2/5/2025

speaker
Charles
CEO, Lundbeck

Thank you, everyone, and thank you for joining, of course, today's call. It's my pleasure to be able to present to you the 2024 full year results, which we see as a transformative year for Lundbeck and, of course, also provide you with guidance for 2025, which reflects really the confidence in our strategy as a focused innovator. So if we go to the next slide, again, today, of course, is subject to forward-looking statements and subject to change. If we can go to the next slide, please. So as I open up with my comments, I see this as really as a transformative year for Lundbeck. Twelve months ago, we introduced the focus innovative strategy. There are three pillars, one of growth, pipeline and funding of that future in growth and innovation. And I could say today that When you look at 24, the growth is a record year for Lundbeck. The pipeline has fundamentally changed over the last 12 months with a profile of more late stage and with the funding that we are generating through capital reallocation, we're able to also absorb many of the incremental investments we're making in the pipeline. So truly a transformative year for Lundbeck in 2024. If we then go to the next slide, Of course, behind a transformation like this is a very strong leadership team that you have met before. And, of course, today I'm pleased to be joined by our two executive vice presidents of our geographies, Tom and Michaela. You'll hear from Johan an update on the pipeline, and Jörg will give us a financial update and more details on the outlook for 2025. Then go to the next slide. So let me go a little bit deeper into the results of 2024. And it is truly a remarkable year for the company. And I want to thank all the Lundbeck employees, of course, who have generated these results and tirelessly work on serving patients. And what you see here is really the strong growth momentum. We look at our strategic brands, which is 21% growth on a constant basis year over year, which is 75% of the company's portfolio today growing at 21%. And, you know, really the targeted investments we've spoken to you many times about investing in Rexalti and Vyepti are truly paying off as we see the underlying trends of those assets really forming the basis of future growth and also for the 2025 guidance. When we look at innovation, we are seeing two very strong positions emerging in our neuro-specialty space with the expansion, of course, of VIEPTI, with the Sunrise results now also able to file and launch in the future in Asia, which really makes it a global asset for us. And, of course, Anti-PayCap that will continue in its development program and provide, therefore, a compelling solution severe migraine portfolio in the Nero specialty space for the long-term growth of the company. You also see a very strong position in Nero Rare, emerging of course with the longboard acquisition, adding to that also Amlenituk in Phase 3 and a number of other assets that Johan will talk about later. So again, two very strong future positions we see as growth engines for the long-term success of the company. When we think about funding and we think about our future here 2025, you see our guidance here is built on a very strong confidence of our strategy and belief in the underlying growth of the company, the growth engines and the strong cash flow generation that allows us to, of course, deleverage relatively fast, but also being able to, with a capital allocation, absorb a significant amount of the additional R&D investment specifically coming from Bexie-Catherine. So that allows us to really maintain a more healthy R&D investment of 20-25% in terms of a corridor in the mid-term and also our adjusted EBITDA at greater than 30%, which is, in our view, a healthy financial dynamic while, of course, building more on a pipeline for long-term success of the company. So with that, let me hand over to our geographic executive vice presidents, and I'll start here with Tom to take us through the performance on Rexalti. So over to you, Tom.

speaker
Tom
Executive Vice President, Geography

Great, thank you, Charles. As Charles mentioned, we are pleased with our commercial performance in 2024, which was highlighted by 21% growth of our strategic brands. I will first review the performance details for Rexalti. Next slide, please. Mixalti continues to perform well, propelled by the continued strong progress of the AADAD launch in the US. Global reported revenue increased 16% in 2024 versus prior year. We did see some destocking in December with inventories in the US exiting 2024 at the lower end of normal ranges. Importantly though, revenue growth was driven by strong underlying TRX demand growth in the US with 21% year over year growth. Resulting growth accelerated throughout the year in the US exiting 2024 with strong demand trends with weekly record highs in market share, TRXs and NRX volume. Growth in the U.S. was supplemented by continued strong demand growth in other prioritized markets including Brazil, Canada, Australia, and Mexico. Overall revenue growth in Europe and international operations was 32%. As we look forward, we expect for Xulti to continue to be a key driver of growth for Lundbeck, primarily driven by continued expansion of the AADAD franchise, supported by solid growth of our base business in MDD. We will now take a deeper look at our progress in AADAD. Next slide, please. Rixalti AADAD volume is becoming increasingly important to overall Rixalti growth, and we expect this to continue through 2025 and beyond. AADAD monthly TRX volume has increased 426% versus baseline pre-launch, and AADAD contribution to the overall demand for the brand has grown to 19% based upon our most recent patient claims data for October 2024. and this is on track to meet our expectations for 20% or higher once data are available for December. Growth is being driven in AADAD primarily by an expansion of the HCP prescriber base growing from a baseline of 2,451 to nearly 11,000 prescribers. We're also encouraged by some of the leading indicator data that we track, particularly our awareness trial and usage market research from November, indicating that Regsulti is the most frequently cited product by HCPs as their first choice treatment, more than any other product or drug class. The AADAD launch has also had a positive halo effect on the overall brand. AADAD has fueled 54% growth in the 65 plus non-AADAD segment since launch. Next slide, please. Moving on to VIEPTI. VIEPTI delivered strong results during the quarter and full year, and this performance has been fueled by accelerating growth in the U.S. and supported by the continued robust adoption of VIEPTI in prioritized ex-U.S. markets, including Canada, France, Spain, and Germany. VIEPTI global net revenue for 2024 was 2.909 billion DKK, and this represents 72% growth year on year. Net revenue for VIEPTI in the US was 2.557 billion DKK, and this represents 63% growth over 2023. We also saw some destocking by our specialty distributors for VIEPTI exiting 2024 at the lower end of our normal range. Importantly, we are beginning to see meaningful contribution to global sales by XUS markets with VIEPTI now available in some 29 markets. These markets are exhibiting strong anti-CGRP market growth and VIEPTI continues to gain meaningful market share across these markets. XUS sales will receive a significant boost if approved in Asia based upon the positive sunrise data, and we expect to submit for approval by the end of 2025. I want to take a moment to focus on the US. Over the past year, we've worked very hard to refine our specialty commercial model to support VIEPTI through a patient-centric focused ecosystem that appropriately supports the patient throughout their patient journey. we continue to see accelerating demand by driving breadth and depth of prescribing and continued positive momentum in new patient starts supported by high written to infusion conversion ratios and patient persistency. Weekly market share for December hit an all-time high of 10.85% versus 6.8% in January 2024, which is attributable to strong underlining demand exiting 2024. Looking forward, we expect VIEPTI to continue to deliver strong growth driven by new patient starts in the US and expanded usage of VIEPTI in all ex-US markets where the brand has launched. I'll now turn the presentation over to Michaela to review our other strategic brands. Michaela.

speaker
Michaela
Executive Vice President, Geography

Thank you, Tom. Next slide, please. So let's start with a look at the Brintelex performance in 2024, where we saw a very strong performance across our key markets and continued double-digit growth. If you look at our global results, we delivered 14% growth in revenue versus last year at 4.847 billion DKK, a very strong performance overall for a brand that has been on the market for approximately 10 years. If we look further, you can look at this regionally and see that in the US we saw 12% growth and when you look at Europe and international operations we delivered 16% growth versus last year. When we look across our key markets, we continue to see double-digit growth and we continuously outgrow the market in several of our countries. I here want to highlight especially Japan and Spain, where we've seen 28% and 24% growth respectively compared to 2023. When we look ahead to the year ahead of us with Brintelex, we expect to see continued solid demand growth in Europe and Japan, As you may recall, we extended our market exclusivity in Japan by two years. And in the U.S., with the revised agreement with Takeda that we announced earlier last year, we expect that this will slightly reduce our revenue while we'll increase our profitability. In Canada, we expect to see generic competition sometime during the year. Next slide, please. If we look at the performance of the Abilify franchise in 2024, we also here see a solid performance, growing at 10% and now at 3.5 billion DKK in total, and this is driven by increased conversions to Asymptify. When we look at the US specifically, we see growth at 12% versus 2023, and this is specifically driven by the Abilify Asymptify performance, and we see a 2.2 market share growth for the franchise. Also encouragingly, we continue to see strong uptake with Abilify and Asymptify, where we now see that more than 50% of the new-to-brand patients are coming from either orals or naive patients. When we look at Europe and international operations, the growth was at 9% versus 2023 at 2.193 billion DKK. And the Abilify LAI franchise has continued to see strong growth across many markets, also driven by additional launches of Abilify 960 mg across Europe. When we look ahead, we expect the continued strong uptake of Abilify two-monthly or Simtify in the US, while at the same time expecting negative impact in Europe from the generic launches during 2025. Let's take another look at the Abilify, Simtify or Abilify two-monthly performance on the next slide, please. So if we dive a little bit more into the dynamics we're seeing with Abilify and Symptify, we see that the penetration generally is ramping up. If we start with the US on the left side, you can see that the growth is outpacing other LLIAs. And as I said, more than 50% of our new-to-brand patients are coming from oral or naive patients. When we look at the conversion rate in the US, we see that Asymptify now constitutes 14% of total Abilify franchise TRX volume. That's December data. And we see that it's 18%, importantly, of the NBRX with November data, a leading indicator of future TRX development. So very strong conversion rates in the US and also accelerating. As you may recall, we got approval for Abilify 960 or Abilify Asymptify in Europe last year and started the rollout or the launches in June of last year and we have now rolled it out in 13 markets across Europe. We're also here beginning to see a meaningful contribution from these launches and a strong increase in the conversion rate as you can see on the right graph. The feedback is very positive from the market and all in all we're very pleased with what we're seeing. If we look ahead, then we will continue the rollout of Abilify and Symptify across Europe and international operations as we see regulatory approvals. That concludes the business update. And with that, I'd like to hand over to Johan to give an R&D update.

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