Novo Nordisk's CEO Discusses Q3 2012 Results - Earnings Call Transcript

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Novo Nordisk A/S (NYSE:NVO)

Q3 2012 Results Earnings Call

October 31, 2012 8:00 AM ET


Lars Rebien Sorensen - Chief Executive Officer

Jesper Brandgaard - Chief Financial Officer

Mads Krogsgaard Thomsen - Chief Science Officer


Michael Novod - Nordea

Tim Race - Deutsche Bank

Richard Vosser - JP Morgan


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 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 of Tresiba and Ryzodeg continue to progress in the major markets.

In Japan, the Ministry of Health, Labor and Welfare approved Tresiba on 28 September. We're currently in the process of negotiating price with the Japanese authorities. We expect to launch Tresiba once these negotiations have been completed.

In Europe, the Committee for Medicinal Products for Human Use issued a positive opinion on Tresiba and Ryzodeg on the 18th of October. A formal marketing authorizations [committee] - European committee is expected within a couple of months after which Tresiba will be launched in the first European markets.

In the U.S., the FDA has confirmed that the advisory committee meeting for Tresiba and Ryzodeg will take place on November 8 of this year. Further the FDA has disclosed that the advisory committee meeting will focus on the benefits associated with lower risk of hypoglycaemia and the cardiovascular risk profiles of the two products.

Turning to financials, reported operating profit grew 34% and diluted earnings per share grew 31% in the first 9 months. Reflecting the strong sales performance in the first 9 months, we have increased our expectations to sales growth for the full year to the range of 10% to 12% in local currencies compared to a growth expectation of 9% to 12% when we released the second quarter results on August 9.

We have also increased our expectations for operating profit growth as we now expect growth on 16% to 18% measured in local currencies. Previously our expectations were around 15%. The preliminary outlook for 2013 indicates high single-digit growth in both sales and operating profits as measured in local currencies. The outlook reflects an expected positive contribution from Tresiba primarily in United States, EU, and Japan accounted by impact from the challenging operating environment in major markets. In addition, the outlook for operating profit reflecting (Inaudible) cost related it expected to launch Tresiba.

Turn to slide number 5. In the first nine months of this year, North America accounted for 64% of the growth, followed by International Operations accounting for 21% of growth, both measured in local currencies. Sales growth in North America was 19% in local currencies reflecting a continued robust market penetration of Modern insulins, in particular, NovoLog and Levemir.

Victoza also continues to perform well, despite the launch of a competitive product. The sales growth in Europe in the first 9 months was 2% measured both in local and reported currencies. The sales development reflect the continuous solid performance of Victoza and progress for the portfolio of Modern insulins.

Sales growth rmillionemains negatively impacted by decline in sales of Human insulins, low insulin volume growth as well as healthcare pricing reforms. Sales within international operations grew 16% in local currencies, driven by continued penetration of all 3 Modern insulins, robust solid human insulin sales and continued expansion of the GLP-1 market.

Sales in Japan and Korea were unchanged in local currencies when compared to the first 9 months of 2011. Sales development in Japan and Korea reflects a negative impact from lack of insulin volume growth and continued challenging competitive environment. Sales in region China increased 17% in local currencies in the first 9 months. The growth was driven by a Modern insulins especially NovoLog Mix and sales growth of NovoNorm, our tablet treatment for type-2 diabetes also contributed significantly to growth in China.

Turn to slide number 6. The Modern insulins continued to exhibit double-digit growth rate and Victoza continues also its steady growth trajectory. The first 9 months of Diabetes Care franchise grew 15%, while the Biopharmaceutical franchise grew 1%, both measured in local currencies.

Modern insulins were the primary growth drivers, accounting for 54% of growth; followed by Victoza, accounting for 45% of growth in local currencies. Sales of NovoSeven decreased 1% compared to the same period last year when measured in local currencies. The market for NovoSeven remains negatively impacted by stricter budgetary controls and the increase in inhibitor patients participating in clinical trials.

Sales of Norditropin increased 8% measured in local currencies. The sales growth is mainly driven by North America and International Operations. Novo Nordisk remains second largest company in the global growth [hormone] market, with a volume market share of 24%.

Turn to the next slide. five years the insulin market has grown more than 15% in value on an annual basis. The growth in value has been driven and by an annual 13% on the line volume growth in directional shift from Human to Modern insulins as well as increased penetration of devices. In the growing insulin market Novo Nordisk is successful, and been able to sustain the (Inaudible), today the company owns around 46% of the Modern insulins market measured in volume.

Turn to slide number 8, on update on Victoza. Sales of Victoza reached DKK6.8 billion in the first 9 months. This reflects steady sales performance across all regions. Victoza continues to exhibit solid sales growth rate, with an average quarterly increase of approximately DKK200 million per quarter.

In the U.S., Victoza continues to be encouraging despite the launch of a competitor product. Victoza is gradually increasing its market share, now accounting for 59% of the GLP-1 scrips in the U.S. Victoza's capture rate for new GLP-1 patients are also gradually increasing this now also 59%. In Europe, we continue to see strong uptick for Victoza across all key markets, and Victoza remains the leading GLP-1 product with a market share of 75%.

With this, I'd like to hand over to Mads who'll give you an update on research and development.

Mads Krogsgaard Thomsen

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 that the focus of the discussion at the meeting will be an assessment of the benefits associated with the low risk of hypoglycaemia and the cardiovascular risk profile of the two products.

Please turn on to next slide. Novo Nordisk has previously demonstrated significant clinical benefits of combining the use of long long-acting GLP-1 and insulin analogues in type 2 diabetes patient and were adequately controlled on all anti-diabetic agents as well as in population in need of intensification of your GLP-1 therapy.

Now, Novo Nordisk has competed a 26-week [pre target] extension to the once long Tresiba study 3579 in patients with type 2 diabetics. The extensive study evaluated the efficacy and safety of a adding 1 daily injection of Victoza or NovoRapid to the patients of HbA1c of 7% on Tresiba treatment at the start of extension as well assessing the durability of Tresiba plus metformin treatment in patients being low on HbA1c 7% at the start of the trial extension.

Patients in the extension trial were in fact expect in their third year treatment since they had previously participated in one year comparative study investigating insulin degludec and glargine, as well as one year extension of this insulin comparison.

From the page 9, HbA1c from 7.7% in both randomized treatment arms. The group randomized to the chose treatment achieved a significantly lower in trial HbA1c 7% compared to 7.3% for patient treated with once daily NovoRapid at the main meal.

Furthermore patients treated with Victoza experienced a significant lower rate of overall and nocturnal hypoglycaemia compared to patients NovoRapid. With regard to body weight, patients treated with Victoza achieved a weight loss of two kilograms with the patients treated with NovoRapid experienced a slight weight increase.

On HbA1c of 6.4% at the start of trial extension the nonrandomized patients continued Tresiba treatment in correlation with metformin experienced a stable HbA1c throughout the treatment period ending with the A1c of 6.5%. Rates of overall and nocturnal hypoglycaemia were low and de-comparables were (inaudible) for Tresiba, moreover the Tresiba patients experienced no weight gain during this extension trial.

In conclusion, the excellent clinical results from treatment with Tresiba in the BEGIN program are confirmed and furthermore patients that needed intensification experienced clear and significant benefits following addition of Victoza therapy for six months. In general, the safety and tolerability profiles of Tresiba, Victoza and NovoRapid were confirmed in this extension trial.

In October, Novo Nordisk initiated the first phase 1 trial for OG987SC before all GLP-1 project (Inaudible) into chemical deployment. The phase 1 trial will investigate safety, tolerability and pharmacokinetics of single all doses of long acting GLP-1, analogue in healthy volunteers.

Let's now move to biopharmaceuticals R&D, during the last two months both the European Commission and Swiss Agency for Therapeutic Products, SwissMedic has approved NovoThirteen of recombinant factor XIII product. The product was approved for once-monthly prophylactic treatment of congenital factor XIII A-subunit deficiency in patients above the age of six years. NovoThirteen will be the only recombinant treatment option for this rare disease. Novo Nordisk expects to launch NovoThirteen in the first European countries towards the end of the year.

In October, Novo Nordisk submitted a regulatory application for Turoctocog alfa to the EMA and FDA. Turoctocog alfa is a novel recombinant coagulation factor VIII molecule intended for prevention and treatment of

bleeding in people with haemophilia A.

In September, Novo Nordisk announced the decision to discontinue the development of the development of vatreptacog alfa for haemophilia patients with inhibitors. The decision followed analysis of the data from the phase 3 trial, in which a few patients, developed anti-drug antibodies to the vatreptacog alfa. None of the antibodies were clinically inhibitory, and the patients responded well to treatment during the course of the trial.

In Ocboter Novo Nordisk, initiated a phase 2a trials in recombinant factor XIII for the treatment of ulcerative colitis. The rationale for investigating factor XIII in this indication, is on the one hand the factor XIII has exhibited tissue generated in models of the disease and on the other hand that ulcerative colitis is associated to reduced levels of circulating factor XIII.

In this phase 2 trial factor XIII treatment, we will take patients with a mild to moderate disease and factor XIII is approved for comparison factor XIII as A-subunit deficiency now in EU, Canada and Sweden. In September, Novo Nordisk initiated first phase 2a trial with anti-IL21 for the treatment of rheumatoid arthritis. The trial will evaluate the impact of anti-IL21 compared to placebo in patients with excess rheumatoid arthritis on a background of (inaudible).

Finally, in October, Novo Nordisk initiated the first phase 1 trial with anti-IL21 for the treatment of systemic lupus erythematosus. The trial will evaluate the safety and tolerability of anti-IL21 in patients with ischemia

With that, over to you Jesper.

Jesper Brandgaard

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 2012 to 22 billion. In local currencies that growth was 21%. A financial here in the expense of 1.543 billion in the first nine months of 2012 compared to the 679 million in the first nine months of 2011. In line with Novo Nordisk treasury policy, the most significant foreign exchange risks for the group have been hedged primarily through foreign currency contracts.

Reflecting the portfolio of foreign currency exchange hedging contracts, the foreign exchange result was an expense of 1.455 billion compared to an expense of 109 million during the same period of 2011. This development reflects losses on foreign exchange hedging involving especially the U.S. dollar and Japanese yen due to the appreciation versus the Danish kroner compared to the exchange rate level prevailing in 2011. The effective tax rate for the first nine months of 2012 was 23%.

Please turn to the next slide. The two graphs illustrate the development of the U.S. dollar and the Japanese yen versus the Danish kroner. The tables on the right show the annual impact on our operating profit of the 5% movement in each of our key emerging currencies and the current exchange – for the same currencies. During the first nine months of 2012, the average exchange rate for the U.S. dollar versus the Danish kroner was approximately 8% above the level prevailing in 2011. The Japanese yen likewise was approximately 9% above the level in 2011.

At present, the value of the U.S. dollar and the Japanese yen is in line with the average 2012 year to date levels. Please turn to the next slide. We now expect sales growth in 2012 of 10 to 12% measured in local currencies. We now expect the also in 2012 of 10% to 12% makes sure in loan crisis. This is based on the expectations of continued market and inflation of the as well as the expectations for continue in change commoditization and impact from the of health care and pricing reforms.

Even the current level of the change rates verses the the force sales is now expect could be around 6% from higher and the growth ratios in local currencies. But 2012 the expectations for already profit growth is increased to 16% to 18% growth in local currencies. The expectations for higher level of operating profit growth reflect the increase expectations of sales growth.

the out go for operation profit growth reflects a significant increase in cost in the low fall of 2012 current by the expanded due to sales cost as well as sales and marketing investments in china and this is in the number of in its international operations. Even the current level of exchange rates versus the reform to operating in profit growth is now expected to be around 7 to 6 higher in the growth basis in the local currencies.

But 2012 bit in mid financial expense of along $1.7 billion reflecting in this loss on the foreign exchange is in contract growing the appreciation of the U.S $ and the Japanese YEN versus the compare to the exchange rate provision in 2011. The expectations for mortgage related currents in basic contracts is more than off sets by the bas significant cost to the impact on the operation profits from the appreciation of this mortgage currencies verses the.

The basic tax for 2012 is still expected to be around 23%. Capex is the basis is also to be expected to be around 3 and half billion 2012 from the earlier we related to the investments in the billing capacity and refill device and facility in Denmark. Expectations for this amortization and gain and loss are still around $2.9 billion and free cash is still expect to be around $19 billion reflecting significant cash payments expected in the 4th quarter of 2012.

With regards to the financial outlook for 2013 is to provide detail guidance on the expectations in connections with the release of the full year, financial results of 2012 on 23rd of January of 2013. for 2013 indicate high single basis percentage point grow in sales and operating profit both basis in local currencies.

The out flow with basic expectations will continue to inflation of the port folio in continue flow to and the positive sales contribution from primarily in the U.S EU and Japan this sales by the impact from the challenging pricing environment in guidance to nearing competition to all EBITDA basic products an attempted by a competition with the both as well as the mark economic conditions in the long flow of markets in international operations.

In addition the out flow of operating profit reflects significant cost related to the expected global. As the current exchange rate reported both in sales and operation profits, is expected to be in line with the globe major local currencies. All of the evolving expectations are based on the assumptions as the global economic environment do not significant to change the business conditions during the reaming part of 2012 and into 2013 and that currencies exchange rate specially the U.S $ will remain at the current level verses.

This concludes the financial.

And we are moving to the Q and A part

Question-And-Answer Session


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

Michael Novod - Nordea

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 will continue martialine we see and forces it would require for them to either come up with the significant improve at straighten difference at more better for them and completely formulation and by demand of the current situation and believe that it's going to be sometimes the making.

So no change in the current trends than expect 2012 financial even the month longer.

To protect the individual lines of cost and reduced the guidance of 2012 for how to develop in one of the individual cost line and decrease we think that the guidance we've given for 2012 which is the big in one of the basic points improving on the line cost margin and we now see the currently is approximately 60 basis points during the at the most margin level. On the it is incremented the positive development on the from the provisions of top prior may provisions relating to the disputes.

One of this minimal disputes were know to the market which was related to the on compensation of single forces of overtime where the U.S in June in a case registered to the modest that such liability within exist for people employed on the medical is like conditions. And that’s the consequence of that drowning Q2 – Q3 that provisions we have been base for this cases has been reversed following the of those case that

So I would look at the 2012 open to now we've had a reversal of legal provisions in the attitude of $60million to $70 million on the adjustments on the most significant wanted to give you feel more that makes this provisions actually moving into specifications that basic reversal. Then our deep ratio for the full year around 14% is.

You should anticipate a R&D ratio for the full year around 14%. It’s correct that the growth this year so far has been slightly lower than the underlying growth in sales, we have seen growth in the core type of 9%, whereas sales growth in currency have been growing 11%. Of course when we do the plan we cannot do the plan in local currencies and we are clearly benefiting on the R&D ratio from this very significant currency effect as we have a high proportion of our R&D cost in the Eurozone. We did in 2011 have some nonrecurring costs including in our R&D partly related to the discontinuation of our insulin [platform] project, and if you adjust for those nonrecurring items a year before the growth in our underlying R&D process has been very close to the level of growth in sales at around 11%. So that matches pretty well.

Then the final line, the R&D line in this, sorry the admin line is – it is unusually low in the first three quarters of this year and that mainly has to do with so much [expense] between the individual cost line and the admin line is very small, so small adjustment there actually to make a meaningful change to the totality. If you adjust for that and the nonrecurring items regarding a repayment of the fine (inaudible) five years ago. Then you are looking at an underlying growth level in our (inaudible) cost at the level of around 2%. So as far as the other factors this year should be of a nonrecurring nature and hence I would more see our admin cost in the quartile of probably around 4.5%, which I do feel is a very positive development and I should also just note for the admin costs going into next year we are anticipating a probably higher growth in admin cost as we in 2013 will have nonrecurring cost relating to a relocation both in the US to a new office facility and also towards the end of the year a relocation of the headquarter here in Bagsvaerd. So that will bring admin cost slightly up next year not to the level, but of course to the level in sales for the target higher percentage point than what we have been used to in the last few years. So that was quite elaborate.

Unidentified Participant

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


Tim Race, Deutsche Bank. Please go ahead.

Tim Race - Deutsche Bank

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

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

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

Yes, thank you very. (inaudible).

Unidentified Participant

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

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

Thank you very much. Next question please.


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

Richard Vosser - JP Morgan

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

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

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

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

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

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


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

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

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

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

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

(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

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

Thank you, (inaudible).

Unidentified Participant

Next question please?


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

Unidentified Analyst

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

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

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

Unidentified Participant

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 benefits for the products you do see there is a 25% risk reduction for an external Hypoglycemia that is actually increase in the statistic period and more rolling (inaudible) begin to realize that the vast majority between 80%, 90% of the overall 24 hour Hypoglycemic episodes are related to the bullish component and it is important to mentioned that when the bonus insulin was given at approximately the same unit amounts, improve the (inaudible) and the Degludec arms. And henceforth, even in terms of infant dosing, the arms were pretty well matched.

So, I would argue that what you should do with that in type 1 study, if it’s not internal hypoglycaemia because this is the way you could wash out the affect of the three day bonus insulins and you should do so in well matched groups. And we actually believe that the groups are well matched here.

Obviously, we will consider doing studies where we just like lenses were titrated around with 20% in patients who came from the previous therapy then we will do the same for degludec such that we got even less hypoglycaemia in the running period. That would be my comment at this point. Overall, well matched studies.

Unidentified Participant

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.


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

Sachin Jain - Bank of America

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

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

Unidentified Participant

And historically, he had come next week.

Unidentified Participant

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

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

Unidentified Participant

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

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


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

Unidentified Analyst

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

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

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

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.


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

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