Thank you for standing by and welcome to the Half Year Report Q2 for the Six Months Period Ended June 30, 2021 Conference Call. At this time, all participants are in a listen-only mode. There will be a presentation followed by question-and-answer session. [Operator Instructions] I must advise you the call is recorded today, Wednesday, August 25, 2021. And I would now like to hand over to your speaker today, Mr. Rolf Sass. Please go ahead, sir.

Thank you, operator and welcome to everybody listening in. Good morning to some, good afternoon to the rest. And welcome to our Q2 presentation after what have been a couple of very, very busy weeks for Bavarian Nordic. With me today I have President and CEO, Paul Chaplin; and Assistant Vice President, CFO, Henrik Juuel. And before we start our presentation, I will briefly read the statements about this presentation that includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside our control, that could cause actual results to differ materially from the results discussed. Forward-looking segments include statements regarding our short-term objectives, opportunities, financial expectations for the full year as well as statements concerning our plans, objectives, goals, future events, performance and information that is not historical information. All such forward-looking statements qualified by these cautionary statements which may accompany the forward-looking statements. We undertake no obligation to publicly update forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law. So with this, I will hand over the presentation to Paul.

Thanks, Rolf and welcome, everyone, to the Q2 update. If you turn to Slide 3; just before I get into the highlights for the first six months, I just want to talk a little bit about the company and where we're heading. So by '25, we aspire to be one of the largest pure play vaccine companies, improving and saving lives by excelling in R&D innovation, manufacturing and commercialization and we're well on the way to that journey as I speak. We have four marketed products against rabies, tick-borne encephalitis, smallpox and Ebola and that is really driving the profitable growth of the company over the coming years. To that end, obviously, in the last 18 months, we've begun a transition to a full-scale commercial company. And we have set up a commercial infrastructure in record time which supports our key markets in the U.S. and EU and I'll come back more to how we're doing in terms of our commercial excellence. We have established a full commercial manufacturing facility here in Denmark, where we can do everything from drug substance to now fill-finish-and-pack and we've set up a worldwide distribution network for our products. The first product is already established on our new fill-and-finish line which is our smallpox vaccine, JYNNEOS and that's already been inspected and approved by the regulators. And as you know, we're also expanding this facility, as we speak and that expansion remained on time and on budget which would be part of the transfer of the production of the two products we acquired last year for rabies and TBE. On that pipeline and I'll come back to that in the coming slides, we've see a lot of progress in the last few weeks, where we have an RSV, late-stage asset, where we have HUMAN challenge trial data coming very shortly. And on COVID-19, of course, the big topic of the day, we've gone from strength to strength, reporting fantastic data and obviously securing the funding which will allow us to accelerate this product all the way to licensure. So as I said, really, well on our road to reaching the vision that we have for 2025 to become one of the largest pure play vaccine companies. So if we go to Slide 4; when we came out with our guidance earlier this year, we came out with a range. The upper part of that range was a reflection of what we hoped would be a recovery of some of the markets, particularly for rabies and TBE as we came out of the COVID pandemic. And the lower end of that range reflected, unfortunately, the reflection that is COVID still impacted both of the markets for rabies and TBE. And as we've seen from our Q2 announcement, unfortunately, we still are facing strong headwinds for COVID-19. On rabies, it particularly impacted our sales in Europe due to the lack of international travel. And I'm sure Henrik will walk you through some of the more details later on. But then we've seen basically a 90% decline in the market in Germany. On TBE, it's a slightly different story. We had signed the initial recovery in Q1. But as you can see from later in the slides, we saw a decline in Q2 which is unexpected. But due to the fact that in one of our major markets, Germany, most of the physicians were too busy with COVID vaccinations and that has, in fact, affected the TBE sales. So, all the reduction in sales or the difficulty that we're seeing is purely related to COVID and not the execution in terms of our commercial strategy. So unfortunately, for that reason, we are firming up our guidance in the lower range. On the pipeline; we've really gone from strength to strength in the first six months. On COVID-19, we reported some of the best clinical data that anyone has reported for a COVID-19 vaccine and I'll come back to that more in the coming slides. We've initiated Phase II which we will report data later this year. And this, we had a milestone event in that we secured funding from Danish government which now will allow us to accelerate based on obviously positive Phase II data into Phase III next year with an approval hopefully no later than '23. On RSV; we're weeks, months away from an exciting announcement, hopefully on the human challenge trial data which hopefully will derisk the future development moving into Phase III. And on smallpox, we shouldn't forget there's a lot of activities ongoing. And while we have transferred the liquid frozen smallpox already to the line and new fill-and-finish line in Denmark, we have begun the tech transfer of the freeze-dried product. So an extremely busy and active in successful activities in terms of our development programs. So, I want to spend a little time talking about ABNCoV2, COVID vaccine candidate. So, if you turn to Slide 6; so as I said earlier this year, we had a milestone event in that we were able to finally secure funding from the Danish Ministry of Health, who has pledged up to DKK800 million to support the development of ABNCoV2 all the way through to licensure. Bavarian Nordic is already committed to invest up until the end of Phase II, including the scale up for Phase III. And with this announcement from the Danish Ministry of Health, we now have the full funds necessary to execute on the plans that we have to license this product. The funding will be based on milestones. So as and when we successfully meet certain milestones, we will receive payment. And repayment of this funding will be in the form of vaccines and/or royalties based on reaching certain sale volume -- annual sale volumes. So as I said, we've entered Phase II already; and for Phase III, we plan, based on positive data, to start in '22 where we will be hopefully doing a non-inferiority trial to existing or an existing COVID vaccine looking at immediate efficacy endpoint. So turning to Slide 7; again, a question I'm often getting over the last few days is, is there really a need for another COVID-19 vaccine with so many already approved? And the answer is, we believe the answer is, obviously, yes, as obviously does the Danish government. So one of the reasons is that the durability and breadth for detection is a little uncertain. There are reports already coming out this week, actually, from some clinical studies that the efficacy might wane after already six months. So maybe improved vaccines with a longer durability or protection may be needed. It's unlikely, obviously, COVID-19 will be eliminated as initially hoped and it's a disease that we're going to have to live with. So there is going to be a need for regular boosters to provide protection, particularly against the emergence of new variants that we're seeing week after week. And of course, there is a need for a worldwide distribution of vaccines and therefore, more vaccines are going to be required. If we go to the next slide, Slide 8; just to sum up a little bit of where we are. So ABNCoV2 is based on a viral like particle technology that we licensed from AdaptVac which is some technology coming out of Copenhagen University. It's a very similar technology to some of the existing vaccines -- some existing vaccines that are already approved. For example, vaccines against HPV that have been safely administered to millions and millions of people worldwide. The data that we've generated and already confirmed in a Phase I shows that it's highly immunogenic and a favorable safety profile with some exciting data showing that we get good neutralization against all the circulating variants. As I said, we've entered Phase II. We'll be reporting that data later this year and are already gearing up to start Phase III trial next year. Slide 9; the Phase I results which -- Phase I study which was funded by an EU consortium grant, was a dose-ranging study, looking at doses ranging from 60, 6-0, to 70 micrograms, formulated with and without adjuvant. And what we've seen at all doses is that it's a very well-tolerated vaccine with a safety profile comparable to other recombinant protein technologies. So a really good safety profile, no serious adverse events. The local adverse events such as pain, redness and swelling were all mild to moderate, that's Grade I or II. And the systemic events, we only saw two possibly related Grade III and these were both related to either migraine or headache and quickly resolved after vaccination. So really well-tolerated vaccine. On the next slide, Slide 10; is the new data. If you just look at the left-hand side of the slide; this is the neutralizing titers that are induced by the various different doses running from 6 to 25. And you can see a nice dose effect and what's really encouraging here is that the 25-microgram dose level, we're at a 12-fold higher neutralizing titer than the convalescent sera which is the gray. A convalescent sera is sera taken from people who have recovered from COVID. And in other publications, we've shown that if you have a comparable titer to human convalescent sera, you have -- you have at least an 80% efficacy against COVID. And here we're showing at a moderate dose of 25 micrograms with 12-fold higher than that protected level. On the right-hand side, there's also some outstanding data. Here, we're looking at the neutralizing capability of the 25-microgram dose against all the major variants of COVID. You'll see the Wuhan strain, the Alpha and Delta strain. There's absolutely no difference in the neutralizing titers. And these are all well above the human convalescent sera, as I've just described. The beta variance, there is actually a 2-fold lower neutralizing capability. However, please note that this is still way above the level of human convalescent sera. And this reduction against beta variant is much, much lower than has been reported for other approved vaccines which varies from 4-to-16 fold lower neutralizing titers. So, this is really probably some of the best clinical data, albeit in relatively small number of subjects currently but this is a very, very strong data, showing a good safety profile and a great strong neutralizing capability that is against all circulating major variants of COVID. So on Slide 11; so we are advancing, obviously, based on the excellent data into Phase II which we announced we initiated on Monday. We're going to enroll 210 healthy adults, 150 will be previously vaccinated who will receive a single booster of ABNCoV2. Another 60 individuals will be vaccine-naive or haven't been vaccinated or infected, so they don't have antibodies against COVID. And these will receive two vaccinations four weeks apart of ABNCoV2 at 100-microgram dose. The endpoint of the study is, obviously, safety as usual but it's also to look at the immune responses that we induce following either a single boost of vaccination or a prime boost vaccination in naive people. As I said, the study has already initiated and we anticipate we'll be reporting the results later this year. So, changing gears a little bit and talking about our RSV program. If you turn to Slide 13; obviously, RSV is also very prominent in the news. There is a lot of competition about to or have already entered Phase III. We have a very interesting RSV candidate, late stage, that has shown to be safe and highly immunogenic in Phase I/Phase II clinical studies. And prior to starting Phase III, we're running a human challenge study right now. That study is near to completion. Everyone has been enrolled, vaccinated and actually challenged. We're just waiting for the data to be collected and analyzed and we will be reporting that data in, as I said, shortly. This hopefully, if positive, will derisk the future development of this vaccine in Phase III. And we will be looking to start Phase III hopefully next year based on positive readout from the Phase II. So on my last slide; before I hand over to Henrik, I just want to talk a little bit about our commercial strategy and where we are in our plans. So when we took over the two assets last year, we had a number of goals in mind. We wanted to build up a commercial organization that could sell and distribute the products and stop the historical market share loss which we've seen year after year prior to our acquisition. So, we wanted to avoid losing ground while we're in this transitional phase as we transferred the markets and we wanted to increase the awareness of Bavarian Nordic and our new assets in health care professionals. And I'm really pleased to say that today we can tick all those boxes. We have set up an international commercial team in record time. We have maintained or even grown our market share in a very difficult market due to headwinds of COVID. We've transferred all markets as planned from GSK, that's over 30 markets, in record time. And we have increased the awareness of Bavarian Nordic through surveys we've done with health care professionals who would promote not only Bavarian Nordic but also our products. So, we've really come a long way and really the difficulties that we're seeing with the sales is primarily and only due to the impact of COVID-19, both on our rabies and TBE markets. So with that, I'll hand over the presentation to Henrik Juuel.

Thank you, Paul. So let's continue on the commercialization of our business here on Slide 15. Let's start having a look at how the markets have developed for our two products, Rabipur and Encepur. And on this first slide here, it's all about our rabies businesses. And as many of you will recall, I think this is characterized by two very distinct markets. We have the U.S. market which is a mix of post-exposure and pre-exposure segments. And then we have the European market which is a pure travelers vaccine market. So if we start with the bottom end of this slide here, the German market, then the situation is just like we have seen for the last several quarters. Due to lack of international traveling, the market has really been reduced to one-tenth of what it was pre-COVID-19. So that's an unfortunate situation, of course. And we can only hope that international travel resumes sooner rather than later. If we turn to the U.S. market, the story is somewhat different. And that is, of course, because this is also the post-exposure market, so people will need immediate treatment if they have been exposed to rabid animals. And there, we are actually seeing some signs of recovery now. I think in the first quarter of this year, we saw a quarter that is slightly below the same level of last year. But now in the second quarter, we've actually seen a significant growth of 41% just comparing the quarter-to-quarter between the two years. However, this is still not at the level it was pre-COVID. It's approximately 15% down but some good signs of recovery here. And in the U.S., I think we can proudly say that we are holding on to 68% market share in the U.S. market, quite as expected. We have lost market share since our competitors came back after a stock-out situation. But we have -- after many months back on the market, we have -- we can say, we have gained a position approximately 7 percentage points higher than the period prior to the stock-out situation. So I think we are pretty well positioned to benefit from the market when it comes back with good signs of now. So, if we then move to the right side of this slide here, you will see that our revenue for the second quarter was DKK127 million, so it was 10% down compared to last year. And I think for the reason that just discussed here. I think the key explanation for this is really that last year, we had very little competition in the U.S. which we do have now, obviously. And for the first six months, just to mention those numbers, they are not on this graph here but we delivered DKK207 million which was 42% down compared to last year. But remember that, that includes the first quarter with no COVID impact in 2020. So let's turn to the next slide which talks about the other acquired product, our TBE vaccine, Encepur which is a pure European business. Encepur here, I think exemplified by Germany, that's a representative for market development in Europe. We saw some, as Paul alluded to previously actually in the first quarter of this year, some good signs of recovery, up 8% in the German market. But we're caught a little by surprise, we have to honestly admit, in the second quarter of this year, we saw the market decline by 26% compared to the same quarter last year. And this is simply due to the logistics in Germany where the GPs, they are involved in the COVID-19 vaccinations and simply, they have prioritized this as there have not been enough resources to deal with things like the TBE vaccinations to the same extent as previously. So this means if we just compare that to the period prior to COVID-19, we're talking about a decline of 41%. So, you can say both our rabies business and our TBE business are impacted but for very different reasons. I think the TBE market, there is no impact on the underlying demand. On the contrary, you could maybe even say, here, it's all about logistics, getting access to your physician to get vaccinated. So there is, I think, from our cycle, that this market will return sooner than the rabies market. If you look to the right on this slide here and then you will see we delivered a revenue of DKK146 million compared to DKK193 million for the second quarter last year. So that's a decline of 24% but in a market where Germany had a negative growth of 26%. Market shares, we have managed to maintain the level of market share in Germany of around 30%. And we're actually seeing some good signs that the efforts we put into [indiscernible] is actually working and we are gaining share in those regions where we are active with our field force. Turning to the next slide, an overview of our profit and loss, having this one focus on the half year results and with a few references to the third quarter. So total revenue of DKK905 million. You can see how that is broken down by product on the donut chart to the right. So smallpox business, DKK336 million. DKK90 million of that comes from sale of the smallpox products through other markets than the U.S. and the rest is related to the U.S., -- bulk orders to the U.S. government. DKK245 million comes from Encepur which we just talked about, DKK207 million from Rabipur/RabAvert. Then we have close to DKK90 million related to our Ebola vaccine which we sold bulk USD 40 million orders for Janssen. And then some minor contracts were adding up to DKK28 million. So total of DKK905 million. Gross profit, DKK279 million. And as we talked about in the first quarter, first quarter was impacted by the manufacturer of RSV clinical material where we actually spent two out of the three months in the first quarter producing the material we will need for the future Phase III trial on RSV. Most of that cost was charged through the R&D line but still there were some residual manufacturing costs remaining on the production costs. On R&D, DKK219 million, so up from DKK124 million last year. And the key explanation here is really our investments into the RSV project where we have, as I said, this year manufactured all the material we need for the Phase III to come and we're also running the human challenge trial as well. SG&A cost of DKK254 million, so down from DKK276 million. And the key driver here is really a significant saving on distribution costs in connection with taking over, as Paul said, up to nearly 30 markets we have now taken over from GSK. And we have now -- we're now using our own distribution network and not pay GSK to do that work. So adding all this up gives us, for the first six months, an EBITDA loss of DKK8 million. Turning to the next page; an overview of our cash flow and balance sheet. So the net cash flow for the period was minus DKK102 million. Cash flow from operating activities is negative by DKK377 million, mainly explained by changes in working capital and here we're primarily talking about inventories increasing as we take over more and more markets from GSK. So all in line with plans. Cash flow from investment activities of nearly DKK1.2 billion. Most of that is really investing some of the money we got from the private placement in March, investing that in securities. But also included here are some of the investment that goes into the current construction work in our plant in Kvistgaard. To be precise, so far, year-to-date, we've spent DKK171 million on investments in that expansion and more still to come for the last six months of this year. And finally, cash flow from financing activities obviously contributed positively with nearly DKK1.5 billion. DKK1.1 billion comes from the private placement that we did in March and the rest comes from repo transactions, where we have hedged some of the securities we have invested in against cash. To the right, just some selected pictures from our balance sheet. I will only sort of highlight the equity, as now it stands at approximately DKK5.8 billion. The increase from last year is of course driven by the private placement that we raised in March. The numbers below, you will see securities, cash and cash equivalents after six months stands at DKK2.5 billion. That includes approximately DKK300 million in cash from our repo transactions. Debt to bank and institutions of approximately DKK700 million. So that also includes, of course, the approximately DKK300 million repo transaction. So net cash of DKK1.8 billion which is, of course, not sensitive to our repo transaction. So strong position that really leads us to pursue the projects. And I think as Paul said previously, with the funding agreement with the Danish states, it also means that we have the funds we need to take our ABNCoV2 project all the way to the finish line with the current plans. On the next slide, our 2021 outlook. When we issued the first outlook for 2021, we chose intervals where we explicitly described that the lower end of this will refer to a scenario where the COVID-19 restrictions and impacts would continue throughout '21. And where the upper end, we would expect those to be relaxed, the restrictions and we would start to see international traveling resume that leads to some level in '22. Unfortunately, it is the first scenario that is playing out right now. And therefore, we have firmed up our guidance and we are sticking within -- staying within the intervals at the low end. So, now guiding approximately DKK1.9 billion revenue and then EBITDA -- positive EBITDA of approximately DKK100 million and the cash position by the end of the year of approximately DKK1.4 billion. And of course, if you compare our current cash position of DKK2.2 billion and then targeting DKK1.4 billion by the end, I think here you need to understand, of course, the continued investments that will happen during the second half of this year. Approximately DKK450 million would go into the facility expansion and it's like transfer of activities from GSK. We will also capitalize the DKK200 million that we raised in connection with the larger private placement earlier this year on the ABNCoV2 project, so there will be no impact on the P&L with the current plans but they will, of course, have an impact on our cash position. So that's included in the cash guidance for this year. We will also continue to pay milestone payments to GSK. And then these numbers here, we have assumed that we will draw down to DKK30 million existing credit facility with the European Investment Bank. So you could say, an outlook that is maintained but firmed up and we are targeting now the low end of the interval to guide previously. For that, only reason is really the COVID-19 market impacts on Encepur and Rabipur/RabAvert markets. To the right, just a quick recap of some of the important milestones for this year. On the R&D, I think we have several activities going on solely for RSV. We had plans for initiating the human challenge trial started and everyone has been vaccinated right now. And as Paul said, we are just awaiting the data and the analysis. So hopefully, soon, we could come out and communicate the results from that trial. And in parallel, we continue our preparations for a Phase III trial. That said, we have to manufacture all the material. And of course, once you see the data from Phase II, I think that will also be part of the input to a Phase III design. On COVID-19, we want to advance that, of course and we have started Phase II on Monday. We vaccinated the first people on our two sites in Germany. And now in parallel and with the funding agreement in place, we can continue to develop the high-scale adoption processes so that we can manufacture Phase III material and eventually, commercial scale as well. Then, of course, we also need to advance the development of our freeze-dried version of the smallpox vaccine, where we expect to be able to submit a BLA next year and we continue the work on intravenous administration of brachyury within immuno-oncology. Within commercial, I think here, our job is really to continue our efforts to drive growth in these very difficult markets. Secondly, take over physical distribution, I think we can take that one off now. In May and June, we took over the remaining markets and actually only Japan is outstanding and there is a deliberate plan and an agreement with GSK. Japan is a very complicated pharmaceutical market and we have agreed on a longer transition. Of course, we are responsible eventually for the sales of the products there and the revenue will go to us but we will, for a period of time, rely on getting services from GSK from our historical markets. In the commercial, we continue working on improving the awareness and the image of Bavarian Nordic with key stakeholders in our key markets through close interactions with the health care professionals. And we're actually already in some of the research and the interviews, producing some good results there. On the manufacturing side, we are, this year, going to deliver the first order of finished products filled at our own site. So that will be the products filled for the U.S. government. And then we are also planning to complete the construction of the new expanded facility and of course, continue the project to transfer Rabipur/RabAvert and Encepur to our site in Kvistgaard. So, it has been an extremely eventful first half of '21 and I would say, in particular, the last few weeks here. But I think as you will see from this one, we still have several key milestones and significant events ahead of us in the months to come. So with that, I will give the word back to Paul. Well, perhaps we should take Q&A. So, I think we hand it back to the operator for Q&A.

Thank you. [Operator Instructions] We have a question on the line from Michael Novod from Nordea.

Yes, thanks. It's Michael Novod from Nordea in Copenhagen. So a few questions. First of all to RSV; we have also seen -- we've seen Pfizer report some intriguing human challenge data. So I would just like to sort of ask you around what is the hurdle for efficacy you want to see to sort of decide whether this is good or bad data or whether to progress it into Phase III? And also in that context, what is sort of the hurdle besides data in terms of RSV infections, et cetera, for going into Phase III? We have seen recent spikes -- unusual spikes during summer, both in the U.S. and Europe of RSV. But otherwise, what is your thoughts around infection rates and seasonality? And then lastly, also on RSV, could you decide to push for a partner if you see good Phase II data on COVID? Can you then sort of also cope with running a large Phase III for RSV? So would that sort of trigger a partner discussion on the RSV?

Thanks, Michael. So what would be good data? It's a good question. So in the human challenge, our primary endpoint is looking at the viral load in the blood of the placebo treated versus the vaccine treated. In Janssen study with Ad26 RSV vaccine, they saw a significant difference in the viral load. That's the bad moment that we would want to see. When you start comparing the viral load curves, you can get a statistical readout of efficacy and they have ranging from basically for the 55% efficacy depending on which method you use to measure the viral load. They also see a significant reduction in the mild symptoms. And that is what Pfizer is also reporting or at least they're having 100% reduction in the mild symptoms. I haven't seen any data but that's basically what they're stating. So I think those are the thresholds really that we're up against. So, we would definitely need to see a significant reduction in the viral load placebo to treated and a bare minimum vaccine efficacy with that measure of at least 50%, I would say. And we would also want to see a significant reduction in the symptom score between the two groups. So basically, we have to match or better the data that at least Janssen has published that we can all see in read and review. I think that's the threshold that we would have to beat or meet. In terms of the RSV design, the infection rates, that's a very good question. And again, I wish I had a better view of that, to be honest, a clear view. You're right, there have been some higher rates of infection during the summer in those parts of the globe but not everywhere. And overall, the rates of RSV are slightly lower than historical levels. You may be lucky if you're running a study in a certain area where it spikes. But overall, the rates are slightly lower. And that's probably and I'm speculating now, the reason why everyone else has increased the number of subjects in their Phase III. So, GSK has done that. And the numbers that I was talking about are higher than the protocol that we currently have agreed with the FDA. So basically the plan is once the data from the human challenge trial comes through, we will most likely, if it's positive of course, have to open up the dialogue again with regulators to talk about Phase III design and it's our speculation that we will need a slightly larger study than we've previously planned. Of course, that's going to put pressure on the timing and how we're going to fund it and that will only open the door to accelerated, I guess, partner discussions. We've always said we wanted a partner for commercialization. And if we could get that partner on board before Phase III; that would even be better.

Okay, great. Thanks a lot.

Thank you. [Operator Instructions] Your next question comes from the line of Jesper Ilsoe from Carnegie.

Thank you so much. Just to follow-up on that RSV question. So you mentioned a partner before Phase III. How large should this Phase III potentially be? So you still mentioned on the slide that it could cost DKK110 million. So how large will be several, say, thousands more or what are we talking here? And also a question on the COVID-19 vaccine progress. Just to get a feeling of how you -- if you have positive Phase II data, how you will design Phase III in the non-inferiority study? Will it be fair to assume it could be against the mRNA such as Pfizer, Moderna, will it be against [indiscernible]?

Yes. So, how large would the RSV Phase III study have to be and that is -- there are a number of factors that were set aside in the RSV trial. One, how efficacious do we believe our vaccine truly is and, of course, hopefully, we get a better feeling for that based on the human challenge study. So the greater the efficacy that we want to gamble on, the smaller the study. The other one that will impact it is really the rates of RSV, the assumptions that we're going to use. As I said, just briefly, what we're seeing with everyone else that's going into Phase III or have modified their Phase III, we're at the 20,000 or larger subject study, where, as you know, we originally had a study design of 12,000 to 14,000 subjects based on the assumptions that we had pre-COVID. And that's why I'm saying after the human challenge study, we'll look at it. But I don't think we have a magic wand but I think we're going to be in the same range as anyone else which will be the 20,000 subject range. On your COVID-19 question, how does the Phase III look? So our current assumption is that the regulators will catch up with the reality. So if you look at the guidance right now from EMA and FDA, you're still asked to do a field efficacy trial for new COVID vaccines. And if you want to do a booster study, there's regulations for that but they're only currently foreseeing boosters. We use the time booster as the primary vaccination. So Pfizer boosting Pfizer and Moderna boosting Moderna. We believe that regulation will change with the reality that you do need general boosters. And there are a lot, as you know, mix and match studies ongoing right now in terms of clinical programs and that data will come out. So we believe the regulations will change and the way we're looking at it is we would do a non-inferiority or potentially a superiority trial to existing vaccines. Whether that's one vaccine or a number of approved vaccines will depend on the discussions with the regulators. But I would envisage it would be at least the RNA vaccines or one of the RNA vaccines; and so in total, our plan is the 4,000 to 5,000 subjects, Phase III.

Okay. Thank you so much.

Thank you. The next question comes from the line of Thomas Bowers from Danske Bank.

Yes, thank you very much. A couple of questions regarding the TBE vaccine; so in regards to also to primarily, Germany. So, I'm just wondering if you're seeing any recovery into July-August numbers. And you would say still with your guidance, I assume that it sort of implies that you need a rather solid H2 to reach to those DKK1.9 billion in total for the year. And maybe in regards to Germany, can you maybe just say how does the TBE sort of -- what's the focus now? Are they sort of getting back to the normal practice? Or I guess a large portion of the subjects have been vaccinated now also in Germany. So any color here would be very helpful. And then, just on the market share data. So, I'm just wondering how accurate are these actually because we are seeing Pfizer with a 36% year-over-year growth for TICOVAC in Q2 and of course, there is quite a lot of fluctuations on also inventory levels and that's -- but just to get some color and understanding on how accurate these projections actually are.

Okay. Thomas, this is Henrik. Let me try to answer those questions. I think first of all, for July, we're not disclosing too much. I think we can say that the situation is unchanged in Germany with regard to the GP's the priority that factored into our guidance. The situation with the TBE market is also that we are approaching the end of the main vaccination season, of course. So that means in our revenue for the rest of the year, there's less risk, of course, because we have less GPE included in that one as it is a very seasonal product. And just to the other question on that we have a lot to deliver in the second half. Actually, more than half of the revenue to come for the second half comes from either smallpox or Ebola business. Remember, we still have the remaining part of the DKK202 million and we have with us filling of finished products to part of that. And we have the DKK28 million order to barter on April that we need to deliver on. And I'm talking a little about the market share data. I think in my experience, it's relatively reliable. This kind of data, of course, it's not an exact science. And sometimes, it can be difficult to explain differences between what we're actually selling and then these in-market data but they are based on samples and they're not always covering the full market. Yes, it's correct that Pfizer reported strong growth but they are facing the same market conditions as we are, 26% drop and our market share is unchanged. We looked into the Pfizer numbers. And I think if you go one year back, you will see that they actually sold significantly less than what's reported in the market. Now we see the opposite situation. So that can only, in my view, be explained by inventory movements, meaning that in the second quarter 2020, wholesalers consumed from inventories and they sold less than the mid-market data showed and now it was the other way around. So I hope that answers your questions.

Just maybe -- just to -- for clarification just on your full year revenue guidance. So I fully understand also there's fluctuations also with JYNNEOS and Ebola. But I'm assuming that Ebola is well DKK250-ish million and then JYNNEOS is around DKK600 million. So is there anything aside from that? And of course, Rabipur, Encepur that we're sort of meeting, I know, well, potentially you have maybe DKK100 million for contract work. So I guess if all else with Ebola -- I guess you still need some BAVA material on Rabipur and Encepur sales also in the second half. So is that correct? Or am I missing something in this calculation?

No. It is correct, of course. We are still expecting business from Rabipur/RabAvert and on TBE on Encepur as well. And then I think we are seeing some positive segments on Rabipur/RabAvert -- sorry, in the U.S. We do not honestly expect much from the rabies business in Europe as it is what it is. But we do particularly expect business coming in from the U.S. And then as I said, I think it's a little more than half of the revenue to come, comes from other products.

Okay, yes. Because, of course, Encepur is definitely going to be lower than -- in second half than first half due to seasonality. But -- so it's primarily, of course, Rabipur that I'm looking at here and you still need to have some BAVA material, also maybe even a better second half in '21 than compared to '20. I guess also there was some fluctuation in Q4, as far as I remember which I think it was down at DKK80 million in Q4?

No, that's right. I think that is -- amongst these markets here, I think for the remainder of the year, that is our strongest comp. That's our rabies business in the U.S., where we saw some good signs here in the second quarter with a 41% increase actually over last year. So some signs that this market is coming back and we do expect that to drive a significant portion of the revenue in the second half year.

Okay, got it. Okay, great. Thank you very much.

Thank you. And we have another question from the line of Michael Novod from Nordea.

Yes, just a follow-up question. I was just thinking around the manufacturing capacity, initial capacity in terms of contract manufacturers and when we should be able to get some news on that and how you will deal with that? If you also should be able to, during 2022, let's assume the Phase II data is positive and you're running the Phase III, you're able to do any sort of advance procurement contracting, et cetera? Just some more thinking around capacity -- external capacity. Then of course, also in the longer term, whether you would plan to sort of take it all home to Kvistgaard?

Yes, let me take that. So actual fact, we -- you're right, finding external manufacturing capacity right now is tricky. However, I'm pleased to say that we have secured a contract manufacturer, where we are actually in the process right now of scale up and transferring the product -- the process. And we will do the fill-and-finish ourselves. So in fact, I believe we have secured what we believe will be the necessary capacity. We plan, obviously, to have that process transferred and validated next year rather than when we do the Phase III so that we're ready to start filing towards the end of next year. And like others and depending on what else is happening in the world, there is an opportunity to start looking at advance procurement and that's something that we'll definitely be pursuing.

All right. Thanks a lot.

Thank you. We have no further questions at this time, if you wish to continue.

Okay. Well, thanks everyone for your time, the questions and have a great day. Thank you.

Thank you. That does conclude your call for today. Thank you all for participating. And you may now disconnect.