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Novo Nordisk A/S (NYSE:NVO)

Q4 2009 Earnings Call Transcript

February 2, 2010 7:00 am ET

Executives

Lars Rebien Sørensen – President and CEO

Jesper Brandgaard – EVP and CFO

Mads Krogsgaard Thomsen – EVP and Chief Science Officer

Analysts

Richard Vosser – J.P. Morgan

Michael Novod – Handelsbanken

Henrik Simonsen – SEB Enskilda

Sam Fazeli – Piper Jaffray

Jacob Thrane – Standard & Poors

Dani Saurymper – Goldman Sachs

Martin Parkhøi – Danske Bank

Carsten Madsen – Carnegie Bank

Sebastien Berthon – Exane

Jack Scannell – Sanford Bernstein

Operator

Good day, and welcome to the Novo Nordisk financial year 2009 results conference call. For your information, this conference is being recorded. At this time, I'd like to turn the call over to your host today, Mr. Lars Rebien Sørensen, CEO. Please go ahead.

Lars Rebien Sørensen

Yes, and welcome, ladies and gentlemen, to this Novo’s conference call regarding our 2009 full year results, which was released earlier today. I’m Lars Rebien Sørensen, the CEO of Novo Nordisk. With us, I have our Chief Financial Officer, Jesper Brandgaard; Mads Krogsgaard Thomsen, Chief Science Officer; and, present are also our investor relations officers.

Today's earnings release is available on our home page novonordisk.com, along with the slides that we would be using for this conference call. The conference call is usually scheduled to last approximately one hour. And I’d like to start with the presentation as outlined on slide number two. The Q&A session will begin in about 25 minutes.

Turn to slide number three. 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. Further information on the risk factors could be seen in the earnings release and the slides prepared for this presentation. Note, as mentioned, that the conference call is being webcast live, and the replay will be made available on the Novo Nordisk's Web site after the call.

Turn to slide number four. We’re satisfied with the sales result in 2009 with a sales growth of 12% reported and 11% in local currencies. This performance was driven by continuous penetration of our modern insulins in our key markets.

North America continues to expand its position as the largest sales region for Novo Nordisk with sales growth of 31% reported, and correspondingly 15% in local currencies. However, international operations, it’s the fastest growing region with 19% growth in local currencies. Within our (inaudible), we’ve achieved numerous significant milestones since the release of our full year results 2008.

Victoza has been approved across the triad markets, the US, Europe, and Japan. The commercial launch is ongoing and progressing well in Europe while we are looking forward to launch Victoza both in the United States and in Japan.

We have initiated a phase 3 program for our two new generations of insulins, which we now call degludec and DegludecPlus, respectively. This is the largest clinical trial program ever to be conducted within diabetes, and we expect to enroll more than 10, 000 patients in total.

Further, we have started our first trials with oral insulin and oral GLP-1. We still have many challenges to overcome. However, we are encouraged by the progress made by our research and development team during the past couple of years. Our cornerstone is our business model and the financial performance we achieved in a manner which is environmentally and socially responsible.

In this context, I’m happy to note that we have achieved our 2014 target for reduction of CO2 emissions already in 2009, a target we set back in 2004. More specifically, we have, in our five years, reduced our CO2 emissions by 30% despite a significant increase in production volume. The realization of this target five years ahead of plan is a result of energy savings in all productions facilities globally.

This year, we also launched the Changing Diabetes in Children Program. Today, the program has enrolled more than 400 children with type 1 diabetes in six developing countries, the promising start of the program, which eventually is expected to include around 10, 000 children.

Now turning to the financials, operating profit grew 21% reported and 15% adjusted for the impact for currencies and non-recurrent costs in 2008 related to the closure of our pulmonary diabetes project. The cash flow in 2009 was Danish kroner 12.3 billion, compared to Danish kroner 11 billion in 2008. The high cash flow is driven by higher net profit and lower income tax paid, counted by at least capital expenditures during 2009.

In 2010, we expect our solid performance to continue. We expect sales growth of 6% to 10%, and a growth of operating profit of 10%. We expect growth (inaudible) to be similar for both local and reported currencies. Later in this call, Jesper will add some details to our guidance for 2010.

Turn to slide number five. Our portfolio of modern insulin continues to show strong performance overall. In 2009, the portfolio of modern insulin was one of the main growth drivers accounting for more than 80% of total sales growth in local currencies.

Biopharmaceuticals grew 11% reported and 9% in local currencies. Contributing the most with sales, NovoSeven, which increased 11% in Danish kroner and 10% in local currencies. Sales growth in NovoSeven was primarily realized in Europe and the international operations.

Also our growth on old franchise showed solid performance with 14% sales growth in Danish kroner and 10% in local currencies. Novo Nordisk remains the second largest company in the global growth hormone market with 24% volume market share.

Turn to the next slide for an update on the regional state of sales. 2009, sales growth was realized in all regions. North America was the main contributor with 48% share of growth measured in local currencies, and our North American sales region continues to expect a leadership position. International operations and Europe contributed 32% and 19% respectively of total sales growth. European sales growth was impacted by currently low volume growth at the insulin market assumed to be a temporary nature and linked to the launch of the (inaudible) in Europe.

Sales growth in Japan during 2009 has been around 1% measured in local currencies. The growth of sales continues to be impacted by a change in the underlying insulin market dynamics where growth of the baseline segment, in particular oral insulin, has accelerated at the expense of the pre-mix segment where Novo Nordisk casts its strongest position.

Turn to the next slide for an update on the insulin market dynamics. Around 59% of the global insulin market measured by volume has now been converted to modern insulins, compared to 55% same time last year. The conversion can be stable and looks -- said to continue in all markets globally. Of the major markets, the US is still leading the conversion with almost 70% of the insulin market being converted. In Europe, the modern insulins, which represents more than 60% of all insulins, whereas in modified China, a significant opportunity remains in converting patients, which they're only around 20% use in modern insulins.

The conversion is driving the value of growth of the insulin market, along with the ongoing conversion to pre-filled devices. Novo Nordisk continues to gain market share within the modern insulin market segment. Novo Nordisk's market share in the modern insulin segment is now 45% measured in volume. Novo Nordisk continues to be the only company that offers [ph] a full range of modern insulins with short-acting premix and long-acting modern insulins in advance, and use a branded delivery system such as the easily to use disposable FlexPen.

Turn to the next slide for an update on our global rollout of Victoza. The rollout of Victoza is progressing well. In Europe, Victoza has been commercially launched in nine markets, the data of which are Greece, Sweden, The Netherlands, and Switzerland. We expect the European rollout to continue for 2010. And with the recent approvals in the United States and Japan, we are eager to start rollout outside of Europe.

In the countries where Victoza was first launched, market penetration continues to improve, and Victoza has now attained market leadership in Germany and in Denmark. In Germany, Victoza has captured more than 1.5% of the total diabetes market and successfully expanded the GLP-1 market to more than 3% of the total diabetes care market.

In the UK, Victoza’s also gaining margins now close to 1% of the total diabetes market. This should be seen in the context where we continue to expand primary care (inaudible) access for Victoza in the UK.

With this, I’d like to hand it over to Mads who will give you an update on the development within our clinical pipeline.

Mads Krogsgaard Thomsen

Thank you, Lars. Please turn to slide nine for the overview Europe R&D pipeline within diabetes and obesity.

Significant regulatory progress has been made for Victoza, the first once-daily human GLP-1 analog that was previously known under the INN name liraglutide. As announced on the 20th and 26th of January, respectively, Victoza has now received approvals both in Japan and the US. Following this, Victoza has now being approved in all of the triad markets within the timeframe of only 20 months, which is setting a new standard for regulatory approvals in the major territories.

In the US, Victoza’s indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. The detailed update on the FDA approval was recently provided at our conference call on January the 26th. We’re very excited to be able to launch Victoza in the US in the weeks to come. And we’ll also continue to work diligently with the FDA to ensure that the post-marketing requirements, including the cardiovascular clinical trial and other studies are addressed by Novo Nordisk.

As regards the benefits and risks of being put to (inaudible), I’d like to point your attention to our review article in the February issue of Diabetes Care, in which a number of reporters, including Dan Droca [ph] and several past and present ADA presidents summarized today’s knowledge. One of the conclusions in the review article had said that sustained GLP-1 receptor activation induced by long-acting GLP-1 receptor agonists leads to growth and seasonal changes that are not replicated in monkeys, and that in man, further studies of long-acting GLP-1 receptor agonists are warranted to rule out human relevance.

Moving now to Japan, Victoza is the first GLP-1 analog to be approved by the Ministry of Health, Labor, and Welfare, and the awarded indication covers monotherapy and combination therapy for a sulfonylurea in type 2 diabetes.

Novo Nordisk expects to launch Victoza in Japan in the first half of 2010 upon completion of price negotiations. Results from clinical trial extensions of the three, comparing Victoza to a sulfonylurea in monotherapy and a phase 3B trial comparing Victoza to a DPP4 inhibitor, comparing both the superiority and the sustainability of the HB1 (inaudible) reduction and weight loss that was seen in the main study periods with Victoza.

The trial extensions have now led to treatment periods of 3 years and 52 weeks in the two trials, respectively. The phase 3A programs begin at BOOST for the two new generation ultra long-acting insulins, degludec and DegludecPlus, respectively, continue to progress according to plan. More than 4,200 patients had by now been recruited in phase 3A.

The ongoing BEGIN program now also includes trial comparing degludec with sitagliptin in insulin-naïve type 2 diabetes patients. Likewise, the BOOST program now includes two trials comparing once-daily injection of DegludecPlus with once-daily injection of Insulin Glargine in patients with type 2 diabetes, or insulin-naïve, or already treated with insulin, respectively. DegludecPlus is expected to be initiated during the first half of this year.

With focus on harnessing the beneficial actions of the two natural glucose-regulating hormones GLP-1 and insulin in one product, Novo Nordisk has briefly initiated a phase 1 study of the combination product of insulin degludec and Victoza. From a therapeutic standpoint, such a product may be seen to improve even further on the efficacy that can be reached for GLP-1 based treatment, or alternatively, as allowing insulin therapy with less risks of weight gain and hypoglycemia.

To further improve the future treatment outcomes and convenience in the pathological management of diabetes, the development of tailor-made proteins for all administration has been a long-standing Novo Nordisk aspiration. The biggest challenge in developing proteins for all delivery is to achieve sufficient uptake of the drug into the body. Over the last few years, we’ve developed strong expertise within the discovery of stable insulin and GLP-1 analogs that are optimized for the oral administration route. And we have recently forged partnerships with the protein formulation technology providers, industry and technologies, and (inaudible) pharmaceuticals.

Based from these activities, Novo Nordisk now feels ready to overcome the hurdles related to protein degradation in the gastrointestinal tract and subsequent lack of absorption into the circulation. The first phase 1 clinical trial within the Novo Nordisk insulin analog designed for oral administration has been initiated with the aim of investigating the safety or ability and the pharmacokinetics and dynamics in healthy volunteers as well as in people with type 1 and 2 diabetes. The trial has planned to enroll about eight subjects.

Within oral GLP-1, Novo Nordisk has initiated a phase 1 clinical trial with a long-action human GLP-1 analog. The objective of the trial is to investigate the safety, tolerability, and viability in about 155 healthy volunteers.

Novo Nordisk has also initiated a phase 1 trial with a compound NN9161 to be the developed for the treatment of obesity. This trial will investigate safety, tolerability, pharmacokinetics, and potential signs of efficacy in approximately 140 obese or otherwise healthy volunteers.

Please turn to the next slide for an overview of the Haemophilia pipeline. In June 2009, the European label for NovoSeven RT was updated to reflect that safety and efficacy has not been established outside the approved indications for the drug. From the 15th of January this year, the US FDA approved some updates to the NovoSeven RT label. A boxed warning was added stating that serious arterial and venous thrombotic and thromboembolic events associated with its use outside of licensed indications. The label change was initiated by Novo Nordisk as part of routine periodic safety updates.

As regards to the portfolio, the phase 1, 2, and 3 pipelines with Hemophilia are progressing according to plan.

Please turn to the next slide for wrap-up on the pipeline of other biopharmaceuticals. Both the US and European regulatory agencies have now approved Vagifem 10 micrograms for local treatment of vaginal atrophy. The product represents a reduced strength of the already approved vaginal estrogen product Vagifem 25 micrograms. The introduction of a low dose of Vagifem is in line with the recommendations from the International Menopause Society, the North American Menopause Society, and the American College of Obstetricians and Gynecologists. And Novo Nordisk expects to launch Vagifem 10 micrograms in the first quarter of this year in the US, and in the third quarter in Europe.

To strengthen its activities within inflammation, Novo Nordisk has been licensed a fully-human Anti-IL21 monoclonal antibody developed by ZymoGenetics as well as a broad intellectual property rights platform covering the field of Anti-IL21 monoclonal antibodies. Development of these pre-IND candidates for the treatment of both immune and inflammatory diseases is expected to lead to initiation of phase A, phase 1 trial late this year.

With that, over to Jesper for an update on the financials.

Jesper Brandgaard

Thank you, Mads. Please turn to the next slide. We’re satisfied with the financial results for 2009. Total sales growth was 12% as reported and 11% in local currencies. Growth was realized within both diabetes care and biopharmaceuticals and the primary goal contribution originated from the modern insulins.

Our gross margin for 2009 increased to 79.6%, compared with 77.8% in 2008. This improvement primarily reflects improved production efficiency, higher average selling prices in the US, and 0.4% point positive contribution from currencies.

In 2009, total non-production related operating costs increased by 12%, around 1.5% point of the increase in non-production related operating costs reflected the higher value of key currencies that there is to Danish kroner in 2009, compared to '08. The underlying development in non-production related operating costs relates to the expanded sales forcer especially in the US, the UK, Germany, Japan, and China, supplemented by a stable level for research and development costs.

The unchanged absolute level for research and development costs primarily reflects in non-recurring costs in 2008 related to the discontinuation of all pulmonary diabetes projects and also discontinuation of the growth hormone therapy project in patients with low serum albumin in dialysis. This was matched by costs related to the late stage development of the new insulins degludec and DegludecPlus, which we formerly knew as SIBA and SIAC in the second half of 2009.

Operating profit in 2009 increased by 21% to almost Danish kroner 15 billion, compared to 2008, and is slightly higher than the latest guidance for growth in reported operating profit of around 18%.

In financials, (inaudible) net expense of Danish kroner 945 million, compared to a net income of Danish kroner 322 million in 2008. For 2009, the foreign exchange result was an expense of Danish kroner 751 million, compared to the income of Danish kroner 141 million in 2008. This development reflects losses on foreign exchange hitting of especially US dollar and Japanese yen, primarily due to the appreciation of these currencies versus Danish kroner in 2009, compared to the exchange rate prevailing in 2008.

The realized effective tax rate for 2009 was 23%, leading to an increase in net profit of 12% to Danish kroner 10.8 billion. Reflecting the impact from the completion of our full year Danish kroner 19 billion share repurchase program in 2009, earnings per share increased by 15% to Danish kroner 17.82 per share.

The number of full-time employees increased by 7% to nearly 29,000. This development reflects international expansion of sales forces in key markets such as US, UK, Germany, and China as well as manning for international expansion of the manufacturing sites.

Please turn to the next slide. The significant free cash flow for 2009 of Danish kroner 12.3 billion has enabled us to complete the share repurchase program while at the same time proposed an increase in the dividend for 2009, compared to 2008. The suggested dividend for 2009 is Danish kroner 7.50 per share, equaling a payout ratio of just above40%, which we believe is comparable to the payout ratio of our payouts in the healthcare industry.

For 2010, we will initiate a share repurchase program of Danish kroner 7.5 billion, which, in line with previous years, will be executed through a Safe Harbor program with an international financial institution.

Please turn to the next slide for an update on the currency development. The development of the US dollar and the Japanese yen versus the Danish kroner is shown on this slide. While the US dollar continued to depreciate during the fourth quarter, it has recently appreciated again versus Danish kroner. In contrast, the Japanese yen has been fairly stable. The expected annual impact of -- on operating profit of the 5% movement in the currencies as stated on the slide has been updated to reflect the expected impact in 2010.

At 2010, the annual impact of a 5% movement in the US dollar is around Danish kroner 580 million, and for the Chinese yuan the annual impact is around Danish kroner 100 million on operating profit. Therefore, from a Danish kroner or even at a euro perspective, the de facto combined effect of a 5% movement in the US dollar amounts to a currency impact of Danish kroner 680 million on operating profits.

Please turn to the next slide for the financial outlook for 2010. Novo Nordisk expects sales growth in 2010 of 6% to 10% measured in local currencies. It is based on expectations of continued market penetration for Novo Nordisk's key strategic products within diabetes care, including continued global rollout of Victoza and biopharmaceuticals as well as expectations of continued intense competition, potential generic competition for Novo Nordisk in EU and US as well as adoption of a healthcare reform in the US. Given the current level of exchange rate versus Danish kroner, the reported sales growth is now expected to be at a similar level to the growth rate measured in local currencies.

At 2010, the gross and operating profit is expected to be around 10% measured in local currencies. The forecast reflect continued improvement of the gross margin, increased spending level for R&D activities primarily related to insulin degludec and DegludecPlus and higher license fee and other operating income. Given the current level of exchange rate versus Danish kroner, the reported operating profits are now expected to be at a level similar to the growth rate measured in local currencies.

But let me highlight that given the development in key currencies during 2009, a higher share of the 2010 growth of reported sales and operating profits is expected to be realized in the second half of 2010. Our 2010 donors expect a net financial expense of around Danish kroner 100 million. The current expectation primarily reflects Novo Nordisk's share of losses in associated companies.

The effective tax rate for 2010 is expected to be maintained at around 23%. Capital expenditure is expected to be around Danish kroner3.5 billion, primarily related to the new insulin formulation and filling plant in China and additional diabetes device capacity in Denmark.

Expectations for depreciation, amortization, and impairment losses are around Danish kroner 2.7 billion and free cash flow is expected to be around Danish kroner 12 billion.

All of the above expectations are based on the assumption that the global economic environment will not significantly alter the business conditions for Novo Nordisk during 2010, and that currency exchange rate, especially the US dollar, remains at the current level versus the Danish kroner during the remaining part of 2010.

This concludes our presentation of the financial results. Lars Rebien Sørensen will now moderate the Q & A session. Please note that there will be a maximum limit of two questions per individual with the objective of allowing as many conference participants as possible to have the opportunity to ask questions.

Lars Rebien Sørensen

Thank you very much, Jesper and Mads. Please note, ladies and gentlemen, that this conference is being taped and the replay will be made available as mentioned on our Web site.

And operator, we are now ready to take the first question please.

Question-and-Answer Session

Operator

Certainly. Thank you, sir. (Operator Instructions) We now move to our first question, which comes from Richard Vosser from J.P. Morgan. Please go ahead.

Richard Vosser – J.P. Morgan

Hi. Thanks for taking my question. I’m Richard Vosser from J.P. Morgan. A couple of questions on the liraglutide please, I wonder if you could disclose your sales of liraglutide in Europe for 2009, and whether you could explain how your guidance changed following Victoza approval in Japan and overseas -- in the US? And whether you could comment on the -- you expect the effects from both the sales guidance and operating profit guidance, whether you’ve built any extra cost assumptions in that aspect? And then just one on the pipeline, which is, I wonder if you could explain what sort of peptides NN9161 (inaudible) product is. Should we exclude that is a GLP-1 based approach? And I wonder if you could go into a bit more detail of the rationale of your development process there? Thanks very much.

Lars Rebien Sørensen

Okay. This is Lars Rebien here. I’ll try to give you just a little light on this (inaudible) on Victoza. We prefer not to disclose specifically sales of Victoza in the first quarters. And you should not expect that we will so either in 2010 because the numbers are so heavily impacted on the launches in individual countries and pipeline ceiling. And so for the rather modest, as you can expect, given the size of the markets, where we have a launch for it so far. But more importantly, I think it’s the penetration and the quick uptake that we have seen in the markets where we have launched.

In regards to the guidance on 2010, you noticed that we have narrowed the range in from 5% to 10%, to 6% to 10%. And that is a reflection of some more visibility on our ability to launch Victoza in the US, giving us visibility of the full years on the market, in the US. And that has what has impacted the top line guidance.

Jesper, do you want to comment on the operating profit guidance, what has happened between Q3 and what we are guiding now? And then, Mads, we’re going to put you on this (inaudible) whatever later.

Jesper Brandgaard

Yes. First, as Lars alluded to, we're basically taking the button of the sales range out now. This 5% is no longer relevant. So within the 6% to 10% range, we are certainly assuming that within this range that we have a US healthcare reform that could have a significant impact on the numbers also.

In terms of costs for Victoza, we have included a cost in our guidance of having an operating profit of around 10%. And if you want to get form the original at least 5% operating profit growth that we stipulated in local currencies in connection with Q3 that was the minimum level of operating profit we would have if we were at the bottom range of the internal guidance.

The guidance we’re giving now is assuming what operating profit growth we will have at the mid-interval of our sales guidance. You should also note that we have now expected a slightly higher level of other operating income. Now we are predicting that other operating income will be in the full part of Danish kroner 500 million, partly reflecting slightly higher royalty income in 2010 and the years beyond.

Richard Vosser – J.P. Morgan

Thank you very much.

Lars Rebien Sørensen

And so Mads, on toNN9161, can you -- will you -- should you disclose the nature of this molecule?

Mads Krogsgaard Thomsen

Well, I can say what it is not. It is not a GLP-1 analog. It is a stabilized human variant using a kind of new launch technology as opposed to post-stabilization of peptides and proteins. An analog of an anorexigenic peptide hormone that plays a major role or is believed to play a major in the natural homeostasis of human feeding behavior.

Lars Rebien Sørensen

Thank you very much. If you got any wiser from that, thank you. Next question please.

Operator

Thank you. Our next question comes now from Michael Novod from Handelsbanken. Please go ahead.

Michael Novod – Handelsbanken

Yes. Hello. It’s Michael Novod from Handelsbanken. Could you try to give us some flavor on initial feedback you have from keeping leaders, senior doctors in the US because there so much different opinions traveling around starting the Victoza label in the US? So could you give us some flavor on what you hear? And then secondly, could you try to elaborate a bit more on the subpoena from the Department of Defense in the US, try to give us some of the feeling of what are we dealing with here?

Jesper Brandgaard

Thank you very much, Michael. And Mads Krogsgaard, what is your initial feedback from KOLs in the US given that that we now know the label of Victoza in the US and compare that to the situation perhaps in Europe and in Japan? And then, Jesper, if you’d care to comment as much as you can on the subpoena on NovoSeven from the Department of Defense after Mads?

Mads Krogsgaard Thomsen

Yes. Well, I think maybe the most unbiased way to do it is really to reflect a little bit upon the couple of both review articles and editorials that had just emerged this week in the Diabetes Care journal. They have been (inaudible) by both a number of past presidents of the ADA and the current one, past president Rogga [ph] from Toronto. And they pretty much reflect the perception that I have and we have from a number of key wills that we're attaching on a very regular basis in the US.

And that is that the class of GLP-1 agonists, as you can read in this issue, essentially in their view has a clearly beneficial ratio between the benefits and the richness of the compounds. They actually see that the long-acting GLP-1 agonists do have this propensity to stimulate rodent C cells whereas they do not do so in monkeys. And they feel that they’re still for -- due to the sustained activation of the GLP-1 receptor by the long-acting class of (inaudible) ones. They essentially feel that we need to even further solidify the human safety. And that is what we do in this part of the (inaudible) zone.

So if you want my personal view, I think due to the B program and the many, many chemical studies and investigators that we have had on board in our phase 3 AMV programs, we are in the situation where each individual KOL is pretty much able to make up his or her own mind as to the merits of these products. Of course, they will look into the label, and so on, but they have a pretty good feel for what Victoza does in terms of benefit-risk profile.

Michael Novod – Handelsbanken

And any comments on Europe and Japan and as with the continents?

Jesper Brandgaard

Well, in Europe and Japan, of course, we have the direct hands-on user experience. And quite frankly, we had a meeting with 600 diabetologists in Paris a couple of months ago. And it was really, really nice to see how they felt about the product and how they were using it and tried trading in the events of transient nausea. They had made their own ways of getting about this and so on. And the same goes for Japan, where we don't have it on the market yet, but we have very nice feedback. We have the first GLP-1 analog to -- or agonist to come to the Japanese market and there’s a lot of excitement out there.

Lars Rebien Sørensen

So basically, at the back works warning in the US market is obviously not a positive. It’s going to mean that it's a little bit more uphill to expand the old market for GLP-1’s in the US? Long term, what' going to be decisive for us is work up to the label of other sustained release versions of a -- (inaudible) from our competitors. And you can appreciate it from our stance, since scientifically we believe that they would be having the same block -- back warning as we have. Of course to market it, that’s going to be difficult.

Michael Novod – Handelsbanken

Yes, but subpoena -- NovoSeven, Department of Defense of the United States?

Jesper Brandgaard

Yes. We received in January a subpoena from the Department of Defense, which directed Novo Nordisk to provide its document related to NovoSeven. Although we do not know the specific reason or scope of this investigation, the thing we are aware of it is that the US Army doctors have at their discretion been using NovoSeven. And the US Army had been purchasing NovoSeven for trauma use within soldiers. But we do not know the specific scope for this investigation. And hence, we cannot predict the outcome of the investigation nor the timeline of financial consequences for this investigation. So that is as much clarity I can provide at this stage.

Jesper Brandgaard

Yes. Again, this is Lars Rebien here. The interesting thing is we’ve not been marketing the product to the Department of Defense, so that was a program, which was adopted based on that potential wave of the label, research had been on NovoSeven in United States.

So we need more clarity on that, and hopefully, we can update you next time when we have our earnings release. Next question please.

Operator

Thank you. Our next question now comes from Henrik Simonsen from SEB Enskilda. Please go ahead.

Henrik Simonsen – SEB Enskilda

Yes. Hello, gentlemen. Henrik Simonsen here. Two questions from my side, I think call mentioned about half a year ago, no idea (inaudible) he would be willing to comment on the Victoza launch, so to speak in Europe about the six months. And we had Victoza now on the German market for about six months. Would you be willing to comment on how you see the uptake and how much switching you’ll see in from Byetta and how the German doctors have to see this untoward risk?

And second to question, I guess to Jesper, if you would comment give a little bit guidance on the cost structures of 2010/ I noticed that the sales and distribution costs shot up to about 32% of sales in the fourth quarter against 28% in the third quarter, and admin costs were down year-on-year on the fourth quarter. So could you drive a little bit clarity on cost structure guidance for 2010 please?

Lars Rebien Sørensen

Yes. Thank you, Henrik. This is Lars Rebien here. And Mars, so can you quantitatively talk a little bit about the adoption in Germany? Obviously, we’re not disclosing the specific sales numbers but nonetheless, relativity speaking, into other products to the company that’s in the marketplace, and what are you seeing and where we are getting the patients form?

Mads Krogsgaard Thomsen

Yes. Well, first of all, we can say that the trend we also reported on the DAST conference call where the most of the patients we were taking in Germany essentially were not coming from Byetta switches, but approximately maybe one out of three did so. We have seen a consistence -- let’s say market penetration where the most of the patient are coming from oral antidiabetics. We are actually also seeing some patients switching from insulin, but the majority is still coming from oral antidiabetics. And we are growing the market, you can say, to some extent, it may be one-third or so to the -- at the expense of Byetta, but mostly by a market expansion.

And you can say at this point, it seems as if the target group that we are mostly hitting are the ones that are failing on one or two OADs, which is essentially also the main target for this one, the GLP-1. So we’re consisting of -- we are continuing the performance that we alluded to at the EST meeting.

Henrik Simonsen – SEB Enskilda

Thank you, Mars. Jesper, the cost guidance or the cost structure of our expectations for 2010?

Jesper Brandgaard

Hi, folks. The first thing of course will be a continuation of our expansion of gross margin. We continue to expect that we will improve our gross margin also going into 2010. Our guidance is both an improvement in the gross margin between 50 to 100 basis points in 2010 over 2009, no currency effect expected at present. In terms of the S&P ratio, we will expect a ratio around 30%. I do note that we have expanded our sales forces in all the major markets. And hence, do not expect any significant expansion our sales force in 2010 in the market where we launched or rollout Victoza.

In terms of R&D, clearly, a slightly disappointing numbers for us with the 15.4% on the ratio in 2009, and we expect to avail that in terms of investments in 2010. And I would anticipate the R&D ratio to be in the full part 15% to 17% of sales in 2010. So that should be made up by a round percentage point or so.

In terms of admin costs, we continue to improve the admin to sales ratio. And I would predict that the admin ratio will be in the range of 5% to 5.5% or so. And although operating income, as I alluded before, we have made some agreements regarding intellectual property that will provide some royalty income for us. And our guidance now for other operating income would be around Danish kroner 500 million for 2010. And we believe that that income level is a sustainable level for new launch also in the years to come. So that is hopefully, if you use the mid-range of our sales growth, should get you to a growth level of around 10%.

Lars Rebien Sørensen

Thank you , Jesper. Next question please.

Operator

Thank you. Our next question now comes from Sam Fazeli of Piper Jaffray. Please go ahead.

Sam Fazeli – Piper Jaffray

Oh hi, gentlemen. Thank you very much. My two questions, can you tell us if 9068 is degludec or Levimir in it? And also with regard to the impact of the formulation patent progress that you’ve had for the European Union, what do you think -- does this raise the bulk further for a generic launch after the competition of matter patent on the analogs expires?

Lars Rebien Sørensen

Thank you very much. Mars Krogsgaard, this is for you. The 9068, the components, and what can we read out of the extension of our formulation patent with regard to generic competition in the European market?

Mads Krogsgaard Thomsen

Right. Well, there are, you can say, some similarities between Victoza and degludec. They are both neutral, stable preparations with a duration of action of 24 and 30 hours-plus in humans. And they're both actually to the analogs of insulin and GLP-1. And those properties have rendered them (inaudible). So it is indeed a combination of degludec and Victoza, where as I was discussing, you can either achieve as a product where you get a safer insulin with less weight gain and hyper risk or they -- even more indication with GLP-1 with a boost insulin. That remains to be seen because we are only in phase 1 at this point.

As regards the aspart formulation pattern, you are aware that we have previously had a situation where there was a lawsuit with Sanofi-Aventis that actually revoked our original patent that related to some ways of stabilizing physically and chemically the insulin aspart in the formulation for a long shelf life and without risk of degradation and other problems. That was revoked giving us, you can see, an IP situation that was going to leave us without any protection beyond 2011 in Europe and 2014 in the US.

Now what has happened here in the last instance and that is the final round is that actually the patent has been put back in place again, and we have prevailed. Meaning that the ways through which -- by different means of -- you can see excipients in the formulation changes in various proper constituents and other elements of stabilization of the insulin aspart molecule. We have covered that now until 2017. That implies then that any attempt to make a biosimilar version of insulin aspart will have to do and work around in terms of the rather broad scope of activities that we have in our patent to make sure that you have the physically, chemically-stable product. So it has made it more uphill for biosimilar companies, so to speak.

Lars Rebien Sørensen

Thank you very much, Mads. Next question please.

Operator

Thank you. Our next question now comes from Jacob Thrane from Standard & Poors. Please go ahead.

Jacob Thrane – Standard & Poors

Hi. Good afternoon, gentlemen. Thank you for taking my questions, most of them have been answered already. Just a question on the switching you mentioned in the German markets, say roughly one-third of the uptake of new patients. There's a switch from Byetta. Do you get envy -- well obviously, but would you like to share with us what the reports back from the markets had been and why patients have been switching from Byetta into Victoza, and if that is obviously indicative of what we can expect in the US market? Thank you very much.

Lars Rebien Sørensen

Yes. Mads, can you say something qualitatively about the reason for switches on these one-third that's assumed to be switching from Byetta to Victoza?

Mads Krogsgaard Thomsen

Yes. Well originally, it was higher because of course many doctors were ready and waiting for this product. But we are seeing that number coming down. And that is also as we would hope because that's what you need to see in order to be able to expand the market. I think overall, what you will see as going forward that it is becoming more and more oral antidiabetic failures after -- either metformin failure or metformin plus one more OAD failure. So you should expect somewhat a pessimistic situation in the US where the only labeling difference is of course that here it can be used also in monotheraphy albeit not in first-line diet failure patients.

So essentially, our expectation is that we have, as Lars alluded to, to grow the market, expand the market, which is today you can see very small considering the excitement surrounding the GLP-1 class. And that predominantly means tapping into the market for all antidiabetic failures preferably already at the metformin failure stage.

Lars Rebien Sørensen

And of course, for people switching from current Byetta use to--

Mads Krogsgaard Thomsen

Well the response we have from at least 600 physicians that came on board there that was essentially that in many cases they didn't want to continue because of the nausea associated with Byetta or the inflexibility of the dosing. And that's their personal observation, as you can see. But there are different reasons. After all, you can see Victoza, at least according to the LEAD 6 study that we have conducted, does are for more -- too close control with a more simple dosing regimen. And that's also what we are witnessing now in the real life setting. If anything, people, once they get to know which patients to use this product in actually feel that they're getting very satisfactory treatment outcomes.

Lars Rebien Sørensen

Thank you very much, Mads. Let continue on with the next question please.

Operator

Thank you. Our next question now comes from Dani Saurymper from Goldman Sachs. Please go ahead.

Dani Saurymper – Goldman Sachs

Hi. Good afternoon. I have two questions if I may. One relates to NovoSeven, it seems as though there's a little bit of softness in the fourth quarter. Can you perhaps maybe just comment as to what you're expected the drug trends might be for that product going forward? And by contrast, human growth hormone was stronger than expected in the fourth quarter. Is there any stocking or anything we should be aware of within that?

And then just lastly, I wanted to ask with regard to following off on the formulation patent comment in Europe, just to confirm the 2014 patent for the US still holds or is that extended to 2017 (inaudible)?

Lars Rebien Sørensen

This is Lars Rebien here. First question's on growth rates at Q4, respectively on NovoSeven and the human growth hormone and what are the expectations for 2010. And then, the second question was the 2014 US patent on NovoLog and if the compound patent for NovoLog still stands at 2014 in the United States if -- what has been prolonged (inaudible) and that means -- and so it's the same situation as in Europe.

A biogeneric version of the molecule could be made, but the formulation of its current form the way it's being used in Europe and United States cannot be done directly. So as Mads was alluding to, any biosimilar entry will have to reformulate outside of the physical, chemical parameters which we have stipulated in our formulation patent, and of course, stipulated in the pattern because it's difficult to stabilize the NovoLog product. And therefore, it gives meaningful protection. In fact, we believe, a big hurdle for biosimilar entries and postponing the likelihood until 2017.

Jesper, would you comment on the Q4 and perhaps -- more importantly the growth rate expectation for 2010 for NovoSeven and human growth hormone.

Jesper Brandgaard

Yes, especially for NovoSeven, one has to be a little bit careful watching the currencies in Q4 as be -- in comparison in Q4 of 2008 was quite significant. So if you basically back wrap the currencies take out of almost 10% at this point, you have a local currency growth of NovoSeven in the fourth quarter to the tune of 6%. And then you also have to bear in mind that we -- as we also noted when we did the 2008 report, we had a bit of a pipeline fill in Q4 2008 in the US because there was some speculation in the wholesaler level of distributors on pricing because they competed such price rise.

And hence, if you adjust that out, I think you are quite close to a normal growth level. But 6% growth in local currency trends for NovoSeven in the final quarter, I think that's pretty representative of what the product is able to do. The guidance we are giving for 2010 for NovoSeven will be about in the single digit level. Whether it would be mid or high single digit, I think we'll have to get a little bit further into the year before we'll know more about it.

In terms of growth hormone, the local currency growth we have for Norditropin in the year -- in the final quarter of 2009 was a growth of around 15%, so we're very happy with that. The growth guidance for 2010 for Norditropin will be in the 5% to 10% range. We continue to gain a little bit of market share and we are closing in on Pfizer as the global market leader within growth hormone. So we expect to continue to expand our franchise with Norditropin.

Lars Rebien Sørensen

Thank you very much, Jesper. And thank you for the question. And we could take the next question please.

Operator

Thank you. Our next question comes from Martin Parkhøi from Danske Bank. Please go ahead.

Martin Parkhøi – Danske Bank

Hello. I also have two questions. Firstly, going back to patent expiries, I was wondering -- I know of course that there are NovoRapid is expiring in Europe, the (inaudible) patent in -- next year. I know that it's not very likely that any biosimilar competition will arrive at that time. But do you actually see the risk that some healthcare authorities would force you to take down your price? And I'm thinking a market for example France.

And then secondly, I remember when you gave your new long term guidance in connection with the fully resolved last year. You were asked if you -- what kind of price increases you have included in your long term guidance in duress. And at that time I think you said it was not as dramatic as you have seen in the past. Nevertheless, I noticed that insulin allows for increased in price in general by 5% to 10%. And human insulin was increased by 20%, of course on a list price sake. Could you please elaborate a little bit on that?

Lars Rebien Sørensen

Yes. Thank you, Martin. First of all, Mads, would you comment on your expectations how the authorities would view a compound patent expiry on NovoRapid in Europe, whereas (inaudible) the formulation pattern, meaning that they will be imminent entry into this from a biosimilar perspective.

So as to -- I think Martin, you should not take too much indication from the -- despite the increase in the United States of human insulin. It's just basically signaling that we are moving on in the human insulin segment altogether. And as you well know, a lot of this human insulin is actually being sold to government contracts and the hospitals under Medicare or under the Medicare programs and they're -- hence, the actual prices are quite different from the list price. But this is an indication that we are moving out of the market and this is prudent for us.

I think that the price increase is -- as you've indicated on the modern insulin's somewhere between 5% to 10% has been historical levels. In some years, it's actually been higher. It's been 10% dollar anticipation that going forward it would be rather conservative market where we are not very likely to continue being able to raise prices as indicated.

But Mads, do you have any comment on -- your view on the NovoRapid situation in Europe?

Mads Krogsgaard Thomsen

Yes, I do actually. I'd just like to emphasize a few points. One is that unlike the human growth hormone situation where six or seven contenders are all offering exactly the same protein with 191 amino acids in the same place, here we're talking different insulin analogs with different properties, i.e. they are in their own right new molecular entities. With that borne in mind, we first of all have no legislation in place in Europe, or US for that matter, that actually allows for biosimilar analogs of insulin to be brought to market at this point even though it's being discussed.

And second of all, we have no examples where protein-based molecules of different backbone structures undergo class substitution in any society. You can have generic substitution of the same molecule, but not of a different molecule. So the short version is, should a lispro arrive, for instance in the European market a couple of years from now, that is not expected to significantly impact the NovoRapid situation.

Martin Parkhøi – Danske Bank

That wasn't actually my question. My question was that I understand that there would not be any generic versions arriving. But the question was if the health authorities could say that, "Now you have earned your money on this compound," and then actually force you to take down the prices on the compound. Nevertheless there will not be any generics out there.

Lars Rebien Sørensen

This is Lars here, Martin. We're reading all (inaudible) lowering the prices by different governments. It's pure speculation. You have seen the discussion with the Quick [ph] in Germany. And we just saw the cluster here scientifically-based arguments for why certain comparisons should be used in considering price. It's all speculation. We, of course, will state our case. And then it'll have to be a discussion and negotiation with the given authorities.

I think that was it, next question please.

Operator

Thank you. Our next question comes from Carsten Madsen from Carnegie Bank. Please go ahead.

Carsten Madsen – Carnegie Bank

Thank you very much. I just have two questions to growth rates in the quarter actually. First of all, lets look at North America in the diabetes franchise growth rate. It seems to drop significantly from Q3. Could you elaborate a bit on what has happened here? And at the same time also touch up on what is happening in international operations where growth rate is the other way -- drawing in the other way significantly up. Could you shed some more color on this?

Lars Rebien Sørensen

Yes. We certainly will try. This is growth rate in Q4 in the United States. I think we -- actually we saw growth rates in North America of around 12% in local exchange rate in the Q4. On the line growth, it's actually more like 20%. The Q4 sales in local currencies was impacted by the fact we had taken some provisions in anticipation of a healthcare reform and that may or may not come to operation until -- of course to the extent which that is being (inaudible). It'll have some impact both on those provisions, but also have impact for our guidance on the top line in 2010. And we also have some other provisions for returned goods, for discontinuation of products, which is impacting the US business as such. So there's no -- in our view, no underlying signs that the business had deteriorated in the fourth quarter in the US.

Jesper Brandgaard

But do note that the currency effect in comparing Q4 with Q4 for the North American market is in exceeding 10%. So a lot of the challenges here are very, very significant currency effect in that specific quarter. And that's also a part of the reason why we're seeing -- when we look at the guidance we gave for 2010, do bear in mind that the growth rates in the second half of 2010 is going to be higher than what they are in the first half because of the comparisons during 2009, of course assuming stable rates throughout 2010.

Lars Rebien Sørensen

And do you have any comments, Jesper, to the IO sales in Q4, which were in the opposite direction, came in quite strong.

Jesper Brandgaard

Yes. The overall sales in IO was developing quite nicely. And the key driver here was a very strong quarter in the Q4 in local currency trends in China, but also a solid development in Turkey. So that was some of the main markets delivering positive development for IO.

Lars Rebien Sørensen

But this is all across -- highlight the issue of looking at quarter-to-quarter variations. It's rather complicated. We don't want to see any major shifts in our business either way. The United States is not going down and we see that IO is going through the roof. So you should expect more like the annualized numbers than what you have seen reported in the fourth quarter.

Thank you very much. Next question please.

Operator

Thank you. That comes from Sebastien Berthon from Exane. Please go ahead.

Sebastien Berthon – Exane

Yes. Hello, gentlemen. A few backline questions please. First, can you update us on your plans with semaglutides for phase 3 as well as Victoza -- obesity in the US following the approval of Victoza? And secondly, when will we have some first entry results for degludec? Can we have that towards the end of this year?

Lars Rebien Sørensen

Yes. Thank you very much Sebastien. Last quarter, semaglutide was of that program, we chose obesity in the United States. Now we have a green light. Will you be moving forward and when? We will see some recourse on degludec and DegludecPlus during this year.

Jesper Brandgaard

Yes. Well the last one first, degludec and DegludecPlus, you can imagine having recruited a 1,200 patients over the last months. This implies that some of the six-month studies are indeed going to start reporting as of you can see mid this year, maybe into Q3. And that would mean that from then and onwards, there's going to be almost an avalanche of reporting of these, you can say, 16 to 18 trials that have been kicked off in those programs. So that's something we'll get back to later this year.

In terms of the GLP-1 situation, it is true that the Victoza approval for diabetes treatment in the US now enables us, we feel, to, with a deep and broad portfolio, really progress significantly, whether it's the combination treatment with the degludec, whether it's now going to the FDA discussing the path for -- what's for obesity. Where as you know, we have only initiated the small of the three phase 3 trials. And the two big ones have not been initiated. Obviously, we'll now be discussing with the agency how they see the situation going forward. And that is something we plan on replying for meetings regarding -- in the very near future.

Semaglutide there, as you know, we've completed phase 2 trials with strong efficacy results. And there, we want to wrap up all the monthly little experiments and you can say elements of this whole program and have discussions with the agency before -- in the second half of this year, are able to come with a stop-go decision for phase 3, which if everything works out fine both on the regulatory and on the non-clinical side would enable us to then proceed into phase 3.

Lars Rebien Sørensen

Thank you very much. Ladies and gentlemen, let's have the last question please.

Operator

Thank you. Our final question comes from Jack Scannell from Sanford Bernstein. Please go ahead.

Jack Scannell – Sanford Bernstein

Thanks very much. Two questions, the first, on the Victoza conference call after approval, you alluded to some studies looking at the range of long-acting GLP-1s suggesting that you saw a similar thyroid signal for a range of different molecules. Can you just clarify or remind us whether those were whole animal studies looking at (inaudible) or were there some kind of cellular or cell culture based receptive binding study?

Secondly, in this (inaudible), there was a post editorial to which you alluded, by Drucker, on the GLP-1 class. There was also a less positive editorial by Butler on pancreatitis. And I just wonder if you can give us your thoughts on that, both in relation to class in general, also possible differential risk with the long-acting GLP-1s such as LAR or (inaudible).

Lars Rebien Sørensen

Thank you very much. Mads, so the reference you made to us having started the long-acting GLPs, including our own, obviously, were they done in the whole animal studies or were they done in gel-based studies? And finally, what's your comment as to the Butler editorial on the pancreatitis, on the long-acting GLPs?

Mads Krogsgaard Thomsen

Okay. So the paper that would be coming out in the near future is a very comprehensive paper that looks at both human and non-human, i.e. reptile, GLP-1 analogs. Obviously, with the amount of compounds that are being studied, not everything is going into the in vivo situation, where you need to produce large amounts of compounds, use large amounts of animals, and so on. What we have done though is for each and every relevant late stage GLP-1 agonist of the long-acting and the short-acting ones, we've constructed full dose response curves on the relevant rodent assays looking at (inaudible) release and functional activation of B cell systems that we know in the pre-clinical situation are predictive of a leader response in the vivo situation.

And so in that end, we have been -- done pharmokinetic experiments to map out what are the equivalent bioexposures that you need for a reptile peptide known as exanitide and the human one known as the raglutide to match activity exposure that equivalents the doses that are needed to exert the antidiabetic effect. And then we've, in that situation, done studies where repeated dosing of the animals have led to a seasonal proliferation and hyperplasia, and they are, as will be shown in this paper, completely identical and super imposable whether you use the human -- the raglutide molecule or the reptile exanitide molecule.

Also, we have in this publication GLP-1 receptor knockout data and we have the human data from the liraglutide meter analysis. So this will be a very comprehensive paper with a lot of data and is coming, we believe, in the next month.

And then the Butler--

Lars Rebien Sørensen

Butler's concern about pancreatitis.

Mads Krogsgaard Thomsen

Yes. Well yes, we should remark one thing, and that is that when the FDA is talking in their (inaudible), whether it's for Byetta or whether it's for liraglutide, they do actually use the phraseology, "the risk of pancreatitis," where when you talk about the C cells, they talk about the potential risk. Hence, it is at this point the verdict of the FDA that they do discuss the risk of pancreatitis. Even though you can say the numbers are small and is not scientifically proven, then this is at this point something that the producers of GLP-1, such as Novo Nordisk, have to relate to.

That being said, the Peter Butler paper is using, I would say, one particular model of a transgenic mouse diabetes where pancreatitis has been seen initially with a DPP-4 inhibitor. And actually, it is contradicted by other models that are used in other laboratories where they see no difference whatsoever on the occurrence of pancreatitis. Also, Novo Nordisk has not seen this in its pre-clinical studies. So I think the jury is out and it's quite clear that pancreatitis is one area for further studies.

Lars Rebien Sørensen

So with that, thank you very much, Mads. It was a conclusion based on Victoza.

And ladies and gentlemen, this is the conclusion of our teleconference. A copy of the webcast will be made available on our home page. Our investor relations officers will be available to answer questions shortly after our -- there's a conference in Copenhagen, which takes place in about one hour. So we thank you for your attendance. And we will be back in connection with our first release. So see you then.

Operator

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

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Source: Novo Nordisk A/S Q4 2009 Earnings Call Transcript
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