Q2 2024 Novo Nordisk AS Earnings Call - London
Thank you. Bye-bye.
So good morning everybody, I'm James Quigley, European Farm Analyst here at Goldman Sachs and it's a pleasure to welcome you all here to the Novo second quarter management meeting.
Speaker Change: So today we're joined by Lars Jorgensen, CEO , Karsten Knudsen, CFO , Camilla Sylvest, Head of Commercial, and also Martin Lange, Head of Development.
Speaker Change: That will explain, I'll hand straight over to you guys to kick off.
Lars Jorgensen: Thank you James and thank you Goldman Sachs for hosting us today. We're excited to be here. You have probably seen some of our slides. We'll go through them quickly just to set the stage and then get to the Q&A. So the first slide is the forward-looking statements.
Lars Jorgensen: You know, we will be talking about the future, it could turn out to be different than what we preach here, so be aware of that and there are more notes in our website, etc.
Lars Jorgensen: So you know our strategic aspirations. We feel we're making good progress serving more patients. With that, I'll leave the work to Camilla for some comments on the commercial area. Thank you, Lars.
Lars Jorgensen: So, you know our strategic aspirations. We feel we're making good progress, serving more patients.
Lars Jorgensen: a strong commercial execution we're really glad about how we're strengthening our market position in diabetes how we're growing in obesity
Lars Jorgensen: We have a few challenges in rare diseases, but we are encouraged by future growth, not least because of the great data we have received on mimates over the past quarter, excited about that. And you can say all of the...
Lars Jorgensen: Financial Execution, commercial execution turns into that we have upgraded our outlook for the year so you should see that as a sign of confidence in the momentum we have in the business and also having a supply of products to fuel that continued growth
Lars Jorgensen: and
Lars Jorgensen: With that, I'll leave the work to Camilla for some comments on the commercial area. Thank you, Lars. And here you see our sales growth of 25%, how it's distributed on regions and therapy areas. 36% growth in North America, 11% growth in international operations, growth driven by all regions.
Camilla Sylvest: And here you see our sales growth of 25 percent, how it's distributed across regions and therapy areas. Thirty-six percent growth in North America, 11 percent growth in international operations, growth driven by all regions. And when it comes to therapy areas, really our key brands, Usenpig, Rebelsus, Vigovy, that are driving our growth. You see strong growth in GLP-1 diabetes, where we also continue to exceed our leadership in diabetes care, now with a market share in total diabetes above 34 percent.
Camilla: And when it comes to Therapeare, it's really our key brands, Usenpig, Rebelsus, Vigovy, that is driving our growth. You see a strong growth in GLP-1 diabetes, where we also continue to exceed our leadership in diabetes care, now with a market share in total diabetes above 34%.
Camilla Sylvest: And if we zoom in on obesity, we have, you know, 37 percent growth. If we take a look at the U.S. on the next slide, you can see that we are continuing to expand the number of starter doses into the market, and also on total scripts, we now have, since the beginning of the year, a doubling of total scripts. So we are progressing very nicely in terms of our ability to provide Vigovy to patients in the U.S., but also in the rest of the world, where we have launched it in 14 countries and are continuing to launch it in more and more countries as well.
Camilla: and if we zoom in on obesity we have you know 37% growth if we take a look at the US on the next slide you can see that we are continuing to expand the number of
James Quigley: So, good morning everybody, I'm James Quigley, European Foreign Minister here at Goldman Sachs, and it's a pleasure to welcome you over here to the Novoi Second Court, a major meeting.
James Quigley: So, today we join by Lars Jorgensen, C, Jörg Kusten, Nudsen, CFO, Camilla Sylvest, Harry Comercio, Anders, and Martin Lange, Head of Development.
Camilla: All of the data doses into the market and also on total scripts we now have since the beginning of the year, a doubling of the total scripts.
Camilla: So we are progressing very nicely in terms of our ability to provide the COVID to patients in the U.S., but also in the rest of the world, where we are now have launched in 14 countries and are continuing to launch in more and more countries as we speak.
Hans Schindler: So, we'd like to explain now, Hans Schindler, what do you guys think? Good thinking. Thank you James, and thank you Goldman Sachs for hosting us today. We're excited to be here. You have probably seen some of our slides. We'll go through them. We'll go through them quickly just to set the states and then get to the Q&A.
Hans Schindler: So, the first slide is the forward-looking statements. You know, we'll be talking about the future. It could turn out to be different than what we preach here. So, be aware of that and there are more notes in our website, etc. So, you know our strategic aspirations. We feel we're making good progress serving more patients, strong commercial execution. We really glad about how we're strengthening our market position in diabetes. How we're growing in obesity.
Camilla: And with that over to Dr. Lange to give us an update on R&D. Thank you very much, Camilla.
Dr. Lange: If I could have the next slide. As Lars already alluded to, we're very happy with the results that we saw from France here to our Pivotal trial. It was a complex trial, investigating the broad range of hemophilia A, with and without inhibitors,
Speaker Change: Across the spectrum of hemophilia in terms of severity, we had both males and females in the study, and we were investigating patients coming from either prophylaxis or on-demand treatment.
Hans Schindler: We have few challenges in rare diseases, but we are encouraged by future growth, not least because of the great data we have received on my mates or the past quarter. Excited about that. And you can say all of the financial execution turns into that we have upgraded our outlook for the year. So, you should see that a sign of confidence in the momentum we have in the business. And also having supply products to fuel that continued growth.
Unknown Executive: We're also investigating both once weekly and once monthly. So, quite a complex study with a lot of permutations when it comes to the primary.
Speaker Change: We're also investigating both once weekly and once monthly. So quite complex study with a lot of permutations when it comes to the primary endpoint.
Unknown Executive: At the end of the day, what you should take away is that for the primary endpoint, regardless of whether you look at once weekly or once monthly compared to prophylaxis treatment or previous on-demand treatment, we see a mean annual bleed rate reduction of somewhere between 60 and 90 plus percent, which is obviously exceedingly gratifying, even for patients coming from previous on-demand. So, very, very strong efficacy data. Similarly, we saw a strong safety profile with no thromboembolic events. And somewhere between five and 12, again, depending on the analysis, the percent of patients reporting injection site reaction. So, very attractive, if I could have the next slide.
Speaker Change: At the end of the day, what you should take away is for the primary endpoint, regardless of looking at once weekly or once monthly, comparing to prophylaxis treatment or previous on-demand treatment,
Speaker Change: We see the mean annual bleed rate reduction of somewhere between 60 and 90 plus percent, which is obviously exceedingly gratifying, even for patients coming from previous on-demand treatment.
Camilla Sylvest: With that, I'll leave the word to Camila for some comments on the commercial area. Thank you, last. And here you see our sales growth of 25 percent. How it's distributed on regions and terp areas, 36 percent growth in North America, 11 percent growth in international operations, growth driven by all regions. And when it comes to terp areas, really our key brands. We send pick rebalances, we go via that is driving our growth.
Speaker Change: Sorry, Prophylaxis Treatment.
Speaker Change: If we look at the median annual breech rate, it was zero across the board, indicating that regardless of which analysis we did,
Speaker Change: More than 50% of patients had had zero bleeds. And if we look at the actual numbers, again, it's between 60 plus and 90 plus percent of patients that have zero bleeds.
Camilla Sylvest: You see, you see a strong growth in GLP1 diabetes, where we also continue to exceed our leadership in diabetes care. Now with the market share total diabetes above 34 percent. And if we zoom in on obesity, we have, you know, 37 percent growth. If we take a look at the US on the next slide, you can see that we are continuing to expand the number of the data doses into the market.
Speaker Change: So very, very strong efficacy data. Similarly, we saw a strong safety profile with no thromboembolic events.
Speaker Change: And somewhere between 5 and 12, again, depending on the analysis, percent of patients reporting injection site reactions. So a very attractive number.
Camilla Sylvest: And also on total scripts, we now have since the beginning of the year, a doubling of the total scripts. So we are progressing very nicely in terms of our ability to provide, we go with two patients in the US, but also in the rest of the world where we are now, have launched in 14 countries and are continuing to launch in more and more countries as we speak.
Speaker Change: Novo, really, really happy with these data and obviously moving towards a submission during the first half of 2025.
Martin Lange: We see broad pipeline progress, of course, and we're really, really happy with the almost global access, sorry, approval for insulin iCodec. Focusing on manufacturing and also obviously type 1 diabetes, we expect to be able to resubmit the iCodec file in the U.S. during the course of the first half of 2025. Broadly speaking, we see a lot of progress in our pipeline. I want to call out, obviously, the data that we'll see from LunarBand in this half of the year, first on obesity and secondly on diabetic kidney disease, two phase two studies that we'll read out in Q3 and Q4, respectively. I am very much looking forward to seeing our first character semidata, the redefined one file that we'll read out in the second half.
Speaker Change: If I could have the next slide.
Speaker Change: We see broad pipeline progress. Of course, really, really happy with the almost global access, sorry, approval for Insulin iQTEC.
Martin Lange: And with that over to Dr. Lange to give us an update on R&D. Thank you very much, Camilla. If I could have the next slide. As I was already alluded to, we're very happy with the results that we saw from Friends here to our MIME Pivotal trial. It was a complex trial investigating the broad range of hemophiliae with them without inhibitors across the spectrum of hemophiliae in terms of severity. We had both males and females in the study and we were investigating patients coming from either prophylaxis or on-demand treatment.
Speaker Change: I have to mention a complete response letter in the U.S.
Speaker Change: Focusing on manufacturing and also obviously type 1 diabetes, we expect to be able to resubmit the iCodec file in the U.S. during the course of first half of 2025.
Speaker Change: Broadly speaking, we see a lot of progress in our pipeline. I want to call out, obviously, the data that we'll see from LunaBand.
Speaker Change: This half of the year, first on obesity and secondly on diabetic kidney disease, two phase two studies that we'll read out in Q3 and Q4 respectively. Looking very much forward to see our first character semidata, the redefined one trial that we'll read out in December of this year.
Martin Lange: We're also investigating both once weekly and once monthly. So quite complex study with a lot of permutations when it comes to the primary end point. At the end of the day, what you should take away is for the primary end point regardless of looking at once weekly or once monthly comparing to prophylaxis treatment or previous on-demand treatment. And we see the mean annual lead rate reduction of somewhere between 60 and 90 plus percent, which is obviously exceedingly gratifying even for patients coming from previous on-demand.
Speaker Change: I've already talked to MIMAPE, but maybe also mention that we have resubmitted Contizumab in the U.S. for both hemophilia with inhibitors, but also without inhibitors.
Speaker Change: And then finally, we've initiated the ARTEMIS study, which is a study in acute myocardial infarction with CILTiVIC.
Martin Lange: Treatment, sorry, Prophylaxis Treatment. If we look at the median annual breake rate, it was zero across the board, indicating that regardless of which, which analysis we did, more than 50% of patients had, had zero please. And if we look at the actual numbers, again, it's between 60 plus and 90 plus percent, percent of patients that have zero please. So very, very strong efficacy data, similarly, we saw a strong safety profile with no thrompolytic events.
Karsten: Thank you Martin. So when we look at the results in the first six months, then we delivered fantastic 25% sales growth. This is really industry leading sales growth and a continuation of the sales growth we saw in the first quarter.
Speaker Change: The 25% has a benefit from rebate adjustments related to the U.S. and also benefits from a reasonably easy comparator from last year linked to phasing of rebates last year.
Speaker Change: and I'll come back to why that's important. Our commercial investments are at a low level in that respect, 6%, adjust for something, legal provisions last year around 10%, so really indicating we have the commercial infrastructure in place.
Martin Lange: And somewhere between 5 and 12, again, depending on the analysis, percent of patients reporting injection slide reaction, so a very attractive number, really, really happy with these data and obviously moving towards a submission during the first half of 2025.
Speaker Change: Unless we talk about obesity, where we're really investing in obesity market development activities across the board.
Martin Lange: If I could have the next slide, we see broad pipeline progress, because really, really happy with the almost global access, sorry, approval for insulin eye cortex, I have to mention complete response letter in the US, focusing on manufacturing and also obviously type 1 diabetes, we expect to be able to resume the eye cortex. I'll in the US during the course of first half of 2025. Broad is speaking, we see a lot of progress in our pipeline.
Speaker Change: R&D really stepping up. 78% is overstating the true R&D step-up, P&L-wise.
Speaker Change: due to the fact that we had an impairment on osadurinone and also another acid in the second quarter. So adjusting for that, R&D is still stepping up more than 30%.
Speaker Change: which is linked to our intent to really build a competitive pipeline for the company's future growth for the coming decades.
Speaker Change: Net-Net yields an operating profit growth of 19% for the first 6 months, as I said we have impairment impacts in the quarter, so if you look at it from an EBITDA point of view then we have an EBITDA growth for the first 6 months of 32%.
Martin Lange: I want to call out, obviously, the data that we'll see from a lunar band in this half of the year, first on obesity, and certainly on diabetes, two phase two studies that will read out in Q3 and Q4 respectively, looking very much forward to see our first category, semi data, the redefine. One file that will read out in December of this year. I've already talked to my mate, but maybe also mentioning that we have resubmated consumer in the US for both Hemophilia with inhibitors, but also without inhibitors.
Unknown Executive: Next slide, please. Lars spoke to me about upgrading our full-year sales outlook, and that's why I said the first half is benefiting from growth-to-net adjustments and an easy comparator. On the contrary, the second half has a tough comparator because it is facing competition from last year. So the 25% implied in the second half of this year to get to the midpoint of our guidance range actually requires underlying growth closer to a 30% mark if you take the comparator into account.
Speaker Change: Next slide, please.
Speaker Change: So Lars spoke to that we're upgrading our full year sales outlook and that's why I said
Lars Jorgensen: First half is benefiting from growth-to-net adjustments and an easy comparator. On the contrary, the second half has a tough comparator because it was facing from last year.
Speaker Change: So the 25% implied in the second half of this year to get to a midpoint of our guidance range.
Martin Lange: And then finally, we've initiated the Artemis study, which is a study in acute myocardial infarction with Chilciviknet.
Speaker Change: Actually, it requires underlying growth closer to a 30% mark, if you take the comparator into account. So really talking to an acceleration of underlying growth in the second half, driven by a GLP-1 franchise, and of course enabled by scaling of supply chain.
Unknown Executive: So really talking to an acceleration of underlying growth in the second half driven by the GLP-1 franchise and, of course, enabled by the scaling of supply chains. On operating profit, it's important to note that since we issued guidance in Q1, we had the impairment of Osadurinon, which had a 6% negative impact. And then the sales upgrade we did this quarter had a 4% percentage point positive impact on our operating profit growth. So we really have a significant flow through, 2% up on sales growth, 4% on OP. So a really solid gearing in terms of financial performance. And then, of course, I was about to say that translates into a step up in our forecasted free cash flow for the year.
Karsten Knudsen: I think with that over to you, Karsten. Thank you Martin. So when we look at the results in the first six months, then we delivered fantastic 25 cents sales growth. This is really industry leading sales growth and a continuation of the sales growth way we saw in the first quarter.
Karsten Knudsen: So the 25% has a benefit from rebate adjustments related to the US and also benefits from a reasonably easy comparator from last year linked to facing a rebate last year. And I'll come back to why that's important. Our commercial investments are at the low level in that there are a respect 6% adjust for something legal provisions last year, around 10%. So really indicating we have the commercial infrastructure in place, perhaps with unless we talk about obesity, where we're really investing in obesity market development activities across the board.
Speaker Change: Operating Profit.
Speaker Change: It's important to note that since we issued guidance at Q1, we had the impairment of osoderminon which had a 6% negative impact and then the sales upgrade we do this quarter has a 4% percentage point positive impact on our operating profit growth, so we really have a significant flow-through
Speaker Change: 2% up on sales growth, 4% on OP. So a really solid gearing in terms of financial performance. And then, of course, I was about to say that translates in into a step up in our forecasted free cash flow for the year.
Speaker Change: That takes us back to you Lars. Yeah, so just in summary, we are executing well on...
Karsten Knudsen: R&D really stepping up 78% is overstating that the true R&D step up, piano wise, due to the fact that we had an impairment on also during on and also another asset in the second quarter. So adjusting for that R&D is still stepping up more than 30% which is linked to our intent to really build compared to pipeline for the company's future growth for the coming decades net net that that yields a operating profit growth of 90% for the first six months. As I said, we have impairment impacts in the quarter. So if you look at it from an EBDA point of view, then we have an EBDA growth for the first six months of 32%.
Lars Jorgensen: Progressing towards our strategic aspiration for 2025. We're very encouraged by the growth momentum we have.
Lars Jorgensen: We have scaled our supply chain to be able to continue that trajectory in the second half of the year, as Karsten just alluded to, and we have really exciting, say, pipeline readout also coming in the second half of the year.
Karsten: Strong start to the year and even more to come. With that, I think we should close on the slides and get to the Q&A, so please.
Speaker Change: Thank you very much.
Speaker Change: As per usual, please state your name and your institution, and we'll have one question per person, so we'll take multiple rounds.
Speaker Change: We have some mics going around and I think we'll start with James as per tradition, our host.
Karsten Knudsen: Hanson, Next slide please. So Lars spoke to that we are operating our full-year sales outlook and that's why I said first half is benefiting from growth to net adjustments and an easy competitor. On the contrary, the second half has a tough competitor because it was facing from last year. So the 25% implied in the second half of this year to get to a midpoint of our guidance range actually required. So the second half applies underlying growth closer to a 30% mark if you take the competitor into account.
James Quigley: Thank you. James Quigley from Goldman Sachs. Just starting on Wegovy net pricing. So again, I think there's a bit of confusion here on the development following the call. Perhaps on the comments on...
Speaker Change: Channel Mix, rebate adjustments, competition, etc. So could you take us through how you expect the Rogovia net prices to develop and what are the key impacts from the rebate adjustments that we saw in the quarter?
Unknown Attendee: Yes, so if I
Speaker Change: Yes, so if I start, so...
Speaker Change: We will not get into guiding specifically on net price development for individual products, but I will just say that we don't see any, say, change in the marketplace. What happened in the second quarter was that we had a one-time one-off true-up for rebates given last year.
Karsten Knudsen: So really talking to an acceleration of underlying growth in the second half driven by a tier 21 franchise and of course enabled by scaling up of supply chain operating profits. It's important to note that that since we issued guidance at Q1, we had the impairment of also during on which had a 6% negative impact. And then the sales upgrade. We do this quarter has a 4% percentage point positive impact on our operating profit growth.
Speaker Change: and of course if you look at the book of business and say the sizeable...
Speaker Change: Rebate adjustments or rebate accruals we make.
Speaker Change: When we end up knowing, understanding the real flow of products and true that up.
Speaker Change: yeah
Speaker Change: You know, that can lead to, say, changes in the quarter, but these are, when you look at the total book of business and, say, the yearly flow of business, we're down to a very small adjustment for that, say, business.
Karsten Knudsen: So we really have a significant flow through 2% up on sales growth, 4% on OP. So a really solid gearing in terms of financial performance and then of course, I was about to say that translates into a step up in our forecasted free cash growth for the year.
Speaker Change: So, I think it's difficult to adjust the business based on one quarter when you have these, so we have to look at it in totality.
Speaker Change: And with the guidance upgrade we have given, you know, that's value. So you can take that as a sign that I think we have strong value development in our business and that's what leads to the upgrade procedure.
Lars Jorgensen: That takes back to you last. Yeah, so just in summary, we are executing well on progressing towards our strategic expression for 2025. We are very encouraged by the growth momentum we have. We have scaled our supply chain to be able to continue that trajectory in the second half of the year. It has cast and just alluded to. And we have really exciting, say, pipeline readout also coming in the second half of the year. So strong start to the year and even more to come with that.
Lars Jorgensen: Thank you, lads.
Speaker Change: We'll move over here to Jo.
Speaker Change: Thank you. A question for Martin, please.
Jo: In the past you've said that you don't think that there are any scalable small molecules and that the market will largely remain in the injectable space.
James Quigley: I think we should close on the slides and get to the Q&A. So please take a seat. A bit more than half an hour for the Q&A. After usual, please state your name and your institution and we'll have one question per person. So we'll take multiple rounds.
Jo: Since those comments we've seen a couple of small molecule GLP type drugs. I wonder if you could update us on your view as to how the market's going to split between injectables and
Unknown Attendee: and also, if I can just ask you how you're going to choose between your next injectable. Should we expect all of them to come to the market, or should we expect you to just develop one of them, your best?
Speaker Change: Orals, and also if I can just ask how you're going to choose between your next injectables, should we expect all of them to come to the market or should we expect you to just only develop one one of them your best?
Lars Jorgensen: We have some mics going around and I think we'll start with James as per tradition, our host. Thank you James, quickly from Goldman Sachs. To just starting on, we're going to be net pricing. So again, I think there's a bit of confusion here on the development following the following the call grounds on the comments on channel mix, rebate adjustments, competition, etc. So could you take us through how you expect that we're going to be net prices to develop and what are the key impacts from the rebate adjustments that we saw in the quarter?
Unknown Executive: First of all, on small molecules, I actually said that I think monolunar band, from a scalability perspective, seems to be an attractive offering. Obviously, right now, we're working on demonstrating the safety and efficacy of monolunar band, but from a scalability perspective, it seems to be, by conventional wisdom, a true small molecule that can be easily used. When we look at what else is out there, and, of course, we're looking through the same lens.
Speaker Change: Thank you.
Speaker Change: First of all, on the small molecules, I actually said that I think monolunar band, from a scalability perspective, seems to be an attractive offering. Obviously, right now we're working on demonstrating safety and efficacy of monolunar band, but from a scalability perspective,
Speaker Change: It seems to be, by conventional wisdom, a true small molecule that can be easily scaled.
Lars Jorgensen: Yes, so if I start so we'll not get into guiding specifically on net price development for individual products, but I'll just say that we don't see any say change in the marketplace. What happened in the second quarter was that we had a one time, one of true up for rebate rebates given last year. And of course, if you look at the book of business and say the sizeable rebate adjustments or rebate accruals we make when we end up knowing understanding the real flow of products and true that up.
Speaker Change: When we look at what else is out there, and of course we're looking through the same lens of certification, is it safe and can it be scaled?
Unknown Executive: The certification, is it safe, and can it be scaled? And most of what we see out there is, from a chemistry perspective, slightly more complex than conventional small molecules. And that basically means that they are more difficult and more expensive to scale. Of course, if you make the investment, you can scale. And then the question comes, to what number of patients? The way we think about this and the way that we scale, as you've seen our investments in the subcutaneous space, you would have to invest quite substantially to be able to scale those small molecules to an impactful degree. I think Karsten and Lars can talk more about that.
Unknown Executive: But from a pure chemistry perspective, they are not trivial. But, of course, they can be produced. But they will not be sort of conventional small molecules that you can just produce for, let's say, double, triple million patients, tens of millions of patients, specifically for our own pipeline. And the way that we look at this, and this is maybe more Camilla that should speak to that, if we see clinical medical differentiation between our molecules, we expect them to be able to coexist to cater to different patient needs. And that's the way that we build our pipeline, both in the oral and in the written. Thanks, people. Great. Can we move to, actually, Inchley?
Speaker Change: And most of what we see out there is, from a chemistry perspective, slightly more complex than conventional small molecules. And that basically means that they are more difficult and more expensive to scale. Of course, if you do the investment, you can scale. And then the question comes...
Speaker Change: through what number of patients?
Speaker Change: The way we think about this and the way that we scale, as you've seen, our investments...
Lars Jorgensen: You know, that can lead to say changes in the quarter, but these are when you look at the total book of business and say the the yearly flow of business, we're down to a very small adjustment for that say business. So I think it's difficult to judge the business based on one quarter when you have these, so we have to look at it in totality. And with the guidance upgrade we have given, you know, that's the value. So you can take that as a sign that I think we have strong value development in our business and that's what leads to the upgrade we see here.
Speaker Change: in the subcutaneous space.
Speaker Change: You would have to invest quite substantially to be able to scale those small molecules to an impactful degree. I think Karsten and Lars can talk more to that. But from a pure chemistry perspective, they are not trivial. Of course they can be produced.
Lars Jorgensen: Thank you, Lars.
Speaker Change: But they will not be sort of conventional small molecules that you can just produce to, let's say, double, triple million patients, digit million patients.
Speaker Change: Specifically for our own pipeline, we see obesity as a complex disease.
Jo Walton: We'll move over here to Jo.
Speaker Change: And for us, obviously, to have the leading molecules in the Incretin space, but also working on new modalities based on amylin biology, based on CB1 biology, that allows us to cater to different patient needs.
Jo Walton: Thank you.
Martin Lange: A question for Martin, please. In the past, you said that you don't think that there are any scalable small molecules and that the market will largely remain in the injectable space. Since those comments, we've seen a couple of small molecule GLP type drugs.
Speaker Change: And the way that we look at this, and this is maybe more Camilla that should speak to that, if we see clinical-medical differentiation between our molecules, we expect them to be able to coexist, to cater to different patient needs. And that's the way that we build our pipeline, both in the oil and in the shop.
Martin Lange: I wonder if you could update us on your view as to how the market is going to split between injectables and orals. And also, if I can just ask how you're going to choose between your next injectable, should we expect all of them to come to the market or should we expect you to just and develop one one of them your best. First of all, on the small molecules, I actually said that I think monolunabant from scalability perspective seems to be an attractive offering.
Unknown Executive: We move over here to meet Pete. Thanks, Peter.
Speaker Change: We move over here to Pete.
Unknown Executive: Greg, can we move to insulin just for a second and give, let's go for a rest for a bit. Just can you help us understand why there was such a positive rebate adjustment given what we've seen in terms of the insulin price cap and changes there? And when you think about IRA next year, is it really going to matter? Are insulin prices really already at rock bottom? Or is there going to be another downdraft when IRA hits on some of your insulin portfolio? Thank you.
Pete: Thanks, people.
Speaker Change: Hello, can we move to actually insulin just for a second and give, we go VRS for a bit.
Speaker Change: Just can you help us understand why there was such a positive rebate adjustment given what we've seen in terms of the interest in price cap and Changes there and when you think about IRA next year Is it really gonna matter our interest in price is really already at rock-bottom or is there going to be another? Downdraft when IRA hits on some of your interest in portfolio. Thank you
Martin Lange: Obviously, right now we're working on demonstrating safety and efficacy of monolunabant, but from scalability perspective, it seems to be by conventional wisdom through small molecule that can be easily scaled. When we look at what else is out there and of course, we're looking through the same lens, the certification, is it safe and can it be scaled. And most of what we see out there is from chemistry perspective, slightly more complex than conventional small molecules and that basically means that they are more difficult and more expensive to scale.
Karsten: Thanks Pete. Karsten, will you give data a go on insulin technicalities and underlying movements?
Unknown Executive: Yeah, so for instance, back to Lars's comment from before, when we estimate gross net in the U.S., we sell to wholesalers and charge list price, and then it takes like three, four months before we receive rebates, and then the rebates can go to different channels at different rates. So that's the estimates going into it, and that's also what happens, for instance. We had a bigger adjustment in the first quarter, but we also made an adjustment in the second quarter based on these estimates.
Karsten: Yeah, so.
Speaker Change: So for instance, back to Lars's comment from before, when we estimate gross net in the US, we sell to wholesalers and charge list price and then it takes like 3-4 months before we receive rebates and then the rebates can go to different channels at different rates.
Martin Lange: Of course, if you do the investment, you can scale. And then the question comes to what number of patients, the way we think about this and the way that we scale, as you've seen, our investments in the subcutaneous space, you would have to, it is quite substantial to be able to scale those small molecules to an impactful degree. I think the last control modes to that, but from a pure chemistry perspective, they are not trivial. Of course, they can be produced, but they will not be sort of conventional small molecules that you can just produce through, let's say, double triple million patients, digit million patients.
Speaker Change: So that's the estimates going into it.
Speaker Change: and and that's also what happens for for for influence
Speaker Change: We had a bigger adjustment in the first quarter, but also an adjustment in the second quarter based on these estimates. I don't think it benefits anyone in here to go into the gory details about what channels and what rates and what channel mix.
Unknown Executive: I don't think it benefits anyone here to go into the gory details about what channels and what rates and what channel mix. But it is true that instant growth in the U.S. was very significant in the second quarter, and it was all driven by price adjustments or rebate adjustments in the second quarter of this year. But underlying, when we look at it, insulin in the U.S. is a declining market in terms of market growth, and our market share is also declining, linked, amongst other things, to the level of product consumption.
Speaker Change: It is true that the instant growth in the US was very significant in the second quarter and it was all driven by price adjustments or rebate adjustments in the second quarter.
Speaker Change: of this year. Underlying, when we look at it, insulin in the U.S. is a declining market in terms of market growth, and our market share is also declining, linked, amongst other items, to the levomere product discontinuation.
Martin Lange: Specifically for our own pipeline, we see basically as a complex disease. And for us, obviously, to have the leading molecules in the increase in space, but also working on new modalities based on Emily and biology based on CP one priority, that allows us to cater to different patient needs. And the way that we look at this, and this is maybe more communal, that you speak to that, if we see clinical medical differentiation between our molecules, we expect them to be able to co-exist, to cater to different patient needs. And that's the way that we build our pipeline, both in the oil and in the subcutaneous space.
Emily: Thank you, Karsten. We'll move to Emily.
Emily: Hi, thanks. Emily Fields from Barclays. It seems that there's been, you know, growing concern also coming from the FDA regarding the safety of these compounded formulations of GLP-1s.
Emily Fields: and I was just wondering, you know, with your lowest dose remaining on the drug shortage list and no doses of Truzepatide, at least from what we've seen on the FDA website, does that mean that compounders
Unknown Attendee: We move over here to speed.
Speaker Change: can still make your drug and not theirs, you know, how much does the growth of compounding concern you, both from a patient safety perspective, and then also taking what share, you know, could be Novo Nordisk?
Unknown Attendee: Thanks, people.
Lars Jorgensen: I can we move to actually insulin just for a second and give, we go for a rest for a bit. Just can you help us understand why there was such a positive rebate adjustment given what we've seen in terms of the insulin price cap and changes there. And when you think about IRA next year, is it really going to matter? Our insulin price is really already at rock bottom, or is there going to be another down draft when the IRA hits on some of your insulin portfolio?
Speaker Change: Thank you, Emily. I'll give that to you, Lars, on that shortly.
Speaker Change: So just to underline, there's only one SEMA, and that's produced by Novo Nordisk.
Speaker Change: So I don't know what compounders, well, the compound, but I don't know where they get API from and what the quality of that is. And we've also seen that...
Lars Jorgensen: Thank you. Thanks, Pete. We'll give that a go on insulin, take the calacies and on the language. Yeah, so, so for instance, back to last coming from from from before when when we estimate the gross net in the U.S., we sell to wholesalers and and Charles Litz Prize and then it takes like three or four months before we receive rebates and then the rebates can go to different channels at different rates.
Speaker Change: I think some of the safety reportings has, you know, there's been a high representation from compounded drugs, so we take patient safety very seriously, and so does, you know, the U.S. FDA.
Speaker Change: Specifically, on your point, we have, in dialogue with the FDA, removed the drug shortage notification on the other doses.
Lars Jorgensen: So, so that's the estimates going into it. And and that's also what happens for for for instance, we had a bigger job to estimate in the first quarter but also an adjustment in in in the second quarter based based on on these estimates. I don't think it benefits anyone in here to go into the gory details about where what channels and what rates and and and what what channel makes. But it is it is true that that the instant growth in in the U.S, was was very significant in the second quarter and it was all driven by by price adjustments or rebate adjustments in in the second quarter.
Speaker Change: We have all along said that we want to dynamically start patients in a way where they can have a good journey on the titration doses.
Lars Jorgensen: We actually scaled capacity significantly, so we could, in principle, have decided also to remove... So that led us to keep the notification at the start of those, but we could, in principle, have taken it away also because we still, you know, manage the dosage. Then how do we look at individual doses and also classify that from a drug choice classification? I don't think compounding is a way forward generally to serve patients. Thank you Lars, then we'll move on to Sachin.
Speaker Change: We actually scaled capacity significantly.
Speaker Change: No, the shortest notification on the start of those if we wanted to, but we just think that we've been out consistently saying to physicians and also FDA that we want to have a responsible approach to starting patients
Speaker Change: So you can trust that when you start treatment with Regovi from Novo Nordisk, we take care of you in the sense that you can titrate up to the doses.
Lars Jorgensen: Of of of of this year underlying when when we look at it's insulin in the U.S, is declining market in terms of market growth and and our market share is is also declining linked amongst other items to the live me up product is continuation.
Speaker Change: So that led us to keep the notification on the start dose, but we could in principle have taken it away also, because we still managed the doses.
Speaker Change: So, when we look at it, we have significant step-up in capacity. We allocate that to different doses, and that leads to a significantly higher number of total scripts in the U.S. market, and that's what fuels the growth, and that's what turns into this upgraded outlook.
Casper: Thank you, Casper.
Emily Field: We'll move to Emily.
Emily Field: Hi, thanks Emily feel from Barclays. It seems that there's been you know growing concern also coming from the FDA regarding the safety of these compounded formulations of GLP ones. And I was just wondering you know with with your lowest dose remaining on the drug shortage list and no doses of truce up a tide at least from what we see in the FDA website. Does that mean that compounders can still make your drug and not theirs. You know how much just the growth of compounding concern you both from a patient safety perspective and then also taking what share you know could be no but notice. Thank you Emily.
Speaker Change: Then how we how we look at individual doses and also say classify that from a drug source classification
Speaker Change: You know, those are minor tactics, and we could have taken them all away if we wanted to, but we just think for consistency, because we have said that for some time, that we stick to that. Whether that leads into a massive compounding, I don't know, because we could just remove it, and then there was no compounding.
Speaker Change: I don't think compounding is a way forward generally to serve patients.
Speaker Change: Thank you Lars, then we'll move to Sachin.
Lars Jorgensen: I'll give that to you last on that show. So so just through online there's only one similar and that's produced by no notice. So I don't know what compounders well the compound but I don't know where they get API from and what the quality of that is and we've also seen that. I think some of the safety reporting has you know there's been a high representation from compounded drugs so. So we take patient safety very seriously and so does no the US FDA specifically on your point.
Unknown Executive: Can I just take one clarification on that last point and then I'll ask my CB1 question. I think there was confusion about the lower dose yesterday because it was answered in two different ways as to whether the 0.25 was going to grow or not grow. Just interpreting from your answer just there, the 0.25 can grow, but it's just not within the boundary of how FDA defines a shortage. I just want to clarify that before I ask my CB1.
Speaker Change: hel
Speaker Change: yes
Sachin: Can I just take one clarification on the last point and then I'll ask my CB1 question. I think there was confusion on the lower dose yesterday because it was answered two different ways.
Sachin: As to whether the 0.25 is going to grow or not grow, just interpreting from your answer just there, the 0.25 can grow.
Sachin: But it's just not within the boundary of however FDA defines shortage. I just want to clarify that before I ask my question. Yes, it can grow. So, now I'm just thinking hypothetically, we could allocate all our capacity to produce a starter dose and we would have...
Lars Jorgensen: We have in dialogue with the day removed the drug shortage on location on on the other doses. We have all along said that we want to dynamically start patients in a way where they can have a good journey on on the situation doses. We actually scale capacity significantly so we could in principle have all decided also to remove. You know the shortest notification on the start of those if we wanted to but we just think that we have been out consistently saying to physicians and also FDA that we want to have a responsible approach to starting patients.
Speaker Change: Newscripts explode, but we want to make sure that patients can start and titrate to high doses.
Lars Jorgensen: So you can trust and when you start treatment will go we from no notice we take care of you in the sense that you can tie trade up to the doses. So that led us to keep the notification on the start dose but we could in principle have taken a way also because we still you know manage the dose. Roses, so when we look at it, look at it, we have significant step up in capacity, we allocate that to different doses, and that leads to a significantly higher number of total scripts in the US market, and that's what fuels the growth, and that's what turns into this upgraded outlook.
Sachin: Because that's good for the patient, but it's also good for our business because we get, you know, we grow the business by that. So don't put too much emphasis into underlying individual doses because it's totality of the business and how we allocate our capacity to produce that, that matters.
Unknown Executive: and how we allocate our capacity to produce that that matters.
Speaker Change: Thank you very much. CB1 has a lot of focus predominantly on the CNS safety.
Unknown Executive: So I wonder if you could just frame for us how you're thinking about it on two metrics. The GLP-1 sees psych adverse event rates in the high single digits, I think if that's correct from what we gave you. So what delta relative to that would give you comfort or not? And then on suicidal ideation, a complier was about 0.5%, so in 600 patients across the two studies, we're literally talking about...
Speaker Change: So I wonder if you could just frame for us how you're thinking about it on two metrics.
Speaker Change: The GLP-1 sees psych-adverse event rates in the high single digits, I think if that's correct what we gave you. So what delta relative to that would give you comfort or not comfort? And then on suicidal ideation, a complier was about 0.5%. So in 600 patients across the two studies, we're literally talking about...
Speaker Change: 1, 2, 3 events. So if you see any, is that a problem? And how many patients would you need to see low suicide allegation before you get really comfortable in the site profile? Thank you.
Speaker Change: So.
Speaker Change: The way we think about this is that, and it's a little bit going back to Joe's question, we aim to scale one lunar band to a great number of patients. And that basically means that we need to, the level that we can, exclude concerns about an excess.
Lars Jorgensen: Then how we, how we look at individual doses, and also say classified that from a drug shortage magnification, you know, those are minor tactics, and we could have taken all the way if we wanted to, but we don't know what to do.
Lars Jorgensen: So that's the first thing for consistency, because we have said that for some time, that we stick to that, whether that leads into a massive compounding, I don't know, because we could just remove it, and then there was no compounding, so I don't think compounding is a way forward generally to serve patients.
Unknown Executive: So to your own point, in any clinical study, there will be patients who report neuropsychiatric events. And just to give you an example, in the SELECT file, we had 10 events of suicidal ideation on placebo, and we had 10 events of suicidal ideation on temaglutide, so there was no excess.
Speaker Change: of Neuropsychiatric Side Effects.
Speaker Change: So to your own point, in any clinical study, there will be patients who report neuropsychiatric events.
Sachin Jain: Thank you, Lars, then we'll move to Sachin.
Speaker Change: And just to give you an example, in the select file, we had 10 events of suicidal ideation on placebo, and we had 10 events of suicidal ideation on Tamagotchi, so no excess.
Sachin Jain: Can I just take one clarification at last point, and then I asked my CB one question. I think there was confusion on the lower dose yesterday, because it was answered two different ways, as to whether the point 25 was going to grow or not grow. I just interpreting from your answer just there, the point 25 can grow, but you just not within the boundary of however, FDA defines shortage. I just want to clarify that before I see if you want.
Speaker Change: We intend to take the same approach for Montluna Band and at the end of the day...
Speaker Change: for the two ongoing phase two studies.
Speaker Change: A reasonably large, more than 600 patients, additional phase two study, continuously de-risking the asset. And then obviously our bigger development program.
Sachin Jain: Yes, it can grow, so now I'm just thinking hypothetically, we could allocate all our capacity to produce a start of dose, and we would have new scripts explode, but want to make sure that patients can start and tie straight to high doses, because that's good for the patient, but it's also good for our business because we get, you know, we grow the business by that. So don't put too much emphasis into underlying individual doses, because it's totality of the business, and how we allocate our capacity to produce that that matters.
Speaker Change: to generate, with actually a dedicated focus on this specific issue, enough data to say we don't see an excess risk as compared to anything else out there.
Speaker Change: That's sort of our approach, but that is also the bar. I think that's our bar, but that would also be the bar from regulators.
Speaker Change: Thank you, Martin. Thank you, Sachin. We'll move to the table at the back and Mark Purcell first.
Sachin Jain: I hope that's good.
Mark Purcell: Mark Purcell from Morgan Stanley . A question on obesity timelines. A lot of your competitors are trying to accelerate their programs, doing relatively small phase two studies and
Sachin Jain: Thank you very much.
Martin Lange: CB one is a lot of focus and predominantly on the CNS safety, so we're going to give you just a frame for us how you're thinking about on two metrics. The GLP1 see site adverse event rates in the high single digits, I think if that's correct, we're going to be so what Delta relative to that would give you comfort or not comfort. And then on suicide ideation, a complier was about 0.5%.
Mark Purcell: taking over as the FDA and looking to go into phase three or phase two and parallel phase three studies together.
Speaker Change: So in terms of amicrete, can you help us understand the probability you can go from a couple of Phase 1 studies, one Phase 2 ongoing in diabetes, to a full Phase 3 program, both for the oral and the injectable side?
Martin Lange: So in 600 patients across the two studies, we're literally talking about one, two, three events. So if you see any, is that a problem? And how many patients would you need to see low suicide ideation before you get really comfortable in a site profile?
Speaker Change: And then following up on what Sacha was just asking, I mean, I don't think you'll learn a lot from an additional 600 patient phase 2B study with IMV 202.
Speaker Change: So if you see 15% weight loss in the obesity study with no excess of grade 1, grade 2 CNS events, what would stop you from moving into phase 3 straight away?
Martin Lange: Thank you. So the way we think about this is that, and it's a little bit going back to Joe's question, we aim to scale on luna band to a great number of patients, and that basically means that we need to the level that we can exclude concerns about an excess of neuropsychiatrics. So to your own point, in any clinical study, there will be patients who report neuropsychiatric events. And just to give you an example in this elect one, we had 10 events of suicide ideation on placebo, and we had 10 events of suicide ideation on the mental side, so no access.
Unknown Executive: So maybe I will take the last question first. I disagree a little bit in the sense that if you look at the historical data where we have seen neuropsychiatric side effects with other compounds quite soon after treatment initiation. You have a reasonable volume, and you have a reasonable exposure duration to say, with any likelihood, before you make, or I convince Karsten to make, phase 3 investments, we have excluded the safety events. Again, there are no guarantees until we have the phase 3 data, but given the historical data, I think the sample size and the duration of exposure will take us a long way.
Speaker Change: So maybe I take the last question first. I disagree a little bit in the sense that if you look at the historical data where we have seen neuropsychiatric side effects with other compounds,
Speaker Change: In one specific example, 30% of patients...
Speaker Change: reported neuropsychiatric events in the development program, 30%.
Speaker Change: and most of these reported their events.
Speaker Change: quite soon after treatment initiation.
Speaker Change: And that basically means that with a sample size of 600 plus two additional studies that also amount to almost 600 patients.
Martin Lange: We intend to take the same approach for maluna band, and at the end of the day, for the two ongoing phase two studies, a relatively large, more than 600 patients, additional phase two study, continuously be risking the asset. And then obviously our bigger development program to generate will actually dedicated focus on this specific issue in off data to say we don't see an excess risk as compared to anything else.
Speaker Change: You have a reasonable volume and you have a reasonable exposure duration to say
Speaker Change: with any likelihood before you make, or I convince Karsten to make phase three investments.
Karsten: We have excluded the safety events. Again, there are no guarantees until we have the first free data.
Karsten: But given the historical data, I think the sample size and the duration of exposure will take us a long way. So if we see those three studies, phase two studies, come together with no excess safety concerns,
Unknown Executive: So if we see those three studies, phase 2 studies come together with no excess safety concerns and, let's say, 15% weight loss if we do that. In the phase one studies, we had to see clear differentiation on efficacy, on safety, and on pharmacokinetics so we could pick the right dose. Thanks, Jacob, for just one question.
Speaker Change: And let's say 15% weight loss. I'm super happy. And then I will try to convince Karsten to invest in phase three.
Mark Purcell: [inaudible] Mark Purcell, Mark Purcell, So maybe I take the last question first. I disagree a little bit in the sense that if you look at the historical data where we have seen neuropsychiatric side effects with other compounds, in one specific example, 30% of patients reported neuropsychiatric events in the development program, 30%. And most of these reported events quite soon after treatment initiation. And that basically means that with a sample size of 600 to additional 30s that also amount to almost 600 patients, you have a reasonable volume and you have a reasonable exposure duration to say, with any likelihood before you make, or I convinced Carson to make phase three investments, we have excluded the safety events.
Speaker Change: Could you remind me of the other questions?
Speaker Change: Thank you. Thank you.
Speaker Change: Yes.
Speaker Change: So, so, um...
Speaker Change: At the end of the day, you have to have a reasonable assumption and exposure to secure that safety is reasonable to go into phase three.
Speaker Change: That is why the combination of the Phase 1 studies that we have done in obesity and the Type 2 study that we are currently initiating.
Speaker Change: will be able for us to potentially make a decision during the course of 2025 to say maybe we can go directly into phase three.
Speaker Change: If we do that...
Speaker Change: In the phase one studies, we had to see clear differentiation on efficacy, on safety, and on pharmacokinetics, so we can pick the right dose.
Speaker Change: Then it's down to our risk willingness to say do we want to go into phase 3, have we picked the right dose, do we believe the efficacy, do we believe the safety, but we also have to convince the authorities that we have sufficient safety.
Speaker Change: to take that leap of faith. We've, in our history, done that twice. One with Saltify and one with Kagoshima. And I feel confident that we've sort of gotten that process right. It's not easy. It's not trivial. And certain things have to be in place.
Speaker Change: Thank You Martin. We'll stay at the same table with Richard Vosser and a reminder on one question per person please.
Speaker Change: Thanks, Jacob, for just one question.
Speaker Change: which would be just you mentioned it in your behest to remove the starter dose cap and you're managing that so is that a removal in 25 or is that a removal in 26? How should we think about the step up into 25 and beyond in terms of the overall doses?
Mark Purcell: Again, there are no guarantees until we have the phase three data. But given the historical data, I think the sample size and the duration of exposure will take us a long way. So if we see those phase two studies come together with no excess safety concerns, and let's say 15% weight loss, I'm super happy. And then I will try to convince Carson to invest in phase three.
Speaker Change: But when does that start to dose? When you're comfortable enough on supply? So if you look at what has happened the first six months, we have grown total scripts from 100,000 to 200,000.
Speaker Change: That's a significant number of doses.
Speaker Change: So the debate about what is data dose, what is titration dose, is a bit irrelevant in a way.
Speaker Change: Because with the guidance we have, and with the comparison Karsten spoke about, if you start doing the math in terms of how many doses are going to the market in the second half, that's significantly more doses.
Martin Lange: Could you remind me the other question? Yes, so at the end of the day, you have to have a reasonable assumption and exposure to secure that safety is reasonable to go into phase three. That is why we are the combination of the phase one studies that we have done in obesity. And these have two studies that we are currently initiating will be able for to potentially make a decision during the course of 2020.
Speaker Change: So I mentioned before, you know, if there was a priority on start of doses, we could just produce all the start of doses.
Martin Lange: And if I'm to say maybe we can go directly into phase three, if we do that in the phase one studies, we have to see clear differentiation on efficacy on safety and on pharmacokinetics so we can pick the right.
Speaker Change: and we would be flooding the market and the new scripts would be skyrocketing but that's not a sustainable patient journey so we want to you know do what creates.
Speaker Change: A good mix.
Speaker Change: You know titrating up and that's what fuels the growth and also creates, you know
Speaker Change: efficacy of the product.
Speaker Change: So the whole discussion about starter doses and new scripts is becoming less relevant. It's a total number of scripts across all doses that matters. When you launch a product, it's new scripts and starter doses. Later on, it's actually, say, the total book of business.
Speaker Change: So in a way it's not a 24-25 decision because we manage this dynamically to create the best possible growth and patient experience.
Speaker Change: Thank you Lars, then we'll move to Simon, same table.
Peter Welford: Joergensen, Peter Welford, Peter Welford, and some things have to be in place. Thank you, Martin.
Simon Beck: Thank you. Simon Baker from Redburn Atlantic. First, a quick clarification on Sachin's question on the CB1 development program. Are there any specific exclusion criteria from the studies related to the suicide ideation risk? And then the question I was going to ask, going back to what I asked yesterday, on the monthly dose form.
Richard Vosser: We'll stay at the same table with Richard Votter, and a reminder on one question per person, please. Thanks, Jacob, just one question. Which would be just, you mentioned it in your behest to remove the starter dose cap and you're managing that. So is that a removal in 25 or is that a removal in 26? How should we think about the step up into 25 and beyond in terms of the overall doses?
Speaker Change: You're not there yet. I was just trying to get an idea of how far away you are, what the challenges are, because others are in this space as well. Is this a question purely of formulation? Is it about the specific pharmacokinetics of the molecules you're trying?
Richard Vosser: But when does that starter dose, when you're comfortable enough on supply? So if you look at what has happened the first six months, we have grown total scripts from 100,000 to 200,000. That's a significant number of doses. So the debate about what is starter dose, what is starter dose is a bit irrelevant, in a way, because with the guidance we have, and with a competitor cast and spoke about, if you start doing the math in terms of how many doses are going to the market in the second half, that's significantly more doses.
Speaker Change: Pin you down on a date, I'm sure you won't give me one, but how far away is a month before injectable formulation as a viable product?
Unknown Executive: So, specifically for CP1, for us, it's a journey, depending on data, so if we get through the first two studies, which exclude certain patients without any new psychiatric side effects in excess, then we will discuss what the next solution criteria we have for the next phase two study. We'll be opening up a little bit more if we do that, and that also comes out in a good way.
Unknown Executive: So specifically,
Speaker Change: Thank you. So specifically for CB1, we...
Speaker Change: For us, it's a journey, depending on data. So if we get through the first two studies, which are excluding certain patients without any new psychiatric side effects in excess,
Speaker Change: Then we will discuss what in the next solution criteria we have for the next phase 2 study will be open up a little bit more. If we do that, and that also comes out in a good way, then we can maybe having...
Unknown Executive: Then we can maybe have it. We have tested it once-monthly in clinic. It was honestly not a viable clinical profile. So we were sort of going back to the bench. In research, we are still pursuing, and Pete Woodhouse. I think for anyone, maybe apart from one player, if you're not in clinic, you're still at least six years away from bringing it into patients.
Richard Vosser: So I mentioned before, if there was a priority on starter doses, we could just produce all the starter doses, and we would be flooding the market, and the new scripts would be skyrocketing, but that's not a sustainable patient journey. So we want to do what creates a good mix, and that's what fuels the growth, and also creates the efficacy of the product. So the whole discussion about starter doses and new scripts is becoming less relevant.
Speaker Change: No or very few exclusion criteria in phase 3. It has to depend a little bit on the data.
Speaker Change: And if at the end of the day we had to have an exclusion in our label, I think that is also acceptable. But right now, obviously our full aspiration would be that they should be forward, but it has to depend on the data.
Speaker Change: and
Speaker Change: On the once-monthly, there are many technologies that you can apply for sort of extended delivery. Our approach is always first to focus on efficacy and safety. And if we can make that more convenient, then we'll do that.
Richard Vosser: It's a total number of scripts across all doses that matters. When you launch a product, it's new script, and starter doses later on is actually the total book of business. So in a way, it's not a 24-25 decision because we manage this dynamically to create the best possible growth and patient experience.
Speaker Change: We have tested once monthly in clinic. It was honestly not a viable clinical profile. So we are sort of going back to the bench. In research we are still pursuing.
Simon Baker: Thank you, last, then we'll move to Simon, same table. Thank you, Simon, we've been Atlantic. First, a quick clarification on Sachin's question on the CB1 development program.
Speaker Change: As far as I can see...
Simon Baker: Are there any specific exclusion criteria from the studies related to the suicide ideation risk? And then the question I was going to ask, going back to what I asked yesterday, on the monthly dose form. You're not there yet. I was just trying to get an idea of how far away you are. What the challenges are, because others are in this space as well. Is this a question purely of formulation? Is it about the specific pharmacokinetics of the molecules you're trying?
Speaker Change: at least three different ways of protecting administration. It's not our biggest priority. It is a priority because we still see efficacy, safety driving any decision in this space. But obviously it would be
Speaker Change: It's good for us to have that offering as well, so therefore we are looking at it. But I think for anyone, maybe apart from one player, if you're not in clinic, you are still at least six years away from bringing it into patients.
Martin Lange: And I'll pin you down on a date, I'm sure you won't give me one, but how far away is a month before injectable formulation as a viable product? Thank you.
Unknown Executive: Thank you, Martin, and we'll move over here.
Speaker Change: Thank you, Martin, and we'll move over here.
Speaker Change: Thank you for watching!
Martin Lange: So specifically for CB1, we force it's a journey, depending on data. So if we get through the first two starters, we try excluding certain patients without any new psychiatric side effects in excess, then we will discuss what in an exclusion criteria we have for the next phase two starter will be open a little bit more. If you do that, and that also comes out in a good way, then we can maybe have no or very few exclusions criteria in phase three.
Speaker Change: I just wanted to briefly touch on the Catalan transaction. It's been going on for some time. How do you today feel about the likelihood of reaching a beneficially, you know, mutually beneficial agreement with first Sali Ledi, and then with all the other potential complainants?
Speaker Change: Thank you for joining us. Have a great day. Have a great day.
Speaker Change: Karsten, on the Katalan transaction? Yeah, so we're still confident that the transaction will close by the end of the year. We had a lot of advice before entering into the transaction in the first place in the beginning of this year. And then we've had a lot of interactions with regulators in the US and outside the US.
Martin Lange: It has to depend a little bit on the data. And if at the end of the day, we have to have an exclusion in our label. I think that is also acceptable. But right now, obviously our fullest inspiration, would be that they should be for all, but it has to depend on the data. On the once monthly, there are many technologies that you can apply for sort of extended delivery. And our approach is always first to focus on efficacy and safety. And if we can make that more convenient, then we'll do that. We have tested one monthly as it in clinic.
Speaker Change: and we believe that we have a solid case to get to a close of the transaction towards the end of the year. So we look very much forward to that.
Speaker Change: Thank you, Karsten. Can we move to Alexander?
Alexander: Thank you. I had a question on China. You have approval for Wigobi in China. You have a very short patent window there, two years ago, I think.
Speaker Change: Can you just comment on whether you still retain a lot of optimism around the China opportunity? The noise being made by the generics is getting louder all the time. There are plenty of people who are going to have a pop at this market.
Martin Lange: It was honestly not a viable clinical profile. So we are sort of going back to the bench in research. We are still pursuing as far as I can see at least three different ways of protecting administration. It's not our biggest priority. It is a priority because we still see efficacy safety driving any decision in this space. But obviously, it would be good for us to have that offering as well. So, therefore, we are looking at it.
Speaker Change: Do you have any indication about how quickly you've gone off with WeGovi in China?
Martin Lange: But I think for anyone, maybe apart from one player, if you're not in clinic, you are still at least six years away from bringing it into patients.
Unknown Executive: Yeah, thanks a lot. In China, there are more than 200 million people living with obesity, and we see a great opportunity to make a difference in terms of BCOVI in China. And what is important, of course, is that we have a very strong presence in China in terms of our regional presence, in terms of our ability to launch new products. And we have worked in China before with local competition before, in competition with locals. We, at the moment, do not see anyone sort of being represented in the short term on BCOVI.
Speaker Change: I'll give that to you, Camilla. China, Unmet Need, and Vigovi. Yeah, thanks a lot. So in China, there are more than 200 million people living with obesity, and we see a great opportunity to make a difference in terms of...
Speaker Change: BGOVI in China. What is important, of course, is that we have a very strong presence in China in terms of our regional presence, in terms of our ability to
Speaker Change: to launch new products and we have worked you know in China also.
Speaker Change: with local competitions before, in competition with locals before.
Speaker Change: We, at the moment, do not see anyone sort of being represented in the short term on Vigovi. So we feel, as long as we continue to bring innovation to China, we will continue to be a step ahead.
Unknown Attendee: Thank you, Martin. We'll move over here.
Unknown Executive: So we feel as long as we continue to bring innovation to China, we will continue to be a step ahead. Our understanding from our dialogues with Chinese authorities is also that they very much value the innovation that we bring to China. Then, of course, over time, there will most likely, as we've seen before, a system in China that would allow local generics to produce and to compete. But so far, this has been constructed in a way where there is always an intensive to bring innovation to China.
Unknown Attendee: I just wanted to briefly touch on the Catalan transaction. It's been going on for some time.
Speaker Change: our understanding from dialogues with
Speaker Change: Chinese authorities is also that they very much value the innovation that we actually bring to China.
Karsten Knudsen: How do you today feel about the likelihood of reaching a beneficially, you know, mutually beneficial agreement with first salilality, and then with all the other financial complainants, all the other parties. Martin, on Catalan transaction? We are still confident that the transaction will close by the end of the year. We had a lot of advice before entering into the transaction in the first place in the beginning of this year. And then we've had a lot of transactions with regulators in the US and outside US. And we believe that we have a solid case to get to a close of the transaction towards the end of the year. So, we look very much forward to that. Thank you.
Speaker Change: Then, of course, over time, there will be most likely, as we've seen before, a system in China that would allow local generics to produce
Speaker Change: and to compete, but so far this has been constructed in a way where there is always an intensive to bring innovation to China.
Unknown Executive: And as we are a very innovation-based company, we are quite happy to see now that all of our new products, BCOVI, Rebelsus, and so on, including also a weekly or once-weekly insulin, have now been approved in China much faster than in the past. So this actually allows us to compete even faster in the Chinese market than just five years ago.
Karsten Knudsen: Thank you, Karsten.
Speaker Change: and as we are a very innovation-based company.
Speaker Change: We are quite happy to see now that all of our new products, Vigovy, Rebelsus and so on have, including also a weekly or once weekly insulin, has now had approval in China much faster than in the past. So this actually allows us to compete even faster in the Chinese market than just five years back.
Unknown Executive: Hi, good afternoon. Can I just clarify your CB1 comments earlier in terms of, this is not my question, by the way; I want to ask about rebates. On CB1, are you going to do trial control with semaglutide or trisepatide rather than placebo and compare neuropsychiatric outcomes there? Or is it just going to be a placebo control, and then you'll see how the
Rogers: Thank you Camilla, we'll move to Rajesh.
Rogers: Hi, good afternoon, can I just clarify your CB1 comments earlier in terms of, this is not my question by the way, I want to ask about rebates, on CB1,
Alexander: We move to Alexander.
Camilla Sylvest: Thank you. I had a question on China. You have approval for Wigobee in China. You have a very short patent window there two years ago, I think. Can you just comment on whether you still retain a lot of optimism around the China opportunity, the noise being made by the generics is getting louder all the time. There are plenty of people who are going to have a pop at this market. Do you have any indication about how quickly you've gone off with Wigobee in China?
Speaker Change: Are you going to do a trial control with semaglutide or trazepatide rather than placebo and compare neuropsychiatric there? Or is it just going to be a placebo control and then you'll see how the...
Unknown Executive: Without going into details, there will be an active comparator. There will also be a placebo comparator, and there will potentially also be combinations.
Speaker Change: Without going into details, there will be an active comparator, there will also be a placebo comparator, there will potentially also be combination therapies.
Unknown Executive: On rebate, you mentioned that you get data back from the wholesalers within two to three months. So based on my very preliminary understanding of how the accrual accounting and the IT systems work there, you probably are guessing at the moment the level of rebate you have booked in for Vigovi this quarter, right?
Speaker Change: Thank you. On rebate, you mentioned that you get data back from the wholesalers two to three months, so if my
Camilla Sylvest: I'll give that to you, Camilla, China, on McNeid and Wigobee. Yeah, thanks a lot. So in China, there are more than 200 million people living with obesity and we see a great opportunity to make a difference in terms of Wigobee in China. And what is important, of course, is that we have a very strong presence in China in terms of our regional presence in terms of our ability to launch new products.
Speaker Change: Very preliminary understanding of how the accrual accounting and the IT systems work there. You probably are guessing at the moment the level of rebate you have booked in for Wicovi this quarter, right?
Camilla Sylvest: And we have worked in China also with local competitions before, in competition with locals before, we at the moment do not see anyone sort of being represented in the short term on Wigobee. So we feel as long as we continue to bring innovation to China, we will continue to be a step ahead. Our understanding from dialogues with Chinese authorities is also that they very much value the innovation that we actually bring to China.
Speaker Change: Correct.
Speaker Change: and and and just to be precise we don't get the data from the wholesalers we get data from the insurance companies so we we charge the wholesalers at list price yeah then the rebate claims comes from the PBMs who get the claims of course through pharmacies and and that's where you get them
Camilla Sylvest: Then, of course, over time, there will be most likely, as we've seen before, a system in China that would allow local generics to produce and to compete. But so far, this has been constructed in a way where there is always an incentive to bring innovation to China. And as we are a very innovation-based company, we are quite happy to see now that all of our new products, Wigobee, Wigobee, Wigobee, and so on have, including also a weekly, a once-weekly insulin, has now has approval in China much faster than in the past. So this actually allows us to compete even faster in the Chinese market than just five years back.
Camilla Sylvest: Thank you, Camilla.
Speaker Change: I would imagine that given the projection you've made for your full year, you have assumed that there would be a step up in volumes, therefore a step up in rebates in the second half, and therefore you've reflected that in the prices.
Speaker Change: You've assumed for the quarter
Speaker Change: No. So the prices for the quarter, that's an estimate based on the volumes we sold. Then we make an estimate linked to what channels and under what formularies and hence conditions and rebates have they been sold to.
Speaker Change: The upgrade for the second half takes into consideration what pricing will be and that we upgrade the value.
Speaker Change: Thank you.
Rajesh Kumar: We'll move to the Rajesh. I'm good afternoon. Can I just clarify your CB1 comments earlier in terms of, this is not my question, by the way, I want to ask you out a bit.
Speaker Change: and Peter Van Damme.
Speaker Change: forsay
Speaker Change: Wow!
Speaker Change: Please cease the hostility and ask the question in the comments...
Rajesh Kumar: On CB1, are you going to do trial control with thermal glutide or traithapatide rather than placebo and compare neuropsychiatric there? Or is it just going to be a placebo control and then you'll see other? Without going into details, there will be an active comparator that will also be a placebo comparator that will potentially also be combinations happy in that story.
Camilla: Camilla, will you give that a go? Yes. So, thanks a lot. So, we keep in mind that six months is an average stay time. And it's based on experience in the U.S. where we've seen some interruptions to supply in the past.
Lars Jorgensen: Thank you. You mentioned that you get data back from the wholesalers two to three months. So it's my very preliminary understanding of how the accrual accounting and the IT systems work there. You probably are guessing at the moment the level of repaid you have booked in for Wigobee this quarter, right? Correct. And just to be precise, we don't get the data from the wholesalers, we get data from the insurance companies. So we chart the wholesalers at least price.
Camilla: So we continue to be very encouraged about the development of that stay time and when we look at
Speaker Change: You say other countries where we haven't had that interruption of supply, we've seen that.
Speaker Change: For example, in Denmark, where people started on treatment beginning of 2023, you know, a big part, very big part, close to 90% were on the treatment also at the end of the year. So we are continuously, you know, encouraged about stay time.
Speaker Change: When we look at different groups of people, we see stay time is significantly longer for people that have been on Fexenda before, maybe they are more prone to usage of GLP-1.
Lars Jorgensen: Then the rebate claims comes from the PBMs who get the claims of course through pharmacies and that's where you get them. And I would imagine that given the projection you've made for your full year, you have assumed that there would be a step up in volume, therefore a step up in rebates in the second half. And therefore you've reflected that in the prices. No, so the prices for the quarter, that's an estimate based on the volumes we sold, then we make an estimate linked to what channels and under what formulas and hence conditions and rebates have they been sold to. The upgrade for the second half takes into conservation what pricing will be that we upgraded value.
Speaker Change: and we also see that stay time is significantly longer with people that are living in...
Speaker Change: So to say more affluent areas, so more on the east coast and the south of the US.
Speaker Change: and so.
Speaker Change: You know, also in terms of age, we see stay time being longer for people older than 30 to 40 years compared to younger and so on. So keep in mind, six months is really impacted by all these things. Having said that, you know, close to...
Speaker Change: More than 80% of VGOVI scripts are to patients that are naïve to therapy, meaning they have not been on therapy before.
Speaker Change: So, of course, there are some switches between GLP-1s, but I think this is close to, you know, if we look at competition, they are sourcing probably
Unknown Attendee: We move over here and before that just a reminder and a reminder in terms of one question. I agree. Where could we just continue in around six months maybe longer.
Speaker Change: around 10 to 11% from Vigovy and so on. So there will always be sort of changes of that. But the majority of all patients starting on obesity treatment are new to treatment.
Speaker Change: You know just based on the fact that obesity really hasn't been treated to a large extent before so we are still in the early days of a very low percentage of the total population being treated
Speaker Change: Yep, same table.
Unknown Attendee: Are they then re-challenging on a JLP one and are you seeing switches between JLP ones there and do you expect over the longer term that people aren't going to take this as a one and done and are willing to go back on after that. Can we then will you give it a go? Yeah, so thanks a lot. So we keep in mind that six months is an average daytime and it's based on experience in the US where we've seen some interruptions to supply in the past.
Speaker Change: Hi there. Another question, if I may, on Catalan. I wanted to ask,
Speaker Change: if you have a sense of how
Speaker Change #100: Quickly, you can ramp up on the filth.
Speaker Change #101: Finish lines, because my understanding is that
Unknown Attendee: So we continue to be very encouraged about the development of that daytime and when we look at you say other countries where we haven't had that interruption of supply. We've seen that for example in Denmark where people started on treatment beginning of 2023. You know a big path very big pattern close to 90% for on the treatment also at the end of the year. So we are continuously you know encouraged about daytime when we look at different groups of people we see daytime is significantly longer for people that have been on fact send up before maybe they are more prone to usage of the JLP one.
Speaker Change #102: Most of them are under a contract that might take a while to complete.
Speaker Change #103: Thanks, bye.
Speaker Change #104: Thank you.
Kasten: Pass it, I'll give it to you.
Kasten: Yeah, we do have a good sense of that because that's the core of the entire acquisition case, to access additional capacity.
Speaker Change #106: So do bear in mind that we are already working with Catalan as a CMO, so there are lines working for Novo Nordisk already with Catalan. So what we're getting is additional capacity on the different lines at the different sites.
Unknown Attendee: And we also see that daytime is significantly longer with people that are living in so to say more effluent areas or more on the east coast and the south of the US. And so you know also in terms of age we see daytime being longer for people older than 30 to 40 years compared to younger and so on. So keep in mind six months is really impacted by all these things having said that you know close to more than 80% of the big OV scripts are two patients that are they eat to therapy meaning they have not been on therapy before.
Speaker Change #106: and of course we honor the contracts that are in place with existing customers so they have to run off.
Speaker Change #106: and then let's say the deal closes by the end of this year.
Speaker Change #106: Then we'll have to do a technology transfer.
Speaker Change #106: to the new lines also during 2025. So you would say additional capacity beyond what we have already contracted as a CMO will gradually start from 2026 and onwards.
Speaker Change #106: Thank you, Karsten. Then we'll go to Emily. Oh, sorry, Dave. Yeah, over here, same table.
Unknown Executive: Hi Kritika Kalia from Berenberg. Just a question on Wigobi access.
Unknown Attendee: So of course there are some switches between JLP ones but I think this is close to you know if we look at competition they are sourcing probably around 10 to 11% from the big OV and so on. So there will always be sort of changes of that but the majority of all patients starting on obesity treatment are new to treatment. You know just based on the fact that obesity really hasn't been treated to a large extent before so we are still in the early days of a very low percentage of the total population being treated.
Kritika Kalia: Hi, Kritika Kalia from Berenberg. Just a question on Wigobi access. So we've heard that certain employers have reversed their initial decisions to provide access to obesity medications just because of the escalating demand and associated costs.
Speaker Change #108: Is this a trend that you have seen? And related to that, could you just provide us an update as to your current formulary access and specifically the proportion of covered lives that have employer opt-in?
Unknown Executive: So we've heard that certain employers have reversed their initial decisions to provide access to obesity medications just because of the escalating demand and associated costs. Is this a trend that you have seen? And related to that, could you just provide us an update as to your current formulary access and, specifically, the proportion of covered lives that have employer opt-in?
Speaker Change #108: Thank you.
Speaker Change #108: In terms of employer updates, Camilla, will you give that a go?
Camilla: Yeah, so, first of all, we have more than 50 million patients being covered in the U.S., so very strong access, and around 80% of them, 80% pay up to only $25 per script in terms
Unknown Attendee: Yeah same table.
Andrzej Popkowski: Hi there. Another question if I may on Catalan. I wanted to ask if you have a sense of how... Andrzej Popkowski, Dr. Schindler, Dr. Schindler, Dr. Schindler, Dr. Schindler Dr. Schindler, Dr. Schindler, Dr. Schindler, Dr. Schindler,[inaudible] Dr. Schindler, Dr. Schindler, Dr. Schindler[inaudible] Dr. Schindler, Dr. Schindler, Dr. Schindler, Dr. Schindler, Dr. Schindler, Dr. Schindler, Dr. Schindler, Dr. Schindler, Dr. Schindler, Dr. Schindler, Dr. Schindler, Dr. Schindler,[inaudible] Thank you, Camilla, and before handing over to you, Lars, we'll find remarks.
Unknown Executive: First of all, we have more than 50 million patients being covered in the U.S., so very strong access, and around 80% of them pay up to only $25 per script in terms of self-pay. When it comes to opt-ins and opt-outs, there will always be opt-ins and opt-outs, but we continue to have a net opt-in, so to say, of employers, so it just means that we continue to
Camilla: When it comes to opt-ins, there will always be opt-ins and opt-outs, but we continue to have a net opt-in, so to say, of employers, so it just means that we continue to broaden our access.
Speaker Change #109: Thank you, Camilla. And then the last question will go to Emily before we round off.
Speaker Change #109: Emily Fields from Barclays. A somewhat similar question, but going back to the question of stay time, you know, how much do you think that
Speaker Change #110: Insurance coverage in the U.S. dampens stay time just with people switching jobs, aging into Medicare, and so they might not have coverage to that degree. I mean, do you see that as also a big dampening effect in addition to supply constraints?
Unknown Executive: Yeah, so I think, you know, there will always be people that may opt from one team to another where they are not covered. And so, and that, of course, happens.
Speaker Change #111: Yeah, so I think, you know, there will always be people that may opt from one team to another where they are not covered or so, and that of course happens, but given that 50 million lives are covered, I think we don't need to be preoccupied with the potential in terms of coverage. Also, keeping in mind on stay time,
Unknown Executive: But given that 50 million lives are covered, I think we don't need to be preoccupied with the potential in terms of coverage. Also, keeping in mind, on stay time, it's really in the first sort of 60 days that we really see the drop off, probably part of getting used to GLP-1. But then once people continue to stay on, then they stay on longer. So keep in mind that six months is truly an average.
Speaker Change #112: It's really in the first sort of 60 days that we really see the drop-offs, probably part of getting used to GLP-1. But then once people continue to stay on, then they stay on longer. So keep in mind that it's...
Unknown Executive: And you have to think about the variation in this. And so, of course, that's also why there is significantly higher stay time for people who have been on GLP-1 before, most likely because they have been, they are either used to, you know, being initiated on GLP-1, knowing more what to expect. And therefore, the average stay time is much longer. So think about it much more like that. But we have, we think, you know, we're treating a million patients now, but 50 million are being covered, that this is not what is, you know, what is holding anyone back.
Speaker Change #113: Six months is truly an average and you have to think about the variation in this and so of course that's also why they significantly higher stay time for people who have been on GLP-1 before most likely because they have been
Speaker Change #113: They are either used to, you know, being initiated on DLP1, knowing more what to expect, and therefore the average stay time is much longer. So think about it much more like that.
Speaker Change #114: We think, you know, we're treating a million patients now, but 50 million being covered, this is not what is, you know, what is holding anyone back. So, to the points from before, we're truly scaling production, you know, to be able to supply more doses into starter doses.
Unknown Executive: So to the point from before, we're truly scaling production to be able to supply more doses into starter doses so people can start and continue on the treatment. That's really what we're working on.
Speaker Change #114: So the people can start and continue on the treatment. That's really what we are working on right now.
Speaker Change #115: Thank you Camilla and before handing it over to you Lars for final remarks thanks to everybody in the room for for coming and for everyone online for dialing in in case of any follow-ups please reach out to Investor Relations
Lars Jorgensen: Thank you, I hope it comes across that we are very pleased about where we are as a company.
Unknown Executive: Thank you very much for the second half of the year, not only in terms of growth from a growth point of view, but also in terms of inflection points for the pipeline. And I think Martin had some good points.
Lars Jorgensen: both in terms of our traction with
Lars Jorgensen: with SEMA and other products, not least in the U.S. market.
Lars Jorgensen: We upgrade because we have more supply coming, and we upgrade in value, so we don't need to worry about the price per script, so to say.
Speaker Change #116: A lot of questions, I appreciate that on Pipeline because we have a really exciting second half of the year, not only in growth point of view but also in terms of inflection points for Pipeline and I think Martin had some good points there.
James Quigley: So thank you very much for your interest. We look forward to it. [music]
Martin: So thank you very much for your interest. We look forward to sharing more details on all these aspects as they evolve over time. Thank you.
Martin: Thank you for watching!
Martin: Thank you for watching!
Andrzej Popkowski: Thanks to everybody in the room for coming. And for everyone online for dialing in, in case of any follow-ups, please reach out to Investolations. There's a great value, so don't need to worry about the price to script, so to say. A lot of questions are appreciated on Pipeline because we have a really exciting second half of the year, not only in the growth point of view, but also in terms of infliction points for Pipeline and I think Martin had some good points there.
Andrzej Popkowski: So thank you very much for your interest. We look forward to share more details on all these aspects as they were all over time. Thank you. Andrzej Popkowski, Paul Peter Welford, Peter Welford, Peter[inaudible] Welford, Peter Welford, Peter Welford, Peter Welford,[inaudible] Welford,[inaudible] Development, so we won't explain now. Hans Rode, what do you guys think? Good, thank you. Thank you, James, and thank you, Goldman Sachs for hosting us today. We are excited to be here. You have probably seen some of our slides. We'll go through them quickly just to set the states and then get to the Q&A.
Martin: Thank you for watching!
Martin: Thank you for watching!
Martin: Thank you for watching!
Speaker Change #118: music music music
Speaker Change #118: oh
Speaker Change #118: Thank you for watching!
James Quigley: So good morning everybody, I'm James Quigley, European Fire Manager here at Goldman Sachs, and it's a pleasure to welcome you all here to the Novo second quarter management meeting. So today we're joined by Lars Jorgensen, CEO, Karsten Knudsen, CFO, Camilla Sylvest, Head of Commercial, and also Martin Lange, Head of Development. So with that all explained, I'll hand it straight over to you guys to kick off.
James Quigley: So good morning everybody, I'm James Quigley, European Fire Manager here at Goldman Sachs, and it's a pleasure to welcome you all here to the Novo second quarter management meeting. So today we're joined by Lars Jorgensen, CEO , Karsten Knudsen, CFO , Camilla Sylvest, Head of Commercial, and also Martin Lange, Head of Development.
Speaker Change #119: With that all explained, I'll hand straight over to you guys to kick off.
Lars Jorgensen: Thank you James and thank you Goldman Sachs for hosting us today. We're excited to be here. You have probably seen some of our slides. We'll go through them quickly just to set the stage and then get to the Q&A. So the first slide is the forward-looking statements.
Unknown Executive: You know, we'll be talking about the future, and it could turn out to be different than what we preach here, so be aware of that, and there are more notes on our website, etc., and I'm not sure I can answer all of them. I don't know how many of them I can answer. I don't know how many of them I can answer. Thank you. I hope you will enjoy it.
Lars Jorgensen: You know we will be talking about the future. It could turn out to be different than what we preach here, so be aware of that and there are more notes in our website, etc.
Lars Jorgensen: So, you know our strategic aspirations. We feel we're making good progress, serving more patients.
Lars Jorgensen: strong commercial execution we're really glad about how we're strengthening our market position in diabetes how we're growing in obesity
Lars Jorgensen: We have a few challenges in rare diseases, but we are encouraged by future growth, not least because of the great data we have received up on mimates over the past quarter, excited about that.
Lars Jorgensen: and
Lars Jorgensen: And you can say all of the financial execution, commercial execution turns into that we have upgraded our outlook for the year.
Lars Jorgensen: So you should see that as a sign of confidence in the momentum we have in the business and also having a supply of products to fuel that continued growth.
Lars Jorgensen: and
Lars Jorgensen: With that, I'll leave the work to Camilla for some comments on the commercial area. Thank you, Lars. And here you see our sales growth of 25%, how it's distributed on regions and therapy areas. 36% growth in North America, 11% growth in international operations, growth driven by all regions.
Camilla: And when it comes to therapeutics, it's really our key brands, Usenpig, Rebelsus, Vigovy, that is driving our growth. You see a strong growth in GLT-1 diabetes, where we also continue to exceed our leadership in diabetes care, now with a market share in total diabetes above 34%.
Camilla: and if we zoom in on obesity we have you know 37% growth if we take a look at the US on the next slide you can see that we are continuing to expand the number of
Camilla: On the start of doses into the market and also in total scripts we now have since the beginning of the year a doubling of the total scripts.
Speaker Change #120: So we are progressing very nicely in terms of our ability to provide the COVID to patients in the U.S., but also in the rest of the world, where we are now have launched in 14 countries and are continuing to launch in more and more countries as we speak.
Speaker Change #120: And with that over to Dr. Lange to give us an update on R&D. Thank you very much, Camilla.
James Quigley: So the first slide is the forward-looking statements. You know, we'll be talking about the future. It could turn out to be different than what we preach here, so be aware of that and there are more notes in our website, etc. [inaudible] Treatment, sorry, Prophylaxis Treatment. If we look at the median annual bill rate, it was zero across the board, indicating that regardless of which, which analysis we did, more than 50% of patients had, had zero please.
Dr. Lange: If I could have the next slide. As Lars already alluded to, we're very happy with the results that we saw from Frontier2, our Pivotal trial. It was a complex trial investigating the broad range of Haemophilia A with and without inhibitors.
Dr. Lange: Across the spectrum of hemophilia in terms of severity, we had both males and females in the study, and we're investigating patients coming from either prophylaxis or on-demand treatment.
Unknown Executive: We're also investigating both once weekly and once monthly. So, quite a complex study with a lot of permutations when it comes to the primary.
Dr. Lange: We're also investigating both once weekly and once monthly. So quite complex study with a lot of permutations when it comes to the primary endpoint.
Unknown Executive: At the end of the day, what you should take away is that for the primary endpoint, regardless of looking at once weekly or once monthly compared to prophylaxis treatment or previous on demand treatment, we see a mean annual bleed rate reduction of somewhere between 60 and 90 plus percent, which is obviously exceedingly gratifying, even for patients coming from previous on demand, Sorry, prophylaxis treatment. If we look at the median annual bleach rate, it was zero across the board, indicating that regardless of which analysis we did, more than 50% of patients had zero bleach.
Dr. Lange: At the end of the day, what you should take away is for the primary endpoint, regardless of looking at once weekly or once monthly, comparing to prophylaxis treatment or previous on-demand treatment,
Dr. Lange: We see the mean annual bleed rate reduction of somewhere between 60 and 90 plus percent, which is obviously exceedingly gratifying, even for patients coming from previous on-demand treatment.
Dr. Lange: Sorry, Prophylaxis Treatment.
Dr. Lange: If we look at the median annual breech rate, it was zero across the board, indicating that, regardless of which analysis we did,
Unknown Executive: And if we look at the actual numbers, again, it's between 60 plus and 90 plus percent of patients that have zero, really, really happy with these data and obviously moving towards a submission during the first half of 2020. I have to mention a complete response letter in the U.S. Focusing on manufacturing and also obviously type 1 diabetes, we expect to be able to resubmit the iCodec file in the U.S. during the course of the first half of 2025.
Dr. Lange: More than 50% of patients had had zero bleeds. And if we look at the actual numbers, again, it's between 60 plus and 90 plus percent of patients that have zero bleeds.
Dr. Lange: So very, very strong efficacy data. Similarly, we saw a strong safety profile with no thromboembolic events. And somewhere between 5 and 12, again, depending on the analysis, percent of patients reporting injection site reactions. So a very attractive number.
Dr. Lange: We are really, really happy with these data and obviously moving towards a submission during the first half of 2025.
Dr. Lange: If I could have the next slide.
Dr. Lange: We see broad pipeline progress, of course, really, really happy with the almost global access, sorry, approval for Insulin iCodec.
Dr. Lange: I have to mention a complete response letter in the U.S.
Dr. Lange: Focusing on manufacturing and also obviously type 1 diabetes, we expect to be able to resubmit the iCodec file in the U.S. during the course of first half of 2025.
Dr. Lange: Broadly speaking, we see a lot of progress in our pipeline. I want to call out, obviously, the data that we'll see from LunaBand in...
Dr. Lange: This half of the year, first on obesity and secondly on diabetic kidney disease, two phase two studies that we'll read out in Q3 and Q4 respectively. Looking very much forward to see our first character semidata, the redefined one file that we'll read out in December of this year.
Speaker Change #121: I've already talked to MIMAPE, but maybe also mention that we have resubmitted CONFISOMAP in the U.S. for both hemophilia with inhibitors, but also without inhibitors.
Speaker Change #121: And then finally, we've initiated the ARTEMIS study, which is a study in acute myocardial infarction with celtivic
James Quigley: And if we look at the actual numbers, again, it's between 60 plus and 90 plus percent, percent of patients that have zero please. So very, very strong efficacy data. Similarly, we saw a strong safety profile with no thrompolytic events. And somewhere between five and 12, again, depending on the analysis, percent of patients reporting injection slide reaction. So, so a very attractive number, really, really happy with these data and obviously moving towards a submission during the first half of 2025.
Speaker Change #121: I think with that over to you Karsten. Yeah, thank you Martin.
Karsten: So when we look at the results in the first six months, then we delivered fantastic 25% sales growth. This is really industry-leading sales growth and a continuation of the sales growth we saw in the first quarter.
Speaker Change #122: The 25% has a benefit from rebate adjustments related to the U.S. and also benefits from a reasonably easy comparator from last year linked to facing of rebates last year.
Speaker Change #122: and I'll come back to why that's important. Our commercial investments are at a low level in that respect, 6%, adjust for something, legal provisions last year around 10%, so really indicating we have the commercial infrastructure in place.
Speaker Change #122: Unless we talk about obesity, where we're really investing in obesity market development activities across the board.
James Quigley: If I could have the next slide, we see broad pipeline progress, because really, really happy with the almost global axis, sorry approval for insulin eye cortex. I have to mention a complete response letter in the US focusing on manufacturing and also obviously type one diabetes. We expect to be able to resubmit the eye cortex in the US during the course of first half of 2025. Broadly speaking, we see a lot of progress in our pipeline.
Speaker Change #122: R&D really stepping up. 78% is overstating the true R&D step-up P&L-wise due to the fact that we had an impairment on osadurinone and also another acid in the second quarter. So adjusting for that, R&D is still stepping up more than 30%.
Speaker Change #122: which is linked to our intent to really build a competitive pipeline for the company's future growth for the coming decades.
Speaker Change #122: Net-Net yields an operating profit growth of 19% for the first six months. As I said, we have impairment impacts in the quarter. So if you look at it from an EBITDA point of view, then we have an EBITDA growth for the first six months of 32%.
James Quigley: I want to call out, obviously, the data that we'll see from a lunar band in this half of the year. First, on obesity and secondly, on diabetic kidney disease, two phase two studies that will read out in Q3 and Q4 respectively, looking very much forward to see our first category, semi data, a redefined one file that will read out in December of this year. I've already talked to my mate, but maybe also mentioning that we have resubmated consumer map in the US for both hemophilia with inhibitors, but also without inhibitors.
Speaker Change #122: Next slide, please.
Speaker Change #122: So Lars spoke to that we're upgrading our full-year sales outlook, and that's why I said the first half is benefiting from growth-to-net adjustments and an easy comparator. On the contrary, the second half has a tough comparator because it was facing, from last year,
Speaker Change #123: So the 25% implied in the second half of this year to get to a midpoint of our guidance range actually requires underlying a growth closer to a 30% mark if you take the comparator into account.
James Quigley: And then finally, we've initiated the Artemis study, which is studying acute myocardial infraction with tissue pigment. I think with that over to you, Carson. Thank you, Martin. When we look at the results in the first six months, then we delivered fantastic 25 cents sales growth. This is really industry leading sales growth and a continuation of the sales growth way we saw in the first quarter. The 25% has a benefit from rebate adjustments related to the US, and also benefits from a reasonably easy comparator from last year linked to facing a rebate last year.
Speaker Change #124: So really talking to an acceleration of underlying growth in the second half driven by a GLP-1 franchise and of course enabled by scaling of supply chain.
Speaker Change #124: Operating Profits.
Speaker Change #124: It's important to note that since we issued guidance at Q1, we had the impairment of osadurinone which had a 6% negative impact and then the sales upgrade we do this quarter has a 4% percentage point
James Quigley: And I'll come back to why that's important. And our commercial investments are at the low level in that there are a respect 6% adjust for something legal, provisions last year around 10%. So really indicating we have the commercial infrastructure in place, perhaps with unless we talk about obesity, where we're really investing in obesity market development activities across the board. R&D really stepping up 78% is overstating that the true R&D step up PNL LWIS due to the fact that we had an impairment on also during on and also another asset in the second quarter.
Speaker Change #124: Positive impact on our operating profit growth, so we really have a significant flow through.
Speaker Change #124: 2% up on sales growth, 4% on OP, so a really solid gearing in terms of financial performance.
Speaker Change #124: And then, of course, I was about to say that translates into a step up in our forecasted free cash flow for the year.
Unknown Executive: Yeah, so just in summary, we are executing well on progressing towards our strategic aspiration for 2025. We're very encouraged by the growth momentum we have. We have scaled our supply chain to be able to continue that trajectory in the second half of the year, as Karsten just alluded to. And we have really exciting, to say, pipeline readouts also coming in the second half of the year. So, a strong start to the year and even more to come. With that, I think we should close the slides and get to the Q&A.
Speaker Change #124: that takes us back to you Lars. Yea, so just in summary...
Lars Jorgensen: Progressing towards our strategic aspiration for 2025. We're very encouraged by the growth momentum we have.
Lars Jorgensen: We have scaled our supply chain to be able to continue that trajectory in the second half of the year, as Karsten just alluded to, and we have really exciting, say, pipeline readout also coming in the second half of the year.
James Quigley: So adjusting for that R&D is still stepping up more than 30% which is linked to our intent to really build a competitive pipeline for the company's future growth for the coming decades. Net net that yields an operating profit growth of 19% for the first six months. As I said, we have impairment impacts in the quarter. So if you look at it from an EBDA point of view, then we have an EBDA growth for the first six months of 32%, and, next slide please.
Speaker Change #125: Strong start to the year and even more to come. With that, I think we should close on the slides and get to the Q&A, so please.
Speaker Change #126: Thank you very much.
Speaker Change #127: Thank you, bye.
Speaker Change #128: That leaves us with more than half an hour for the Q&A. As per usual, please state your name and your institution, and we'll have one question per person, so we'll take multiple rounds.
Speaker Change #128: We have some mics going around and I think we'll start with James as per tradition, our host.
James Quigley: So Lars spoke to that we are operating our full-year sales outlook and that's why I said first half is benefiting from growth to net adjustments and an easy competitor. On the contrary, the second half has a tough competitor because it was facing from last year. So the 25% implied in the second half of this year to get to a midpoint of our guidance range actually requires underlying growth closer to a 30% mark if you take the competitor into account.
Unknown Executive: Thank you, James Quigley from Goldman Sachs. So just starting on Wegovy net pricing, so again, I think there's been a bit of confusion here on the development following the call around some of the comments on channel mix, rebate adjustments, competition, etc. Could you take us through how you expect Wegovy net prices to develop and what are the key impacts from the rebate adjustments that we saw in there?
James Quigley: Thank you, James Quigley from Goldman Sachs. Just starting on Wegovy net pricing. So again, I think there's a bit of confusion here on the development following the call. We'll have some comments on...
Speaker Change #129: Channel Mix, Rebate Adjustments, Competition, etc. So could you take us through how you expect the Rigobi net prices to develop and what are the key impacts from the rebate adjustments that we saw in the quarter?
Speaker Change #130: Yes, so if I start, so...
Speaker Change #131: We will not get into guiding specifically on net price development for individual products, but I will just say that we don't see any, say, change in the marketplace. What happened in the second quarter was that we had a one-time one-off true-up for rebates given last year.
James Quigley: So really talking to an acceleration of underlying growth in the second half driven by a tier two one franchise and of course enabled by scaling of supply chain. Operating profit, it's important to note that since we issued guidance at Q1, we had the impairment of us during on which had a 6% negative impact and then the sales of great, we do this quarter has a 4% percentage point positive impact on our operating profit growth.
Speaker Change #131: and of course if you look at the book of business and say the sizeable...
Speaker Change #131: Rebate adjustments or rebate accruals we make, when we end up knowing, understanding, you know, the real flow of products and true that up, you know, that can lead to, say, changes in the quarter, but these are, when you look at the total book of business and, say, the yearly flow of business,
James Quigley: So we really have a significant flow through 2% up on sales growth, 4% on OP. So a really solid gearing in terms of financial performance and then of course I was about to say that translates into a step up in our forecasted free cash flow for the year. That takes back to you last.
Speaker Change #131: We're down to a very small adjustment for that business.
Speaker Change #131: So, I think it's difficult to adjust the business based on one quarter when you have these, so we have to look at it in totality.
Speaker Change #131: And with the guidance upgrade we have given, you know, that's value. So you can take that as a sign that I think we have strong value development in our business and that's what leads to the upgrade procedure.
Lars Jorgensen: Yeah, so just in summary, we are executing well on progressing towards our strategic expression for 2025. We are very encouraged by the growth momentum we have. We have scaled our supply chain to be able to continue that trajectory in the second half of the year as Carson just alluded to. And we have really exciting, say, pipeline readout also coming in the second half of the year. So strong start to the year and even more to come.
Lars Jorgensen: Thank you, lads.
Unknown Executive: In the past, you've said that you don't think that there are any scalable small molecules and that the market will largely remain in the injectable space. Since those comments, we've seen a couple of small molecule GLP-type drugs. I wonder if you could update us on your view as to how the market's going to split between injectables and... and also, if I can just ask how you're going to choose between your next injectables, should we expect all of them to come to the market, or should we expect you to just develop one of them as your best?
Speaker Change #132: Thank you. A question for Martin, please.
Martin: In the years you have said that you don't think there are any small molecules that can be identified and that the market will be mostly in the key part.
With that, I think we should close on the slides and get to the Q&A. So please take a seat. Thank you Mark. A bit more than than half an hour for the Q&A. After usual, please state your name and your institution and we'll have one question for persons. We'll see. We have some mics going around and I think we'll start with James as per tradition. Our host. Thank you James. We're going to be net pricing.
Martin: Since those comments, we've seen a couple of...
Speaker Change #133: Small Molecule GLP Type Drugs. I wonder if you could update us on your view.
Martin: about how the market will divide between resources and...
Speaker Change #134: and also if I can just ask how you're going to choose between your next injectables. Should we expect all of them to come to the market or should we expect you to just only develop one of them your best?
Speaker Change #135: Thank you.
Speaker Change #136: First of all, on the small molecules, I actually said that I think monolunar band, from a scalability perspective, seems to be an attractive offering. Obviously, right now we're working on demonstrating safety and efficacy of monolunar band, but from a scalability perspective.
So I think there's been a confusion here on the development following the call. On the comments on channel mix, rebate adjustments, competition, etc. Could you take us through how you expect that we're going to be net prices to develop and one of the key impacts from the rebate adjustments that we saw in the quarter? Yes, so if I start, so we'll not get into guiding specifically on net pricing development for individual products, but I'll just say that we don't see any say change in the marketplace.
Speaker Change #136: It seems to be, by conventional wisdom, a true small molecule that can be easily scaled.
Speaker Change #136: When we look at what else is out there, and of course, we're looking through the same lens. Is it efficacious? Is it safe? And can it be scaled?
What happened in the second quarter was that we had a one time one of two up for rebate, rebate is given last year and of course if you look at the book of business and say the sizeable rebate adjustments or rebate accruals we make when we end up knowing understanding the real flow of products and true that up. That can lead to say changes in the quarter, but these are when you look at the total book of business and say the yearly flow of business, we're down to a very small adjustment for that say business.
Speaker Change #136: And most of what we see out there is, from a chemistry perspective, slightly more complex than conventional small molecules. And that basically means that they are more difficult and more expensive to scale. Of course, if you do the investment, you can scale. And then the question comes.
Speaker Change #136: to what number of patients?
Speaker Change #136: The way we think about this and the way that we scale, as you've seen, our investments in the subcontinuous space.
Speaker Change #137: You would have to invest quite substantially to be able to scale those small molecules to an impactful degree. I think Karsten and Lars can talk more to that. But from a pure chemistry perspective, they are not trivial. Of course they can be produced.
So I think it's difficult to adjust the business based on one quarter when you have these. So we have to look at it in totality and with the guidance upgrade we have given you know that's a value so you can take that as a sign that I think we have strong value development in our business, and that's what leads to the operate procedure. Thank you, Lars. We'll move over here to Jo.
Speaker Change #138: But they will not be sort of conventional small molecules that you can just produce to, let's say, double, triple million patients, digit million patients.
Speaker Change #139: Specifically for our own pipeline, we see obesity as a complex disease.
Speaker Change #140: and for us obviously to have the leading molecules in the increase in space but also working on new modalities based on amylin biology, based on CB1 biology, that allows us to cater to different patient needs.
Thank you. A question for Martin, please. In the past, you said that you don't think that there are any scalable small molecules, and that the market will largely remain in the injectable space. Since those comments, we've seen a couple of small molecules, GLP type drugs. I wonder if you could update us on your view as to how the market is going to split between injectables and orals. And also, if I can just ask how you're going to choose between your next injectable, should we expect all of them to come to the market, or should we expect you to just and develop one of them your best?
Unknown Executive: And the way that we look at this, and this is maybe more Camilla that should speak to that, if we see clinical medical differentiation between our molecules, we expect them to be able to coexist to cater to different patient needs. And that's the way that we build our pipeline, both in the oral and in the. Thanks, people.
Speaker Change #140: And the way that we look at this, and this is maybe more Camilla that should speak to that, if we see clinical-medical differentiation between our molecules, we expect them to be able to coexist, to cater to different patient needs. And that's the way that we build our pipeline, both in the oil and in the sugar.
Speaker Change #141: continue, please.
Speaker Change #141: We move over here to Pete.
First of all, on the small molecules, I have actually said that I think more lunar band from scalability perspective seems to be an attractive offering. Obviously, right now we're working on demonstrating safety and efficacy of one lunar band, but from scalability perspective, it seems to be by conventional wisdom through small molecule that can be easily scaled. When we look at what else is out there, and of course, we're looking through the same lens, the certification, is it safe, and can it be scaled?
Pete: Thanks, people.
Pete: I like...
Speaker Change #142: Can we move to actually insulins just for a second and give, we go VRS for a bit. Just can you help us understand why there was such a positive rebate adjustment given what we've seen in terms of the insulin price cap and changes there? And when you think about IRA next year, is it really going to matter? Are insulin prices really already at rock bottom or is there going to be another downdraft when IRA hits on some of your insulin portfolio? Thank you.
And most of what we see out there is from chemistry perspective, slightly more complex than conventional small molecules, and that basically means that they are more difficult and more expensive to scale. Of course, if you do the investment, you can scale. And then the question comes to what number of patients? The way we think about this and the way that we scale, as you've seen, our investments in the subcutaneous space, you would have to, it is quite substantial to be able to scale those small molecules to an impactful degree.
Karsten: Thanks Pete. Karsten, will you give DataGo a go on insulin technicalities and underlying movements?
Karsten: Yeah, so...
Karsten: So for instance, back to Lars's comment from before, when we estimate gross net in the US, we sell to wholesalers and charge list price and then it takes like 3-4 months before we receive rebates and then the rebates can go to different channels at different rates.
I think the last control modes to that, but from a pure chemistry perspective, they are not trivial. Of course, they can be produced, but they will not be sort of conventional small molecules that you can just produce to, let's say, double triple million patients, digit million patients. Specifically for our own pipeline, we see completely as a complex disease. And for us, obviously, to have the leading molecules in the increase in space, but also working on new modalities based on amelian biology, based on CP1 biology, that allows us to cater to different patient needs.
Karsten: So that's the estimates going into it, and that's also what happens for insolence.
Speaker Change #143: We had a bigger adjustment in the first quarter, but also an adjustment in the second quarter based on these estimates. I don't think it benefits anyone in here to go into the gory details about what channels and what rates and what channel mix.
Speaker Change #143: It is true that the insulin growth in the US was very significant in the second quarter and it was all driven by price adjustments or rebate adjustments in the second quarter of this year underlying when we look at it.
Speaker Change #143: Incident in the U.S. is a declining market in terms of market growth, and our market share is also declining, linked, amongst other items, to the level of product discontinuation.
Unknown Executive: Thank you, Kasper. We'll move to Emily now.
Emily: Thank you Kasper. We'll move to Emily.
And the way that we look at this, and this is maybe more communal, that you speak to that, if we see clinical medical differentiation between our molecules, we expect them to be able to coexist, to cater to different patient needs. And that's the way that we build our pipeline, both in the oil and in the subcutaneous space. We move over here to speed. Thanks, people. Can we move to, actually, insulin, just for a second and give, we go for a rest for a bit.
Emily Fields: Hi, thanks. Emily Fields from Barclays. It seems that there's been, you know, growing concern also coming from the FDA regarding the safety of these compounded formulations of GLP-1s. And I was just wondering, you know, with your lowest dose remaining on the drug shortage list and no doses of Truzepatide, at least from what we see in the FDA website, does that mean that compounders can still make your drug and not theirs? You know, how much does the growth of compounding concern you, both from a patient safety perspective and then also taking what share, you know, could be Novo Nordisk?
Just can you help us understand why there was such a positive rebate adjustment given what we've seen in terms of the insulin price cap and changes there. And when you think about IRA next year, it's really going to matter. Our insulin price is really already at rock bottom, or is there going to be another down draft when the IRA hits on some of your insulin portfolio? Thank you. Thanks, Pete. We'll give that a go on insulin, take the calacies and on the language.
Emily Fields: Thank you, Emily. I'll give that to you, Lars, on the short list.
Lars Jorgensen: So just to underline, there's only one simmer, and that's produced by Novo Nordisk. So I don't know what compounders, well, the compounds, but I don't know where they get API from and what the quality of that is. And we've also seen that...
Speaker Change #144: I think some of the safety reporting has, you know, there's been a high representation from compounded drugs. So we take patient safety very seriously and so does, you know, the U.S. FDA.
Yeah, so, so for instance, back to last is coming from from before when when we estimate the gross net in the US, you know, we sell the wholesalers and and Charles Litzfries, and then it takes like three or four months before we receive rebates, and then the rebates can go to different channels at different rates. So, so that's the estimates going into it, and that's also what happens for for for instance, we had a bigger job to estimate in the first quarter, but also an adjustment in in the second quarter based based on on on these estimates.
Speaker Change #145: Specifically on your point, we have, in dialogue with FDA, removed the drug shortage notification on the other doses.
Speaker Change #145: We have all along said that we want to dynamically start patients in a way where they can have a good journey on the titration doses. We actually scaled capacity significantly, so we could, in principle, have decided also to remove...
Unknown Executive: We actually scaled capacity significantly, so we could, in principle, have decided also to remove... So you can trust that when you start treatment with Regovi from Novo Nordisk, we take care of you in the sense that you can titrate up to the dose. So when we look at it, we have a significant step-up in capacity. We allocate that to different doses, and that leads to a significantly higher number of total scripts in the US market. And that's what fuels the growth, and that's what turns into this upgraded outlook.
I don't think it benefits anyone in here to go into the gory details about what channels and what rates and and what what channel makes, but it is it is true that that the instant growth in in the US was was very significant in the second quarter, and it was all driven by by price adjustments or rebate adjustments in in the second quarter. Of of of of this year underlying when when we look at it, insulin in the US is declining market in terms of market growth, and and our market share is is is also declining linked amongst other items to live me up product is continuation.
Speaker Change #145: No, the shortest notification on the start of those if we wanted to, but we just think that we've been out consistently saying to physicians and also FDA that we want to have a responsible approach to starting patients.
Speaker Change #145: So you can trust and when you start treatment with the Gobi from Novo Nordisk, we take care of you in the sense that you can titrate up to the doses.
Speaker Change #145: and
Speaker Change #145: So that led us to keep the notification on the start dose, but we could in principle have taken it away also, because we still managed the doses.
Speaker Change #146: So, when we look at it, we have significant step-up in capacity. We allocate that to different doses, and that leads to a significantly higher number of total scripts in the U.S. market, and that's what fuels the growth, and that's what turns into this upgraded outlook.
Thank you, Casper. We'll move to Emily. Hi, thanks Emily, feel some Barclays. It seems that there's been, you know, going concern also coming from the FDA regarding the safety of these compounded formulations of GLP ones, and I was just wondering, you know, with with your lowest dose remaining on the drug shortage list and no doses of truce up a tide, at least from what we see in the FDA website, does that mean that compounders can still make your drug and not theirs.
How much just the growth of compounding concern you both from a patient safety perspective and then also taking what share, you know, could be no, but Nordic. Thank you, Emily. I'll give that to you last on that show, so just through online there's only one similar and that's produced by no, Nordic. So I don't know what compounders, well, the compound, but I don't know where they get API from and what the quality of that is, and we've also seen that I think some of the safety reporting has, you know, there's been.
Speaker Change #146: Then how we how we look at individual doses and also say classify that from a drug choice classification.
Speaker Change #147: You know, those are minor tactics, and we could have taken them all away if we wanted to, but we just think for consistency, because we have said that for some time, that we stick to that. Whether that leads into a massive compounding, I don't know, because we could just remove it, and then there was no compounding.
Speaker Change #147: I don't think compounding is a way forward generally to serve patients.
Speaker Change #147: Thank you Lars, then we'll move to Sachin.
Sachin: Can I just take one clarification on the last point and then I'll ask my CB1 question. I think there was confusion on the lower dose yesterday because it was answered two different ways.
Speaker Change #148: As to whether the Point 25 was going to grow or not grow, I just interpreted from your answer just there that Point 25 can grow.
High representation from compounded drugs. So so we take patient safety very seriously, and so does know the US FDA. Specifically on your point, we have in dialogue with the day removed the drug shortage notification on on the other doses. We have all along said that we want to dynamically start patients in a way where they can have a good journey on on the transition doses. We actually scale capacity significantly. So we could in principle have all decided also to remove, you know, the shortest notification on the start of those if we wanted to.
Speaker Change #148: But it's just not within the boundary of however FDA defines shortage. I just want to clarify that before I ask my question. Yes, it can grow. So I'm just thinking hypothetically, we could allocate all our capacity to produce a starter dose and we would have...
Speaker Change #149: Newscripts explode, but we want to make sure that patients can start and titrate to high doses.
Unknown Executive: because that's good for the patient, but it's also good for our business because we get, you know, we grow the business by that. So don't put too much emphasis on underlying individual doses because it's the whole business.
Speaker Change #149: Because that's good for the patient but it's also good for our business because we get, you know, we grow the business by that. So don't put too much emphasis into underlying individual doses because it's totality of the business and how we allocate our capacity to produce that, that matters.
But we just think that we have been out consistently saying to physicians and also FDA that we want to have a responsible approach to starting patients. So you can trust that when you start treatment with the gov from Nordic, we take care of you in the sense that you can tie trade up to the doses. So that led us to keep the notification on the start of those but we could in principle have taken a way also because we still, you know, manage the dose.
Speaker Change #150: Thank you very much. CB1 has a lot of focus and predominately on the CNS safety. So I wonder if you could just frame for us how you're thinking about it on two metrics.
Speaker Change #151: The GLP-1 sees psych-adverse event rates in the high single digits, I think if that's correct for Wigovy. So what delta relative to that would give you comfort or not comfort? And then on suicidal ideation, a complier was about 0.5%. So in 600 patients across the two studies, we're literally talking about...
Unknown Executive: 1, 2, 3 events. So if you see any, is that a problem? And how many patients would you need to see low suicide allegation before you get really comfortable with the site profile?
Speaker Change #152: 1, 2, 3 events. So if you see any, is that a problem? And how many patients would you need to see low suicide allegation before you get really comfortable in the site profile? Thank you.
Unknown Executive: The way we think about this is that, and this is a little bit going back to Joe's question, we aim to scale monolunar band to a great number of patients. And that basically means that we need to, at the level that we can, exclude concerns about an excess of neuropsychiatric side effects. That's sort of our approach, but that is also the bar. I think that's our bar, but that would also be the bar from Reggae.
Speaker Change #152: So.
Speaker Change #153: The way we think about this is that, and it's a little bit going back to Joe's question, we aim to scale monoluban to a great number of patients. And that basically means that we need to, the level that we can, exclude concerns about an excess.
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Speaker Change #153: of Neuropsychiatric Side Effects.
Joe: So to your own point, in any clinical study, there will be patients who report neuropsychiatric events.
Speaker Change #155: And just to give you an example, in the SELECT trial, we had 10 events of suicidal ideation on placebo, and we had 10 events of suicidal ideation on tamagotide, so no excess.
Speaker Change #155: We intend to take the same approach for Mondunaband and at the end of the day...
Speaker Change #155: for the two ongoing phase two studies.
Speaker Change #155: A reasonably large, more than 600 patients, additional phase two study, continuously de-risking the asset. And then obviously our bigger development program.
Speaker Change #155: to generate, with actually a dedicated focus on this specific issue, enough data to say we don't see an excess risk as compared to anything else out there.
Speaker Change #155: That's sort of our approach, but that is also the bar. I think that's our bar, but that would also be the bar from regulators.
Speaker Change #156: Thank you, Martin. Thank you, Sachin. We'll move to the table at the back and Mark Purcell first.
Mark Purcell: Mark Purcell from Morgan Stanley . A question on obesity timelines. A lot of your competitors are trying to accelerate their programs, doing relatively small phase two studies and
Marc Purcell: Thank you for taking over CFDA and looking to go into Phase 3 or Phase 2 and parallel Phase 3 studies together.
Speaker Change #158: So in terms of amicretin, can you help us understand the probability you can go from a couple of phase one studies, one phase two ongoing in diabetes, to a full phase three program, both for the oral and the injectable side?
Speaker Change #158: And then following up on what Sacha was just asking, I mean, I don't think you'll learn a lot from an additional 600 patient phase 2B study with IMV202. So, if you see 15% weight loss in the obesity study with no excess of grade 1, grade 2 CNS events,
Unknown Executive: So maybe I will take the last question first. I disagree a little bit in the sense that if you look at the historical data where we have seen neuropsychiatric side effects with other compounds, reported neuropsychiatric events in the development program, 30%, and most of these reported events quite soon after treatment initiation. I'm super happy, and then I will try to convince Karsten to invest.
Speaker Change #159: What would stop you from moving into phase 3 straight away?
Speaker Change #160: So maybe I take the last question first. I disagree a little bit in the sense that if you look at the historical data where we have seen neuropsychiatric side effects with other compounds,
Speaker Change #161: In one specific example, 30% of patients...
Speaker Change #161: 30% reported neuropsychiatric events in the development program, 30%.
Speaker Change #161: and most of these reported their events.
Speaker Change #161: quite soon after treatment initiation.
Speaker Change #161: And that basically means that with a sample size of 600 plus two additional studies that also amount to almost 600 patients.
Speaker Change #161: You have a reasonable volume and you have a reasonable exposure duration to say with any likelihood before you make, or I convince Karsten to make phase 3 investments, we have excluded the safety events. Again, there are no guarantees until we have the phase 3 data.
Speaker Change #161: But given the historical data, I think the sample size and the duration of exposure will take us a long way. So if we see those three studies, phase two studies, come together with no excess safety concerns, and let's say 15% weight loss,
Speaker Change #161: I'm super happy and then I will try to convince Karsten to invest in phase three.
Carsten: Could you remind me of the other questions?
Carsten: Thank you.
Carsten: Yes.
Carsten: So, so, um...
Speaker Change #163: At the end of the day, you have to have a reasonable assumption and exposure to secure that safety is reasonable to go into phase three.
Speaker Change #164: That is why the combination of the Phase 1 studies that we have done in obesity and the TATU study that we are currently initiating will be able for us to potentially make a decision during the course of 2025 to say maybe we can go directly into Phase 3.
Speaker Change #164: If we do that...
Speaker Change #164: In the phase 1 studies we had to see clear differentiation on efficacy, on safety, and on pharmacokinetics so we can pick the right dose.
Speaker Change #164: Then it's down to our risk willingness to say do we want to go into phase 3, have we picked the right dose, do we believe the efficacy, do we believe the safety. But we also have to convince the authorities that we have sufficient safety.
Speaker Change #164: to take that leap of faith. We've, in our history, done that twice. One with Saltify and one with Kagoshima. And I feel confident that we've sort of gotten that process right.
Speaker Change #164: It's not easy, it's not trivial, and certain things have to be in place.
Unknown Executive: Thank you, Martin. We'll stay at the same table with Richard Vosser. And a reminder of one question per person, please.
Speaker Change #165: Thank you, Martin. We'll stay at the same table with Richard Vosser. And a reminder on one question per person, please.
Richard Vosser: Thanks, Jacob, for just one question.
Speaker Change #167: which would be just you mentioned it's in your behest to remove the starter dose cap and you're managing that so so is that a removal in 25 or is that a removal in 26? How should we think about the step up into 25 and beyond in terms of the overall doses but when does that start to dose?
Speaker Change #168: When you're comfortable enough on supply, you know, so so if you look at what has happened the first six months we have grown total scripts from 100,000 to 200,000
Unknown Executive: That's a significant number of those.
Speaker Change #169: That's a significant number of doses.
Speaker Change #170: So the debate about what is data dose, what is titration dose, is a bit irrelevant in a way.
Speaker Change #170: Because with the guidance we have, and with the comparison Karsten spoke about, if you start doing the math in terms of how many doses are going to the market in the second half, that's significantly more doses.
Speaker Change #171: So I mentioned before, you know, if there was a priority on starter doses, we could just produce all the starter doses, and we would be flooding the market and the new scripts would be skyrocketing. But that's not a sustainable patient journey. So we want to, you know, do what trades
Speaker Change #172: A good mix.
Speaker Change #172: You know titrating up and that's what fuels the growth and also creates, you know, best efficacy of the product
Speaker Change #172: So the whole discussion about starter doses and new scripts is becoming less relevant. It's a total number of scripts across all doses that matters. When you launch a product, it's new scripts and starter doses.
Speaker Change #172: Later on, it's actually, say, the total book of business. So it's, in a way, it's not a, say, a 24, 25 decision, because we manage this dynamically to create the best possible growth and patient experience.
Speaker Change #173: Thank you Lars, then we'll move to Simon, same table.
And I feel confident that we've sort of gotten that process right. It's not easy, it's not trivial, and certain things have to be in place. Thank you, Martin. We'll stay at the same table with Richard Vosser and a reminder on one question for person, please. Just one question, which would be just you mentioned it in your behest to remove the starter dose cap and you're managing that. So is that a removal in 25 or is that a removal in 26?
Simon Beck: Thank you, Simon Baker from Redburn Atlantic. First, a quick clarification on Sachin's question on the CB1 development programme. Are there any specific exclusion criteria from the studies related to the suicide ideation risk? And then the question I was going to ask, going back to what I asked yesterday, on the monthly dose form.
Speaker Change #174: You're not there yet. I was just trying to get an idea of how far away you are, what the challenges are, because others are in this space as well. Is this a question purely of formulation? Is it about the specific pharmacokinetics of the molecules you're trying? So, how...
How should we think about the step up into 25 and beyond in terms of the overall doses, but when does that starter dose, when you comfortable enough on supply? So if you look at what has happened the first six months, we have grown total scripts from 100,000 to 200,000. That's a significant number of doses. So the debate about what is starter dose, what is starter dose is a bit irrelevant, in a way, because with the guidance we have, and with a competitor cast and spoke about, if you start doing the math in terms of how many doses are going to the market?
Unknown Executive: Here's a question I have for you guys, and how far away is an injectable formulation from use as a viable pollution agent?
Speaker Change #175: Pin you down on a date. I'm sure you won't give me one, but how far away is a month before injectable formulation?
In the second half, that's significantly more doses. So I mentioned before, if there was a priority on starter doses, we could just produce all the starter doses and we would be flooding the market, and the new scripts would be skyrocketing, but that's not a sustainable patient journey. So we want to do what creates a good mix, and that's what fuels the growth and also creates the efficacy of the product. So the whole discussion about starter doses and new scripts is becoming less relevant.
Unknown Executive: So, specifically for CB1, for us, it's a journey, depending on data, so if we get through the first two studies, which exclude certain patients without any new psychiatric side effects in excess, Anyway, those are three different ways of protecting administration. It's not our biggest priority. It is a priority because we still see efficacy and safety driving any decision in this space. But obviously, it would be...
Speaker Change #175: as a viable partner.
Speaker Change #175: Thank you.
Speaker Change #176: Thank you. So specifically for CB1, we...
Speaker Change #177: For us, it's a journey, depending on data. So if we get through the first two studies, which are excluding certain patients without any new psychiatric side effects in excess.
Speaker Change #177: Then we will discuss what in the next solution criteria we have for the next phase 2 study. Will we open up a little bit more if we do that? And that also comes out in a good way, then we can maybe having...
Speaker Change #177: No or very few exclusion criteria in phase 3. It has to depend a little bit on the data.
Speaker Change #177: And if at the end of the day we had to have an exclusion in our label, I think that is also acceptable. But right now, obviously our full aspiration would be that they should be forward, but it has to depend on the data.
Speaker Change #177: and
Speaker Change #177: On the once monthly, there are many technologies that you can apply for sort of extended delivery. Our approach is...
And it's a total number of scripts across all doses that matters. When you launch a product, it's new script and starter doses later on is actually the total book of business. So in a way, it's not a 24 25 decision because we manage this dynamically to create the best possible growth and patient experience. Thank you, last, then we'll move to Simon, seems able. Thank you, Simon, we've been Atlantic. First, a quick clarification on Sachin's question on the CB1 development program.
Speaker Change #177: Always first focus on efficacy and safety, and if we can make that more convenient, then we'll do that.
Speaker Change #177: We have tested once monthly in clinic. It was honestly not a viable clinical profile. So we are sort of going back to the bench. In research we are still pursuing.
Speaker Change #177: As far as I can see.
Are there any specific exclusion criteria from the studies related to the suicide ideation risk? And then the question I was going to ask going back to what I asked yesterday on the monthly dose form. You're not there yet. I was just trying to get an idea of how far away you are. What the challenges are, because others are in this space as well. Is this a question purely of formulation? Is it about the specific pharmacokinetics of the molecules you're trying?
Speaker Change #177: at least three different ways of protecting administration. It's not our biggest priority, it is a priority because we still see efficacy safety driving any decision in this space. But obviously, it would be
So how can you down on a date? I'm sure you aren't giving one, but how far away is a monthly for injectable formulation as a viable product? Thank you. So specifically for CB1, we force it's a journey depending on data. So if we get through the first two studies, we try excluding certain patients without any new psychiatric side effects and access. , then we will discuss what in an institution criteria we have for the next phase to study will be open a little up a little bit more.
Speaker Change #177: It's good for us to have that offering as well, so therefore we are looking at it, but I think for anyone, maybe apart from one player, if you're not in clinic, you're still at least six years away from bringing it into patients.
Unknown Executive: I just wanted to briefly touch on the Catalan transaction. It's been going on for some time. How do you today feel about the likelihood of reaching a beneficially, you know, mutually beneficial agreement with first Salai Leli and then with all the other potential complainants? Translation. Yeah.
Speaker Change #177: Thank you, Martin. And we'll move over here.
Speaker Change #178: I just wanted to briefly touch on the Catalan transaction. It's been going on for some time. How do you today feel about the likelihood of
Speaker Change #179: is reaching a mutually beneficial agreement with firstly Salih Lely and then all the other potential complainants from the other parties.
Karsten Knudsen: So we're still confident that the transaction will close by the end of the year. We had a lot of advice before entering into the transaction in the first place at the beginning of this year. And then we've had a lot of interactions with regulators in the U.S. and outside the U.S., and we believe that we have a solid case to get to a close of the transaction towards the end of the year. So we look very much forward to that.
Speaker Change #180: Question on the Katalan transaction? Yeah, so we're still confident that the transaction will close by the end of the year.
If you do that, and that also comes out in a good way, then we can maybe having no or very few right now, obviously our full aspiration would be that they should be for all, but it has to depend on the data. On the ones monthly, there are many technologies that you can apply for sort of extended delivery. And our approach is always first to focus on efficacy and safety. And if we can make that more convenient, then we'll do that.
Speaker Change #180: We had a lot of advice before entering into the transaction in the first place, in the beginning of this year. And then we've had a lot of interactions with regulators in the US and outside US.
Speaker Change #180: and we believe that we have a solid case to get to a close of the transaction towards the end of the year. So we look very much forward to that.
Unknown Executive: Thank you, Karsten. Now we move on to Alexander.
Speaker Change #180: Thank you, Karsten. We'll move to Aleksander.
Aleksander: Thank you. I had a question on China. You have approval for Wigobi in China. You have a very short patent window there, two years ago, I think.
Aleksander: Can you just comment on whether you still retain a lot of optimism around the China opportunity? The noise being made by the generics is getting louder all the time. There are plenty of people who are going to have a pop at this market.
We have tested one monthly, as it in clinic, it was honestly not a viable clinical profile. So we are sort of going back to the bench in research. We are still pursuing as far as I can see these three different ways of protecting administration. It's not our biggest priority. It is a priority because we still see efficacy, safety driving any decision in this space, but obviously it would be good for to have that offering as well, so therefore we are looking at it.
Speaker Change #182: Do you have any indication about how quickly you've gone off with Wigo in China?
Camilla Sylvest: I'll give that to you, Camilla. China has an unmet need, and we go, we.
Camilla Sylvest: Yeah, thanks a lot. In China, there are more than 200 million people living with obesity, and we see a great opportunity to make a difference in terms of BKOV in China. And what is important, of course, is that we have a very strong presence in China in terms of our regional presence, in terms of our ability to launch new products. And we have worked, you know, in China before with local competition before, in competition with locals. We, at the moment, do not see anyone sort of being represented in the short term on BKOV.
Speaker Change #182: I'll give that to you, Camilla. China, Unmet Need, and Vigovi. Yeah, thanks a lot. So in China, there are more than 200 million people living with obesity, and we see a great opportunity to make a difference in terms of...
Speaker Change #183: We go in China and what is important, of course, is that we have a very strong presence in China in terms of our regional presence, in terms of our ability to
Speaker Change #183: to launch new products and we have worked, you know, in China also.
Speaker Change #183: We have somewhat of a similar situation with local competitions before, in competition with locals before. We at the moment do not see anyone sort of being represented in the short term on Vigovy. So we feel as long as we continue to bring innovation to China, we will continue to be a step ahead.
But I think for anyone, maybe apart from one player, if you're not in clinic, you are still at least six years away from bringing it into patients. Thank you, Martin. We'll move over here. I just wanted to briefly touch on the cuttle and transaction. It's been going on for some time. How do you today feel about the likelihood of reaching an officially, you know, mutually beneficial agreement with first salilality and then with older, potential complainants or the other parties?
Camilla Sylvest: So we feel as long as we continue to bring innovation to China, we will continue to be a step ahead. Our understanding from our dialogues with Chinese authorities is also that they very much value the innovation that we bring to China. Then, of course, over time, there will most likely, as we've seen before, a system in China that would allow local generics to produce and compete. But so far, this has been constructed in a way where there is always an incentive to bring innovation to China.
Speaker Change #183: Unknown Speaker Our understanding from dialogue with
Speaker Change #183: , Chinese Authorities is also that they very much value the innovation that we actually bring to China. Then of course over time, there will be, most likely as we've seen before, a system in China that would allow local generics to produce and to compete.
Speaker Change #183: But so far this has been constructed in a way where there is always an intent to bring innovation to China.
Camilla Sylvest: And as we are a very innovation-based company, we are quite happy to see now that all of our new products, BKOV, Rebelsus, and so on, including also our weekly, our once-weekly insulin, have now been approved in China much faster than in the past. So this actually allows us to compete even faster in the Chinese market than just five years ago.
Fasten on cuttle and transaction? Yeah, so we're still confident that the transaction will close by the end of the year. We had a lot of advice before entering into the transaction in the first place in the beginning of this year, and then we've had a lot of transactions with regulators in the US and outside US. And we believe that we have a solid case to get to a close of the transaction towards the end of the year.
Speaker Change #183: and as we are a very innovation-based company.
Speaker Change #183: We are quite happy to see now that all of our new products, Vigovy, Rebelsus and so on have, including also a weekly or once weekly insulin, has now had approval in China much faster than in the past. So this actually allows us to compete even faster in the Chinese market than just five years back.
Unknown Executive: Thank you, Camilla; we'll move to Rajesh.
Speaker Change #183: Thank you Camilla, we'll move to Rajesh.
So we look very much forward to that. Thank you, Karsten. We move to Alexander. Thank you. I had a question on China. You have approval for Wigobee in China. You have a very short patent window there two years ago, I think. Can you just comment on whether you still retain a lot of optimism around the China opportunity, the noise being made by the generics is getting louder all the time. There are plenty of people who are going to have a pop at this market.
Rajesh: Hi, good afternoon, can I just clarify your CB1 comments earlier in terms of, this is not my question by the way, I want to ask about rebates, on CB1,
Speaker Change #185: Are you going to do a trial control with semaglutide or trazepatide rather than placebo and compare neuropsychiatric there, or is it just going to be a placebo control and then you'll see how the...
Speaker Change #186: Without going into details, there will be an active comparator. There will also be a placebo comparator. There will potentially also be combination therapy.
Do you have any indication about how quickly you've gone off with Wigobee in China? Thank you. I'll give that to you, Camilla, China on Medneed and Vigovie. Yeah, thanks a lot. So in China, there are more than 200 million people living with obesity, and we see a great opportunity to make a difference in terms of Vigovie in China. And what is important, of course, is that we have a very strong presence in China in terms of our regional presence, in terms of our ability to launch new products, and we have worked in China also with local competitions before, in competition with locals before, we at the moment do not see anyone sort of being represented in the short term on Vigovie, so we feel as long as we continue to bring innovation to China, we will continue to be a step ahead.
Unknown Executive: in that story. Understanded.
Speaker Change #187: Thank you. On rebate, you mentioned that you get data back from the wholesalers two to three months, so if my
Speaker Change #188: Very preliminary understanding of how the accrual accounting and the IT systems work there. You probably are guessing at the moment the level of rebate you have booked in for Wicovi this quarter, right?
Speaker Change #188: Great.
Speaker Change #189: And just to be precise, we don't get the data from the wholesalers, we get data from the insurance companies, so we charge the wholesalers at list price, then the rebate claims come from the PBMs who get the claims, of course, through pharmacies, and that's where we get them.
Our understanding from dialogues with Chinese authorities is also that they very much value the innovation that we actually bring to China. Then, of course, over time, there will be most likely, as we've seen before, a system in China that would allow local generics to produce and to compete, but so far this has been constructed in a way where there is always an intensive to bring innovation to China. And as we are a very innovation-based company, we are quite happy to see now that all of our new products, Vigovie, Vigovie, Vigovie, and so on have, including also a weekly, a once-weekly insulin, has now has approval in China much faster than in the past.
Speaker Change #190: I would imagine that given the projection you've made for your full year, you have assumed that there would be a step up in volumes, therefore a step up in rebates in the second half, and therefore you've reflected that in the prices you've assumed for the quarter.
Speaker Change #191: No. So the prices for the quarter, that's an estimate based on the volumes we sold. Then we make an estimate linked to what channels and under what formularies and hence conditions and rebates have they been sold to.
Speaker Change #191: The upgrade for the second half takes into consideration what pricing will be and every upgraded value.
So this actually allows us to compete even faster in the Chinese market than just five years back. Thank you, Kamila. We'll move to the budget. I'm good afternoon. Can I just clarify your CB1 comments earlier in terms of, this is not my question, by the way, I want to ask you out a bit. On CB1, are you going to do trial control with semaglutide or trezapatide rather than placebo and compare neuropsychiatric there?
Speaker Change #191: Thank you.
Speaker Change #192: Based on a true story
Speaker Change #192: fordata
Speaker Change #193: Au revoir!
Joel Wegardy: and Joel Wegardy.
Or is it just going to be a placebo control and then you'll see how the... Without going into details, there will be an active comparator that will also be a placebo comparator that will potentially also be combinations happy in that story. Thank you. You mentioned that you get data back from the wholesalers two to three months. So it's my very preliminary understanding of how the accrual accounting and the IT systems work there.
Unknown Executive: Yeah, so thanks a lot. We should keep in mind that six months is an average stay time. And it's based on experience in the US where we've seen some interruptions to supply in the past. So we continue to be very encouraged about the development of that stay time. And when we look at, you say, other countries where we haven't had that interruption of supply, we've seen that, for example, in Denmark, where people started treatment at the beginning of 2023, a big part, a very big part, close to 90% were on treatment also at the end of the year.
Joel Wegardy: Camilla, will you give that a go? Yeah. So, thanks a lot. So, we keep in mind that six months is an average stay time, and it's based on experience in the U.S. where we've seen some interruptions to supply in the past.
Joel Wegardy: So we continue to be very encouraged about the development of that stay time and when we look at
Camilla: You say other countries where we haven't had that interruption of supply, we've seen that.
You probably are guessing at the moment the level of repaid you have booked in for Vigovie this quarter, right? Correct. And just to be precise, we don't get the data from the wholesalers, we get data from the insurance companies. So we charge the wholesalers at least price, then the rebate claims comes from the PBMs who get the claims of course through pharmacies and that's where you get them. And I would imagine that given the projection you've made for your folio, you have assumed that there would be a step-up in volume, therefore a step-up in rebates in the second half, and therefore you've reflected that in the prices you've assumed... [inaudible] no, no, no, no, no, no, no no, no, no, no no, no, no, no, no,[inaudible][inaudible] Thank you.
Speaker Change #195: For example, in Denmark, where people started on treatment beginning of 2023, you know, a big part, a very big part, close to 90% were on the treatment also at the end of the year. So we are continuously, you know, encouraged about stay time.
Karsten Knudsen: So we are continuously, you know, encouraged about stay time. When we look at different groups of people, we see stay time is significantly longer for people that have been on Fexenda before. Maybe they are more prone to the usage of GLP-1. And we also see that stay time is significantly longer with people that are living in, so to say, more affluent areas, so more on the East Coast and in the South of the US.
Speaker Change #196: When we look at different groups of people, we see stay time is significantly longer for people that have been on Fexenda before, maybe they are more prone to usage of GLP-1.
Speaker Change #196: and we also see that stay time is significantly longer with people that are living in...
Speaker Change #196: So to say more affluent areas, so more on the east coast than in the south of the US. And so, you know, also in terms of age, we see stay time being longer for people older than 30 to 40 years compared to younger and so on. So keep in mind six months is really impacted by all these things.
Karsten Knudsen: And so, you know, also in terms of age, we see stay time being longer for people older than 30 to 40 years compared to younger people, and so on. So keep in mind, six months is really impacted by all these things. Having said that, you know, close to about 10 to 11% from Avigovi and so on. So there will always be some sort of changes like that. But the majority of all patients starting on obesity treatment are new to it.
Thank you. [inaudible] Thank you. Thank you. [inaudible] Thank you. Thank you. [inaudible] Thank you, Camilla, and before handing over to you, Lars, we'll find remarks. Thanks to everybody in the room for coming, and for everyone online for dialing in. In case of any follow-ups, please reach out to Investivalations. It's a great value, so don't need to worry about the price to script, so to say. A lot of questions are appreciated on Pipeline because we have a really exciting second half of the year, not only in growth, but also in terms of infliction points for Pipeline, and I think Martin had some good points there. So thank you very much for your interest. We look forward to share more details on all these aspects as they were.
Speaker Change #196: Having said that, you know, close to...
Speaker Change #197: More than 80% of the Vigovi scripts are to patients that are naïve to therapy, meaning they have not been on therapy before.
Speaker Change #198: So, of course, there are some switches between GLP-1s, but I think this is close to, you know, if we look at competition, they are sourcing probably
Speaker Change #198: around 10 to 11% from Vigovy and so on. So there will always be sort of changes of that. But the majority of all patients starting on obesity treatment are new to treatment.
Speaker Change #198: You know, just based on the fact that obesity really hasn't been treated to a large extent before. So we are still in the early days of a very low percentage of the total population being treated.
Speaker Change #198: Yep, same table.
Speaker Change #199: Hi there, another question if I may on Catalan. I wanted to ask if
Speaker Change #200: If you have a sense of how...
Speaker Change #201: Quickly, you can ramp up on the filth.
Speaker Change #202: Finish lines, because my understanding is that
Speaker Change #203: Most of them are under contract, that might take a while to...
Speaker Change #204: Thanks, bye.
Speaker Change #205: Thank you.
Speaker Change #205: Karsten, I'll give it to you. Yeah, we do have a good sense of that because that's the core of the entire acquisition case, to access additional capacity.
Speaker Change #206: So do bear in mind that we are already working with Catalan as a CMO, so there are lines working for Novo Nordisk already with Catalan. So what we're getting is additional capacity on the different lines at the different sites.
Speaker Change #206: and of course we honor the contracts that are in place with existing customers.
Speaker Change #206: So they have to run off.
Speaker Change #206: And then let's say the deal closes by end of this year, then we'll have to do technology transfer to the new lines also during 2025. So you would say additional capacity beyond what we have already contracted as a CMO will gradually start from 2026 and onwards.
Unknown Executive: Thank you, Karsten. Then we'll go to Emily. I'm sorry. Yeah, over here, same table.
Emily: Thank you, Karsten. Then we'll go to Emily. Over here, same table.
Emily: Hi, Kritika Thalia from Berenberg. Just a question on Wgovi access. So we've heard that certain employers have reversed their initial decisions to provide access to obesity medications just because of the escalating demand and associated costs.
Kritika Thalia: Is this a trend that you have seen? And related to that, could you just provide us an update as to your current formulary access, and specifically the proportion of covered lives that have employer opt-in?
Kritika Thalia: In terms of employer updates, Camilla, will you give that a go?
Speaker Change #208: Yeah, so, yeah, first of all, we have, you know, more than 50 million patients being covered in the U.S., so very strong access.
Camilla: and around 80% of them, 80% pay up to only $25 per script in terms of...
Speaker Change #209: When it comes to opt-ins, there will always be opt-ins and opt-outs, but we continue to have a net opt-in, so to say, of employers, so it just means that we continue to broaden our access.
Camilla Sylvest: Thank you, Camilla, and then the last question will go to Emily before we round off.
Speaker Change #209: Thank you Camilla, and then the last question will go to Emily before we round off.
Speaker Change #209: Emily Fields from Barclays. A somewhat similar question, but going back to the question of stay time, you know, how much do you think that
Emily Fields: Insurance coverage in the U.S. deflates or dampens stay time just with people switching jobs, aging into Medicare, and so they might not have coverage to that degree. I mean, do you see that as also a big dampening effect in addition to supply constraints?
Speaker Change #210: Yeah, so I think, you know, there will always be people that may opt from one team to another where they are not covered or so and that of course happens. But given that 50 million lives are covered, I think we don't need to be preoccupied with the potential in terms of coverage. Also keeping in mind on stay time, it's really in the first sort of 60 days that we really see the drop-offs.
Speaker Change #210: probably part of getting used to GLP-1 but then once people continue to stay on then they stay on longer so keep in mind that it's
Speaker Change #211: Six months is truly an average and you have to think about the variation in this.
Speaker Change #211: and so of course that's also why they significantly higher stay time for people who have been on GLP-1 before most likely because they have been
Speaker Change #211: They are either used to, you know, being initiated on DSP-1, knowing more what to expect, and therefore the average stay time is much longer. So think about it much more like that.
Speaker Change #212: We think, you know, we're treating a million patients now, but 50 million being covered, this is not what is, you know...
Speaker Change #212: together, to the point from before, scaling production to be able to supply more doses into starter doses so people can start and continue on the treatment. That's really what we're working on right now.
Speaker Change #213: Thank you Camilla and before handing it over to you Lars for final remarks thanks to everybody in the room for coming and for everyone online for dialing in. In case of any follow-ups please reach out to Investor Relations.
Lars Jorgensen: Thank you. I hope it comes across that we are very pleased about where we are as a company.
Lars Jorgensen: both in terms of our traction with
Lars Jorgensen: with SEMA and other products, not least in the US market.
Lars Jorgensen: We upgrade because we have more supply.
Lars Jorgensen: coming.
Lars Jorgensen: and we're upgrading value, so don't need to worry about.
Lars Jorgensen: You know, the price-per-script, so to say.
Lars Jorgensen: A lot of questions, I appreciate that on pipeline because we have a really exciting
Martin: second half of the year, not only in growth point of view, but also in terms of inflection points for pipeline, and I think Martin had some good points there. So thank you very much for your interest. We look forward to share more details on all these aspects as they evolve over time. Thank you.