Paul Chaplin
Analyst · Thomas Bowers from SEB
Thank you, and welcome, everyone, to our half year conference call. Today, we've announced our Q2 results. And before I go into them and then hand over the call to Henrik Juuel, the CFO, obviously, we've announced tremendous results today, driven by very strong growth across the whole commercial portfolio. And before I get into those numbers, I just want to say these sort of numbers don't happen by chance. It's an endorsement of our strategy, but more importantly, it's an endorsement of our employees and their hard work and dedication, but also our partners around the world and our healthcare professionals who work together with Bavarian Nordic to really ensure that we improve the access to our life-saving vaccines. So for the first half year, we've reported just over DKK 3 billion in revenue and an EBITDA margin of 35%. As I said, this really equates to a tremendous result. On Travel Health, we've seen a tremendous growth of 26% for the first 6 months compared to this time last year and actually 45% for the second quarter. And that's driven for the whole portfolio, but primarily driven by rabies and TBE, the first assets we acquired back in 2020, but also by a very successful launch for our chikungunya vaccine, Vimkunya. We have received additional approvals in both Switzerland and Canada for Vimkunya. And we've continued to launch in different countries and now have 15 countries where we've launched the product, and that launch plan will continue into the second half of this year and I would say is going faster than the original plan that we set out last year. Importantly, these numbers are also contributed by our Public Preparedness business, which is exceeding our base business of DKK 1.5 billion to DKK 2 billion. And we already have contracts worth DKK 2.3 billion in the books for this year. And this strong performance that we've seen in the first 6 months is leading to an upgrade in our guidance, which Henrik will talk more about in the coming slides. But essentially, we're confirming the approximate upper range of DKK 5.7 billion in revenue and an EBITDA margin of around 30%. We are also coming off the back end of a very strong cash position. And because of that, we have decided to launch another share buyback program up to DKK 750 million. So as I said, very, very strong financial numbers driven by very strong commercial performance across the board, and that is translating into improved access for people who want to receive our life-saving vaccines. If you go to the next slide, Slide 6. So as I said, on Travel Health, we're really seeing a strong performance, 26% growth compared to this time last year for the first half of the year. And if we look at rabies, we are really seeing a strong growth, 40% growth for rabies. If we look at both U.S. and Germany, our key 2 markets, these are both above 20%, and we have very strong market share and maintaining that strong market share in both those key markets. But also there is outstanding growth in other markets in Europe with a 91% improvement compared to last year. And this, I have to say, comes down to strong brand performance and an endorsement of our strategy of turning these assets around. We are also obviously seeing continued outbreaks of rabies in the U.S., but I would say we're now moving into the fact that travelers are really much more aware of the devastating effect of rabies, and rabies is becoming one of the standard choices of Travel Health vaccines. On TBE, we've also seen strong growth compared to this time last year, and we're seeing a slight improvement in our market share in the key market in Germany. And importantly, and we've talked about this in previous quarters, we have extended the shelf life now to 24 months based on the latest data, and we believe that will have improvements moving forward in terms of our sales. While I'm focusing on this slide to really only talk about rabies and TBE, we shouldn't forget that we are also seeing performance with Vivotif and Vaxchora, our other assets within the Travel Health portfolio. Go to the next slide, Slide 7. On Vimkunya, we are still very much in the launch phase. And we -- obviously, as I already mentioned in the first slide, we've seen additional approvals in both Switzerland and Canada. Switzerland, we've already launched, bringing the total number of countries where we're currently launched to 15. And Canada, hopefully, we'll be launching later this year. We've also submitted the dossier with our partner, Eurofarma, in Brazil, which is the first stage, obviously, of bringing this product to endemic markets. We are, in the guidance, readjusting the Vimkunya sales guidance down to DKK 200 million for this year. And while we are seeing encouraging demand in Europe, particularly in Germany, but some other markets that we've launched such as the U.K., in the U.S., we are seeing headwinds due to the lack of the publication of the ACIP recommendation. This, we've talked about before. And unfortunately, while we were hoping that would be already published, it is delayed, and this is causing, as I said, slight headwinds in terms of convincing certain distributors and wholesalers to buy the product. But as I said, encouraging sales in Europe and other territories, and we really believe Vimkunya will be a future growth story as part of our Travel Health portfolio. On Public Preparedness on the next slide, a number of years ago, we guided the market to say that our base business for Public Preparedness would be somewhere between DKK 1.5 billion to DKK 2 billion each and every year, and that was based on the 5 to 6 recurring customers or governments that we have around the world. And I must say, since we have guided on that range, we have exceeded the DKK 2 billion range every year. Now that is primarily because we've come through a number of different mpox outbreaks, which have obviously impacted sales. And this year, the original guidance was DKK 1.8 billion to DKK 2 billion, again, based on the customer base that we've built up. And we have recently announced a number of new contracts. One was with the U.S. government, another was with an undisclosed EU government. And that's meant that this year, we've already secured DKK 2.3 billion in contracts. And today, we're confirming the upper end of the range, the revised range of DKK 2.5 billion. And this really is an endorsement that we are seeing repeat business from the customer base. And I think really, we should be anticipating that our base business is more around the DKK 2 billion moving forward. We've also seen some regulatory improvements. The EU has approved the younger indication. So MVA is now approved for 2 years old -- 2 years plus. And this is important because children are the main targets in Africa where the disease is endemic and for future UNICEF orders. And of course, it now means that MVA in Europe and hopefully will expand that to include U.S. and other territories. It will be approved for 2 plus. And there are ongoing studies looking at breast-feeding women and even younger children that could potentially support an indication for the whole population. This is not only important for access, ensuring that everyone who needs this vaccine can get access to the vaccine. But of course, it already -- it also improves the indication for MVA and obviously makes it harder should there be any competition arising in the near term. If you go to the next slide, just a few words on the pipeline. We have a lot of life cycle management activities. These are activities that we invest in to support our commercial portfolio. A large part of the R&D budget for '26 is to support our Vimkunya vaccine, not only the approvals, but the regulatory requirements. So we have a number of ongoing studies in children, also an efficacy study, which is taking a significant part of the R&D budget. We also have an ongoing study where we're trying to improve the manufacturing process for our MVA, smallpox, mpox vaccine. This will actually read out preliminary results later this year. We have a study funded by DoD for equine encephalitis which is currently in Phase II, and we have submitted a proposal for additional funding to move into Phase III, and those discussions are ongoing with DoD. And we have 2 other assets that are in preclinical. One is for Lyme and one is for EBV. And today, we're actually announcing that EBV will actually be initiating the Phase I study later this year. We had originally said that, that study would start in '27, but we're bringing that forward. And on Lyme, we have further worked on our Lyme candidate and have an improved candidate vaccine that will now go into clinical development in '28. And I actually want to spend just a couple of slides talking about Lyme because we are actually incredibly excited about the new candidate that we've developed. So if you go to the next slide, Slide 10. A little bit about Lyme. The number of cases of Lyme disease are increasing both in the U.S. and in Europe. It is a tick-borne disease caused by bacteria. And in the middle part of this slide, you can see the endemic regions in the U.S. and Europe. And this is caused by a bacteria that has 6 different strains. And we've been working on a Lyme vaccine for a number of years now, and we have refined our candidate that will now protect, based on preclinical data, against the 6 main strains that we see in Europe and the U.S. And it's based on a new vaccine platform that we developed, which we're referring to as the self-assembling antigen particle, or SAP platform. It's a protein-based nonviral particulate vaccine that is designed specifically to stimulate very high immune responses in people, and high immune responses translates into better protection. So if we go to the next slide, Slide 11. If you look at the left-hand side, what we're looking at here is a positive control Lyme vaccine. This is based on a technology that's currently being developed in the clinic by others. And here, you can see what we're looking at is the ability of the vaccine to stimulate immune responses that kill the bacteria that cause Lyme. And with the positive control, there's no protection or activity after 2 vaccinations. And you can see you actually need 3 vaccinations to see bacterial killing, and this is at a level that is protective. The second part of that graph is our vaccine candidate. And you can see that with 1 vaccination, you get bacterial killing at a level that is protective, that is equivalent to 3 vaccinations of the positive control. And if you give 2 vaccinations, you're now in a completely different league in terms of the immune responses in the bacterial killing. And then on the right-hand side, this is a mouse model where you challenge with infected ticks to the 3 different strains of Lyme. And with the negative control, there's no protection, you can detect bacteria. And with 2 shots of our vaccine, you get complete protection against all the 3 different strains that are evaluated in this study. So we have a vaccine candidate that in preclinical models is better than the current vaccines that are being developed, whether they're based on RNA or based on other technologies. And note that I'm showing you in this data, this data is actually highly durable, long-lasting in the mouse model, which is something that's also a weakness of the current vaccines that are being developed. So we're extremely excited about our Lyme candidate. In animal models, it certainly looks better than what's being currently developed by others. We will spend most of next year manufacturing the material and having discussions with regulators and then moving to the clinic in '28. And with that, I will hand over the presentation to Henrik Juuel.