Bavarian Nordic A S

Welcome everyone to this first half or Q2 update from Bavaria Nordic. Q2 was full of news flow and we are still in a very eventful period. To do this presentation we still have the A-team, Paul Chaplin and Henry Guell, President and CEO and Executive Vice President and CFO. to do the presentation and to do Q&A afterwards. So before we start doing that, just go through the forward-looking statements. This announcement includes forward-looking statements that involve risks, uncertainties, and other factors, many of which are outside our control, that could cause actual results to differ materially from the results discussed Forward-looking statements include statements concerning our plans, objectives, goals, future events, performance and other information that is not historical information. 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. So by this, Paul, I would leave it up to you to start the presentation.

Thanks, Rolf, and welcome everyone to the Q2 update. If you turn to slide three, we had an exceptionally strong performance in the second quarter and in the first half of this year. And importantly, that is due to a strong performance across both parts of our business, both the travel health and the public preparedness. In addition to that, I'm delighted to report that we're seeing strong progress in other areas of the business that will add to future growth, such as the launch of Chicken Gunya next year and the completion or the nearing completion of the tech transfer of some of the assets we purchased back in 2020. So we've seen strong demand on our travel health business with a 15% year-on-year growth. That is driven strongly by the rabies business, but we'll come back more to that in the coming slides. We're on track to complete the tech transfer of both the rabies and TBE vaccines. And on Chikungunya, we are advancing slightly ahead of our planned schedule in that we have made the submissions to the regulatory authorities in both the EU and the FDA, where we're now under a priority review status. On smallpox and pox, we're advancing both on the free stride contract that we have with the U.S. We've submitted for approval, which is an important milestone for that whole program. In terms of our lifecycle management, we're progressing on a number of fronts, including effectiveness data from the 22-23 MPOX outbreak, also hopefully expanding the indication to include adolescents, and through a collaboration with CEPI, soon to be initiating a study in children in Africa. In terms of public preparedness at the beginning of the year, we gave a range of the guidance for this part of the business. And for the first time in our history, we were including revenue from non-secured contracts. And I'm pleased to say with two recent orders that we've announced, we have largely secured all the contracts we anticipated at the beginning of the year. And for that, we can confirm the upper range of our guidance for 24, but I'll leave that to Henrik to walk you through in the coming slides. So if you turn to the next slide, slide four, talk a little bit about the travel health business As I said, we've seen very strong growth compared to this time last year. It's a 12% growth, which is amazing, considering the growth that we've been seeing over the last few quarters in this sector. On rabies, it's really strong performance in the US, an 8% growth compared to this time last year, and a very strong market share as usual. In Europe, a slightly different story in that we had a setback earlier this year with the temporary stock out, which coincided with the stock out from our competitor. We are rebounding from that position and our market share is recovering back to 82%. Importantly, for Rabies, the tech transfer is almost complete. When we took over this product back in 2020, we had a schedule of a four-year plan to complete the tech transfer. The fill finish component of this manufacturing is complete and product manufactured by Bavaria Nordic in Denmark is now entering into the market. And the bulk manufacturing is under regulatory review and expected to be approved later this year. That means we will have completed the tech transfer of probably one of the most complicated vaccines to produce, test, and release within four years. And you need to also remember that four years included actually building a manufacturing site to allow the tech transfer to occur. So this is an exceptional performance and one that I think really endorses the overall strategy of bringing new assets in-house and building up our own capabilities. Of course, now, by the end of the year, when we have the manufacturing in-house, it gives us a lot more flexibility to turn up, to ramp up or ramp down the production, depending on demand. Plus, it allows us the opportunity to look at the expansion into new territories. On TBE, we see a growth here in TBE as well. And in terms of the transfer, we will be completing this again on time, on budget. by next year. In terms of cholera and typhoid, the new assets we brought in-house, we are seeing an improvement in sales quarter on quarter, and our ambition is to relaunch, or we are in the process of relaunching these assets with the ambition to bring these two new assets up to 100 million a year in the coming years. So really strong performance on travel health and a lot more future growth in the years to come. We turn to the next slide, slide five, a little bit about Chikungunya. We're advancing our Chikungunya program for approvals next year with a plan to launch in both the US and Europe in the first half of next year. In IMA, we submitted the MMA in June, which was accepted in July. And with the FDA, we began a rolling submission in April, which was completed in June. And this BLA was accepted in August. Exceptionally, we have got a priority review both in Europe, but also in the US. And this is quite unusual for a product that's been reviewed when a product already exists on the market for chikungunya. In terms of the US, we made a couple of arguments for them to consider the priority review. One was that our application will hopefully, if approved, include populations that currently aren't covered, because it will include 12 years old and upwards, where the current product is only for adults. We also argued that we believe we have an improved safety profile compared to the approved product. We should also expand access to immune compromise, if approved. which are currently contraindicated for the approved product. These arguments or some of those arguments must have been accepted by the FDA as we have the priority review and we have a PDUFA date or expected approval date of February the 14th, which as I said, should allow us to launch in the first half of next year and address the market which we believe is in the region of 500 million US dollars. We turn to the next slide, slide six, talk a little bit about the public preparedness. And I first want to talk about the graph that's at the bottom, because at our Capital Markets Day back in February, we put the case that after the MPOCs outbreak of 22-23, we had a broader customer base than our historical customer base of primarily the US government. And that allowed us to say that we thought that we would have a base business somewhere in the region typically of around two million, two million krona, two billion krona. And this year we guided actually for three billion krona on the anticipation due to the timing of different orders. We however also explained that from time to time we would see spikes in this business due to unfortunately new outbreaks of MPOCs or one-off orders. So as I said, going into the year, we had unsecured contracts. And I'm pleased to say that with the current orders that we've announced, both from BARDA for additional bulk, but also yesterday for doses to an undisclosed EU country, we have largely secured all the contracts we anticipated at the beginning of the year, meaning that we can confirm the upper range of the guidance for this business, the $3 billion, but also, as Henrik will get to, the total business of 5.3. This does not take away from the fact that we have additional capacity to supply more orders, and I'll get on to that, which is very important, given the current situation with the current outbreak of MPOCs. The other thing that's very important for this part of the business is that we don't sit on our laurels. We have a very effective safe vaccine. However, we need to look at the life cycle management. And as I'll come to in the next slide, we are trying to expand the label by submitting data for adolescents. And through a collaboration with CEPI, we plan to start a pediatric study that hopefully in the years to come will allow us to extend into children And that's extremely important given the current outbreak in Africa is primarily, or a large number of those cases are primarily in people younger than 18. So if we skip a couple of slides and go to slide eight, obviously, and I'm sure most of the questions are gonna be related to the current situation, which is a very serious situation in terms of an outbreak of MPOCs. Both Africa and WHO, Africa CDC and WHO have declared a public health emergency due to the spread and the number of cases of MPOX in Africa. And we need to work with all the relevant stakeholders to ensure that we can provide the equitable access to our MPOX vaccine. Importantly, we've been working with a number of different stakeholders all year because at the beginning of the year, our vaccine is currently not approved in Africa. And until we find some regulatory approval, we could not donate doses or talk about supplying doses of our vaccine to Africa. Importantly, those discussions led to an emergency use authorization both in Nigeria, but also in the DRC. And that very quickly materialized into an order with HERA for 175,000 doses, which we have topped up with 40,000 doses to be donated and supplied as soon as possible to the DRC, which is one of the countries with the highest number of cases. We have importantly established a very strong alliance with the Africa CDC both in terms of supply options, what we can do. We have been very vocal in that we have additional capacity and can manufacture and deliver up to 10 million doses by the end of next year. And of that capacity, we could actually deliver 2 million doses this year. This, however, does require us to have orders, as this will require us to juggle our manufacturing and our resources to move to really fixing our production of our Mpox vaccine. So as I said, it's a serious situation, one that we're very proud to potentially be part of the solution. We are talking to all the key stakeholders in terms of what we can do in terms of supply over the coming years. That also includes exploring ways to expand in our manufacturing capabilities to potentially also manufacturing in Africa. Those discussions have been facilitated again by our alliance with the Africa CDC. So we remain ready and willing to support the international community to actually resolve this outbreak and we see ourselves Hopefully it's part of that solution, but we're not the sole part of the solution. We have to work together with the international community to address this situation. We go to slide nine. We're in such a better place than when I go back to 22, when we had the last outbreak of MPOCs. Not only have we built up inventory to supply the anticipated orders, we've also built up an inventory to allow us to potentially have a capacity for outbreaks, which we currently find ourselves in. Secondly, back in 22, we had an approved product for mpox. However, our products have been approved based on animal data and immune bridging data to a traditional smallpox vaccine. Where we are today is we now have effectiveness data generated from numerous studies that were conducted during the 22-23 outbreak that really show we have now a very effective vaccine against MPOCs. This data that showed up to 90% effectiveness after two shots, we have submitted to EMA to be considered to be included in the label, which has been accepted and recommended by the CHMP. So this will soon be included in our label. Importantly, through a collaboration with the NIH, a study was also conducted back in 22-23 in adolescents, so in individuals 12 years and older. And you can see on the graph on the right-hand side, we could show non-inferiority in terms of the immune response to adults, which is shown to be effective. And therefore, we've shown similar safety profile similar meninginicity in adolescents, and this data has already been submitted to EMA, hopefully for consideration to expand the label. And as I've already indicated through another collaboration with CEPI, who will soon be starting a study in children from two years old and up in Africa, which will hopefully be generating similar data showing both the safety and immunogenicity in children that in future will hopefully allow this vaccine to be used in all age groups. And as I said, this will be critical because more than 70% of the cases in Africa are currently being observed in individuals younger than 18. So with that, I will hand over the presentation to Henrik Jor, the CFO.

Thank you, Paul, and good afternoon, good morning to all the listeners. So on the next slide, let's walk through the commercial performance, the revenue for the first six months of 2024. The first half year of this year has been a very strong and good first half year for Bavaria Nordic, delivering nearly 2.3 billion in revenue. And if we take them from the top, we can look at our public preparedness business first, delivering slightly more than one billion Danish kroner, all in line with the plans that we are executing on and driven entirely by orders from existing customers and agreements. So no impact so far for six months from the current inbox outbreak that we're dealing with. So good, strong performance within the public preparedness business. Obviously, when you compare to 23, it's not a good benchmark. That was the year two after the previous outbreak that started in 22. So not a totally meaningful comparison. But public preparedness performance fully in line with our plans and expectations. If we then turn to the other segment, the travel health segment, we are delivering revenue of 1.1%. a billion Danish kroner, so up 15% compared to prior year, driven by growth across the entire product portfolio. Again, if we take them one by one, we look at the radius business represented by Abipur and Rabevat, 2% growth. It does look a little modest, but remember here that we did face some supply issues during the first half that have been resolved right now. and we are regaining our position in the market. And we shouldn't forget either that on the rabies business, the 2% growth is really growth on growth. We have seen basically this part of the business growing from strength to strength over time. Insapur business had a fantastic first quarter, and we had some suspicion after the first quarter that we were looking at an earlier season than previously. And I think the second quarter and the six-month results have confirmed that partly. We are delivering for six months a 10% growth, so nice, strong performance from the TPE business represented by Insucor. Vivotiv and Vaxcora, the two vaccines we acquired from Emergent BioSolutions last year, delivered together approximately 130 million Danish kroner. We are still in the relaunch phase of these two products here, so it's still early days, can say our expectations to these two products are still intact and we do expect the peak revenue to to get to around 100 million us dollars so all together on the travel health 1.1 billion and with other revenue primarily driven by development agreements with the u.s department of defense we're looking at a nearly 2.3 billion in revenue for the first six months If we then turn to the next slide, we are looking at the full profit and loss for the first six months and for the second quarter. Again, revenue in line with our expectations, strong growth from the travel health and good execution on the existing contracts on the public health side of it. Gross profit close to a billion, 985 million. If you look at the margin, 44%, it's somewhat lower than at the level we saw last year, really explained by, of course, lower level of revenue from the public preparedness side. So it's a product mix. It's a volume explanation. But it's also, to some extent, explained by some of the challenges we highlighted in the first quarter of this year, where we had a water damage in our factory in Kvistgat, north of Copenhagen. But 44%, you will see that already in the second quarter, we are at 51% gross margin. So moving back to a more normalized level compared to what we saw in the first quarter. Total operating costs for the first six months, 848 million Danish kroner. It's lower than last year, primarily driven by lower R&D spend, of course, as we are not running as many expensive phase three trials as we did last year. are still investing, of course, in the Chikungunya development. If we move all the way down to the end of the P&L here, we are looking at an EBITDA performance of 441 million Danish kroner, equivalent to an EBITDA margin of 20%. So strong second quarter with an EBITDA margin of 29%, taking us up to 20% for the first six months. So strong performance that we are very pleased with. Let's turn to the next slide here. Just a couple of highlights from our cash flow and from our balance sheet. Cash flow first. You can see cash flow from operating activities is a significant positive amount of more than one billion Danish kroner driven by positive earnings. also to a large extent by positive impact from reduced level of receivables. Remember, last year we had significant high revenue in quarter four, which we have cast in the money for that here during the first six months. And we have also, during this period here, invested in line with plans in the increase of inventory levels. Casual from investment activities, just want to highlight that 1.7 billion Danish kroner, one billion of that is simply just placement of liquidity into securities. And it also includes a milestone to GSK that was triggered when we finalized the drug substance production process for Insipor, a milestone payment to GSK. To the right, I just want to highlight here that our current CASPR session We still owe GSK and Emergent Biosolutions approximately 2 billion together. These milestones will all be paid within sort of the next nine months. And don't forget, I think on top of the current cash position, we also have access to an undrawn sustainability-linked loan of 1 billion Danish kroner. So strong cash position that really enables us to fulfill our commitments over the next nine months to GSK and Emergent and still run the business. Next slide. We are looking at the outlook. As Paul alluded to, given the recent orders that we have received, all the way from the BARDA order we got, the HERA order, and the undisclosed European country order announced last night, We are now in a position where we can clarify our guidance. And instead of using the range of 2.7 to 3 billion for the public preparedness business, we can move it all the way to the 3 billion. And we can also now say that this is all largely secured by contract already. As our travel health business is also performing strongly, We can stick to that guidance and that means we can basically take the total combined guidance for the company to a level where guidance for revenue will be approximately 5.3 billion Danish kroner and the EBITDA will be approximately 1 billion and 350 million Danish kroner. Both numbers were the top end of the originally guided range. So very pleased that we at this point in time we can claim that largely all of the public preparedness business has now been confirmed by contracts. And just to preempt the question we might get, I think first of all, first six months is not impacted at all by the current outbreak. The outlook that we are providing now to 5.3 billion Danish kroner is only limited or impacted very little by the outbreak, basically only by the order that we got from HERA for a donation to Africa. Other than that, I think the rest is basically existing business. So with that, I will give the word to the operator and open up for questions.

Thank you. If you would like to ask a question, you'll need to press star 1 and 1 on your telephone and wait for your name to be announced. And to withdraw your question, you can press star 1 and 1 again. Please stand by while we compile the Q&A roster. Thank you. We'll now take our first question. This is from Peter Verdelt from Citi. Please go ahead.

Thank you, Peter Verdelt, Citi. Paul or Henrik, it sounds like more contracts are coming over the days and weeks going forward. I just want to be clear in terms of what you said publicly. After we take yesterday's order into account, it's the message from Bavarian that you could supply 1.5 million additional doses this year if all has come through, and then 8 million in 2025. So the question is, is that right? And also just want to explore whether this 10 million number you put out by the end of next year Is that a best case scenario or does that assume that you're able to use bulk that you have on hand on BARDA? I'm just basically trying to explore whether that number is the very best that you think you can do or whether potentially an upside if you were to be able to use the BARDA bulk or expand capacity. Thank you.

Yeah. Thanks, Tejan. Yeah, so, yeah, let's talk about the capacity. So we've said 10 million by the end of next year. And what we're saying is we can still supply 2 million in addition to everything that we've already announced by the end of the year based on orders. So that's 2 million by the end of the year and 8 million next year in addition to everything else that we've talked about. That 10 million, however, comes, that 10 million including the 2 million this year comes, we can't produce everything that we're currently planning. So if we go ahead and ramp up the Mpox vaccine production, we will have to make choices of stopping production in other areas. Now that could be the freeze-dried manufacturing, which again, I know is still Mpox, but it could be the freeze-dried manufacturing, uh or the like so uh i think that's important that everyone understands that there will be compromises if we go ahead with that 10 million um so in terms of best case i mean um we have inventory that is barter's inventory um so everything that we're talking about in terms of the uh up to 10 million is what we're manufacturing ourselves To go beyond that 10 million, we would have to expand our capacity. We would either have to bring other manufacturers on board, which, as you know, we're exploring in terms of fill finish. But in fact, the biggest bottleneck, I think, really is drug substance in terms of expanding beyond that. And the options for that, there are options that we were in discussions before back in 22, 23, but that's what we would have to do. We would have to bring on other manufacturers to expand the drug substance manufacturing.

Sorry, Paul, kind of one clarification. So are you saying that were BARDA to allow you to use some of that bulk on hand, that would not be, would that be included in the 10 million or would that be upside from that? That would be an upside. Thank you.

Thank you. We'll now take our next question. This is from Thomas Bowers from Danske Bank. Please go ahead.

Yes, thank you very much. I'll kick off actually with a question not related to MPOC. So just regarding Rabipur, Insipur and tech transfer, I'm just first of all wondering how far you are with Insipur in regards to filthiness and bulk and then in regards to to inventory levels, so working capital, so should we still expect a small decrease for 2025, excluding any possible impact from MPOCs? And then just on your full year guidance, I believe the public preparedness guidance reflected two of three likely sizable Joneos orders for the year. So I guess this 440,000 dose order, and then of course BARDA a few weeks ago, So the last one, is that one still in play? And have you already produced bulk material for this order? So just wondering whether you actually could free up capacity or if that order comes through that you actually are looking at less than 2 million for capacity for the rest of the year. And then... Maybe just on Chikungunya. So normally we will see a voucher for tropical disease or priority voucher. Of course, we know about Valneva. So given that you have a priority review now, does it actually potentially qualify you still for a voucher? I'm not sure if that age 12 and up actually qualifies for any pediatric or you can be given another tropical disease voucher. So I'll stop there. Thank you.

Yeah, thanks, Thomas. I'll take the tech transfer first. That was your first question. So where are we on Entepor? Well, we're on track is where we are. So the drug substance tech transfer has been completed from a From an activity point of view, we're compiling the file and we'll be filing later this year according to plan. The drug product PPQ or qualification, it will be occurring in the second half of this year. Again, we're looking for an approval in the first part of next year. So it should all be completed within the first half of next year in terms of regulatory approvals. So as I said, that remains on track. It was always going to take a little bit longer than the rabies tech transfer. Let me take the chicken.

The inventory impact. Yeah, maybe let's take that in continuation of the tech transfer. Thomas, you're right that we are expecting to see a reduction in inventory levels post the tech transfer. And the timing of that, I think it is, is very much linked to the tech transfer process. So Rapius is done. We are waiting for the final approval, so we should start to see inventory reductions on the Rapius product sooner. Entepur will be finalized next year, and then we can really start selling the BN manufactured products and should then also start to see reductions in inventory. So I expect that we start to see signs of this in 2025, but more in 26. And then, as we know, this will also lead to the margin improvements, which also will have an impact on future inventories as the future manufacturing costs per dose will be reduced. And that we will start to see the impact of in 26 and a full 12 months impact in 27.

And there was one on the capacity and the number of orders. So I would say, I think we should stick to what we're saying in Q2. So the number of orders that we were anticipating are largely secured. And I say largely, some of the orders that we've actually received were larger than we were anticipating. So we're essentially secured. all the contracts that we, all the volumes that we were anticipating in terms of the guidance. So that just again means that we still have the 2 million capacity on top this year. Yeah, yeah. And the last question was on Chikungunya. Oh, do you have it? Yes. Chikungunya? On the voucher. Yeah, on the voucher, yeah. So Chikungunya is part of the tropical disease list that entitles companies, incentivize companies to develop vaccines for. And if you get a priority review for a product that is on that list, and as I tried to say in the presentation, you can only get a priority review if you're addressing certain aspects, so you bring in a new population or you're addressing improved safety or access to more populations, you are potentially entitled to a PRV. But again, that all depends on the approval and what is approved and what the label looks like. But again, if we bring in new populations that currently aren't covered, you are entitled to a PRV. Great.

Thank you very much.

Thank you. We'll now take our next question. This is from Suzanne Van Vortuusen from Van Langshock Kempen. Please go ahead.

Hi, team. This is Suzanne. Thank you for taking my questions. First one on the monkeypox outbreak. How should we think about the potential for additional orders? Could you perhaps describe what you see being similar and what is different in this outbreak versus the 22-23 one? And can you give a sense of how far along you feel you are with regards to the process of discussing potential new contracts? And then I have another question on this topic as well.

Yeah, thanks for the question. So what do we see different from 22, 23? Well, one, there's a couple of differences. One, I think we're better prepared in the fact that we have inventory that would allow us to potentially supply this 2 million this year. So that's one. Secondly, there are, I mean, we're not aware of what the inventory levels are of all the doses we sold, but we sold 15 million doses in 22, 23. We're unaware of how many of those doses were actually used, but, you know, I think there's a lot of speculation that there are doses available. So, you know, the panic is not as high maybe as it was in 22, 23. The other issue that we currently have is the major outbreak is in Africa. We only have regulatory approvals for two countries in Africa right now. So it is really critical that we work together with the WHO on an emergency use listing, as they call it, to expand the approval to all countries in Africa. That, I think, is one of the bottlenecks we really are facing in terms of orders, because obviously right now we're restricted in where the product can actually be used. So it is a process, as I said, of working with all the various different stakeholders. We need to work with WHO on the regulatory path. We need to maybe work with individual countries on the regulatory path. We need to work with Gavi, with the Africa CDC, with CEPI, really on how can we supply doses into that territory as quickly as possible.

Got it. Thank you. And can you elaborate on this new variant, what is known about it, and how you think about scenarios of how this can potentially further develop? And to what extent there's information on your vaccine's efficacy to this other variant that's causing the current outbreak? Thank you.

Yeah. So there isn't any So there isn't any data that we can point to where we have shown efficacy against this current clade or variants, as it's relatively new. The reason why we and I think the international community have confidence is that monkeypox, smallpox, cowpox, a lot of pox viruses belong to one family. And, you know, the very original smallpox vaccine was based on a cowpox variant. So it's known that if you're protected against one virus in that family, you're protected against all the viruses. One of the speculations why mpox has actually emerged is because smallpox vaccinations ceased in the late 70s, 1980. And that meant that the world's population became more susceptible to pox viruses. And it's that period where we started to see mpox, sorry, mpox emerge in Africa. So again, that's the thesis, that if you're protected against one virus, you're protected against all. We know we have very good effectiveness data from the 22-23 outbreak. So as I said, I think we remain confident, as does the international community. Having said that, we will be trying to generate data against the latest clade through collaborations with other partners.

Got it. And regarding the scenarios of how you think about how this can further develop?

Well, again, I'm not sure I'm qualified really to talk about the scenarios, but one thing I would say is that the outbreak in 22-23 originated from Africa. It was endemic in Africa and it came out of Africa and spread because the levels of immunity in the population are very low. I think we should all international everyone have learned from COVID and from MPOCs in 2022-23 that you cannot ignore an outbreak of an infectious disease in one part of the world and not to expect it to eventually land at your doorstep. So as I said, I think the international community has got that message. I think now with the declared emergency, I really see a change in the urgency in the discussions that we're having. And I think the whole international community needs to come together. We can play our role in that, but they need to come together and address this outbreak in Africa as soon as possible.

Thank you very much.

Thank you. As a reminder, if you would like to ask a question, you can press star 1 and 1 on your telephone. We will now take our next question. This is from Ben Jackson from Jefferies. Please go ahead.

Hi, thank you for the question. It's Ben Jackson from Jefferies. Just two quick questions from my side. Firstly, what's driven the decision to not height guidance above the prior range that you reference? And does this reflect the material uncertainty over the additional 2 million doses that you could supply? Or perhaps is it more signifying the extent of cannibalization required elsewhere in the business to reach the levels that you cite. And then secondly, when we're thinking about the potential tech transfer to manufacturers in Africa, and I understand this is still ongoing discussion, but how would you anticipate monetizing these relationships and over what timeline do you expect these to be able to ramp? And I guess

building from there is there any kind of indication on the relative volumes that could be achieved through this expansion thank you yeah thanks so just on the guidance so i think historically at the very nordic we have not included for public preparedness we have never really included non-contracted uh guide sales in our guidance simply because of the While we may be very confident that contracts will come through, the timing of those always remains a bit uncertain. This year was the first time we actually included non-contracted sales in our 24 guidance. And the reason for that is when we came out of the last outbreak of MPOC, we had more customers. So we had more shots on goal, I would say, in terms of contracts coming through. We were relatively advanced in some of the discussions. But even there, I would highlight, we thought some of these orders that we've talked about more recently would have come earlier. But they came when they came, and they're through. Where we are right now is that we have a capacity, there are discussions, there is obviously, unfortunately, a new MPOCs outbreak that needs to be dealt with. However, the timing of that is uncertain. And to your point that you mentioned it, and I've said it several times already today, To produce the 2 million, it would come at a consequence of some other things. So the mix of that and what that would do to the new guidance is very unclear and would probably be very wrong for us as a company to introduce that. So that's the real reason for that. In terms of tech transfer, you know, facilitated by Africa CDC, we are in discussion with quite a wide range of companies in Africa. We are, I would say, still in the infancy of those discussions, really looking at the technical capabilities, whether they could actually fill our products, whether it can be fitted into their facilities. Exactly to your point, what are their capacities? How quickly could we do it? Back in 22, we expanded our footprint with a CDMO in the U.S., That was done in conjunction with almost the FDA hand-in-hand walking through the process, and we managed to do that in the four to six months. Again, we're nowhere near coming up with a plan in Africa yet, and we'll have to see how long it will take. But the one thing that should be clear to everyone, mpox is not going away. There's a flare-up now in Africa that needs to be dealt with, but mpox has been endemic in countries in Africa for decades. And I think, you know, again, talking to stakeholders and the international community, you know, we need to deal with that issue. So if there's a, you know, there could be longstanding vaccination campaigns that could develop in that region. And for that, we would need to expand our footprint.

Makes sense. Thank you.

Thank you.

there are no further questions at this time so i will hand back to the speakers for any closing remarks thank you and thanks everyone for joining the call and for the questions appreciate the questions and your time thank you very much goodbye