BioArctic AB

STO:BIOA B

Earnings Call Transcript 2023-Q1

[Operator]

Welcome to BioArctic Q1 report 2023. [Operator Instructions]Now I will hand the conference over to CEO, Gunilla Osswald; and CFO, Jan Mattsson. Please go ahead.

[Gunilla Osswald, executive]

Good morning, and welcome to BioArctic's presentation for the first quarter of 2023. I'm Gunilla Osswald, and I'm CEO of BioArctic, and I will share today's presentation with our CFO, Jan Mattsson; and our Chief Medical Officer, Tomas Odergren.We will give an update on BioArctic and on lecanemab, and focus on the great start of this year with the approval in the U.S. by the accelerated pathway and the submission of applications for full market approval of lecanemab in 3 continents. These submissions are based on the groundbreaking results for lecanemab in the Clarity AD Phase III study in Early Alzheimer's disease. And I think it's really exciting that lecanemab, or Leqembi as it's named in the U.S., now it's available for patients in the U.S., and we'll talk more about that here today.Next slide, please. This is our disclaimer. Next slide, please. BioArctic's aim is through world-leading innovative research, create drugs that improve the lives of patients with neurodegenerative diseases. We focus on research and development of innovative treatments for brain diseases with high unmet medical needs, like Alzheimer's disease and Parkinson's disease. As you know, these diseases affect large patient groups and their relatives and comes with large costs for society. There is a high medical need for disease-modifying treatments, which is affecting the underlying disease and slowing down the disease progression.We are also building a commercial organization and preparing for commercialization of lecanemab in the Nordics, together with our partner, Eisai. We have an attractive and well-balanced project portfolio with projects spanning from discovery to Phase III and now also in the regulatory process in 3 continents and on the market in the U.S. We have partnered projects that generate revenues by milestones and royalties and where our strategic partners carry the cost for clinical tracks. And we also have earlier fully owned projects with substantial marketing and out-licensing potential.BioArctic is well financed, and we have a strong cash position with about SEK 1.1 billion on the bank, which is approximately USD 110 million. We have valuable collaboration agreements with companies like Eisai. And during the first quarter of this year, we got regulatory milestones of EUR 35 million. BioArctic is listed at nasdaq.com large cap, and our market cap is about SEK 21 billion. BioArctic is an innovative and dynamic and very exciting company with a huge potential.Next slide, please. BioArctic has a rich and balanced project portfolio that focus on brain disorders. Alzheimer's disease is our largest area. And for lecanemab, which is our most advanced program, which now is on the market in the U.S. based on the accelerated approval and in regulatory phase in the U.S., Europe, Japan and China for a full approval. All that is driven in a great way by our partner, Eisai. We have one more large Phase III program ongoing with lecanemab, in even earlier phases of Alzheimer's disease.So even if this first step with the first disease modification treatments are successful, there is still a large medical need for more treatment options and for combination of therapies. Therefore, it's very important that we and others continue to do research before Alzheimer's disease. We have 4 early Alzheimer's disease, disease-modifying programs, including 2 where we have combined the antibodies with our brain transporter technology in order to get more of the antibody into the brain and hopefully then have even better effects. 2 of our projects in Alzheimer's disease are targeting truncated forms of Abeta such as pyroglu Abeta, and that is including BAN1503 and AD-BT2803, which is then combined with our brain transporter technology.Based on lecanemab's positive Phase III results, I think that the probability of success has increased for our other programs with similar approach that are targeting misfolded aggregated forms of proteins that we call oligomers or protofibrils and that is soluble aggregated forms or the proteins and they are toxic. In Parkinson's disease, the protein is called alpha-synuclein and in ALS, the protein is TDP-43. The ALS projects that are targeting TDP-43 are progressing really well and quickly, thanks to our technology platform and our vast experience from Alzheimer's disease and Parkinson's disease projects.We're also working on another rare disease, Gaucher disease with GD-BT6822, which is an enzyme replacement therapy with the aim of also being able to target the CNS effects of Gaucher disease, which is a major unmet medical need today. Our brain technology, brain transporter technology platform, which you know I think is a very exciting part. It's progressing really well. And we have now transferred the platform into preclinical development, and it's now included in projects in all our disease areas. And in the future, we could also foresee the brain transporter technology could be applied to other companies, antibodies or proteins on nonexclusive license basis. Lecanemab, is, of course, very important for BioArctic. But I want to point out that BioArctic is even more than lecanemab. And our portfolio is progressing really well.Next slide, please. We have a long-standing and successful partnership with Eisai in Alzheimer's disease all the way back since 2005, and we have 2 license deals and have had several research collaborations, and we have a research collaboration still ongoing with Eisai. During the first quarter of this year, we got EUR 35 million in regulatory milestones from Eisai, and that was based on the U.S. approval, the submissions in Europe and Japan. We have another EUR 101 million remaining for milestones if it continues to progress well. And they are linked to regulatory approvals in Japan and Europe and some sales and marketing milestones.BioArctic is entitled to royalties of high single-digit percentage for the first 10 years following launch and mid-single-digit percentage for the following 5 years on a country-by-country basis. After the 15-year period, Eisai has an option to extend the agreement period with continued royalties. I think that lecanemab is of substantial value or blockbuster potential, which means that we could -- if everything continues to go well, foresee more than USD 1 billion per year in revenues without any cost for the clinical programs in Alzheimer's disease. BioArctic has also retained rights to other indications outside of Alzheimer's disease, and we have the right to market in the Nordics, which we are very much looking forward to be doing together with Eisai.Next slide, please. Leqembi is the name for lecanemab, when it's launched in the U.S. And Leqembi has the potential to become the first anti-beta-amyloid antibody to receive full approval on a global basis. Lecanemab is now in regulatory review process for a full approval in 3 continents. The FDA has approved lecanemab by the accelerated pathway in the U.S., and we got that feedback from the FDA on the 6th of January this year. And that approval was based on the Phase IIb biomarker data, showing that lecanemab clears amyloid plaques from the brain.In the full approval applications that are submitted, they are based on Phase III efficacy data. Eisai has submitted the application for their traditional pathway, and they did that on the same day as the accelerated approval was received, which I think is very impressive. We are looking forward to an advisory committee meeting on the 9th of June and the response from the FDA by the 6th of July at the latest.Reimbursement is, of course, also important, and the Veterans Health Administration has decided to provide coverage for veterans with Alzheimer's disease. A full approval based on the Phase III efficacy data will be important in order to get broader reimbursement in the U.S. by CMS and a broader access for the patients. If Leqembi is granted a full approval on the 6th of July, then it is expected that CMS will broaden that coverage under the existing national coverage determination.Eisai is also exploring less frequent dosing for maintenance dosing and subcutaneous administration, and they plan to file those submissions in the first quarter of next year. In Japan, while lecanemab has undergone a pre-review process of data during 2022, Eisai has then submitted a full marketing authorization application on the 16th of January to the Japanese authorities. And the application has also been granted priority review by PMDA, and Eisai expects a response later this year, in second half of this year.In Europe, Eisai has submitted a marketing authorization application to the European Medicines Agency on the 9th of January. And that was based on both the Phase IIb and the Phase III data. The application was accepted on the 26th of January, and it will follow a standard review process and the response is expected on the first quarter of next year.In China, Eisai initiated the application process in December last year and the priority review designation was provided in February and response in China is expected by the first quarter of next year. I want to complement our partner Eisai for that dedication and hard work with the clinical studies and regulatory submissions in such a timely way. I think this is very important since every day matters for the patients.Next slide, please. One of the 3 most important Alzheimer congress is every year is called AD/PD and this year, it was held in Gothenburg. The Swedish Queen Silvia inaugurated the meeting with a warm and crucial message of the importance of the effects for these patients. I think it was a very positive atmosphere at the Congress with a lot of hope for the patients and a lot of talking about the new era for Alzheimer's disease. It was very nice to see the great progress, both with new treatment opportunities like lecanemab and on blood-based biomarkers.Lecanemab was mentioned in numerous presentations and lecanemab was the focus in 4 different presentations on health-related outcomes, safety and the unique binding profile of the antibody. And our CMO, Tomas Odergren, will now talk about some of these presentations at AD/PD and the clinical program of lecanemab.Next slide, please, and hand over to Thomas.

[Tomas Odergren, executive]

Thank you, Gunilla. Dr. Sharon Cohen from the Toronto Memory program in Canada presented on the Clarity AD Quality of Life results. The analysis showed statistically significant benefits of lecanemab treatment across scales assessing quality of life, both for the subject affected by Alzheimer's disease as well as the care partner of the subject.As seen on the graph at the top right of the slide, the subject experienced 56% less decline in the quality of life over the 18 months treatment period compared to subjects in the placebo group on the disease-specific quality of live scale. A similar result with 49% less decline in quality of life was seen on another instrument, which is used across many different disease areas, EQ5D-5L. Alzheimer's disease is a condition that profoundly affects the life of the family members. The experienced burden of caring for the subject to the Alzheimer's disease either partner or family member, providing the care was assessed in Clarity AD with the Zarit Burden Interview.Across the 22 domains assessed, everyone detected a point estimate in favor of the lecanemab treatment group. In aggregate, a clear increase in the burden for the care partner is seen over the 18-month study period as seen in the black curve in the lower graph on the right-hand side. This was reduced by 38% with lecanemab treatment. The results on all instruments of quality of life were consistent across the randomization strata in Clarity AD, such as the disease stage and ApoE genotype.Next slide, please. This slide goes into more details of the domains assessed with the quality of life AD instrument. A point estimate to the right of the vertical line identifies a domain detecting a numerical benefit of lecanemab treatment as perceived by the subjects. As you see in the graph, such a benefit was seen in all but 2 of the 13 domains. The clinical significance of lecanemab treatment is readily apparent by the observations on such domains as ability to do chores and things on the top of the graph as well as the ability to manage money, family, friends and life as a whole, further down.Next slide, please. Three further oral presentations were given on the lecanemab program at the AD/PD conference. The first was given by the co-founder of BioArctic, Professor Lars Lannfelt, who reviewed the unique binding profile of lecanemab consequent to it being selected based on a preference for binding to soluble aggregated amyloid species.It was noted by Professor Lannfelt that there may be an association between this binding profile and the relatively lower incidence of amyloid-related imaging abnormalities, ARIA in the lecanemab Phase III trial compared to several other anti-amyloid treatment candidates. This higher risk with these other candidates is apparent despite them having been initiated with several months of a titration regimen, whereas lecanemab treatment can be initiated at a full dose from the start.The 2 other presentations by respectively, Dr. [indiscernible] from the U.S.A. detailed lecanemab's safety profile in the Clarity AD study focused on 2 aspects of the ARIA data in the study. In analysis of the possible impact on ARIA of the use of antiplatelets or anticoagulants, it was seen that the incidence of ARIA occurred at a similar frequency in the lecanemab-treated participants, irrespective of antiplatelet or anticoagulant use. The analysis of isolated observations of hemorrhage associated with ARIA, ARIA-H, the frequency, temporal pattern and association with ApoE genotype of isolated ARIA-H in lecanemab group was similar to that in the placebo group in the Clarity AD study.Next slide, please. The treatment paradigm underpinning the lecanemab program is the need to continue treatment to ensure that the soluble aggregated amino species that drive neurodegeneration are continuously cleared from the brain. The recent publication by Manfred and co-authors in Neurology and Therapeutics have now applied the Clarity AD data to a previously published model of the impact of long-term treatment maintained for as long as the subjects remain at the stage of early AD.The data show that lecanemab treatment applied in this manner slows the rate of disease progression and delay the progression to moderate to Alzheimer's dementia with several years and thereby reduce the need for institutional care.Next slide, please. As seen in this slide, Eisai is diligently continuing the important clinical development program for lecanemab. The Phase III globally conducted AHEAD study, together with the ACTC academic consortium for subjects with pre-symptomatic Alzheimer's disease is progressing well to meet the target of 1,400 enrolled subjects with intermediate or elevated levels of brain amyloid. The study is applying blood biomarkers for prescreening to enhance trial efficiency and reduce unnecessary PET scans.Lecanemab is also being assessed as background treatment in conjunction with anti-tau therapies in the DIAN-TU Tau NexGen study for subjects with dominantly inherited Alzheimer's disease. To provide a more convenient treatment option than biweekly IV infusions, Eisai is exploring less frequent maintenance dosing. Eisai has also developed a subcutaneous formulation of lecanemab, which is presently being assessed in subjects treated in the open-label extension phase of the Clarity AB. The subcutaneous formulation is also being progressed with the aim of providing the option for self-administration through an autoinjector.And with that, I hand it back to Gunilla for the next slide.

[Gunilla Osswald, executive]

Thank you so much, Tomas. So reflecting on the population of patients with early Alzheimer's disease, I think this is enormous. Eisai has estimated the global prevalence for future early Alzheimer disease subject to include about 240 million people by 2032, of which about 75 million people are in the Americas, EMEA and Japan.Of course, will not all patients be treated with disease-modifying therapies. The patients need to come to health care and to be diagnosed with mild cognitive impairment or mild Alzheimer's disease with confirmed amyloid-beta pathology. And they have to fulfill other requirements such as, for example, not having pacemaker and so forth in order to be eligible for disease-modifying treatment. So even if a proportion of all patients with early Alzheimer's disease will be treated, it's still a huge opportunity.More and more patients could potentially be treated if we work and handle some of the challenges. Eisai has estimated that approximately 3 million patients will be treated with disease-modifying treatments by 2032. And I think that's a lot of patients that we hopefully will be able to help. There are several opportunities that could be worked on to increase access and some of them are listed here to the right. It's important to increase patient awareness, especially on mild cognitive impairment and earlier signs of the disease since there are no such treatments available today and working on less sigma for Alzheimer's disease patients.Education on primary care on diagnosis and biomarkers and treatment options is, of course, also important. Access to specialist care, it's a very important area to try to facilitate. I think, for example, memory clinics and so forth has an important role in order to making sure that the right patients get the right treatment. In the beginning, the confirmation of pathology has to be done by lumbar puncture CSF or PET scan. In the future, hopefully, more and more blood-based biomarkers can be used.Following treatment with MRI is important for safety aspects and access to infusions and so forth. So there's a lot of things to work on to facilitate access. When we get more improved diagnostics with blood-based biomarkers, that will definitely help. And it's great that the blood-based biomarkers are progressing so well in parallel with the treatment options like lecanemab.Another really important opportunity to increase access is the subcutaneous formulation. And that will make the administration more convenient in getting the treatment earlier and -- or easier and at home. We and our partners are working on all these aspects for the benefit of the patients. And we, of course, would like as many relevant patients as possible that could benefit from lecanemab, to be able to get access if it's wanted by the patients.Next slide, please. And by that, we come to the financial summary, and I hand over to our CFO, Jan Mattsson.

[Jan Mattsson, executive]

Thank you, Gunilla. Net revenues in the quarter amounted to SEK 393 million compared to SEK 4 million in Q1 of previous year. And the reason for this increase is related to the 3 regulatory milestone payments totaling EUR 35 million that we received from Eisai and that were recognized in the first quarter.Total costs in the quarter were higher than in last year and amounted to SEK 96 million compared to SEK 48 million in previous year. The main reason for the cost increase is related to onetime effects that are linked to our milestones from Eisai. This led to a milestone payment to LifeArc and to variable remuneration to the BioArctic employees.Operating result was SEK 301 million in the quarter compared to minus SEK 44 million same quarter of last year. And our operating expenses are expected to be in the range of SEK 330 million to SEK 380 million for the full financial year 2023 compared to SEK 246 million in '22. And the reason for the cost increase is the buildup of the commercial organization prior to the launch of lecanemab in the Nordics and to costs for the expanded in-house project portfolio.Next slide, please. Cash balance amounted to SEK 1.1 billion at the end of March, and the reason for this increase has to do with the received milestones. Operating cash flow amounted to SEK 299 million during Q1 compared to minus EUR 40 million in Q1 '22. Net results for the quarter was SEK 294 million compared to minus SEK 44 million in Q1 of previous year. And in summary, BioArctic continues to have a strong financial position, which is even stronger than a quarter ago.And with that, next slide, please hand back to Gunilla.

[Gunilla Osswald, executive]

Thank you so much, Jan. And now I come to the upcoming news flow and some closing remarks. So next slide, please. The upcoming news flow, if we look at this, we can also note that we had a very intensive and great first quarter.Looking forward, in the coming period that we are in now the second quarter of this year, we will look forward to the U.S. Advisory Committee meeting on the 9th of June. And then we have the regulatory processes with and reimbursement in the U.S. in the coming months. The regulatory process in Japan for the second half of this year with a response in China and Europe within the coming year. And of course, we'll come back with more information when that is relevant. We also look forward to further Alzheimer's Congresses.And the next one to look forward to is Eisai in July in Amsterdam, and we will also provide more information from our other projects when that is relevant. And early next year, first quarter of next year, our partner Eisai is also preparing to file maintenance dosing with less frequent dosing and subcutaneous formulation if all those results is positive. So that's also something to look forward to. So I think that we can conclude that we have had a great start this year and that we have a very exciting year ahead of us.Next slide, please. So I would like to end today's presentation by thanking our CFO, Jan Mattsson, for his valuable time as the CFO. And he will now move into a new role as VP Finance at BioArctic. And I would also like to welcome Anders Martin-Lof with our new CFO from 1st of May.Next slide, please. So by that, I say thank you so much for your attention, and we are happy to take some questions.

[Jan Mattsson, executive]

Operator, we're happy to take some questions.

[Operator]

[Operator Instructions] The next question comes from Joseph Hedden from Rx Securities.

[Joseph Hedden, analyst]

Congratulations again on all of the events achieved over the quarter. A couple of questions. Firstly, lecanemab, having been approved earlier in the year was launched pretty quickly buy Eisai in the U.S. although we know that largely it would only be available to private payers for the majority of the quarter until the VHA decision. Can you confirm if Eisai has made any sales and are you due any royalties for sales made in Q1 or if not, when do you expect to record first royalties? That's the first question.Second question, I noticed that the VHA is criteria for prescribing Leqembi to people under coverage excludes the use of the drug in ApoE4 homozygotes, and that's not in line with the accelerated approval label. What are your thoughts on that? And is that a potential risk for other insurers to follow suit in your view?

[Gunilla Osswald, executive]

So I think the first question will be for Jan.

[Jan Mattsson, executive]

Yes. We have not yet any information about lecanemab sales in the U.S., and we have consequently not received any royalty for lecanemab. We are in discussions with Eisai about the royalty and sales reporting, and we will get back to that next quarter for more information.

[Gunilla Osswald, executive]

Okay. And for then for the second question, if I start and then we can see if Tomas wants to build. So I think with regard to the accelerated approval, we should recognize that there were very few homozygotes in the top dose of the Phase IIb trial. So I think that might be one of the reasons for why they were a bit reluctant for the first approval that they would like to see more data from the Veterans Health Administration. But we don't really know exactly why they have limited it. But I think that the most important as we have said all the time, will be a full traditional approval, which is based on all the efficacy data from the large Phase III trial. So -- and you're right, it's not excluded in the label, but they did this as a first step. And they pioneered by taking this decision and grant coverage in the U.S. before CMS. So maybe they wanted to be a little bit more careful when they started. I don't know, Tomas, if you want to build any further.

[Tomas Odergren, executive]

No. I mean, I would just want to add that in the appropriate use guidelines that have been published in the U.S., there's no such restriction in respect to [indiscernible] So we await now the evaluation by the FDA and other regulatory process about the Clarity AD data, which provide a much better data set in terms of determining benefit risk in ApoE4 homozygotes.

[Operator]

The next question comes from Patrik Ling from DNB.

[Patrik Ling, analyst]

Just a few questions. Just a follow-up on the first one regarding royalties. What's your agreement with Eisai when it comes to when you will receive royalties? Is it the same quarter of sales is generated or is it the quarter after?

[Gunilla Osswald, executive]

So Jan, you can...

[Jan Mattsson, executive]

Yes, that is the quarter after the sales have taken place. So we will get a report from -- so there will be a 1 quarter or a little more than 1 quarter delay before we get the payment.

[Patrik Ling, analyst]

Okay. And when will it be booked from an accounting perspective?

[Jan Mattsson, executive]

That depends on when we get the information. We are not yet through this with Eisai. So we have to come back with that next quarter.

[Patrik Ling, analyst]

Okay. So potentially next quarter, we could get the royalties both for the second quarter, if you have any and for the first quarter or should we know that in the first quarter.

[Jan Mattsson, executive]

We don't know that yet.

[Patrik Ling, analyst]

Okay. Okay. Then I had a follow-up question on one of the comments that you gave, Gunilla, regarding the royalty agreement. Can you just clarify what happens after 15 years if they decide not to extend the royalty agreement Eisai that is?

[Gunilla Osswald, executive]

Then it comes back to BioArctic.

[Patrik Ling, analyst]

Okay. So they cannot continue to sell it. So you will receive the product back.

[Gunilla Osswald, executive]

Correct.

[Patrik Ling, analyst]

Then I had a question on the AHEAD 345 trial. If you know anything about recruitment there when it's expected that the trial is fully recruited or how far they have got into this 1,400 patients as for now?

[Gunilla Osswald, executive]

So I think it's fair to say that the study started in the U.S. and it has been expanded broader and broader around the world. So it's also now ongoing in Japan and Australia, Singapore and some different places in Europe. We're hoping it will come to Sweden soon. And its recruitment is going quite well. And -- but it's -- we have not yet gotten all the patients included. So there is still some time to get all the patients included. I don't know, Tomas, if you want to say anything more. No. And I think that's one really important thing was also last year when they also now started to have blood biomarkers as a screening tool to come into the trial, and that has really simplified and facilitated the recruitment part. Since you screen many patients and some of them get the very positive news that they do not have amyloid. And for those who have amyloid, the next part is to find out how much they have if they have intermediate or clearly elevated levels that decides if they go into A3 or A45?

[Patrik Ling, analyst]

Then my last question, I think this might be for Jan as well. I mean you talked about your operating expenses now in the first quarter, and you said that there were some costs associated with the milestones. Maybe you can elaborate a little bit on that?

[Jan Mattsson, executive]

Yes. As we had an agreement with LifeArc in the U.K., and we paid a milestone payment to them, which was linked to the milestone that we received from Eisai the EUR 25 million milestone payment. And then we had some payments to our staff under remunerating program for the staff as BioArctic received milestone payments, also the employees will get a share of it.

[Patrik Ling, analyst]

And is that something that we should expect? I mean, assuming that you get the full approval, for example, now in Q3, if you get a milestone associated with that, which I would expect you to get, should we expect some additional costs associated with that as well?

[Jan Mattsson, executive]

No.

[Gunilla Osswald, executive]

I think it's very important to clarify, Patrik, that the remaining milestones that we have are linked to Japan and Europe. And as you saw, I mean, the regulatory milestones is 1 for U.S., 1 for Japan and 1 for Europe. And we have already got the 1 for U.S. So the next one to look forward to will be Japan and then Europe. If it continues to go up. I think it's important that we clarify. That point in that the staff will get some remunerations when we get milestones.

[Operator]

The next question comes from Fredrik Thor from Redeye.

[Fredrik Thor, analyst]

I was wondering a bit about the AD/PD presentation about the relationship between anticoagulant patients with on anticoagulants and ARIA frequency. Could you elaborate a bit on that? And what does this mean for the previous hypothesis that maybe the risk could be higher in this patient group?

[Jan Mattsson, executive]

So what this analysis shows is that in terms of the risk level of having such an event, there is no implication of being on antiplatelets or anticoagulants. However, if you get a major hemorrhage, there is a greater impact of that if you are in such treatment potentially. So what these data do not tell us is that there is no risk consideration in terms of initiating lecanemab treatment for subjects who have antiplatelets or anticoagulants.I think it's very important that if the regulator decision is to provide full approval that prescribers are given the insight in terms of having a conversation with [indiscernible] on such treatments so that they are aware that the consequence if there is an area event associated with bleeding may be worse if you have that type of concomitant treatment. But as of yet, we have a limited data set based on control clinical studies. It's important to build on that evidence once lecanemab is more broadly available to further assess the potential risk if you have those type of concomitant treatments.

[Fredrik Thor, analyst]

Okay. And also wondering a bit about the market potential in China, could you maybe develop a bit on that mark yet? What type of approach Eisai could take and maybe how ready, yes, the market is for lecanemab?

[Gunilla Osswald, executive]

Yes. No, I think that China is very difficult to estimate in any way. I think that we are happy to see that Eisai and the Chinese authorities are really working on lecanemab for the patients. But I don't think that we can say anything about how big an uptake could be in China. We know that the population is very, very large, but it's very difficult to judge China. So I see that as a very positive upside, but it's difficult to foresee.

[Fredrik Thor, analyst]

Got it. And a final question for markets beyond these four, what's the status here? Yes, the rest of the world beyond the, yes.

[Gunilla Osswald, executive]

Excellent question. And we will provide more information about other parts in the world when that becomes relevant. The focus so far has been those 4 major markets that we talked about right now. But of course, there are other important markets that Eisai is working on, and we will provide more information when that is relevant.

[Operator]

[Operator Instructions]

[Gunilla Osswald, executive]

So if there are no more questions, then I think I just want to conclude that we have had a great start this year and that we have a very exciting year ahead of us. And I thank you so much for your attention and for the great questions. Bye.