H Lundbeck A/S B

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.

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.

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.

Thank you, Michaela, and thank you, Tom. It's great to see the strong full year results with growth of our key brands. So let us turn the page for the 2024 summary of R&D activities. Coming out of 2024, we can conclude that we had a strong pipeline progression last year with key regulatory activities, strong lifecycle management activities, and important progression in several development programs linked to positive readouts in some cases during last year. Among regulatory activities, we naturally had the validation to file of the SNDA submission to FDA of Brexbiprazole in post-traumatic stress disorder. I'll come back to that a little bit more in a minute. As Michaela already mentioned, we had an important improvement of the two-monthly long-acting injectable version of Abilify for the EMA-covered markets in early last year, a brand addition in the Otsuka Lundbeck anti-psychotic LEI product portfolio. The product is available with a ready-to-use formulation for more convenient administration. For VIEPTI, as mentioned by Charles and Tom already, we finished the Sunrise trial in the fall of 2024, which was ahead of the 2025 planned readout. The trial showed again how impactful the drug is against severe migraine. The data from this trial form a cornerstone in the planned Asian regulatory submissions, together with the past spearheading Sunlight trial, as well as the Pivotal Promise program. For VIEPTI, we also got results from some interesting lifecycle management activities June 24. Among those, I'd like to mention the resolution trial that we finished in December. In this randomized placebo-controlled trial, VIEPTI confirmed a strong efficacy we see consistently with the drug. The resolution results show rapid treatment benefits even in most severely impacted patients, those with chronic migraine and medication overuse headache. Also in the review, real-world evidence study, we found an overall reduction in burden on migraine after OVIP treatment, including improvements in so-called brain fog or cognitive symptoms. In review, the effectiveness of OVIP was observed even for patients previously on other anti-CGRP treatments. In the NME pipeline, we have seen a buildup of development programs into late development during last year. After encouraging AMOLED proof-of-concept trial readout with our alpha-synuclein antibody, amlinitug, at the start of 2024, we presented late-breaking data at a major conference, while moving as fast as possible with global regulatory interactions, enabling a phase 3 start already in December of the innovative MASCOT trial. Through the longboard acquisition, we went straight into the upstart of a pivotal program for bexicasirine in developmental and epileptic encephalopathies. During the late spring of 24, we also formally moved 2-2-2, our anti-PACUP antibody, into late development with the initiation of the Proceed Phase 2b Adaptive Dose Finding Study. Also in the early development and research portfolio, we had important activities during 24. I'd like to highlight the initiation of a small Cushing's disease trial with our ACTH monoclonal antibody 909. This trial is adding to the already ongoing congenital adrenal hyperplasia trial. Both programs already delivering interesting data for this first-in-class program. We also started a trial with 515-RCD40 ligand binder in thyroid eye disease, or TED, during 24, a trial that is now progressing by actively randomizing patients. Phase one is also the place where we like to weed out less promising molecules. So we terminated our peripherally restricted monoacylglycerol lipase inhibitor 74 last year after a comprehensive and decisive proof of principle study in pain indications. Next slide, please. As Mikael already referred to, together with Otsuka, we've already seen Abilify maintain and simplify obtaining approval this year in Canada. This was also followed this week by Australian approval. So we're looking forward to how this brand is now rolled out in the rest of the world. This week we also have received a positive CHMP opinion by EMA on our schizophrenia pediatrics indication extension application for Rixalti for patients aged 13 to 17 years. Concerning our SNDA FDA application for Brexbiprazole in combination with Sertraline for the treatment of PTSD, we learned from FDA in early January that they would like to host an advisory committee meeting to discuss the program. The target date for this outcome and a potential new PDUFA date are still to be set. If you're interested in the PTSD Phase 3 data, I'd like to highlight that we had key data from the program published in JAMA Psychiatry in December. As mentioned, the Amlenetuk Phase 3 program got off the ground before Christmas, with enrollment progressing already in the United States. For bexicasirine, two pivoted trials have been initiated called DEEP-C in Dravet syndrome and DEEP-OCEAN in other DE patients, including Linoga STO patients. Both trials are now actively enrolling patients in the United States. As we communicated last week, for bexicasirine, we also obtained 12 months Pacific OLE data. Pacific is the phase two study that was done with the program. So let us look at some data from this readout. Next slide, please. All patients in the Pacific Phase II trial were offered to continue into an open-label extension study, or release study, with dose on placebo transitioning to bexacathrin. In the left side of the graph, in the gray shaded area, you can see the treatment effects within the control part of the trial, and then followed by the shift into active arm of the previously placebo-treated patients through a dose titration. The nine-month data previously reported showed an overall median seizure reduction of almost 58%. Now, the 12-month OLE data demonstrated a maintained durable response in motor seizures with bexicasirine, as shown in the right side of the graph in the yellow shaded area. At the 12-month OLE time point, bexicasirine achieved an overall median seizure reduction of over 59% in countable motor seizures. It is important to note that there was a remarkable high patient retention, with almost 93% of patients staying through the full 12-month OLE period. Moreover, the favorable safety and tolerability profile of bexicasirine continues to be observed. Next slide, please. In the coming period, we expect a number of key events by progressing the pipeline towards milestones. I have already mentioned some of the upcoming events and the 12-month OLE readout for bexacathrin, but I'd like to call out the expected proof-of-concept readout for our anti-ACTH program during 2025. Additionally, in 2026, we expect a proof-of-principle and possibly a proof-of-concept readout for our CD40 ligand binder program in TED. Two critical progression opportunities to further build a late-stage portfolio during the coming years with potentially first-in-class molecules in high medical need indications. With that, I'd like to hand over to Jörg.

Thank you, Johan. Great progress in our pipeline. 2024 was truly a landmark year for Lundbäck. We achieved a record revenue of 22 billion, growing 14% at constant exchange rates, At the same time, becoming a focused innovator requires to perform and transform at one and the same time. So let's start with our performance in 2024 and take a look at our key figures. Next slide, please. Our revenue grew 14% in 2024, driven by the accelerated growth of our strategic brands of plus 21%, with significant contribution of IAPTI globally and Rick Salty mainly in the US. The adjusted gross margin was 88.4%, increasing 0.1 percentage points and is in line with the previous year despite inflationary pressures in the beginning of 2024. Sales and distribution costs increased 10% to 8.1 billion, reflecting mainly the continued investments in sales and promotion activities in Rick Salty and Biapti in the U.S., including PTSD preparation for Rexalti, as well as the global rollout of VIEPTI. Administrative expenses increased 11% to 1.4 billion, primarily driven by legal provisions for ongoing litigations that were recognized earlier in the year. R&D costs increased by 30%, reaching 4.5 billion, mainly driven by investments into anti-pay cap and anti-fosinuclein MAP. In addition, the 4.5 billion of R&D costs include the impact of the Marglin payment loss of 547 million that we recognized in Q3 2024. Adjusted EBITDA increased by 20% by the revenue growth, which more than offsets the increased investments in the R&D pipeline. The commercial investments support the growth of our strategic brands. The adjusted EBITDA margin was 28.8%, representing an increase of 0.4 percentage points, primarily due to OPEX ratio improvements on strong growth, partially offset by higher R&D costs and unfavorable currency and hedging effects. Next slide, please. Our EBIT increased by 15% to 3.3 billion, growing in line with the underlying operating performance, benefited by lower amortization of product rights, This growth was mainly offset by an impairment loss due to the negative market readout of 547 million and transaction and integration costs related to long-bore acquisition of 420 million. Net financials reached an income of 450 million equivalent to an increase of 322%, the positive Development is mainly driven by the gain from a hedging transaction settled in connection with the acquisition of Longboard and the positive development in interest income. Our effective tax rate dropped significantly to 15.5%, down from 23.5% in the same period last year, mainly due to reversal of an uncertain tax position related to a tax audit that was closed. Net profit increased by 37 percent to 3.1 billion. Adjusted net profit and EPS rose by 26 percent to 5.3 billion and 5 crowns and 31 euro, respectively. This growth reflects strong EBITDA performance, positive net financial results, and a lower effective tax rate. Next slide, please. Our cash flow statement and the overall net cash position is of course impacted by the Longboard acquisition that we closed in Q4 24. The cash flow from operating activities represents an inflow of 3.3 billion compared to an inflow of 4.1 billion. The decrease was driven by the settlement of liabilities regarding the acquisition of Longboard as well as higher receivables partially offset by lower inventory levels due to the completion of the fixed supply agreement for Biapti in 23. Of course, cash flow from investing activities, 15.3 billion mainly due to the settlement of the acquisition price for Longboard. Cash flow from financing activities, similar part here where an outflow of 11.6 billion compared to an outflow of 2 billion in 23, 24, primarily driven by loans related to the acquisition of Longboard of around 12.4 billion lower debt due to the repayment of the revolving credit facility initially and offset by higher dividend payment in 24. Net debt increased to 12.2 billion 24, driven by the strategic acquisition of Longboard. The net debt to EBITDA ratio rose to 2.4 with interest bearing debt reaching 16.8 billion. Next slide, please. Now, the performance aspect of our strategy is demonstrated in our 2025 revenue guidance, with continued momentum in our strategic brands, leading to an overall revenue guidance of 7 to 10% of growth based on constant exchange rates. The outlook for 2025 sees a strong contribution from Biapti and Rixalti in the U.S., robust double-digit growth. At the same time, for the Abilify maintainer LAI franchise, we protect continued increased conversion to the two-month formulation, offsetting the anticipated impact of generic entries in Europe. Brintelix will be affected by the modified collaboration with Takeda in the US, as well as generic entry in Canada. At the same time, we foresee double-digit growth continuing in Europe. Mature brands are expected to continue their erosion, showing a mid-single-digit revenue decline, overall leading to the aforementioned revenue guidance of 7 to 10 percent of growth based on constant exchange rates. Next slide, please. The transformational aspects of our strategy are clearly bearing fruits. Our approach towards disciplined but also forward-looking capital allocation allows us to safeguard current adjusted EBITDA margins despite significantly elevated R&D investment levels We guide towards an adjusted EBITDA growth of 5% to 11% at constant exchange rates. The strong growth of Rexalti and VIEPTI, together with the advancement of our capital reallocation efforts, allows us to fully absorb the significant increase in our R&D costs driven predominantly by the Phase 3 investment in bexicasirine, aiming in principle for a margin-neutral addition of the largest acquisition in the company's history to our P&L. With that, I would like to hand over back to Charles.

Thank you, Jörg. And let me make some closing remarks before we open for questions. So if we can go to the final slide. Again, what I want to reiterate and what you've heard from my colleagues as well is really a path of strong, sustainable growth that we see. We have a strong foundation we've built on from 2024 as our first year of our focused innovative strategy that gives us strong confidence in the underlying trends of our growth assets. to also guide to 2025 with a very strong growth in VIEPTI and Rexalti. You see a pipeline that is transformed essentially through 2024 and now building in 2025 with the execution of the clinical programs of the late stage pipeline. And of course, the funding reflects also the position where we are, of course, investing more in R&D, which is part of our strategy to fund the long term innovation of the company. But of course, through the capital reallocation, we are able to remain within very competitive and healthy margins on adjusted EBITDA. which of course gives us confidence that as we enter into the second year of our focused innovator strategy that we are on a good path with strong confidence that this is the right path to follow for Lundbeck for the long-term sustainable growth of the company. So with that, I think we can conclude the formal presentation and open the line for questions.

Ladies and gentlemen, we will now begin the question and answer session. Anyone who wishes to ask a question may press star and one the telephone. You will hear a tone to confirm that you have entered the queue. If you wish to remove yourself from the question queue, you may press star and two. Anyone who has a question may press star and one at this time. Our first question comes from Charles Pitman King in Barclays.

Please go ahead. Hi, guys. Thanks very much for taking my questions. One first just on VIEPT, just kind of noting the very strong performance over the course of the year, but then the presentation just shows a bit of a kind of dip recently. I just wanted to double check if there are any kind of seasonal effects that occur in January that you might want to kind of flag or whether or not I could push you for any quantification around that destocking. that you kind of highlighted. I think you said it was toward the lower end of expectations, but just kind of what that really means. And then just kind of second point, two parts. Just if you give us a little bit of an update on your expectations for the competitive dynamics within the major depressive disorder space, how you expect that to progress over FY25. with relation to kind of Rick Salty and Rincelex, Rincelex Outlook. And if I could just maybe squeeze a kind of final one just on the competitive expectations that you see going forward from J&J's acquisition of Intracellular with Capuleta coming potentially to compete in schizophrenia and depressive disorder. Obviously, big read across to your portfolio how you think about those competitive pressures. Thank you.

Thank you Charles for that and just I will ask Tom to make a few comments on VIEPTI and of course also Rexalti competitive environment but just to mention again you know we certainly are managing the company from an annual basis on not a quarterly basis so we might see some of these fluctuations but the underlying trend of VIEPTI remains very solid and is of course feeding our confidence into 2025. So I would not read too much into the quarterly noise that you might see, but Tom, you want to comment more on VIEPTI and then also if you follow on with Rex Salty, competitive environment.

Thanks for the question, Charles. As Charles had said, when we look at overall VIEPTI performance, we focus on what the underlying demand is. And as we look through Over the course of the year, VIEPTI is the fastest growing anti-CGRP in the marketplace, and that includes the oral agents as well. As we look more specifically at December, the three weeks of December that are normal weeks, VIEPTI performance was the highest that we've seen all year, approximately 10% higher than we saw in November. You will see some fluctuations when you have holiday weeks. So, for example, because it's a medical benefit, in the Christmas week and the New Year's week, there's only three business days, so that's where you see some volatility. But again, overall, when we look at where we exited December, we exited at an all-time high from a SharePoint perspective, 10.85%, and we're confident in the demand moving forward. Moving on to Rigsulti and the MDD marketplace, I think it's really important first that we take a look at where Rigsulti is in MDD. It's been on the marketplace since 2015, but when we look at the growth rate for Rigsulti for the last three months, the non-AADAD business grew at 9%. which was actually faster, if we look at NBRXs, faster than both Kaplida and Vreular if we look at October versus May. So really have good underlying performance there. Now, of course, we do see an evolution of the competitive landscape with Kaplida getting an MDD indication. We expect that to happen in October of 2025. So we see minimal impact as it relates to the business for 2025. Looking forward with the purchase of intracellular by J&J, I think it's important to note that intracellular was investing significantly to support Kaplida, I think, at the levels where J&J is likely to be supporting it. So from a competitive standpoint, We don't see that that's going to be a major change as relates to what we need to do to continue to grow Rigsulti, not just being able to drive MDD, but more importantly, continuing to accelerate performance in AADAD where we are the market leader.

And, Tom, you also see sometimes a halo effect of the AAD indication on MDD for the brand itself, so also a very important point.

Importantly, when we look at over the year, if we look at non-AAD ADs, specifically 65 and above, the AAD halo effect has helped propel 54% growth in that segment. So, again, using that as a continued driver of growth, having a halo effect in MDD.

Thank you very much, Rayclay.

The next question comes from Michael Norwood in Ordea. Please go ahead. Thank you very much. Michael Norwood from Ordea.

So two pipeline questions. One is on pay cap and sort of the evolution in that product depending on the data that sort of feasibility data you will get during the year. When will you have sort of a final decision on making the choice around either sub-Q or whether you need to do this on a on an IV basis, and whether you prefer this is going. Obviously, I would imagine that it's up to you in order to capture earlier patients, but maybe some more elaboration on that. And then on Amlenitok and the recruitment process. So you started recruiting patients. We know that in this area it can be difficult to recruit. What is the status? I know it's early, but what is the status on recruitment for Amlenitok?

Okay. Thank you, Johan.

Yeah, thanks for those questions, Michael. So, Paycap Evolution is really, we're in the midst, as you know, of this proceed trial, and we expect to be able to wrap that up maybe within this year, mid-fall. So, that's the aim. It's an adaptive trial. It has two parts, and different parts are optional. So, in the best scenario, we have full optionality with the different roads and administrations, sub-Q and IV. I'd like to remind you that VIEPTI is doing extremely well being an IV product, so it's really hard to tell until you gather the full efficacy data and have a better grip on that aspect. and another important aspect progressing with this program primarily for the pivotal program is to build in further points of differentiation migraine is not just headache migraine is a number of symptoms including brain fog but also a number of autonomic symptoms and we will look more deeper into those in the phase three program which could be possible to see effects on when you have a different mechanism of this kind that actually more broadly reaches into autonomic system functions so It's too early to say. In an ideal scenario, we have more flexibility out of that study. In less ideal, we may have to stick to one road administration in the coming program. For Amlinitog, yeah, with our... Phase 2 program, we didn't really see any problems with enrollment. It was actually going extremely well. It was a trial done in the U.S. and Japan. And the enthusiasm for that trial, I went out visiting a lot of sites, was really extraordinary. Clinicians, I didn't talk to patients, but clinicians really were very engaged in this trial. We don't expect that to be different for phase three. We're adding more sites, of course, and more geographies. But I think there is a pretty big built up interest in this. There's nothing else to offer for these patients. And we get actually quite a lot of outreach to join the trial. So it's more to get it off the ground in the proper geographies. U.S. is just the first start, and so far it's going okay. But it's at the very, very first start of a trial, so we'll come back when we know better how it's progressing.

Thank you very much. The next question comes from Shana Hama in Jefferies. Please go ahead.

Hi there. Thank you for taking my question. Just two from me. I understand that a date has yet to be provided for the FDA outcome for resulting PTSD. But have you received any communication from FDA further to the initial announcement? And then just secondly on biopsy. So obviously we know that now you plan to submit an initial announcement. Yes. Okay.

So, Sian, we could not really pick up your second question, but maybe we start with PTSD, which is the piece we could at least, based on the bad connection, hear from you. So maybe, Johan, you want to comment on PTSD first?

Yeah, I actually don't have so much more to say. Of course, we have a few correspondence from FDA. That's normal at this stage. We got at the beginning of the year the information that they would like to have an outcome, which came fairly late in the review process. That happens. Nothing extraordinary with this, but it's not routine, of course, because that's often at the time of validation they communicate this. But given that there is no treatment here for the last 23 years approved, I think it's very diligent of them to look forward for an outcome. When it comes to the date of this and maybe a new PDOFA date, we know nothing more than they basically say it's postponed, it's being worked on.

and as you can imagine there are certain things going on right now that may make this little more unclear and just to add to to johan there that of course this is not in any of our guidance today the ptsd indication um i don't know sean if you want to repeat your second question which we couldn't hear so well yeah can you hear me a bit better now yes thank you

Okay, perfect. So I was just asking on biopsy. So I know that you plan to submit in Asia by end of 2025. And is the expectation that commercialization will happen via a partner sale? Or are you planning on doing this by yourself?

Thank you. Maybe you want to answer first the question on the regulatory timing of submission?

Yeah, we have the data now from the Sunrise trials, so we have all the clinical data we like to see. It's building up the files, having interactions with the regulators, etc., throughout the program, including the CMC package. Those interactions have gone well, so we're on the rails. We expect at least to progress with Japan during this year. But maybe, Michaela, you can comment how we will perform thereafter.

Yes, thank you. Thank you for the question. So I don't believe we've said we will go with a partner. I believe we've said that we are exploring our options. And I think it depends on the different markets. So we're still evaluating our commercial plans for Epti, also depending, of course, on the regulatory timelines. So I think at this stage, options are open for us and we're exploring.

Thank you.

Our next question comes from and UBS. Please go ahead.

Hey, thank you for taking my questions. Two, please. And the first one is kind of a follow-up on Charles' first question. It's just wondering, for both VFT and Rick Salty, you mentioned a bit of destocking for both of them. So just wondering if you could give us a bit more color on that. And just wondering, is this sort of a destocking because you shipped a bit more in Q3, so it's kind of a reversal of a positive effect from Q3, or is that a negative impact? in Q4, which we can expect to reverse somehow next quarter? That's the first question. The second one is on Bexie Catherine, please. So, given now you have, you know, completed the acquisition of Longboard, so just wondering if you could give us some color on the FDA feedback on the broad label from the Phase III trials, please. Just wondering if there's any comment you could share in terms of, for example, has the FDA agreed with, you know, how many patients you should enroll for whatever subtype and, you know, that sort of thing, and then And if the chart is positive, then there should be a straightforward broad label. So any color on that, that would be great. Thank you.

Thank you, Jian. So Tom, you want to comment on inventory?

Yeah, so thank you, Jian, for the question. And I just want to be clear that when we look at what the normal ranges of inventory are, it's between 10 and 20 days. And so long as the inventories stay within those range, we've followed the purchasing patterns of the wholesalers or distributors. When we look at where we were in third quarter, it was where you would expect it in the middle of the range. What we saw over the fourth quarter is we exited at the lower end of the range and we have seen a rebound in January to the normal middle of the range.

Thank you, Tom. Exicastrin, FDA view?

Yeah, so obviously we have a breakthrough destination for this drug, which gives a little bit more flexibility in terms of regulatory interactions with FDA. So there are different discussions going on now and then. Most of those happened before the end of the year, but there's really nothing new to say more than we have this Indication possibility, orphan drug for DE, generally. It's a big tent, but it's not really different from any other trial. You look at the subset of patients in the trial and the design, the proper balance of the different studies, two studies with different patient balance. has of course been through the regulatory approval process. So we assume that this is valid and we're building further on that framework. I also like to add, we are of course looking forward to a global trial. So this is being now rolled out to other regulators in Europe Japan and other places. And that is also a process that is fairly early, but those activities are ongoing and we'll learn more how different other regulators may view. But the driving is, of course, the framework from the U.S. here.

Thank you very much.

Our next question comes from Mark Goodman. Please go ahead.

Hi. Number one, can you give us what we should be expecting when you give us the data on the CAH product in the second quarter? And then second of all, can you help us with how to think about the tax rate for this year, given that last year was so funky? And then third, just on VIEP, can you help us understand where are these patients coming from? Are you getting patients that are being switched from other CGRPs or these naive patients to secure some more flavor there. Thanks.

Thank you, Mark, for those questions. Johan, you want to start with commenting on ACTH?

Yeah, thank you. And I think your question was really about the congenital adrenal hyperplasia study that we expect to read out this year. We have the benefit here of having biomarkers that are also registration endpoints. You have very strong biomarkers linked to the axis, signal and axis here. So we expect to get primarily biomarker data that are also the type of biomarker you bring to regulatory approval. We're also, of course, looking at symptoms. And it's a smaller study. And the nature of the study makes it a little harder to really build strongly on symptoms only. But that's not entirely solely necessary for progression of the program. We have a gradual proof of concept, I have to say. In this field, you're benefiting from having those readouts. So it's a program where we already have ideas where it's heading, and that's why we talk about it. I also like to mention that this is a very dynamic indication by itself with several players, but none with this mechanism of action, which is the broadest and has the potential to be differentiated.

Thank you, Johan.

And on your question for the tax rate, what we are forecasting is a range of 21 to 24 percent that is in principle in line with historical levels and it's reflected in the investor deck on slide 28.

Tom, do you want to talk about source of business? I think was the question for VIEPTI.

Yeah, thank you, Mark. So as we look at VIEPTI and we look at the overall contribution of the business, VIEPTI has been used historically in later lines, which is after anti-CGRP. So if you look at third or fourth line. I think what's important that we saw over 2023 to 2024 is on a percentage basis, the growth rate has been greater moving up to third line and second line. And that's consistent with our strategy where we believe we have the opportunity to move VIEPTI up the treatment paradigm and not have to wait for the third or fourth treatment, but look at a first switch or a second switch, which we think represents the greatest opportunity for growth moving forward and a priority in 2025.

Thank you. Our next question comes from John Pritzner and JP Morgan. Please go ahead.

Hi, John Pritzner, JP Morgan. Thanks for taking my questions. So maybe just on the adjusted EBITDA guidance, which is about 6 percentage points wide, can you help us understand the push and the pulls around the potential 28% to 30% margin? I know you announced the cost-saving measures at the CMV around SG&A. When do you expect those to start kicking in? Are you continuing to invest in the brick-solid PTSD launch activities or are those paused for now? And then maybe looking slightly further out, how should we be thinking about that margin progression towards the medium-term target of greater than 30%? Maybe a second question, if I can, on the Abilify franchise. I think you've guided for growth in 2025, but more specifically, how should we really be thinking about the development there? Could it be kind of mid-single-digit growth, high single-digit growth? And ultimately, what level of conversion are you targeting from the one-month to the two-month formulation in both the US and EU? Thank you.

Thank you, John. Jörg, you want to comment on adjusted EBITDA?

Well, happy to do so. I think, first of all, I think the range we're using for the adjusted APTA guidance is in line with what we previously used. And I think predominantly from a mid midpoint perspective that clearly supports our argument of onboarding longboard without in principle any impact on the margins. When it comes to push and pull, I think there are a couple of impacts, of course. I think, first of all, Just as a disclaimer, PTSD is not included in the guidance. Some push and pull always come a little bit around the foreseen generics entry that we see potentially in Canada for Trintelix, as well as Sabilify in Europe, which I think so far we're saying we're more than able to offset with Simplify. R&D spend is significantly ramping up. That is always something that we and monitor very closely. I think that's a good part on the push and pulls i think margin progression uh we we don't necessarily you know give and accept let's say ramp up curve what we did say was in the capital market event that we aim towards a greater than a 30 margin in adjusted abda and i think if you look at the implied margin for the 25 guidance then we're in pretty good shape getting there And I think you had one last question when it came to capital reallocation efforts. They're ongoing and they're, of course, to a large extent, already integrated into the 2025 just the WTA guidance, partially driven by the You can say disproportionate reallocation of spend into Viapti and Rexalti, allowing us to grow faster than previously estimated. But at the same time, of course, what's a favorable development on the margin is, of course, also the divestment of Trintelix back to Takeda in the US, where we're in principle taking promotion out and reallocate our sales efforts into Rexalti.

Thank you, Jörg. Michaela, you want to comment on Abilify conversion, but also how we see maybe LOE?

Yeah, so thank you for the question. So on Abilify, of course, we see a number of dynamics that we expect to continue into 2025. So first of all, the continued penetration of the two monthly or Simtify, where we see very encouraging data from the US. But also as we begin to roll it out in Europe, as I said, in 13 markets now and more to come, and also the rest of international operations, we of course will see that brand continue to grow and help us. At the same time we see in Europe, we expect to see generic competition sometime in 2025, and that will of course dampen the growth in Europe. You also asked about conversion and what our expectations is on conversion. We've previously said 20-25% and we still feel that that is a good estimate. We are encouraged by the conversions we're seeing not only of course in the US but also the early signs from Europe. So we still feel comfortable that we will be able to probably outperform analogues and 20-25% still feels like a reasonable ambition for us.

And just to build on Michela's comments, the conversion is not only from the one monthly, but we also see source of business coming from orals directly to the two monthly. So, you know, there's more potential we see in this asset as well.

Great. Thanks for taking my questions. Our last question for today's call comes from Manos Mastourakis and Deutsche Bank. Please go ahead.

Thank you very much.

So the question is on your latest views on the MSA competitive landscape, especially given the development of an oral synuclein agent and everything else you have on your radar on MSA. And if I can squeeze a question on timelines across Bexcasrin and MSA as well as PTSD. So what gives you the confidence that an FDA outcome and decision could still take place in H1? Just to clarify if that came from the FDA or not. Thank you.

Johan, so I think those two questions are for you.

Thank you for those questions. Let's start with the MSA question. We have always been considering that there will be other competitors. It's not a very busy space. It's kind of the little brother of Parkinson and gets less attention. But as you noted, there was a readout very recently with a smaller trial, not so different from ours in size, but quite different in design. with this iron chelator. And it definitely looked like something was going on there. We're looking over that data. We don't know more than what they presented in Investor Call. But I think I welcome more actors in this space. We are not particularly concerned about enrollment. We have a head start here. They announced that they will progress and that will obviously come after proper regulatory interactions. So they will probably be in the back end of our enrollment activities if you worry about that. And I think the more noise and more activities around one indication sometimes helps each other. This is an oral agent, yes, but we know so little and there's so much more to learn here. So I think it's really too early to say more than that. Sometimes IV administrations are better convenient for some patients that are immobilized and have hard times following and speaking. So at some stage of the disease, it could be a benefit to have a parental administration. There are other programs in this space, other antibodies. They have not gone into MSA other than the Takeda program together with AstraZeneca and MedImmune that we follow. We have not yet seen any readout from that phase 2 trial. Maybe Timeline Bexicasirine, if I understood. Yeah, I mean, obviously, when it comes to timelines, the critical one is now to execute the two pivoted trials that are starting up right now. As I said before, we're just at the very, very start of a trial, and that's the period when there are a lot of things going on, site activation, rolling out in your countries, etc., A lot of activities. We're very busy with all these things. As usual, we're starting up a big program. So timelines, we have estimated being the same as we communicated before. But we need to come back when we really see how enrollments go around. the world um obviously this is one of top priorities so it's and we have a good team integrated now into the lundbeck team so we're looking forward to continue the good work done by the former longboard team many of this thing ptsd yeah um As I said before, we don't really know much more than that they need more time, FDA. And obviously, there could be other delays. It's in the hands of government and other organizations in the U.S. We just have to follow what they communicate to us. So each one still remains what we believe is reasonable. If that wouldn't happen, it's an extraordinary situation.

Thank you.

Ladies and gentlemen, this was our last question.

Good. So thank you for joining the call today. I look forward to interacting with you for the rest of the year. Thank you so much.