Q1 2024 Novo Nordisk A/S Earnings Call - London
Speaker Change: I will let regularly.
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unknown: Transcribed by https://otter.ai
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unknown: I'm sorry; I didn't mean to pick on you. (inaudible)
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Speaker Change: Good morning.
unknown: Transcribed by https://otter.ai
I had a question.
Speaker Change: Okay.
Speaker Change: You too.
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Yes.
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unknown: [inaudible] Thank you for watching. No, no, no, no. Just in case. We're a bit unloved.
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Speaker Change: Yes.
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Speaker Change: Justin.
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unknown: Oh, yeah, yeah. We've reserved some seats here for you guys, for later. Okay, perfect. Give me a bit of time. When do you want to start? Now? All right. Team, are you ready? You ready?
Speaker Change: We possess a latecomer.
Speaker Change: Okay perfect.
Scott: Hi, Scott.
Scott: Okay.
Scott: Alright, okay.
Scott: Are you ready have you already.
Scott: Yeah.
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Scott: Hi.
Scott: Good morning.
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Scott: Yes.
unknown: Okay, are you ready?
Scott: Okay, you're right.
Scott: Yes.
unknown: Are you ready? I'm ready.
Scott: Alright, okay.
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Scott: Yes.
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unknown: Yeah. Okay. We're standing there. Okay. Take your jacket off, come on, no need to have it at home. What are you doing? You look like an ass fuck.
Speaker Change: Thank you Chuck and thank you Chuck ill come up later.
Speaker Change: Okay.
Speaker Change: Just wondering if I could ask but.
Speaker Change: Yeah.
Speaker Change: Thank you.
Tons into the market.
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Speaker Change: I'll be quick.
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Thanks Mark.
Speaker Change: Thanks.
Speaker Change: Okay.
Speaker Change: Yes, Michael.
Speaker Change: Yes.
Yes.
unknown: Transcript by Rev.com. Page of
Speaker Change: Okay.
Speaker Change: So.
Speaker Change: Good afternoon, everyone welcome to revert selling square feet.
Speaker Change: And good afternoon to everyone listening into the webcast.
Tamsin: Tamsin should have the mics. Tamsin, you've got the mics for Q&A.
unknown: I need to stay for a few minutes. Yeah, yeah, exactly.
Speaker Change: Good afternoon, and good evening.
Speaker Change: It's very busy week.
Speaker Change: But we are we are ending the week.
Speaker Change: With the Q1.
Speaker Change: Sure.
Speaker Change: The speaker that really need instructions are pushed out of courtesy.
Speaker Change: <unk> group CFO committed equity commercial strategy.
Speaker Change: Last but not least multi kind of R&D joined less and they are ready.
unknown: Can you hear me? This is my coat. Yeah.
Speaker Change: Mr Relations that usually I would say without therapy.
Speaker Change: W. What's causing some slides some Q&A, but I think it is worth just causing and recognizing that it is a mix of debt.
unknown: Okay, good afternoon everyone, welcome to the revamped Stirling Square at Citibank and good afternoon to everyone in the room and to those listening in on the webcast. Good morning, good afternoon, good evening. It's been a very busy week for earnings and other events, but we are ending the week on a high with the Q1 London Roadshow of No More Noise.
unknown: The speakers don't really need introductions but just have Kirstie Karsten, the Group's CFO, Camilla, the Group's Commercial Strategy Head, and last but not least, Martin, the Head of R&D, joined by an array of other investor relations people. Now usually, I'd be saying without further ado and straight over to Karsten for some slides and some Q&A, but I think it is worth us just pausing and recognising that it is Mr. Daniel Bohsen, his last role as the Head of Novo Investor Relations. I think that needs to be recognized by the audience in the room, not just yet, not just yet, but a few more minutes to say.
Speaker Change: Is lost.
Speaker Change: Sure.
Speaker Change: Yes.
Speaker Change: No you bet.
Speaker Change: The relationship I think that needs to be.
Speaker Change: So the recognized by the audience.
Speaker Change: Not just yet not just yet.
unknown: But on that note, I have known Daniel for over 15 years, he was the whittlesnapper of the Novo Junior IRR and I was still a whittlesnapper of an analyst covering Novo Nordisk and we were discussing insulin and Victova back in the days and then I think with Martin's blessing he was sent off to Colombia to go and sell some drugs and then we came back in 2020 to be a Head of Investor Relations and I think you can all agree being Head of IRR in 2020 to 2024 for Novo, not a bad place to be. So Daniel I mean this and hopefully I'm speaking on behalf of everyone here and on the line, your professionalism, your patience dealing with people like yourself, your responsiveness, helpfulness and just all around being a good bloke, really appreciate it and we wish you well on your next venture with Novo Nordisk, plenty of good times I have to say, just cool that I think Nording 2016 was a particular highlight so thank you for making that one special.
Speaker Change: But.
Speaker Change: I have laid out.
Speaker Change: For over 15 years.
Speaker Change: We will discover that.
Speaker Change: <unk> noticed it.
Speaker Change: My favorite analysts covering never noticed who will discuss discussing boosting in Victoria that back in the days and then I think with Myelodysplastic Nevis central to Colombia to get yourselves. Some drugs and then came back in 2020 to be head of Investor Relations and I think you'll agree being head of IR in 2000, 22020 full Tonight, but no.
Speaker Change: The bad place to be.
Speaker Change: I'm speaking on behalf of everyone here on the line your professionalism.
Speaker Change: Your patients the more people ourselves.
Speaker Change: Youll responsiveness.
Speaker Change: Alex on this and just over half being at the good like really appreciated and we wish you well Aurora, Although next adventure with Novo Nordisk.
Speaker Change: Good time, but I have to say just called out yielding 2016 was that it was a particular highlight correct. Thank you for making that inspection.
unknown: So before we say goodbye to Daniel and wish him well, I do have a little gift for you. It's within my compliance policy of less than $25, but it says it is to help you immerse yourself in the Taiwanese culture. So, Daniel, on behalf of everyone here, I do want to say thanks for everything and good luck going forward, so thank you, and I will be asking Karsten about Taiwan and the change in performance over the next few quarters under the new management. So, thank you.
So I said before we've taken by that and wish them well if you have a gift for you.
Speaker Change: It's within monarch.
Speaker Change: <unk> policy is less than $25 per se.
Speaker Change: To help you much yourself in the Taiwanese culture, So Daniel behalf of everyone here I do want to say, thanks for everything and good luck going forward. So thank you.
Speaker Change: Sure.
Speaker Change: And I will be up and costs about Taiwan.
Speaker Change: What could change in performance over the next few quarters on any metrics like that.
Speaker Change: [laughter].
Pete: Great. Thank you, Pete, for those nice words to Daniel. We're all sad he's leaving, but we're also very much looking forward to following him in Taiwan. And, you know, we have a materiality assessment on what we report externally in terms of our segment split and so on. And every week, we'll be tracking our weekly sales to see if Taiwan's sales are becoming big enough to include in the quarterly external announcements. So we're all rooting for you, Daniel, for Taiwan to make one of the coming quarters. And thank you to Pete and Philip for hosting us in your beautiful new premises here.
Great.
Speaker Change: Thank you Pete.
Speaker Change: Nice work.
Speaker Change: We're all set is leaving but there, but we're also very much looking forward to to.
Speaker Change: To follow him in Taiwan.
Speaker Change: And you know, we Havent materiality assessment on what we report externally in terms of a second splitter and so on that day and every week, we will be tracking in our weekly sales if Taiwan sales, it's becoming big enough to included in the quarterly external announcements so and.
Speaker Change: So we're all rooting for you Daniel.
Speaker Change: I want to make it to make one of the coming quarters.
Speaker Change: And I think it's a pizza and Citi for hosting it in your beautiful new premises here.
unknown: A nice revamp, so we appreciate that. And then we're bringing another strong quarter from Team Novo in terms of performance. So continued growth, continued momentum from last year amongst the strongest growth stories in the industry, as you know. And we keep pushing that. So, as you know, the future is uncertain, and it might play out differently, and hence we have a nice deck with a forward-looking statement included, so no further details on that. In every quarter, we bring you a status on our strategy execution. And I'm not going to go through all the details.
Speaker Change: Nicely revenge. So we appreciate that and then we're bringing in.
Speaker Change: Another strong quarter from man from T. Mobile in terms of the outperformance. So continued growth continued momentum from it from last year.
Speaker Change: Amongst the strongest growth with storage and the interest you know and we keep pushing that.
Speaker Change: So.
As you know.
Speaker Change: The future is uncertain and it might play out differently and hence we have a nice day with the forward looking statements.
Speaker Change: <unk>.
Speaker Change: No further details on that.
unknown: You'll hear a lot more about that in the coming hour. But just to say on the environmental side, we keep pushing forward. Now we started reporting on full scope 1, 2, and 3, and you see that it is up 32%. And there's one singular key driver for our CO2 emissions being up that much. That's the fact that we're building a lot of new factories, which goes directly into our scope 3 emissions. So we don't take it lightly.
Speaker Change: And every quarter, we bring a status on data on our strategy execution and I'm not going to go through details.
Speaker Change: A lot more about it in the coming off.
Speaker Change: Just to stay on the environmental side, we keep pushing forward now we now we started reporting on full scope one two and three.
Speaker Change: And you see that being up to 2%.
Speaker Change: And Thats, one singular key driver.
Speaker Change: Our Q2 emissions being up that much.
unknown: But now we're fully transparent around our environmental footprint. 42 million people are now on Novo products, up 4 million compared to a year ago. And then continued strong commercial execution that Camilla will come back to. I think it was actually one of the biggest years ever in Novo history in terms of the magnitude and importance of the R&D readout. I'm getting an echo from the new audio, I'll keep talking, and the net net 24% sales growth. So really pushing on all fronts. You'll hear much more. So without further ado, over to Camilla on commercial execution.
Speaker Change: That we're building a lot of new factors, which goes directly into our scope three emissions. So and so we don't take it lightly but there but now we are fully transparent around environmental footprint 42 million people now on novel products up four 4 million compared to a year ago, and then continued strong commercial execution.
Speaker Change: But can you come back to you.
Speaker Change: I think actually one one of the biggest yes ever in <unk> history in terms of the magnitude and importance.
Speaker Change: R&D readout im getting an echo from that.
Speaker Change: From a menu.
Speaker Change: I'll keep talking.
Speaker Change: And then net net 24% sales growth. So so really pushing on the on all fronts.
Speaker Change: Small so without further Ado also camila on there on commercial execution.
Speaker Change: Okay.
Karsten: Thank you, Karsten. And just to recap on our sales growth numbers for this first quarter, we had 24% sales growth and 30% operating profit growth. As you can see from the slide here, 35% growth in North America and 11% growth in international operations. The growth is really driven by GLP-1. We see a 32% growth in GLP-1 in diabetes and a 42% growth in obesity. We are very pleased with the progression of, of course, our GLP-1 business, both in diabetes and in obesity.
Speaker Change: Thank you and just a recap on ally.
Speaker Change: The first quarter, we had 24% sales growth, 30% operating profit growth as you can see from the slide here, 35% growth.
Speaker Change: North America, and 11% growth in international operations.
Speaker Change: The growth is really driven by DLC, one we see at 32% growth in P&C, one in diabetes, 42% growth in BCP, we are there.
Speaker Change: We're pleased with the progression of our call today, Alex you have one business both in diabetes and obesity on total diabetes.
Karsten: On total diabetes, we continue to gain market share. We have also increased our market share this last quarter and are now at 33%. And if we now look at the obesity business here, you see a gradual increase in supply continuing to expand our obesity business. We very much, of course, understand that at this point in time, the obesity business is a lot driven by supply into the market. The underlying business is performing very well.
Speaker Change: Do you need to gain market share we have.
Alex: <unk> also increased market share this last quarter and now at 33% and if we now look at their base of business here you see a gradual increase of supply continue to expand our obesity business.
Alex: We very much of course understand that at this point in time.
Alex: Basically this is a lot driven by the supply into the market. The underlying business is performing very well and no major changes to that compared to last year. So we continue to be happy to wait to ask a question that we see here.
Karsten: There are no major changes to that compared to last year, so we continue to be happy with the progression that we see here. We have gradually increased our supply of the lower-dose strength since May last year but again from January this year. And with broad commercial access to the formula, it means that we have approximately 50 million lives covered in the U.S. And we have now also launched Wigovi in nine countries in international operations plus Canada. So that means there are now 10 countries where we have made Wigovi available. We'll probably talk a little bit more about that later. So now I'll just hand over to Martin to say a few words about R&D.
Alex: Gradually increase our supply of to know what dose strength since may last year.
Alex: But again from January this year.
Alex: The solid commercial access on the formularies means that we have approximately 50 million lives covered in the U S. And we have now also known and resulting in nine countries in international operations plus the Canada. So that means since entrees now that we have made the call will be available.
Alex: We've probably felt a little bit more about that later, so now depend over to Matthew <unk> with about <unk>.
Okay.
Camilla: Thank you very much, Camilla. As you all know, we conducted a small study called SELECT that went out last year, and we were very excited about the results. We're equally excited about the update to the US label that we received during this quarter. Obviously, we get the CV indication indicating that phenagotite is associated with a 20% risk reduction from ACE, major adverse cardiovascular events, that is, myocardial infarction, stroke, and cardiovascular death.
Thank you very much committed as you all know.
Doctor, that's most Arctic cold connect.
Matthew: Out last year, and we're very excited about the results.
Matthew: We are equally excited about the update to the U S Navy.
We shipped during this quarter.
Matthew: Obviously, we get the CV indication, indicating that the magnetite is associated with a 20% risk reduction for mace major adverse cardiovascular event, that's myocardial infarction stroke and cardiovascular deaths.
Martin: On top of that, this risk reduction is now reflected in the label is achieved regardless of baseline gender, age, race, ethnicity, body mass index, and baseline function. Furthermore, we also saw were allowed to indicate the data despite the fact that it was outside of the testing hierarchy that we see a 15% numerical reduction in cardiovascular death and a 19% significant reduction in all cause mortality. And that is now reflected in the making, which obviously is something that we are very, very excited about.
Matthew: On top of that.
Matthew: <unk> risk production is now reflected.
Matthew: In the neighbor is a cheap regardless of baseline gender age race administrative body mass index.
And baseline renal function.
On top of it.
Matthew: We also saw.
Matthew: To indicate the data despite the fact that it was outside of the testing hierarchy that we see at 15% numerical reduction in cardiovascular death.
Matthew: 92% significant reduction.
Matthew: On all cause mortality and that is now reflected in the making which obviously is something that we're very very excited about.
Martin: In addition, the FDA has indicated that the mechanism of the CV benefit is not fully understood, indicating that that benefit is associated with more than just body weight loss. And this is something that we've talked about a couple of times; we see something intermittent that goes above and beyond body weight loss when it comes to the CV benefit, potentially also the real benefits that we have observed with the model, in line with our broader cardiovascular strategy.
Matthew: In addition, the FDA has indicated that the mechanism of the CV benefit is not fully understood indicating that.
Matthew: That benefit is.
Matthew: With more than just the body weight loss.
Matthew: And this is something that we've talked to a couple of times, we see something in <unk> that goes above and beyond body weight loss. When it comes to the CV benefit potentially also of the renal benefits.
Speaker Change: Good luck.
Speaker Change: Okay.
Speaker Change: Nine with our broader cardio vascular.
Speaker Change: Strategy.
Martin: We are continuing to do acquisitions to both our pipelines. As you know, our focus when we talk about cardiovascular disease is not any cardiovascular disease. It's basically the broader metabolic aspects of cardiovascular disease. The key focus is on A, C, and D and inflammation, and Owen Hartzinger with preserved projection fractures.
Speaker Change: We are continuing to do acquisitions to bolt on pipeline as you know our focus when we talk when we talk about cardiovascular disease.
Speaker Change: It is not any cardiovascular disease, it's basically in the Florida.
Speaker Change: Mr. Pollack aspects of cardiovascular key focus is on <unk> and inflammation and all in heart failure with Pacific take some traction.
unknown: We recently acquired a company called Cartel, which had a lead asset, which was an ASO, targeting microRNA 132, which is directly involved in heart failure pathology. So this goes directly into our strategy of expanding our cardiovascular presence. We'll focus on heart failure, we'll focus on ACVD, and we're very excited about progressing the cardio assets into further clinical development. These were just two highlights.
Speaker Change: We recently acquired.
Speaker Change: A company called Concho.
Speaker Change: Having a need answers.
Speaker Change: What all is in Arizona.
Speaker Change: <unk> and micron a $1 32.
<unk> is directly involved in heart failure official it.
Speaker Change: So this goes directly into our strategy of expanding our cardiovascular presence will focus on heart failure with focus on the CBD and we're very excited.
Speaker Change: Tom and Bob progressing Macaco Asics into further clinical development.
Speaker Change: Okay.
unknown: Obviously, it's quite exciting, as Karsten also alluded to, to be in R&D in the Novo Nordisk space. We do see progress across all of our therapy areas. Obviously, we do focus on diabetes, cardiovascular disease, obesity, and rare blood disorders, but we do also see progress in our hepatology focus, where we will see the readout of the ACES phase III trial later this year. We also see progress in our reno, obviously exemplified by flow, and that basically means that we continue to press on all cylinders and see very successful readout, very successful initiation, and throughout the course of the year.
Speaker Change: These were just too high not.
Speaker Change: Obviously, it's quite exciting as constant also alluded to to be in R&D in Illinois is thanks.
Speaker Change: <unk> progress across all of us at the areas, obviously is to focus on diabetes cardiovascular disease obesity and red blood disorders, but we do also see progress.
Our.
Speaker Change: The hematology.
Speaker Change: Our focus specifically.
Speaker Change: For niche, where we will see the readout of the phase III trial later this year.
Speaker Change: I also see progress in our renal obviously exemplified by backflow.
Speaker Change: And that basically means that as we continue to press on Olson in two very successful readout very successful initiations.
unknown: This I think is almost going to be the quiet corner because, moving into the later stages of this year, we are looking towards two advisory committees with the US FDA. One is on IQEDEC. IQEDEC has already received a positive ACHMP opinion from the European authorities. It's approved in Canada and Switzerland.
Speaker Change: Throughout the course of the year. This I think is almost kind of feed the quiet quarter.
Speaker Change: Moving into the later stages of this year.
unknown: And it has an action date in the US in July. And the outcome for IQEDEC in the US is focused specifically on type 1 diabetes. And the outcome is also from the timing perspective, so that this is in due time for the action date. So it's going to be a good discussion.
We are looking towards two.
Speaker Change: Advisory committees with the USA today.
Speaker Change: One is on <unk> <unk> has already received a positive <unk> opinion from.
As the European authorities is approved in Canada and Switzerland.
Speaker Change: And it has an action date in U S in July and the outcome for <unk>.
Speaker Change: I could take in U S is focused specifically on type one diabetes.
Speaker Change: And the outcome is also from the timing perspective.
Speaker Change: So with that business in due time for the extra day.
Speaker Change: It's going to be a good discussion.
unknown: We have been informed that the committee will not discuss the type 2 indication, which we've already discussed is clearly demonstrating a very nice benefit risk but also some very nice convenient benefits of IQTEC in this. The other advisory committee hearing is going to be about heart failure with preserved ejection fraction and somatotype, and this is a huge upside. So, as you know, we conducted the step-by-step test trials with the purpose of looking at six-minute walking tests in Kansas City high school students.
Speaker Change: We have been informed that the.
Speaker Change: The committee will not discuss the type two indication, which we've already discussed is clearly demonstrating.
Speaker Change: Very nice benefit risk, but also some some very nice convenience benefits of iconic.
Speaker Change: In this space.
Speaker Change: Although advisory Committee hearing is going at the heart failure.
Speaker Change: Infection and <unk>.
Speaker Change: And this is a huge upside.
Speaker Change: You know we conduct at the steady pace.
Speaker Change: Trials with a purpose of looking at six minute walk in traffic in Kansas City half question there.
unknown: But in those two studies, we also saw heart endpoints, heart failure, hospitalization, and cardiovascular death, and when we submitted the data, the FDA actually granted us both priority review, indicating that the data were actually exciting, clinically relevant, but also coming from two small studies. So we also got the advisory committee hearing to discuss the impact of it, and again, a huge upside for Samantha's side, specifically with E. coli. I can feel Karsten is becoming impatient, so I have to start focusing.
Speaker Change: But in those two studies, we also saw <unk> hot.
Heart failure.
<unk> and cardiovascular death.
When we submitted the data.
Speaker Change: I sleep granted us both proactive review, indicating that the data are.
Speaker Change: Exciting given the clear relevant but also coming from tools. Most orders. So we also got the advisory committee hearing to discuss.
Speaker Change: The impact of it.
Speaker Change: And again, a huge upside for us and emphasize specifically.
Speaker Change: We go.
Speaker Change: Yeah.
I can see customers, becoming impatient and want to answer.
Speaker Change: Okay.
Speaker Change: Maybe just calling out that in a couple of weeks, we will see the dung weighted data.
unknown: Maybe just calling out that in a couple of weeks we'll see the long-awaited data in our rare blood disorder franchise from MyMed, which obviously could potentially be something very, very exciting. So with that, back to you, Karsten.
Speaker Change: In our rare blood disorder franchise from my mate, which obviously also could potentially be something very very exciting so with that thank you.
Speaker Change: Okay.
Martin: Thank you, Martin, for an elaborate walkthrough of the slides, as always. Joking aside, an amazing year from R&D in terms of readouts and actions. I cannot remember a year where we've had so much action and so many readouts and decision points, so really, really important to deliver on this. Results for the first three months, you've all seen in our company announcements, coming back to 24% growth, continuing the momentum from last year, the same growth drivers being CentPig and Bigovi and Rodalysis. Thank you.
Speaker Change: Thank you Martin and the level of book two of the slides.
Speaker Change: As always.
Speaker Change: [laughter].
Speaker Change: Talking aside theyre amazed.
Amazing year.
Speaker Change: R&D in terms of Readouts and actions.
Speaker Change: Cannot be met by year.
Speaker Change: So much action and so many readouts and decision points. So so really really important to us.
Speaker Change: Live on this.
Karsten: Then, in the quarter, we had a one-off in terms of an accounting estimate adjustment, which bumped up growth by 5%. To adjust for that, we are in the 19 range. Yes, last year's comparator was easier, but then there are some supply issues.
Speaker Change: <unk> results.
Speaker Change: Our results the press three months, you've all seen it in our company announcements.
Speaker Change: Coming back to a 24% growth.
Speaker Change: Continuing the momentum from last year at the same growth drivers being <unk> and <unk> and robustness.
Speaker Change: Then in the quarter, we had a one off in terms of an accounting estimate adjustments, which bumped up growth by by 5%.
Speaker Change: So adjusted for that.
Speaker Change: We're in the 19 range.
Speaker Change: Yes last year's comparator was.
Speaker Change: But then there are some supply issue. So just to say the run rates in the first quarters around 20%.
unknown: So just to say, the run rate in the first quarter is around 20%, apples to apples. In terms of our capital and resource allocation, as I covered at Capital and Markets Day, of course, we continue to drive productivity for a broadly stable gross margin. Lower growth in commercial investments than sales growth is simply due to the fact that we have the infrastructure in place and the demand nature of our products.
Speaker Change: Apples to apples.
Speaker Change: Then in terms of Wildcats, a capsule and resource allocation.
Speaker Change: I call it at the capital markets day.
Speaker Change: Of course, we will continue to drive productivity for the broadly stable gross margin.
Speaker Change: Lower growth in the commercial investments and sales growth is sensitive to the fact that the infrastructure in place.
Speaker Change: And the demand nature of our products, but then on the other hand.
unknown: On the other hand, linked to the slide you just saw, there is a lot of opportunity in R&D, so really pushing to expand and broaden our R&D pipeline, stepping up R&D investments by 28%. All in all, operating profit was up 30%, and our earnings per share were up 29% for the quarter. Outlook for the year. If you adjust for the accounting estimate adjustment in the first quarter, then our guidance is unchanged, the account exchange rates, but bumped by 1% linked to the one-off.
Speaker Change: A link to the slides you just saw a lot of opportunity in R&D, so really pushing through to expand and broaden our R&D pipeline stepping up R&D investments by 28%.
Speaker Change: All in all operating profit up 30% and our earnings per share up 29% for the quarter.
Speaker Change: Outlook for the year.
Speaker Change: If you adjust for the accounting estimate adjustment in the first quarter then our guidance is unchanged at constant exchange rates.
Speaker Change: But from five 1%.
unknown: So now our full expectations are between 19% and 27% on top-line growth and 22% and 30% on OP. And then given the strengthening dollar, currencies are a little bit more variable, which is then, in turn, offset by our losses on the net financials. All right, this covers the formal presentations, and then we have Daniel Bohsen facilitating his last Q&A, so we look forward to that, and of course, any specific questions on Taiwan, Daniel is more than open to covering them himself. Should we move to a
Speaker Change: So the one off so so now fully expectations are between 19, and 27% on top line growth and 20% to 30% on the op.
Speaker Change: And then given the strengthening dollar.
Speaker Change: Then currency saw a little bit more favorable which had been interim offset by by hitting losses on the on the net financials.
Speaker Change: Alright. This covers the former presentation and then we have set an important facilitating as last Q&A. So so we look forward to that and of course any any specific questions on Taiwan, Dana that's more than open to cover them himself.
Speaker Change: Yes.
Speaker Change: Should we move to <unk>.
Speaker Change: Yes.
Daniel Bohsen: Thank you, Karsten. And luckily, I know Camilla has been a general manager for Reaching China, so she will cover those questions today. But please state your name and institution. Let's go with one question per person, then we can take several rounds. And Emily had her hand up very fast.
Speaker Change: Yeah, No kabila has been the general manager for reach in China. So as you recover those questions today.
Speaker Change: But please state your name and institution, let's go with one question per person and then we can take several rounds and Emily had her hand up very fast.
Elise Hill: Hi, thank you. I'm Elise Hill from Barclays. I'm not going to ask directly about the competitor data overnight, but when could we expect to see the phase one data from your once monthly GLP-1 GIP? And, you know, how important do you think it is to have dose inconvenience that goes, you know, beyond once weekly?
Emily: Thank you Emily field from Barclays.
Emily Field: I'm not going to ask directly about the competitor data overnight, but.
Emily Field: When could we expect to see the phase one data from your once monthly <unk> one Jackie.
Speaker Change: How important do you think it is to have.
Speaker Change: Dosing convenience that goes beyond once weekly.
Martin: Martin, I think this one is for you, a few words on that, our progress there. The study for the once monthly GIP-1-GIP is going to be ongoing. We expect to see the readout around the turn of this year. In terms of importance, I think the current dynamics, as I see it, and obviously Camilla can also speak to that, there's a clear, transcription by https://otter.ai, and then obviously the convenience becomes a secondary factor. We will continue to pursue that, but efficacy, as I see it, comes first. So let's go to Simon.
Speaker Change: And I think this one is for you a few words.
Speaker Change: Our cultural fit.
Speaker Change: I started by the once monthly <unk> is going to the ongoing we expect to see.
Speaker Change: Read out around the turn of this year.
Speaker Change: In terms of the importance I think the current dynamics as I see it and obviously you can be you can also speak to that.
Speaker Change: Yeah.
Speaker Change: Drive by efficacy over a preference or anything else.
Speaker Change: In this space.
Speaker Change: And obviously our question.
Speaker Change: Have stuff in.
Our pipeline is always is differentiated efficacy.
Speaker Change: And then obviously the convenience becomes.
Speaker Change: A secondary factor.
Speaker Change: We'll continue to pursue that.
Speaker Change: But the efficacy.
Speaker Change: As I see it comes first.
Speaker Change: Okay. So let's go to Simon.
Simon Baker: Thank you. Simon Baker from Redmond Atlantic.
Simon: Thank you.
Simon: Until Q.
Simon: Two we will refrain from asking you to comment on someone else's data the MDC, but just just in terms of.
unknown: I, too, will refrain from asking you to comment on someone else's data that nobody's seen. But just in terms of how you see the market evolving over time, it seems highly unlikely that it'll be the same in 2030 as it is today because of your own products that you have, as well as others. It also seems unlikely that everything else outside Novo that's in development will fail, although equally unlikely are Portfolio Evolution and the efforts of others. Thank you.
Simon: How you see the market evolve because the time it seems it seems highly unlikely that it will be the same in 2013.
Simon: Because of your own products that you have as well as others. It also seems unlikely that everything else outside.
Simon: The development will fail equally unlikely work so what's your assumption of how this market evolves.
Simon: Portfolio evolution.
Speaker Change: It's about this thank you.
Camilla: Camilla, can you give some perspectives on the obesity market, and how we think it will develop?
Speaker Change: I mean, I think can you give some perspective on the obesity market. How do we think is developed.
unknown: Simon, so if we take a starting point in the number of people living with obesity, we know that there are more than 800 million. We also know that today we are helping treat, you know, less than a million in terms of fully equivalent patients, if we may call it that. And that basically means that there is ample opportunity to grow in this space and to help many more patients. It's likely that there will be different segments in the future, where the highest ticketing segment is, of course, where we have our strong focus.
Speaker Change: The assignment so of course, if we.
Speaker Change: Take us adding funding a number of people living with obesity will be noted that more than 800 million, we know of today via helping treat.
Speaker Change: Net than a million in Santa Fe is pretty equivalent in patients, who we may call. It like that and that basically means there's ample opportunity to grow in this space and to help many more patients it's likely that that would be different segments in the future where the highest ticketing segment is of course, where we have a strong focus.
unknown: From a science point of view, we have a strong label now with Select on Vigovi where we are addressing not just weight loss but also, beyond weight loss, cardiovascular risk profile. We know that that is where people die. 31% of everyone dies from cardiovascular issues.
Speaker Change: From a science point of view, we have a strong label now with both the Nick on the call we will be addressing not just weight loss, but also beyond weight loss cardiovascular risk.
Speaker Change: Profile, we know that that is what people die from 31% of everyone dies from cardiovascular issues. Now we have also of course, they also data and so to complement.
unknown: Now we also, of course, have our flow data. And so to complement, you know, the Vigovi label with that is, of course, a life cycle management plan for us. In addition to that, we are then bringing in new compounds with, hopefully, greater efficacy. But it's not to say that there will not also be a space for high convenience products, maybe with lower efficacy. So having said that, today there are two companies that are competing in this space, but it's still early days.
Speaker Change: The Kobe nasal big basket of costs and lifecycle management plan for US. In addition to that we have been bringing on new compounds and we'd also hopefully greater efficacy.
Speaker Change: It's not to say that that would not also be faithful.
Speaker Change: Convenience product may be with no way secrecy, so having said that today that some companies that are competing in this space. It's still early days, there's probably room for mall.
unknown: There's probably room for more, just given the magnitude of the numbers. So I do expect that we've seen a lot of progress in the last few years on physicians that are willing to prescribe obesity products just a few years ago. We all remember it wasn't exactly like that. So, there has been a lot of development, and hopefully, we can address more of these comorbidities related to obesity. And that, of course, clearly goes beyond just weight loss. Thanks, Camilla. So let's move over here. I'm not going to ask about the FTC's second request.
Speaker Change: Just given the magnitude of the number so I do expect that we've cleaned a lot of progress in the last few years on physicians that are willing to prescribe obesity products. Just a few years back we all remember it wasn't exactly like that so there has been a lot of development and then hopefully will mean, we can address northeast.
Speaker Change: Comorbidities related to obesity and that's of course pinnacle's beyond just whitehouse.
Camilla: Thanks, Camilla. So let's move over here.
Speaker Change: Thanks, Camilla so let's move over here.
Speaker Change: Cynthia <unk> from BMO capital markets, So im not going to ask about the FTC second request, because I know thats not you.
Cynthia: <unk>, specifically, but I did want to ask about how much more capacity do you think you can get from the three facilities from Catlin and what does that do to the supply of all of your products by 2026. Thank you. Thank you Evan and Kathryn.
unknown: Thank you. Thank you, Evan and Karsten.
Karsten: Yeah, so in terms of the FTC, to cover that one first, it's completely normal that when you have a big transaction, there's a process with the FTC to assess any antitrust considerations. So there's nothing unusual there.
Speaker Change: Yeah. So.
Speaker Change: So in terms of FTC towards covered that one first.
Speaker Change: It's completely normal when you have a big transaction.
That process with the FTC.
Speaker Change: Assess any antitrust considerations. So that's nothing unusual there and we have no changes in our expectations in terms of deal certainty and confidence and that's just to cover that piece.
Speaker Change: <unk>.
Speaker Change: This capability.
unknown: And we have no changes in our expectations and in terms of deal certainty and confidence in that, just to cover that piece. As to scalability, we're not out explicitly guiding on the magnitude. But if you look at our current footprint on fill finish, where we have around a handful or so of filling sites today, then adding three filling sites of varying sizes, this is a meaningful step up in capacity on our old fill finish.
Not out explicitly.
Speaker Change: Guiding on the magnitude.
Speaker Change: But if you look at our current footprint and fill finish this.
Speaker Change: Where we have around a handful of us also.
Speaker Change: Any thoughts today than adding three billing types of varying sizes. This is a meaningful step up in capacity on our order fill finish.
Speaker Change: And.
Speaker Change: And I would say on that on this single dose syringes.
Speaker Change: We have very very limited capacity in house today, So thats, mainly CMO setup and with this change then we would take a key platform for the company for unit. Four currently people will use as the main product, but then we would take a very important production platform in house under full control. So thats also.
Speaker Change: Our risk control element.
Speaker Change: What we're doing here.
unknown: So, but a significant step up. And the important part, the reason why we do it, just to remind you, this is about speed and scale. So it is to step up capacity as fast as possible compared to other alternatives.
Speaker Change: But a significant step up and the important part the reason why we do it just to remind you. This is about.
Speaker Change: The speed and scale. So it has to step up capacity as fast as possible compared to other tranches.
Speaker Change: Thank you thank.
Speaker Change: Thank you Pat and thanks for the question Joe.
Joe: Joe? So let's just assume that Cagri-Sema has good data. Should we be assuming that you would expect pretty much everyone to move from Sema to Cagri-Sema? Because that seems to be an even more difficult manufacturing problem given that Cagri-Lunatide you're making externally? And I just wonder whether governments, particularly when Sema is cheaper, if it's in IRA, will say that's good enough, and that Sema will be your base load of product, and then Cagri-Sema will just be reserved for the, you know, more, more difficult patients. So that it's more, perhaps, or Simon's question about how the situation evolves and whether we should think of that transition that we Thank you.
Joe: Hi, Joe with UBS.
It's along the same lines in terms of capacity.
Speaker Change: I guess, it's the cumulative just one perhaps.
Speaker Change: In the market today for obesity people move from Saks and so.
Speaker Change: They've really moved up.
Speaker Change: So you did the lower efficacy.
Speaker Change: So, let's just assume that calculation.
Speaker Change: Good data.
Speaker Change: Should we be assuming that you would expect pretty much everyone to me from Cymer.
Speaker Change: Calgary Cymer, because that seems to be an even more difficult manufacturing problem, given the canker lunacharski youre, making.
Speaker Change: Sternly.
Speaker Change: I, just wonder whether governments, particularly when summer is cheaper fats and oil Ray who will say that's good enough.
Speaker Change: Simon will be Youll baseload of product and then Calgary Simon would just be reserved for the.
More more difficult patients.
Speaker Change: It's more perhaps Simon's question about how the situation evolves and whether we should think.
Speaker Change: So is that true.
Speaker Change: <unk> that we've already seen leaving until the next one or not.
Camilla: Thank you, Joe. Camilla.
Speaker Change: Thank you Joe Camilla.
unknown: Thanks Jo, I think you are right; it is a completely different situation than what we had with Saxenda and Vigovi, not least just for the bare efficacy of what we have on Vigovi today, including the select trial that Martin has just presented. And so because of the magnitude of the numbers and because of the number of people being treated, plus the need and the demand out there, it's more likely to see an expansion of the market with new products coming in, a very strong base, of course, with Vigovi for many years into the future.
Speaker Change: So Ann Thanks, Joe I think it is youre right its a completely different situation than what we have to expect zander, Andy Colby not least just towards the bay area efficacy.
Ann: We have an equal with today, including the select trial that Matson has just presented.
Ann: So.
Ann: Because of the magnitude of the numbers and because of the number of people being treated testing needs and the demand out there it's more likely to see an expansion of the market with new products coming in and a very strong base of course with the Kobe also into many years into the future and so I would not see this.
unknown: So I would not see this whole addition of a strong pipeline as purely a cannibalization exercise. It wouldn't be the right thing to do because we have so many patients that need to be treated, and some need a higher focus on weight loss, while others need a higher focus on comorbidities. So there is a place for new innovations that add to the existing base that we are developing for many years into the future with Vigovi.
Ann: Holding additional of a strong pipeline as purely account penetration exercise it wouldn't be the right thing to do it because we have so many basis that needs to be treated and some need of higher end.
Ann: Focus on weight loss other needs higher focus on Comorbidities. So there is a position for it but also new innovations that are add ons to existing base that we are developing and for many years into the future with docomo.
James: Thank you, Camilla. Let's go to James.
Thank you Camilla <unk>.
James: Go to James.
Ann: James.
Martin: I've got a question for Martin on muscle sparing. So what do you hear from doctors in terms of if there's like a desirable ratio in terms of fat loss versus muscle loss, or is it more of a case of losing weight in general? And then as you think about Select versus Step 1 and Sustain 8, where it was a 40% loss from lean body mass. Have you seen any data from Select that suggests that flips over time or gets a bit better?
James: Okay. Thanks, Peter from Goldman Sachs.
James: I've got a question for Martin on muscle sparing.
James: So what are you hearing from doctors in terms of if there is okay.
James: Desirable ratio incentive such as muscle loss.
James: In terms of.
Martin: Or is it more of a case of.
Martin: Excluding the waste in general.
Martin: And then as you think about select especially as step one.
Martin: Many nights versus 40% plus from lean body mass have you seen any data from select suggest that.
Martin: Over time, we will get.
Martin: Thanks.
Martin: Okay.
Martin: So.
Martin: <unk>.
unknown: [inaudible] What we hear from training positions is that that is currently not a consideration. I think it comes from a lot of these positions have introduced weight loss with non-drug interventions for a period of time. And if you look into sort of the broader literature, when you introduce weight loss, the proportional weight loss coming from lean body mass is typically somewhere between 25 and 45 percent, and the driver of that ratio between the body mass loss and fat mass loss is typically the speed of weight loss.
Martin: What we hear from treating physicians.
Martin: Bad debt is currently not a consideration.
Martin: Income from a lot of these decisions have introduced weight loss.
Martin: It's not profit interventions for a period of time.
Martin: And if you look into sort of the broader literature, when you introduce a weight loss.
Martin: The proportional weight loss coming from new body mass is typically between somewhere between 25% and 45%.
Martin: And the driver of.
Martin: Of that ratio between the biomass, Lois and fitness specifically the speed of Windows.
unknown: So when you have a proportional weight loss from lean body mass, around 35-40%, they attack you within that realm. And that basically means that that is a normal and healthy weight loss. You could actually argue, and this is obviously also why we're super happy with data from Select; we can actually show that even in, [inaudible] So based on current treatments, I don't see this as a border problem. I think it has to be a focus area.
Martin: So so so when you have when you have it.
Martin: Proportional weight loss from limbo remarks around 35% to 40%.
Martin: Within that realm.
Martin: Basically means that that is a normal and.
Healthy weight loss.
Martin: You could actually argue and business office and also why we were happy with data from select.
Martin: We can actually show even in <unk>.
Martin: Cardiovascular disease.
Patients, so so presumably slightly more frail.
Martin: <unk> patients.
We show that we improve not only cardiovascular.
Martin: <unk> also all cause mortality.
Martin: Basically again just plays into this.
Martin: This appears to be a healthy weight loss.
unknown: Also, with current treatments, in particular in frail patients, and when we move into the potential for bigger weight loss, it has to continue to be a focus area. This is where we take some comfort from animal biology because it is based on animal studies, both from us, but also from others. Admin appears to be associated with an even bigger improvement in the lean to fat mass ratio, who didn't do body composition assessment and select, so I don't have any data from there. But again, based on what we see, but also based on the actual outcomes for patients, do they live longer? Do they live healthier lives?
Martin: So based on current treatments.
Speaker Change: I don't see this as a board.
Speaker Change: No problem I think it has to be a focus area.
Speaker Change: Also with countries in particular in frail patients.
Speaker Change: And when we move into the potential for bigger weight loss. It has to continue to be a focus area. This is where we take some comfort from the enemy priority because based on animal studies, both from us, but also from others.
Speaker Change: And and appear to be associated with.
Speaker Change: And even bigger improvements.
The trophic mis.
Speaker Change: Our ratio.
Speaker Change: David.
Speaker Change: Sure.
Speaker Change: Body composition.
Speaker Change: It's been to Insulet.
Speaker Change: So I don't have any data from there, but again based on what we see also based on the excellent outcomes for patients do they live longer.
Speaker Change: Yeah.
Speaker Change: Quite comfortable with what we see right now.
Martin: We're quite comfortable with what we see right now. Thank you, Martin. Thank you, James. Let's go to Satyen in the first row.
Speaker Change: Thank you Matthew Thank you James Let's go to search again Christopher.
unknown: Pats and Jane Bank of America, Pats for Karsten, on S&D phasing through the year alongside supply. So the question is, first quarter S&D and the full year guide obviously implies inflection and spend through the year. So any color on what is causing that inflection and spend? Is it linked to an inflection in supply? And is the supply inflection linked to whatever promotional activities you do around the end of the year? So, for example, select or heart failure towards the end. Thank you.
Speaker Change: Sachin Jain Bank of America has a carsten.
Sachin Jain: On F&B phasing through the air alongside a surplus of the question.
Sachin Jain: First quarter <unk> and the full year guide, obviously implies inflection spend through the year. So any color on what is gating that inflection and spend is it linked to an inflection supply supply.
Sachin Jain: Supply inflection linked to whatever promotion like CTG around.
Sachin Jain: We gave you. So for example, select so heart failure.
Karsten: Thank you, Septim. Karsten, any comments on the S&D facing issues? Yeah, so S&D in the quarter was 20% of sales. Full year, we're looking at more around 22% or something like that in terms of the S&D ratio. So you are correct that our S&D budget is slightly backloaded. And, of course, that's linked to our commercial strategies, and our commercial strategies are linked to supply availabilities as well as R&D readouts. So, for instance, we now have Select, and now we'll start promoting it even more based on the updated label from Select.
Speaker Change: Thank you Sachin.
Speaker Change: And it comes from just the deficient.
Speaker Change: So S&P in the quarter was 20% of sales full year, we're looking at more around 22% or something like that in terms of the ratio. So so you are correct that are facing us is slightly better.
Speaker Change: Alright.
Speaker Change: And of course, that's linked to our commercial strategies and our commercial strategies I think so too.
Speaker Change: To supply those businesses as well as R&D Readouts. So for instance.
Speaker Change: We've had select and Mt.
Speaker Change: Start promoting even more based on the updated data from select that of course entails some promotional spending linked to that in the U S. As a specific.
Karsten: That, of course, entails some promotional spending linked to that in the US as a specific example. So you shouldn't link it directly as a direct causality that then there's more out of manufacturing in a specific quarter. But, of course, it's all tied together in the logic. So I think that's as precise as I can give it.
Speaker Change: Specific examples so you shouldn't you shouldn't didn't get directly.
Direct causality that then that's more out of manufacturing in a specific quarter.
Speaker Change: Of course, it's all tied together in a logic. So so I think that's as precise as I can get it on R&D sorry.
unknown: and on R&D, sorry, is there anything other than select that you'd call out?
Speaker Change: That you'd call out.
unknown: in terms of in terms of readouts
Speaker Change: In terms of in terms of Readouts I guess, you said commercial links RMB.
unknown: Yes, you said commercial link to R&D other than selectors. Sorry, apologies. So you said commercial-linked R&D. Other than selectors, is there anything else that we should be thinking about that's being linked to? Well, you could say...
Speaker Change: Is there anything.
Speaker Change: Commercially it's RMB, yes, and select is there anything else that we should be thinking about mix being linked to you could say.
unknown: Well, you could say in terms of weekly launches, there will, of course, be some launch preparations taking place there. And then, you saw, Martin's infamous pipeline slide there: whatever we get in terms of feedback from the advisory committees also on FPF will impact our commercial strategies for the rest of the year. Thank you, Sebastian. Thank you, Karsten.
And in terms of weekly launches.
Speaker Change: And then of course be some launch preparations.
Taking place there.
Speaker Change: And then Martin and payments for our pipeline slide.
You saw that.
Speaker Change: Whenever we get in terms of feedback from the Advisory Committee is also on that aircraft.
Yes.
Will impact.
Commercial strategies for the rest of the year.
Karsten: So we can go to Richard. Yeah, Richard Parkes from BNP Paribas Exam. It's a follow-on from a question I asked yesterday, but it's on the same theme related to potential segmentation of the market because, obviously, the other
Speaker Change: Thank you Stephanie thank you.
So we can go to Richard.
Speaker Change: Yeah.
Speaker Change: Yeah, Richard Parkes from BNP power bar exam.
Richard Parkes: Follow on question I ask Jeff, but it's on the same theme related to central segmentation of the market because of these other companies.
Speaker Change: Making a bet.
Richard Parkes: If you can develop a scalable oral solution, then you can unlock a much broader opportunity, and that's the value.
Speaker Change: You can develop a scalable than you can unlock a much broader opportunity and maybe that's the value base people with overweight and.
unknown: Novoselic, Daniel Bohsen, Novoselic, Novoselic, Novoselic, Novoselic,
Speaker Change: Issues.
unknown: So you've placed your bet on the Lula band.
Speaker Change: Thank you Belmont during the bomb, which.
unknown: I suppose my question is, how confident are you that the drug isn't getting into the brain and therefore won't have the psychiatric side effects, because we see other companies developing BTK inhibitors arguing about who's got the best data on the ability of drugs to penetrate the brain? So what underpins your confidence that the drug isn't getting into the brain and therefore unlikely to cause those side effects? That's in this one's for you. Yep. Thank you. And so it goes.
My question is how confident are you that the drug is getting into the brain and therefore, we're not sarcastic side effects because we see other companies that are developing PTK inhibitors talking about who's got the best actor.
Belmont: <unk> ability to penetrate the Brian so what what underpins your confidence the drug isn't getting into the buy in and therefore, we might need to close those side effects.
Speaker Change: This one is for you.
Martin: So we're quite confident that brain penetration is substantially less than what has been the case for previous drugs in this class. But we've never talked about ruling out some brain penetration. But if you look back at the historical cases, it was actually about exposure, and therefore, with a very low penetration that we expect to potentially see here, based on the data, also clinical data that we've seen so far, we're not concerned. We take it seriously.
Speaker Change: Yes.
Speaker Change: So so we're quite confident that the brain penetration is substantially less than what has been the case for previous drugs.
Speaker Change: In this class.
Speaker Change: Never talk about moving out some.
Brain penetration, but if you look back at the historical cases, it was escape out exposure.
Speaker Change: And therefore with a very.
Speaker Change: No.
Penetration that we expect to potentially see here.
Speaker Change: Based on the data also clinical data that we've seen so far.
Speaker Change: We're not concerned.
unknown: And that's also why you'll actually see us, normally I talk about the speed of going into phase three and further development. In this specific case, we actually specifically want to do a large-scale phase two study with the purpose of ruling out any new psychiatric risks. Thank you, Martin. We can go on a low. Oh, there's a mic.
Speaker Change: We take it seriously and that's also why you will actually see is normally I'll talk about the speak to going into phase III in further development in this specific case.
Speaker Change: We wanted to Alaska in phase III, starting with the purpose of ruling off.
Speaker Change: And in neuropsychiatric risks.
Speaker Change: Thank you Matthew.
Speaker Change: We can go to a loan.
Matthew: Well, Mike Thank you.
unknown: Thank you. Thanks, Lauren Indy Ehrenberg. Just going back to the once monthly, what is the latest on applying your once monthly technology to your other pipeline assets? So could you apply it to Amercretin, Kagosema? And if not, what's the limiting factor?
Mike: Thanks, Noah handy, but just going back to the one month basis, what is the latest on applying your once monthly technology to other pipeline asset did you plan to increase in Pakistan.
Mike: And if not what's the limiting factor.
Speaker Change: And this one smart safe high and why you've progressed, the DLP lunch combination, even thats 160 progression.
Martin: And does once monthly tie into why you could progress the GLP-1-GIP combination, even though it's a once weekly progression? Thanks. Thank you, Martin. That's also for you.
Speaker Change: Thank you Martin that's also for you.
unknown: So we actually have several different modalities for protracted action, and obviously, the one that we have in the clinic right now is attracting some attention that could potentially be applied elsewhere. But we currently have, as I said, several modalities being investigated in the preclinical space, and what we will move forward with at the end of the day. Development depends obviously on efficacy but also on the potential for scalability.
Speaker Change: So we have actually several different modalities for protected the action.
And obviously the one that we have in the clinic right now is attracting some attention.
It could potentially be applied elsewhere.
But we currently have several modalities being investigated in the preclinical space and what we at the end of the day will move forward also into later stages of development defense of the screen.
Speaker Change: The efficiency, but also the potential for scalability. So we are not committed to anything yet and you'll have to see the current ongoing once monthly we will get to once you have T. S anecdotal story to investors.
unknown: So we're not committed to anything yet, and you have to see the current ongoing once monthly. We'll get the 1GIP as an exporter started to investigate the technology. Thank you. So we can go to Peter. Hi, Peter Welford for Jeffreys. Can I come back to the topic that came up a while ago on Wegerby in terms of the fourth...
Investigating technology.
Speaker Change: Thank you so we can go to Peter.
Peter: Alright, Thank you up with Jefferies can.
Peter: Can I come back to a topic that came up a while ago on what could be in terms of the fourth of different formulations, all types that could be available in the U S. So the game will be U S strategy.
unknown: ,......
Peter: <unk> revised until you sort of thinking in terms of sticking with the single use pen in the U S market did not launching any other alternatives.
unknown: or thinking in terms of sticking with a single-use pen in the US market and not, you know, launching any
unknown: All Alternatives, and equally any thoughts on a sort of direct distribution system that I think your competitor obviously has done as well, where they've cut out the middleman to some extent to supply US patients.
Peter: And equally any thoughts on sort of direct distribution.
Peter: System that I think what youll come back strong system as well.
Peter: We're able to cut out the middleman to some extent to supply U S patients.
Camilla: Thank you, Peter. Camilla, portfolio considerations?
Speaker Change: Thank you Peter Camilla portfolio considerations.
unknown: Yeah, so we continue to of course evaluate how we can optimize our portfolio considerations also for the U.S. Right now, we're very focused on the single dose device, but of course, over time, we're looking at also how we can make efficient dosing of DLP1s in fixed, you can say, dosing regimens. How can we do that in a smarter way that requires less capacity? It's something that we constantly look at across our value chain. How can we optimize the presentation formats we have across the world? How can we release more products and, with that, also increase our scalability? So constantly, we will be evaluating those things.
Camilla: Yes. So we continue to of course evaluate how can we optimize our portfolio considerations also for the U S and right. Now we are very focused on the same dose device, but of course over time. We're looking at also how can we make hay.
Speaker Change: <unk> dosing of DLP, one thing in <unk>.
Speaker Change: You can see dosing regimen is how can we do that it's not a way that required less capacity is something that we constantly look at across our value chain, how can be optimized with a presentation followed us we have had a cost involved how can be really small products and would that also increase our scalability. So.
Speaker Change: And we will be evaluating those things.
Rajesh Kumar: Good. Let's go up here to Rajesh.
Good let's go up here.
Speaker Change: Yeah.
Martin: Hi Rajesh Kumar from NADCPC, one to Martin. It would be unfair of me to ask you to comment on how others would design their clinical trials, but given the data packs we have seen so far on cerviclotide, if you were designing next generation trials for your next generation product, would you be, say, for example, the like for like for a select? CKD, would you be using placebo as a control, or would you be using something else? Inaudible.
Speaker Change: Just one for me.
Speaker Change: One for Martin.
Speaker Change: It would be unfair of me to ask you to comment on how others define there.
Speaker Change: The nickel clients, but given the data we have fee profile is tight.
Speaker Change: If you were designing next generation trials.
Speaker Change: Our next generation products would you be saying for example, like for like for select.
Speaker Change: <unk> would you be using.
Speaker Change: Placebo or the control or would you be you were thinking.
unknown: And what does that mean about how do you need to power the trial? What size of trial do you need? Thank you, Martin, trial design consideration. So a really complex question and a lot of regulatory considerations also. I think the U.S. is seeing different approaches across industry right now.
Speaker Change: It's kind of like low tide, and what does that mean about.
Speaker Change: How do you need to power the trial what size do you need.
Speaker Change: Thank you Martin trend design considerations.
Speaker Change: Really complex question than a lot of regulatory considerations also.
Speaker Change: I think.
Speaker Change: You're actually seeing.
Martin: We're getting closer to, for example, obesity in the cardiovascular space. If there is a gold standard, you can't compare to placebo; you have to compare to that gold standard, and that could potentially be a somatic trial. That basically means from our perspective, if we, for example, look at Cagway Center, If we want to claim the same benefit as the Magnetite, we have to show parity with the Magnetite and not inferiority to the Magnetite if we do a head-to-head comparison. That would require, and I would say a normal-sized outcomes trial if going for the same endpoints. If you have to show superiority over phlegmocytes, obviously, we're talking about a taller order.
Different approaches across the industry right now, we're getting closer to a sampling of boots in the cardiovascular space at physical standards, okay, compared to placebo compared to the gold standard and that could potentially be some exercise.
Speaker Change: That basically means from our perspective, if we for example look at <unk>.
Speaker Change: Emma.
Speaker Change: If we want to claim the same benefit estimate at this time we have.
Speaker Change: So parity with some items that are not intuitive to some maintenance that if we did enhancement that would require.
Speaker Change: I would say in almost science.
Speaker Change: The outcomes trial.
Speaker Change: And for the same endpoints.
unknown: And then we would have to look at, obviously, the sample size, but also what are the potential endpoints and what are other aspects of the trial design that would allow us to, within reason, demonstrate superiority on the relevant endpoints. For example, you see others adding to the number of composites in the primary endpoint. And that's obviously a way to increase the number of events that you're looking at and, thereby, by inference, allowing you to go with a smaller family size.
Speaker Change: If you had to show superiority.
Speaker Change: Obviously, we're talking about a total order and then we would have to be looking at obviously the sample size, but also what are the potential endpoints and what are the aspects of the trial design that will allow us to within reason demonstrate superiority on the relevant inputs.
Speaker Change: You will see.
Speaker Change: We see also adding to the number of campuses in the primary endpoint and Thats obviously.
Speaker Change: At vehicles to increase the number of events that were looking and thereby.
Speaker Change: By inference.
Speaker Change: Allowing them to go with us more often.
Speaker Change: So all of that has to play.
unknown: So all of that has to play in. If there is no gold standard, it still makes a lot of sense to compare to placebo. And if we look at other aspects of our product's benefits, we would potentially also still be comparing to placebo. Cariclozema, for example, is compared to placebo when it comes to cardiovascular outcomes.
Speaker Change: If theres no cost and it makes a lot of sense to compared to placebo.
Speaker Change: And if we look at other aspects of.
Speaker Change: Our.
Speaker Change: Products' benefits, we would potentially arthroscopy compared to placebo calculus. Similar for example, compared to placebo when it comes to cardiovascular outcomes and that is basically because.
Speaker Change: The point is that where we initiated the trial that was notebooks tablets.
Martin: And that is basically because at the point in time when we initiated the trial, there was no gold standard. Thank you, Martin. So, we have time for a few more questions. Hi, thanks. Richard Prosser from JPMorgan.
Speaker Change: Thank you Barton so let's go through Richard fossil here on the front row, we have time for two more questions.
Speaker Change: Alright, Thanks, Richard Wilson from JP Morgan.
Richard Vosser: Just a thought on the Part D redesign that we're going to see next year. How could that impact the net pricing for Zempik and Robausses into 2025? Thank you, Richard. Karsten, I think this one's for you. Thank you.
Speaker Change: Also on the part D redesign that we are going to see next year.
Richard Vosser: How that could impact the net pricing for <unk>.
Richard Vosser: I'm.
Speaker Change: Rob assets into into 25%.
Speaker Change: Thank you Richard.
Speaker Change: I think just wanted to you. Thank.
Karsten: So first of all, we are in negotiations. This is negotiation season. So we haven't had formularies played out yet. So there's really a lot of uncertainty at this point in time. I'll say two pieces to that.
Speaker Change: Thank you.
Speaker Change: First of all we are in negotiations business negotiation season. So so we havent formulary played.
Speaker Change: Played out yet so.
Speaker Change: That's really a lot of uncertainty at this point in time.
unknown: That's the redesign. And then there are the negotiations dynamics in Part D. On the redesign, it's important to note that with the redesign benefit design, then yes, that's a benefit because the donor toll is being eliminated. But then there's a different exposure in terms of catastrophic coverage as well as some other coverage. So, net-net, while we initially thought it was directly positive, now we believe it's more than neutral on the redesign.
Speaker Change: Two pieces to it that the redesign.
And then that the.
Speaker Change: That negotiation said dynamics in part D.
Speaker Change: The redesigned its important to note that the.
Speaker Change: With the redesign benefit design.
Speaker Change: Yes, that's a benefit because the donut hole is being eliminated but then that's a different exposure in terms of catastrophic coverage.
Speaker Change: As well as some other coverage so so net net.
Speaker Change: While we initially thought it was.
Speaker Change: Directionally positive now.
Speaker Change: Now we believe it's both a neutral.
Speaker Change: On the redesign and and then I'd say on the redesign impacts to the plan sponsors and hence the insurance companies and how much how are they it takes them and how much they can pass entre that cosmos.
unknown: And then I'd say on the redesign impact on the plan sponsors and the insurance companies and how much it impacts them and how much they can pass on to their customers and what that, in turn, indirectly impacts us remains to be defined. But I would say that the competitive situation in the marketplace is unchanged between suppliers into the marketplace.
Speaker Change: That in turn indirectly impacts us.
Speaker Change: It remains to be defined.
Speaker Change: But I would say the competitive situation in the marketplace is unchanged between supply into the marketplace. So so too early to comment on.
Karsten: So, truly, it's coming on. Thank you, Karsten. Sebastian, you had a question, and we'll take Emily afterward, and then...
Speaker Change: Thank you.
Speaker Change: <unk> you had a question and we take Emily absolutely and.
Speaker Change: Yeah.
Sebastian: Thank you, Satchin J. Bang, for Martin.
Emily Field: Thank you thanks for taking my market for mountain semi mash increasing mix towards year end. So just to clarify a comment you made on the call yesterday I think the way that you can kind of if I was wrong with if you repeated the phase two it would be a good outcome.
Martin: Sema, NASH, increasing focus towards year-end. It's one of the clarified comments you made on the call yesterday. I think the wording you clarified was wrong, was if you repeated phase two, it would be a good outcome. It's one of the things you clarified about phase two; you didn't hit that thing on fibrosis. So is just NASH resolution enough without fibrosis for a biline commercial? And if that is incorrect, what's your confidence around hitting fibrosis? Is the effect size you saw in phase two enough to get you across the hurdles in phase three? Thanks.
Emily Field: The counterpart faced you didn't hit stat Sig on fibrosis. So.
Emily Field: He is just Nash resolution and no fibrosis finally commercial and.
Emily Field: And if not is incorrect whats your confidence around hitting fibrosis. The effect size, you're starting phase two enough to get you across the hurdles and thanks, great. Thanks. Thank you Martin.
unknown: Thank you, Septim. Martin.
Martin: For regulatory approval, both improvement in steatosis and fibrosis are required, and the study is designed to look at that. However, our dialogue with BFDA was that our phase 2 trial was never sample-sized to look from a statistical perspective at fibrosis. So we saw a highly significant reduction in steatosis, and we actually saw a great numerical reduction in fibrosis as well. And the statement from BFDA was that if we saw a similar numerical reduction in a properly sample-sized study, obviously, that would become statistically significant.
Emily Field: If our regulatory approval both improvement in Steatosis and fibrosis.
Speaker Change: As required and the study is designed to look at that.
Speaker Change: Our dialogue with the FDA was that the Alpha <unk> was never San Besides two to look from a statistical perspective on fibrosis. So we saw a significant reduction in <unk>.
Speaker Change: To assist with <unk>.
Speaker Change: Numerical reduction in fibrosis, as well and the statement from the FDA was if we saw similar numerical reduction in probably seven precise study.
Speaker Change: That would become statistically significant and from a regulatory perspective that would also be.
Martin: And from a regulatory perspective, that would also be acceptable. So instead of asking us to conduct two phase 3 studies, they said that the phase 2 study could serve as one of the two regulatory studies, and we now are doing it as the other.
Speaker Change: Acceptable so so instead of asking us to conduct two phase III studies, they said that the phase two study could serve as one of the two regulatory studies.
Speaker Change: Now doing.
Speaker Change: As the auto study.
Speaker Change: Okay.
Speaker Change: Development, that's repeatedly phase III path.
unknown: That's repeatedly a base rate that accounts for that. Slightly more than 10%. And yes, if that becomes statistically significant, then we are in a good place. Thank you, Martin. Let's take the last question from Emily, and then we'll have time to talk with management afterwards also before they depart.
Yes.
Speaker Change: Slightly more than 10%.
Speaker Change: And yes, that's it.
Speaker Change: Statistically significant.
Speaker Change: Then we are in a good place.
Speaker Change: Thank you Mark and things that just take the last question is from the preliminary and then we will have time to talk with management Dr. Let's also before that about.
Emily Field: Thank you, Emily Filson-Barclays. Going back to Wigobi pricing, I know this was asked yesterday, but there's an FT article today talking about NovoCox Wigobi prices. So maybe to ask a little differently, has the net price evolution for Wigobi in the U.S. been within your expectations? And you also mentioned pricing movements in certain channels. I know you'll have more Medicare going forward with Deluxe, but could you just give some granularity on what you meant by that? Probably me being quoted. Then I better stand up for it.
Speaker Change: Emily field from Barclays on going back to Adobe pricing I know this is asked yesterday, but.
Speaker Change: There is an FTE article today talking about Novo custom agave price so maybe to ask a little differently. How is the net price evolution for what kind of lead in.
Speaker Change: The U S than within your expectations and you also mentioned pricing movements in certain channels I know youll have more Medicare going forward with <unk>, but could you just give some granularity on what you meant by that so.
Karsten: So Karsten... probably me being quoted. Then I had better stand up for it. So this is completely as expected, right? So what we're looking at in the market is that this is a volume of opportunities. And we're very happy with the market access we have in the US. So we have more than 50 million people with obesity covered in the US today. So our market access is very good, and, of course, we work with payers to ensure that we have the appropriate market access that ensures this level of coverage or even more. And, of course, the market is also defined through competition and competitive entry, so there are no surprises in pricing in the US.
Speaker Change: Yes.
Karsten: So this is completely as expected, right? So what we're looking at in the market is that this is a volume opportunity. And we're very happy with the market access we have in the US. So we have more than 50 million people with obesity covered in the US today. So our market access is very good, and, of course, we work with payers to ensure that we have the appropriate market access that ensures this level of coverage or even more.
Speaker Change: With me being quoted.
Speaker Change: I bet I've set out for us.
Speaker Change: So.
Speaker Change: So this is completely as expected.
Right.
So.
Speaker Change: What we're looking at in the market is that the.
Speaker Change: This is the volume of Jumanji, and we're very happy with the market exits we have in the U S. So we have more than 50 million people with the BC covered in the U S. Today, so our market access.
Very good.
Speaker Change: And of course, then we worked with the payers to ensure that we have the appropriate market access that ensures this level of coverage or even more and then of course. The market is also defined through competition and a competitive entry. So so there are no surprises in there.
Karsten: And then, of course, the market is also defined through competition and competitive entry, so there are no surprises in pricing in the US. And just reminding you, this is a significant volume opportunity. So the 50 million people with obesity that we have covered today, we are only serving a fraction of that.
Speaker Change: And pricing in the U S and just reminding you. This is a significant volume opportunity so the $50 million.
Karsten: And just reminding you, this is a significant volume of opportunity. So the 50 million people with obesity that we have covered today, we are only serving a fraction of that. So less than a million.
Speaker Change: People with obesity that we have coverage for today.
We're only serving.
Fraction of that.
Speaker Change: So less than a minute.
Daniel Bohsen: Thank you, Karsten. And that concludes the Q&A session. Before giving the word to Karsten for his final remarks, I just want to say thanks, Pete, for the kind words. And thanks to all of you that many of you have met many times over the last four years. And I've truly enjoyed the conversations, the challenging questions, and also the pushback. So thank you so much. And, Please remember to keep them on their toes also in the future.
Karsten: So, Thank you, Karsten. And that concludes the Q&A session. Before giving the word to Karsten for his final remarks, I just want to say thanks, Pete, for the kind words. And thanks to all of you that many of you have met many times over the last four years. And I've truly enjoyed the conversations, the challenging questions, and also the pushback. So thank you so much. And please remember to keep them on their toes also in the future.
Thank you Catherine.
Speaker Change: The Q&A session before given the work too costly for his final remarks, I just want to say thanks, Peter for the kind words and thanks to all of you that many of you have met.
Speaker Change: Many times over the last four years and I've truly enjoyed the conversation the challenging questions.
Speaker Change: Also in the also the pushback. So thank you so much and please remember too.
Speaker Change: Keep them on their toes.
Speaker Change: Future.
Daniel Bohsen: Karsten, Otto, do you have any final words? Very briefly, thank you again. You feel we're on a roll. Amazing levels of sales growth continuing into this year, 24% for the quarter, turning into attractive profit growth, 30% for the quarter at the exchange rate. Our innovation machine is really also on a roll in terms of readouts and what you have just seen thus far between select flow, and hopefully, to be replicated in the near future with the coming readouts. So, very strong push on innovation for the rest of the year. So thank you for your attention, and we'll be around for another quarter. I'm looking forward to discussing more detail. Thank you.
Karsten: Karsten, Otto, do you have any final words? Very briefly, thank you again. You feel we're on a roll. Amazing levels of sales growth continuing into this year, 24% for the quarter, turning into attractive profit growth, 30% for the quarter at the exchange rate. Our innovation machine is really also on a roll in terms of readouts, and what you've just seen thus far between select flow, and hopefully, it will be replicated in the near future with the coming readouts. So, very strong push on innovation for the rest of the year. So thank you for your attention, and we'll be around for another quarter. I'm looking forward to discussing more detail. Thank you.
Speaker Change #100: Or do you have any final words.
Speaker Change: Very briefly I think this is Dan again.
Dan: You feel we are in a row. So so so amazing levels of sales growth continuing into this year, 24% for the quarter turning into attractive profit growth, 30% for the quarter at current exchange rates, our innovation machine is.
Dan: Also on a roll in terms of Readouts and want to just have seen thus far between select flow and hopefully.
Be replicated into the near future.
Dan: Becoming readouts, so a very strong push on innovation for the rest of the year. So thank you for your attention and we'll be around for.
Dan: Another quarter or so so so looking forward to discuss in more detail. Thank you.
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