Great. Good afternoon. I'm James Gordon, J.P. Morgan European Pharma and Biotech Analyst, and today I've got the pleasure of introducing the Lundbeck Presentation and Q&A at the J.P. Morgan Conference. So we have Lundbeck CEO Deborah Dunsire joining us for the presentation for 20 minutes, and then we'll have the Q&A straight after. So with that said, looking forward to the presentation, and over to you, Deborah. Thanks, James, for the introduction, and thanks everybody for joining us today. On slide two, you'll see our forward-looking statements, and you'll be glad we won't be reading them aloud. We're talking to you today about, on the next slide, we've made significant progress on our strategy to expand and invest to grow Lundbeck across all our five strategic imperatives. Obviously, critically important for the business is the growth of our brands, and we now have four strategic brands: Rexulti, Abilify Maintena, Trintellix, and now Vyepti that have given us a really strong portfolio of growing assets. We've seen accelerating momentum for Vyepti in 2021 versus the height of the pandemic year in 2020 when we launched, and we're also profiting from driving a digital agenda within Lundbeck to support not only the existing brands but also our R&D portfolio. We've expanded our operating space, taking us broadly into neuroscience, focusing on brain health, and really focused in niche psychiatry, niche neurology, and rare disease neurology, and made significant progress in R&D of transforming Lundbeck's R&D, getting it ready for the future, building a way to de-risk in development through the use of biomarkers. We've also made significant progress transforming the culture and the operating of the company to be much more agile and flexible, much more cross-functionally collaborative, really strengthening the performance culture of the organization. We maintain a focus on profitability with a clear target for our EBIT to return to 25% or greater by the end of 2024. Next slide, please. So as we focused forward, we've continued to refine that strategy and taking Lundbeck as a mid-sized company, saying that our goal is to focus in brain health in areas where we're focused on indications with very high unmet medical need that are treated by the specialists, where we don't need a broad commercial footprint covering primary care, indications where there's tractability with biomarkers. So that we can plan and de-risk development, de-risking early, making decisions early on which compounds can really make it into late-stage development and to the market, and focusing on areas where we can get sustainable innovation premium for our products, so in R&D, we've moved to continue the strength that Lundbeck has in signaling but add other areas of novel biology in neuroimmunology, neuroinflammation, in neuropeptide signaling, and also continue to build in protein aggregation and protein folding deficiencies. We've made transformation in R&D, turning over around 40% of the organization to be able to bring in talent and new capabilities in biomarkers, in neuroinflammation, and we've made good progress with late-stage lifecycle management. We saw the DELIVER trial, phase III-B trial, in previous preventive therapy failures for Vyepti in chronic and frequent episodic migraine. Our Rexulti agitation and Alzheimer's trial is on track to deliver in the middle of the year. We've made progress in rebuilding the mid-stage pipeline with two assets having entered phase II development: another neuropeptide molecule, a PACAP inhibitor, which is going exploring that biology first in migraine but has a range of other biology that we can go after, and then our alpha-synuclein mAb compound, and I'll talk to those a bit later. So we're rebuilding the pipeline both through internal and external innovation. Next slide, please. We've got good growth visibility for the foreseeable future, targeting mid-single-digit growth over the next five to seven years, an EBIT margin of 25% by the end of 2024, and maintaining our dividend policy of 30%-60% of net results. Next slide, please. The strategic brands through the first nine months have continued to be the major revenue contributors, and all four brands showed double-digit growth in local currency of 26% in local currency in Q3 of 2021. Of course, we do need to say that that was versus a quarter in 2020 that was heavily impacted by the pandemic. The strategic brands are DKK 6.8 billion through the nine months, and strong growth obviously coming from Vyepti, the newest launch, but also Brintellix, Trintellix, and Rexulti, with the year-to-date growth having been somewhat impacted by the COVID-19 dynamics, particularly in depression, where we haven't fully recovered the pre-COVID-19 diagnosis levels. We also had some Forex headwinds, but that impacted a bit during the third quarter. Next slide, please. Vyepti did launch in the height of the pandemic in 2020, so 2021 was a year of significant growth and recovery of momentum, and we do plan for more than 15 launches in 2022. We did get a positive CHMP opinion in November and anticipate the EMA approval in the first quarter. Vyepti has consistently delivered the strongest efficacy of the class, together with a very fast onset of action and a sustained effect lasting at least 12 weeks between infusions. Additionally, it's the only anti-CGRP which has medication overuse headache within the approved label, again a testimony to its efficacy. We are developing the product for global utilization with our Asia development in the Sunrise trial for Japan, Sunlight for China, and then, of course, an episodic cluster headache, our Alleviate trial. The Deliver trial we did communicate data on, and that trial shows the powerful effect of Vyepti in treatment prevention failures. Next slide, please. The study details on that: we had 892 patients, and Vyepti not only delivered the incredibly strong significance in the primary endpoint but also hit on all the secondary endpoints, including some of the more health economic outcome measures like the Headache Impact Test measurement. So this was a trial we did to ensure that we had the dataset in preventive treatment failures for European reimbursement, but it just underscores the extremely powerful efficacy of Vyepti. So we look forward to the growth of this brand for many years to come. Next slide, please. Brintellix, Trintellix has continued to grow. Europe and international markets have grown particularly well, with very strong second-year post-launch in Japan, Japan having been the fastest uptake of Trintellix in any of our launch markets. We've also had good growth in China in spite of the fact that Brintellix is not included in the national reimbursed drugs list. We've had great data around expanding the profile of Trintellix in major depressive disorders in our RECONNECT study showing that people with MDD who have concomitant generalized anxiety disorder had significant improvement in both depression and anxiety. The RELIEF study looked at Trintellix in real-world study, which demonstrated the ability for patients to really return to their lives and function while on treatment for their MDD. We've finished the recruitment for our trial head-to-head versus desvenlafaxine, and we look forward to data on that trial later this year. Next slide, please. Rexulti has grown well, and we were able to achieve the FDA approval for schizophrenia in adolescents through our supplemental NDA that was approved, I think, early this year, right? January, December. Yeah. Okay, December. Our agitation in Alzheimer's disease is on track for a pivotal headline result in the mid of 2022. We hope to accrue the final patients into that trial within the next weeks. Post-traumatic stress disorder, we have communicated, is a challenge that particularly the pandemic seems to have really inhibited people with post-traumatic stress disorder coming in for trials, and so we are considering how to redesign that program in order to get to finalization. Next slide, please. Abilify Maintena, the market has grown solidly, and we've continued to increase market share with Abilify Maintena. The profile continues to strengthen. Things like the PRELAPSE study showed that an LAI like Abilify Maintena can significantly delay time to next hospitalization for patients early in their disease, which is critical because with each relapse, patients lose capability, lose cognition, so delaying that hospitalization for the second episode can be significant for their future. We also had a new initiation regimen, the dual injection initiation regimen approved by Health Canada, and then we have the clinical data on hand now and are awaiting the manufacturing validation data to be able to submit the two-month formulation for approval towards the middle of the year this year, so that will continue to help grow the Abilify Maintena brand into the future. Next slide, please. Within our R&D pipeline, I've said that we've focused in four key areas of biology: the neuropeptide signaling with Vyepti and PACAP. Now our PACAP in phase II. The signaling area where, of course, we've got these strong brands Rexulti, Abilify Maintena, our D1D2 agonist in Parkinson's disease, our MAG lipase inhibitor that is in four phase I-B trials exploring that novel biology, and then our protein folding protein aggregation, our alpha-synuclein in MSA in phase II and a tau antibody still progressing through phase I. Next slide, please. It's exciting to have these two novel molecules entering phase II. MSA, as you know, is a very rare synucleinopathy. It's very fast progressive, and we believe that we could have the first disease-modifying therapy for MSA. The AMULET trial started in the fourth quarter and will continue with 60 participants in this rare disease. Next slide, please. The PACAP inhibitor addressed (it's a ligand binder, so it does address all the receptors to which PACAP binds) could have broader biology than CGRP that could take it into different areas from migraine to other types of headache with the autonomic symptoms of cluster headache, and we are exploring it in a phase I-B in allergic rhinitis, looking at mast cell functioning, so very interesting biology to explore in this particular molecule that came in from the Alder acquisition. Next slide, please, so to summarize, Lundbeck is focused on delivering growth today and building sustainable, profitable growth for tomorrow through maximizing the growth drivers that we have in hand, expanding Vyepti globally and expanding its indications, building Rexulti in its current indications, and then adding Alzheimer's agitation. When we read out that data in mid 2022, we've got really good growth visibility from these strong assets for the coming five years, and then our R&D pipeline is being replenished to deliver for the long term. Lundbeck is a financially strong company with a solid balance sheet, a very disciplined approach to investment, and a company that is building sustainability for the future. So with that, I'll thank you for your attention, and we can go to questions. Great. Thanks very much for the presentation, and the Q&A session is now open. Just as a reminder, you can submit your questions through the website on the Lundbeck page where you've been watching this from, and I should be able to see your questions, and I can ask them for you. You can email them, but I may miss them. I have been emailed one question already. So the email question was on the top line. So the investor noted that Lundbeck talked about the top line growing mid-single digit for the next six to eight years, and as the company has previously said, that could even grow high single digit in years where mature brands outperform. So how should we think about growth in 2022? Have you got an easy comfort of 2021, or are there reasons to be cautious on 2022? So I'm not sure I heard that last sentence, James. Is there an easy something on '21? Yes. I think the question was that you've given a six to eight-year outlook, which is mid-single digit top line growth or potentially faster in years where some of the products can outperform. So then the question is, but when thinking about 2022, does that apply to 2022, or could that be one of the faster years? How to think about 2022 versus the midterm six to eight-year outlook that you've given? Anders Götzsche, I'll take that one. So we are not going to give any indications for the growth for next year and be specific. The question is too specific. The only thing that we have said is that we will grow top line in 2022, and we also is our hypothesis that we will also grow earnings numbers next year. And the components that will be included in that equation is, of course, that we will invest more in more or less a couple of components that will impact is that the revenue will grow, we will have more gross profit. Some of that gross profit will be tied into more investments behind Vyepti in the U.S. We will invest also behind the launches or building up capabilities in the rest of the world, Europe, and international markets, and then there will be a gradual. It will be anticipated that we have more push behind the other strategic brands globally, but net-net, we expect that to have a positive contribution to earnings compared to 2021. Thank you. And because they also asked a second question, which is with relation to operating margins, so you've set a target for quarterly EBIT margin to exceed 30% by 2024 from more like 21% last year in 2021. So should 2022 be a year of significant expansion on that pathway or more of an investment year? I think it would be a step on the way to the 30% plus core EBIT margin, but we have not finalized the numbers yet, so I'm not willing to go into details about margin expansion, but it will be a gradual expansion during the years. So it's not like you should expect a massive increase next year because we will still be in investment phase. We'll still have double or more than 20% investment in R&D due to we have continuously investing in Vyepti. We have the Sunlight and no, yeah, the two Sunlight and Sunrise studies investing in China and Japan, so that will be also a year of investment. But it goes without saying that the U.S. will grow also for Vyepti. That means that profitability is getting closer in the U.S., but then we start to invest in some of the newer countries. The next two years, we'll probably launch 25-30 countries globally, and that will mean that you have some initial investment, and then gradually you would build up your revenue base. I think the other thing to say about 2022 is that 2021, yes, it was impacted by COVID somewhat on the top line, but it also we saved a lot of money that we were not able to invest in the promotion in the same way we might have liked because of the restrictions of COVID. We will see a return to a more normal spending level, and it is a year of investment behind Vyepti. While we do expect the margin to improve versus 2021, it will not be a step change because it is an investment year. Makes sense. Thank you. There's another question here. This might be one for Johan. What would be considered an acceptable safety profile for the PACAP program in headache given the widespread receptor biology? Yeah. Thanks for that question. Obviously, the PACAP biology is a fairly rich biology, but in terms of migraine, which is our main highway of indication, we obviously don't have much margin for safety liabilities. It has to be a high bar for safety when we progress on that indication. We have a rich biology, as I said, so we are contemplating other indications where we may have more tolerability for side effects and intolerability issues, but our hope is that this will be a very tolerable molecule. We have finished quite a few early studies that point that there is really yet no issue with that to achieve that. Thank you. I've also been asked about Omicron and COVID in general, the question being that things seem to be getting better at Q3, but seems to have got worse with COVID. So are you seeing that for your business? What are you seeing for Omicron worsening or not worsening? How is that impacting Lundbeck? Yeah. So interestingly, I think Europe was impacted a little bit earlier in general, not specifically talking about our business, but in general in the U.S. a bit later. So I think we definitely have seen some impact on the U.S. And again, it's patchy because in the U.S., people are moving about their business much more than they were in the early part of 2021, even in spite of a rise in the number of cases. Places that we see impact is in practices where you may have staff out because they have been affected by COVID. So practices are not shutting down. They may stop reps coming in. They may say, "Hey, we want to just see our patients." So that can variably impact rep access. It can impact the ability to potentially give infusions if staff are out. So it's very individual, but as the cases rise in the community, it does have a bit of a drag, but it's not the same as it was in the early part of 2021 or even worse in 2020. And this is a follow-up to that. Could it be then that COVID actually or Omicron actually means that sales and marketing doesn't ramp quite as much in 2022 as you had originally planned? So it could be a negative for the top line, at least in the early part of the year, but it might also mean you don't have the opportunity to really go and spend a lot more in terms of marketing spend? That's always a possibility. It is not what we've been planning for. But of course, you're right. If we're not able to get out, then we won't be able to spend the money, but it will have a downer on the ability to ramp the revenue. I think one place that we have seen kind of a puzzling impact is that in the category of depression, even through the nine months, we hadn't seen a complete recovery of the diagnoses of depression. We'd started to see recovery in more the generics had come back to almost their pre-pandemic levels, but the branded drugs, new-to-brand, had not. And what we attribute that to is psychiatrists have been using telemedicine more, and we know that they're 50% at least less likely to initiate a new-to-brand therapy on a telemedicine visit. So we're hopeful that over 2022, that impact diminishes, but it certainly has been an interesting impact through the 2021 year. Thank you. Could we move to a big trial readout coming up? So questions about Rexulti for Alzheimer's agitation. So one of the questions has been about how sure can you be on the exact timing, and is it exactly mid-year? Is that defined? And then another one, just how confident are you in success considering that the trial wasn't successful at interim? Great. Johan, I think that's your. Yeah. In terms of the timelines, we are looking forward to see the last patients being included. So we are very close to finished enrollment of that study. So we are very confident about timelines. We have a handful of patients still to recruit to reach the 330 subjects we're looking for, 330 subjects. In terms of confidence of data readouts, of course, you need to see the data to be confident. It's always a risk with the trials, but in this case, we're building on a lot of prior, and the prior here is, of course, two previous trials that we did, bigger trials on slightly lower doses that we're exploring in this particular trial. We had two trials, one at one and two mg fixed doses, and the two mg worked well in that trial, and then in the flexible dose, one to two mg, we had actually starting at 0.5 mg-two mg, we had a good effect in the two mg subgroup, so now we go up to three mg. We have a flexible dose between two and three mg, so we're actually going higher, so that probably gives us pretty good confidence that it could work. In terms of the interim, this was a regular interim that we introduced in the trial after we re-engineered it to increase the sample size to 30 to really make a robust trial out of it. This was a regular interim, meaning we just looked at futility, success with a high bar, or continue the trial, and the trial was allowed to continue. That's basically what we're doing. It was nothing particular with that interim that would make us more nervous about the outcome of the study. High dose could mean stronger efficacy, but it could also mean worse tolerability. What do we know already about whether the high dose hasn't led to any tolerability issues? Yeah. I think we may have been a little timid when we went into this phase III program with going up to a max of two mg. The regulators wanted to see a little higher dose. That's why we introduced three mg. The drug has had a very, very benign profile in the two previous trials for being a neuroleptic drug in particular. We have not seen any particularly disturbing reporting of AEs or tolerability issues or dropouts in this particular trial. So if you look at the blinded data, there is really no signal that we would face any bigger tolerability issues with the three mg dose. It looks like we're pretty much behaving like in the previous two trials. Are there any nuances to the outcome? Is it as simple as it hits statistical significance or it doesn't, or there's anything else important to look out for when you get the data? Yeah. Obviously, the agreement with the regulators is to run a third trial with a positive readout on the primary and hopefully on secondaries. There is always a matter of wiggle room for discussions if we would have some gray zone in the data or something like that. We have those two previous trials with a pretty convincing data set, and they wanted to see that three mg safety data, and that's what we're generating in this trial. So I'm sure there would be some possibility to discuss the data set if it's just borderline significant. If the product is or the trial is significant, or if it's not significant, or if the product is approved or not approved for this indication, does it change anything else at Lundbeck? If unfortunately it wasn't positive and didn't happen, could the company potentially become more aggressive in terms of in-licensing, and could you even reconsider the 2024 target? So it's a really good question. I think we want to be aggressive in building the company, so we keep a strong eye on the landscape in any event. So I strongly hope and believe that the AAD data will be positive, but that in itself would not make us back off wanting to continue with the external innovation. So I think they're in some ways independent because we are committed to looking for those growth opportunities in any event. Thank you. I've also been asked about a different Rexulti trial, which is PTSD. So on this one, I believe at Q3, you noted that there have been some continued enrollment challenges, and you're going to discuss with the FDA. So what is the range of outcomes for that study? Yeah. First of all, we have been quite public about the difficulties of running this trial, particularly the pandemic hit that particularly hard, and the type of patients we're dealing with here are the type of people that don't want to go out, leave home basically, and the pandemic that causes, of course, a much bigger challenge. We've done, together with our partner, Otsuka, who is the main sponsor of the trial, we've done two trials actually going on. It's two sets of trials. We have done a lot to try to regain the momentum of the trial. We're not getting it really back on track. We're far from getting it back on track. It's a difficult indication on top of that to enroll in anyway. So we do have conversations coming up between the partners and also with regulators to see if we can do something about the trial in terms of re-engineering and getting understanding for that kind of re-engineering. I don't want to preempt those discussions and how we will land with those discussions, but obviously, something needs to be done with the trials to make sure we get some reasonable data out of it. Thank you. I've also been asked about Vyepti and oral CGRPs that could now be used chronically. So have you seen any slowdown in new patients starting Vyepti, or the patients using Vyepti change at all with oral options having improved? Yeah. So I think the oral drugs coming into the market have first and foremost addressed the totally unmet for decades need in acute migraine. And then more recently, of course, there has been preventive data. There's a tremendous amount of push in the marketplace. AbbVie has about 1,000 reps on their migraine franchise, a huge amount, $300 million of DTC advertising. And of course, that creates a churn in the market. So I do think that it brings in new patients, people who are not diagnosed, who would come in and seek diagnosis, people who have stepped off therapy because it hasn't done them any good coming back in for new therapy. So ultimately, the overall market grows. But in the short term, when there's a tremendous amount of sampling, a tremendous amount of flash, I guess, in the marketplace, people will more likely want to start on an oral. So I do think that there's some churn short term in the marketplace with the advent of the orals. And of course, the orals do have data that they can support some people, particularly with frequent episodic migraine. In the chronic migraine space, Vyepti has still hands down the best profile. And what we know anecdotally is that even people who have failed on other CGRPs, including some on the orals, have had success with Vyepti. Over time, we look to the market to grow, and we look to Vyepti to be that solution that the headache specialists and neurologists focus on for those very heavily impacted patients and patients that don't necessarily do as well on an oral medication. Thank you. I've also been asked about Vyepti trends. So looking into when I say next year, I think that means 2022, is it a continuation of the previous trend, or could things get tougher because you've got the oral options that are strengthened, or could things get better because the COVID situation hopefully improves? Is the base case that it continues the existing trend? I think we certainly are looking for it to continue to grow. I think that there could be some ups and downs with COVID allowing more patients to come in, with the orals being used, the samples potentially being used. Overall, we're looking for continued growth in Vyepti, not only next year, but over the many years to come. We anticipate that Vyepti will be a slow, steady build over time, not that we'll see suddenly an inflection to an exponential curve. I've been asked, are there warehouses of patients that haven't come in, and I don't believe that to be the case. It's going to be a slow, steady build. Do you have a sense of patients who started on the drug, how many of them, what proportion of them have stayed on the product? Is it snowballing in that sense? Certainly, we're hearing more that patients are getting multiple doses. I think one of the things that we're still adjusting to is how does this behave, for instance, at the beginning of the year where we know in the U.S. people change insurance, and that could make people look like new patients rather than repeat prescriptions. So teasing that out, I think, is going to be a little bit more challenging, but over time, I think we'll build an understanding of how that behaves. But certainly, we are hearing from the physicians that are using Vyepti that they're using it again for patients who've already had it, and that they're using it in more new patients. So we see patients getting repeat dose. We see the same physicians treating more, and we see new practices ordering Vyepti. So there's growth, as you would expect from a new launch, but we're seeing growth in all of those ways, which we're happy about. Thank you. One other one was Trintellix and Rexulti. I think when we were discussing a year ago, there was a thinking that we didn't know COVID would go on so long, but a thinking that the products might be turning a bit of a corner in terms of accelerating. As outpatient products, they may not have been as heavily impacted by COVID, but yet in 2021, the products have still been a bit slower. So is the thinking that it might just be that they're now more mature products, pending any other clinical data that comes along, or is this still a big COVID headwind for them? And if COVID does finally start to go away this year, do you still expect that we will see a significant acceleration in those products? So I'd say they are mature brands, so you do anticipate a rather slowing of the growth rate as brands mature, unless there's some new data like agitation and Alzheimer's for Rexulti. We've been a little bit surprised, and I think I commented about this a little bit earlier with the diagnosis gap in depression, that it's only recently started to come back to the pre-COVID levels, and really the generics have recovered faster, which tends to support the behavior of physicians treating on telemedicine still. And we're hoping that that trend changes. But I do think we're seeing some COVID impact, and we're seeing some mature brand impact. The COVID impact will lift. Obviously, the brands don't become less mature with time. Thank you. A final question I've got is just emerging markets. So the EM angle for the company. So to what extent has the EM business been disrupted by COVID, and are the new launches still happening in the EM, for instance, Vyepti? So could we see an EM acceleration for the business? So it has been somewhat impacted by COVID, but interestingly, one of the mitigators for that was that our Lexapro business did extremely well. So where physicians went to any new diagnosis getting an old favorite, Lexapro really delivered. And I think we actually saw growth, if I'm not mistaken, through the nine months for Lexapro. So that has mitigated. Trintellix, and obviously, it's not an emerging market, but in Japan, that launch has gone extremely well. So in what we report as the international markets business, one of the strengths of Trintellix has been from the launch in Japan and also uptake in China in spite of not being on the NRDL, partly through some of the work we've done on digital channels and other channels for Trintellix. So is there growth in the emerging markets? The answer is yes, as we roll out Vyepti, but that comes over time. It doesn't, certainly not all in 2022, but we'll see growth of Rexulti. We've launched it in a couple of markets. We won't be launching it broadly, but that will continue to grow, and Trintellix will continue to grow in those markets. Great. Thank you very much. We do have a couple of Trintellix patent expiries in the year to comment on. One is Canada, which I think is the third quarter, and one is Brazil, which I think is also the third quarter. So those impacts are out there. Great. Great. Thank you very much. With that, we're out of time. So thanks everyone for Lundbeck for participating in the presentation and Q&A, and enjoy the rest of the conference. Thanks, James. Enjoy, everybody. Yeah, everyone.