Good day and thank you for standing by. Welcome to the Bavarian Nordic First Quarterly Report Q1 for the Three Months Period Ended 31st of March 2022. At this time, all participants on a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions]. Please be advised that today's conference is being recorded Monday the 9th of May 2022. [Operator Instructions]. I would now like to hand the conference over to speaker today, Rolf Sass. Please go ahead.

Yes, good afternoon. Thank you, operator. And welcome to this Q1 presentation of Bavarian Nordic's first quarter results and as usual, I'm here together with BA team President and CEO, Paul Chaplin; and Executive Vice President, CFO, Henrik Juuel. Before we start our presentation, just want briefly to walk through this disclaimer. This presentation 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 and cash position as of year-end as well as statements concerning plans, objectives, goals, future events, performance and other information that is not historical information. All such 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. And with this, I will hand the presentation over to you, Paul.

Thanks, Rolf, and welcome everyone to the Q1 update. So if you turn to Slide 3, just want to walk through a little bit of background on Bavarian Nordic. So in the last two years, Bavarian Nordic is truly transformed into a commercial company. And of course, the journey continues as we have a big ambition to become one of the largest pure play vaccine companies by '25. So up till now, we have for commercial products and to sell and distribute, we've built up an excellent commercial infrastructure, both in the U.S. and in Europe and that allows us to drive strong growth and have a strong financial position. And you'll see that we've recorded at the end of Q1, a cash position of $2.9 billion. So we're in a very strong financial position to continue the transformation and move towards that vision to become this largest pure play vaccine company. Obviously, what we've achieved to date has built the foundation where we can add new products. We obviously also this year will be selling and distributing three additional products for other companies in territories but we want to continue to add to our commercial portfolio through our internal growth. And this year in '22 is a year of investment as we are investing in the future growth in two in-house programs, one for RSV and one for COVID-19, both of which will have enter Phase 3 during '22. We will be completing the investment in our manufacturing here in Denmark, which will allow us eventually to bring our two new products, for rabies and TBE in-house. And we will be finalizing the tech transfer of our freeze-dried to our new state-of-the-art facility this year. And this will allow us to unlock the current option with the U.S. government for almost $300 million, which will be revenue recognizing in the years ahead in '23, '24 and '25. So it's truly a year of investment. It's one that's been planned. And it's one, obviously through the successful completion of RSV and COVID-19 will allow us to fulfill our vision, become the largest pure play vaccine company by '25. To go to the next slide, to some of the key highlights from an extraordinarily strong quarter in terms of our pipeline progression. On RSV, we saw a breakthrough designation from the FDA, which means after review of our data to date, the FDA has concluded that this program is likely to meet a high unmet medical need in terms of preventing RSV infection in the elderly, it will also allow us to have expedited review and allows the firm to accelerate the regulatory process for this program. Later in the quarter, we secured a license agreement with Nuance Pharma who will distribute and sell RSV vaccine in China in selected Asian markets. And this is part of our partnering strategy to ensure that we can sell and distribute this product when we launch. And then in April, we initiated the Phase 3 trial as planned, which will be 20 -- which will enroll 20,000 subjects this year, and will read out in the first half or mid of next year in '23. Our ABNCoV2 our COVID-19 vaccine candidate has also seen a lot of activity in this quarter, we've reported additional Phase 2 data, which I'll come to in later in the slides and we're on course to start our Phase 3 program. However, as I'll come to in later slides, the regulatory environment is changing, which may change some of the timelines in terms of initiation. But we're still confident that we'll be able to report the data and continue the filing process later this year. In terms of the sales of our commercial products, I know Henrik will be coming back to that. But we've seen some positive growth of our rabies business, albeit coming from a low point in Q1, and our TBE franchise as sluggish starts with a decline in the market. But the main quarter for TBE is Q2. So we're hopeful to see some sort of a rebound later this year. And we've added to the executive management with the arrival of Russell Thirsk, who is a highly experienced individual coming out of GSK. And I'm sure he will be a strong contribution to the team moving forward. So if we go to the next slide, Slide 5, let's talk a little bit about ABNCoV2. Again, I'm frequently asked, why are you continuing to develop a vaccine? Aren't you too late? We already have vaccines on the market and my answer to that is yes, it's true. We have vaccines on the market that has allowed us to come out of lockdown. However, the data from those vaccines is clearly showing that the level or the durability of protection is quite short and winding within six months. So it's really not even providing protection for a full flu like season and therefore there is an unmet medical need for better vaccines given new longer lasting protection. And we believe with ABNCoV2, which is based on a viral like particle technology that is designed specifically to stimulate strong B cell responses, that we will address the durability issue and have an improved vaccine. To date, we've reported Phase 2 data that shows exactly that, that this vaccine which is designed specifically to stimulate B cells is generating very strong antibody responses to all the variants of concern including Omicron to levels that have been reported to be associated with high levels of efficacy greater than 90%. So we're really now geared up to start the Phase 3 and really evaluate this vaccine and the head-to-head comparison with an RNA based COVID-19. Up until a few weeks ago, we were about to start a study which we've reported before, which was utilizing national booster programs where we get access to the comparator vaccine in these national programs because we had previously been told that member states in the EU and the U.S. could not provide the vaccine directly to companies. That situation has now changed or I should say is changing in the EU, at least and that really that indications that member states and EU has the potential to provide vaccines to companies and under that development, we really have to change the trial design and truly do a randomized head-to-head comparison with the RNA based vaccine. This, however is seen by us as a very positive development. A randomized controlled study is a lot easier to conduct than trying to enroll subjects in a national booster program. Many of the national booster programs are coming to a halt in Europe. And it was challenging to find sites that you could enroll. So we see this as a positive development. However in this, we're about to start the other studies that this development comes, so it will have an impact. We're hopeful that that impacts will not be that great and we're still very, very confident that we'll be able to read out the results later this year. And if allowed by the regulators continue to filing BLA by the end of the year. So let's move to the next slide. And let's talk about some of the latest data. Just to try and explain this data. As you know in the Phase 2 study, we evaluated two doses 50 micrograms, and 100 micrograms and we've previously concluded that both doses gave very highly comparable results. And what we're showing you here is both groups combined and the neutralizing antibodies that were generated two weeks post booster against the various variants of concern. So the last cluster is the Wuhan strain, which obviously is the original strain. And then the various different variants of concern, both the fold increase in the GMT. And you can see that similar to other vaccine candidates that have reported neutralizing titers against different variants of concern, it goes that will have an Alpha are very, very similar, then you get Delta, Beta and the lowest response is always against Omicron. And that is true with our data set. However, it should be noted that while Omicron is generated, or we're generating the weakest antibodies against Omicron, it's still at levels that have been associated with efficacy about 90%. So we're very, very happy with this dataset is showing the concept that we're developing the vaccine for as a universal booster. And we will be entering Phase 3 very shortly. And the comparator will be against an RNA vaccine against the Wuhan variants, as we've agreed with the regulators. So let's turn to the next slide, Slide 7. So a little bit about RSV. So RSV is often a disease that goes unmissed or unrecognized by many investors in the community. However, RSV causes as many deaths in the elderly annually, as influenza. However, what many people also don't realize is that the burden of disease is much higher on RSV than flu. And what I mean by that is the stay in hospital if you are hospitalized is longer and the mortality post being hospitalized is higher, if you've been hospitalized with a severe RSV infection, than if you've been hospitalized with flu. So there's a huge unmet medical need for a prophylactic vaccine that will prevent infection in the elderly. And in risk adults, we have a completely differentiated approach in our vaccine candidate that has shown some excellent immune responses in Phase 2. And last year, we reported on some exceptional efficacy in-human challenge study of almost 80%. So an exciting candidate, one that clearly meets the criteria to be evaluated further in Phase 3. And as I said in April, we began enrolling in the Phase 3 study which will enroll 20,000 subjects, both in Germany and in the U.S. and we'll read out in the first half of next year. As I said, it's also has a breakthrough designation from the FDA which again is confirming the excellent data set that we have and we've already begun to think about launch with a partnership with Nuance Pharma for China and selected Asian countries. With that, I will also move on one more slide, next slide, Slide 8. Just one last word, so we are investing along in '22. And part of that is also completing the investment in manufacturing facility in Denmark, which is going on track, on budget -- excuse me. And when this is completed later this year, it will allow us to truly start the physical tech transfer of our Rabies and TBE vaccine, which will be able to manufacture at this site by '24. It will also allow us in parallel to manufacture other MVA based products, such as JYNNEOS, or Ebola vaccine or RSV vaccine for launch. So as I said, it's a great investment that's going on according to schedule and it's really building off the center of excellence in terms of manufacturing of viral based vaccines. And with that, I will now hand over the call over to Henrik.

Thank you, Paul. And good afternoon, good morning to all the listeners. So let's jump into Slide number 10. I will start with a quick overview of the revenue generated during the first quarter of '22. So in total, we delivered revenue of DKK 320 million, which was 40% lower than prior year, which included a significant revenue related to BARDA business and which you know, most of you is quite sort of chunky business that happens in some corners and not all corners. But let's have a quick look at the individual lines here. Our Rabies business, the Rabipur/RabAvert delivered total revenue of DKK 117 million up 45% compared to prior year, and driven by extremely strong market performance both in the U.S. and in Germany, which I'll come back to on one of the next slides. In contrast to this Encepur delivered DKK 69 million so 30% down compared to prior year due to a still unfortunately depressed the TBE market in Germany. And here we should also remember that we are comparing against a strong first quarter of last year, where we saw an 8% positive growth, which gave us optimism for the TBE market coming back. During the first quarter we also delivered DKK 30 million revenue in our Mvabea or Ebola vaccine to Janssen. This was finalization of the order that we executed upon last year. So no more revenue is expected on Ebola for this year. We delivered the first revenue on the two products that we have an agreement under the Valneva on so that's the IXIARO and DUKORAL products that delivered a total revenue for the first quarter of DKK 14 million and then we also saw a nice milestone revenue being recognized from the agreement we signed with Nuance Pharma for China and selected markets on RSV. So under half million U.S. dollars translated into DKK 83 million. And finally we have a little contract work mainly related to the qualification of the fill and finish facility and BARDA contract. So in total DKK 320 million for the first quarter. If we turn to the next page, and let's spend a little time this is a built I'll just show all the builds here. Talking a little about our Rabies business. And if we first up looking at the markets. The U.S. markets showed strong growth 22% compared to the same quarter of last year, and getting to a level close to the pre COVID-19 levels. So strong -- continued strong growth in the U.S. market and we are nearly looking at a market that is back to pre-COVID levels. If you look at the German market, that was really a market that was severely hit by COVID-19. As people were not traveling to exotic destinations. However, we have during the last three quarters seen strong growth from a low level though, but I think here in the first quarter, it's actually a 257% growth. So despite that it comes from a low level, the growth is material enough to have an impact on our total numbers. And therefore you also see strong Nordic revenue on the Rabies business DKK 117 million so up 45%. And really driven by both the U.S. and the German markets. We have under market share basis that the U.S. market share ended at approximately 64% after the first quarter, which is in line with the level we saw prior to our competitor facing a stockout situation in the autumn of 2020. So really strong performance in the Rabies markets and by our team. Next slide. Again, this is a built slide. So this slide talks about the TBE market, whereas Europe is just representing most of our businesses -- sorry, Germany is representing most of our business here. And unfortunately, what we saw here in the first quarter is that the sort of depressed situation we have seen the last quarters in the German the market for TBE continued. And we basically saw a market being down by 23%, compared to the same quarter last year. Based on our intelligence in the market, I think what we are seeing right now is that there is, again, access to physicians is there we suffered from that in the past, as physicians were occupied with the COVID-19 vaccinations. That is not so much the problem any longer. Now, it's mainly coming from the weak demand from patients. There's some indications of some temporary vaccination fatigue amongst people who have been vaccinated one, two, three, or even four times with the COVID. There is at the moment relatively poor republic press covers of TBE. And I think this is unfortunately a trend that cuts across many vaccines in the space. It's not only TBE, I think if you look into some of the big vaccine companies like GSK, and Pfizer, and you look into the performance of their vaccines in Europe, you will see the same tendency that the vaccine market is unfortunately still depressed in Germany. We are however, still optimistic that this market will come back relatively soon. We have as Paul alluded to expectations to the second quarter, second and third quarter are the most important quarters for us in the TBE business. So hopefully, we will see some signs of the markets coming back here in the second quarter already. Our performance in Germany on Rabies shows that there is pockets within the vaccine space with good growth already. So we remain optimistic that also for the TBE market, we are going to see growth soon. On the next slide, that is just to remind you about the marketing and distribution partnerships that we have concluded to two bottom ones IXIARO and DUKORAL. We made the partnership with Valneva, and we have already launched these two products in Germany and in Switzerland and delivered the first DKK 40 million in revenue during the first quarter. Then we have the third one HEPLISAV-B, which we have in license from Dynavax and which we are planning to launch here in the second quarter in May this month, actually it should be more precise. And this is going to be launched in Germany only. But it is quite exciting launch as this is a real first time launch of this product in the market. On Slide 14, quick overview of the total profit and loss. As already presented revenue of DKK 320 million, we have total production costs of DKK 292 million leading to a gross profit of DKK 28 million relatively low gross margin partly due to the plant shutdown of the bulk facility, which means we have less production costs being absorbed by the manufacturing of revenue generating products. Research and development costs ended at DKK 105 million so somewhat lower than the same period of last year and primarily explained by the fact that we manufactured the whole the RSV Phase 3 material in the first quarter of last year. SG&A costs came in at DKK 150 million. So below last year's level, and primarily due to lower cost, distribution cost, and commercial costs. Adding net financial items and tax et cetera. It takes us to a net profit for a period of negative DKK 272 million or an EBITDA of a loss of DKK 94 million. Remember is the level that we guide on. So these two are the slide here includes two of the parameters that we guide on revenue and EBITDA. And based on these results, which are overall in line with our own expectations, we are confirming our guidance for the full-year on these two parameters. Next slide. Quick overview of the cash flow and our balance sheet. So net cash flow for a period was a negative of DKK 192 million. We saw positive contribution from operating activities of DKK 24 million driven by improved working capital, primarily over receivables during the quarter. Then we saw negative contribution from investment activities of close to DKK 300 million were more or less equally split between investments in finance the expansion of our bulk facility, and the other part going into investments and intangible assets, which includes our tech transfer process of Rabipur/RabAvert and Encepur and our development of the COVID-19 vaccine that we are capitalizing. Finally, we had a positive contribution from financing activities of a net of DKK 75 million and its primarily explained by another DKK 80 million we got from today's Minister of Health as part of the agreement we signed last year. To the right, we see some selected balance sheet figures and I will only now focus on our net cash position. So that is the DKK 2,594 million when we have excluded all debts. If we add back the current engagement with the European Investment Bank, that takes us to a current casts and cash equivalent position of DKK 2,947 million, which brings us in a very strong position to continue pursuing our strategy and all our plans including the Phase 3 trials that we either have or will initiate very soon. So, if we go to the next slide. I already mentioned that we have confirmed or maintained our guidance on revenue and EBITDA, and I can say the same on the cash position based on the previous slide. So that is we still have a guidance in terms of revenue of between DKK 1.1 billion and DKK 1.4 billion. We are guiding earnings before interest, taxes, depreciation, and amortization. Guiding here a loss between DKK 1 billion and DKK 1.3 billion and we are guiding a cash position by the end of year of between DKK 1 billion and DKK 1.2 billion. To the right on this slide, you'll see our usual overview of key activities and key milestones. For the remainder of the year, I'll just highlight a few of the most important ones. And obviously, if you look on RSV, we already initiated a Phase 3 enrollments. So the next important milestone is of course to complete enrollment, which we are planning to do by the end of '22. COVID-19, next major important milestone will of course be the initiation of the Phase 3 trial. And as Paul alluded to, we are still targeting to complete or have the first data readout from this COVID-19 trial. And if the regulatory bodies allows it start rolling submissions already this year. If you look further down, I already mentioned at the key important commercial milestone would be to have a successful launch of HEPLISAV-B in Germany, which would be initiated here during the months of May. So, just final remarks. Overall, we are happy with the financial results we have seen. And therefore we are in a position where we can maintain our guidance for the full-year despite all the uncertainties in the world at the moment. So with that, I will ask the operator to open up for questions.

Thank you. [Operator Instructions]. And your first question comes from the line of Gil Blum from Needham and Company. Please ask your question.

Good morning/good afternoon, everyone. Thanks for taking our question. Maybe a broader one, considering trends that we've seen both in Rabies and TBE. What do you think are the attitudes of the average European towards COVID right now. I would say that in the U.S. there's a bit of a reading through COVID. But I would appreciate your commentary around this? Thank you.

Yes, I can take that. Well, I can speculate if you want. So I think as Henrik alluded to, there seems to be a little bit of fatigue, vaccine fatigue, I don't know whether there's a better word for it in Germany at least, where we're seeing slower than normal uptake not only of our vaccines, but others are reporting the same thing. So I think there is some fatigue out there. And I think in Europe at least, all the lockdowns have essentially come to an end, and we're all back moving around. And people tend to forget about COVID, when the Sun is shining, and things are getting back to normal. I do believe however, it was the same last year, this time last year. And then of course, Omicron emerged. And there was obviously a need for everyone to get a third booster. And I feel the sentiment will be very similar as last year. We're all happy, and we've forgotten about COVID. But as we get nearer to the Autumn, I will imagine the number of cases will increase, particularly as the data is showing that the third booster really wears off before six months. So I would imagine that whether there's fatigue or not, we're going to be needed -- we're going to need to get revaccinated in the Autumn.

Thank you, Paul. That's very helpful. Maybe a follow-up question, just to remind me, what do we think the primary endpoint is going to be for the pivotal study of your COVID vaccine? Thank you.

Yes, it's to demonstrate non-inferiority of the peak neutralizing titers. Again, Wuhan between ABNCoV2 and RNA comparator.

Okay, so it's not and will include like secondary endpoints such as rate of hospitalization and things like that?

Well, it's a smaller study, while obviously we'll be looking at hospitalization and real cases of COVID. It's not ours for that. So it's purely an immune to this the endpoints obviously the second, there are secondary endpoints. Safety, of course is a key one, but also looking at the immune responses to other variants of concern. But the primary endpoint, which will allow for registration is a 90 RSV immune endpoint to compare that RNA.

Okay, gotcha. Thank you very much for taking our questions and congrats on the progress.

Thank you.

Thank you. Your next question comes from the line of Peter Verdult from Citi. Please ask your question.

Thank you. Just one for Paul really on the timelines -- timelines. COVID timelines still be in a position to file this year, a sensible base case or would you concede them as optimistic and the risks on the timelines is more slipping is quite high, so wanted to get a sense with the change that you're having to deal with and the trial design, where the risks are similarly, as you get ready as you with the RSV program prevalence rates, we're seeing enrollment rates, that's still how much confidence you have it will be having that data mid-year. I think some one of your competitors, the timeline something to somewhat for their Phase 3 readouts, so just the confidence around the timelines on the pivotal Phase 3 programs. Thank you.

Yes, thanks, Peter. So on COVID as I said this latest regulatory development is relatively new. Unfortunately, so that's the unfortunate side of it. We were literally about to start the previous study. I call it previous because we have to adapt. And the reason we definitely have to adapt is that the approval that we had with the regulators was that they were happy for us to conduct, to enroll in a national booster program, only if we could not get access to a comparator. So as soon as the door opens, it looks like we can now get access to a comparator. The regulator, the regulators have clearly stated then you have to do a fully randomized study to the comparator. The good news is I said in the presentation, that is a simpler study to conduct potentially even faster. And that's why I'm saying that any slight delay we have in the start, I think will lead to a faster study. The other thing just to raise your own confidence that we are confident is that I've said several times, we're working in parallel on both approaches, both a randomized study design but also go in with the National Booster Program. Obviously, for many months now we've got the National Booster Programs, the approach that we actually have dropped protocols, and things that we've already discussed with the regulators for the randomized approach. So I think we can catch up relatively quickly. As I said, it is relatively decent development. So I can't be very firm on exactly when we'll start that study. And we're still in the number of member states to actually get access to the vaccine. So we are confident that we should see data readout later this year. As I said, at the latest, it will start the role, in terms of RSV, we wanted to start with the enrolment which is a critical phase, enrolment is going okay, and that means it is going okay. So we're on track as we stand. But as I said, we're only one month in. There is competition. As you know, there are a number of competitors also conducting RSV studies. And even those some of those that started last year have expanded their study and now are also enrolling. We've taken that into consideration in the site selection. So yes, we remain confident that we will enroll 20,000 this year that we hopefully, the data readout next is dependent that we see the total number of events that we need to read out. But if that's the case, I do believe we'll have data next year.

Thank you.

Thank you. [Operator Instructions] Your next question comes from the line of Peter Welford from Jefferies, please ask your question.

Hi, thanks, four questions. Hi, sorry. Nice to meet you, well four questions if I can please. Firstly just on the timing of the booking of revenues on the JYNNEOS for U.S. government and Canada. Should we assume that the bulk of these happened at the very end of the year given the manufacturing was there or is this unrelated to what's going on there? And then it could be, it could happen during the earlier quarters of this year? Secondly, then on Encepur in Germany, you mentioned vaccine fatigue and other sort of a willingness, is this something you're considering actively addressing, I guess I'm thinking with regards to marketing, perhaps some campaigns to get out there to address the potential lack of willingness by people apparently to go forward to it? Or is this something of a more general aspect that you basically wait for the next season at this point in time. Thirdly, then just on the outlook obviously, you've had the milestone from RSV, from Nuance Pharma. And also FX obviously is moving much more in your favor by 10% or so the dollar versus the original guide, are we in situation where we should be thinking about some of the weaknesses and things like Encepur et cetera gives you the confidence that actually there's a sort of offset here, or should we be thinking more that given the milestone and given FX that realistically the upper end of your guidance is more sensible at this point now. And then just finally on COVID, coming back to the primary endpoint, I understand obviously the choice of primary endpoint as standard, but is it potentially under consideration to perhaps do a slightly larger study? And also look at some of the other strains of secondary endpoints, I'm thinking particularly Omicron. Would it be viable to consider trying to show superiority, given obviously, we know that the existing mRNA vaccines don't necessarily induce strong immunity against some of the new strains, is it possible to try and tease out some sort of benefit? I guess I'm just thinking, from your perspective coming late to the market. This seems potentially like an opportunity where you could actually use this study to your advantage at this point, or is it just realistically too costly and too big to be able to achieve those sorts of measurements? Thank you.

Yes, thanks, Peter. Let me check the first couple of questions here. First of all, timing of the revenue from JYNNEOS. We have in our guidance included the Canada of approximately DKK 200 million and then we have DKK 100 million left over from the orders from last year. So that's DKK 300 million in the order toward that DKK 100 million cannot be executed until we have opened the facility again. So that will be in the fourth quarter. And the Canada order, I think we are expecting most of that to happen in the second half of the year. So most part of our smallpox revenue $300 million will take place in the second half of this year. In terms of Encepur in Germany, what can we do to help the market to turn around and this is something we can address in terms of marketing, et cetera. I think we are basically doing everything we can here. But I think we should also remember that we have approximately 30% of the German market are a strong markets here, sits on 70% of the market, they should really be turning this market around and they will be gaining most from it. And according to our own intelligence, they are doing what they're supposed to do. But what we are lacking right now is there's not much communication from National authorities in the market, which that usually is, where people in sort of national campaigns are reminding people about the season kicking in, and the risks of not being vaccinated, et cetera. That's probably where more can happen. And we of course doing our best for this to happen again, I think the good thing is that we are seeing, as we said pockets of vaccine markets developing well, we saw a long rageous market in Germany, showing fantastic growth. So we do see this as a temporary phenomena, and are optimistic that the TBE market will also return in the near future. In terms of outlook, you're right. We haven't changed our outlook. Despite we got the Nuance milestone payment, which was not in our original guidance. On the top-line we have helped on foreign, we are stronger dollar. That's correct. But we simply believe with the uncertainties that we are seeing in today's world, that it was just a TAT too early to change anything in terms of our guidance. We are a little uncertain about of course how Encepur will develop despite we are optimistic. So I will assume that we will have a close look at this again in connection with our second quarter report. But for now, I think we have concluded that it's a little too early with all the uncertainties we are seeing in the world at the moment to change the guidance. And on the Forex. Remember also that the currency might help us on the top-line. Unfortunately, not so much on the bottom-line as a lot of the clinical trials that we are investing in U.S. dollar denominated. And then I think the -- there was a question for you, Paul on the primary endpoint on COVID.

Yes. So thanks, Peter. Yes, so the primary endpoint really is locked in, in that the regulators and when I said regulators that [indiscernible] and also the FDA, have been pretty insistent that the primary endpoint should be only against the Wuhan strain, which is the only strain any vaccine has been -- has shown efficacy against to at least the RNA vaccines. And to go for superiority claim there. One, we probably won't get away with it that as an endpoint, but don't forget against Wuhan we're looking at 95% efficacy, so it's going to be very difficult to trump that to be honest. Having said all that, of course, the secondary endpoints we will look at variant as a concern. And whilst secondary endpoints may not be allowed in the so called label claim, of course, if we can generate superior data that may well be used by other bodies such as ASIP, who you know, make the final recommendation in the U.S. anyway. So we are trying to address some advantages that we may think we have over the RNA in terms of the overall trial design. As I said, the primary endpoint is really locked in.

So I just follow-up, I understand how to build the program. But I guess my question was just on the last point now, which is given what you see with Omicron and the neutralizing antibody titers that you generated it. So when you think about the sizing of this study, are you thinking about potentially sizing appropriately to get possible periodicity for naps against Omicron? Because I would imagine the trial size to achieve that is probably not massively, but fairly, significantly larger than the trial size required to just show noninferiority against Wuhan on the primary endpoint immunogenicity?

I think you've answered my -- the question. So is exactly, that's the problem, this trial size will be significantly larger, it will take longer, and then you may still miss that, that endpoint. So I think, the risk, the expense, and the timing risk is too great to go for such a trial design.

That's great. Thank you.

Thank you. Your next question comes from the line of Michael Novod from Nordea Equities. Please ask your question.

Yes, thanks a lot. Further question on RSV, maybe, Paul, you can explain a bit on sort of the importance of the T cells, especially regarding hospitalization, which is the primary endpoint in in Phase 3, also with the data in mind on [indiscernible] we saw earlier, just to get a feeling on how you actually differentiate or how you believe you differentiate also versus all the data readouts coming out rather soon probably? And then secondly, on the Rabies business? Can you explain the big jump? Did you get some contract wins in the U.S. during the quarter during the end of last year to sort of explain the significant jump also in revenues compared to the market? And then lastly, third-party revenues, you're starting to put more and more. Maybe Henrik could detail a bit on what sort of level we should expect just for modeling purposes in 2022?

Yes, I'll take the first one. Thanks, Michael. Yes, so one of the big differentiating factors is in data T cells as you mentioned, when we were developing this RSV candidate vaccine, we only really saw full protection in animal models, when we had all five antigens from RSV expressed in our NDA. And what we see in preclinical studies is that T-cells play a very major role in clearing the virus. That's also seen in the clinic. And there's a number of publications that point to that fact. So when you look at some publications, looking at the human challenge model, neutralizing antibodies in the blood do not correlate with protection in that model. The two parameters that do correlate, however, is IGA from nasal swabs, which is a special type of antibody in the mucosa and mainly T-cells in the lung. Also, there's a publication looking at a group of elderly subjects. And looking at factors, which was correlated with facts, whether they got RSV in a normal season, or they didn't. They're here again, neutralizing antibodies in the blood did not correlate with being protected from RSV. But what did correlate in protection was whether you have a strong T-cell response before the RSV season. Again, indicating that T-cells play an important role. And you brought up the therapeutic antibody data recently that was published, I think it's in the Lancet. There -- that was a very interesting publication, because that therapeutic antibody in children showed very high efficacy from mild RSV symptoms, that when you looked at hospitalization rates -- so severe disease virus, there was absolutely no difference between placebo and we need to -- and the therapeutic antibody. And what I conclude from that and all we have a bits of data I've just said that T-cells play a really important role. And in the absence of T-cells, such as a therapeutic antibody, you don't prevent the hospitalization in the severe disease, you're only preventing mild disease. And we're the only vaccine candidate that generates a very strong and broad T-cell response against multiple RSV antigens. So time will tell, but it is a differentiating factor. And there is a lot of data pointing that we have a very good vaccine design.

Yes, okay. Thanks, Michael. Let me take the question on the Rabies first. I think we feel extremely strong growth 45% and so and so, but it's actually not explained by any particular contract, so on -- in the U.S., but it is really, I think the abnormal grills its really explained by what we see in the German market. The German market grew by 257%, and it comes from a very low base. But here, we should remember that we have more than 90% of that market, in Germany. So we are having a huge benefit of the market coming back. And actually, if you look at the total growth in absolute terms, in our Rabies business, it's more or less equally divided between U.S. and Germany. And then, of course, we did see a nice growth in the U.S. But it's actually from the 22% we saw in the U.S. and to the 45% that is actually explained by the significant growth in Germany, given our strong market share there still. So I'm done. I'm afraid I missed your second question you want to some input on revenue to be able to model for '22? Which product did you talk about?

It was more of the third party revenues that you're booking. So from partnering products, it was more to get a feeling of that. And you're also starting to book additional products for the rest of the year. Just to get a feeling of where we are sort of in terms of the share of revenue grew?

Yes, and we haven't guided anything that yet. And it's still relatively new business too. So I do not feel comfortable starting guiding on that in particularly not HEPLISAV-B, which is a totally new launch. It's quite an exciting launch, of course, total market value €20 million to €25 million for the German market. But when we hopefully come in with a strong product, it's the see so far, the only two dose only Hepatitis B vaccine coming into the market. And in terms of the other two products from Valneva, I can't really guide and that it's a little too early. And it's also two products that have been heavily impacted by COVID-19. And we need to see perhaps at some of the positive trends we have seen under Rabies business also will spill over to other travel vaccines, but that's a little too early to say unfortunately. So I'm afraid I can't help you much more as we'd have very few data points on these new products here.

Okay, thanks a lot.

[Operator Instructions]. There seems to be no further questions at this time. Please continue.

Thank you. So thank you everyone for attending the Q1 update and for the questions in your interest. Have a great day.

That does conclude our conference for today. Thank you for participation. You may all disconnect.