Earnings Call: Q4 2025

Feb 4, 2026

Summary

Revenue rose 13% at constant exchange rates in 2025, led by 19% growth in strategic brands and expanding adjusted EBITDA margin. 2026 guidance calls for 5%-8% revenue growth, with pipeline investment and partner-model effects shaping results.

Ladies and gentlemen, welcome to the Lundbeck financial statement for the full year 2025 conference call. I am 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 question at any time by pressing star and one on your telephone. For operator assistance, please press star and zero. The conference must not be recorded for publication or broadcast. At this time, it is my pleasure to hand over to Charl van Zyl, President and CEO. Please go ahead. Good morning, everyone. Welcome to our full year 2025 earnings call. Of course, it is my pleasure to really present to you our outstanding results. It has been, again, another record year for Lundbeck in 2025, and it is really underpinned by very strong fundamentals, very much underpinned by our focused innovator strategic path. You will hear me say a lot about the results, very much in the sense of it is not by chance, but by clear intent that we are delivering these outstanding results. We can go to the next slide, please. Of course, our discussions today are containing forward-looking statements, which of course are subject to change. Let us go to the next slide, please. Here, I would like to take a moment just to pause and reflect on the last two years of our focused innovator strategy. There is so much to say about this transformation that Lundbeck has gone through, but I have to say, I am really proud of the progress that we have made. Again, it is not by chance, but by clear strategic intent that we see these very strong results. If you recall, our focus innovator strategy is very much about growth, innovation, and funding. When I speak about growth, you would have seen over 2024, 2025, that we have had double-digit growth across our strategic portfolio, which allows us, in a way, to extend our growth also into 2026. Secondly, when you think about innovation, we made the acquisition of Longboard that bolstered our late-stage pipeline, but we have truly seen a transformation of this pipeline over the last two years with a position we are in now with five to six mid to late stage assets that are really the growth engine of the future of Lundbeck. It is a pipeline that is characterized by first-in-class or best-in-class molecules. The third foundation of our strategy is really the funding, the largest capital reallocation that the company has undertaken, and it has allowed us to fund the growth and the pipeline and keep us in a flexible financial position to continue that journey into 2026. If we go to the next slide, I would like to focus a little bit more on 2025. Truly it was an outstanding and a record year for Lundbeck. Again, our intent was to focus on investing in our strategic brands, but also in our pipeline. On the growth level, we've seen that continuation of the double-digit growth on the strategic brands being at 19% in 2025, underpinned by stellar growth in Vyepti at 59%, and also stellar growth for Rexulti at 23%. As you recall, we also made very clear moves in 2025 around sharpening our commercial model to focus on 12 key markets and allowing us to work with partners across 27 markets. Again, allowing us to focus our efforts on where we can play to win and grow very strongly as we go also into 2026. When you think about the pipeline, keep thinking about the fact that we're building strong diversification of this pipeline, building a strong position in neurospecialty and also in neuro rare. When you think about neurospecialty, of course, Vyepti, a growth engine in the U.S. and in Europe, but also soon to become a growth engine with the filings that we've done in China, Japan, and Korea to truly make this a global launch for Lundbeck. You will also, in the first quarter, receive results on our anti-PACAP PROCEED trial that will further enhance our position in the space of severe preventative migraine. When we think about neuro rare, we think clearly about bexicaserin, of course, the Longboard acquisition that is very much in its phase III and in execution of the clinical program. So is amlenetug in its fast enrollment, also an MSA. Both of these really high unmet need areas where we can see the opportunity very strongly in the phase III results. Then we will talk a bit more today about further elements of the pipeline in the mid stage, our anti-ACTH in congenital adrenal hyperplasia and as well as Cushing's disease, and you'll hear more about that from the pipeline discussion later today. Fundamentally, the funding that you see is a continuation of the first two years of our focus innovator strategy, where we will continue to be disciplined around our capital reallocation in this range of DKK 1.3 billion to DKK 1.5 billion that we are freeing up to create that flexibility for us to invest in growth and also in innovation. Therefore, we are guiding today very much in a position of strength from 2024 to 2025, going into 2026, with revenue growth of 5%-8% and adjusted EBITDA between 4%-12%, with that spread also taking into account a strategy of investing in the pipeline as we see the triggers unfold in 2026. With that, let me just introduce the other speakers for today on our agenda, and you will hear a business update from the team as well as the portfolio update and of course, the financial results in more detail. With that, it is my pleasure to first of all start with a business update and hand over to Tom Gibbs, our Head of the U.S. Thank you, Tom. Great. Thank you, Charl. As Charl just mentioned, we are pleased with our commercial performance for 2025, which is headlined by strong growth of Vyepti and accelerated growth of Rexulti. Please turn to the next slide, and I will first review the performance details for Vyepti. Vyepti delivered strong and sustained growth for the full year 2025, and we expect this to continue in 2026. This performance has been powered by continued strong growth in the U.S. and supported by robust adoption of Vyepti in prioritized ex-U.S. markets, including Canada, Italy, France, Spain, and Germany. Vyepti global net revenue for 2025 was DKK 4.476 billion, and this represents 59% growth over the same period last year. Net revenue for Vyepti in the U.S. was DKK 3.908 billion, growing 58% over prior year. In the U.S., our focus has been to make purposeful investments in our patient-centric model, supporting Vyepti through our disciplined capital allocation program that Joerg will speak to later. We will continue to make incremental investments in 2026 to elevate the impact of our execution informed by our advanced analytics capability, and this includes a sales force expansion as well as optimized direct-to-consumer advertising. We expect to sustain 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 ratio and best-in-class patient persistency. In Europe and international operations, significant work is being done preparing for the launch of Vyepti in Asia. If approved, we see this region as a significant opportunity to drive further growth for Vyepti. Next slide, please. Now moving on to Rexulti. Rexulti continues to perform well and deliver consistent growth propelled by continued strong progress within the AADAD segment in the U.S. Reported revenue was DKK 5.745 billion, increasing 23% for the full year 2025 versus prior year. Importantly, revenue growth in the U.S. was driven by strong underlying TRX demand, delivering 24.2% growth in 2025 compared to 2024. Rexulti AADAD volume is becoming increasingly important to overall Rexulti brand growth, and we expect this to continue through 2026 and beyond. AADAD monthly TRX volume has increased 725% versus pre-indication baseline, and the AADAD contribution to overall Rexulti demand has grown to 24.4%. Importantly, the 65 plus segment now contributes 34.8% or more than one out of every three Rexulti TRX claims based upon the most recently available claims data. The team in the U.S. is continuing to focus on the levers to drive continued growth for Rexulti, informed by our marginal return on investment analyses. As you may recall, we reallocated a portion of our DTC advertising for AADAD to expand our sales footprint, and this is mainly in the primary care segment. The first wave of the expansion of our multi-specialty sales force team was deployed during 3Q 2025, and we are encouraged by the early results. The second wave is ongoing and we expect to be fully deployed during first quarter 2026. Overall, we are pleased with the momentum of Rexulti demand exiting 2025 despite an increasingly competitive market and evolving policy landscape. TRX demand in fourth quarter 2025 grew 24.2% versus fourth quarter 2024. Precision execution across the marketing mix, including our expanded sales team in primary care, is expected to reinforce the long-term growth for Rexulti and help address increased competition. Michala, over to you. Thank you, Tom. Let us turn our heads to the Abilify franchise performance, where 2025 was another year of solid growth momentum for the franchise, growing at 10% versus last year overall, now at DKK 3.776 billion. If we look at the U.S. first, the Abilify franchise delivered a 9% growth compared to the year before, and that was also resulting in a gain of 1.1 percentage point market share. Importantly, as the U.S. is transitioning from franchise maximization to conversion maximization, Abilify continues to be a key growth driver with an encouraging 22% NBRx weekly conversion rate. If we turn to Europe and international operations, the franchise delivered 10% growth versus last year. This was driven by continued launches of Abilify 960 milligram, which is now launched in a total of 27 markets across Europe and international operations. We continue to see strong conversion rates across our key markets, with several markets surpassing 20%. Across the markets, we also continue to see encouraging conversion rates from other orals and atypicals in LAIs that are outside of our Abilify Maintena franchise. Looking ahead, conversion maximization remains a critical strategic focus, and with regards to generic competition for Abilify 1 M in Europe and international operations, we expect to see generics in the market in Q2 of 2026. Next slide, please. If we turn to the 2026 outlook, as Charl said, we are pleased to see that despite the pressures from generics that we expect, the strong performance of our strategic brands reinforces our confidence in updating our 2026 growth outlook, where we are pleased to guide a 5%-8% revenue growth in constant exchange rates. Let me unpack that for you. In 2026, we expect to see headwinds from increased generic pressures on Abilify Maintena and Brintellix, the reprioritized resources with the Takeda agreement in the U.S., as well as emerging competition on Rexulti. This is outweighed by a continued strong performance of Vyepti, Abilify Asimtufii, and Rexulti. 2026 will also reflect in-year commercial adjustments that impact on our reported revenue and growth. As mentioned by Charl, in December 2025, we implemented a sharpened commercial model where we introduced 27 partner-driven markets. These partners will receive a commission fee of 25%-30% of our revenue, which will reduce our net revenue compared to 2025. In addition, as part of the transition to the partner model, the partners are building up inventory in the markets, which is expected to amount to approximately DKK 500 million positive revenue impact in 2026, which will be a one-time effect for this year. When adjusting for the partner model impacts, we are encouraged that our underlying performance is expected to be at 6%-9% underlying growth, reflecting strong fundamentals as a result of the strategic decisions we have taken in 2025 and 2020. Sorry, 2024 and 2025. Specifically for our guidance for 2026, as stated, we are pleased to guide a 5%-8% constant exchange rate revenue growth for 2026, which is driven by our continued strong brand execution and our accelerated capital reallocation towards high-value opportunities globally. Joerg will come back to this in his section. With this, I conclude the performance section and hand over to my esteemed colleagues, Maria and Johan, for a portfolio update. Thank you, Michala and Tom. It is great to see the continued very strong commercial performance throughout the full year 2025. Maria and I will take you through the portfolio update. Overall, during 2023 and 2024, we paved the way for the pipeline to go through critical value inflection points in 2025, with positive data emerging from several early-stage projects. Thus, this means, as you heard from Charl, that we can with confidence say that we will have five to six mid-to-late-stage assets in the pipeline by end of 2026 for six to eight indications. So from our perspective, 2025 has been a solid year of execution and progression. We have continued to advance our research pipeline with innovative assets, with highly innovative and strong programs entering into development. I would like to highlight that we initiated a strategic partnership with Contera Pharma, marking Lundbeck's first entry into oligonucleotide-based medicines. As I mentioned, maturing the phase I portfolio has triggered several programs to progress towards phase II starts during 2026. At the same time, we have executed well on our late-stage development programs, as well as continue with critical brand support, primarily for Vyepti. In early-stage development, we have made extensive use of focused phase I-B exploratory proof-of-concept studies, allowing us to generate patient data and progress programs with strong biological and clinical validation. As you have seen in the last two quarters, this has led to data supporting progression of our D1/D2 agonist 996 in Parkinson's disease and our CD40 blocker 515 in thyroid eye disease to phase II initiations. Next is our anti-ACTH, mAb 909, now with the INN name asedebart. Maria and I will return to asedebart in a few minutes. For late-stage programs, 2025 marked the year executing on our two phase III programs, bexicaserin and amlenetug, with progressing recruitment and continued health authority interactions. In Q4, bexicaserin was granted breakthrough designation in China for DEE, and amlenetug received Fast Track designation with the FDA, as well as orphan drug designation in Japan. Also during 2025, we completed enrollment in the PROCEED phase IIb trial. Finally, turning to our strategic brands, Vyepti, we have now completed the Asia filings based on the SUN programs in 2025, with submissions in China and Japan in Q4, completing the global rollout of the program. On Vyepti, we also continue to generate strong data on efficacy and effectiveness in severe migraine. Overall, this reflects a year of discipline and generally very successful pipeline progression. Next slide, please. Our pipeline progression is underpinned by strong scientific momentum. During 2025, Lundbeck maintained broad engagement across the scientific and medical community with many medical conference attendance and with 114 scientific presentations, and several high-impact publications in peer-reviewed journals. This level of activity is not just about visibility. It enables continuous external dialogue and validation of our science with clinical and academic experts. Importantly, this momentum continues in 2026 with strong presence planned at several medical conferences. Let me showcase some of those. For ADPD here in Copenhagen, we will present phase I data for our D1/D2 agonist 996, with further data being presented at the MDS meeting. Also, at ADPD, we will present the design of the innovative approach in the amlenetug pivotal program. For AAN, we have four programs presenting data. Vyepti, including new data from an infused real-world evidence study in prior anti-CGRP treatment failures. Bexicaserin data from its phase II PACIFIC trial, and amlenetug expert input in what would constitute a clinical meaningful effect. Finally, for 222, our anti-PACAP mAb will present data from two phase I trials. However, much more importantly, for 222, we will present the PROCEED 2b headline results at the American Headache Society meeting, as well later in June at the European Academy of Neurology. Since Lundbeck in recent period has obtained very encouraging data in neuroendocrinology for the CD40 blocker 515 and asedebart, we will showcase our emerging presence in this space at the ENDO conference in June. As promised, we will now turn over to speaking more about asedebart. Maria. Thank you. As Johan just outlined and Charl mentioned in his opening remarks, our pipeline is progressing with increasing clarity, focus, and value inflection. Asedebart is a strong illustration of that strategy in action. Asedebart represents one of our most differentiated first-in-class programs, moving forward with a clear scientific rationale and a well-defined development path. Asedebart is an anti-ACTH monoclonal antibody designed to address the root cause of cortisol and androgen excess. This mechanism directly differentiates it from existing therapies that focus on downstream hormone control rather than disease modification. We are advancing asedebart in two rare endocrine indications, ACTH-driven Cushing's syndrome and congenital adrenal hyperplasia. Together, these indications represent more than 80,000 patients globally, currently underserved, and share a common prescriber base enabling efficient development, regulatory alignment, and future commercial leverage. Importantly, we have already secured orphan drug designation in CAH in both the U.S. and E.U., reinforcing the regulatory attractiveness of the program. From an unmet need perspective, the rationale is clear. In ACTH, patients lack targeted disease-modifying options and are often exposed to complex polypharmacy with significant safety limitations. In CAH, currently approved treatments provide suboptimal disease control and rely on chronic glucocorticoid exposure with well-known long-term risks. asedebart's differentiated profile positions it to create value across different stakeholders. For patients, it offers the potential for improved tolerability in ACTH and superior efficacy in CAH. For payers and reimbursement authorities, meaningful differentiation on key outcomes supports reduced total cost of care. For healthcare professionals, it enables a simpler, more predictable approach to long-term disease management. For Lundbeck, solidifying our ambition in neuro rare diseases, supporting long-term pipeline and value growth. In summary, consistent with the pipeline progression Johan described, asedebart perfectly exemplifies how we are advancing focused high-impact assets with clear differentiation, regulatory momentum, and significant upside potential. For a more detailed look into one of these indications, I will hand back to Johan. Yeah. Thank you, Maria. Next slide, please. Yeah. So with that, onto your medical need defined by Maria, let me show an example of the strong data we obtained for asedebart, in this case, for congenital adrenal hyperplasia. In CAH, chronic ACTH elevation drives adrenal overstimulation, leading to excess production of androgens and their precursors. Current treatments primarily rely on glucocorticoids, cortisol replacement, which represses ACTH indirectly. But as you heard from Maria, often with a cost of long-term overexposure and associated complications. By directly targeting ACTH, asedebart is designed to intervene upstream in the disease pathway, reducing adrenal overstimulation and downstream hormone excess at its source. This provides a clear, strong biological rationale. 17-hydroxyprogesterone, 17-OHP, is a precursor in the production of cortisol. When cortisol production is hindered by CAH, the body produces excess of 17-OHP in the adrenal glands and gonads, and thus elevated 17-OHP is a diagnostic biomarker for the indication. In an ongoing multi-site open label, a typical dose trial in patients, we could demonstrate effective engagement of the ACTH pathway. As you can see, following infusion of asedebart, at 24 hours, there's a 90%-98% reduction of 17-OHP from baseline. We also looked at androstenedione, or A4, a key marker used to monitor treatment efficacy and disease control. Like 17-OHP, we see a reduction in A4 following asedebart infusion ranging from 65%-90% compared to baseline. These pharmacodynamic effects provide a strong reason to believe in the potential of asedebart to address core disease drivers in CAH. From a safety perspective, asedebart was well-tolerated, with no serious or severe adverse events reported. With this data set, we can now conclude the phase I-B part of the ongoing phase I and II study and move into the phase II part of the study. Next slide, please. Finally, let me place this in a broader pipeline context. In addition to CAH, we also have data for asedebart in a similar phase I/II open-label study in Cushing's disease. Cushing's is a condition caused by ACTH-secreting pituitary adenomas, leading to excess cortisol production by the adrenal glands. We have now very encouraging phase I-B data to be presented at ENDO, supporting progressing asedebart to phase II for this indication. Together with our CD40 blocker, 515, in thyroid eye disease and our D1/D2 agonist, 996, in Parkinson's disease, we have three assets across four indications progressing towards larger phase II trials. As mentioned already, 222 headline results from PROCEED phase IIb is near-term catalyst. If positive, the program holds potential to expand our migraine efforts into franchise with addition of a novel mechanism action product. In conclusion, while progressing our current phase III programs, we are progressing several additional first-in-class and sometimes first-in-indication programs supported by clinically validated biology, building a solid mid- to late-stage pipeline. With this, I'd like to hand over to Joerg. Thank you, Johan and Maria. Please allow me a few opening remarks before we turn to our key figures. Over the past two years, we have executed within a very clear financial framework, prioritizing growth behind our strategic brands, accelerating innovation, and funding this through disciplined capital reallocation. This focus is clearly reflected in our results. From a growth perspective, we delivered strong double-digit revenue growth in 2024 and 2025, exceeding expectations and underpinned by exceptional performance from Vyepti and Rexulti. This has translated into a strong gross profit growth, providing operational leverage, allowing us to both expand margins and step up investments where it matters most. This is why we enter 2026 with confidence and a clear strategic intent. We have strong commercial momentum, a sharpened operating model, and a significantly strengthened mid- to late-stage pipeline with several key milestones ahead, including PACAP. From a financial standpoint, this supports both our growth outlook and the guidance ranges we have provided. With that, I will now turn to the financial performance for 2025 and our guidance for 2026. Next slide, please. Revenue reached DKK 24.6 billion, growing 13% at constant exchange rates, driven by strong momentum across our strategic brands to 19%, predominantly reflecting accelerated growth in Rexulti and Vyepti. The adjusted gross margin was 87.5%, impacted by a reservation fee related to a manufacturing contract for amlenetug. Sales and distribution costs decreased slightly by -2% to DKK 7.7 billion, reflecting the execution of the focused innovator strategy alongside disciplined resource allocation and capital reallocation. Administrative expenses reached DKK 1.5 billion, corresponding to a slight increase of 4% at constant exchange rate in line with expectations. R&D costs increased by 10%, reaching DKK 4.9 billion, mainly driven by the continued progression of our phase III programs for bexicaserin and amlenetug, and a maturing mid-stage pipeline. The increase was partially offset by the MAGLi impairment loss recognized in 2024. Other operating expenses reached DKK 969 million, primarily reflecting an impairment loss of a non-strategic production site in Italy, around DKK 600 million, and commercial restructuring costs of around DKK 400 million related to the transition of 27 markets to a partnership-led model. Adjusted EBITDA grew 24% constant exchange rates, mainly driven by the strong performance of our strategic brands. Adjusted EBITDA margin expanded to 32%, up 3.2 percentage points, reflecting our strong performance in 2025, continued disciplined capital reallocation, more than offsetting the R&D cost increase from the acquisition of Longboard Pharmaceuticals and the shift to a more mid- and late-stage R&D pipeline. Next slide, please. EBIT rose 59% to DKK 5.3 billion, driven by higher gross profit and lower sales and distribution costs. This performance was partially offset by higher R&D costs and other operating expenses associated with our commercial restructuring and an impairment loss of a non-strategic production site, as earlier mentioned. Net financials reached an expense of DKK 788 million, mainly due to higher interest costs related to the new debt obtained in connection with the acquisition of Longboard and unfavorable currency effects, especially from the US dollars. Our effective tax rate was 28.9% compared to 15.5% in 2024. 2024 was positively impacted by the reversal of a provision related to the U.K. tax audit that was closed. Increase in 2025 in the effective tax rate to 28.9% is driven by two non-recurring items in Q4. The primary driver was a non-deductible impairment related to the plant divestment of our manufacturing site in Italy, combined with the finalized outcome of a U.S. advanced pricing agreement adjustment that had a larger tax impact than previously expected. Looking ahead, we are guiding an effective tax rate of 20%-23% for 2026, reflecting the absence of these one-off items and a more stable tax position following the APA finalization. Net profit increased by 2% to DKK 3.2 billion, and adjusted net profit increased by 5%, reaching DKK 5.2 billion, again, reflecting strong performance and capital reallocation, partially offset by higher financial expenses and income expenses. In line with our dividend policy is this proposed to pay out a dividend of one krone and 15 øre per share, which is an increase of 21% compared to 2024. The proposed dividend corresponds to approximately 36% of Lundbeck's net profit and 30% of net profit adjusted for the impairment loss for our manufacturing site in Italy. Next slide, please. Cash flow from operating activities was in line with the EBIT performance, reaching DKK 5.5 billion, reflecting strong EBIT growth and a significant working capital improvement. Keep in mind that the change in working capital in 2024 was highly impacted by around DKK 2.8 billion of acquisition-related transaction and settlement costs. Cash flow from investing activities was an outflow of DKK 611 million, reflecting the purchase of intangible assets and property, plant, and equipment, whereas 2024, again, was highly impacted by the acquisition of Longboard. Cash flow from financing activities was an outflow of DKK 6 billion, mainly driven by the repayment of the loan facility used for the acquisition of Longboard, partially offset by a €500 million bond issued in Q2 to refinance the loan facility. Next slide, please. An essential part of Lundbeck's focused innovator strategy is our capital reallocation program, through which we have taken a number of deliberate decisions to support funding for growth and innovation. During 2025, we increased our level of ambition and continue to operate with a high degree of discipline, maintaining our target of freeing up approximately DKK 1.3 billion to DKK 1.5 billion by 2027, as communicated last year. Importantly, we have been able to absorb the Longboard costs while still expanding margins in 2025. The capital reallocation program is built around several strategic pillars, spanning both value creation and efficiency initiatives. These have been successfully executed across 2024 and 2025, providing strong financial flexibility and a solid foundation as we enter 2026. One key pillar we acted on in the fourth quarter is our production model optimization. As part of this, we have initiated a plant divestment of a non-core production site, which will further reduce complexity and streamline our manufacturing footprint. In summary, we have more than delivered on the commitments we made two years ago during our capital markets event and remain firmly on track to achieve our midterm target. Next slide, please. Let me now turn the focus on the outlook for 2026, where we expect to deliver another year of profitable growth, building on the strong momentum we achieved in 2025. For 2026, we are guiding a revenue growth of 5%-8% at constant exchange rate. This guidance is underpinned by continued strong underlying growth across our core portfolio, particularly our key brands, which remain the primary drivers of value creation. As explained by Michala, there are a couple of one-time effects impacting our 2026 revenue. While the sales from the new partner markets are reduced by the partner commission fee, this decline is partially offset by a one-time inventory impact of approximately DKK 500 million in Q1 2026. This impact is specific to 2026 and relates to inventory buildup within the partner channel and is not expected to be a recurring driver of revenue growth. Excluding these one-time effects and restating 2025 on a comparable basis, our underlying revenue growth would be in the range of 6%-9%. Turning to profitability, we're guiding adjusted EBITDA growth of 4%-12% at constant exchange rates in 2026. This range is driven by strong gross profit growth, reflecting again continued momentum in Vyepti and Rexulti. At the same time, we are increasing investments in R&D to support long-term growth. With several critical clinical trial initiations and read-out plans during 2026, especially PACAP, our guidance therefore assumes a wider adjusted EBITDA margin range. The wider range still points towards margins within our midterm guidance. And with that, I would like to hand over back to Charl. Thank you, Joerg, and thank you to the entire executive leadership team for these outstanding results. I will make a few closing remarks on the next slide, please. You've seen clearly from us the 2-year window of where we've put some of the fundamentals in place that allow us to now extend our growth very clearly into 2026 with very clear priorities. We are extending our growth, as we said, with clear focus on our strategic assets. But fundamentally, you've also seen a transformation in the pipeline that allows us to really bring those five to six mid to late stage assets further into their cycle of development, allowing us to continue in our strategic path of developing them for the long-term success of Lundbeck. We enter into 2026 really from a position of strength with a very clear strategic path. As I said, these results are not by chance, but really by clear strategic intent and choices we've made that allow us now to enter 2026 in this very strong position. We want to open it now for your questions, and I'll hand it back to the operator. We will now begin the question and answer session. Anyone who wishes to ask a question may press star and one on their telephone. You will hear a tone to confirm that you are entering the queue. If you wish to remove yourself from the question queue, you may press star and two. Questioner on the phone, I request to disable the loudspeaker mode while asking a question. Anyone who has a question may press star and one at this time. The first question comes from Charles Pitman-King from Barclays. Please go ahead. Morning, guys. Thanks so much for taking my questions. Two from me, please. A first question just on Rexulti growth dynamics. I was just wondering if you could provide a little bit more detail on how you're thinking about the potential impact of the IRA listing Rexulti from 2028 ahead of the 2029 LOE. Coupled with that, just I know it's super early, but if you're able to comment at all on the initial impact from J&J's Caplyta on Rexulti's growth trajectory. Just wondering, can MDD and schizophrenia keep growing into that 2028 erosion timeline now? Then just secondly, on M&A. Back in November, Lundbeck pursued a potential acquisition of Avadel. Just wondering if you could provide some thoughts more on the potential commercial opportunity within the narcolepsy space that you saw, what the rationale behind your approach was for that asset, and just thinking about kind of the future BD, and the rise of M&A activity at the end of last year, how you're kind of viewing the market today, and what therapeutic areas you're most interested in pursuing. Thank you. Thank you, Charles. Before I hand to Tom to speak more about Rexulti, just one word to say on Rexulti is that what you've seen and what we're guiding is very much as expected and also planned in our strategic outlook for the brand. But I think Tom can talk more to that and then I will come back and speak about M&A. But Tom. Good. Thanks for the question, Charles. Just first off on the IRA. Based upon the established role Rexulti has as a treatment option for many Medicare patients, with MDD, schizophrenia, and AADAD, Rexulti did meet the criteria for selection of the IRA price setting in 2028. I think it's important to note that this was aligned with our expectations. I think it's also important to note that since approval in 2015, Rexulti has treated over 1 million patients across all these indications. Lundbeck and Otsuka are committed to ensuring as many patients as possible have access to Rexulti and will formally enter into the CMS process. Because the negotiation process is just the beginning, it is too early to really comment about our expectations related to the impact of the IRA. What I will say is that we believe Rexulti is and remains a key growth driver for Lundbeck, and our focus remains on driving growth of this brand. I think this is evident, as you said, in the fourth quarter. Overall, TRX demand growth, and this is in the fourth quarter of 2025, so it's really important as we think about the exit momentum, was 24.2% versus the same period last year. That's 16.6% growth in MDD and 63.8% growth in AADAD. Overall demand in fourth quarter 2025 is similar to what we saw throughout the year. As it relates to Caplyta, I think it's also important to note that there's so much unmet need when we think about mental illness, additional products is welcome for patients. Again, it's very early to look at the impact of CAPLYTA, but I think CAPLYTA, from their perspective, is probably doing a pretty good job. I think it's important for us to understand where their source of business is coming from. If you look at their source of business for MDD, 26% are coming from anxiolytics, 25% from SSRIs and SNRIs, 12% from mood stabilizers, and 10% from generic atypicals. If we look at Rexulti specifically, it's 1.5%. Even within the context of a new competitor, as you can see, Rexulti is still growing strongly within MDD, but most importantly across the overall franchise. Charles, to talk about M&A, again, I think the example you raised of Avadel is a normal process that we go through in bolstering our innovation. We keep looking externally, in our M&A BD strategy, in this notion of a string of pearls, like we've spoken before, where we look at opportunities that can either strengthen our positions we have. So we often look at them through the lens of the neuro rare space or neuro specialty, where we can have synergies with our existing pipeline or our sales organization to build sufficient scale. In the case of the space of sleep disorder, this is, of course, one of the spaces that we keep looking at. We also have some early programs that we will speak more about later in the year that would be in this space of sleep disorder, but it's not the only space that we are looking at. So, thank you for your question. Thanks very much, Volker. The next question comes from the line of Xian Deng from UBS. Please go ahead. Thank you very much. Xian from UBS. Thank you for taking my questions. Also 2, please, from my side. First one, maybe just to follow up on Charles' previous question regarding M&A. Just wondering, you also have this year moving 4 of your programs into phase II, but in the meantime, you also made the bid for Avadel last November, but then in the end, didn't increase a bid further, so you didn't have the deal in the end. Just wondering if you could maybe help us to reconcile your strategy in terms of R&D, considering both internal and external opportunities, please. Do you mainly look at external for the late stage while developing prioritizing internal for early stage, or any color on that? That would be great. That's the first question. The second one is on Rexulti, please. Understanding the underlying trend from TRx, everything looks great. But still this quarter, you have a 9% miss versus consensus. Just wondering, is there any soft comparisons that we should be aware of? If yes, I wonder if you could quantify that, please. Thank you. Good. Let me start with the M&A topic. First of all, I think to just emphasize further what I mentioned, it is an ongoing process of how we build a sustainable pipeline. We look at this through the phases of phase I, II, and III, and of course, how do we create more optionality long term? We have a full pipeline, which is a great thing. We are investing in that pipeline, but we will not be agnostic to looking at other innovations that are coming from outside. If they are more interesting, have more potential than what we have, we will make some of those choices and trade-offs in the pipeline. From that perspective, yes, we really look across the range and we feel that it is very much part of how we will build the long-term sustainability of Lundbeck by looking both at the external environment that supplements exactly what we are doing also internally to build a compelling pipeline. Good. Then the second question, we go to Tom. Thanks for the question, Xian, and I am glad we can clarify this for you. I said overall, as we talk about TRx demand growth exiting the year was 24.2%, and we saw strong growth across both of our key indications. I think some of the mechanics to help close the gap between what was reported for revenue and the underlying demand, I think are twofold. One is there is one less shipping day this year. And I think it is important to note that we only ship to the three big wholesalers on Mondays and Tuesdays. So, basically when you have one day missing, in one day, we will ship one-third of the orders for the week, and then the second day we will ship two-thirds of the orders for the week. I think that is a dynamic that is worth noting. Secondly, as we look at inventories, we exited the year for inventories at the low end of our normal range, and I think it is those two dynamics that will help bridge the gap for you. Thank you very much. Just wondering, the last part, you mentioned the inventory low end of normal range. This is relating to the wholesalers, right? Not your inventory. Yes. It's the wholesalers. Yes. We're just quoting the days on hand for wholesalers. Got it. Thank you very much. The next question comes from the line of Kirsty Ross-Stewart from BNP Paribas. Please go ahead. Morning. Thanks. Kirsty Ross-Stewart from BNP. Two questions from me. On the broad R&D expense range, I understand that PACAP progression is the key swing factor. Can you talk to your thoughts on probability of success here, especially in light of the positive HOPE data that we have already seen? Outside of that progression decision, are there any other moving parts that we need to be aware of? You have mentioned the phase II starts, but I think we already knew that they were moving to phase II, so can we assume that those are incorporated into the bottom end of the guidance? If there is anything else, just inquire contributing to that broad range. Then a second question on asedebart, the anti-ACTH. Interested on your perspectives on the phase II data that we saw from Crinetics and CAH in January this year, which showed good reduction of ACTH production and how you see this asset from a competitive perspective and how your antibody approach is differentiated versus the Crinetics molecule at atumelnant. Thanks very much. Kirsty, just a very quick question before I hand to Johan on the views on PACAP. I mean, overall, from an R&D perspective, yes, it is one of the important investment triggers, but of course, you know that we also have bexicaserin and amlenetug in phase III. So these are also sizable investments that we are making to complete these studies. From that perspective, we have a healthy pipeline to fund, which is reflected also then in the range of R&D spend that we see. But I think, Johan, you wanted to make comments on your views of what you think you can say at this point on PACAP, and then maybe on your thoughts on Crinetics. Yeah. Thanks, Kirsty. I mean, obviously you would like to know some PoS, how we view this, but we will get the data soon, and we will take a look at it. There is, of course, prior information, and if you believe in priors, there is, of course, the HOPE trial. Then recently in June, I believe, last year, Lilly presented data from their very early terminated program in 38 patients that showed also an effect. So there is, of course, overall encouraging data in the field. Now we just need to expand it with a much wider dose finding range. We will see what the data will get. So you can draw your own conclusions based on that, basically. For Crinetics. Yeah. I mean, we are happy to see that data. It is a good validation that the pathway is really to be addressed, and you can see effects. I'd like to remind you that Crinetics working with the ACTH receptor blocker, MC, melanocortin receptor 2 blocker. It's at the adrenal gland stage, so it's further down in the biology, which means that you don't cover all the different aspects of the overproduction in the system. Here we have the ability with this mechanism to have a broader symptomatic effect across different adrenal hormones that are hyperactive in this condition. Great data, but we believe it can have even broader effect, this molecule. Thanks very much. Going forward, I think what we, again, guided for was the range of DKK 5.5 billion to DKK 5.9 billion for 2026. That principally compasses bexicaserin and amlenetug and also the advancement of anti-PACAP and anti-ACTH. I think on the rest of investments, that's always dependent on, you can say, milestone outcomes. The next question comes from the line of Tobias Nissen from Danske Bank. Please go ahead. Yes. Hello. I have a question on Vyepti here. It's been a very solid 2025 with accelerating growth here over the last three quarters. I'm just wondering if you can quantify some of the growth drivers here for 2026. You have lifted the persistency ratio quite significantly over the last few years. Are you hitting the ceiling here? Also, if you can give some insight into the dosing mix and what you expect here in exit 2026, and also perhaps on expected approval and first time sales timing here for the APAC region, both Japan, China, South Korea. Thank you. Thank you, Tobias. Let me ask Tom to comment more on the growth drivers for the U.S. But just to emphasize that this is, of course, a key asset of investment for us, both in U.S. and in Europe. Then we have filed in Asia, so expect to see more of the sales impact on Vyepti in Asia more in 2027. But I think, Tom, you want to just talk quickly about how you see your insights on 2025, how it carries forward to 2026. Yeah. So thanks for the question. As you stated, we're pleased with the progress that we're making on Vyepti. As we think about the key drivers for growth, it all starts with new patient starts. That's where our focus is, and new patient starts by being able to drive Vyepti further up the treatment paradigm to be used earlier in treatment. Then within that context also to make sure that we're maximizing the written to infusion ratio as part of our patient centric model. As it relates to the 100 milligrams versus 300 milligrams, for the most part, we saw that allocation between 100 and 300 milligrams pretty stable over the course of 2025. We expect that to continue. But we will also say that the majority of patients are on 300 milligrams because the observation from clinicians is that you see improved efficacy at the 300 milligrams for most patients. Perfect, Tom. Thank you. I will jump back in the queue. The next question comes from the line of Alyssa Larios from Leerink. Please go ahead. Hi, everyone. Thank you for taking my question. This is Alyssa on for Marc Goodman. I was wondering if you can give us a little bit more color on how the partnership model is expected to impact total revenue for Vyepti and Rexulti. Also related to the one-time inventory build, should we think about the impact as being more front-loaded in the year or will there be some inventory stocking spread across the quarters as some of the international partners kind of come online? Thank you. Alyssa, could I just clarify your last question? We did not quite get a clear line there. Yeah. Related to the one-time inventory build, is that going to primarily be seen in Q1 or will there be some stocking across the quarters as well? Very clear. Michala, do you want to comment on your thoughts on how that's going? First of all, with the partnership model, as you know, we have, of course, the provision we need to, or the commission we pay the partners, as I explained. Then we have the one-off effect of inventory, which we expect to be at Q1, and it relates specifically to partners needing to build up safety stock in the market. It's, you can say, a technicality, so to speak, of them taking over the distribution of our assets or our products in these markets. In terms of our expectations, I think you asked about our expectations for Rexulti and Vyepti in the partnership markets, and we don't guide specifically at brand level, but generally, of course, our expectation is that the partners will be able to continue to deliver with the momentum we've seen when we had the business in our own hands. We expect to see that will continue. Okay. Thank you very much. The next question comes from the line of Alexander Moore from Bank of America. Please go ahead. Hi. Two from me. One on Abilify Maintena. Slide 8 shows conversion to two monthly are continuing to increase in Europe and IO. I just wondered if you could give any color on what your conversion rate assumptions are factored into the full year guidance. Secondly, just one on pipeline. Slide 36 highlights potential benefit of little to no monitoring requirements of bexicaserin. I wondered if you could just give any color on what monitoring is currently included in the phase III DEEp SEA and DEEp OCEAN trials. Thanks. Good. Thank you, Alexander. Abilify conversion ratio, do you want to start, Michala, with that? Yeah. Generally, as I stated, for EIO or European International, we see an average of 19%. What you have to bear in mind is that we are launching at different times, so not all markets have launched at the same time, and that, of course, also impacts the conversion rate as it progresses. When we look to 2026, we expect this to continue, and as I also mentioned, we expect to see generics in Q2, where we previously expected to see them earlier. Of course, that also gives us a chance to convert more patients. We continue to focus on that. Tom, on your views on the U.S.? Yes. Well, I think if we look back over the course of the last 2 years with Abilify and Asimtufii, our focus has really been on franchise maximization, and we have been able to grow our market share over the past year for the franchise 1.1 share points to 24.9. I think as we look into 2026, our focus is really going to be moved from maximizing conversions, and we have seen some good momentum in NBRxs. With the latest week, we saw a 22% conversion ratio, and our expectation is, and ambition continues to be to exceed the conversion rates of the other benchmarks in the LAI marketplace. Tom? I think the question from Alexander, Johan, is on bexicaserin Phase III, what are the endpoints? What are we monitoring? Yeah. First of all, it is the trial in what we call DEE, which is the broad indication here, across all developmental and epileptic encephalopathies. We have two trials, as you know, DEEp SEA and DEEp OCEAN. What we are monitoring is, of course, how we are progressing with the trials. In terms of progressing with the global rollout, we are doing well. We have now activated all sites across the world, but remember, we started the trial during early 2025, and it has been a gradual rollout of the trial. What we are monitoring in terms of blinded data in the trial, we are very careful with that. We have some monitoring of data acquisition, and we know that we get the right kind of populations in at the front door, that we have a good balance between various parts of the spectrum, and we are doing well on that. There are little differences in enrollment between the two trials. Dravet syndrome is more challenged, but that is a standalone trial. The balance is good across the whole system. In terms of medical monitoring, we have good news on what is going on so far with the patients. No concerns there, what we have seen so far. As you know, we are out of the box not having to have a cardiovascular monitoring with this mechanism. That is a big benefit for trial sites. How much I can say, and we are looking forward to try to wrap up the randomization during the year. Ladies and gentlemen, that was the last question. I would now like to turn the conference back over to Charl van Zyl for any closing remarks. Yeah. Thank you again for joining today, and again, want to reiterate, very strong position we are in from the last two years of focused innovator strategy, and we are, of course, very confident as we enter into 2026 with another strong year of performance ahead of us. Thank you again for joining today.