Bavarian Nordic A/S

Bavarian Nordic A/S

DKK211.5
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Copenhagen
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Biotechnology

Bavarian Nordic A/S (BAVA.CO) Q2 2024 Earnings Call Transcript

Published at 2024-08-22 12:25:06
Operator
Good day, and thank you for standing by. Welcome to the Half Year Report Q2 for the Six-Month Period Ended 30th June 2024. At this time, all participants are in a listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised today’s conference is being recorded. I would now like to hand the conference over to your first speaker today, Rolf Sorensen. Please go ahead.
Rolf Sass Sorensen
Yes. Thank you, operator, and welcome, everyone, to this first half or Q2 update from Bavarian Nordic. Q2 was full of news flow, and we are still in a very eventful period. And to do this presentation, we still have the A team, Paul Chaplin and Henrik Juuel, 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, but 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.
Paul Chaplin
Yes. Thanks, Rolf, and welcome, everyone, to the Q2 update. If you turn to Slide 3, 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 chikungunya 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 registry authorities in both the EU and the FDA, where we’re now under a priority review status. On smallpox and mpox, we’re advancing both on the freeze-dried 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 a life-cycle management, we’re progressing on a number of fronts on including effectiveness data from the ‘22, ‘23 mpox outbreak, also hopefully expanding the indications include adolescents and through 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 Juuel to walk you through in the coming slides. If you turn to the next slide, Slide 4, talk a little bit about the Travel Health business. As I said, we’re seeing very strong growth compared to this time last year to 12% growth, which is amazing considered the growth that we’ve been seeing over the last few quarters in this sector. On rabies, it’s really strong performance in the U.S., 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 Bavarian 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 the 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 tech transfer, we will be completing this again on-time, on-budget by next year. In terms of color and [tie forth] (ph), the new assets we brought in-house, we are seeing an improvement in sales quarter-on-quarter, and our ambition is to re-launch or we are in the process of re-launching these assets with the ambition to bring these two new assets up to a $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 5, a little bit about chikungunya. We’re advancing our chikungunya program for approvals next year with a plan to launch in both the U.S. and Europe in the first half of next year. In EMA, we submitted the MAA 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 U.S. 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 U.S., we made 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 with the current product designed 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 compromised 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 second half in the first half of next year, and address the market, which we believe is in the region of US$500 million. We turn to the next slide, Slide 6, 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 mpox outbreak of ‘22, ‘23, we had a broader customer base than our historical customer base of primarily the U.S. government. And, that allowed us to say that we thought that we would have a base business somewhere in the region typically of around DKK2 billion. And this year, we guided actually for DKK3 billion 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 mpox 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 billion. 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 mpox. 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 latest in the next slide, we are trying to expand the label by submitting data for adolescents and through 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 8, obviously, and I’m sure most of the questions are going to be related to the current situation, which is a very serious situation in terms of, an outbreak of mpox. Both 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 a 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 the, 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 place have orders as this will require us to juggle our manufacturing and our resources to move to really [enhancing] (ph) 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 extending 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, as 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 9. We’re in such a better place than when I take go back to ‘22 when we had the last outbreak of mpox. 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 mpox. 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 immunogenicity 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, we 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, our 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 Juuel, the CFO.
Henrik Juuel
Yes. 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. First half year of this year has been a very strong and good first half year for Bavarian Nordic, delivering nearly DKK2.3 billion in revenue. And, if we take them from the top, we can look at our public preparedness business first delivering slightly more than DKK1 billion 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 the six months from the current mpox 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 DKK1.1 billion, 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 Rabies business represented by Rabipur and RabAvert 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. Encepur 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 months result have confirmed that partly. We are delivering first six months of 10% growth, so nice strong performance from the TBE business represented by Encepur. Vivotif and Vaxchora, the two vaccines we acquired from Emergent BioSolutions last year delivered together approximately DKK130 million. We are still in the re-launch phase of these two products here. So, it’s still early days, but you can say our expectations for these two products are still intact, and we do expect peak revenue to get to around US$100 million. So altogether, 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 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 1.985 billion. If you look at the margin, 44%, it’s somewhat lower than 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 Kvistgaard, north of Copenhagen. And, that’s 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 DKK848 million lower than last year, primarily driven by lower R&D spend. Of course, as we are not running as many expensive Phase 3 trials as we did last year, we 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 DKK441 million 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 DKK1 billion 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 4, which we have cashed 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. Cash flow from investment activities, just want to highlight that DKK1.7 billion, DKK1 billion of that is simply just placement of liquidity into securities. And, it also includes a milestone of GSK that was triggered when we finalized the drug substance production process for Encepur, a milestone payment to GSK. To the right, I just want to highlight here that our current cash position is at 2.2 billion [for very strong cash position sales] (ph). 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 DKK1 billion. 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 billion 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 DKK5.3 billion and the EBITDA will be approximately DKK1.350 billion. 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 a 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 DKK5.3 billion 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 words to the operator and open up for questions.
Operator
Thank you. [Operator Instructions] Thank you. We’ll now take our first question. This is from Peter Verdult from Citi. Please go ahead.
Peter Verdult
Thank you. Peter Verdult, 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, is 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 the 10 million number you put out by the end of next year, is that a best case scenario, or should I 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 there’s potential upside if you were to be able to use the BARDA bulk or expand capacity? Thank you.
Paul Chaplin
Yes. Thanks, Peter. Yes. So yes, 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 - would 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 or the like. So, I think that’s important that everyone understands that there will be compromises if we go ahead with that 10 million. So, in terms of best case, I mean, we have inventory that is BARDA’s inventory. So, everything that we’re talking about in terms of the 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 another manufacturers to expand the drug substance manufacturing.
Peter Verdult
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?
Paul Chaplin
That would be an upside.
Peter Verdult
Thank you.
Operator
Thank you. We’ll now take our next question. This is from Thomas Bowers from Danske Bank. Please go ahead.
Thomas Bowers
Yes. Thank you very much. I’ll kick off actually with a question that’s related to mpox. So, just regarding Rabipur, Encepur and tech transfer. I’m just first of all wondering how far you are with Encepur in regards to fill finish and bulk? And then, in regards to inventory levels, so working capital, so should we still expect a small decrease for 2025 excluding any possible impact from mpox? And then, just on your full-year guidance, I believe the public preparedness guidance reflected two of three likely sizable JYNNEOS 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 both 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 the 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.
Paul Chaplin
Yes. Thanks, Thomas. I’ll take the tech transfer, first. That was your first question. So, where are we on Encepur? Well, we’re on-track is where we are. So, the drug substance tech transfer has been completed from an activity point of view where 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 chikungunya.
Thomas Bowers
And, on the inventory impact? I’m sorry.
Henrik Juuel
Yes. Maybe I can just 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, is very much linked to the tech transfer process. So, rabies is done. We are waiting for the final approval. So, we should start to see inventory reductions on the rabies product sooner. Encepur 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 ‘25, 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 cost 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 --
Paul Chaplin
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 essentially secured all the contracts that we or 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. Yes, and the last question was on chikungunya.
Thomas Bowers
Yes.
Paul Chaplin
Chikungunya?
Thomas Bowers
On the voucher.
Paul Chaplin
Yes, on the voucher. Yes. 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, 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.
Thomas Bowers
Great. Thank you very much.
Operator
Thank you. We’ll now take our next question. This is from Suzanne van Voorthuizen from Van Lanschot Kempen. Please go ahead.
Suzanne van Voorthuizen
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.
Paul Chaplin
Yes. 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 with 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 I think there’s a lot of speculation that there are doses available. So, 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 to countries in Africa right now. So, it is really critical that we work together with the WHO on the emergency use listing, as they call it, to expand the approval to as many 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.
Suzanne van Voorthuizen
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 it is, there’s information on your vaccines efficacy to this other variant that’s causing the current outbreak? Thank you.
Paul Chaplin
Yes. So, there isn’t any data that we can point to where we have shown efficacy against this current clade as it will variance 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, the very original smallpox vaccine was based on a cowpox variance. 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 vaccination 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 seeing mpox, sorry, mpox Emergent 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 was the international community. Having said that, we will be trying to generate data against the latest clade once we can through collaborations with other partners.
Suzanne van Voorthuizen
Got it. And regarding, the scenarios of how you think about, how this can further develop?
Paul Chaplin
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, right. 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 mpox in ‘22, ‘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.
Suzanne van Voorthuizen
Got it. Thanks very much.
Operator
Thank you. [Operator Instructions] We will now take our next question. This is from Ben Jackson from Jefferies. Please go ahead.
Ben Jackson
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 hike guidance above the prior range that you referenced? 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 time line 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.
Paul Chaplin
Yes. Thanks. So, just on the guidance. So, I think historically at the Bavarian Nordic, we have not included for public preparedness, we have never really included non-contracted 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 mpox, 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 mpox 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 as 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, 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, again, talking to stakeholders and the international community, we need to deal with that issue. So, if there’s a, there could be long standing vaccination campaigns that could develop in that region, and for that, we would need to expand footprint.
Ben Jackson
Makes sense. Thank you.
Operator
Thank you. There are no further questions at this time. So, I will hand back to the speakers for any closing remarks.
Paul Chaplin
Thank you, and thanks, everyone, for joining the call and for the questions. I appreciate the questions and your time. Thank you very much. Goodbye.
Operator
This does conclude the conference for today. Thank you for participating, and you may now disconnect. Speakers, please stand by.