Good day, and thank you for standing by. Welcome to the third quarterly report, Q3 for the nine-month period ended 30th September 2022 conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one and one on your telephone. You will then hear an automated message advising your hand is raised. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Rolf Sass, Investor Relations. Please go ahead.
Yeah. Thank you, operator. Good afternoon to some of them, good morning to the rest of you. My name is Rolf Sørensen, Investor Relations, and with me today I have Executive Vice President, CFO, Henrik Juuel, and President and CEO, Paul Chaplin, as usual. We will go through the third quarter announcement slides, followed by Q&A afterwards. We've had a very busy quarter, but before we start, I just want to go through this disclaimer. This presentation 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 regarding our short-term objectives, opportunities, financial expectations for the full year and cash position as of year-end, as well as statements concerning our plans, goals, future events, performance, and other information that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements. We undertake no obligation to publicly update forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law. After this, I will hand it over to you, Paul, for the first introduction.
Yeah. Thanks, Rolf, and welcome everyone to our Q3 update. As Rolf indicated, we've had an extremely strong last three months, strong quarter, driven by strong sales of both our rabies, Rabipur and RabAvert, particularly in Germany and U.S., but also of our smallpox, monkeypox sales in response to the ongoing outbreak of monkeypox. This has allowed us to record sales of more than DKK 1 billion and highly profitable results in the last quarter, based on EBITDA, and even leading to a profitable result in the first nine months. These strong sales and opportunities have allowed us to change our guidance numerous times this year, and we're heading towards a break-even result.
2022 was always gonna be a challenging year in that we're investing more than DKK 2 billion in R&D as we have two phase III programs ongoing, and both RSV and ABNCoV2 are going according to plan in terms of the enrollment. However, the big events of the year since May has been the outbreak of monkeypox, and I'm extremely proud of the way that Bavarian Nordic responded to this public health emergency. We've been able to address all demand for our monkeypox vaccine, and we've done that through obviously increasing our capacity and manufacturing capacity and working diligently to supply the vaccine to now more than 70 countries worldwide. If you go to the next slide four, I'll talk a little bit more about monkeypox. The first case of monkeypox was reported on May 6 in the U.K.
As I said, I'm extremely proud that our first supply was also in May of 2022. We rapidly scaled up our manufacturing capacity in terms of our fill and finish, allowing us to produce doses that we had in terms of bulk on stock to meet the demand. We've also expanded our filling capacity by bringing a contract manufacturer in the U.S. on board, and we're currently transferring the manufacturing process and that CMO will be up and running in the coming months. This, as I said, has allowed us to supply all demand that we've received and more, and we've given access to our vaccine to more than 70 countries worldwide. More than 3 million doses have been manufactured and distributed to date, with many more vaccines in the order books, including for next year.
A really encouraging sign is that our JYNNEOS, IMVANEX or IMVAMUNE, vaccine has historically been manufactured, and delivered to countries for cold storage, in the event that smallpox should be released. We're extremely encouraged that the vaccine is now being actively used with more than 1 million doses having been administered and many more likely to be so. The other thing that we're encouraged by is that the effectiveness data that's now coming through, various different studies is really demonstrating that even a single vaccination of JYNNEOS and the next Imvamune has a high degree of efficacy in the range of 79%. This, in part, has led to a drop in cases of monkeypox in certain territories such as the EU.
However, the outbreak continues, particularly in certain regions like Latin America, and the public health emergency has been continued both by the WHO and the U.S. in November. If we go to the next slide, change tracks and talk a little bit about COVID-19 and our vaccine candidate, ABNCoV2. We currently are conducting a phase III study both in Europe in Belgium and Denmark, and also in the U.S. We will eventually enroll 4,000 subjects, 3,000 in the U.S., which will be primarily for safety, and then an additional 1,000 subjects here in Europe, where we'll be comparing the immune responses to Comirnaty. The enrollment has been initiated, and we are on course to complete enrollment by the end of the year.
However, the study started a little later than planned due to some registry challenges, late regulatory challenges and logistics of access to Comirnaty. For that reason, the results of this study will be read out early next year. The other exciting thing about our vaccine candidate, ABNCoV2, it's been designed to generate strong immune responses against all variants of concern, and that data we've already reported from both phase I and phase II studies. However, it's based on a virus-like particle technology, which is known from the scientific community to induce durable, long-lived immune responses. We're extremely encouraged by the six-month follow-up data from our phase II study, where from 41 subjects where we had follow-up data, we could see that we had long-lived, durable immune responses.
The neutralizing responses were six or 10 x higher than the pre-boost levels, whether you were talking about Wuhan or the Omicron variants. This represented less than a 50% decline in the peak booster response, and these responses are in the range that has been reported to be highly efficacious in the range of 90%. I don't need to remind everyone that this data is rather unique in the COVID-19 space, as the current licensed vaccines based on RNA really have rapidly declining immune levels after already four months. This is unique. It fits into the hypothesis that this could really be a universal booster vaccine that could be giving high protection against multiple variants of concern and giving you long-lasting protection. Go to slide six.
RSV is another late-stage vaccine candidate that we've been developing for a number of years. It's differentiated in its approach in that we're really trying with our vaccine to mimic immune responses that a natural RSV infection would induce. We know a natural RSV infection protects people for a couple of years, and that's the hypothesis and approach of our vaccine. Our vaccine has shown to be highly immunogenic, generating broad antibody T-cell responses. In the human challenge that we've already reported showed a 79% efficacy against mild disease. We're currently conducting a phase III study in 20,000 subjects, and enrollment is going according to plan, both here in Europe and in the US, and we expect to complete enrollment by year-end. Top-line data will likely be reported mid of next year.
Now, we often get the question, "What is the market opportunity for RSV?" Obviously, it has a high disease burden, with a large number of people being hospitalized each and every year, very similar to the levels of flu. Many people estimate that the RSV market will have a value of somewhere between $5 billion and $6 billion by 2025. It offers an extremely important commercial opportunity. More importantly, we believe that this vaccine could really meet a high unmet medical need, and provide great protection against the disease that causes a lot of death and hospitalization. With that, I will hand over the presentation to Henrik Juuel.
Thank you, Paul. Let's turn to slide number eight and then talk a little about our commercial performance in the quarter. In this respect, I'm really pleased to announce a record quarter for Bavarian Nordic, with revenue exceeding DKK 1 billion, as Paul said. An extremely strong quarter driven by two strong growth drivers. It is, of course, the monkeypox business, but it is certainly also the performance of our Rabies business, driven by strong market performance but also strong brand performance. DKK 1 billion and 4 million, to be exact, as total revenue for the third quarter.
Highest contributor to that was our smallpox, monkeypox business, coming in with DKK 578 million in revenue, followed by our rabies business represented by Rabipur and RabAvert with DKK 338 million. Encepur suffered a little from a temporary stock-out during the quarter and came in with DKK 62 million. A strong, very strong quarter taking us to a nine-month revenue level of close to DKK 1.9 billion. Again, on a nine-month basis, you actually see that the rabies business and our smallpox, monkeypox business are more or less at the same size, getting close to DKK 700 million for nine months.
Very strong quarter, leaving us with another approximately DKK 1 billion for the fourth quarter to achieve our guidance of DKK 2.8 billion-DKK 3 billion. Before we turn to the next slide, we have also had some help from the strong U.S. dollar at the moment. If you look at the third quarter of this year in isolation, approximately close to DKK 400 million out of our DKK 1 billion is U.S. dollar-denominated revenue coming both from our rabies business in the U.S., our business with BARDA, but also our business with Canada as well. If you look at where we guided in the beginning of the year, we guided with an exchange rate of approximately 6.5 Danish kroner per U.S. dollar.
Now it is around 7.4, so that actually for the third quarter, if you just compare those two, has given us an exchange rate gain of close to DKK 50 million. But I have to say, of course, we also have expenses in U.S. dollars, and in particular our ongoing RSV trial. It means that on an EBITDA level, you can say the impact is much lower than the impact on the top line. Let's have a closer look at the commercial markets, and on slide nine, we have the first look at the rabies markets. Again, here we are dividing it between the U.S. market and the German market. The U.S.
Market in the third quarter showed continued strong growth, 35% growth, taking us to a full year growth so far after nine months of a little more than 30%. Extremely strong growth, supported by increased travel levels in the U.S., both inside domestic travel, but also outside of the U.S. If you look at the German markets, even stronger growth, but of course also coming from an extremely low level during the pandemic. We have seen, if you look at the third quarter alone, more than 300% growth. Now I think it is getting to a level close to the pre-COVID, but not fully there yet. The U.S. market actually has gone beyond the pre-COVID levels, but there's still a way to go for the German markets.
Both markets contributed extremely well, and I think our brand and our organization performed extremely well in these markets as well. We have, by the end of September, a market share in the U.S. of 67%, so that is slightly above the level we saw some years back before competition went out of stock for a period of time. In Germany, we have maintained our market share of approximately 95%. That is also one of the reasons that strong growth in Germany, even though it's from a low level with our market share, it has a substantial impact still. Very strong performance in the rabies business. On slide number 10, our tick-borne encephalitis business, where we often use Germany as the proxy for how things are going in Europe.
We have in the last two quarters finally seen that the market's recovering. They are not fully back to the level prior to the pandemic, but some good signals in the last two quarters. Unfortunately, during the third quarter, we were impacted by a stockout situation. The stockout situation created, you can say mainly due to the fact that we have seen demand picking up faster than we have been able to handle with the relatively still inflexible setup we have with GSK manufacturing our products. There's unfortunately some lead time before we can have additional products. I'm happy to say that this situation has been resolved right now, and we have products in the markets again. Turning to slide number 11, our full profit and loss. Again, more than DKK 1 billion in revenue for the quarter.
Total operating cost of DKK 492 million, primarily driven by increased research and development costs of DKK 360 million, with the vast majority of that all related to our RSV program. Both the costs related to the phase III trial, but also costs related to the manufacturing process. That takes us to an EBIT-EBITDA of DKK 226 million. As Paul also alluded to, even on an EBIT level, we are positive for the quarter by DKK 128 million, and even net profit for the period after net financial items and tax, we are looking at a period with profits of DKK 12 million.
For the full nine months, revenue of close to DKK 1.9 billion and a positive EBITDA of DKK 14 million Danish kroner. Also when we look at a full profit and loss, an extremely strong quarter for Bavarian Nordic. On the next slide, just a quick update on our cash flow and balance sheet. First of all, you see cash flow from operating activities slightly positive, of course, driven by the net profit for the period. We have seen working capital worsen and that is particularly driven by the receivables, as we haven't collected all the revenue or the cash associated with all the revenue we have generated in the quarter. Cash flow from investment activities negative by DKK 291 million.
Here, I think DKK 295 million was invested in our property in our plants and equipment related to the expansion of our drug substance facility for the future production of our rabies and our TBE products. Cash flow from financing activities, DKK 405 million, most of that related to the financial support we get from the Danish Ministry of Health related to the COVID-19 program, and that takes us to a positive net cash flow for the period of DKK 117 million. Selected balance sheet figures to the right. I will only this time focus on our net cash position, so close to DKK 2.4 billion, so that is after deducting all the debts we currently hold.
If we instead look at cash and cash equivalents, then we are talking about DKK 2.7 billion, which is the number you should focus on when you are comparing to our guidance for the year. Again, very strong cash position and, of course, significantly improved by the monkeypox performance and the rabies performance during the quarter. Next slide, I will talk a little about our financial guidance. Again, as Paul alluded to previously, we have adjusted our guidance 7x this year to reflect the ongoing orders that we have received for monkeypox but also reflecting a very strong performance within our vaccine business and to some extent also reflecting the change in the exchange rate environment. Right now we are guiding top line revenue of between DKK 2.8 billion and DKK 3 billion.
We are guiding an EBITDA between a loss of DKK 200 million and a breakeven result, and we are guiding a cash position of more than DKK 1.7 billion by the end of the year. The reason we are still guiding with intervals, despite that there is now only close to 1.5 months left of the year, is simply due to the fact that our guidance is still pretty sensitive to the specific shipping schedules close to year-end. We might have orders secured already that could either be shipped in the second half of December or into January.
I will also just mention here that please keep in mind that since our original guidance, and that is still the case on our cash position, we are assuming a debt level of DKK 600 million by the end of the year. Of course, the recent improvement in our cash position enables us to reconsider that position, but it is still the assumption in our guidance that we will have a debt position of DKK 600 million. Very pleased that we can maintain our guidance and a guidance that is a significant improvement to the original guidance we issued in March, where you can say we have labeled 2022 as the investment year.
We are now looking at a guidance on an EBITDA level getting close to a breakeven in a year where we are investing around 2 billion DKK in very promising phase III trials. With that, I will actually ask the operator to open up for any questions.
As a reminder, to ask a question, you will need to press star one and one on your telephone and wait for your name to be announced. Please stand by while we compile the Q&A queue. Our first question comes from the line of Thomas Bowers from Danske Bank. Please go ahead. Your line is open.
Yes, thank you very much. A couple of questions here from my side. So maybe just kicking off with your full year outlook, just to sort of follow up on your comments. I appreciate the color on the EBITDA range. I'm just wondering, is it fair to assume that gross margin tailwinds here in Q4 from product mix when we compare quarter-over-quarter here? Then also on R&D costs. Are we looking at a sort of materially higher level here in Q4 again, comparing quarter-over-quarter due to some moving parts in the RSV trial? Second question, just on 2023.
I'm just wondering if you're willing to sort of give us any indications about the minimum revenue outlook based on what you already have in the order books on monkeypox, and maybe also give us some sort of flavor on a sort of a flow on profit. It seems like it's quite difficult for you to avoid any black numbers for next year, at least. So any color here would be appreciated. Then maybe just lastly on the monkeypox. So you previously stated that you expect to fill your 15-20 million dose capacity here in 2023. Is this still the case? And how should we think of the comments made, also you made on the external bulk capacity?
Is it still a likely scenario that you will chase an external bulk manufacturer in order to meet the expected demand in 2023 and beyond that? Thank you.
Okay. Thanks, Thomas Bowers. Let me at least take the first question here. On the gross margin, I can't really comment on the specific expectations to the gross margin for Q4, but I can of course, if you look at the seasonality of our other commercial products, I think it is fair to assume that there will be more monkeypox than there will be there will have a higher proportion of the total sales in the fourth quarter. That's the closest I can get to that one.
On the R&D, I think that's a good question because, let's say we come out after nine months with a positive EBITDA of DKK 14 million, and then you can ask how come you're still guiding an EBITDA between -DKK 200 million and the breakeven, and that is exactly due to the expected R&D costs in the fourth quarter. We are expecting with the ongoing RSV trial to incur significant expenses in the fourth quarter. That is the reason that we are still guiding the interval we do on an EBITDA level. In terms of 2023, we are not guiding yet, so I can't help you with specific things as the numbers.
What we have said previously, I believe that was during our last call, I think we did talk about the number of doses that we have secured by orders. At that time we talked about that it was relatively evenly split between 2022 and 2023, however, skewed a little towards 2023. Since then, we have announced in particular the larger Canadian order. We can only say now that it's even more skewed towards 2023. In other words, we have secured orders for 2023 worth more than what you will see in 2022.
I think in terms of whether we are still chasing a bulk manufacturer, I think on that one, what we've said previously is that we are constantly looking at partnering to expand our capacity, but it has to be driven by demand. The best example we have of that is really the agreement we made with Grand River, that is based on the back of an order with BARDA. We are working on this so that we are prepared to exercise potential options with the new partners should there be a demand going beyond what we can handle ourselves. I hope that answered all your questions, Thomas.
Yeah. You still sort of expect to at least fill your internal capacity for 2023? Is that what I'm hearing?
So far we haven't seen a demand going beyond that, but we are still in 2022, of course, so it's early days, but so far.
Sure.
We haven't seen demand going beyond what we can handle. We are preparing options should there be a higher demand, so we can act as swiftly as possible.
Okay. Got it. Thank you very much.
Thank you. We'll now move on to our next question. Please stand by. Our next question comes from the line of Gil Blum from Needham & Company. Please go ahead. Your line is open.
Good morning, and good afternoon, and thanks for taking our question. Considering quite a lot of phase III data has been coming out for RSV, how do you view your competitive positioning for this program? Thank you.
Yep. Thanks. Yeah, as you said, there's been two readouts from phase III for RSV, both by Pfizer and GSK. You know, it's kind of in line with what we expected to happen based on the phase II data and the human challenge data, particularly with Pfizer. If I remind you on the human challenge data, we essentially got the same result as Pfizer and as Janssen. I think we're quietly confident that we have an effective vaccine and that we will be as competitive as the two companies that have already read out.
Operator, please. I think that was the answer to the question.
Thank you. We'll now move on to our next question.
Please stand by. Our next question comes from the line of Peter Verdult from Citigroup. Please go ahead. Your line is open.
Yeah, thank you. Peter Verdult, Citi. I have two questions. I just wanna follow up from the last question, and push a bit harder, Paul. I think you've always talked about needing big gorillas to create the market, which I can buy into, but it just seems highly unlikely that the headline data you produce, you know, will be able to match GSK. I know. I hear your comments on Pfizer, I get that. But you know, without you know, without that and then having to wait longer term to potentially generate this durability data, I just wanted to push you really on how you think you can compete and generate meaningful revenues, in the absence of, you know, long-term data.
You know, are you gonna put me in my box and tell me that you think that headline efficacy data could be at the same level as that demonstrated by GSK. Just big picture on monkeypox. Just wanted to get your latest thoughts on, you know, where government heads are at and how you feel about the JYNNEOS franchise, both in smallpox and monkeypox, in terms of, you know, the recurring nature of that business, beyond 2023, in terms of contracts being signed, beyond 2023, for both smallpox and monkeypox. Just any sort of improving visibility or is it still up in the air? Thank you.
Yeah. Thanks, Peter. As you know, the headline data from both Pfizer and GSK is still a little unclear. A little more clarity was given at a recent conference in terms of the definition of the lower respiratory tract disease. That's the primary endpoint, LRTD. Pfizer revealed what their definition was, GSK didn't. It's a little unclear whether GSK has. What is the definition that GSK has? And that will be quite meaningful. If you go back to the recent ACIP meeting where RSV was discussed, that exact point was brought up by the committee that it's very difficult to compare studies if we don't know what the final definition or comparable or equal definitions are used to define the primary endpoint.
As I said, Pfizer has been open and transparent now at that conference and at ACIP, what their definition is. GSK wasn't. Having said all that, I still am not scared of the GSK data and their readout. We anticipate a high degree of efficacy, and we'll have to wait and see when more data is actually finally published, what the individual definitions are and how LRTD was defined. Because we have a fairly strict definition. Pfizer has a slightly different definition, and it's unknown what GSK's definition is. I think it's too early to say when one company is winning the race or has an advantage over the others. We're still in the mix of evaluating data or waiting for data to come through.
Regarding monkeypox, smallpox, you know, I think as we've talked before, there's no doubt that a lot of the sales that we have today are with customers that are concerned about the current outbreak. As I said, I'm very proud that we've been able to meet that demand or will meet that demand and supply that market. We're also unsure, as everyone else is, how monkeypox will develop. Will it remain, with pockets of infection and outbreaks, or will it be so-called eradicated back to the endemic regions and just come back in future years? It's unclear, but that will have a big impact to how the monkeypox market develops and whether in fact there's even a private market that we should consider tapping into.
The other aspect of the monkeypox outbreak that has undoubtedly had an impact is how certain governments are viewing orthopoxviral infections and the importance of having a stockpile of a safe, effective vaccine like JYNNEOS. We've seen that with Canada. With Canada's been a long-term customer with Bavarian Nordic on IMVAMUNE. But with their recent order, they've gone way beyond what they've previously ordered or considered stockpiling. We have an EU country, and we haven't announced which one that is, but has placed a large order next year, which I think goes beyond the requirements for monkeypox. There are ongoing discussions with some other countries that are also considering their position on smallpox. I think there will be a knock on effect on smallpox and on monkeypox.
We'll have to wait and see how the disease outbreak continues and how that develops. I still believe that will also develop into a continued commercial opportunity. Hope that answered your question.
Thank you. Thank you. Just had to get off mute. Thanks a lot.
Thank you. We'll now move on to our next question. Please stand by. Our next question comes from the line of Boris Peaker from Cowen. Please go ahead. Your line is open.
Great. Thanks for taking my questions. I have two questions, one on RSV and the other one on JYNNEOS. On RSV, based on the infection rate that's observed in the community at this point, can you comment on your thoughts whether or not you think a second year would be required or one season should be sufficient to generate the events required for the trial? For JYNNEOS, can you just comment how long would it take at your current manufacturing capacity to satisfy the existing contracts and when should we be expecting additional contracts?
Thanks, Boris. The good news in terms of RSV is that the current data is indicating it's a fairly strong season in adults. The trick, however, when you're enrolling 20,000 subjects is that you keep a close eye on the epidemiological data, and you're enrolling in the regions where the disease is still active. For example, in the U.S., it spreads from the East to the West Coast during the season. You wanna make sure you're tracking that infection. It's not as easy to say because there's a strong season, you're bound to get a large number of events. You have to be in the right regions to get those events. Having said all that, the fact that there's a relatively strong season is very encouraging.
We're of course mapping the number of events we get as we go along. We're hopeful we won't need a second season. Again, time will tell. We have to wait until we get to the endpoint and get enough events and unblind the study and take a look. We're hopeful we'll get data readout that's definitive next year. We'll have to wait and see. We're doing everything we can to make sure that we're enrolling in the regions where the disease is still active and getting out of the sites where the epidemiological data suggests the season is coming to an end. On JYNNEOS, I assume you're talking about the U.S. contract. The U.S.-
No, I guess more generally, like the contracts you already have, how long would it take to just fill those at the current manufacturing capacity? When should we expect additional contracts?
For the vast majority of the contracts we have that we've been securing, we will fulfill that demand next year. Having said that, there are some contracts like Canada, which is multi-year, and the demand is split over multiple years, so that will take multiple years. With BARDA, as you know, we have a contract to manufacture the, you know, approximate 13 million freeze-dried doses. That now requires new contracts or new orders for the bulk to replace the bulk that has been utilized for the 5.5 million doses of liquid. We will be validating that freeze-dried process next year. That is also a multi-year manufacturing delivery exercise as well.
Great.
Yeah.
Yeah. Thank you for taking my question.
Thank you. We'll now move on to our next question. Please stand by. Our next question comes from the line of Sten Westerberg, Analysguiden . Please go ahead. Your line is open.
Thank you, operator. I wonder if you could spend some more time discussing the data on the COVID vaccine, phase II data, and the fact that even from low levels still, you are boosting the Omicron strain, the BA.1 antibodies, more potently than the Wuhan antibodies. Is this a possible conclusion from these numbers? That would be my first question. Second question, if you can also discuss this cohort of 41 patients, if they were prospectively chosen, and on what basis. Thank you.
Yep. Thank you. Thanks for the question. Let me just take the 41 cohort, 41 subjects from the 103. They were just basically randomly selected. People were asked to come back for a follow-up. You know, in these sort of studies, not everyone comes back. There were 41 that returned, that were included in the follow-up. As we indicated, I think we did on the slide, we certainly have in the announcement, two were excluded from the analysis as they had a confirmed PCR positive infection for COVID-19. There was no special screening or immunological screening or anything like that. We were just asking everyone to come back for follow-up, and these were the 41 that did. Your other question related to, I believe the potential differences between the Wuhan and the Omicron variants at the six-month follow-up.
I think you need to be careful with the fold higher judgments that we made because the Wuhan titers are actually at a higher point than the Omicron titers. I think the real emphasis to get here is that there isn't a major decline in the titers to both Wuhan or Omicron over the six-month period, which is completely different to what you see with RNA vaccines.
The fact that there appears to be no waning of the BA.1 antibodies, is that a claim that you may be able to repeat in the phase III study?
As I said, you know, the virus-like particle technology, and I won't get too technical here. One of the reasons we got excited about that technology is virus-like particles are extremely good at stimulating antibody responses, and those antibody responses from other commercial vaccines based on VLPs are known to be long-lived. Our working hypothesis has always been with a VLP, we should be able to generate strong antibodies that would be across all variants. I think we have that data now and that it would be durable. We are certainly gonna follow up on the durability in the phase III. This really is quite strong data in the phase II that we really are seeing durable responses after the six-month time point.
On phase III, I think we're going up to a year follow-up in the subject, so we'll get even more data.
Thank you so much. That concludes my questions.
Thank you. As a reminder, to ask a question, you will need to press star one and one on your telephone and wait for your name to be announced. Please stand by. We have a follow-up question from the line of Thomas Bowers from Danske Bank. Please go ahead. Your line is open.
Oh, yes. Thank you very much for taking the follow-up here. So just on RSV. So you're sort of flagging the go it alone strategy potential. I know it's still the plan B, so to say. But I guess you can say the market differs quite a lot from your current portfolio of vaccines. So can you maybe quantify what sort of investments needed to prepare for a potential launch in RSV? And then will this be in key markets or in U.S. only? And then lastly, just I asked this last quarter, so hopefully you have an update now. But I'm just wondering about the cell lines, the RSV, the new RSV cell lines.
I guess you still have an ongoing dialogue with the FDA. Is there any updates here on how the FDA requirements will be? Do you need to do a bridging study post-phase III pre-filing, or do you have any updates here? Thank you.
Yeah. Thanks, Thomas. I'll take the cell line first. Yes, we are transitioning from primary chicken embryo fibroblast process to a proprietary quail cell line that we've developed. We've had continued recent dialogue with the regulators, both in Europe, mainly in Europe actually, under our PRIME designation. Again, it will all be data-driven, so there is no conclusion until the data's been generated. Our arguments that we can base comparability between phase III and commercial are not being rejected by the regulators. As I said, it will really depend on generating that data in terms of the manufacturing quality data and some preclinical and safety data that we'll be generating. At the moment, our strategy remains in place, and we don't believe we'll need any clinical comparability, at least.
In terms of our launch strategy, yes, there are many options that we're exploring, but I don't think we're in a position now to flesh out if we were to go it alone in certain territories, what that would take. It's one of the options that we're exploring as is partnering with a global partner or regional partners, and everything is still very much on the table.
Okay, understood. Thank you very much.
Thank you. There are no further questions at this time, so I'll hand the call back to you for closing remarks.
Thank you. Thanks, everyone, for your time attending the call and for your questions and interest in Bavarian Nordic. Have a great day. Goodbye.
This concludes today's conference call. Thank you for participating. You may now disconnect. Speakers, please stand by.