Bavarian Nordic A/S

CSE:BAVA

Earnings Call Transcript 2022-Q3

[Operator]

Good day, and thank you for standing by. Welcome to the third quarterly report Q3 for the 9-month period ended 30th September 2022 conference call. [Operator Instructions] 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.

[Rolf Sorensen, executive]

Yes. Thank you, operator, and good afternoon to some and good morning to the rest of you. My name is Rolf Sorensen, Investor Relations. And with me today, I have Executive Vice President, CFO, Henrik Juuel; and President and CEO, Paul Chaplin, as usual. And we go through the third quarter announcement slides and 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, growth, 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.

So after this, I will hand it over to you Paul, for the first introduction.

[Paul Chaplin, executive]

Yes. Thanks, Rolf, and welcome, everyone, to our Q3 update. As Rolf indicated, we've had an extremely strong last 3 months, strong quarter, driven by strong sales of both our Rabies, Rabipur/RabAvert, particularly in Germany and U.S., but also of our smallpox, monkeypox sales in response to the ongoing outbreak of monkeypox.

And this has allowed us to record, 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 9 months. This has allowed us the strong sales and opportunities, has allowed us to change our guidance numerous times this year, and we're heading towards a breakeven result.

'22 was always going to be a challenging year in that we're investing more than DKK 2 billion in R&D as we have 2 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 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, Slide 4, I'll talk a little bit more about monkeypox. The first case of monkeypox was reported on May 6 in the U.K. And as I said, I'm extremely proud that our first supply was also in May of '22. We rapidly scaled up our manufacturing capacity in terms of our fill and finish, allowing us to produce doses that we have 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 getting access to our vaccine to more than 70 countries worldwide and 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 store -- cold storage in the event that smallpox should be released. And 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, IMVANEX or IMVAMUNE has a high degree of efficacy in the range of 79%. And 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 regulatory challenges, late regulatory challenges and logistics of access to Comirnaty. And 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 being 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 viral-like particle technology, which is known from the scientific community to induce durable long-lived immune responses. And we're extremely encouraged by the 6-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. So the neutralizing responses were 6x to 10x higher than the pre-boost levels, whether you were talking about Wuhan or the Omicron variant.

And this represented less than a 50% decline in the peak booster response. And these responses are in the range, has been reported to be high 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 4 months. So 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.

Turn to Slide 6. 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.

And 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 U.S., and we expect to complete enrollment by year-end. And top line data will likely be reported mid of next year.

Now we often get the question, what is the market opportunity for RSV? And 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 and many people estimate that the RSV market will have a value with somewhere between DKK 5 billion and DKK 6 billion by '25. So it offers an extremely important commercial opportunity. But more importantly, we believe that this vaccine could really meet the high unmet medical need and provide great protection against the disease that causes a lot of death and hospitalization.

And with that, I will hand over the presentation to Henrik Juuel.

[Henrik Juuel, executive]

Thank you, Paul. So let's turn to Slide #8 and then talk a little about our commercial performance in the quarter. And in this respect, I'm really pleased to announce the -- a record quarter for Bavarian Nordic with revenue exceeding DKK 1 billion, as Paul said. So an extremely strong quarter driven by 2 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. So DKK 1.004 billion to be exact as total revenue for the third quarter. Highest contributors 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. So a very strong quarter, taking us to a 9-month revenue level of close to DKK 1.9 billion.

And again, on a 9-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 9 months. So a very strong quarter, leaving us with another approximately DKK 1 billion for the fourth quarter to achieve our guidance of DKK 2.8 billion to 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. And if you look at the third quarter of this year in isolation, approximately close to DKK 400 million out of DKK 1 billion is U.S. dollar-denominated revenue coming both from our rabies business in the U.S., our business with -- but also our business with Canada as well.

And if you look at where we guided in the beginning of the year, we guided with an exchange rate of approximately DKK 6.5 per U.S. dollar. Now it is around DKK 7.4. So that actually for the third quarter, if you just compare, those 2 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 particularly 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.

So let's have a closer look at the commercial markets. And on Slide #9, 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 9 months of a little more than 30%. So 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. But we have seen, if you look at the third quarter alone, more than 300% growth. And now I think it is getting to a level close to the pre-COVID but not fully there yet. The U.S. market has actually -- has gone beyond the pre-COVID levels, but there's still a way to go for the German market. So 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. And in Germany, we have maintained our market share of approximately 95%. And 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. So very strong performance in the rabies business.

On Slide #10, our tick-borne encephalitis business, where we often use Germany as the proxy for how things are going in Europe. We have the last 2 quarters. Finally seeing that the market is recovering. They are not fully back to the level prior to the pandemic, but some good segments the last 2 quarters. Unfortunately, during the third quarter, we were impacted by a stock-out situation.

The stock-out 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. But I'm happy to say that this situation has been resolved right now, and we have products in the markets again.

Turning to Slide #11. Our full profit and loss, again, more than EUR 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. So both the cost related to the Phase III trial, but also cost related to the manufacturing process. That takes us to an EBIT -- EBITDA of DKK 226 million.

And 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 the profit of DKK 12 million. So for the full 9 months revenue of close to DKK 1.9 billion and a positive EBITDA of DKK 14 million. So 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 in particularly driven by 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. And here, I think, DKK 295 million was invested in our property and 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 EUR 117 million. Selected balance sheet figures to the right, I will only just try and focus on our net cash position, so of 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. So 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.

So right now, we are guiding top line revenue of between DKK 2.8 billion and DKK 3 billion. We are guiding an EBITDA of between a loss of DKK 200 million and the 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.

So 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.

So 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 DKK 2 billion in very promising Phase III trials.

So with that, I will actually ask the operator to open up for any questions.

[Operator]

[Operator Instructions] Our first question comes from the line of Thomas Bowers from Danske Bank.

[Thomas Bowers, analyst]

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. But I'm just wondering, is it fair to assume that, that gross margin tailwinds in Q4 from product mix when we compare quarter-over-quarter here? And then also on R&D costs. So are we looking at a sort of a material higher level in the Q4, again, comparing quarters or quarter due to some moving paths in the RSV trial.

Then second question, just on 2023. I'm just wondering if you're willing to sort of give us any indications about you would say 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 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.

And then maybe just lastly on monkeypox. So you previously stated that you expect to fill your 15 million to 20 million dose capacity here in '23. 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 manufacture in order to meet the expected demand in 2023 and beyond that?

[Henrik Juuel, executive]

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 we 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 -- that 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 we say we come out after 9 months with a positive EBITDA of DKK 14 million. And then you can ask, how come you're still guiding an EBITDA between minus EUR 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. And 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. But what we have said previously, what I believe that was during our last call. I think we did talk about the number of doses that we have secured by orders. And at that time, we talked about that it was relatively evenly split between 22% and 23%, however, skewed a little towards 23%. And since then, we have announced in particularly the larger Canadian order. So we can only say now that it's even more skewed towards 2023.

In other words, we have secured orders for '23 worth more than what you will see in 2022. And I think in terms of whether we are still chasing a bulk manufacturer. I think on that one, I think 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 the Grand River. That is based on the back of an order with BARDA. But 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.

[Thomas Bowers, analyst]

Yes. So you still sort of expect to at least fill your internal capacity for '23. Is that what I'm hearing?

[Henrik Juuel, executive]

So far, we haven't seen a demand going beyond that, but we are still in '22, of course. So it's still early days. But so far, we haven't seen demand going beyond what we can handle, but we are preparing options should there be a higher demand, so we can act as swiftly as possible.

[Operator]

[Operator Instructions] Our next question comes from the line of Gil Blum from Needham & Company.

[Gil Blum, analyst]

Considering a lot of Phase III data has been coming out for RSV, how do you view your competitive positioning for this program?

[Paul Chaplin, executive]

So yes, as you said, there's been 2 readouts from Phase II for RSV, both by Pfizer and GSK. It's kind of in line with what we expected to happen based on the Phase II data and the human channels data, particularly with Pfizer. If I remind you on the human channels data we essentially got the same results at Pfizer and Janssen. So I think we're quietly confident that we have an effective vaccine and that we will be as competitive as the 2 companies that have already read out.

[Operator]

[Operator Instructions] Our next question comes from the line of Peter Verdult from Citigroup.

[Peter Verdult, analyst]

I have 2 questions. I just want to follow-up from the last question and push you a bit harder Paul. I think you've always talked about needing big curators to create the market, which I can buy into, but it just seems high unlikely that the headline data you produce, we'll be able to match GSK. I hear your comments on Pfizer. I get that. But 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 long-term data or are you going to put me in my box and tell me that you think that headline [ FC ] data could be at the same level as that demonstrated by GSK. And then just big picture on monkeypox. Just wanted to get your latest thoughts on where government heads are at and how you feel about the JYNNEOS franchise, both in smallpox and monkeypox in terms of the recurring nature of that business beyond '23 in terms of contracts being signed beyond '23 for both smallpox and monkeypox. Just any sort of improving visibility or is it still up in the air?

[Paul Chaplin, executive]

So as you know, the headline data from both Pfizer and GSK is still a little unclear. So 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. So it's a little unclear 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 you don't know what the final definition or equal definitions are used to define the primary endpoint. As I said, Pfizer has been open and transparent now at that conference in ACIP what the definition is, GSK wasn't.

Having said all that, I still am not scared of the GSK data and the 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. So 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, 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. And 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 on shore 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 event regions and just come back in future years, it's unclear that, 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 Orthopoxvirus infections and the importance of having the stockpile of a safe effective vaccine like JYNNEOS. We've seen that with Canada. So we've -- Canada has been a long-term customer with Bavarian Nordic on IMVAMUNE but with their recent orders have 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. And there are ongoing discussions with some other countries that are also considering their position on smallpox. So 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, but I still believe that will also develop into a continued commercial opportunity. I hope that answers your question.

[Operator]

[Operator Instructions] Our next question comes from the line of Boris Peaker from Cowen.

[Boris Peaker, analyst]

I have 2 questions, one on RSV and the other one on JYNNEOS. So 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 the second year would be required or one season should be sufficient to generate the events required for the trial? And for JYNNEOS, can you just comment how long would it take in your current manufacturing capacity to satisfy the existing contracts? And when should we be expecting additional contracts?

[Paul Chaplin, executive]

So 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 enrolled in 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 collected. So for example, in the U.S., it spreads from the east -- east of the West Coast during the season. So you want to make sure you're tracking that infection. So 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 give 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. And we're hopeful we won't need a second season. But 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. So we're hopeful, we'll get data readout that definitive next year, but we'll have to wait and see. But 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.

[Boris Peaker, analyst]

No. Generally like the contracts you already have, how long would it take to just fill those at the current manufacturing capacity? And then when should we expect the additional contract?

[Paul Chaplin, executive]

So for the vast majority of the contracts we have that we've been securing we can -- we will fulfill that demand next year. Having said that, there are some contracts like Canada, which is multiyear, and the demand is fit over multiple years. So that will take multiple years. And with BARDA, as you know, we have a contract to manufacture the approximately 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, and we will be validating that free stride process next year. So that is also a multiyear manufacturing delivery exercise as well.

[Operator]

[Operator Instructions] Our next question comes from the line of Sten Westerberg, Analysguiden.

[Sten Westerberg;Analysguiden;Equity Analyst, analyst]

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 to BA.1 antibodies more potently than the Wuhan antibodies is a possible conclusion from these numbers? And that would be my first question. Second question, if you can also discuss this cohort of 41 patients, if they were prospectively chosen on what basis?

[Paul Chaplin, executive]

So let me just take the 41 cohorts, 31 subjects from the 103. They were just basically randomly selected people were asked to come back for a follow-up, if 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, what we certainly have in the announcement, 2 were excluded from the analysis as they had a confirmed PCR-positive infection for COVID. So there was no special screening or immunological screening or anything like that. We were just asking everyone to come back for a 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 variance a 6-month follow-up, I think you need to be careful with the fold hire judgments that we've 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 and Omicron over the 6-months period, which is completely different to what you see with RNA vaccines.

[Sten Westerberg;Analysguiden;Equity Analyst, analyst]

So the fact that there appears to be no waning of BA.1 antibodies? Is that a claim that you may be able to repeat in the Phase III study?

[Paul Chaplin, executive]

It's certainly -- well, as I said, the viral life particle technology, and I won't get too technical here. One of the reasons we got excited about that technology is viral light 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. So our high working hypothesis has always been with the 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 going to follow-up on the durability in the Phase III, but this really is quite strong data in the Phase II that we really are seeing durable responses after the 6 months timepoint. And on Phase III, I think we're going up to a year follow-up in the subject. So we'll get in more data.

[Operator]

[Operator Instructions] We have a follow-up question from the line of Thomas Bowers from Danske Bank.

[Thomas Bowers, analyst]

So just on RSV. So you're sort of flagging the go alone strategy potential. I know it's still the plan B, so to say. But I guess you could 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 will this be in key markets or news 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 new RSV cell lines. So I guess you still have an ongoing dialogue with the FDA. So is there any update here on how the FDA requirements will be? So do you need to do a bridging study post Phase III prefiling or do have any updates here?

[Paul Chaplin, executive]

I'll take the cell line first. So yes, we are transitioning from primary chicken embryo fibroblast process to a proprietary coil cell line that was developed. We've had recent -- continued recent dialogue with the regulators, both in Europe, mainly in Europe, actually, under our prime indication. And again, it will all be data driven. So there is a conclusion until the data has been generated. But our arguments that we can base comparability between Phase III and commercial are not being rejected by the regulators.

But 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. So at the moment, our strategy remains in place, and we don't believe we will 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 alone in certain territories, what that would take. It's one of the options that we're exploring, and is partnering with a global partner or regional partners and everything is still very much on the table.

[Operator]

Thank you. There are no further questions at this time. So I'll hand the call back to you for closing remarks.

[Paul Chaplin, executive]

Thank you, and thanks, everyone, for your time attending the call and for your questions and interest in Bavarian Nordic. Have a great day. Goodbye.

[Operator]

This concludes today's conference call. Thank you for participating. You may now disconnect. Speakers, please stand by.