Good day, and thank you for standing by. Welcome to the Bavarian Nordic conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be the question and answer session. To ask a question during the session, you need to press star one one on your telephone keypad. You will then hear an automatic message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to our first speaker today, Rolf Sass Sørensen. Please go ahead. Yeah. Thank you, operator, and welcome to everyone listening in on this rainy Monday here in Copenhagen. My name is Rolf Sass Sørensen, VP Investor Relations, and online here we have President and CEO, Paul Chaplin, and Executive Vice President, CFO, Henrik Juuel. Today, we have a pipeline update where we have presented data on chikungunya, ABNCoV2, and of course, RSV. First we have a few slides, and after that, of course, Q&A session. To start that, before we start, I just briefly would have run through the disclaimer and hand it over to Paul afterwards. 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 our short-term objectives and opportunities, financial expectations for the full year, as well as statements concerning our plans, objectives, goals, future events, performance, and other information that is not historical information. 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. By this, I will hand over the presentation to you, Paul. Thanks, Rolf. Welcome everyone to our update call today. As Rolf said, it's been an incredibly busy summer as three of our phase 3 programs have read out. I want to update you on all those different readouts. Henrik Juuel will talk a little bit more about the progress that we're making on our, on the commercial business. We'll open up to Q&A. If you turn to slide 4, let's start with chikungunya. Obviously, today, we've reported the positive results from the largest phase 3. Before I get to that, let's just remind you about chikungunya itself. It's a mosquito-transmitted disease. It's prevalent in large parts of the globe, particularly South America and Asia. While it has a low fatality, it causes a rather severe disease in terms of fever and joint pain that can become a chronic condition for more than 40% of the people that contract it. Currently, there are no treatments or prophylactic vaccines. It's an exciting area, both from a travel vaccine perspective, which is one of our specialties, but also for the millions and millions of people who live in these endemic regions. The market, from a travel perspective, is believed to be in the region of $500 million. It's an extremely attractive segment and one that would fit in as almost a plug-and-play in terms of our commercial setup, as obviously one of our key areas is in travel vaccines. If you go to slide 5, today, we reported data from the largest phase 3 study, which is in just over 3,000 subjects. These were people aged from 12 all the way up to 64 years of age. Here what we've shown is that the vaccine candidate, which is based on a virus-like particle, was highly immune, immunogenic, inducing levels of protection in terms of neutralizing antibodies in the majority of subjects by day 22. Now, the important thing here, and a key differentiator to the competition, is that we also saw these, these high response rates already at week 2, and at week 1, actually, almost 50% of the subjects had the same levels of protection. We're seeing a much faster onset of protection with our chikungunya VLP candidate than the competition, which we think is a key differentiator. In terms of safety, it's extremely well tolerated, with site reactions that were typically mild or moderate in nature. Together with the safety profile, the faster onset of protection, the fact that it comes in a prefilled syringe, which we know physicians prefer, we really think we have a competitive advantage, and we are really setting up this vaccine to be the best in class in terms of protecting against chikungunya. Earlier, this summer, we reported on another phase 3 in elderly subjects, so that's subjects above 65, and we saw similar results, slightly lower seroconversion rates, but still extremely high. I think we, we really are spanning the total age group from adolescents from the age of 12 all the way to elderly adults. The plan moving forward is. We will, we're gearing up now to do the regulatory filings. This is the end of the clinical development that was agreed together with the regulators required for filing, and we plan to file next year with a launch date in 2025. Go to the next slide, slide 6. We also, earlier, this summer, in late June, reported the results from our COVID vaccine, ABNCoV2. This is also based on the virus-like particle technology that we licensed in from University of Copenhagen. Here, again, we were successful in meeting the primary endpoints of the phase III. This endpoint was to show that the neutralizing antibodies induced by the vaccine were non-inferior to Comirnaty, which is the original RNA vaccine from Pfizer. Here we were successful. This clearly demonstrates that this, this vaccine platform and this COVID vaccine had utility, would have been able to-- would have been used in the pandemic because this was obviously against the original Wuhan strain. The other thing that this study shows is that once again, the right order is shown that public-private partnerships can really work. Historically, we've developed a smallpox and pox vaccine based on a strong partnership with the US government. Here, we've demonstrated that it's-- that this VLP technology has utility in a pandemic, thanks to the funding and support from the Danish government. The regulatory environment for COVID vaccines has changed since we began this program, and actually since we even began the phase III. Now regulators are really requiring variant-specific COVID vaccines, which our vaccine is not. The future path here is a little bit more complicated, and we have to await the data, which is coming later this month, in how good is the vaccine against the current circulating variants. That will be key data and will need to be extremely strong to overcome the current regulatory requirements to have a variant-specific vaccine. In the coming weeks, we will report that data and give clarity to the market on how we're going to proceed with this asset. Go to the next slide, slide 7. We also had a phase III readout for RSV, and unfortunately, this was negative. This was completely unexpected, given the prior results, particularly the human challenge trial that we've already reported, which showed very high efficacy, comparable efficacy to other candidates that have gone on to report positive phase III results. It's a setback, it's a disappointment, and one that obviously we have to learn from to try and understand why this vaccine failed. While we try to do that, we are closing this program and will not proceed with any additional funding. As you'll hear in the coming slides, you know, there was a significant amount of future R&D in the region of about DKK 0.5 billion for next year alone, that will no longer be funding. I think in terms of R&D, you'll see a reduction in our overall spend in the coming years. With that, I'll hand over the presentation to Henrik Juuel. Thank you, Paul. While the agenda here today is really about the update on the recent development in the pipeline, I just wanted to remind everyone that Bavarian Nordic is so much more than a pipeline company. We have an extremely strong commercial business. We demonstrated that last time when we announced the Q1 numbers. You can see the numbers to the right here, where we basically show very significant growth across the board of our portfolio, driven really by rebound in the markets, but also very strong brand performance, both on our rabies vaccine and our TBE vaccine. Without disclosing too much, we haven't finalized, and we haven't announced yet our Q2 results. I can just say that we are seeing this strong performance continuing into the Q2. We are in a situation with a very strong commercial business, securing profitable growth for the company. We have also recently, as you have seen, announced additional order from BARDA, $120 million, with approximately $100 million of those expected already this year. In connection with that, we raised our full year guidance for 2023. We are now guiding a revenue level of DKK 6.9 billion, approximately, and then EBITDA, it was increased by DKK 100 million to now DKK 2.3 billion. These numbers also includes the anticipated impact from the recent acquisition from Emergent, where we are adding two commercial-stage assets, upon the chikungunya asset as well. We have added approximately DKK 165 million from this business, corresponding to 7.5 months ownership, and then negatively, the debt contribution of approximately DKK 375 million, primarily driven by the continued development of the chikungunya vaccine. Extremely strong, positive numbers. We are also seeing beyond that, we have included smaller orders on mpox, 3 orders to be specific, showing that there is still a demand, continued demand out there for mpox. We are also having very good discussions with the EU on their stockpiling, both in terms of mpox, but also smallpox stockpiling eventually. Paul already alluded to the financial impact of the termination of the RSV program. What we will happen financially is that we were, in our guidance, expecting, milestone payments related to the development of RSV from our Chinese partner, Nuance. DKK 195 million. Obviously, we are not getting those milestone payments, but they are compensated by the very strong commercial business, and that's already assumed in our new guidance here. For next year, had we been successful with RSV, we would have had to invest more than DKK 500 million into RSV next year in committed trial programs, looking at longevity, and other efficacy measures that you are committing to the regulators post-approval. This is not going to happen. Before this sad outcome on RSV, we were already in a strong financial position. We had DKK 3 billion in cash by the end of the Q1. We have spent approximately half of that on the upfront payment to Emergent, but beyond that, we are still in a very good financial position. Before this outcome on RSV, we had absolutely no plans to raise cash, no needs to do so according to our plans. I would just say that without RSV now, the need is even less. It will, it's a setback, as Paul said, but short term, I mean this year and probably the next two years, it brings us in a stronger financial position as we are not going to invest the amounts that was needed to complete the RSV program. A strong financial position, absolutely no need for us to raise capital to support the current business. We have enough cash and enough runway to look through the period where we are going to pay back the remaining milestones to GSK, which will end in 2025. With that, I will give the word back to you, Paul, for a quick wrap. Yeah, thanks, Henrik. Just before I wrap up and open for Q&A, I just want to turn the clock back a little bit. In 2020, we decided as a company to change our strategy. Up until that point, we had been known really as a vaccine developer and manufacturer, particularly of our smallpox vaccine. We know in R&D, it's risky. For every success, there's normally a few failures along the way, and we wanted to make the business more robust so that we could withstand some setbacks. We invested in the acquisitions of our rabies and TBE, and again, thank you for the investors for supporting that. We've recently added to those acquisitions with the travel franchise from Emergent BioSolutions, creating what is now the largest travel vaccine company in the world. That, as Henrik has said, is going from strength to strength. Despite the COVID pandemic, we're really beginning to see the benefits of what we said we would deliver. We said we would build up a commercial organization. We said we would grow those assets to levels that no one else has taken them. That's exactly what we're seeing with rabies and TBE. Our smallpox business is growing, continuing to grow. It's a different kind of business, as it's directly to government. It's a little bit more lumpy and unpredictable. Nonetheless, we have probably in the region of $500 million in the order books with the US government alone in the coming years. The base business is extremely healthy. Henrik has reinstated several times there was no need to raise capital before the setback of RSV. There is certainly no need, now that our cash flow is actually is only going to improve. We're in a really healthy position as a company with our commercial business and an extremely bright future for BN. Today is a day to celebrate with our CHIKV result. It adds beautifully to the portfolio, will add to the top line and the profitability in the years to come. With that, I just want to acknowledge once again that while the RSV is a setback, we have geared up the company to, to be able to absorb such setbacks and move forward, as a healthy company. With that, I think I will end and open up for Q&A. Thank you. Dear participants, as a reminder, if you wish to ask a question, please press star one one on your telephone keypad and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by, we will compile the Q&A roster. This will take a few moments. Now we're going to take our first question from Peter Verdult from Citi. Your line is open. Please ask your question. Yeah, thanks. Peter Verdult, Citi. Paul, maybe just 1 for you and a couple for Henrik, but the 1 for you is more a strategic question. I mean, given how COVID-19 and RSV has played out, how should investors think about... Bavarian going forward, do you still see yourself as a R&D focused company, or, or will it be more search and development, as we've seen you do with Emergent and acquiring those assets going forward? If you still argue that you're an R&D focused company, where will future efforts lie? Then 2 quick financial ones for Henrik, and 1 to follow on to these, the, the first question. You know, COVID-19, RSV, chikungunya, phase 3 trials all end this year. Given the state of the pipeline, what sort of run, sensible run rate for R&D would be, you know, would you be giving us for next year, assuming nothing changes with the current pipeline? Just lastly, you hinted at some European stockpiling, but just is there anything else apart from Europe, nothing more in the U.S. that you expect in terms of potential Jynneos contracts for 2023? Thank you. Yeah, thanks, Peter. Let me take the first one. Well, you, you gave it to me, so let me take it. Yeah, so a focused R&D company. I think, of course, that term can be labeled to be very Nordic, because we had three phase 3 running in one year, which has never happened before, and, and, and from a lot of companies has never happened before. As I said, I think back in 2020, we tried to create a more integrated commercial company that had R&D as part of the company. As I said, the focus this year changed a little bit because of the three phase 3s, which is a very unusual situation. I think moving forward, our near-term focus is really on our commercial business. Growing that commercial business, optimizing all the opportunities that we have. Clearly, the R&D will continue, but at a completely different level, because we'll have very early assets that we'll be bringing through. The R&D spend, which I'll let Henrik answer, after me, is gonna be dramatically reduced in the coming years, as we obviously will be at a different stage of development. I, I think we're -- we were a balanced company before this year with these large phase threes that all came at the same time. Moving forward, our near-term focus is really on the commercial assets, on optimizing those commercial assets, optimizing the profitability. We will bring other assets through into the pipeline, but these are a much earlier stage, and the level of investment is much lower. And Henrik, I'll hand over to you. Yeah. Thanks, thanks, Peter, for the question. In terms of R&D, I think maybe we should start with looking at the, what we have guided for, for this year. That we have previously said that R&D spend would be approximately DKK 1.9 billion, including the COVID-19 part that is being capitalized. The real spend is DKK 1.9. It's clear that with, with, with, with these two programs, not in the, in the mix, it will be significantly lower. On the other hand, we know that the chik program, fortunately, we had very positive readout, announced today. There will, of course, be some additional costs associated with completing that program, investing in CMC and some committed trials that we have committed to vis-a-vis the regulators. I think if we exclude the, the chikungunya, R&D, spend the next couple of years, then we should see our R&D spend sort of, migrating towards the historical, the Bavarian Nordic R&D level. Thank you. On Jynneos contracts, anything over and above the European stockpiling, anything else major that could play out this year? I thought Henrik was going to answer that, but I can take it. I think the, I think the major contracts are in. There are discussions with a number of different governments. Whether they'll come in this year, I think it's more likely therefore, next year or beyond. Thank you. Thank you. Now we're going to take our next question. Just give us a moment. The next question comes from the line of Gil Blum, from Needham & Company. Your line is open. Please ask your question. Good morning, everyone, and thanks for taking our questions. Just to make sure I fully understand here, you guys measured for rapid onset of protection at day 15 for chikungunya VLP. This is likely to get on the label. Is that, is that correct? Yeah. We believe it will get on the label because it's one of the measured endpoints in the phase three. How important do you consider protection at six months, considering you guys are kind of aiming for the travel market here? Well, I think the level of protection is still very high at 6 months. I think the... You know, for travel, it's primarily the, the initial travel where the focus is in terms of the efficacy, and in our experience, it's about the time to protection because people, you know, don't plan their vaccinations well in advance of travel. It's how many shots do you need before you're protected? Because that's typically the focus because you're traveling in a few weeks. As I said, I, I, I think the long, the 6 months data is the high 80s is still extremely strong. The real advantage with travel is the onset or how fast you're protected before you travel. Okay. And maybe a less general one, kind of given this year has been a bit of a clearing of that. Bavarian will be profitable this year and potentially also next year. Do, do you think we've, you know, shifted gears here and we should start considering, Bavarian a profitable company for the next few years? Thank you. Our strategy is to be profitable, so we will be profitable this year, and we will be in the years to come. I mean, that's the whole shift in strategy that we made in 2020, that we wanna be a profitable business moving forward. Excuse me, Gil, any further questions from you? No, thank you. I appreciate you guys taking my questions. Thank you. Now we're going to take our next question. The next question comes from the line of Boris Peaker from TD Cowen. Your line is open. Please ask your question. Thanks for taking our question. This is Megan for Boris. Just one from me. Given that there is no approved chikungunya vaccine currently, there is that competitor that's closer than, just a little bit closer than you guys. What is your plan for commercialization? Will there be significant outreach needed to educate physicians on chikungunya? Will you be able to utilize your rabies and TBE markets? Yeah, just some general comments on that would be great. Thanks. Yeah, thanks for the question. Yes, the competition is a little ahead of us. They will be in the market, in the US, at least, at least a year before we are. Some marketing and awareness campaigns are required because not everyone is fully aware of chikungunya. Obviously, our competitor will take the lead on that, as they will launch before we do. However, when I say it's an ideal plug-and-play, our whole commercial setup in terms of how we sell our vaccines in the US, are geared to the travel market. Of course, we have our customers, all lined up and, you know, we can piggyback on the work that our competitor will do in terms of the awareness, to have, we hope, a successful launch in the US. Likewise, in Europe, in Germany and in other markets, we're geared up for the travel market, where we have relationships with the key people, which will allow us, again, pretty much to plug and play. In Europe and the U.S., we're very much looking to keep this in-house and to use our own commercial setup. In the endemic markets, we're likely to be looking for partners. Got it. Thank it very much. Thank you. Now we're going to take our next question. The next question comes from line of Michael Novod from Nordea. Your line is open. Please ask your question. Thank you very much. Three questions. First, on the CHIKV data. Maybe, Paul, you could talk a bit about the... Also, going back to one of the earlier questions, around the 6 months durability. Looking at your data, the size of the trial and how you, and the size of the population you measure on in terms of comparing to your competitor, just to get some flavor on 86% versus 96%. Then also on manufacturing, how progressed is all this, and how, where will you be manufacturing CHIKV VLP? Then lastly, on Jynneos, and we've seen some very concrete comments from a country like France around trying to address or change their stockpiling strategy. Would that be something mainly for, for 2024, would that be something that is like a, I don't know, three, four, five-year contracting option? How should we expect this to materialize if it happens? Thank you. Yeah, thanks, Michael. On-- let's take them in order on the chick. The first thing to point out is that, you know, when we're comparing between the two vaccines, our vaccine and that of the competitor, we use completely different assays. The level of seroconversion and in fact, the cutoff that's been agreed with the regulator is also different because the assays are different. You're not really comparing apples to apples. That's the first thing. Is there a material difference between 88, and I can't remember what the number was, 97, I think you said? Probably not, in my opinion, particularly when you look at the size of the trials and you look at the confidence intervals, which I believe will be overlapping. I think in terms of the longevity and the peak efficacy, let's call it efficacy, based on seroconversion of a certain titer, we're very, very similar. Where we're distinctly different is when you look at the earlier time points. There, it doesn't matter, you, you can take different assays or whatever. When the competitor looks at earlier time points, there is little or no detectable neutralizing antibodies in their assay. There, there is a distinct difference. There, we're not comparing apples to oranges, we're actually comparing, do you detect something, yes or no? We do, they don't. The earlier onset is real. I would say really, given the size of the trials and the levels that we're reporting and the overlapping confidence intervals, we're all about the same once you get to that 29 days and 6 months time point. In terms of manufacturing of CHIKV, we will be manufacturing the product in our new facility in Bern, in Switzerland. We're currently finalizing the validation as we speak. That's where we will be launching the product from, and everything remains on track. In terms of Jynneos, you're right. France, we can talk about France as it's more of a public statement from their side on their increased, potential increased requirements for a smallpox vaccine. You know, I believe if this materializes, it will be a multi-year order because the numbers are quite large, that have been discussed. The timing of which is always difficult with governments, predicting exactly when they will make the decision and when the budgets will become available. There are concrete, I would say, serious discussions in that area, and we're confident that something will materialize, hopefully as early as next year. Okay. Thank you very much. Thank you. Dear participants, as a reminder, if you wish to ask a question, please press star one one on your telephone keypad. Now we're going to take our next question. Question comes from line of Peter Verdult from Jefferies. Your line is open, please ask your question. Hi, yes, thanks for taking the questions. I've got three. Firstly, just coming back to Peter Verdult's question at the start, really, in a way. Obviously, the removal of RSV in particular, I guess, removes a significant potential sort of avenue of growth longer term, if you like. Does this, in any way create an extra sort of impetus for you to do more deals in the near term? I guess, do you feel any pressure to add, you know, more late stage assets in the near term? Or do you think the current portfolio together, obviously now with Chick, you know, is sufficient over the next few years to provide the sort of, the sort of growth and the sort of, you know, optionality that you're looking for? Secondly, then, just coming to RSV, I don't want to sort of dwell on it, but I guess I'm curious if you've done any digging so far as to the rationale for why it failed. Just more curious from a sort of scientific point of view, if possible, as to, you know, is there anything that you've sort of uncovered so far as to the potential rationale behind that? Then just on COVID, I guess, understand from the FDA point of view, and I think the situation's pretty clear as well, given the sort of market that has been addressed there. I guess, curious from a, from a Danish point of view, if you've had any discussions with the Danish government in so far as we, we have seen some other countries, obviously, despite data and despite everything else, take the decision still to back products, given the sort of desire to keep local national capacity. Any sort of discussion, I guess, so far with the Danish government, bear in mind with the data you've got in hand. Thank you. Thanks, Peter. Yes, there's no hiding from the fact that RSV, whether we kept it or partnered it, the partners, the program, has left a hole in the, in the projected future, future revenues. What I would say is, is that, you know, our hands are pretty full right now in terms of the new assets we've acquired earlier this year, and also coming out of the COVID fog in terms of travel, in terms of building those assets and, and launching a chikungunya vaccine in the coming years. I would say at the moment, our hands are full. I think we have a healthy commercial business that we're adding to with chick that will keep us busy in the coming years. I, I don't feel the pressure that we need to do more deals or late-stage deals currently. On RSV, I wish I could answer the question, why it failed. We, we are scratching our heads. I mean, we're in a situation where our vaccine, obviously in the human challenge, but also in the phase 3, prevented mild symptoms, but failed to prevent severe symptoms, and we fundamentally don't understand that outcome. We, we're not challenging it. I mean, the data is the data, and that's one of the things we're really gonna try and dig into, if we can better understand why that is the case, because I'm not aware of another vaccine that prevent... or another vaccine that failed, that prevented mild disease, but didn't prevent severe disease. We are scratching our heads, I'm afraid. On COVID, we haven't had direct discussions with the Danish government in terms of, obviously, we've had a lot of discussions with them as we've, as we've developed the vaccine and, you know, moved through phase 3. We haven't had specific discussions on their requirements for COVID moving forward. We've mainly kept those discussions with the regulators, both the FDA and EMA, and there is a level that we'll have. I'm sure at some stage we will have direct discussions with the Danish government. That's great. Thank you. Thank you. Now we're going to take our next question. The next question comes from the line of Samir Devani from Rx Securities. Your line is open, please ask your question. Yeah, hi. Thanks for taking my questions. I guess I've got a couple. The first is just on your CHIKV. Just thinking about the durability, I think you've mentioned sort of 86% at 6 months. I, I'm just wondering, if we were to sort of speculate what you might see at 1 year, 2 years, is there a level of seroprotection which would trigger the requirement for a booster? I guess that- that's the first question. The second question is really more about the commercial business. I know you said you're not under any pressure or you don't feel under any, any pressure to do deals. If the focus is on the commercial business, I, I guess my question is really, do you see many other travel vaccines available to you that, you could potentially acquire going forward? Thanks very much. Yep. Thanks for the question. You know, one of the, one of the post-approval commitments that both we will have, and our competitor will have, will be to perform an efficacy study in an outbreak scenario of chikungunya. Currently, these seroconversion or seroprotective levels are based on antibody titers that the company and the regulators believe is likely to predict protection, but it's not known, and I would say these titers are most likely conservative. Post-approval, in an outbreak scenario, we'll have the responsibility to perform an efficacy study, and that will answer many of the questions in terms of what is the true level of efficacy, what is the durability moving forward. I would still say, you know, let's see what the data looks like after 12 months. A high 80 level of efficacy is still an extremely high level that probably wouldn't require a booster. Where would that be? It just depends, I think, in terms of the overall data set. The other question related again to other travel vaccines or, or, or deals that we may do. You know, I, I think it's clear for us is that right now we have a handful with our day-to-day business, and our day-to-day business is primarily focusing on the bucket of assets we already have, growing them. The travel vaccines we just acquired this year really need to be relaunched to get them to where we want them to be, and now we have a CHIKV asset that we have to launch in the next couple of years. I think that's our primary focus moving ahead. Great. Thanks very much. Thank you. The speakers are done for the questions. I would now like to hand the conference over to the management team for any closing remarks. Yeah, thank you. Thanks everyone for joining and, all the great questions. Have a great day, and we'll meet up again soon. Thank you. That does conclude our conference for today. Thank you for participating. You may now all disconnect. Have a nice day.