Welcome to everybody listening in. Good morning to some. Good afternoon to the rest. And welcome to our Q2 presentation after what have been a couple of very, very busy weeks for Verano Nordics. With me today, I have President and CEO, Paul Jaffin and Executive to Vice President, CFO, Henrik Yull.
And before we start our presentation, I will briefly read the statements This presentation that includes forward looking statements that involve risks, uncertainties and other factors, many of which outside our control that could cause actual results to differ materially from the results discussed. Forward looking statements includes statements regarding our short term objectives, opportunities, financial expectations for the full year as well as statements concerning our plans, objectives, Stolt's future events performance and information that is not historical information. All such forward looking statements qualified by these forward looking statements, which may accompany the forward looking statements. We undertake no obligation to publicly update forward looking statements to reflect subsequent events or circumstances after the date made, except as required by laws. So with this, I will hand over
the presentation to Paul. Thanks, Ralf, and welcome, everyone, to the Q2 update. If you turn to Slide 3, just before I get into the highlights for the 1st 6 months, I just want to talk a little bit about The company and where we're heading. So by 2025, we aspire to be one of the largest pure play vaccine companies, Improving and Saving Lives by Selling in R and D Innovation, Manufacturing and Commercialization. And we're well on the way to that journey as I speak.
We have 4 market products against rabies, tick borne tephalidis, smallpox and Ebola. And that is really driving the for growth of the company over the coming years. To that end, obviously, in the last 18 months, we began the transition to a full scale commercial company. And we have set up a commercial infrastructure in record time, which supports our key markets in the U. S.
And the EU. And I'll come back more to how we're doing in terms of our commercial excellence. We have established a full commercial manufacturing facility here in Denmark, where we can do everything from drug substance to now fill finish and pack, and we've set up a worldwide distribution network for our products. The first product is already established on our new finished line, which is our smallpox vaccine, Jynase, And that's already been inspected and approved by the regulators. And as you know, we're also expanding this facility As we speak, and that expansion remains on time and on budget, which is part of the transfer of the production of 2 products we acquired last year for rabies and TBE.
On our pipeline, and I'll come back to in the coming slides. We've seen a lot of progress in the last few weeks. But we have an RSV, late stage asset, where we have Human challenge trial data coming very shortly. And on COVID-nineteen, of course, the big topic of the day, We've gone from strength to strength reporting fantastic data and obviously this week securing the funding which will allow us to accelerate So as I said, really well on our road to reaching the vision that we have for 2025, the number one largest European vaccine companies. So if we go to Slide 4, When we came out with our guidance earlier this year, we came out with a range.
The upper part of that range was a reflection of what we hoped Would be a recovery of some of the markets, particularly for rabies and TBE as we came out of the COVID pandemic. And the lower end of that range reflected, unfortunately, the reflection that is COVID Still impacted both of the markets for rabies and TBE. And as you've seen from our Q2 announcement, unfortunately, We still are facing strong headwinds for COVID-nineteen. On rabies, it particularly impacted our sales in Europe Due to the lack of international travel, and I'm sure Henrik will walk you through some of the more details later on, There we've seen basically a 90% decline in the market in Germany. On TB, it's a slightly different story.
We had signed the initial recovery in Q1. But as you'll see from later in the slides, we saw a decline in Q2, which is unexpected, but it's due to the fact that in one of our major markets, Germany, most of the physicians were too busy with COVID vaccinations and that has in fact affected the TB sales. So all the reduction in sales All the difficulties we're seeing is purely related to COVID and not the execution in terms of our commercial strategy. Unfortunately, for that reason, we are firming up our guidance at the lower range. On the pipeline, we've really gone from strength to strength in the 1st 6 months.
On COVID-nineteen, we reported some of the best clinical data that anyone has reported for a COVID-nineteen vaccine, and I'll come back to that More in the coming slides. We've initiated Phase 2, which we'll report data later this year. And this We had a milestone event in that we secured funding from Danish government, which now will allow us to accelerate based on obviously positive Phase II data into Phase III next year with an approval hopefully no later than 2023. On RSV, we're weeks, months away from an exciting announcement, hopefully, on the human challenge trial data, which hopefully will de risk the future development moving into Phase III. And on smallpox, we shouldn't forget there's a lot of activities ongoing.
And while we have transferred the liquid frozen smallpox already to the line and new fill finish line in Denmark, We have begun the tech transfer of the freeze dried products, so an extremely busy and active and successful activity in terms of our development programs. So I want to spend a little time talking about ABN FOSS2 COVID vaccine candidate. If you turn to Slide 6. So as I said earlier this year, we had a milestone event in that we were able to finally secure funding from the Danish Ministry of Health, who has pledged up to DKK 800,000,000 to support the development of ABN CO2 all the way through to licensure. The very modestly already committed to invest up until the end of Phase II, including the scale up for Phase III.
And with this announcement from the Danish Ministry of Health, we now have the full funds necessary to execute on the plans that we have to license this product. The funding will be based on milestones. So as and when we successfully meet Certain milestones, we will receive payment. And repayment of this funding will be in the form of vaccines and our royalties based on reaching certain cell volume annual cell volumes. So as I said, we've entered Phase 2 already.
And for Phase 3, we plan, based on positive data, to start in 'twenty two where we will be hopefully doing a non inferiority trial to existing or an existing COVID vaccine looking at immunogenicity endpoint. So turning to Slide 7. Again, a question I'm often getting over the last few days. Is there really a need for another COVID-nineteen vaccine with so many already approved? And the answer is we believe the answer is obviously yes, as obviously does the Danish government.
So one of the reasons is that the durability of the main for protection is a little uncertain. There are reports already coming out this week actually from Some clinical studies that the efficacy may wane after already 6 months. So maybe improved vaccines with a longer Durability of protection may be needed. It's unlikely, obviously, COVID-nineteen will be eliminated as initially hoped, It's a disease that we're going to have to live with. So there is going to be a need for regular boosters to provide some protection, particularly against the emergence of new variants that we're seeing week after week.
And of course, there is a need for a worldwide distribution of vaccines and therefore more vaccines are going to be required. The next slide, Slide 8. Just to sum up a little bit of where we are. So ABN cost 2 is based on a viral white particle technology that we licensed from Adaptec, which is some technology coming out of Copenhagen University. It's a very similar technology to some of the existing vaccines.
Some existing vaccines are already approved. For example, vaccines against HPV that have been safely administered to millions and millions of people worldwide. The data that we generated and already In a Phase I shows that it's highly immunogenic, a favorable safety profile with some exciting data showing that we get Good neutralization against all circulating variants. As I said, we've entered Phase II. We'll be reporting that data later this year and are already gearing up to start Phase III trial next year.
The Slide 9, the Phase I result, which Phase I study, which was funded by an EU consortium grant, It was a dose ranging study looking at doses ranging from 66 to 70 micrograms formulated with or without And what we've seen at all doses is that it's a very well tolerated vaccine with a safety profile comparable to other recombinant protein technologies. So a really good safety profile, no serious adverse events. The local adverse events such as pain, redness and swelling were all mild to moderate. That's Grade 1 or 2. And the systemic events, we only saw 2 possibly related Grade 3s, And this was both related to either a migraine or headache and quickly resolved after vaccination.
So really a well tolerated vaccine. On the next slide, Slide 10, is the immune data. If you just look at the left hand side of the slide. This is the neutralizing targets that are induced by the various different doses ranging from 6 to 25. And you can see we can see a nice dose effect.
And what's really encouraging here is that the 25 microgram dose level, We're at a 12 file higher neutralizing titer than convalescent sera, which is the gray. Our convalescent sera is sera taken from people who have recovered from COVID. And in other publications, it's shown that if you have a comparable tiler to human convalescence, Sarah. You have at least an 80% efficacy against COVID. And here, we're showing at a moderate dose of 25 micrograms with 12 fold higher than that protected level.
On the
right hand side is also some outstanding data. Here, we're looking at the neutralizing capability of the 25 microband dose against all the major variants of COVID. You'll see the Wuhan strain, the alpha and delta strain. There's No difference in the neutralizing titus, and these are all well above human convalescent sera, as I've just described. The peak variance, there is actually a twofold lower neutralizing capability.
However, please note This is still way above the level of human convalescent sera. And this reduction against beta variance It's much, much lower than has been reported for other approved vaccines, which varies from 4 to even 16 fold lower neutralizing titers. So this is really probably some of the best clinical data, albeit in relatively small number of subjects currently. But this is very, very strong data showing a good safety profile and a great strong neutralizing capability that is against all circulating major variants of COVID. So on Slide 11.
So we are advancing, obviously, based on the Data into Phase II, which we announced we initiated on Monday. We're going to enroll 210 healthy adults, 150 will be previously vaccinated who will receive a single booster of ABN COF 2. Another 60 individuals will be vaccine naive or haven't been vaccinated or infected, so they don't have antibodies against COVID. And these will receive 2 vaccinations 4 weeks apart of ABN COF2 at the 100 microgram dose. The endpoint of the study is obviously safety as usual, but it's also to look at the immune responses that we induce following either a single booster vaccination or a prime booster vaccination in naive people.
As I said, the study has already initiated, and we anticipate we'll be reporting the results later this year. The changing gears a little bit and talking about our RSV program, if you turn to Slide 13. Obviously, RSV is also very prominent in the news with a lot of competition about who have already entered Phase III. We have just a very interesting RSV candidate late stage that is shown to be safe and highly immunogenic in Phase I, Phase II clinical studies. And prior to starting Phase III, we're running a human challenge study right now.
That study is near to completion. Everyone has been enrolled, vaccinated and actually challenged. We're just waiting for the data to be collected and analyzed, and we will be reporting that data in, as I said, shortly. This hopefully, if positive, will de risk the future development of this vaccine in Phase III. And we will be looking to start Phase III hopefully next year based on positive readout from the Phase II.
So on the last slide before I hand over to Henrik, I just want to talk a little bit about our commercial strategy and where we are in our plans. So when we took over the 2 assets last year, we had a number of goals in mind. We wanted to build up a commercial organization that could sell and distribute the products and stop the historical market share loss, which we've seen year after year prior to our acquisition. So we wanted to avoid losing ground while we were in this transitional phase as we transferred the markets, We wanted to increase the awareness of the very Nordic and our new assets to health care professionals. And I'm really pleased to say that today, we can tick all those boxes.
We have set up an international commercial team in record time. We have maintained or even grown our market share in a very difficult market due to headwinds of COVID. We've transferred all markets as planned from GSK. That's over 30 markets in record time. And we have increased awareness of the Vero Nordic through surveys we've done with health care professionals Who would promote not only the Vireo Nordic but also our products.
So we've really come a long way. And really, The difficulties that we're seeing with the sales is primarily and only due to the impact of COVID-nineteen both on diabetes and TV Markets. So with that, I'll hand over the presentation to Henrik Knoll.
Thank you, Paul. So let's continue on the commercialization of our business here. And on Slide 15, Let's start having a look at how the markets have developed for our 2 products, the Aramtour, AbbVie and Ensor. And on this first slide here, it's all about our Radius business. And as many of you will recall, I think this is Characterized by 2 very distinct markets.
We have the U. S. Market, which is a mix of post exposure and pre exposure segments. And then we have the European market, which is a pure traveler's vaccine market. So if we start with The bottom end of this slide here, the German market.
Then the situation is just like we have seen for the last several quarters. Due to lack of international traveling, the market has really been reduced to a tenth of what it was pre COVID-nineteen. So that's an unfortunate situation, of course, and we can only hope that International travel resumes sooner rather than later. If we turn to the U. S.
Market, the story is Somewhat different and that is of course because this is also the post exposure market. So people will need immediate treatment if they have been exposed to Rapid Animals. And there we are actually seeing some signs of recovery now. I think in the Q1 of this year, We saw a quarter slightly below the same level of last year. But now in the second quarter, we've actually seen a significant growth of 41% Just comparing the quarter to quarter between the two years.
However, this is still not at the level it was So pre COVID, it's approximately 15% down, but some good signs of recovery here. And in the U. S, I think we can proudly say that we are holding on to 68% market share in the U. S. Market Quite as expected, we have lost markets here since our competitors came back after a stock out situation.
But we have after many months back on the market, we have you can say we have gained the position approximately 7 percentage points higher Than the period prior to the stock up situation. So I think we are pretty well positioned to benefit from the market when it comes back With the good signs up now. So if we then look to the right side of this slide here, you will see that our revenue for the second quarter It was €127,000,000 So that was 10% down compared to last year. And I think for the reason that I just discussed here, I think the key explanation for this is really that last year, we had very little competition in the U. S, which we do have now obviously.
And for the 1st 6 months, just to mention those numbers, they're not on this graph here, but we delivered DKK 207,000,000 which was 42% down compared to last year. But remember that, That includes the Q1 of the low COVID impact in 2020. So let's turn to the next slide, which talks about the other acquired product, our TBE vaccine ensipor, which is a pure European business. Ben Sippur here, I think exemplified by Germany. That's a representative for the market development in Europe.
We saw some, as Paul alluded to previously, actually in the Q1 of this year, some good signs of recovery, up 8% in the German market. What we call a little by surprise, we have to be honestly admit, in the Q2 of this year, We saw the market decline by 26% compared to the same quarter last year. And this is simply due to logistics in Germany, where the GPs, they are involved in the COVID-nineteen vaccinations and simply they have prioritized this and there has not been enough resources to deal with things like the TB vaccinations to the same extent as previously. So this means if we just compare that to the period prior to COVID-nineteen, we're talking about a decline of 41%. So you can say both our rabies business And our TBE business are impacted for very different reasons.
I think the TBE market, there is no impact on the underlying demand. On the contrary, Could you maybe even say, here it's all about logistics, getting access to your physicians to get vaccinated. So there is I think from our side hope that this market will return sooner than the Radius markets. If you look to the right on this slide here, and then you will see we delivered revenue of $146,000,000 compared to $193,000,000 for the Q2 of last year. So that's a decline of 24%, but in a market where Germany Had a negative growth of 26%.
Market shares, we have managed to maintain of the level of market share in Germany of around 30%. And we're actually seeing some good signs that the efforts we put into electronic consultation is actually working, And we are gaining CR in those regions where we are active with our field force. Turning to the next slide, an overview of our profit and loss. I want this one focused on the half year results A few references to the quarter. So total revenue of DKK905 1,000,000.
You can see how that is broken down by product on the donut chart to the right. So smallpox business, DKK 336,000,000, dollars 90,000,000 of that comes from sale of the smallpox products to all that markets and the U. S. And the rest is related to BDS bulk orders to the U. S.
Government. €245,000,000 comes from Insipour, which we just talked about, €207,000,000 from And we have close to $90,000,000 related to our Ebola vaccine, which we sold Bulk USD 14,000,000 orders for Janssen and then some minor contract work adding up DKK 28,000,000. So total of DKK 905,000,000 Gross profits, DKK 207,000,000. And as we talked about in the Q1, 1st quarter was impacted by the manufacture of RSV clinical material, where we actually spent 2 out of the 3 months in the Q1 Producing the material we will need for the future Phase III trial on RSV. Most of that cost It was charged to the R and D line, but still there was some imprecision manufacturing costs remaining on the vessel production costs.
On R and D, DKK219 1,000,000, so up from DKK124 1,000,000 last year. And the key explanation here is really our investments into the RSV project, where we have, as I said, this year manufactured all the material we need For the Phase 3 to come, and we're also running the human challenge trial as well. SD and A cost was 254,000,000 So down from $276,000,000 And the key driver here is really a significant saving on distribution costs In connection, we're taking over, as Paul said, up to nearly 30 markets. We have to now take note from GSK. And we have now we're now using our own distribution network and not paying GSK to do that work.
So adding all this up gives us for the 1st 6 months an EBITDA loss of DKK 8,000,000. Turning to the next page, an overview of our cash flow and balance sheet. So the net cash flow for the period was minus $102,000,000 Cash flow from operating Service is negative by €377,000,000 mainly explained by changes in working capital. And here, we are primarily talking about inventories increasing as we take over more and more markets from GSK, so all in line with plans. Cash flow from investment activities of nearly DKK1.2 billion, most of that is really Placing some of the money we got from the private placement in March, placing that in securitization, but What is also included here are some of the investment that goes into the current construction work in our plant in Kvistgard.
To be precise, so far year to date, we spent DKK171 1,000,000 in investments in that expansion and more It's to come for the last 6 months of this year. And finally, cash flow from financing activities obviously Contributed positively, the nearly $1,500,000,000 $1,100,000,000 comes from the private placements that we did in March. And the rest comes from the vehicle transactions where we have hedged some of the securities we have invested in against cash. To the right, just some selected figures from our balance sheet. I will only sort of highlight the equity here.
Now it stands at approximately DKK 5,800,000,000. The increase from last year, this is, of Course driven by the private placement that we did in March. The numbers below, you will see securities, cash and cash equivalents After 6 months stands at €2,500,000,000 That includes approximately €300,000,000 in cash from our paper transactions. Debt to bank and institutions of approximately $700,000,000 So that also includes, of course, the approximately $300,000,000 OIBO Transaction. So net cash of 1.8, which is, of course, not sensitive to our Repos transaction.
So Strong position. That really enables us to pursue the projects. And I think as Paul said previously, With the funding agreement that are being stated, this also means that we have the funds we need to take our ABN CAR2 project all the way to the finish line with the current plans. On the next slide, our 2021 Outlook. When we issued the first outlook for 2021, we chose in Zohr's, where we explicitly described that the lower end of this would refer to a scenario where the COVID-nineteen Restrictions and impacts would continue throughout 2021.
And when you hop ahead, we would expect those to be relaxed, The restrictions and we will start to see international traveling resume at least to some level in 2022. Unfortunately, it is the first scenario that is playing out right now. And therefore, we have firmed up our guidance and we are sticking within staying within the insulars but at the low end. So now guiding Approximately DKK 1,900,000,000 in revenue and then EBITDA, positive EBITDA of approximately DKK 100,000,000 and a cash position By the end of the year, it was approximately €1,400,000,000 And of course, if you compare our current cash position of €2,200,000,000 And then targeting 1.4 by the end. I think here you need to understand, of course, the continued investments that will happen During the second half of this year, approximately €450,000,000 will go into the facility expansion and the tech transfer activities from GSK.
We will also capitalize the DKK 200,000,000 That we raised in connection with a larger private placement early this year on the ABN Cal II projects. So there will be no impact on the P and L with the current plans, but they will, of course, have an impact on our cash position. So that's included in the cash guidance for this year. We will also continue to pay milestone payments to GSK. And then in these numbers here, we have assumed that we will draw down to €30,000,000 Existing credit facility with the European Investment Bank.
So you could say an outlook that is maintained, But firmed up and we are targeting now the low end of the gains of those guys previously. For that, only reason is really the COVID-nineteen market impacts on EnsorCore and Harvipur and RBF Markets. To the right, just a quick recap of some of the important milestones for this year. On the R and D, I think we have several activities going on for the 4R3. We had a plan to initiate the human challenge trial that started and everyone has been vaccinated right now and as Bo said, we are just awaiting The data and the analysis.
So hopefully soon, we could come out and communicate the results from that trial. And in parallel, we continue our preparations for a Phase III trial. That said, we have manufactured all the material. And of course, once we see the data from the Phase II, I think that will also be part of the input to a Phase III design. On COVID-nineteen, we want to advance that, of course, and we have started Phase 2.
On Monday, we vaccinated the first people on our 2 sites in Germany. And now in parallel and with the funding agreement in place, we can continue to develop the high scale production processes so that we can manufacture Phase 3 material and eventually Commercial scale as well. Then of course, we also need to advance the development of our freeze dried version of the smallpox Where we expect to be able to submit a BLA next year, and we continue the work on Intravenous administration of BRAFRI urine within immuno oncology. Within commercial, I think our job is really to continue our efforts to drive growth in these very difficult markets. Secondly, take over the physical distribution.
I think we can take that one off now. In May June, we took over the remaining markets Actually, only the Japan is outstanding, and that is a deliberate plan. And in agreement with GSK, Japan is a very The pharmaceutical market and we have agreed on a longer transition. Of course, we are responsible eventually for the sales of the products there And the revenue will go to us, but we will for a period of time rely on services from GSK to metastatic markets. Thirdly, in the commercial, we continue working on improving the awareness and the image of Ferra Nordic with key stakeholders in our key markets through close interactions with the healthcare professionals.
And we are actually already in some of the research In the interviews, we do see some good results there. On the manufacturing side, we are this year Going to deliver the first order of finished products filled at our own site. So that will be the Genius products fields for the U. S. Government.
And then we are also planning to Complete the construction of the new expanded facility and of course, continue the project to Transfer, ARBPU, RF and NIN support to our site in KRYSTGUARD. So it has been an extremely eventful First half of twenty twenty one, I would say, in particularly the last few weeks here. But I think as you will see from this one, we still have Several key milestones and significant events ahead of us in the months to come. So with that, I'll give the word back to Paul or perhaps we should take Q and A. So I think we hand it back to the operator for Q and A
We have a question on the line from Michael Novod from Nordea.
Thanks a lot. It's Michael Lobot from Nk Copenhagen. So a few questions. First of all, to RSV. We have also seen or we've seen Pfizer report some intriguing human challenge data.
So I would just like to sort of ask you around What is the hurdle for efficacy you want to see to sort of decide whether this is good or bad data or whether to progress it into Phase 3. And also in that context, what is sort of the hurdles besides data in terms of RSV infections, etcetera, for going into Phase 3. We have seen recent spikes, unusual spikes during summer, both in the U. S. And Europe of RSV.
But Otherwise, what is your thoughts around infection rates and the seasonality? And then lastly, also on RSV, Could you decide to push for a partner? If you see good Phase 2 data on COVID, Can you then sort of also cope with running a large Phase III for RSV? So would that sort of trigger a part of discussion on the RSV?
Thanks a
lot. Yes. Thanks, Michael. So what would be good data? It's a good question.
So in the human challenge, our primary endpoint is looking at the viral load in the Love of the placebo treated versus the vaccine treated. In Janssen's study with Ad26 based RSV vaccine. They saw a significant difference in the viral load. That's the bare minimum that we would want to see. When you start comparing the viral load curves, you can get a statistical readout of efficacy and they have ranging from basically 40% to 55% efficacy depending on which method you used to measure the viral load.
They also saw a significant reduction in the mild symptoms, And that is what Pfizer is also reporting or at least they're claiming 100% reduction in the mild symptoms. I haven't seen any data, but that's basically what they're stating. So I think those are the thresholds Really, that we're up against. So we would definitely need to see a significant reduction in viral load placebo to treat it. And a bare minimum vaccine efficacy with that measure of at least 50%, I would say.
And we would also want to see a significant reduction in the symptom score between the two groups. So basically, we have to match or better the data that Lee Janssen has published that we can all see in read and review. I think that's the threshold that we would have to beat or meet. In terms of the RSV design and the infection rates. That's a very good question.
And again, I wish I had a better view of that, To be honest, a clear review. You're right, there have been some high rates of infection during the summer in various parts to the globe, but not everywhere. And overall, the rates of RSV are slightly lower than historical levels. You may be lucky if you're running a study in a certain area where it spikes, but overall, the rates are slightly lower. And that's probably, and I'm speculating now, the reason why everyone else has increased the number of subjects In that Phase 3, so GSK has done that.
And the numbers that others are talking about are higher than the protocol that we currently have agreed with the FDA. So basically, the plan is that once the data from the human challenge trial comes through, we will most likely, if it's positive, of course, Happy to open up the dialogue again with the regulators to talk about the Phase III design. And it's our speculation that we will need a slightly larger study than we previously planned. Of course, that's going to put pressure on the timing and how we're going to fund it, And that will only open the door to more to accelerated, I guess, partner discussions. We've always said we wanted a partner for commercialization.
And if we could get that partner on board before Phase 3, that would even be better.
Okay. Great. Thanks a lot.
Thank you. Thank you. Your next question comes from the line of Jesper Ilsso from Carnegie.
Thank you, Soren, so much. Just to follow-up on that RSV question. So you mentioned a partner before Phase III. How large should this Phase III So you still mentioned on the slide that it could cost these $110,000,000 So how large will it be? Will it be Several, say, 1,000 more or what are we talking here?
And also a question on the COVID-nineteen vaccine progress. Just to get a feeling of how you if you have passed the Phase II data, how you will be designed Phase III in the non inferiority study, Will it be fair to assume it could be against the mRNA such as Pfizer, Moderna? Or will it be against the AstraZeneca just like vanilla has done?
So how large would the RSV Phase III study have to be? And that is There are a number of factors that will affect the size of the RSV trial 1. It's how efficacious do we believe that vaccine truly is. And of course, hopefully, we get a better feeling for that based on the human challenge study. So the greater the efficacy that we want to gamble on, the smaller study.
The other one that will impact it It's really the rate of RSV and the assumptions that we're going to use. As I've said just briefly, what we're seeing with everyone else that's going into Phase 3 or has modified their Phase 3. We're at the 20,000 or larger Subject Study, whereas as you know, we originally had a study design of 12000 to 14000 subjects based on the assumptions that we had pre COVID. And that's why I'm saying after the human child study, we'll look at it. But I don't think we have a magic wand.
I think we're going to be in the same range as everyone else, which will be the 20,000 subject range. On your COVID-nineteen question, how would the Phase III look? So our current assumption It's that the regulators will catch up with the reality. So if you look at the guidance right now from EMA and FDA, You're still asked to do a field efficacy trial for new COVID vaccines. And if you want to do a booster study, there's regulations for that, but they're only currently foreseeing boosters being used, the same booster as the primary vaccination.
So Pfizer boosting, Pfizer Moderna, boosting Moderna. We believe that regulation will change with the reality that You do need general boosters. And there are a lot of mix and match studies ongoing right now in terms of clinical programs, and that data will come out. So we believe the regulations will change. And the way we're looking at it is we would do an ICRRT or potentially a superiority trial to existing vaccines.
Whether that's one vaccine or a number of approved vaccines We'll depend on the discussions with the regulators, but I would envision it would be at least and the RNA vaccines or one of the RNA vaccines. And so in total, Our plan is the 4,5000 subjects Phase 3.
Okay. Thank you, Solank.
The next question comes from the line of Thomas Bauer from Danske Bank.
Yes. Thank you very much. A couple of questions Regarding the TB vaccine, so in regards to also to primarily Germany. So I'm just wondering if you're seeing any recovery here in the July, August numbers. And you can say still with your guidance, I assume that it sort of implies that you need a rather So it's H2 to reach to those SEK1.9 billion in total for the year.
And maybe in regards to Germany, can you maybe just Say, how does the GPs sort of what's their focus now? Are they sort of getting back to their normal practice or I guess a large portion of the subjects have been vaccinated now also in Germany. So any color here would be very helpful. And then just on the market share data. So I'm just wondering how accurate are these actually because we are seeing Pfizer with a 36% year over year growth for TCOBAC in Q2.
I know, of course, there is Quite a lot of fluctuations on also inventory levels and that's but just to get some color and understanding on how accurate these Projects actually are. Thank
you. Okay. Hi, Thomas. This is Henrik. Let me try to answer those questions.
I think First of all, for July, without disclosing too much, I think we can say that the Situation is unchanged in Germany, but we pass to the GP's priority. That's factored into our guidance. The situation with the TB market is that we are approaching the end of the main vaccination season, of course. So that means in our revenue for the rest of the year, There's less risk, of course, because we have less TBE included in that one as it is a very seasonal product. And just to your other question on that we have a lot to deliver in the second half.
Actually more than half of the revenue to come for the second half comes from either smallpox or Ebola business. Remember, we still have The remaining part of the $202,000,000 order and we have the filling of finished products, so Baader is part of that. And we have the $28,000,000 order to buy them on April that we need to deliver on. And talking a little about the market share data, I think in my experience, it's relatively reliable, these kind of days. Of course, it's not an Sometimes it can be difficult to explain differences between what you're actually selling and these in market data As they are based on samples and they are not always covering the full market.
Yes, it's correct that Pfizer reported Strong growth, but they are facing the same market conditions as we are, 26% drop and our market share is unchanged. We look into the Pfizer numbers. And I think if you go 1 year back, you will see that they actually sold significantly less than was reported in the market. Now, let's see the opposite situation. So that can only in my view be explained by inventory movements, meaning that in the Q2 of 2020, Wholesalers consumed from inventories and they sold less than in market days as shown and now it was the other way around.
So I hope that answers your questions.
Yes. Thank you. Maybe just to for clarification, just on your full year revenue guidance. So I fully understand also there's fluctuations also with the Jynneos and Ebola. So but I'm assuming that Ebola is well 250 Dij and then Junaeus is around €600,000,000 So is there anything aside from that and of course, RAVI POR, Interpol that we are sort of meeting?
I know well, Potentially, you have maybe €100,000,000 for contract work. So I guess, if all else were equal, I guess, you still need Some raw material, Avipur and Interpol sales also in the second half. So is that correct? Or am I missing something In this calculation?
No, it is correct. Of course, we are still expecting business from Arbitur, Abivant And on TV, on Instapore as well. And I think we are seeing some positive signals on Or rather we're sorry in the U. S. We do not honestly expect much from the Radius business in Europe as it is what it is.
But we do in particular expect this is coming in from the U. S. And then as I said, I think it's a little more than half of the revenue to come It comes from other products.
Okay. Yes, yes. Because of course, Interpol is definitely going to be Lower than in second half and first half due to seasonality. But so it's primarily, of course, RAVI BOR that I'm looking at here and you still need to have some raw material also maybe even a better second half In 'twenty one then compared to 'twenty, I guess. Also, there was some fluctuation in Q4 as far as I remember, which So I think it was down at €88,000,000 in Q4.
So
No, that's right. I think that is Amongst these markets here, I think for the remainder of the year, that is our strongest comp. That's our Radius business in the U. S. Where we saw some good signs The Q2 with a 41% increase actually over last year.
So some signs that this market is coming back and we do expect That's to drive significant portion of the revenue in the second half year.
Okay, great. Thank you very much.
Thank you. And we have another question from the line of Michael Novog from Nordea.
Yes. Just a follow-up question. I was just thinking around manufacturing capacity, initial capacity in terms of Contract manufacturers and when we should be able to get some news on that and how you will deal with that. If you also should be able to during 2020 2, let's assume the Phase II data is positive and you're running the Phase III, you're able to do any sort of advanced procurement contracting, etcetera. Just some more thinking around capacity, external capacity.
Then of course, also in the longer term, whether you would plan to sort of take it all home to Christgaard?
Yes. Let me take that. So Actual fact, we you're right, finding external manufacturing capacity right now is tricky. However, I'm pleased to say that we have secured a contract manufacturer where we are actually in the process right now of Caleb from transferring the product, the process. And we will do the full finish ourselves.
So in fact, I believe we have secured what we believe will be the necessary capacity. We plan, obviously, to have that process transferred and validated next year as and when we do the Phase 3, so that we're ready to start filing towards the end of next year. And like others and depending what else is happening in the world, there is an opportunity to looking at Advanced Q and A. That's something that we'll definitely be pursuing.
All right. Thanks a lot.
Thank you. We have no further questions at this time. If you wish to continue.
Okay. Well, thanks everyone for your time and the questions, and have a great day. Thank you.