Novo Nordisk A/S (NYSE:NVO)
Investor presentation on Victoza® launch and International Operation
April 29, 2010 03:00 pm ET
Jesper Brandgaard - CFO
Jakob Riis - SVP
Jim O'Neill - Head of Global Economic Research, Goldman Sachs
So welcome to Zurich and to this investor presentation where we have taken the opportunity of actually conducting a road show here in Zurich and then being able to go upon two critical players in the Novo Nordisk management team. First we have Jakob Riis who is the Senior Vice President and responsible for our global Victoza launch and roll out and could be interesting to hear an update on how he sees the world performance of Victoza. And secondly, we have Jesper Høiland who has been based in Zurich now for what eight years or so? Six years. And being responsible for our international operations with the base here in Zurich.
So that should be the focus of today's presentation. I'll just start with a few slides and of course, I wouldn’t be CFO if I didn't start with this slide. Today, we are going cover over prediction about the future which involve significant uncertainties and of course, you need carefully to read this when the presentation will be made available on our web. And then moving on to what are we going to go through? I'm just going to cover quickly the highlights of the first quarter. I'm just going to review a little bit of how do we see the next generation of insulin developing Degludec and DegludecPlus.
And then Jakob is going to take over. I would, should probably not speak more than approximately 15 to 20 minutes and then I hope we would dedicate approximately 40 minutes to Victoza and approximately 40 minutes to Jesper review of the big countries. And that should leave approximately an hour and 20 minutes and then we have 40 minutes for Q&A after.
And I would suggest to keep a flow in the presentation there. If there are questions, we will differ them to after the presentation unless there's something that just wants to you just clarifying when we're moving along to make it a little bit interactive. That's fine.
So, with that, I'll begin with the first quarter numbers. Basically, we are seeing a very positive first quarter where we have begun the roll out of Victoza in the US Jakob will allude much more to that. We are seeing the modern insulin that continues to drive our sales top line growth, close to 70% of the internal growth coming from our portfolio of modern insulin. We're seeing 11% growth in local currency terms. In the first quarter, we had 2% negative currency impact. This is changing with the currency level we have when we released this. It's even better now with all the challenges that the Greek economy is going through.
So when we get into Q2, you'll begin to see tail wind for Novo Nordisk. So higher reported numbers than the local currency numbers and then we will see a total positive currency momentum for the full year, probably to the tune of 3%.
Key drivers of course, North America and international operations, no changes there so it's critical that we should stay focus on international operations. In terms of the research and development, we have launched now a new exciting pen in the US FlexPro for growth hormone and you would see that it’s a little bit of a prototype for what we're going to launch also in the diabetes care, universe a very advanced pen with a simple to use administration where you basically have auto administration and you have an audible click when the administration is done.
So you can see this as the next generation disposable devices. We have our roll out of the phase 3 programs of Degludec and DegludecPlus, the next generation insulin well underway. We have more than 8,000 out of the 10,000 patients we need in the phase 3 program, recruited and we expect to complete the recruitment in the first half of this year. And then finally, we have moved the new oral GLP-1 interface, one clinical development as further substantiating our ambitions within all administrations uploading.
In terms of financials, we continue to improve our gross margin this quarter showing in local currency terms 100 basis point improvement coming from increased production efficiencies but also because of the mixed effect selling more of our higher priced modern insulin and also having the launch effect from Victoza having approximately a pipeline fill in the US of $250 million.
In terms of operating profit growth, we had 15% reported, 5% negative currency impacts so in local currency terms, approximately 20% growth. We had in the first quarter, I should note, we had $100 million, one time income related to a settlement of intellectual property which helped the performance.
In terms of the guidance for the full year, we have made our guidance for the sales growth a little bit more precise. We're taking out the bottom of the intervals and now we see 7 to 10 because we now have certainty on the impact of the US healthcare reform and we have up also as a consequence to that the guidance for operating profit. Now we are anticipating that we will have more than 10% growth invested in local currencies and for the operating profit, in reported terms, we currently predict we're on 6% higher level for reported than local currency growth.
If you look at the overall market for diabetes care, this is looking at the global market, how does it look to last 10 years? We've seen an overall growth in the ballpark of 10% but witnessing a higher growth for the core area where Novo Nordisk have been active in the insulin franchise seeing a compounded annual growth rate of 13% and we always say if you go back all the way to the foundation of Novo industry back in 1925, you can also calculate at 13% compounded annual growth rate on our insulin franchise from the 1925 up until today.
Also importantly you can begin to see that GLP-1 are emerging as a significant element of the overall treatments and it's today so that the protein based treatment of diabetes care is the same size as all of the tablets small molecule top which you have down here, and it's a our prediction that the protein base segment in the next couple of years will out grow here the small molecule segment.
It's a dedication to the protein segment that has made Novo Nordisk a stable, long-term leader in diabetes care, and also a leader which has much less fluctuation in our market share compared to what you see the all players having seen significant variations from work for GlaxoSmithKline et cetera. There is much more stability in being a provider of protein to this industry.
We look at the US healthcare reform now implemented and having a significant effect on our top line, and on our operating profit. We have here given the impact 1% in of total sales in 2010, 2% in 2011. The reason why we give it percent of total sales even though it's only applicable to government sales, in the US is to make our investors aware what implication it has on the overall growth sales produce order for Novo Nordisk. If we zoom in and say how big is the impact on the government sales in the US as a rule of thumb you can say the US is a third of all sales, and the government sales in the US is a third of the US sales, so to factor this 1% of the global sales is equivalent to almost 10% rebate on the government sales in US in 2010, and an additional 10% of extra rebates, taking the rebates to almost 20% on government sales when we casually based on 2011 effect of the healthcare reform.
The key effect are the three in 2010 listed here and out of these three effects the moving, we managed to mitigate pricing to and mitigate pricing is the most significant impact covering around three quarters of the overall impact. In 2011 you will both have the cover of the total hold it will only be implemented from 2011 onwards because of the system has to be established to calculate how the pharmaceuticals spending is for the individual patient, and then how the pharmaceutical companies should split their share of the whole where the patient historically had to own pay between around US $3000 up to $6000.
That will be established from 1st of January and then the second thing is the annual manufacturers fee which is basically calculating what are the cost indication of all the other parameters, and what is that then lacking to make it up to the long-term commitment of the pharma industry of providing in total US $80 billion in funding for implementation of the US healthcare reform over a 10 year period, and that will be the most significant part, the excise fee or the annual manufacturers fee is going to be the most substantial part of the extra cost effect. We are going to have in 2011.
That's on the cost side, significant and measured in percentage of government sales in the US On the positive side, I just highlight two things, one is that we have 32 million people now being under decent healthcare cover in the US and this would typically be the lower income end of the US population where the prevalence of diabetes will be quite significant.
So longer term getting these patients to the physician having them diagnosed for diabetes prevalence, and longer term initiating treatment, we believe that will be very positive longer term for Novo Nordisk, and also we like that the cap for insurance plans have been eliminated and that can in certain instances be challenging for patients with homophobia and with inhibitors and hopefully that would enable more orthopedic surgeries et cetera for the Novo serving community. So that is in short the impact of the US Healthcare reform on Novo Nordisk in India and longer term.
Then rounding off, I just like to highlight the two new insulins we have in phase 3 clinical development. We believe we have a fantastic opportunity with the two insulins. The two insulins is Degludec, our new long acting insulin and combing that with NovoRapid, you get the product. DegludecPlus, a soluble combination insulin that also enables simple treatment. If we take the basal insulin first, Degludec, the significant advantage is the lower variation you have of the insulin effect when you inject it. But Degludec is based on our phase 1 clinical trials, where we were able to show significantly less variation. And if you have low variation on a basal insulin, you will be able to titrate the patient down into guideline control in the absence of hyperglycemia which is the major concern.
So when you will be looking at the phase 3 data from the Degludec portfolio from mid or in the second half of 2010 onwards, you should look very much not solely on how is the blood sugar regulation, what percentage of patient gets down below the guideline control of seven because you can always use an insulin to getting good control. What you need to do is you need to keep the patients in good control in the absence of hyperglycemia, and the high predictability of the Degludec effect is what we believe would enable us to show that we have created a highly predictable basal insulin with Degludec.
And then secondly, we can also combine and here you see Degludec illustrated with dark green color. We can also combine Degludec with NovoRapid. We've done that here in creating a insulin that is ideal for starting type 2 treatment with insulin. You take the insulin DegludecPlus with the biggest meal of the day. Despite of NovoRapid, we will clear the bit of the sugar from the biggest meal of the day and then the long acting profile will cover the patient through 24 hours.
And then here you compare the profile of DegludecPlus with NovoMix, who has probably a little bit too high insulin effect after the main meal and you also compare it with Lantus or Glargine which you see here. And the challenge we have with Glargine is you have probably too little effect at the main meal and you have also somewhat reduced effect going towards the 24 hours, where this is the very predicable long-term insulin.
One of the things we are actually testing Degludec also is whether you can actually take the insulin only three times a week in type 2 diabetes and that will of course enable the patients even if they are on a daily regiment. If they forget the insulin injection one day per week, they will still be in very good control. So we believe these products will be very significant. We expect to complete the Degludec and DegludecPlus trials at the mid of next year and then hopefully file for approval in all of the triad markets at the turn of 2011 and to 2012. And you saw with the filing of Victoza which Jakob will cover little bit later that we were actually able to file for approval not only in US and Europe simultaneously but we within 50 days were able also to file in Japan. In the Degludec trial package we have also included studies in Asian patients and that will then help us actually also to filing in Japan shortly after filing in US and Europe.
So with those comments on our phase 3 program for new insulins and here you see the details that's leading to two programs begin and boost both for initiations and intensification, and you could say DegludecPlus have great opportunities especially in relation to insulin initiation and then later also for intensification where both the products should be used. I won't go through all the individual trials that would probably take too long.
And then I will hand over to Jakob for a review of Victoza.
I will take you through Victoza, and the performance of Victoza so far splited into a couple of parts. It's only a little bit about the launch preparations and an overview of the Victoza launch, talk something about the positioning of patients, where are we getting patients from which is important also for the outlook of Victoza, key market overview, some details on some of the markets we have launched, and finally also a brief discussion on the future of the GLP-1 landscape.
We devised a new plan for how to launch products in Novo Nordisk, and maybe it's worth mentioning a little bit of background. Although for myself as seen in this context, I have been with the company for close to 14 years now, worked in head office in the central marketing function for about five years until I was going to the US to be part of the US sales force and the launched product there is part of being in the field. Went to Japan to head of marketing for three years, to then come back and head of our marketing function globally in Novo Nordisk. A couple of years ago as the Liraglutide data kept coming in and looking increasingly interesting. It was decided to make a new construction where we put under a Senior Vice President the entire launch to secure that everything would be aligned and that we would somehow create a new model for how to launch compounds globally, and as Jesper also alluded to within a much shorter and more ambitious timeframe for how fast we would get it out to market.
So, this is sort of the recipe as simple as it looks, but being a single person in charge of everything, not a more broad organization allows me to keep track of these seven elements, securing that we would get the label globally, securing that we would get the production alliance so we would have no constraints and could deliver fast whenever we have the opportunity to launch, get the organization ready to fully understand that this going to be a different launch and a bigger launch, obviously getting the brand in place, the classic marketing you could say. The data is so fantastic, yes, but that's also a rich source for a lot of discussions that could take people in different directions. So the challenge is the same, to make sure everybody has the same view on what is it we are selling so the customers get the same understanding and immediate understanding of that.
Then we needed also to launch with a good understanding in the market from a scientific point of view what is now this GLP-1 compound reaching them? How is it going to work in their clinical practice? And we've been fortunate enough that there has been strong interest driven by the data, but we've also been very conscious about early on opting our resources and our preparedness to engage in all these discussions to the tune of 200,000 interactions last year of more than an hour's length with physicians globally explaining the science behind GLP-1.
And I will show you a couple of numbers on the awareness levels that we reached as we came into the launch. Then market access, securing agreement also from payers that this is a unique opportunity and not another source of cost in their budgets that required a whole new level of effort from us so that we dedicated a special track to that, making sure we were optimally prepared, and finally centralizing to a higher degree exactly how we were training the sales force in preparation for the launch.
It's taken us more than twelve and a half years to go from lot of the idea until it reaches the market and we certainly didn't want that to get confused in the final five minutes of that journey because the sales representative was not optimally prepared to explain the story correctly. So there we centralized also the sales force training to a much higher level than before.
So that was the recipe and then I go into the status here. So where are we now? We have it approved in 39 countries, the European approval contributing with 27 and notably the US and Japan approvals that sort of completes the approval in the triad markets again in record pace for us and also setting a new industry standard and how fast we both filed and gotten it through to approval.
We have still couple of key markets outstanding. Couple of them, we have a positive opinion about Australia, so anticipating an administered procedure leading to approval. But in two markets of interest, Canada and China, you could say we are in ongoing dialogue with the authorities progressing towards approval. But with those two approvals or the first two ones that are going to come and the other two, we just need to complete the review you could say. We have actually approvals worldwide from what we need for our full global launch.
Then we have it commercially available though so far in 15 countries of course the difference here being that in some marketplace, a price negotiation that has to take place. So some of the differences between the previous list and this one would be countries like Italy and Spain where we still need to complete the pricing negotiations, Japan as well. But also here, a lot of key markets with Germany and UK where we've been on the market since July last year, US in February but also here recently France and other big country that has come in with full reimbursement and a full launch here.
So again, already its pretty far down the road and within a foreseeable future, near completing you could say the global launch.
And what are the labels that we've achieved? In Europe, we achieved the combination with performing or issue or the two in combination are actually also in the forming a TCD combination. So a fairly good and broad label but nothing on a therapy that we have in almost all of the other markets notably here in the US, there are more broad indications in the US, so it's basically for the treatment of type 2 diabetes whether it being it mono-therapy or in combination with orals. So we've got everything that is mentioning and that's what's alluded to appear in the second line therapy that FDA has inserted a comment that's is recommended, its not recommended the first line therapy, i.e., some of the algorithms normally applied in diabetes that talk about starting with mid forming is what they suggest you do first but if there are specific reasons, we have the indication that they can go from diagnosis and straight onto Victoza. And I think that covers this. So very, very good labels generally and in full support of our positioning.
Then going to talk a little bit about what the positioning is and where we get the patients from. Positioning first of course important because it's a big crowded market. So a couple of things you want as you launch the diabetes product. If possible, you want to go early. If you want to make sure that you get to the patients early enough that they can get the full benefit of your product then they could stay on it for a long time.
But before I speak more to that, you could say how we, with what benefits are we introducing Victoza. I mean there's a lot of data out there but just to recap, it is about a significant reduction in the blood glucose. That is what diabetes drugs are about. With a very important added benefit of weight loss whereas many of the competing compounds come with a weight gain as a result of increasing your glycaemic controls. And that's a very, very important part of this class but in particular also Victoza because it is a frustration for a patient that has probably, for 80% of the cases been diagnosed with type 2 diabetes because of obesity then to go on a treatment that further worsens that part of the problem as opposed to getting on a drug that actually also begins to address what was part of the root cause for getting diabetes.
And it's a big motivator, an important part because an A1C is as you know a biochemical market, its not something that is readily visible, a lot of patients will feel better but they don't see the A1C but they see their weight and they feel that also very, very fast. So, you could say weight is in itself a clinically relevant parameter but it's also a very important parameter in driving a higher rate of compliance from the patient's point of view and getting part of that treatment success that patients are really looking for and honestly of course also the physicians but also breaking a little bit with the tradition in diabetes that diabetes is progressive and visit by visit is a matter of seeing if its now time to step up your therapy but few things move in the right direction.
With Victoza just with the A1C and its weight, some will feel that they are better off at the next visit than they were at the past visit. So, not to go too much further into the psychology. I'll give you a little bit of the feedback from the market as well but it's just a part of the reason why a talk like this is very well received by the market.
It does change a little bit, some of the fundamental rules of the game that are tough when you treat diabetes or you are diagnosed with diabetes. We also do see a reduction in systolic blood pressure and improvements in the beta cells response to glucose. If you look at the importance of the claims, they are important to understand the full picture of Victoza but the primary selling points are related to A1C and weight that's the concrete clinical parameters that you are looking for when prescribing Victoza.
And I mentioned the positioning while part of the message here and our tag line is expected to think from a physician's point of view to do more than the blood glucose and this will enable you to do that. And we also position it as targeting the beta cell and giving you good glycemic control when the Metformin is no longer adequate to control your type 2 diabetes. So, you could say from a physician point of view, we are being very specific, not intentional early or something that's hard to relate to but to physicians saying that's where we think you should use it when you have started the patient on Metformin, but that's enough you add Victoza.
But let see if that's what they do. And yes I know, there are two ways to answer the question. Actually what we do see is when we look at the US patients that is from what we can see already and lot of patients at Victoza onto the OADs. We do see some that switch from exenatide type but that's a sizable fraction and then we do see some that ultra insulin with Victoza.
This is overall a really good outcome for a couple of reasons. We wanted added on to OAD. Can it always be Metformin? No. If you look at all utilization of drugs in the type 2 space, it's being used in a lot of different combinations that's hard to control. The importance is at least you give them a clear message to start from.
It is very important that we, here in the US market see limited switch from exenatide because to be truly interesting in the long run for us we need not to be the biggest in the GLP-1 category, we need to grow the GLP-1 category. I think as we look at the numbers and the outlook for Novo Nordisk as company for this to be significant for us, we need to grow the category. And for this to be a significant draw in type 2 treatment, it needs to move out of the part of the market where it is currently.
So I would say all-in-all, this is very, very encouraging. If you look in Germany, you will see that we still get a large proportion where we add on to OAD, so that's really good from persisting point of view. We do see more, sorry this was for exenatide. We still see a third that comes on with OADs and after the statement, we see more coming from exenatide and partly also driven by the fact when we talk about the driven market is one that is relative conservative towards new drugs and somewhat restrictive from a market access point of view.
So there's a higher prepensely to at least utilize that if you are using drugs of premium price, you at least want to make sure you are used the best one. Whereas in some of other markets, we see that they more taking a lot of new patients on Victoza. I think in that sense, Germany is maybe a little bit special but still we do see a significant expansion of the overall category for GLP-1 in Germany. And I eluded to the see pack, not something I can fully quantify but as I said, it is very, very well received both amongst specialty but also in primary care and some of feedback we're getting is exactly the excitement they see patients that suddenly have different heartthrob with diabetes.
So and if I compare to the past three launches I have been part of where we are bound to when we touch that many customers occasionally to get to this emails that we just thank you, it really made a difference in my life. What we see with this launch is just at a different level then what we seen it before. The language is stronger. It means more to the patients and there are lot more spontaneous feedback from the customers as we seen with any of the other launches. One woman even showed up at our affiliate phase fill me or usually I want to spread the words. You have to let me tell my story. And so, we actually did in the company and lot of people were still surprised with what a difference Victoza made even though they knew in and out all the lead data. But one thing is clinical data in a table and other things when a person tells you that it changed their outlook.
We've also seen a high level of satisfaction with the device, its ease of use. We have one device for all dosages so there's not much to be confused about. (Inaudible). And it's a symbol once daily injections that once you're into, it takes few seconds to do with a very fine gauge needle. And as I said, the feedback on both blood glucose and weight is very positive. So far, an extremely positive story from that point of view.
If we go into the key market overview, first a little bit on the US. When you get to that market and the emphasis I showed to this the general recipe for how to launch the product globally. We've certainly followed that, a couple of things were particularly for the US. One thing was we wanted to make sure we minimized the time when we got their approval until we had the product in all pharmacies. And a couple of years ago, we basically took the whole process that we usually followed and completely reengineered that. That allowed us to set a stretched target of bringing the past timeline down to about a third of what it has been historically in Novo Nordisk. But when reality and the approval came and everybody worked extra hard, we actually managed to get it down to only six of what it was before. So in 15 days we had the whole pipeline filled for the US launch in the US warehouses and on the way to the pharmacies.
So lot of focus on that and it really paid off. We've also looked a lot on the market access and here trained all our comp executives to focus on and fully understand the value of Victoza. In other words, when you have a product that is of this nature and brand new, it's important that you don't anticipate others to quickly understand the value of it. That is something you really have to talk to a lot versus not utilizing other means that could be for instance rebating all the ways of getting it. So here it is a clinical sale more than an economic sale on the price and rebating, that we are not utilizing, creating strong efficacy continuing with the interactions.
As I said, lot of interest in the molecules, but again what you need is that when the sales rep meets the customers especially, we should be fully prepared to meet them. You don't want to waste the first call that they have to sort of get back to where you from and what is it about? There they have to be like, oh yeah, I know, I understand the science but tell me briefly what is it for benefit? So that was really a focus area and finally also getting the sales force prepared I alluded to that. But here we also [launched], is also about risk taking to someone you did to calculate it but you have somewhat of an issue when you don't know exactly the timing of the approval and you still have to host a meeting for close to 3000 people. It’s not something you do overnight. So let's just say we ran a lot of dual tracks and then in the end [with all fairness] we got the approval 10 days before we met the whole sales force in Las Vegas. I happen to fly over there to greet the audience and happen to actually be on a sales plan that had 48 pallets of Victoza down below which was part of the pipeline field.
So to say for me that day was quite special because two years before it was a big process that hopefully would come to fruition and suddenly you are there meeting 3,000 colleagues in Las Vegas and you even had 48 pallets with you. That was very motivating and they for sure also took that motivation with them because if we look at probably the numbers today with the high significance looking ahead, it would be when we look at the actual uptakes of the TRx for Victoza in the US market.
You can look at other notable launches here, a couple of our own; Onglyza, Apidra, and you could see that we far exceed that. You will see that we are more or less tracking to the tune of what Byetta did when they launched, Amylin really launched the compound with a lot of interest in this whole new class. So all in all you could say we are very encouraged by that initial uptake. One thing to note also is that this is the number of patients, and of course when you calculate the value of that and multiply by price you could see that it's from a value perspective a very competitive entry into the US market.
Yes, that's a good question. Part of it is simply the amount of patients that flow through the doctors clinics every week. And of course you could say I wouldn't say a limit, but how quickly can you get all those prescribers convinced to stop prescribing? So, that would be a limit. I will show you market access is not an issue here in the US, 91% have access to it. So it's a matter of how quickly they get it into a habit of prescribing and how fast they see patients that are relevant for this.
Okay, good. Hang on to that. And then part of it is also a matter of how quickly you get to, how broader prescriber base, how quickly you turn on prescribers that begin prescribing your product, and that's where you will see some differences between primary care focused sales forces bringing (inaudible) and are slightly more intensive, so on a protein that hasn't been delivered in the past.
If we go within the GLP-1 segment and look at it, that is the equivalent that here, week 15 of this year, we've taken about 11% of the segment. If you look at the new scripts within not Victoza but the new scripts made will vary about, a fifth of the scripts made for GLP-1 is now Victoza and with a very nice trend. So I think that is something we certainly just need to keep going. And what I alluded to is how many have access to this? I said 9% are not covered so 91% have access, mostly on Tier 3 versus Tier 2, means they have a higher co-pay, they need to pay. But that is something where we have programs to mitigate that, either comps or other means of covering the difference between being on Tier 2 or Tier 3. So our approach is not to force our way into Tier 2 as much as it is to make sure that for the patients point of view, there's a little difference Tier 2 and Tier 3 from them.
We have, and this should be, this is the prior off part of it, and that means there's a developed paperwork going in before. The doctors are allowed to write the prescription, and that's a part we can address. It is about 30% for us or 35% and it’s about 15% for exenatide. So that’s something to work with that and bring that down so the prescribers can just write a script without having to have a back and forth on a form.
Then, with some of our key priorities going forward, its continued the primary care focus a little bit back to beginning or continuing that expansion of the prescriber base. It is to launch our materials because so far we have launched with what's called an annotated package insurance on prescriber information here. That's all we had until we have had some FDA clearance on our actual sales. And this works okay with specialist but when you are in the primary care segment, you want something that is shorter and easier to detail from. And that is being launched in the near future. We have received a DDMAC as it’s called from FDA feedback. So that's coming along.
Then the formulary status, we are improving that as much as we can also to make sure that once we have passed the launch phase that we have a good status. So that's one of the big focus areas and then obviously the additional clinical data that we are getting or have gotten, for instance with a couple of oral presentations and 19 abstracts for the upcoming ADA is a way to continuously fuel the scientific interest in GLP-1.
In Germany here, we targeted the specialist, both before launch or meeting their demand for scientific information, reaching high levels of unaided awareness, so they are full aware that Liraglutide is out there. If you look at our share voice in the total diabetes market, you will note that it's a 5% simply because the denominator is crowded with a very intense promotion of DDP4 inhibitors. So you could say we are not trying to be competitive on share voice with the DDP4s. We are beating them on higher efficacy and are very competitive within the GLP-1 segment and expanding slowly. But the first focus is to make sure that we establish leadership in the category and drive the category.
If we look to the UK, you will note firstly that we are up so that hardly any UK physicians are not aware of GLP-1, you will also notice that we have a about a fourth of the entire share voice in the UK, that is because GLP-1 is a bigger part of the UK market compared to the German. So that difference is there and dynamic should be aware of. That we also see here when we look at the situation in Germany where we see the entry curve for Victoza and we see that exenatide has come down somewhat but totally we've grown the category above what it was before. The dynamic in the UK is different because of the need to go to all the primary care trust and get them to support prescription of Victoza, the entry curve is less steep.
And we also see another thing that the compound that has been there before you and has been through a lot of these PCTs still maintain some momentum. That is in a way not bad for us because it means the whole category is growing. And once we get the status fully cleared in the PCTs we know. We know that we have a very, very competitive product against exenatide. So, all-in-all it looks really good in the UK as well as in Germany, even though the dynamics are somewhat different.
Then further on market access, you can say when you have a product that meets the [indiscernible] in Tier 2 type diabetes so well. We have competitive sales force, we have a good story, a part of what may hinder you in a European market would be market access aspects. And Germany had a very fast uptake because they are the specialist can start prescribing immediately that doesn't mean you are done discussing the value of your product because TPA would then issue of therapy advice and that they will do here expected in June with effect from the year. So this year we will continue most likely with limited impact from this but looking ahead of course that's fact though.
One of the main institutions worldwide that looks at new pharma technologies is National Institute of Clinical Excellence in the UK, nice and they just select (inaudible) for a single technology assessments which is positive because they have not done it with the others of course that also puts you on a risk but we know the preliminary guidance recommends Victoza 1.2 milligram for using in treatment therapy in combination with either met+SU or Met+TZD.
So we'd say we come out of an assessment actually with the recommendation of use and that means that out of the 150 TZD in the UK for about 80 of those, this conclusion out of Nice means that they have to accept and reimburse Victoza because its mandatory to follow this guidance as it comes out of the technology assistant. So, we see overall positive, although you could say this is more restricted than we have in the label but still it will open up a lot more access in the UK market for us.
Then, we are in dialogue in Japan. We have the approval now it's about agreeing with the Japanese authorities on price and we expect to reach an agreement and the launch here in the summer. And with China, we are sort of getting into the final steps of the regulatory process, we still need to secure an approval there and that's expected in Q4 2010.
And that brings me to the last part which is the fugitives the one landscape. We can talk a lot about that. I'll give you a quick overview but as said to me, Victoza is such a big part of the future. We shouldn't get ahead of ourselves and too far into follow on molecules I think. I see the journey for Victoza is just beginning now and it has the potential to do a lot in the market.
But we also do know that there are other approaches within GLP-1 and we need to be prepared to match that. Our overall ambition is that the leadership we are heading for with GLP-1 or with Victoza here that we're going to stay there. And that means also working on new molecules. So whether once we could becomes a factor, we are working with Semaglutide as our version of that. If you go further back, we also have oral as a mode of administration but then we talked phase 1 and a lot of issues to be resolved there. So we need to remember that.
But in phase 1, also notably here, a combination of the best deals you want on the market and a very promising basal insulin. So the combination of Degludec and Liraglutide is a compound that is in phase 1 but you can say its two molecules that one is already approved and one is in phase 3. So not in phase 1, in the same way as we would have with orals and a compound that we are looking towards with a lot of interest to see how that would fit into the treatment discussed.
And then we are in phase 3 with Liraglutide and obesity but as already communicated have wanted to clarify the full regulatory status of the Victoza before proceeding with the remaining phase 3 trials and are in dialogue with FDA to make sure that we are in complete agreement of what is needed for the remaining two pivotal phase 3 trials of obesity. And all-in-all see this as a good combination of follow on molecules but also with an expansion with the existing molecule in an indication that is also highly interesting.
So I will round off as a conclusion and say launch in 50 markets, more launches coming within a very foreseeable future. We have succeeded in a positioning that gives us a possibility to expand the segment and we have promising non performance both in Europe and in the US and are also working to ensure that we can follow on to that process with new molecules and launches. So we maintain our leadership. And with that, I think I will end the Victoza part. But we will take questions afterwards.
Which is over 24 years? It is almost so good that we don't need to sell it but of course then again, we need to a few things right and I think Jakob, you really trusts base on that. I'm going to talk about the BRIC economies but starting out just to setting the stage, if we are looking at the world today of international operations which is what I'm responsible for is roughly 20% of the Novo Nordisk business. It's a bigger share in terms of share growth. It's all countries that are not North America, Europe and Japan, Korea. So it is relatively easy to remember, the countries that we are responsible for in international operations.
And if I should put it and why I do believe that the BRIC economies in particular but also all of the international operations countries have huge opportunities. If we are looking at the world today, only 15% of the world's population live in the western world whereas they consume 85% of the world's healthcare and as a consequence of that of course that 85% of the world's population that only have the 15% available but as these countries are getting richer, there's no doubt in my mind that one of the things that they really, really would like to change is healthcare and the outlook coming from healthcare. So that is one of the drivers for it.
Speaking for myself, I've been 23 years with Novo Nordisk. I've spent the last six years in international operations plus I travel roughly 200 days a year. And that means on average, I've calculated that I've spent 20 hours a week on a plane. On top of that of course, sometimes I also work in between. But that's just to give you a background of where do I come from. I wish I could share some of the many experiences that I have throughout the world with you but for the time being, I will be focusing on the numbers and why I do with these, this is a great investment opportunity.
If we are looking at this chart, I think its one of the reasons why Novo Nordisk is relatively popular with investors because as you can see here, over a five year period, Novo Nordisk has grown 13%, 14% year-on-year which is in a class of its own for the pharmaceutical industry whereas if you can see some of the other companies, they have had a negative growth over a five years period.
At the same time, if we can agree to that much, sometimes it's called the pharma emerging market or the BRIC economies or adding a few other countries to it, they are the growth engine for the future. There you will see that Novo Nordisk, over that five year horizon has grown to almost 30% year-on-year and that's why we are talking about this huge growth opportunity.
This slide is made by IMS, International Medical Statistics and is of course only on the basis of the data that is available throughout the world. If not all markets that has a proper data collection yet, it's mainly in the western world but it at least gives once a good feeling for where we are. One can see that on average corporations have been growing 15% in international operations where as I said growing 30% and the industry as such has only grown 5% revenue more than double that number by 13%, 14% growth for the last five years.
Now, I've decided to make a little interactive stunt. I have asked Jim O'Neil the founding father and one of your navy competitors, Goldman Sachs to give his review in only three minutes on the BRIC economy. It was Jim O'Neil who has been known as Mr. BRIC who phrased this. So if you will allow three minutes to pass by, we go straight into the Goldman Sachs net and technology rich, output tool. Sometimes it is a little difficult to get all the things going.
I'm Jim O'Neill. I am head of the Economic Research globally, Goldman Sachs and I am the creator of the acronym BRIC. I'm amazed, might be a slight exaggeration but it has been pretty dramatic and it's changed the nature of how I function here at Goldman Sachs. I used to be regarded as somebody that focused on the currencies as well as managing the department but at least I come down as Mr. BRIC. When we first wrote about it and particularly when we first looked at the 2050 potential, many people believed that we were being very conceptual and it was idiotically optimistic and some kind of fantasy for the future. But here we are and many financial markets are completely dominated at the moment by what's going on in these countries. BRICs economy is collectively are now 15% of global GDP, about half that of the US. And China, interestingly exactly in line of when we projected it could happen, is poised to overtake Germany to be the third largest economy in the world.
I could go on and on. There are hundreds of examples. I would have to give very specific advice to each of them. In China, it would be, try to do more with your currency reform and accelerate the speed and (inaudible) the appreciation With India, if there was one single thing; it would be try to boost foreign direct investments to allow more investors in. And if it were Mr. Putin in Russia, it would be, try to make it easier for so many people in the west to understand you because many people don't realize what a good story the Russian story in BRIC is.
Some ways, the Brazilian example at the moment is arguably the most interesting. There have been times in the past few years where our journalist and some academics have written articles saying why don’t Goldman Sachs drop the B in BRIC. But in the past six months, there is growing evidence that Brazilian economic growth is starting to accelerate significantly.
There are many, many misunderstandings about all the BRICs countries. Russia, I think often leads the way. Many western people have a very Anglosaction westernized view of how all these countries should behave and in essence should be like us. I think it's highly important as part of the new integrated BRICs influence global economy that everybody understands that we are not like each other. We don't need to like each other. One of the reasons why the world economy is doing better is because of all these big countries sustaining growth on their own basis. China for example, to become the biggest economy by another 20 odd years, only needs to grow on average by just over 5%, half what it's currently doing. India to become the challenger to the US to become the second by 2040 only needs to grow by 6%. It's being growing recently between 8% and 9%. And it's true for all of them. It's important that people realize some slowing in growth might actually be helpful for the sustainability of it.
Beyond that, I think the biggest of many issues that I would highlight in a discussion like this is that it’s highly important that global policy making organizations start to give more role to these countries within the global setting. I could give many.
So, thanks to Jim. This was just to give you a flavor and some of the backgrounds for what really passed away for the acronym BRICs and what was his thinking behind it? And I clearly remembered when I read these huge reports and was discussing them with Kåre Schultz, the COO of Novo Nordisk. He was a little skeptical, that it will go in this direction and as fast as we have seen it happening in the last number of years. I have taken here some of the interesting points worthy that I find is worth highlighting about the BRICs. The BRICs represent roughly 42% of the world’s population. That’s on its own when we are talking diabetes, is of course a very strong driver.
If we're looking at one of the things that have changed dramatically over the years, then it is life expectancy. Really if go back 20-30 years, then it would not be common to see life expectancy around the 50s but one of the drivers for diabetes is getting older. As a matter of fact, if we all get old enough, we will all get diabetes. So that's food for thought. One of the things is of course also the urbanization that has taken place in the last 20-30 years. We have really, really seen huge shifts, masses of people coming from rural areas into the city and coming into the city meant for many people; white shirts, ties, working in offices, not the hard work that people has been used to in the past, working out in the hills and other places. And as a consequence of that, we have seen explosions in numbers with diabetes. We're talking about a pandemic in this area.
Business of course is not a totally fair number. Just to pick, we all know about the financial crisis and the background for this to happen, strong numbers underlying here. I think it's worth looking at the BRIC economy in a 5-10 year horizon if one really wants to understand the numbers. And therefore, compounded annual growth rate might have been more relevant here.
One of the things that we should not forget is if we do go back just 200 years, these two economies would represent 30% of the world's GDP whereas the US would only represent roughly 5% of the world's GDP. Today it's of course reversed as we know but it's changing very rapidly to also these economies are catching up to the front leader. If we were breaking into and that's one of the things that I think Jim O'Neill was highlighting that is that you cannot just think about one country, you have to dig further into to understand the real background to it.
If we took the numbers from Shanghai then as a matter of fact, Shanghai has the same life expectancy as the average American. Shanghai has the same income per capita as the average American. So things are changing very fast and therefore of course if we are saying China, some of us might imagine Beijing, Shanghai and some of the bigger cities where only 450 million people live. We should not forget the 800 million people that are still living in the rural areas that are shifting towards the city. So that's part of the changes that we are seeing.
One other things also to notice out here and this is before the healthcare reform, this is in 2006. We are looking at some spending of more than 16% of total GDP on healthcare. As a matter of fact, we are seeing only one-third being spent in the BRIC economies, but we are seeing these numbers rising very, very fast because of course as we are seeing a delta growth and incremental growth in GDP. There is nothing different in Chinese or Indian population. They say we also would like to have the same outlook. We will also like to have the same lifestyle and the same quality of life that the rest of the world. And as a consequence of that things are changing very rapidly.
I then pick the funny number here you might say because I pick how many mobile phone users are there in the country? And today the world’s biggest country for mobile users is China, more than 600 million people are having a mobile phone. And the argument that I want to bring forward here is, if you can afford a mobile phone, you can also afford diabetes treatment. Because it is so that we can treat a patient for anywhere between $0.20 and $0.30 a day and that's less of the cost of having a mobile phone. And what would you prefer to being able to communicate or live a healthy and normal life style and thereby increasing life expectancy. So in my mind this is very indicative for what happens in the world today and that we will see very fast uptakes, 40% of the world’s mobile phones is today used in the BRIC economies.
If we are looking at it just before we are digging into the Novo Nordisk numbers but if you allow me just to look at it in a very short horizon, 2009, 2013 the BRIC economies are all represented, and I even think maybe China will overtake Japan in this period of time. These are external data, but it's very powerful to see that they are in the Top 15.
As a matter of fact, one other things that very few people realize, if you take a country like India, they are the fourth largest country in the world in terms of volume consumption of pharmaceuticals. So it's only because the prices in India are extremely low that they are not up here. But as living standards are increasing and are increasing very rapidly in India, people will of course ask you to have the same quality products and the same care that the rest of the world, and that's part of the numbers that we are seeing. But I think we have few surprises here that I will highlight, may be that's countries like Venezuela and other where you could debate whether or not they will make it to the Top 15. But many other countries are really important for the pharmaceutical market and therefore the countries is that the pharmaceutical companies that are successful have invested at long time into these BRIC economies and other emerging markets.
One of the things not to forget is very big out of pocket in almost all of the markets but as we have also seen an example is in Russia, the DLO program, the healthcare reform that was implemented in 2005 by Mr. Putin. A very big portion of people living in Russia more than five million people has been included into the healthcare program called DLO and are fully covered that has not happened in the past but of course as countries are getting more wealthy, politicians are more likely to spread the wealth and healthcare reforms are one of the real strong points in this respect.
If we are looking then at diabetes and now are going closer into the numbers that I'm going to talk more about then it is that we are estimating today that there is roughly 300 million people living with diabetes, but if we just look 20 years ahead almost half a billion people will be suffering from diabetes. And in contradiction to much of the normal believe is, it is indeed in the BRIC economies in the developing markets that diabetes is exploding.
You are seeing a number, I'm talking about 44 million people with diabetes in China. I have just participated recently in a conference in China where they pointed at a number of 90 million people suffering from diabetes. So, these numbers might even be on the lower side compared to what we're going to see in the future. And therefore as I also said, I do believe that the BRIC economies hold a very strong platform for Novo Nordisk going forward.
This year is then cutting out where we're seeing the growth, this is in volume growth. I'm going to come back and share with you some of the value and volume growth which was because of course value is what really drives the business. But if you're looking at it from a volume point of view, Novo Nordisk is market leader both in India and China with over 60% in volume disregarded of bio stimulus and all the other things that are existing in the market. If we are looking at it from a value point of view, it's even more than 70%.
Russia is right in the middle of the 50% market share and growing with around 15% whereas Brazil is a little behind and I will come with an explanation on why we do not have market leadership in Brazil and the market is also growing somewhat slower in volumes. If we just go back to two years that we have indexed so we don't want to share with our competitors. But basically what we're saying if we look at year 2000 how are we stacking up in terms of number of sales people. In 2009, just two years later we have 60% more sales people in BRIC countries.
Of course it’s mainly driven by China because China is really out spearheading in Novo Nordisk business. And I think it's when you're growing the sales force with some 30% year-on-year then its really talking about where things are heading up. And if we're taking at China, each time I'm in the China. I approve between 200 and 300 people more to be hire into the sales force because of the dynamics that I will share with you a little later, strong support that sort of investment.
If we're taking the Brazilian market, a somewhat different market. But you will see here is only roughly about 10 million people or not only but roughly around 10 million people are having diabetes, half of them are only getting diagnosed of those 10 million only about 1 million people are achieving acceptable life saving control. What interesting about Brazil is they have huge tender the world's biggest tender, 40,000 mega units is what we are taking about when the annual tender takes place and that is an auction, a Dutch auction where basically the prices are coming down and then those prices, when the price get accepted to sell onto the market.
There is still also a huge private market because we should not also forget out of 200 million people there is a very big middle class that can afford paying for themselves so presumed by and large very interesting market. There has been challenges as you will see on the next slide here but indeed if we are looking at modern insulin penetration and device penetration getting close to almost 50% in volume of all patients are today converted to modern insulins and at the same time Pen penetration is really taking off.
The long acting insulin here is of course Levemir competing with Glargine. The real sad story is for Novo Nordisk is and there we have to be honest to say we purchased acquired by Biobras, a local Brazilian manufacture. When it took the product of Biobras off the market because we have double of all of our products, we lost significant market share when it comes to volume, when it comes to value the market is somewhat different. I alluded to it a little earlier, one of the two numbers that you indeed should look at when we are showing this BRIC numbers is what if the compound is annual growth rate in volume only 7%, but as you have seen in value coming up 30% year-on-year so certainly a dynamic market.
If we are looking at Russia, again close to 10 million people even fewer patients here are getting acceptable control. Four to five million people are part of the DLO program and here one should also not forget because very often we are talking when they are talking international operations, we are talking about diabetes but it certainly also possible to sell products such as NovoSeven and human growth hormone.
Novo Nordisk has been competing very well in international operations in these settings. One of the initiatives as I said by Putin again being very popular is to offer healthcare and make it widely available to the Russian population. If we are taking the leadership position of Russia again, you saw the market growing with a whopping 15% volume year-on-year but again, 26% in value. So it's really markets that are taking off very rapidly, two reasons for the vast penetration and also modern insulin. Today, more than 35% of the Russian market in volume has been converted onto modern insulin in value. This number is of course way over 50%.
If we are looking at Novo Nordisk’s position here, it's a little more volatile and has to do with shipments to Russia but basically 50% of the Russian markets belong to Novo Nordisk and we have rapidly increased our sales force after 2005 and after the implementation of the DLO program.
A lot of reforms, currently one of the big subjects in Russia is what's called Pharma 2020 and that is the Russian government being focused on establishing the healthcare industry. Some of you might have noticed yesterday Novo Nordisk was out announcing that we are building a factory in Toluca in Moscow or close to Moscow, in the Moscow region and Novo Nordisk will make that sort of investment. The reason for that is the Russian government will do favoritism to local manufacturers. So we have to be in the forefront. We have to invest into it.
It will be too busy to go through all the details but you can see the slide afterwards. One of the things that they would like to do is to push total investment of all pharmaceutical drugs for the populations. One of the things in the past when we were talking about the western world and international operations, people saw huge differences in the way things were operated, whereas time goes by and as these countries are getting richer and richer, these countries are also getting closer and closer to each other. At the same time, we are seeing of course the European continent is tightening the rules for investment and other things. And therefore, the markets and more look alike than one in these first clients anticipate.
If we're looking at the Indian market, 7% but one of the world’s biggest markets in terms of number of diabetics, 45 million people are suffering from diabetes in India. That is just about double the amount of number of Americans being diagnosed or estimated having diabetes. Very, very small portion is in good control and very little spending is taking place in India out of the total GDP. But one of the things that is emerging is early stage but it's coming that is implementations of insurance, companies that are now outsourcing to India to a higher and higher degree will offer the same sort of healthcare packages that we're having through the rest of the world.
But still one should not forget 90% plus is out of pocket. So it's paid by itself and therefore price sensitive is fairly big. But again, also in India, we are seeing a growing population of middleclass that can afford drops. Here, very slow penetration, I would say for modern insulin, it’s only 10% but they've also only been introduced recently within 2004 but penetration in devices somewhat higher.
If we're looking at out market share, steady state 60% as a matter of fact, it's closer to 70% if we take it in value and not in volume as it's taken here. One will see that the bio stimulus are having sort of the market share in India. They are having roughly 15% market share in volume but they have less than 7% in value.
So, of course, they are having the low end of the market. They are selling still adrenaline insulins that the big multinational companies have not been distributing. If we then are looking at what are the opportunities? They are in deep financing coming in this way and there are initiatives going in the right direction following India but its going very, very slowly.
What the approach that Novo Nordisk has taken and that we are communicating about is for instance, the State of Goa, unfortunately a very small state with only five million people but in Goa, together with Novo Nordisk, we have made a healthcare program that means that we can provide more or less the same standards as your seeing in the rest of the world. We are very pleased with the work that we are doing in Goa.
And again, one of the things that one has to remember when talking these huge countries is very few of them are run centrally. Many of them are running by states or provinces and therefore it’s more complex to organize yourself in these markets. But I'm sure that in my mind, India will be the next China for Novo Nordisk. So in five to 10 years outlook with 50 million people suffering from diabetes with India coming up very rapidly in terms of GDP per capita, there's no doubt that India is going to be the next market.
If we then are looking at China, even the smaller portions are getting good (inaudible) in a control, only a quarter are getting treated. So very, very huge differences and here we like to put your attention to in rural areas, only about 2% are estimated of having diabetes where if we are seeing in the most developed cities, we are seeing diabetes in up to 10% and that is not that surprising because it would take comparatives such as Singapore or Hong Kong, there we do know that the Chinese population is very prone to diabetes. As a matter of fact, if we're seeing Westerners, we would say a usual BMI of 30 plus is an indicator for high risk factor for diabetes whereas if we are seeing a BMI of only 22 which is very lean for the Indian and the Chinese populations, then you start to see the same risk factors for diabetes. And that’s why also we are seeing these very high numbers.
Of course, one of the big problems that we are having is in the rural areas how do we get access to these markets but as a matter of fact, Novo Nordisk has been front cheering in this area and we are having representatives out living in cities where there are really living a million people. And that can be somewhat surprising if you are at least coming from Copenhagen or other places that we can afford having a person living there and even in those smaller cities, we have to do the investment and we have to help the doctors diagnosing diabetes because many doctors are not even aware of it.
Huge healthcare reform, I won’t spend too much time on it. One of the take home messages is this is a part of a three years plan with a time that I worked with China. I would say it is extremely optimistic thinking that this is going to come through in three years but I do believe this is the road that the Chinese central government is paving and this will maybe take eight to 10 years but I'm not in doubt that we will see huge populations going to be covered by healthcare. Again, relatively small funding you could say by only about $20 or 100 Danish Krona per patient living in the rural areas so very small portions but if you pull them up with 800 million people then even $20 times 800 million people becomes a very significant number.
And if we are looking at China, the volume growth of China is 23%, the value growth of the last five years is year-on-year 34%. So indeed a very, very fast growing market. And in similarities to the Indian market is a high, high premix market dominating by Novo Nordisk. Novo Nordisk in India by the way has the second most sold brand of all brand sold in India called (inaudible).
So, that just tells how big Novo Nordisk as an organization. We are driving this market. We have just in the months of February of this year introduced our long acting Levemir and we do believe that we will even see a faster up tick in the modern insulins because only 22% of the market has been converted. However if we are looking at this number, it is above 70% market share that we are having in value whereas the bio stimulus are having next to nothing in the Chinese market.
So, the second story here is also one of the things you pay attention that I was almost forgetting is the vast penetration, almost 80% of all patients in China are using a pen device and they are extremely pleased with Novo Nordisk, NovoPen 3 and NovoPen 4.
We have a club, a Novo Club with more than 600,000 patients that I’m engaging into, they’re receiving material from us and are engaging in an active dialogue with Novo Nordisk So, also broadly used, modern technologies.
Many things are changing in China as I said from a very basic system that they are having today, more and more people being call it. I do not believe that is going to by 2011 but it is also acceptable and very big numbers we are looking at. It is going to be by 2015 or 2020 that we'll see 90% of this huge country’s population being covered. What they are doing in China is that they are doing a lot of piloting in order to find out what sort of cost and what sort of impact will this have because it is so that it essentially decided what is locally paid for and that means each of the provinces, each of the 31 provinces has to pay themselves for providing healthcare and that’s why that sort of penetration is a little slower.
So in conclusion, on the BRICs and I don't know if I’ve been speaking too fast or too slow but just also to give a little more energy maybe into the room, a little more fresh air, I will just sum up in saying indeed, there is a possibility that in the next 20 years, we will see 60 to a 100 million more diabetics in the BRIC economies. We are also one of the areas where we need to do a much, much better job is to diagnose these patients and get them a proper treatment.
Of course, as we’re seeing incremental growth, GDP is increasing in the BRIC economies, we are seeing that in particular chronic disease such as diabetes is going to be funded more and more frequent and then last but not least, Nova Nordisk is the market leader in the BRIC economies and the reason for being is that we have invested in these markets for the last 15 years plus where as many other companies have come in, done half the efforts and then pulled out again, where as Nova Nordisk has had a long-term view into these economies.
So I think Jesper, we have one more slide and that’s yours if my memory serves me.
Jakob, sorry, that’s Victoza. So that’s the right caller. Anyway, closing remarks, I think we’ve been through the parts of the business that we wanted to go through. I don’t want to delay the things too much but just stating that hopefully, we have shown through this presentation that the annual diabetes market provides excellent opportunities for a company with a position Nova Nordisk had with a strong position (inaudible) want in any emerging markets. 51% market share in emerging markets. We have 60% of the global market convergent to modern insulin that we have an increasing market share in modern insulin.
We have as Jakob alluded to a very exciting position for our GLP-1 exciting product. And we are the only company who has dedicated a lot of resources to continuous development of insulin and hence we're the only one with two new insulins in phase 3 clinical development and then finally we haven’t had time to trust specifically today.
We have an expanding franchise within hemophilia trying to use exactly the same approach we have used within diabetes, so also to take a therapy leadership within the area of hemophilia but that would be now, and they will cover that. And then we will move over the Q&A and I think if I can have a mike here and then we'll share the three of us. And I think I will ask you up here and then we will send the mike around. If you would just state your name and your company when you ask the question then actually we will pass around the mike. Any questions?
Thank you. What sort of level of clinical indications you need to prove that the product will be accepted as with low hypoglycemia.
[Answer Inaudible]. And you can do that in the absence of hypoglycemia, that’s really in short, what we'll have to do. So when you're looking at the clinical program we have done. We have done a program which consists of six and twelve month studies. There is no requirement for an insulin to actually do cardiovascular study so you don’t have the up to two year requirements you have the most of diabetes care products. Here you dedicated to only do up to 12 month studies, and that’s why we are already expecting to complete those studies by mid next year.
I don’t think we should focus on Degludec today I think that would be bizarre. We have another question here?
(Inaudible) Partners, my question is regarding how Victoza is actually used. You mentioned where they are coming from. My question however what percentage is mono therapy, dual therapy, triple therapy. And also could you comment on the pre-approval, what’s your experience is to the pre-approval process try to steer people from mono-therapy use.
The first to the split mono therapy versus combination, it was how that splits further on and the limited mono therapy use so far but you could say also limited experience in as much as we have launched for them in Europe, where we don’t have that indication now we see it in the US. So there I would say we'd have to get a little more little bit of data in the US to see that.
There is a wide tradition for combination used in diabetes, so I think we'd also expected to be used in combination most often to be frank. If we look in Europe how much in combination we want versus (inaudible) roughly 50-50 split on that is what we see now sort of in true terms.
And then maybe just adding to that, that we are currently doing a phase 3B study where we try to combine the use of insulin together with Victoza, and we expect that trial to finish in the second half of this year and hopefully we can use that to actually get the label indication so that we also have the opportunity of use, GLB-1 together with insulin.
And actually quite big opportunities there keeping the patient longer on a GLP-1 and actually having the additional long acting insulin, in this case Levemir ensuring that you spare the insulin capacity of the pancreas for the need when you have the spikes at the meal times, and we are seeing anecdotally and also with Byetta combination with insulin in the US. I think that's been a number positive example of that combination and then of course as (inaudible) also alluded to in presentation excitingly if we can then combine Degludec with Victoza to combine not having to do one insulin injection and GLP-1 injection doing in one combined product in the liquid size device one injection per day combination product. I think that could be quite nice and actually ensuring that we could keep a long life cycle for the GLP-1 and that I think it will be stuff like that that will be required to take the GLP-1 segment towards the 10% of the overall diabetes segment.
And could you comment on the pre-approval process?
Yes, the pre-approval process is a fairly standard process in many ways simply to have a handle from many field organizations on the uptake of new drugs securing that there is a strong medical rationale for applying a new drug. So that's not specifically targeting anything, the positioning test as I said that and a little bit of a lever for the organizations to control the uptake. So typically in the first phase or if you have very expensive drugs that they may continue.
Have you seen any hinder for those patients that have or those doctors that have tried to get the approval?
Yes and no. I think by or large they go through. The challenge is that it imposes an administrative burden on the doctor. So you could say, if the doctor makes a decision of knowing that he or she has to go through a prior authorization. There is no doubt it has a dampening effect where that is in place, but it’s not as much as they do it and it gets denied. I think they are typically in a case like this because you probably see it go through if they take the effort to write off the pretty short form but still it’s a piece of paper that has to go back and forth.
Martin [Tucker] from (inaudible) Bank. Firstly, to Jakob and of course this has been a nice launch but what kind of concerns have there been raised for some of the decisions which have used it. And then secondly, could you give us now you just said it’s all about competitors at least your landscape but you will see one go forward your own but what about the competitive landscape. What are you doing there?
Firstly, concerns, I think it’s fairly obvious in the whole record until process that through that concerns have been raised and will always be about safety of a compound and there has been also questions about the safety on thyroid or pancreatitis. So, have we had concerns? Yes we occasionally do meet physicians that express a concern around that and that ones then a discussion with him. I think the very good news is that once we take the time we have the opportunity to go over what the fact are in this, they are very typically or predominantly we would reassure that there were no concerns for prescribing. But for the specialist it’s very, very rare.
There too they seem already to anticipate that in primary care also maybe because there is a competitive field out there that may also stir up these discussions. We occasionally meet that. And then we need to take a little time to go over what the facts are. The only thing rode into that is that has no human data to support it. There are other things like we get a concern like, there’s a box warning how do I handle that? We remind them that they pretty much have box warnings on a lot of the type 2 drugs they use, how they’re handling that? Yes, that’s actually true. So it’s often a matter of demystifying and just walking through that. But it takes a little time, and it might be an extra step in the process.
And then your second question was to the competitive landscape. Well there are two things to talk about there I think is the once weaker version of LAR expected potentially later this year and there my view is that there are a couple of issues there that’s going to be interesting to see how they play out. There’s one about the antibody formation with that I think is one general concern, that there is also out in the physician environment. But if you ask me I think the main thing will be that as far as we’re seeing that there are multiple steps in administering, I think counting up to 18. That’s a fairly challenging process to go through when you have to reconstitute by various means and inject within certain timeframes to avoid that it jells up, and you can’t do it.
You’re going to do it with a 23 gauge needle. All these things combined puts a big burden on the training in the physicians office, and puts I think a risk to that process of mistakes being made of the need for further consultations with physicians or nurses, would again draw on resources.
So, with that I think our anticipation of LAR will be that in the specialist segment, there will be, of course, interest but as a broad based product out in the type 2 field, I think that will be the challenge they have and I think we are obviously going to emphasis that it’s a matter of half a minute or so and then you have your daily injection.
And there are some elements of the daily management of your diabetes that fits well with the daily administration of your drugs, that’s not something that you necessarily want to forget altogether. So there are many aspects of that and I think that is going to make it interesting to see when they come in, how they’re going to handle that. Down the road, we know that other compounds are coming that’s the blue type. That they may not have the same challenges but lets see how the whole market involves up until that, but that of course, they have addressed, I think the primary barrier for LAR being that its going to be very (inaudible) to instruct and use.
Then of course, I think we need to see what label we’re going to compete up against. If there are similarity in labels and box warnings et cetera or whether there are significant differences, I think that will be quite significant and we’ll have to wait and see how the regulatory process evolves for Byetta. Next question.
Mark (inaudible). But which of the compounds is currently in development do you regard or which is the most competitive to your product?
I think it was inherent from the reply that Jakob gave that’s even if the challenges that we anticipate for Byetta we would probably expect that except for blue type products seems to have overcome significant part of those administrative burdens with the ones we could compound. So as it looks now, it maybe that which are the most significant, what it seems like similar efficacy to the 24 hour working versions of tier 2-1 (inaudible) or Victoza. And if they can do that in the absence of nausea, it looks like it's a competitive compound. But we will have to see more data also from tests for glutide before that can be fully assessed but that is how as we look at them. I was wondering if you have more comments on that.
Then a couple of questions on the international operations; I think the only weak, I saw in the recent report was Korea and Japan where the demographics should be there. But why is the growth quite moderate there? And then another, my third question is, I mean looking at the slides, you are dominating in Chinese and Indian markets by 40 to 50 percentage points compared to the low competitors, what's behind that? How can you be so strong in these countries?
Okay. If I just first comment on the market position in Japan and Korea, which is outside of scope, certainly those markets are growing way less than you are across country as Brazil. I think the key challenge we have currently in the Japanese market is an overall relative low growth of insulin. You are looking at currently the insulin market only growing approximately 3% in volume. An element of that is a move in the market from mixed initiation, so patients are initiated on combination insulins towards basal initiation in type 2 and that typically will use slightly lower volumes of insulin, and that leads to a relative lower growth.
And then, we are also in a challenging position in terms of the basal segment as we have two basal analogs there taking the predominant target of market share and prior to the launch of Lantus, we probably had more than 80% market share in the long acting segment in Japan and Korea. So that's been where we've been challenged. Of course, it's been crucial for us to now. In this quarter, we will roll out some high mixes, the mix market is till almost 50% in Japan so quite significant. That’s hopefully can improve our competitive situation versus say by unit, in the mid segment and then we hope to generate a lot of incitement in the second half of 2010 as Jakob will be bringing the Victoza product, reimbursed hopefully to the Japanese market. We think it has very high hopes tier 2-1 product in Japan.
Interesting, when we look at the HbA1c reduction, we saw in Victoza in Japan, we were approaching reductions at the level of two percentage point in HbA1c whereas the resulting completions was only around 1.5 percentage point. So a very high degree of efficacy and they are hoped for a high proportion of the Japanese patients getting good line, good control directly with Victoza. So, I think that will generate a lot of enthusiasm among the specialists in Japan and give us a much higher share voice in terms of what's the recall. We can see in the US that it has had effect and we have been rolling out Victoza, and the US have had a direct impact on our share voice because of course when you come with a new product, new therapy, the recall that they have in terms of share voice will benefit under one providing innovation, and I think that will also spill over to our Japanese sales force.
So, that's a short comment. Then Jesper what's the position in Japan, sorry in India and China?
I think there's not one answer to it. If I should point at one thing, I would think its quality. The most important thing in India and China today is quality. And it’s a misnomer that some people are having that they think that the Chinese is lower quality. I know they want exactly the same quality, even best quality than the rest of the world. They are very critical users of products because they pay for it and therefore expectations are this top quality. And there I think we've been able to do it. I think we've been able to drive the business penetration by devices. Nora Nordisk was first to come up with a device back in 1985. Ever since, we had a very strong uptick of devices around the world and for the ease of user device convenience, again quality, I think stands out. I think one of the other points that we can point out, not in so much in comparison to the local manufacturers but comparison to the other multinationals, we have been there for a long time.
We started in India, exporting to India in 1937 and had an ongoing relationship with the Indian healthcare professionals. We have developed, educated the doctors in many parts of India and are continuing to do so. Same story in China, we were one of the first multinational companies in China. We are today the fifth largest multinational pharmaceutical company in China. In India, we are number four of the multinationals. So again from being along and then the last point of course is, it is relatively cheap to treat diabetes and therefore a broad group can afford it. If they cannot afford it themselves because we should never forget that there are four billion people living on $2 a day. But even for those who are having $2 a day, if they pay for it as a family as they have a different way in each microenvironment to pay for things. So if someone suffers from diabetes, grandfather, grandmother gets diabetes, the whole family will chip in and pay what they can in this respect.
One of the problems that we are having in terms of getting patients to use insulin is the mixed perception of insulin in many parts of the world because it is so that for many families that runs type 2s in families and particularly in the Chinese and Indian populations, they have seen their grandfather or grandmother or uncle getting diabetes, being put on insulin at the very, very last stage when they were blind with kidney failures and (inaudible) they have been through the whole; severe problems that is caused by diabetes and then they die. So they have the idea, I was put on insulin or my uncle was put on insulin, six months later he passed away. Maybe it was the insulin. So that's a part of what we are up against. There are a lot of local herbs treatments and other things that we also are competing with. But if I should say, quality is the way we have approached the market. We are by far the largest sales forces. And then by history, our history tells us that it can be done.
And then maybe just adding, in India, we have also a very cost competitive set up where we are exporting our insulin crystals produced in Denmark through a local manufacturer called (Pharmelle) Pharmaceuticals, who then failed interest the small Indian (valve) that made it affordable for the individual patients to buy it in relative small increments. That is a key requirement for being competitive on the Indian market. Small units, cost efficiency and the labor intensive part of manufacturing insulin is very much in the filling part. That's what comes smaller you can say. Okay? Next question.
Well that, we talk obesity then, I mean as we move in ahead of diabetes. That's a good question. That's an interesting dynamic. It’s a little bit, I’m also going to say parallel to what we've seen from BRIC because the numbers are there. There’s an absolutely enormous amount of people suffering from obesity or being obese that could need that. Well, you have a good business and that's all. Let's leave BRIC and focus on obesity. But there's hardly any existing market for pharmaceutical treatment in the obesity area.
So what's going to be interesting for us to look at as we look at progressing with the phase 3 trials when we make that decision and how to commercialize it, how to identify a segment of that market. So we secure balancing that there's a strong medical need but the weight loss we offer is also giving a clinically relevant difference to people. You move too high up when people are too far progressed. They need something else. They may need surgery and also medicare incrementals.
You are too far down in BMI. You have payers being very skeptical in some markets like the German, classifying it as a lifestyle drug, not even want to touch reimbursement. So we have to find the area where we have a clinical relevant offering and there's a willingness to pay because we can make the medical argument that it's not all about losing weight, it's about slowing the progression into diabetes or getting to avoid some of the core morbidities that's being associated with the high weight. So yeah, not the best of the answers to say but the potential is that I think it's a matter of how you approach it. And I think we need to go through phase 3 to fully understand, if we can replicate the phase 2 data and exactly what we have and then we will make a more specific decision on how to approach the market. But it fits very well with both the whole vision of the company in terms of addressing diabetes, not only treating it when it's the reality but maybe also moving out and addressing the recruitment of new patients with diabetes. So we will need more data I think before we make most on our process about how to do that.
Or if I may add just a little bit of statistics there, we estimate today that more people are dying from obesity than from starvation and there's an estimated 300 million people that suffer from obesity or severe obesity, and that's about the same amount of patients that we are having suffering from diabetes. So the potential is of course enormous if it works out.
And then maybe the final comment from me would be the key markets here will be the US, and currently we are in a dialogue with the FDA as to the final design of the phase 3 program. The further development of the obesity indication for Victoza will be dependent on the clearance from FDA in terms that they agree that the design we have can lead to approval provided we deliver on the main design parameters, which typically is that we are able to demonstrate over a six-month period, are able to lose approximately 5% of the body weight, that’s the key way of judging it. And that dialogue is ongoing and we anticipate that we will have clarity on that in the second half of this year. So we will revert on that one.
Another question if there are metabolic syndrome market opportunities, the prevention of diabetes?
Well clearly, Jakob maybe even add a bit of comment. But clearly there's a big opportunity and you are pointing to an important fact because in the phase 2 trials we did with obesity, we could see that the patients we have entering the trials, and from my reconciliation it was about 30% to 40% of the patients entering who had elevated glucose levels. So they had (free) diabetes. And out of these patients with impaired glucose tolerance, we saw that approximately 70% to 80% of the patients at that stage reverted following the use of the product. Now that’s very interesting, it’s extremely encouraging, but it’s not an indication. So impaired glucose tolerance is not an indication that I can get on the label, so the indication you would have to pursue in this setting most likely would be, I don’t know whether you want to add something now?
In your last comment, you exactly addressed that. Now we have been through an approval process where there is a very defined target of a type 2 indication. That can be complicated enough. Then I’m told that shoot for something that is not exactly defined and there’s no history of approvals in that area. I think you might run into some very problematic discussions. But there is approach where you take an existing indication like weight-loss as the hard outcome you’re aiming for, but all your medical arguments are centered around what you can do with pre-diabetes and all that.
So, you could say at the end of it, maybe there’s not as much indication, that is the medical claims you can make and what’s your scientific document you do, so we can get close to that? But I think as an indication we’d probably take a target that exists before we shoot.
It’s quite impressive what you did on diabetes in international operations, but can it be replicated if high priced drugs like NovoSeven and growth hormone?
Yes, I would say. In the area of hematology, we are indeed market leader as we are in the rest of the world. We are seeing within a very small portion of patients. But we are seeing relatively or very good reimbursement, totally paid by government. Latin America is an area that comes to mind, where we are really seeing a lead, where the government goes in. Because it’s such a small group and helps them out, we should not forget that when we are talking hematology, we are only talking about 3,500 patients in total. Growth hormone I would say more or less same story. When you talk growth hormone, we have to segment things out which we often have to do to digest them, and as the high price segment, and that is indeed where Novo Nordisk is competing. Jesper was just talking about our new Nordisk (inaudible) which is a fantastic product and of course also a higher price than a product that you need to reconstitute and take it out of the vial and what you want to do with it at that point of time. So, indeed also in our part of the world, we should not forget that there are many, many wealthy people also in the BRIC economy. Russia and Moscow having the city with most billionaires in the world, just a small example and of course, it’s not that many. But at least they are willingness to pay for a much bigger group than we anticipate.
But I think importantly for the biopharmaceutical products in the international operations; the key decision is as Jesper alluded to, will be the willingness of the government to provide reimbursement for these specialist type of treatment, especially for hemophilia patients with inhibitors. So I would say to some degree, it’s a reality, a political decision as far as the Ministry of Health, typically whether they want to have a excellent treatment for the hemophilia population and to some degree also dependent on tradition in the country. Take a country like Iran, Iran has historic have a significant hemophilia population with close access to the (Shah) family and had a tradition of having a strong treatment for hemophilia. So we are seeing that they have been one of the significant countries we had on NovoSeven. So I think there is tradition and willingness to be also involved. And of course you can try to influence the effort but it’s not a factor of a change overnight.
I think one of the big opportunities we have ahead of us is China. Today, the treatment of hemophilia in China is very basic and typically based on (inaudible) derived products and their clearly moving towards the competent products in China. It’s a good opportunity. I think this is probably more and maybe Jesper you can elaborate a little bit on that. But I think that’s more probably a 5-10 year horizon than it’s something that will happen within the next three to five years.
No further comment. I think that’s a right product. I still think it’s going to happen as it certainly goes on because, we should not forget that by 2030-2035 China is more wealthier than the United States. By 2050, the average Indian is having about the same income as the average American, if we believe in the projections at Goldman Sachs and others have made.
Unidentified Company Representative
That was a long no comment. Any additional comment?
Of course I know its early days but one of the problems has been that the patients actually leave their treatment again. So stay on time has been low. If you look at Germany while you’ve been in the market for nine months or so, can you say a little bit about how many people are leaving treatment of Victoza versus the case have been with Pfizer?
I can say that the preliminary numbers we have, and again, we’ve been there for a while but it’s the same tale when you go back half a year. So it’s not a lot, just sort of really get heartache. We see very few leaving. We see very few leaving Victoza. I cannot tell you how many. Well, a lot are leaving exenatide but that’s because they are going to Victoza you could say. But spontaneous, I wouldn’t be able to address that number. But let me just stay with our own product, and we say it’s very limited. That’s been very encouraging. But to go as far as giving it a percentage for months and at the same time I think I will refrain from that now. That is still a little bit early days, but looking very good in that section.
I also have one question more. We assume that the target has taken off some of the growth recently, have you experienced that there are more health reforms having a tougher impact on your business now than we saw five years ago and what would you expect kind of you know, what kind of impacts do we actually see going forward there?
Unidentified Company Representative
I think the Turkey case is one of its kind. I think that they have learnt a lot from the Europeans in these matters. We see challenges but not necessary because of the Turkey’s approach but the economies that are devaluating Venezuela, Ukraine; a number of countries have had a lot of problems in the last couple of years. Turkey’s example is special in this case. But one should also not forget that the Turkey’s pharma market has been one of the fastest growing markets in the past and is almost on par with the big European markets in terms of size, 80 million people of course living in Turkey but in terms of value, it's a huge market.
I have a question regarding the kind of short-term, long-term Victoza. You reported 370 million of sales on the Victoza two days ago, of which 250 million was stock building, can you kind of elaborate what would a normal stock building be. That’s one question compared to other products and the other question is have you seen any thing in the launch so far that makes you rethink your targets on what kind of potential you have in this product. I think you used the word encouraging in the US and as expected in Europe. Could you elaborate on that maybe?
Unidentified Company Speaker
If I first comment on the pipeline filling of 250 million of course will take the product which goes much broader out into the DP territory compared to traditional insulins. If you go back some four years ago we launched Levemir in the US and I think if my regulation is right, I think the pipeline still at that point was around 130 million. So there is typically a pipeline fill and that’s most predominant for a launch in the US market.
At that point in time we saw the reorders occurring with a four to six month time lag, so there will be a window also in Q2 for Victoza where there will be limited sales coming out of the US, the European sales will of course continue to grow and there will not be any of these significant subsequent markets who will lead to big pipeline fills. So, that’s I’d say a special issue with the US launch.
In terms of the opportunity and the growth, I think when we use the word encouraging, it was certainly meant both for the US launch and for the European launch. We think the trend we are seeing in both geographies are encouraging Jakob whether you want to add more color to that?
No, other than to add to the pipeline so they say its more mathematical, it’s a part how many of the pharmacies where that the sides were stock up with the packet or two and then time to supply and that will give you the value. I think as an indicator of success, I would not trusted that, you could say its nice to see that the wholesalers, it’s a vote of confidence but at the end of the day, it means nothing. It’s what time that you begin to see as the reorders coming in and it’s the TRX that says everything.
The rest I think is that more matter of the master value and the amount of packets that you need to have, we have them in two versions depending on so you can get a full month supply. So that in itself was distinctive from a Levemir launch where it’s the same package you have, so wouldn’t read too much into that.
And clearly a high value per pack with Victoza compared to Levemir.
Last thing on zinc consumed, I have a question regarding, you sure that (inaudible) showing the prevalence in the BRIC countries is 113 million. Do you have the number of diagnosed patients and the number of treated patients and secondly, what can you do to make the diagnosed patients increase?
Basically if you want to have the BRIC numbers, you should take the four slides that are identical and back them on each other and then take the math. But if we are breaking it, the rough numbers, then you could say about less than 10% are in adequate control going from China, if my memory serves me, it was around 3% to Russia, 7%,8% maybe all the way up to 10% are in good control of the total population and then of course, stack it up only a quarter if diagnosed give and take.
So yes, there’s shoot on mass need that we need to do something about. but again, you have to understand that its not something that goes very fast, its something that you decide to put a representative in either Mongolia and then it takes some time before that business is built up and before you get it going. There’s a lot of windshield time, we call it the reps will have to drive back and forth before you build up that sort of infrastructure and get the doctors educated.
It is so that the vast, vast majority of our sales representatives are doctors themselves and that’s why they ask, treating the (inaudible) on how to look for diabetes, how to diagnose it and how then to of course treat them.
And especially if we look at China, one of the major challenges we have, or the Chinese government have is building up healthcare capacity. There are enough clinical to do the test for diabetes. So, building up a local community clinics is one of the major efforts in what we have just showed on the new Chinese healthcare policy. And I think bringing that capacity up and then I think we should try to take an active role in educating the physicians in the Chinese systems on how to diagnose diabetes and treat it then hope long term for growth but this is certainly going to be for the long haul.
I think the same tends to be largely said for the Indian systems where you have the big patient numbers. Okay. We take final question and we will round off.
If you are already that short so why but still you have more than 20% of the people diagnosed but much less than 10% are adequately controlled so why this huge difference?
First argument is money of course as Jesper is alluding to showing here is a part, that can they afford it? Can they not afford it? That‘s one of things and another thing is that they try the products if we have the type 2s they don’t buy by not taking the insulin they die from the diabetes in the medium to long-term. So they try it and they go off the product if it works and then they come back again and then someone convince them that this strategy can help them and so on so forth. There is a huge market in that part of the world of changing and a willingness to change because someone here bought something that might have worked then indeed can be done.
We should not forget though that one of the prime drivers that you can also avoid it with by losing weight. But again there is also big problem and we usually think that weight is only associated to the western of the world. It is indeed also we are seeing now children down to age of five and six in China getting obesity and thereby becomes type 2 diabetics.
So just a quick comment to that. I think just to note, it's not specific for BRIC. I mean diabetes is generally globally often talked about as the disease of heart. So it's not unusual that you would see only 50% treatment success and that's a factor of course at growth opportunity globally for us and I think one that needs to go hand-in-hand with addressing as with us, what we can do on the diagnosis side, getting more patients in. I think at the same time, we need to make sure that once they are diagnosed, we also increase the success rate because otherwise we are just looking for more patients without a full answer to how to deal with them. So but anyway, just to say that its not specific to BRIC.
Well, thanks to all you for managing through these two hours in Ohio like temperatures. It's certainly warm in here and thanks to Jakob and thanks for Jesper for sharing your insight and thanks for all of you for coming. Thank you.
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