Q3 2022 Novo Nordisk A/S Earnings Call (London-Based Investors)
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Can you give us citizens.
Good afternoon, all thank you for joining us.
And I got one more.
All of the banks will have to be in London.
Pleasure to have them the day after they've made your lifetime value from a stock price perspective.
Right.
Thank you Carsten to make some opening comments and then we'll go to.
Great. Thank.
Thank you and thank you took Goldman Sachs for hosting our quarterly London launch meeting and what an opening right. So it's a tough act to follow but there, but clearly with the dream team Ly like this with my good colleague said would it be Cal Scott from Red Sea. Some artsy lineup from development and committed to this day.
Our commercial strategy area than that then I think we're set up for a great session today.
We had.
Kind of an ultimate unfortunate situation yesterday without conference call that day.
Some people would say did you plan for that day.
And at least not web a sample size of one Matson will say, it's not enough, but the part that we cut the conference call and then we get the all time high on us yet price.
So I'm not sure.
If you can do any training on that.
That wouldn't be no trend.
At least at the <unk>.
Now looking on what would the all kinds of technical support today that the that this is being webcast at the end.
And out there just to follow that follow us to be aware about that.
So far.
For todays presentation, and we have brought to not too many sites. It will go through in the beginning and then in case there should be questions. Then we'll have time for that then.
And then we'll run off but I'd be surprised if that.
Wouldn't be a few questions on.
And four a decrease or whatever the flavor of today is.
So jumping into our interim statements and then of course.
As usual our forward looking statements.
That there is a risk that the future doesn't pan out in line with our forward looking statements.
It could be better it could be worse, but there, but that said the risks that we all live under and enjoy it.
And then just one slide on our strategic aspirations, which is basically how we portray the.
Progress in terms of our corporate strategy execution.
Without taking too much all of my colleagues presentations and then briefly on each of the quadrants purposes sustainability. This is a core area for US. This is ESG in then when Horst language, we continue to progress on the on our carbon emissions. So we're down 18.
In carbon emissions compared to pre Covid 2019.
And actually 18%.
Even not where we'd like to be way more ambitious than that we have some pressures from distribution of our products. So that's why it could have been even better but it's something that we're really driving performance management on.
In terms of adding value to society.
As of today, we are serving more patients than ever before in the history.
The company so of course, the core premise and the core objective of our company like Norsk is to discover and develop innovative medicine and make it available to patients on a global scale and therefore, it's not only a pressure based on the financials.
The share price that you alluded to but but even more importantly, with driving more patients than ever before.
We are progressing.
Progressing on our diversity and inclusion efforts and being sustainable.
Hello.
Commercial excuse me.
Go go through but.
But the 16% sales growth in the in <unk>.
In an industry like the pharma industry I don't know what the current run rate is but.
The last few years when we've been looking at evaluate pharma run rate for the global industry is to the tune of four 5% that's something like that so it will be.
Having a clock speed at a 16% is of course, clearly competitive and in the top tier of the industry.
And then.
Pipeline again as I said before this is why we're here.
This is to discover and develop innovative products for the benefit of patients and the.
And it's just really a pleasure to see the progress we're making both in.
Within diabetes care progress within obesity and rare disease. So as you'll recall, we are pursuing a cobra strategy, where we are.
Our expanding and diversifying our R&D pipeline and I think this is this is clearly picture in March and we'll come back to it.
Yeah.
Stepping up investments in R&D to expand and diversify the pipeline and then and then finally on financials, 16% translating to a 14% operating profit growth.
I'll come back to the details continued efficiency drive and a very competitive.
Cash flow.
Conversion and more than 40 billion returned to shareholders. So and when you look at our balance sheet. Then on an MHC basis were around 12% return on invested capital. So so fast growing high margin company with a 1% return on invested capital I think.
These findings folks like myself that said Thats metrics, we proved it in time.
So so with that I'll hand, the old you Camilla on commercial yes. Thanks, a lot the castle and let's just look at the 16% growth how that stupid.
And North America, and International operations, you see 22% growth in North America, 62% of Alex Yeah of close and then we have 11% growth in Io, that's driven mainly by growth in EMEA at the obligated and also in the rest of the world. We have as you can see a minus 5% in China that's related to the volume based procurement davita.
And that was in.
Amended as of May this year and when we look at how that is distributed across the therapy I should see that G. L. P. One driving 44% growth.
And negative growth in insulin both in Io and in North America.
And then obesity CAG willing 75% interestingly at 73% in IL without N V go Obi, but only from <unk> and then in North America combination of sand and Debbie Kobe growing 77%.
<unk> will come back to in a minute growing at 2%.
And if we then look at the <unk>, one class, especially in the U S. You will see a significant step up in terms of the market growth. This is also what we've seen the previous launches into the segment that the market growth keep expanding but now we are at a level where.
Volume growth is above 40% and we can come back to that.
How that is it being driven also by guidelines, but why did you see some call it that with Sam. Thank you Stuart and the leading brand in the cash part of call. It with the market growing so significantly volume growth becomes a much more significant let's say, it's an actual market share and developments and then add on.
Obesity is a here again, you see the 75% growth in the first nine months.
In the meter also a very strong volume growth of 63% and I'm sure we'll come back to how our rollout plans are in the rest of the world and also that'd be expecting to supply the Kobe and make all the doses available towards the end of this year, that's still the plan exactly as we also discussed.
Last time, when we met and with that over to Ludovico.
Madison is exactly very quickly just a rare disease franchise grew 2% in this year to date with the great growth on the rare blood disorder franchise all BD.
Driven by hemophilia, a hemophilia b and Novo seven as you can see still a growth of 6% of Noble's seven just to give you. An example for a part of that he has been there for 26 years, we'd see the growing a growing franchise.
And then a decrease in the endocrine disorder side, mostly driven by by pricing essentially because from a volume perspective.
The brand is clearly leader across the world more than 60% of market share in the U S around 36% worldwide.
So overall this price decline, mostly in the U S, which explain the 3% safety kind of North America was in I O.
It's a 4% sales growth. So we are on all sort of long term trajectory with 2% growth in it.
Year to date 2022.
Let me move to the <unk>.
The rest of the pipeline.
Vodafone cost, we're investing more than ever in R&D and that is leading to a very nice progress of our pipeline early research stage, but certainly also in supervised.
Super Nice progress in our clinical pipeline.
The development space.
More than ever patients in clinical trials more than ever active clinical trials and more than ever.
This is areas and we're seeing nice progress across the board.
So.
So in from the 50000 patients that we used to have and clinical clients as we speak I wanted to talk about 92.
And Thats basically because you are.
Let's talk about K, kusama and you'd be fitted space.
I think that we have an asset that will lead to a 25% plus weight loss in the obesity space that's exciting in and of itself. Hopefully you also noticed that we initiated phase III okay.
This week, which is going to be Super Super excited we did not know what to expect in the space of type two diabetes and placebo control.
Therefore, we conducted a very small phase II study 90 patients being equally randomized one okay kusama magnified immunotherapy, okay, great insight in monotherapy.
Super excited after 32 weeks of treatment to observe that we saw not only a numerically.
Potentially numerically better reduction in hemoglobin, <unk> <unk> as compared to <unk> and that was maybe not so surprising.
But equally excited about seeing the weightless no most of the rule.
And accruing weight loss in type two diabetes.
Actually more difficult than what we see and not by Peter So so both with magnetek, but also what anybody else is out there you see somewhat less weight loss in type two diabetes than what you see.
These patients.
But combining cartwheel inside.
And so banks outside that.
Leads to a 15% weight loss and 32 weeks, if we extrapolate that as usual six eight weeks is a 20 plus percent weight loss.
And that is better than anything we've seen in the type two diabetes space.
Now looking at a different slant on that now.
Maybe I should just look at my side, but that is okay.
You heard all my stories about cargo shipments that is super exciting.
I could do it without looking at the slide.
It is because it helps me someone easy number to remember because this gives me a great opportunity to it you also told upon what are we seen with I could take an almost five points.
<unk> four percentage point difference in agency superior reduction as compared to what it was out there that is also super exciting.
We have the vast majority of our patients.
Paul.
Sorry of our diabetes patients on insulin treatment scope.
More than $30 million.
Across the board.
And imagine that you can show eight 4% of the push different in this space.
Actually if I extrapolate U K P. J, if I could start talking about.
Reduction in <unk>.
Patrick vascular mortality reduction in all cause mortality, 20% reduction in risk of amputations.
That makes it meaningful for the individual patients obviously, but.
But actually also for payers and I think when when can we start to do.
Pricing negotiations for I could take that will make it to bring signing so obviously the progress of Iclusig and submission during the course of the first half of next year, there's going to be super exciting.
I don't want to call out in the beauty space. We also what we'll see.
The readout of high dose makes attack.
In that space 50 milligrams of <unk>. We also have a 25 milligram study ongoing in.
In the rare disease space.
Has already touched on that but suffice it to say super exciting to see the progress of my man. So we initiated my mate.
Weak.
And that basically means that we will and I hope you kind of agree with me that is an impressive record we will spend approximately four years of clinical development that has to be compared with the normal <unk> in hemophilia that we spend in clinical development.
Typically for Miami progressing very fast.
Now in phase III and you should expect.
Doc from the trial during the course of 'twenty four.
And then thank you Luca.
Thank you Martin.
Financial outlook.
So you've seen a nine months numbers, 16% sales growth really amazing pause on our on <unk>, one in diabetes as well as how obese franchise is comino was alluding to so that has enabled us to raise our outlook for the year from 12 to 16 to now 14% to 17%.
Sales growth at same crunches, and then you layer in the currency impacts another 10 percentage points, mostly from the strengthening U S dollar.
So so or when you look at the magnitude of growth for the company then of course in absolute terms. This is the biggest absolute sales growth ever ever in the history of the company at local exchange rates and then you add in the currencies. So so the sheer size of step up in growth is really remarkable in a historic setting.
That of course, it goes through to our operating profit performance, where we are raising our numbers correspondingly.
And we lose the currencies step up in hedging debts.
It's to be expected I think when you do are net numbers on hedging without going into details.
And our hedging performance this year.
Net currency performance. This year is very very attractive.
Even after after hedging costs and then finally, our cash flow to be clear how can how can you ratio outlook for the year in terms of sales and <unk> and then lower free cash flow and that's a very simple explanation to that because the reason is that we lower our free cash flow guidance by $3 billion.
Range, but the point that is a function of the fact that we close the formal therapeutics transaction in the fourth quarter at around 5 billion kroner impact to our free cash flow and then underlying benefit of 2 billion. So that's how we get to the net minus three on free cash flow. So excluding BD a step up in free cash flow.
Generation, which we of course had okay to shareholders. According to the classic principles around around a 50% dividend payout ratio and then the remainder is.
Dawn through share buyback program as we call it before so no changes on on capital allocation.
So these are our aspiration for 25 <unk> seen them before so I'm not I'm not going to reiterate that I'm I think we're ready to get into Q&A.
I think we have a long tradition of having the host.
Shoot off the first couple of questions and if we could just restrained.
Two questions each and then than we do the round says as we move forward.
Thank you Carsten <unk> Parekh Goldman Sachs, if I could start with two please the first one is.
In the unfortunate circumstance that Catlin Wall Street receive a warning letter for the Belgium facility between now and your relaunch date in kind of end of December early January .
Confident are you of maintaining kind of that date.
Is that going to be a function of supply from other parts of the manufacturing network or would you reconsider kind of pushing the date out. So that's kind of question number one.
And then separately.
Laws and you both kind of yesterday mentioned a few times about.
Confidence in maintaining current trajectory of growth and having supply kind of from a GOP one perspective to kind of continue doing Doc.
How should we think about the timelines associated with that was that kind of a fourth quarter comment was that a 2020 pre 2024 outlook. So just kind of any context around that thank you.
Thank you.
Yeah.
On the first question vis vis <unk>.
We do appreciate the sensitivity around.
The <unk> situation in the capital markets and as a consequence, it's not a comment that we take lightly and Ed and put into our company announcements. So so of course the comment we put in is based on a careful assessment around the current level of inventory is the fact that cats and is producing for inventory of commercial.
As we speak and then an assessment based on.
From a quality organization in terms of of the quality situations at our CMO.
So so.
Of course, there are no guarantees in this world, but we would not put this statement into our company announcements unless we're confident that we'd be able to re supply the U S market.
In December with the with the Goldman.
Then to the second point and your question around our forward looking commentary. So we put a statement in our outlook section.
Where we're basically saying that we are continuously expanding our supply capacity at the end.
And our assessment is that a potential.
That we have to supply capacity to supply. According to the current growth trajectory of the company and the reason why we put it in just to be clear was that.
In the beginning of that.
Section, we're talking about supply chain limitations.
Including for CMP. So this was just to avoid becoming overly concerned that we're not able to supply at all.
We're kind of kept at all at our current level of supply.
So so this is a comment intended as a as a forward looking statement that we're scaling and that we'll be able to cater for the current.
If that materializes based on demand the current level of growth.
Well I think we have enough questions.
I think actually just to make it simple for me. So it's another speed conscious than we than we thought.
Hello at the interim.
Now ask Joanne from interim.
Just a couple of questions on <unk>.
<unk> launch it looks like it got.
To almost 10% of total.
<unk> scripts and.
Just like a phenomenal launch in four months.
Two things one.
Some of that drives that or is there a big bolus of patients that need to dose intensify and therefore should we expect that growth to slow down when you can re supply and the <unk>.
Thing is there any reason to think that this isn't 25, 30% of total Olympics scripts in the in the years to come as patients progress from.
From the half makes it makes it a two meg and it becomes a big part of the business. This is not something that I felt that.
You guys are focused on mass really but I could see it feels like it can be a very big opportunity.
Alright, I think thats for you so you're absolutely right that we've seen.
Great I'll take rate coupons here so far.
And of course.
These opportunities in place to make sure the patient can continue on Santee treatment over time, and we also know from our initial data that not everyone is progressing to the one point or two from the get go. So some people at 2.5 and approximately half are progressing two one points. You. So you can imagine that over time people will be able to stay on aseptic filling.
And to find the treatment and being very good control.
Both with their blood sugar and the weight and of course also with the cardiovascular protection that was mtv's, giving them. So.
Youre right that over time.
The individual person is likely to upgrade but of course, as we see more and more patients coming onto S&P with a pulse of the market then it's likely that there'll.
That'd be a ratio of people on to part two but with many more coming in it's not so that this ratio is going to significantly differ from I would assume you know.
A quarter or 25% of the total.
Ballpark right, but that of course time will show, but its really identification on the same product that's the whole purpose of it.
Thanks Joanna.
Things will go to Microsoft.
Thank you Carsten small peso from Morgan Stanley . So two questions. The first one just going back to Oh.
The stack technology, so moving one squeak into <unk>.
<unk> clinical development. So could you help us understand where you are with the various generations of snack as you try to eliminate food and water interactions you work on the cost component and give us an idea of.
The advantages and disadvantages versus a capsule peptide, but as competitors entering the market as well as the oral small molecules, where we see a lot more tighter over the next six months, we'll say that's the first question and the second question is kind of going back to the ratios.
The message around some are becoming increasingly complex Hugo outcome trials such as.
Flow in stride and focus on one milligram injectable you've got.
You've got obviously two milligrams going to eight milligrams going to 60 milligrams than you have right. Both as a <unk> study, but then youre going to 50 milligrams and then the OTC Dovish I presume is going to go up as well. So how would you take all this complexity I'm trying to bridge accumulating evidence into the molecule to create a simple message given that some of your competitors.
Just far more simple messaging when it comes to doses, which they're using consistently for diabetes for obesity, so sleep apnea et cetera et cetera.
Thanks, Mark Martin if you were the first one on the on <unk> technology.
Technology and branding Zuckerman.
So I think you're exactly right. We are focusing a lot of underlying technology, because we want to win we need to increase.
<unk> ability basically to reduce the APL amount needed.
For the.
Efficacious and safe treatment.
Yeah.
We are currently in clinical trials and fourth generation.
And have made some substantial upgrades to the bioavailability that we have seen without going into too much details.
It goes without saying.
Will give us.
A good leverage on <unk>.
On the FMC part.
Our clear aim is actually also going a little bit too.
Question number two efficacy and the safety has to be on par with what we see in subcutaneous and actually while we have currently right now.
So this is.
Probably from an efficacy perspective somewhere between <unk>, five and one milligram of subcutaneous authentic all exploration news for 25, and 50 milligrams to be able to.
With $2 to $2 four milligram of Olympic and we'd go away.
It goes without saying, if we substantially increase the bioavailability.
There will be a little bit of a regulatory complexity and discussing the actual sort of doses because all of us Jordan what was 50 milligram.
And the next generation correspond to something lower but I think that for us at that point in time will be a luxury problem. When you talk about other formulations I think what we've seen so far and we are carefully monitoring. This technology is by far the most attractive in terms of securing a bioavailability of <unk>.
The peptide and protein.
Comparing to two.
Small molecules.
I think you know.
Precision on this I think there will be reasonably good when it comes to efficacy I think they will we still have to evaluate the safety, there's always some unknowns with small molecules.
My understanding is actually from an FMT perspective, there's not really a big difference and therefore, I think and Camilo can also talk to this.
The small molecules.
Place, but it will not be.
Sort of Super competitive from an efficacy and safety of all under FFC perspective.
Welcome.
As a vehicle to maybe also broadening.
The field.
Thanks, Mike.
Yes.
Zach molecule, it's clear that we are of.
Of course, optimizing the impact of this molecule can have on defined patient population and that also does for the fact that some of these proceeds areas are very different for example, diabetes very often driven by the physician in terms of specialists and primary care physicians and then you have the obesity segment that is sure to Alaska stand out.
Driven by demand from patients is easy to diagnose and you have Nash said, we are looking into and very difficult to diagnose. It at the moment requires a biopsy and then of course, we are going at it anti must also that is yet a completely different tack at group. So the reason that I'm mentioning all of this is actually that it can sound complicated when you look at it across but if you look at.
Each of the disease areas and a tactical welcome tends to have patients and physicians, we exited April with different.
As we have it also now Takeda for a specific group of specific key message that relates to that particular target population and we are also able format.
Rebating structure point of view to actually work with different segments. So that has some advantages of doing this plus at the very end, we are able to confirm.
<unk> and <unk>.
Detailed and promote directly on labor, which is of course very important for us to do and so whenever we make sure that we stay.
Very strongly in our business ethics, and with regards to what gets promoted to whom especially their tactical except doctors and and and this actually gives us a very flexible approach.
Thanks Camilla move.
Yeah, So farha.
Thanks.
Sorry, Sidney Richard Vasa J P. Morgan.
One question on <unk>.
Good day, and almost five look very very strong, but the type one.
Hi page was not to.
<unk> noninvasive wasn't non inferior what needs to happen for that and does that have any commercial implications when youre talking to pay us.
From that from a pricing standpoint.
And then second question just on <unk>.
Calgary time, or an <unk> combinations maybe.
<unk>.
Kevin It looks pretty good and on weight loss, but the <unk> was not really yet mongiello rate levels. It was better than us and people are not.
Jewelry, what can you do to further enhance the H B O N C control. Thanks.
So if I can take the last question first.
Okay.
As is.
Investigated and a 32 week study.
And specifically on <unk>.
Glucose control part of the effect is seen by the weight loss and that basically means that if we extrapolate that.
Weight loss over time into what we would say.
Richard Great timeline, six to eight weeks actually up to two years and in type two diabetes.
Our extrapolations, indicating.
<unk> on glycemic control.
Uh huh.
On a normal day be on par with Vascepa side and on a good day could actually also turned out to be superior.
And if you combine sort of the base case.
Or even the oxide with the weight loss that we've seen this will be the most attractive offering that we would have in it.
In type two diabetes.
Also because as we've discussed previously.
Previously the safety profile, Okay, Chris had met appears to be very very attractive.
So from that perspective.
You have to factor in the timing.
Of treatment and that's why we felt confident.
We will be able to show superiority of the mono components, but potentially also of potential competitors.
And I.
I could take.
I think the type one diabetes.
Is that something where we had to go into a dialogue on the risk of hypoglycemia as well.
We've also discussed even though.
We did see more hyperglycemia.
Aggregates that we did.
With the other basal insulins.
It was still at a fairly low level.
And therefore, the risk benefit discussions that we'll have.
Regulators.
I think we are still in a reasonably good place.
I don't want to speak to the commercial and enterprising negotiation that spoke of Mueller.
But overall the type one population.
Is sort of the minority.
In this space.
And my sense is that that pricing discussions will be based on phase sorry type two diabetes patients and this is where we see the superiority with on par.
The risk of hypoglycemia.
Okay.
Okay. Thank you.
Okay. That's helpful. Thanks, Good evening and thank you Richard answer Joe.
Jay Wilson Credit Suisse.
Wonder if you could give us an update on the <unk>.
<unk> sort of attitude of people and pay.
Given that there's so much publicity about these drugs.
I'll tell you is thinking God, if I don't put some restrictions I'm going to have unfettered demand and perhaps within that you could say, whether you're seeing any.
Jeff achieve people on.
So we're sort of five months with <unk>.
All people showing their enthusiasm for <unk> Z by staying on it so much longer.
And my second question is just a broad one on U.
U S pricing. So now that you should only raise your prices in line with CPI <unk> and CPI is so high is there an opportunity in 2023 to have your list prices high isn't used material you had historically because CPI will be 809, perhaps.
Which is most unusual.
<unk>.
Thanks, So maybe I'll start with the first one and then I think hey, Catharine wed like to speak to that next year.
No reinvestment attitude to watch and.
Same thing is of course generally very strong in markets that traditionally reimbursed when it comes to.
Weight loss products like <unk> and <unk>.
Colby then we have now 15 markets in international operations that have reimbursed extender of course it comes at a at a BMI normally around 30 or 35 every comorbidities in the U S. We have about 30 million lives covered so a very good starting point in general to continue at S. P.
Ascribing from all patients with reimbursement.
The attitude of course with and to watch.
And with <unk> to make sure that is not prescribed off label.
Is increasing the awareness is increasing he of course, we have the advantage that we have two different brands. So at EC ECR two.
To understand the document that we have been looking back at can we see it change India with empty patients that have been prescribed to naive to treatment patients.
Follow on after their vehicle launch.
And so we took one five years before the launch until up until July .
Yes, 'twenty, one and then and up until now and there has been an increasing trend of prescribing at tier one products in type two diabetes earlier that trend continues at an accelerated a bit after the launch of the COVID-19, but not significantly. So I just wanted to say that the trend of prescribing tier one products earlier too.
Two patients has increased a lot coming from guidelines from both ESP and and <unk> also and of course, we also then.
How well it works, especially video centric with a tree benefits it has including the cardiovascular risk profile.
That's a great understanding of that.
And then when it comes to real estate time on an on the go we we don't have new numbers to share with you, but we are following up on that and as soon as we have more to share we will share that but we do know from.
Thanks, and then in the countries where that is now being reimbursed that this day time of course is significantly extended class that we have seen in our data some vehicles that people continue to lose weight beyond 60 weeks. So that also gives us an indication that stay tuned is likely to be and much longer in the gobi than it has been traditionally.
On Tech Center.
Yes.
Yes.
On the inflation parents in the U S. In the most recent legislation.
I would say where it takes a baseline back to 2021 as you know and consequently.
We will face a minor negative impact.
Already here from the fourth quarter on products, where we have taken price increases.
One of.
The inflation since 'twenty one.
As to our list price increases in 'twenty three.
There is a multitude of factors that goes into auto just not under these price increases are first of all the benefits of the products, where we're providing and the clinical data supporting that for patients the competitive situation and of course your pricing environments. So so this is not the primary factor up but of course, we take all factors.
Into account when we make that decision. So no no further commentary around that because there's also a certain level of compared to competitive into Intel on that front. Thank you.
Yeah Jeffrey.
Can I just come back to legacy.
But a different question, which is.
If the facility were to have to temporarily close for any reason would that in any way impact your timeline and have your thoughts on the amount of drug you need for the launch changed at all since the start of the year or are you still aiming for the same if you like.
The different doses by the end of the year before you make that decision to launch.
And then can I just ask with next year, then when you bring on the other fill finish should we think about the first half with the second CMO and then the second half with the second Castleton facility.
This is sort of step from Shouldnt, given we're talking about to finish we're not talking about sort of ramping up API. If you like surface LNG comes online or is this gradual increase we should think can feel fill and finish capacity coming during the course of 223.
Yeah, so so as to re supply in the U S market towards the end of the year.
As I said before this is based on.
Our combined knowledge and the fact that.
I'm always is producing as of today and the required inventory levels two to launch that they are viable.
Of course, there are 100 scenario in the world that can can impact any parts of the business, but we would not put into our company announcement.
The fact that we are re supplying them unless we believe that that's relevant scenario speculating in all kinds of of hypothetical items are I don't think that any value.
Then then we would then we've now to put this wording in <unk>.
So next year end capacity as you state.
The second CMO.
It will go online in the first half and online means that they will be supplying to them.
Marketable product.
And then the second site get online in the second half of 'twenty three.
Consequently, we will have four different sites supplying fill finish sorry filling for the Kobe. So that will be step changes in filling capacity and of course additional backup capacity in that sense.
Simon.
Uh huh.
Sachin.
Okay.
It's actually James for America.
[laughter] I'm going to kick off with a comment you made on it yesterday with people trying to gauge off label usage and how much of the switches you made a comment around 40%.
Being naive to diabetes treatment I think was that in Rx OTC Rx could you give a sense of what that number was pre week Ov are you, indicating this is a potential switch population to pick up I just want to be super clear what the message was around that if that's okay.
Then the second question.
As you can imagine we go V supply.
I just had a really simple question on process. So having had before it's when you've been a receipt of it is there any FDA inspection or process, you're aware of that.
Could drive a decision change between now and launch or is it just status quo as facilities operation until you hear otherwise.
The background of the question is I'm trying to understand.
If there is a risk the timeline of when that risk would emerge for you and for the market and as part of the confidence you don't know everybody understand inspection and therefore, you can bridge the gap to your second facility.
Right.
So if we start with the so my specific comment was it was related to a question that the conference call around <unk>.
<unk> is also a business. So so source of business is basically new starts growing going onshore and pick and that was my comment as to the 40% and then the evolution on that metric Camilla.
So and we've tried to look at.
And the 18 months ahead of the Golden launch for peak and see what how what's the evolution in that and that basically moved with a delta that is very close to similar within 12 months. After the V. Go relaunch. So it's just to say that we are now at the Wisconsin said close to 40% in status.
One have you have out.
Around 17% and in the middle of <unk> launch just below a 30% or more around 28, 29%. So it's just to say if you look at those still says this of course doesn't give us the full answer but these are new to.
New to treatment and.
Patients on <unk> and so there is an increase in the trend, but not a significant increase in that trend, while we're trying to save the fall was that.
All along.
It started with having a lot of DSP one source of business and then it would move gradually to less and less of that so it's natural that moves early in earlier in the treatment landscape because the guidelines is now also recommending that.
Good and then a simple answer to a simple question on <unk>.
So we would not say that we plan to resupply the U S market in December NK cells major uncertainty based on our perception of the ongoing regulatory or quality process.
So I don't think that's any value to them to get into more speculative around to regulatory interactions and so on and this is based on our best assessment of the situation and I don't think we can give more on that.
Can I say it won't fall off so the increase in starts of naive from mid teens, when you said, 17% to 40.
On spec correctly how.
How much of that is translated into total Trs or what percentage of Trs do you think is naive to therapy. Paris. We gave you is an increase relative to before you would say this as a percentage of existing <unk> business that we're not quite sure. What's there may switch.
I wouldn't know exactly how that translates it's quite difficult to get into that but of course, if you look at the graphics that Michelle before you will see that the number of patients has increased significantly just due to the underlying market growth whenever there's a new launch into this segment, we have seen and you've been following this for many years ever since Victoza two leases.
The authentic and analysis appetite loans keeps growing and the underlying market. So of course this transformation from NPR extra Trs is a bit of a over time, it's difficult to compare directly.
And.
I think I won't speculate on that from here.
Thank you Tamara.
And then it's island.
Thank you Simon Baker from Redburn two.
Two questions looking firstly looking forward.
We've obviously had quite a big development issue in outside the us. So I just wanted to get your perspectives on the impact of the kind of map on outside there's more moving the point of view of.
Given the reaction to that data how does it change what you feel you need to do with smack Detroit.
And related to that is there any preclinical data on combination John Chamberlain GOP warm.
And then sticking with the pipeline on category, we call. The data looks really impressive we can't quite see from the slide because when a confidence intervals. So is is it additive with genuinely synergistic and if the latter what's the reason thanks so much.
So specifically on Alzheimer's.
Hey.
Research and development.
It made us even more.
Sort of enthusiastic.
What we have on our hands.
Yeah.
It's increasing the awareness of <unk>.
Potential treatment in this space.
We have to see.
Don't Misunderstand me a regulatory approval of what comes next the data so far looks good.
But they also have to be able to stay true to regulatory scrutiny.
I see this sort of as we just discussed will be used to I mean, there's no real treatment out as we speak so so being more than one player building establishing the market.
Plus we have a complementary mechanism of action to to what is in other companies' pipeline.
And that allows us to to establish the efficacy part of this and we would expect to have similar efficacy to what we've seen.
From other companies coming out with a drug that has.
Well established safety profile.
We'll be.
Really really attractive offering so.
I think you'll see us more enthusiastic than ever.
And we obviously are full speed ahead in terms of our development.
Now you'll have to remind me of the other two questions.
So the second part of that was is there any preclinical data on the combination on channel Lloyd and.
GOP, one and the second one was on.
Sure.
Additive.
January should logistical.
I'll give you two flop your answer to that one so.
Yes. They are preclinical data then on published we have them in house and we have them both on amyloid in hotel and it seems as if there.
One treatment has.
Impact on.
Central inflammation, neuroplasticity, potentially amyloid and Tau and that obviously gives us some confidence in that is a reasonable mode of action. In addition to what we've seen in the clinical space.
And then on <unk>.
Yeah.
It's a big big caveat in clients, who are doing that kind of interpretation based on 90 patients 30 in each treatment arm.
If we just take the numbers and also Duke.
What we call it the spaghetti plots of the individual patients.
It could be a potential for synergy, but right now we will settle with additive it because that again, we'll show superiority versus anything else out there.
Thanks Martin.
And I just need to move.
Go ahead.
Just a question on some supply constraints is the constraint fill and Justin and finish or is it API as well.
Yeah, So I'll take that one so.
So on the on.
It was simply supply constraints as we have.
In it in a number of magazine with issued.
Drug shortage notification, which is something.
The company has to issue when when demand is greater than supply. It's not that we're not supplying its just demand is greater than that than supply.
And we're not going into any details about where we're at where our constraints, but but again coming back to that that we're scaling our manufacturing platforms and we'd be able to cater for the growth trajectory. We are currently on when we look forward.
Got it.
Sure.
Okay.
Right.
So the guidance is.
As I said before the contract growth trajectory and then we're doing everything we can of course on our side. It is frustrating that we're not able to meet patient demands and in some cases, we will have to go and go with the product. So so we're we're not holding back and as you see right now on Olympic we're growing.
Year to date, we're growing 70% in value, which means almost double up in volume and so we're already scaling as we speak and we'll continue to do that into next year and then whether we meet full demand in all geographies. That's of course also folks about how the demand picture will look into next year, but the significance.
Also next year.
And yes go ahead.
From Morgan Stanley I, just wanted to get your latest thoughts on glucagon agonist.
And youll capacities here have Shane increasingly encouraging data. Thank you.
Yeah. So.
She also had glucagon agonist.
Pipeline.
You may have seen a publication that we should recently.
Talking to potential safety issues, specifically, obviously on all avenues, but potentially also in.
Sort of a broader class.
In fact, I can't speculate to that obviously, but I mean that at least our thinking that this could be.
A potential.
And in that space, we will duking it reasonable efficacy, yes, it's all good efficacy with our Tri agonist.
But we did also see the safety issues and then having both Egypt, one J P, but more specifically in our pipeline.
Risks to benefit was not really in support of continuing Oculus go on our approach.
I really have to stress we did see efficacy. It look good it did not look as good as <unk> and therefore.
Our confidence is based on the fact that calculus him appear to have the superior efficacy profile.
And probably also the superior safety profile.
Thanks, Martin then we have Michael Jordan and then if you can there.
Get ready after Michael.
Thank you two questions from marketplace, just on the ultra high dose in the phase II.
It's a step change in dose that's quite different from what you tried before just wondering.
Where that came from the go that aggressive on the dose ranging in all categories.
The tolerability in a phase two I think at the 60 something percent of Gi Tolerability in I think discontinuation is up to 20%.
<unk> managed to get that down in phase III, just wondering what you can do in phase III to get a better tolerability.
Super Good question first of all any Gi tolerability issue as a function of saturation in this space.
That would go to both of your questions specifically.
I'm going to higher doses.
We were actually following our normal step of a more or less doubling the dose we've shown that we can do that without introducing.
Multiple ability issues and based on what we know already now you feel confident that this column step increases will not introduce more tolerability issues that we've seen obviously, we have to show that that's why we do the clinical trials.
Our assumption is that when we get to that level.
Tolerability has already been built and you can actually do the next step.
Without introducing more Gi side effects.
The other part of it is actually and you see that from us in alpha from our competitors.
Side effects reporting in terms of proportions in rates is more often than not a function of how often do you ask how many visits to have that.
Why do you see.
Higher rates in early development and the order rates as we progress because you have fewer site visits as ubiquitous we also become wiser on how to titrate and specifically for <unk>.
It's Tom.
Don't Misunderstand me I don't think we should look at the actual rate because they are functional.
How did we how many visits that we have.
Okay.
In the study, but looking to the comparison to <unk> and.
And in that specific story.
Similar rate between some advertising.
And therefore, we are fairly confident that when we do saturation right.
I actually have a super attractive tolerability profile of <unk> with them.
Alright, Thanks Martin.
Hey, good marker party of a bunting. Thanks for the question. So first can I just ask on.
We'll go V price. Please I know you don't like to talk about net price, so I'm going to ask anyway.
Just first of all is it fair to assume there was no co pay volumes in the third quarter and if the answer is yes.
Net price it looks at about 28 Bucks.
Hey.
Is that a fair.
Estimated for the net price of will go V. And then maybe if you could just comment on the mix between cash and commercial volumes and then my second question for one for Maarten is at obesity week. This week, there's been a bit of discussion around the type of weight loss.
So there is a competitor drugs that have shown quite a nice fat loss, but.
Actually you saw an increase in in being met.
So I guess my question really is and if you look at that one I should say you saw a reduction in also lean mass so I guess how much of the.
This is considered by physicians today and as we think about.
The increase in weight loss with Calgary Summer does the quality and the type of weight loss really matter to.
Thank you.
Alright, Thanks, Omar so so as to as to net price I know you like to talk about that more than I do and at this meeting.
Then.
Yeah.
Then in the when you look at the third quarter than what I can say is that.
As to our early experience program, what we call. The bridge program correct, there's nothing of that in third quarter numbers, but but clearly that would be co pay support program, so buying down copay.
It will also be in the third quarter. That's that's normally you U S. Tactic. So so so as to your reflection about about the net pricing as you can see it's clean from the bridge program, but it's it's impacted by copay and classic rebate structures in the U S and as to the cash yeah, it's to the tune of 10%.
Yeah.
And then Martin.
Hey, Ryan healthy weight loss.
I don't want to call. It the next frontier, but it is certainly important.
It's also important for me to call out that debt.
What we call lean body mass as a function of water and mud.
Muscle mass.
And the way that we assess it unless we are careful doesn't really allow you to distinguish.
That also means that debt.
When we discuss either increases in lean body mass or losses of the body mass, it's not always one to one fat mass as fat mass.
No matter, how you look at it was always a magnetite was actually a modest decrease in lean body mass and a substantially bigger decrease in fat mass.
That is.
As good as it gets right now, but we also have a clear focus on obviously preserving as much lean body mass as we can.
While obviously introducing.
Substantial fed nationals.
It's too early to say, what we will see you will take with him. Obviously, we will look into this I think it's fair to say in a research effort.
We're looking very much into their social.
I think it's also important going back to Michael's question in how you titrate, how faster introduced the weight loss.
There is a risk if you introduce a very fast and dramatic weight loss you will lose.
Almost 50, 50 lean body mass and fat mass so the tempered, but consistent body weight loss could potentially be healthier than a very dramatic fast weightloss all of these factors.
Something that.
And I think all of those are looking very actively at.
Thanks Martin.
Christian Thank you.
Hi, Emily field from Barclays, you've talked about in the past about the inflation cap component of the IRA as being a limited negative I was just wondering if you could Brian any more color or context on the expected impact of the U S business.
Yeah. So.
So the function is as house covering before it's basically for the products, where we've taken this price increases on above inflation.
So the base.
First off Jan 2021, those products.
And then you can look at our list price history, you'll see it's mainly.
What was on our <unk> based products in diabetes.
As promised we would be exposed to too.
Inflationary potency, so and so to say already in the first quarter.
We have not called it out more specifically then it's it's it's not big enough to justify that normally when talking about anything beyond 3% on the U S business, we'd be calling out and since we're not specifying. It then it means that we're below that threshold.
Alright, then I need a time check.
Yeah.
One final question.
Anyone who hasn't asked a question. There then we go all the way sorry.
Okay.
This is good exercise.
All the way to the other end.
Yeah.
Yes, Richard Parkes from BNP Powerbar exam.
I just wanted to could you update us on where you think we are now in terms of penetration of <unk>. One in diagnosed diabetics in the U S. And then secondly on I know, it's been talked about indirectly, but off label use of <unk> at the moment in obesity, how much real visibility.
If you go around how much of that is happening in the U S. If that visibility is low how do you factor that into your planning assumptions.
Less certainty around how long patients stay on drug for an off label prescription versus <unk>.
Diabetes prescription for <unk>. Thank you.
Well go to Jonathan Ho Hum, so today around 10%.
T O P. One treatment is about 10% of U S volume.
And of course.
In diabetes, and then and when we talk about the Patel.
Potential off label use I think we talked to it earlier, it's difficult to estimate exactly the size of that but we have of course looked at the trends on the on the MBR exactly as we talked about earlier. So that's the closest we can get to giving you an estimate of that there is no significant change in the trend that was already there before the launch of <unk>.
Once weekly <unk>, one and obesity, but there is an increase in the trend, but not a significant stair step up.
And then there was the modeling of the switching between simply can't end to go over.
Yes, so and when we look at international operations I don't know Youre asking about the U S. But when we look at international operations, you see an increase.
73% in Tech Center, and you'll also see a very steep increase in <unk>. So you have those two.
Products in parallel growing significantly.
And of course, that's not that's the best sort of.
One to one Peter we can imagine why would also happened when we now start to supply.
<unk> in the U S. We are supplying to extent that now that also sort of obesity franchise growth.
Also in the Seventy's and U S. As of now why do we also see a continued growth of authentic that Kathy mentioned also 70% so.
Those two franchises.
So actually coexist at very high growth rates, because the underlying demand is very very big.
More than 700 million people living with obesity in the world and more than 500 million living with diabetes, and we are all together trading including Insulins just around 35 million patients.
No.
It's fair to say that there's still unexploited potential for better treatment for patients.
Thanks, Camille and I think that was a perfect way to end on a high note lots of potential for treating patients with or without years. Once in many years to come. So thank you for attending <unk> Q3 launch meeting in London, and thanks to <unk> and Goldman Sachs Phil for hosting this.
Fantastic resulted a fantastic venue and they're looking forward to see you all if not before then first in February when we come with our with our full year results and 2023 guidance. Thank you. Thank you.
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