11/12/2025

speaker
Lorenzo
Chorus Call Operator

Ladies and gentlemen, welcome to the LUDBEC financial statement for the first nine months of 2025 conference call. I'm Lorenzo, the chorus call operator. I would like to remind you that all participants will be in listen-only mode and the conference is being recorded. The presentation will be followed by a Q&A session. You can register for questions at any time by pressing star and 1 on your telephone. For operator assistance, please press star and 0. The conference must not be recorded for publication or broadcast. At this time, it's my pleasure to hand over to Charles Van Zyl, President and CEO. Please go ahead, sir.

speaker
Charles Van Zyl
President and CEO

Welcome to everyone. Thank you for joining our quarter three earnings call and, of course, also full year guidance. From the outset, I just want to make a few quick remarks. Again, very pleased, of course, with our strategic progress. We see very strong momentum that continues, and we've made some very targeted investments in VIEPTI and Rexalti that underlie that momentum. If we can go to the next slide, please. So, of course, what we discussed today is forward-looking statements that are subject to change. If we can go to the next slide. So, let me just lay out the agenda for today. And, of course, I'm very pleased to be joined here with my leadership team that will take us further into some of the insights that help us to understand better how we are performing and, of course, also transforming Rundbeck for the long term. So, let me start with the results and we take the next slide, please. So from a results perspective, again, very strong growth. As I said from the outset, momentum continues to be very strong for us. We see our growth essentially faster than what we had assumed. And that's very much focused on very targeted investments that we have made, choices we have made to our key strategic brands to invest more behind VIEPTI. and Rexalti and you see the result of that with a very strong double digit growth across both of those brands. On the innovation side, we continue to see very, very strong advancement of our pipeline. We're in a stage where we have five to six mid to late stage opportunities that are advancing well. And I would just highlight a few key points, which will be further expanded by Johan and Maria later. First of all, VIEPTI, of course, we are advancing with our submissions and filing in Asia as important growth drivers for the future growth of VIEPTI. And we are also advancing our anti-pay cap phase to be with expected headline results in quarter one, 2026. As we also build further the pipeline, we see the build of the Nero Rare franchise with enrollment advancing, of course, with Bexie Catherine and Amlena Tug. And we will also highlight today more specifically some of the new elements of the pipeline, specifically our CD40 ligand that really allows us to address further immune modulation. And Johan will talk more specifically about a key program there. the final pillar of our strategy is really around funding and of course we have been very clear with you around our very targeted capital reallocation program that is very disciplined to ensure that we can invest in additional growth opportunities but also sufficiently invest in the pipeline for the long-term sustainable growth and we see very good progress that remains on track and specifically the rollout of our commercial model has been a major highlight of the last quarter. So, with that, of course, we announce, as we did yesterday, an upgrade to the guidance based on the very strong fundamentals, based on the very targeted investments we've made behind our key strategic brands that give us confidence on the momentum for the full year. So with that, to take us further into some of the specific elements of our strategic assets, I would like to hand the floor to Tom. You can take the next slide, please.

speaker
Tom
Head of Commercial

Thank you, Cheryl. And good morning or good afternoon, everyone. As Cheryl just mentioned, we are pleased with our commercial performance through the first three quarters of 2025, which is headlined by strong growth of VIEPTI and accelerating growth of RIGSALTI. Please turn to the next slide and I'll first review the performance details for VIEPTI. VIEPTI delivered strong results during the first nine months of 2025. This performance has been powered by continued strong growth in the U.S. and supported by robust adoption of VIEPTI in prioritized ex-U.S. markets including Canada, Italy, France, Spain, and Germany. VIEPTI global net revenue for the third quarter year to date 2025 was 3.254 billion DKK, and this represents 57% growth over the same period last year. Net revenue for VIEPTI in the U.S. was 2.834 billion DKK, growing 56% over prior year. I want to focus a moment on the U.S. We continue to make purposeful investments in our patient-centric model supporting VIEPTI through our discipline capital allocation program that Jörg will speak to later. These incremental investments, including our Salesforce expansion in July of this year and our direct-to-consumer patient engagement, continue to outperform our expectations, driven by precision execution and informed by our advanced analytics platform. We expect to continue to see market leading demand growth by driving depth and breadth of prescribing and continued positive momentum in new patient starts supported by high written to infusion conversion ratios and best in class persistency. Next slide, please. Rigzulti continues to perform well, delivering consistent growth propelled by continued strong progress within the AADAD segment in the US. Reported revenue were 4.695 billion DKK, increasing 26% through 3Q 2025 versus prior year. Think importantly, revenue growth in the US was driven by strong underlying TRX demand, achieving 24% growth through the first nine months of 2025 versus the same period in 2024. RIGSULTI AADAD volume is becoming increasingly important to the overall RIGSULTI brand growth. And we expect this to continue through 2025 and beyond. AADAD monthly TRX volume has increased 664% versus pre-indication baseline and AADAD contribution to the overall Resulti demand has grown to over 23%. The 65 plus segment now contributes 33.7% or more than one out of every three of Resulti TRX claims based upon the most recently available claims data. I believe this positive halo effect on overall Regsulti's 65 plus segment truly reflects the full value of the AADAD indication for the brand. The team is continuing to focus on the levers to accelerate growth for Regsulti informed by our marginal return on investment quarterly analyses. As I shared with you last quarter, we are applying our dynamic resource allocation focused innovator principle to redirect a portion of our AADAD direct-to-consumer funds to expand our primary care footprint to drive greater breadth and depth of prescribing. The first wave of the expansion of our multi-specialty Salesforce team was deployed during 3Q 2025, and we're encouraged by the very early results. Michaela, over to you.

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