Ladies and gentlemen, thank you for standing by, welcome to the third quarterly report for the nine-month period ended 30 September 2019 conference call. At this time, all participants are in listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one on your telephone. I must advise you that this conference is being recorded today, Thursday, 7th of November 2019 . I would now like to hand the conference over to your first speaker today, Rolf Sørensen. Thank you. Please go ahead.
Yeah, thank you. My name is Rolf Sørensen , Investor Relations. With me, I have CFO Henrik Juuel, and on the line from the U.S., I also have President and CEO Paul Chaplin. Before we start the presentation, I will read the following statements. This presentation include forward-looking statements that involve risks, uncertainties, and other factors, many of which are outside of our control, that could cause actual results to differ materially from the results discussed. Forward-looking statements include statements regarding our short-term objectives, opportunities, financial expectations for the full year, and financial preparedness as of year-end, as well as statements concerning our plans, objectives, goals, future events, performance, that is not historical information. All forward-looking statements are expressly qualified by these cautionary statements.
We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law. With this, I will hand the presentation over to Paul Chaplin.
Thanks, Rolf, and welcome everyone to our Q3 announcement. I think 2019, or the first nine months of 2019, we've really outperformed where we wanted to be. I think 2019 will always be remembered as the year that we took a highly promising company, strong in R&D, and manufacturing, and took it to the next level through the planned acquisition of the two products, Rabipur and Encepur, from GSK. Earlier this year, we came out with a vision that by 2023, we wanted to be a leading and profitable biotech company. With this transformative deal, we've basically accelerated that vision by three years. It's not just only on the commercial ambitions where we've been strong.
With the approval of JYNNEOS, our first FDA-approved vaccine, with the expanded indication of monkeypox, we have truly maintained and cemented our global leadership in smallpox vaccines. On infectious diseases, we've seen numerous advances. Today, together with our partner, Janssen, we announced the filing of approval of our combined vaccine for Ebola in Europe. We've advanced our freeze-dried vaccine into phase III. We've advanced a new vaccine against emerging infectious disease spread by mosquitoes, equine encephalitis, into phase I. We've finalized our plans for RSV. Again, on our immune oncology, although we've had setbacks, we continue to move forward and are encouraged by the new advances and the new technologies that we're bringing forward.
Of course, on commercial, now with the acquisitions or the planned acquisitions, we will build up a commercial infrastructure that will be synergistic with JYNNEOS, but also for other future products through launches such as RSV, but also through future M&As. On Slide four, it's been a truly transformative year that will accelerate our pathway to profitability, and we're already guiding now that we expect profitability in 2020 at the EBITDA level. With the approval of JYNNEOS, not only did it come with an expanded indication, which I'll get to, will have significant impacts in terms of our future revenues, it came with a priority review voucher, which we intend to sell.
We also initiated a fully funded phase III study for the freeze-dried version. This is particularly important as this will also unlock future value. We currently have $300 million in a current order from the U.S. government, which will be unlocked when the facility comes online and the freeze-dried version gets approved. This study, which was initiated, is extremely important. The acquisition of the two commercial vaccines from GSK, as I said, accelerates our vision by three years. It exploits significant manufacturing synergies. All of our products are manufactured using eggs, which we've become a world leader in. These products will generate, together with JYNNEOS, a strong cash flow, which will allow us to invest in our exciting pipeline. For RSV, we've finalized the design. We've announced today that we'll be initiating that study in 2021.
On Ebola, we've seen numerous events. We've seen studies initiated in Uganda, the donation from our partner, Janssen, of 500,000 to Congo. The event today that we're filing for approval in Europe. Equine encephalitis is, it's a new emerging infectious disease, where there's a current large outbreak in the U.S., has entered phase I and is fully funded by the U.S. Our fill-and-finish facility, which will unlock future commercial opportunities, remains fully on track in terms of budget and timeline, as does our guidance for 2019.
As you'll hear from Henrik Juuel later, we fully expect profitability in 2020 at the EBITDA level due to our improved and increased commercial activities. On Slide five, we now have generated or will generate, when the acquisition is complete, a leading infectious disease commercial franchise with JYNNEOS for both smallpox and monkeypox, Rabipur for rabies, and Encepur for tick-borne encephalitis. These will be generating strong cash flows that will allow us to invest in our exciting pipeline. We have some exciting mid to late stage programs. We have our Ebola program, where we've just filed for approval in Europe, which we expect approval next year. Our smallpox vaccine has entered phase III. The RSV vaccine, where we've finalized discussions with the FDA, and we're going into phase III in 2021. Our BN-Brachyury in chordoma that's generating some really exciting results.
This is further supported by some early stage programs, not only the programs we've partnered with Janssen, but there's future milestones and revenues. We've got our equine encephalitis, which is a really exciting opportunity, which could be synergistic with many of the commercial opportunities we already have, and our new exciting, cancer vaccines coming through next year. On Slide six, JYNNEOS is our first FDA-approved vaccine for smallpox and monkeypox. It's the only approved, FDA-approved vaccine that's unreplicated smallpox vaccine and the only vaccine that's approved against monkeypox. As I said, it's come with a priority review voucher, which offers another opportunity to have a cash injection into the company, if and when we sell.
On Slide seven, those of you who've been following the company know a lot about our smallpox, which has allowed us to build our commercial, allowed us to build up our company to what it is today, and it's been primarily on delivering vaccine through stockpile. We've already delivered 28 million doses to create this initial stockpile to protect 10 million U.S. citizens before approval, under what we call an Emergency Use Authorization. Post-approval, the U.S. government has always said it wishes to build up a capability to protect 66 million Americans against smallpox, who really shouldn't receive the current, the other version of, that's approved, ACAM2000, and that's 132 million doses.
We currently have an order under our pre-strike contract to convert all the bulk that we've manufactured to approximately 13 million doses, which will unlock this $300 million of revenue. 13 million doses, as you can see, does not go a long way to fulfilling either of the U.S. government's ambitions, pre-approval or post-approval. We believe there are new opportunities lying ahead. It's not just about stockpiling. Now there's an approved, safer alternative vaccine, we believe there are alternatives other than stockpiling. Currently, there are 50,000 soldiers that are vaccinated with ACAM2000. That offers an immediate opportunity. Obviously, with a safer alternative, the U.S. may change the policy and vaccinate all new recruits, which would be approximately 500,000 doses a year.
Obviously, if they vaccinated all military personnel that are currently employed, that would be three million people. In addition, there's an existing policy to vaccinate anywhere between 0.5 million-10 million healthcare workers, and obviously the millions who wish to be vaccinated, which offers another opportunity in the smallpox market just in the U.S. On Slide eight, however, it's not just about smallpox. We obviously have the expanded indication of monkeypox, and are the only approved vaccine against this indication. Monkeypox is a closely related disease. There's currently an ongoing outbreak in Nigeria, and the potential here is to sell the vaccine to people living in endemic areas, people traveling for business, leisure, or charity, multinational companies that are operating in that area, such as oil companies, which have a lot of activities in Nigeria.
Just based on the Nigeria opportunity alone, we are predicting peak sales of around $65 million. That's over and above what we've been historically seeing for smallpox, which is between $50 million and $100 million a year. Of course, this could further expand, based on numerous different things, whether there are more travelers other than the U.S. going into Nigeria, with an expanded indication, WHO recommendations, ACIP recommendations, all could have an effect. Our prediction here on 65 is just based on the Nigeria situation alone. Great opportunities for JYNNEOS in the years to come. On Slide nine, obviously with the proposed acquisition of Rabipur and Encepur, we'll be creating a leading infectious disease franchise together with JYNNEOS.
Both Rabipur and Encepur are two highly effective, established vaccines with strong revenue streams, expected to be $175 million in 2019 and growing, and with attractive margins. As I've said, the opportunity here is that there's gonna be great synergy in manufacturing, as it's all based on our egg-based technology, so we could leverage those super synergies in the years ahead. Slide 10, to talk about the pipeline. With RSV, we've now finalized the design. It's in line with what we've guided before. It will be a randomized, placebo-controlled study with an adaptive design, meaning we'll vaccinate anywhere between 12,000-14,000 subjects over two seasons. The first season, which will start in 2021, will be 6,000 subjects.
The total number of subjects will depend on the independent analysis performed after the first season, which will also include futility. If we pass that futility threshold and go into season two, there's approximately a 75% chance of success of reaching the efficacy endpoint at the end of season two. The first season will cost $40 million, and the second season will cost an additional $50 million-$70 million, depending on the total number of subjects. Anywhere between total cost of $90 million-$110 million for the trial, but $40 million to get the initial efficacy readout and the chance to move into season two with a 75% chance of success.
Due to the additional time we believe we need to develop an improved commercial scale production, but also formulation, we're actually planning to initiate this study in 2021. On Ebola, on Slide 11, obviously, with the news today, surpasses this slide in that our partner, Janssen and BN, have now announced that we're filing the MAA in Europe, which we hope will come under an accelerated review and approval next year. That approval will trigger a $10 million milestone for under our collaboration. It's not just the filing where we've seen great progress this year. We've seen in Uganda, a trial being initiated to vaccinate 800 healthcare workers.
Recently, Janssen, our partner, donated 500 doses to the Congo, we're all hopeful that these activities will help assist contain the outbreak and together with the other international efforts, hopefully, control this outbreak and eliminate it. Slide 12. Equine encephalitis is an emerging infectious disease that's spread by mosquitoes. There are three different viruses. There's the Eastern, which is often referred to in the U.S. as Triple E, where there's currently an ongoing outbreak, Venezuelan and Western. While they differ in their severity, they can cause flu-like symptoms and can also then lead to neurological infections, and unfortunately, through encephalitis, death. In the U.S., currently, 30 cases have been reported this year, also nine deaths. About a third of the people that actually develop symptoms can actually go on to die.
This is a serious disease that's emerging, that's being spread by mosquitoes, and we've just entered phase I this year in a program that's fully supported by the Department of Defense in the U.S. Obviously, with phase I results coming out next year, we'll have to see whether that leads to future funding or whether we, as BN, take this program forward, as this could be highly complementary with some of our other commercial assets we already have. Looking at the cancer portfolio on Slide 13, our focus now remains primarily on BN-Brachyury in combination with radiation therapy in chordoma. We came out with some exciting results earlier this year, which led to an expansion of the study, which was enrolled very rapidly.
We now expect top-line results no later by the end of next year. We're keeping a close eye on those results. Our other focus remains on our new approaches, one of which was recently published in Nature Communications earlier this week, which is the intravenous application of constructs encoding CD40 ligand. The initial study looking at the safety of this approach has already been initiated using MVA-BN Brachyury, with the hope that the next generation constructs, both intravenous and intratumoral, will enter the clinic in the next 12 to 18 months. Again, some exciting opportunities, albeit early stage, in immunotherapy. Looking at Slide 14, we have, over the last couple of years, been investing $75 million to expand our manufacturing capabilities at fill-and-finish. We did this for numerous opportunities.
One was we were encouraged by the U.S. government for our freeze-dried order to bring the whole manufacturing in-house. We also knew it would give us new commercial opportunities to look at bringing in products like Rabipur and Encepur. This program remains fully on track. The construction and equipment will be in place by year-end, and we'll start all the qualification activities next year. The current bulk facility will be adapted to allow the integration of the two products we're requiring from GSK, which will occur next year. To allow an increased capacity and an ability to produce products in parallel, we'll be investing in a new clean room suite starting from next year. That, as I said, will allow us to produce products in parallel and improve our capability of producing even more products in the years ahead.
These investments will allow us to support our ongoing partnerships, such as the U.S. government orders, and also our partnership with Janssen, but it will also allow us to look for new opportunities to bring other products, either through commercialization of our pipeline or for future M&As. With that, I thank you for your attention, and I'll hand over the presentation to Henrik Juuel.
Thank you, Paul. Let's turn to slide number 15, which gives you an overview of the results for the first nine months of 2019. The key message really is that we are maintaining the previous guidance for the full year, which spells out the revenue level of DKK 600 million expected for the full year, and an EBIT loss of DKK 360 million. Finally, a cash preparedness of around DKK 1 billion. The DKK 1 billion guidance was updated in connection with the announcement of the acquisition. It assumes both the payment of the upfront payment for the acquisition, EUR 301 million, and the bridge loan of EUR 270 million from the two banks as supporting us with the rights issue process to take place next year.
Looking at the numbers for the first nine months, a revenue level of DKK 372 million, consisting of DKK 130 million, coming from the manufacture and revenue recognition of eight Imvamune batches for BARDA in the U.S. We have, for the full year, guided that we will produce and revenue recognize 20 batches, so we have 12 more batches to be revenue recognized in the fourth quarter, and we are on track to deliver on that. The other part of the revenue for the first nine months, that's DKK 242 million, mainly driven by CMC activities and Phase III lot consistency studies funded by BARDA, and then our equine encephalitis project funded by the U.S. Department of Defense.
Finally, the numbers here, again, enables us to reiterate the guidance for the full year, and as usual, we are not including any potential income from the sale of the priority review voucher we have. Turning to the next slide, number 16. Here, a key message is that we continue to have a very strong financial position, enabling the continued execution of our strategy. The cash preparedness at the end of September was DKK 1.7 billion, sufficient enough to take us to profitability on a Bavarian Nordic as-is basis, and puts us in a very strong position going forward.
On the next slide, number 17, just want you to remind you of the financial impact and contribution we expect from the two acquired products from GSK and put it into perspective with regards to the preliminary 2020 guidance for the combined company. First of all, as you will recall, the two products that we are acquiring are two well-established products that together, for this year, is expected to deliver revenue of EUR 175 million. These products are highly profitable and cash generating from day one, basically. The margins expected from these products will improve during the transition period, and we will see the full impact of that being above 50% EBITDA margin post the full transition in 2025.
We do expect a starting point in terms of profitability in the range of 30%-40% EBITDA margin. Slightly lower, could be five to 10 points in 2020 due to expected non-recurring integration costs. If we combine that with the expected business development and profitability for the current Bavarian Nordic business, we are right now in a position to give a preliminary 2020 guidance, saying that we will deliver positive profit on an EBITDA level for 2020. Again, this does not include any income from the sale of the priority review voucher. On the final slide, just the usual overview of our priorities and goals for this year. As Paul said, I think really within our smallpox vaccine business, we have made very significant progress this year.
Of course, with the approval of JYNNEOS in the U.S. and the associated award of the priority review voucher, but also the initiation of the phase III lot consistency study, that will eventually, with the approval of the freeze-dried version, together with the fill and finish facility, will unlock significant future revenues. Within the other strategic focus area, the other infectious disease programs, we have now finally communicated our RSV plan and made the agreement with the FDA, and we are planning to initiate the study in 2021. We have also, together with the Department of Defense, initiated the phase I dose-finding study of equine encephalitis virus into this new and emerging market. It could be a very interesting market for the future. We have previously reported that we expected Janssen to initiate a phase I/II study within HIV.
This has not happened yet, and it's not within our control. Given that we are in November, I think we should probably more expect this to move into next year. What we don't have on this strategic focus area is the Ebola filing, which was announced today. Had we known it would come this fast, we would probably have put it on the list for this year, but we are very happy that it is progressing this fast, of course. Third strategic focus area is our cancer immune therapy portfolio. Here, as Paul said, we have reported positive data from our BN-Brachyury phase II study, which enabled us to progress into stage II, and within a year, approximately, from now, we should be able to have the readout from that study.
On the initiation of phase I studies in the new administrations, IV and IT, that is in progress to happen soon. On CV301, unfortunately, we did not see the positive result, the results we had hoped for in the stage one of the bladder study, which meant that we are not progressing this study into the stage two with an expanded enrollment. Again, as Paul also alluded to, our focus right now within the cancer immunotherapy is really on the BN-Brachyury, the new administration forms, and of course, also our new constructs going forward. The final strategic focus area, which is about the expanding the commercial footprint and our capabilities. The key task for this year will be to finalize the construction of our fill-and-finish facility, which is on track to happen.
Obviously, for next year, post the closing of the acquisition, our focus in this area will be to establish the commercial operations and grow the business from there. Quite an eventful year so far for the company, with a lot of significant progress made. With that, I would hand back to the operator and ask for question and answers, please.
Thank you, ladies and gentlemen. We will now begin the question-and-answer session. As a reminder, if you wish to ask a question, please press star one on your telephone and wait for your name to be announced. If you wish to cancel your request, please press the hash key. Once again, please press star one if you wish to ask a question. Your first question comes from the line of Michael Novod from Nordea. Please ask your question. Your line is open.
Thank you very much. Yes, it's Michael Novod from Nordea Markets in Copenhagen. Just a question to Ebola, we just saw the Janssen filing. Could you talk a bit about the discussions you also have with Janssen? Because it is a while since you entered the deal. We know that they're giving away around 500,000 doses. How many doses do they have left? We have a feeling for it, but maybe just give an update on that. What happens if they need more doses, they need to acquire them from you? What kind of financial terms would be on that? I can't recall, when you did the deal, were there any milestones attached to approval, either in Europe and in the U.S.?
Of course, also, do they expect to be able to file for approval in the U.S. as well? That's a lot of questions in one, on Ebola.
Hi, Michael. Thank you for the questions. The first one was the number. Yes, Janssen has donated half a million. I think, you know, I think publicly, we've talked about that they have one and a half to two million doses in various forms, whether it's in bulk or final product. There are still doses available. However, you know, these doses were manufactured some time ago, they're not gonna last forever. In terms of the terms, if there are new orders, you know, Under the initial agreement that we had, that was a one-off order. We've, we've stated that we would need to basically negotiate new orders as and when they come in, we don't have terms set up of that.
In terms of milestone payments, yes, there is a $10 million milestone payment on the first approval, whether that is in Europe or the U.S. It now looks like it's most likely gonna be in Europe. We, the partnership, is in dialogue with the FDA. The reason why Janssen BN have filed in Europe first is simply that the requirement is just a little bit different between the two regulatory bodies. We do anticipate to file in the U.S., but I'm not at liberty to say when that will be. But yes, there's a $10 million milestone on the first approval, as I said, whether that's in the U.S., if they catch up for, you know, if we catch up there or in Europe.
Maybe just a follow-up. Do you have any kind of discussions with them regarding what to do if they need new doses, et cetera? I know it was a one-off order that you got it back then, but on the other hand, they have a vaccine regimen that doesn't work if they don't have yours. I'm just thinking if there's any sort of dialogue between the parties around what happens if we suddenly need WHO to build up a stock pile, et cetera.
Yes, we have a very close relationship, so there's always dialogue.
Okay. Thanks.
Your next question comes from the line of Boris Peaker from Cowen. Your line is open. You may ask your question.
Good afternoon. This is John Scott on for Boris. Can you comment a little bit more on what were the specific gating factors that led to the decision to start the RSV trial in 2021 rather than 2020? Do you envision that RSV vaccine being produced in the facility you have under construction now, or would you be looking at outsourcing that to a contract organization? Thanks.
Yeah. Thanks, John. No, we'll be manufacturing it in our facility. The reason why we're going in 2021 is there's multiple factors, really. One of them is actually manufacturing. The way we manufacture currently is using wave bags and wave rockers, which has been, you know, very successful for JYNNEOS and other products going into the clinic. However, it has limited scalability because the wave rockers are quite large, and obviously, our facility only has a certain size. We have actually, over the last 18 months or so, been moving to bioreactors, which obviously offer a different scalability. Because RSV clearly has a different market potential than the other products that we're manufacturing.
In addition to that, we've been looking at new formulations because we believe the current formulation that we're using for JYNNEOS is, it could work, but it may not be ideal because likely you wanna ship RSV vaccines and allow at least six months storage at two to eight, which is a challenge for our current formulation. We are working on new formulations, and we know we need more data to be able to really decide whether we move forward. It's basically really making sure we have the commercial formulation and process really locked down before we move into phase III, and we will be manufacturing in our own facility.
Okay, thanks. Maybe just a quick one on CV301. Are there going to be new trials planned that we should expect to see, or is that kind of being put on the back burner in favor of the brachyury vaccine?
Yeah, we still have two ongoing studies, which are investigator-led studies. CV301 in colorectal cancer in combination with BMS's drug and CV301 in colorectal and pancreatic cancer with AstraZeneca's. Those studies are ongoing. You know, we support the investigators in those studies, and as and when they become available, we will report them. Our strategy for CV301 was to do three studies in three different indications with three different checkpoint inhibitors and see if we could get a signal of efficacy. Clearly, in bladder, we didn't get that signal, so we're not continuing. The other two studies will continue, and we will report if and when we get a signal.
Our primarily company focus, in terms of our sponsored studies, is, as you said, is on Brachyury, and our new approaches with IV and IT.
Okay. Thank you very much for taking my questions.
There are no further question at this time. Please continue, sir.
Okay, well, thank you everyone.
Oh, we have one, sir.
Okay.
We have one coming up. It comes from the line of Peter Welford from Jefferies.
Hi.
Go-
Hi. Yeah, sorry, but thank you for taking my question. I think there was a technical issue there. Just a couple of things. Firstly, just on RSV, I understand the explanation you gave us to what you're doing. I guess my question would be, why wait to do that until you have the FDA, you know, sign off, if you like, for the phase III design? What was it perhaps that led the decision to start that now, given, you know, presumably some of that could have been initiated beforehand. I guess curious to understand the timing there.
Secondly, just again, sort of on RSV, with regards to the discussion, I think previously we had, we understood that part of it was obviously about the interim and the futility of 6,000 patients, which you've confirmed. I think also then there was a lot of discussion as well on how you measure respiratory tract infections and sort of how you look at the interim and what an acute respiratory disease episode looks like. I wonder if you could give us any visibility, I guess, on what the agreement with FDA is, with regards to the chosen endpoints and how that therefore would impact the study readout and I guess, interim analysis that will occur? Thank you.
Thanks, Peter. Yeah, I mean, it's not like we've just started the manufacturing activities. They've been going on in parallel, of course, they've been also part of the discussions we've had with the FDA in terms of we've obviously done clinical studies with a different process up to now, then we're changing, going to phase III. That's all been part of the discussions we've had with the FDA. I think unfortunately, the issue came down to have material available to start the study in 2020, we would actually had to have already manufactured the material. We're simply not in a position to do that.
We don't have sufficient data on the formulation to go into a $40 million investment for season one. We need a little bit more work on the process. It's basically the two activities were going on in parallel. Of course, there are discussions on CMC with the FDA as well. We just need a little bit more time. Regarding endpoints, it's a good question. We've deliberately left that off the slide. We're very happy with the discussions we've had with the FDA, but we don't want to reveal what our endpoints and how we'll measure them are at this point. Obviously, we'll do that when we get nearer to initiating the study.
Okay, that's great. We'll wait and see. Thank you very much.
All right, thanks.
There are no further question at this time. Please continue, sir.
All right. Well, thank you everyone, for taking the time for the questions. We appreciate the support, and thank you very much. Have a great day.
That does conclude our conference today. Thank you all for participating. You may all disconnect.