Q2 2025 Novo Nordisk A/S Earnings Call - London
So I think we.
David Moore: Joined by Martin Lange, Nancy Bagenal, who's going to tell you more, Head of your North American Operations. Ludovic Herborn, Head of Product and Portfolio Strategy. Martin's gonna kick off as usual with a presentation, and then we'll go straight into the Q&A. Martin, thank you for joining us. Over to you.
James Quigley: Joined by Martin Lange, Nancy Bagenal, who's going to tell you more, Head of your North American Operations. Ludovic Herborn, Head of Product and Portfolio Strategy. Martin's gonna kick off as usual with a presentation, and then we'll go straight into the Q&A. Martin, thank you for joining us. Over to you.
I will tell you more.
North America pricing.
Good luck.
I had to put up and hopefully the stock.
Okay.
No.
Awesome. Thank you for joining us.
Thank you James and welcome to the <unk> Q2 results meeting here in London. The launch meeting. Thank you all for coming and thank you to the once that are listening in online.
Karsten Munk Knudsen: Yeah. Thank you, James, welcome to the Novo Nordisk Q2 results meeting here in London, the launch meeting. Thank you all for coming, thank you to the ones listening in online. We have a good team here. Again, we have Martin Lange in his first day as CSO of Novo Nordisk. Congratulations to you, Martin.
Karsten Munk Knudsen: Yeah. Thank you, James, welcome to the Novo Nordisk Q2 results meeting here in London, the launch meeting. Thank you all for coming, thank you to the ones listening in online. We have a good team here. Again, we have Martin Lange in his first day as CSO of Novo Nordisk. Congratulations to you, Martin.
So we have a good team here so again, we have Martin.
Firstly.
So I've known artist so.
Congratulations for your margin on that one.
I think a good timing of their becoming CSO will talk about.
Ludovic Helfgott: Thank you.
Martin Lange: Thank you.
Karsten Munk Knudsen: ... on that one. I think good timing of becoming CSO. We'll talk more about that later. Then David Moore, from the US, known person, so president of our US business, and Ludovic, from running commercial strategy and our portfolio planning. We're gonna go through our results briefly, and then we're gonna host the Q&A session moderated by Jacob Rode, our Head of Investor Relations. As always, then there will be forward-looking statements discussed today. Forward-looking statements, they are associated with risks and assumptions.
Karsten Munk Knudsen: ... on that one. I think good timing of becoming CSO. We'll talk more about that later. Then David Moore, from the US, known person, so president of our US business, and Ludovic, from running commercial strategy and our portfolio planning. We're gonna go through our results briefly, and then we're gonna host the Q&A session moderated by Jacob Rode, our Head of Investor Relations. As always, then there will be forward-looking statements discussed today. Forward-looking statements, they are associated with risks and assumptions.
More about that later and then take more.
From the U S.
Personal <unk> president of our U S business and the Ludwig from running commercial strategy and our portfolio planning.
So.
We have.
We're going to go through our results briefly and then we're going to host the Q&A session motivated by <unk>, our head of Investor Relations.
As always.
Then there will be forward looking statements discussed today and forward looking statements.
They are associated with risks and assumptions. Unfortunately, that's also what we saw last week with our downgrade because.
Karsten Munk Knudsen: Unfortunately, that's also what we saw last week with our downgrade because we made some assumptions that unfortunately didn't fully pan through, and that's why we had to downgrade our outlook for the year, but I'm sure we'll come back to. Talking about the results in the first half of the year through our strategic aspirations, I would say we continue to expand our patient reach. I think this is really the core of Novo Nordisk, driving change for patients suffering from serious chronic disease, progressive diseases within diabetes and obesity. Now we're serving more than 45 million patients. We added more than 3 million patients compared to a year ago.
Karsten Munk Knudsen: Unfortunately, that's also what we saw last week with our downgrade because we made some assumptions that unfortunately didn't fully pan through, and that's why we had to downgrade our outlook for the year, but I'm sure we'll come back to. Talking about the results in the first half of the year through our strategic aspirations, I would say we continue to expand our patient reach. I think this is really the core of Novo Nordisk, driving change for patients suffering from serious chronic disease, progressive diseases within diabetes and obesity. Now we're serving more than 45 million patients. We added more than 3 million patients compared to a year ago.
We've made some assumptions that unfortunately, it didn't fully pass through and that's why we we had to downgrade our outlook for the year that I'm sure we'll come back to them.
So talking about about the results in.
In the first half of the year in our.
Through our strategic aspirations I would say we are.
We continue to expand our patient reach and I think this is really the core of nynorsk.
Yeah.
Driving change for patients suffering from serious chronic disease progressive diseases within diabetes and obesity.
And.
And now we are serving more than 45 million patients, we added more than 3 million patients compared to a year ago.
So it speaks to the scaling of our business and.
Karsten Munk Knudsen: It speaks to the scaling of our business and also the future prospects of what we're operating under. On the commercial side, my colleagues will come into it and the same for R&D. Financials, we deliver 18% top line growth at constant exchange rates in the first half of the year and 29% operating profit growth in the first half. Operating profit impacted by an impairment in the first half of last year and then some additional costs due to M&A and Catalent this year. Net-net operating profit underlying is closer to the 20% growth, but still very healthy operating profit growth.
Karsten Munk Knudsen: It speaks to the scaling of our business and also the future prospects of what we're operating under. On the commercial side, my colleagues will come into it and the same for R&D. Financials, we deliver 18% top line growth at constant exchange rates in the first half of the year and 29% operating profit growth in the first half. Operating profit impacted by an impairment in the first half of last year and then some additional costs due to M&A and Catalent this year. Net-net operating profit underlying is closer to the 20% growth, but still very healthy operating profit growth.
And also the future prospects of what we are what we're operating under.
On the commercial side my colleagues will come into it and it's the same for our R&D and financials.
We delivered 18% topline growth at constant exchange rates in the first half of the year and 29% operating profit growth in the first half.
Operating profit impacted by.
An impairment in the first half of last year, and then some additional costs due to M&A encapsulant. This year. So net net operating profit underlying is closer to the 20% growth, but still very healthy operating profit growth and in terms of cash flow generation that's of course a key.
Karsten Munk Knudsen: In terms of cash flow generation, that's of course a key premise for the company. We generated almost DKK 34 billion in free cash flow, despite investing DKK 28 billion in CapEx in the first half of the year. We returned also more or less our full free cash flow to shareholders here in the first half of the year. A disciplined approach on capital allocation. I hand it over to Ludo.
Karsten Munk Knudsen: In terms of cash flow generation, that's of course a key premise for the company. We generated almost DKK 34 billion in free cash flow, despite investing DKK 28 billion in CapEx in the first half of the year. We returned also more or less our full free cash flow to shareholders here in the first half of the year. A disciplined approach on capital allocation. I hand it over to Ludo.
Premise for the company we generated.
Almost 34 billion in free cash flow, despite investing $28 billion in capex in the first half of the year and and we returned also more or less a full case free.
Free cash flow to shareholders here in the first half of the year. So a disciplined approach on capital allocation.
Then I'll hand, it over to Laura commercial updates very very quickly.
Ludovic Helfgott: Absolutely
Ludovic Helfgott: Absolutely
Karsten Munk Knudsen: for our commercial update.
Karsten Munk Knudsen: for our commercial update.
Yeah.
Ludovic Helfgott: Very, very quickly. From a sales perspective, the region US actually grew 17% in the first half of the year, and the IO grew 19%, which is an overall 18% growth for Novo Nordisk in the first half of the year. If you look at the IO in particular, really double-digit growth on UK, emerging markets, and APAC, and a 6% in China that I'm sure we might come back to that at a later stage. From a therapeutic area perspective, you can clearly grow an 18% overall growth, logically. GLP-1 diabetes plus 10%. The obesity care, 58%. The rare disease actually back to growth with a 15% growth rate across the board.
Ludovic Helfgott: Very, very quickly. From a sales perspective, the region US actually grew 17% in the first half of the year, and the IO grew 19%, which is an overall 18% growth for Novo Nordisk in the first half of the year. If you look at the IO in particular, really double-digit growth on UK, emerging markets, and APAC, and a 6% in China that I'm sure we might come back to that at a later stage. From a therapeutic area perspective, you can clearly grow an 18% overall growth, logically. GLP-1 diabetes plus 10%. The obesity care, 58%. The rare disease actually back to growth with a 15% growth rate across the board.
From a sales perspective.
The region U S actually grew 17% in the first part.
Of the year and <unk> grew 19%, which is an overall, 18% growth for Novo Nordisk in the first half of the year. If you look at the Io in particular really double digit growth on UK in emerging markets in APAC and 6% in China that I'm sure we might come back to that at a later stage.
Therapeutic area perspective, you can clearly clearly growing 18% overall growth logically.
GOP line diabetes, plus 10%, the obesity care, 58% and the rare disease actually back to growth with a 15% growth rate.
Cross the border and you of course with Dave here, we can do have a bit more into into that I guess.
Ludovic Helfgott: You, of course, with Dave here, we can delve a bit more into that, I guess, at some point. If you look from an IO perspective, the international operations growth, so 19% driven by the GLP-1 diabetes and obesity care. You had this overall GLP-1 diabetes care sales growth, 10%, I said, with double digits in UK, and emerging market, and APAC, and this decrease in China, which is driven by the market itself. It's not a competition issue. It's actually a market expansion discussion, which we might wanna talk about that at a later stage. On the obesity side, in IO, a growth of 125% versus last first semester in 2024. UK, 64%. Emerging market, 157%. And then, 361% for APAC.
Ludovic Helfgott: You, of course, with Dave here, we can delve a bit more into that, I guess, at some point. If you look from an IO perspective, the international operations growth, so 19% driven by the GLP-1 diabetes and obesity care. You had this overall GLP-1 diabetes care sales growth, 10%, I said, with double digits in UK, and emerging market, and APAC, and this decrease in China, which is driven by the market itself. It's not a competition issue. It's actually a market expansion discussion, which we might wanna talk about that at a later stage. On the obesity side, in IO, a growth of 125% versus last first semester in 2024. UK, 64%. Emerging market, 157%. And then, 361% for APAC.
At some point.
If you look from an I O perspective, the international operations growth of 19% driven by the <unk> diabetes and obesity care you had this overall <unk> diabetes care sales growth, 10% I said.
With double digit in UK in emerging market in APAC and this decrease in China, which is driven by the market itself. It's not a competition issue. It's actually a market expansion discussion we might want to talk about that at a later stage on the obesity side in <unk>.
A growth of 125% versus last.
First in a three in 2024, you can 64% emerging market 157, and then 361 central APAC, China is growing a lot but of course out of a small base. So mathematically it doesn't make much sense, but really a healthy growth on obesity care in sales and growth for the first six months in <unk>.
Ludovic Helfgott: China is growing a lot, but of course, out of a small base. Mathematically, it doesn't make much sense, but really a healthy growth on obesity care in sales and growth for the first 6 months in IO. Over to you, Dave, for the US.
Ludovic Helfgott: China is growing a lot, but of course, out of a small base. Mathematically, it doesn't make much sense, but really a healthy growth on obesity care in sales and growth for the first 6 months in IO. Over to you, Dave, for the US.
And then over to you Dave for the U S. Thanks Lou.
So.
David Moore: Thanks, Ludo. When we think about the obesity market in the US, everyone knows we're in a competitive environment. We're in a competitive environment with Lilly. We'll talk a little bit about that. We're also in a competitive environment with fake, cheaper alternative of our medicine that's being imported by China, which we are keenly focused on putting an end to that, so we go back to competing in the branded obesity market. If you think about the dynamics in the branded market, you know, this is what we typically see when you have the lead, the first mover position, another product comes in. It's an easier position to be in, to go into the doctor and say, Switch to my product. Start new patients on my product. By the way, I experienced the same thing when I launched Ozempic versus Trulicity, and it works.
David Moore: Thanks, Ludo. When we think about the obesity market in the US, everyone knows we're in a competitive environment. We're in a competitive environment with Lilly. We'll talk a little bit about that. We're also in a competitive environment with fake, cheaper alternative of our medicine that's being imported by China, which we are keenly focused on putting an end to that, so we go back to competing in the branded obesity market. If you think about the dynamics in the branded market, you know, this is what we typically see when you have the lead, the first mover position, another product comes in. It's an easier position to be in, to go into the doctor and say, Switch to my product. Start new patients on my product. By the way, I experienced the same thing when I launched Ozempic versus Trulicity, and it works.
When we think about the obesity market in the U S. Everyone knows we're in a competitive environment or competitive environment with Lilly will talk a little bit about that we're also in a competitive environment with fake cheaper alternative medicine, that's being imported by China, which we are keenly focused on putting an end to that so we go back to competing.
And the branded obesity market.
So if you think about the dynamics and the branded market.
This is what we typically see when you have the lead the first mover position. Another product comes in it's an easier position to be in to go into the Doctor and say switch to my product to start new patients on my product by the way I experienced the same thing when I launched Olympic versus <unk> and it works.
That's the dynamic that we had and what we learned in the beginning of the year I took this job over in January there was a shift last year just in terms of messaging actually makes sense you have select data, it's compelling it's meaningful clinical data real world outcomes and you switch the message to be beyond weight that was <unk>.
David Moore: That's the dynamic that we had. What we learned in the beginning of the year, I took this job over in January, there was a shift last year just in terms of messaging. Actually makes sense. You have SELECT data, it's compelling, it's meaningful clinical data, real-world outcomes, and you switch the message to be beyond weight. That was actually the name of the campaign, Treat Beyond the Weight. What we learned is it's a little premature to do that. There probably will be a time to do that, and there's a meaningful discussion to have around comorbidities. There's two players in the game, and it's still about weight loss. That's the primary reason for prescribing, is around weight loss. It's what patients are looking for, it's what doctors are looking for.
David Moore: That's the dynamic that we had. What we learned in the beginning of the year, I took this job over in January, there was a shift last year just in terms of messaging. Actually makes sense. You have SELECT data, it's compelling, it's meaningful clinical data, real-world outcomes, and you switch the message to be beyond weight. That was actually the name of the campaign, Treat Beyond the Weight. What we learned is it's a little premature to do that. There probably will be a time to do that, and there's a meaningful discussion to have around comorbidities. There's two players in the game, and it's still about weight loss. That's the primary reason for prescribing, is around weight loss. It's what patients are looking for, it's what doctors are looking for.
The name of the campaign treat beyond the week.
What we learned is a little premature to do that there probably will be a time to do that and there is a meaningful discussion to have around comorbidities, but theres two players in the game and it's still about weight loss. That's the primary reason for prescribing is around weight loss what patients are looking forward to what doctors are looking for which.
That message in June to go back to driving the weight loss competitive message, we have real world data that is head to head versus if there's appetite and some idle time, we have some <unk> data, where we followed patients for two years and we see the average weight loss is 20% actually just got updated to 'twenty, one because we continue to follow.
David Moore: We changed that message in June to go back to driving the weight loss competitive message. We have real-world data that is head-to-head versus tirzepatide and semaglutide. We have semaglutide data where we follow patients for 2 years, and we see the average weight loss is 20%. Actually just got updated to 21% because we continue to follow these patients in the WeGo Together campaign. That's starting to resonate again. We're starting to see the impact of having that weight loss message. Once we solidify that competitively, then you move on to the other elements, right? You have a discussion about the other aspects. What we're starting to see is a shift in NBRXs. NBRX is our sign of health. It's the leading indicator. How's your brand doing?
David Moore: We changed that message in June to go back to driving the weight loss competitive message. We have real-world data that is head-to-head versus tirzepatide and semaglutide. We have semaglutide data where we follow patients for 2 years, and we see the average weight loss is 20%. Actually just got updated to 21% because we continue to follow these patients in the WeGo Together campaign. That's starting to resonate again. We're starting to see the impact of having that weight loss message. Once we solidify that competitively, then you move on to the other elements, right? You have a discussion about the other aspects. What we're starting to see is a shift in NBRXs. NBRX is our sign of health. It's the leading indicator. How's your brand doing?
These patients and the we go together campaign, that's starting to resonate again, we're starting to see the impact of having that weight loss message. Once we solidify that competitively then you move on to the other elements right and you have a.
Discussion about the other the other aspect and so what we're starting to see is a shift in <unk> <unk> as our sign of health. It's the leading indicator How's your brand doing and from about May of 2024 April may 2024 to may of 2025 the <unk>.
David Moore: From about May 2024, April, May 2024 to May 2025, the NBRXs of Wegovy were going down. That's a bad indicator of your health of your brand. We're still growing. The market's growing. You can see there's growth, but the NBRXs were going down. In May, that has stopped, and we're starting to see growth. We're seeing growth with Wegovy competitively, especially versus devices. Nationally, NBRx of Wegovy device passed Zepbound device, and that is in part due to CVS conversion, but that's not all of it. It's also that we're seeing growth outside of the CVS conversion. We will continue in this competitive dynamic. We now have an opportunity to go out and talk about a difference in CVOT outcomes.
David Moore: From about May 2024, April, May 2024 to May 2025, the NBRXs of Wegovy were going down. That's a bad indicator of your health of your brand. We're still growing. The market's growing. You can see there's growth, but the NBRXs were going down. In May, that has stopped, and we're starting to see growth. We're seeing growth with Wegovy competitively, especially versus devices. Nationally, NBRx of Wegovy device passed Zepbound device, and that is in part due to CVS conversion, but that's not all of it. It's also that we're seeing growth outside of the CVS conversion. We will continue in this competitive dynamic. We now have an opportunity to go out and talk about a difference in CVOT outcomes.
We'll go we were going down.
It's a bad indicator of your health of your brand we're still growing the market is growing as you can see there's growth, but the <unk> going down and may that has stopped.
And we're starting to see growth, we're seeing growth with would go will be competitively, especially versus devices nationally <unk> device past that pound device.
And that is in part due to Cvs conversion, but that's not all of it. It's also that we're seeing growth outside of the Cvs conversion. So we will continue in this competitive dynamic we now have an opportunity to go out and talk about a difference in cbot outcomes.
Once again, we saw outcomes last week with the surpass data and our reps are armed to go in and say that this is not a class effect.
David Moore: Once again, we saw outcomes last week with the SURPASS data, and our reps are armed to go in and say that this is not a class effect. It's very easy to walk in and say, you know, we have a little bit better data, and by the way, it's a class effect. They'll all be the same. It is not. They're not the same. 12% is not 26%. That's a conversation with Ozempic. It's also a conversation with Wegovy. Moving forward, in weeks, we'll launch MASH. MASH is a primary indication, one that entire companies have been built upon, and we have an opportunity to go out and differentiate Wegovy further in terms of that strength of the label and go out and start selling in the MASH market. We have a dedicated sales force. It's small.
David Moore: Once again, we saw outcomes last week with the SURPASS data, and our reps are armed to go in and say that this is not a class effect. It's very easy to walk in and say, you know, we have a little bit better data, and by the way, it's a class effect. They'll all be the same. It is not. They're not the same. 12% is not 26%. That's a conversation with Ozempic. It's also a conversation with Wegovy. Moving forward, in weeks, we'll launch MASH. MASH is a primary indication, one that entire companies have been built upon, and we have an opportunity to go out and differentiate Wegovy further in terms of that strength of the label and go out and start selling in the MASH market. We have a dedicated sales force. It's small.
Very easy to walk in and say, we are a little bit better data and by the way. It's a class effect will all be the same it is not they're not the same 12% is not 26%. So that's a conversation with those entities and also in conversation with would go moving forward.
Forward and weeks, we'll launch mash.
The primary indication one that entire companies have been built upon and we have an opportunity to go out and differentiate will go further in terms of that strength of the label and go out and start selling in the mass market. We have a dedicated sales force small we've hired about 130 people they'll call on Herpetologist in Gi.
David Moore: We probably have about 130 people. They'll call on hepatologists and GIs. There's only about 300 hepatologists in the US. We'll focus on about 15,000 gastroenterologists. Our obesity sales reps will be armed with the MASH launch. Remember, it's about 80% overlap with obesity, 40% overlap with type 2 diabetes. We're not waving any victory flags. We've got a long way to go, but this is a growth story. It's an expansion of the obesity market story. In the beginning of the year, we'll be launching oral sema for obesity, and we'll come back to that in a little bit. Over to you, Martin.
David Moore: We probably have about 130 people. They'll call on hepatologists and GIs. There's only about 300 hepatologists in the US. We'll focus on about 15,000 gastroenterologists. Our obesity sales reps will be armed with the MASH launch. Remember, it's about 80% overlap with obesity, 40% overlap with type 2 diabetes. We're not waving any victory flags. We've got a long way to go, but this is a growth story. It's an expansion of the obesity market story. In the beginning of the year, we'll be launching oral sema for obesity, and we'll come back to that in a little bit. Over to you, Martin.
It was only about 300 herpetologist in the U S and we will focus on about 15000, Gastroenterologists and our obesity sales reps will be will be armed with the match launch remember, it's about 80% overlap with obesity, 40% overlap with type two diabetes, we're not waiving any victory.
<unk>, we've got a long way to go but this is a growth story, it's an expansion of the obesity market story and in the beginning of the year, we'll be launching oral sema for obesity, and we'll come back to that a little bit.
Over to you Mark Thank you very much and with Dave here obviously.
Martin Holst Lange: Yep. Thank you very much. With Dave here, obviously, as you all remember, we filed oral semaglutide for obesity in US earlier this year. We expect to see an approval of that filing towards the end of this year with a strong US launch starting 2026. Just to remind you of the data, with oral semaglutide in obesity, we saw a 16% weight loss, almost 17% weight loss. With the safety and tolerability profile that we already know very well from semaglutide subcutaneously. We are actually able to achieve the same weight loss, the same safety and tolerability orally as we do subcutaneously. That's very, very strong. Again, 17% weight loss, we think that is gonna be outpaced or unsurpassed for a long period of time.
Martin Lange: Yep. Thank you very much. With Dave here, obviously, as you all remember, we filed oral semaglutide for obesity in US earlier this year. We expect to see an approval of that filing towards the end of this year with a strong US launch starting 2026. Just to remind you of the data, with oral semaglutide in obesity, we saw a 16% weight loss, almost 17% weight loss. With the safety and tolerability profile that we already know very well from semaglutide subcutaneously. We are actually able to achieve the same weight loss, the same safety and tolerability orally as we do subcutaneously. That's very, very strong. Again, 17% weight loss, we think that is gonna be outpaced or unsurpassed for a long period of time.
As you all remember we filed also made insightful piece the U S earlier this year.
We expect to see an approval.
That filing.
At the top.
At the end of this year with a strong U S launch starting 2026.
Just to remind you of the data with all its amazing side of obesity, we saw a 16% waitrose almost 17% weight loss.
With the safety and Tolerability profile that we already know very well from the types of continuously. So we actually are able to achieve the same weight loads the same safety and tolerability the ability.
As we do.
A couple of things.
It's very very strong and again, 17% weight loss, we think that is.
Got it.
And surpassed for a long period of time.
In addition to that and this is a potential.
Martin Holst Lange: In addition to that, and this is a potential, we aim to have the comorbidity benefits in the label, starting with the MACE benefits that we know well from subcutaneous semaglutide. A really exciting offering in the obesity space to be launched in US by Dave and his team early 2026. Broader in the R&D space, obviously, you know our focus on diabetes and obesity. We also have other therapy areas, and we see progress and activities across the board. Obviously, in the diabetes space, it's gonna be very exciting to see what CagriSema can do in REIMAGINE 3, i.e., glycemic control and weight loss in patients with type 2 diabetes for CagriSema. It's gonna be very interesting to see the phase 2 data for amycretin also in the diabetes space. In the obesity space, we continue to progress.
Martin Lange: In addition to that, and this is a potential, we aim to have the comorbidity benefits in the label, starting with the MACE benefits that we know well from subcutaneous semaglutide. A really exciting offering in the obesity space to be launched in US by Dave and his team early 2026. Broader in the R&D space, obviously, you know our focus on diabetes and obesity. We also have other therapy areas, and we see progress and activities across the board. Obviously, in the diabetes space, it's gonna be very exciting to see what CagriSema can do in REIMAGINE 3, i.e., glycemic control and weight loss in patients with type 2 diabetes for CagriSema. It's gonna be very interesting to see the phase 2 data for amycretin also in the diabetes space. In the obesity space, we continue to progress.
Aim to have the comorbidity benefits in the label starting with the base benefits that we know will for subcutaneous amount of time.
So a really really exciting offering into piece the space to be launched.
Just by Dave and his team early 'twenty.
The order in the R&D space, obviously, you know our focus on diabetes and obesity. We also have other therapy areas, we see progress and activities across the board.
Obviously in the diabetes space is going to be very exciting to see what <unk>.
Remit inquiry I E similar control and weight loss in patients with type two diabetes with Zimmer.
It's going to be very interesting to see the phase III data for him accretive also in the diabetes space.
In the <unk> space, we continue to progress.
We aim to have a $7 two milligram EU submission.
Martin Holst Lange: We aim to have a 7.2 mg EU submission already here in Q3. We aim to see the readout of our triple agonist, and importantly, we'll initiate the cagrilintide and monotherapy phase 3 program also later this year. That's gonna be incredibly exciting in the diabetes and obesity space. I would be remiss, Lundbeck is no longer so interested in rare disease. I still have to mention US approval and positive CHMP opinion for Alhemo and imminent regulatory filing of Mim8. Obviously in other disease areas, we closed down zalfermin, not because it was a bad offering, it was just not better than semaglutide. As you know, right now we have, at least in the phase 3 space, the strongest data in MASH. As Dave mentioned, we expect regulatory approval for that in US within a couple of months.
Martin Lange: We aim to have a 7.2 mg EU submission already here in Q3. We aim to see the readout of our triple agonist, and importantly, we'll initiate the cagrilintide and monotherapy phase 3 program also later this year. That's gonna be incredibly exciting in the diabetes and obesity space. I would be remiss, Lundbeck is no longer so interested in rare disease. I still have to mention US approval and positive CHMP opinion for Alhemo and imminent regulatory filing of Mim8. Obviously in other disease areas, we closed down zalfermin, not because it was a bad offering, it was just not better than semaglutide. As you know, right now we have, at least in the phase 3 space, the strongest data in MASH. As Dave mentioned, we expect regulatory approval for that in US within a couple of months.
Already here in Q3, we aim to see.
Readout of our Triple agonist and importantly, we will initiate the brilliant side and more safety Phase III program also later this year.
That's going to be incredibly exciting in the diabetes and obesity space I would be remiss little big is no longer so interested in rare disease, but I still have two mentioned U S approval and positive <unk> opinion for hemo and imminent.
The regulatory filing of <unk> and then obviously in other disease areas, we closed down sell Permian not because it was a bad offering it was just a better sense.
And as you know right now we have at least in the phase III space the strongest data in mesh and as Dave mentioned, we expect regulatory approval for that EU is within a couple of months.
Finally, obviously devote data I have to remind you we see that as high risk high reward.
Martin Holst Lange: Finally, obviously the FLOW data, I had to remind you, we see that as high risk, high reward, but the readout will come towards the end of the year in Q4, and obviously gonna be exciting. With that, back to you, Carsten.
Martin Lange: Finally, obviously the FLOW data, I had to remind you, we see that as high risk, high reward, but the readout will come towards the end of the year in Q4, and obviously gonna be exciting. With that, back to you, Carsten.
But the readout will come.
Towards the end of the year in Q4, and obviously going to be exciting and with that back to you guys.
Alright, Thank you Watson.
On the outlook, which we announced last week. So we lowered our outlook linked to a predominantly and lower volume growth in the U S compared to what we expected back at our Q1 release, so lower volume outlook for <unk> and the Kobe, Dave was just touching on that we do see positive signs on the globe.
Karsten Munk Knudsen: Great. Thank you, Martin. On outlook, which we announced last week. We lowered our outlook, linked to predominantly a lower volume growth in the US compared to what we expected back at our Q1 release. Lower volume outlook for Ozempic and Wegovy. Dave was just touching on that we do see positive signs on Wegovy now over the last few weeks and data points. Sales growth outlook now 8% to 14% for the full year, and operating profit 10% to 16% for the full year. Currency is up-updated based on 31 July, so a slight tweak compared to last week.
Karsten Munk Knudsen: Great. Thank you, Martin. On outlook, which we announced last week. We lowered our outlook, linked to predominantly a lower volume growth in the US compared to what we expected back at our Q1 release. Lower volume outlook for Ozempic and Wegovy. Dave was just touching on that we do see positive signs on Wegovy now over the last few weeks and data points. Sales growth outlook now 8% to 14% for the full year, and operating profit 10% to 16% for the full year. Currency is up-updated based on 31 July, so a slight tweak compared to last week.
Now over the last few weeks and data points.
So sales growth outlook now, 8% to 14% for the full year.
And operating profit, 10% to 16 for the full year currencies update it based on the July.
July 31st so slight tweak compared to last weeks or so now three five percentage points lower respectively, mainly linked to the U S dollar.
Karsten Munk Knudsen: Now 3 and 5 percentage points lower respectively, mainly linked to the US dollar, and the corresponding adjustment to net financials linked to the hedging of our core currencies. CapEx unchanged, while free cash flow is reduced to between DKK 35 billion and 45 billion, mainly as a function of the lower US outlook amplified by the gross to net payment term in that model. That's really what drives the cash flow delta compared to the Q1 guidance. There are a few comments around cash flow in the second half of the year versus what we realized in the first half of the year. The simple explanation is really twofold.
Karsten Munk Knudsen: Now 3 and 5 percentage points lower respectively, mainly linked to the US dollar, and the corresponding adjustment to net financials linked to the hedging of our core currencies. CapEx unchanged, while free cash flow is reduced to between DKK 35 billion and 45 billion, mainly as a function of the lower US outlook amplified by the gross to net payment term in that model. That's really what drives the cash flow delta compared to the Q1 guidance. There are a few comments around cash flow in the second half of the year versus what we realized in the first half of the year. The simple explanation is really twofold.
And the corresponding adjustment to net net finance is linked to the hedging of our of our core crunches Capex unchanged.
While free cash flow is reduced to between $35 45 billion in Danish krone.
Mainly as a function of the lowest U S outlook amplified by the gross to net payment term in that model. So that's really what drives.
The cash flow delta compared to the Q1 guidance.
A few comments around cash flow in the second half of the year versus what we realized in the first half of the year and the simple explanation is really twofold. One is a higher capex spend in the second half of the year compared to the first half of the year and and the second reason is that the debt.
Karsten Munk Knudsen: One is, higher CapEx spend in the second half of the year compared to the first half of the year. The second reason is that on account tax payments, mainly in Denmark, is back-end loaded into the second half of the year compared to the first half of the year. Adjusting for that, it's way more normalized in terms of cash flow generation across the year. That covers the financial outlook, and now we're ready to move over to Q&A. Over to you, Jacob.
Karsten Munk Knudsen: One is, higher CapEx spend in the second half of the year compared to the first half of the year. The second reason is that on account tax payments, mainly in Denmark, is back-end loaded into the second half of the year compared to the first half of the year. Adjusting for that, it's way more normalized in terms of cash flow generation across the year. That covers the financial outlook, and now we're ready to move over to Q&A. Over to you, Jacob.
On account tax payments mainly.
Denmark is backend loaded into the second half of the year compared to the first half of the year adjusting for that it's way more normalized in terms of cash flow generation across the year.
So that covers the financial outlook and now we're ready to move over to Q&A. So Jr.
Thank you Pat and thank you, Dave and margin and we play by the usual ground rules for one question per person. Please and please state your name and institution and we start with James.
Jacob Rode: Thank you, Karsten. Thank you, Dave, Ludo, and Martin. We play by the usual ground rules, so one question per person, please. Please state your name and institution. We start with James, our host.
Jacob Rode: Thank you, Karsten. Thank you, Dave, Ludo, and Martin. We play by the usual ground rules, so one question per person, please. Please state your name and institution. We start with James, our host.
Excellent. Thank you.
Thanks Pete.
James Quigley: Excellent. Thank you, Jacob Rode. James Quigley from Goldman Sachs. A quick question, Martin Holst Lange, on orforglipron. Phase 3 data from ATTAIN-1 has just been released. The placebo-adjusted weight loss of around 11.5% at 72 weeks, 24% vomiting, 10% discontinuations at the highest dose. What is your view on the product relative to Wegovy and to orsemia 25 mg? Dave Moore and then Ludovic Helfgott, you had a good slide in the back of the presentation yesterday on the segmentation of the market. Does this data change how you think the competition would, will develop in those segments? Thank you.
James Quigley: Excellent. Thank you, Jacob Rode. James Quigley from Goldman Sachs. A quick question, Martin Holst Lange, on orforglipron. Phase 3 data from ATTAIN-1 has just been released. The placebo-adjusted weight loss of around 11.5% at 72 weeks, 24% vomiting, 10% discontinuations at the highest dose. What is your view on the product relative to Wegovy and to orsemia 25 mg? Dave Moore and then Ludovic Helfgott, you had a good slide in the back of the presentation yesterday on the segmentation of the market. Does this data change how you think the competition would, will develop in those segments? Thank you.
Thanks.
So a quick question Martin.
Okay.
Data from the Phase one has just been just been released to the placebo adjusted weight loss of around 11, 5% to 72 weeks 24 weeks implements anytime soon just continuation at the highest dose. So what is your view on the products relative to <unk> and two.
25 milligrams and then David.
Have a good slide in the back of the presentation yesterday on the segmentation of the market.
Does this data change how you think the competition.
Given up in both segments. Thank you.
So so.
I think the number speaks for themselves.
Martin Holst Lange: I think the numbers speaks for themselves. If we're to compare 17% weight loss to 12% weight loss. Withdrawal rate due to adverse event on the highest dose of 10% versus 7%. Overall withdrawal rate on the highest dose, 25%, which was I think 18% for oral semaglutide 25 milligram. It speaks for itself. It appears that, and again, it's an indirect comparison. There is a substantial difference in weight loss potential, but also in the safety tolerability profile between the two offerings. At the same time, we can scale oral semaglutide, and therefore, I think it's fair to say we're super excited about launching that product in a competitive space.
Martin Lange: I think the numbers speaks for themselves. If we're to compare 17% weight loss to 12% weight loss. Withdrawal rate due to adverse event on the highest dose of 10% versus 7%. Overall withdrawal rate on the highest dose, 25%, which was I think 18% for oral semaglutide 25 milligram. It speaks for itself. It appears that, and again, it's an indirect comparison. There is a substantial difference in weight loss potential, but also in the safety tolerability profile between the two offerings. At the same time, we can scale oral semaglutide, and therefore, I think it's fair to say we're super excited about launching that product in a competitive space.
If we compare 17% weight loss of 12% weight loss.
With all rate due to adverse event on the highest dose.
10% versus 7% overall renewal rate on the highest dose of 25%, which was I think 18.
For us, we're making 25 milligram it speaks for itself.
It appears that.
Again, it's an indirect comparison.
That is a substantial difference in weight loss potential, but also in the safety tolerability profile between the two offerings at the same time, we can scale.
<unk> and therefore, we.
It's fair to say, we're super excited about launching that product in a competitive space.
We're really excited to launch this product. This is a good old fashion Novo Nordisk loans.
Karsten Munk Knudsen: We're really excited to launch this product. This is a good old-fashioned Novo Nordisk launch where we have a competitive, compelling profile. The reason we decided to move forward with this launch, regardless of orforglipron, was because we had a product with meaningful weight loss, with a known compound, and familiarity and safety, and millions of people using this worldwide, in addition to the broadest label. That's the reason we decided to bring that forward. We know what 16, 17% weight loss means, and I think what we're really excited about is this sort of segments of the market that are not motivated to go and seek treatment today, either because of the way they see their disease, or they're not motivated to go and seek a medicine that would require an injection.
Karsten Munk Knudsen: We're really excited to launch this product. This is a good old-fashioned Novo Nordisk launch where we have a competitive, compelling profile. The reason we decided to move forward with this launch, regardless of orforglipron, was because we had a product with meaningful weight loss, with a known compound, and familiarity and safety, and millions of people using this worldwide, in addition to the broadest label. That's the reason we decided to bring that forward. We know what 16, 17% weight loss means, and I think what we're really excited about is this sort of segments of the market that are not motivated to go and seek treatment today, either because of the way they see their disease, or they're not motivated to go and seek a medicine that would require an injection.
We have a competitive compelling profile. The reason, we decided to move forward with this launch regardless of ortho was because we had a product with meaningful weight loss with a known compound and familiarity and safety and millions of people using this worldwide. In addition to.
The broadest label. That's the reason, we decided to bring it forward, we know what 16, 17% weight loss means and I think what we're really excited about is this sort of segments of the market that are not motivated to go and seek treatment today, either because of the way they see their disease or they are not motivated to go and seek.
A medicine that would require an injection there is another segment of people out there living with obesity.
Karsten Munk Knudsen: There is another segment of people out there living with obesity that are very interested in an oral daily GLP-1, and we're going to treat it that way in an unconstrained, you know, type of launch in the US.
Karsten Munk Knudsen: There is another segment of people out there living with obesity that are very interested in an oral daily GLP-1, and we're going to treat it that way in an unconstrained, you know, type of launch in the US.
That are very interested in an oral daily GOP, one and we're going to treat it that way in an unconstrained.
<unk> launch in the U S.
And if you take a step back and the whole idea that we shared which is this idea that you don't have one single population of three of a patient with a <unk>, but actually sub segments of them can only be reinforced by that views. We don't believe that if anything we believe that the share of the overall market will actually grow significantly given the quality of what your heavier efficacy wise to our liquidity wise.
Ludovic Helfgott: If you take a step back, the whole idea that we shared, which is this idea that you don't have one single population of people, patient with obesity, but actually subsegments of them can only be reinforced by that views. We don't believe that. If anything, we believe that the share of the oral market will actually grow significantly given the quality of what you have here, efficacy-wise, tolerability-wise, and including with the cardiovascular benefits, we can really bang that into the profile. That will be very helpful to start unlocking all these groups of segments that are today not really already getting to the obesity market, but will get there. We start to have quite precise ideas of who these groups could be. In other words, we believe in the overall part of the market.
Ludovic Helfgott: If you take a step back, the whole idea that we shared, which is this idea that you don't have one single population of people, patient with obesity, but actually subsegments of them can only be reinforced by that views. We don't believe that. If anything, we believe that the share of the oral market will actually grow significantly given the quality of what you have here, efficacy-wise, tolerability-wise, and including with the cardiovascular benefits, we can really bang that into the profile. That will be very helpful to start unlocking all these groups of segments that are today not really already getting to the obesity market, but will get there. We start to have quite precise ideas of who these groups could be. In other words, we believe in the overall part of the market.
And including with the cardiovascular benefits. They can we can really bank debt into into their profile and that will be very helpful to start unlocking all of these groups are segment that are today, not really already <unk>.
<unk> two of the obesity market, but we'll get there and we start to have quite beside the idea that these groups could be so in other words, we believe in the overall part of the market we believe that there.
PD is actually.
Ludovic Helfgott: We believe that, the Wegovy pill is actually has the potential to be best in class there right now, given the data that we saw this morning, and we have a trust that we can really do a super launch in the US.
Ludovic Helfgott: We believe that, the Wegovy pill is actually has the potential to be best in class there right now, given the data that we saw this morning, and we have a trust that we can really do a super launch in the US.
Has the potential to be.
Best in class that right now given the data that we saw this morning, and we have a chart that we can reduce our super launching now in the U S.
Thank you.
David Moore: Yeah. Thank you. I mean, we're gonna team up pretty well as we start putting these things together. You can already imagine the type of DTC is I'm thinking about. You know, I'm pretty simple sales and marketing guy. When you can say your product is better, things usually happen in the marketplace. At least from what we've seen in the first generation, sort of oral small molecule, you know, taking the lead from our CSL, we made a good move in terms of thinking about oral sema for obesity, and it was a good call.
David Moore: Yeah. Thank you. I mean, we're gonna team up pretty well as we start putting these things together. You can already imagine the type of DTC is I'm thinking about. You know, I'm pretty simple sales and marketing guy. When you can say your product is better, things usually happen in the marketplace. At least from what we've seen in the first generation, sort of oral small molecule, you know, taking the lead from our CSL, we made a good move in terms of thinking about oral sema for obesity, and it was a good call.
We're going to team up pretty well as we start putting these things together you can already already imagine that type of BTC as I'm thinking about.
No.
I'm pretty simple sales and marketing Guy.
When you can say your product is better.
Things usually happen in the marketplace and at least from what we've seen in the first generation sort of oral small molecule.
<unk>.
Taking the lead from our CSL, we made a good move in terms of thinking about oral sema for obesity and it was a good call.
Okay.
Building on that and to finish up your question.
Ludovic Helfgott: Building on that, to finish up your question, it's not only good for the oral market, it's also good because you're increasingly seeing that the patients will have a journey towards obesity. They might start with an oral, get to injectable. They might start with injectable, get to an oral. It's not just the subgroup themselves you're opening, it's actually the full lifetime value of a patient. You can actually multiply by having several different offerings of high quality, which is the one we believe we are bringing to patients today. It's a double whammy in a sense for us.
Ludovic Helfgott: Building on that, to finish up your question, it's not only good for the oral market, it's also good because you're increasingly seeing that the patients will have a journey towards obesity. They might start with an oral, get to injectable. They might start with injectable, get to an oral. It's not just the subgroup themselves you're opening, it's actually the full lifetime value of a patient. You can actually multiply by having several different offerings of high quality, which is the one we believe we are bringing to patients today. It's a double whammy in a sense for us.
It's not only good for the oral market. It's also good because you're increasingly seeing that the patients will have a journey towards ability they might start with an oral you get to injectable MOSFET with injectable get to a normal so its not just the subgroup themselves you're opening it is actually the full lifetime value of a patient can actually multiply by having several different offerings of high quality, which is the one we believe.
We are bringing to patients today, so it's a double whammy in a sense for it.
Brilliant wonderful, let's move to the frontier people first and then we'll go to Simon Thank afterwards.
Operator: Brilliant. Wonderful. Let's move to the front table here. Thibault first, and then we'll go to Simon Baker afterwards.
Jacob Rode: Brilliant. Wonderful. Let's move to the front table here. Thibault first, and then we'll go to Simon Baker afterwards.
Thank you.
Can you just a clarification from marching on.
[Analyst]: Thank you. Actually, just a clarification from Martin on CagriSema single chamber. I think you mentioned yesterday the need to run a clinical equivalence study. Can you just help us a bit with the timeline, when you think you can start this study, how long it would take? What does the submission process look like for this type of study? I guess, I mean, the reason I ask this question is just to sort of compare the timeline for CagriSema single chamber with amycretin subcutaneous, because if they get close, how do you think of one versus the other?
[Analyst]: Thank you. Actually, just a clarification from Martin on CagriSema single chamber. I think you mentioned yesterday the need to run a clinical equivalence study. Can you just help us a bit with the timeline, when you think you can start this study, how long it would take? What does the submission process look like for this type of study? I guess, I mean, the reason I ask this question is just to sort of compare the timeline for CagriSema single chamber with amycretin subcutaneous, because if they get close, how do you think of one versus the other?
Thank you Ms single Chamber.
You mentioned yesterday as you need to run the Pinecone keeping steady.
Can you just help us because the timeline when you think you again started this study how long it would take.
What does the submission process look like for these type of.
A study and I guess I mean.
The reason I ask this question just to sort of compounds.
Timeline for catching some are single chamber with any accuracy as it gets bigger.
Because as they get close how do you think of one versus the other.
Maybe you do on the timelines afterwards, and then you can do on Emricasan versus placebo.
Operator: Maybe you do on the timelines afterwards, then Ludo, you can do on amycretin versus CagriSema.
Karsten Munk Knudsen: Maybe you do on the timelines afterwards, then Ludo, you can do on amycretin versus CagriSema.
So absolutely and obviously, we see a benefit in terms of supply flexibility to have the single chamber to want to call out we are scaling to to have a very strong launch with the dual chamber device, but it will give us that flexibility.
Martin Holst Lange: Absolutely. Obviously, we see a benefit in terms of supply flexibility to have the single chamber. I don't wanna call out, we are scaling to have a very strong launch with the dual-chamber device, but it will give us that flexibility. It's an upside if we can do it. And I had to do the clinical equivalent study. It's gonna be smaller and shorter than what you would conventionally think with a phase 3 study. We just had to show similar weight loss, introduction weight loss, and similar safety and tolerability profile. We intend to initiate the study around the turn of the year. I won't go further into the timelines.
Martin Lange: Absolutely. Obviously, we see a benefit in terms of supply flexibility to have the single chamber. I don't wanna call out, we are scaling to have a very strong launch with the dual-chamber device, but it will give us that flexibility. It's an upside if we can do it. And I had to do the clinical equivalent study. It's gonna be smaller and shorter than what you would conventionally think with a phase 3 study. We just had to show similar weight loss, introduction weight loss, and similar safety and tolerability profile. We intend to initiate the study around the turn of the year. I won't go further into the timelines.
It's an upside if we can do it.
And I had to do.
The clinical equivalent so it's going to be smaller in solar that you would conventionally sync with our phase III study. So we just have to show similar weight loss and traditional retailers and Simba.
Safety and Tolerability profile.
We intend to initiate the study around the turn of the year.
I won't go further to the covenants.
Having multiple treatments into market a little I.
Operator: On having multiple treatments in the market, Ludo?
The whole question is bringing diversity to the to the different patient populations and we really believe in the value and efficacy and safety profile of the firm.
Karsten Munk Knudsen: On having multiple treatments in the market, Ludo?
Ludovic Helfgott: Again, I think the whole question is bringing the diversity to the different patient populations, and we really believe in the value and efficacy and safety profile of amycretin. By the way, we have the injectable, we have the oral as well, which is not the case for CagriSema. Again, you're offering to the patients a portfolio of options that are really based on helping them adapting the treatments to what they really need and the associated comorbidities. 'Cause for me, what's really interesting beyond the formats is the kind of programs we're designing. I'm sure that Martin will come to that later on.
Ludovic Helfgott: Again, I think the whole question is bringing the diversity to the different patient populations, and we really believe in the value and efficacy and safety profile of amycretin. By the way, we have the injectable, we have the oral as well, which is not the case for CagriSema. Again, you're offering to the patients a portfolio of options that are really based on helping them adapting the treatments to what they really need and the associated comorbidities. 'Cause for me, what's really interesting beyond the formats is the kind of programs we're designing. I'm sure that Martin will come to that later on.
If I may <unk> by the way, we have the injectable via the oral as well, which is not the case look everything I forget your offering to the patients a portfolio of options that are really based on helping them adapting the treatments to what they really need and the associated comorbidities because to me, what's really interesting beyond the formats is the kind of programs redesigning and im sure that nothing will come to that later.
But the idea is to replicate from a scientific perspective.
Ludovic Helfgott: The idea is to replicate from a scientific perspective, the diversity of patients that you find in the market and enriching the AMAZE program, as an example, with sub-studies or sub-path and sub-populations on which we're gonna study the very specific needed endpoints. The sleep apnea, talk of psoriasis, we talk to other benefits that we will enrich the program with. For me, it's not just a formal discussion, it's the ability to answer the weight first, 'cause we won't do the same mistake twice. Weight first, the comorbidities that are associated with the various subpopulations we're targeting.
Ludovic Helfgott: The idea is to replicate from a scientific perspective, the diversity of patients that you find in the market and enriching the AMAZE program, as an example, with sub-studies or sub-path and sub-populations on which we're gonna study the very specific needed endpoints. The sleep apnea, talk of psoriasis, we talk to other benefits that we will enrich the program with. For me, it's not just a formal discussion, it's the ability to answer the weight first, 'cause we won't do the same mistake twice. Weight first, the comorbidities that are associated with the various subpopulations we're targeting.
The diversity of patients that you find in our markets and enriching the Mais program. As an example, with sub studies are set forth in sub populations on which we're going to study there a very specific need.
Sleep apnea took off so we're trying to as we talk to other benefits that will enrich the program with so for me. It's not just a form of discussion is the ability to answer the weight fast because we wont do the same mistake twice wait first and then.
The comorbidity that are associated with the various subpopulations, we're targeting very good. Thanks, a lot Bill, let's go to Simonton and onwards to Harry afterwards.
Operator: Very good. Thanks a lot, both. Let's go to Simon then, and onwards to Harry afterwards.
Jacob Rode: Very good. Thanks a lot, both. Let's go to Simon then, and onwards to Harry afterwards.
Yeah.
Thank you so let me make some chunk of redburn.
David Moore: Thank you. Simon Baker from Rothschild & Co Redburn. Let's go back to the market as it stands today. You are seeing encouraging upticks in NBRx, but you still got the problem of compounding, which you said is pretty much unchanged. Can you give us some sort of help in thinking what is a reasonable timeframe over which to expect that to change? I know it's a difficult thing to ask, but if things go as planned, would we expect this to be meaningfully low in 2026 or 2027? How long do you or indeed 2025. How long would it take to have an impact there? Related to that, it doesn't look like you filed a Section 337 complaint with the International Trade Commission to block infringing API coming into the States. Is that true?
Simon Baker: Thank you. Simon Baker from Rothschild & Co Redburn. Let's go back to the market as it stands today. You are seeing encouraging upticks in NBRx, but you still got the problem of compounding, which you said is pretty much unchanged. Can you give us some sort of help in thinking what is a reasonable timeframe over which to expect that to change? I know it's a difficult thing to ask, but if things go as planned, would we expect this to be meaningfully low in 2026 or 2027? How long do you or indeed 2025. How long would it take to have an impact there? Related to that, it doesn't look like you filed a Section 337 complaint with the International Trade Commission to block infringing API coming into the States. Is that true?
Back to the market as it stands today.
You won't see encouraging upticks in and build expertise to what the problem is compounding, which you said is pretty much unchanged.
So can you give us some sort of helping thinking what is a reasonable timeframe.
Which do you expect that to change and it's a difficult thing to answer but if things go.
As planned would we expect this to be meaningfully lower in 'twenty six 'twenty seven how long do we need 25, how long would it.
To have an impact that and related to that.
Like you filed a section <unk> seven complaint with the International Trade Commission to block infringing AEP like coming into this stage is that true and if not do you plan to do so and you said wind.
David Moore: If not, do you plan to do so? If so, when? Thank you. Yeah. I may let Karsten answer kinda any legal action or comments. Let me focus on US and enforcement right now. We have not seen a meaningful change in the compounding in the US after 22 May, which is when compounding became illegal again, except for rare circumstances, which is a grace period after being removed from the drug shortage list. We have seen some change in the dynamics in terms of moving from 503B to 503A, kind of the who is compounding, and you know, kind of moving towards a more mass personalization versus just, you know, mass production and compounding. We haven't seen a change on where it's coming from, Simon.
Simon Baker: If not, do you plan to do so? If so, when? Thank you.
Yes.
Carson answer kind of any legal action or comments, but let me focus on U S.
David Moore: Yeah. I may let Karsten answer kinda any legal action or comments. Let me focus on US and enforcement right now. We have not seen a meaningful change in the compounding in the US after 22 May, which is when compounding became illegal again, except for rare circumstances, which is a grace period after being removed from the drug shortage list. We have seen some change in the dynamics in terms of moving from 503B to 503A, kind of the who is compounding, and you know, kind of moving towards a more mass personalization versus just, you know, mass production and compounding. We haven't seen a change on where it's coming from, Simon.
Enforcement right now.
We have not seen a meaningful change.
In the.
Funding in the U S. After may 22nd which is when compound became a legal again, except for rare circumstances, which is a grace period after being removed from the drug shortage list. We had seen some change in the dynamics in terms of moving from $5 <unk> to $5 three a kind of a who.
As compounding.
And kind of moving towards a more mass personalization versus just mass production and compounding we haven't seen a change in where it's coming from Simon.
We track it we see it most of it is coming in from China.
David Moore: You know, we track it. We see it. Most of it's coming in from China, largely from plants that are not approved. Certainly, the methodology is not approved in terms of the way that they're producing synthetic API, fake synthetic, and the way that it's coming into the country. It's coming in in containers that says, "Not for human use, for research purposes only," right? That is where we're in active dialogue right now with FDA, and we're having meaningful dialogue. You can imagine we've been having conversations for 2 years, right? Since we were put on the shortage list, and we saw this compounding. That dialogue has changed to be productive, to be responsive. I can't put a date, like, in terms of when we're gonna see something. We do have expectations.
David Moore: You know, we track it. We see it. Most of it's coming in from China, largely from plants that are not approved. Certainly, the methodology is not approved in terms of the way that they're producing synthetic API, fake synthetic, and the way that it's coming into the country. It's coming in in containers that says, "Not for human use, for research purposes only," right? That is where we're in active dialogue right now with FDA, and we're having meaningful dialogue. You can imagine we've been having conversations for 2 years, right? Since we were put on the shortage list, and we saw this compounding. That dialogue has changed to be productive, to be responsive. I can't put a date, like, in terms of when we're gonna see something. We do have expectations.
Largely from plants that are not approved certainly the methodology is not approved in terms of the way that they're producing synthetic API fake synthetic and the way that it's coming into the country.
And it's being coming in and containers that does not for human use for research purposes only right.
That is where we are in active dialog right now with FDA and we're having meaningful dialogue you can imagine we've been having conversations for a couple of years right. Since we were put on the shortage list. We saw this compounding that that dialogue has changed to be productive to be responsive.
Can't put a date like in terms of when we're going to see something we do have expectations. We do have timelines, we discussed with them.
David Moore: We do have timelines we discuss with them, and unless it's going to escalate on our end to further action. In terms of how fast does it go away, it's a little bit difficult to say. The most important thing for us is to get enforcement and to stop the fake API from coming in. We can go into our next order of execution and, you know, in combating this and bringing it back to the what is the rule letter of the law, and it's for rare circumstances. It's not, you know, launching a dose that's not even approved in a mass marketing way, and that's what we're really focused on stopping.
David Moore: We do have timelines we discuss with them, and unless it's going to escalate on our end to further action. In terms of how fast does it go away, it's a little bit difficult to say. The most important thing for us is to get enforcement and to stop the fake API from coming in. We can go into our next order of execution and, you know, in combating this and bringing it back to the what is the rule letter of the law, and it's for rare circumstances. It's not, you know, launching a dose that's not even approved in a mass marketing way, and that's what we're really focused on stopping.
Unless it is going to escalate on our end to further action.
In terms of how fast does it go away, it's a little bit difficult to say.
The most important thing for us is to get enforcement and to stop the fake API from coming in then we can go into our next order of execution.
And combating.
This and bringing it back to the what is the rule letter of the law and as for rare circumstances, it's not launching a dose that's not even approved and a mass marketing way and Thats what were really focused on stopping.
Yeah, So and just covering the second part of the question around ICC. That's that's correct I would say that building on Dave's comments that all options are on the table. So so now with the commercial messaging and the public Fas angle to it the regulator dialogue and a.
Karsten Munk Knudsen: Just covering the second part of the question around ITC, that's correct. I would say that building on Dave's comments that all options are on the table. Now, you know, we're, you know, the commercial messaging and the public affairs angle to it, the regulator dialogue and of course, the litigation pathway on several avenues. We are all in on both capabilities, advisors, et cetera, to have all options on the table. Then we find the best way forward. For obvious reasons, we cannot comment on yet undisclosed litigations.
Karsten Munk Knudsen: Just covering the second part of the question around ITC, that's correct. I would say that building on Dave's comments that all options are on the table. Now, you know, we're, you know, the commercial messaging and the public affairs angle to it, the regulator dialogue and of course, the litigation pathway on several avenues. We are all in on both capabilities, advisors, et cetera, to have all options on the table. Then we find the best way forward. For obvious reasons, we cannot comment on yet undisclosed litigations.
Of course, the litigation path.
That way on several several avenues. So so we have we're all in on both capabilities advisors et cetera. So I have all options on the table and then we find the best way forward and for obvious reasons, we cannot comment on on yet undisclosed litigations.
Thanks Harry.
Operator: Very good. Thanks. Let's move to Harry.
Jacob Rode: Very good. Thanks. Let's move to Harry.
Thank you Henri <unk> from UBS, just wanted to touch on capacity.
Harry Sephton: Thank you. Harry Sephton from UBS. I just want to touch on capacity. You've previously guided to Catalent capacity coming more on stream in 2026. Clearly you've been ramping up your CapEx since around to 2023, so we should expect that to further add to that. Combine that with sales having disappointed this year, what are we looking like in terms of capacity utilization going into next year? What does that mean in terms of looking to compete maybe more aggressively on price to try and boost volumes? To just wrap into that, you've obviously got the loss of exclusivity of SEMA in a number of markets next year. Will you look to compete on price in those markets with generics? Thank you.
Harry Sephton: Thank you. Harry Sephton from UBS. I just want to touch on capacity. You've previously guided to Catalent capacity coming more on stream in 2026. Clearly you've been ramping up your CapEx since around to 2023, so we should expect that to further add to that. Combine that with sales having disappointed this year, what are we looking like in terms of capacity utilization going into next year? What does that mean in terms of looking to compete maybe more aggressively on price to try and boost volumes? To just wrap into that, you've obviously got the loss of exclusivity of SEMA in a number of markets next year. Will you look to compete on price in those markets with generics? Thank you.
The guidance to gasoline capacity coming more on stream in 2026, and clearly you've been ramping up your capex since around 2023, So we should expect that to start to add.
Add to that.
Buying that with south having disappointed this year.
Are we looking like in terms of capacity utilization going into next year.
And then what does that mean in terms of looking to compete maybe more aggressively on price to try and boost volumes and maybe to just wrap into that you've obviously got the loss of exclusivity of <unk> and a number of markets next year will you look to compete on price in those markets with generics.
Yeah absolutely.
Operator: Can you offer that one, Carsten?
Jacob Rode: Can you offer that one, Carsten?
On capacity.
Karsten Munk Knudsen: Yeah. Absolutely. On capacity, clearly ramping capacity, and we see very good progress on the different programs. I can inform you that now all three Catalent sites are producing Wegovy. That builds, of course, a lot of resilience in our system. Our CapEx plan, of course, yields a lot of extra capacity for the company. That's back to my introductory comment about how much we're scaling. We're scaling more than 3 million patients just compared to a year ago. Enabling that future scaling, then we believe that the CapEx program, also in light of the significant unmet needs in our portfolio, is spot on what we have to do.
Karsten Munk Knudsen: Yeah. Absolutely. On capacity, clearly ramping capacity, and we see very good progress on the different programs. I can inform you that now all three Catalent sites are producing Wegovy. That builds, of course, a lot of resilience in our system. Our CapEx plan, of course, yields a lot of extra capacity for the company. That's back to my introductory comment about how much we're scaling. We're scaling more than 3 million patients just compared to a year ago. Enabling that future scaling, then we believe that the CapEx program, also in light of the significant unmet needs in our portfolio, is spot on what we have to do.
So clearly ramping capacity and we see very good progress on the different programs.
And I can I can inform you that the that now all three kevlin sites are producing.
So.
Of course, a lot of precision in our system and then our Capex spend of course yields a lot of extra capacity for the company and Thats back to my introductory comment about how much. We're scaling so we're scaling more than 3 million patients just compared to a year ago, so enabling that future scaling than that.
Then we believe that the Capex program also in light of the significant unmet need in our portfolio.
Spot on what we have to do.
In terms of the Capex program and competition.
Karsten Munk Knudsen: In terms of the CapEx program and competition, and competitiveness, I would say that clearly we're going for defending our space in this market, and we're gonna defend volumes. With our productivity, our unit costs and our manufacturing footprints, we're gonna fight for our space.
Karsten Munk Knudsen: In terms of the CapEx program and competition, and competitiveness, I would say that clearly we're going for defending our space in this market, and we're gonna defend volumes. With our productivity, our unit costs and our manufacturing footprints, we're gonna fight for our space.
And competitive competitiveness I would say that the that clearly we are going for defending our space in this market and we're going to defend volumes and with our productivity our unit costs and manufacturing footprint.
We're going to fight for space.
Great. Thanks, very much thanks, let's move you to Pete.
Operator: Great. Thanks, Harry. Thanks, Carsten. Let's move here to Pete.
Jacob Rode: Great. Thanks, Harry. Thanks, Carsten. Let's move here to Pete.
Thanks pivotal BNP just one question.
Peter Verdult: Thanks. Peter Verdult, BNP. Just one question. You talked about the market segmenting. What about price segmentation? I realize you're not gonna talk about pricing in detail, but high level, it's pretty obvious you're talking about oral 25 being Wegovy in a pill. I think everyone in the room would think, you know, parity pricing to where we are today. You've got a competitor who had rave reviews about orforglipron data and diabetes at ADA and have now produced data that is clearly not to the upside like. In terms of base case expectations, when you think about that oral GLP-1 segment of the market, are you assuming base case that it's a much lower price segment versus the injectable market? Thank you.
Peter Verdult: Thanks. Peter Verdult, BNP. Just one question. You talked about the market segmenting. What about price segmentation? I realize you're not gonna talk about pricing in detail, but high level, it's pretty obvious you're talking about oral 25 being Wegovy in a pill. I think everyone in the room would think, you know, parity pricing to where we are today. You've got a competitor who had rave reviews about orforglipron data and diabetes at ADA and have now produced data that is clearly not to the upside like. In terms of base case expectations, when you think about that oral GLP-1 segment of the market, are you assuming base case that it's a much lower price segment versus the injectable market? Thank you.
You talked about the market segmenting worried about.
This segmentation I realize youre not going to talk about pricing in detail, but high level, it's pretty obvious you're talking about <unk> 25, We gave you an appeal. So I think everyone in the room.
Parity pricing to where we are today.
You've got a competitor who had rave reviews about ultra data in diabetes.
Now produce data that is clearly no.
So I'd like so.
In terms of the base case expectation when you think about the overall GOP one segment of the market.
<unk> base case that it's a much lower price segment versus the injectable market. Thank you.
Okay.
Do you want answer that one Dave Yep, Yep happy to constant outdoors.
Operator: Take it. Anyone offer that one? Dave?
Jacob Rode: Take it. Anyone offer that one? Dave?
David Moore: Yeah. Yeah, happy to.
David Moore: Yeah. Yeah, happy to.
Yes, not guiding and of course on any pricing strategy right.
Operator: Karsten, afterwards.
Jacob Rode: Karsten, afterwards.
David Moore: Yeah, not guiding, of course, on any pricing strategy, right? You know, we're not in a hurry to race the price down in this category, right? Take compounding aside, it's still largely two manufacturers. I think there's, you know, a shared view of really balancing the value and access. As you said, you know, it is sema in a pill, and we certainly wanna protect that ratio of value to access. There is, of course, segments of the population that open up as price goes down, and we're learning from that. In the cash channel, we're learning from that, and what we see in telehealth and partnerships, and that's just something that, you know, we're gonna continue to watch and get smart about.
David Moore: Yeah, not guiding, of course, on any pricing strategy, right? You know, we're not in a hurry to race the price down in this category, right? Take compounding aside, it's still largely two manufacturers. I think there's, you know, a shared view of really balancing the value and access. As you said, you know, it is sema in a pill, and we certainly wanna protect that ratio of value to access. There is, of course, segments of the population that open up as price goes down, and we're learning from that. In the cash channel, we're learning from that, and what we see in telehealth and partnerships, and that's just something that, you know, we're gonna continue to watch and get smart about.
Yeah.
We're not in a hurry to race.
The price down in this category right.
We will take compounding aside is it still largely too.
Two manufacturers and I think there is.
A shared view of really balancing the value and access.
As you said.
It is a semi in a pill and we certainly want to protect that that ratio of elite access.
There is of course segments of the population that open up as price goes down and we're learning from that and the cash channel or learning from that and what we see in telehealth and partnerships and that's just something we're going to continue to watch and get smart about it.
Maybe if you are on that side.
Ludovic Helfgott: I think maybe on that side. We're looking at the price, as a price point one-off. It's actually not the way the market is reacting. The people are looking at longer view, at subscriptions, as we can see in some of the direct channels. It's actually much more, again, a lifetime value of a patient throughout the journey of initiation and then maintenance that needs to be taken into account. That's why the one-off doesn't really matter. What matters is if you discount back what you're gonna get from a pricing perspective month after month in the whole journey. That's actually what we're experimenting as we speak, more than just having a 1 single price point. That's the thing, it's important.
Ludovic Helfgott: I think maybe on that side. We're looking at the price, as a price point one-off. It's actually not the way the market is reacting. The people are looking at longer view, at subscriptions, as we can see in some of the direct channels. It's actually much more, again, a lifetime value of a patient throughout the journey of initiation and then maintenance that needs to be taken into account. That's why the one-off doesn't really matter. What matters is if you discount back what you're gonna get from a pricing perspective month after month in the whole journey. That's actually what we're experimenting as we speak, more than just having a 1 single price point. That's the thing, it's important.
We're looking at.
The price is the price 0.1 off and it's actually not the way the market is reacting that people are looking at longer longer view at subscriptions. If we can see some of the some of their direct channels. So it's actually much more again, a lifetime value of a patients throughout the journey of initiation and then maintenance that needs to be taken into account.
Thats why the one off doesn't really matter what matters is extra discount back what you're going to get from a pricing perspective month after month in the whole journey, that's actually what we're experimenting as we speak.
More than just having a one thing on price point.
I think it's important and it's also important to make sure that from a cash perspective, we have to preserve a certain consistency as you can imagine between all the various channels, we have otherwise, it's becoming messy India of arbitrage that we don't want to create.
Ludovic Helfgott: It's also important to make sure that from a cash perspective, we have to preserve a certain consistency, as you can imagine, between all the various channels we have. Otherwise, it's becoming messy, and you have arbitrage that we don't wanna create.
Ludovic Helfgott: It's also important to make sure that from a cash perspective, we have to preserve a certain consistency, as you can imagine, between all the various channels we have. Otherwise, it's becoming messy, and you have arbitrage that we don't wanna create.
Thanks, Luke thank Dave.
And we have Richard Vasa hiding in the corner.
Operator: Thanks, Ludo. Thanks, Dave. We have Richard Vosser hiding in the corner. I'll switch it.
Operator: Thanks, Ludo. Thanks, Dave. We have Richard Vosser hiding in the corner. I'll switch it.
Richard.
I just had one question just stay time globally, how is that evolving and how do you think stay time will evolve in different channels like all I can imagine that with you flip one data maybe this data would be rather short.
Richard Vosser: I just have one question. Just stay time globally, how's that evolving, and how do you think stay time will evolve in different channels like oral? I can imagine that with the orforglipron data, maybe the stay time would be rather short. Do you think payers will use that to step through in the US market? Just different stay times, different market segments, and how is it evolving now?
Richard Vosser: I just have one question. Just stay time globally, how's that evolving, and how do you think stay time will evolve in different channels like oral? I can imagine that with the orforglipron data, maybe the stay time would be rather short. Do you think payers will use that to step through in the US market? Just different stay times, different market segments, and how is it evolving now?
Do you think payers will use not to step through.
In the U S market, but just different state times different market segments, and how is that evolving now absolutely and I think it's very interesting what youre, saying Youre right I think is going to be by group of patients.
Ludovic Helfgott: Absolutely. I think it's very interesting what you're saying. You're right. I think it's gonna be by group of patients. We know that right now it's around seven months, if I'm not mistaken, on Wegovy, and I think it's more years, several years in on Ozempic. We believe that some of these patients, also based on the pricing structure of subscription, et cetera, might actually have a longer stay time. We might also have patients that are very active for seven, eight, nine months, and then they will pause and start again. I think it's gonna be very difficult to have one single weighted average stay time that is meaningful for the variety of patterns and behaviors we're seeing. This being said, everything we're doing is to extend stay time.
Ludovic Helfgott: Absolutely. I think it's very interesting what you're saying. You're right. I think it's gonna be by group of patients. We know that right now it's around seven months, if I'm not mistaken, on Wegovy, and I think it's more years, several years in on Ozempic. We believe that some of these patients, also based on the pricing structure of subscription, et cetera, might actually have a longer stay time. We might also have patients that are very active for seven, eight, nine months, and then they will pause and start again. I think it's gonna be very difficult to have one single weighted average stay time that is meaningful for the variety of patterns and behaviors we're seeing. This being said, everything we're doing is to extend stay time.
We know that correct right now returned seven months, if I'm not mistaken on we go via I think slide four years.
Several years on S&P, we believe that some of these patients also baseband.
The pricing structure of subscription et cetera might actually have a longer stay time. We must also have patients that are very active for 789 months and then they will pause and start again. So I think it's going to be very difficult to have one single weighted average day time that is meaningful for the verity of patterns and behaviors. We're seeing these big.
Set.
Everything we're doing is to extend stay time, and we're doing and then making sure that they've had coming on that we are launching a lot of initiatives to make sure that the longer you stay there longer you see the benefits and if you think about what we saw we surpass.
Ludovic Helfgott: I'm sure that Dave could comment on that. We are launching a lot of initiatives to make sure that the longer you stay, the longer you see the benefits. If you think about what we saw with SURPASS, in the data, if you now see that all the GLP-1s are now the same, that the CVOT benefits are gained on the long run, all this actually pleads for longer stay time for the patients. That's true for Wegovy as much as for Ozempic. We're doing a lot to extend it, but I think that the average would be less and less meaningful with time.
Ludovic Helfgott: I'm sure that Dave could comment on that. We are launching a lot of initiatives to make sure that the longer you stay, the longer you see the benefits. If you think about what we saw with SURPASS, in the data, if you now see that all the GLP-1s are now the same, that the CVOT benefits are gained on the long run, all this actually pleads for longer stay time for the patients. That's true for Wegovy as much as for Ozempic. We're doing a lot to extend it, but I think that the average would be less and less meaningful with time.
And the data we now see that the all the Geofence another thing that the CV benefits.
Gains on the long run all of these actually plead for longer stay time for their patients. That's true for we gave you as much as far as <unk>. So.
We're doing a lot to extend it but I think that the average will be less and less meaningful with with time.
Thank you Darla, we'll move here in the middle.
Operator: Thank you, Ludo. We'll move here in the middle.
Jacob Rode: Thank you, Ludo. We'll move here in the middle.
Scott Morris from Diamondback.
Callum Morris: Thanks. Callum Morris from Berenberg. I just had a another question on pricing. Obviously, in the cash channel, we've seen a lower penetration for Wegovy than anticipated. Obviously, we've talked about lots of factors for that. How much do you think that is also to do with price competition with Lilly? Ozempic coming through into that channel in H2 this year, do you expect to go in at a lower price point than what you've got with Wegovy at the moment? Thank you.
Callum Morris: Thanks. Callum Morris from Berenberg. I just had a another question on pricing. Obviously, in the cash channel, we've seen a lower penetration for Wegovy than anticipated. Obviously, we've talked about lots of factors for that. How much do you think that is also to do with price competition with Lilly? Ozempic coming through into that channel in H2 this year, do you expect to go in at a lower price point than what you've got with Wegovy at the moment? Thank you.
Another question on pricing, obviously in the channel we've seen a lower penetration, but we'll go with unanticipated.
And obviously, we've talked about the factors for that but how much do you think that is all CTG with price competition with Lilly and.
And his impact coming through into that channel and H. Two this year do you expect to go into a lower price point than what you've got with the JV at the moment.
Thank you.
In terms of the dynamics of the our cash channel right.
David Moore: In terms of the dynamics of our cash channel, right? I mean, Lilly started about a year before we did in terms of having LillyDirect and then the Zepbound vials. We have an interest to continue to expand that, and we will. You'll see more efforts and initiatives in order for us to expand that cash channel with partners, with NovoCare Pharmacy, right, and other intermediaries, because we think that market is opening up, right? The sort of consumerism of obesity, it's clear and it's apparent, and we intend to participate in that. We'll have a portfolio of offerings, right, in that cash channel. I think we compete well on price right now with Lilly. I don't think there's a meaningful difference that I can glean from the research.
David Moore: In terms of the dynamics of our cash channel, right? I mean, Lilly started about a year before we did in terms of having LillyDirect and then the Zepbound vials. We have an interest to continue to expand that, and we will. You'll see more efforts and initiatives in order for us to expand that cash channel with partners, with NovoCare Pharmacy, right, and other intermediaries, because we think that market is opening up, right? The sort of consumerism of obesity, it's clear and it's apparent, and we intend to participate in that. We'll have a portfolio of offerings, right, in that cash channel. I think we compete well on price right now with Lilly. I don't think there's a meaningful difference that I can glean from the research.
Literally started about a year before we did in terms of having really direct and was up and while we have an interest to continue to expand that and we will and youll see more efforts and initiatives in order for us to expand that cat channel with partners with Novo care pharmacy right and.
And other intermediaries, because we think that market is opening up right in the sort of consumerism of obesity, it's clear and it's apparent and we intend to participate in that and we will have a portfolio of offerings and that cash channel.
I think we compete well on price.
Right now.
I don't think Theres, a meaningful difference that I can I can glean from the research is a different story right and compounding and what dynamic exists there and why all of our efforts are on the table as Carter mentioned.
David Moore: It's a different story, right, in compounding and what dynamic exists there. It's why all of our efforts are on the table, as Carsten mentioned, to curtail that. With respect to Ozempic coming into the cash channel, you know, no specific comments that we would make. You could probably understand why we would not want those prices to be meaningfully different, as Ozempic, you know, does participate in the obesity market, even if not by design.
David Moore: It's a different story, right, in compounding and what dynamic exists there. It's why all of our efforts are on the table, as Carsten mentioned, to curtail that. With respect to Ozempic coming into the cash channel, you know, no specific comments that we would make. You could probably understand why we would not want those prices to be meaningfully different, as Ozempic, you know, does participate in the obesity market, even if not by design.
To curtail that.
With respect to Olympic coming into the cash channel.
No specific comment that we would make.
But you can you can probably understand why we want would not want those prices to be meaningfully different.
As the Olympic.
Does participate in the obesity market, even if not by design.
Good let's move over to Jan.
Operator: Good. Let's move over here to Yihan.
Jacob Rode: Good. Let's move over here to Yihan.
Hi, Honey from Buckhead. Thank you for taking our question. So I think we have one.
Yihan Li: Hi. Yihan Li from Barclays. Thank you for taking our question. I think we have one compounding market size because you mentioned currently you still have 1 million people on the compounding. We are just wondering how confident you are in terms of the projecting of the size of the compounding market, on how bigger or smaller it could be, because we previously heard from Hims that they were saying there are around 1.5 million people on personalized therapy and continues to grow every day. Of course, we know it's not all on GLP-1s, but yeah, just curious, is it possible the marketing market could be bigger? Also, just wondering in terms of your revised guidance, anything you could share that is attributable to this persistence of the compounding market? Thank you.
Yihan Li: Hi. Yihan Li from Barclays. Thank you for taking our question. I think we have one compounding market size because you mentioned currently you still have 1 million people on the compounding. We are just wondering how confident you are in terms of the projecting of the size of the compounding market, on how bigger or smaller it could be, because we previously heard from Hims that they were saying there are around 1.5 million people on personalized therapy and continues to grow every day. Of course, we know it's not all on GLP-1s, but yeah, just curious, is it possible the marketing market could be bigger? Also, just wondering in terms of your revised guidance, anything you could share that is attributable to this persistence of the compounding market? Thank you.
Compounding marquee size because you mentioned currently Youll still have like 1 million people on the compounding.
Just wondering how confident you are in terms of the project King of the size of the company Mark at all like how bigger or smaller it could be because we previously heard from <unk> that we're seeing there.
One 5 million people on personal lines of therapy and continues to grow every day.
And of course, we know it's not all on.
Ones, but just curious.
Curious is it possible like the marketing market could be bigger and also like just wondering in terms of your revised guidance.
Anything you could share like that is attributable to this participants of the company market. Thank you.
Michael first David and because your guidance assumptions.
Operator: You wanna go first, Dave, and then go to you, Carsten, on guidance assumptions?
Jacob Rode: You wanna go first, Dave, and then go to you, Carsten, on guidance assumptions?
I'm happy to start I think the level of precision right that we can get in terms of this fake market, which runs through medical spas aesthetic clinics places like <unk> that are public companies.
David Moore: Yeah. I'm happy to start. I think the level of precision, right, that we can get in terms of this fake market, which runs through medical spas, aesthetic clinics, places like Hims & Hers that are public companies, is certainly not as accurate as we can with our own longitudinal data in IQVIA, right? Even though I think IQVIA was broke this week with NBRx. It's just not as precise. We do it through market research. We do qualitative, we do quantitative, larger studies, and it gives us a good feel in terms of the amount of prescribing that's happening, the number of patients that are on. Our triangulation of that, you know, currently is we still believe it's 30% of the market around 1 million patients.
David Moore: Yeah. I'm happy to start. I think the level of precision, right, that we can get in terms of this fake market, which runs through medical spas, aesthetic clinics, places like Hims & Hers that are public companies, is certainly not as accurate as we can with our own longitudinal data in IQVIA, right? Even though I think IQVIA was broke this week with NBRx. It's just not as precise. We do it through market research. We do qualitative, we do quantitative, larger studies, and it gives us a good feel in terms of the amount of prescribing that's happening, the number of patients that are on. Our triangulation of that, you know, currently is we still believe it's 30% of the market around 1 million patients.
Certainly not as accurate as we can with our own longitudinal data in <unk>, even though I think accumulate was broke this week with <unk>.
It's just not as precise we do it through market research with your qualitative we do quantitative larger studies and it gives us a good feel in terms of the amount of prescribing that's happening the number of patients that are on and our triangulation of that curve.
Currently as we still believe it's 30% of the market around 1 million patients of course, there's different stay time people coming on and off in switching but thats.
David Moore: Of course, there's different stay times, people coming on and off and switching, you know, but that's the, you know, as precise as we're able to get at this point.
David Moore: Of course, there's different stay times, people coming on and off and switching, you know, but that's the, you know, as precise as we're able to get at this point.
As precise as we are able to get at this point.
Yeah and on our outlook for the year, we have not included any upside from from compounding in our guidance for the year. So even if there were some positive signals say from regulators.
Ludovic Helfgott: Yeah. On our outlook for the year, we have not included any upside from compounding in our guidance for the year.
Karsten Munk Knudsen: Yeah. On our outlook for the year, we have not included any upside from compounding in our guidance for the year.
Karsten Munk Knudsen: Even if there were some positive signals, say from regulators, in the coming weeks or months, it's not baked in. One of the reasons or the key reasons really, that there will be a lag effect before inventories are wound down and everything is stopping. This would more be a benefit into 2026 and 2027.
Karsten Munk Knudsen: Even if there were some positive signals, say from regulators, in the coming weeks or months, it's not baked in. One of the reasons or the key reasons really, that there will be a lag effect before inventories are wound down and everything is stopping. This would more be a benefit into 2026 and 2027.
In the coming weeks or months, it's not baked in and one of the reasons are the key reason is really that there will be a lag effect before our inventories are wound down and.
Everything is stopping so this would be a benefit into into 2006 and 2027.
Okay. Thank you, let's move to Michael for next one.
Operator: Very clear. Thank you. Let's move to Michael for the next one.
Jacob Rode: Very clear. Thank you. Let's move to Michael for the next one.
Thank you Michael Jefferies cost question for you.
Michael Leuchten: Thank you. Michael at Jefferies. Carsten, question for you. Novo used to guide for the next year with Q3 a long time ago, there's quite a few balls in the air for 2026, whether this is Ozempic trajectory or a launch cost base. Do you think you'd be in a position to offer a view on 2026, or would you want to with the Q3 results?
Michael Leuchten: Thank you. Michael at Jefferies. Carsten, question for you. Novo used to guide for the next year with Q3 a long time ago, there's quite a few balls in the air for 2026, whether this is Ozempic trajectory or a launch cost base. Do you think you'd be in a position to offer a view on 2026, or would you want to with the Q3 results?
Nobody used to guide for the next year with Q3, a long time ago, and there's quite a few balls in the air for 2026, whether this is assembly trajectory or a launch cost base do you think you'd be in a position to offer a view on 2026, what do you want to with the Q3 results.
Sure.
Well.
So I can only talk generally about 226, because as you know we're only guiding come come our full year results.
Karsten Munk Knudsen: Well, I can only talk generally about 2026 because as you know, we're only guiding, come our full year results. I believe in the market space we're in now, that's the appropriate point in time to be guiding for 2026. The starting point is really the notion of unmet need and the ramp of patients, as I spoke to before, with more than 3 million patients year on year. That's of course our key focus to continue to drive that. We're focused on launching also obesity in the US. Of course that's a key priority. Mim8 is also getting closer.
Karsten Munk Knudsen: Well, I can only talk generally about 2026 because as you know, we're only guiding, come our full year results. I believe in the market space we're in now, that's the appropriate point in time to be guiding for 2026. The starting point is really the notion of unmet need and the ramp of patients, as I spoke to before, with more than 3 million patients year on year. That's of course our key focus to continue to drive that. We're focused on launching also obesity in the US. Of course that's a key priority. Mim8 is also getting closer.
I believe in the mortgage space, we know that's the appropriate point in time to be guiding for for 2006 <unk>.
Dialing point Israeli.
The notion of unmet need and the ramp of patients as I spoke to before with more than 3 million patients year over year. So that's of course, our key focus to.
Continue to drive that then we're focused on launching <unk> in the U S. So of course, that's a key for Archie. My made is also getting closer may not be a big positive.
Karsten Munk Knudsen: g positive in 2026, but it's still getting closer. Then you say in terms of LOE, there's been some discussions. At the call, I was saying what we're looking into when we take everything we know today in terms of timelines and price points, et cetera, and LOE, then it's a low single digit impact to top line growth next year. These are some of the key building blocks that we're looking into, but very focused on driving growth.
Karsten Munk Knudsen: g positive in 2026, but it's still getting closer. Then you say in terms of LOE, there's been some discussions. At the call, I was saying what we're looking into when we take everything we know today in terms of timelines and price points, et cetera, and LOE, then it's a low single digit impact to top line growth next year. These are some of the key building blocks that we're looking into, but very focused on driving growth.
In 2006, but but but it's still getting closer and.
And then you have to say in terms of <unk>, there's been some discussion so at the call as I was saying what we're looking into when we take everything we know today in terms of timelines and price points et cetera.
Then it's a low single digit impact to top line growth next year. So these are some of the key building blocks that were looking into it but very focused on driving growth.
Thank you Carsten. Thank you Michael let's move back to James <unk>. Thank.
Operator: Thank you, Karsten. Thank you, Michael. Let's move back to to James for round two.
Jacob Rode: Thank you, Karsten. Thank you, Michael. Let's move back to to James for round two.
Thank you very much.
Question is on health care tourism.
James Quigley: Thank you very much. My question's on healthcare tourism. Next year, Canada will have generics. There's gonna be generics flooding into the market, and Sanofi were in the FT yesterday or the day before talking about 60% to 70% discounts to list price. How do you assess the risk of either generic semaglutide, generic Ozempic coming down from Canada through into the US? More so if there is branded Ozempic, branded Wegovy in the US that could also potentially where patients go over and get prescriptions and then come back and potentially create a market that way. What are the defenses that Novo has to guard against that?
James Quigley: Thank you very much. My question's on healthcare tourism. Next year, Canada will have generics. There's gonna be generics flooding into the market, and Sanofi were in the FT yesterday or the day before talking about 60% to 70% discounts to list price. How do you assess the risk of either generic semaglutide, generic Ozempic coming down from Canada through into the US? More so if there is branded Ozempic, branded Wegovy in the US that could also potentially where patients go over and get prescriptions and then come back and potentially create a market that way. What are the defenses that Novo has to guard against that?
Canada.
Generics.
There's going to be generic studying and sandoz.
Yesterday or the day before talking about 60.
60% to 70% discounts to.
This price so how do you assess the risk of either generic.
Generic coming.
Coming down from Canada into the U S.
Or more so if there is branded as <unk>.
In the U S that could also potentially but patients can we bring up prescriptions and then come back and potentially.
So what are the defense as it never has to guard against that.
Cross border <unk>.
Oh, Yes, I think we can do and also head of course, probably build on it.
Operator: Cross-border trades for you, Dave?
Jacob Rode: Cross-border trades for you, Dave?
David Moore: Yeah, I mean, I think we...
David Moore: Yeah, I mean, I think we...
Operator: You can also add, of course.
Jacob Rode: You can also add, of course.
There is not a legal mechanism for generic product to enter into the United States. So it's not approved right and then you could say well that's what we said about compounding but.
David Moore: ... probably build on it. You know, there's, there is not a legal mechanism for generic product to enter into the United States that's not approved, right? Then you could say, well, that's what we said about compounding. You know, there's not an incentive for Canada or companies operating in Canada to allow that to happen. If you're talking about border states and, you know, crossing the line with your car, I mean, that happens today, right? I think what we have to be really clear about is, you know, the legal activities that we can take and we can enforce and be prepared for. You know, when there is generics that are approved around the world and make it clear really what our response is here in the US to stop it.
David Moore: ... probably build on it. You know, there's, there is not a legal mechanism for generic product to enter into the United States that's not approved, right? Then you could say, well, that's what we said about compounding. You know, there's not an incentive for Canada or companies operating in Canada to allow that to happen. If you're talking about border states and, you know, crossing the line with your car, I mean, that happens today, right? I think what we have to be really clear about is, you know, the legal activities that we can take and we can enforce and be prepared for. You know, when there is generics that are approved around the world and make it clear really what our response is here in the US to stop it.
There's not an incentive.
For Canada or companies operating in Canada to allow that to happen. If you are talking about border states.
Crossing the line with your car and when that happens today right.
I think what we have to be really clear about is.
The legal activities that we can take and we can enforce and be prepared for when there is generics that are approved around the world and make it clear really.
Our responses here in the U S to stop it.
Yes.
Not a lot more to add so so it's part of the building block I gave for outlook that is erosion in Canada. So so it is going to happen in Canada, and then of course our.
Karsten Munk Knudsen: Yeah. Not a lot more to add. It's part of, you know, the building block I gave for outlook there, that is erosion in Canada. Of course our legal and regulatory teams, they're looking at defending our US business in this context from inappropriate parallels rate.
Karsten Munk Knudsen: Yeah. Not a lot more to add. It's part of, you know, the building block I gave for outlook there, that is erosion in Canada. Of course our legal and regulatory teams, they're looking at defending our US business in this context from inappropriate parallels rate.
Legal and regulatory team said Theyre looking at defending our U S business in this context from inappropriate.
Apparel that's right.
Indeed, thanks, a lot, let's move back to peak before coming to the mid <unk> afterwards.
Operator: Indeed. Thanks a lot. Let's move back to Pete before coming to the mid-table afterwards.
Jacob Rode: Indeed. Thanks a lot. Let's move back to Pete before coming to the mid-table afterwards.
<unk> from BNP Karsten, just a follow up from yesterday's question on Capex I know you'd be very clear low double digit, but you are spending an inordinate amount this year at $10 billion and let's be fair. If you asked around the maybe revenue is going to be in three or four years it could be a wide range of.
Peter Verdult: Yeah. Peter Verdult again from BNP. Karsten, just to follow on from yesterday's question on CapEx, I know you've been very clear, low double digit, but you are spending an inordinate amount this year at DKK 10 billion. Let's be fair, if you ask everyone around the room what Novo revenue is going to be in 3 or 4 years, there's going to be a wide range of expectations. Can I just ask the question differently? When will the bulk, you know, when can you start to get more towards normalized CapEx in terms of, you know, not having to spend DKK 10 billion a year? Can I just push you a little bit more on that?
Peter Verdult: Yeah. Peter Verdult again from BNP. Karsten, just to follow on from yesterday's question on CapEx, I know you've been very clear, low double digit, but you are spending an inordinate amount this year at DKK 10 billion. Let's be fair, if you ask everyone around the room what Novo revenue is going to be in 3 or 4 years, there's going to be a wide range of expectations. Can I just ask the question differently? When will the bulk, you know, when can you start to get more towards normalized CapEx in terms of, you know, not having to spend DKK 10 billion a year? Can I just push you a little bit more on that?
The expectation so.
Just don't ask the question differently.
When will the boat when could you start to get more towards numerous capex in terms of not having to spend timber in those years. So can I.
Push you a little bit more on that.
Yes.
Welcome to push on your questions. Please.
Karsten Munk Knudsen: Yeah. You are always welcome to push on your questions, Pete. The short version is we're very close to the peak. Whether it's, you know, this year, next year, but we're very close to the peak, and then you should see our absolute CapEx level levels to be coming down from there.
Karsten Munk Knudsen: Yeah. You are always welcome to push on your questions, Pete. The short version is we're very close to the peak. Whether it's, you know, this year, next year, but we're very close to the peak, and then you should see our absolute CapEx level levels to be coming down from there.
Sure.
The short version is we are very close to the peak.
Whether it's.
This year next year, but but but.
We're very close to the peak and then you should see our absolute capex level levels to be coming down from there.
Then we move to Simon.
Operator: Good. We move to Simon and, yeah, start with Simon.
Jacob Rode: Good. We move to Simon and, yeah, start with Simon.
Yes that was all of them.
Okay.
Thank you for taking the second one.
I just want to get back to a comment you made yesterday about what else is you said you.
Simon Baker: Thank you, taking the second one. Just wanna go back to a comment you made yesterday about Rybelsus. You said you're adjusting, de-emphasizing the commercial focus on Rybelsus. That prompted a client to ask, well, we have an all version of an injectable drug and they're de-emphasizing commercialization efforts on it because it's not performing particularly well. Why would obesity be any different? I'm sure there are lots of good reasons why, but can you just say why we should not extrapolate from the Ozempic Rybelsus experience towards the obesity setting?
Simon Baker: Thank you, taking the second one. Just wanna go back to a comment you made yesterday about Rybelsus. You said you're adjusting, de-emphasizing the commercial focus on Rybelsus. That prompted a client to ask, well, we have an all version of an injectable drug and they're de-emphasizing commercialization efforts on it because it's not performing particularly well. Why would obesity be any different? I'm sure there are lots of good reasons why, but can you just say why we should not extrapolate from the Ozempic Rybelsus experience towards the obesity setting?
Adjusting deemphasizing the commercial focus on on what doses.
That pumped you declined to two hours.
We have the <unk>.
<unk> version of an injectable drug.
Deemphasizing commercialization efforts on it because it's not performing particularly well why would it be used to be any different now I'm sure lots of good reasons, why but can you just say why we should not extrapolate from the Zen.
<unk> experience towards the obesity.
I'm happy to from a from a commercial perspective, Martin and Lou May have some too.
David Moore: Yeah. I'm happy to. From a commercial perspective, Martin and Ludo may have some too. They're very different. In terms of what we've seen, what we've learned about Rybelsus in the diabetes market and the place that it takes up in terms of a place in therapy is wildly different than obesity. In diabetes, all of the medicines that a patient was on as they sequenced through and their disease progressed were orals. They were all oral medicines, right? Right up through SGLT2s. The meaningful difference in clinicians was, you know, changing that to the injectable, right? Which came in the form of Trulicity, Ozempic, Mounjaro. It didn't have that same sort of level of, you know, an upgrade, if you will, in the way it was viewed in Type 2 diabetes.
David Moore: Yeah. I'm happy to. From a commercial perspective, Martin and Ludo may have some too. They're very different. In terms of what we've seen, what we've learned about Rybelsus in the diabetes market and the place that it takes up in terms of a place in therapy is wildly different than obesity. In diabetes, all of the medicines that a patient was on as they sequenced through and their disease progressed were orals. They were all oral medicines, right? Right up through SGLT2s. The meaningful difference in clinicians was, you know, changing that to the injectable, right? Which came in the form of Trulicity, Ozempic, Mounjaro. It didn't have that same sort of level of, you know, an upgrade, if you will, in the way it was viewed in Type 2 diabetes.
They're very different in terms of what we've seen what we've learned about rebel Sis in the diabetes market and the place that it.
It takes up in terms of replacement therapy.
Is wildly different than obesity and diabetes all of the medicines at a patient was on as they sequence through in their disease progressed, where oral <unk>.
All of our medicines right.
Right up through <unk> and the meaningful difference in clinicians was changing that to the injectable right, which came in the form of <unk>.
And it didn't have that same sort of level of.
An upgrade if you will and the way it was viewed in type two diabetes.
Conversely, when we think about oral we do research and have conversations with oral <unk> is just the opposite Theres only injectables right and now there's the promise and the openness of <unk>.
David Moore: Conversely, when we think about oral, we do research and have conversations with oral, it's just the opposite. There's only injectables, right? Now there's the promise and the openness of, I could have a GLP-1 in a pill. You know, I could have Wegovy in a pill. It's viewed very differently in terms of what that unlocks and what the potential is. I think, you know, on the company side, it's more. We see more opportunity, more growth, more potential, right, in Ozempic and Wegovy and then oral Wegovy, you know, than we have seen with Rybelsus and make those choices.
David Moore: Conversely, when we think about oral, we do research and have conversations with oral, it's just the opposite. There's only injectables, right? Now there's the promise and the openness of, I could have a GLP-1 in a pill. You know, I could have Wegovy in a pill. It's viewed very differently in terms of what that unlocks and what the potential is. I think, you know, on the company side, it's more. We see more opportunity, more growth, more potential, right, in Ozempic and Wegovy and then oral Wegovy, you know, than we have seen with Rybelsus and make those choices.
I could have a <unk> in a pill could have will go in a pill and his view.
Very differently in terms of what that unlocks and what the potential is and I think.
On the company side.
Moreover, we are seeing more opportunity more growth more potential right in Olympic and would go away and then.
<unk>, then we have seen with rebel CIS and make those choices.
Can you imagine.
Yes.
Operator: Anything to add from you, Martin?
Jacob Rode: Anything to add from you, Martin?
Fully agree on sort of the preference dynamics, but there is also the fact that with the doses that we have for both of us.
Martin Holst Lange: I think fully agree on sort of the preference dynamics, but there is also the fact that with the doses that we have for Rybelsus, the efficacy is not comparable to that of the subcutaneous in the diabetes space. In the obesity space, we've exactly designed 25 milligram of oral semaglutide to match what we can do with the subcutaneous. I think from the clinical perspective, that just gives freedom for the patients to choose.
Martin Lange: I think fully agree on sort of the preference dynamics, but there is also the fact that with the doses that we have for Rybelsus, the efficacy is not comparable to that of the subcutaneous in the diabetes space. In the obesity space, we've exactly designed 25 milligram of oral semaglutide to match what we can do with the subcutaneous. I think from the clinical perspective, that just gives freedom for the patients to choose.
You can see is not comparable to that of the subcutaneous in the diabetes space, but in the new business space. We are excited to design.
Milligram also metro side to match, what we can do with the subcutaneous.
So I think from there from the clinical perspective.
That just gives freedom for the patients to choose.
To summarize you also have a brand named difference. That's one you have the efficacy versus the injectable again the oral we go V and these actually both are broadly in line with the efficacy and Tolerability and then you have the fact that we also need to remember that we built this was launched at the moment, where we started to have to make some tough decisions between injectables and <unk>, which means that in many places.
Ludovic Helfgott: If you summarize, you also have a brand name difference. That's one. You have the efficacy versus the injectable. Again, the oral Wegovy and the injectable are broadly in line in efficacy and enterability. You have the fact that we also need to remember that Rybelsus was launched at the moment where we started to have to make some tough decisions between injectables and orals, which mean that in many places where Rybelsus could actually have been a successful even in diabetes options, we had to pull back because we had to dedicate some API to the injectable form, which means that the launch of Rybelsus per se is by and for me, not a good predictor of what an oral. Irrespective of everything you said, what an oral could be. It's been stop and go.
Ludovic Helfgott: If you summarize, you also have a brand name difference. That's one. You have the efficacy versus the injectable. Again, the oral Wegovy and the injectable are broadly in line in efficacy and enterability. You have the fact that we also need to remember that Rybelsus was launched at the moment where we started to have to make some tough decisions between injectables and orals, which mean that in many places where Rybelsus could actually have been a successful even in diabetes options, we had to pull back because we had to dedicate some API to the injectable form, which means that the launch of Rybelsus per se is by and for me, not a good predictor of what an oral. Irrespective of everything you said, what an oral could be. It's been stop and go.
This could actually have been successful even in diabetes options, we've got to pull back because we got to daily to dedicate some API to the injectable form which means that the launch of rebel per se is buying for me not a good predictor of what an overall.
Think about everything you said, what <unk> could be it's been stop and go in in the markets, where actually we could launch Spain as an example.
Ludovic Helfgott: In the markets where actually we could launch, and that's Spain as an example, we actually did pretty well. I wouldn't use Rybelsus as the proxy for the normal behavior in the oral market for the reasons that I just mentioned.
Ludovic Helfgott: In the markets where actually we could launch, and that's Spain as an example, we actually did pretty well. I wouldn't use Rybelsus as the proxy for the normal behavior in the oral market for the reasons that I just mentioned.
We actually did pretty well.
So I wouldn't use the rebuilt this as the proxy for the.
The normal behavior.
Behavior in the oil market for the reasons just mentioned.
Great. Thanks, let's move to Harry and then we'll go to Tivo afterwards.
Operator: That's great. Thanks. Let's move to Harry. Then we'll go to Thibault afterwards.
Jacob Rode: That's great. Thanks. Let's move to Harry. Then we'll go to Thibault afterwards.
Brendan Thank you Henri <unk> from UBS again.
Harry Sephton: Brilliant. Thank you. Harry Sephton from UBS again. If I could go back to compounding, you talked about working with the FDA to try and limit some of the API coming into the US. Obviously, since the new administration's come into power, we've seen some flux at the FDA. Would you say that given your conversations with the FDA, that they are acting at the speed that you'd want them to? Would you say that disruption is also adding to the delay in getting this compounding situation sorted?
Harry Sephton: Brilliant. Thank you. Harry Sephton from UBS again. If I could go back to compounding, you talked about working with the FDA to try and limit some of the API coming into the US. Obviously, since the new administration's come into power, we've seen some flux at the FDA. Would you say that given your conversations with the FDA, that they are acting at the speed that you'd want them to? Would you say that disruption is also adding to the delay in getting this compounding situation sorted?
I could go back to compounding.
And you talked about working with the FDA to try and limit some of the API coming to the U S. Obviously since the new administration has come into into power.
<unk> seen some flux the FDA would you say that given your conversations with the FDA that they are acting at the speed that you would want them to what would you say that disruption is we'll say.
Turning to the delay in getting this compounding situation sorted.
Yes, thank you for that Harry.
The answer is I would like it to be faster, but that is that is true regardless, how fast they move given what we're experiencing right now right. We haven't we haven't seen.
David Moore: Yeah. Thank you for that, Harry. My answer is I would like it to be faster, but that is, that is true regardless how fast they move, given what we're experiencing right now, right? We haven't seen, you know, There's been a noticeable, you know, disruption in the conversations or the speed because of that. Not by any means. The support that we're getting around Congress is also moving with speed. I mean, just last week, we had 80 congressional leaders send a letter to FDA saying this has to stop. We know that there have been live conversations with some of those leaders with the leadership as well as legal leadership at FDA, and they've assured us that this is a top priority.
David Moore: Yeah. Thank you for that, Harry. My answer is I would like it to be faster, but that is, that is true regardless how fast they move, given what we're experiencing right now, right? We haven't seen, you know, There's been a noticeable, you know, disruption in the conversations or the speed because of that. Not by any means. The support that we're getting around Congress is also moving with speed. I mean, just last week, we had 80 congressional leaders send a letter to FDA saying this has to stop. We know that there have been live conversations with some of those leaders with the leadership as well as legal leadership at FDA, and they've assured us that this is a top priority.
There's been a.
A noticeable disruption in the conversations or the speed because of that.
Not by any means.
And the support that we're getting around Congress is also moving with speed I mean, just last week. We had 80 congressional leaders send a letter to FDA, saying this has to stop and we know that there have been live conversations with some of those leaders with the leadership as well as legal leadership at FDA and they've assured us that this.
As a top priority.
Good morning in the last 10 minutes.
Operator: Good. We're running in the last 10 minutes. Thibaut first.
Jacob Rode: Good. We're running in the last 10 minutes. Thibaut first.
Yes.
Thank you David if you could just.
[Analyst]: Thank you. Dave, if you could just touch on the slowdown of the GLP-1 market, diabetes market in the US. If you could sort of come back on the key reasons behind the general market slowdown for GLP-1 diabetes. Are you experiencing any sort of access or reimbursement frictions, as the category become more costly for payers? Or is it just that the penetration rates are peaking and the market gets a bit more saturated than before?
[Analyst]: Thank you. Dave, if you could just touch on the slowdown of the GLP-1 market, diabetes market in the US. If you could sort of come back on the key reasons behind the general market slowdown for GLP-1 diabetes. Are you experiencing any sort of access or reimbursement frictions, as the category become more costly for payers? Or is it just that the penetration rates are peaking and the market gets a bit more saturated than before?
Touched on the slowdown of the GDP, one market diabetes market in the U S.
If you could sort of come back on the key reasons behind the generic market Sudan Sajid if you in diabetes.
Expanding any sort of access and reimbursement restrictions.
As a category become more Christopher payoffs.
It's just that the penetration rates are peaking and the market gets a bit more saturated than before.
Thank you for that.
As we discussed last quarter, we are seeing a slowdown in terms of the growth for <unk> diabetes.
David Moore: Yeah. Thank you for that. As we discussed last quarter, right, we are seeing a slowdown in terms of the growth for GLP-1 diabetes. It's still growth, right? I think it's in the neighborhood of 15% first half of the year. I think there is still room for growth in the diabetes market. It's slower than what we've seen before, right? Yes, there's more patients that have been on a GLP-1. I think we're in the 30% range in the US, very different than the rest of the world, of those that have been on a GLP-1 for diabetes. You know, we're also seeing, you know, this changeover, if you will, from our supply situation where the GLP-1 diabetes market participated in the obesity market, not by plan, right?
David Moore: Yeah. Thank you for that. As we discussed last quarter, right, we are seeing a slowdown in terms of the growth for GLP-1 diabetes. It's still growth, right? I think it's in the neighborhood of 15% first half of the year. I think there is still room for growth in the diabetes market. It's slower than what we've seen before, right? Yes, there's more patients that have been on a GLP-1. I think we're in the 30% range in the US, very different than the rest of the world, of those that have been on a GLP-1 for diabetes. You know, we're also seeing, you know, this changeover, if you will, from our supply situation where the GLP-1 diabetes market participated in the obesity market, not by plan, right?
It's still growth right I think it's in the neighborhood of 15% first half of the year.
I think there is still room for growth in the diabetes market.
It's slower than what we've seen before right. So yes, there's more patients that have been on the <unk>. One I think we are in the 30% range in the U S very different on the rest of the world.
Those that have been on <unk> for diabetes.
<unk>.
We're also seeing.
This change.
Over if you will from our supply situation, where the <unk> diabetes market participated in the obesity market not by plan right, but we saw those fluctuations right that now we have that sort of smoothing in terms of what the real sort of growth potential looks like as demand has subsided.
David Moore: We saw those fluctuations, right? That now we have that sort of smoothing in terms of what the real sort of growth potential looks like as demand, you know, has subsided and Or sorry, supply issues have subsided. You know, and we are seeing, you know, in that range. There is still room for growth. I think if we compare that, you know, that is the area where we see, you know, a lot more potential for growth in the future for GLP-1.
David Moore: We saw those fluctuations, right? That now we have that sort of smoothing in terms of what the real sort of growth potential looks like as demand, you know, has subsided and Or sorry, supply issues have subsided. You know, and we are seeing, you know, in that range. There is still room for growth. I think if we compare that, you know, that is the area where we see, you know, a lot more potential for growth in the future for GLP-1.
Sorry supply issues have subsided.
We are seeing in that range, there's still room for growth.
If we compare that.
That is the area, where we see a lot more potential for growth in the future for <unk>.
Absolutely, let's move back to Richard Rosa.
Operator: Absolutely. Let's move back to Richard Vosser.
Jacob Rode: Absolutely. Let's move back to Richard Vosser.
Hi, Thanks, Richard versus with J P. Morgan.
I am accretion in the phase two <unk> data that youre going to get in the second half or fourth quarter.
Richard Vosser: Hi. Thanks. Richard Vosser from JPMorgan. Just on amycretin and the phase 2 diabetes data that you're going to get in the second half or Q4, what do you hope to learn from that trial in terms of the doses, dosing, you know, and, you know, the?
Richard Vosser: Hi. Thanks. Richard Vosser from JPMorgan. Just on amycretin and the phase 2 diabetes data that you're going to get in the second half or Q4, what do you hope to learn from that trial in terms of the doses, dosing, you know, and, you know, the?
What do you hope to learn from that trial in terms of the doses.
Dosing.
And.
The titration.
Titration.
Did inform on the phase III.
[Analyst]: Titration, to inform on the phase 3.
Richard Vosser: Titration, to inform on the phase 3.
It's a really good question as you know we've always.
Martin Holst Lange: It's a really good question. As you know, we've always tried to acknowledge the fact that at least for the GLP-1 priority, the ED90 for good glycemic control versus weight loss is different. That has led to different actual doses between diabetes and obesity. We see others do it in a different way, which also makes it sometimes a little bit difficult to see the full dose response on the clinical doses. That being said, we need to understand fully what does amylin do to this dynamic? We need more data to fully understand that. Specifically on the titration obviously, based on everything that we know. Here we can also include REDEFINE 1 and 2.
Martin Lange: It's a really good question. As you know, we've always tried to acknowledge the fact that at least for the GLP-1 priority, the ED90 for good glycemic control versus weight loss is different. That has led to different actual doses between diabetes and obesity. We see others do it in a different way, which also makes it sometimes a little bit difficult to see the full dose response on the clinical doses. That being said, we need to understand fully what does amylin do to this dynamic? We need more data to fully understand that. Specifically on the titration obviously, based on everything that we know. Here we can also include REDEFINE 1 and 2.
Flat to acknowledge the fact that at least <unk> 94, good glycemic control versus weight loss is different.
And that has led to a different doses.
<unk> doses between diabetes and obesity, we see others do it in a different way, which also makes it sometimes a little bit difficult to see.
Full dose response.
On the clinical doses.
That being said, we need to understand fully.
What does emlen parity due to this dynamic.
We need more data to fully understand that.
And specifically on the titration obviously.
Based on everything that we know and here. We can also include redefine one and two.
Expect to learn about.
So much on titration, but the actual doses, we need to get right for diabetes versus repeat.
Martin Holst Lange: I don't expect to learn so much on titration, but the actual doses we need to get right for diabetes versus obesity, evaluating are we going for the same doses or are we going for a differentiated dose range.
Martin Lange: I don't expect to learn so much on titration, but the actual doses we need to get right for diabetes versus obesity, evaluating are we going for the same doses or are we going for a differentiated dose range.
Evaluating of going for the same doses or are we going for.
A differentiator.
At all three dose range.
Thank you Martin before asking constant to wrap up let's go for final question would you Michael Eisner.
[Analyst]: Thank you, Martin. Before asking Carsten to wrap up, let's go for a final question, with you, Michael Leuchten.
Jacob Rode: Thank you, Martin. Before asking Carsten to wrap up, let's go for a final question, with you, Michael Leuchten.
Thank you a follow up to that to that Martin on them accrete in dosing in two phase III I guess, one question coming out of the oil for data today is like how well Ken one actually model PK PD win win when compounds change in structure changes you've decided to move into phase III quite quickly within mccreedy. So confident.
Michael Leuchten: Thank you. Follow-up to that Martin, on amycretin dosing into phase 3. I guess one question coming out of the Orfo data today is like how well can one actually model PKPD when compounds change and structures change? You've decided to move into phase 3 quite quickly with amycretin. Are you still confident with the dose selection, and do you have flexibility to maybe change that if needed in phase 3?
Michael Leuchten: Thank you. Follow-up to that Martin, on amycretin dosing into phase 3. I guess one question coming out of the Orfo data today is like how well can one actually model PKPD when compounds change and structures change? You've decided to move into phase 3 quite quickly with amycretin. Are you still confident with the dose selection, and do you have flexibility to maybe change that if needed in phase 3?
Dose selection and do you have flexibility to maybe change that is needed in phase III.
So the actual doses.
Sure.
Martin Holst Lange: The actual doses, of course, we can change and the dose escalation ranges can also be changed. It's actually by design a little bit, hate to say it, the flexible approach. Some patients will benefit from titrating every four weeks between the individual dose steps. Some will actually be recommended if they lose weight very fast or if they experience gastrointestinal side effects to dose every eight weeks. What we have learned so far, again, combining everything that we know from amycretin, but also from REDEFINE 1 and 2, is giving us confidence that we picked the right doses. We are also confident on the dose titration and the steps that will require. Again, we can adapt.
Martin Lange: The actual doses, of course, we can change and the dose escalation ranges can also be changed. It's actually by design a little bit, hate to say it, the flexible approach. Some patients will benefit from titrating every four weeks between the individual dose steps. Some will actually be recommended if they lose weight very fast or if they experience gastrointestinal side effects to dose every eight weeks. What we have learned so far, again, combining everything that we know from amycretin, but also from REDEFINE 1 and 2, is giving us confidence that we picked the right doses. We are also confident on the dose titration and the steps that will require. Again, we can adapt.
Of course, we can change in the tone.
The dose escalation range. So this can also be changed it's actually by design a little bit.
I hate to say it.
The flexible approach some patients will benefit from titrated every four weeks.
Between the individual dose steps some will actually be recommended if they lose weight very fast or if they experience get additional side effects to dose a bit weak.
And what we've learned so far again, combining everything that we know from accretion, but also from redefined wanted too.
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Is is giving us confidence that we pick the right doses.
Also confident on or the dose titration and the steps that will require.
Again, we can at that I don't think thats going to be relevant.
Martin Holst Lange: I don't think that's gonna be relevant. Obviously as we've also talked, so we've had really good dialogues with regulators who also think about these dynamics. At the end of the day, we will have to wait and see. At this point in time, we are happy with the doses and the dose steps that we've chosen.
Martin Lange: I don't think that's gonna be relevant. Obviously as we've also talked, so we've had really good dialogues with regulators who also think about these dynamics. At the end of the day, we will have to wait and see. At this point in time, we are happy with the doses and the dose steps that we've chosen.
And obviously as.
As we've also talked to we've had really good dialogue with them.
Others, who also think about these dynamics so so.
At the end of the day, we will have to wait and see but at this point in time, we are happy with the doses and those steps that we've chosen.
Good still before giving you the cost of a final remarks distinguish everyone. Julien online is what is showing up in the room and reach out to Investor Relations in case of further follow ups. What would you guys think we are.
[Analyst]: Good. Before giving it to Carsten for final remarks, just thank you to everyone tuning in online as well as showing up in the room and reach out to investor relations in case of, follow-ups. Over to you, Carsten.
Jacob Rode: Good. Before giving it to Carsten for final remarks, just thank you to everyone tuning in online as well as showing up in the room and reach out to investor relations in case of, follow-ups. Over to you, Carsten.
And thank you to all for attending I think we're actually covered a lot of ground to air launch meeting I think it's clear that that we're driving growth for the long term and we spoke about our pipeline and <unk> also obesity competitive profiles. We spoke about all the measures we're taking in the U S to get them back to back strong.
Martin Holst Lange: Yeah. Thank you, Jacob, and thank you to all for attending. I think we actually covered a lot of ground at this launch meeting. I think it's clear that we're driving growth for the long term. We spoke about our pipeline, amycretin, CagriSema, also obesity, and competitive profiles. We spoke about all the measures we're taking in the US to get back to stronger growth. We have the portfolio, we have the leadership. Now it's really about executing on what we have. What we didn't talk a lot about was international operations, which in reality is 90% of the unmet need on a global scale.
Martin Lange: Yeah. Thank you, Jacob, and thank you to all for attending. I think we actually covered a lot of ground at this launch meeting. I think it's clear that we're driving growth for the long term. We spoke about our pipeline, amycretin, CagriSema, also obesity, and competitive profiles. We spoke about all the measures we're taking in the US to get back to stronger growth. We have the portfolio, we have the leadership. Now it's really about executing on what we have. What we didn't talk a lot about was international operations, which in reality is 90% of the unmet need on a global scale.
The growth we have the portfolio we have leadership. So so now it's really about executing on what we have what we didn't talk a lot about was the international operations.
Within raised its 90% of the unmet needs on a global scale. So so just to remind that 19% growth in the first half and a very consistent portfolio like approach in terms of driving growth in.
Martin Holst Lange: Just a reminder, 19% growth in the first half and a very consistent portfolio-like approach in terms of driving growth in a very big area with sizable unmet needs and a portfolio that's only started to really roll into those markets with low penetration rates, both in diabetes and Wegovy. This is really the name of the game, driving growth not only through the end of this year but also into the years to come.
Martin Lange: Just a reminder, 19% growth in the first half and a very consistent portfolio-like approach in terms of driving growth in a very big area with sizable unmet needs and a portfolio that's only started to really roll into those markets with low penetration rates, both in diabetes and Wegovy. This is really the name of the game, driving growth not only through the end of this year but also into the years to come.
Very big area with sizable unmet needs and in our portfolio with its own it only started to really roll into those market with low penetration rates both in diabetes and we go away. So this is really the name of the game driving growth not only through the end of this year, but also into the years to come so 71% mortgage.
What are your market share for Novo Nordisk in this exactly so so thank you for your comments. Thank you for dialing in and thank you for attending this lunch and thank you so James and Goldman for hosting hope to see you next quarter. Thank you.
Michael Leuchten: 71% market share, volume market share for Novo Nordisk in this.
Michael Leuchten: 71% market share, volume market share for Novo Nordisk in this.
Martin Holst Lange: Exactly. Thank you for-
Martin Lange: Exactly. Thank you for-
Michael Leuchten: Hi, coming speak.
Michael Leuchten: Hi, coming speak.
Martin Holst Lange: Thank you for dialing in, thank you for attending this launch. Thank you to James and Goldman for hosting. Hope to see you next quarter. Thank you.
Martin Lange: Thank you for dialing in, thank you for attending this launch. Thank you to James and Goldman for hosting. Hope to see you next quarter. Thank you.
Yes.
Michael Leuchten: Thank you.
Michael Leuchten: Thank you.
Martin Holst Lange: Thank you.
Martin Lange: Thank you.