Bavarian Nordic A/S

CSE:BAVA

Earnings Call Transcript 2020-Q1

[Operator]

Ladies and gentlemen, thank you for standing by. And welcome to our first quarterly report for the 3-month period ending 2020. [Operator Instructions] I would now like to hand the conference over to your speaker today, Rolf Sass. Please go ahead, sir.

[Rolf Sass Sørensen]

Yes. Good afternoon. My name is Rolf Sørensen, Vice President, Investor Relations. Before we start the presentation, I'd 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 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 after this, I will hand over the presentation, first of all to our President and CEO, Paul Chaplin; afterwards to our CFO, Henrik Juuel. Go ahead, Paul.

[Paul Chaplin, CEO & President]

Thanks, Rolf. And welcome, everyone, to Q1 update. We've had a very strong quarter. But 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. So within the next 5 years, we aspire to be one of the largest pure-play vaccine companies. And to do that, we want to be a company driven by commercial excellence. We want to continue to develop innovative life-saving vaccines. And again, we want to build on one of our other key strengths, which is vaccine manufacturing, to become the best-in-class vaccine manufacturer. And in the coming slides, we've structured the presentation around our key strategic goals and ambitions. So 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 2 new commercial assets to our portfolio. And to do that, we had a very successful rights issue, where we raised DKK 2.8 billion. And we can say that we achieved this in rather difficult markets. And 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 USD 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 a 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. And as I said, we maintain our financial guidance, and 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. And 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, and I can get to that when I walk through the pipeline. And we've strengthened our management team by hiring a new CMO. Laurence comes from Takeda and -- 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. 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. And 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, we've -- under this contract, we have already agreed pricing for additional bulk for liquid and freeze-dried, and we received this order for USD 202 million as part of that contract. It's for additional bulk and to create an initial stockpile of 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 USD 106 million, which is being secured will be revenue recognized this year and the remainder next year. And 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 to 6 years. So 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, an agreement with AdaptVac, which is a joint venture between ExpreS2ion Biologics (sic) [ ExpreS2ion Biotechnologies ] and NextGen vaccines, which is a spin-out from the University of Copenhagen. And this is for their capsid 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. But 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, get that to meet the WHO criteria, which, 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; and it should do that within 2 weeks. That's a tall order for many of the vaccine platforms that are going into the clinic, but I believe this platform can succeed. AdaptVac is part of an international consortium that has raised sufficient funds to move this vaccine into Phase I. 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 I into Phase III. And we hope to start the Phase I together with AdaptVac later this year, with data available early next year. Slide 7. Talking a little bit about why we're so excited about this platform. While vaccines, they stimulate the body's defenses to prevent you from being infected. And the most effective vaccines are the ones that stimulate the strongest defense. And 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. And it's a proven technology, HPV vaccines are based on VLPs. And 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, but 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. So the scalability of production is there. We can produce very large quantities, and I believe this stands the greatest chance of meeting that WHO criteria for a successful, safe and effective vaccine. On Slide 8 is the pipeline. Our freeze-dried smallpox vaccine is in Phase III. 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 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 III 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 it in the coming slides, as I will with our Brachyury vaccine, which is in Phase II. If you go to Slide 9. Equine encephalitis is another emerging disease, which is mosquito-driven. It's quite a deadly disease. There are 3 different strains, eastern or often called EEE, Venezuelan and Western. Our vaccine is a trivalent, protecting -- trying to protect against all 3 strains. It's a rather deadly disease and 1/3 of the people that get infected actually die from encephalitis, which is swelling of the brain. And 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. And 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. And 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. So we are quite excited about the opportunity, and it's in 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. However, there is one 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 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. And this trial will readout 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. And with that, I'll hand over the presentation to Henrik Juuel.

[Henrik Juuel, CFO & Executive VP]

Thank you very much, Paul. So let's turn to Slide 11. This quarter, first quarter of 2020, marks a very important milestone for Bavarian Nordic as this is the first time that the company reports some 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. So if we look at Slide #11, I will start by talking about how sales went for the first quarter, with the 2 acquired vaccines from GSK. And if we start with the rabies vaccine, Rabipur/RabAvert, then we saw revenue of DKK 218 million for the first quarter, which was a 20% growth over same period last year. So 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. But 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 advantage of going forward. According to our intelligence, I think the stock out situation has been resolved by now. But 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. On the other hand, the post-exposure, we believe will be largely unaffected by this situation here. And you can say 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. If we then turn to Encepur. We saw revenue of DKK 103 million, which was 40% lower than same period of last year. Here, the confounding factor is that this is actually under unchanged market share. When we compare the 2 markets, market shares between '19 and '20, we still have a market share of around close to 30% of the markets. And basically, I think what has caused this drop was a very large sell into the market by GSK in the first quarter of last year. On the next slide, I will comment 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 we are -- 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. But as soon as we see the health care 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 the 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. So if we turn to the next page. We have included a slide with some quarterly sales numbers on both Rabipur/RabAvert 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 in-market sales, that is the pull out of the pharmacists 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. So 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. And 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 going to a pharmacy, a doctor or the hospital. And those numbers you can say, we have volume data so that we have a good overview of how the market size is developing and the market shares by player in the segment. But these numbers might differ significantly from our sales numbers because we -- remember, we are selling into the wholesalers and who sells to pharmacies, et cetera. So between those 2 numbers, there's, first of all, a time lag, but there is also some inventory movements. If a wholesaler, for instance, is preparing in 1 quarter for a big campaign in the following quarter, they are stocking up, but the real demand is not until the following quarter, et cetera. So if you start looking at the Encepur graph to the right, you can see the quarters from '18, '19 and the first quarter of '20, there, you will see that the first quarter of '19 was a very strong quarter. If you look at the following quarters also for '19, you will see that second quarter was strong as well, but then you actually saw the third quarter fell below the previous year. So it's just again to illustrate and underline that there can be these movements between the quarters. And again, I think we can also use this slide to highlight the strong seasonality that we see with the Encepur product. The vaccination season goes from approximately April to August. So that means the second quarter is typically the strongest. But of course, again, as we are -- have to supply to the wholesalers in advance, you will see pretty strong first quarters normally, very strong second quarters. And also some relatively strong third quarters and then very low fourth quarters as you are out of the season again. If you look at the rabies product, there's very little seasonality. There is some, I think, in particular, when it comes to the travel part of it, there's some seasonality, but limited. And again, here, the same thing apply. I think inventory movements, et cetera, can actually make a difference between the end market demand and the -- our revenue through wholesalers. We do not have the reliable '18 numbers by quarter for Rabipur/RabAvert. That's why you only see '19 by quarter and '20. And in this situation here, it was also more relevant for the Encepur product. So let's turn to Slide #12 (sic) [ Slide #13 ], 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 2 acquired vaccines. Again, on the rabies business, DKK 218 million. The TBE business brought in another DKK 103 million. And the rest was really contract work, primarily performed on contracts with BARDA on the CMC activities for our fill and finish facility and on the Phase III lot-consistency study we're running on freeze-dried version. So 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 first quarter, we also closed the sale of our Priority Review Voucher and earned DKK 628 million, which is, of course, included in our EBITDA and EBIT lines as well, and that helped us take the EBITDA to DKK 641 million, but still positive even without the -- including the voucher income. We have -- if you 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, USD 202 million with USD 106 million being fully confirmed and an option for the rest. And most of the USD 106 million will be recognized this year. And 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 the COVID-19. On an EBITDA, we also still confirm the guidance of DKK 675 million for the full year. And we confirm our cash position of DKK 1.350 billion by the end of the year. When you look at that, the table below, and if you look at sort of -- if you take Q1 and compare to the full year expectations, you will notice that there are significant -- there must be significant variations between the quarters. The revenue, obviously, is skewed more towards the last 9 months. And that is, of course, because during the first quarter, we included no income from supply of bulk or final doses to BARDA on smallpox. So most of the USD 106 million that will be recognized in 2020 will happen in the next quarters. Nothing has been included yet. And I can also say that when it comes to the costs, you will also see that, that is a little more back-loaded this year as we are ramping up the commercial organization, and we will incur more costs during the second half of the year. And the nonrecurring 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. So 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 European Investment Bank of DKK 244 million. We are planning to draw that down during the second quarter. 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. But right now, I think, end of the first quarter, it is close to DKK 2.5 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 9 months of this year, grouped by our key strategic pillars. In terms of the commercial excellence, I think this is -- here, we will continue the work to build up full commercial organization to support our new products but also to support JYNNEOS for the monkeypox 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. And then, of course, in line with our strategic ambitions, with that establishment of the commercial organization, increase the awareness out there for the monkeypox 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 '21. We will further advance the Phase III trial. We are running on the freeze-dried smallpox vaccine, which we are planning to complete in '21 and then 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 second quarter some high-level top line results. And 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 validation of our fill and finish facility, which we are on track to do. And it's also about commencing the investments in the bulk manufacturing to increase both capacity and flexibility, so that we can also transfer Rabipur/RabAvert and Encepur to our site. So with that update, I will ask the operator to open up for questions and answers, please.

[Operator]

[Operator Instructions] Your first question came from the line of Chad Messer from Needham.

[Chad Jason Messer, Senior Analyst]

Great. And 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 base vaccine technology that most of your pipeline is based upon. Just wondering, 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 and then 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.

[Paul Chaplin, CEO & President]

Thanks, Chad. So as I said, we've been looking at the specific VLP technology for some time. And obviously, that was before really COVID. So we were actually looking at it for other indications in mind. Our ambition is to become one of the largest single-play vaccine companies. With that -- we're great believers in our MVA technology. But not every -- not all vaccine platforms can do everything, and there are limitations, both from a manufacturing point of view, scalability point of view, but also MVA doesn't really induce very strong neutralizing antibodies, which is a drawback for certain diseases. So we are looking to broaden our technology platforms. And VLPs, we're really excited about, which could be complementary to MVA and a prime-boost and/or a stand-alone. So most certainly, I do believe they can be used for other indications. And as you know, we do want to expand our pipeline. So 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 has 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 in 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. And 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. And so as I said, that is another attraction for us, is that the ease of scalability, the fact that it's not a specialized manufacturing. A lot of people can manufacture an E. coli in bioreactors. So yes, I think, all in all, this is a winning combination.

[Chad Jason Messer, Senior Analyst]

Great. Very helpful. And then just on Rabipur, appreciate your comments about the pre versus post exposure markets. Just wondering if it is possible, 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?

[Henrik Juuel, CFO & Executive VP]

Yes. Thanks. Chad. This is Henrik. Thanks for the question. I think we have not so far disclosed the exact breakdown. But you can say -- in the U.S., you can say 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 -- whereas in Europe, you can say it's the other way around. It is mainly -- as there is -- Europe is not an endemic area. So it is nearly all, you can say, pre exposure. So you can say it's mainly the European business that is at risk from a COVID-19 perspective. But it is also, you can say, the least profitable part of the business. It is pre exposure. So 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. And then, of course, the European prices are typically somewhat lower than the U.S. prices. So that's probably what I can say about that without going into more details.

[Operator]

Your next question came from the line of Thomas Bowers from Danske Bank.

[Thomas Schultz Bowers, Analyst]

Thomas Bowers from Danske Bank. Just -- maybe just some color on Encepur sales in the first quarter. So how much is actually COVID-19 impact? I believe that Germany closed down in the second part of March. So 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? Are you 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? So any assumptions on the number of doses here. And then 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. But also already looking into '21, are you seeing any risk of sort of having a Phase III that is underpowered, even though I know it's 18 months away. Is that something that should be of concern currently?

[Henrik Juuel, CFO & Executive VP]

Yes. 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. But there is, of course, also a COVID-19 impact. And when we look into our numbers that was only relevant for March when you could 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 2 quarters year-over-year. But that 4% was all generated in 1 month. I think that put us a little into perspective. I think when you totally close down for access to the physicians, it has a significant impact. And then -- but the majority, I think, was really the inventory movements at the wholesaler level. I think we can -- when we look at the -- looking a little forward, as we said, we do expect that as soon as the health care system is opening up again, in particular, in Germany, which is happening already now, we do expect that 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. So that is what we expect. But 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 health care system. So I hope that answered your question.

[Paul Chaplin, CEO & President]

Thomas, I can take the other 2 questions. So 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 million is around about 60 batches of bulk. And then in addition, you have 1.4 million doses of the liquid. And that doesn't mean that the 60 batches are used to make the 1.4 million. It's -- they're 2 separate orders. Then on RSV, of course, 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 0. Of course, we still hope to start the Phase III next year, and that's our ambition. But I mean, realistically, we have to see how the situation with COVID-19 progresses and develops. But if we are 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 we're -- it's in a wait and see pattern right now. But 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.

[Operator]

Your next question came from the line of Boris Peaker from Cowen.

[Boris Peaker, MD & Senior Research Analyst]

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? And if so, what's kind of the time line of this process.

[Paul Chaplin, CEO & President]

Yes. Thanks, Boris. So 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. So the order has already been played -- has been placed, I would say, but the policy change hasn't been made within DoD.

[Boris Peaker, MD & Senior Research Analyst]

And do you have a sense for how long such policy changes take?

[Paul Chaplin, CEO & President]

Well, not really. Some time. That's all I can say. But as I said, I don't think BARDA would have placed an order if those -- I don't believe those doses are going to sit in the SNS and expire. That's my feeling.

[Boris Peaker, MD & Senior Research Analyst]

Got you. Okay. And 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 -- and if so, how many patients and how long can something like that take?

[Paul Chaplin, CEO & President]

Yes. It's another good question. So 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. So we probably are looking at doing an additional Phase II, the size of which and the endpoints of which, I think, depends on the data that we see coming out of this current study. So that's something that's quite fluid. There has been dialogue with the FDA. But 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.

[Operator]

The next question came from line of Nick Nieland from Citi.

[Nick Peter Russell Nieland, Vice President and Analyst]

Couple of numbers and a couple of others, please. So on production costs, so 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. But we'll obviously see an increase for the rest of the year. And then distribution costs, is the Q1 number a fair reflection of your [indiscernible] costs from 2021, i.e. the DKK 75 million that you guided in nonrecurring transition costs. As you mentioned, they were going to be spread out between 2, 3 and 4Q this year. So is the Q1 number of this year reflective of what we can expect from 2021 onwards? Or is that going to ramp even further? And then on your trial initiations by J&J, for example, the HIV vaccine. That -- I presume that's likely to be delayed now because of COVID. And then just a general question. Has this pandemic changed the tone of the discussions you have with various governments around stockpiles? Do you believe to be seeing a difference in attitude from any of the governments around the world on stockpiling?

[Henrik Juuel, CFO & Executive VP]

Yes. Thanks, Nick. Thanks for the questions. This is Henrik. Let me take the first couple of questions at least. On the production costs, I think that the production costs, of course, includes a little related to the contract work, but I think that's separated out in a note. So you can -- I'm sure you haven't seen that already. The rest of the production cost related to the 2 new acquired vaccines, they have been included according to the contract we have with GSK. So 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. And here, it's -- 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 the higher prices, we pay more or less the same COGS in terms of volume. So any difference is really due to the mix -- market mix here. Then when it comes to whether the Q1 cost level, is a good proxy for the '21 level. I would say we haven't guided for '21, of course, but I think you -- I'm expecting that our cost for '21 first quarter 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. But I think we do also have an ambition to ramp up the commercial organization further once we have taken over the market authorization starting with the first markets second half of this year. And then I think you had a question on HIV. And...

[Paul Chaplin, CEO & President]

Yes. I can take that. So we haven't had a specific conversation with J&J, but I think it's safe that I can say that it's our anticipation it will be delayed. Our clinical studies haven't been impacted by COVID-19 because we were in the privileged position that all our enrollment in most of our studies was complete. So 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 governments' attitude to stockpiling? 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 governments' attitudes will change. But to be honest, right now, most governments are in a firefighting situation for COVID. However, there is a lot of discussion and interest in vaccines and vaccine capacity and surge capacity. So 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.

[Operator]

Your next question came from the line of Michael Novod from Nordea.

[Michael Novod]

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 said you have responded to for, one with NIH and one with BARDA for EEE? And maybe just give a bit more flavor to, if these data look good, but then what could we sort of expect in terms of a new sort of contract venture for Bavarian Nordic? And then secondly, on time lines for the AdaptVac collaboration, so I assume that if you start a trial during the second half of this year, we would expect to see data in the first quarter of next year, just to have you confirm that? And then 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 going to 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?

[Paul Chaplin, CEO & President]

Yes. I can take the first couple. Yes. Thanks, Michael. So 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 to license this vaccine, it will have to most likely be done under the animal rule. So there's a big component there in developing the animal models, but also in terms of moving forward in Phase II. So 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 EEE. They actually haven't come out with an RFP yet, but it was more of a request for information. So I think if the data looks good, we're in a strong position. DoD evaluated a number of vaccine platforms, and it was our platform that really was the only one that protected against all 3 strains. So 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 II and do all the animal work. So I'm not really talking about numbers here, you say that specifically, but it will be significant to move the program forward. In terms of -- the next question was about AdaptVac and the time lines. Yes, I can confirm the assumptions. We plan to initiate this study -- or I should say, currently, they plan to initiate the study later this year, and we should have initial data in Q1. And then our role, as I said, is really to aggressively move this study from that initial Phase I into a much larger study where we can really look at doses, regimes and prepare ourselves for a Phase III.

[Henrik Juuel, CFO & Executive VP]

Yes. 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 will be generated by single, low single-digit growth on the 2 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 USD 106 million will be recognized this year, we can cover basically the uncertainties on the travel segment under rabies and the short-term interruption on TBE business, with the scenarios that we have looked at, of course. And I think it is -- the situation is that you can draw many different scenarios. We believe we have assumed a realistic one. But I think given the uncertainty here, I think it's -- we are not going to disclose underlying details of the DKK 1.9 million (sic) [ DKK 1.9 billion ] beyond what we have done already.

[Operator]

Our next question came from the line of Philippa Gardner from Jefferies.

[Philippa Gardner, Equity Analyst]

Just a couple of financial questions, probably for Henrik. I just wanted to ask, were there any one-off charges in the first quarter cost base? And if so, what were they for? My second question is just on CapEx, which looked a little bit light in the first quarter given all the investment in the fill and finish capacity. So should we be expecting any sort of uptick later this year? And then I also wanted to ask about the maintained EBITDA outlook. I guess that sort of suggests that the gross 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?

[Henrik Juuel, CFO & Executive VP]

Thanks for the questions, Philippa. In terms of one-off charges, there are no specific one-off charges included in the first quarter, 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. So there will be a little sort of double counting or double up of the cost in certain areas, but not much in the first quarter. I expect that most of the DKK 75 million that we have mentioned previously will occur in the coming month, where we are ramping faster up and while we're phasing out some of the services from GSK. Then 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 our investment plans and the budgets as well. So that is to invest approximately DKK 300 million for 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 and finish investment. And 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 and the integration project here. So I hope that answered your questions.

[Operator]

We don't have any further questions, sir.

[Paul Chaplin, CEO & President]

Okay. Well, thank you, everyone, for your patience and time. Have a great day, and goodbye.

[Operator]

This concludes the conference for today. Thank you for participating. You may all disconnect.