5/14/2025

speaker
Charles
CEO, Lundbeck

So welcome everybody to the Lundbeck earnings call for quarter one, 2025. From the outset, I want to just make a quick statement to say again, these strong results of the first quarter are really serving as another proof point of the path we are on in terms of a focused innovator strategy, confirming very much that the path is very strong for us going forward. So let's go to the next slide, please. Of course, what we discussed today are forward-looking statements and, of course, subject to change. Let me then go to the next slide, please. Of course, I have the privilege of being joined by my exceptional team here who will cover, of course, the commercial update, but also R&D, the financial update, as well as the outlook for the 2025 period. So let's go to... the key summary slide. And here again, I want to emphasize as we've been consistent with you on a very clear equity story, which is one of advancing a focused innovative strategy around three areas, growing the assets we have, growing them well, making sure that we build a compelling innovative pipeline that will sustain the growth for the long term of the company, sustainable growth, and of course funding, thinking through very careful allocation and deployment of our capital to where we see the most opportunities for growth or innovation. And of course, I'm really pleased with the first quarter results, which are a strong validation of a lot of the effort and work we've done over the last 18 months to build the path going forward for Lundbeck. Firstly, our total revenue is growing at 16% and our strategic brands, which now make up 77% of our revenue, is growing at 24%. And most importantly, two key growth drivers for the long-term, VIEPTI at 62% and Rexalti at 28%. So again, a validation of a strong execution mindset of the company and making sure we focus our investment on where we can grow sufficiently for the mid-term. On the innovation side, we are advancing, of course, the pipeline under two areas, neuro-specialty and neuro-rare. And in neuro-specialty, anti-PACAP in its Phase IIb is progressing now to Part B, which is the intravenous administration of anti-PACAP. We've also, of course, in the first quarter focused significantly on the integration and smooth transition of Longboard with Bexie Castron, which is now in full speed on enrolment in Phase 3, as well as Amlena Tug enrolling according to our plan. And we're also advancing anti-ACTH in congenital adrenal hyperplasia in phase 1b. So of course significant ongoing evolution of the pipeline with more of the late stage phase 3 opportunities emerging. From a financial perspective, of course, the first quarter results, as I said, is a clear confidence in terms of our underlying performance, the investment we've made, the operating model that we've established, which allows us to put ourselves in a position to raise the guidance as indicated on this slide. So when you think about Lundbeck going forward here, it's a company with clear strategic path, one of strategic clarity of where we focus. It's a company that is consistently delivering and executing on what we said we will do, and this is execution-focused company. And, of course, you also see very briefly here, and as you will hear from my colleagues, it's a company that is in transformation and progressing very well. So with that, I would like to hand it over to my team and have Tom and Mikkola comment specifically on the asset performance. Tom, please.

speaker
Tom
Head of Asset Performance

Great. Thank you, Charles. As Charles mentioned, we are pleased with our commercial performance for 1Q 2025, and this was primarily driven by 24% growth of our strategic brands. I'll first review the performance details for RIGSALTI. Next slide, please. Rigsalty continues to perform well and deliver consistent growth, and this is propelled by the continued strong progress within the AADAD segment in the U.S. U.S. reported revenue increased 29% for the first quarter of 2025 versus the prior year. Importantly, this revenue growth was driven by strong underlying TRX demand growth in the U.S. with 22% growth during first quarter 2025 versus the same period last year. Resulting demand growth accelerated through the first quarter of 2025 in the U.S., recording record highs in market share, TRX, and NRX volume. This demand growth is attributable to continued improvement and execution across the marketing mix, and this includes sales force execution across the alliance and optimized direct-to-consumer media mix and patient affordability programs. Growth in the U.S. was supplemented by continued strong demand growth in Europe and international operations, delivering growth of 27% versus the same period last year. Looking forward, we expect Roegzulte to be a key driver of growth for Lundbeck, and this growth will primarily be driven by continued expansion of the AADAD franchise, supported by solid growth of our base business in MDD. Let's take a deeper look at our progress in AADAD. Next slide, please. Rixalti AADAD volume is becoming increasingly important to overall Rixalti brand growth, and we expect this to continue through 2025 and beyond. AADAD monthly TRX volume has increased 472% versus baseline, and the AADAD contribution to overall demand for the brand has grown to nearly 21% based upon the most recent patient claims data. Growth is being primarily delivered by expansion of the HCP prescriber base, growing 374% since launch to over 11,800 prescribers. Rixalti AADAD market share has grown from 0.67 share points pre-launch to 3.44 share points based upon February claims data. Importantly, we continue to see consistent growth on the non-AADAD side of the business, achieving 11.1% growth when comparing January 2025 monthly claims TRX volume to January 2024. The AADAD launch has also had a positive halo effect on the overall brand. AADAD has fueled 907% growth in the 65 plus segment when we look across all indications. The team is continuing to focus on the levers to even further accelerate growth for Exalti and this is informed by our marginal return on investment quarterly analyses. We are applying our dynamic resource allocation focused innovator principle and redirecting a portion of our AADAD direct-to-consumer funds to expand our primary care footprint, and this will allow us to drive greater breadth and depth of prescribing. Let's move on to VIEPTI. Next slide, please. VIEPTI again delivered strong results during the quarter and this performance has been fueled by continued strong growth in the U.S. and supported by robust adoption of VIEPTI in prioritized ex-U.S. markets including Canada, France, Spain, and Germany. VIEPTI global net revenue for 1Q 2025 was $1.042 billion DKK and this represents 62% growth over the same period last year. Net revenue for VIEPTI in the U.S. was $916 million DKK representing 60% growth over first quarter 2024. Importantly, we are beginning to see meaningful contribution to global sales by ex-US 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. Ex-US sales will receive a significant boost if approved in Asia based upon the positive sunrise trial, and we expect to submit for approval by the end of 2025. I do want to take a moment to focus on the US. Over the past 18 months, we have made purposeful investments to refine our specialty patient-centric commercial model to support VIEPTI. We believe our model is a competitive advantage because it enables our team to appropriately support the patient throughout their patient journey. We continue to see accelerating demand by driving depth and breadth of prescribing and continued positive momentum in new patient starts supported by higher written to infusion conversion ratios and best in class patient persistency. Looking forward, we expect VIEPTI to continue to deliver strong growth driven by new patient starts in the U.S. and expanded usage of VIEPTI in all ex-U.S. markets where the brand has launched. VIEPTI remains on track to achieve over $1.3 billion peak year sales at peak. Michaela, over to you.

speaker
Michaela
Head of Commercial Update

Thank you, Tom. Let's start with looking at the performance of Brintelex in the Q1-25 results, where we see a very strong performance overall, growing at 7% versus Q1-24 and now delivering 1.254 billion DKK. We see a continuous strong momentum in Europe and international operations, where we have seen double-digit growth in most of our markets. It's worth highlighting that we have a 17% growth in Europe, which was driven by Spain at 29%, and Italy at 23%, as well as continuous strong growth in international operations at 8%, with Japan delivering 12%, and Canada growing at 22% compared to the same period last year. In Japan, I'm also pleased to share that in the month of April, we achieved a significant milestone and now hold value market share leadership in the market for antidepressants at an impressive 22.6% value market share. When we look ahead, we expect to see continued solid demand growth in Europe and Japan. And I want to remind you that we extended our market exclusivity in Japan by two years, now with loss of exclusivity in 2031. If we look to the US, you can now see the effect of the revised agreement with Takeda, which reflects a lower revenue, but certainly also a higher profitability. And this is a dynamic that we expect will continue throughout the year. I also want to remind you that while we have seen an impressive growth of 22% in Canada in quarter one, we do expect to see generic competition sometime during the year. Next slide, please. If we look at our Abilify franchise, also here we see a solid performance in Q125, growing at 16% and just now a little above 1 billion DKK versus Q1 last year. In the U.S. specifically, we see an accelerated growth at 18% versus Q124, and this has been driven by Abilify and Symptify, and with a 1.6% market share growth for the franchise. Encouragingly, we continue to see a very strong uptake for Abilify and Symptify, with approximately 52% of the Abilify and Symptify new-to-brand patients coming from either oral antipsychotics, other long-acting injectables, or naive patients. In Europe and international operations, we saw growth of 15% versus Q124. And the Abilify LAI franchise continued to see strong growth across many markets, also driven by additional rollout and launches of Abilify 960mg, the Asymptify name in Europe. When we look ahead, we expect to continue to see strong uptake of Abilify 960mg. while we at the same time expect a negative impact in Europe from generic launches towards the end of this year. Let's zoom in specifically on the Abilify, Simtify or Abilify 960 milligram performance. Next slide, please. When we specifically look at the performance of our Abilify Asymptify 960 mg, we do see the penetration ramping up very nicely. In the US, Asymptify growth is now outpacing other LAIs, as I just said, and more than 52% of neutral brand patients are coming from orals, other long-acting injectables, or naive patients. When we look at the conversion rate in the US, we see that Asymptify has had an aggressive conversion rate, now constituting 16% of total franchise in TRX volume. And importantly, we now also see that 20% of the NBRXs, which is a leading indicator of future TRX development, are Asymptify prescriptions. As you may recall, we started launching Abilify, a main 10 and 960 milligram in Europe, June of last year. And we now have the drug available in 18 EIO or international operations markets, with Australia launching just here in May. We see a strong increase in the conversion rate and have seen that both Spain and Finland have actually exceeded 20% conversion rate. The feedback we received from physicians is very positive and early market research has suggested that around a third of the patients are coming from oral aripiprasol. The rollout of Abilify 960mg continues throughout the rest of 2025 across Europe and international operations markets as we continue to see our regulatory approvals. That concludes the business update. I'd now like to hand over to Johan to give us an update from R&D.

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