H Lundbeck A/S B

Welcome and thank you for joining us today on our earnings call. It's of course my pleasure to be with you and be able to express my confidence around our first half results. Our goal today is of course to give you a comprehensive update and we will look forward to of course your questions and engaging with you on the full first half results for 2024. If you can go to the next slide please. Of course, today will contain some statements and these are forward looking statements and are subject to change. We can go to the next slide, and please, of course, the agenda here today is my pleasure to be joined, of course, with my management team. You will hear from our two executive vice presidents for our geographic operations, Tom Gibbs for the U.S. and Michaela Fischer-Hansen for Europe and international markets. You will also hear from Johan Luthman, who is our head of research and development, and, of course, also our CFO, Jörg Hornstein, around the full financial update. To take us to the next slide, again, I want to remind you also of some changes we have announced, of course, previously, but it's important and for me to also welcome our eighth member to our executive leadership team, Maria Alfaita, who is heading up our commercial strategy for Lundbeck and this is the team essentially that will continue to perform and transform Lundbeck for the long-term success of the company and Maria will bring a lot of capabilities that we need around building our strategic understanding of our therapeutic spaces as well as the strategy for some of our commercial operations in the future. So if we then go to the next slide, please. And here again, before we get into the first half results, I think it's important that we just remind you of, as we have consistently done in the past, to remind you of the strategy and where we are going. And this is less than one year ago that I joined and we've undertaken of course the strategic review and developed our focused innovator strategy and it's underpinned by three important elements but firstly to say it's it's really important to emphasize that part of our strategy here is to really look at capital reallocation that will allow us to either invest in more innovation or more growth where we see the opportunities with our existing portfolio So there are three important pillars to the strategy that I just again want to remind you. Our main focus is really to secure long term sustainable growth. We want to continue to pivot to lead in innovation in a very focused way. And we are very committed to deliver sustainable profitability. Also, again, against our midterm guidance that we've given you in the past. And just to emphasize a few quick points. When we talk about secure and stable long-term growth, the most important part here is that we are already making very selected investments in our strategic brands, mainly by Epti and Rexalti. And the aim here is to advance their growth to allow us to bridge across the mid-term LOE and focus our efforts really on the long-term LOE that we see in 2029. We're also advancing the pipeline and you'll hear more from Johan on that, but supplementing that with a very targeted approach to business development that builds on our strengths and builds on our capabilities and really what we call programmatic M&A that will continue to support our innovative pipeline. As we think about focused innovation, we have made some specific elements ready to progress there. One of them, in a sense, our renegotiation of our agreement with Takeda that allows us to reallocate resources more to the growth portfolio of Rexalty in the US. And we are rebalancing a lot of our investments very much around selected markets where we believe we can grow more with the assets that we have. And finally, again here, our commitment to our adjusted EBITDA of 30% to 32% mid-term is very much in our hands, and we feel confident that we can deliver on that to sustain the long-term success of the company. So if we then go to the next slide. It's of course my pleasure to be able to present to you such strong results and I want to take a moment to thank the management team and the leaders at Lundbeck for delivering these stellar results in the first half of the year. We see essentially double digit growth on our total top line of 10%. And we have seen the confidence in the first half of the year with our underlying performance that allowed us to, as of yesterday, raise the guidance for 2024. Again, giving us that confidence that our strategy is delivering on what we said we would do. And in a sense, a strong performance on the strategic brands is evident, as you see in the results. Our strategic portfolio, which is 73% of our current composition of our portfolio, is growing at 19%. And of course, leading the way there is VIEPTI, that continues to excel, as well as Rexalti, both at 78% and 13%. Then we have not stood still of course on the pipeline and we see good advances on the pipeline as we have mentioned to you in the past. We are seeing in the preceded trial with anti-PACAP that that continues to advance in the phase 2b. But you will also hear from Johan more specific elements of the pipeline, specifically areas where we are looking at more neurorare assets. As we've said, this is very much part of our strategic pillar with CD40 in thyroid eye disease and also anti-ACTH, both in Cushing's and also congenital adrenal hyperplasia. And, of course, the alpha-synuclein advancement with fruitful conversations we've had with the FDA will advance to our phase three going forward from there. So we are building a diversified pipeline that will allow us to, of course, build on that long-term success that we expect to have with this pipeline delivering long-term growth for the company. So with that, it's my pleasure, therefore, to hand over to our two geographic executive vice presidents to take you through more specific details of our underlying performance. And therefore, I hand over to Tom.

Thank you, Charles, and good afternoon, everyone. As Cheryl mentioned, we delivered strong commercial performance during 2Q 2024, and this was driven by the 19% growth of strategic brands. This growth was headlined by VIEPTI. We'll go to the next slide, please. We are very pleased with the performance of VIEPTI in the quarter, and this performance was fueled by accelerating growth in the US, and supported by the continued stream of launches and robust adoption in prioritized ex-US markets, including Canada, France, Spain, Germany, and Switzerland. VIEPTI global net revenues for the quarter were $1.342 billion DKK, and this represents 78% growth year-over-year. Net revenues for VIEPTI in the US were 1.18 billion DKK, delivering 68% growth over the first half of 2023. Importantly, we're beginning to see meaningful contributions to global sales by ex-US markets with VIEPTI now available in some 29 markets and delivering 206% growth over prior year. These markets are both exhibiting strong anti-CGRP market growth and VIEPTI continues to gain meaningful market share across these markets. I do want to focus just a moment on the U.S. Over the past year, we've worked very hard to refine our specialty commercial model to support VIEPTI by focusing on HCP engagement, patient activation, patient experience, and market access. These four levers have made material contributions to helping accelerate demand by driving depth and breadth of prescribing and also increasing momentum in new patient starts and driving patient adherence. Next slide, please. RIGSULTI continues to perform well, propelled by the continued strong progress in the AADAD launch in the U.S. US TRX growth during the second quarter of 2024 was 17% versus prior year. As Charle indicated earlier, global reported net revenue increased 13% for the first half of 2024 versus prior year. What I think is important to mention is that the revenue growth during 2Q 2024 accelerated to 18% versus the same time period a year ago. And that's compared to the 6% growth we reported in 1Q 2024. We are pleased with the strong demand growth observed across all of our priority markets. The majority of the volume growth is driven by the US, particularly the AADAD launch with 265% monthly volume growth when we compare May 2024 claims data to the pre-launch baseline. The long-term care channel continues to disproportionately contribute to Rixalti AADAD growth with nearly 656% monthly volume growth since baseline prior to launch, and our market share in LTC has increased more than six-fold. Next slide, please. Regzalti AADAD volume is becoming increasingly important to the overall Regzalti growth and we expect this momentum to continue through 2024 and beyond. AADAD contribution has grown to 14% of the entire brand based upon our most recently available data and represents 22% of new to business prescriptions. We expect AADAD overall contribution to the brand to exceed 20% by year end. The AADAD launch has also had a positive halo effect on the overall brand with non-AADAD volume growing monthly claims volume by 16% from our pre-launch baseline in April 2023 to May 2024. Now, in looking at the most recent TRX data, non-AADAD TRX growth has accelerated to 10% since February due to the continuation of our MBD direct-to-consumer campaign, which was off the air from November through the end of February. And we've also seen improved execution across the broader marketing mix, including our sales team. Importantly, the latest MDD indication level data appear to confirm our decision to elevate our Regsolti strategic investments in 2Q 2024. And this was particularly in DTC and have yielded positive results with Regsolti MDD NBRXs growing at 20.4% over the time period, outpacing our branded competitors. I'll now turn the presentation over to Michaela to discuss performance of our other strategic products.

Thank you for that, Tom. And good afternoon, everyone. If we look at Brintelix, Trintelix, we also here continue to see a very strong performance where we delivered 11% growth versus the same period last year. And as you can see now at 2.35 billion DKK globally. at the reported rates. If we look to the US specifically, we also see a nice growth in solid performance at 5% up compared to last year at 727 million, where we see some indications of stabilization in the market. If we look to rest of world, you can see here that we have 15% growth compared to last year, now delivering 1.624 billion DKK. Specifically, we see Europe having grown 16% versus same period last year, which has been driven by Spain and Italy. And in international markets, we've seen 13% growth, which has been driven by Japan and China. If you look at the right side of the slide, you can see the MAT volume growth in the market versus the growth of our brand. You can see again that we outgrow the market considerably in our key markets, which again underlines the very strong performance of the brand despite several years in the market. And as a result of this, we continue to see all time high market shares in these markets. Next slide, please. If we move to the Abilify LAI franchise, you can also see here a very strong performance with 9% growth globally, now delivering 1.725 billion DKK compared to last year. If we look at the atypical long-acting injectables market, the business here accounts for 38% of the total atypical market in value and as such continues to outgrow the oral atypicals. If we look to the US, you see very strong growth at 11% versus the same period last year. And in the rest of the world, you see 8% growth. We generally see continued strong performance across most of the markets, including US, Spain, Canada, Australia, and France. If you look at the right graph here again, you can see the MAT volume growth and how that has developed between the market and our product, the Abilify LAA franchise. And again, you can see that we continue to outperform the market growth. A reminder that we last year in June launched Abilify Asymptify in the US, the two-monthly. We now see that the brand is performing, delivering 11.5% TRXs and 16.3% of new patient starts for the Abilify LAA franchise. And similarly, the brand was approved in Europe in March of this year. Please bear in mind that here it's called Abilify Mentenna 960mg, and we have at this point launched Abilify Mentenna 960mg in five markets outside the US. With that, I'd like to hand over to Johan for a R&D update.