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

January 10, 2021

Nasdaq Copenhagen DK Health Care Pharmaceuticals conference_presentation 39 min

Earnings Call Speaker Segments

James Gordon

analyst
#1

Good afternoon, and good evening. I'm James Gordon, JPMorgan European pharma and biotech analyst. And today, at the JPMorgan Healthcare Conference, it's my pleasure to introduce Deborah Dunsire, CEO of Lundbeck, for this presentation. So today, we're going to have a 20-minute presentation from Deborah and then 20 mines for questions straight after. And you can immediately start registering your questions. And the way you do that is you use the Q&A function associated with this presentation, and that's on the conference website. And then I'll be happy to read out your questions from there. With that said, I'd like to welcome Deborah to the conference and look forward to the presentation.

Deborah Dunsire

executive
#2

Thank you, James, and thanks, everybody, for joining us today to talk about where we're at, at the time of JPMorgan and talking about driving sustainable profitable growth. Moving on to the next slide. Our forward-looking statements, which I know you've all read before, so I'll move right on. Our focus at Lundbeck is delivering current growth with the brands that we have in hand and setting ourselves up to optimize future growth down the line. We're focused on maximizing the current growth drivers with the excellent core strategic brands as well as our newest launch, Vyepti, into the future. Rexulti, which is one of our largest strategic brands, has been on the market for some time, is growing strongly and has some significant growth drivers in its future. Vyepti, which launched in April in the U.S., is in the beginning of what will be a global rollout and the building of a blockbuster migraine franchise. It's been submitted in multiple markets, and we are awaiting the next approvals shortly. We've started to build solid potential into the pipeline. There's good life cycle management, growth opportunities in Phase III and a very interesting Phase I portfolio. And we look to build through business development selectively into that portfolio, maximizing both internal and external innovation. We do have a loss of exclusivity for Northera coming up in February. But beyond that, we see really strong growth and a good growth visibility in the next 6 to 8 years as the current portfolio continues to grow strongly on the base of a very resilient, mature business. So the company is financially strong with a solid balance sheet and a very strong ability to generate cash. We've also really taken a relentless focus on driving efficiencies through the organization, so that we can optimize the use of our investments to drive future growth. Next slide, please. We do have the loss of exclusivity for Northera this year, but we faced that in the past. And our heritage has shown us that we can continue to grow steadily as we weather these loss of exclusivities. And since 2000, we've had a number of large loss of exclusivities. But when you look at the compound annual growth rate for this company, it's 7.4% over that 20-year time span. And we see that being no different as we go through Northera loss of exclusivity with the dynamism in our strategic brands and the global rollout of Vyepti to carry us forward. Next slide, please. Our strategy to expand and invest to grow Lundbeck profitably into the future is moving forward at pace. The strategic brands have continued to grow. We have a migraine franchise in the making, and we'll talk more about that with Vyepti. You know that we have a global footprint in North America, Europe and the international markets, and we are seeing growth across all those regions. We've been focused in 2019 and 2020 in optimizing our R&D organization. And we've taken some significant transformative steps. We've built out our experimental medicine. And we've also spent time focusing our internal discovery, and we'll talk more about that, too. From our prior acquisitions, we've formed Lundbeck Seattle BioPharmaceuticals with a specialty in antibody process development in Bothell, the site of the former Alder BioPharmaceuticals, and we have a significant innovation engine in La Jolla, the site of the former Abide Therapeutics, where we can generate innovation for our pipeline into the future. We've done that while maintaining a solid profitability, even though we've been investing in the future for growth. And we continue to generate a strong cash flow to be able to think about how to optimize the future. Next slide, please. Our portfolio is across all regions of the world. We've got about 56% of our sales through the 9-month period in North America, 25% in International Markets and the balance in Europe and strong growth across all those regions. I will point out that North America grew 6%. But if we look at excluding the older brands like Onfi, which had lost exclusivity at the end of 2018, the North American would have grown 19%. So that speaks to the dynamism through the 9-month period. Next slide, please. Those strategic brands have grown for a long time. And since 2014, the compound growth rate of 80% for those strategic brands, and they continue to grow. Now we did see challenge, of course, during the pandemic, but that intrinsic power of the profiles of those agents give them the possibility for strong future growth as we emerge, hopefully soon, from the pandemic. Overall, the compound growth rate for the company in its revenue is a compound growth of 5% as we've had the strategic brands growing on a resilient, mature portfolio of products that have continued to decline, but slowly. Next slide, please. We've talked a little about the pandemic. What's good to see is that at the -- towards the end of the year, as the market started to open up, we did see the growth in new-to-brand prescriptions come back pretty strongly. This is U.S. data through the middle of December. And you can see the new-to-brand for Trintellix and Rexulti rebounding as we got our field force more -- back to more normal promotion, a combination of in-person and virtual as well as the opening up for physician offices to see patients in-person again, which we think is critical for that new prescription or a switch prescription to our brands. Next slide, please. We're on Slide 9 right now. Vyepti, our latest launch, of course, did launch as the lockdowns for the pandemic were at their height in the U.S. But we've seen sales double in Q3 over Q2. And we do see strong momentum in the fourth quarter and anticipate the Q4 vial demand has doubled compared to that of Q3. We've done a lot of good work in the U.S. getting the market access in place. We have over 130 million covered lives with -- who would be able to receive Vyepti without having to go through a branded step edit. Of course, they will have to receive the older generic therapies before they're allowed to take the branded Vyepti. We also have the J code published on the 1st of October. And now as of January, the ASP is also published. And all of those take friction out of the system for physicians getting payment for the drug. We know that the drug has been being paid for, but it just gets a little bit easier with these administrative things in place. One of the things that we are delighted with, with Vyepti is how it's performing in the market, the testimonials that we get from patients who have received it. Many of these patients have actually failed other branded therapies before now. And even there, Vyepti is performing well. Of course, that's anecdotal information. Physicians are seeing the profile deliver, what they anticipated from the PROMISE 1 and 2 publications. And the nurses administering the product are finding it very easy to administer. So all told, we are seeing everything that we believed Vyepti would be is delivering in the marketplace. And we're confident that as the pandemic resolves and we can get back out there, we will see continued strong growth. Next slide, please. Of course, Vyepti is going to be more than a U.S. brand and the global rollout will bring significant growth opportunities into the future. On the 22nd of December, we submitted to the European Medicines Agency, and that's they have accepted Lundbeck's application. So that clock starts ticking now, and we anticipate EU Commission approval early in 2022. We've submitted for approval in 10 markets, recently approved in the UAE, and we anticipate approval in the first quarter of 2021 for Canada. The market, obviously, around the world is available for prevention, and we see strong possibilities across the world and including in Asia. And so our development activities are underway to allow us to, in the future, be able to launch in China and Japan. Next slide, please. We also intend to maximize Vyepti across multiple indications. The first additional indication that we are studying is we have initiated a Phase III trial with Vyepti in cluster headache. As you know, this is a headache known as a suicide headache because of its intense severity. It's incredibly disabling, as these clusters, headaches can occur up to 8 times a day. They occur in clusters that can limit people for weeks at a time. And we're studying episodic cluster headache with the ALLEVIATE trial. And the primary end point is the change from baseline in the number of weekly attacks. So the study was able to accrue its first patients in December, and we expect that trial to conclude in the second half of 2023. Next slide, please. We're now on Slide 12. We have talked about an interim analysis being conducted in the -- in Q2 of this year for our third Phase III trial for Rexulti in Alzheimer's agitation. As you know, the symptom of agitation is the symptom that causes Alzheimer's patients to move from home care into institutional care. And within institutions, it makes patients extremely hard to manage. There are no therapies approved for agitation in Alzheimer's disease. And we believe Rexulti has the profile to be able to deliver. We have had 2 previous Phase III trials: one, a positive Phase III trial with a 2-milligram dose; and the other trial was a flexible dose schedule. And the intent-to-treat analysis was not positive, but the 2-milligram dose was positive. So our third Phase III trial looks at a 2- and a 3-milligram dose of Rexulti in these agitated patients. We made the decision to take the interim analysis, which will happen in the second quarter, looking at futility, efficacy and early stop for efficacy or to continue the trial to the full number of patients of 330 patients. So we will be reporting on that when we have that data in Q2 as to which of those outcomes came to fruition. Next slide, please. During 2020, we really worked internally with our R&D organization, particularly our discovery organization, to focus the areas in which we will do our internal discovery research going into the future. We've taken strong steps to transform the R&D organization and to strengthen our ability to make decisions in the portfolio earlier and to de-risk before going into late-stage development through developing our experimental medicine group and our biomarker groups. Next slide, please. On Slide 14, you see that we're focusing our discovery in 4 biological areas. Of course, our heritage in circuitry and neuronal biology, so neurotransmission, synaptic dysfunction, brain circuitry. We're also obviously building capabilities in hormonal and neuropeptide signaling. And Vyepti is the lead in that area. But of course, we have other pathways behind it like the PACAP, which we acquired when we acquired Alder. We've had some focus in protein aggregation folding and clearance for some time with products like our alpha-synuclein antibody and our Tau antibody, which are in our early-stage portfolio. And we'll continue to look for a biomarker-driven approach to those areas. And then we would like to move into neuroimmunology and neuroinflammation, where we see very promising biology. We have some of the work in our La Jolla Research Center, is focusing on bringing new compounds forward in neuroinflammation in addition to some of the Serine Hydrolase areas that we are already focused in from that site. And we believe this gives us a wide opportunity to explore the most promising biology in neuroscience into the future. Next slide, please. On Slide 15, you see that through the 9 months, we had a strong sales growth at 6% for the 9-month period, 8% in Q3, with solid growth for all the strategic brands. We did see a negative currency impact start in that second half of 2020. And of course, it became more exaggerated in Q4. We've had a good core EBIT margin of 27.7% through the 9 months. And we did see strong SG&A savings, obviously, because we had people at home during the COVID lockdowns and couldn't implement a lot of the programming or the travel that we normally would have with savings of between DKK 600 million and DKK 700 million anticipated for the year. Overall, our guidance is between 3% and 4.5% growth in revenue for the year with a core EBIT margin of 24.1% to 25.7%. Our balance sheet continues to be strong with a net debt predicted at DKK 5.006 billion in the end of the 9 months. And the net debt-to-EBITDA was 1.1x at the end of the 9 months, and we do anticipate that has improved during the fourth quarter. Next slide, please. When we think about deploying our cash flow, obviously, we aim to be investment grade. And so we will continue to pay down debt, so that we maintain that investment-grade rating. And we anticipate finishing the year around DKK 5 billion in net debt or potentially even better than that. We continue to prioritize looking for the right opportunities in external innovation. And to make sure that we have the financial flexibility, we did implement Lundbeck's first bond issuance, a eurobond of EUR 500 million that was issued with a very positive rate around it. We also anticipate continuing to pay dividends at between 30% and 60% of net profit into the future. Next slide, please. As we think about the future for where will we go with our Expand and Invest to Grow journey, on Slide 17, you can see that, historically, we've been a midsized company that has been in specialist indications in psychiatry that also potentially have broad reach across PCP footprints. For instance, with Trintellix, where we're partnered with Takeda, who cover a lot of the PCPs. A lot of these have had rather large and challenging development programs. And our ability to get innovative pricing around the world is challenged in some of these areas. So as we go forward into the future, we want to focus on indications that are specialists treated. So indications of very high unmet medical need where true -- we can truly bring innovation and transformation to the patient outcomes. We would prefer to be in indications where we don't need to have primary care coverage, so that we can have a more focused and efficient commercial footprint. And we also are looking for tractability in the biology around our development programs, so that we can progress things through development that have access to biomarkers, defined patient populations that allow us a more tractable development path to market. So that's the direction that we'll be taking Expand and Invest to Grow into the future. We will still continue to consider partnerships in places where, if we have a compound in our portfolio that requires a larger primary care presence, then we would consider partnering for those. And we may enter into regional partnerships where we can get access to innovative products where we might be a tremendous partner for a company that doesn't have a presence in one of our regions -- 1 or more of our regions. And partnership may be the way that we can access, innovate it and differentially -- differential products into our pipeline. But in principle, we'd like to be in areas where Lundbeck can operate alone with a focused commercial footprint. Next slide, please. So we, in 2019, broadened our disease focus out of only 4 areas of neuroscience. We now have the guidance of our focused biological clusters and our refined operating space with our targeted indications in niche neurology, niche psychiatry and rare disease neurology. We know that as we go down that path, particularly when we think about the area of neuroimmunology, it may cause us to have adjacencies that a product may be useful in neuroimmunology and other areas. And if those areas fit within that focused commercial footprint, we would not shy away from them. Next slide, please. So on Slide 19, it's always important that Lundbeck is a company that is committed to being a great member of the community, and we focus on our ESG goals as well as on our business goals. We've implemented an Access to Brain Health strategy, centering on allowing and supporting access to brain health care and reduction in stigma in underdeveloped markets. We've renewed our diversity and inclusion policy and have a zero tolerance for discrimination and harassment of any kind. And we've maintained our focus on climate action. We are a Climate A List as -- from the Carbon Disclosure Project. And we have reduced our CO2 emissions by 68% since 2006 and committed to new and ambitious targets in the Science-Based Target initiative to cover our entire value chain. Next slide, please. We have some things to look forward to in the first half: the approval in Canada for Vyepti; and our full year announcement, 4th of February; the interim analysis for Rexulti in Alzheimer's agitation in Q2. And in the second half, we'll be commencing Phase II trials for 2 of our compounds as well as progressing the Phase II study using Rexulti in borderline personality disorder. And looking into 2022, we see the Rexulti approval by the European Commission as well as the full Phase III outcome for Rexulti in PTSD. Next slide, please. Our ambition is nonetheless than to be #1 in brain health, recognized as having a premier neuroscience pipeline, having a focused commercial footprint around best-in-class medicines and to continue to evolve our company to make the best use of digital technologies to allow us to both discover, develop and commercialize our medicines, and remain on track to be carbon neutral by 2050. With that, I'll stop there and take your questions. Thank you.

James Gordon

analyst
#3

Great. Thanks very much for the presentation. And we'll now go into the Q&A part, and we've got just under 20 minutes for Q&A. Maybe 1 pace to start as I've had quite a few people ask questions about the Rexulti interim analysis that takes place in Q2 for Alzheimer's agitation. I think one of the questions has been -- so if I can say correctly, you're doing the interim. You're not quite sure though how many observations could be missing as a result of COVID-19. Could you talk about the extent to which COVID-19 could have impacted the trial? So maybe before I go into the questions, I should also just introduce who we've actually got from Lundbeck joining for the Q&A as well. So I think we've got CFO, Anders Götzsche. We've got Head of Research, Johan Luthman. I think we've got Head of North America, Peter Anastasiou on the line as well?

Deborah Dunsire

executive
#4

Yes. Yes. Peter is here.

James Gordon

analyst
#5

Right. And we also have Head of IR, Palle Holm Olesen. So thanks, everyone else, for joining as well.

Deborah Dunsire

executive
#6

So Johan, perhaps you'd like to take that question.

Johan Luthman

executive
#7

Yes. Thanks for that question. So obviously, the pandemic has affected enrollment possibilities quite severely for peers, and the trial was actually posed for a while during the spring. So the issue has really been getting patients to the trial. But a little bit to my surprise, people once they get into the study tend to stay. So the dropout rate has not been particularly changed during the pandemic. It's really the enrollment rate that has been the issue.

Deborah Dunsire

executive
#8

But we are fully enrolled for that interim analysis. So we are on track for that.

James Gordon

analyst
#9

But even if fully enrolled, is it the case that you might be missing observations for some patients? Because I think the assessment is done in a care setting and because of COVID-19 you might not be able to go into that care setting to do the assessment?

Johan Luthman

executive
#10

That's correct that we're challenged in terms of having people coming into the clinic. And obviously, this is an Alzheimer's trial. Part of it is done with nursing home patients, about half of them and half of them outpatients. So some of them are sort of easier to access, the in-house, the nursing home patients. But there's been a challenge with their visits. And some of this, we tried to do remotely when we can, but this is a psychometric readout. So you need to do face-to-face measures. And so far, we've been able to keep the meetings we need, the site visits we need to have with some of them, the safety visits, partially off-line digital virtual.

James Gordon

analyst
#11

Great. So if I can sense, you shouldn't have a significant headwind from missing observations. You also have some things that might actually help the study. So for instance, you're doing a 3-mg dose. So do you think you might see stronger efficacy than the 2 previous Phase III trials because of the dose? Or are there any other important differences with the study?

Johan Luthman

executive
#12

Yes. First of all, we had 2 previous studies. Both of them included doses with 2 milligram, which is also in the third study. And at the 2 milligram, we already before saw a good effect of the drug. So overall, if you look at that part of the previous trials, we saw an effect. The current study, we expect to see an effect at 2 milligram, but the 3-milligram dose is added to create a little bit of headroom for safety, but also, of course, see if we can push up the dose a little bit further. When we started this program, we didn't know much about tolerability in this particular patient cohort -- patient group. Now after these 2 previous studies, we were more eager to go up in those. And obviously, we have tremendous information from the other indications in terms of tolerability and much more generated since 2013 when we started the first 2 studies. So aggregated, we are more confident we can deal with higher doses here. But for efficacy, it's the 2 milligram that should be sufficient.

James Gordon

analyst
#13

And when you take an interim analysis, typically, there's a statistical penalty from doing so. Can you talk about how that works? So is it a higher hurdle to work at interim than it is to work at the final results because of sort of statistical penalty there?

Johan Luthman

executive
#14

Yes. I guess you're referring to what we call the alpha hit here. And the overall sample size is 330. And that's increased a tiny bit, but actually, we're not taking a massive hit in terms of alpha, meaning that we need to add so many more subjects into the overall study. At the interim, obviously, we have 3 outcome possibilities, success, study continues or futility. And obviously, there are different bars for this. But the study could, of course, continue to 330 and that is efficiently now powered to compensate for that alpha hit.

James Gordon

analyst
#15

And if the study does work, whether it's in -- whether it's this year or next year, how big an opportunity are you seeing this? How widespread is use of this class of drugs in this patient population already? And how much might it expand?

Deborah Dunsire

executive
#16

So I think that the use of the class of drugs is quite low because there's been a black box warning. And I think Rexulti's profile could be very important because we believe that it can be used safely. So this may be the drug that opens up this area that hasn't been possible before. And Peter, I don't know whether you want to comment on the scale versus MDD or?

Peter Anastasiou

executive
#17

Yes. So it's close to half of the patients that have Alzheimer's have clinical agitation. And of those patients, about 80% of them are in the community setting. The other 20% are institutional settings. But one of the biggest reasons for people migrating from community to institutional settings are these types of agitation symptoms. So it's a big unmet need. And as you know, James, there's no approved therapies for this treatment. There are a variety of off-label uses, some antipsychotics, as you described, but there's also antidepressants, benzodiazepines, various things. Doctors don't really have a good evidence base guiding them in how to treat these patients. So that's why this is such an important advancement to add to the 2 studies we already have. That third, hopefully, definitive study that we can then provide an evidence base and an effective and safe solution for physicians to use.

James Gordon

analyst
#18

And if you were to characterize it relative to where you see the potential in the existing indications as add-on use in depression or for schizophrenia, how would you contrast them?

Peter Anastasiou

executive
#19

We think this is an important sizable opportunity. The depression market is bigger than the Alzheimer's market. So there's overall more patients. And I think that makes sense, and it's probably well understood. But there's also other therapies that we -- that doctors have to choose from, where in this market, albeit smaller, the unmet need is higher, and there's really no approved therapies to compete against. So we find them, of course, both attractive, but in pure numbers, of course, the depression market is bigger.

James Gordon

analyst
#20

And you mentioned that some of the existing drugs who are existing atypical antipsychotics have a black label or warning against use in the elderly. Is that something you still think you'd have for this product even if the trial is successful? Or might you be able to get a milder warning or even no warning if you characterize the safety?

Deborah Dunsire

executive
#21

Johan?

Johan Luthman

executive
#22

Sorry, I want to...

Deborah Dunsire

executive
#23

So the black box warning, we would anticipate that, that will not go away. So the FDA is very low to ever take one of those away. But I think having the evidence base and the label gives physicians the confidence to be able to use the product and have the guidance of how to use the product. So I don't think we could anticipate having no black box warning.

Johan Luthman

executive
#24

No. So this -- it's obviously a class effect. But within -- and obviously, we can argue that we have good data. It's hard to get out of that class effect.

James Gordon

analyst
#25

Good. Maybe switching gears, there was a chart that was, I think, quite encouraging, was it Slide 9, which looked at the rebound we've seen in Rexulti and Trintellix in terms of the U.S. prescription trends. How recent is that data? Is there any concern that we're seeing some quite a lot on headlines, at least based in Europe, about just how bad COVID is? Could there be another rebound, wave 2, wave 3? Could things be as bad again? Or are you seeing that things are a bit different with this wave of COVID?

Deborah Dunsire

executive
#26

So Peter, do you want to comment?

Peter Anastasiou

executive
#27

Yes. I think the rebound that we see is something that we fully expected, but it's heartening to see it in the data. And we expected it as we return to closer to full promotion. We are not yet to be clear at full promotion. But in Q3 and Q4, we were starting to see opening up again, and we were starting to approach between our virtual engagements and our face-to-face engagements something close to what we had before. So that's good to see the rebound. In terms of the future COVID impact, it's tough to predict. But 1 thing I don't think will happen is what we saw in the dark days of Q2. So where they can, our reps are out there calling on customers face-to-face. And where they can't, they're engaging with physicians virtually. At the beginning of the pandemic, we and every other company were trying to navigate through this. We pulled our sales forces out of the field completely. So it would, I think, take something pretty serious to get us back to that point. But there's no doubt that the #1 impact that has affected the growth of those products has been our inability to get to our customers because these are still promotionally sensitive brands that really rely on new-to-brand prescriptions.

Deborah Dunsire

executive
#28

I think the other thing that's changing in addition to our promotion is just physicians being able and willing to see patients and patients being willing to go into physician offices. So we were starting to see that return to more normal. And I think I totally agree with Peter. Everybody around the world is navigating normal life a little bit more than we were at the beginning of the pandemic. So I don't -- I anticipate that with the increase in COVID cases in the U.S. and elsewhere, we will see a downdraft again, but not to the degree we saw in those early days. And it will be in again, out again in a much more flexible way as people manage towards their local guidelines.

James Gordon

analyst
#29

Maybe switching gears, I had some questions about Vyepti and how the launch is going. I mean the question was with COVID and maybe a reluctance to go into doctor's offices. Are you seeing that people might want to try an oral product and then a subcu product and an IV product to be relegated to the last or the aspects of the profile that are resonating such that it's not been kept as a last resort?

Deborah Dunsire

executive
#30

Peter?

Peter Anastasiou

executive
#31

Yes. I think it's important to note that virtually every launch I've ever been part of and almost all launches, the first patients that typically go on a therapy are the ones that have been dissatisfied with previous treatments. So that's not an unusual circumstance. And that's certainly happening with Vyepti. It's probably happening a bit more so because of the pandemic because the patients are having the way risk-benefit, depending on their health status, of going into the office to get an infusion versus taking another therapy. But the important part is that the clinical profile that we saw in the studies is certainly playing out in the real world based on the feedback that we're getting. So the fast onset of prevention, which is mentioned in the label and was then further clarified through the RELIEF study adding the additional understanding of what it does in an acute migraine episode as well as what it does in showing onset of effect within 2 hours. The strong response rates, overall response rates that we see at both a 50% reduction in episodes as well as 75%, both of which are referenced in the label. But even the 100% improvement that you see in the clinical study populations. Doctors are seeing those in the real world. And then also the medication overuse headache information that we have, which is a very difficult-to-treat and challenging patient, and it is referenced in the label that we have comparable effect, whether there's a presence of MOH or not. And so all those things are being seen in the clinical experience, and there's no real side effects that are rate-limiting to people using it earlier in the algorithm. So I expect as the pandemic recedes, as doctors get more clinical experience that the patient population is going to move earlier and earlier in the treatment algorithm.

Deborah Dunsire

executive
#32

I think the other thing to say is that a new patient going on a CGRP at the moment would have to come into a physician office anyway because nobody ever prescribes a self injectable without, first of all, teaching the patient how to do that. And second of all, they're required to be monitored in that first setting. So it's not going to change. Coming in for Vyepti gives them 3 months of coverage with the sustained 3-month efficacy of Vyepti.

James Gordon

analyst
#33

One other question on the top line. And you mentioned one generalization, which is Northera, which could start from February. But once we're passed Northera, how much of breathing room do you think you then have? What are your expectations in terms of how much pressure say you will maintain then? I know there's a bimonthly version? And also, how are you now thinking about the period of exclusivity for Trintellix and Rexulti? How long a runway do you have for growth once we get past Northera?

Deborah Dunsire

executive
#34

Yes. So the Abilify Maintena 1-month patent expiry is at the end of 2024, or beginning of '25. So that's the next one up. And as you pointed out, we have the 2 monthly, which we have the clinical comparability data showing 2 months -- gives the same coverage as 2 times 1 month. And now we just need the manufacturing facility to be completed and validated that Otsuka is progressing with that, and then we'll be able to submit. And we will work to try and transition patients to the 2 months ahead of that patent expiry. We -- that -- the 2 monthly is covered by patents until the early '30s. So it will maintain some of the franchise. So that's -- there's a good trajectory there. And then for Trintellix, it's the end of 2026, that the composition of matter patent expires. So -- and Rexulti is 2029. So there's some very -- that's why we say there's good visibility to continued strong growth for a number of years. And that gives us the runway both to continue to prosecute our internal pipeline and to be disciplined about adding the things from the outside, where we believe we can get a good return. And Lundbeck has done that extremely well. When you think about how the acquisition of Chelsea performed with Northera, the acquisition of Ovation with Xenazine, Sabril and Onfi. Lundbeck's had a very good heritage with its external innovation through acquisition or partnerships as we have with Otsuka or licenses. So that's what we intend to keep doing.

James Gordon

analyst
#35

Great. I'm being told we're almost out of time, and I need to wrap things up. So with that said, thanks very much for taking part today. And thanks for the presentation and the Q&A, and enjoy the rest of the conference.

Deborah Dunsire

executive
#36

Thanks, James.

Johan Luthman

executive
#37

You too.

James Gordon

analyst
#38

Bye everyone.

Johan Luthman

executive
#39

Take care.

Deborah Dunsire

executive
#40

Bye.

For developers and AI pipelines

Programmatic access to H. Lundbeck A/S earnings transcripts and 32,000+ others is available through the EarningsCalls.dev REST API. Plans from $24.99/month — full transcripts, speaker segments, full-text search, and the recently-added /api/v1/transcripts/recent polling endpoint for ETL pipelines.