H. Lundbeck A/S (HLUNB) Earnings Call Transcript & Summary

Good morning. I'm James Gordon, JP Morgan European Pharma biotech analyst. And today, I've got the pleasure of introducing the Lundbeck presentation. So you're going to hear from Lundbeck's CEO, Deborah Dunsire, and we can have a breakout after this in the Georgian room, and I hope you can join us for that. So with that said, thanks very much for joining us today, and I look forward to the presentation.

Thanks, James. Good morning, ladies and gentlemen, and it's a pleasure to talk you through 2019 up through the third quarter at Lundbeck and looking out into 2020. You've seen the forward-looking statements, so I won't spend any time there. When we think about Lundbeck, it's a company that has a very strong heritage, bringing forward transformative medicines for brain disease. And we believe that gives us the platform to build towards meeting the still huge unmet medical needs in neuroscience. We have a very strong momentum in our strategic brands that will continue to grow into the future. And over time, the company has created a very efficient global infrastructure with a very strong commercial execution across the world. We're looking forward this year to the transformative launch of eptinezumab come out of the Alder acquisition and that being the beginning of a pain and migraine franchise for Lundbeck. We've been expanding our pipeline through our internal discovery research as well as through the access to external innovation through our acquisitions. The company is a very strong, stable, cash-generating company. And that gives us the stability to be able to look both internally and externally to continue to advance the pipeline. Everything we do is squarely founded on Lundbeck's purpose. We're tirelessly dedicated to brain health, to restoring brain health so that every person can be their best. We announced in February of 2019, the new strategy, Expand and Invest to Grow with 5 strategic imperatives. And we made, during 2019, significant progress at a pretty quick clip against all of the imperatives. The purpose of all of that is to build the Lundbeck of the future, building growth drivers into the company for sustainable long-term growth as we transform the lives of patients being able to return to our stakeholders. As I said, the 4 strategic brands grew very strongly through the third quarter as a group, being up 29%. Brintellix or Trintellix, as it's known in the U.S. and Japan, up 31% after several years on the market. This product continues to grow strongly based on the very strong profile delivering an improvement in cognition, fewer side effects like treatment-emergent sexual dysfunction. And that's been a very increasingly popular product that physicians are bringing to their MDD patients. Rexulti has grown strongly, up 35%. It's indicated in major depressive disorder and schizophrenia. And we anticipate continued growth of that brand with some good life cycle management. Northera grew 25%, and Abilify Maintena in the long-acting injectable schizophrenia realm grew 23%. Those 4 brands, with their continued growth momentum, now make up 53% of our overall revenue. It was a year where we invested in growth. And it wasn't just one thing. It was investments behind growth in a number of different marketplaces. One of the most significant being the launch of Trintellix in Japan towards the end of the year in 2019, giving us our own Lundbeck sales force in Japan for the first time, of course, partnered with Takeda. 2019 was a transition year for Lundbeck. Our formerly largest product Onfi went -- lost its exclusivity, and so we had the washout of the decline of Onfi, which, of course, we expected. But you can see how the momentum of the strategic brands really was able to counteract, not fully, but counteract a lot of the decline of Onfi. So 2020, for us, is a year where we will be returning to growth. We also made very significant progress in revitalizing the pipeline. We talked about expanding the operating space, not -- really taking advantage of Lundbeck's broad experience in the development and commercialization of products for psychiatry and neurology. And so opening ourselves up to areas that face those particular customer segments that are in areas where we might not have had our own basic research. And so while we continue to advance products from our own discovery engine, we also went out and did 2 acquisitions, the acquisition of Alder Biopharmaceuticals, which closed in October; and the acquisition of Abide Therapeutics in -- which closed in late May. 50% of the programs in our pipeline are new within the last year. We started the year with 10 projects in development and finished with 14 projects, but that number masks the fact that we took out some programs that we felt were not strong enough to continue. And I think that's the emphasis that we'll have. We look forward to filling the pipeline, but also being very disciplined about only advancing those molecules, we believe, have the profiles that are strong enough to make it all the way through and be strong commercial successes. You can see the shape of the pipeline changes. We've begun to rebuild in the late-stage and the launch of eptinezumab, which PDUFA date is February 21 of 2020, is the first indication in chronic and frequent episodic migraine prevention. But that drug also has the opportunity for multiple other different indications to be explored in Phase III. So the pipeline is a bit more balanced. I think we still have work to do in 2020, continuing to fill the early stage and round up the middle stage of the pipeline. So we're looking at transforming the company through the work that we're doing now in the pipeline. From Alder, we created Lundbeck Seattle BioPharmaceuticals, really focusing our Lundbeck Seattle site in the development of biologics. So looking at the manufacturing, particularly of the biologics. And that's a new capability for Lundbeck. Eptinezumab will be our first biologic launch. The preparation for that launch is well underway. As you might imagine, it's been a whirlwind getting ready for that. But we're delighted to have brought over some of the talented people from Alder to support the launch as well as being able to leverage the skills that Lundbeck has within our North American operation. The acquisition of Abide was at a very different stage of the pipeline. That brought in a new platform to generate new first-in-class molecules against the Serine Hydrolase class of enzymes long into the future. And through that, we created Lundbeck La Jolla research center. We focused down to a small group of researchers who can be very agile in moving that science forward. We started the brexpiprazole post-traumatic stress disorder Phase III, both those pivotal studies are underway. And we instituted a new proof-of-concept trial in borderline personality disorder, a totally unmet medical need. There are no products on the market for borderline personality disorder. And that has received fast-track designation from the FDA. Additionally, we put 3 new molecules into the clinical pipeline. Our PDE1b specific molecule, where we're looking at different psychiatry indications with that. Our humanized IgG1 Tau monoclonal antibody against the seeding forms of Tau, which we think is the most profitable approach to addressing the Tau aspect in Alzheimer's and other tauopathies. And then coming in from the Alder acquisition, a Phase I compound, the pituitary adenylate cyclase activating polypeptide. That's a mouthful. We call it PACAP inhibitor for migraine, different types of migraine than the CGRP eptinezumab. So that's another pillar, I guess, in the migraine franchise. We also have some compounds from Abide that may fit into that migraine and specialty pain franchise. So we've said that the acquisition of Alder is a transformational opportunity for Lundbeck with the launch in the first half of 2020. We'll be submitting to Canada in the first quarter. And then submitting for the EU approval towards the end of this year, getting started on the market access and reimbursement required trials, the trials that we believe are required as we speak. There are a lot of life cycle management opportunities. So we continue to believe that we'll be able to build this brand throughout its life cycle. It has IP up to the mid-'30s. The PACAP Phase I is also underway. Now migraine, particularly, this severe chronic frequent episodic migraine, where people are experiencing 4 to 28 migraine days a month, where their lives are extremely significantly impacted. In fact, migrate is the most disabling disease for people under 50, attacks lasting 4 to 72 hours and happening with that frequency, you can imagine that people cannot live a normal life. So there's a lot of attendant sleep disorders, depression, that travel together with migraine. And so the ability to prevent and break that cycle is the ability to restore more normalcy to people's lives. And there are approximately 18 million individuals in U.S. and EU5 who have the eligibility -- disease that makes them eligible for preventive therapy. Roughly around 1/3 of migraine sufferers experience more than 4 migraine days a month. And this market will continue to grow because there are so many people with chronic migraine that require prevention, but that have been underserved. There have not been adequate preventive therapies. So they have fallen away from taking any therapy, and we are seeing those people coming back in, now that there's effective therapy available. The PROMISE 1 and PROMISE 2 pivotal trials that support the filing, the BLA filing, for eptinezumab, both very consistent, very strong results. 888 patients in PROMISE 1, which is frequent episodic migraine, and over 1,000 patients in PROMISE 2, which is the chronic migraine, more than 14 migraine days a month. And I think across those 2 trials, what was so consistent was a very powerful effect reducing migraine days by 50%, 75% and even 100%, the onset being incredibly fast at day 1, 50% reduction in the number of people experiencing migraine, sustained over the full 3 months. So 1 infusion, 3 months of coverage. And then the patient-reported outcomes were very significant in terms of the HIT-6, and we'll go through that in a bit more detail. When we look at PROMISE 1, it met statistical significance across all -- definitely the primary, but all key secondary end points as well. And obviously, the primary end point is the reduction in migraine days so that was very significant. But being an IV infusion, it's 100% bioavailable and so able to take out the ligand, which is driving the migraine, almost immediately. So at 24 hours, which was the prespecified end point, we already see this reduction by at least 50% of the number of people experiencing migraine, and we see that sustained over the period. With second and ultimately third injection, so over the next few quarters, the response rates actually continue to improve. In PROMISE 2, we saw the same pattern. The onset of prevention at 24 hours and sustained prevention over the first month, second month and third month. 61% of patients had a reduction during the period of 75% or greater, 38% of subjects sustained that 75% reduction throughout the 3-month period between infusions. And so we see this as a very powerful and sustained response rate. The significant reduction in migraine days extended even to people who sustained 100% reduction, so between 15% and 20% of patients experienced 100% reduction in their migraine days. The HIT-6, the patient reported outcome. This is a scale that looks at 6 different measures of what is the impact of the headache on a patient's life. And we saw significant improvement in the HIT-6 at both doses, the prespecified secondary end point was at the 300-milligram dose. So we saw significance at the p 0.0001 for the patient-reported outcomes. And that's sustained over the 3-month period. So the profile of this medicine really meets what we see from patients in the market research. What do patients really want? They want excellent control of their disease, and they want it fast. And eptinezumab or [ Viacti ], as it will be called, delivers that. We see this product growing over many years. And so we talk about the marathon, not a sprint. Well, I guess, the starter's gun we're looking forward to being fired at the PDUFA date of the 21st of February. Things seem to be on track for that. And then getting the global rollout, this will be Lundbeck's first global independent launch, and we will file in Canada in the first quarter, Europe at the end of the year. We're getting underway the Asian studies to be able to expand in China, Japan and the rest of Asia. We're also looking at expanding the indications, and there's a long list of potential indications where the CGRP biology could have significant impact in specialty pain syndromes. For instance, cluster headache, is just one of the potential opportunities. And we look to be starting some of the life cycle management trials this year. When we think about eptinezumab, we feel that it's -- was a great acquisition for Lundbeck. It fits very clearly into our experience base with dealing with neurologists and specialists that are treating patients with brain disease. We have a very efficient commercial infrastructure in the U.S. that has great success with multiple launches over the last, I think, just over 10 years since the organization has been operating in the U.S. We know that the migraine market has significant unmet medical need and that eptinezumab's profile of being able to act really quickly and in a sustained and powerful way is going to be very desirable within the migraine space. It is the only infused product. And that also gives the opportunity for people who see their physicians every 3 months with these chronic diseases. The drug administration fits with the cadence of their visits to their physicians. So we think there's a good synergy there. Turning to a brief discussion of Abide Therapeutics. This was a company spun out of the science of Ben Cravatt's lab at Scripps Institute and focusing on understanding and uncovering the targets within the Serine Hydrolase family of enzymes. Now there are a few Serine Hydrolase-associated medicines on the market, Aricept is one of those. There are 250 Serine Hydrolases, but they've been very difficult to characterize and define the targets and address the targets, so the activity-based protein profiling platform out of Ben's lab at Scripps really allows for the exploration and the definition of target and chemistry that addresses those targets covalently and very specifically to be able to explore this class of enzymes over time. The Abide acquisition brought in the first clinical molecule against MAG lipase, a MAG lipase inhibitor. We had it in a small Phase IIa trial for Tourette syndrome. That'll read out in the first quarter, and that'll allow us to define the further development path forward and help us choose indications that we will take forward. We also have a couple of preclinical compounds that are ready to come into the clinic this year. One of which is non-brain penetrant that may allow us to address more peripheral pain syndromes. So we've sustained Lundbeck La Jolla research center to continue to bring these first-in-class targets into our pipeline over time. When I think about the selected deliverables, it's going to be another busy year for us at Lundbeck. We're looking forward first to the Canadian submission of eptinezumab, then the PDUFA date and action date on February 21 in the U.S., the U.S. launch in March and April, early April of this year. Phase II headline result come out on 2 of our compounds in Phase II foliglurax for Parkinson's disease, addressing off time and dyskinesia. And then, as I said, the Phase IIa for -- in Tourette syndrome with this first-in-class MAG lipase. In the second half, we'll have the EU submission as well as the outcome of a trial we call RELIEF, which is to look at characterizing the rate at which eptinezumab acts within the first 24 hours. We know that by 24 hours, we already have the onset of prevention. Now we're looking at how fast does that happen within the first 24 hours. And so RELIEF should read out by the end of 2020. We're also advance -- look to advance another 1 to 2 clinical molecules into the clinical pipeline from our own discovery. And in fact, the first of those has already started Phase I, our KV7 molecule has started accruing in Phase I in January. So we're on track with that. Expanding investor growth will take us forward into 2020. And we look to continuing the momentum with the strategic brands and growing them, also continuing to develop with the Rexulti life cycle management. Trintellix is launched in Japan, so we'll see the growth of that brand. And I just came from the launch meeting. It's being very well received in the early days, and we look to that continuing. The beginnings of the establishing of a new migraine franchise and a specialty pain franchise for Lundbeck will be probably the center point of the year, given that we're launching a new compound for the first time with eptinezumab, but continuing to develop the PACAP and then looking at other of our molecules where we can build a franchise around that. And then accelerating the innovation, working to bring new molecules forward into the pipeline, both externally and internally, and continuing to look at licensing or partnering as we go forward to expand the pipeline. With that, I'm going to stop, and I don't know whether we've any questions in the room, but we do have our Q&A in the Georgian room. And I look forward to meeting you there. Thank you.

Great. We'll kick off. So good morning, everyone. I'm James Gordon, I cover Lundbeck at JPMorgan in London. And for anyone who's dialed in, this is the JPMorgan Healthcare conference. We've just had the Lundbeck presentation, and now we're going to go into Q&A. And we've got CEO. We have head of R&D. I think we're going to be joined by CFO shortly as well and Head of U.S. Commercial.

North America.

North America.

North America commercial. So yes, if anyone would like to kick off the questions.

Right in the start, very exciting launches have gone. Are you -- where are you in terms of the migraine [indiscernible] North America on the one hand, and on the other hand, obviously, you're moving into J code. What is the process for the J code in terms of timing and what happens in terms of following the pipeline in a J code for such a product?

Okay. So a lot of questions about the preparation for launch, the size of the sales force and the J code process that we need to go through. And that's why we have our expert here. So I'm going to hand it over to Peter.

Yes. So thanks for the questions. In terms of the sales force, we're really well ahead of schedule actually in getting ready for all of that. So we're seeking a combination of some of the great folks that we have had that have led to the success we've had in the United States coming over and kind of seeding the Lundbeck culture and how to get things done in Lundbeck. But we've been able to hire some very talented people that have buy-and-bill, infusion and migraine experience, and we're well on track to have the sales force fully staffed, trained, even out profiling accounts and understanding a little bit more about those customers. Obviously, they can't speak anything about the product. They won't be doing anything before the February 21 date other than just understanding. So those preparations are well on track. In terms of the J code, the process is changing a little bit. So this is our first time going through this with that. We've been through J code process before with Abilify Maintena, which also required a J code, so it's not our first time doing this. But the government -- the CMS, has said that they're going to start reviewing these things more frequently, used to be only once a year. But because we haven't been through that process yet, we can't commit to a time frame other than we believe it'll be approved in a year or less from the time we file. And we can't file until after the approval. So within a short time after the approval, we will file for the J code, and we will have it a year or earlier.

And I think the other part of the question was what happens before you have a J code.

Oh, yes. Thank you. So before we have a J code, of course, they can use a not otherwise specified code, a generic code. And prescription claims can still get through and be reimbursed, but it is a bit more cumbersome. Sometimes because it's a nonspecific code, payers ask for additional information and there could be some iterations, so that's why having the permanent J code just makes things go more smoothly. But it's not like there won't be prescriptions that go through from the very beginning. That's clearly not the case that they won't go through. It just adds a bit more administrative burden.

So is it fair to assume because the doctor has to fill out the paperwork, will he [indiscernible] other [indiscernible] that they might chose to [indiscernible] so to speak in going down [indiscernible]?

, Well, I also don't want to overstate the burden. It's not like it's an impossible task. And to be honest, most of our customers that we're going to be targeting are very well experienced. This is not unique to Lundbeck or to eptinezumab. The vast majority of the people that we're targeting are experienced at this process, have infused other therapies for years, and so they're used to this. It isn't a reason to avoid a product. It just makes -- there's just a few additional steps that the staff typically would have to go through.

And actually, in some of the visits that we've done to some of the headache clinics, they know that they need to do this, and they know they want to get started, get the approvals, kind of make the pathways. So they're already thinking about how to take that on. So we don't really see -- yes, it will take some administration, but it's going to happen over the first few months. Questions?

If I could ask a question about what's the next upcoming catalyst as February 21 is the PDUFA date? Is there much of an uncertainty around what label you get? Or can you talk about what would be your dream label versus just quite a good label? So things like speed of onset or patient quality of life scores or anything like that. What matters when we see the label?

Well, I think, I'll start and then I'll let Johan comment. The PROMISE 1 and PROMISE 2 are very clean trials. They're hitting the primary and secondary end points. There's sufficient data. So we anticipate that we'll get an indication for the prevention of migraine in people suffering frequent episodic and chronic migraine. So I think that will be where we're indicated. And we believe that the clinical trial section will clearly describe the data from PROMISE 1 and PROMISE 2, where we meet all the primary and secondary end points. So I think that's what we're expecting. And we don't really see -- what would be a dream label. I think we've -- we know what we're going to look at and get. Johan, do you want to add?

Yes. You covered most of it, Deborah. But I mean, obviously, we have the pretty unique data set with the 24-hour readout. So we anticipate that will be mentioned. Question is the dream, would that be a little more upfront in the label, of course, than the clinical section. We also have the clinical meaningfulness and the HIT-6, which is a recognized patient-reported outcome measure, and maybe that can come up at the forefront that gives us some more value to the label. Otherwise, it will be episodic, chronic migraine. So that's the, maybe, what we're looking for.

And just for the 24 hour [indiscernible], there's the regulatory will be two ways for these [indiscernible] and that -- will that will be [indiscernible] commercial [indiscernible]

So repeat the question, Johan, please?

Yes. So the RELIEF study. That's a study that is going to address your question about the window between 0 and 24, which obviously, we haven't started properly yet. I don't think we will comment on whether this will affect the label or not, but obviously, it will be -- provide critical data, for that period. There are 2 key readouts in that study. One is -- so the infusion is 30 minutes. And it's a pretty simple, nothing strange with infusion. The primary -- one of the core primaries in that study will be to look at the 2 hours from start of infusion and see if we have an impact, significant impact at the -- already at that stage. Then it will also look at the time to the resolution of the most bothersome symptom, which is an event-driven outcome. But obviously, we like to [ feel the very interesting ], we end up between 0 and 24, because we have a very dramatic effect over that 24 hour. So hopefully, we have a more rapid onset.

I think I'd just say really clearly that the 24-hour time point was a prespecified secondary end point in the pivotal trials. So RELIEF is not required for that. RELIEF is helping us characterize the shape of the 24 hours, but that does not affect the prespecified significant end point.

And how will the net pricing compare with the currently available antibodies?

So the question is, how will the net pricing compare to the currently available antibodies. And I'll simply say that price has not been set yet. But obviously, we take into account the marketplace that we are going to be entering. Peter, would you like to comment?

No. Of course, it hasn't been set yet, and we won't comment anything specific. But we, of course, are going through and have gone through an analysis looking at a number of factors that always play into pricing decisions. What's the value the product bring, what competitor price points, a number of different factors that are all considered in triangulating all of those features, and it won't be till after we get FDA approval that we'll be announcing our price.

One good thing is that it seems to us the other subcus, they have been -- launched their products with a pretty consistent price globally. So U.S. and Europe. And that means that you don't have this reference pricing issue, which you normally have while you tend to see that the U.S. price, the gross prices, especially in CNS markets, maybe 10 to 15x higher. So that is at least a benefit from the existing competitors that has already launched.

Just while we're on pricing, so the subcu CGRPs that are already in the market, we've seen quite a lot of rebating. How do you see the market as CGRP is playing out? Do you think it could be a market where every year, you get more rebating as you get more entrants, potentially oral entrants? Could it be downward pressure on net pricing?

So Peter, would you like to...

Yes. So of course, a number of factors come in. But I think as we discussed it or I discussed at the Investor Day, you have to remember that the payment structure is different for a medical procedure like this. This is a medical benefit product, not a pharmacy benefit product. Of course, there's interrelationships between pharmacy and medical benefit. But it's -- structurally, it is very different the payment system and the reimbursement system, than for the subcu CGRPS. It actually will look a lot more like botox for migraine than it will the subcu CGRPs. So that's an important thing to remember.

I don't think [indiscernible] evolution of [indiscernible]. Given now you're starting to have a subcu program that they're doing. Are you guys moving at all into [indiscernible] already subcu?

I don't know the history, but we certainly are looking at this being an IV project.

Is there a program to [indiscernible]?

No, there's no program to transition to subcu.

On the theme of formulations. So you'll be, hopefully an IV-approved product. There are subcu products, but we're also going to get data from [indiscernible] in this year and [indiscernible] product as well. Are you going to be going for completely different patient populations or when those products, if those products are successful and they look clean, could those basically be a competitive threat to your product?

So the first products coming out from the orals have indicated -- are indicated for acute migraine. So these are single episodes, and they'll compete in the triptan space. So we don't anticipate those being competitive. The second flight of oral agents do have trials in chronic. And so they will enter the chronic market. And yes, they will be additional competitors. But remember, this is a big market, an unsatisfied market. There are patients who've fallen out of therapy that are coming back in. And I just point to markets like the markets for the anti-TNFs, there's been multiple launched. And each of them have been able to carve out a good share. So we anticipate this market having a similar phenotype.

Yes, and if I can add to that, as one of the things that I also covered at the Investor Day is everybody wants to talk about how this compares to other CGRPS, oral or subcu, but the truth is 85% -- or actually, I'm sorry, 95% of the market is unrelated to CGRPs. And as Deborah mentioned, there is a great deal of dissatisfaction among patients using those other 95% of treatments. People are still taking amitriptyline, for God sakes, that's been around for 50, 60 years. And the issues around all the significant side effect burdens and weight gain and other things among a lot of different therapies. So I don't think you should see us as trying to battle for 5% of the market with other CGRPs. These patients deserve better. These 95% patients. And I think all, as Deborah mentioned, all of the CGRPs can continue to grow and make a significant inroad in improving the lives of patients, and we believe we will be one of those that will continue to drive this conversion to CGRPs as a class.

Maybe I can add one more element to that. Obviously, the mechanism of action is slightly different with the orals, they go for the receptor. This is a ligand binder, and the small molecules, of course, has a more dynamic pharma quality, while the antibodies have a much more sustained effect on the target. So there -- I usually say, it's a quite different beast, the orals.

On the sales force you're going to have for the U.S., I believe you said that some of them may come from the reps that are currently pushing Northera and some psychiatric. So is that correct that you're going to ease back some of the promotion on some other products? Or are you going to backfill those? And how is that going to work?

No, to be clear, we're not pulling back on promotion. But we've got some very talented people that have relevant experiences. They certainly know how to get things done within the Lundbeck way. But many of them have worked in buy-and-bill infusion products before they joined Lundbeck or like with our Abilify Maintena team, there are people who've been working with injectable products, Northera, knowing neurologists and some of the people that used to promote Onfi, et cetera. So we're trying to create a diverse team that has a core of, although not the majority, but a core of Lundbeck people. But also, we've been able to really identify a number of talented folks around the industry that have those types of experience that we're looking for. And the ideal mix is some Lundbeck people, some migraine experience and some infusion buy-and-bill. So far, that's what we're getting. We're almost complete with the sales force hiring, and so far, it's -- we're hitting exactly the kind of diversity of experiences that we are looking for.

But yes, just reiterating, we're backfilling all of the positions where we've taken people out, because we have great momentum on the strategic brands, and we're counting on growth from all of those.

And you said that Alder is going to bring an incremental DKK 2 billion of OpEx for 2020. Is that the [indiscernible] sales force then done? Or is there another step-up because you then launch into DTC the following year or something like that?

I think there's 2 elements. There's the R&D cost. And you should anticipate for the next 3 to 4 years, we will definitely step up our R&D costs. We have in the past said, we have a threshold around 18%, that threshold will definitely move to above 20%. Some years might be a bit more heavy lifting. And that goes, of course, with that if you saw the presentation that Deborah just -- her presentation 30 minutes ago, you would see that there's a lot of additional indication, cluster headache, MOH, post-concussion pain. There -- so there's a lot of things where we can actually create a lot of value from this molecule, and we are, of course, investing in that. We are investing in making clinical trials that will support launch in Japan and China. We see a great potential. We are -- have the treat and prevent study. We also have initiated a study that can support pricing discussion in Europe, which you have also seen for [indiscernible]. Novartis has done exactly the same. So it's nothing special for Lundbeck, but we will invest in that. And then, of course, the ramp of the sales force will be, first, establish 100 people in the U.S. then we'll have some promotional spend, MSLs and then the spend in the commercialization will ramp up as we'll make the global launch because we have extremely lean European organization that is delivering and also international market that is delivering fantastic double-digit growth. But on the other hand, if we only have, let's say, 6 or 8 reps in Romania, then we -- if you need a push for [ reps ], you need a bit more people. So we would probably hire 100 reps more in Europe, and then we will actually go see what is kind of the need we have. And then second year, you will also see then the DTC is kicking in, in the U.S. So you will see a ramp-up, but you shouldn't then say, okay, now we take the existing analyst model in the market. And then you just add cost on the top. Because in the long run, it will, of course, also be a prioritization. But next year, we have set approximately DKK 2 billion more in cost, DKK 500 million more in amortization.

Next question.

In terms of [indiscernible] some people will argue with you [indiscernible] expect to [indiscernible] because [indiscernible] attractive [indiscernible] triptan [indiscernible]?

If I may just clarify by success, what kind of success are you referring to? You talking about clinical success?

The commercial success.

The oral. Those are just now launching.

So the question was on the profile of the oral CGRPs and why they have not been successful but...

Commercially.

But none have -- the current launches as the CGRPs have been subcutaneous injection.

Sorry, sorry.

Yes. Sorry, I was confused. Yes, yes.

Apologies.

No, no problem.

I guess, subcutaneous. Apologies.

Subcutaneous, I understand.

I think it's hard to comment on other people's launches. I think a new mechanism always takes time to be brought in. Those companies have done a tremendous amount of sampling. And I think that delayed potentially seeing the revenue, but they've made their calculations of how they best believe that they're going to build a market. And any new mechanism will always take -- it doesn't go from 0 to 100 in even 1 year.

What you're saying is that the product definitely has a 6-month window to have a successful commercial launch, unless you have additional clinical data to support it?

If I may on that, I think, to be honest, the latest data wouldn't necessarily -- that used to be what people would think that your first 6 months dictate your long term. But we've seen with our own products, continued growth even beyond what would have been predicted in the first 6 months. We're now 4, 5, 6 years into Abilify Maintena, Northera, Rexulti, and we're still seeing strong double-digit growth. So I think that's a little bit of an evolving paradigm. And I do agree with Deborah that there's natural adoption curves that happen for every product. People need to get exposed to it multiple times. They need to try and see some experience. But if you look at a -- as the category, the CGRPs continue to grow nicely. But I personally wouldn't advise anyone to predict the first 6 months of any launch these days because, again, in our own experience, you could go back and track them. It wouldn't have been predictive.

And then you -- forget about all the revenue numbers you see from our competitors. Because if you go to migraine centers and ask the specialist, do they see that patient report back that this is a game changer for patient that has not received any new treatment for the last 20 years. Everyone say, yes. And you see the data, and the data for, basically, all the agents in the market is showing pretty good data. It's not just a 10% reduction in migraine days. So I believe this market is underestimated. I think the potential is underestimated, and I think it will grow year by year.

I think the other thing to say about speaking to Peter's point about the first 6 months not necessarily being predictive. In eras -- in the era where there was less payer control of new therapies, perhaps that would -- that was more true. I think now there is an adoption curve that's not only the physicians, but the payers. And that, I think, lengthens things out. And I think we've seen on new categories of therapies, really excellent therapies have had a slower launch than they might have done 5 or 7 years ago. I think about Novartis COSENTYX, the PCSK9s where they are coming back now, the payer and the company have come to a conclusion and now utilization is going up. So I think that dynamic is changing.

Have you articulated future strategy for additional M&A?

What we've said is that we will continue to build the pipeline, both internally and externally, and we will use all the levers. So license, partner and acquire. So it's not only M&A.

[indiscernible] have you -- I mean, [indiscernible] could you do another deal the size of Alder?

When we started last year with the new strategy, we said we had $4 billion to $5 billion in firepower, and we used $2.3 billion last year. But at the same time, due to that, we will invest heavily in [indiscernible] then, of course, our firepower after these 2 acquisitions, we assume to be $1 billion to $2 billion. And of course, it depends on the target. If it's a highly cash-generating target, then it's higher. And if it's a target that have -- comes with a cash burn, then it's a lower target -- in the low end.

One quick question, yes?

Yes, I was going to ask how are you stratifying and quantifying dopamine dysfunction in multiple patient populations that are in fact, harder to have dopamine dysfunctions and following them into the right trials to get the best results?

So do you want to comment?

Yes, the question, if I understood it right, how we look at the standard of care or assist in the -- where we position our new drugs that we have in the pipeline? Is that the question? I hope I understood it correctly. Yes, obviously, there are a lot of symptomatic treatments for Parkinson's. And we do have a few new in the pipeline. And the main thing is really to increase 2 parameters to have a longer sustained effect. So the off time is something that happens with standard of care. You like to prolong that. And then while you're on the drug, L-dopa, you have a lot of disturbing overstimulation, dyskinesias. So you like to get after those 2 parameters. And we have pretty clear criteria for what is clinically meaningful for those parameters. Is that really your question or... If she -- would you like to leave your question or ...

Partially.

Yes.

Perhaps you can talk afterwards, as I think we are out of time.

We're out of time.

Yes.

Thank you very much, everyone.

Thank you.

Thank you.