H Lundbeck A/S B

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

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

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

Thank you, Tom. And let's now take a look at the Abilify franchise. Next slide, please. There it is. Here we continue to see sales progressing very nicely with 11% growth versus the same period last year, now at 2.858 billion DKK. And this is driven by the Abilify two-monthly or the Asymptify formulation, which is now launched in 24 countries around the world. The conversion, as you can see on the right side of the slide, from 1M to 2M, is progressing very strongly, where we see 18% TRX share and 20% NBRX share in the US, and an average conversion rate just above 17% in Europe and international operations. We further continue to see encouraging conversion from orals at 59% in the US and an estimated 40% conversion across Europe and international operations. Earlier this year, we saw generic entry of Abilify One Monthly in Australia, and we now have confirmation that two generic versions of Abilify One Monthly has been approved through the decentralized procedure in Europe, as well as in Canada. We expect to see the first launches in the beginning of 2026. Next slide, please. As previously announced and also mentioned by Charles in the opening, we have recently taken important steps to evolve our commercial model by partnering our commercial operations in 27 markets. This is really a signature project in our focused innovator strategy and a key pillar. The purpose of the change is to sharpen our focus on our key markets, markets that drive over 80% of our revenue and markets that also represent 80% of the market potential within neuro-specialty and neuro-rare. I'm pleased to share that the project is progressing as planned and we're on track to complete the transaction by December 1, thereby allowing us to maintain business continuity in these geographies and ensuring continued access to our medicines for the patients. With this critical project, we reduce complexity across the enterprise, and we also free up significant capital that we can reallocate across the enterprise into commercial growth and R&D. It also further allows us to continue to sharpen our focus on our key markets, and thereby maximizing growth of the strategic brands, ensuring that we have the strong readiness we need for the upcoming losses of exclusivity, and importantly securing the build-up and preparations for our neuro-rare and neuro-specialty model. With that, I'd like to hand over to my colleagues Johan and Maria to give you a portfolio update.

Thank you, Mikael and Tom. It's great to see the continuous strong commercial performance. Yeah, let us now turn over to the portfolio update from Maria and I. So, next slide, please. So, let me start with Eptinuzumab, our brand via Epti. We are making good progress on the Asian expansion, which remains the key future growth driver for Epti. The door opener for this were data obtained through the SUN program, in particular the SUNRISE trial. The SUNRISE trial confirmed the efficacy and safety of Iptinuzumab in a predominantly Asian population, with results comparable to previous pivotal trials. Importantly, the trial also substantiated a rapid onset of action. Data were reported in full in June at the European Academy of Neurology Congress and are also now published in Cephalgia in August. Iptinosumab was filed for approval in Korea in early August, as reported last quarter. We have now also filed in China, and the submission in Japan is progressing as planned. In addition, during the quarter, the FDA finished a review and acknowledged the clinical relevance of the previous relief trial. The relief trial demonstrated that when VIEPTI was given during a moderate to severe migraine attack, patients eligible for preventive treatment showed rapid relief of headache, pain, and migraine-associated symptoms. For example, VIEPTI demonstrated efficacy within two hours after start of infusion. and led to a median time to headache pain freedom of four hours versus nine hours for placebo. Also, the treatment reduced the need for rescue medication. The data from the trial are now included as a third clinical study in the US prescribing information for YFD. I also like to mention that we at the International Headache Conference 2025 presented new data from the Resolution Open Label Extension Trial in a very severe migrant population and in the Sunset Extension Trial of the Asia Pivotal Program, both underlining eptinuzumab's sustained efficacy and safety profile. Taking together these developments highlights how we continue to expand our reach and further document the clinical strength of eptinuzumab. Staying within migraine, our Proceed Phase 2 adaptive trial on the anti-PACAT antibody 222 is advancing very well, and we expect full trial results, as Charles already mentioned, in Q1 2026. Bear in mind, the PACAT inhibition offers a distinctly different mechanism of action compared to blocking CDRP signaling, potentially addressing a broader spectrum of migraine biology. Let me also spend a moment on our alpha-synuclein antibody, Amlinitug. As you may recall, based on our very encouraging data we obtained in the Phase IIa AMLET trial, we initiated a pivotal program by this time last year. This global Phase III trial called MASCOT is evaluating Amlinitug's potential to become a first-in-class and first-in-indication treatment in MSA. The mascot trial is progressing very well with site activations completed across geographies and strong recruitment momentum. The high interest to enroll in the mascot trial is obviously driven by the enormous medical need in MSA. However, the program is also recognized for its highly innovative design, for example, applying a basic progression modeling statistical approach suitable for diseases such as MSA. The scientific and medical interest in the program was indeed something that was observed in the International Congress of Parkinson's Disease and Movement Disorders in October. In urinary epilepsy, the Bexar-Catherine DEEP program continues to make steady progress. We have now the three DEEP trials approved in all geographies, and site activations are progressing strongly. In addition, the program recently received a breakthrough therapy destination in China, reflecting a strong confidence in its therapeutic potential for patients with developmental and epileptic encephalopathies. The results of the Phase II Pacific trial on bexacathrin were recently published in Epilepsia, and presented at the International Epilepsy Congress in Lisbon. This data reinforced the durability and consistency of bexacathrin's treatment effect across DEs. Overall, the bexacathrin program sees strong engagement from KOLs, patients, and caregiver groups. In summary, the quarter has seen substantial progress across our late-stage trials with strong execution and expanding global reach. Next slide, please. Let me now turn to another important event in our early development portfolio, this time on our 515 program, our CD40 ligand blocker that's being investigated in thyroid eye disease, TED for short. We are currently running an open-label Phase 1B study. At an interim analysis, we have already observed very encouraging data. First, we've seen a notable decrease in antithyroid-stimulating hormone receptor autoantibodies. Consequently, we have been able to establish target engagement as well as proof of mechanism. Moreover, and more importantly, the TED patients also showed a clear reduction of proptosis. As you can see from the graph on the left side, proptosis reached over 2 mm reduction over time, looking at change versus baseline. This extent of change is considered clinically relevant and used as a primary endpoint in registration trials in TED. So via this exploratory study, we have now not only obtained a clear signal suggesting that 515 is affecting disease-relevant autoantibodies, but also that the CD4D blocker may be efficacious in TED patients. 515 is investigated in TED based on our understanding of the CD40 biology. The CD40 ligand plays a central role in immune activation and B-cell production. By modulating this pathway, 505 may influence inflammatory processes central to disease activity, but it may also affect other changes, for example, fibrotic tissue formation. More broadly speaking, the recently obtained data on 515 exemplifies how we are implementing our strategy by the use of smaller Phase 1b patient studies as a determining decision gate before progressing to mid-stage development. As another example, at our Q2 report, we shared information on a Phase 1b study on 996, a first-in-class oral D1-D2 agonist in Parkinson's disease that triggered the preparations for a larger Phase 2 trial by start next year. Likewise, based on the strength on the exploratory study 515 in TED, we are now preparing for next steps. We are therefore rapidly progressing in the design of a phase 2 trial in TED, also to be started next year. With this, I'd like to hand over to Maria, who will speak a little bit more about the further potential of this program.

Thank you very much, Johan. And when thinking about 515, it's important to retain that despite meaningful progress in recent years, thyroid eye disease remains an area of deep unmet need. TED has seen innovation, but not resolution. Up to two-thirds of patients experience incomplete or only temporary benefit from existing therapies, and what was once viewed as a single active phase disease is now increasingly recognized as chronic and relapsing, a condition where long-term immune control is critical. The T.E.D. market is growing rapidly, projected to nearly double from 2.2 billion U.S. dollars today to 4 billion by 2034, fueled not only by greater diagnosis and biological adoption, but by the shortcomings of current care that drive emergence of novel treatments. Of nearly 2 million people with T.E.D. in the U.S., less than half are diagnosed, and about 100,000 moderate to severe patients remain candidates for biologic treatment. The existing options have shown what's possible, but also where the bar still stands. Limited durability, safety constraints, and relapse rates that remain high. Even for responders, treatment burden and risks from hearing impairment and hyperglycemia to infusion reactions do restrict long-term use. That's why our CD40 blocker represents a true next-generation opportunity, a first-in-class mechanism designed to intervene upstream in the immune cascade, offering a the potential for safer and more inclusive disease control. Importantly, TED is just the beginning. CD40 inhibition is a platform opportunity, a pipeline in a product, with potential across multiple autoimmune and immunologic indications. With a strong biomarker foundation and a unique mechanism of action, this molecule positions LUNBEC at the forefront of neuroimmunology trailblazing, aiming to build long-term value across a number of different stakeholders. Value for patients with meaningful sustained benefit and improved quality of life, value for physicians with confidence in safety and durability and a broader eligibility, for payers and healthcare economies with reduced relapse and surgical burden, delivering long-term savings, and ultimately value for Lundbeck and its shareholders by delivering clear differentiation, multi-indication potential that drives enduring value. And to take us through the financial results and outlook, I would like to now hand over to Jörg.

Thank you very much, Maria.

From a pipeline for product to a readout of strong financials, it was another strong quarter for Lundbeck as we continue to deliver solid performance with double-digit revenue growth in the first nine months of 2025, reflecting robust operational momentum. Vietti and Rexalti remain standard performers, supported by disciplined execution and efficiency gains. Our adjusted EBITDA margin reached 33.8%, underscoring our disciplined capital strategy that balances future investment with near-term delivery and maximizes returns through focused, efficient capital deployment. Reflecting the stronger momentum of VIEPTI and Rexalti, driven by additional investments, allows us to raise and narrow our full-year guidance for this year, but Let's move to the next slide for a deeper look at the financials. Revenue reached 18.5 billion, growing 14% at constant exchange rates, driven by continued strong performance across our strategic brands, which grew 20%. The adjusted gross margin was 87.8%, driven by the effect of costs related to a manufacturing contract for Amlenetuk. Sales and distribution costs increased slightly, by 2% to 5.7 billion, reflecting the redeployment of resources after the US Trintelix divestment and our continued investments in VIEPTI and Rexalti in the US. Admin expenses unchanged and in line with expectations. R&D costs increased by 2%, reaching 3.4 billion, mainly driven by the continued progression of our Phase 3 programs for bexacarcerin, damelinatoc, and a maturing mid-stage pipeline. The increase was partially offset by the margly impairment loss recognized in the third quarter of 2024 in the amount of 540 million. Adjusted EBITDA grew 22% at constant exchange rates, mainly driven by the strong performance of strategic brands. And the adjusted EBITDA margin expanded to 33.8%, up 2.2 percentage points, reflecting strong operating leverage and continued disciplined capital reallocation. Next slide, please. EBIT rose 58% to 4.9 billion, driven by higher gross profit, the reversal of the biaptive provision for inventory obsolescence. This performance was partially offset by commercial restructuring costs and prior year impairment losses. Net financials reached an expense of 773 million, mainly due to unfavourable currency effects, mainly from the US dollar, and high interest costs related to the new debt obtained in connection with the acquisition of Longboard. Our effective tax rate was 22%, and in line with expectation, And net profit increased by 26% to 3.2 billion, while adjusted net profit and EPS rose by 10%, reaching 4.3 billion, reflecting the strong EBIT development partially offset by higher financial expenses. Next slide, please. Cash flow from operating activities was in line with EBIT performance, reaching 4.6 billion, partially offset by higher prepaid tax payments, inflecting expected full-year income. Cash flow from investing activities was an outflow of 409 million, mainly related to investments in property, plant and equipment. Last but not least, cash flow from financing activities was an outflow of €5.3 billion, mainly driven by the repayment of the loan facility used for the longboard acquisition and the dividend payment to shareholders in March 2025. This was partially offset by a €500 million bond issuance in Q2 to refinance the longboard acquisition. Next slide, please. On November 11th, we raised our full-year revenue and adjusted EBITDA guidance at constant exchange rates, reflecting continued strong year-to-date performance and positive momentum across the business. Revenue growth is now expected at 13% to 14%, up from 11% to 13%, driven by stronger-than-expected demand due to additional investments for Biapti and Rexalti in the U.S., Both brands continue to deliver robust growth across key indications, as Mikala alluded to. We now expect generic entry for Abilify maintainer in Europe in 2026. Adjusted EBITDA growth has been upgraded to 22% to 25% from 16% to 21%. reflecting the solid top-line performance and the successful execution of Lundberg's capital reallocation program, which continues to enhance operational efficiency and profitability. Our delta between constant exchange rates and reported rates remains for 2025 as previously guided, around 1.5 percentage points below CER growth, and adjusted EBITDA around 1 percentage point below CER growth. The dollar FX rate has moved sideways between Q2 and Q3, but is of course substantially below the beginning of the year and the average FX rates we have seen in 2024, which for the time being we foresee carrying over into 2026 and our future FX hedging level. Overall, a very good quarter and outlook for 2025, reflecting the additional upside achieved by targeted investments and cost discipline. And with that, I would like to hand over back to Charles for final conclusions.

Thank you, Jörg, and thank you to the team. So, let me make a few closing remarks before we open for questions. If you can have the final slide, please, as a summary. So, first key takeaway for you is we are in a much stronger position than we were one year ago. We are advancing very strongly on our strategic path through very clear focus on growth, on innovation, and on funding. And we also see across the quarters, as we have also again demonstrated today, that we are very clear in our focused execution of our strategy and, of course, very confident also in our mid-term guidance that we have provided. And our focus innovator strategy as a final reminder is there to drive sustainable long-term growth for Lundbeck into the next decade. So with that, I would open the floor for questions.

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 have entered in the queue. If you wish to remove yourself from the question queue, you may press star and two. Questionnaires on the phone are requested 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 the line of Charles Pittman King from Berkeley. Please go ahead, sir.

Hi, guys. Thanks very much for taking my questions. One quick question, please, on FY26. Just trying to think about the expected bridge to margin given the divestment of your rights in non-core regions and this kind of doubling down on the Brintlex Abilify erosion expected over next year. I'm just wondering kind of how, directionally, how we should be thinking about that. given the strong operational leverage that should be offset, which Viopsy and Rick Felty should offset it with. I'm wondering specifically if you could just touch on your thoughts around where FY26 consensus is, including the kind of FX headwind implied with your current hedging levels, just anything you can give. I know that's 3Q, you usually speak at 4Q, but just anything you can give us actually would be really helpful. And then just secondly, a quick question on VIEPT. Given the label update, I'm just wondering if you could give us an idea of what the implication is of this for your formal discussions, given Lundbeck has been aiming to shift VIEPT earlier in the treatment paradigm for migraine and just maybe the split of current use in the various lines of treatment that you see today versus recent quarters. Thanks so much.

Thank you, Charles. And why don't we start with VIEPTI, and then we can go to your question on 26. Johan, would you?

Thank you, Charles, for that question. We submitted an SNDA for review, and this was ending up with a label update, as you understood, which is very, very important because it includes one more study, study three, as it's called, the relief study, which really verifies the very early rapid onset of action. But it's still under the umbrella of the original label, the indication label. But it gives us data to promote and support the use in acute ongoing migraine in prevention paradigms. But Tom can answer a little better how we can leverage on this.

Sure. Thanks for the question, Charles. We see this commercially as an element that enhances the overall clinical value proposition of VIEPTI to really further strengthen what the perception is in the marketplace of having superior efficacy, and we continue to work hard to drive VIEPTI earlier in the treatment paradigm, and we're seeing some good progress in that direction.

Great. Well, let me take the two questions. I think the first one is of course it's a little bit too early to give a full year guidance for 26. I think overall we provided mid-term targets until the end of 27 of a revenue CAGR of mid single digit and that's basically the guidance we currently still see valid. In terms of Abilify maintainer, this is something that will impact us next year, but it's also for us finding out a little bit more of the details of what are the assumptions country by country and also the expected erosion curve. And I think if you look into the effect out of the comm partnership project, then I think as we provided with the press release, we see probably an impact of around 650 million of capital that we're freeing up. On your question regarding hedging levels, we hedge our foreign currency exposure forward looking 12 to 18 months. So in principle, we are nearly fully hedged also for 26. I think the best indication I can give you is to take the current FX level of the Danish crown versus dollar also as the, you can say, average hedge rate for 2026.

Understood. Thank you.

The next question comes from the line of Christy Rossi-Stewart from NBP Paribas. Please go ahead.

Hi there. Thank you for taking my questions. It's Christy Ross-Stewart from BNP. So just firstly on Abilify, you're calling out kind of the 30% share of Abilify Maintenance in several European markets. I'm just interested to what extent you believe this has potential to even grow a little bit in Q4 before you see the generic impact in 2026? And maybe just some color on your experience this year in this quarter in Canada, where you saw greater generic erosion than you expected, and just a bit of detail on kind of where that erosion came from. Was that from patients on O-Synthify only, or did you also see a decline in maintenance prescriptions as well? And then on the TED asset, just looking at your... Just interested to see how you're thinking about the value proposition and positioning for the CD40. So are you thinking about this as a paper like, you know, offering high efficacy, but then... they obviously are played by a few kind of tolerability issues or more like a kind of position that the FCRNs and IL6s are going after, which is the kind of lower efficacy but improved tolerability. And related to that, are you pursuing a sub-Q formulation with this asset like the other kind of later stage pipeline assets here? And just a very quick clarification if I may as well, one of your early slides says about the Asia filings for VIEPT coming in Q4 2026. I just wanted to confirm if it is indeed 2026 or Q4 2025. I think we're expecting that by the end of this year. Thanks very much.

Thank you, Kirsty. So I think the question on our views on our assumptions on LOE, certainly the Canada learnings, and then also how you think about Abilify. Michaela, would you?

Yeah, so thanks, Kirsty, for the question. Let me see if I can take it one by one. So on Abilify, you asked about our expectation for the rest of the year. And of course, we continue to see, as I showed, strong conversion rates with the two monthly formulation, both in the U.S. and Europe International, and we expect to continue to see that also into next year, which, of course, helps us protect the franchise. And when we talk about the Brinzelex Canada erosion, actually the erosion has been as expected, but it happened slightly earlier than we had anticipated. So you can say the curves happened as, of course, there's both an erosion in volume and there is a price impact immediately at launch. and the curves have followed our expectations, but as I said, they just happened a little bit earlier. So, of course, in terms of forecasting the erosion curves, you see both the dynamic on price, also across Europe, and then you see a volume curve, and there, of course, the Brinzelex gives us some learnings. We're here dealing with Abilify. It is an injectable. It's across both vial and pre-filled syringe, so there are a few more dynamics at play here, and then, of course, you have the multitude of countries with different... dynamics as well that will also have an impact on the erosion curves per country.

Johan, do you want to talk about TED?

First of all, let me emphasize the data I showed today were in acute TED. As you may be aware, there are two distinct conditions, acute and chronic. The chronic one is the second one people look into, and that's obviously when the acute inflammation is down and the progression of the disease has ceased. What we're aiming for here is to continue to evaluate this drug in both acute and chronic, which is very fundamental also because the mechanization is, as I mentioned, maybe also reaching into fibrotic tissue, which could have an effect on the proptosis. Yes, the higher efficacious drugs come with side effects and durability problems that are pretty severe. And we have no evidence from the CD40 class that that would be a liability. So in our studies so far and in other people's studies on this mechanism, they have really seen a very beneficial safety profile. So you're obviously right, durability is going to be important. In terms of efficacy, yes, we're looking for the chronic part. But our data are actually quite encouraging. So we'll see what we can get in terms of more than two millimeter, because that's the key one. I'm reversing the proptosis. Totally to tell. Lastly, you talked about sub-Q, and that's something we eventually will explore. It's an IV right now. So the next step is a more extensive dose-response study in TAD, chronic and acute. And through that, we can explore whether we can push the limits of this drug to get sub-Q.

Thank you, Johan. And we confirm submissions in Asia is Q4 2025. Yes. Thank you. Yes.

As a reminder, if you wish to register for a question, please press star and 1 on your telephone. The next question comes from the line of Mark Goodman from . Please go ahead.

Hi, everyone. This is Alyssa on for Mark. Thank you for taking my question. I'm curious for the Bexacastorin program, are you collecting any data that might give an indication on any cognitive benefit over time? or other kinds of developmental endpoints that might give an indication on cognition. Also, have you given any guidance on when we might expect top-line data for that program? And then finally, the restructuring that was recently announced, you said in the press release it will begin to commence in November. I'm wondering when we'll start to see the full impact of the restructuring, if it will be a slow ramp over the next few quarters. Thank you.

Thank you, Lisa. So, Johan, would you comment on vexacastrin?

Yeah, I can start with your question, cognitive benefits. That's a really, really great question. First of all, we're not seeing vexacastrin as a true disease-modifying mechanism, and some people look for cognition more with a longer-term disease modification, but it's a symptomatic modification that eventually can lead to improvements. Cognition is notoriously difficult to measure in children of different ages. So that's clinically something you don't put high on your readout. Of course, we are going to look at those things eventually, but that's not the main part of the program.

Yeah, the second question was on the top line readout.

Yeah, the readout. So as I said, the trials are progressing as we expect, and I think we have communicated our expected readout, and we have not changed on that timeline projection.

Thank you, Johan. Michaela, you want to talk about our commercial operating model?

Yeah, thank you for the question, Lisa. So essentially, the business will transition to the partners by December 1. We will be fully transitioned over. And of course, we have been working for the last many months on planning for this and been in close dialogue with the partners. And therefore, of course, we expect that there will not be a slowing. It will basically be that we continue operations as we did before. As we also mentioned in the press release, several of our employees will transition to the partner that is ongoing. Those processes are ongoing and not completed yet. But given that, of course, also it is our clear expectation that this will transition over and there won't be such an impact on the ongoing business.

Maybe I'll just add, in terms of restructuring cost perspective, we have fully recognized $360 million as one-time costs in our Q3 figures.

Thank you.

Thank you very much.

The next question comes from the line of Lucy Codrington from Jefferies. Please go ahead.

Hi, thank you for taking my questions. A couple on the pipeline, please. Just in terms of Rexelty for Alzheimer's agitation, obviously we have the upcoming readout of Coventry in Alzheimer's psychosis. And I just wanted to get a better understanding of the overlap between those two conditions. How well are they differentiated and is there any potential overlap between the two when it comes to treatment? And then related to that in terms of the primary care rollout, just so I can understand this, is this targeting primary care physicians in a bid to make them more comfortable using My understanding would be that a primary care physician might be more comfortable kind of refilling an antipsychotic rather than doing the initial treatment. And it's the aim to try and improve that initial prescription from a primary care perspective with an antipsychotic. And then secondly, on your amlenotug, any read across from the recent failure of Decatur and AstraZeneca? alpha-synuclein antibody that was reported this quarter. I know it had taken a long time for that study to read out, so perhaps no surprises, but just any insights you might have on the differentiation between the two. And then finally, on Vietti, and forgive me if I've totally misunderstood the market here, but Do you actually have an idea, are all patients treated within the VIEPT infusion network? And if not, what proportion are and do you have an aspiration of what proportion you would like to eventually get treated within the network? Thank you.

Thank you, Lucy. So I think we start with the Rexalti question related to CoBENFI indication.

So obviously agitation and aggression, that is the Rexalti indication, is a much broader tent. And sometimes you can see psychosis as a brother of agitation, but it's a more specific symptom. I'd like to just emphasize that with Rexalti we've seen a set of effects that are strongest in the most bothersome symptoms of agitation aggression. And those bothersome symptoms are not generally psychosis. Those are other symptoms, physical or non-physical, verbal abuse, spitting is part of this, and pushing and showing. So we have a very, very strong profile on a broader set of very troublesome symptoms that drive caregivers to, quite frankly, often give up the care. Psychosis is a subset where you have, as you know, hallucination, etc. That is less playing out, but it can lead to aggression. So that's why they're related to each other.

Thank you, Johan. Primary care focus on Rexalti.

Sure, so thank you for the question, Lucy. As you may or may not know, we have really defined three targets for our AADAD sales force, primary care physicians, psychiatry, and neurology. If we look at our current market contribution, over 60% of the prescriptions are coming from primary care, about 25% from psychiatry, and the remaining from neurology. Based upon what we've seen in the marketplace, the rollout of our expanded sales force will have 80% of our physicians will be targeted within the primary care segment, and they will be called on both for AADAD as well as MDD.

Thank you, Tom. So, the question on Amlinatog and our views on the mechanism of action differentiation.

Thank you for that question. It is the med-immune AstraZeneca molecule that Takeda had in collaboration. The readout is quite limited impact on how we view our own program Amlinitug. Let me explain a few reasons why. Our Amlinitug molecule has an active clearance mechanism. An antibody has something called an FCN, and the FCN is active damlinitug, which actually enhances the clearance of the debris, meaning the different seeds of fosinuclein, through microglia and macrophages. The Takeda AstraZeneca compound does not have that. So it's a very, very distinct and different mechanism. Also, the taquita molecule has shorter half-life and some other characteristics, some safety monitoring that they had in the trial, which we don't have. But I think the key, key one is really that the mechanism is clearly distinct. And if you have some read-through from the Alzheimer field, you know those drugs that made it to the market have active immune clearance through the innate immune system, meaning an FCM that is active.

Thank you, Johan. The VIN network in VIEPTI.

Yes, so thank you again for the question, Lucy. We have continued to drive more and more patients through the VIEPTI infusion network because we think the patient experience is a better experience based upon higher conversion rates and even best-in-class persistencies rate. If we look back in 2023, only about 12% of our patients patients were going through the VIEPTI infusion network. That number is approaching 30% now, and we expect to continue to drive a greater and greater percentage of the business through that channel.

Thank you, Tom.

Great. Thank you.

We have a follow-up question from the line of Charles Peatman King from Barclays. Please go ahead.

Hi, guys. Just one quick follow-up. Wondering what your – just given the kind of progress on tariffs made over the course of this year and NFN agreements between Najcap Pharma and the U.S. administration, just wondering what your thoughts are in terms of trying to quantify any tariff risk in 2025 or 2026. but also what your outlook is for the potential impact of MFN on London's business. What are you expecting? Are you expecting to have to negotiate with the administration, or do you expect 232 tariffs to impact more broadly and no opportunity for avoiding those tariffs through a deal? Thank you.

Yeah, thank you, Charles. So first on tariffs, of course, it's more complex from a supply chain perspective. We also have a partnership with Otsuka. But as things stand now, year to date, we have had no impact on tariffs in our current 2025 numbers. And of course, we keep monitoring it very closely, understanding perspectives on different deals being made between geographies to better quantify 2026. But at this point, It's not possible for us to fully quantify that. On the most favored nation part, we, of course, keenly watch the deals that are being made and monitor the progress there. But at this point, there is too early for us to comment on any impact it might have on our business today. Understood. Thank you.

Ladies and gentlemen, that was the last question. I would now like to turn the conference back over to Charles Wangzi for any closing remarks.

Yeah, again, thank you for joining, of course, today. I appreciate your questions and look forward to meeting all of you very soon and also, of course, for our next engagement on the full year results. Thank you again.