5/15/2024

speaker
Charles
CEO

So thank you for joining the call today. It's of course my pleasure to be able to report the quarter one, 2024 results. It's been a quarter that has been very active and in a sense positive in its dynamic towards the progress to become a focused innovator in neuroscience. So if we can go to the next slide, please. Just to, again, company disclaimer, the forward-looking statements here are that, of course, what we present today is also subject to change. So if we can go to the next slide. Today I'll be joined by Tom Gibbs and Michaela Fischer-Hansen, who is our new heads of our geographic business. And, of course, you know Johan. and Jörg who will join me today to present to you the first quarter results. So if you can go to the next slide, please. So let's get straight into it and start talking specifically about where we see the first quarter heading and how we see the full year. But before we do that, I want to again mention to you in the context of where we stand at Lundbeck today, and I see clearly our progress very much around performing and transforming as we go forward. So I would like to share with you again where we stand in terms of our strategic path. And if we can go to the next slide, This is something we have shared with you, of course, before, and it's consistent with our previous interactions. But I'm really pleased with the progress we're making towards transforming to become a focused innovator. There are three elements that I would highlight for you today in this path. The first is securing that stable long-term growth for the company. leading with focused innovation in neuroscience, but at the same time being very disciplined around our capital allocation to stay within our sustainable profitability margins that we have communicated to you in the past. And I have to say from where we stand today and with the first quarter that we see here, we are well on our way to build that focused innovative strategy going forward with a very strong growth in our strategic brands, VIEPTI and Rexalti, and we'll talk more about that in a short moment. We are also seeing a really nice evolution of our innovation strategy in the pipeline with anti-pay cap as well as our alpha-synuclein in MSA. And of course, we continue to exercise opportunities in the business development area where we think about a programmatic approach to further build on the innovation strategy going forward. All of this, I would again emphasize to you, is underpinned by a very disciplined approach to our capital allocation to reallocate towards either additional growth opportunities or to where we could see additional innovation opportunities in the company. So then if we really go to the more specific points, which is the next slide, please, around our quarterly results. Again, I'm really pleased to see the progress we're making on first quarter. You see our growth here at 7% and adjusted EBITDA at 33%. But most importantly, I think what we want to highlight here is The assets where we are focusing our investment and effort, the strategic brands are growing at 17%, and I have to call out here VIEPTI at 79%, and you'll also hear later from the team on Rexalti where we see also double-digit growth on a total prescription basis. We've also seen in the first quarter, as well as the continuation of last year, a really nice progress on the pipeline with the approval, of course, of Abilify to monthly injection, also in Europe. So it gives an alternative there to our Abilify long-acting franchise. But secondly, also, we see nice advancement with our anti-pay cap into the next phase, Phase 2b, which is the proceed trial. And of course, a really nice result we saw in the first quarter on our study amulet, which is alpha-synuclein in MSA, where we also have the confidence now to advance to phase three. And you would have seen also in the first quarter that we've made a few changes to our leadership team. This is the team that will continue to perform and transform the company. And we feel very confident with these changes that we are in a strong position now to execute our strategy going forward. So I just want to again highlight to you the main management changes. before we continue. So if we can go to the next slide, please. It is, of course, you know, my pleasure to have this team and work with this team. And you know many of the people here, but there are some new people you'll see today. Of course, you know Tom, who's heading up US, but I would also welcome Nicola Fischer-Hansen, who is heading up our europe and international markets we have also yesterday announced maria alfaita who is heading up our commercial and corporate strategy and who will bring additional elements to the capabilities we need for the long-term future of the company and of course we we have johan who you know well jurg and lars who heads up our product development and supply As I've always said in the past, strong companies are built on the foundation of strong people and it's of course great to have Diane with us who will lead our people and organization going forward. With this team in place with a strong momentum, in the first quarter and the path we've set to become a focused innovator in the future i'm really confident around where we are heading for the remainder of the year with of course a commitment to the full guidance that we've set out for the full year So with that, to go to the next slide, I would like to therefore introduce and hand over to Tom and Michaela to take you further through the performance on the asset level at a geographic level as well. So over to you, Tom.

speaker
Tom Gibbs
Head of US Operations

Great. Thank you, Charles. As Charles mentioned, we delivered strong global commercial performance during first quarter of 2024. And this was headlined by 17 percent growth of strategic brands, which now account for almost 71 percent of overall net revenues. And this growth was led by VIEPTI. Next slide, please. We are very pleased with the performance of VIEPTI. VIEPTI's performance has been fueled by accelerating growth in the U.S. and supported by a continued stream of launches and robust brand adoption in our prioritized ex-U.S. markets. VIEPTI global net revenue for the quarter was $617 million DKK, and this represents, as Charles said, 79% growth year-over-year. Net revenue for VIEPTI in the U.S. was 544 million DKK, representing 69% growth over 2023. Importantly, we are beginning to see meaningful contribution to global sales by ex-U.S. markets, with VIEPTI now available in some 25 markets. These markets are exhibiting strong anti-CGRP market growth, and importantly, VIEPTI continues to gain meaningful market share across all of these markets. I do want to take a moment to focus on the U.S., Over the past year, we have worked very hard to refine our specialty commercial model to support VIEPTI, focusing on four key levers, HCP engagement, and this is both on the sales side as well as the medical side, patient activation, patient experience, and market access. It's these four levers which have made material contributions to accelerating demand by driving depth, and breadth of prescribing, and increasing our momentum in new patient starts as well as patient adherence. Importantly, we continue to hear very positive clinical experiences from physicians and patients regarding VIEPTi, which are reported in the review real-world evidence clinical trial, which was published in the Journal of Headache and Pain this past April. Next slide, please. RIGSULTI continues to perform well, propelled by the continued strong progress of the AADAD launch in the U.S. U.S. TRX growth during the first quarter of 2024 was 15.8% increase over the prior year. Global reported revenue increased 7% versus prior year. The difference between the demand growth and revenue growth is attributable to variance that we saw in channel inventories and to a lesser degree, gross to net in first quarter 2024 versus first quarter 2023. We are pleased with the strong demand growth observed across all of our prioritized markets. The majority of that volume growth is driven in the U.S., particularly in AADAD, with 205% monthly volume growth when we compare January 2024 claims to the pre-launch baseline. The long-term care channel is disproportionately contributing to Rigsalti AADAD growth, with 598 percent monthly volume growth since baseline, and the market share in the long-term care channel has increased more than six-fold. Next slide, please. Rigsalti AADAD volume is becoming increasingly important to the overall Rigsalti growth, and we expect this to continue through 2024 and beyond. AADAD contribution has grown to 12.5% based upon our most recently available data, and 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 performance with non-AADAD monthly claims volume growing at 15.9% from April 2023 to January 2024. Now, in analyzing some of the most recent TRX data, non-AADAD TRX growth has moderated over the past quarter. We attribute this to our MDD direct-to-consumer campaign being off the air from November through the end of February. MDD direct-to-consumer promotion has resumed on February 26, 2004, and we're beginning to see the lift in TRXs towards the end of April as we fully deploy the RIGSALTI marketing mix. And I think of note, the latest NBRX or new-to-business prescription data point of 2,690 is an all-time high. I'll now turn the presentation over to Michaela to discuss performance for other strategic brands. Michaela?

speaker
Michaela Fischer-Hansen
Head of Europe & International Markets

Thank you, Tom, and good afternoon, everyone. I'm Michaela Fischer-Hansen, and I'm very happy to be here now in my second month with Lundbeck. If I can have – I already got the slide. Thank you. If we look at Brintelix or Trintelix performance in Q1, you can here see the revenue performance worldwide, very impressively growing at a double digit at 1.17 billion DKK in Q1-24. Very impressive, I think, considering that the brand has been on the market for more than 10 years. If you zoom in on the numbers, you can see that rest of the world is driving majority of the growth, a growth of 13% to 810 million DKK in Q1. where Europe is growing at 16%, and that's primarily driven by Spain with 26% growth. We see international markets growing at 10%, and that's driven by Japan growing at 23% and China at 12%. We also see a very nice growth in the U.S., up 7% with indications of stabilization. If you look to the graph in the middle, you can see this is MAT volume growth versus the market. And here you can see how we, in many of our key markets, actually outgrow the market significantly. And I specifically want to highlight Japan, Spain, Canada and France, where we see a very strong development in our overall growth versus the market. If I could get the next slide, please. Here we see the Abilify LAI franchise, and also here we see double-digit growth in revenue in the first quarter versus same period last year. We have U.S. delivering 9% of that growth and rest of the world delivering 12%, and we're at 859 million DKK in revenue. This is also a very strong performance for a brand that has also been on the market for over 10 years, and the performance is spread across many markets. I want to highlight here the U.S., Canada, France, and the U.K. I want to emphasize that the franchise here has two brands. We have Abilify Maintainer. That's the one that's been on the market for over 10 years. And then we have Abilify Simtify. That's the U.S. brand name. And Abilify Maintainer, 960 milligram, which is the European brand name. And that's the two-month injection in the franchise. Please note that Abilify Simplify was launched in the US in June of last year, and we recently got approval for the Abilify Maintainer 960 milligram in Europe in March. If you look to the graph in the middle of the slide, you again see MAT volume growth of the franchise versus the market. And again, you can see the very strong growth that we're seeing in many of the countries where we're outgrowing the market. And it's also important to note that we hold market leadership position in a good handful of our key markets. For the U.S., if we look at Q1, and that's, of course, also noting the recent launch of Abilify and Symptify, if you look at Q1 23 versus Q1 24, we actually see the market growth at 1.8%, whereas Abilify franchise for us is growing at 5% in the U.S. So that's basically driven by Abilify and Symptify. When we look to the year for the Abilify franchise, it's really about preparing for the launch of the two-month injection. We're bringing a new option to the market, and Johan will come back to that, which allows patients to have fewer dosages since it's a two-month injection and allows continued symptom control of their schizophrenia. And as mentioned, the U.S. launched the product a little over a year ago, and it's driving roughly 10% of sales and continues to grow. With that, I will hand over to Johan to tell us a bit about the R&D highlights from Q1.

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