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Novo Nordisk A/S (NVO)

Q3 2012 Earnings Call· Wed, Oct 31, 2012

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Transcript

Operator

Operator

Good day and welcome to the Q3 2012 Novo Nordisk A/S Earnings Conference Call. Today's conference is being recorded. At this time, I would like to turn the conference over to the CEO, Mr. Lars Rebien Sørensen. Please go ahead, sir. Lars Rebien Sørensen: Thank you, very much and welcome to Novo Nordisk Conference Call regarding our performance in the first nine months of 2012 and an outlook for 2013. I'm Lars Rebien Sorensen, the CEO of Novo Nordisk, with me I have our Chief Financial Officer, Jesper Brandgaard; Mads Krogsgaard Thomsen, our Chief Science Officer; and present are also our Investor Relations officers. Today's earnings release and the slides for the call are made available on our webpage on novonordisk.com. The conference call is scheduled to last approximately one hour and as usual. We'll start today with presentation outlined on slide number 2. The Q&A session will begin in about 25 minutes. Turn to slide number 3. As always, I need to advise you that this call will contain forward-looking statements. Such forward-looking statements are subject to risks and uncertainties that could cause the actual results to differ materially from expectations. For further information on the risk factors, please see the earnings release and the slides prepared for this presentation. Please note that this conference call is being webcast live and a replay will be made available on our website. Turn to slide number 4. We're satisfied with the performance of the first nine months of this year. Sales increased 11% in local currencies compared to the same period in 2011. Sales growth predominantly driven by strong performance in North America and International Operations. Key sales drivers have been our Modern insulins and Victoza, among the Modern insulins in particular NovoRapid and Levemir drives the growth. The regulatory review…

Mads Krogsgaard Thomsen

Management

Thank you, Lars. Please turn to the next slide. Let me start with an update on the insulin degludec products. The regulatory reviews of Tresiba, the intended brand name for insulin degludec; and Ryzodeg, the intended brand name for insulin degludec/insulin aspart combination continue to progress well. In Japan, Tresiba was, as mentioned, approved in September and launch is expected as soon as price negotiations have been completed. On October 18, the Japanese Agency [the FDA] published their assessment report for Tresiba representing the first extensive data review of the global regulatory dosing for Tresiba. In Europe, the Committee for Medicinal Products for Human Use under European Medicines Agency, EMA adopted positive opinions for Tresiba, Ryzodeg in the treatment of diabetes on October 18.Novo Nordisk expects to receive final marketing authorization from the European Commission late this year. We expect [EU] let for Tresiba will reflect at the very long and predictable pharmacological action profile, of insulin degludec, is associated with the reduction in the occurrence of overall and nocturnal hypoglycaemia versus insulin glargine across the pool of type 1 and type 2 diabetes products. It will also reflect the enhanced patient convenience associated with ability to [bury] the time of injection between the [age] as well as the ability to administer doses about to 160 units in one single injection. Recently the Federal Commission for the Protection against sanitary risk, i.e. the regulatory agency COFEPRIS in Mexico approved Tresiba and Ryzodeg for the treatment of diabetes. Novo Nordisk expects to launch Tresiba in Mexico following pricing and reimbursement negotiations. In the United States the FDA has confirmed that the advisory committee meeting to discuss the safety and efficacy of the NDAs for the Tresiba and Ryzodeg will take place at November 8th. On October 25 the FDA further disclosed…

Jesper Brandgaard

Chief Financial Officer

Thank you, Mads. In the first nine months of 2012, our sales increased by 18% measured in Danish kroner to 57.1 billion and by 11% in local currencies compared to the first nine months of 2011. The reported gross margin improved by 150 basis points to 81.9% in the first nine months of 2012. The improvement is mainly due to a favorable price development in North America more than offsetting the price we’ve experienced in markets like Europe. We also see a positive impact on product mix due to increased sales of the modern insulins and Victoza. The improvement in the gross margin is further supported by a positive impact from currencies of 80 basis points. Total non-production related costs increased by 11% in Danish kroner to 25.4 billion and by 7% in local currencies. F&D costs increased by 13% to 15.4 billion and by 7% in local currencies. Growth in local currencies is primarily driven by the expansion of the U.S. sales force and other costs to prepare for the global launch of Victoza. Furthermore, costs increased due to sales and marketing investments in selected countries in IO as well as the Chinese sales force expansion that was completed in mid-2011. Growth in selling and distribution costs is partly offset by a reversal of positions made on the legal dispute. Research and development costs increased by 12% to 7.7 billion and by 9% in local currencies mainly driven by development costs related to the ongoing phase 3 trials for liraglutide in obesity and the phase 3a trials for IDegLira. Within biopharmaceuticals, R&D costs are primarily related to the continued progress of the portfolio of development projects within haemophilia and the phase 2 trial for anti-IL-20 in rheumatoid arthritis. Operating profit increased by 34% in the first nine months of…

Operator

Operator

Thank you. (Operator instructions) And now we'll take the first question from Michael Novod from Nordea please go ahead.

Michael Novod - Nordea

Analyst · Nordea please go ahead

Hello it's Michael Novod from Nordea Markets and just 2 questions. Can you leverage a bit on how you expect that you can won competition depend out that going forward what kind of impact that you see now if you see any from the seek complete sales force of on by doing how you as seeing the landscape going forward. And then secondly to the cost levels I know there you say reversely the provision in Q 3 but know if you look at on the cost lines like they are very low is there a eligible level going forward around the 4% I may be the comment on that and also the remaining part of the cost lines. Thank you very much Michael as said I'll say the question part to be more completion and here what you get a comment on and slightly low development and having cost and how that goes from the And with regards to give up the one competition it is basically guiding the way which we predicted it would be depending on. I believe we said exit recovery is going at we anticipated that the we get 60% and the competition would get 4% and the fact that these two company have now brought out and taking over in all you does not make sure you change that competitive situation as it compared to the situation is in terms and by the perception of the molecule where we have repeatedly demonstrate is a more product and given them their current mobilization and we find it difficult to forcibly to actually change the current trend. So for now and also because we had expanded our sales force in United States and so we had significant weak in the U.S is that the a development…

Unidentified Participant

Analyst · Nordea please go ahead

Thank you very much for that detailed picture. Next question please.

Operator

Operator

Tim Race, Deutsche Bank. Please go ahead.

Tim Race - Deutsche Bank

Analyst

Hi there guys. Tim Race, Deutsche Bank. First question is just on the 2013 outlook. Could you just sort of detail out what you expect in terms of primed in for 2013, also what your prices inferred to see the sales launch cost as well as is there anything included in there in terms of exclusivities in R&D. I presume you can tell us about that at the movement. Then just couple of questions for Mads on the GLP-1, you have now got for all rows in development. Could you just talk through the differences between them and what does this all say about your confidence in any one strategy? I saw there was some of a (inaudible) from Merrion. this morning. So any comments on that as well? And just a question on China, I see newswire comments suggesting that you are seeing pricing challenges in the – you only mentioned China as well. You grew 42% in China in the third quarter. So is there something on the horizon here or is this just a misquote?

Unidentified Participant

Analyst · Nordea please go ahead

Thank you very much. Yes, what you think will be the outlook for ’13 now we’ve included (inaudible), Tresiba, what kind cost have included than if any sales and I don't know whether it’s matchbox common and potential stock. As for Tresiba, then Mad m rand under (inaudible) we have included (inaudible) of what kind of cost that we include anything in sales and I don't know whether that’s what’s common on potential start. As for Tresiba, then Mads if you can comment on the GLP-1 and any good competitive developments in the wallpsace and then I am going to comment on situation in China.

Unidentified Participant

Analyst · Nordea please go ahead

We have delivered this [growth] as for the top line growth in local currency to go with a just in historic terms slightly cautious growth level of high single digits. Of course high single digit and top line are a wide variety of percentages, what’s included in there is an assumption that we’ll see generic competition occurring to branded in the US and is approximately billion Danish kroner that is potentially exposed to generic competition in the US a little bit depending on when that occurs later in 2012 or into 2013. In terms of Tresiba, I don't think Tresiba and operating profit will have the significant impact. We certainly expect it to have a positive impact on sales and it is expected that we will certainly launch in Japan and Europe and we also assume that you’ll get onto the market in the US, but clearly we’ll have more clarity on that, but the range implied in the high single digits is the only point, it also varies on account of the advisory panel in the US. Of course as we are only predicting for 2013 that we are growing costs in line with sales we are assuming that we will be able to handle the launch of Tresiba within the guidance we have provided here, but there will be a clear correlation between the cost level and at what point of time the launch in the US occurs of Tresiba.

Unidentified Participant

Analyst · Nordea please go ahead

Yes, thank you very. (inaudible).

Unidentified Participant

Analyst · Nordea please go ahead

So last, just a quick comment I mean you have to mention that for Tresiba and Ryzodeg the Company is dedicated to do a large number of phase 3b trials, some of them which have already concluded clinically, but a whole range that I in the work schedule speak. They include studies that seek to further expand the label into more combination therapeutic modalities, studies that we look at specific populations, studies that will add to the therapeutic guidance that we can already give the patients as to how to seek the [pie titration] and so on and so forth. And ultimately we could also be looking into conducting outcome studies that is all with the realm of what Nordisk is looking into for Tresiba. When it comes to the all GLP-1 analogs and their carriers it is true that our collaborator Michael Donnelly, Chairman of Merrion has announced today the successful outcome of the Phase 1 trial using the (inaudible) technology and as you know what Nordisk is doing is working with Merrion, working with another company [MSphere] and working with our own technology to actually provide carrier systems that facilitate the transfer across the gut barrier into the circulation of GLP-molecules that have been designed to be resistant towards acid and inter merit degradation in the GI type. That means now that we have no less four all GLP-1 Phase 1 projects it is not because the other ones are feeling such beat, because the one that has just been announced by Merrion was indeed a successful one. It is more because we seek to constantly optimize the use for instance of the (inaudible) technology, the (inaudible) technology can be used with a very full coating of the tablet and with a smaller coating of the tablet and so and so forth. Before Nordisk were to decide hopefully next year to make the decision to enter into phase 2 trials with such an agent. We of course seek to optimize based on human studies the pharmaceutical characteristics of those tablets that we’ll take into phase 2. Indeed I will have to say that we are actually encouraged by the data we have seen so far.

Jesper Brandgaard

Chief Financial Officer

Thank you Matt. Then also (inaudible) question in China. Yes, we had a stellar performance in the third quarter in China and this is of course to some extent because we had such a poor third quarter 2011 due to the healthcare performance which were enacted in this all the time of 2011. So in fact our sales slightly declined in China in the third quarter of ’11 and on that background we are back to a growth trajectory in China. If we look overall on the situation in China it’s sort of with samples in some way it’s a fighting with sameless Europe with a negative drag on pricing in China due to competition and particular human influence and going forward the main potential overhang we had in China is an expected revenue of pricing reimbursement on modern, which has been at future negative impact on our business, but I mean let’s enjoy (inaudible) last quarter and we believe that our business is going to come up for the years, approximately we indicated about 15% growth and that’s where we are trailing at the movement.

Unidentified Participant

Analyst · Nordea please go ahead

Thank you very much. Next question please.

Operator

Operator

We’ll now take our next question from Richard Vosser from JPMorgan. Please go ahead.

Richard Vosser - JP Morgan

Analyst · JPMorgan. Please go ahead

Hi it’s Richard Vosser from JPMorgan. Two questions on Tresiba please. Just wondering now you have seen the label for Japan obviously and have a very good idea of the labeling in Europe. Just your thoughts on pricing and the premiums in these markets and what sort of premium you’ll get and how that could have – how you were thinking about that effecting the speed of launch. Then connected to that just in terms of the volume versus price dynamics in the emerging markets particularly you have mentioned that we could see a price or negative price in China, just how you are thinking about that with respect to Tresiba when that comes to market in the emerging markets. Is there a risk of it by maximizing price that you are going to miss out on a significant amount of volume and hence the launch in emerging markets could be relatively slow? That’s it. Thanks very much.

Unidentified Participant

Analyst · JPMorgan. Please go ahead

Thank you very much. First of all, let me allow Mads Krogsgaard to talk a little bit about the Japanese label, health technology assessments and alike and then we are going to give you some comments on the overall pricing strategy of course within the comparison rounds, as it is possible given that we’re just ending part of the launch. So that’s first and then we’ll revert to we’ll over to….

Unidentified Participant

Analyst · JPMorgan. Please go ahead

Yes, it is indeed true that we know in great details both the European and the Japanese label (inaudible) these products. We cannot announce in great detail until the commissioner officially has stamped it of course and approved it. But what we have included in the phase 3 trials is very extensive health economic outcome research measures both pertaining to a (inaudible) hypoglycaemia and quality of life and other elements of you can say quails such is included in the SF-36 analysis that has been as you know adopted across a range of these trials. Also assessments of the cost of block glucose measurement and the ability to decrease that based on you can say the simplicity of the treatment. All of this has been put in together and based on the data in phase 3, we actually can justify a premium based on the merits and the calculations that have gone and some are being submitted already to agencies in Europe that allow for you can say prelaunch submissions of regulatory or health technology (inaudible). That the price premium that we feel can be justified, we cannot disclose at this point but they are of course clearly relevant based on the data and that will much more be subject to you can see negotiation between us and the agencies and the subsequent reinvestment discussions. That is ongoing in Japan right now by the way and in Europe the first countries have received (inaudible) technology (inaudible).

Lars Borup Jacobsen

Analyst · JPMorgan. Please go ahead

This is Lars here. So what you should be anticipating is that we would be able to conclude the (inaudible) calculations in Japan within the next couple of months and so to get on the market in Japan. With regard to Europe the patent situation in Europe is far more challenging. As we have seen historically over the quarters and therefore the anticipation is that it’s going to be more difficult for us in Europe. In Europe on the other hand we also, we had a very, very strong label suggesting the benefits of the products. So it is not completely top hedged that we especially also when you can see the daily attributable cost for people on currencies like that. This with these products which we’re talking about couple of Euros, so it is not like cancer therapy or MS drops or anything that over our magnitude. The premium itself in Europe will be causing some concerns on the product, (inaudible) of the authorities and you then mentioned in the emerging markets to what extent is that and of course it’s going to (inaudible) the difficulties of getting products illustrating into American market. First of all let me say that in China we are – we have not gotten approval yet because it's just in phase 3 and it is all starting in China and after that there is still going to be a few years before we’ll be able to enter into China. Other emerging markets is typically such that there are private markets there are public markets. In the public market even we were to go with that (inaudible) we wouldn’t be selling Tresiba anyway. So Tresiba initially would be a addressed to more patients .In the private launch that have either the ability to afford to it or the ability through insurance to find this. So it’s much more on the resamples and margin that we chose. We just thought it would become meaningful also in emerging markets and then hopefully as the product gets more well known there would be a increasing tendency then also. Then corporate insurance schemes will be offering that, but and we would be looking probably more at countries like North Africa, like Mexico, like Turkey, like Brazil and (inaudible). South East Asian markets we have to (inaudible) that’s before we see any major penetration there.

Unidentified Participant

Analyst · JPMorgan. Please go ahead

Maybe just (inaudible) in terms of China, we would intend to use the final approval in Europe to file for approval of phase 3 trial in China to start the regualtoiry process there.

Unidentified Participant

Analyst · JPMorgan. Please go ahead

Thank you, (inaudible) and Matt. Next question please.

Operator

Operator

We will now take our next question from Martin Parkhøi from Danske Bank. Please go ahead. Martin Parkhøi - Danske Bank: Hi, Martin Parkhøi from Danske Bank. Just two questions, first with respect to your high single digit sales guidance for 2013. If you look at your (inaudible) numbers on a regional in the third quarter it’s basically all over the place very big volatility from market-to-market. Could you go into a little bit more what you have assumed for markets, which markets are there that actually will decelerate compared to 2011 of course, sorry 2012. Of course with US and (inaudible) and how much have included from a healthcare impact in your top line guidance for 2013. Then secondly, with respect to Victoza, in Q4 last year we saw reversal of rebate in the fourth quarter could something similar or to a smaller extent happen in the fourth quarter of this year.

Unidentified Participant

Analyst · Nordea please go ahead

Thank you very much. Yes, if you would (inaudible) to answer the (inaudible) providing our regional guidance on 2013. Clearly the gross margins are North America and emerging market in China. So you covered on that (inaudible) to be chosen reversal to the same sense as we saw in last year in the fourth quarter and the US.

Unidentified Participant

Analyst · Nordea please go ahead

Then my (inaudible) is going to be more than 680 what you said. This is a preliminary guidance at this point in time. It’s clear that the growth in local currency, same currency has got be very modest in both Japan, Korea and Europe. The growth will be driven by markets like China International Operations going in the all part of 50% and North America getting closer to that North America having benefited in 2012 from the low level of impact quarter could – something similar or to a smaller extent happened in the fourth quarter of this year?

Lars Rebien Sorensen

Analyst

Thank you, very much. Jesper if you prepare yourself to answer the – (Inaudible) all right in our regional guidance on 2013 sales but clearly the main growth markets are North America and emerging markets in China. Color on that with regards to be chosen on not anticipating we were also to the same strength as we saw them in the last year.

Unidentified Participant

Analyst · Nordea please go ahead

In the fourth quarter in U.S. and then my (Inaudible) it's going to be more less what you said. This is a preliminary guidance, at this point in time it's clear that the growth in both currencies, same currencies is going to be very modest in both Japan and Korea, and Europe, is the growth will be driven by markets like China International operations growing in the all part of 50% and North America getting closer to that North having benefitted in 2012 from a low level of impact from healthcare reform and also benefiting especially from winning of the contract leasing to institutions like CBS (inaudible) et cetera we don’t have any knowledge of sub significant contract win for the new year so that should everything knows in same currencies to the North America get down so that would be practice and then you would be mentioned brand in yourself and then let’s get the full year numbers and we will give some more details guidance on the individual markets.

Unidentified Participant

Analyst · Nordea please go ahead

(inaudible) I would say in our mind there has been various processes in U.S. where we have both uncertainty I mean also proceed that we have a branding on, off as we had in previous years and then we had a competitive situation which is quite volatile (inaudible) we’ve gain this year and who knows what’s going to happen going forward.

Unidentified Participant

Analyst · Nordea please go ahead

Actually (inaudible) making the world class market up about the impact pricing (inaudible) and we have been going running rate of about 1.5% point until the sales in 2012 and (inaudible) basin is there is not going lower in 2013.

Unidentified Analyst

Analyst · Nomura. Please go ahead

Thank you, (inaudible).

Unidentified Participant

Analyst · Nordea please go ahead

Next question please?

Operator

Operator

We’ll now take our next question from Amit Roy from Nomura. Please go ahead.

Unidentified Analyst

Analyst · Nomura. Please go ahead

Hello. Thank you. Amit Roy from Nomura. The couple questions around the high (inaudible) claim of placebo, we’ll be not in the phase 3 study on the type 1 phase and that baseline that for the patient who are having had drug that by (inaudible) is quite different in shaping time compare to the baseline traffic of the patient in the (inaudible) I should close to the level and look at the type 2 study that perfectly might still (inaudible) so I am just trying to some if any regional idea I mean answer to quite a bit for shape of glucose control so completely different between the (inaudible) before they should start treatment my first question. And second question just around the because (inaudible) and appreciate that give us much idea yeah there is mentioned (inaudible) that is know (inaudible) expense in the U.S. when we look at the IMS so I guess which are obviously on the maximum so (inaudible) if we could grow in the U.S. to the further back out the rest of the world so I appreciate to those account in both in information, The Europeans I should say the rest of world sales numbers not growing strongly, (inaudible) how the non-U.S. growth of return it growing many thing.

Unidentified Participant

Analyst · Nomura. Please go ahead

Yes. Thank you very much. We had a little bit of poor here on remain at completely have come (inaudible) but we are solid mass just going try to raise the issue of type 1 and baseline comfort issue of those day-to-day (inaudible) and then type 2 patients which we are (inaudible) in new assessment, never get back to we go, we will given recumbence on that. So Sachin if I drew back in time to the point where we had end up a two meetings and questions with the FDA with Phase III design and adherence or non-adherence to the CV guideline from the agency so and so forth. It was a clear discussions and also conclusions between FDA and Novo Nordisk that this was an insulin and being an injectable insulin it should not proceed -- adhere to the CV guideline. When that was said and that also means that the (inaudible) confidence (inaudible) with the upper and lower 95% pounds being (inaudible) 1.8 pre-approval and also 1.3 post approval. Since (Inaudible) when that was said, it was also a clear agreement that we should adjudication of all (inaudible) that were reported by a blinded committee such that we did as professionally as possible to study even though it was designed for glycaemic services and not for cardiovascular outcomes preferences. So that was the discussion then and that is also the circumstance under which of course that you will be looking at this cardiovascular discussion we expect on this Thursday. And that being changes since then other than the fact of course that we are now discussing with the agency based on (inaudible) so on so forth.

Unidentified Analyst

Analyst · Nomura. Please go ahead

Yeah. That’s (inaudible) data on Biogens (inaudible) 3.5 day interval in patient regimen. What are we looking for?

Unidentified Participant

Analyst · Nomura. Please go ahead

Yeah. So it is true that Biogen Idec with (inaudible) yesterday announced the headline results from the long trial and that one did actually reveal what I will call positive data and we would give to patients. Novo Nordisk for the (inaudible) that has provided a hot life (inaudible) that is very reminiscent of what the Biogen Idec (inaudible) has done of 1.8 to 2 (inaudible) is being started on every (inaudible) basis in our phase III program. So they are ahead of us and congratulations with Yeah. Well, first of all the biggest study in the study that publish in the last that the 35, 85 base of bullish type 1 diabetic study, its eventually a big study enormous to 700 patients that was quite frankly we will met in terms of the based on characteristics obviously you never total match winning terms A1C, BMI integration of disease (inaudible) glucose they went only the difference is you can actually accu the thing that could probably have done even pregnant would actually have being to insure that the patient who in prior to repeat and had in screen on the twice daily basis dosing which we know occurs in about going forward to one in five patients with that bundle if could you just so they should have had the 20% reduction in the (inaudible) dose and the (inaudible) this would have give less hypoglycemia in the running space and it something that we have learn for future trials that in the patients are twice 80 previous regimen of this insulin they should defective a dose reduction and this is also being recommended in the way that we will repositions (inaudible) other than that when you looking to the maintenance period where you see you can say that the two…

Unidentified Participant

Analyst · Nomura. Please go ahead

Thank you very much, Matt. Then on to (inaudible), we are giving you sort of a complete accurate numbers and U.S. is of course is still constituting the majority of our share was about 12 months, 80% of the sales coming from the U.S. And the growth rates in non-U.S. sales if you look outside of Europe is of course quite, quite significant. Japan, the takeoff has been slightly less than what we see in other markets and you know the reason for this, we had a very unfortunate situation in initial launch of our product in Japan where due to some – (inaudible) and some patients got hurt in switching from insulin into Victoza, whereas in other emerging markets sales have been growing strongly more than 100%, in fact in recent quarters. So they are becoming noticeable and sizable. Thank you. Next question, please.

Operator

Operator

We’ll now take our next question from Sachin Jain from Bank of America. Please go ahead.

Sachin Jain - Bank of America

Analyst · Bank of America. Please go ahead

Hi. It’s Sachin Jain from Bank of America. A couple of questions, please. Firstly, as we think about next week, I wonder if could just remind us when you plan the placebo begin the studies, could you account what discussions you had with FDA around degludec (inaudible) in spite of the BTCV guidelines? Any perspective that you might have through discussions that that might be changing in their full process? Secondly, on (inaudible) factor rate, long than what you have, (inaudible) has just a headline date for its product and the average dosing for its drug was – there seems about three and a half days. I wonder, can you just remind us, Matt, what dosing (inaudible) planning to achieve within your Phase 3 study. Thank you very much.

Unidentified Participant

Analyst · Bank of America. Please go ahead

Thank you very much, Sachin. Matt, of course it’s you.

Unidentified Participant

Analyst · Bank of America. Please go ahead

And historically, he had come next week.

Unidentified Participant

Analyst · Bank of America. Please go ahead

So, Sachin, if I drew back in time to the point where we had in the peak two meetings and precautions with the FDA with Phase III design and adherence or non-adherence to the CV guideline from the agency so and so forth. It was a clear discussions and also conclusions between FDA and Novo Nordisk that this was an insulin and being an injectable insulin it should not proceed -- adhere to the CV guideline. When that was said and that also means that the (inaudible) confidence (inaudible) with the upper and lower 95% pounds being (inaudible) 1.8 pre-approval and also 1.3 post approval. Since (Inaudible) when that was said, it was also a clear agreement that we should adjudication of all (inaudible) that were reported by a blinded committee such that we did as professionally as possible to study even though it was designed for glycaemic services and not for cardiovascular outcomes preferences. So that was the discussion then and that is also the circumstance under which of course that you will be looking at this cardiovascular discussion we expect on this Thursday. And that being changes since then other than the fact of course that we are now discussing with the agency based on (inaudible) so on so forth.

Unidentified Analyst

Analyst · Bank of America. Please go ahead

Yeah. That’s (inaudible) data on Biogens (inaudible) 3.5 day interval in patient regimen. What are we looking for?

Unidentified Participant

Analyst · Bank of America. Please go ahead

Yeah. So it is true that Biogen Idec with (inaudible) yesterday announced the headline results from the long trial and that one did actually reveal what I will call positive data and we would give to patients. Novo Nordisk for the (inaudible) that has provided a hot life (inaudible) that is very reminiscent of what the Biogen Idec (inaudible) has done of 1.8 to 2 (inaudible) is being started on every (inaudible) basis in our phase III program. So they are ahead of us and congratulations with (inaudible) customer has done of 1.8 to 2 fold over and above net effect to eight, is being started on a every full stay basis in our Phase III program, so they’re ahead of us and congratulations with at least top end results that they’re looking favorable and we will hope to generate equally good results for our product even though that is too early predict.

Unidentified Participant

Analyst · Bank of America. Please go ahead

Thank you very much, Lars. Ladies and gentlemen time for like we should take the last question please.

Operator

Operator

We will now take our last question from Luisa Hector from Credit Suisse. Please go ahead.

Unidentified Analyst

Analyst · Credit Suisse. Please go ahead

Good afternoon. I wonder if we can just go back to the 2013 challenging operating environment, and specifically on two of the points you raised, the tough pricing in major market, would that include the U.S. because I believe Lilly was lagging slightly tougher pricing environment with negotiations getting a bit tougher with the big players. So just any color on the U.S. pricing specifically there, and you did make the comment on the contract so the U.S. so there is new ones so 2013 to be aware of, so we should assume in terms of covered life insulins for 2013 in the U.S so it’s relatively stable pictures as we go into next year? And the second part of your challenging operating environment would be intensifying competition in diabetes and biopharma and your earlier comments on GLP suggested that you don’t see of major change there in dynamics. And then in insulin you’re the one potential launching the new product, so I am just wondering what else is causing this intensifying competition. And then second question on the FDA panel just could you tell us how whether you were surprised by the focus on the cardiovascular and to what extent this came out with the European regulator?

Unidentified Participant

Analyst · Credit Suisse. Please go ahead

Thank you very much, this is Lars Rebien, first of all 2013 and onward U.S. competitive situation and then I will try to answer the second part of the question which is what do we see different in GLP-1 a statement versus insulin segment is I mean it is almost I would say legal Mads to talk about the future competitive situation in the insulin in United States because it’s late in ourselves that are (inaudible) as well what we intend to do about the price but it is correct that Lilly drive a price more in 2010 into 2011 have been very aggressive on certain managed care accounts in the U.S. and we have been starting out interest and became competitive in 2013 and result of that and then they’re not clearly that gives Lilly a very (inaudible) picture on the pricing scenario and what that’s going to be going forward, I mean I am going to speculate on that. We’ll have to see the results, I don’t want to comment on it but it is a very competitive but it’s between Lilly and ourselves. When we talk about Q1 that’s talking about (inaudible) also to companies it due to Lilly and (inaudible) in the future and it’s BMS as a percentage against no logic to entrance into the market they have clear average profiles. And so that gives a completely different pricing environment compared to the channel picture and insulins were that are different treatment choices we see it in Europe were increasingly human insulins are being aggregated and first choice for patient even though there are own (inaudible) products. And that have indications for the competitive situation between human insulin suppliers in Europe and there are several human insulin suppliers in Europe and that also have indications for future pricing of modern insulins and nature of (inaudible) we are planning to introduce . So but primarily out and Lilly rise base that are determined the price base related to insulins and with regards to GLP-1 also (inaudible) going forward Mads (inaudible).

Unidentified Participant

Analyst · Credit Suisse. Please go ahead

So the final round in this one obviously we will be much wise after (inaudible) but what I can say is that ever since the FDA management act of 2007 it is been the default setting that human entities do by default undergo advisory committee hearing on this the something that’s speaks against what happening, and do get in mind the previous insulins are prior to 2007, it’d be (inaudible) so we’re not surprise as such an ADCOM then the focus on CUV well do bear in mind that over the last several years most of the agency hearings have – had an element of cardiovascular risk assessment and in that regard you can see the FDA the EMA and PMDA in U.S. Europe and Japan respectively have all seen the same data and we know today that we are on track EU Commission approval in Europe and we have an approve (inaudible) Japan, and we also hope to be able to convinced the panel on the eight that we have a very favorable benefit risk profile for this (inaudible) in U.S.

Unidentified Participant

Analyst · Credit Suisse. Please go ahead

So with that ladies and gentlemen I hope you share good wishes with us for next week for ADCOM meeting in United States, I know that you were all be tuning it in and I am sure we will be talking to many of you following that ADCOM meeting. So thanks for listening in on this, this one we will be back very shortly.

Operator

Operator

That will conclude today's conference call. Thank you for your participation, ladies and gentlemen. You may now disconnect.