諾和諾德 (NVO) 2014 Q3 法說會逐字稿

Well, welcome to London.

Welcome to the Novo Nordisk nine-month result meeting.

With me, I have a large group today and I will introduce them from -- well, first, I should probably say that my name is Jesper Brandgaard.

I am the CFO of Novo Nordisk and I've been so for the last 14 years.

With me, I have Mike Doustdar, who is our SVP responsible for running our international operations business and we have some dedicated slides included in this set today in order for us to dig a little bit into international operations.

And I also hope that during the Q&A that you will utilize this opportunity to also ask questions about international operations for this roadshow.

And then we have Jakob Riis, our Executive Vice President responsible for marketing and medical affairs.

And on the other side, we have Mads Krogsgaard Thomsen, who also for something like 14 years has been Chief Science Officer of Novo Nordisk.

We have our new SVP for corporate finance, (inaudible), who in summer came back from US.

He's been Finance Director for our US operations or North American operations for some four years and then finally with us, we have Lars Furergaard Jorgensen, who is also Executive Vice President and responsible for IT and corporate development and quality.

So that's the team.

It falls on my shoulders to introduce what we're going to go through today and of course, we're going to have an agenda that includes the usual topics.

I've been designated that I can be allowed to cover the highlights and key events, then Jakob will cover a sales update.

Mike will go through key facts of international operations.

Mads will do an R&D update.

Karsten will go through the financials and I've been allowed also to conclude.

So I got four slides in total, which I should be able to manage.

The first one is, or the second one is that we need to be careful about making statements about the future.

Event may evolve differently then we anticipate, so do read this with a lot of care.

And then if I move to the next page, which is really what are the key events in the first nine months of this year.

And first of all, we're seeing a pickup in Novo Nordisk growth levels.

We did grow 10% in the third quarter and that took our growth rate on a year-to-date basis to 8%.

We also saw a deceleration of the negative currency impact we had and it's now down to 4% where it was 5% at the half-year.

So a reported 4% growth in Danish kroner and Karsten will get back to how the impact of currency is on Novo Nordisk going forward as we have a significant change in the situation looking ahead.

In terms of growth, the growth component on a geographical dimension, growth has been driven by China, by international operations and North America growing 11%, 13% and 14% respectively.

The modern insulins have been growing 13%, driven particularly by Levemir, which has been growing to the tune of 29% and that has been spearheaded by the performance in North America, which has been in the ballpark of 40%.

So a very strong performance by Levemir in the North American market.

Victoza, we've also seen a pickup in growth for Victoza in the third quarter and reporting more than 20% growth in third quarter and a 15% growth year-to-date in local currencies.

And Victoza continues to drive the growth of the overall market with a capture rate of about 70% of new patients.

Tresiba is our new basal insulin, doing really well within 1.5 years in Japan.

It has captured a quarter of the market.

We're very, very excited about the opportunity for Tresiba around the world and Jakob will get back and give you a bit more update on that.

On research and development, Xultophy has been approved now in Europe.

Remember, Xultophy is the combination of Tresiba with Victoza, liraglutide, creating a combination that is unique in taking type 2 patients to good control.

In a number of trials, we've been able to demonstrate that around 80% of patients can get to target control of an HbA1c level below 7 in the trials with Xultophy.

So exciting to be able to roll that product out for Novo Nordisk in 2015.

In terms of Saxenda, which is the 3 milligram version of liraglutide used for obesity, it's filed in the US and Europe.

It's in regulatory process.

We had a very positive advisory committee in North America with a 14 to 1 vote in favor of approval and we are in constructive dialogue with the agency and awaiting feedback for them on the approval.

And then, finally, we had to conclude following the failed development in Phase 2b of our anti-interleukin 20.

We had to conclude when we looked at the overall portfolio of inflammatory activities that the likelihood of Novo Nordisk being able to provide a reasonable return on the investment for our shareholders was not very forthcoming with the inflammatory diseases and consequently, we've decided to terminate that and we've taken a one-time charge in the third quarter of DKK600 million in order to close down those activities primarily being a write-off of intangible assets invested in that area.

On the financials, you've seen an 11% growth in operating profit in local currencies.

After nine months, we saw a slightly lower level of operating profit growth in the third quarter alone.

But do bear in mind when you look at the third quarter that we have taken two significant one-off charges.

One, the one I just talked about in inflammatory, inflammatory diseases making a DKK600 million write-off for discontinuation there and on top of that we have, because of the changed way that the manufacturer has dropped fee in the US is being accounted for, we have taken a one-time charge of some DKK400 million to our selling and distribution costs in the third quarter, de facto actually expensing in the third quarter five quarters of expense to the manufacturer's fee and as a consequence, you could -- if you adjust for these two factors of a non-recurring nature hitting our P&L in the third quarter, you would see in local currency terms more than 20% growth for Novo Nordisk in the third quarter.

We have updated our sales growth for the full year and we have zoomed in on the sale growth guidance and are now seeing 7% to 9% growth and in that growth guidance is a reflection of a slightly lower growth level in China.

We are seeing that the level of economic activity in China is coming down and with that, the volume growth of insulin and we're also seeing that the ability to grow newer products in China is being hampered by the more restricted access that we have to physicians and hospitals in China.

So those two factors have actually impacted our Chinese business and we are now more seeing a growth level for China around 10%, whereas we previously were watching 15% growth year-on-year.

In terms of operating profit, we have maintained the guidance in local currencies of an operating profit growth of around 10%, but do bear in mind that we are doing that despite having taken these extraordinary charges in the third quarter.

We still expect to keep it around 10% and then for 2015, we are expecting a sales growth in the ballpark of 6% to 9% growth and then for operating profit, it will be higher, approximately 10%.

Of course, we have a relative easy comparator as we've taken the DKK600 million charge for closedown of the inflammatory diseases.

If we adjust for that, the growth in operating profit next year is going to be at a similar level as the growth in sales, all in local currencies.

And also do bear in mind that we will have a significant positive impact on our growth next year both in terms of sales and in terms of operating profit because of the higher level of the US dollar.

So if that's maintained, you will see the higher growth level.

I think Karsten will refer to that.

So with those introductory comments, I will hand over to Jakob.

Thank you, Jesper.

I'll be brief.

I'm between you and Mike, who's sort of the special feature here and I think the numbers are mostly known.

So a quarter that doesn't distinguish itself from previous quarters inasmuch as North America continues to be the main driver.

I'd like to focus a little bit on Victoza here and showing to your left here the continuation of the growth of this segment that has come down and is now a little bit less from a segment point of view below the 10% mark.

We make up a part of that as we continue to take share and remain very solid with about two-thirds of the market.

If we look at the Levemir performance, that has been very strong.

You can see here North America growing 46%.

In the other growth regions, IO and China, Levemir is also contributing, but, of course, in absolute terms at a different level.

Europe, low growth and no contribution this time from Levemir, small impact on the ongoing Tresiba launches.

Where we see a significant impact is in Japan where Tresiba is now 25% of the segment and that obviously has an impact on the growth here, which is minus 21% for Japan.

To the right, just to show from 2011 and onwards the steady and increasing share of the basal segment in the US with Levemir.

Tresiba, a bit more on that.

Also here a continuation that we also showed in previous quarters, a continuation of the strong penetrations in most of the markets where we've launched.

There are some outliers here where market access is constrained, UK and Denmark, but apart from that, we take a very significant share in the basal segment and we're reaching now in Japan the level of about a quarter of the market.

But markets as Switzerland, India Mexico is also doing very, very well.

The last slide I want to share here on Tresiba is just zooming in on the Japanese market to show how does it look when Tresiba takes a quarter of the market.

And you can see here the dynamic we had up until the launch of Tresiba was we saw a steady increasing share of glargine.

We were losing share in the basal segment.

After the launch, our overall share has gone up and we reversed the trend, so glargine has come down.

What we also see, which is very positive, is that in the total insulin value marketshare, after years of steady decline after the launch, we are now, and a little bit into the launch, we are now at a magnitude with Tresiba where we reversed the trend and are beginning to gain share in the overall insulin segment.

I think that was brief, but intended to be so and then over to you, Mike.

So I'll use one slide basically to just brief those of you guys who are less familiar with international operations what it is.

It's a combination of 153 markets for us in IO, which spans from Australia all the way to Latin America, up north-Russia, down south-South Africa, combined with very different diversities.

We manage this with six different business areas.

You see this in different colors.

This is a part of the business that has been growing double digits for many, many years, the last decade or so.

Jesper alluded to it.

We have done 13% growth the first nine months, 16% in Q3, up this year and now our 23% of share of the growth of the Company and 14% of the sales.

We do this with 4,500 employees and we basically sell more or less the same tune as the rest of the Company, diabetes split versus biopharm.

So 77% of the sales is coming from diabetes; the rest is coming from biopharm and with relatively high volume marketshares.

Now what most people that I talk to do recognize from international operations is this part of the graph.

This is where the diabetics of the world really are living.

According to IDF, there are 382 million diabetics and 207 million of them are in what we call IO and together with, of course, China, this is really also the part that is growing, that has been growing and will continue to grow.

What some people don't know about international operations is that even in this part of the world, which is to a large extent combinations of countries that have very low GDP per capita compared to the Western Hemisphere, we are larger than all of our competitors combined.

And that's, of course, Sanofi and Lilly, but also all the biosimilars here.

And that's the part that I think most people find a little bit fascinating because, in these places, then logic tells you that because quite often we sell the products out-of-pocket, there is no insurance, then why people are opting for Novo products and Novo prices and then there are number of reasons for that we can get into later.

But the reality of the matter is that not only we are the majority marketshareholder both in volume and value in an ever-growing market, we also sell most of the sales from our modern insulins and devices.

So two-thirds of my sales comes from analog insulins and next-generation insulins and one-third from human insulin and 60% of the sales is coming from devices.

Even if you look at it from a volume point of view, approximately half of the sales is coming from modern insulins.

So that I think is something quite nice.

Now it doesn't come without challenges.

I think there's a lot of different challenges in this part of the world as well.

First and foremost what we talk about nowadays is macroeconomic challenges that both us and China to some extent are facing.

As the capital flow to emerging markets is decreasing, you're seeing a situation where GDP growth rates are coming down by a couple of percentage points compared to the turn-of-the-century and it's projected also to go down further a couple of percentage points for the next three, four years.

And that, of course, does make an impact on the pharma market in most of these markets.

Also, some particularities that impacts us shortly, actually short to medium term, is when the oil prices go down.

We have a number of our key markets, if you take Russia as an example, Saudi Arabia, Iran, Algeria, most of the Middle East actually, which are good businesses for us and quite often the purchaser is the government, they are financing the various different either tenders or Social Security systems that they have via their oil exports.

And when the oil price goes less than $110 per barrel, then there's less money -- their country goes into deficit, there is less money for pharmaceuticals and that impacts us.

I think the good news is that it impacts the car industry more than it impacts us.

We sell insulin and everyone needs it.

So at the end of the day, depending on our negotiations, the impact of it is less so, but it is there.

And then when you have 150 markets, there will always be political conflicts and security crises.

A decade ago, we talked about Afghanistan and Iraq; now we're talking about ISIS in the same region and Ukraine and Russian situation is not helping anyone.

But, again, the sheer number of the countries helps us to focus in places where there is less security problem and then hopefully balance the whole thing out.

And financial instability is the same.

I think for a decade we've been talking about Argentina and their near collapse and all of you guys also are very aware that we have lost quite a bit of money during the last 18 months or so in currency depreciation.

Many of the local currencies of these markets have depreciated.

The good news is that a number of them are coming back up, but still I think this has been a challenge for us.

Now on the positive note, I think, as I mentioned, we have the tailwind of demographics and epidemiology and that, of course, really, really helps us to be able to balance some of the challenges that we have when you look mid to longer term.

If you take a look and ask what we do, we typically go to new markets and open up offices.

So right now, we have a lot of focus on opening new setups.

In Southeast Asia, in Latin America in middle Africa, are places where we see stability has increased, infrastructure is fastly being improved and the wealth of those markets are increasing, so we set up our own setup rather than use the various distributors or agents that we historically have been using and we will continue to do that.

On the other hand, we make sure that these millions of people who are diabetic and their physicians are aware what diabetes is, so we do a lot of education with them and make sure that not only we have diabetes in these regions, but diabetes who understand what the disease is and what the treatment paradigms available to them are.

And lastly, we make sure when then they are on our insulin and our products then we do the same as we do everywhere else.

We upgrade them to the more modern medicines, as I mentioned to you also and this will go on for a very, very long time.

We make sure if they are on human insulin, then eventually we move them on modern insulins and from modern insulins, we will give them the Tresiba and the degludecs of this world and continue doing that as we will have newer products.

And I brought with me one graph that shows an example of that from Tresiba launch in Mexico.

We have launched Tresiba in eight of the international operations markets and plan to do a number more going forward, but you can see here Mexico is a place where we are basically out-of-pocket with our Tresiba, but also with our Levemir, but also Lantus and the competitors are also out-of-pocket and after about less than a year, then we see a very good uptake and this slide already is at 14% marketshare if you update it with the latest numbers that we have showing how a good launch in a market like that is able to take our total insulin marketshare actually up.

So that was from my side and now it's Mads.

Thanks, Mike.

So talking about Tresiba story, as Mike just alluded to in Mexico, we also have a US situation as you are all pretty much aware and generally speaking, the DEVOTE trial, which is going to cater for the, we hope, the cardiovascular concerns of the agency as expressed at the advisory committee meeting a long time ago before the complete response letter, we are now getting very far down the road of having recruited the patients for the DEVOTE trial.

Hence, we are now speaking about hundreds that remain to be recruited rather than thousands, i.e., we are approaching the full recruitment of the trial.

Now what has happened since the last quarter when we were over here about three months ago is two things.

One, on the one hand, is that the FDA has had the advisory committee meeting on the use of interim analysis for cardiovascular outcome trials in the diabetes setting and the other is the more specific guidance that the agency since then has, you can say, issued to Novo Nordisk and discussed with us and that makes me happy to provide an update that what we're saying now is that inasmuch as we'll have the data to support the interim analysis early 2015 allowing us to, if we submit the class 2 resubmitted NDA based on the interim, do that in the first half of next year.

What is the news that we're now seeing that we will decide and communicate the decision to submit or not based on the interim and that will happen as soon as the unblinded small team that is going to work with the interim data, unlike the rest of us, who will know nothing and neither will the market, in order to preserve the integrity of the residual DEVOTE trial.

That decision to submit or not will be communicated as soon as it is made and then, obviously, even when the FDA acknowledges the receipt of the file and decides to review it, we will, of course, also inform the market.

Now that basically means that we see no change in the risk assessment associated with Tresiba or the cardiovascular outcomes associated with the DEVOTE trial, but the approach with which we are going to come to the US market is now based on both generic and more specific guidance from the FDA and as listed up here.

If we then move to Xultophy, yes, we alluded to the notion that the world's first and only combination product between a long-acting GLP-1 and a long-acting basal insulin preparation, also known as Xultophy, has been approved by the European Commission with a very strong label.

It's a label that has everything you'd ask for in terms of the clinical claims as related to efficacy, as related to low hypoglycemia rates, as related to even a weight loss in the presence of patients who have been on prior insulin therapy and even basically a chart showing what is on a meter analysis basis the relative risk of getting hypoglycemia at any prevailing HbA1c level where you can see exactly reduced even compared to Tresiba.

So we are extremely happy to confirm that Xultophy will be rolled out in the first countries in the first half of 2015.

Obviously, in the US, Xultophy is part of the degludec family and is subject obviously to the DEVOTE analysis.

Other key development milestones, semaglutide is well underway.

SUSTAIN program has enrolled five out of six trials.

The sixth one will complete -- or sorry, will be initiated very, very soon.

Also in Japan, we've initiated a specific comparison trial against a DPP-4 inhibitor.

We've completed two rather sizable Phase 1 programs, one with 100 to 200 and one with 200 to 300 individuals subject to treatment with either analog 987 in the [JIVET] carrier system or in the [SNK] carrier system.

And the data are promising and show that there is a statistically significant and clinically meaningful weight loss on these once-daily tablet administrations.

Also, we've initiated yet another insulin analog into clinical development called LAI338.

Importantly, Saxenda, as you know, has been through in the realm of weight management, a very exciting AdComm on September 11 that came out with a 14 to 1 vote in favor of approval and since then, we've been in constructive dialogue with the FDA and we are awaiting their verdict, which we'll communicate as soon as we hopefully hear from them in the very near future.

G530L, as some have speculated, is indeed a stable liquid ready-to-use long-acting glucagon analog, not for the treatment of emergency treatment of hypoglycemia, but rather for the combination treatment together with liraglutide of that meta-semaglutide in the management of obesity.

It is thought that there is a synergistic action at very low dose levels of glucagon when used together either as the fixed ratios or in other versions of dual-acting formulations.

In this case, it will be a fixed ratio that we are developing together with a long-acting GLP-1 analog.

Jesper has already alluded to the notion that our inflammatory disorder therapeutic area has been discontinued and I will not dwell further on that.

So with that, over to Karsten for the financials.

Thank you, Mads.

So as you saw on our reported financials, then our sales growth in the first nine months was 4% reported or 8% in the comparable currencies.

On the back of 7% in the first half year, that drives a 10% growth in the third quarter.

And on the more discretionary basis, then remember that we had Prandin go off patent, have biosimilar competition mid-last year and that has been washed out basically with Q3.

So that is going to be out of the comparison numbers fully starting Q4.

It has like half effect in Q3.

So when we look at our gross margin, then you see 100 basis points reported improvement in our gross margin or 120 points underlying driven by pricing in the US product mix where we operate through more high-margin products.

That would be our modern insulins, it would be Victoza, it would be actually less sales of Prandin in the US and then there's a slight negative impact due to the fact that there are (inaudible) sales growth in the third quarter or year-to-date was below average.

Then, finally, then we have productivity gains to the tune of 30 basis points also supporting our gross margin driven by our improved capacity utilization, first of all, but also due to some discretionary impacts in the first nine months of last year.

Looking at sales and distribution costs then, you see that down 2% reported underlying the up 1%.

We have the manufacturer's fee in the US you heard about earlier impacting roughly DKK400 million being booked in the third quarter of 2014, a nonrecurring impact, but that, of course, impacts the ratio by some 78, 80 basis points.

R&D costs, 21% growth reported.

When we look at underlying, then we're at 15% if we exclude the charge related to closedown of information as you see listed up there at DKK600 million.

Again, a non-recurring charge impacting the third quarter.

So if we say adding the manufacturer's fee and the information closedown, then we are roughly around DKK1 billion of non-recurring charges impacting the third-quarter operating profit growth, which was 9% underlying.

Then if we go further down operating profit reported, 5% year-to-date or 11% in underlying terms.

So a solid improvement in our margin in underlying terms of 120 basis points.

When we look at our financials, then we still have a hedging gain, but I'll come back to that with the change in -- or the strengthening of the US dollar then we see that changing in the quarters to come.

As goes for our tax rate, then it's 22.5% for the first nine months, so it's up slightly compared to when you saw the first half-year result, which again links to the US manufacturer's fee that is of a non-deductible character.

So again, it's a non-recurring, but that increases our effective tax rate by some 30 basis points for the full year.

And then we caught up so to say in Q3 for the first couple of quarters, so that's why the tax rate in Q3 in isolation is about 23%.

So again, that takes us to a net profit growth of 4% and earnings per share up some 7% driven by the share buyback program of 2.5% to 3% this year as compared to the same period last year.

When we look at what's happening on currencies, then we put it in two buckets, so our main currencies that we hedge and then our side currencies.

When we look at our main currencies, the big change compared to when we report for our first half-year result is that the US dollar has appreciated some 6% against the Danish kroner.

So last time when we reported, then we based it on a US dollar rate of DKK5.55 per $1 and now we are -- in this chart, we are basing it on DKK5.87.

So we've seen a steady strengthening of the US dollar since Q2.

That has a positive impact both on this year, as you will see our reported impact currency conversion is more favorable.

It's still negative, but more favorable and then when we look at the guidance for 2015, as Jesper covered in his opening, where we talk about a high single digit sales growth, that will have, in rough terms, a 3% positive currency impact when we go to reported numbers.

And when we look at our operating profits, then that will have a 5% positive currency impact at the current dollar levels for 2015.

So looking at our non-hedged currencies and now we have Mike with us also today, so very strong underlying sales growth in IO, as Mike covered.

In reported terms in the first nine months, we had 1%.

So we see some depreciation of a lot of the key currencies in our international operations, most notably, of course, the Argentinian peso, the Russian ruble and the Turkish lira.

Then when we go to the financial outlook for 2014 and going through what are the main changes, then in terms of our underlying sales growth, then as we get closer to year-end and of course, we narrow the interval with which we are guiding.

So now we take the interval from 7% to 9%, so slightly lower than what you would say at Q2, at least the top point and that is driven by the fact that we have softer (inaudible) sales, especially in Europe as you've seen in the Q3 numbers and then also in China and the overall Chinese market growth being slightly lower than what we saw earlier in the year.

Then when we look at our operating profit growth, then we maintain our guidance there around 10%, so meaning that we're basically able to cover the DKK1 billion I covered before in non-recurring charges in Q3.

So we are able to manage that within our current guidance.

Effective tax rate we have is slightly tweaked and that's back to the US manufacturer's feem so now we're around the 22.5% effective tax rate, which is where we expect to end the year.

Then the final changes related to depreciation and amortization that we take up from DKK3 billion to DKK3.5 billion and that's linked to the closedown of the information business that we covered before.

So basically write-downs of tangible and intangible assets in that respect.

So that covers the financials and over to you, Jesper.

Thanks, Karsten.

Basically a short roundoff.

Basically, we are in a market which is characterized by 10% value growth year-on-year.

The diabetes care market is driven by our insulin franchise.

Our insulin franchise is on a moving annual total growing 10%, so that's the cornerstone of Novo Nordisk.

We have a leadership position in insulin.

We have a leadership position in GLP-1.

Those are the two key drivers.

We've got a great portfolio of insulin.

We've got a good portfolio of GLP-1.

We've got a combination product that will be unique in getting type 2 patients in control.

We have Saxenda hopefully on the way to the market in Europe and US providing a new opportunity for Novo Nordisk, but I do note that this is a market that is very, very immature and modest in size at this point in time, so we will have to build the market.

Building market takes time, but it is, of course, a significant potential and then we have a promising pipeline within hemophilia and also have a longer-acting growth hormone in development.

So with those comments, I will hand over to Q&A.

And I think the first one I will start with as our host will be Michael.

Over to you.

Thank you.

It's Michael Leuchten from Barclays.

Two questions.

One, you made very clear yesterday that your outlook in terms of pricing for the US market is flat to slightly up.

If we look at the US market from a volume perspective, is there any reason to believe that managed care can make this market more dynamic than it has been in the past, given that it's been one of the features of this market, the stickiness that has really protected it?

And then the second question, it's an unusual year for Novo.

You've got four launches if Saxenda in obesity comes through in the US.

I think four launches in parallel is unusual for Novo.

What does that mean for the organization in terms of resource allocation, phasing, and just distress on the organizational role?

Well, thanks, Michael.

First, I think the motivation in the US is probably on top currently, having recently been praised by the Chairman of our main competitor for doing an outstanding job and making their progress quite challenged.

So I think the motivation there has been top, and they are certainly motivated to do a good job with the portfolio.

You're right in alluding to the assumptions that we have -- the high-level assumptions that we've built our forecast for 2015 on in terms of price impact on gross margin will be roughly neutral, and the sole positive pricing impact we have in 2014 is coming from the US market.

So I think it's reasonable to assume that that will be roughly flat next year.

Of course, still depending a little bit on how list pricing increases will evolve over the next 15 months.

In terms of the volume impact, I think my high-level comment would be I would not at this point of time anticipate any significant volume changes in the US market in the insulin space, whereas in the GLP-1 space I think it is an interesting situation with a new competitor, Trulicity, offering clearly a better offering in the once-weekly segment than what has been there before.

And that could potentially lead to an expansion of the GLP-1 segment.

We would certainly hope for that that would occur at the expense of OADs, as there is a very, very significant proportion of patients solely treated on oral treatment in the US which are inadequately treated, not reaching the HbA1c targets desired.

I don't know, Jakob, whether you have more detailed comments on volumes in the US and also, of course, on the portfolio of launches next year.

No, in short, no, not to the volume.

I would agree with your comment there.

On the launches, yes, we may face a challenge.

We've learned that we've got to take them one by one as they become a reality, because too much planning may not make sense.

There's always going to be uncertainty around it.

We have -- a potential launch of Saxenda is going to target a very specific and small subsegment of the prescribers in the US, and we're only going to allocate a smaller proproportion of the field force to that job, which means in the diabetes space we're open.

Should we get in that we get Tresiba, that's a first and a very, very high priority.

We need to get that into the market before potentially Xultophy will then arrive a little bit later.

What we do in biopharm with no wait, for instance, next year is from the biopharm part of the business, so no sort of spillover or disruption effect of that.

So it's going to be a challenge but a very positive challenge.

And if need be, you could say it will also offer growth opportunities that will allow us to potentially further strengthen our footprint in the field should that be warranted.

But with what we have today, we can launch the assets.

Longer-term, we would potentially expand to remain competitive in all the segments we're then active in.

Yes, I think the comment that Kare Schultz made, our Chief Operating Officer, he made yesterday in terms of need for expansion of sales force.

At present, we believe we have the sales force that we need to be competitive.

And the outlook we hae given for our operating profit performance in 2015 is based on current sales forces.

If the competitive situation should change, of course, we may want to look at that, but not build in in our current expectations for 2015.

Peter?

Peter Verdult here from Citi.

Two questions.

I note with interest that you start off today with the messaging about international operations and the growth outlook there.

At the same time, it's fair to say you were let off pretty lightly yesterday in terms of questions about the situation in the US.

So you've clearly caught Sanofi on the hop for 2015.

You'd have to assume they're going to try and come back somehow.

And then thinking to 2016, the payers are going to be thinking about your attempts to hopefully be launching Tresiba with unrestricted access, and also biosimilar insulins.

So I know you get asked this every quarter for the last 10 years, but why are we not in the endgame now as it relates to US pricing and reimbursement?

And then secondly to Mads, on Saxenda, the market's reacted pretty -- sanguine reaction to the PDUFA passing and no news is not the most logical conclusion, essentially, that the label FDA wants to grant you is not the label you're looking for, and that's basically the reason why we haven't heard anything.

Thanks.

Thanks, Peter.

If I give the opening comment, then maybe Jakob also wants to get some additional comment.

Well, first in terms of having Mike here, well, the way we plan roadshows is not something we do very opportunistically on a Monday morning when we're going to London on a Friday.

No, this was planned half a year ago and we thought it would be important for the market to get an insight into the long-term growth opportunity that international operations do provide.

And I still hope that there will be a few questions for Mike when we now have brought him here, but let's see how that plays out.

And then secondly, on the US environment it's clear that the comments we've given have been as regards the competitive situation for 2015, as that's where the formulary has been negotiated.

It is apparent that both the two major players in the US have ensured that there are access on quite similar terms to something like 90% of the insured lives.

So the key focus have been to provide patients and physicians with choice, and that's been secured for 2015.

It's also, I think, apparent that the payers have had concerns in their minds in terms of duration of contracts as they would anticipate that there will be changes to the market.

And I think that's part of the reason why we've, to a very large degree, have solely made contracts for 2015 and not with a longer duration.

So I think you're right in predicting that there will be negotiations occurring regarding 2016, as more clarity on the product players in the market at that point in time.

But I think it will be highly speculative to basically at this point in time anticipate fully what happens.

The way I look at this from a helicopter perspective, I think it's evolving into a scenario where you will have three generations of insulin on the market.

And if we just take the basal segment as an example, and this also covers more than 50% of the value in the North American market, then you'll have human insulin with NPH insulin where you have currently Eli Lilly and Novo Nordisk.

It's a low proportion of the market, but it will still be relevant for segments of the markets like Walmart, like Veterans Administration, the Kaisers of this world, who want to look for very affordable care at low cost and still probably be acquiring the insulin in vials.

Then you have a medium-priced segment which will be the likes of glargine, and will probably also over time if we assume that we will have Tresiba approved to the market, it will involve Levemir and generic versions of glargine.

And that is more and more being offered in devices.

We're seeing that something like two-thirds of the modern basal insulin is now being provided in devices in the US.

And then you will have a high, very premium end of the market probably covering a U300 version, assuming that will be approved of glargine potentially, a pegylated version of Lispro being there, and then our Tresiba.

And that probably will be priced at a higher end, offering even better blood sugar regulation at a lower risk of hypoglycemia to the patient.

So that would be my anticipation of how you should look at the market for 2016.

I don't know, Jakob, if you've got additional comments.

Yes.

Well, you could say everybody's looking for sort of -- there's a trigger of a dramatic new development.

I think the case we're making here is that what we see now is a continuation of a development that has taken place over multiple years.

We acknowledge that there is a tightening of the environment, that we've seen that, and that's also part of why we guide the way we do on the price and the overall sales outlook.

But it's more than five years ago.

We were in a situation that it was basically free of charge to take price increases, because both the PPMs, the manufacturers, would in a way benefit from that.

And the bill was just passed on to the ultimate payer, often the employer.

They started pushing back and said, that's not acceptable, and that's why we've seen a gradual history of price controls coming into place.

More and more strict, initially only for a year, figuring out that that didn't address the problem, now into multiyear or accumulated price controls.

And where we are now is just that that is more the norm than not, and we're going to continue to see that.

So high value for also now the PPMs is that they can offer predictability.

So that's why you can say we anticipate a further tightening, but also a scenario where there's more predictability around the pricing.

That's not the same as to say we're entering into a phase where the game is going to be very different.

That's not our belief.

Okay, I think -- sorry, on Saxenda you need to comment.

(inaudible -- microphone inaccessible) Well, since September 11, less than two months have elapsed.

So it's still you can say not that far from the outcome until today.

And what I can say rather than comment on the label, which for obvious reasons I cannot, I'd rather say that in a matter of any point in time -- could be a day, could be a week -- we would be able to hear an action from the FDA, and then you can make your own deductions.

All right.

I think I promised Sachin a question.

Sachin Jain, Bank of America.

Just two on the US and then one on Tresiba.

So on the three price buckets you've talked about for the US insulin market, what price differential do you think exists between the three buckets?

And the reason for the question is, given the changes do you believe the US payer environment will support premium pricing for innovation?

One of your competitors in respiratory earlier, late last week talked about a significant change in that aspect.

Secondly, what do you think drives payers to move insulin or -- sorry, basal insulin or GLP-1 to single-source formularies from copreferred?

Is there anything that can drive that change from that perspective?

And then one question for Mads; you've referenced a small team on Tresiba.

Can you just give us any color on what level of experience exists within that team in dealing with the FDA, and any level of color on the most senior person in that team?

Just give some color around that interaction.

Thanks.

Thanks, Sachin.

I would probably defer from speculating into what price differential will exist between the three buckets of different products in the basal segment, as I would anticipate given the current timelines of product in development that the first of the new generation, next-generation insulins to the US market seems to be likely to be the U300 version of glargine.

And it doesn't fall into my area to basically decide or have influence on where they will price it.

So we'll have to see.

I think the pricing point on that is going to be very important for what will happen to the others.

I think there will be a tendency to look very carefully at the U300 price when the pricing will be set, both for the pegylated version of Lispro if that comes to market and Tresiba if that comes to market.

So I think that would be the initial comment on pricing for the new generation of basal insulins.

As for the current generations, you can see a very substantial price differentiation on the realized prices between the human insulin and the modern insulin.

There will be multiple facts of difference in price, and I think that will be the comment.

It depends on a little bit whereas which supplies it to and whether it's in device or whether it's in (technical difficulty) substantial price difference between the generations.

And I had just one follow-on.

Sanofi's indication is that they would probably see two buckets, and the Toujeo sits within the Lantus bucket; hence the question.

So if it is that case, where do you see Tresiba pricing?

I think it, again, will be speculative, because in there you are assuming at the time when we come with Tresiba to the market that Lantus and Toujeo will be at exactly the same pricing points.

One could speculate that the introduction of a generic version of glargine would have impact on the price on Lantus.

So I'd actually refer to comment on the pricing on Tresiba.

That will be a tactical decision.

I think the product profile of Tresiba will ensure that we certainly are able to price Tresiba at the premium end of the market and at least at the same level of the best product which is on the market at that point in time.

I'll be quite assured of that.

But it is a decision that has to be taken, given the market circumstances.

Jakob, over to you in terms of what could make payers work with single-source suppliers of of GLP-1 and the basal insulins.

Well, I think that's one of the trends that drive towards that, so I think that's not the main task you can maybe also offer.

But I think that's something they would often try to invite for.

But, of course, it takes two to make that agreement, so it also takes manufacturers that are willing to go down that path.

And as I said, we firmly believe that there is differentiation in the basal segment also in the GLP-1.

So the appetite to begin to treat this as product that are freely substitutable, we think is not taking the right approach.

Also, from a patient perspective because they are not, so we wouldn't have really an appetite.

I think our philosophy is that there should be choice for the patients and the prescribers between the different products.

So we would maintain that a copreferred status is clearly our intention.

And Mads, could you give some comments on the qualifications of the dedicated team we're going to have to oversee the US process for Tresiba?

Yes.

So, Sachin, these will be extremely competent, extremely experienced individuals that are selected, already have been selected, on the basis of their ability to have drugs approved with the FDA, to have great insight into even conduct if there were to be a hosted, a small local maybe secret AdComm or even that kind of event that could happen if that were to be the case.

So you will have extreme clinical medical experience, regulatory experience, biostatistical experience, cardiovascular experience, data management experience.

Now, I say it's a very small team, so this is not like having five of each.

It's a small team, so it's like having one of each, or one or two or so.

And that basically means that -- and, of course, general safety.

So that being said, these folks are going to handle the unblinded interim.

Do bear in mind that a Class 2b submission of an NDA of this kind is not a total trivial thing because the easy part, quote/unquote, is the unblinded because it's very limited what data sets the FDA is actually going to receive.

But the blinded part -- or sorry, the standard part, i.e., the general safety update or the Phase 3b, etc., the pharmacovigilance, all of that of course is going in as part of the NDA as an update on where has the world evolved surrounding insulin degludec since the approval in the multitude of territories clinically, real-world and so on, so forth.

So that is another team that I will be able to communicate freely with, unlike the unblinded team.

But don't worry, these are the best people.

Okay, thanks Mads.

Then, Johan.

Yes, Johan Unnerus, Swedbank.

And first on DEVOTE, sort of a follow-up there.

How many patients are likely in the interim stage; 150 or so?

Secondly, we had seen that numbers of events has clearly increased.

Is that likely to push the time of the full trial further, or where are we on that point?

And lastly, finally, on the guide I think you alluded to 50 basis points on the gross margins and roughly flat R&D margins, but still no change in margins overall alluding to no leverage.

Is that -- that doesn't add up.

Is that because you have some safety guide there?

Unfortunately, there's no management reserve involved in the guidance, but could I keep (inaudible)?

Mads, if you'd just comment first on DEVOTE, and then I'll get back on the explanation.

So I think your suggestion as to the number of [measurements] at the interim is pretty much the real ballpark, the real magnitude, the amount of measurement.

Which actually also, by the way, then implies that we are below a quarter of the total amount of events.

That's the nature of such an interim.

If you had done twice as many so that you were more into the study, you have to bear in mind that that would come at a cost, namely the cost that if you were not reassuring at the interim, that would put the rest of the trial in terms of statistics and so on at greater risk.

So this is a logical solution on that one.

As regards the event rate overall, I can only refer to the notion that we guided you at the ESD meeting, not this year but last year, that the LEADER trial was at 3% or above.

And here we have a population that in terms of risk characteristics at the baseline demographics is actually slightly/somewhat more sick than the LEADER population.

So the guidance we've given, i.e., that it's in 2016 or 2017 that the trial will complete, stands as it is today.

But obviously, when I have more firm assessment of what is the true (inaudible) in this population, we will be able -- just like Jesper always firms up his guidance on the top line and this, that and the other, we can also trim up the guidance on the completion of the trial.

But I think this is -- with almost completed recruitment of the trial, you can also do your own back of the envelope kind of thing.

It's anybody's guess, but I'll get more crisp as time goes by.

That's good, Mads, getting crisp as time goes by.

I'll try as well.

On gross margin, it's right that we anticipate in 2015 that we'll see a slight improvement.

But as there's no significant contribution from pricing, it will be up towards the 50 basis point, but clearly coming from a low level.

So slight improvement in the gross margin.

In terms of R&D and if we adjust for the DKK600 million one-time charge on inflammation, it will be roughly stable.

On the admin costs, I think we have a long track record of delivering improvement there in the 10 to 20 basis points year on year.

I would anticipate we would be in the 10 basis points next year without having seen the detailed numbers yet, but I can't see any paradigm shift there.

We've had some, in other operating income this year, we have benefited from some onetime income events, so maybe a slightly smaller contribution from other operating income.

And then where do we then spend more?

Well, we're going to spend more on selling and distribution, and I think that's logical with the discussion we had before.

The exact magnitude of that is still a little bit uncertain.

But I think there is a reasonable degree of transparency in the level of something like 6% to 9% growth in sales, and then assume operating profit will match that in terms of growth level, so a relative constant operating margin.

I hope that clarifies the question.

Keyur.

Three questions, please.

First, as you think about the guidance, and you've obviously factored in flat to slightly increasing pricing, does that assume rebate levels where they are today?

Or does that assume increased rebate levels that havel already been agreed to as a part of getting access for next year?

That's one.

Secondly, Mike, Biocon has been suggesting that in the international markets, they will have meaningfully incremental capacity once stimulation plan for them comes onstream in 2015.

Can you help us think about if you see them as a threat in 2015, 2016?

If not, why not?

And then lastly in the sense of IDegLira and as you kind of getting close to launching it in Europe, can you help us think about pricing for that product and how you -- what kind of negotiations are with the payers on that?

Thank you.

Thank you.

First on guidance for 2015, the preliminary guidance we have given includes the knowledge we have on the pricing situation in the US as the contract portfolio looks as per today.

Can that change?

Sure, it can, but I'd feel reasonably assured that it's a meaningful reflection of the market conditions that will be prevailing in 2015.

Mike, you got a question on Biocon.

That's nice.

I actually have seen the factory from outside, so I could -- the preliminary purpose of that factory has been communicated, of course, to try and come to the US market, but they might also have access for elsewhere.

With regards to the US market, I'm not an expert, but they are going to come relatively late, if at all.

That factory has to pass inspections of FDA which Biocon is not really used to.

So they have a couple of, I think, hurdles before we can see them in the US.

And when they do arrive, probably as Jesper said, they will be the third or fourth player into it.

And then we have to see what type of an impact they can play.

With regards to how that would impact the rest of the world, the emerging markets, I'm not really right now worried about it.

And the main reason for this, we have -- most of the emerging markets are basically out-of-pocket.

And on the low spectrum of the market, you typically have human insulin in tenders that the government is purchasing and will be able to compete as much as anyone else due to economy of scales.

We have been very good at managing that so far.

At the high spectrum of the market, the Tresibas and the modern insulin ones, we have typically have seen that in a number of these markets -- India, China, are the good examples of it -- the buyers are extremely -- they are very affluent members of that society.

And that they typically would like to buy Danish-made or French-made or an American-made product when they have to spend so much money, and so far have not been able to see any indication why they would be able to do well going forward.

So right now, we're not worried about them.

Great, thanks.

And Jakob, IDegLira pricing in Europe?

Yes.

I mean, I think as we also said yesterday, we have the first market, Switzerland, where we have reimbursement secured for Xultophy and ready for launch.

So you could say that's one point to consider.

For the rest we've said that the starting point will be the two components of Xultophy, of which I would remind you that the GLP-1 part is largely reimbursed across Europe.

So when we bring Xultophy into the market, part of it is already agreed to by payers being good value for money.

So we're really down to the basal insulin component, which as a starting point is the degludec price.

So that's what we've gotten in Switzerland.

But we are also in the process generally with pricing in Europe where we have negotiations upcoming on Tresiba in Germany to clarify that situation.

And for Xultophy in isolation, some of the European markets -- Spain, Italy, France -- the system is you put in your application for reimbursement; you go through the negotiation.

That will be the process over next year.

So it's a little hard to give you a set point in time where there's one negotiation of Xultophy.

We would have to refine that and update that as we go through discussions in the various markets.

But as I said, we're good to go in Switzerland with full reimbursement, so we look very much forward to that.

Why don't we take -- yes, I think you were first.

Yes, hi.

I have a few questions on international.

It looks sales-wise bigger than China.

What's the aggregate population the way you see international?

That's the first one.

Then is there any difference in terms of the growth rate of diabetes in international compared to China or the developed world?

And thirdly, could you give us a sense of what the -- how much lower the price point is on average in international, please?

So in terms of the total population of these markets, we're talking about 4.6 billion people, and 207 million of them are according to IDF believed to have diabetes.

We currently approximately cater to 11 million of those 207 million with regards to insulin sales, and have a 55% volume marketshare.

So you can calculate how many people are on total insulin.

In terms of growth rates and vis-a-vis versus China, then we have been more or less on par with each other during the last, let's say, five to six years with a compounded annual growth rate of around 15% from 2008 to 2013, has been our sales.

Any given point of time, that can a little bit deviate back.

So right now, we are doing 13% for the first nine months and they are doing 14% as you saw, and that I think will basically continue.

The dynamics in some ways are similar, but then we have their own particularity.

I think what differentiates us is that, of course, our number of countries here.

So when there is a bit of a problem, then we might be able to manage it with someone else doing better, and China is one country.

Then with regards to prices, if you take a look, actually, with regards to our flagship product.

So modern insulins and/or Tresiba has been the name of the discussion today, or even things like NovoSeven, our prices are pretty much at European levels, so very much the same.

And in some instances also, when you take a look at Tresiba, even sometimes more than what we sell the product in Europe for, we are selling it in international operations.

And then we have the tender markets for human insulin, and there we compete depending on, of course, the market and the size of the market with whoever else is in the market and quite often successful.

And then we have some 40, 50 of these markets labeled as LDC, least developed countries by United Nations, where we actually give them products at 20% off anywhere else.

So extremely cheap due to humanitarian purposes.

So very vast range of prices, depending on what you're talking about.

Richard, you had a question?

Yes, thanks.

Firstly, just if you could give some more color on the investigation that the subpoena in the US is driving at, and give us some reassuring over your insulin and NovoSeven manufacturing facilities, quality, etc., there.

And then secondly on to international operations.

Just wondering about the Tresiba rollout, how that's going dynamically within those countries, and also whether you will see incremental -- you think you'll see incremental competition from Sanofi lowering the price for different pens potentially, and trying to drive some growth of that franchise.

And then similarly on Victoza, how you see the competition developing in IO as well.

Thanks.

Perfect.

Thanks, Richard, and thanks for the question.

First, Lars, will you care to comment on the subpoena in Kalundborg.

So we were quite surprised, obviously, to receive this subpoena.

It's quite general in its wording, so it's not pointing towards a specific issue.

Of course, we are collaborating with the US prosecutors, and we've also been in some initial dialogue with them just to confirm that they don't see us having falsified products on the market.

Because we don't see any reason for them to believe that, and they have confirmed that.

So it's still quite general in its scope.

We have, of course, gone back and checked, based on our quality management system, just to confirm that we don't see that we have any issues.

And that we have confirmed.

So it's still too early to determine specifically what they are looking after, and then what has triggered them to do this.

There's been some speculations in the media that, well, it was caused by a whistle blower.

We don't know.

So, as of now, we don't see a significant risk here.

We believe that we have a robust setup.

We have a good quality management system, and we have also had a number of actually FDA inspections this year also in Kalundborg that have gone quite well.

So that's kind of the level of detail that we can provide right now.

Thanks, Lars.

Mike, over to you, and Tresiba rollout, Lantus pricing, Victoza in IO?

So we have launched, as I mentioned, in eight markets so far Tresiba within international operations.

That's out of, I think, 22 or so global launches.

And we have plans, of course, to continue that into the remaining of the year and the next couple years with relatively good speed.

The prices typically in IO are between 40% to 50% premium to basically double as much as Lantus is, depending on the market.

As we see, most of these markets -- all of these markets -- are completely out-of-pocket, so the patients are financing that themselves.

And the uptake have been very, very good in practically all of the places.

The first two launches we have had has been Mexico and India where I can give you the data from.

And in Mexico we have now 15% of the basal market penetration, and in India 12%.

So both have been good.

And then equally, we believe that in the rest of the markets we will see similar type of uptake.

Okay, thanks, Mike.

Tim?

Thanks.

Tim Race, Deutsche Bank.

A question for Mads.

With Tresiba discussion with the FDA and the filing, you talked about general guidance and specific guidance.

The general guidance really kind of answers the FDA's specific issue, which was a separation of Tresiba and Lantus after one year of treatment.

Your interim analysis, most patients won't have been on the study for one year.

So how does the specific guidance from the FDA incorporate that one-year problem as such, or are we just dealing with just satisfying the FDA with generic numbers that don't really answer anything?

Yes.

So, first of all, it is true that what the FDA thought or felt they saw was this increasing, you can say, difference between the accumulated measurement rates over time.

As you recall, Tim, that's obviously in the extension part of the trials where we in general saw a reduced reporting of any adverse events in the Lantus arm, whereas there was continued rigorous reporting of all kinds of AEs, including [mazes] in the degludec arm.

But the specifics of what you're asking about, i.e., is it so that there is a time course effect or exposure relationship and how does that impact the ability to do an interim analysis; that has obviously been part of the communication with the FDA.

And I think the interim per se, depending on confidence intervals and hazard ratio point estimates, is set to do the job if it pans out the way we are all hoping.

So there shouldn't be that level of uncertainty.

The uncertainty is more about what are the data, actually, when you're only, as alluded to over here, have between 100 and 200 measurement rate.

So we are crossing our fingers and looking forward not to seeing the data, because we're not going to, but to hearing about it at some point.

We will cross our legs as well, Mads.

Vincent, you had a question.

Vincent Meunier from Morgan Stanley.

So two follow-up questions on the US and one on Tresiba.

On the US, a very simple one first.

What is the proportion of a single-sourced payer today in the breakdown of what is sold with Levemir?

What is coming from exclusive formularies?

And the second question is an assumption and a question on what can happen in 2016 for the next round of negotiations?

Because if Sanofi has increased the level of rebates, then how can you protect your position without further increase the level of rebates for the next round of the negotiations, particularly in 2016, in the context of the launch of Toujeo and Tresiba?

And also for Tresiba, the question is what if there is an AdComm?

Because if there is an AdComm, the FDA will not be happy with any disclosure of any data, so how can you manage that?

Okay, first on the part of the contracts which (inaudible) about to say it's very limited, and I also refer to that we had equal access on something like 90% of the insured lives.

But maybe, Karsten, you've been deeply involved in those negotiations, so maybe you can give a little bit from the machine room some insights into how the US pricing negotiation is ongoing.

As part of Karsten's responsibility as finance director was being responsible for the pricing unit over there.

So Karsten, over to you.

So I think first, just to remind you how does it work in the US in terms of sole sourcing.

So in the US, they apply a tiered system, and normally it's a five tiered system.

So it's not like either you are copreferred or you are exclusive.

It's a little bit more complicated than that.

So you could say you have the different tiers that is driven by copays, also.

But to your question about the sole sourcing in the basal segments -- and let's take human insulin out because then we get into the VA stories of the world.

But if you take in the modern insulin side, then we're looking at less than 10% of the market which is sole sourcing at this point.

And to the prior comment about the risk of sole sourcing in basal and GLP-1, then of course from a manufacturer point of view, it's not necessarily what we want to do.

From a payer point of view, it's also not necessarily what they want to do because it also drives disruption.

So if you're an employer and you have a lot of employees that are suddenly switched between products, that disruption of costs has a pain as well.

And you see in a lot of segments, also more mature segments, that then it's not only necessarily one product; that then the manufacturers actually end up with more manufacturers, but of course still in a very competitive setting.

Then you say going forward and coming back to the sole sourcing, then you could say ultimately, what is the key driver behind sole sourcing and the key defense behind sole sourcing.

And where it's tough for the payers and the insurance companies to pull off sole sourcing is when you have products with a very high marketshare.

So if you take in the basal segment with Lantus with a very high marketshare, then sole sourcing and switching to Levemir would be at quite a risk on the payer side.

Because then they have to be confident that they have the controls in place to move a lot of Lantus patients to Levemir.

And what is the pushback from prescribers in patients and so on.

So that is basically one of the key factors in the basal segment.

But also in the GLP-1 segment around what is the driver between sole sourcing and more open access or copreferred access.

Then going forward to your question about that and increasing rates with the potential biosimilars and so on, we see Lilly at the market no earlier than mid-2016, first of all.

So they will not be able to participate in the contracting related to 2016.

And just to remind you about the contracting cycles, so actually right now -- and I'm not in the US anymore -- but actually right now, we are starting to get the first RFPs for Medicare Part D related to 2016 coverage.

So the contracting is mostly done pretty much starting now and ending in summertime 2015, related to 2016.

It's not 100%, but most of it.

And then you say then it's always what are the levers in terms of rates going forward?

And that remains to be seen because that's, of course, a competitive dynamic between us and our competitors and the payers.

Thanks, Karsten.

And then over to Mads' comments on the Tresiba process in the US and the risk of an advisory committee, how do you see that evolving?

Yes, and those of you that followed the August 11 -- not the September 11, but the August 11 -- advisory committee panel meeting on the use of interim analysis in CV trials for diabetes will also recall that there was a lot of discussion about how to preserve integrity.

In fact, in the one extreme was one of the senior leadership actually arguing that could we not have the data monitoring committee that oversees the trials simply submit the NDA or the data.

Obviously, that could not happen, but that was the one extreme.

So I think where we stand on that when is that we as a sponsoring Company totally agree with the FDA that there's an extreme need for preserving the integrity of the residual trial.

And one way of doing that AdComm-wise, if there were to be one, would actually be for the FDA to host that in a restricted and secluded way where none of us hear about it.

So this would not be one of the ones where you link in via the Internet and see all these happy faces or grumpy faces in the AdComm.

This would be different, I would believe.

All right.

I think this will conclude the Q&A.

Thank you very much for your interest in Novo Nordisk.

We're looking forward to be back end of January with the full-year result.

Thank you.