Welcome to everybody listening in. Good morning to some, good afternoon to the rest. 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 Executive Vice President, CFO, Henrik Juuel. Before we start our presentation, I will briefly read the statement 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 statements 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 laws. With this, I will hand over the presentation to Paul.
Thanks, Rolf, and welcome everyone to the Q2 update. If you turn to slide three, 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. By 2025, 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. 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 began the 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 the EU.
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. 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. As you know, we're also expanding this facility as we speak, and that expansion remains on time and on budget, which is part of the transfer of the production of the two products we acquired last year for rabies and TBE. On our pipeline, and I'll come back to that in the coming slides, we've seen a lot of progress in the last few weeks.
We have an RSV late-stage asset where we have human challenge trial data coming very shortly. On COVID-19, of course, the big topic of the day, we've gone from strength to strength, reporting fantastic data, and obviously this week securing the funding which will allow us to accelerate this product all the way to licensure. 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. If we go to slide four, 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.
The lower end of that range reflected, unfortunately, the reflection that is COVID still impacted both of the markets for rabies and TBE. 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. There, we've seen basically a 90% decline in the market in Germany. On TBE, it's a slightly different story. We had signs of initial recovery in Q1. As you'll see from later in the slides, we saw a decline in Q2, which was unexpected.
It's 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. All the reduction in sales, or the difficulties we're seeing, is purely related to COVID, and not the execution in terms of our commercial strategy. Unfortunately, for that reason, we are firming up our guidance at the lower range. On the pipeline, we've really gone from strength to strength in the first six months. On COVID-19, we've reported some of the best clinical data that anyone's reported for a COVID-19 vaccine, and I'll come back to that more in the coming slides. We've initiated phase II, which will report data later this year.
This week, we had a milestone event in that we secured funding from the 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 2023. On RSV, we're weeks, months away from an exciting announcement, hopefully, on the human challenge trial data, which hopefully will de-risk the future development moving into phase III. On smallpox, we shouldn't forget there's a lot of activities ongoing. While we have transferred the liquid frozen smallpox already to the line, our new fill- finish line in Denmark, we have begun the tech transfer of the freeze-dried products. An extremely busy and active and successful activity in terms of our development programs. I want to spend a little time talking about ABNCoV2, our COVID vaccine candidate.
If you turn to slide six. 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 DKK 800 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. 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. As and when we successfully meet certain milestones, we will receive payment. Repayment of this funding will be in the form of vaccines and/or royalties based on reaching certain annual sale volumes.
As I said, we've entered phase II already, and for phase III, we plan, based on positive data, to start in 2022, where we will be hopefully doing a non-inferiority trial to existing or an existing COVID vaccine, looking at an immunogenicity endpoint. Turning to slide seven. Again, a question I'm often getting over the last few days is there really a need for another COVID-19 vaccine with so many already approved? The answer is, we believe the answer is obviously yes, as obviously does the Danish government. One of the reasons is that the durability or the length of protection is a little uncertain. There are reports already coming out this week, actually, from some clinical studies that the efficacy may wane after already six months. Maybe improved vaccines with a longer durability of 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. There is going to be a need for regular boosters to provide sort of protection, particularly against the emergence of new variants that we're seeing week after week. Of course, there is a need for a worldwide distribution of vaccines, and therefore more vaccines are going to be required. We go to the next slide eight. Just to sum up a little bit of where we are. ABNCoV2 is based on a virus-like particle technology that we licensed from AdaptVac, which is some technology coming out of University of Copenhagen. It's a very similar technology to some of the existing vaccines. Some existing vaccines 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, 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 will be reporting that data later this year and are already gearing up to start a phase III trial next year. To slide nine. The phase I result, which, phase I study, which was funded by an EU consortium grant, was a dose-ranging study looking at doses ranging from six to 70 micrograms formulated with or without adjuvant. 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. 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 1 or 2. The systemic events, we only saw two possibly related grade 3s, and these were both related to either a migraine or headache and quickly resolved after vaccination. Really a well-tolerated vaccine. On the next slide 10, is the immune data. If we just look at the left-hand side of the slide, this is the neutralizing titers that are induced by the various different doses, ranging from six to 25. You can see we can see a nice dose effect. What's really encouraging here is at the 25 microgram dose level, we're at a 12-fold higher neutralizing titer than the convalescent sera, which is the gray bar. A convalescent sera is sera taken from people who have recovered from COVID.
In other publications, it is shown that if you have a comparable titer to human convalescent sera, you have at least an 80% efficacy against COVID. Here we are showing at a moderate dose of 25 micrograms we are 12-fold higher than that protective level. On the right-hand side is also some outstanding data. Here we are looking at the neutralizing capability of the 25 microgram dose against all the major variants of COVID. You will see the Wuhan strain, the Alpha, and Delta strain. There is absolutely no difference in the neutralizing titers, and these are all well above the human convalescent sera, as I have just described. The Beta variants, there is actually a two-fold lower neutralizing capability.
However, please note that this is still way above the level of human convalescent sera, and this reduction against Beta is much, much lower than has been reported for other approved vaccines, which varies from 4-16-fold lower neutralizing titers. This is really probably some of the best clinical data, albeit in a relatively small number of subjects currently. This is very, very strong data showing a good safety profile and a great strong neutralizing capability that is against all circulating major variants of COVID. On slide 11. 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. These will receive two vaccinations four weeks apart of ABNCoV2 at the 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 booster 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. 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, with a lot of the competition about to or have already entered phase III.
We have just a very interesting RSV candidate, late stage, that has shown to be safe and highly immunogenic in phase I, phase II clinical studies. 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'll be reporting that data in, as I said, shortly. This hopefully, if positive, will de-risk the future development of this vaccine in phase III. We will be looking to start phase III hopefully next year based on positive readout from the phase II. 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.
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. We wanted to avoid losing ground while we were in this transitional phase as we transferred the markets, and we wanted to increase the awareness of Bavarian Nordic and our new assets to healthcare professionals. 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 the 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 healthcare professionals who would promote not only Bavarian Nordic but also our products. We've really come a long way. 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. With that, I'll hand over the presentation to Henrik Juuel.
Thank you, Paul. 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 2 products, Rabipur, RabAvert, and Encepur. On this first slide here, it's all about our rabies business. 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. 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 a tenth of what it was pre-COVID-19.
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 a post-exposure market, so people will need immediate treatment if they have been exposed to rabid animals. There we are actually seeing some signs of recovery now. I think in the first quarter of this year, we saw a quarter slightly below the same level of last year. Now in the second quarter, we've actually seen a significant growth of 41% just comparing the quarter-over-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.
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 competitor came back after a stockout situation. We have, after many months back on the market, you can say we have gained a position approximately seven percentage point higher than the period prior to the stockout situation. I think we are pretty well positioned to benefit from the market when it comes back, which there are good signs of now. If we look to the right side of this slide here, you will see that our revenue for the second quarter was DKK 127 million. That was 10% down compared to last year.
I think for the reason that is 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. For the first six months, just to mention those numbers, they're not on this graph here, but we delivered DKK 207 million, which was 42% down compared to last year. Remember that that includes the first quarter with no COVID impact in 2020. 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, as a representative for the market development in Europe. We saw some, as Paul Chaplin alluded to previously, actually in the first quarter of this year, some good signs of recovery, up 8% in the German market.
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. This is simply due to logistics in Germany, where the GPs, they are involved in the COVID-19 vaccinations, and simply they have prioritized this, and there has not been enough resources to deal with things like TBE vaccinations to the same extent as previously. This means if we just compare that to the period prior to COVID-19, we're talking about a decline of 41%. 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 physicians who get vaccinated. There is, I think, from our side, hope that this market will return sooner than the rabies markets. Looking to the right on this slide here, you will see we delivered a revenue of DKK 146 million compared to DKK 193 million for the second quarter last year. That's a decline of 24%. 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 actually seen some good signs that the efforts we put into the transformation 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. I want this one focus on the half- year results and with a few references to the quarter. Total revenue of DKK 905 million. We can see how that is broken down by product on the donut chart to the right. Smallpox business, DKK 336 million. DKK 90 million of that comes from sale of the smallpox products to all the markets than the U.S., and the rest is related to BDS bulk orders to the U.S. government. DKK 245 million comes from Encepur, which we just talked about, DKK 207 million from Rabipur/RabAvert. We had close to DKK 90 million related to our Ebola vaccine, which we sold bulk $14 million orders to Janssen, and some minor contract work adding up to DKK 28 million. A total of DKK 905 million.
Gross profit, DKK 279 million. As we talked about in the first quarter, first quarter was impacted by the manufacture 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 to the R&D line, but still there was some residual manufacturing costs remaining on the idle production cost. On R&D, DKK 219 million, so up from DKK 124 million last year. 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 IIIs to come, and we are also running the human challenge trial as well. SG&A cost was DKK 254 million, so down from DKK 276 million.
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 to now take north from GSK. We are now using our own distribution network and not paying GSK to do that work. Adding all this up gives us, for the first six months, an EBITDA loss of DKK 8 million. Turning to the next page, the overview of our cash flow and balance sheet. The net cash flow for the period was minus DKK 102 million. Cash flow from operating activity is negative by DKK 377 million, mainly explained by changes in working capital. Here, we are primarily talking about inventories increasing as we take over more and more markets from GSK. All in line with plans. Cash flow from investment activities of nearly DKK 1.2 billion.
Most of that is really placing some of the money we got from the private placement in March, placing that in securities. What is 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 have spent DKK 171 million in investments in that expansion, and more is to come for the last six months of this year. Finally, cash flow from financing activities obviously contributed positively with nearly DKK 1.5 billion. DKK 1.1 billion comes from the private placements 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 figures from our balance sheet. I will only sort of highlight the equity here.
Now it stands at approximately DKK 5.8 billion. The increase from last year is of course driven by the private placement that we did in March. The numbers below, you will see securities, cash and cash equivalents. After six months, stands at DKK 2.5 billion. That includes approximately DKK 300 million in cash from our repo transactions. Debt to bank and institutions of approximately DKK 700 million. That also includes, of course, the approximately DKK 300 million repo transaction. Net cash of DKK 1.8 billion, which is, of course, not sensitive to our repo transaction. Strong position that really enables us to pursue the projects. I think as Paul said previously, with the funding agreement with the Danish state, this 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 would refer to a scenario where the COVID-19 restrictions and impacts would continue throughout 2021, and where the upper end, we would expect those to be relaxed, the restrictions, and we would start to see international traveling resume at least to some level in 2022. Unfortunately, it is the first scenario that is playing out right now, and therefore, we have firmed up our guidance, and we are staying within the intervals, but at the low end, now guiding approximately DKK 1.9 billion in revenue, and then positive EBITDA of approximately DKK 100 million, and a cash position by the end of the year of approximately DKK 1.4 billion.
Of course, if you compare our current cash position of DKK 2.2 billion and then targeting DKK 1.4 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 DKK 450 million will go into the facility expansion and the tech transfer activities from GSK. We will also capitalize the DKK 200 million that we raised in connection with a larger private placement earlier this year on the ABNCoV2 projects. 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. That's included in the cash guidance for this year. We will also continue to pay milestone payments to GSK.
In these numbers here, we have assumed that we will draw down the EUR 30 million existing credit facility with the European Investment Bank. You could say an outlook that is maintained but firmed up, and we are targeting now the low end of the intervals guides previously for that. Only reason is really the COVID-19 market impacts on Encepur and Rabipur and 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 for the RSV. We had a plan to initiate the human challenge trial. That's done. Everyone has been vaccinated right now, and as Paul said, we are just awaiting the data and the analysis. Hopefully soon we can come out and communicate the results from that trial.
In parallel, we continue our preparations for a phase III trial. That said, we have manufactured all the material. Of course, once you see the data from the 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. Now in parallel and with the funding agreement in place, we can continue to develop the high-scale production processes so that we can then manufacture phase III material and eventually commercial scale as well.
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 the physical distribution. I think we can tick that one off now. In May and June, we took over the remaining markets, and actually only Japan is outstanding, and that is a deliberate plan. In 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 services from GSK to manage that market. Thirdly, 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 healthcare professionals. We are actually already in some of the research and the interviews we do, seeing 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. That will be the JYNNEOS products filled for the U.S. government.
We are also planning to complete the construction of the new expanded facility and of course, continue the project to transfer Rabipur, RabAvert, Encepur to our site in Kvistgaard. It has been an extremely eventful first half of 2021, I would say in particular the last few weeks here. I think as you would see from this one, we still have several key milestones and significant events ahead of us in the months to come. With that, I will give the word back to Paul Chaplin. Perhaps we should take Q&A, so I think we hand it back to the operator for Q&A directly.
Thank you. As a reminder, ladies and gentlemen, if you wish to ask a question, press the star and one on your telephone keypad and wait for your name to be announced. If you wish to cancel that request, you can use the hash key. The star and one if you wish to ask a question. We have a question on the line from Michael Novod from Nordea.
Yeah, thanks a lot. It is Michael Novod from Nordea in Copenhagen. A few questions. First of all, to RSV. We have also seen, or we have seen, Pfizer report some intriguing human challenge data. 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? Also in that context, what is sort of the hurdles 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. Otherwise, what is your thoughts around the infection rates and the seasonality? 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? Would that sort of trigger a partner discussion on the RSV? Thanks a lot.
Yeah. Thanks, Michael. What would be good data? It's a good question. 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's study with their Ad26-based RSV vaccine, they saw a significant difference in the viral load. That's the bare minimum that we would want to see. When you start comparing the viral load curves, you can get a statistical readout of efficacy, they had ranging from basically 40%-55% efficacy, depending on which method you use to measure the viral load. They also saw a significant reduction in the mild symptoms. That is what Pfizer is also reporting, or at least they're claiming 100% reduction in the mild symptoms. I haven't seen any data, that's basically what they're stating.
I think those are the thresholds really that we're up against. We would definitely need to see a significant reduction in viral load, placebo to treated, and a bare minimum vaccine efficacy with that measure of at least 50%, I would say. We would also want to see a significant reduction in the symptom score between the two groups. Basically, we have to match or better the data that at least Janssen has published that we can all see and read and review. I think that's the threshold that we would have to beat or meet.
Sure.
In terms of the RSV design and the infection rates, that's a very good question. Again, I wish I had a better view of that, to be honest, a clearer view. You're right that there have been some high rates of infection during the summer in various parts of the globe, but not everywhere. 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. That's probably, and I'm speculating now, the reason why everyone else has increased the number of subjects in their phase III. GSK has done that, and the numbers that others are talking about are higher than the protocol that we currently have agreed with the FDA.
Basically, the plan is that once the data from the human challenge trial comes through, we will most likely, if it is positive, of course, have to open up the dialogue again with the regulators to talk about the phase III design. It is our speculation that we will need a slightly larger study than we had 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. Once again, if you wish to ask a question, press star and one on your telephone keypad. Thank you. Your next question comes from the line of Jesper Ilsøe from Carnegie.
Thank you so much. Just to follow up on that RSV question. You mentioned a partner before phase III. How large should this phase III potentially be? You still mention on the slide that it could cost these DKK 100 until DKK 10 million. How large will it be? Will it be several, say, thousands more, or what are we talking here? 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 or Moderna, or will it be against AstraZeneca, just like Valneva has done?
Yeah. Thanks. How large would the RSV phase III study have to be? There are a number of factors that will affect the size of the RSV trial. One is how efficacious do we believe our vaccine truly is. Of course, hopefully we get a better feeling for that based on the human challenge trial. 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 and the assumptions that we're going to use. As I've said just previously, what we're seeing with everyone else that's going into phase III or has modified their phase III, we're at the 20,000 or larger subject study. Whereas, as you know, we'd originally had a study design of 12,000-14,000 subjects based on the assumptions that we had pre-COVID.
That's why I'm saying after the human challenge trial, we'll look at it. I don't think we have a magic wand. I think we're going to be in the same range as everyone else, which will be the 20,000 subject range. On your COVID-19 question, how would the phase III look? Our current assumption is that the regulators will catch up with the reality. 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. If you want to do a booster study, there's regulations for that, but they're only currently foreseeing boosters being used the same booster as the primary vaccination. Pfizer boosting Pfizer, Moderna boosting Moderna.
We believe that regulation will change with the reality that you do need general boosters and there are a lot of mix- and- match studies ongoing right now in terms of clinical programs, and that data will come out. 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. I would envisage it would be at least the mRNA vaccines or one of the mRNA vaccines. In total, our plan is 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. Two questions regarding the TBE vaccine. In regards to also primarily Germany. I'm just wondering if you're seeing any recovery here in the July, August numbers and you stay still with your guidance. I assume that it sort of implies that you need a rather solid H2 to reach to those DKK 1.9 billion in total for the year. Maybe in regards to Germany, can you maybe just say, how does the GPs, what's their focus now? Are they sort of getting back to their normal practice or I guess a large portion of the subjects have been vaccinated now also in Germany. Any color here would be very helpful. Just on the market share data.
I am just wondering how accurate are these actually because we are seeing Pfizer with a 36% year-over-year growth for TicoVac in the Q2. I know, of course, there is quite a lot of fluctuations on also inventory levels and that, but just to get some color and understanding on how accurate these projections actually are. Thank you.
Okay. Hi, Thomas. This is Henrik. I think, first of all, I think for July, without disclosing too much, I think we can say that the situation is unchanged in Germany with regards to the GP's priority. That's 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. That means in our revenue for the rest of the year, there's less risk, of course, because we have less TBE included in that one, as it is a very seasonal product. 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 DKK 202 million order, and we have this filling of finished products to BARDA as part of that. We have the DKK 28 million order to BARDA on Ebola that we need to deliver on. 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 you're actually selling and these in-market data, as they are based on samples, and they're not always covering the full market. Yes, it's correct that Pfizer reported a 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. I think if you go one year back, you will see that they actually sold significantly less than was reported in the market. Now they see the opposite situation. That can only, in my view, be explained by inventory movements, meaning that in the second quarter of 2020, wholesalers consumed from inventories, and they sold less than the in-market data showed, and now it was the other way around. I hope that answers your questions.
Yes. Thank you. Maybe just for clarification on your full year revenue guidance. I fully understand also there's fluctuations also with JYNNEOS and Ebola, but I'm assuming that Ebola is DKK 250-ish million, and then JYNNEOS is around DKK 600 million. Is there anything aside from that, and of course, Rabipur, Encepur, that we're sort of missing? I know, potentially you have maybe DKK 100 million for contract work. I guess if all else were equal, I guess you still need some rather material Rabipur and Encepur sales also in the second half. 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. I think we are seeing some positive signals on Rabipur or 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 in particular expect business coming in from the U.S. Then, as I said, I think it's a little more than half of the revenue to come, comes from other products.
Okay. Yeah, because of course, Encepur is definitely going to be lower in the second half than first half.
Yes
due to seasonality. It's primarily, of course, Rabipur that I'm looking at here, and you still need to have some rather material also maybe even a better second half in 2021 than compared to 2020, I guess. There was some fluctuation in Q4 as far as I remember, which I think it was down at DKK 80 million in Q4.
No, that's right.
Okay.
I think that is amongst these markets here, I think for the remainder of the year, that is our strongest card. 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. 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, yeah.
Okay, got it. Okay, great. Thank you very much.
Thank you. We have another question from the line of Michael Novod from Nordea.
Yeah, 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 advanced 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.
Yeah. Let me take that. Actual fact, you're right. Finding external manufacturing capacity right now is tricky. 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 process. We will do the fill-finish ourselves. 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 as and when we do the phase III so that we're ready to start filing towards the end of next year. Like others, and depending what else is happening in the world, there is an opportunity to start looking at advanced procurement. 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, thank you everyone for your time and the questions, and have a great day. Thank you.