Ladies and gentlemen, thank you for standing by, and welcome to our first quarterly report for the three-month period ending 2020. At this time, all participants are in listen-only mode, and after the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press Star and One on your telephone. I would now like to hand the conference over to your speaker today, Rolf Sørensen. Please go ahead, sir.
Yes. Good afternoon. My name is Rolf Sørensen, Vice President, Investor Relations. Before we start the presentation, I like to read the following statement. This presentation includes forward-looking statements that involve risks, uncertainties, and other factors, many of which are outside of our control, that could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements regarding our short-term objectives and opportunities, financial expectations for the full year, and financial preparedness as of year-end, as well as statements concerning our plans, objectives, goals, future events, performance, and other informations that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements. We undertake no obligations to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law.
After this, I will hand over the presentation, first of all, to our President and CEO, Paul Chaplin, and afterwards to our CFO, Henrik Juul. Go ahead, Paul.
Thanks, Rolf. Welcome everyone to our Q1 update. We've had a very strong quarter. Before I get into those activities, if you turn to Slide 3, I'd just like to set the scene by reminding everyone of our vision and our ambitious strategy. Within the next 5 years, we aspire to be 1 of the largest pure-play vaccine companies. To do that, we want to be a company driven by commercial excellence. We want to continue to develop innovative life-saving vaccines. Again, we want to build on 1 of our other key strengths, which is vaccine manufacturing, to become the best-in-class vaccine manufacturer. In the coming slides, we've structured the presentation around our key strategic goals and ambitions. If you turn to Slide 4, as I said, we've had an extremely strong Q1.
This is a transitional year as we integrate the two new commercial assets to our portfolio. To do that, we had a very successful rights issue where we raised 2.8 billion DKK. We can say that we achieved this in rather difficult markets. I would just like to thank our shareholders for the trust they've shown, both in the management and the employees of Bavarian Nordic, in supporting us in the acquisition and in the rights offering. We started the year with a very strong, large order from the U.S. government, valued at $202 million.
It's larger than we anticipated, and despite COVID-19, we can stick to our financial guidance, primarily due to the fact that we have some impact of COVID-19 on some of our commercial sales, which I'm sure Henrik will allude to, but because other parts of our businesses are more robust, such as our smallpox business, we are able to weather the storm of COVID-19. On COVID-19, we've been looking for several months now of what we can do as a vaccine company, and we have come to an agreement or heads of agreement with AdaptVac on their technology, which I'll allude to later, but we are going to aggressively move this vaccine to hopefully bring a safe and efficacious vaccine that will allow all of us to return to normality.
We have a strong cash position. As I said, we maintain our financial guidance, I'll leave the details to Henrik later. In terms of our strategic priorities on our commercial front, our commercial leadership is now in place. We are probably slightly ahead of schedule of where we wanted to be internally, We're well geared up to take over some of the key markets in the second half, both for Encepur and Rabipur. On the portfolio programs, we're largely unaffected by COVID-19, I can get to that when I walk through the pipeline, We've strengthened our management team by hiring a new CMO. Laurence comes from Takeda, but formerly from GSK.
She has a proven track record in vaccine development, but is also very familiar from her time at GSK with both Encepur and Rabipur, and will be a great strength for the management moving forward. On the manufacturing, everything goes according to plan. Our manufacturing is moving as we expected. Our fill-finish plant is being qualified as we speak, and we'll be bringing the first product on the line at the end of the year. The tech transfer of Rabipur and Encepur remains on track. If you turn to Slide 5, I want to talk a little bit about the smallpox order that we received the other week. It's part of the contract that was awarded in 2017.
As I've said, under this contract, we have already agreed pricing for additional bulk, for liquid and freeze-dried, and we received this order for $202 million as part of that contract. It's for additional bulk and to create an initial stockpile of the liquid-frozen JYNNEOS of 1.4 million, which will go into the SNS and supply the use within the U.S., both for DOD and other first-line responders. Most of the $106 million, which has been secured, will we revenue recognize this year and the remainder next year. As you can see by the schematic, we now actually have over $500 million in orders and options, both for the liquid, bulk, and also the freeze-dried, which we'll be able to revenue recognize over the next 5-6 years.
A very, very strong commitment, continued commitment from the U.S. government in our smallpox business, and one that we believe will go from strength to strength, as the use of JYNNEOS is expanded from simply being stockpiled to starting to being used by first-line responders. Turn to Slide 6. Last week, we announced that we've come to at least terms in agreement with AdaptVac, which is a joint venture between ExpreS2ion Biotechnologies and NextGen Vaccines, which is a spin-out from the University of Copenhagen. This is for their captured virus-like particle, COVID-19 vaccine. We've been looking at this technology for some time.
I'll talk more about the technology on the next slide. We clearly, when we were looking at what could we do in this space, came to the conclusion that actually, this technology, I believe, is one of the few technologies that's being pushed into the clinic, that can meet the WHO criteria. If you see at the bottom of the slide, the vaccine should be suitable for all ages, that's including the elderly, which is one of the high-risk populations. It should work in a single shot, it should prevent infections of SARS-CoV-2, it should do that within two weeks. That's a tall order for many of the vaccine platforms that are going into the clinic. I believe this platform can succeed. AdaptVac is part of an international consortium that has raised sufficient funds to move this vaccine into phase one.
We believe that with our proven expertise, what we've done for Ebola, together with Janssen, and what we've done for smallpox, we can really aggressively move this vaccine from phase 1 into phase 3. We hope to start the phase 1 together with AdaptVac later this year, with data available early next year. Slide 7, talking a little bit about why are we so excited about this platform. Well, vaccines, they stimulate the body's defenses to prevent you from being infected. The most effective vaccines are the ones that stimulate the strongest defense. Viral-like particles, the advantage of these is that they present a large amount of antigen in exactly the same way a virus would to the body. It's a proven technology.
HPV vaccines are based on VLPs, they have been shown to work with a single shot because they, as I say, stimulate the body in a very powerful way. We're particularly excited about this technology. There are other VLPs out there, the capsid can be expressed in E. coli, it can be rapidly scaled up, it has a very high yield, and the protein, which is the specific part that you're trying to target for this disease, you express separately. The scalability of production is there. We can produce very large quantities, I believe this stands the greatest chance of meeting that WHO criteria for a successful, safe, and effective vaccine. Slide 8 is the pipeline. Our freeze-dried smallpox vaccine is in phase 3.
it remains unaffected by COVID-19, primarily because we completed enrollment last year. We're currently in the 6-month follow-up phase, which is actually done by telephone, so that we don't actually see any impact on that, and we plan to report the top-line data from that lot consistency safety study later this year. On RSV, we're gearing up for a phase 3 initiation next year, so we're currently manufacturing the material and gearing up our activities to start that trial in the first half of next year. Our Ebola vaccine, which is partnered with Janssen, as you know, has been filed for approval in the EU, and we expect that approval in the coming months. Our Western equine encephalitis vaccine, I'll talk about in the coming slides, as I will with our Brachyury vaccine, which is in phase 2.
If you go to Slide 9, equine encephalitis is another emerging disease which is mosquito-driven. It's quite a deadly disease. There are three different strains, Eastern, or often called Triple E, Venezuela, and Western. Our vaccine is a trivalent, trying to protect against all three strains. It's a rather deadly disease, and a third of the people that get infected actually die from encephalitis, which is swelling of the brain. This has come to the forefront because last year there was an outbreak in the U.S. 38 cases were recorded, and unfortunately, 15 deaths. It caused a massive disruption on the East Coast, because of concerns of this disease. We're in a completely funded trial from the Department of Defense. That trial, we plan to report the top-line results in the coming months.
In fact, we have already this year responded to 2 requests for proposals, 1 from the NIH and 1 from BARDA, for further development of such a vaccine. We are quite excited about the opportunity, and it's, again, our ability to put our platform against a new emerging infectious disease. On Slide 10, changing gears from infectious diseases to immuno-oncology, we have a cancer vaccine, which we call Brachyury. It's a cancer antigen. It's a transcription factor that's overexpressed in late-stage cancers. There is 1 rare cancer called chordoma, which is of the base of the skull and spine, which universally expresses Brachyury at all stages of its growth, and therefore makes it an ideal target to test a Brachyury-based cancer vaccine. We started a 2-step trial last year.
We enrolled an initial number of patients. We saw 1 responder, meaning we saw tumor shrinkage in 1 individual. That meant we expanded the enrollment and enrolled a total of 29 patients, which was rapidly enrolled last year. These patients are also getting radiation together with the vaccine, and we're looking for a successful readout of 4 responders in total, which would be an outstanding result, as radiation has less than an impact in 5% of patients. This trial will read out in the second half of this year, and again, we still remain extremely excited at the outcome of this, as this could be a new treatment for this rare cancer. With that, I'll hand over the presentation to Henrik.
Thank you very much, Paul. Let's turn to Slide 11. This quarter, Q1 of 2020, marks a very important milestone for Bavarian Nordic, as this is the first time that the company reports on real commercial sales data, the recurring sales data, and that has, of course, led us to change the layout somewhat in our Q reports, putting the financial numbers in a more prominent position on page 1 and adding some commentary to the quarterly development of the recurring commercial sales. If we look at Slide 11, I will start by talking about how sales went for the Q1 with the 2 acquired vaccines from GSK.
If we start with the rabies vaccine, Rabipur and RabAvert, we saw revenue of DKK 218 million for the Q1 , which was a 20% growth over the same period last year, very strong and healthy growth. Main key driver for that growth was a stock out situation that a competitor faced end of last year and running into primarily January and February of this year. Again, highlighting some of the opportunities we identified already when we looked at this acquisition, that it has been a business that has been associated with many stock outs, both from GSK, but also from the competitor in the market, and this is something that we hope to take advantages of going forward.
According to our intelligence, I think the stock out situation has been resolved by now. Again, we delivered a 20% growth. We did see a lower revenue in March, where some of the COVID-19 impact started to kick in, but even despite that, it was a 20% growth. Looking a little near term ahead of us and just talking a little about what kind of impact we could anticipate from the COVID-19 situation, there one needs to understand the rabies market is basically divided in 2 segments. There's the pre-exposure, which is primarily a travel vaccine market, and then there's the post-exposure, which is really when a person has been in contact with rabid animals, and here it's really a question of life or death.
On the pre-exposure, the travel part of the segment, this segment will, of course, be hurt by the COVID-19 situation. The post-exposure, we believe will be largely unaffected by this situation here. In terms of revenue, the travel part does represent a material part of the total rabies revenue, but measured on profitability, it's a much lower component, as prices are typically higher in the post-exposure segment. Encepur, we saw revenue of DKK 103 million, which was 40% lower than the same period of last year. Here, the confounding factor is that this is actually under unchanged market share.
When we compare the two markets, market shares between 19 and 20, we still have a market share of around close to 30% of the market. Basically, I think what has caused this drop was a very large sell into the market by GSK in the Q1 of last year. On the next slide, I will come a little more into that to give you a much better understanding of the invoicing flow versus the end market sales. Looking a little forward again on Encepur, really the demand for the TBE, we expect that to remain unchanged despite the COVID-19. Here, I'm talking about the underlying demand, as this is not a travel vaccine, it's a vaccine that we sell in the endemic areas.
Of course, if a person cannot get access to the doctor, there will be an immediate impact, and we saw that in March, where we saw very low sales of the TBE vaccine. As soon as we see the healthcare system opening up again, which is actually happening gradually already now in the bigger markets, we expect vaccinations to go back up again, and we even expect that there could be a kind of catch-up effect as some of these people who were meant to get vaccinated will get back to their physicians. This is, of course, assuming that all of this happens, a gradual opening of access to the physicians before the end of the vaccination season, which is in August this year.
If we turn to the next page, we have included a slide with some quarterly sales numbers on both Rabipur, Rabivax, and Encepur, to give you a better insight into the seasonality of these products, but also to have a chance to talk a little about the difference between our revenue recognition and the end market sales that is the pull out of the pharmacies to the patients. I think for some of you, this is common knowledge, and you know it already, but we feel as this is the first time, I think we would also like just to spend a couple of minutes explaining this. First of all, I think at the moment, it is still GSK who is responsible for distribution of these products.
We will take over physical distribution in the first key markets in the second half of this year. GSK are selling through wholesalers and distributors, who then sells and distributes to pharmacies, hospitals, et cetera. Then patients, of course, picks up their medicine at the pharmacy, or they get it at the hospital, et cetera. When you look at the real demand, that is, of course, created at the end of the chain, that is when the patient is being vaccinated, either they're going to a pharmacy, a doctor, or the hospital. Those numbers, you can say we are buying data so that we have a good overview of how the market size is developing and the market shares by player in the segment.
These numbers might differ significantly from our sales numbers because remember, we are selling into the wholesalers, and who sells to pharmacies, etc. Between those two numbers, there's first of all, a time lag, but there's also some inventory movements. If a wholesaler, for instance, is preparing in one quarter for a big campaign, in the following quarter, they are stocking up, but the real demand is not until the following quarter, etc. If you start looking at the Encepur graph to the right, you can see the quarters from 2018, 2019, and the Q1 of 2020. There you will see that the Q1 of 2019 was a very strong quarter.
If you look at the following quarters, also for 2019, you will see that Q2 was strong as well, but then you actually saw the Q3 fell below the previous year. It's just again, to illustrate and underline that there can be these movements between the quarters. Again, I think we can also use this slide to highlight the strong seasonality that we see with the Encepur products. The vaccination season goes from approximately April to August, so that means the Q2 is typically the strongest. Of course, again, as we have to supply to the wholesalers in advance, you will see pretty strong Q1 s, normally very strong Q2 s, and also some relatively strong Q3 s, and then very low Q4 s as you are out of the season again.
If you look at the Rabies product, there's very little seasonality. There are some, I think in, particularly when it comes to the travel part of it, there's some seasonality, but limited. Again, here, the same thing apply. I think inventory movements, et cetera, can actually make a difference between the end market demand and our revenue to wholesalers. We do not have the reliable 2018 numbers by quarter for Rabipur, Rabivax that's why you only see 2019 by quarter and 2020. In this situation here, it was also more relevant for the Encepur product. Let's turn to Slide 12, where we have our usual full overview of the financial results. We delivered total revenue of DKK 365 million. Most of that actually came from the two acquired vaccines.
On the Rabies business, DKK 218 million. The TBE business brought in another DKK 103 million. The rest was really contract work, primarily performed on the contracts with BARDA on the CMC activities for our fill-finish facility and on the phase 3 lot consistency study we're running on freeze-dried version. I think really highlighting the impact of the acquisition that we have done, had it not been for the acquisition, you can look at the numbers here, our revenue would have been DKK 44 million for the quarter.
During the Q1 , we also closed the sale of our priority review voucher and earned $628 million, which is, of course, included in our EBITDA and EBIT lines as well, that helped us take the EBITDA to $641 million, still positive, even without the including the voucher income. If we look at the guidance, we have also communicated that we maintain our guidance for the full year. We did get a very large order from the U.S. government, $202 million, with $106 million being fully confirmed and an option for the rest. Most of the $106 million will be recognized this year.
I think that enables us to confirm our guidance and absorb, you can say, the uncertainty related to those segments of our business that are affected by COVID-19. On an EBITDA, we also still confirm the guidance of DKK 675 million for the full year, we confirm our cash position of DKK 1,350 million by the end of the year. When you look at that, the table below, if you look at sort of, if you take Q1 and compare to the full year expectations, you will notice that there must be significant variations between the quarters. The revenue obviously is skewed more towards the last nine months.
That is, of course, because during the Q1 , we included no income from supply of bulk or of final doses to BARDA on smallpox. Most of the $106 million that will be recognized in 2020 will happen in the next quarters. Nothing has been included yet. I can also say that when it comes to the cost, you will also see that that is a little more backloaded this year as we are ramping up the commercial organization, and we will incur more cost during the second half of the year.
The non-recurring costs that we have previously announced in our outlook is mainly related to the next 9 months and related to the further implementation of the or the integration of the new products. With that, let's turn to the next page. Just the usual overview of our financial position. We have in cash and cash equivalents, DKK 2.2 billion, and we still have an unutilized credit line with the European Investment Bank of DKK 244 million. We are planning to draw that down during the Q2, and after that, we will stop talking about cash preparedness and focus on what is basically our position in terms of cash and cash equivalents.
Right now, in the Q1 , it is close to DKK two and a half billion, so it brings us in a very healthy financial position that enables us to pay the future milestones to GSK and continue in line with our strategy, basically. Final slide is just to remind you of some of our key strategic activities and the milestones for the remaining nine months of this year, grouped by our key strategic pillars. In terms of the commercial excellence, here we will continue the work to build up a full commercial organization to support our new products, but also to support JYNNEOS for the mpox indication.
Our focus will be in terms of the integration work to take over physical distribution in our key markets in the second half of this year. Of course, in line with our strategic ambitions, with that establishment of the commercial organization, increase the awareness out there for the mpox indication as well, and the general awareness of Bavarian Nordic as a commercial company. In terms of our R&D, I think here we will continue our preparations for the RSV to be launched in 2021. We will further advance the phase 3 trial we are running on the freeze-dried smallpox vaccine, which we are planning to complete in 2021. We are waiting for an approval of the Ebola vaccine that Janssen, together with us, submitted for approval earlier.
As Paul alluded to, I think we also have some results coming out from our pipeline later this year. On the equine encephalitis, we are expecting already in the Q2 , some high-level top-line results. On our brachyury study, we are expecting the first objective response data later this year as well. In terms of our strategic focus area within manufacturing, I think here the task is really about completing the qualification and audit validation of our fill-finish facility, which we are on track to do. It's also about commencing the investments in the bulk manufacturing to increase both capacity and flexibility so that we can also transfer Rabipur and Rabivax and Encepur to our site. With that update, I will ask the operator to open up for question and answers, please.
Ladies and gentlemen, we now begin the question and answer session. As a reminder, if you wish to ask a question, please press star one on your telephone and wait for your name to be announced. If you wish to cancel your request, please press hash key. Once again, please press star one if you wish to ask a question. Your first question came from the line of Chad Masiya from Needham. Please go ahead. Your line is open.
Great. Thank you. Congratulations on the strong execution all across your business in a very challenging year. My first question is on the VLP technology. Obviously, very different than the sort of smallpox-based, vaccine technology that most of your pipeline is based upon. Just wondering, you know, particularly as you are looking to grow into a larger vaccine company, are there other opportunities besides COVID that you think this would be appropriate for? Maybe a related but more naive question, since I know a lot less about this: Are there any manufacturing considerations? These are obviously very different, vaccines.
Hi. Thanks, Chad. As I said, we've been looking at this specific VLP technology for some time. Obviously, that was before really COVID, we were actually looking at it for other indications in mind. You know, our ambition to become one of the largest single-play vaccine companies, with that, you know, we're great believers in our MVA technology, not all vaccine platforms can do everything, there are limitations, both from a manufacturing point of view, scalability point of view, also, you know, MVA doesn't really induce very strong neutralizing antibodies, which is a drawback for certain diseases. We are looking to broaden our technology platforms, VLPs we're really excited about, which could be complementary to MVA in a prime-boost or a standalone.
Most certainly, I do believe they can be used for other indications, and as you know, we do want to expand our pipeline. I won't go more into what we're thinking, but yes, we're looking at broadening the platform base. In terms of manufacturing, AdaptVac have actually partnered up with a contract manufacturer, who has actually a lot of potential capacity. As I said, the capsid is produced in E. coli and bioreactors and has a very high yield. The protein can be produced in a variety of different platforms, but right now, we may work with expression in their Drosophila cell line.
Again, the yields are very high, and that's another thing that really attracted me, particularly for the COVID-19 situation, in that there are a lot of platforms and approaches being rushed into the clinic, and little thought into how you can actually scale up and manufacture and actually deliver this vaccine if it's successful. As I said, that was another attraction for us, was that the ease of scalability, the fact that it's not a specialized manufacturing, a lot of people can manufacture an E. coli bioreactors. Yeah, I think, you know, all in all, this is a winning combination.
Great. No, thank you. Very helpful. Then just on Rabipur, you know, appreciate your comments about the pre-versus post-exposure markets. Just wondering if it's possible, you know, historically or maybe even just looking at 2019, to give us a little bit better understanding of what the breakdown is there. I know you said pre is more profitable, but what sort of is the top line breakdown?
Yeah, thanks. Hi, Chad, this is Henrik. Thanks for the question. I think we have not so far disclosed the exact breakdown. You can say, in the U.S., you can see more than half. I can give you some indications. In the U.S., more than half of the turnover comes from post-exposure, which is the most profitable part. I think it. In Europe, you can say it's the other way around. It is mainly, as there is, Europe is not an endemic area, it is nearly all, you can say, pre-exposure. You can say it's mainly the European business that is at risk from a COVID-19 perspective. It is also, you can say, the least profitable part of the business.
It is pre-exposure, typically, you can say these segments are more under price pressure. I think when it's a matter of life and death, I think, and typically, you can say the whole distribution is more expensive, and it's easier to maintain good prices there. Of course, the European prices are typically somewhat lower than the U.S. prices. That's probably what I can say about that without going into more details.
Thank you. Appreciate it.
Thank you for your question. Your next question came from the line of Thomas Bowers from Danske Bank. Please go ahead. Your line is open.
Yeah, thanks. I think it's me, Thomas Bowers from Danske Bank. just maybe just some color on Encepur sales in the Q1. how much is actually COVID-19 impact? I believe that Germany closed down in the second part of March. maybe if you can give us some color on the split between the COVID-19 impact and then actually the inventory movements. and also, how much have you seen here during the month of April? I already seeing sort of a catch up already here also in Germany, in May, with the gradual reopening. and then maybe just a question on JYNNEOS.
Can you maybe add any color on the size of the bulk part of the order? Any assumptions on the number of doses here? Lastly, just on RSV, given the COVID outbreak here, of course, quite fortunate that you are not starting the phase III here in the fall. Also already looking into 2021, are you seeing any risk of sort of having an phase III that is underpowered, even though I know it's 18 months away? Is that something that should be a concern currently? Thank you.
Do you wanna take the first one?
Thanks, Thomas, for the questions. This is Henrik. Let me take the first one on the Encepur revenue and what the growth factors or the decline factors really were. I think what we are, according to our analysis, I think the majority of the explanation is really the inventory movements. There is, of course, also a COVID-19 impact. When we look into our numbers, that was only relevant for March, when you can say the whole COVID-19 situation escalated. I can share some public numbers with you. I think the total market for TBE declined approximately 4% when you compare the two quarters year-over-year. That 4% was all generated in one month. I think that put it a little into perspective.
I think when you totally close down for access to the physicians, it has a significant impact. The majority, I think, was really the inventory movements at the wholesaler level. I think when we look at the looking a little forward, as we said, we do expect that as soon as the healthcare system is opening up again, in particular in Germany, which is happening already now, we do expect that the patients or clients are coming back for vaccinations, and we could even expect to see a catch-up effect as people still have the demand to become vaccinated. That is what we expect.
I think April, we haven't seen final sales data for April yet, but we still expect April to be heavily impacted by the COVID-19 system, as we are only now seeing sort of a gradual opening, in the healthcare system. I hope that answered your question.
Hi, Thomas, I can take the other two questions. Your other question related to the new order from the U.S. government and the size of the bulk. The total size of the bulk from the 202 is around about 60 batches of bulk, and then in addition, you have 1.4 million doses of the liquid. That doesn't mean that the 60 batches are used to make the 1.4 million. They're two separate orders.
On RSV, of course, you know, if we had been successful and had started or had planned to start the RSV trial this year, everything that we would have invested would have been wasted, because I think it's impossible to conduct an RSV trial during a pandemic, particularly as people are social distancing, the infection rate will be much lower, and your ability to pick up those infections is probably close to zero. Of course, we still hope to start the phase III next year, and that's our ambition. I mean, realistically, we have to see how the situation with COVID-19 progresses and develops.
If we're all still social distancing, and there are very, very large trials ongoing already for COVID-19, it could mean that we have to make the decision to postpone the trial again, but it's in a wait and see pattern right now. I would say that would be the same for everyone. That's not unique to Bavarian Nordic. That would be for everyone who's in the RSV space. It could be impractical to run a phase III if we're in the same situation this time next year.
Okay. Got it. Thank you.
Thank you for your question. Your next question came from line of Boris Peaker from Cowen. Please go ahead. Your line is open.
Great. My first question is on the JYNNEOS approval. I'm just curious, have you had discussions with the U.S. military about making JYNNEOS kind of the first choice for a smallpox vaccine? If so, what's kind of the timeline of this process?
Thanks, Boris. There have been discussions, and we started discussions with the DoD, which, as you know, is multiple departments, but with all the relevant departments within DoD, before the approval last year. I think there is real interest in switching from ACAM2000 to JYNNEOS simply due to the safety profile improvement. However, these things do take time. It will be a policy change within DoD. I would say that this latest order from BARDA is in part to have doses in the SNS, which DoD and others can access to vaccinate. The order's already been placed, I would say, but the policy change hasn't been made within DoD.
Do you have a sense for how long such policy changes take?
Well, not really. some time. That's all I can say. As I said, I don't think BARDA would have placed an order if those I don't believe those doses are gonna sit in the SNS and expire. That's my feeling.
Gotcha. Okay. My last question on the brachyury trial. Could you just kind of comment, like, what's the path to approval? Is a single phase II study sufficient, or if so, how many patients, and how long could something like that take?
Yes, that's another good question. you know, I think it depends on the strength of the data, what the FDA will require. We've already had, obviously, dialogue with the FDA on whether this trial in itself could be sufficient. I think those discussions are basically implying that as we don't have a placebo control, generally, the FDA probably won't approve it based on this study. We probably are looking at doing an additional phase two, the size of which and the endpoints of which I think depends on the data that we see coming out of this current study. That's something that's quite fluid.
There has been dialogue with the FDA. As I said, I think until that trial reads out, it's a little difficult to say exactly what the follow-on trial, if there needs to be one, what it will look like.
Great. Thank you very much for taking my question.
Thank you for your question. The next question came from line of Nick Nilan from Citi. Please go ahead. Your line is open.
Hi, guys. Thank you for taking the question. A couple on numbers and a couple of others, please. On production costs for the acquired vaccines was 44%, which seems lower than your guidance when you made the transaction. I thought this would kind of start out a bit higher. We likely to see an increase for the rest of the year. Then distribution costs, is the Q1 number a fair reflection of your kind of ongoing costs from 2021, i.e., the DKK 75 million that you guided in non-recurring transition costs? I think you mentioned they were in, they were going to be spread out between 2, 3, and 4 Q this year.
Is the Q1 number of this year reflective of what we can expect from 2021 onwards, or is that going to ramp even further? On your trial initiations by J&J, for example, the HIV vaccine, is that I presume that's likely to be delayed now because of COVID. Just a general question, has this COVID pandemic changed the tone of any discussions you've had with various governments around stockpiling? Have you seen a difference in attitude from any governments around the world on stockpiling? Thank you.
Go on, Henrik.
No, thanks, Nick. Thanks for the questions here. This is Henrik. Let me take the first couple of questions, at least. On the production cost, I think that the production cost, of course, includes a little related to the contract work, but I think that's separated out in a note, so I'm sure you haven't seen that already. The rest of the production costs related to the 2 new acquired vaccines, they have been included according to the contract we have with GSK. That's basically fixed cost per dose, including a markup to GSK during this period. I think what can change over time is, of course, the mix. Here it's a.
When you just look at the revenue versus the production cost and the margin, I think this is extremely sensitive to the mix of products. First of all, between the Rabipur, Encepur, but also between markets, that some markets have a higher prices, we pay more or less the same costs in terms of volume. Any differences is really due to the mix, market mix here. When it comes to whether the Q1 cost level is a good proxy for the 2021 level, I would say we haven't guided for 2021, of course, but I think I'm expecting that our cost for 2021 Q1 will probably be somewhat higher. We have not implemented the full commercial organization yet.
We are ramping up, of course, and we are paying at the moment, expenses to, for instance, GSK for some of the services, which will not exist next year. I think we do also have an ambition to ramp up the commercial organization further once we have taken over the marketing authorisation, starting with the first markets, second half of this year. Then I think you had a question on HIV and,
Yeah, I can take that. You know, we haven't had the specific conversation with J&J, but I think it's safe that I can say that it's our anticipation it will be delayed. You know, our clinical studies haven't been impacted by COVID-19 because we were in the privileged position that all our enrollment and most of our studies was complete. I do believe most people wouldn't be starting new studies in the current environment, so I believe that will be impacted. Your other question related to, has the COVID-19 situation changed government's attitude to stockpiling? You know, I think what we're going through right now has been a global wake-up to all of us on the importance of preparedness. I think government's attitudes will change, but to be honest, right now, most governments are in a firefighting situation for COVID.
However, you know, there is a lot of discussion and interest in vaccines and vaccine capacity and search capacity. I do anticipate that as we gradually get back to normality, there will be more discussions, and we're in a much stronger position now, to talk about preparedness and the importance of emerging diseases.
Great. Thank you very much.
Thank you for your question. Your next question came from the line of Michael Novod from Nordea. Please go ahead. Your line is open.
Yeah, thanks a lot. It's Michael Novod from Nordea in Copenhagen. A couple of questions. First, Paul, maybe you can talk a bit to the RFPs that you say you have responded to for one with NIH and one with BARDA for Triple E. Maybe just give a bit more flavor to if these data look good, well then what could we sort of expect in terms of a new sort of contract venture for Bavarian Nordic? Secondly, on the timelines for the AdaptVac collaboration. Assuming that if you start a trial during the second half of this year, we would expect to see data in the Q1 of next year, just to have you confirm that.
Thirdly, on the combined revenues for Rabipur, RabAvert, and Encepur. You did guide in connection with the full year report that the DKK 1.3 billion would grow single digits. I guess now with COVID-19, it's gonna be sort of different, but maybe you can give a sense of where we expect the combined revenue, just to get a feeling of that and the full COVID-19 impact that you judge it right now.
Yeah, I can take the first couple. Yeah, thanks, Michael. The RFPs or the request for proposals that we've responded to, they were both talking about the next development, both from an animal efficacy, because, you know, to license this vaccine, it will have to most likely be done under the Animal Rule. There's a big component there in developing the animal models, but also in terms of moving forward in the phase II. It is really to take it from where we are now to the end of phase II, including doing all the animal work. That was the specific one for the NIH and for BARDA. They were actually asking for companies to respond and flag where they are in their development of Triple E.
They actually haven't come out with an RFP yet, it was more of a request for information. You know, I think if the data looks good, we're in a strong position. You know, DoD evaluated a number of vaccine platforms, and it was our platform that really was the only one that protected against all three strains. I guess if we come out with strong clinical immunogenicity data, we're in a very strong position to get additional funding to move this into phase two and do all the animal work. I'm not really talking about numbers here, you'll see that specifically, but it will be significant to move the program forward. In terms of the next question was about AdaptVac and the timelines. Yes, I can confirm the assumptions.
We plan to initiate the study, or I should say, currently, they plan to initiate the study, later this year. We should have initial data in Q1. Our role, as I said, is really to aggressively move this study from that initial phase 1 into a much larger study, where we can really look at doses, regimes, and prepare ourselves for phase 3.
Yeah. Hi, Michael, this is Henrik. Let me take the last question regarding our full year guidance. You're right, that when we issued the full year revenue guidance first time for 2020, we did put in a note that part of the revenue would be generated by a single, low single digit growth on the two acquired vaccines, growing from a base of DKK 1.3 billion. Very deliberately, we are not spelling out the details of the full year guidance any longer, given the uncertainty. I think many companies are taking the stand that they're basically withdrawing guidance due to the uncertainty.
We are not doing that because we feel comfortable that with the order we have now from BARDA, where most of the $106 million will be recognized this year, we can cover basically the uncertainties on the travel segment, on the Rabies, and the short-term interruption on the TBE business, with the scenarios that we have looked at, of course. I think it is, the situation is that you can draw up many different scenarios. We believe we have assumed a realistic one. I think given the uncertainty here, I think it's. We are not going to disclose underlying details of the 1.9 million beyond what we have done already.
Okay, fair enough. Thanks a lot.
Thank you.
Thank you for your question. Your next question came from line of Philippa Gardner, from Jefferies. Please go ahead. Your line is open.
Oh, thank you. Just a couple of financial questions, so probably for Henrik. I just wanted to ask, were there any one-off charges in the fiQ1 cost base? If so, what were they for? My second question is just on CapEx, which looked a little bit light in the Q1 , given all the investment in the fill-finish capacity. Should we be expecting any sort of uptick later this year? I also wanted to ask about the maintained EBITDA outlook. I guess that sort of suggests that the growth margin for the U.S. government, smallpox vaccine order, might be lower than what we've seen in the past, or is there some other kind of offsetting costs that are now anticipated this year? Thank you.
Thanks for the questions, Philippa. In terms of one-off charges, there are no specific one-off charges included in the Q1 , but there are types of expenses where you can say there's a little double up. Like for instance, at the moment, while we are establishing our own commercial infrastructure, we have also engaged GSK to support the sales and promotional activities in some key markets until we take over the marketing authorizations. There will be a little sort of double counting or double up of the cost in certain areas, but not much in the Q1 .
I expect that most of the DKK 75 million that we have mentioned previously will occur in the coming months, where we are ramping faster up and while we are phasing out some of the services from GSK. On the CapEx, you're right that we haven't invested much yet, but we still expect to stay on plan, both in terms of the progress on the, our investment plans and the budgets as well. That is to invest approximately DKK 300 million this year, with the majority of that going into the, you can say, modifications we need to do to our existing plant to transfer Encepur and Rabipur, but also to finalize the fill-finish investment.
On the EBITDA outlook, I think it's a little related to the talk around the one-off charges. It is not that we have a lower margin on the BARDA business, but you can say our OpEx spend is a little back-end loaded due to the ramp-up activities in the integration project here. I hope that answered your questions.
Oh, great. Thank you.
Thank you for your question. We don't have any further questions, sir.
Okay. Well, thank you, everyone, for your patience and time. Have a great day, and goodbye.
That concludes the conference for today. Thank you for participating. You may all disconnect.