go as quite as expected that you always have those two profitable trials to ensure that you can file in the U.S.? Thank you.

David Veitch

It’s David here. I’ll start off with the commercialization questions, and I will leave Marc to comment on those two versus three trials for Zevtera in the U.S. I mean, just to come back to the big picture, so I would say that now with the exception of the U.S. whereas you heard we have this Phase 3 program with the aim of getting an approval for the U.S. for Zevtera, which is the critically important market for Zevtera and we have a plan there. Pretty much everywhere else. All the other major markets for both Cresemba and Zevtera when you look at market potential are covered by our existing agreements.

Just to be, again clear though, we have our matching authorization in Europe already for a few years and we launched ourselves in Europe. So actually, for Cresemba and for Zevtera. So, actually the partners that took over Europe we transitioned those markets that we had already launched into Pfizer, and to Cardiome last year, and then as I said, Pfizer have already launched in a new market, which is Spain and they plan other launches this year, and Cardiome will do likewise.

And so actually where we had a matching authorization things are on track and the early feedback is similar to we have which is, it’s positive feedback I mean I think we haven't guided separately in terms of sales for the two products but obviously the majority of the sales at Cresemba and for Cresemba the feedback we get is very similar to what we had in the sort of, the early signs are similar and it is all positive. I mean I think the other parts of the world, which obviously covers a lot of the world there we are actually going through because we did not have matching authorization when we signed the agreement.

The first stage is to support them with the regulatory submissions and then subsequently get from the - exceptions get approvals and get launches. And basically, as we speak during the course of 2018, we will be launching in other countries around the world that cover places like Latin America, Middle East North Africa. So, there are many countries this year that have planned to launch from other partners, and like I said they cover many of the geographies where we had to get a regulatory approval ahead of then sales staff and hopefully that makes sense. I don't know if I have fully answered your question, but - does that answer your question about commercialization?

Unidentified Analyst

Yes, that is fine. I was just trying to get a feel for how long it will take to get BMA's and launch all these missing markets, because it is quite a lot of countries and I believe that you launched in a few of those before, but given there is a lot of partners in place, and they have all the - they have the people on the ground, it should be fairly quick, I would have thought for them to get all the BMA standard and go ahead with launching. So, I just want to get a feel for how effective that was going to happen?

David Veitch

Yes, I think if I would characterize it, because it’s not just a query, I mean the regulatory submission process is actually different for the two brands in many respects because Cresemba being an orphan drug in many geographies seems to have a speedier regulatory pathway Zevtera has a more standard regulatory pathway and then some of the processes in some of these geographies takes longer than other geographies. So, there is really a staggered sort of launch rollout, I think 2018, 2019, probably the last 20 and then as you alluded to actually, you know for China, for Japan where we have potentially or actually faced three studies or additional clinical programs to run, they are obviously more like on a time line up to potentially the U.S. type timeline. So, different markets have very different timelines, but the good news is that 2018 was a number - quite a number of launches. And Marc do you want to take the question about the two versus?

Marc Engelhardt

Yes, so I think it was a question about our Phase 3 studies in terms of ABSSSI, so the skin study, the staph aureus bacteremia study and the potential community-acquired pneumonia study. The way we've been looking at this was really from our medical need perspective. The staph aureus bacteremia study in our view point has the highest medical need that are only very limited treatment options available, and Ceftobiprole can be clearly differentiated with a number of advantages over for example, daptomycin. There are aspects like gram-negative coverage for mixed or polymicrobial infections, efficacy in lung infections, and also low propensity to resistance development.

So, this to us is a key indication and then combining to this, we believe that the ABSSSI indication has a number of reasons why it’s the preferred combination study, one of which is that there is a high prevalence of staph aureus infections in skin, which is less so in community acquired pneumonia. The other part is that from a medical need perspective, this staph aureus prevalence, together with a lot of mixed infection in gram-negative kind of provides the coverage of medical needs with Ceftobiprole even in ABSSSI, where there are clearly more alternatives out there. The decision whether to conduct an additional community applied pneumonia study, which we could do will be taken at a later point in the BARDA contract, this is also timeline wise at a later stage, and I think we will now see how the two studies that are in our key interest, SAB and ABSSSI, are progressing and make a definitive decision at a later time point.

Unidentified Analyst

Thank you very much. I’ll jump back in the queue.

Operator

The next question comes from Bruno Bulic, Baader-Helvea. Please go ahead.

Bruno Bulic

Hello, good afternoon. I would have a question on your R&D costs reported for 2017. I'm trying to figure out how much you had actually for Ceftobiprole and how much you had for oncology. You reported about CHF53 million R&D costs 2017, which should be about CHF 42 million net of BARDA reimbursements, if I'm correct. So, the first question is how much is oncology in the mix, and how much is Ceftobiprole? Then a second question about R&D costs net of BARDA expenditures, those CHF 42 million. The correct base to extrapolate R&D cost in 2018, and if we should assume an increase also of the oncology expenses in the mix for 2018. And a follow-up question later, if I may.

Donato Spota

Hello Bruno, this is Donato speaking. I will take the two first question, and so, as you know we have not indeed have disclosed what portion of our developed or R&D cost is oncology related and which one is related to the other compounds, primarily Ceftobiprole. But I think generally speaking I can say taking everything together on a net basis it is probably meanwhile around 50/50 split. So, the 42 million that you indicated is actually correct. For the cost net of BARDA reimbursement as you can see from the financials we got 10 million from BARDA reimbursed last year. Now, going forward, I think what you are trying to get to, is it correct that we anticipate a significant increase in the development cost, the R&D cost, while as I said, I think we will increase the investments in both the Ceftobiprole U.S. program. We have started to rollout patients now into skin study and we will start also rolling out in the bacteremia study. So, this will add to the cost and we are also planning to increase our investments in all the assets.

Bruno Bulic

Okay, thank you. And then very briefly about the cost of goods, would you expect a decrease in cost of goods after the out-licensing of Zevtera and Ceftobiprole?

Donato Spota

Well, this is again Donato, as you know under the agreements that we have on the distribution agreements, but also for at least for certain period of time on the agreement which we have with Pfizer. We are providing products, selling products to the partners. So, for the time we are doing that we will probably see an increase in the absolute number of cost of goods going along with the expected increase in sales.

Bruno Bulic

Okay. Thank you.

Operator

We have of follow-up question from Ms. [indiscernible]. Please go ahead.

Unidentified Analyst

Hi to everyone. I have got to left. The first one is sort of the big picture of you and your pipeline, if I take the birds eye view, and on Basilea I see two products in the markets commercialize and growing very nicely, and then I see an early stage oncology pipeline and I am sure what investors ultimate thinking is, how you are going to bridge that gap in the middle of having something sort of late stage, but could hit the market in the next couple of years or so? So, without wanting to up some of your current displays, but what are you looking to seeing that you could potentially bring in-house, either through licensing deal or else? And what sort of areas are you focusing on more and more inclined to look for something in your oncology space, are seeing interesting things in infection disease space? And then the second question, tricky question not sure you can answer, but any indication on actual Zevtera in markets sales? I have got a number somewhat below 20 million, but I'm just wondering if you can provide any clarification on that? Thank you.

Ronald Scott

This is Ron. I will take the first question that you had related to the bird’s eye view of our pipeline, certainly we are focused on increasing our R&D pipeline both early-stage and late stage. And we’re very active like doing that with of course not only from our internal research for the earlier stage opportunities, but also from external, you know that we have added certain compounds to our portfolio like 3833 was something we have brought in from in collaboration with the welcome trials, and we are continuing to aggressively look for opportunities externally. We would hope to be able to add additional compounds to our portfolio this year.

We are looking in both the areas that we are active again focusing on overcoming resistance in the area of oncology and in any infectives. There are more opportunities in oncology. There are a few opportunities that we find that are really adding significant clinical benefit in the area of any infectives, but of course in oncology where there are more opportunities there is also more competition for assets. So, we have been able to be active and are identifying opportunities even where there is more competition you have oncology. However, we continue to look for any effectives that our interesting, it is just there are many fewer opportunities there. I’ll turn over to David to respond to your end market question.

David Veitch

Yes. The question was - we don't break out the sales individually by products. So, your question, I can't give you a direct answer, what I would say though is that if you look at analyst reports on the potential globally of Zevtera it is anything in the range of 250 million to 550 million and our own thinking we don't give long-term guidelines, but that is what we see from analyst reports, and as I said earlier in my few words earlier, the USA and China and by far the USA is the most critical market for us.

So, the fact that where we will access and if you look at recently launched brands, similar brands to Ceftobiprole that are active against MRSA, anything from between 70% to 90% of their sales were in the US marketplace. So, actually that’s why it’s good that we’ve got a plan and mark out line in the plan to access, potentially access the US market. So that’s what I would say. The good news is we have a plan for both the USA and China and then we will realize hopefully the biggest part of the potential that is Ceftobiprole.

Unidentified Analyst

That’s very helpful. So, I guess we should see this sort of the typical hockey stick then for Zevtera where we sort of have more long-term weighted, if you wish. That’s very helpful. Thanks so much.

Ronald Scott

Okay.

Operator

We have a follow-up question from Mr. Bob Pooler. Please go-ahead, sir.

Bob Pooler

Just a follow-on question on the checkpoint controller BAL101553, when do you expect the next clinical read out and also when do you expect the first glioblastoma results to report?

Marc Engelhardt

Hi Bob, this is Marc. So, we have completed two Phase 1 studies recently. Those escalation studies in advanced solid tumor patients, with daily oral dosing and the 48-hour infusion regimen and these will be presented at the upcoming scientific meetings in 2018. So, we have submitted them and we will see when they are accepted and they will be presented in around June timeline, otherwise we will present them later in the year.

The glioblastoma, there are currently three studies, one is the daily oral dosing in the UK that’s a dose escalation safety study then we are planning to start a study with 48-hour infusion that’s also recurrent glioblastoma in Switzerland and we have a combination study with radiation with standard radiotherapy in the U.S. and in patients with newly diagnosed glioblastoma. So, the data from these ongoing studies will accumulate and we expect that we will have some efficacy read-out depending on the progress on the study throughout 2019.

Bob Pooler

Okay. Thank you.

Operator

Gentlemen, that was our last question.

Ronald Scott

I would like to thank you for your interest in Basilea and your participation in our call today. We’re very pleased with the foundation that we have financially to be able to - with the revenues that we have to be able to finance Basilea. I think we have established a very solid foundation for growth, long-term growth, and sustainability of our company. We are actively looking to extend our portfolio with the compounds we have currently in our portfolio bringing them into the market and then adding additional compounds from both our research and from external sources, and so we would look forward to being able to accomplish that as far as expanding our portfolio further this year. It’s really a focus that we have this year. So, we look forward to being able to provide you more information from my colleagues as we go forward. And thank you for your interest in our call today. Thank you very much.

Operator

Ladies and gentlemen, the conference is now over. Thank you for choosing chorus call and thanks for participating in the conference. You may now disconnect your lines. Goodbye.